Access to Urgent PCI for ST Segment Elevation Myocardial Infarction

Size: px
Start display at page:

Download "Access to Urgent PCI for ST Segment Elevation Myocardial Infarction"

Transcription

1 Access to Urgent PCI for ST Segment Elevation Myocardial Infarction Final Report and Recommendations Submitted to the Ontario Ministry of Health and Long-Term Care April 30, 2004 Cardiac Care Network of Ontario 4211 Yonge Street, Suite 210 Toronto, Ontario M2P 2A9 Telephone: (416) Fax: (416) Website: Public Release Date July 5, 2004

2 Mission We are an advisory body to the Ontario Ministry of Health and Long-Term Care that is dedicated to improving quality, efficiency, access and equity in the delivery of the continuum of adult cardiac services in Ontario. Using data- and consensus-driven methods, we offer planning advice for the future of cardiac services and the provision of exemplary care, in collaboration with the Ministry and others. Vision As a dynamic partnership between professional providers, institutions, community members, and government, providing advice based on data analysis and scientifically valid information, we will become an essential resource in improving the delivery of adult cardiac care in Ontario. Report Submitted to the Ontario Ministry of Health and Long-Term Care on April 30, 2004 Cardiac Care Network of Ontario, Yonge Street, Suite 210, Toronto, Ontario, M2P 2A9 Telephone: Fax: mail@ccn.on.ca Internet:

3 IMPORTANT NOTICE This consensus report has been commissioned by the Ontario Ministry of Health and Long-Term Care to provide policy and planning advice. The recommendations contained herein should not be construed as Ministry policy decisions nor as clinical practice guidelines. Access to Urgent PCI for STEMI Consensus Panel Report 3

4 TABLE OF CONTENTS 1.0 EXECUTIVE SUMMARY HISTORICAL BACKGROUND THE CURRENT STATE THE RECOMMENDED STATE FUTURE MONITORING AND EVALUATION RECOMMENDATIONS INTRODUCTION BACKGROUND TO THE CONSENSUS PANEL SCOPE OF THE PANEL ELIGIBLE POPULATION METHODOLOGY OVERVIEW DECISION-MAKING FRAMEWORK LITERATURE REVIEW STAKEHOLDER SUBMISSIONS UNPUBLISHED DATA CLINICAL DATA GEOGRAPHICAL INFORMATION SYSTEMS QUANTIFYING IMPACT ON ACCESS SECONDARY REVIEW REPORT APPROVAL PROCESS LIMITATIONS LITERATURE REVIEW OVERVIEW FIBRINOLYTIC THERAPY FOR ST ELEVATION MYOCARDIAL INFARCTION PRIMARY PCI FOR ACUTE ST ELEVATION MYOCARDIAL INFARCTION FACILITATED PERCUTANEOUS INTERVENTION FACILITATED PERCUTANEOUS INTERVENTION PCI FOR CARDIOGENIC SHOCK COMPLICATING ACUTE MI EXPERTISE IN PRIMARY PCI COST EFFECTIVENESS REVIEW OF OTHER CANADIAN JURISDICTIONS RECOMMENDATIONS THE CURRENT STATE LIMITATIONS ESTIMATED NEED ORGANIZATION OF CARDIAC CARE IN ONTARIO CURRENT PRACTICE PATTERNS FOR STEMI REFERRAL AND TRANSFER PROCESS (ACCESS TO CARE) EMERGENCY SERVICES BARRIERS TO ACCESS THE RECOMMENDED STATE Access to Urgent PCI for STEMI Consensus Panel Report 4

5 6.1 PHASE I INFRASTRUCTURE DEVELOPMENT PHASE II: MANAGEMENT FOR PATIENTS TRANSFERRED TO PCI CENTERS PATIENTS BEYOND A NINETY MINUTE DOOR TO BALLOON TIME CARDIOGENIC SHOCK RECOMMENDATIONS FUTURE DIRECTIONS FUTURE MONITORING AND DATA COLLECTION RECOMMENDATIONS REFERENCES GLOSSARY OF TERMS LIST OF FIGURES Figure 1 Location of Cardiac Centres in Ontario by Ministry Planning Region Figure 2 - Primary, Advanced and Critical Care Paramedics Figure 3 Ontario Paramedic Distribution, Figure 4 Acute Care Hospitals and Communities within a 90 Minute Door-to-Balloon Time of a PCI Hospital LIST OF TABLES Table 1 One-Year Re-admission Rates per 100 Acute MI in Ontario aged 20 to Table 2 -- Overview of PCI human and physical resources in Ontario, June Table 3 Number of Paramedics in the Province of Ontario, January Table 4 Total No. of Estimated STEMI / PCI Cases (Current) and Incremental PCI Cases Above Current for Phase I Model A Table 5 Estimated No. of STEMI / PCI Volumes (Current) and Incremental PCI Volumes Above Current for Model B Table 6 Estimated Number of STEMI / PCI Cases (Current) and Incremental Cases Above Current for Model C LIST OF APPENDICES Appendix 1 Consensus Panel Terms of Reference Appendix 2 Consensus Panel Membership Appendix 3 - Declaration of Industry Support and Conflicts of Interest Appendix 4 - Acknowledgements Appendix 5 Consensus Panel Working Group(s) Membership Appendix 6 - Organizations Providing Submissions of Interest to the Panel Appendix 7 - Acute Care Hospital Survey Appendix 8 List of Acute Care Hospitals Receiving and Responding to Survey* Appendix 9 EMS Base Hospital Director s Survey Appendix 10 EMS Operations Director s Survey Appendix 11 List of EMS Municipalities and Base Hospitals Receiving and Responding to Surveys Appendix 12 Catheterization Lab Medical Director Interview Questions Appendix 13 PCI Hospital Cardiac Administrator Survey Access to Urgent PCI for STEMI Consensus Panel Report 5

6 Appendix 14 List of PCI Hospitals Participating in Survey and Interview Process Appendix 15 Secondary Reviewers Appendix 16 Clinical Services Committee Membership Appendix 17 CCN Committee/ Board of Director Membership Appendix 18 Absolute and Relative Contraindications to Fibrinolytic Therapy Appendix 19 AMI and STEMI Hospital Abstract Data for 1999/00 to 2001/ Appendix 20 - PCI Hospital Cardiac Administrators Survey Summary Results Appendix 21 Survey Results Appendix 22 Base Hospital Survey Results Summary Appendix 23 - EMS Operations Survey Results Appendix 24 - Travel Distances of Acute Care Hospitals that fall Within a 30-minute Drive Time of a PCI Hospital Appendix 25 Travel Distances of Acute Care Hospitals that fall Within a 60-minute Drive Time of a PCI Hospital Access to Urgent PCI for STEMI Consensus Panel Report 6

7 1.0 EXECUTIVE SUMMARY 1.1 HISTORICAL BACKGROUND The treatment of acute myocardial infarction (AMI) 1 has undergone significant changes over the past several decades. Fibrinolytic therapy has served as the cornerstone for reperfusion therapy for patients with ST segment elevation MI (STEMI). However, significant improvements in percutaneous coronary interventions (PCI) have allowed this technique to be adopted safely for many patients with STEMI with very good rates of success. Many randomized clinical trials comparing primary PCI 2 to fibrinolytic therapy have found superior clinical outcomes with PCI including reduced short- and long-term rates of mortality, reinfarction and stroke. However, trials have also demonstrated the time-dependent nature of these outcomes, in that the best outcomes are achieved the sooner the patient receives the intervention. This presents a unique challenge in Ontario where advanced cardiac services are regionalized, and where there are large geographical distances between many acute care hospitals and PCI centres. The importance and relevance of these findings in the Ontario context has been recognized for several years by the many cardiac care stakeholders across the province including health care providers, planners and funders. In June 2001, the CCN Consensus Panel on Invasive Cardiology made several recommendations to the Ministry of Health and Long-Term Care (the Ministry) regarding planning for PCI services, including that the Ministry request that CCN develop, either through a dedicated Panel or an existing working group, a coordinated regional approach that facilitates the provision of emergency PCI services for patients with acute MI. In the fall of 2002, the Ministry commissioned CCN to conduct an expert consensus panel (the Panel) on Access to Urgent PCI for ST Segment Elevation Myocardial Infarction. The mandate of this Panel was to develop recommendations regarding the coordination and provision of urgent PCI for the province of Ontario, with the following key deliverables: Complete a literature review of existing guidelines for the interventional component of the treatment of AMI and a literature review relating to outcomes; Examine the provision and coordination of urgent and emergent PCI in other jurisdictions to determine the applicability and implications for implementation in Ontario; Define a model for the provision of urgent PCI in Ontario and provide recommendations regarding the implementation of a coordinated urgent PCI model; and Identify resource implications of a coordinated urgent PCI referral model. The foundation of this Panel s work was a comprehensive review of the scientific literature and published guidelines. The findings from the literature were supplemented 1 See Glossary of Terms for definitions 2 Acute PCI performed immediately for the treatment of a STEMI is called primary PCI. Access to Urgent PCI for STEMI Consensus Panel Report 7

8 by an extensive review of the current delivery of PCI services in Ontario and across Canada via data gathering from several sources including provincial surveys and structured telephone interviews, unpublished data from several jurisdictions within and outside of Canada, and solicited opinions from recognized experts in the field and stakeholder groups. 1.2 THE CURRENT STATE Currently, there is no commonly agreed upon standard of practice for the provision of primary PCI across the province. The majority of PCI centres report being able to offer primary PCI to only a small number of patients presenting with STEMI to their centres. 3 Although all centres report being able to provide primary PCI if needed 24 hours / 7 days per week, this is generally limited to high-risk, shock, and fibrinolytic ineligible patients due to limitations in resources, including available staff. The current referral and interfacility transportation process is quite onerous and time-consuming, and there are no standard or coordinated policies or procedures in the majority of municipalities. The provincial survey and stakeholder submissions identified several current barriers to the provision of primary PCI in the province of Ontario, many of which are associated with a lack of sufficient resources or funding. The barriers included, but were not restricted to: The lack of a provincial policy and an explicit commitment to the systematic delivery of primary PCI. A common policy was identified as a requirement in order for PCI centres, acute care hospitals, EMS and the Ministry to work together to achieve common goals and expectations. The need for a coordinated approach to service delivery, including centralized and coordinated communication and transfer processes/protocols between referring hospitals, PCI hospitals and EMS to facilitate patient referral and transportation. The current funding of EMS operations at the municipal level creates structural barriers and disincentives to implement a provincial policy and change in practice. Availability of ambulances and appropriately trained paramedics to support the additional transportation and care requirements of STEMI patients. Human resources, including catheterization laboratory staff and in some centres, interventionalists, to expand capacity and scheduling at PCI sites to support primary PCI on a 24/7 basis. For referring hospitals, qualified nurses to accompany patients during transfers or to receive patients back after PCI. Physical resources, including CCU beds to accommodate extra cases at several PCI sites and telemetry beds to receive patients back at some referring hospitals. Long travel distances and/or uncontrolled transport delays to the nearest PCI centre. 1.3 THE RECOMMENDED STATE The success of treating patients with STEMI is dependent on appropriate patient selection and timely treatment. Therefore, the Panel recommends that reperfusion therapy, whether 3 Based on survey data in the summer of 2003, one site reported 95% primary PCI. However, practice patterns for STEMI are rapidly evolving and other sites are moving towards implementing primary PCI models since this time. Access to Urgent PCI for STEMI Consensus Panel Report 8

9 PCI or fibrinolytics, be offered to all patients presenting within 12 hours of symptom onset with STEMI. However, based on the available evidence, it is recommended that primary PCI become the dominant strategy for the reperfusion of STEMI in Ontario. Fibrinolytic therapy will remain an important treatment for patients in whom primary PCI is not available in a timely manner and for patients presenting very early after symptom onset. The Panel acknowledges that many of the infrastructure and resource barriers identified to a primary PCI service delivery model cannot be rectified in the short-term, but rather, require time for planning and discourse among the many stakeholders involved in this process. Therefore, the Panel recommends a phased-in approach for implementing a primary PCI model for Ontario, which starts with development of the supportive infrastructure (Phase I) and comprises three essential elements Phase I Regional MI System: The back bone of this infrastructure is the development of a regional MI system, which is based on a hub and spoke concept. The hub of the model is the PCI centre, while the spokes include the surrounding acute care hospitals and associated communities. A regional steering committee composed of representatives from all stakeholder groups, including PCI and referring hospital physicians, nurses and administrators, municipal EMS, Base hospitals and the public, would implement and monitor the acute MI programs for their regions. It is anticipated that the MI system would benefit other aspects of cardiac care, and would enhance the standardization and quality of patient care across all regions of the province. Emergency Medical Services: The EMS is an essential component of the regional MI system, in order to ensure timely, reliable and appropriate transportation of the acute MI patient. However, it has been identified as presenting significant structural barriers. It is recommended that a working group consisting of representatives from Municipalities, the Ministry, Base hospitals, and dispatch centres be implemented immediately to identify the barriers, strategies to overcome these barriers, and required resources to implement and support the recommended primary PCI model. Treatment of STEMI at PCI Centres (Model A): Prior to implementing a model for primary PCI for referred-in or transferred patients, all PCI sites should be structured and resourced to enable them to provide 100% primary PCI to patients presenting at their hospital with STEMI on a 24 hour 7 day a week basis by the fiscal year 2005/06 (Model A). The target door to balloon time is 90 minutes. This strategy is strongly supported in the literature and provides the advantages of improved patient outcomes. Data from the literature suggests that for every 1000 patients treated with primary PCI rather than fibrinolytics, 23 deaths or 59 events including death, repeat MIs or strokes could be avoided. In addition to the clinical benefit, the strategy of primary PCI will result in a cost savings of over $3,000 ($Cdn) at six months per patient treated. It is rare in medicine to have a treatment that is both clinically effective as well as cost saving. Access to Urgent PCI for STEMI Consensus Panel Report 9

10 To support a 24/7 policy for primary PCI, changes at the PCI will be required in current patient management, infrastructure processes and the resource base of these sites. Patient care algorithms will require the timely assessment of STEMI, direct notification of the interventionalist on-call, direct patient transfer to the catheterization laboratory without delays imposed by arranging a CCU bed, and an early discharge policy. Although this model will not affect the numbers of patients presenting at the PCI site with STEMI, the total number of PCI procedures will increase and is estimated to be approximately 800 cases above current funded volumes. The increased number of PCI procedures will need to be funded incrementally and should not impact on the current funded and elective cases Phase II The majority of patients in Ontario with acute STEMI (approximately 80%) do not initially present to a PCI centre. Therefore, there has been tremendous interest in developing primary PCI programs for these patients in order to allow them access to this therapy. Recent trials suggest that patients that can be transferred expeditiously to a PCI centre for primary PCI experience superior outcomes compared to patients treated with fibrinolytics. Phase II involves the implementation and piloting of two integrated models for transferred-in patients, which are patient presentation based. The model of care is determined by the location in which the patient presents with the acute MI patients transferred to PCI centres from other acute care hospitals and patients transferred from the community. A comprehensive system to support transferred-in patients must support both these scenarios. It is important that the PCI hospitals have the 24 / 7 primary PCI model successfully in place (Model A), prior to implementing the programs for transferred-in patients. It is recommended that the Pilot evaluations begin in 2005/06 in several municipalities, similar to the stroke strategy. The pilot areas should reflect the varied geography and populations of Ontario in order to fully assess the model s generalizability. The Pilot would allow a more full assessment of the costs, resources, structures and processes required before full implementation, and would provide an opportunity to assess their cost-effectiveness compared to alternative treatments. In the face of the evolving scientific literature, including the efficacy of facilitated PCI, the pilot provides a cautious approach that can be adapted to changing evidence before full provincial implementation. Model B: Management of STEMI Patients Transferred from Acute Care Hospitals Model B targets patients presenting or transported to acute care hospitals with STEMI. Hospitals within a 90 minute door to balloon time of a PCI centre would be eligible to Access to Urgent PCI for STEMI Consensus Panel Report 10

11 participate in this model and have been identified in Appendix Each eligible hospital is linked to their recommended PCI centre based on distance and existing referral patterns for PCI services. The Panel recommends that regional partnership agreements be developed between the PCI centre, the referring acute care hospitals and EMS, in order to facilitate the implementation and ongoing management of this program and the associated standards of care. The partnership agreement would address such issues as mentorship, education and development of clinical care pathways, transfer and repatriation agreements, and responsibilities for patient care through the course of transfer, treatment and recovery. The EMS is an important partner in this model. A priority transfer code to identify this transfer as an emergent transfer versus a routine inter-facility transfer would need to be developed. Additional EMS vehicles and paramedics with the appropriate level of training would be required to support this model over the long-term. Although there have been no cost-effectiveness analysis conducted on primary PCI for transferred-in patients, it is anticipated that many of the savings demonstrated for patients presenting directly to PCI centres would be seen, including reduced hospital lengths of stay. It is important to note that the associated upfront costs in a primary PCI model will result in back-end savings through the avoidance of another scheduled admission for an elective PCI. As well, the superior outcomes demonstrated by primary PCI would have a tremendous impact on society and costs, in terms of reduced disability, readmissions and re-interventions. Model C: First Response - Management of Patients Transferred from the Community The most efficient way to provide an acute reperfusion model is First Response whereby patients are assessed by the municipal EMS team at the point of symptom onset and either administered fibrinolytics in the field or transferred directly for primary PCI to the nearest PCI centre, using a medical bypass protocol. This model would apply to those patients that live in communities in which the transport time to the PCI centre would result in no more than a 60 minute delay compared to arrival to the closest acute care hospital for fibrinolytic therapy. This would result in a 90 minute door-to-balloon time which includes the 30 minutes required for paramedic assessment. Medical redirect models have been successfully implemented with trauma patients, and are currently being implemented with stroke patients. First response would eliminate the time required to transport and assess patients at the local hospital, thereby reducing the 4 Currently, the 90 minute door-to-balloon time allows for 30 minutes for patient assessment at the referring hospital, 30 minutes for patient travel to the PCI site, and 30 minutes at the PCI site to transfer the patient from the ambulance to the first balloon inflation. It is anticipated that with additional improvements in the system the total front- and back-end organizational time of 60 minutes could be reduced, thereby allowing travel distances to increase and include hospitals within a longer travel time of the PCI center. Access to Urgent PCI for STEMI Consensus Panel Report 11

12 time from symptom onset to intervention and optimizing clinical outcomes for the patient. As part of this First Response pilot model, acute reperfusion with pre-hospital fibrinolytics will be evaluated for those patients in municipalities where timely (<90 minutes door to balloon time) access to primary PCI is not currently available. Fibrinolytics would be administered in the field by the paramedic team, in consultation with the base hospital physician, and then transported to the nearest acute care hospital. Subsequent transport to a PCI center would be determined on a case by case basis. The First Response model would require the significant and committed involvement of the municipal EMS programs and the province. Detailed descriptions of the resource requirements to support this model are provided in this report and would be further clarified and quantified by the Phase I EMS Working Group. Paramedics would be required to perform 12-lead EKG s in the field and transmit centrally for immediate interpretation and diagnosis of STEMI by a base hospital physician. Additional paramedic training will also be required for those regions utilizing pre-hospital fibrinolytic therapy. A priority EMS code system would again be required as well as a supportive communication system that links the ambulance, base hospital physician and the receiving PCI centre. Regional partnership agreements, as described previously, would be essential to support this model. Management for STEMI Patients Beyond a Ninety Minute Door to Balloon Time There is currently relatively little data regarding transfer of STEMI patients for primary PCI longer than 90 minutes. In the absence of clear scientific evidence, it is the recommendation of this Panel that these patients be treated immediately with optimal fibrinolytic therapy. These patients should be monitored closely and a decision made within 60 to 90 minutes as to whether or not fibrinolysis was successful. In the event fibrinolysis is unsuccessful, then arrangements for transfer to the regional PCI centre should be made for rescue PCI. These patients may derive benefit from pre-hospital fibrinolytic therapy which will be examined as a part of the pilot project described in Model C. 1.4 FUTURE MONITORING AND EVALUATION The Panel recommends a provincial monitoring system for STEMI in Ontario in order to assess the impact of the system changes and the model of care on patient access, quality of care and health outcomes. A new or existing working group, such as the CCN Cath/PCI Working Group, could assume this monitoring function with additional responsibilities to a) monitor the treatment of STEMI in Ontario and the implementation of the proposed model of care; b) monitor new changes in the treatment of STEMI as they develop, such as the use of pre-hospital fibrinolytics and the use of facilitated PCI, and to make recommendations for implementation as appropriate; c) monitor changes in clinical need and indications for treatment; and d) monitor access, safety and efficacy of the STEMI model in Ontario through the tracking and reporting of data. The Access to Urgent PCI for STEMI Consensus Panel Report 12

13 recommended door-to-balloon times in this report are maximums, and need to be monitored carefully to ensure best practice and outcomes across all sites. The Panel also recommends centralized coordination of the PCI models across the municipalities in order to create efficiencies and shared learnings. The composition of such a working group should include representatives from the regional MI systems, and include interventionalists, nurses, emergency room physicians, referring physicians, and municipal EMS and base hospital representatives. 1.5 RECOMMENDATIONS Recommendation 1- That primary PCI for STEMI patients, presenting within 12 hours of symptom onset, be the preferred therapy for: All eligible patients presenting to a hospital with on-site PCI facilities with an experienced interventional team, with a maximum door to balloon time of less than 90 minutes. All eligible patients who can be transferred from an acute care hospital to a primary PCI center with a maximum door to balloon time of less than 90 minutes. All patients who have contraindications to fibrinolytic therapy, regardless of distance, as long as the procedure is performed within 12 hours of symptom onset. Patients who present after 12 hours of symptom onset are to be managed on a case by case basis. Class I indication, Level A evidence Recommendation 2 That the Ministry of Health and Long-Term Care require all centres providing primary PCI services to maintain an infrastructure that enables it to perform to high standards of safety and efficacy, including: A minimum standard of 150 PCI procedures per operator per year. An annual review process to ensure that: o All operators achieve minimum procedure volumes; and o The centre performs a minimum of 500 diagnostic catheterization procedures and 400 interventional procedures per year of which greater than 50 must be primary PCI. Sufficient number of operators and catheterization laboratory staff performing PCI to ensure the availability of PCI services 24 hours a day, seven days a week. Class I indication, Level C evidence Access to Urgent PCI for STEMI Consensus Panel Report 13

14 Recommendation 3- That fibrinolytics be administered to STEMI patients who present to hospital within 12 hours of symptom onset and who cannot receive primary PCI within the recommended door to balloon times, or for whom PCI is contraindicated. Patients who present after 12 hours of symptom onset are to be managed on a case by case basis. Class I indication, Level A evidence Recommendation 4 - Patients presenting within 2 hours of symptom onset represent a special subset of STEMI patients who derive particular benefit from early reperfusion therapy. Careful case by case consideration of treating these patients with fibrinolytic therapy rather than primary PCI should occur, weighing the risk of fibrinolytic therapy with the potential delay in performing primary PCI. Class IIa indication, Level B evidence Recommendation 5 - Rescue angioplasty should be performed for patients with acute STEMI who receive fibrinolytic therapy but continue to present with on-going ischemic symptoms and ECG changes 90 minutes following the administration of the fibrinolytics. Class IIa indication, Level B evidence Recommendation 6 - Patients less than 75 years of age who present with cardiogenic shock within 18 hours of symptom onset, should be transferred immediately to an advanced cardiac center with on-site cardiac surgery for immediate angiography and revascularization. Patients over 75 years of age are to be managed on a case by case basis. The use of fibrinolytics has not been proven effective in this setting and its use should be individualized. Class I indication, Level B evidence Recommendation 7 Primary PCI should be performed in centres with on-site cardiac surgical capability or in established stand-alone PCI centres with demonstrated ability to transport patients to a cardiac surgical centre within 90 minutes of decision to transport. Class I indication, Level C evidence Recommendation 8 That a regional MI system, involving PCI hospitals, referring acute care hospitals and municipal emergency medical services, be developed to provide effective, efficient and quality patient management for STEMI patients from patient assessment through to post-mi care. Ministry of Health and Long-Term Care funding is required to support the administrative infrastructure of the regional MI system. Access to Urgent PCI for STEMI Consensus Panel Report 14

15 Recommendation 9 That the Ministry of Health and Long-Term Care support an emergency medical system (EMS) working group composed of representatives from municipalities, base hospitals and the Ministry to identify strategies, processes and resources necessary to overcome current EMS transportation barriers and to support the primary PCI model and recommendations described in this report. The planning of this working group should begin immediately. Recommendation 10 That the Ministry of Health and Long-Term Care provide sufficient funding for a transportation infrastructure that is capable of providing medically appropriate, reliable and efficient service to allow for optimal utilization of advanced services and regionalized systems. Recommendation 11 That all PCI hospitals begin to implement immediately the following processes and infrastructures to support the delivery of primary PCI provincially for patients with STEMI presenting at PCI hospitals on a 24/7 basis by 2005/06 (Model A): The development of emergency room care maps that ensure the timely assessment of STEMI and transfer of the patient direct to the catheterization laboratory; The development of direct communication links from the emergency room to the responsible interventionalist; The development of processes/algorithms to accept patients directly to the catheterization laboratory prior to obtaining a CCU bed (de-linking the CCU from the catheterization laboratory); Early discharge policy for uncomplicated infarcts undergoing PCI; and Referral to cardiac rehabilitation (which includes secondary prevention programs). Recommendation 12 That the Ministry of Health and Long-Term Care plan for funding to support the infrastructure and resource requirements at PCI hospitals for Model A implementation provincially by 2005/06, which would include: Incremental funding for additional primary PCI cases; Recruitment, hiring and training of additional catheterization laboratory and post-pci care staff; and Funding to support additional CCU beds where warranted to add the needed flexibility to de-link the CCU from the catheterization laboratory. Access to Urgent PCI for STEMI Consensus Panel Report 15

16 Recommendation 13 - That a pilot project involving several regional MI centers, which include the PCI hospital, referring acute care hospitals and emergency medical services, be established to support primary PCI for patients transferred from acute care hospitals to PCI sites (Model B) by 2005/06. These pilot projects will include the development of tripartite agreements between PCI sites, referring hospitals and emergency medical services (including municipal operations, base hospitals and dispatch centres) to ensure: The development and achievement of standards for transportation of STEMI patient from the referring hospital to PCI hospital; The development of timely and cost-effective transportation systems for patients being repatriated back to the referring hospital; The development and monitoring of emergency room patient care management algorithms for the rapid triage, diagnosis and management of STEMI patients; The development of post-pci care maps for repatriation, acute- and recovery-care management, early discharge and rehabilitation; and The development of efficient and rapid communication processes. Prior to implementation, the pilot PCI centre should have implemented, at a minimum, Model A of the primary PCI model. Recommendation 14 - That the Ministry of Health and Long-Term Care support a pilot project to evaluate a model of "First Response for primary PCI in Ontario, where patients are assessed at the point of presentation of the STEMI and are transferred directly to the closest PCI hospital for primary PCI. The pilot project should involve both urban and non-urban municipalities to appropriately assess the generalizability of the model. Prior to implementation, the pilot PCI centres should have successfully implemented, at a minimum, Phase A of the primary PCI Recommendation 15 - That the Ministry of Health and Long-Term Care plan for funding to support the infrastructure and resource requirements for the pilot projects by 2005/06, which would include: Incremental funding for additional primary PCI cases; Increased catheterization laboratory staff and post-pci care nursing; Funding for expanded emergency medical services (vehicles, staff, equipment, medications) and training for paramedics to a level appropriate to meet the assessment and transport needs of the STEMI patients; Increased CCU/STEMI beds at PCI centers; and Enhanced access and delivery of cardiac rehabilitation (which includes secondary prevention programs). Access to Urgent PCI for STEMI Consensus Panel Report 16

17 Recommendation 16 That the Ministry of Health and Long-Term Care develop a provincial monitoring system for STEMI in Ontario that would: Monitor the treatment of STEMI in Ontario and the implementation of the proposed models of care; Monitor new changes in the treatment of STEMI as they develop, such as the use of pre-hospital fibrinolytics and the use of facilitated PCI, and to make recommendations for implementations as appropriate. Monitor access, safety and efficacy of the STEMI model in Ontario through the tracking and reporting of data. To support this ongoing monitoring system, additional data elements need to be collected and reported, as described in this report. Recommendation 17 That the Ministry of Health and Long-Term Care fund a centralized working group and process to support the coordinated implementation of the primary PCI model across Ontario. Access to Urgent PCI for STEMI Consensus Panel Report 17

18 2.0 INTRODUCTION The treatment of acute myocardial infarction (AMI) has undergone profound changes over the past several decades. The understanding that myocardial damage occurs over a time-dependent course that could be limited by restoration of coronary blood flow to the blocked artery serves as the fundamental principle of acute reperfusion therapy. Fibrinolytic drugs have traditionally been used to restore blood flow to blocked coronary arteries, but these therapies are limited by their lack of efficacy in many patients and major hemorrhagic complications, including intracranial hemorrhage. Recently, published data has demonstrated that the use of percutaneous coronary intervention (PCI) results in better clinical outcomes compared to fibrinolytics in patients presenting to emergency rooms with ST segment elevation myocardial infarction (STEMI). However, in order to be effective, PCI has to be completed within a short and finite period of time from onset of symptoms. This presents a unique challenge in Ontario where advanced cardiac services are regionalized, and where there are large geographical distances between PCI centres and many acute care hospitals and communities. The Ontario Ministry of Health and Long-Term Care (the Ministry) has requested that the Cardiac Care Network of Ontario (CCN) convene a consensus panel of experts, to review the clinical evidence and to provide recommendations regarding a model of care for the provision of urgent PCI in STEMI for the province of Ontario. For the purposes of this report, the following definitions of PCI will be used 5 : Primary PCI performing acute PCI immediately for the treatment of a STEMI as the primary form of reperfusion. Rescue PCI performing PCI for STEMI after fibrinolytics have been given but have failed to reperfuse the infarct related artery. The decision to perform Rescue PCI is generally made minutes following the administration of fibrinolytics. Facilitated PCI the practice of combining early pharmacological reperfusion therapy prior to a planned PCI for STEMI (i.e., all patients receive PCI). Primary, Rescue and Facilitated PCI procedures are performed immediately during the evolution of an acute MI. Urgent PCI refers to all PCIs performed for patients with STEMI as it relates to primary, rescue, and facilitated PCI as well as patients in cardiogenic shock. 5 Refer to the Glossary for further definitions. Access to Urgent PCI for STEMI Consensus Panel Report 18

19 2.1 BACKGROUND TO THE CONSENSUS PANEL In June 2001, the CCN submitted a report to the Ministry on invasive cardiology in Ontario 6 which made the following recommendations regarding urgent PCI services: That the Ministry request that CCN develop, either through a dedicated Panel or an existing working group, a coordinated regional approach that facilitates the provision of emergency PCI services for patients with acute MI. The Panel also recommends that the Ministry support the necessary infrastructure to provide, where appropriate, emergency PCI services to patients with acute MI with the eventual goal of providing these services on a 24/7 basis. The Ministry should also support one or more pilot projects to evaluate the feasibility and economic impact of providing these services on 24/7 basis. That emergency angioplasty for acute MI (direct or rescue) not be performed in a centre that does not have an established elective angioplasty program. In the fall of 2002, the Ministry commissioned CCN to conduct an expert consensus panel (the Panel) on Access to Urgent PCI for STEMI. At the same time, the Ministry also commissioned CCN to conduct a Target Setting Consensus Panel for CABG, PCI and cardiac catheterization procedures, as well as to conduct an external evaluation of Ontario s first stand-alone PCI program. As some of the findings from these other CCN reports are relevant to the work of this Panel, they will be referenced where appropriate. 2.2 SCOPE OF THE PANEL The mandate of the Panel was to develop recommendations regarding the coordination and provision of urgent PCI for the province of Ontario as it applies to ST segment elevation MI. The specific deliverables were to include: 1. Complete a literature review of existing guidelines for the interventional component of the treatment of AMI and a literature review relating to outcomes. 2. Examine the provision and coordination of urgent and emergent PCI in other jurisdictions to determine the applicability and implications for implementation on Ontario. 3. Define a model for the provision of urgent/emergent PCI in Ontario and provide recommendations regarding the implementation of a coordinated urgent PCI model. 4. Identify resource implications of implementation of a coordinated urgent PCI referral model. 6 Expert Panel on Invasive Cardiology in Ontario. Final Report and Recommendations, CCN, June Access to Urgent PCI for STEMI Consensus Panel Report 19

20 The terms of reference for the Panel are provided in Appendix 1. The Panel s membership is listed in Appendix 2. All Panel members were asked to sign confidentiality agreements as well as a declaration of conflict of interest and declaration of industry support, the latter of which is documented in Appendix 3. Other individuals who have made significant contributions to this report are listed in Appendix ELIGIBLE POPULATION The focus of this report is the development of a provincial model for urgent PCI for the management of STEMI and recommendations for its coordinated implementation. Patients eligible for urgent PCI are patients presenting within 12 hours of symptom onset with at least 1 mm ST segment elevation on two contiguous leads on a 12 lead EKG or new left bundle branch block (LBBB). Access to Urgent PCI for STEMI Consensus Panel Report 20

21 3.0 METHODOLOGY 3.1 OVERVIEW Data was gathered from multiple sources and jurisdictions along the full continuum of care delivery for PCI services. The foundation of the Panel s work was a comprehensive review of the scientific literature relating to practice patterns for STEMI and procedural outcomes. The findings of the literature review were supplemented by an extensive review of the current delivery of PCI services in Ontario and data gathering across the province via surveys and structured telephone interviews, by unpublished data from several jurisdictions within and outside of Canada, by the solicited opinions of acknowledged experts in this area, by submissions from stakeholders, and information presentations by emergency services representatives and a bioethicist. The Panel adopted a three-level framework, common to many CCN consensus panels, to support its recommendations. The Panel developed its recommendations on the basis of scientific literature findings, review of available data and the members own expertise and experience. Accordingly, recommendations in this report use the ACC/AHA classifications of Class I, II or III. These classes summarize the indications/conditions for primary PCI for STEMI. Class 1- Class II Class III Conditions for which there is evidence for and/or general agreement that the procedure is useful and effective. Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of performing the procedure Class IIa: Weight of evidence/opinion is in favour of usefulness/efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/opinion. Conditions for which there is evidence and/or general agreement that the procedure is not useful/effective and in some cases may be harmful. The weight of evidence in support of the recommendations for each listed indication/condition is presented as follows: Level A Evidence: The presence of multiple randomized clinical trials. Level B Evidence: The presence of a single randomized trial or non-randomized studies. Level C Evidence: Expert Consensus 3.2 DECISION-MAKING FRAMEWORK The Panel was asked to conduct its deliberations and produce a final report within nine months. This time was extended to 12 months due to the extensive data gathering requirements and the delays imposed on the process related to the SARS outbreak in Toronto. Eleven Panel meetings were held between March 2003 and March 2004 (four Access to Urgent PCI for STEMI Consensus Panel Report 21

22 face-to-face meetings and 7 teleconferences). The first meeting was organizational and focused on understanding the scope of the project and the data gathering requirements and processes. Three working groups were developed with content experts to facilitate the process and distribute workload: 1) literature review working group; 2) a survey development working group; and 3) a PCI centre interview working group. See Appendix 5 for a listing of working group members Reaching Consensus In advance of its deliberations, the Panel members agreed on the following process for developing recommendations. It was clearly preferred and hoped that a consensus could be reached on all issues, leading to a series of consensus recommendations. The Panel agreed in advance that, should consensus not be possible, it was important that the Panel provide recommendations, even on difficult or controversial issues. Therefore, if consensus were not reached, the Panel s recommendation on a specific issue would be based on a majority opinion. On any matters of substantial disagreement, the text would fully represent the range of opinions. A quorum of 50% plus one, excluding ex-officio members, was required for incorporating recommendations either by consensus or by vote. If members could not be present for discussion or voting, an alternate opportunity was provided for them to provide comment on any decisions Context for Deliberations In developing recommendations, the Panel considered several dimensions relevant to the organization and provision of urgent PCI services: The perspective from which various stakeholders view the care system (e.g. as viewed by the patient, provider or funder; as it affects individual institutions, regions or the system as a whole) and the potentially differing values that underlie stakeholders beliefs and opinions. The desirable attributes of care (e.g. quality of outcomes, timeliness, close to home) and the need to establish priorities for these attributes when they cannot be simultaneously achieved. Balancing equity in the allocation of scarce resources versus the efficiency of restricting use of valuable resources to maximize the number and quality of lives saved Medical Ethical Perspective The Panel recognized that some of its key decisions would involve tradeoffs in the dimensions noted above. The improved clinical outcomes of primary PCI versus fibrinolytics for STEMI has to be balanced against the resources that would be required to support a comprehensive provincial infrastructure that would be accessible to all who may benefit, within the requisite transfer time for efficacy. Access to Urgent PCI for STEMI Consensus Panel Report 22

23 The Panel invited a representative from the University of Toronto Centre for Bioethics 7 to discuss ethical issues around the implementation of a model of access to urgent PCI in Ontario, and to help the Panel develop an ethical framework that could inform their decision making. The discussion highlighted the importance of an ethical framework that emphasizes process because it is very difficult to achieve agreement on what decisions to make (1). Additionally, as a pluralistic society, we will never reach agreement on what outcomes are correct or preferable in priority setting dilemmas (1,2). A fair process, according to Daniels and Sabin (3,4) involves important elements of transparency regarding reasons behind decisions, the use of reasons or rationales for decision making that are deemed relevant by all in meeting health care needs, and a process to revise decisions in light of new evidence or challenges. These key elements ensure accountability for reasonableness (2,4). Fair procedures must also be sustainable and acknowledge the contexts and varied goals of all involved in the kinds of institutions where priority setting decisions are made (4). The Panel adopted the following ethical framework for decision making, which encompasses the notions of accountability for reasonableness and outlines conditions for fair and legitimate decision making processes. The following conditions constitute key elements of a fair decision-making process. Publicly accessible decisions and rationales outcomes of decisions and rationales for these decisions are clearly stated and publicly accessible which improves the quality and rigour of the decision making process and deliberations over time. This will be achieved via the public release of the final Panel report which will document the methodology, rationale and recommendations resulting from the consensus panel process. Relevance of reasons decided upon by fair minded persons in the circumstances broad representation of fair-minded stakeholders, who can make decisions on what is relevant in circumstances of finite or scarce resources. Stakeholders should include the public. This was achieved through expert deliberations, broad stakeholder input and a comprehensive secondary review process which included a member of the public. All members of the Panel were required to sign a declaration of conflict of interest and declaration of industry support which is documented in Appendix 3. A mechanism for appeal an opportunity for stakeholders who were not part of the original process to have input into the recommendations which could result in the revisiting and revising of the recommendations. The appeals mechanism should also allow for revision of decisions in light of new evidence. The former was achieved through a comprehensive secondary review process involving 21 individuals representing various professional groups and geographic regions both within and outside of health care (see Section 3.8). All secondary review 7 Dr. Nancy Walton, University of Toronto, member Joint Centre for Bioethics Priority Setting Research Team Access to Urgent PCI for STEMI Consensus Panel Report 23

24 comments were discussed by the primary Panel and incorporated as appropriate into the final report. Although this Panel was a time limited process that integrated new evidence as it developed throughout the deliberations process, it could not anticipate all future developments. Therefore, the Panel could only address revisions to the recommended model based on new and evolving evidence via recommendations for a process for ongoing systems monitoring. 3.3 LITERATURE REVIEW The first step in gathering information on the issues of interest to the Panel was to conduct a literature review. At the first organizational meeting, the framework for the literature review was established. Topics were assigned to various experts on the consensus panel. Each expert reviewed the scientific literature up to and including publications in September Since the literature on this topic is extremely large, a systematic hierarchical review was not conducted; rather each member was asked to prepare a focused and comprehensive summary of the topic. The various sections were collated into a single document and reviewed by the entire committee for content and completeness. 3.4 STAKEHOLDER SUBMISSIONS At the initiation of this Panel, a communiqué was issued notifying CCN Committee representatives, hospitals and stakeholders in Ontario that written submissions on specific issues related to the scope of the project would be reviewed by the Panel. The purpose of the submissions was to solicit input from a broad group of stakeholders early in the process in order for the Panel to understand issues that would inform subsequent discussions. A listing of the responding organizations is provided in Appendix 6. In total, five organizations responded to the submission process and included cardiac and community hospitals, and a community cardiology organization. Each submission was distributed to and discussed by the Panel. Specific recommendations from the submissions were brought forward for further reflection during the model development discussion phase by the Panel. 3.5 UNPUBLISHED DATA An important source of qualitative information for this Panel was the data gathered via extensive provincial surveys. Surveys were sent to acute care hospitals, PCI hospitals, and emergency medical service (EMS) providers from across the province in order to understand current practices, access and barrier issues, and the infrastructure requirements to support a primary PCI model of care. Survey development was supported by the content experts on the Panel as well as by the University of Toronto Health Services Research Unit. Data analysis was also conducted by the University Health Services Research Unit Survey of Acute Care Hospitals Surveys were sent to all code A, B and C acute care hospitals in Ontario (excluding PCI centres), using the Ministry classification system for hospitals. See Appendix 7 for a copy of the survey and Appendix 8 for a complete list of all hospitals that received and Access to Urgent PCI for STEMI Consensus Panel Report 24

25 responded to the survey. In total, 161 surveys were distributed and 94 were returned within the requested response time (58% response rate) 8. Surveys were sent to the administrative manager for cardiac or medical services for that site, and were required to be completed and signed by this representative in addition to the medical director for cardiac/medical services and the medical director for emergency services Survey of Emergency Services Two EMS surveys were developed with the assistance of EMS representatives on the Panel. Surveys were sent to all 50 EMS Operations Directors (response rate 32%) and all 22 Base hospital Directors (response rate 55%) across the province. (See Appendix 9 and 10 for a copy of the surveys and Appendix 11 for a list of the municipal operations and base hospitals receiving and responding to the surveys.) Provincial data on EMS services was also provided by the Emergency Health Services Branch of the Ministry Survey of Angioplasty Centres Separate surveys were sent to all 11 PCI sites in Ontario, including sites with catheterization labs in development. The PCI survey process was conducted in two phases: 1) a brief written survey sent to the administrative directors for cardiac services to obtain facility and utilization data; and 2) telephone interviews conducted between the clinicians on the Panel and the PCI site catheterization lab medical director. (See Appendix 12 and 13 for copies of the surveys and Appendix 14 for the list of participating PCI sites.) Surveys and Data Gathering from Other Jurisdictions Telephone interviews were conducted by the Panel Chair with catheterization laboratory medical directors from provinces across Canada to gather information and documentation regarding the practice of primary PCI for STEMI in these jurisdictions. Representatives from all provinces participated in the interview process except two (Manitoba and Saskatchewan) as they were unable to be contacted during this time. 3.6 CLINICAL DATA In order to understand the number of eligible patients for urgent PCI and the potential impact a large change in practice pattern may have on current resource utilization and outcomes, an analysis of hospital discharge abstracted data for Ontario residents from the Canadian Institute for Health Information (CIHI) was conducted. Analysts from the Institute of Clinical Evaluative Sciences (ICES) assisted in this data gathering and analysis. The numbers of acute myocardial infarction (AMI) were determined for three fiscal years (1999/00, 2000/01 and 2001/02) from the CIHI Discharge Abstract Database (DAD) for patients between 20 and 85 years of age. 9 The number of STEMIs was calculated based 8 An additional 7 surveys were returned past the response deadline and were not able to be included in the final survey analysis. 9 Most responsible diagnosis codes = ICD9 code 410 (AMI); excludes in-hospital complications and transfers, invalid health insurance numbers. Access to Urgent PCI for STEMI Consensus Panel Report 25

26 on a 1:2 ratio of STEMIs to non-stemis. This is the same cohort and assumptions that were used for the 2003 Target Setting Consensus Panel that was deliberating at the same time as this Panel. The ratio was based on reviewing data from clinical trials (5,6) observational registries (7) and the expert opinion of the Target Setting Consensus Panel. It should be noted that there is a general lack of reliable data and professional agreement on what this actual ratio is at the present time. Estimates provided by secondary reviewers ranged from 1:1 to 1:4. Reported estimated fibrinolytic useage by hospitals responding to the provincial surveys indicate the ratio may be closer to 1:1. However, the 1:2 ratio was adopted for internal consistency and comparative purposes to the Target Setting report for calculating primary PCI target volumes for this report. One year re-admission rates per 100 acute MI categorized by AMI, angina and CHF were also obtained, in addition to length of stay data (LOS) and in-hospital mortality rates. 3.7 GEOGRAPHICAL INFORMATION SYSTEMS QUANTIFYING IMPACT ON ACCESS Geographical information systems (GIS) were used to locate and quantify the number of STEMI patients and PCI procedures that would be captured by the recommended primary PCI model. Two analyses were conducted: 1. Identifying referring acute care hospitals and the associated number of STEMI patients that meet the criteria for transport to a PCI hospital for primary PCI: Using conservative assumptions of average travel speeds by road type, the hospitals that fell within and outside the recommended transport time criteria were identified. The average road speeds used under usual conditions were 80 km/hr for major highways, 60 km/hr for other highways, 50 km/hr for arterial roads and 40 km/hr for streets. Hospitals that fell within the recommended drive time of more than one PCI centre were linked to one unique PCI site by using 2002/03 CCN referral data to identify usual referral patterns. Acute care hospitals were then able to be uniquely assigned to their usual PCI site. For the two new PCI sites, for which 2002/03 PCI referral data was not available, 2002/03 catheterization referral data was used. As STEMI cases were estimated for the province using AMI data and ratios based on best available evidence, the numbers of STEMI patients presenting to specific hospitals was unknown. Therefore, estimates were made based on two sources of data: a) estimation of STEMI cases at PCI and non-pci sites based on reported fibrinolytic usage in the provincial surveys; and b) assignment of STEMI cases to hospitals based on the ratio of hospital beds as a surrogate for STEMI volumes (assuming linearity across sites). 10 Identifying STEMI patient residence (at the FSA postal code level) and associated distance to the nearest PCI centre to quantify how many patients in the community would fall within the recommended transport distance for primary PCI: 10 Data on the number of acute care hospital beds provided by Priority Programs Branch, MOHLTC, March 31, Access to Urgent PCI for STEMI Consensus Panel Report 26

27 Recommended patient transport time was determined, and using average road speeds, the FSAs that fell within and outside the transport time criteria were identified. The same average road speeds were used as described above. STEMI patient data at the FSA level was used to quantify how many cases fell within and outside the recommended transport time. Sub-analyses were also done at the county and planning region. As not all patients would be transported by EMS, two hospitals felt to be representative of large urban and small urban/rural hospitals were requested to submit data on the percentage of STEMI patients presenting to their ER by EMS versus self-presentation (University of Ottawa Heart Institute and Peterborough General Hospital). This data was used to quantify the impact of the model on emergency transportation services and transport volumes. 3.8 SECONDARY REVIEW An opportunity for external review of the draft report was provided to a secondary panel of individuals and organizations who represented constituencies with related expertise and interest in the issues addressed by the Panel and whose opinion would help to inform the Panel in its deliberations. As well, members of the public and non-related health care fields were invited to participate in this process. As EMS is a critical component of the success of this model, several individuals from EMS, representing large urban, small urban and rural areas, as well as the various levels of the EMS organizational structure were invited to participate as secondary reviewers. Twenty-two individuals were approached, of which 20 agreed to participate - 16 of which completed the final review. A list of the reviewers is provided in Appendix 15. The comments received from this secondary panel were reviewed by the primary Panel and incorporated as appropriate into the final report. 3.9 REPORT APPROVAL PROCESS The work of this Panel was accountable to the CCN Board of Directors via the Clinical Services Committee (CSC). Throughout the development of this report, the Panel reported to these committees and feedback was solicited on the methodology, key findings and the recommendations. The final report and recommendations were presented to the full membership of the CCN Board and CSC for final review and approval prior to submission to the Ministry. (See Appendix 16 and Appendix 17 for membership representation on these committees.) 3.10 LIMITATIONS This consensus panel conducted its deliberations during a time of significant evolution in the scientific literature related to primary PCI. For example, the AHA/ACC guidelines will be released after the completion of this report and will contain recommendations related to primary PCI. As well, the results of several trials on facilitated PCI are ongoing and pending publication, the findings of which could have contributed to the recommendations of this report. Therefore, it is important that a process be in place to review and incorporate these findings as appropriate into the Ontario primary PCI model Access to Urgent PCI for STEMI Consensus Panel Report 27

28 of care. To address this issue, recommendations pertaining to implementing a system for ongoing monitoring and review will be made by this Panel. Access to Urgent PCI for STEMI Consensus Panel Report 28

29 4.0 LITERATURE REVIEW 4.1 OVERVIEW The treatment of acute STEMI has undergone tremendous advances in the last several decades. The realization that myocardial necrosis occurred in a time-dependent fashion that could be limited by restoration of coronary blood flow serves as the fundamental principle of acute reperfusion therapy. Fibrinolytic agents are used to reperfuse occluded vessels, but these therapies are associated with major hemorrhagic complications and lack of efficacy in many patients. Significant improvements in PCI have allowed this technique to be used in patients with STEMI with a very high rate of success. Many randomized clinical trials have now compared primary PCI to fibrinolytic therapy and found generally superior outcomes with primary PCI. However, there are a number of logistic issues that must be addressed in order to make this therapy available to the majority of patients in Ontario. The purpose of this review is to examine the current evidence for fibrinolysis and PCI for the treatment of acute STEMI. 4.2 FIBRINOLYTIC THERAPY FOR ST ELEVATION MYOCARDIAL INFARCTION ST segment elevation acute myocardial infarction usually results from the rupture of an atheromatous plaque with superimposed thrombus ( blood clot ) with or without concomitant vasoconstriction resulting in occlusion of a major coronary vessel (8). Myocardial infarction (MI) caused by complete coronary artery occlusion begins to develop after fifteen to thirty minutes of severe ischemia and will progress from the subendocardium to the sub-epicardium in a time dependent fashion (the wave-front phenomenon). Prompt restoration of blood flow to the infarct related artery (IRA) has become the cornerstone of treatment for STEMI; this reduces infarct size, minimizes myocardial damage, and preserves left ventricular (LV) function as well as reduces mortality. This can be achieved either by intravenous fibrinolytic therapy or primary PCI The Natural History of Acute Myocardial Infarction: Community studies (9,10) have demonstrated the overall mortality of AMI within the first month is between 30 and 50% with one half of those deaths occurring within the first two hours. This initial high mortality has not changed substantially over the last thirty years. By contrast, there has been a profound reduction for in-hospital mortality. Prior to the introduction of coronary care units (CCU) in the 1960s, the in-patient mortality was in the range of 25 to 30%. A review of mortality studies in the pre-fibrinolytic era of the mid 1980s showed an average in-hospital mortality of 18% (11). With the advent of fibrinolysis and adjunctive therapy, the one month mortality has fallen to between 6 and 7%, at least as demonstrated in the large fibrinolytic trials. The absolute mortality in community based studies may be slightly higher. In the recent European Heart Survey, the one month mortality in patients presenting with STEMI was 8.4% (12). Access to Urgent PCI for STEMI Consensus Panel Report 29

30 4.2.2 Fibrinolytic Therapy (The evidence of benefit) More than 150,000 patients (13-18) have been randomized in trials of fibrinolysis versus control or one fibrinolytic regime versus another. There is overwhelming benefit for patients treated with fibrinolysis within twelve hours of symptoms onset. According to the Fibrinolytic Therapy Trialists (FTT), those patients presenting within six hours of symptoms onset with ST segment elevation or a new left bundle branch block pattern, approximately 30 deaths are prevented per thousand patients treated and 20 deaths prevented per thousand patients treated between seven and twelve hours. The ISIS-II study demonstrated the additional benefit of Aspirin so there was a combined reduction of approximately fifty lives per thousand patients treated. There is less convincing evidence of benefit in patients presenting beyond twelve hours, however fibrinolysis might still be effective particularly in patients who have ongoing or a stuttering chest pain syndrome, even though most myocardial necrosis occurs early within the first 90 to 180 minutes (19). The advantage of late reperfusion presumably relates to the presence of a patent IRA vessel, leading to improved ventricular healing, reduced infarct expansion and greater electrical stability. Currently, the fibrinolytics tpa, rpa, TNK, and SK are available in Canada and all reduce mortality in STEMI. Comparative Mortality Trials There are five important comparative mortality trials designed either as superiority trials to exclude equality between two fibrinolytic drugs or as equivalence trials to exclude clinically meaningful differences between two drugs (18,20-22). In Gusto-I, tpa was shown to be more effective than SK with a lower 30- day mortality of 6.5% versus 7.5% representing a 1% absolute reduction and a 15% relative risk reduction in mortality. In the Gusto-III trial, rpa did not show survival benefit over tpa. In the equivalence trials, equal mortality was observed when comparing rpa with SK in the INJECT trial and between tpa and TNK in the ASSENT-2 trial as well as between rpa and tpa in the IN- TIME2 trial Time to Reperfusion Regardless of the agent used, the efficacy of the reperfusion therapy is highly dependent upon the time in which reperfusion occurs and the degree of flow obtained. The greatest benefit is seen in those patients treated earliest after the onset of symptoms. The FTT reported a progressive increase of about 1.6 deaths per hour of delay per 1000 patients treated (23). In another meta-analysis of 22 trials, a larger mortality reduction was found in patients treated within the first 2 hours the so-called golden hours (24,25). Early therapy also has the greatest impact on infarct size and left ventricular ejection fraction (26) The Open Artery Hypothesis (TIMI Flow) Reperfusion (TIMI II or TIMI III flow) is achieved in 60 to 75% of patients receiving fibrinolytic therapy (27). The presence of TIMI III flow at 90 minutes is an important predictor of outcome, including improved left ventricular function and survival both short-and long-term (28). When TIMI III flow is achieved there is a 42 day mortality rate of 4.7% compared with 7% for TIMI II flow patients and 10.6% for TIMI 0-1 flow Access to Urgent PCI for STEMI Consensus Panel Report 30

31 patients (29). Therefore, in order to further decrease mortality by 1%, from the current 7% average 30 day mortality, there would be a need of an additional increase of 20% of TIMI III flow opening as demonstrated in the 90-minute angiogram. In the Gusto-I angiographic sub-study, accelerated tpa produced TIMI III flow at 90 minutes in only 54% of treated patients compared to 30% in the streptokinase group Risks for Fibrinolytic Therapy Gusto-I found a 1.8% incidence of severe bleeding (30). The incidence of moderate bleeding defined by the need for transfusion but without hemodynamic compromise or need for an intervention was 11.4%. Significant bleeding was associated with CABG in 3.6% of patients and at the femoral puncture site in 2% of patients undergoing PCI. The most common site for spontaneous bleeding was the gastrointestinal tract with an incidence of 1.8%. Intracranial hemorrhage (ICH) occurred in 0.55 to 0.9% of patients. Fibrin selective agents such as tpa and TNK-tPA have been shown to reduce the incidence of noncerebral bleeding but not of ICH. In the Gusto-I trial, the rate of ICH with streptokinase was 0.8% while it was 1.2% for the more fibrin selective TPA. In other large scale clinical trials, there was no significant difference in the ICH rates between the agents regardless of agent use or the degree of fibrin specificity (31). Predictors of ICH include advanced age, lower body weight, female gender, history of previous CVA, and history of hypertension. There is also evidence that suggests a higher rate of ICH in patients older than 75 also receiving a combination of fibrinolytic therapy and anti-platelet therapy such as a glycoprotein IIb/IIIa inhibitor (32). Overall, there is a 1.4% incidence of stroke which includes about a 0.7% incidence of ICH. Stroke is fatal in 41% and produces moderate or severe disability in 31%. The majority of strokes occur within the first five days of therapy (33). Single bolus rate adjusted TNK-tPA is equivalent to accelerated tpa for thirty-day mortality but has been associated with a lower rate of non cerebral bleeds and less need for blood transfusion. Single bolus fibrinolytic therapy may facilitate more rapid treatment in and out of hospital and reduce the risks of medication errors (34). Absolute and relative contraindications for fibrinolytic therapy are listed in Appendix Limitations of Fibrinolytic Therapy Despite the beneficial effects of fibrinolytic therapy, a minority of patients presenting with an AMI are candidates for this treatment. Of those treated only about one-half achieve TIMI III flow. About a third of these recently opened arteries with high-grade residual obstructive lesions are prone to re-occlusion over time (35). In these patients with STEMI, once the IRA is opened by reperfusion therapy re-occlusion increases the risk of death, LV dysfunction or clinical congestive heart failure. According to the results of GUSTO-I and the ASSENT-2 trial, the incidence of re-infarction after fibrinolytic therapy is 4% (36). Access to Urgent PCI for STEMI Consensus Panel Report 31

32 4.2.7 Combination Strategies Fibrinolytic therapy is particularly successful in dissolving the fibrin rich thrombus leaving behind a platelet rich core. Platelet aggregation is only partially inhibited by aspirin; glycoprotein IIa/IIIb inhibitors block the final pathway of platelet aggregation resulting in a more complete platelet inhibition. In an effort to achieve higher TIMI III flow rates and to reduce re-occlusion and re-infarction, combination therapies with fibrinolytic agents and glycoprotein inhibitors have been undertaken. Angiographic trials demonstrated that the combination of glycoprotein IIa/IIIb inhibitors with half dose fibrinolytic therapy and reduced dose of heparin induced similar or slightly higher TIMI III flow rates when compared to full dose fibrinolytic therapy alone (37-41). This was also associated with more complete resolution of ST segment elevation suggesting an improvement in tissue reperfusion. The clinical benefit and safety of these combinations have been tested in two large scale trials that is the GUSTO-V and the ASSENT-3 Trials (32,34). There was no reduction in the 30-day mortality or intracranial hemorrhage rates; there was a lower rate of in hospital re-infarction but at a cost of an increase in noncerebral bleeding complications especially in the elderly. The routine use of a reduced dose fibrinolytic with a glycoprotein IIa/IIIa inhibitor cannot be recommended at present Low Molecular Weight Heparin Earlier clinical studies suggested that low molecular weight heparins compared to unfractionated heparin might reduce the risk of recurrent ischemia (42). In three more recent angiographic studies enoxaparin or dalteparin were associated with a trend towards less re-occlusion and more late patency of the IRA (43-45). In the ASSENT-3 trial, the combination of enoxaparin (30mg IV bolus and 1mg/kg Q12H) given in association with TNK for a maximum of seven days reduced the risk of in-hospital re-infarction or inhospital refractory ischemia as compared to unfractionated heparin. There was no increase in intracranial hemorrhage and only a modest increase in non-cerebral bleeding. Mortality at 30 days also tended to be lower with enoxaparin. However, in the ASSENT- 3 PLUS Trial, pre-hospital administration of the same dose of enoxaparin resulted in a significant increase in the ICH rate when compared with heparin (46). This excess was seen primarily in patients greater than 75 years. It has been recommended to exercise caution in this age group and perhaps to eliminate the bolus dose of enoxaparin Direct Thrombin Inhibitors Earlier studies using hirudin, bivalirudin and argatrobin as an adjunct to fibrinolysis showed superior patencies and a decreased rate of bleeding compared to heparin (47,48). However, in two large clinical trials, hirudin showed no clear cut benefit over heparin in patients given fibrinolytic therapy (49,50). A recent multicentre trial comparing bivalirudin in combination with streptokinase did not demonstrate any mortality reduction at 30 days compared to intravenous heparin, but there were significantly fewer re-infarctions when the bivalirudin was given for forty-eight hours (51). This was at a cost of a modest but non-significant increase in non-cerebral bleeding complications Fibrinolysis in the Elderly In 5754 patients over the age of 75 treated within twenty-fours, the survival benefits as shown in FTT meta analysis was small and not statistically significant (13). Two recent Access to Urgent PCI for STEMI Consensus Panel Report 32

33 registry type studies questioned the benefit of fibrinolytic therapy in the elderly, with one of these studies even suggesting more harm than good (52,53). In a more recent reanalysis of the FTT data using the conventional criteria of ST elevation or new left bundle branch block pattern presenting less than twelve hours from symptom onset showed that among 3300 patients over the age of 75, the absolute risk reduction was 34 per 1,000 patients treated (54). Mortality rates were significantly reduced by fibrinolytic therapy (from 29.4% to 26% P = 0.03). In a large Swedish registry fibrinolytic therapy administered to patients over the age of 75 years with STEMI was associated with a similar 13% adjusted relative reduction in the composite of mortality and cerebral bleeding complications after 1 year. (55) Overall, there appears to be a decreasing relative risk reduction benefit with fibrinolysis in the elderly but there remains a significant absolute mortality risk reduction due to the higher adverse outcome for myocardial infarction in the older age groups; the weight of clinical data appears to favour fibrinolytic therapy among appropriately selected elderly patients Pre-hospital Fibrinolysis Analysis of 58,600 patients in the FTT demonstrated a maximal effectiveness of fibrinolytic therapy within the first hour of symptom onset (65 lives saved per 1,000 treated patients) whereas the benefit is reduced by nearly 50% in the subsequent hour (37 lives saved per 1,000 treated patients) (23). Data from the contemporary fibrinolytic trials dating from 1990 to 2001 failed to show any improvement in the median time to treatment with the average time to presentation being somewhere in the range of 2.6 hours. Recognizing a presentation delay exists, community education programs have been developed in the United States and Europe in order to minimize patient delay. Despite comprehensive education campaigns using the public media, there has been no reduction in the presentation delay in patients suspected of sustaining an acute coronary syndrome. The focus of providing more timely fibrinolytic therapy has been shifted to the process of care delivery in order to achieve a reduction in the interval from symptom onset to treatment. These initiatives may include alerting the hospital to the likelihood that they are dealing with a myocardial infarction, pre-hospital ECG with transmission to the emergency room and finally pre-hospital fibrinolysis administered either by a physician or paramedic. Prior to 1993, pre-hospital fibrinolysis was tested in numerous randomized trials largely in Europe. A meta-analysis of six randomized studies involving 6434 patients randomized to pre-hospital fibrinolysis versus in-hospital fibrinolysis demonstrated the time to treatment was reduced by 58 minutes (56). This reduction varied from 33 minutes in urban Seattle with transmitted 12- lead ECGs and aggressive in-hospital management to 130 minutes in a rural region in Scotland (24,57). The overall 58 minute reduction in time was associated with a 17% relative risk reduction in mortality. This represents a 1.7% absolute risk reduction which translates into one life saved for every 62 patients treated with pre-hospital fibrinolysis. This was not associated with any compromise in patient safety. Access to Urgent PCI for STEMI Consensus Panel Report 33

34 There are three new studies which represent more contemporary pre-hospital fibrinolysis. The Early Retavase Thrombolysis in Myocardial Infarction 19 (ER-TIMI-19) enrolled 1,000 patients to open label rpa (58,59). This project was stopped after 315 patients demonstrating a 31-minute reduction in time to treatment compared to a historical control group. The recently published Comparison of Angioplasty and Pre-hospital Thrombolysis in AMI trial (CAPTIM) was a French study which planned to randomize 1,200 patients to pre-hospital fibrinolysis (accelerated tpa) or pre-hospital triage for PCI (60). This study was stopped after 840 patients because of slow enrollment and competitive trials, however there was no difference in the primary end point which was a composite of death, re-infarction and stroke at 30 days. Advantages for PCI included reduction in re-infarction and in disabling stroke, however no benefit in hemorrhage or mortality rates. It should be noted that for patients randomized to primary PCI, the mean door-to-balloon time was approximately 80 minutes achieving TIMI-III flow in 90% of cases. Among the patients who received pre-hospital fibrinolysis, 26% of patients did require rescue PCI. The final study includes the ASSENT-3 PLUS Trial (61,62). This randomized 1,600 patients to pre-hospital fibrinolysis with TNK and enoxaparin or unfractionated heparin. This will be compared to an analogous population from ASSENT III parent trial (non-randomized comparison). This study demonstrated a reduction of almost one hour in time from symptom onset to treatment. Overall pre-hospital fibrinolysis trials do demonstrate the feasibility of this strategy with demonstrable savings in time to treatment. 4.3 PRIMARY PCI FOR ACUTE ST ELEVATION MYOCARDIAL INFARCTION Fibrinolytic therapy in the management of acute STEMI has been convincingly demonstrated to reduce mortality (13); however even the best fibrinolytic regimens provide far from complete reperfusion as discussed previously, and early re-occlusion occurs frequently (63,64). Overall, 50 to 60% of patients achieve optimal and sustained reperfusion with fibrinolytic therapy. Significantly higher rates of reperfusion can be achieved with PCI used as primary treatment for acute MI (65). A decrease in reinfarction, stroke and in particular the incidence of hemorrhagic stroke is also consistently seen (66). A total of twenty-three randomized trials comparing primary PCI to fibrinolytic therapy for acute STEMI have been conducted between 1990 and 2003 (67-88). These trials are in general not large, and none had adequate power to detect a significant decrease in mortality. However most did show a trend to decrease mortality with primary PCI and most showed improvement in a composite end-point, usually including death, non-fatal reinfarction and stroke. A meta-analysis of these 23 trials has recently been published (89). The total number of patients randomized in these 23 trials to primary PCI was 3872, and to fibrinolytic therapy was It should be noted that over the period of time during which these trials were conducted interventional practice has changed significantly. In the initial trials Access to Urgent PCI for STEMI Consensus Panel Report 34

35 the standard of practice was balloon angioplasty with heparin and ASA as adjunctive pharmacotherapy; in more recent trials intracoronary stents, Gp IIb/IIIa inhibitors and thienopyridine agents have been used. Similarly, there has been a variation in the use of fibrinolytic agents, with eight of the trials using streptokinase, and 15 using fibrin specific agents (12/15 used accelerated TPA). The inclusion and exclusion criteria also varied between the trials as well as the conjunctive medical and interventional therapy for recurrent ischemia or failed reperfusion. The meta-analysis does provide evidence supporting improved clinical outcomes for PCI as compared to fibrinolytic therapy. The short term mortality (4-6 weeks) was decreased from 7% with fibrinolytic therapy to 5% with PCI (excluding the SHOCK trial (13) data; the literature regarding cardiogenic shock will be reviewed separately), non-fatal reinfarction reduced from 7% to 3%, total stroke from 2% to 1%, and hemorrhagic stroke from 1% to 0.05%. The composite end-point of death, reinfarction and stroke was reduced from 14% with fibrinolytic therapy to 8% with PCI. These outcomes were also improved to a similar degree over the longer term (6-18 months). Using data from this meta-analysis, it is estimated that for every 1000 patients treated with primary PCI compared to fibrinolysis, 59 deaths, non-fatal re-infarctions or strokes would be prevented. Examining each individual outcome, there would be 23 fewer deaths, 42 fewer non-fatal re-infarctions and 11 fewer strokes with a primary PCI strategy. Of note, five trials (78,79,86-88) have compared on-site fibrinolytic therapy with emergent hospital transfer for primary PCI, which is of significant importance when considering providing urgent PCI in Ontario. Despite the delay inherent in transfer (average 39 minutes) there was a trend to decreased mortality which was of borderline significance, and significant reductions in non-fatal MI, total stroke and the combined end-point of death, non-fatal reinfarction or stroke (89). The results were similar to the overall meta-analysis. Using data from this meta-analysis, it is estimated that for every 1000 patients transferred for primary PCI compared to on-site fibrinolysis, 53 deaths, non-fatal re-infarctions or strokes would be prevented. Examining each individual outcome, there would be 30 fewer non-fatal re-infarctions and 12 fewer strokes with a primary PCI strategy. Of these five trials, the DANAMI-2 study (88) is particularly noteworthy. The DANAMI- 2 study was conducted in Denmark, and included five PCI centres and 24 referral hospitals. It is the largest single study of primary PCI compared to fibrinolytic therapy. A total of 1572 patients were randomized to fibrinolytic (accelerated TPA) therapy or primary angioplasty; 1129 of these were randomized at referral centres, of whom 567 were transferred to a PCI centre, traveling a median of 50 km and a maximum of 150 km. The median transfer time (defined as the time from randomization at the referral hospital to arrival in the catheterization laboratory) was 67 minutes; only 4% had transfer times greater than two hours. There were no deaths during transportation; 13 patients developed intermittent advanced AV block, 8 developed VF, and 14 developed atrial fibrillation. All patients transferred were accompanied by a physician. Four percent of patients screened at referral hospitals were excluded as they were judged to be unable to tolerate transport. Access to Urgent PCI for STEMI Consensus Panel Report 35

36 The total interval from onset of symptoms to start of treatment for the PCI group was 224 minutes for the referral hospital patients and 188 for patients presenting to a PCI centre; for the fibrinolytic group, the intervals were 169 minutes and 160 minutes. The primary end-point of death, non-fatal re-infarction or disabling stroke within 30 days occurred in 13.7% of the patients in the fibrinolytic therapy group and 8.0% in the PCI group. There was a trend to reduction of each of the individual components of the primary end-point, but the only one that achieved statistical significance was re-infarction (6.3% in the fibrinolytic group vs. 1.6% in the PCI group). The benefit was similar for patients transported from referral hospitals and those presenting to PCI centres. The C-PORT trial (85) took a different and novel approach. Eleven community hospitals in the eastern United States with diagnostic labs but no interventional or cardiac surgical programs were trained to perform primary angioplasty. An extensive formal training program for the catheterization lab staff was undertaken. Of note, no information on the experience of the interventionists was provided except that all were required to perform at least 50 procedures per year and therefore, presumably practiced in established programs at other hospitals. The patients were randomized to fibrinolytic therapy or primary angioplasty. The projected sample size was 2550 but the study was terminated after 451 patients were enrolled due to lack of funding. Overall 225 patients were assigned to intervention; of these, 212 actually went to the catheterization lab, and in 169, PCI was actually performed so that of those assigned to PCI, only 75% actually underwent the procedure. The composite end-point of death, reinfarction or stroke at six weeks was reduced from 17.7% of the fibrinolytic therapy group to 10.7% in the PCI group (P=0.03). Each component of the end-point showed a non-significant trend to reduction. It is important to note that the majority of patients in this study were randomized during usual working hours and co-intervention with rescue angioplasty was not provided for patients with recurrent ischemia on site. The CAPTIM study (82) is the only randomized trial to compare primary PCI and prehospital fibrinolysis. The study was conducted in France; a system of mobile emergencycare units that included a physician was already routinely able to diagnose MI and administer fibrinolytic therapy. The planned enrollment was 1200; the study was terminated after 840 patients due to slow enrollment and lack of funding. Patients were enrolled within 6 hours of onset of acute STEMI and randomized to prehospital accelerated TPA or primary PCI; all were transported to a PCI centre. There was liberal use of rescue angioplasty, which was performed in 26% of the 419 fibrinolytic patients. The primary endpoint was a combination of death, non-fatal reinfarction, and disabling stroke; this occurred in 8.2% of the fibrinolysis group and 6.2% of the PCI group, which was not a significant difference. The mortality was surprisingly low in both groups (fibrinolytic 3.8%, PCI 4.8%, p = NS). In the CAPTIM trial several important observations were made. First, the early administration of fibrinolytic therapy was associated with a reduction in development of cardiogenic shock. The second is the apparent trend towards superior outcomes with fibrinolytic therapy over primary PCI in Access to Urgent PCI for STEMI Consensus Panel Report 36

37 patients presenting within 2 hours of symptom onset. Finally, the trial highlighted the concept that fibrinolysis as a sole reperfusion strategy is inadequate and concomitant PCI is required in a significant number of patients. (90) While interesting and important, these results are dependent on a pre-hospital emergency care system not readily available in Canada. Furthermore, these retrospective, post-hoc observations were noted in a relatively small number of selected patients and additional confirmation by further prospective randomized trials is needed. Finally, adjuvant therapies such as thienopyridines and routine use of upfront abciximab in the PCI group may have reduced the efficacy of primary PCI. The maximum door-to-balloon time that would still confer a benefit of PCI over fibrinolytic therapy has not been determined. Cannon et al (91) reported that a door-toballoon time of less than 60 minutes was associated with a mortality of 4.2%, whereas a door-to-balloon time of greater than 180 minutes was associated with a mortality of 7.9%. Angeja et al (92) reported that predictors of increased door-to-balloon time included the need for transfer, presentation at night, and procedures conducted in lower volume facilities. In a detailed analysis of the 23 randomized trials of primary PCI versus fibrinolytic therapy, the two reperfusion strategies appear to become equivalent with regard to mortality when the delay to PCI ( door-to-balloon time ) is 62 minutes beyond the time to fibrinolytic administration ( door-to-needle time ). However, the time for equivalence for the composite of death, reinfarction or stroke appeared to be longer at 93 minutes. It is important to note that the mean PCI-related time delay in these published studies was 39.5 minutes suggesting that rapid transfer to a PCI laboratory is feasible in the majority of patients. (93) The current recommendation for door to needle time in patients receiving fibrinolysis is < 30 minutes but a recent report of Ontario hospitals revealed that the actual median door to needle time is 37 minutes (94). Using the above data, it would appear that an additional minutes would be an acceptable delay for primary PCI to ensure superior outcomes compared to fibrinolysis. These assumptions would therefore lead to a door-to-balloon time of 90 to 120 minutes. Clearly, the earlier the PCI can be performed, the better the outcomes, and as such a recommendation of a door-to-balloon time of 90 minutes would appear to be appropriate at this time. In summary primary PCI for acute STEMI results in higher rates of infarct-related-artery patency, less re-occlusion and re-infarction, less stroke and hemorrhagic stroke. No single trial has demonstrated a significant mortality improvement but such a benefit is suggested by the most recent meta-analysis. The outcomes of patients transferred from a referral hospital are similar to those presenting to a PCI centre; however to achieve these results highly organized systems of triage, referral, and transport were developed. The door-toballoon times achieved in clinical trials have not yet been demonstrated in routine clinical practice, particularly for patients requiring transfer to a PCI centre. 4.4 FACILITATED PERCUTANEOUS INTERVENTION Facilitated PCI is defined as a strategy of early pharmacological reperfusion therapy followed by a planned PCI. Access to Urgent PCI for STEMI Consensus Panel Report 37

38 The rationale for facilitated PCI is that it attempts to optimize reperfusion therapy by maximizing the ease and accessibility of early and prompt pharmacological reperfusion with the benefits of sustained and complete reperfusion that is often achieved with PCI (13,18,20,69-71,81). The initial pharmacological therapy may consist of fibrinolytic therapy, potent anti-platelet therapy in form of platelet glycoprotein IIb/IIIa inhibitors or thrombin inhibitors or a combination of these three agents. Fibrinolytic therapy can be administered rapidly and easily to most patients, but it is limited by the fact that only approximately 50-60% of patients achieve adequate myocardial perfusion at 90 minutes after administration (63,95). Primary PCI is limited by the fact that not all patients present to hospital where facilities are available and even in those hospitals in which facilities are available, there is time lost in mobilizing an interventional team to perform the interventional procedure. Several studies have highlighted the inverse relationship between favourable outcomes with PCI and delays in door-to-balloon times (92,96). In addition, procedural success with PCI appears to be enhanced in patients with an initially patent artery compared to one that is completely occluded. It is possible that combining these two reperfusion strategies will improve the chance of achieving early and sustained reperfusion. Historically, the systematic use of PCI following fibrinolytic therapy was associated with a significant increase in adverse outcomes (35,97). However, these studies were performed in the era of balloon angioplasty prior to modern coronary stents and prior to modern PCI pharmacotherapy including glycoprotein IIb/IIIa inhibitors, thienopyridines and direct thrombin inhibitors. More recent preliminary work has suggested that the use of glycoprotein IIb/IIIa inhibitors and low dose fibrinolytic agents may enhance reperfusion allowing for facilitated PCI without the adverse outcomes observed with the earlier studies (37,98). The first trial to examine the role of facilitated PCI was the Primary Angioplasty Combined with Thrombolysis Trial (PACT) (35). This trial randomized 606 patients to a 50 mg bolus of TPA or placebo followed by immediate angiography. If TIMI grade III flow was absent on arrival to the catheterization unit, PCI was performed regardless of the randomization group. In this study, the medium time of study drug to initial contrast injection was 49 minutes and the initial angiogram showed a significant improvement in TIMI III flow in those patients randomized to TPA vs placebo (33 vs 15%), P< Although the study was too small to yield any conclusive results with clinical endpoints such as death and re-infarction, the PACT Study did conclude that tailored half dose of fibrinolytic regimes is compatible with early percutaneous intervention and leads to early patency of the infarct related artery and greater left ventricular function preservation with no increase in serious adverse events. The ADMIRAL (Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long term follow up) trial was a facilitated PCI trial which examined the use of abciximab, a platelet glycoprotein IIb/IIIa inhibitor as the facilitating pharmacological agent prior to PCI (97). This trial randomly assigned 300 patients with STEMI to abciximab plus stenting or placebo plus stenting. The abciximab Access to Urgent PCI for STEMI Consensus Panel Report 38

39 therapy was given at the time of randomization and prior to angiography. The primary endpoint of the trial was the composite of death, reinfarction or urgent target vessel revascularization at 30 day and occurred in 6% of patients treated with abciximab compared to 14.6% treated with placebo (P=0.01). Six month follow up continued to show the combine triple endpoint remained lower in the abciximab group (7.4% vs 15.9% P=0.02). Initial TIMI III flow was observed in 16.8% of patients treated with abciximab vs 5.4% in the placebo group. In addition, TIMI III flow was also more frequently present after the PCI in the abciximab treated group (95.1% vs 86.7% P=0.04). A Canadian trial currently underway is examining the role of full dose fibrinolytic therapy with facilitated PCI. The combined angioplasty and pharmacological intervention vs fibrinolysis alone in acute myocardial infarction (CAPITAL AMI Trial) is randomizing patients with acute STEMI presenting within six hours of chest pain to either full dose TNK followed by immediate PCI vs full dose TNK. The primary endpoint of the trial is a composite of death, re-infarction, recurrent and stable angina or stroke at 30 days. The study is being conducted in Ottawa and includes hospitals with and without on-site interventional facilities. Several large randomized trials are currently being planned or have just started enrollment and will further clarify the role of this strategy. Therefore in conclusion, although the rationale for facilitated PCI appears to be logical, further studies will clearly need to be done in order to define its role and whether it is truly efficacious. Other important issues such as transfer of patients and cost effective analysis will be important to be considered. Due to the present lack of conclusive scientific evidence and the number of large ongoing clinical trials evaluating this strategy, no specific recommendation regarding facilitated PCI was made by the Panel. 4.5 FACILITATED PERCUTANEOUS INTERVENTION Rescue PCI is the process by which PCI is performed for ST segment elevation MI after fibrinolytics have been administered but have failed to reperfuse the infarct related artery. In contrast to facilitated PCI, the primary intention is for the fibrinolytics to result in complete reperfusion and so PCI is not part of the initial management strategy. Although the use of rescue PCI to achieve complete reperfusion for patients with failed fibrinolysis if performed promptly, effectively and safely seems logical, there is very limited clinical data to support such a strategy. In addition to the actual performance of the rescue PCI procedure, there is a need to correctly recognize the failure of fibrinolysis in a timely fashion with relatively simple non-invasive methods. Most of the data regarding rescue PCI is derived from early studies performed prior to the advent of many important changes in interventional technique and adjuvant pharmacotherapy including coronary stents, glycoprotein IIb/IIIa inhibitors and platelet ADP antagonists. Nevertheless, these studies do provide some important information. Four studies have examined the role of rescue PCI in the setting of totally occluded vessels. The first was reported by Belenkie and coworkers in 1992 (99) in which 28 patients treated with streptokinase were randomized to conservative therapy or rescue Access to Urgent PCI for STEMI Consensus Panel Report 39

40 PCI. There was only 1 death in the PCI group and 4 deaths in the conservative group (p=0.13). The largest study was the RESCUE 1 study which randomized 151 patients with a first anterior wall MI to rescue PCI or conservative therapy (100). There was no difference between the 2 groups with respect to the primary endpoint of 30-day resting left ventricular ejection fraction. However, there was a significant reduction in the composite of death and severe CHF at 30 days (16.6% versus 6.4%; p=0.05) with rescue PCI. One-year follow-up of the combined data from RESCUE 1 and the Belenkie studies would suggest that rescue PCI is associated with a significant survival advantage compared to conservative therapy (p=0.001)(89). In addition to the reduction in mortality, these combined studies find an early reduction in severe CHF and recurrent MI. Similar trends were observed in 2 more recent studies. Widimsky and colleagues (101) reported a trend toward a reduction in the composite of 30-day death, repeat MI, severe CHF or urgent revascularization in 40 patients treated with rescue PCI following fibrinolysis with streptokinase (20% versus 45%; p=0.09). In a larger study of 149 patients, Vermeer and coworkers (102) reported a trend towards an improvement in the composite of 30-day death or recurrent MI in patients with occluded vessels following fibrinolysis (5% versus 12%; p=0.15). Although there are several important limitations to all of these studies, it would appear reasonable to refer patients with a moderate or large MI manifested electrocardiographically or by hemodynamic instability, and who had not been successfully reperfused by fibrinolytic therapy by 75 to 120 minutes for emergent rescue PCI by an experienced interventional center. There is much less data for patients with small infarcts or situations where the delay for transfer is prolonged. 4.6 PCI FOR CARDIOGENIC SHOCK COMPLICATING ACUTE MI Cardiogenic shock is the major cause of death of patients presenting with acute MI (103) and occurs in 4-7% of patients presenting with acute STEMI. There is some evidence that the incidence of cardiogenic shock is decreased by the use of fibrinolytic therapy (103), however, for patients who do have established shock, fibrinolytic therapy does not appear to improve mortality (104). The mortality may have improved a small amount over time, but remains high and in a recent retrospective study was 59% (105). Data from registry and retrospective studies has suggested an improvement in the mortality of patients with cardiogenic shock undergoing early revascularization with angioplasty or bypass surgery. However, there is a clear bias in the selection of patients for revascularization as demonstrated by the SHOCK registry investigators (106). This prospective registry was conducted in ; 251 patients were registered. The patients selected at the discretion of their physicians for cardiac catheterization and possible revascularization were significantly younger than patients who did not undergo cardiac catheterization (64.0 vs 70.0 years). The mortality of those patients who did not undergo catheterization was 85%; the mortality of all patients undergoing catheterization was 51% and interestingly the mortality of those patients who underwent cardiac catheterization but not revascularization was 58%, suggesting that patients selected for an invasive strategy in non-randomized data do have an inherently lower mortality than those who are treated conservatively. Access to Urgent PCI for STEMI Consensus Panel Report 40

41 Two randomized trials (107,108) of early revascularization in the management of cardiogenic shock complicating acute MI have been conducted. The trial conducted by Urban and colleagues (107) was terminated prematurely due to an insufficient patient enrollment rate; a total enrolment of 114 was planned but ultimately only 55 patients were randomized. The 30 day mortality of the 32 patients undergoing an invasive strategy with early revascularization was 69%, and the mortality of the 23 patients in the conservative medical management arm was 78%, which was not a significant difference. However, given the small size of the trial, a clinically meaningful difference could have been missed. Hochman et al conducted the SHOCK trial (108); they randomized 312 patients presenting with cardiogenic shock complicating acute infarction to a strategy of medical stabilization, or of emergency revascularization; 64% in the latter group underwent percutaneous intervention, and 36% underwent coronary bypass surgery. The primary end-point of 30 day mortality occurred in 46.7% of the early revascularization group and 56.0% of the medical stabilization group which was not a significant difference (p=0.11). The six month mortality was 50.3% in the early revascularization group and 63.1% in the medical stabilization group which did achieve significance (p=0.027). All of the benefit appears to have been confined to patients aged less than 75 years. For those patients greater than 75 years (n=56) the six month mortality in the early revascularization group was 79.2% and in the medical stabilization group was lower at 56.3%. It should be noted that of the patients in the SHOCK trial undergoing PCI, 35.7% received a stent, 41.7% received a Gp IIb/IIIa inhibitor; hence the trial does not truly reflect current interventional practice (the patients were enrolled from 1993 to 1998). In summary cardiogenic shock remains a very high mortality condition, and its management and the benefits of revascularization have not been well studied. Based on one small randomized trial (108) there appears to be a modest benefit of early revascularization. That benefit appears to be confined to patients less than age 75 and there is an indication of worse outcomes in patients greater than age EXPERTISE IN PRIMARY PCI Institutional and Operator Expertise and Volumes An inverse relationship between procedure volume and patients outcome in coronary angioplasty has been established for more than a decade (109). Based on this relationship recommendations have been made for institutional standards as well as standards in training and maintenance of competence for operators performing invasive and interventional procedures ( ). Does this relationship apply to outcomes in patients with AMI treated with primary PCI? Most of the studies comparing primary PCI versus fibrinolytic therapy have been performed in centres with established primary PCI programs. Access to Urgent PCI for STEMI Consensus Panel Report 41

42 The excellent results attained in the patients studied in the randomized trials to date can be attributed to several factors, including 1) experience of these investigators in performing PCI in the setting of acute MI; 2) their commitment to all details of the protocol and dedication of institutions and support personnel to the project; and 3) the capability to perform PCI within a short time frame (by 60 to 90 minutes of arrival at hospital). These important considerations may not be reproducible in the community setting and for all AMI patients not enrolled in specific protocols. Experience with PCI in AMI outside of large hospitals participating in clinical trials is more limited. Less than 20% of US hospitals have established programs for primary PCI and greater than 80% of those with established programs perform less than three primary PCI procedures per month (115). Separate analyses of several large registries of treatment of AMI, have independently demonstrated lower in-hospital mortality rate for AMI patients treated with primary PCI in high-volume centres than in low volume centres. The two earliest reports on the relationship of the volume versus outcome specific to primary PCI were by Grassman et al and Zahn et al from the American Society for Cardiac Angiography and Intervention Registries and the German registry for the Working Society of Leading Cardiologic Hospital Physicians respectively (116,117). Both independently showed a significantly lower in-hospital mortality rate for primary angioplasty in high-volume centers than in low-volume centers. Subsequent analyses in more contemporary primary PCI settings have been consistent with these initial reports. Using data from a registry of 62,299 patients with AMI treated at 446 hospitals with primary PCI or fibrinolysis between , Magid et al demonstrated an incremental difference in in-hospital mortality between the two therapies: low volume (<16 procedures/annum; 6.2% vs 5.9%; p=0.58), intermediate volume (17-48 procedures/annum; 4.5% vs 5.9%; p<0.001) and high volume hospitals (>49 procedures/annum; 3.4% vs 5.4%; p<0.001) (118). Adjusting for differences in demographic, medical history, clinical presentation, treatment or hospital characteristics did not significantly alter these findings. Of interest, in this registry, in-hospital mortality rates were similar between low, intermediate and high volume hospitals for patients treated with fibrinolysis. Using data from the National Registry of Myocardial Infarction, Canto et al divided hospitals with full interventional capabilities into four groups based on volume. They showed a 28% mortality difference between hospitals with the highest primary PCI volume versus the lowest primary PCI volume (119). This translated to 2 fewer deaths per 100 patients treated with primary PCI. In this study, high volume centres were those that performed more than 35 primary procedures per year or an average of 3 per month. These results were independent of use of adjunctive therapies known to improve survival such as aspirin and beta-blockers. Furthermore, in this analysis there was no difference in mortality between low volume and high volume hospitals for patients treated with fibrinolytic therapy. Finally, using data from the 1995 New York state Coronary Angioplasty Reporting System Registry, Vakili et al showed that in-hospital mortality Access to Urgent PCI for STEMI Consensus Panel Report 42

43 was reduced by 44% when patients were treated in high volume institutions rather than low volume institutions (120). In addition, these investigators observed a 57% relative risk reduction among patients who underwent primary PCI by high volume versus low volume operators at these hospitals. The favourable outcomes noted with institutions with higher procedural volumes of primary PCI may be related to better processes of care such as 1) streamlined procedures to provide care expeditiously and 2) higher use of evidence based treatments that have been proven to improve outcome (121). For primary PCI, processes need to be in place for expedited transfer to the catheterization lab and rapid deployment of dedicated staff with expertise in management of critically ill patients who need intensive medical therapy as well as intra-aortic balloon support. In addition expertise in post-procedural management is important. There is a relationship between door to balloon time and outcome (91); in the study by Canto et al, the door to balloon time was on average 28 minutes shorter in high volume hospitals which demonstrated better outcomes. In general, PCI in the context of AMI is more difficult than in the elective situation, both in terms of clinical characteristics of the patients as well as lesional characteristics and requires significant expertise in management. In addition a significant amount of data has accumulated on adjuvant pharmacological therapies in PCI. Understanding the appropriate indications for and uses of these medications requires a specialized knowledge of hemostatic mechanisms. Therefore, interventional cardiologists should meet the minimum criteria for training and proficiency for PCI outlined in the CCN Expert Panel document Need for emergency cardiac surgery back-up PCI in the early phase of an acute MI can be difficult and requires even more skill and experience than routine PCI in the stable patient. Even in highly experienced centres, approximately 2% of patients initially referred for PCI may require emergency CABG surgery, either because the artery is not suitable for PCI or failed angioplasty requires further surgical intervention. The CCN Invasive Cardiology Panel Report recommends that all centres performing PCI procedures have either on-site cardiac surgery or a formal arrangement for off-site surgical back-up. An established plan for rapid access to cardiac surgery is even more essential for primary PCI. The Ministry criterion document for stand-alone angioplasty centres requires emergency transportation to a surgical centre within 90 minutes of the decision to transfer (122). 4.8 COST EFFECTIVENESS As discussed above primary PCI when compared to fibrinolysis yields superior clinical outcomes in patients with STEMI in most circumstances. However, since this strategy appears to be a more complicated process with a greater need for resources, the cost of a routine PCI strategy for STEMI must be considered. Surprisingly, there are relatively few studies evaluating the cost-effectiveness comparing PCI with fibrinolysis. Access to Urgent PCI for STEMI Consensus Panel Report 43

44 Zwolle and colleagues compared balloon angioplasty with streptokinase and found the combined in-hospital and outpatient costs at 12 months to be $17,306 with balloon angioplasty and $16,681 with streptokinase (123). In the Primary Angioplasty in Acute Myocardial (PAMI)-1 trial, the investigators compared in-hospital charges (not cost) for only the initial hospitalization and found non-statistically significant lower charges with balloon angioplasty compared to non-accelerated t-pa. ($27,653 versus $30,227) (124). A similar result was obtained from a study comparing balloon angioplasty to t-pa conducted at the Mayo clinic in the early 1990 s but again these investigators looked at charges and did not examine actual costs (70). It is also important to note that these studies were conducted with balloon angioplasty rather than stents and did not use modern fibrinolytic regimes. A recent study has analyzed the cost-effectiveness of stenting compared to accelerated t- PA in a single center Canadian study (125). In this study, stenting was associated with significantly lower composite endpoint of death, recurrent MI, stroke or repeat revascularization for ischemia. Furthermore, detailed analysis of direct costs at six months demonstrated that stenting was less expensive compared to t-pa ($USD 7,100 versus $USD 9,559; p=0.001). Patients assigned to the stent group had significantly shorter hospitalizations and fewer complications resulting in the overall lower costs. The authors concluded that stenting is the dominant cost-effective strategy for the treatment of STEMI in centers where facilities and experienced interventionalists are available. In addition to the reduction in direct costs as outlined by the previously mentioned studies, numerous indirect costs are likely to be reduced. Specifically, shorter hospitalizations and fewer complications will result in earlier return to work for many patients. Furthermore, it could be anticipated that a strategy of primary PCI may result in less congestive heart failure and improved left ventricular function with a reduction in the need for automated internal defibrillators. The above mentioned studies all deal with patients presenting to hospitals with established interventional facilities. Unfortunately there is no data with respect to costeffectiveness of transferring patients to interventional facilities or the establishing and maintaining of new interventional programs where these facilities are not present. In Ontario, the majority of patients with STEMI present to hospitals without interventional facilities and therefore the cost-effectiveness of transferring patients and establishing new programs is of paramount importance. In addition, most studies have used currently available staff and facilities for treating STEMI patients with primary PCI and have generally involved small number of patients in a relatively small number of institutions. It is unclear whether this approach would remain cost-effective if a new policy of universal primary PCI is established requiring the construction of additional interventional catheterization laboratories, expansion of current EMS service and hiring significantly more staff. Access to Urgent PCI for STEMI Consensus Panel Report 44

45 4.9 REVIEW OF OTHER CANADIAN JURISDICTIONS Many of the other large interventional centers throughout Canada were interviewed by telephone to determine their policy regarding primary PCI for STEMI. Individual site data will not be presented but rather a summary of the general themes. The vast majority of PCI centers have an informal program for primary PCI. Most centers in Canada offer the service for patients presenting to their own hospital during regular working hours. These patients are accommodated into their regular work schedule, treated by intervention and returned to the CCU thereafter. Some centers will cancel elective patients and rebook the following day, while other centers will simply prolong the working hours in order to accommodate the emergency procedure. Most centers who offer primary PCI during the day only offer it at night for patients who are in cardiogenic shock, who require rescue angioplasty or who are ineligible for fibrinolysis due to medical contraindications. A small but growing number of centers across Canada are now beginning to offer primary PCI on a 24 hour / 7 day basis for patients presenting to their emergency room. Generally, this has been occurring in the larger more experienced centers which have a large number of interventional cardiologists and cardiac catheterization lab staff that can share the on-call responsibilities. A small number of centers outside of Ontario are beginning to develop programs to have patients transferred in for primary PCI. This again appears to be limited to a few large metropolitan centers in which transfer times are relatively short. The major issue that was raised regarding the use of primary PCI for STEMI was human resources, particularly in the smaller centers which may have only three or four interventional cardiologists and only one or two cardiac catheterization labs. It was felt by the smaller centers that a 24 hour / 7 day a week policy may be too onerous for staff and that additional staff would be required before a routine policy could be implemented. Representatives from one province stated their general reluctance to provide primary PCI, with the exception of contraindications for fibrinolytics, due to expressed concern over the stress it could create on the system (extra cases and staffing requirements), and feel that fibrinolytics is an appropriate alternative at this time. Another issue identified by several other centers was the remoteness of the population of their particular province and the inability to transfer patients in a timely fashion. Issues regarding the EMS system were also identified as an important limitation in the ability to develop a broad based transfer policy for AMI. In general, there is a shortage of EMS services across the country and substantial changes in this service would be required before adopting a routine policy. Establishing unique ambulance codes allowing for immediate and reliable hospital-to-hospital transfer for these patients and the agreement to repatriate patients back to the referring hospitals within 24 hours has also been sited as important determinants of success or failure for the program. In those centers that have begun treating patients on a transfer basis, the importance of a direct communication link between the referring hospital and the interventional cardiologist has been identified as an important step. A few hospitals indicated that they do not believe that the scientific Access to Urgent PCI for STEMI Consensus Panel Report 45

46 literature supports a routine policy around the clock for patients presenting at their site and in particular, patients being transferred from other sites. Some of the centers also suggested that further work needs to be done regarding the development of facilitated angioplasty protocols. These centers have decided to await the results of the randomized facilitated angioplasty trials before establishing a routine policy for PCI for STEMI in their regions RECOMMENDATIONS Recommendation 1 - That primary PCI for STEMI patients, presenting within 12 hours of symptom onset, be the preferred therapy for: All eligible patients presenting to a hospital with on-site PCI facilities with an experienced interventional team, with a maximum door to balloon time of less than 90 minutes. All eligible patients who can be transferred from an acute care hospital to a primary PCI center with a maximum door to balloon time of less than 90 minutes. All patients who have contraindications to fibrinolytic therapy, regardless of distance, as long as the procedure is performed within 12 hours of symptom onset. 11 Patients who present after 12 hours of symptom onset to be managed on a case by case basis. Class 1 indication, Level A evidence Recommendation 2 That the Ministry of Health and Long-Term Care require all centres providing primary PCI services to maintain an infrastructure that enables it to perform to high standards of safety and efficacy, including: A minimum standard of 150 PCI procedures per operator per year. An annual review process to ensure that: o All operators achieve minimum procedure volumes; and o The centre performs a minimum of 500 diagnostic catheterization procedures and 400 interventional procedures per year of which greater than 50 must be primary PCI. Sufficient number of operators and catheterization laboratory staff performing PCI to ensure the availability of PCI services 24 hours a day, seven days a week. Class I indication, Level C evidence 11 See Appendix 18 for a list of absolute and relative contraindications to fibrinolytic therapy. Access to Urgent PCI for STEMI Consensus Panel Report 46

47 Recommendation 3 - That fibrinolytics be administered to STEMI patients who present to hospital within 12 hours of symptom onset and who cannot receive primary PCI within the recommended door to balloon times, or for whom PCI is contraindicated 12. Patients who present after 12 hours of symptom onset are to be managed on a case by case basis. Class 1 indication, Level A evidence Recommendation 4 Patients presenting within 2 hours of symptom onset represent a special subset of STEMI patients who derive particular benefit from early reperfusion therapy. Careful case by case consideration of treating these patients with fibrinolytic therapy rather than primary PCI should occur, weighing the risk of fibrinolytic therapy with the potential delay in performing primary PCI. Class IIa indication, Level B evidence Recommendation 5 - Rescue angioplasty should be performed for patients with acute STEMI who receive fibrinolytic therapy but continue to present with on-going ischemic symptoms and ECG changes 90 minutes following the administration of the fibrinolytics. Class IIa indication, Level B evidence Recommendation 6 - Patients less than 75 years of age who present with cardiogenic shock within 18 hours of symptom onset, should be transferred immediately to an advanced cardiac center with on-site cardiac surgery for immediate angiography and revascularization. Patients over 75 years of age are to be managed on a case by case basis. The use of fibrinolytics has not been proven effective in this setting and its use should be individualized. Class I indication, Level B evidence Recommendation 7 Primary PCI should be performed in centres with on-site cardiac surgical capability or in established stand-alone PCI centres with demonstrated ability to transport patients to a cardiac surgical centre within 90 minutes of decision to transport. Class I indication, Level C evidence 12 Contraindications for PCI include: a) lack of femoral access; b) elevated creatinine clearance; and c) prior CABG on a case by case basis. Access to Urgent PCI for STEMI Consensus Panel Report 47

48 5.0 THE CURRENT STATE 5.1 LIMITATIONS The information provided in the following section is based on the Panel s data gathering for this report. It is important to note the limitations of the data collected in defining and understanding the current state, which are listed below: Responses to the surveys ranged from 100% to 32%. The lowest response rates were for the EMS Operations survey (32%) and the Base hospital Director survey (52%). EMS services is a critical component of a primary PCI model, and a full understanding of the issues across a representative sample of all municipalities was important for the work of this Panel. Data was not universally available for all survey questions. Consequently, respondents would either estimate values or state that the information was unavailable, both of which affected the completeness and accuracy of some survey questions. Where data is estimated or incomplete, it is indicated as such in the text below. Data on emergency response and transfer times was not available to this Panel from the Ministry Emergency Services Branch; therefore, transfer times were estimated using geographical information systems software (GIS) based on assumptions for average road speeds. The EMS response time and hospital administrative time associated with a patient transfer was estimated based on expert opinion. 5.2 ESTIMATED NEED AMI and STEMI Hospital Admissions and Outcomes Based on the analysis of the CIHI hospital abstract data, approximately 20,000 Ontarians were hospitalized with AMI in 2000/01, of which over 6,500 admissions were due to STEMI. These numbers have been increasing by approximately 2% per year since 1999/00. (See Appendix 19 for data tables.) In general, the incidence of STEMI increases with age and occurs more frequently in men than in women. Average in-hospital mortality for AMI remains high at 8.7% in the CIHI cohort, with rates higher in women (11.5%) than men (7.2%). Rates range from 6.7 to 8.7 (age/sex adjusted) across the Ministry planning regions. Many AMI and STEMI patients who survive the initial event go on to have repeat admissions. Although one year re-admission rates have been decreasing in AMI patients, they still remain high at 7.2% for congestive heart failure, 10% for acute MI and 12.2% for angina, as seen in Table There has been a trend towards longer lengths of hospital stay (LOS), with the average LOS in 1999/00 at 7.7 days and in 2001/02 at 8.0 days. 13 STEMI specific re-admission rates, in-hospital mortality rates and LOS not available. Access to Urgent PCI for STEMI Consensus Panel Report 48

49 Table 1 One-Year Re-admission Rates per 100 Acute MI in Ontario aged 20 to 85 WOMEN MEN Total Total AMI 2000/ / / Total Angina 2000/ / / Total CHF 2000/ / / Total Source: CIHI Discharge Abstract Database Inclusion criteria: Most responsible diagnosis code (MRD) = ICD9 code 410 (AMI) Exclusion criteria = age<20 and >85; non-ontario residents, in-hospital complications, transfers, invalid HIN *AMI, CHF, and angina as MRD, but not in-hospital complication, days from index discharge to readmission The Canadian Cardiovascular Outcomes Research Team (CCORT) recently released its findings from the EFFECT 14 study (Phase I) which was based on the analysis of clinical data collected from retrospective chart review of AMI and CHF hospitalizations in 44 hospital corporations (1999 to 2001) (126). The EFFECT aggregate one year readmission rate was similar to the CIHI administrative data at 11%. The average 30-day mortality rate was 12% and one-year mortality rate was 20% for AMI patients in the EFFECT study Angioplasty Volumes- There were over 13,500 PCI cases completed in Ontario in 2002/03. The PCI procedure rate has been increasing by an average of 12% per year since 1992/93. Most of this growth has occurred since 1997/98, at which time catheterization laboratory capacity in Ontario was increased. The 2003 Target Setting Consensus Panel is currently reviewing PCI targets for Ontario using a needs-based methodology. This methodology integrates recommended practice patterns for specific procedures based on clinical indications. The estimated utilization for PCI in STEMI is approximately 22% (2001/02) provincially. Recommended future targets will be based on full adoption of clinical evidence for STEMI (72% rate provincially). 14 EFFECT Enhanced Feedback for Effective Cardiac Treatment Access to Urgent PCI for STEMI Consensus Panel Report 49

50 5.3 ORGANIZATION OF CARDIAC CARE IN ONTARIO PCI Centres Tertiary cardiac care services in Ontario are centrally organized within the Ministry s Health planning regions. Figure 1 (next page) illustrates the seven Ontario planning regions and the location of the PCI centres within each of these regions. At the time the PCI sites were surveyed for this report (June 2003), there were 9 PCI centres operational in Ontario (excluding the pilot stand-alone PCI site - PCI without onsite cardiac surgical back-up). Two additional PCI centres were scheduled to be opened in July 2003 and November 2003, and were included in the survey process. In total, all eleven sites completed the survey (100% response rate). Collectively, these PCI centres operate 29 catheterization laboratories in 11 locations (83% of all catheterization laboratories in the province) with an additional 6 laboratories either approved to be opened or under construction. They draw on the services of 56 interventionalists 15 and over 200 full-time equivalent catheterization laboratory staff, as shown in Table 2. These institutions range in size from 102 to 780 acute care beds. For detailed responses to the survey questions, see Appendix 20. Table 2 -- Overview of PCI human and physical resources in Ontario, June Resource Number Beds Acute care 3,802 CCU beds 122 Post-PCI, step-down and telemetry beds 270 Cath Labs No. of current laboratories 29 Approved or under construction 6 Human Resources Cardiologists 191 Interventionalists 56 Cath lab staff (e.g., nurses, technicians) 203 FTEs Source: Survey of PCI Hospital Cardiac Administrators, June Including the 3 interventionalists at the stand-alone site, there were 59 interventionalists operating at the 12 adult cardiac care sites in Ontario, June Responses to the survey of administrative directors for cardiac services at PCI centres, which is described in Section 3.5.2; excluded stand-alone PCI site. Access to Urgent PCI for STEMI Consensus Panel Report 50

51 Figure 1 Location of Cardiac Centres in Ontario by Ministry Planning Region Cardiac Centres in Ontario within Ministry of Health and Long Term Care Planning Regions NORTH REGION EA EA CENTRAL CENTRAL EA E 33 CENTRAL CENTRAL EAST EAST REGION REGION EAST EAST REGION REGION CENTRAL CENTRAL WEST WEST REGION REGION TORONTO REGION SOUTH SOUTH WEST WEST REGION REGION CENTRAL CENTRAL SOUTH SOUTH REGION REGION LEGEND ID No Full Service Centre Hopital Regional de Sudbury Reg. Hospital Kingston General Hospital University of Ottawa Heart Institute St. Michael's Hospital Sunnybrook and Women's Health Sciences Centre University Health Network Trillium Health Centre Hamilton Health Sciences London Health Sciences St. Mary's General Hospital Southlake Regional Health Centre 12 Stand-alone PCI Centre Rouge Valley Health System Cath Only Centre Thunder Bay Regional Health Sciences Centre Sault Area Hospital Hotel Dieu Grace Hospital - Windsor Peterborough Regional Health Centre Toronto East General Hospital 18 Cath Centre - in development William Osler Health Centre Access to Urgent PCI for STEMI Consensus Panel Report 51

52 All PCI centres offer fibrinolysis for STEMI patients. In 2002/03, these centres reported administering approximately 1,173 doses of lytics to cardiac patients. All of the nine operational PCI centres offer Primary PCI, while 7 offer rescue PCI and only 1 conducts facilitated PCI. However, the centres were unable to provide reliable data on the number of these procedures. This data is not collected in the CCN registry Acute Care Centres (non-pci Centres) The information on acute care centres is derived from the responses to the Acute Care Hospital Survey (July 2003), which was described in Section (See Appendix 21 for a summary of the survey responses). It is important to note that although 58% of the acute care hospitals responded to the survey, these hospitals represent only 45% of the total acute care beds, indicating a possible under-representation of the larger acute care hospitals in the findings from this survey. Two-thirds of the responding hospitals serve a catchment area of fewer than 100,000 people, and almost 50% have fewer than 50 beds. In the North region, 92% of the responding hospitals have a catchment area of fewer than 100,000 with 72% having fewer than 50 beds. Only 70% of the hospitals reported having an Emergency Room (ER) that is open 24/7. Some reported limited service on weekends and statutory holidays, and after business hours. Most hospitals offer at least emergency treatment (fibrinolysis) for cardiac patients and have a general medical inpatient unit. However, 22% of responding sites did not have telemetry beds and 31% did not have an ICU. Collectively, these hospitals recorded almost three million ER visits in 2002/03, of which 5,700 were estimated patients with STEMI. These hospitals administered an estimated 4,000 doses of fibrinolytics to these emergency patients. These centres reported 715 internists and 206 cardiologists with privileges at these centres. 5.4 CURRENT PRACTICE PATTERNS FOR STEMI The information presented in this section is based on the responses of the eleven PCI centres to the structured telephone interviews, as described in Section This data is also supplemented by the findings from the CCORT on the EFFECT study for AMI (126). Reperfusion strategies for STEMI include fibrinolysis and urgent PCI. Urgent PCI can be sub-defined into three categories including: 1. Primary PCI; 2. Rescue PCI; and 3. Facilitated PCI. Access to Urgent PCI for STEMI Consensus Panel Report 52

53 A formal definition for each of these treatments was included in each survey instrument, and is provided in Section 2.0. All eleven PCI centres agreed with these operational definitions Reperfusion Therapy According to the EFFECT findings, 59% of patients with STEMI received acute reperfusion therapy (fibrinolytics, PCI or a combination). Of these patients, 99% received fibrinolytics and 3% received PCI within 24 hours of admission. It should be noted that a relatively small number of the organizations involved in this study have the capability to provide PCI (6 of 44 sites). In this sub-set, STEMI patients receiving PCI within 24 hours of admission ranged from 10 to 40%. Data is not available on patients receiving primary PCI within this 24-hour window. The remaining 41% of STEMI patients did not receive reperfusion therapy. The EFFECT researchers postulated that this could reflect later hospital arrival after symptom onset or contraindications to reperfusion therapy, concern about its use in the elderly, or missed opportunities to provide this therapy. This potential under-utilization of effective reperfusion therapy indicates that considerable more work needs to done with respect to public education and uptake by physicians on current practice guidelines for treatment. The median door-to-needle time in the EFFECT study was 37 minutes (target = 30 minutes or less). Several factors were seen to influence this time. For example, the time was eleven minutes less when the emergency physician made the decision to administer the fibrinolyics and 10 minutes less when the fibrinolytic therapy was administered in the emergency department rather than in CCU/ICU Indications for Treatment In general, the type of reperfusion strategy used and the associated indications reported were highly variable across the PCI sites. Although all centres were supportive of the concept that all eligible STEMI patients should receive primary PCI, they were generally limited in their ability to provide this service to all comers due to resource and procedural constraints such as available catheterization laboratory time and staff, funding, available CCU beds and the potential impact of a primary PCI policy on their ability to respond to their elective cases and staff scheduling the next day Fibrinolysis/No PCI The first line of treatment reported for STEMI is fibrinolysis with no PCI. All eleven PCI centres offer this treatment, and most report using it for between 60% and 100% of all patients presenting with STEMI. These findings are generally consistent with the EFFECT data. The participating PCI sites in the EFFECT study reported a 75% to 97% fibrinolysis rate. Any patient for whom STEMI is recognized and who has no contraindications for fibrinolysis is treated with a fibrinolytic agent. Generally, the ER physician makes this decision, which is also consistent with the EFFECT findings. As well, patients presenting with STEMI and with conventional indications for fibrinolysis, will receive Access to Urgent PCI for STEMI Consensus Panel Report 53

54 lytics at most sites if the patient arrives after regular catheterization lab hours 17 when primary PCI is not available Primary PCI Primary PCI is offered at all nine operational PCI centres. Most centres reported between 3% and 25% of their patients receiving primary PCI. Only one centre reported 95% of STEMI patients receiving primary PCI. However, all centres report being able to provide primary PCI 24 / 7 as needed for patients with contraindications to fibrinolysis, or who are in cardiogenic shock or high risk. In general, the clinical criteria used for accepting patients for primary PCI includes presentation to the ER within 12 hours of symptom onset with at least 1 mm ST segment elevation on two contiguous leads on a 12-lead EKG or new left bundle branch block (LBBB). However, sites will often only provide primary PCI in cases of large or complicated MIs, heart failure, shock or fibrinolytic ineligibility. Patients presenting with STEMI outside of regular catheterization laboratory hours are not routinely provided primary PCI. Generally, only patients who are haemodynamically compromised, especially younger patients with a large infarct, who are fibrinolytic ineligible, or who are in cardiogenic shock or high risk will receive PCI. For patients transferred from a non-pci centre, some centres will perform primary PCI for patients with contraindications for fibrinolytics and cardiogenic shock, even outside of regular working hours, while others only accept patients during regular catheterization laboratory hours. The timeliness of transfer is an additional consideration for accepting a patient for primary PCI Rescue PCI Two of the 9 PCI centres do not perform Rescue PCI. In the remaining seven centres, between 3% and 30% of patients presenting with STEMI will receive Rescue PCI after failed fibrinolysis. The decision to perform rescue PCI is generally made 90 minutes after the fibrinolytic agent has been administered. Acceptance for the procedure depends on the operator and on the timeliness of the referral. The probability of receiving Rescue PCI is operator and time dependent. Most centres will offer rescue PCI 24 / 7 for high risk cases or shock, or as needed during regular catheterization laboratory hours because of difficulties in staffing the lab for the procedure or difficulties in recalling staff for the next day. The criteria for rescue PCI are generally the same for patients referred from a non-pci centre. Most centres accept transfers from referring hospitals for rescue PCI for large infarcts, unstable patients and if there is a bed available. 17 PCI centres reported regular cath labs hours as starting between 7:00 am and 8:00 am, and ending between 5:00 pm and 6:30 pm, Monday through Friday. Access to Urgent PCI for STEMI Consensus Panel Report 54

55 Facilitated PCI Only one centre reported providing facilitated PCI. Estimated volume was less than 1% of all STEMI patients. A second centre reported that facilitated PCI is available within a research study in which the protocol applies only to large MI s, and is available 24/7. About 50% of all STEMI are entered into the protocol and 50% of those entered (i.e., 25% of the total STEMI patients) receive facilitated PCI. Outside of the research protocol, this centre does not perform any facilitated PCI. If the patient is in shock related to a large MI and is being transferred from a non-pci centre, the sending hospital is generally instructed to administer a full dose of fibrinolytics and arrange immediate transfer for facilitated PCI Logistics In most centres, the referral for primary PCI is made by the ER physician to a cardiologist or an interventional cardiologist. Patients that are referred-in are typically sent directly to the catheterization laboratory or, if the catheterization laboratory is not available, to the CCU to await the procedure. For patients presenting to the ER of a hospital with a PCI laboratory, the estimated time from decision to do PCI to the start of the actual procedure is 15 to 60 minutes (average 37 minutes). No time estimates were provided with respect to transferring patients from the ER of non-pci hospitals to the catheterization laboratory. All centres send patients to the CCU for recovery immediately following the procedure. Patients who presented to the ER of the PCI hospital are kept at that hospital until discharge. For patients referred-in for primary PCI, four centres transfer patients back to the referring hospital, and five keep the patient on-site for the recovery period Scheduling of Procedures In all cases, urgent PCI takes priority over previously scheduled but less urgent cases. Centres will try to fit emergency cases into the catheterization laboratory schedule, but if this is not feasible, most centres prefer to cancel elective procedures rather than to incur overtime. Some centres will accommodate as much as possible with overtime Administrative Considerations When a primary or rescue PCI procedure is required outside of regular catheterization laboratory hours, the PCI centre must arrange for staffing (e.g., physician, nurses, and technicians). If an interventional cardiologist is called in for an evening or early morning procedure, he or she typically must perform their regularly scheduled duties the following day. Nurses and other catheterization laboratory staff are often covered under a collective agreement that governs whether they can or should report for work the following Access to Urgent PCI for STEMI Consensus Panel Report 55

56 morning if they are called in for procedures after regular hours. This arrangement can have a significant impact on staffing on the following day Transfer Arrangements Most of the 11 PCI centres have no formal agreements with referring hospitals regarding the transfer of patients with STEMI for urgent PCI. The ability to accept transfers is dependent on the availability of an ambulance (with a paramedic or a physician in attendance), the ability to transport the patient within acceptable time frames, the availability of an interventional team and the availability of a CCU bed. 5.5 REFERRAL AND TRANSFER PROCESS (ACCESS TO CARE) As PCI services are centralized in advanced cardiac centres, the referral and transfer of patients from non-pci centres to PCI centres is a critical component in delivering primary PCI care Patient Referrals In general, patients are referred to the closest PCI centre. In larger regions, patients may be transferred from a small hospital to the nearest cardiac centre (may not be a PCI centre e.g., Thunder Bay) for further assessment and/or stabilization before being transferred to a PCI centre (e.g., Sudbury). Patient condition, physician opinion, and availability of transportation and receiving hospital resources all play a major part in triaging patients when patient transfer resources are limited. In some cases, patients are transferred across health planning region borders, and even across provincial (i.e., to Winnipeg) and national (i.e., to Michigan and Minnesota) borders. The referral process is currently quite onerous for the sending hospital. The referring physician must first locate a specialist to accept the patient for transfer. The accepting physician must then ensure that he or she has the appropriate supporting resources (e.g., catheterization lab time, catheterization lab staff, and CCU beds). This process is complicated by a lack of formal protocols for identifying a specialist and a receiving hospital. Acute care administrators consistently spoke to a need for a one number to call approach to arranging the transfer. Survey respondents also identified difficulties in delivering timely and detailed patient information to the receiving physician Patient Transfers Once a receiving physician and facility have been located, arrangements need to be made for land or air ambulance transportation as well as an appropriately qualified escort. Transferring potentially unstable STEMI patients, requires supportive medical equipment (e.g., monitors) and qualified staff trained in its operation. Frequently, the sending facility Access to Urgent PCI for STEMI Consensus Panel Report 56

57 must provide the escort and equipment for the transfer. For smaller centres, sending one of the nursing staff on a transfer can create complications for back-filling staff or for scheduling staffing on the following days. For most PCI centres, 90% to 100% of patients are transferred by land ambulance. In the North, most patients (95%) are transferred by air ambulance. Travel times from the referring hospital to the PCI centre (as reported by seven PCI centres 18 ) averages 52 (up to a maximum of 150) minutes. Not all acute care hospitals are able to take back PCI patients. Some hospitals lack the resources needed to meet the medical and clinical requirements of these patients. Twenty-two percent of the non-pci centres reported that they have no CCU or telemetry beds, and some have no cardiologists on staff. Lack of transportation services to return patients back to the sending facility is a frequently cited limitation. The sending facility is responsible for the costs of transfer. Few centres track the costs associated with these transfers, and only one centre stated that these costs are a barrier to care. 5.6 EMERGENCY SERVICES The information in the following section is based on information provided to the Panel by representatives from EMS and the Emergency Health Services Branch of the Ministry and from responses to the EMS surveys described in Section (See Appendices 22 and 23 for a summary of the survey responses). As noted earlier, the response rate for these surveys was relatively low, and the results should be interpreted with caution THE POLICY FRAMEWORK The Ministry is responsible for ensuring a balanced and integrated system of land ambulances and communication services. To fulfill this responsibility, the Ministry: Maintains and operates communication services; Establishes standards for the management, operation and use of ambulance services and ensures compliance with these standards; and Designates hospitals as base hospitals to monitor quality of care provided by ambulance services in the regions. The Ministry is also responsible for the funding of: Air ambulance services; Ambulance communication services; and Base hospital programs. The provision of land ambulance services is the responsibility of Upper Tier Municipalities (UTMs) and Designated Delivery Agents (DDAs) pursuant to Subsection 6(1) of the Ambulance Act centres did not provide data for transfer times Access to Urgent PCI for STEMI Consensus Panel Report 57

58 Each of the 22 base hospitals in Ontario is responsible for providing: Delegated authority to paramedics for controlled medical acts. All paramedics provide patient care under the delegated authority of a base hospital physician. Medical advice to paramedics relating to pre-hospital care and transportation. Quality assurance information and advice. Continuing medical education for paramedics to maintain the delegation of controlled medical acts. The UTM/DDA is responsible for determining the level of service to be provided by EMS within their designated areas. This includes decisions around the number of ambulances, the type of equipment carried on each ambulance, the number of paramedics and level of training, and utilization of these resources. All ambulance services are required to meet response time standards for emergency calls. Paramedics can be trained to three levels of proficiency: primary care paramedic (PCP), advance care paramedic (ACP) and critical care paramedic (CCP). The care performed by the paramedics at each level is shown in Figure 2 on the following page. The minimum level of training required to transport a STEMI patient is to be determined; however, the required skill set is described in Section LAND AMBULANCE SERVICES There are a total of 5,851 land ambulance paramedics (Table 3) in Ontario. The responding municipalities reported having 1,516 paramedics (20% of provincial total). Although 21% of the paramedics are ACPs, of the 1,248 ACPs in Ontario, only 9.6% are located outside of major metropolitan areas. Eighty-two percent of ACPs are collectively located in three major areas: Toronto, Ottawa and the area known as the Golden Horseshoe. All CCPs (n=16) are located in Toronto. (See map on following page.) The 16 responding EMS operations Directors reported that all ambulances are active on weekdays during the day shift. 90% of the available ambulances are reported active on day shifts on the weekend. Coverage drops to an average of 71% of available ambulances on night shifts. None of the respondents reported having Heparin or IIB/IIIA platelet inhibitors in the ambulances drug inventory. In 2002/03, the 16 responding EMS Directors reported responding to almost 250,000 emergency calls. Ten services reported a total of 24,300 calls for cardiac chest pain. Calls for emergency transport from the community (89,571, N=7) were much more common than inter-facility transfers (4,391, N=9). This finding is consistent with the municipalities stated priority to respond to community 911 calls over inter-facility transfers. Access to Urgent PCI for STEMI Consensus Panel Report 58

59 Figure 2 - Primary, Advanced and Critical Care Paramedics Level of Certification Primary Care Paramedic List of Controlled Acts that May be Performed Administration of glucagon, oral glucose, nitroglycerin, epinephrine, sabutamol and ASA (80 mg form). Semi-automated external cardiac defibrillation. Advance Care Paramedic (or PCP if authorized) Critical Care Paramedic (or ACP if authorized) Administration of drugs referred to above, in addition to any other drug approved by the Director on the recommendation of one or more medical directors of base hospitals. Semi-automated external cardiac defibrillation. Peripheral intravenous therapy Endotracheal intubation Non-automated external cardiac defibrillation and monitoring Administration of any drug that an ACP may administer, in addition to any other drug approved by the Director on the recommendation of one or more medical directors of base hospital programs. Any controlled act that an ACP may perform. Non-automated external cardiac defibrillation, electrical cardioversion and pacing. Maintenance and monitoring of arterial and central venous catheters Gastric intubation and suction Ventilation (mechanical) and setting of ventrillatory parameters Lab value interpretation. Management of chest tubes and chest drainage systems Chest x-ray interpretation Urinary catheter insertion Intravenous blood product administration Doppler flow monitor use Use of infusion pumps Other advanced airway techniques, e.g., needle thoracostomy, cricothyroidotomy. Source: MOHLTC Emergency Health Services Branch Access to Urgent PCI for STEMI Consensus Panel Report 59

60 Figure 3 Ontario Paramedic Distribution, 2003 Access to Urgent PCI for STEMI Consensus Panel Report 60

61 Table 3 Number of Paramedics in the Province of Ontario, January 2004 Category Level of Paramedic PCP ACP CCP Total Land Ambulance Land ambulance (all) Land ambulance (excl (90%) 823 (66%) 0 (0%) 4958 (85%) Toronto) % outside of major N/A 9.6% 0% metropolitan areas Air Ambulance Source: MOHLTC Emergency Health Services Branch, January AIR AMBULANCE SERVICES In areas of the province where distances to advanced acute-care services are large, air ambulance services are required for rapid patient transport. The key differences between air and land ambulance (for the purpose of this Panel) are as follows: In general, the air ambulance paramedics have a higher degree of training than land ambulance paramedics. However, critical care service is not available in all aircraft. Air ambulance aircraft are staffed at either the primary, advanced or critical care levels. Similarly, the air ambulance has more equipment than is typically available in a land ambulance. However, equipment will vary depending on the level of care provided. Although greater distances can be covered in a shorter period of time, the total time for transporting a patient may be much longer due to the longer distances traveled and the need for the air ambulance to travel from its base to the patient s location. Many acute care hospitals do not have adjacent helipads. In those locations, the patient must first be transported by land ambulance to a location where the patient can be transferred to the air ambulance. Air ambulance services are especially vital in northern Ontario and/or where land ambulance services are not well developed. The air ambulance program provides approximately 17,000 patient transfers annually. Air ambulance services provide the benefit of the ability to provide full patient care without taking local staff or equipment from the sending hospital. Because of the requirement for the air ambulance to travel from its base of operations to the sending facility, limited air ambulance availability, and the frequent lack of hospital based helipad access, total time required to transport the patient to the PCI centre can be prolonged beyond 120 minutes. However, for patients being transferred for rescue PCI without a strict time window, for geographic regions with limited land ambulance service or inability for land services to provide transfer within 120 minutes, air ambulance could be the preferred mode of transportation for these patients. Access to Urgent PCI for STEMI Consensus Panel Report 61

62 In Ontario, there are 13 fixed wing bases in Ontario 19 and 7 helicopter bases 20. For the rapid transfer of STEMI patients for primary PCI, fixed wing transportation would not be a consideration; however, helicopter transportation could be an option in some areas, if heliports are available at sending and/or receiving sites REGIONAL VARIATIONS IN AMBULANCE SERVICES In the EMS Operations survey there were regional variations in the issues identified, such as: The Northern services often reported that their catchment populations were too small to warrant the costs of expanding service levels, equipment, the numbers of paramedics, or a higher degree of training. In contrast, the Southern services were more likely to report the need for additional funding to provide more equipment or training as a significant barrier to service provision. Travel times in or from the North are often too long to provide primary PCI. For example, there is no PCI centre within 90 minutes of the District of Thunder Bay. Average transfer times from the sending hospital to the nearest PCI hospital were reported to be as high as 13 hours in one Northern jurisdiction. All regions reported the lack of qualified staff and/or equipment as a barrier to maintaining or increasing service levels JURISDICTIONAL ISSUES As described earlier, the responsibility for providing emergency medical services is shared across multiple jurisdictions including the municipalities, base hospitals (which are agents of the Ministry), and the Emergency Health Services Branch (EHSB) of the Ministry. However, operational and budget decisions rests with the 50 UTMs, which has implications for cross municipal border transfers and implementing regional health care delivery models. For example, as stated in the Ambulance Act, any transportation within a municipal jurisdiction is the responsibility of that jurisdiction. Therefore, municipalities with PCI sites receiving patients transferred by EMS from neighbouring municipalities will be billed for that transfer. This system creates disincentives for receiving cross border transfers. Developing a system-wide approach to the delivery of primary PCI services will require all jurisdictions to be involved in its planning and delivery. Another frequently cited example of inter-jurisdictional issues is the repatriation of PCI patients to the sending hospital. The post-pci patient is generally stable and not considered an urgent transfer by EMS. Therefore, this inter-facility transfer, which could take a vehicle out of service for an extended period for longer travel distances, would be considered low priority and may take several days to complete. As well, an ambulance may not be available to immediately transport the medical or clinical escort back to the PCI hospital if required. 19 Almonte, Dryden, Fort Frances, Island Lake, Kapuskasing, London, Muskoka, Sioux Lookout, Smith s Falls, Sudbury, Thunder Bay, Timmons and Toronto. 20 Kenora, London, Moosonee, Ottawa. Sudbury, Thunder Bay and Toronto. Access to Urgent PCI for STEMI Consensus Panel Report 62

63 In some municipalities, formal agreements have been made for ambulance to cross municipal borders. However, very few of the responding EMS Operations Directors reported having this type of agreement with bordering municipalities. EMS operations are limited in the number of ambulances that can be out of the home jurisdiction at any given time. The UTM/DDA sets the deployment strategy for their municipality. This is a more significant issue for smaller municipalities with fewer ambulances to spare at any one time. A model of care that requires patient transfers to cross municipal boundaries regularly would need to address this issue AVAILABILITY OF SERVICES FOR TRANSFER FOR URGENT PCI The in-transit needs of a primary PCI patient vary depending on the origin and destination of the trip: If a patient is being transported from the community to an acute care hospital, the patient will need basic life support until the ambulance reaches that acute care hospital and is taken into a physician s care. A PCP, supported by basic equipment, provides the needed services. This is the current standard of care for community transfers. For inter-facility transfers, if the patient s needs are high, a nurse or physician can accompany the patient on the ambulance, thereby reducing the skill requirements for the paramedic. 21 However, depending on the patient s condition, the ambulance may need more sophisticated equipment for the transfer which is provided by the sending facility. Current EMS standards for community response require patients to be transported to the closest acute care hospital. If the patient then needs to be transferred to a PCI centre, the inter-facility transfer requires another ambulance to be dispatched. In general, emergency calls from the community will take priority over inter-facility calls, even if coded as emergent. One hospital responding to the survey reported using their own ambulance dedicated to inter-facility transfers to deal with these issues in order to ensure timely transportation for urgent cases and/or to create available bed space. Regional systems and EMS protocols have been developed over the past decade for trauma, high-risk obstetrical and stroke patients. In the trauma model, EMS paramedics, after appropriately assessing the patient, will bypass the local acute care hospital to transport the patient to the regional centre for specialized care. A similar protocol has been developed for stoke patients and is in the early implementation stage. A onenumber to call concept has been used successfully in high risk obstetrics. The trauma and high-risk obstetrical programs are mature systems that demonstrate that a system integration model can work. 21 Five out of 11 base hospitals reported hospital medical staff accompany the patient on emergency transfers more than half the time. The same number reported sending an RN/RRT more than half the time. Access to Urgent PCI for STEMI Consensus Panel Report 63

64 5.7 BARRIERS TO ACCESS The barriers to access to a primary PCI model, and suggestions to overcome these barriers, were identified in the surveys and submissions, and are described below A Provincial Policy for Primary PCI One of the most significant barriers to providing a primary PCI model is the lack of a provincial policy. It was felt that Ontario, and most of Canada, is falling behind the international standards of practice for primary PCI. Without an explicit recognition of the value of primary PCI in the treatment of STEMI, a commitment and policy for delivering primary PCI on a systematic basis, or the funding to implement the needed service enhancements to support such a policy, Ontario will fall even further behind. It was felt that an explicit policy on primary PCI would mobilize the PCI centres, acute care hospitals, municipal EMS operations, the base hospitals, and the Ministry to work together towards common goals and objectives. With common expectations and performance measures, the system could be made to work effectively. As well, practice guidelines developed to support this policy would ensure that standards and quality of patient care and appropriate allocation of resources are maintained across the province Central Coordination and Communication Acute care hospitals and PCI centres both spoke frequently about the need for a coordinated approach to delivering primary PCI services, including centralized communication. The concept of one call to call to arrange transfer was high on the priority list for sending hospitals, who believed that a centralized approach could help significantly to expedite the referral process by identifying an accepting facility and an available interventionalist and PCI team, CCU beds and other support services needed to ensure acceptance of the patient at the PCI centre. A coordinated approach would require the collaboration of EMS and PCI centres to work towards a common goal of meeting transfer standards to the nearest PCI centre. Acute care hospital administrators identified the challenges in delivering detailed and timely patient information to the receiving specialist as a barrier to timely patient transfers for primary and rescue PCI. Survey respondents also indicated a need for better communication capabilities between the ambulance paramedics and the ER physicians. A centralized approach to service coordination could also assist with these requirements. It was suggested that a centralized approach might also include standardized treatment protocols (e.g., care maps, triage protocols, checklists) and standards for timeliness of services Human Resources Most PCI centres identified a need for more catheterization laboratory staff (i.e., nursing and other support staff) to expand capacity to meet the potential demand for primary and rescue PCI. Some centres are currently challenged to meet the need for staffing during Access to Urgent PCI for STEMI Consensus Panel Report 64

65 regular catheterization laboratory hours. These pressures are compounded when staff is called in for an off-hours procedures and the staffing plan for the following day is compromised. Although many centres have requirements in place regarding response time for emergency after-hours calls, ensuring routine timely response to these calls is not guaranteed, especially in some areas with larger geographical distances, traffic or adverse weather conditions. Six centres noted that additional interventionalists and RNs are needed in the face of current and pending shortages of suitably qualified physicians and nurses. Few centres have succession plans in place to accommodate turnover in human resources. In addition, pressures from other clinical and research responsibilities compete with the time available for procedures, especially in the Health Science Centres. Non-PCI centres were most concerned with the transfer process, and highlighted a need for more nursing staff, especially nurses certified in monitors, to accompany the patients Physical Resources Five PCI centres identified a shortage of CCU beds (which were limiting the ability to handle all of the STEMI patients who could be referred to the facility), and some reported that catheterization laboratory time and CCU beds are usually available. Two other PCI centres identified a shortage of beds, without specifying whether these were CCU beds or not. One centre indicated that additional PCI beds 22 would also help to ensure services were available when needed. Some centres commented on the utilization of existing physical resources. In one case, the catheterization laboratory is in a different location than the ER, which increases response time. In another, the administrator felt that the catheterization laboratory hours could be extended to increase capacity. Access to these services is severely limited (emergency only) after regular catheterization laboratory hours. In areas where acute care hospitals do not have 24/7 ER operations, patients have limited access to emergency services. Acute care hospitals trying to arrange the transfer of a patient to a PCI centre cited the availability of beds (and monitored beds) as a key barrier to transferring patients Geography/Environmental As noted earlier, the delivery of tertiary cardiac services in Ontario is relatively centralized. With a short treatment window from presentation with STEMI at the ER in an acute care hospital to treatment at a PCI centre, long transfer times create a significant barrier to service in many communities. Many (68%) of the non-pci centres reported average transfer times to PCI centres of over one hour, and 39% reported transfers times of longer than two hours. Fifteen hospitals reported transfer times of more than three hours for emergency transfers. The 22 A PCI bed is a short-term acute care bed for recovery immediately after the PCI procedure. Access to Urgent PCI for STEMI Consensus Panel Report 65

66 longest transfer times are reported in the North, where emergency transfers can take over two hours (23 hospitals) or even over three hours (nine hospitals). When asked if they would transfer patients for primary PCI if this service were available at the usual referral centre, only 39 (42%) said that they would use such a service. For some centres, the distances involved do not allow a timely transfer, and only very serious conditions would result in a decision to choose delayed primary PCI over fibrinolytics. As well, many sites reported inclement weather as a potentially significant factor contributing to delays in patient transfer, particularly for air EMS transport Financial Many of the PCI centres reported a need for additional funding for incremental PCI volumes and an addition to the operating budget, in part to increase staffing levels. In the short-term, more funds are needed for staff overtime. Some centres speculated that hiring more staff could save money in the long-term as overtime costs are then avoided. Non-PCI centres identified the need for additional funding to cover the costs of transporting the patient to the receiving facility and back again. Many EMS operations, particularly in the North, reported that the population size was not sufficient to warrant a larger investment in EMS equipment and personnel at this time Credentials/Training The availability of paramedics is a key issue for all EMS operations. Human resource shortages are experienced across the province. The degree of training for paramedics may also be a barrier to delivering broader access to primary PCI, especially if a bypass protocol is developed whereby the potentially unstable STEMI patient from the community requires in-field assessment and transportation directly to a PCI centre. The paramedic skill set required for this level of response will need to be determined Patient Transfer For the sending facility, the patient referral and transfer process is reported to be complicated, time consuming, and frustrating, and results in significant delays in getting the patient to the PCI centre. Acute care hospital administrators spoke frequently about the need for an organized network and broadly accepted protocols for referrals and transfers within that network. A major element of the delay is the time needed for the sending hospital to locate a specialist who is willing to accept the patient and has the supporting human and physical infrastructure (e.g., catheterization lab time, CCU beds, catheterization lab staff) to provide the services needed. Arranging for a land or air ambulance, with appropriate escorts, is reported to take up to three hours at some centres even for emergency transfers. Cardiac administrators spoke often of the availability of emergency transfer vehicles and personnel, and the level of training of EMS paramedics as a potential barrier to timely and safe transfer of urgent PCI patients. Where ambulance personnel do not meet the Access to Urgent PCI for STEMI Consensus Panel Report 66

67 level of care required for a STEMI transfer, the availability of an appropriately qualified escort (e.g., RN or physician) from the sending hospital becomes an issue. For receiving centres, the identified transfer barriers related primarily to the ability to repatriate the patient after the procedure. Repatriation may be difficult if there is no ambulance available to return the patient to the referring hospital, or if the referring hospital does not have the resources to accept the returning patient. Of the 94 acute care hospitals who responded to the survey, few had transfer arrangements in place for the transfer of primary PCI candidates and none had formal transfer policies or procedures in place that could be shared with the Panel. Access to Urgent PCI for STEMI Consensus Panel Report 67

68 6.0 THE RECOMMENDED STATE The treatment of acute STEMI has undergone tremendous change over the last several decades. Much of the additional knowledge has reflected the superiority of primary PCI compared to fibrinolytic therapy for the treatment of acute MI. Despite the advancement of scientific knowledge, the major impediment of applying this knowledge to practice in Ontario has been the lack of a provincial policy and the appropriate infrastructure and resources. The following section describes a phased-in approach for implementing a primary PCI model of care for Ontario, which starts with the development of the supportive system infrastructure (Phase I). Phase II involves the implementation and piloting of several integrated service delivery models which are patient presentation-based. Each model is determined by the location in which the patient presents with the acute MI. This graduated approach, combined with a pilot implementation phase, will provide an opportunity to fully assess the feasibility and generalizability of the across the different regions of the province; to assess the full resource and cost implications; and to monitor patient outcomes and quality of care. A discussion of the specific infrastructure and resource implications of each model is also presented. Understanding the number of STEMI patients eligible to receive primary PCI and the number of referring hospitals and associated patient transfers is an important component of understanding the resource implications for each model. Therefore, an estimate of the number of eligible STEMI patients is calculated for each model presented. It is important to note that these calculations are sensitive to the assumptions applied. For example, the proportion of STEMIs in the acute MI population is derived from the estimated 1:2 ratio of STEMI:non-STEMI. However, estimated ratios provided by secondary reviewers ranged from 1:1 to 1:4. Therefore, the calculated volumes provided in this section could vary as much as 50% higher (1:1 ratio) to 40% lower (1:4 ratio) depending on the ratio applied. As stated earlier, the 1:2 ratio was adopted for this report in order to be consistent with the work of an earlier CCN Panel (Target Setting Consensus Panel, March 2004). It is clear that better data collection on indications for procedures is required to support future planning and projections for these procedures. 6.1 PHASE I INFRASTRUCTURE DEVELOPMENT The Regional MI System In order to successfully implement and support a comprehensive model for the treatment of STEMI in Ontario, it is recommended that a regional MI system be created, similar to the stroke model currently being implemented in Ontario. The regional MI system is based on a hub and spoke concept. The hub of the model is the PCI center, while the spokes include the surrounding acute care hospitals and associated communities. For the purposes of a primary PCI model, the hospitals and communities that are within the Access to Urgent PCI for STEMI Consensus Panel Report 68

69 recommended transfer time are the spokes. As further scientific data accumulates on facilitated PCI which would allow for longer transfers, larger regions could be created. The regional MI system could also include those communities that are not eligible for primary PCI due to excessive transfer distances. In the case of these communities, the PCI center would still serve as the hub for referral of patients with cardiogenic shock and rescue PCI. In addition, the PCI center would also serve as a resource center for these communities to assist in the development of common treatment algorithms and care maps for STEMI. If there is no PCI center that is within a reasonable distance, a large referral acute care hospital may serve as the primary hub and the closest PCI center would serve as the secondary hub. A regional steering committee would oversee the regional MI system, and include representatives from all stakeholder groups including emergency and interventional physicians, nurses, administrators, hospital emergency departments, municipal EMS operations, base hospitals, Central Ambulance Communications Centres (CCAC), District Health Councils and the public. These committees would be responsible for the implementation and monitoring of the acute MI program for their regions. The program should be as comprehensive as possible, spanning from patient education to early diagnosis to acute transfer for revascularization to early post-mi care and cardiac rehabilitation. Standard care maps would need to be developed, most appropriately, on a provincial level, with local adaptations. This would ensure a provincial standard of care for STEMI. In addition, the regional MI centers and steering committees would monitor the system in their region and measure patient and process outcomes. The regional MI system would coordinate with the provincial standing committee on STEMI recommended later in this report. It is anticipated that the infrastructure developed for STEMI therapy could further be expanded to encompass and benefit other aspects of MI and cardiac care beyond STEMI, including acute non-st elevation coronary syndromes and congestive heart failure. The system would enhance the standardization and quality of patient care in a comprehensive manner across all regions of the province. Since this regional system would cross municipal boundaries, funding the EMS component of this model provincially would also address the jurisdictional issues associated with patient transfer as identified earlier in this report. Specific funding will also be required for the administrative infrastructure of the regional MI system Emergency Medical Services A critical theme that surfaces throughout this report is the important role of efficient and responsive emergency transportation services. It was apparent from the data gathering process that the EMS system, as it currently exists, presents a barrier for successful implementation of a primary PCI model. Stakeholders felt it was imperative to address EMS issues prior to implementing any model which relies heavily on patient transportation services. Improvements in inter-facility transfers and repatriation processes, in particular, would enable PCI sites to increase capacity for procedures and move more rapidly towards a 24/7 PCI service model. Access to Urgent PCI for STEMI Consensus Panel Report 69

70 The CCN Expert Panel on Invasive Cardiology in Ontario (2001) made a recommendation that the MOHLTC provide sufficient funding for a transportation infrastructure that is capable of providing reliable and efficient service to allow optimal utilization of a regionalized system. Because this affects all invasive cardiac centres in Ontario, as well as all referring physicians and institutions, the MOHLTC should work with CCN to review this issue and coordinate a response. This Panel endorses this prior CCN recommendation, and feels that enhancements are still required in order to optimize the current EMS system. These enhancements will require the coordinated efforts of the Ministry, EMS municipal services, CCACs and base hospitals Model A: Treatment of STEMI at PCI Centres The Model of Care The management of patients with STEMI at PCI centers applies to patients presenting directly to the emergency department with STEMI as well as to patients already admitted to a PCI center for an acute coronary syndrome which evolves into an acute STEMI. It is recommended that these patients all be treated by primary angioplasty on a 24 hr / 7 day a week schedule, with a target door-to-balloon time of < 90 minutes. Key elements of this model include the timely assessment of STEMI, direct notification of the interventionalist-on-call (possibly with the use of a cellular phone) and direct patient transfer to the catheterization laboratory without delays imposed by arranging a CCU bed. Ideally, the CCU bed should be de-linked 23 from the availability of the catheterization laboratory. The strategy to achieve this would need to be determined locally, but ideally would entail the creation of dedicated PCI or CCU beds. Alternatively, patients could be admitted to the medical ICU, a step-down unit, a post- PCI monitoring room, or the emergency room as a last resort. This concept of de-linking the CCU bed from the catheterization laboratory has already been adopted at some centres (University of Ottawa Heart Institute, Kingston General Hospital, and Trillium Health Sciences Centre). Since these patients are already being admitted to the PCI centre, with many receiving fibrinolytic therapy, additional CCU beds may not be required. However, sites operating routinely in excess of 80% bed capacity may require additional beds to create surge capacity in order to have the flexibility to respond to these urgent cases. Most importantly, an organizational commitment is required to accept these patients immediately for primary PCI. An early discharge policy for STEMI patients receiving primary PCI should be implemented to realize the potential cost savings of reduced lengths of stay associated with the improved patient outcomes. During the recovery process, the patient should receive MI education as well as a referral to cardiac rehabilitation upon discharge. 23 Traditionally, transfer patients are not accepted for a PCI unless a CCU bed is available for the patient for pre- or post-pci care. Therefore, the term de-linking, when used in this context, means to exclude securing an available CCU bed from the process of accepting a patient for a PCI. The patient is automatically accepted for the procedure regardless of the availability of a CCU bed. Access to Urgent PCI for STEMI Consensus Panel Report 70

71 This strategy is strongly supported in the literature and provides the advantages of improved patient outcomes with reduced hospitalization and associated costs. Therefore, the Panel recommends that the implementation of this model start immediately. For Ministry budget planning purposes, it is recommended that this model be in effect provincially during the 2005/06 fiscal year, and be in place prior to initiating a systematic program for referred-in patients to PCI hospitals from other sites or transferred-in from the community Supporting infrastructure In order for this model to be successful, changes in current STEMI management and infrastructure processes have to occur at the PCI site including patient care algorithms for rapid assessment and response, direct communication links with the interventionalist- oncall and the catheterization laboratory staff, staff availability on a 24/7 basis, and a process to de-link the catheterization laboratory from the CCU. It is anticipated that this model could be implemented fairly rapidly and should be in place prior to initiating programs for referred-in patients from other hospitals or transferred-in patients from the community by EMS. The infrastructure change required to support 24/7 primary PCI services for the PCI site s own patients will lay the foundation to support primary PCI for patients referred- or transferred-in (see Phase II, Model A and B, Section 6.2) Resource Implications a) Funded PCI Volumes Based on the responses to the PCI survey, this model will apply to approximately 20% of the eligible STEMI population in Ontario (approximately 1,200 STEMI cases arrive directly to a PCI site based on estimates derived from fibrinolytic usage). It is difficult to quantify the impact of this model on the actual volume of PCI cases, as STEMI specific procedural data is not collected. However, data provided by ICES for the CCN 2004 Target Setting Consensus Panel estimated a 22% average provincial PCI rate for STEMI in This rate can be further broken down to approximately 30% for invasive hospitals and 20% for non-invasive hospitals, based on the work of Alter et al (127). Assuming 95% of all STEMI patients would be clinically eligible to receive primary PCI (DANAMI-II), the incremental PCI cases that would need to be funded above the current practice for STEMI patients at PCI sites is in the magnitude of 780 PCI cases annually (See Table 4). This model has a relatively small impact on overall case volumes for PCI for the province (approximately 5%). The greater impact of this model is on the timing of the PCI cases cases that may have been previously scheduled as elective once the acute episode has been stabilized will now be required to be completed within 90 minutes of presentation. These acute cases will be high priority, and enough flexibility and capacity will need to exist in the system to accommodate these cases with minimal disruption to elective and 24 CCN Target Setting Consensus Panel Report, January Access to Urgent PCI for STEMI Consensus Panel Report 71

72 other in-patient case volumes. Funding for these cases will need to be incremental to the currently funded and elective cases, and processes need to be developed, so as not to prolong elective waiting lists. Table 4 Total No. of Estimated STEMI / PCI Cases (Current) and Incremental PCI Cases Above Current for Phase I Model A Current (2001/02) Total # PCI (% Total STEMI) Eligible # STEMI Model A Total # PCI (% Total STEMI) Presenting Hospital # STEMI PCI hospital primary PCI * (6%) ^ (17%) Acute Care Hospitals - other PCI * (16%) (16%) Total (22%) (34%) Increment above current PCI cases 780 Source: Total No. of STEMI based on 2001/02 AMI discharges (MRD = ICD9 code 410) Source CIHI DAD; and estimated 1:2 ratio of STEMI:Non-STEMI. No. of STEMI allocated to PCI and acute-care hospitals based on the ratio of fibrinolytic useage reported in surveys, Assumptions: Current PCI reperfusion assumptions: 25 *30% of AMI revascularized when presenting at PCI hospitals (127) *20% of AMI revascularized when presenting at acute care hospitals (127) Model A PCI assumptions: ^95% of STEMIs presenting at PCI centres will be clinically eligible to receive primary PCI (88) b) Physical Resources It is anticipated that the total numbers of patients presenting to the PCI sites with STEMI will not be measurably altered by the implementation of this model. It has generally been the experience in other jurisdictions, such as Alberta, that patients are not more likely to self-present to PCI emergency rooms or for ambulances to transport more STEMI patients to these sites. 26 Therefore, Model A would have a minimal impact on the number of in-patient care resources; however, this issue would warrant monitoring. De-linking the CCU beds from the catheterization laboratory can only occur if additional resources are provided to expand CCU beds or create dedicated PCI beds to provide the needed flexibility at sites currently operating at capacity. c) Human Resources, Training and Credentials In most centres, there are adequate numbers of interventional cardiologists to perform the procedures on a 24 hour/7 days a week basis. The optimal number of interventionalists per centre is difficult to define, as it depends on numerous factors. However, it is believed that if there are less than three interventional cardiologists per center that a sustained 25 Improved update of clinical practice guidelines could change the non-urgent PCI rate for STEMI from the current estimated rate of 22% to a more appropriate rate of 40 to 50%. 26 Personal communication, Dr. Merril Knudtson, Alberta Access to Urgent PCI for STEMI Consensus Panel Report 72

73 program will be difficult to achieve. 27 Centres may need to reassess and realign workload in order to focus their expertise on these high impact clinical care responsibilities. For example, the activity of interventional cardiologists may have to undergo significant changes including the reduction of some non-interventional cardiac services and the development of working shifts. It may be necessary to recruit, train and credential additional interventional cardiologists in order to sustain this emergent volume. This may also lead to a redistribution of routine day time interventional cases to ensure that the interventional cardiologists have sufficient elective procedures to maintain minimum operator volumes. Additional interventional support staff (catheterization lab nurses, cardio-pulmonary and x-ray technicians) and post-pci care nursing will be required to manage the 24/7 coverage and additional PCI cases, which will require increased funding, recruitment and training. Various strategies could be employed to provide the additional coverage for the catheterization laboratory during non-regular hours such as hiring additional nursing staff that can work in the CCU or other units, and be transferred to the catheterization laboratory for an emergency procedure as needed. When volumes warrant, it is important that supplemental staff be hired versus call-back staff in the event of excessive off-hour procedures, as there are scheduling restrictions imposed by local union agreements, costs associated with over-time, and time delays in staff returning to work. Staff cannot work continuous shifts, nor can the catheterization laboratories be closed the next day due to procedures performed during the prior night System Benefits a) Potential Lives Saved Based on the number of eligible STEMI patients presenting for primary PCI at PCI sites in Model A (Table 4; n = 1140), the incremental net benefit of PCI over fibrinolytics results in approximately 26 lives saved each year in Ontario or 67 combined events avoided (death, repeat MI and stroke). b) Cost Savings There is good support in the literature from a cost-effectiveness viewpoint to implement this phase immediately. Prospective data comparing fibrinolytics to 24/7 primary PCI in a Canadian center has shown a cost savings of over $3000 ($Cdn) at 6 months with a primary PCI policy for patients presenting to a PCI center capable of performing acute primary PCI. (125) In addition, length of hospital stay was also significantly reduced. In addition to a reduction in direct costs, numerous indirect costs are likely to be reduced. Specifically, shorter hospitalizations and fewer complications will result in earlier return to work for many patients. Furthermore, it could be anticipated that a strategy of primary PCI may result in less congestive heart failure and improved left ventricular function with a reduction in the need for automated internal defibrillators. 27 Expert Panel on Invasive Cardiology: Final Report and Recommendations. CCN, June Access to Urgent PCI for STEMI Consensus Panel Report 73

74 6.2 PHASE II: MANAGEMENT FOR PATIENTS TRANSFERRED TO PCI CENTERS The majority of patients in Ontario with acute STEMI (approximately 80%) do not present initially to a PCI center. 28 Therefore, there has been tremendous interest in developing primary PCI algorithms for these patients in order to allow them access to this therapy. As discussed in Section 4.0, both individual trials as well as a recent metanalysis suggests that patients that can be transferred expeditiously to a PCI center for primary PCI experience superior outcomes compared to patients treated with fibrinolysis. Although the exact time interval allowed for transfer has not been clearly defined, it appears that a 90 minute time interval from arrival at the referring hospital to angioplasty at the PCI site is currently appropriate. In this section, two paradigms will be discussed patients transferred to PCI centres from other acute care hospitals and patients transferred from the community as patients can either self-present with or develop STEMI at their local hospital or arrive at a hospital via the EMS. A comprehensive system to support transferred-in patients must encompass both these scenarios. The success of both of these paradigms is contingent on efficient and rapid patient transportation, which can be influenced by several factors. It is important to emphasize that fibrinolysis is an effective treatment for STEMI, and that all centres need to maintain their fibrinolytic programs. An initial prompt assessment of STEMI, the risk of fibrinolytic therapy, and environmental and operational conditions needs to be made prior to the selection of the best reperfusion therapy. In the majority of cases, this will be transfer for primary PCI; however, in the event of anticipated transfer delays, treatment with fibrinolytics should be initiated immediately. It is recommended that due to the time, resource and infrastructure requirements to implement and support these two paradigms, plus the rapidly evolving nature of the scientific literature, that the models described below be implemented initially on a pilot basis in several municipalities, similar to the stroke pilots, and that these pilots begin by 2005/06. It is important to note that some municipalities/pci sites in Ontario are in the early stages of developing the infrastructure to already pilot and/or support these types of models. Therefore, for these communities, consideration should be given by the Ministry to include and fund these local initiatives as part of the pilot phase Model B: Patients Transferred to PCI Centres from Acute Care Hospitals The Model of Care Patients presenting with a STEMI at an acute care hospitals within a 90 minute maximum door-to-balloon time of a PCI center will be considered eligible for transfer for primary 28 Access to Urgent PCI Consensus Panel Survey of Acute Care Hospitals, July Access to Urgent PCI for STEMI Consensus Panel Report 74

75 PCI. 29 This would include patients presenting with STEMI to an acute care hospital emergency room, or in-patients with acute coronary syndromes which evolve into an acute STEMI. The critical time element in this model is the total 90 minute time period, and all partners in the process need to work together and share responsibility to ensure that this target is achieved. However, for planning purposes, the 90 minute transfer time can be sub-divided into three components each with respective targets. It is recommended that the target door/medical contact to ambulance time at the acute care hospital not exceed 30 minutes, the actual travel time not exceed 30 minutes, and the arrival to balloon time at the PCI site not exceed 30 minutes, to achieve the total door-to-balloon time criteria of < 90 minutes. It is important to note that these are suggested time intervals only. For example, if the administrative and assessment time at either the referring acute care hospital or receiving PCI hospital are reduced, the travel time component, and therefore the catchment area for primary PCI, may be increased for stabilized patients. a) Referring Hospitals Model B requires the implementation of patient care maps at the referring hospitals, which would include rapid patient triage, assessment and 12-lead ECG. The use of a prehospital questionnaire completed by the paramedics may be potentially beneficial in expediting the diagnosis. Significant time can be saved by having the emergency room physician assess the patient and complete the 12-lead ECG while the patient remains on the ambulance stretcher. Direct communication to the interventionalist-on-call at the PCI centre would occur while the patient is stabilized for transfer. This could be achieved either by pager or preferably by cellular telephone to allow for immediate and direct communication between the two parties. The patient is then transported to the PCI site by the same EMS team, or if the original ambulance is not staffed by paramedics with the required level of training, then by a replacement ambulance with the appropriate equipment and level of training. 30 An ACLS RN or advanced-trained paramedic 31 would be required to accompany the patient during the transfer to manage any required supportive equipment/medications or to deal with any clinical conditions that could arise during transportation. b) PCI Hospitals In order to achieve the target 90 minute door-to-balloon time, the call to the interventionalist at the PCI site needs to activate the algorithm at the PCI site as described in Model A. The admitting and triage coordinators and the catheterization laboratory staff are notified in order to ensure that an appropriate monitoring bed is created for the patient and that the catheterization laboratory is prepared for the arrival of the patient. The interventionalist needs to be prepared to accept the patient and not wait for the availability of a CCU bed as described previously. These processes can be running 29 Door-to-balloon time is the time from the patient arrival at the acute care hospital to the first balloon inflation at the PCI site in the catheterization laboratory 30 The regular PCP staffed ambulance may be able to be supplemented by an ACP staffed ambulance if available. 31 The level of training required by paramedics for the primary PCI model is still to be determined. Access to Urgent PCI for STEMI Consensus Panel Report 75

76 coincidentally to the preparation and transfer of the patient from the referring hospital so the PCI site is ready to receive the patient upon arrival at the emergency room. Upon arrival at the PCI site, the patient would ideally be taken directly to the catheterization laboratory. However, since most laboratories are running at full capacity during daytime hours, an area such as a STEMI room 32 adjacent to the CCU or catheterization laboratory could be created in order to accommodate these patients on their arrival while awaiting the procedure. This room could also be used during the offhours to monitor patients while waiting for the arrival of the members of the interventional team. This room would be equipped with full telemetry monitoring units and have a CCU nurse in attendance that could deal with any unstable situations. In the event of critically unstable patients, it would be anticipated that a physician from the referring hospital accompany the patient and that they would be available to monitor the patient until the arrival of the interventional physician. c) Emergency Medical Services The EMS is a critical partner in this model. A high priority transfer code to identify this inter-facility transfer as an emergent transfer would need to be developed, similar to the stroke and trauma systems. The requirements for this priority code could involve the ambulance remaining at the emergency department with the patient for transfer, or the quick replacement of this ambulance with an alternate ambulance team. 33 Additional trained paramedics and vehicles would be required to support this model over the longterm. As well, dispatchers from the CACC will need to be trained to manage the transport of patients under these guidelines. Unstable patients would require the accompaniment of an ACLS trained nurse or physician. d) Repatriation Timely repatriation of the patient back to the referring hospital is also an important success factor in this model, as the additional PCI cases would occupy beds at the PCI site that would be needed for the incoming acute cases. Therefore, following successful intervention, stable patients with no complications should be considered for transfer and repatriation back to the referring hospital. Typically, the transfer back could occur between 8 to 24 hours following the procedure. The referring hospital would be required to accept their patient back and maintain an open bed for the arrival of this patient or be willing to accept the patient back into the emergency room. However, it is important to note, as identified in the Acute Care Hospital Survey, that not all hospitals have the facilities to manage the recovery care of the post-pci STEMI patient. Consideration could be given within each municipality to designate sites to which the patient is 32 A recognized and dedicated room/area that is fully equipped with monitoring equipment, medications, and defibrillator that is available at all times to receive patients with STEMI. A nurse is available for this room, but it is anticipated that he/she would have other duties when the room is not being used. The room allows for patients to be prepared and monitored while the cath lab is being prepared. This room could also potentially be used following the PCI for short periods of time to monitor the patient until a CCU bed becomes available. This STEMI room allows the cath lab to be de-linked from the CCU. 33 In the stroke model, a PCP team is first to respond to the call and conducts the initial assessment. The ACPs in an emergency response vehicle are the second level response and assume the patient management through the transfer process as required. Access to Urgent PCI for STEMI Consensus Panel Report 76

77 transferred for post-pci management. It is important to note that the transfer of the stable patient back to the referring hospital will be low priority for EMS and not require any special paramedic skill set. Therefore, a system would need to be established that could accomplish this transfer in a timely and cost-effective manner, and could be accomplished either through the EMS or via private services. Patients developing complications or requiring additional interventions should remain at the PCI center. Transfer back to the referring hospital could be arranged at a later date Supporting Infrastructure Regional partnership agreements between the PCI centres, referring hospitals and emergency services, similar to the regional stroke and trauma models, are essential to the success of this model. The regional MI system will provide the necessary infrastructure to support and maintain these regional agreements. The PCI site, as the hub of this model, should assume a leadership role in this initiative. a) PCI Centres and Referring Hospitals Model B requires identifying the referring hospitals that would be part of the regional MI system and partnership agreement. The map on the following page illustrates the geographical area and referring acute care hospitals that fall within the 90 minute doorto-balloon time of a PCI hospital. Assuming a 30 +/- 5 minute transport time criteria within this 90 minute window, this model will capture approximately 60% of all STEMI patients provincially (combined cases from 39 acute care hospitals and the PCI centres.) In Appendix 24, referring hospitals are linked to PCI centres based on a combination of distance and existing referral patterns. For six of the 12 PCI hospitals, there are no alternative PCI centres within 30 minutes, and therefore, referring hospitals can be uniquely assigned to a PCI hospital. However, for the other six sites, which fall within the Central West, Central East and Toronto Regions, many referring hospitals have more than one PCI centre within this transport time window. In these cases, sites are assigned based on most common existing referral patterns (or in the case of new PCI sites, based on existing catheterization referral patterns). In the GTA region, where there are multiple PCI sites and feeder hospitals, these relationships become more complex. Regional planning would need to encompass all the PCI sites and would need to include a defined process and criteria for partnerships, such as closest distance or existing referral patterns. It is important to note the impact that improved efficiencies would have on the number of eligible of referring hospitals. By reducing the non-transportation component of the patient transfer, the allowable transportation time, and hence, the number of eligible referring hospitals could increase. For example, Appendix 25 shows the number of referring hospitals that fall within a 60-minute transportation time of PCI sites. Based on a 60-minute transport time criteria, an additional 25 acute care hospitals could participate in the primary PCI model. Access to Urgent PCI for STEMI Consensus Panel Report 77

78 Figure 4 Acute Care Hospitals and Communities within a 90 Minute Door-to- Balloon Time of a PCI Hospital Legend Red squares are PCI hospitals, green squares are acute care hospitals, blue shaded areas represent 30 +/- 5 minutes from a PCI hospital. Access to Urgent PCI for STEMI Consensus Panel Report 78

Advancing the One Acute Care Network and Our Strategic Aims Regional Cardiac Services. December 2009

Advancing the One Acute Care Network and Our Strategic Aims Regional Cardiac Services. December 2009 Advancing the One Acute Care Network and Our Strategic Aims Regional Cardiac Services December 2009 Patient Story No local access to PCI results in more extensive heart damage for patients. A 62 year old

More information

NEBRASKA STEMI CONFERENCE 2015 Dr. Doug Kosmicki. 2013, American Heart Association

NEBRASKA STEMI CONFERENCE 2015 Dr. Doug Kosmicki. 2013, American Heart Association NEBRASKA STEMI CONFERENCE 2015 Dr. Doug Kosmicki 2013, American Heart Association 1 Dr. Doug Kosmicki Reperfusion Strategies Disclosure Information Report any disclosure information of conflicts of interest.

More information

Needs Assessment and Plan for Integrated Stroke Rehabilitation in the GTA February, 2002

Needs Assessment and Plan for Integrated Stroke Rehabilitation in the GTA February, 2002 Funding for this project has been provided by the Ministry of Health and Long-Term Care as part of the Ontario Integrated Stroke Strategy 2000. It should be noted that the opinions expressed are those

More information

Ministry of Health and Long-Term Care. Palliative Care. Follow-Up on VFM Section 3.08, 2014 Annual Report RECOMMENDATION STATUS OVERVIEW

Ministry of Health and Long-Term Care. Palliative Care. Follow-Up on VFM Section 3.08, 2014 Annual Report RECOMMENDATION STATUS OVERVIEW Chapter 1 Section 1.08 Ministry of Health and Long-Term Care Palliative Care Follow-Up on VFM Section 3.08, 2014 Annual Report RECOMMENDATION STATUS OVERVIEW # of Status of Actions Recommended Actions

More information

County of Santa Clara Emergency Medical Services System

County of Santa Clara Emergency Medical Services System POLICY # 408 County of Santa Clara Emergency Medical Services System Policy #408: STEMI Receiving Center Standards STEMI RECEIVING CENTER STANDARDS Effective: September 1, 2009 Replaces: New Review: November,

More information

ST-elevation myocardial infarctions (STEMIs)

ST-elevation myocardial infarctions (STEMIs) Guidelines for Treating STEMI: Case-Based Questions As many as 25% of eligible patients presenting with STEMI do not receive any form of reperfusion therapy. The ACC/AHA guidelines highlight steps to improve

More information

Improving the Outcomes of

Improving the Outcomes of Improving the Outcomes of STEMI Shelley Valaire, ACP; and Robert Welsh, MD, FRCPC Presented at the University of Alberta s 6th Annual Cardiology Update for General Practitioners and Internists, Edmonton,

More information

Spring 2011: Central East LHIN Options paper developed

Spring 2011: Central East LHIN Options paper developed Glenna Raymond, Chair, RSGS Governance Authority Victoria van Hemert, RSGS Executive Director 1 Spring 2011: Central East LHIN Options paper developed Called for new entity to oversee and improve the coordination

More information

ACTION Registry GWTG Research and Publications Update

ACTION Registry GWTG Research and Publications Update ACTION Registry GWTG Research and Publications Update Dr. Michael Kontos Director, Coronary Intensive Care Unit Pauley Heart Center, Virginia Commonwealth University The following relationships exist:

More information

Facilitated Percutaneous Coronary Intervention in Acute Myocardial Infarction. Is it beneficial to patients?

Facilitated Percutaneous Coronary Intervention in Acute Myocardial Infarction. Is it beneficial to patients? Facilitated Percutaneous Coronary Intervention in Acute Myocardial Infarction Is it beneficial to patients? Seung-Jea Tahk, MD. PhD. Suwon, Korea Facilitated PCI.. background Degree of coronary flow at

More information

Policy Register No: Status: Public. Contributes to Care Quality Commission Outcome 4

Policy Register No: Status: Public. Contributes to Care Quality Commission Outcome 4 Operational Policy for Transfer of ST Elevation MI (STEMI) patients to Essex Cardiothoracic Centre (ECTC) for Primary Percutaneous Coronary Intervention Policy Register No: 09122 Status: Public Developed

More information

Trauma Service Area - B (BRAC) Regional Cardiac Plan

Trauma Service Area - B (BRAC) Regional Cardiac Plan Trauma Service Area - B (BRAC) Regional Cardiac Plan Trauma Service Area- B (BRAC) P.O. Box 53597 Lubbock, Texas 79453 806.791.2582 (office) BRAC serves the counties of Bailey, Borden, Castro, Cochran,

More information

1 a) Please confirm or deny whether your Trust has admitted patients for acute myocardial infarction in 2008/09, 2009/10 or 2010/11

1 a) Please confirm or deny whether your Trust has admitted patients for acute myocardial infarction in 2008/09, 2009/10 or 2010/11 May 2011 1 a) Please confirm or deny whether your Trust has admitted patients for acute myocardial infarction in 2008/09, 2009/10 or 2010/11 Yes b) If confirmed please provide details on the number of

More information

Advocacy Framework. St. Michael s Hospital Academic Family Health Team

Advocacy Framework. St. Michael s Hospital Academic Family Health Team Advocacy Framework St. Michael s Hospital Academic Family Health Team Purpose To provide a framework by which the St. Michael s Hospital Academic Family Health Team (SMH AFHT) can expand its commitment

More information

The Burden of Kidney Disease in Rural & Northern Ontario

The Burden of Kidney Disease in Rural & Northern Ontario Ontario Branch The Burden of Kidney Disease in Rural & Northern Ontario Contact: Janet Bick Director, Policy & Programs The Kidney Foundation of Canada Ontario Branch Tel: 905-278-3003/1.800-387-4474 ext.4970

More information

Low Tolerance Long Duration (LTLD) Stroke Demonstration Project

Low Tolerance Long Duration (LTLD) Stroke Demonstration Project Low Tolerance Long Duration (LTLD) Stroke Demonstration Project Interim Summary Report October 25 Table of Contents 1. INTRODUCTION 3 1.1 Background.. 3 2. APPROACH 4 2.1 LTLD Stroke Demonstration Project

More information

Updated Stroke Clinical Handbook: Endovascular Treatment (EVT) and what it means for me

Updated Stroke Clinical Handbook: Endovascular Treatment (EVT) and what it means for me Updated Stroke Clinical Handbook: Endovascular Treatment (EVT) and what it means for me Dr Grant Stotts, Co-Chair, Provincial Endovascular Treatment Steering Committee March 29, 2017 Beth Linkewich, Provincial

More information

Provincial Cancer Control Advisory Committee

Provincial Cancer Control Advisory Committee Provincial Cancer Control Advisory Committee Annual Performance Report 2012-2013 Table of Contents 1.0 Overview... 4 2.0 Shared Partnerships... 7 3.0 Highlights and Accomplishments... 7 4.0 Report on

More information

Patient Involvement in Drug Coverage Review Ontario Public Drug Programs Patient Evidence Submissions

Patient Involvement in Drug Coverage Review Ontario Public Drug Programs Patient Evidence Submissions Patient Involvement in Drug Coverage Review Ontario Public Drug Programs Patient Evidence Submissions Sherry O Quinn A/Senior Manager, Drug Benefits Management Ontario Public Drug Programs Ministry of

More information

IDU Outreach Project. Program Guidelines

IDU Outreach Project. Program Guidelines Ministry of Health and Long-Term Care Ministère de la Santé et des Soins de longue dureé Prepared by: AIDS Bureau Revision Date: April 2001 TABLE OF CONTENTS 1 Introduction...1 1.1 Program Goals... 2 1.2

More information

Controversies on Primary angioplasty in STEMI

Controversies on Primary angioplasty in STEMI Controversies on Primary angioplasty in STEMI 원주의대이승환 Case ( 51/M) CC C.C: ongoing squeezing chest pain D : for 2 hours Risk factors Current smoker ( 40 PYs) Hypercholesterolemia (+) Case ( 51/M) Physical

More information

REGIONAL SPECIALIZED GERIATRIC SERVICES GOVERNANCE AUTHORITY. Call for Expressions of Interest from Seniors Advocate/Public Member

REGIONAL SPECIALIZED GERIATRIC SERVICES GOVERNANCE AUTHORITY. Call for Expressions of Interest from Seniors Advocate/Public Member REGIONAL SPECIALIZED GERIATRIC SERVICES GOVERNANCE AUTHORITY Call for Expressions of Interest from Seniors Advocate/Public Member A. BACKGROUND Specialized Geriatric Services (SGS) provide a range of services

More information

Management of STEMI in era of Reperfusion. Eagles Peter Moyer, MD, MPH Medical Director Boston EMS, Fire and Police

Management of STEMI in era of Reperfusion. Eagles Peter Moyer, MD, MPH Medical Director Boston EMS, Fire and Police Management of STEMI in era of Reperfusion Eagles 2007 Peter Moyer, MD, MPH Medical Director Boston EMS, Fire and Police STEMI in US ST Segment Elevation Myocardial Infarction (STEMI) ~500 K per year Thrombolysis

More information

JAWDA Quarterly Waiting Time Guidelines for (Specialized and General Hospitals)

JAWDA Quarterly Waiting Time Guidelines for (Specialized and General Hospitals) JAWDA Waiting Time Guidelines for (Specialized and General Hospitals) January 2019 Page 1 of 22 Table of Contents Executive Summary... 3 About this Guidance... 4 Performance Indicators... 5 APPENDIX -

More information

North Simcoe Muskoka Specialized Geriatric Services Program ACCOUNTABILITY & AUTHORITY FRAMEWORK

North Simcoe Muskoka Specialized Geriatric Services Program ACCOUNTABILITY & AUTHORITY FRAMEWORK North Simcoe Muskoka Specialized Geriatric Services Program ACCOUNTABILITY & AUTHORITY FRAMEWORK February 4, 2016 March 31, 2018 SPECIALIZED GERIATRIC SERVICES PROGRAM ACCOUNTABILITY & AUTHORITY FRAMEWORK

More information

Port of Portland Hillsboro Airport Master Plan Update Planning Advisory Committee Charter

Port of Portland Hillsboro Airport Master Plan Update Planning Advisory Committee Charter Port of Portland Hillsboro Airport Master Plan Update Planning Advisory Committee Charter Charter Purpose The purpose of this charter is to define the role of the Planning Advisory Committee () within

More information

Alberta s Fire/Search and Rescue Safety Strategy

Alberta s Fire/Search and Rescue Safety Strategy Alberta s Fire/Search and Rescue Safety Strategy A Plan for the Office of the Fire Commissioner MANDATE As the province s fire safety authority, Alberta s Office of the Fire Commissioner (OFC) engages

More information

The Window for Fibrinolysis. Frans Van de Werf, MD, PhD Leuven, Belgium

The Window for Fibrinolysis. Frans Van de Werf, MD, PhD Leuven, Belgium The Window for Fibrinolysis Frans Van de Werf, MD, PhD Leuven, Belgium ESC STEMI Guidelines : December 2008 Reperfusion Therapy: Fibrinolytic Therapy Recommendations Class LOE In the absence of contraindications

More information

Standards of excellence

Standards of excellence The Accreditation Canada Stroke Distinction program was launched in March 2010 to offer a rigorous and highly specialized process above and beyond the requirements of Qmentum. The comprehensive Stroke

More information

Committee of Senior Representatives Tenth Meeting Oslo, Norway 11 December 2006

Committee of Senior Representatives Tenth Meeting Oslo, Norway 11 December 2006 Committee of Senior Representatives Tenth Meeting Oslo, Norway 11 December 2006 Reference CSR 10/7.1/1 Title Proposed Terms of Reference for the EG on HIV/AIDS Submitted by Secretariat Summary / Note As

More information

Ministry of Children and Youth Services. Follow-up to VFM Section 3.01, 2013 Annual Report RECOMMENDATION STATUS OVERVIEW

Ministry of Children and Youth Services. Follow-up to VFM Section 3.01, 2013 Annual Report RECOMMENDATION STATUS OVERVIEW Chapter 4 Section 4.01 Ministry of Children and Youth Services Autism Services and Supports for Children Follow-up to VFM Section 3.01, 2013 Annual Report RECOMMENDATION STATUS OVERVIEW # of Status of

More information

Mission: Lifeline Addressing the System of STEMI Care

Mission: Lifeline Addressing the System of STEMI Care Mission: Lifeline Addressing the System of STEMI Care Alice K. Jacobs, M.D. Boston University Medical Center Boston, MA, USA ACC West Virginia Chapter, April 2017 Disclosure Information FINANCIAL DISCLOSURE:

More information

Message from the Toronto HIV/AIDS Community Planning Initiative Co-Champions

Message from the Toronto HIV/AIDS Community Planning Initiative Co-Champions Toronto HIV/AIDS Community Planning Initiative (TCPI) Final Report March 2007 Message from the Toronto HIV/AIDS Community Planning Initiative Co-Champions As Co-Champions of the Toronto HIV/AIDS Community

More information

Cardiovascular Health Nova Scotia Update to Antiplatelet Sections of the Nova Scotia Guidelines for Acute Coronary Syndromes, 2008.

Cardiovascular Health Nova Scotia Update to Antiplatelet Sections of the Nova Scotia Guidelines for Acute Coronary Syndromes, 2008. Cardiovascular Health Nova Scotia Update to Antiplatelet Sections of the Nova Scotia Guidelines for Acute Coronary Syndromes, 2008. ST Elevation Myocardial Infarction (STEMI)-Acute Coronary Syndrome Guidelines:

More information

Call for Applications

Call for Applications 2013 Knowledge Synthesis Grant Program Call for Applications Program Guidelines Overview Technology Evaluation in the Elderly Network (TVN or the Network) is a new network funded by the Government of Canada

More information

Door to Balloon : The Big Deal. Shaiful Azmi Yahaya,, M.D. Consultant Cardiologist Institut Jantung Negara

Door to Balloon : The Big Deal. Shaiful Azmi Yahaya,, M.D. Consultant Cardiologist Institut Jantung Negara Door to Balloon : The Big Deal Shaiful Azmi Yahaya,, M.D. Consultant Cardiologist Institut Jantung Negara Lecture Outline Pathophysiology of ACS History Door to balloon -? The big deal Myocardial ischaemia

More information

$1.4 Million Allocated to Cardiac Rehabilitation Services!

$1.4 Million Allocated to Cardiac Rehabilitation Services! $1.4 Million Allocated to Cardiac Rehabilitation Services! Cardiac Rehabilitation in New Brunswick- A Province on the Move! Background The incidence of cardiovascular disease (CVD) in New Brunswick (NB)

More information

Optimal System Specification by Point of Care Operations Manual

Optimal System Specification by Point of Care Operations Manual Optimal System Specification by Point of Care Operations Manual The Steering Committee of the Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments (RACE) Project Version 2.1 April

More information

Rural Minnesota STEMI Systems of Care

Rural Minnesota STEMI Systems of Care CARDIOVASCULAR HEALTH UNIT Rural Minnesota STEMI Systems of Care Almost 250,000 Americans experience ST-elevation Myocardial Infarction (STEMI), the deadliest form of heart attack, each year. Of approximately

More information

Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Antiplatelet Section of the Guidelines)

Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Antiplatelet Section of the Guidelines) Cardiovascular Health Nova Scotia Guideline Update Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Antiplatelet Section of the Guidelines) Authors: Dr. M. Love, Dr. I. Bata, K. Harrigan

More information

Ischemic Heart Disease Interventional Treatment

Ischemic Heart Disease Interventional Treatment Ischemic Heart Disease Interventional Treatment Cardiac Catheterization Laboratory Procedures (N = 11,61) is a regional and national referral center for percutaneous coronary intervention (PCI). A total

More information

REFERRAL HOSPITAL. The Importance of Door In Door Out Time DIDO

REFERRAL HOSPITAL. The Importance of Door In Door Out Time DIDO REFERRAL HOSPITAL The Importance of Door In Door Out Time DIDO Jean Skonhovd,RN,BSN,MSAS Emergency Department Director Avera Heart Hospital of South Dakota Time to Treatment is critical for STEMI patients

More information

Literature Review and Recommendations Prehospital Fibrinolytics Administration for Acute Myocardial Infarction

Literature Review and Recommendations Prehospital Fibrinolytics Administration for Acute Myocardial Infarction Literature Review and Recommendations Prehospital Fibrinolytics Administration for Acute Myocardial Infarction EMS Bureau Protocol Review Steering Committee Background In 2009, approximately 683,000 Americans

More information

4. Which survey program does your facility use to get your program designated by the state?

4. Which survey program does your facility use to get your program designated by the state? STEMI SURVEY Please complete one survey for each TCD designation you have in your facility. There would be a maximum of three surveys completed if your facility was designated as a trauma, stroke and STEMI

More information

Toronto Mental Health and Addictions Supportive Housing Network TERMS OF REFERENCE

Toronto Mental Health and Addictions Supportive Housing Network TERMS OF REFERENCE 1 Toronto Mental Health and Addictions Supportive Housing Network BACKGROUND: TERMS OF REFERENCE The Toronto Mental Health and Addictions Supportive Housing Network (TMHASHN), is a network of organizations

More information

Geriatric Emergency Management PLUS Program Costing Analysis at the Ottawa Hospital

Geriatric Emergency Management PLUS Program Costing Analysis at the Ottawa Hospital Geriatric Emergency Management PLUS Program Costing Analysis at the Ottawa Hospital Regional Geriatric Program of Eastern Ontario March 2015 Geriatric Emergency Management PLUS Program - Costing Analysis

More information

Part 1: Introduction & Overview

Part 1: Introduction & Overview Part 1: Introduction & Overview We envision a collaborative, participative partnership around IDU that: Provides all relevant and interested stakeholders with a voice and role. Promotes awareness of the

More information

We are currently recruiting new members to advisory groups for the following research programmes:

We are currently recruiting new members to advisory groups for the following research programmes: Information for applicants to join NIHR as an advisory group member: HTA Programme Topic Identification, Development and Evaluation (TIDE) panel Chairs 1. Background information The goal of the National

More information

Dementia Priority Setting Partnership. PROTOCOL March 2012

Dementia Priority Setting Partnership. PROTOCOL March 2012 Dementia Priority Setting Partnership PROTOCOL March 2012 Purpose The purpose of this protocol is to set out the aims, objectives and commitments of the Dementia Priority Setting Partnership (PSP) and

More information

Sanford Chest Pain Network: Improving Rural STEMI Outcomes

Sanford Chest Pain Network: Improving Rural STEMI Outcomes Sanford Chest Pain Network: Improving Rural STEMI Outcomes Naveen Rajpurohit, MD Cardiovascular Fellow Sanford Cardiovascular Institute Sanford Heart Hospital The University of South Dakota Sioux Falls,

More information

HeartRescue Global Policy Brief STEMI: ST-segment elevation myocardial infarction. HeartRescue Global MEDTRONIC FOUNDATION

HeartRescue Global Policy Brief STEMI: ST-segment elevation myocardial infarction. HeartRescue Global MEDTRONIC FOUNDATION HeartRescue Global Policy Brief STEMI: ST-segment elevation myocardial infarction HeartRescue Global MEDTRONIC FOUNDATION STEMI, or ST Segment Elevation Myocardial Infarction, is one form of cardiovascular

More information

Ministry of Children and Youth Services. Independent Clinical Review Process for the Ontario Autism Program. Guidelines

Ministry of Children and Youth Services. Independent Clinical Review Process for the Ontario Autism Program. Guidelines Ministry of Children and Youth Services Independent Clinical Review Process for the Ontario Autism Program Guidelines January 2018 Copies of this report can be obtained from: Ontario.ca/autism 2 Table

More information

Mark C. Bieniarz, MD Andrew Harrell, MD Peter Berger, MD

Mark C. Bieniarz, MD Andrew Harrell, MD Peter Berger, MD Mark C. Bieniarz, MD Andrew Harrell, MD Peter Berger, MD Should PCI center activate the cathlab off EMS field interpretation of ECG? Is this happening consistently in New Mexico? What is acceptable rate

More information

Primary Angioplasty for the Treatment of Acute ST- Segment Elevated Myocardial Infarction

Primary Angioplasty for the Treatment of Acute ST- Segment Elevated Myocardial Infarction Ontario Health Technology Assessment Series 2004; Vol. 4, No. 10 Primary Angioplasty for the Treatment of Acute ST- Segment Elevated Myocardial Infarction An Evidence-Based Analysis August 2004 Medical

More information

LSS Tariff Review Phase 2 Report

LSS Tariff Review Phase 2 Report LSS Tariff Review Phase 2 Report November 2004 I. EXECUTIVE SUMMARY This report is an interim report on progress during Phase 2 of the Legal Services Society (LSS) Tariff Review, which involved research

More information

HAAD quality KPI; waiting time

HAAD quality KPI; waiting time Type: Waiting Time Indicator Indicator Number: WT001 Primary Care Appointment- Outpatient Setting Time to see a HAAD licensed family physician or member of their team (GP) Time of request (walk-in or by

More information

Paramedic Service Chiefs, Municipal CAOs, First Nations and Ornge. RE: Training Bulletin, Issue Number 118 version 1.0 STEMI Hospital Bypass Protocol

Paramedic Service Chiefs, Municipal CAOs, First Nations and Ornge. RE: Training Bulletin, Issue Number 118 version 1.0 STEMI Hospital Bypass Protocol Ministry of Health and Long-Term Care Emergency Health Services Branch 5700 Yonge Street, 6 th Floor Toronto ON M2M 4K5 Tel.: 416-327-7909 Fax: 416-327-7911 Ministère de la Santé et des Soins de longue

More information

Know the Quality of our Care at Every Step. Kansas City ACS Summit BI-State Cardiovascular Education Consortium

Know the Quality of our Care at Every Step. Kansas City ACS Summit BI-State Cardiovascular Education Consortium Know the Quality of our Care at Every Step Kansas City ACS Summit BI-State Cardiovascular Education Consortium Welcome to the Kansas City ACS Summit Objectives: Follow the flow and care of an ACS patient

More information

Cover Page. The handle holds various files of this Leiden University dissertation

Cover Page. The handle  holds various files of this Leiden University dissertation Cover Page The handle http://hdl.handle.net/1887/21543 holds various files of this Leiden University dissertation Author: Dharma, Surya Title: Perspectives in the treatment of cardiovascular disease :

More information

Section #3: Process of Change

Section #3: Process of Change Section #3: Process of Change This module will: Describe a model of change that supported the development and implementation of a palliative care program in long term care. Describe strategies that assisted

More information

PRASUGREL HYDROCHLORIDE (Effient Eli Lilly Canada Inc.) Indication: Acute Coronary Syndrome

PRASUGREL HYDROCHLORIDE (Effient Eli Lilly Canada Inc.) Indication: Acute Coronary Syndrome CEDAC FINAL RECOMMENDATION PRASUGREL HYDROCHLORIDE (Effient Eli Lilly Canada Inc.) Indication: Acute Coronary Syndrome Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that

More information

Canadian HIV/AIDS Pharmacists Network. Association Canadienne des Pharmaciens en VIH/SIDA. Terms of Reference

Canadian HIV/AIDS Pharmacists Network. Association Canadienne des Pharmaciens en VIH/SIDA. Terms of Reference Canadian HIV/AIDS Pharmacists Network Association Canadienne des Pharmaciens en VIH/SIDA Terms of Reference Revised 11 May 2016 Canadian HIV/AIDS Pharmacists Network Association Canadienne des Pharmaciens

More information

Study protocol. Version 1 (06 April 2011) Ethics ref: R&D ref: UK CRC portfolio ID:

Study protocol. Version 1 (06 April 2011) Ethics ref: R&D ref: UK CRC portfolio ID: Identifying and prioritising important research questions for the treatment of eczema a collaborative partnership between patients, carers, clinicians and researchers Study protocol Version 1 (06 April

More information

By 20 February 2018 (midnight South African time). Proposals received after the date and time will not be accepted for consideration.

By 20 February 2018 (midnight South African time). Proposals received after the date and time will not be accepted for consideration. Invitation for Proposals The United Nations Population Fund (UNFPA), an international development agency, is inviting qualified organizations to submit proposals to promote access to information and services

More information

RESEARCH PROTOCOL. December 23 nd, 2005 ITHA

RESEARCH PROTOCOL. December 23 nd, 2005 ITHA RESEARCH PROTOCOL December 23 nd, 2005 ITHA RESEARCH PROTOCOL 1. Introduction Inter Tribal Health Authority is committed to the generation and dissemination of knowledge. Research is defined as the development

More information

Point-of-Care Hemoglobin A1c Testing: OHTAC Recommendation

Point-of-Care Hemoglobin A1c Testing: OHTAC Recommendation Point-of-Care Hemoglobin A1c Testing: OHTAC Recommendation Ontario Health Technology Advisory Committee July 2014 Point-of-Care Hemoglobin A 1c Testing: OHTAC Recommendation. July 2014; pp. 1 11 Suggested

More information

Timing of Surgery After Percutaneous Coronary Intervention

Timing of Surgery After Percutaneous Coronary Intervention Timing of Surgery After Percutaneous Coronary Intervention Deepak Talreja, MD, FACC Bayview/EVMS/Sentara Outline/Highlights Timing of elective surgery What to do with medications Stopping anti-platelet

More information

Ischemic Heart Disease Interventional Treatment

Ischemic Heart Disease Interventional Treatment Ischemic Heart Disease Interventional Treatment Cardiac Catheterization Laboratory Procedures (N = 89) is a regional and national referral center for percutaneous coronary intervention (PCI). A total of

More information

Phase I Planning Grant Application. Issued by: Caring for Colorado Foundation. Application Deadline: July 1, 2015, 5:00 PM

Phase I Planning Grant Application. Issued by: Caring for Colorado Foundation. Application Deadline: July 1, 2015, 5:00 PM Phase I Planning Grant Application Issued by: Caring for Colorado Foundation Application Deadline: July 1, 2015, 5:00 PM Executive Summary Caring for Colorado is currently accepting applications for SMILES

More information

Transfer in D2B. Scott D Friedman, MD FACC Medical Director, Cardiology Services Shore Health System of Maryland. The Problem

Transfer in D2B. Scott D Friedman, MD FACC Medical Director, Cardiology Services Shore Health System of Maryland. The Problem Transfer in D2B Scott D Friedman, MD FACC Medical Director, Cardiology Services Shore Health System of Maryland The Problem NRMI-5: North Carolina, July 2003- June 2004 NC Nation Guidelines N 2,738 79,927

More information

The Scarborough Hospital (TSH)/Rouge Valley Health System (RVHS) Hospital Services Facilitated Integration

The Scarborough Hospital (TSH)/Rouge Valley Health System (RVHS) Hospital Services Facilitated Integration The Scarborough Hospital (TSH)/Rouge Valley Health System (RVHS) Hospital Services Facilitated Integration Central East LHIN Board of Directors April 22, 2013 Table of Contents Introduction Board Motions

More information

ST Elevated Myocardial Infarction- Latest AHA recommendations

ST Elevated Myocardial Infarction- Latest AHA recommendations ST Elevated Myocardial Infarction- Latest AHA recommendations Sherry Turner, DO, MPH, FACOEP Medical Director Emergency Services Wesley Medical Center The Problem 250,000 Americans each year 30% fail to

More information

Human and Fiscal Implications of Heart Disease and Stroke

Human and Fiscal Implications of Heart Disease and Stroke 1 Texas Council on Cardiovascular Disease and Stroke Report for the 84 th Regular Texas Legislative Session Heart Disease and Stroke in Texas: A Call to Action Enacted by the 76 th Legislature (House Bill

More information

Myocardial Infarction In Dr.Yahya Kiwan

Myocardial Infarction In Dr.Yahya Kiwan Myocardial Infarction In 2007 Dr.Yahya Kiwan New Definition Of Acute Myocardial Infarction The term of myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting

More information

Prostate Cancer Priority Setting Partnership. PROTOCOL June 2009

Prostate Cancer Priority Setting Partnership. PROTOCOL June 2009 Prostate Cancer Priority Setting Partnership PROTOCOL June 2009 Purpose The purpose of this protocol is to set out the aims, objectives and commitments of the Prostate Cancer Priority Setting Partnership

More information

King County EMS STEMI Patients Receiving PCI at King County Hospitals in 2012

King County EMS STEMI Patients Receiving PCI at King County Hospitals in 2012 King County EMS STEMI Patients Receiving PCI at King County Hospitals in 2012 Objective The goal of this report is to evaluate demographics, pre hospital and hospital response times and outcomes of ST

More information

Update Guidelines in STEMI Management: Focus on Logistic and System Approach to Reperfusion Therapy

Update Guidelines in STEMI Management: Focus on Logistic and System Approach to Reperfusion Therapy March 14 th, 2018 The First Asia Forum in Emergency Medicine BNH Hospital, Bangkok, Thailand Update Guidelines in STEMI Management: Focus on Logistic and System Approach to Reperfusion Therapy Wacin Buddhari,

More information

2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction

2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction Developed in Collaboration with American College of Emergency Physicians and Society for Cardiovascular Angiography and

More information

The Role of DHMC as an ST Elevation Myocardial Infarction Receiving Center in a Regional STEMI Care Network:

The Role of DHMC as an ST Elevation Myocardial Infarction Receiving Center in a Regional STEMI Care Network: The Role of DHMC as an ST Elevation Myocardial Infarction Receiving Center in a Regional STEMI Care Network: Nathaniel Niles, MD CREST Symposium November 7th, 28 STEMI = Acute Coronary Thrombosis STEMI

More information

Surgical Outcomes: A synopsis & commentary on the Cardiac Care Quality Indicators Report. May 2018

Surgical Outcomes: A synopsis & commentary on the Cardiac Care Quality Indicators Report. May 2018 Surgical Outcomes: A synopsis & commentary on the Cardiac Care Quality Indicators Report May 2018 Prepared by the Canadian Cardiovascular Society (CCS)/Canadian Society of Cardiac Surgeons (CSCS) Cardiac

More information

Regional STEMI Transfer Systems: the Mayo and NC RACE Experiences

Regional STEMI Transfer Systems: the Mayo and NC RACE Experiences Regional STEMI Transfer Systems: the Mayo and NC RACE Experiences Dr. Henry H. Ting, Mayo Clinic College of Medicine Dr. James G. Jollis,, Duke University Medical Center Mayo Clinic STEMI System for Transferred

More information

By 20 February 2018 (midnight South African time). Proposals received after the date and time will not be accepted for consideration.

By 20 February 2018 (midnight South African time). Proposals received after the date and time will not be accepted for consideration. Invitation for Proposals The United Nations Population Fund (UNFPA), an international development agency, is inviting qualified organizations to submit proposals to promote access to information and services

More information

PROPOSED WORK PROGRAMME FOR THE CLEARING-HOUSE MECHANISM IN SUPPORT OF THE STRATEGIC PLAN FOR BIODIVERSITY Note by the Executive Secretary

PROPOSED WORK PROGRAMME FOR THE CLEARING-HOUSE MECHANISM IN SUPPORT OF THE STRATEGIC PLAN FOR BIODIVERSITY Note by the Executive Secretary CBD Distr. GENERAL UNEP/CBD/COP/11/31 30 July 2012 ORIGINAL: ENGLISH CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITY Eleventh meeting Hyderabad, India, 8 19 October 2012 Item 3.2 of

More information

A Framework for Optimal Cancer Care Pathways in Practice

A Framework for Optimal Cancer Care Pathways in Practice A to Guide Care Cancer Care A for Care in Practice SUPPORTING CONTINUOUS IMPROVEMENT IN CANCER CARE Developed by the National Cancer Expert Reference Group to support the early adoption of the A to Guide

More information

Supplementary material 1. Definitions of study endpoints (extracted from the Endpoint Validation Committee Charter) 1.

Supplementary material 1. Definitions of study endpoints (extracted from the Endpoint Validation Committee Charter) 1. Rationale, design, and baseline characteristics of the SIGNIFY trial: a randomized, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease without clinical

More information

APPENDIX F: CASE REPORT FORM

APPENDIX F: CASE REPORT FORM APPENDIX F: CASE REPORT FORM Instruction: Complete this form to notify all ACS admissions at your centre to National Cardiovascular Disease Registry. Where check boxes are provided, check ( ) one or more

More information

Introduction to the POWER Study Chapter 1

Introduction to the POWER Study Chapter 1 ONTARIO WOMEN S HEALTH EQUITY REPORT Introduction to the POWER Study Chapter 1 AUTHORS Susan K. Shiller, MSc Arlene S. Bierman, MD, MS, FRCPC INSIDE Why do we need a Women s Health Equity Report in Ontario?

More information

Primary Angioplasty and Thrombolysis for the Treatment of Acute ST- Segment Elevated Myocardial Infarction

Primary Angioplasty and Thrombolysis for the Treatment of Acute ST- Segment Elevated Myocardial Infarction Ontario Health Technology Assessment Series 2010; Vol. 10, No. 17 Primary Angioplasty and Thrombolysis for the Treatment of Acute ST- Segment Elevated Myocardial Infarction An Evidence Update Presented

More information

I have no financial relationships to disclose

I have no financial relationships to disclose I have no financial relationships to disclose Networking decreases mortality Vasil Velchev,MD,PhD UH St. Anna Sofia time = myocardium = life Transfer for angioplasty vs. Immediate Thrombolysis (hospital

More information

STEMI Care 2014 at the Crossroads: Taking the right road

STEMI Care 2014 at the Crossroads: Taking the right road STEMI Care 2014 at the Crossroads: Taking the right road Robert C. Welsh, MD, FRCPC, FESC, FAHA, FACC Professor of Medicine Vice President, The Canadian Association of Interventional Cardiology Director,

More information

MS Priority Setting Partnership. PROTOCOL August 2012

MS Priority Setting Partnership. PROTOCOL August 2012 MS Priority Setting Partnership PROTOCOL August 2012 Purpose The purpose of this protocol is to set out the aims, objectives and commitments of the MS Priority Setting Partnership (PSP) and the basic roles

More information

NHS QIS National Measurement of Audit Acute Coronary Syndrome

NHS QIS National Measurement of Audit Acute Coronary Syndrome NHS QIS National Measurement of Audit Acute Coronary Syndrome Things have changed based on the experience and feedback from the first cycle of measurement and, for the better we think! The Acute Coronary

More information

ST Elevation Myocardial Infarction (STEMI) Reperfusion Order Set

ST Elevation Myocardial Infarction (STEMI) Reperfusion Order Set Form Title Form Number CH-0454 2018, Alberta Health Services, CKCM This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. The license does not

More information

NQF Members NQF Staff Voting Draft Report: NQF-Endorsed Measures for Cardiovascular DA: October 17, 2016

NQF Members NQF Staff Voting Draft Report: NQF-Endorsed Measures for Cardiovascular DA: October 17, 2016 Memo TO: FR: RE: NQF Members NQF Staff Voting Draft Report: NQF-Endorsed Measures for Cardiovascular DA: October 17, 2016 Background Phase 4 of this project, the 24-member Cardiovascular Standing Committee

More information

Manitoba Action Plan for Sport (MAPS)

Manitoba Action Plan for Sport (MAPS) 2016-2020 Manitoba Action Plan for Sport (MAPS) About Sport Manitoba Sport Manitoba is the lead planning, programming and funding agency for the development of amateur sport in the province. The primary

More information

Critical Review Form Therapy Objectives: Methods:

Critical Review Form Therapy Objectives: Methods: Critical Review Form Therapy Clinical Trial Comparing Primary Coronary Angioplasty with Tissue-Plasminogen Activator for Acute Myocardial Infarction (GUSTO-IIb), NEJM 1997; 336: 1621-1628 Objectives: To

More information

An Evaluation of the Bruce Grey Hospital-Community Smoking Cessation Program

An Evaluation of the Bruce Grey Hospital-Community Smoking Cessation Program May, 2011 An Evaluation of the Bruce Grey Hospital-Community Smoking Cessation Program Prepared for Keystone Child, Youth and Family Services & Partners By The Centre for Community Based Research www.communitybasedresearch.ca

More information

SECTION III GUIDELINES FOR SUBSIDIARY BODIES. SECTION III: Guidelines for Subsidiary Bodies

SECTION III GUIDELINES FOR SUBSIDIARY BODIES. SECTION III: Guidelines for Subsidiary Bodies SECTION III: Guidelines for Subsidiary Bodies SECTION III GUIDELINES FOR SUBSIDIARY BODIES Guidelines to Host Governments of Codex Committees and ad hoc Intergovernmental Task Forces. (Adopted in 2004)

More information

EXTRACT FOR USE BY NORTH WEST AMBULANCE SERVICE PARAMEDICS

EXTRACT FOR USE BY NORTH WEST AMBULANCE SERVICE PARAMEDICS PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PPCI) PROTOCOL EXTRACT FOR USE BY NORTH WEST AMBULANCE SERVICE PARAMEDICS ** Final Implementation** 9.00am 1 st June 2010 Liverpool Heart and Chest Hospital

More information

Equine Infectious Anemia Disease Control Program. A Report on the Recommendations of the EIA Program Working Group. Canadian Food Inspection Agency

Equine Infectious Anemia Disease Control Program. A Report on the Recommendations of the EIA Program Working Group. Canadian Food Inspection Agency Equine Infectious Anemia Disease Control Program A Report on the Recommendations of the EIA Program Working Group Canadian Food Inspection Agency Animal Health, Welfare and Biosecurity Division Animal

More information