Formation of Vascular Network and Centralised Intervention Centres

Transcription

1 Cardiac and Stroke Networks in Lancashire & Cumbria Formation of Vascular Network and Centralised Intervention Centres Vascular Services SERVICE SPECIFICATION The provision of vascular surgery needs to ensure not only that patients are getting the best outcomes possible but also that they are getting a world-class, quality service. Vascular services have historically been very fragmented; referral patterns and geography currently dictate where patients are treated. The purpose of this review is to guarantee equal access to vascular surgery so patients get the highest standard of treatment for their condition regardless of geographic location. Both the Vascular Society of Great Britain and Ireland (VSGBI) and NCEPOD have recently published recommendations around emergency vascular provision. They stated that the best outcomes are achieved in specialist vascular units with dedicated vascular teams available 24 hours a day, seven days a week. These documents also state it is in the best interests of patients that hospitals should come together to provide high volume intervention centres. Reconfiguration of Vascular Services Reconfiguration of vascular services is driven by its growth as a clinical specialisation, concerns about the safety and quality of care and an expectation that it could lead to lower costs. The coalition government announced that all future reconfigurations should meet four tests: Support from GP commissioners Strengthened public and patient engagement Clarity on the clinical evidence base Consistency with current and prospective patient choice These will all be addressed as part of the full vascular review. Service Specification This Service Specification incorporates the recommendations and findings of relevant published research, studies and papers. The VSGBI have developed guidance for the provision of emergency and elective vascular services. There is also published evidence regarding minimum numbers of procedures that vascular units should undertake and linking surgeon volume with outcome. 1

2 Objectives of Reconfiguration The delivery of a sustainable vascular service within Lancashire and Cumbria should include: The provision of evidence-based models of elective and emergency care that achieve the optimal service. The provision of robust end to end care pathways including the route that a patient will take from their first contact (including diagnosis) to the completion of their treatment. World class outcomes for patients in a way that is sustainable and provides equality of access for all residents. The delivery of a vascular service that is in line with the most up-to-date evidence and the financial principles agreed by commissioners. National Standards and Related Targets Vascular services are subject to all the relevant standards within the Standard NHS Contract for Acute Services relating to patient safety, medicines management, infection control, workforce requirements, information requirements, access to transport services and waiting times. In addition NICE guidance exists that should be adhered to (a full list can be seen in Appendix 1). Vascular Services The strategic aims of the vascular service are to: Improve survival following admission to a vascular unit (short and long-term). Contribute to a reduction in the incidence of stroke and ruptured abdominal aortic aneurysm (AAA). Deliver elective vascular services in the most efficient way possible whilst improving patient experience for those accessing the service. Improved patient experience and reduce patient length of stay due to improved patient management and earlier specialist rehabilitation - particularly for amputee patients. The purpose of centralising vascular services is to improve the diagnosis, treatment and outcome of patients with vascular disease, including preventing stroke due to carotid artery disease, preventing the incidence of rupture in patients with AAA and preventing leg amputation due to peripheral arterial disease. Surgery for Vascular Disease includes a range of arterial and venous reparative and reconstructive surgery for the treatment of aneurysm and other abnormal blood vessels, limb ischemia, carotid artery disease, peripheral and visceral arterial disease and venous disease. Treatment may be by open surgery or endovascular techniques, in addition to risk factor modification and medical treatment. Patients should have access to a range of treatment options offered by a vascular surgeon and interventional radiologist including angiography (both invasive and non invasive), angioplasty, thrombolysis, embolisation for bleeding and stenting. 2

3 Vascular surgeons are also involved in joint procedures with urologists, plastic surgeons and others for the combined treatment of sarcomas, bone tumours and retro-peritoneal lymph node dissections. Interventional Radiology for Vascular Disease includes a range of minimally invasive imageguided techniques for stenting and repair of blood vessels for the same range of diseases. Interventional Radiology for non vascular surgical disease. It is important to note the skills and knowledge of vascular service personnel support and contribute to a range of other specialities (e.g. surgery for stroke, limb salvage surgery for diabetes, renal services). Vascular Anaesthetists - consultant anaesthetists experienced in vascular anaesthesia are required for the care of all vascular surgical patients. Vascular Nurses - have expertise in caring for patients with complex wounds and ulcer management, diabetic foot, claudication, aneurysm surveillance and post EVAR procedures. Vascular Procedures are categorised into four levels: Level 1 Describes work that falls into vascular HRG codes but is non-specialised in nature and can be legitimately done in a hospital without a vascular inpatient unit, as day case surgery - provided there are formal links with a vascular unit for advice. Level 2 - Level 2 makes up the vast majority of vascular services. All other arterial and venous surgery, requiring input from a vascular surgeon or interventional radiologist and all miscellaneous procedures not included within Level 1, above. This includes lower and upper limb arterial surgery, venous surgery and amputations. Hospitals treating these patients must have day case, inpatient and 24/7 emergency surgical and interventional radiology consultant cover. The review notes that there are potential short term workforce issues in delivering 24/7 interventional radiology for this group of patients. (This is a critical factor to consider when reviewing service configuration options). Level 3 - AAA and carotid endarterectomy (CEA) surgery and interventional radiology (IR). Whilst the surgical and IR skills needed for AAA and CEA are the same as those needed for other arterial work and cannot therefore be viewed in isolation, these procedures are low volume and there is clear evidence linking volume and outcome. Hospitals treating these procedures must have 24/7 consultant surgical and interventional radiology cover in order to deal with emergency admissions and complications of treatment. 3

4 Level 4 Very complex, rare or requiring other highly specialist input, such as cardiothoracic surgeons; including: Treatment of aortic arch and thoracoabdominal aneurysms Treatment of aortic dissections Thoracic aortic stent grafts Open or endovascular surgery for thoracic and thoracoabdominal aortic aneurysms Surgery for carotid body tumours Treatment of infected aortic grafts Treatment of mid-aortic syndrome Complex revision of arterial surgery Treatment of vascular malformations Deep vein reconstruction Treatment of difficult aneurysms by fenestrated and branched aortic stenting Laparoscopic aortic surgery. Service Description The service is characterised by the following: Patients with vascular disorders should be cared for by a vascular specialist. The vascular service should have access to appropriately trained staff, equipment and facilities. Patients should have access to a robust 24/7 vascular emergency service. The service adheres to evidence based best practice and national guidance. Appropriate recording and audit of procedures and outcomes is recorded onto the relevant databases. This Vascular Service will contribute to meet national screening targets, specifically, The National Abdominal Aortic Aneurysm Screening Programme (NAAASP): Current criteria for inclusion in the NAAASP includes: minimum population of approximately 800,000, demonstrates a strategic fit within a geographically acceptable region. Each Trust that provides vascular surgery will belong to the Vascular Services Network, and each local AAA Screening Programme will be coterminous with the Vascular Network. (The Vascular Network must adopt the Quality Improvement Framework set out by the VSGBI). Range of services offered at a Vascular Intervention Centre Each service should be able to offer patients the choice of the full range of surgical and interventional radiological vascular procedures, including but not limited to: Non-invasive diagnostic vascular imaging, e.g. Doppler ultrasound, CT angiography, MR angiography Catheter angiography for occlusive disease, bleeding and trauma Open aneurysm repair Endovascular aneurysm repair 4

5 Complicated EVAR Carotid surgery Carotid stenting Angioplasty/stenting for peripheral arterial occlusive disease Distal bypass and amputation surgery, including vascular reconstruction Tibial artery angioplasty in critical limb ischaemia Vein bypass surgery Deep venous surgery Caval filter insertion and removal Treatment of renal artery disease Treatment of mesenteric vascular disease Treatment of thoracic outlet syndrome Treatment of thoraco-abdominal aneurysm Treatment of arterio-venous malformation Management of massive pulmonary embolus Management of vascular trauma and bleeding, including stent grafting and embolisation Thrombolysis and thrombectomy for acute limb ischaemia Elective and acute embolisation for bleeding Venous access (e.g. renal replacement therapy) Management of failing/failed dialysis access, including insertion of tunnelled central venous catheters Varicose veins (possibly in reduced or limited numbers) Management of lymphodoema and wound care Full service protocols and agreed pathways should be in place for all the above procedures. Minimum Volume Requirements AAA 20 elective AAA procedures was chosen by the VSGBI in order to provide a minimum volume of data to allow meaningful analysis, it is not based on published evidence. Published evidence suggests a minimum figure of between 43 and 50 elective AAA procedures. (The Vascular Clinical Advisory Group has agreed a minimum of 50 at each standalone site). EVAR The intervention centre should expect to serve a population that will generate a minimum of EVAR procedures annually, with 50% to 80% of all elective AAA interventions being EVAR (in order to maintain optimal patient outcomes from both interventions). CEA If carrying out elective CEA, each site should treat at least 35 CEA per year. (The Vascular Clinical Advisory Group has agreed a minimum of 35 at each standalone site). General Requirement 1. Minimum requirement: Out of hours diagnostic vascular imaging with the support of an appropriately trained radiologist. Aim - out of hours therapeutic vascular imaging. 2. Interventional radiologists and vascular anaesthetists should form part of the same clinical network as vascular surgeons and provide 24/7 emergency cover. 3. Spiral Computerised (Axial) Tomography Scanner (CT) and Magnetic Resonance Imaging Scanner (MRI). 4. Easy access to non invasive assessment. 5. Critical care (at least Level 3) facilities appropriate to cope with the vascular workload. 5

6 6. A dedicated vascular intervention suite with specialist nurse and radiographers available for urgent vascular interventional procedures, including the management of complications. 7. On site Haematology (for urgent cross-match and blood products) and biochemistry. Vascular Unit Requirement Each Intervention Unit should have as a minimum six WTE vascular surgeons. The minimum population for an independent Vascular Unit is 800,000 with a minimum of one interventional radiologist and one WTE vascular surgeon per 125, ,000 population. There should be sufficient members of the team to provide a comprehensive service 24 hours a day, seven days a week in both vascular surgery and IR (for IR, this should also include comprehensive provision of out of hours non-vascular intervention, in particular nephrostomy). A supporting team of specialist trainees should be in place. On-call rotas for all grades of doctor should be compliant with the European Working Time Directive. It may be necessary, due to patient numbers, that the requirement would be two surgeons on call at any one time in the designated intervention centre to ensure cover for an emergency vascular surgical list and cover for the patients on the vascular ward. This would ensure patient flow and minimum length of stay. There is a growing consensus that the vascular specialist of the future will have operative and interventional skills, rather than being principally a surgeon. The Vascular Society has put forward proposals to address the training needs of surgeons who wish to become a vascular specialist, to ensure that this is accommodated within modernising medical careers (MMC) arrangements. Interventional Radiology Interventional radiology is used for both diagnosis and treatment, with more and more vascular diseases now being treated by radiological procedures. It is anticipated that in future anywhere between 30% - 50% of vascular surgical patients will have the option of getting treated by interventional radiological methods rather than open surgery with improved morbidity, mortality and shorter lengths of hospital stays. Up to 40% of referrals to interventional radiology can come from specialties other than vascular surgery. Interventional radiologists are also involved in the joint clinical management of patients referred from a wide spectrum of clinical specialties, e.g. renal medicine, transplant surgery, general/gastrointestinal surgery, gastroenterology, oncology, obstetrics and gynaecology, etc. Minimum numbers of procedures are not defined for practicing interventional radiologists. However, there is a duty that interventional radiologists (this includes other practitioners undertaking interventional/endovascular procedures) have adequate training to perform interventional procedures and maintain their skills. They should monitor their practice to ensure they stay within the acceptable limits of performance stipulated by the Royal College of Radiologists. (The vascular service should comply with the recommended standards for diagnostic and interventional vascular radiology, set out by the Royal College of Radiologists). 6

7 Anaesthesia Requirement Services should be organised so that anaesthesia for all patients undergoing vascular surgery should be provided by a consultant experienced in vascular anaesthesia as special skills and knowledge is required by anaesthetists involved in the care of vascular surgical patients. Provision should be made for those who may cover vascular emergencies, but do not have regular sessions in vascular anaesthesia to spend time in a supernumerary capacity with a consultant anaesthetist who has a regular vascular commitment. Pre-operative Assessment Facilities A consultant lead vascular pre-operative assessment clinic should be available where risk assessment, patient referral and optimisation in advance of surgery are done. Clinics should have adequate support infrastructure and investigation facilities. Clinicians in the assessment clinic should have access to other specialists including cardiology, respiratory medicine, radiology and tools for non-invasive risk assessment, e.g. CPX and stress echocardiogram. Departments should provide written information leaflets explaining the planned procedure and possible risks. Anaesthetic Organisation and Administration There should be a lead clinician for vascular anaesthesia. Their role should include close collaboration with wider vascular team and other specialities, attendance at vascular multidisciplinary meetings, promotion of local evidence-based guidelines and co-ordination of joint audit/research. Acute Pain Management Vascular Units should incorporate a fully staffed and functional acute pain management team, with the facility to provide post-operative epidural analgesia services in the ward setting. Junior Staff Support Staffing issues have been an important driver of reconfiguration. Implementation of the European Working Time Directive, by limiting the number of hours junior doctors work, has forced hospitals to consider new ways of providing care safely out of hours. Nursing Most emergency vascular patients need to be cared for by nurses experienced in specialist vascular care including skills in caring for highly dependant patients. Team Structure Requirement Vascular surgeons, vascular anaesthetists and interventional radiology should work on the same site and function as a team. It is envisaged that the amputee patient would come under shared care between the treating vascular surgeon and the rehabilitation physician. 7

8 The optimal vascular service should have a similar number of vascular surgeons and interventional radiologists. There should be sufficient members of the team to provide a comprehensive service at all times in both vascular surgery and IR. A supporting team of specialist trainees, radiographers and nurses should be in place. Care of patients should be managed through regular multi-disciplinary team meetings (MDT), which should occur at least twice per week. The meetings should be underpinned by established care pathways for problems requiring more rapid consideration (e.g. ruptured AAA). Vascular Ward Requirement Patients with vascular disease should have access to dedicated vascular beds. There should be sufficient dedicated beds to accommodate the routine elective work and emergency admissions. Vascular beds should be staffed by an appropriate skill mix of nurses who have been trained in the care of vascular patients. Vascular patients should have access to specialist physiotherapy and occupational therapy; in particular amputees should have access to specialist facilities. Operating Theatre Requirement A full vascular theatre suite should be accessible at all times to undertake emergency vascular procedures. Day time vascular urgency or emergency lists should be organised, staffed by senior anaesthetists and surgeons who have no conflicting clinical commitment. Theatre staff that possess appropriate competencies in cell salvage techniques should be available. Specialist Equipment in Dedicated Vascular Theatre - Rapid blood transfusion devices - Cell salvage devices - Fluid and patient warming devices and infusion pumps - Peri-operative invasive cardiovascular monitoring modalities (e.g. non-invasive cardiac output monitoring and transoesophageal echocardiography) - Equipment to perform one lung ventilation - Blood gas analyser and coagulation analyser - Equipment to provide spinal cord protection and visceral perfusion. The vascular service should have access to dedicated theatre nurses with specialist training in vascular procedures. 8

9 ITU and HDU Requirement Vascular units should possess adequate critical care facilities to provide appropriate Level 2 or Level 3 care at all times before the start of any vascular procedure. Bookable HDU/ITU should be available for elective patients. Critical Care facilities on site be able to provide renal replacement therapy. Outpatient Facilities Requirement Outpatients will still be held at the local DGH facility. Outpatient clinics should have access to nurses experienced in ulcer management and wound dressing. Doppler ultrasound machines should also be available. The vascular service should provide a comprehensive one stop diagnostic clinic for all patients requiring duplex scanning. Vascular Laboratory Requirement A vascular laboratory service should be available for the diagnosis and assessment of arterial and venous disease. VSGBI A vascular service, serving a population of 500,000 should employ a minimum of three WTE vascular technologists, accredited by the Society of Vascular Technology (SVT) or appropriately trained sonographers, with appropriate clerical support. Vascular emergency services should have 24/7 availability for all vascular laboratory investigations, although these may not necessarily be within the confines of a vascular laboratory. Each DGH vascular day case and outpatients would also need to provide vascular laboratory facilities and vascular technologists. Emergency Surgical and IR Cover Requirement Emergency vascular services should be consultant led and provide 24/7 consultant cover for emergency vascular surgery. The VSGBI 2009, note that clinical networks covering populations in excess of one million people will have to deal with higher volumes of emergency cases and, in such cases, the emergency rota should be no more onerous than 1 in 8 to account for this. Minimum specification: should be scheduled to clarify and ensure robust elective and emergency cover. Consultant cover should be no more onerous than 1 in 8 for surgeons and interventional radiologists covering the intervention centre. Each site should have one vascular surgeon and one interventional radiologist per 125,000 to 150,000 population Collaborative arrangements for 24/7 surgical and IR cover must be robust and sustainable. 9

10 The surgical consultant on-call rota should be supported by junior medical staff rotas and 24/7 access to emergency operating theatres and vascular anaesthetic support. The IR consultant on-call rota should be supported by appropriately trained radiographers, IR nurses, access to 24/7 anaesthetic support, non-invasive diagnostic imaging support and appropriate facilities and consumables. Dedicated vascular radiographers and IR nurses should be available for all elective and emergency vascular radiology procedures. It is not acceptable to treat vascular patients at different hospital sites unless in exceptional circumstances (such as obstetric emergencies) as they create inequity for patients and fluctuations in admissions for individual sites/trusts. Clear robust pathways need to be in place for any vascular patients being treated in outlying hospitals who become emergencies. Abdominal Aortic Intervention Service Requirements All patients undergoing open repair and EVAR of AAA should be seen in pre-assessment by an anaesthetist with experience in either preoperative assessment or elective vascular anaesthesia. All elective procedures should be reviewed preoperatively in an MDT that includes surgeon(s) and radiologist(s) as a minimum. The facility to offer both procedures to be available either in house, or by referral through an agreed pathway. A critical care facility with ability to undertake mechanical ventilation and renal support and with 24 hour on-site anaesthetic cover is required for all Vascular Intervention Centres. The Vascular network should have defined pathways for the correction of significant medical risks (cardiac/renal/respiratory) before intervention, in order to ensure a speed of access appropriate to the urgency of the situation. Specific Requirements Regarding EVAR The intervention centre should share common protocols and clear referral pathways to ensure equal access to EVAR within the SHA. Aim: All units providing inpatient vascular services will provide both EVAR and open repair for AAA. The intervention centre should expect to serve a population that will generate a minimum of EVAR procedures annually. An intervention centre will require a full MDT, including nurses and other allied health professionals whose level of expertise should be commensurate with the ability to offer care across the entire patient pathway. The team should have extensive experience of: Supporting patients and carers in assessing complex information for decision making. This would include appropriate written materials and the opportunity for discussion of management options on more than one occasion. Assessing suitability for endovascular repair including both anatomical and physiological parameters. 10

11 Management of complex cases requiring modification to standard procedures and devices. Stent deployment and the management of common complications in the intraoperative and post operative period. Follow up surveillance with a demonstrable record of low reintervention rates commensurate with published research and audit data. Analysis of four year follow up should be available for these purposes. Mentoring and training at all levels of practice. Multidisciplinary team working to include vascular surgeons, interventional radiologists, clinical nurse specialists, clinical vascular scientists (vascular technologists), theatre staff and radiographers with specific appropriate experience. Clinicians and other members of the MDT should be capable of offering education in the form of continuing professional development to their peers and training to those in developmental posts. This function should be supported by the Trust and reflected in the work plans of clinicians. Equipment Requirement (EVAR) There should be 24 hour access to imaging (ultrasound and multislice CTA equipment). This equipment should be good quality multislice CT plus workstation with appropriate software for endovascular planning. High quality imaging either fixed or mobile. Appropriate IT to view remote Imaging. MR scanning. Transport Considerations Centralisation will clearly impact on transport for patients attending for elective surgery in terms of the time and distance of the journey. The intervention centre would have to ensure clear protocols for diagnosing and transferring patients with a ruptured abdominal aortic aneurysm. There is likely to be a similar number of 999 patients requiring emergency treatment and consideration would need to be given to developing ambulance triage to ensure patients arrive at the appropriate centre, minimising subsequent inter healthcare facility transfers. There would be a cost implication which is not yet known. Specialist Mobility and Rehabilitation Service The vascular service must ensure its patients have access to a local limb fitting service, which meets the standards set by The British Society of Rehabilitation Medicine. If this is not provided within the vascular service, there must be written referral protocols and mechanisms in place to review processes and gain patient views. The Specialist Mobility and Rehabilitation Service should be integrated into the vascular team and attend the MDT meetings earlier intervention by the rehabilitation team is associated with reduced length of stay (LOS) and improved patient outcomes. 11

12 Pathways Clear end to end pathways from prevention in primary care through secondary care and on to appropriate home/community arrangements will be set in place as part of the service reconfiguration. Referral/Entry Routes Presently there are two major entry routes to elective vascular services, as follows: GP Referral. Referral from hospital specialist. It is recommended that all patients are triaged and assessed and confirmed appropriate, prior to referral to the intervention centre to prevent inappropriate referrals. Emergency Entry Routes Emergency admission (A&E) Emergency admission (GP) In-hospital transfer Transfer from other hospitals By 2013 the NAAASP will have been rolled out throughout the UK creating another major entry route to elective vascular services. This Review recommends that all patients should have been assessed by a doctor and confirmed appropriate prior to referral to the intervention centre. Discharge/Exit Routes Patients should be discharged following inpatient care in line with the requirements set out in the Standard National Contract for Acute services. Discharge back to primary care should be made as early as possible, accompanied by a discharge communication, including ongoing management plan. Performance Monitoring The vascular service will provide commissioners with routine performance monitoring, in a format to be agreed, from their input into the surgical and interventional national registries. The intervention centre will routinely monitor its medium and long-term outcomes from treatment. Data Collection Each centre must undertake regular local audit of their practice and outcomes, including a minimum requirement of: Mortality/Morbidity. Length of stay. Readmission. Complication Rates. 12

13 Providers must make arrangements for regular, robust internal audit of data collection and data. Data entry to the National Database is also required. Internal Governance The vascular network should have bi-weekly MDT meetings for discussion of current cases and to enable multidisciplinary decision making in the treatment pathways of patients. The MDT should include specialist nurses, therapists and the mobility rehabilitation consultant when appropriate (MDTs can take place through video conferencing where appropriate). The vascular service will routinely review its cases (Significant Event Audit) to continually improve clinical practice. A multidisciplinary review is desirable. Patient Information The vascular service should have care protocols and patient information for all common vascular procedures and should ensure all patients are provided with information regarding their surgery at the point at which surgery is offered including: A written individual care plan A permanent record of consultations at which changes to their care plan are discussed A key worker/named contact. A copy of the patient s care plan should be sent to their General Practitioner. Patients should receive a copy of their care plan within a week of the consultation at which it was discussed. Patient Transportation For the majority, centralisation of vascular services will mean that patients and visitors will be travelling longer distances. Travel times and distances to each site within Lancashire and Cumbria have been fully documented in the document entitled A Case for Centralisation of Vascular Services in Lancashire and Cumbria. The vascular service should have mechanisms and links in place to provide transport services to the intervention centres from outlying hospitals for patient relatives (e.g. free shuttle bus service). The intervention centre needs to have strong public transport links and access to provision for overnight stay for patient relatives. 13

14 Appendix 1 NICE Guidance AG167 Endovascular stent-grafts for the treatment of abdominal aortic aneurysms (February 2009) IPG127 Endovascular stent-graft placement in thoracic aortic aneurysms and dissections - guidance (June 2005) IPG229 Laparoscopic repair of abdominal aortic aneurysm: guidance (August 2007) IPG163 Stent-graft placement in abdominal aortic aneurysm - guidance (March 2006) IPG060 Thrombin injections for pseudo aneurysms - guidance (June 2004) CG46 Venous thromboembolism: NICE guideline (April 2007) CG34 Hypertension - NICE guideline (all the recommendations) (June 2006) CG66 Diabetes - type 2 (update): NICE guideline (May 2006) CG68 Stroke: NICE guideline (July 2008) TA90 Vascular disease - clopidogrel and dipyridamole: Guidance (May 2005) IPG217 Ultrasound-guided foam sclerotherapy for varicose veins: Guidance (May 2007) TA94 Cardiovascular disease - statins: guidance (January 2006) IPG052 Endovenous laser treatment of the long saphenous vein - guidance (March 2004) IPG079 Stent placement for vena caval obstruction - guidance (July 2004) IPG094 Uterine artery embolisation for the treatment of fibroids - guidance (October 2004) IPG8 Radiofrequency ablation of varicose veins: guidance (September 2003) 14