Development of Cardiac Catheterisation Facilities in the North of Scotland

Transcription

1 Development of Cardiac Catheterisation Facilities in the North of Scotland Business Case March 26

2 Contents Developing Cardiac Catheterisation Facilities in the North of Scotland Executive Summary 3-5 Introduction/Background 6-9 Page Process Strategic objectives Clinical needs Proposed outcomes Service Description 1-34 Current service Planning Assumptions Proposed service Percutaneous Coronary Intervention (PCI) : Guidelines for Good Practice & Training List of Options Preferred Option 4 Affordability Capital and Revenue Costs Risk Assessment 45 NHS Boards Approval 46 2

3 1. Executive Summary This business case seeks approval from NHS Grampian, NHS Highland, NHS Orkney, NHS Shetland and NHS Tayside (NHS Tayside is asked to support this business case in the context of the Electrophysiology service only) to expand cardiac catheterisation capacity in the North of Scotland by 21/11 through The replacement of the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 26/7 The commissioning of a new 2 nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 27/8; and The commissioning of a dedicated cardiac catheter laboratory at Raigmore Hospital during 27/8 which will undertake Percutaneous Coronary Intervention (PCI) from 1 st April 21 The business case is set within the strategic context of matching diagnostic and interventional cardiac catheter laboratory capacity in the North of Scotland with projected demand to 21/11. It is consistent with the recommendations made in the Capacity Review for Coronary Heart Disease Services Angiography and Cardiac Revascularisation published in June 24, and the Coronary Heart Disease and Stroke Strategy for Scotland published in October 22. The key recommendations of the capacity review report are outlined below: Angiography and Percutaneous Coronary Intervention (PCI) has demonstrated considerable growth over the last four years and this continued growth is unlikely to change in the near future. 5% of PCI procedures are undertaken non-electively Additional capacity will be required to cope with the projected growth in Angiography and PCI. Plans to increase capacity for angiography and PCI, which take account of the projected growth and achievement of waiting times guarantees should be brought forward by NHS Boards and resources to support this should be given priority. 3

4 The North of Scotland Cardiac Services Sub Group organised two planning workshops (the first in November 24 and the second in August 25) to look at the development of cardiac catheterisation facilities in the North of Scotland. It set out develop a regional strategy for expanding cardiac catheter laboratory capacity in order to meet nationally agreed waiting time guarantees set out in Fair to All, Personal to Each. The 2 nd planning workshop in August 25 was underpinned by detailed activity analysis and demographic profiling which resulted in a preferred option being identified. A report on the workshops was submitted to the North of Scotland Planning Group on 3 th September 25. A copy of the report is set out in Appendix one. The North of Scotland Planning Group noted the contents of the report and agreed that a business case should be produced by the end of March 26. This approach to regional planning was highly commended by the National Advisory Group on Coronary Heart Disease (CHD) in December 25. Regional Planning groups will establish the volume of service provision needed across the region for each specific condition based on advice from the National Advisory Group for Coronary Heart Disease. Once that has been agreed, the cost of each NHS Board s activity will be calculated, and the Board will then enter into a binding agreement on its contribution to the total cost of that regional service. It is helpful that HDL(22)1 acknowledges the need for clear links between the regional planning groups and managed clinical networks. (CHD/and Stroke Strategy for Scotland published in October 22) There are significant clinical gains that would result from the approval of this business case for NHS Boards and CHD Managed Clinical Networks in the North of Scotland. In summary it provides the following clinical gains. a) The ability to maximise clinical skills and expertise across the North of Scotland b) To provide safe and effective services to achieving high standards and improving quality for patients b) The ability to deliver national waiting time guarantees set out in Fair to All, Personal to Each. d) To cope with a predicted increase in demand for diagnostic and interventional cardiac procedures driven by several factors, such as demographics, changes in clinical practice, the introduction of troponin testing and reduction in waiting time guarantees 4

5 The business case is guided by recommendations made by a Joint Working Group on Coronary Angioplasty of the British Cardiac Society (BCS) and British Cardiovascular Intervention Society (BCIS) The Joint working group set out indicators relevant to the delivery of a quality interventional cardiology service, the means by which these indicators might be assessed, and the training required for those who will become interventional cardiologists in the future. A long list of options was prepared and reviewed during the process and five short list options were considered as follows: A. Do nothing, i.e. continue to operate with the existing cardiac cath labs in the North of Scotland - this is not an achievable or realistic option due to their age and lack of reliability. B. 2 new cardiac catheter laboratories in Aberdeen C. 2 new cardiac catheter laboratories in Aberdeen plus 1 one mobile cardiac catheter laboratory D. 2 new cardiac catheter laboratories in Aberdeen plus 1 new cardiac catheter laboratory at Raigmore Hospital which could undertake PCI E. 3 new cardiac catheter laboratories in Aberdeen Extending the working day to 3 sessions was considered but discounted at this stage due to a number of factors see section 7.1. The option appraisal considered the optimum development of cardiac catheter laboratory facilities in the North of Scotland over the next 5 years. The preferred option was identified as option D providing the clinical gains outlined above. Capital and revenue costs by NHS Board are outlined in pages 41 to 44. This business case seeks approval to the capital and revenue costs outlined on these pages. 5

6 2. Introduction 2.1 Background This business case seeks approval from NHS Grampian, NHS Highland, NHS Orkney, NHS Shetland and NHS Tayside (NHS Tayside is asked to support this business case in the context of the Electrophysiology service only) to expand cardiac catheterisation capacity in the North of Scotland by 21 through The replacement of the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 26/7 The commissioning of a new 2 nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 27/8; and The commissioning of a dedicated cardiac catheter laboratory at Raigmore Hospital during 27/8 which will undertake Percutaneous Coronary Intervention (PCI) from 1 st April 21 The last few years has seen a large growth in diagnostic and interventional cardiac procedures driven by several factors, such as demographics, changes in clinical practice, the introduction of troponin testing and reduction in waiting time guarantees. As a consequence existing cardiac catheter laboratory facilities in the North of Scotland are reaching the end of their useful lives and were recognised to be increasingly unreliable and unable to cope with increasing demand. The business case is set within the strategic context of matching diagnostic and interventional cardiac catheter laboratory capacity in the North of Scotland with projected demand to 215. It follows on from detailed activity analysis and demographic profiling undertaken by the North of Scotland Cardiac Services Sub Group. The business case makes reference to the recommendations made in the Capacity Review for Coronary Heart Disease Services Angiography and Cardiac Revascularisation published in June 24, and the Coronary Heart Disease and Stroke Strategy for Scotland published in October Evolution of the Project The North of Scotland Cardiac Services Sub Group organised two planning workshops (the first in November 24 and the second in August 25) to look at the development of cardiac catheterisation facilities in the North of Scotland. It set out develop a regional strategy for expanding cardiac catheter laboratory capacity in order to meet nationally agreed waiting time guarantees set out in Fair to All, Personal to Each see overleaf 6

7 By the end of 27, the target is for all patients to have received both angiography and revascularisation (PCI and CABG) intervention within 16 weeks The current waiting time is 8 weeks for angiography and 18 weeks for PCI and CABG. The workshops were well attended by clinical and non-clinical staff from NHS Boards in the North of Scotland (with the exclusion of the Western Isles who send referrals to Glasgow and Edinburgh). The 2 nd planning workshop in August 25 was underpinned by detailed activity analysis, projections and demographic profiling which resulted in a preferred option being identified. A report on the workshops was submitted to the North of Scotland Planning Group on 3 th September 25. A copy of the report is set out in Appendix One. The North of Scotland Planning Group noted the contents of the report and agreed that a business case should be produced by the end of March 26. This approach to regional planning was highly commended by the National Advisory Group on Coronary Heart Disease (CHD) in December Strategic Objectives The strategic objectives of the project are: To provide services locally to support local communities To provide safe and effective services so achieving high standards and improving quality To provide sustainable services To provide quick access to treatment To reflect effective planning and use of resources 7

8 2.4 Clinical Needs NHSScotland published the Capacity Review for Coronary Heart Disease Services Angiography and Cardiac Revascularisation in June 24. Outlined below is a summary of the recommendations made in the final report Angiography and Percutaneous Coronary Intervention (PCI)has demonstrated considerable growth over the last four years and this continued growth is unlikely to change in the near future. 5% of PCI procedures are undertaken non-electively Additional capacity will be required to cope with the projected growth in angiography and PCI. Plans to increase capacity for angiography and PCI, which take account of the projected growth and achievement of waiting times guarantees should be brought forward by NHS Boards and resources to support this should be given priority. The provision of at least one cardiac surgery centre in each region is beneficial to local access for patients and NHS Boards should work together through regional planning groups to ensure sustainability of each centre through agreed levels of activity The clinical benefits of Percutaneous Coronary Intervention (PCI) as an established and effective therapy for a defined group of patients with coronary artery disease are set out in Appendix Two. 2.5 Proposed Outcomes To improve local access to services To improve the timeliness of treatment for patients To cope with a predicted increase in demand for diagnostic and interventional cardiac procedures resulting from new waiting times, improvements in technology, better detection of Acute Coronary Syndrome and an increase in the ageing population. To increase progressively the number of revascularisation procedures being undertaken per million population in line with the CHD and Stroke Strategy for Scotland 8

9 2.6 Health Profile in the North of Scotland Demography Increase in the Elderly population. Grampian, Highland and Orkney show similar increases in the age groups 6 to 74 years of age and 75 + years of age. Both age groups are predicted to rise between 25 to 35%. Shetland is expected to have the highest increase of 41.5% in the age group 6-74 years of age Intervention Cardiac Intervention ratios. The Performance Assessment Framework (PAF) ratio attempts to filter out the differences due to age structure and the prevalence of CHD in the population. Theoretically, therefore, rates across the North of Scotland would be expected to be similar, but are not. 2.7 Regional Planning in the North of Scotland The North of Scotland Cardiac Services Sub Group is committed to developing a regional strategy for cardiac services. This is consistent with recommendations set out in the CHD and Stroke Strategy Report and NHS HDL(23)39 Tertiary / Specialist Services Capital Developments see statements below Regional Planning groups will establish the volume of service provision needed across the region for each specific condition based on advice from the National Advisory Group for Coronary Heart Disease. Once that has been agreed, the cost of each NHS Board s activity will be calculated, and the Board will then enter into a binding agreement on its contribution to the total cost of that regional service. It is helpful that HDL(22)1 acknowledges the need for clear links between the regional planning groups and managed clinical networks. (CHD/and Stroke Strategy for Scotland published in October 22) When a new development is planned, and investment is required, all NHS Board areas which use, or will use, these services, are expected to contribute both revenue and capital funds, on an agreed shared basis. NHS Board areas who host these types of services have not been allocated capital or revenue, to specifically support such developments. Conversely, it is essential Boards providing these services embark upon collective discussions with all interested parties to ensure agreement, throughout the planning process, is achieved regarding the financial expectations of the proposed development. NHS HDL(23)39 Tertiary / Specialist Services Capital Developments 9

10 3. Service Description Existing cardiac catheter laboratory facilities in the North of Scotland are reaching the end of their useful lives and are recognised to be increasingly unreliable and unable to cope with increasing demand. 3.1 Aberdeen Royal Infirmary Service Overview Aberdeen Royal Infirmary has one dedicated cardiac catheter laboratory which is now 1 years old and requires regular maintenance. Due to its age there is increasing down time and this places significant pressure on patient care. In order to achieve and maintain nationally agreed guarantee waiting times, a mobile cardiac catheter laboratory was added in November 24. It operates 3 days a week, 48 weeks per annum, with additional days purchased when required. This is a short term solution and is financially unviable in the medium to long term. The existing cardiac catheter laboratory at Aberdeen Royal Infirmary undertakes a range of activities including Left and right heart catheterisation; Insertion of pacemakers; Diagnostic angiogram; Left and right heart catheterisation; Investigation and treatment of adult congenital heart disease; Electrophysiological studies investigation and treatment; ICD and Cardiac resynchronisation device activity Heart failure investigation and myocardial biopsy; Percutaneous Coronary Intervention (PCI). Appendix Three (pg 64) sets out definitions of cardiac catheterisation procedures outlined above Referral Patterns The cardiac catheter laboratory at Aberdeen Royal Infirmary takes referrals from Grampian, Highland, Shetland, and Orkney. A small number of referrals are received for electrophysiology from Tayside. The receiving population is therefore 79,594. 1

11 3.1.3 Number of Cardiac Catheter Laboratory Sessions per week The existing cardiac catheter laboratory at Aberdeen Royal Infirmary operates 1 planned sessions per week, 48 weeks per annum. The 1 planned sessions per week are routinely exceeded due to workload (at least once a week) An on-call team is available 24 hours a day, 7 days a week. The Consultant Cardiologists operate a 1:6 on-call rota and do not have any commitments to the general medicine within Aberdeen Royal Infirmary. The mobile cardiac catheter laboratory operates 6 sessions per week (3 days), 48 weeks per annum, with additional days purchased when required Workforce Profile There are 5 Consultant Cardiologists, 1 Senior Lecturer and 5 Specialist Registrars based at Aberdeen Royal Infirmary. There is 1 Consultant Cardiologist based at Dr Gray s Hospital in Elgin, who has a full day in the cardiac catheter laboratory at Aberdeen Royal Infirmary. There are no vacant posts Activity The total activity of the cardiac catheter laboratory at Aberdeen Royal Infirmary for the three year period 23/4 to 25/6 (first 6 mths) is outlined below in table one: Table One Cardiac Catheter Laboratory Activity at ARI 23/4 to 25/6 (first 6 mths) Procedure 23/4 24/5 Apr to Sept 25/6 Angiogram Percutaneous Coronary Intervention (PCI) Implantable Cardioverter Defibrillators (ICDs) Radio Frequency Ablations (RFAs) Electrophysiology Studies (EP) Pacemaker + Generator Changes Total Table Two highlights the significant growth in PCI activity by NHS Board area over the last three years within the cardiac catheter laboratory at Aberdeen Royal Infirmary. 11

12 Table Two PCI Activity at ARI by NHS Board area 23/4 to 25/6 (first 6 mths) Total PCI 23/4 24/5 Apr to Sept 25/6 Grampian Highland Orkney Shetland Tayside Others Total % of the 62 PCI procedures undertaken during 24/5 had stents implanted. An average of 1.6 stents is used during each PCI procedure. The increasing use of drug eluting stents for a defined group of patients (predicted 3% of all PCI procedures as per NoS Drug Eluting Stent paper see Appendix four) will increase the overall cost of a PCI procedure. 3.2 Raigmore Hospital Service Overview Raigmore Hospital has one catheter laboratory which is now 9.5 years old. The cardiology service shares the catheter laboratory with the radiology service. Like Aberdeen Royal Infirmary, due to its age, there is increasing down time in the catheter laboratory at Raigmore Hospital and this places significant pressure on patient care. There is no planned out of hour s service for cardiac procedures in the catheter laboratory. The catheter laboratory at Raigmore Hospital undertakes a range of cardiac activities including Insertion of pacemakers; Diagnostic angiogram; Left and right heart catheterisation; Referral Patterns The catheter laboratory at Raigmore Hospital takes the majority of its referrals from NHS Highland. 12

13 3.2.3 Number of Cardiac Catheter Laboratory Sessions per week The cardiology service operates 3 cardiac sessions per week (1.5 days), 42 weeks per annum. This includes 2 sessions per week for angiograms, pacemakers and box changes in the shared catheter lab and 1 pacemaker session per week in main theatre at Raigmore Hospital Workforce Profile There are 2 Consultant Cardiologist posts and 1 Specialist Registrar post based at Raigmore Hospital. There is currently one vacant Consultant Cardiologist post which will be appointed to in August 26. A 3 rd Consultant Cardiologist post is required during 27/8 in order to provide sufficient consultant staffing for future catheter laboratory expansion. A North of Scotland Consultant Cardiologist Post established from 1 st April 26 will provide support and training to Raigmore Hospital in setting up its PCI service Activity The total cardiac activity of the catheter laboratory at Raigmore Hospital for the three year period 23/4 to 25/6 (first 6 mths) is outlined below in table three: Table Three Cardiac Catheter Laboratory Activity at Raigmore Hospital 23/4 to 25/6 (first 6 mths) Procedure 23/4 24/5 Apr to Sept 25/6 Angiogram Pacemaker + Generator Changes (Cath Lab + Main Theatre) Total

14 Table Four Cardiac Catheter Laboratory Activity for Highland Patients by all Providers for the Period 24/5 to 25/6 (first 6 mths) Procedure 24/5 Apr to Sept 25/6 Angiogram Percutaneous Coronary Intervention (PCI) Implantable Cardioverter 4 12 Defibrillators (ICDs) Radio Frequency Ablations 8 3 (RFAs) Electrophysiology Studies (EP) 8 5 Pacemaker + Generator Changes Total * Figures outlined above have been obtained from the relevant Cardiology Service Providers in Glasgow, Aberdeen and Edinburgh. On advise from the service provider in Edinburgh, PCI and Angiogram activity for the Royal Infirmary of Edinburgh has been obtained by adding up angiogram and PCI, then taking away PCI's to get the total no of angiograms. This is based on the clinical assumption that angiograms follow on directly to PCI if required at Royal Infirmary of Edinburgh, but not at the Western Infirmary. 3.3 Key Drivers in the North of Scotland Developing sufficient cardiac catheter laboratory capacity in the North of Scotland in order to meet nationally agreed waiting time guarantees and manage urgent and emergency admissions. Age of existing Cardiac Cath Labs Equipment. Patients who require cardiac catheter lab procedures block inpatient beds due to limited Cardiac Catheter Laboratory capacity. It is difficult to recruit Consultant Cardiologists into the North of Scotland without offering access to interventional cardiac catheter laboratory sessions. Opportunity to look at the provision of coronary heart disease services across Health Board boundaries maximising clinical skills and expertise 14

15 Despite the successful launch of a North of Scotland Implantable cardioverter defibrillator (ICD) and electrophysiology (EP and RFA) service in September 22 with a trained electrophysiologist and associated support staff, this service is restricted by limited sessions within existing cardiac catheter laboratories. 4. Planning Assumptions 4.1 Outcome of the 2 nd Planning Workshop At the 2 nd planning workshop in August 25, Dr Susan Vaughan, Epidemiology and Clinical Effectiveness Manager from NHS Highland presented the work undertaken on activity projections using 3 rates of PCI activity growth mapped on to 3 possible options to 21. The methodology used is outlined below:- SCENARIOS A OPTIONS B C 1. Apply age-specific rates of Current PCIs to 21 & 215 Status Quo 1 Raigmore PCI Centre 2 NoS PCI Centre 3 2. Project historical trends to 21 and 215 Status Quo 1 Raigmore PCI Centre 2 NoS PCI Centre 3 3. Apply intervention rate of total revascularisation of 2 per million population in 21 and 215 (CABG rate to remain constant) Status Quo 1 Raigmore PCI Centre 2 NoS PCI Centre 3 1 current pattern of uptake, no PCI in Highland 2 applying reasonable catchment population for Raigmore i.e 87% of the Highland Population which excludes Lochaber and 46% of Moray population which equates to 1% of Grampian activity. 3 catchment population of Highland, Shetland, Orkney and Grampian for an Aberdeen only centre 15

16 It was emphasised that the 3 options were for presentation only to show the likely changes in activity flows. The workshop was not constrained in discussing other options. The 3 rates of growth in activity were: 23/4 age specific rate of PCI i.e. no growth other than due to change in demographics. This produced a minimum level of growth of 12%. Growth based on historical trend. The trend line predicted a very large growth of 217%. Growth based on a target of 2 interventions per million of population by 21 which gave a percentage growth of 86%. The activity projected ranged from 6 to 2, PCIs per annum. Following discussion the workshop concluded that the trend would ameliorate, but it was likely that it would move closer to European rates of intervention (total intervention rate including CABG: 2,5 pmp), which would mean a PCI activity of between 1,5 and 1,7 for the NoS. Tayside was in the process of repatriating PCI, which would draw some minor levels of activity from Grampian. Therefore, based on throughput of 6 PCI per cath lab the NoS will require up to 3 cath labs to meet estimated demand by 21. The projection also predicted that activity levels would support a PCI site at Inverness that would meet the guidelines set out by BCIS. The evidence was also clear that the use of stenting had reduced the rate of patients having complications and requiring emergency CABG to.29%. Therefore the requirement to meet the 9 minutes limit from referral from failed PCI to cardiac surgery could be met by use of helicopter from Inverness. There was therefore no bar to establishing PCI in Inverness if the workshop wished to propose that option. Ros Wilkinson, Health Intelligence Manager from NHS Grampian, gave a presentation focusing on the geographic distribution of patient flows under the 3 options and how these might change to support each of the 3 options. The capacity constraints of cath labs were also addressed. 16

17 5. Predicted Growth 5.1 Overview There are a number of factors which require to be taken into account when modelling required capacity including the predictable growth in the number of patients referred for revascularisation and the waiting times targets. NHS Scotland will require additional capacity if the new waiting times guarantees are to be delivered and maintained for angiography, PCI and cardiac surgery. Undoubtedly there will need to be an increase in the number of laboratory sessions across Scotland and in some areas new labs NHSScotland Capacity Review for Coronary Heart Disease Services page 31& Predicted Growth at Aberdeen Royal Infirmary Table five sets out the projected activity position at Aberdeen Royal Infirmary for 25/6. Table Five Projected Activity at ARI for 25/6 Procedure 23/4 24/5 25/6 Projected Angiogram Percutaneous Coronary Intervention (PCI) Implantable Cardioverter Defibrillators (ICDs) Radio Frequency Ablations (RFAs) Electrophysiology Studies (EP) Pacemaker + Generator Changes Total * ICD Service established at ARI in October 22 * RFA/EP Service established at ARI in December 23 17

18 The required cardiac catheter laboratory capacity at Aberdeen Royal Infirmary is based on the following assumptions total intervention rate of 25 per million population (pmp) including CABG (assumes CABG rates will remain static), which would mean PCI activity of between 1,5 and 1,7 for the NoS Each cardiac cath lab working 48 weeks per year x 1 sessions per week = 48 sessions per annum per lab out of hours session per week x 48 weeks = 72 sessions per lab. This gives a total of 552 sessions per annum for one lab undertaking out of hours work and the 2 nd lab would undertake 48 sessions per annum. The Implementation of the consultant contract precludes a more intensive number of weeks planned activity. Throughput in the catheter labs to be around the expected rate of - 5 angiograms per session; - 3 PCI per session - 3 pacemakers / generator changes per session - 2 ICDs per session RFAs per session - 3 EP Studies per session Assume continued growth, based on a 5 year average of 7% per annum for angiograms, 7% for pacemakers, 15% per annum for ICD, EP and RFA procedures and 15% per annum for PCI (predicted growth rates as set out in the NHSScotland Capacity Review for CHD services During 21/11, 2 PCIs will transfer from other service providers to the Cardiac Catheter Laboratory at Raigmore Hospital. Using the methodology outlined above, table six sets out the required cardiac catheter laboratory capacity within ARI 18

19 Table Six Required Cardiac Catheter Laboratory Capacity within ARI Procedure 24/5 25/6 1 26/7 27/8 3 28/9 29/1 21/11 Angiogram Activity Sessions PCI Activity Sessions Pacemaker & Generator Changes Activity Sessions ICD Activity Sessions RFA Activity Sessions EP Studies Activity Sessions Total Activity Sessions /6 activity is projected based on first 6 months activity PCI activity has not been adjusted to reflect PCIs being switched from ARI to the PCI centre in Raigmore in 21/11. This adjustment will need to be made once actual numbers are agreed. Opportunities to move some angiogram activity from the Moray area (currently going in to ARI) to the new catheter laboratory at Raigmore Hospital in 27/8 will be explored, but the limiting factor to this, is that the clinician will be unable to convert during the angiogram procedure to PCI. This results in the patient returning to ARI for a PCI procedure until such time as a PCI service is established at Raigmore Hospital. 19

20 The chart outlined below illustrates the number of cardiac catheter laboratory sessions that would be available using 2 cardiac catheter laboratories at ARI. This is working on the assumption that each cardiac catheter laboratory works 48 weeks per annum x 1 sessions per week = 48 sessions. One cath lab would work an additional 1.5 sessions (out of hours) per week x 48 weeks per annum = 72 sessions. The first cath lab would therefore have = 552 sessions per annum and the 2 nd cath lab would have 48 cath lab sessions per annum giving a total of 132 sessions per annum. Available Cardiac Cath Lab Sessions at ARI Utilising 2 Cath Labs No of Sessions Cath 1Lab 2 Cath 2Labs Cath Lab The phased development plan of the proposed service is enclosed in section Predicted growth and the plan to manage this are outlined below. 25/6 During 25/6 it is projected that 86 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The existing cardiac catheter laboratory will cover at least 552 of these sessions. The remaining 244 sessions (122 days) will be covered by the modular cardiac catheter laboratory. ARI will ensure that there is sufficient capacity in place during 25/6 to meet projected demand. This is subject to the reliability of the existing cardiac catheter laboratory. 2

21 Cath Lab Capacity required at ARI during 25/6 12 No of Sessions Cath Labs 132 Sessions 1 Cath Lab 552 Sessions Cath Labs Required 26/7 During 26/7 it is projected that 889 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The existing cardiac catheter laboratory will be taken out of commission and replaced during the period July to Sept 26. The Modular Catheter Laboratory will operate in place of the existing cardiac catheter laboratory and a mobile cardiac catheter laboratory will be used to provide additional capacity during this period. The replacement for the existing catheter laboratory will become operational on 1st October 26 and a modular cardiac catheter laboratory will be used alongside this to provide the capacity required to meet projected demand. A combination of the existing and replacement cardiac catheter laboratories will cover at least 552 of these sessions. The remaining 337 sessions (168.5 days) will be covered by the modular cardiac catheter laboratory. Cath Lab Capacity required at ARI during 26/7 No of Sessions Cath Labs 132 Sessions 1 Cath Lab 552 Sessions Cath Labs Required 21

22 27/8 During 27/8 it is projected that 984 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. A 2 nd new cardiac catheter laboratory will become operational on 1 st October 27. This will work alongside the replacement cardiac catheter laboratory. The 2 cardiac catheter laboratories will have the capacity to deliver 132 sessions but staffing etc will be adjusted to reflect actual demand. Cath Lab Capacity required at ARI during 27/8 No of Sessions Cath Labs Required 2 Cath Labs 132 Sessions 1 Cath Lab 552 Sessions 28/9 During 28/9 it is projected that 188 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The 2 cardiac catheter laboratories will have the capacity to deliver 132 sessions. The remaining 56 sessions (28 days) will be covered by a mobile cardiac catheter laboratory depending on actual demand. If the projections outlined in table 6 are too high then the 2 cardiac catheter laboratories at ARI may be able to manage demand but if this is not achievable then a mobile cardiac catheter laboratory can be brought in to increase additional capacity. Cath Lab Capacity required at ARI during 28/9 No of Sessions Cath Labs 132 Sessions Cath Labs Required 22

23 It is recommended that a detailed review of cardiac catheterisation capacity/demand is undertaken during 28/9 by the North of Scotland Cardiac Services Sub Group, to enable planning for the next 5-1 years. 29/1 During 29/1 it is projected that 123 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The 2 cardiac catheter laboratories will have the capacity to deliver 132 sessions. The remaining 171 sessions (85.5 days) will be covered by a mobile or modular cardiac catheter laboratory depending on actual demand. Cath Lab Capacity required at ARI during 29/1 No of Sessions Cath Labs Required 2 Cath Labs 132 Sessions 21/11 During 21/11 it is projected that 1334 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. PCI activity has not been adjusted to reflect PCIs being switched from ARI to the PCI centre in Raigmore in 21/11. This adjustment will need to be made once actual numbers are agreed. The 2 cardiac catheter laboratories will have the capacity to deliver 132 sessions. A decision will need to be made whether the remaining 32 sessions (151 days) will be covered by a modular cardiac catheter laboratory or a 4 th cardiac catheter laboratory is commissioned in the North of Scotland. This decision should be based on a detailed review of cardiac catheterisation services undertaken by the North of Scotland Cardiac Services Sub Group during 28/9. 23

24 Cath Lab Capacity required at ARI during 21/11 No of Sessions Cath Labs Required 2 Cath Labs 132 Sessions 24

25 5.3 Predicted Growth at Raigmore Hospital Table seven sets out the projected activity position at Raigmore Hospital for 25/6. T able Seven Cardiac Catheter Laboratory Activity at Raigmore Hospital 23/4 to 25/6 (25/6 projected based on first 6 mths activity) Procedure 23/4 24/5 25/6 Projected Angiogram Pacemaker + Generator Changes Total Table eight sets out NHS Highland cardiac catheter laboratory activity by all providers for the period 24/5 to 25/6 (projected based on first 6 mths activity). Table Eight Cardiac Catheter Laboratory Activit y for Highland Patients by all Providers for the Period 24/5 to 25/6 (projected) Procedure 24/5 25/6 Projected Angiogram Percutaneous Coronary Intervention (PCI) Implantable Cardioverter 4 24 Defibrillators (ICDs) Radio Frequency Ablations 8 6 (RFAs) Electrophysiology Studies (EP) 8 1 Pacemaker + Generator Changes Total * Angiogram activity will be restricted during 25/6 due to limited cardiac catheter laboratory capacity in the North of Scotland. New waiting time guarantees for angiogram and PCI outlined in Fair to All;, Personal to Each, will result in the requirement for increas ed numbers and increased capacity to sustain waiting time guarantees. 25

26 The required cardiac catheter laboratory capacity at Raigmore Hospital is based on the following assumptions total intervention rate of 25 per million population (pmp) including CABG (assumes CABG rates will remain static), which would mean PCI activity of between 1,5 and 1,7 for the NoS Cardiac cath lab in Raigmore Hospital working Current Capacity : 3 sessions per week, 42 weeks per annum (includes pacemaker session in main theatre) = 126 session per annum From 1 st April 28 : 4 sessions per week x 42 weeks per annum = 168 session per annum. Excludes PCI. From 1 st April 21 : 6 sessions per week x 42 weeks per annum = 252 sessions per annum. Includes PCI. Throughput in the catheter lab to be around the expected rate of - 5 angiograms per session; - 3 PCI per session - 3 pacemakers / generator changes per session - 2 ICDs per session RFAs per session - 3 EP Studies per session - For the purposes of this paper it has been assumed that ICDs, RFAs and EPs will continue to go to a tertiary centre. Assume continued growth, based on a 5 year average of 7% per annum for angiograms, 7% for pacemakers, 15% per annum for ICD, RFA and EP procedures and 15% p er annum for PCI (predicted growth rates as set out in the NHSScotland Capacity Review for CHD services Assumes 2 PCIs will transfer from other service providers to Raigmore Hospital from 1 st April % of Highland s PCI activity (excluding Lochaber) will be repatriated in the future from other PCI centres to the Cardiac Catheter Laboratory at Raigmore Hospital. Using the methodology outlined above, table nine sets out the required cardiac catheter laboratory capacity within Raigmore Hospital 26

27 Tab le Nine Required Cardiac Catheter Laboratory Capacity for NHS Highland Procedure 24/5 25/6 1 26/7 27/8 28/9 29/1 21/11 2 Angiogram Raigmore Activity Sessions Other Centres Activity Sessions PCI Raigmor e Activity Sessions *2 67 Other Cen tres Activity Sessions Pacemaker Generator Changes & *22 68 R aigmore Activity Sessions O ther Centres Activity Sessions ICD Raigmore Activity Sessions Other Centres Activity Sessions

28 Procedure 24/5 25/6 1 26/7 27/8 28/9 29/1 21/11 2 RFA Raigmor e Activity Sessions Other Cent res Activity Sessions EP Studies Raigmore Activity Sessions Other Centres Activity Sessions Total Raigmore Activity Sessions Other Centres Activity Sessions /6 activity is projected based on first 6 months activity PCI activity has been adjusted to reflect 2 PCIs being switched from other service providers to the PCI centre in Raigmore in 21/11. 28

29 The chart outlined below illustrates the number of cardiac catheter laboratory sessions that would be available in Raigmore Hospital. This assumes that Current Capacity : 3 sessions per week, 42 weeks per annum (includes pacemaker session in main theatre) = 126 sessions per annum From 1 st April 28 : 4 sessions per week x 42 weeks per annum = 168 sessions per annum. Excludes PCI. From 1 st April 21 : 6 sessions per week x 42 weeks per annum = 252 sessions per annum. Includes 2 PCIs. Cath Lab Sessional Capacity at Raigmore Hospital ions No of Sess /6 28/9 21/11 Year The phased development plan of the proposed service is enclosed in section Predicted growth and the plan to manage this are outlined below. 25/6 During 25/6 it is projected that 12 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The existing catheter laboratory will cover at all of these sessions. 29

30 26/7 During 26/7 it is projected that 129 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The existing catheter laboratory will cover all of these sessions. The remaining 3 sessions will be picked up through negotiation of additional space within the existing catheter laboratory out of hours 27/8 During 27/8 it is projected that 138 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The existing catheter laboratory will cover 126 of these sessions. The remaining 12 sessions will be picked up through negotiation of additional space within the existing catheter laboratory out of hours. 28/9 During 28/9 it is projected that 148 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The new replacement catheter laboratory will cover all of these sessions. 29/1 During 29/1 it is projected that 159 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The new replacement catheter laboratory will cover all of these sessions. 21/11 During 21/11 it is projected that 237 cardiac catheter laboratory sessions will be required at Raigmore Hospital. This assumes that 2 PCIs will be switched from other service providers to the PCI centre at Raigmore Hospital. From 1 st April 21 : 6 sessions per week x 42 weeks per annum = 252 sessions per annum to includes 2 PCIs have been planned for. The remaining 15 sessions could be used to repatriate m ore patients from other service providers and to manage demand in the North of Scotland. 3

31 5.4 Proposed Service Summary of the Proposed Service To provide sufficient cardiac catheter laboratory capacity in North of Scotland to meet projected demand over the next five years, the following is required:- replace the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 26/7 commissioning a new 2 nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 27/8; commissioning a dedicated cardiac catheter laboratory at Raigmore Hospital during 27/8 which will undertake Percutaneous Coronary Intervention (PCI) from 1 st April 21 This proposed service would build on the good clinical relationships that already exist across the North of Scotland, maximising clinical skills and expertise. 31

32 5.4.2 Phased Development Plan of the Proposed Service Phase Phase One : -12 mths April 26 to March 27 Action Sub ject to approval of the business case, July to Sept 26 - replace the existing cardiac catheter laboratory at Aberdeen Royal Infirmary. The replacement catheter laboratory could be operational by 1 st October 26. This will require a modular cardiac catheter laboratory to work, 5 days a week, for a period of 3 months, plus out of hours if required, in place of the existing cardiac catheter laboratory at ARI. This will be between July and Sept 26. A mobile catheter laboratory will also be required, 3 days a week, for a period of 3 months, between July and Sept 26. It will work alongside the modular cardiac catheter laboratory. From October 26, the modular cardiac catheter laboratory will work alongside the replacement cardiac catheter laboratory, 3 days per week. August 26 - fill vacant Consultant Cardiologist Post in Raigmore Hospital. This should be revenue neutral unless the general medical component of the previous post holder needs to be filled. Oct 26-2 cardiac sessions be made available within ARI for the vacant consultant cardiologist post at Raigmore Hospital. This will allow whoever is appointed to this post to maintain their PCI skills in ARI prior to developing the PCI service in Raigmore in 21/11. It will also allow other operators to develop PCI skills where this is required. A North of Scotland Consultant Cardiologist Post will be established from 1 st April 26 and will provide support and training to Raigmore Hospital in setting up its PCI service. Approval to proceed with the replacement cardiac catheter laboratory and the commissioning of a new 2 nd cardiac catheter laboratory will be required by NHS Grampian, NHS Highland, NHS Orkney and NHS Shetland. The cardiac catheter laboratories will need to be funded by referring NHS Boards on a pro rata basis (activity) subject to approval of this business case. This would include the use of the mobile and modular cardiac catheter laboratories and additional bed capacity where required. 32

33 Phase Phase Two : mths April 27 to March 28 Action Subject to approval of the business case Commission a new 2 nd cardiac catheter laboratory at Aberdeen Royal Infirmary. This could be operational by 1 st October 27. Equipment and Build costs will be incurred during 26/7 and 27/8. 1 st October 27 - new 2 nd cardiac catheter laboratory at Aberdeen becomes operational. It will operate 1 sessions per week, 48 weeks per annum. April 27 to March 28 - commission a new dedicated cardiac catheter laboratory at Raigmore Hospital. This could be operational by 1 st April 28. Equipment and Build costs will be incurred during 27/8. August 27 - Fund a new Consultant Cardiologist Post to work in Raigmore Hospital. New Funding will be required for this post. This will increase the number of Consultant Cardiologist s based at Raigmore Hospital from 2 to 3. January 28 Appoint non-medical staff to work in the dedicated cardiac catheter laboratory at Raigmore Hospital. This will become operational on 1 st April 28. A training period of 3 months is required for non-medical staff prior to the new facility opening. It will operate 4 sessions per week (2 days) with no on-call provision. Phase Three mths April 28 to March 29 Subject to approval of the business case 1 st April 28 - dedicated cardiac catheter laboratory becomes operational at Raigmore Hospital. It will operate 4 sessions a week (2 days), 42 weeks per annum, with no on-call provision. During 28/9 a mobile cardiac catheter laboratory will be required for 56 sessions (28 days) at ARI to ensure there is sufficient capacity to meet demand. It is recommended that a detailed review of cardiac catheterisation services is undertaken during 28/9 by the North of Scotland Cardiac Services Sub Group, to enable planning for the next 5-1 years 33

34 Phase Phase Four mths April 29 to March 211 Action Subject to approval of the business case During 29/1 a mobile cardiac catheter laboratory will be required for 171 sessions (85.5 days) to ensure there is sufficient capacity to meet demand. During 21/11 an additional 32 sessions (151 days) will be required at ARI to ensure there is sufficient capacity to meet demand. A decision will need to be made whether a 4 th cardiac catheter laboratory needs to be commissioned in the North of Scotland. This decision should be based on a detailed review of cardiac catheterisation services undertaken by the North of Scotland Cardiac Services Sub Group during 28/9 1 st April 21 - dedicated cardiac catheter laboratory at Raigmore Hospital starts a PCI service. It will now operate 6 sessions a week (3 days a week), 42 weeks per annum, with no on-call provision. 1st April 21 2 PCIs switched from other service providers to the PCI centre at Raigmore Hospital. 15 additional sessions will be available within the cardiac catheter laboratory at Raigmore Hospital to repatriate more Highland patients or to manage demand within the North of Scotland. 34

35 6. Percutaneous Coronary Intervention (PCI) : Guidelines for Good Practice and Training A Joint Working Group on Percutaneous Coronary Intervention of the British Cardiovascular Intervention Society (BCIS) and the British Cardiac Society (BCS) set out indicators relevant to the delivery of a quality interventional cardiology service, the means by which these indicators might be assessed, and the training required for those who will become interventional cardiologists in the future. Factors affecting the delivery of high quality care may be divided broadly into issues relating to Institutions Operators Case selection Audit (data collection & analysis, peer review, resources) Training The indicators were updated by this joint working group in 25 to reflect a number of changes in both technology and health care delivery. Open access chest pain clinics have resulted in the more rapid assessment of the patient with CHD. The patient with C HD is now more frequently under the care of a specialist cardiologist who is familiar with the evidence base for the appropriate investigation and treatment of this group of patients. Similarly the coronary care unit is more often managed by a cardiologist, such that patients are treated on care pathways according to agreed guidelines and protocols. The redefinition of acute myocardial infarction, together with the consensus statements on the appropriate management of both ST elevation and non-st elevation myocardial infarction have resulted in a dramatic increase in the invasive investigation of these patients. Cardiac catheterisation is an integral step in the assessment of the patient with an acute coronary syndrome (ACS); furthermore invasive investigation has been brought forward in the natural history of the condition, particularly in patients with positive markers for risk (e.g. elevated troponin). The concept of 'diagnostic catheterisation query proceed to PCI' ('follow-on' or ad hoc PCI) has become common place and now accounts for more than 5 percent of the procedures in many centres. Centres undertaking Percutaneous Coronary Intervention (PCI) must be properly equipped and staffed, their operators competent and the cases selected appropriate. The business case is guided by recommendations made by the joint working group. 35

36 In summary the joint working group made the following recommendations In the guidelines published in 2, 2 procedures per annum was the standard. The Committee favours maintaining this minimum acceptable institutional number of procedures, whilst encouraging individual centres to increase activity to a minimum of 4 cases per annum as there are some data to suggest that quality can be further improved if a centre performs at this higher level of activity. Centres performing less than 2 procedures per annum should be encouraged to have a robust plan demonstrating how these numbers will be increased to in the future to achieve the minimum standard The current guidelines suggest that a minimum of 75 PCI cases per operator per year are required to maintain competence as an independent operator, i.e. one who can decide on PCI as appropriate management, plan the strategy and perform the PCI without consulting any other operator, 'buddy', 'mentor' or trainer A centre performing PCI requires at least one cardiac catheterisation laboratory; A dedicated laboratory for cardiac procedures is likely to have a small enough image intensifier to allow for a wide variety of angulation, whilst maintaining table manoeuvrability and access to the patient. A high resolution digital imaging chain in one or two planes, with freeze frame, zoom, road mapping and play back facilities is desirable. Contemporary archiving is usually on CD in a digital DICOM compatible format which should be stored and accessible for a minimum of eight years. In PCI centres remote from surgical/tertiary centres, there should be facilities for real time image transfer to facilitate discussion/advice in individual cases As in previous guidelines, BCIS recommends that all centres should be in a position to establish cardiopulmonary bypass within 9 minutes of the referral having being made to the cardiac surgical service. The surgical team should be aware of the scheduling of PCI cases, both within the working day and out of hours. Methods of communication must be formalised, and written protocols agreed between the various parties: these should be regularly updated to reflect changing practice. For elective patients a robust arrangement needs to be in place between the DGH or non-surgical centre and the local surgical centre. The relationship between the cardiologists in the non-surgical centres and the local cardiac surgeons is fundamental to a safe and successful outcome. The transfer of a patient between one centre and another must be considered in the greatest detail and should be agreed in writing between the local hospital, the ambulance service and the surgical centre. Arrangements for patient transfer will vary from one centre to another and may include a dedicated ambulance, helicopter etc. BCIS recommends that the system be tried and tested to check that the 9 minute rule can be met. 36