5.3 interventional cardiology business case

Development of Cardiac Catheterisation Facilities

in the North of Scotland

Business CaseMay 2006

Contents

Developing Cardiac Catheterisation Facilities in the North of Scotland

Page

Executive Summary 3-5

Introduction/Background 6-9

Process Strategic objectives Clinical needs Proposed outcomes

Service Description 10-34

Current servicePlanning AssumptionsProposed service

Percutaneous Coronary Intervention (PCI) : Guidelines for Good Practice & Training

35-37

List of Options 38-39

Preferred Option 40

Affordability – Capital and Revenue Costs 41-44

Risk Assessment 45

NHS Boards Approval 46

2

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 2010/11 through

The replacement of the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 2006/07

The commissioning of a new 2nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 2007/08; and

The commissioning of a dedicated cardiac catheter laboratory at Raigmore Hospital during 2007/08 which will undertake Percutaneous Coronary Intervention (PCI) from 1st April 2010

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 2010/11. It is consistent with the recommendations made in the “Capacity Review for Coronary Heart Disease Services – Angiography and Cardiac Revascularisation” published in June 2004, and the Coronary Heart Disease and Stroke Strategy for Scotland published in October 2002. The key recommendations of the capacity review report are outlined below:

Angiography and Percutaneous Coronary Intervention (PCI) has demonstratedconsiderable growth over the last four years and this continued growth is unlikely to change in the near future.

50% of PCI procedures are undertaken non-electively

Additional capacity will be required to cope with the projected growth inAngiography 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

The North of Scotland Cardiac Services Sub Group organised two planning workshops (the first in November 2004 and the second in August 2005) 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 2nd planning workshop in August 2005 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 30 th

September 2005. 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 2006. This approach to regional planning was highly commended by the National Advisory Group on Coronary Heart Disease (CHD) in December 2005.

“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(2002)10 acknowledges the need for clear links between the regional planning groups and managed clinical networks”.

(CHD/and Stroke Strategy for Scotland published in October 2002)

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

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

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 2010 through

The replacement of the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 2006/07

The commissioning of a new 2nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 2007/08; and

The commissioning of a dedicated cardiac catheter laboratory at Raigmore Hospital during 2007/08 which will undertake Percutaneous Coronary Intervention (PCI) from 1st April 2010

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 2015. 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 2004, and the Coronary Heart Disease and Stroke Strategy for Scotland published in October 2002. 2.2 Evolution of the Project

The North of Scotland Cardiac Services Sub Group organised two planning workshops (the first in November 2004 and the second in August 2005) 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

‘By the end of 2007, 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 2nd planning workshop in August 2005 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 30th September 2005. 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 2006.

This approach to regional planning was highly commended by the National Advisory Group on Coronary Heart Disease (CHD) in December 2005.

2.3 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

2.4 Clinical Needs

NHS Scotland published the Capacity Review for Coronary Heart Disease Services – Angiography and Cardiac Revascularisation in June 2004. Outlined below is a summary of the recommendations made in the final report

Angiography and Percutaneous Coronary Intervention (PCI)has demonstratedconsiderable growth over the last four years and this continued growth is unlikely to change in the near future.

50% of PCI procedures are undertaken non-electively

Additional capacity will be required to cope with the projected growth inangiography 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.

8

To increase progressively the number of revascularisation procedures being undertaken per million population in line with the CHD and Stroke Strategy for Scotland

2.6 Health Profile in the North of Scotland

2.6.1 Demography

Increase in the Elderly population. Grampian, Highland and Orkney show similar increases in the age groups 60 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 60-74 years of age.

2.6.2 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(2003)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(2002)10 acknowledges the need for clear links between the regional planning groups and managed clinical networks”.

(CHD/and Stroke Strategy for Scotland published in October 2002)

“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

9

the planning process, is achieved regarding the financial expectations of the proposed development”.

NHS HDL(2003)39 Tertiary / Specialist Services – Capital Developments3. 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

3.1.1 Service Overview

Aberdeen Royal Infirmary has one dedicated cardiac catheter laboratory which is now 10 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 2004. 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.

3.1.2 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 790,594.

10

3.1.3 Number of Cardiac Catheter Laboratory Sessions per week

The existing cardiac catheter laboratory at Aberdeen Royal Infirmary operates 10 planned sessions per week, 48 weeks per annum. The 10 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 modular cardiac catheter laboratory operates 6 sessions per week (3 days), 48 weeks per annum, with additional days purchased when required.

3.1.4 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.

3.1.5 Activity

The total activity of the cardiac catheter laboratory at Aberdeen Royal Infirmary for the three year period 2003/04 to 2005/06 (first 6 mths) is outlined below in table one:

Table One Cardiac Catheter Laboratory Activity at ARI 2003/04 to 2005/06 (first 6 mths)

Procedure 2003/04 2004/05 Apr to Sept 2005/06

Angiogram 1495 1671 929Percutaneous Coronary Intervention (PCI)

582 602 387

Implantable Cardioverter Defibrillators (ICDs)

31 42 34

Radio Frequency Ablations (RFAs)

9 52 31

Electrophysiology Studies (EP) 5 2 2Pacemaker + Generator Changes 218 263 147

11

Total 2340 2632 1530

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.Table Two PCI Activity at ARI by NHS Board area 2003/04 to 2005/06 (first 6 mths)

Total PCI 2003/04 2004/05 Apr to Sept 2005/06

Grampian 437 457 289Highland 100 93 57Orkney 12 17 17Shetland 5 10 4Tayside 13 12 9Others 15 13 11Total 582 602 387

94% of the 602 PCI procedures undertaken during 2004/05 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 30% 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

3.2.1 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;

3.2.2 Referral Patterns

12

The catheter laboratory at Raigmore Hospital takes the majority of its referrals from NHS Highland.

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.

3.2.4 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 2006. A 3rd Consultant Cardiologist post is required during 2007/08 in order to provide sufficient consultant staffing for future catheter laboratory expansion. A North of Scotland Consultant Cardiologist Post established from 1st April 2006 will provide support and training to Raigmore Hospital in setting up its PCI service.

3.2.5 Activity

The total cardiac activity of the catheter laboratory at Raigmore Hospital for the three year period 2003/04 to 2005/06 (first 6 mths) is outlined below in table three:

Table Three Cardiac Catheter Laboratory Activity at Raigmore Hospital 2003/04 to 2005/06 (first 6 mths)

Procedure 2003/04 2004/05 Apr to Sept 2005/06

Angiogram 273 334 172 Pacemaker + Generator Changes (Cath Lab + Main Theatre)

107 93 76

Total 380 427 248

13

Table Four Cardiac Catheter Laboratory Activity for Highland Patients by all Providers for the Period 2004/05 to 2005/06 (first 6 mths)

Procedure 2004/05 Apr to Sept 2005/06

Angiogram 495 243 Percutaneous Coronary Intervention (PCI)

157 99


4 12


8 3

Electrophysiology Studies (EP) 8 5Pacemaker + Generator Changes 104 81 Total 776 443

* 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

Despite the successful launch of a North of Scotland Implantable cardioverter defibrillator (ICD) and electrophysiology (EP and RFA) service in September 2002 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 2nd Planning Workshop At the 2nd planning workshop in August 2005, 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 2010. The methodology used is outlined below:-

SCENARIOSA

OPTIONS

B C

1. Apply age-specific rates ofCurrent PCIs to 2010 & 2015

Status Quo1 Raigmore PCI Centre2 NoS PCI Centre 3

2. Project historical trends to 2010 and 2015


3. Apply intervention rate of total revascularisation of 2000 per

million population in 2010 and 2015 (CABG rate to remain constant)


1current pattern of uptake, no PCI in Highland

2applying reasonable catchment population for Raigmore i.e 87% of the Highland Population which excludes Lochaber and 46% of Moray population which equates to 10% of Grampian activity.

3catchment population of Highland, Shetland, Orkney and Grampian for an Aberdeen only centre

15

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:

2003/04 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 2000 interventions per million of population by 2010 which gave a percentage growth of 86%.

The activity projected ranged from 600 to 2,000 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: 2,500 pmp), which would mean a PCI activity of between 1,500 and 1,700 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 600 PCI per cath lab the NoS will require up to 3 cath labs to meet estimated demand by 2010.

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 0.29%. Therefore the requirement to meet the 90 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 Watkinson, 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

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’

NHS Scotland Capacity Review for Coronary Heart Disease Services page 31&32

5.2 Predicted Growth at Aberdeen Royal Infirmary

Table five sets out the projected activity position at Aberdeen Royal Infirmary for 2005/06.

Table Five Projected Activity at ARI for 2005/06

Procedure 2003/04 2004/05 2005/06Projected

Angiogram 1495 1671 1858Percutaneous Coronary Intervention (PCI)

582 602 774


31 42 68


9 52 62

Electrophysiology Studies (EP) 5 2 4Pacemaker + Generator Changes 218 263 294Total 2340 2632 3060

* ICD Service established at ARI in October 2002* RFA/EP Service established at ARI in December 2003

17

The required cardiac catheter laboratory capacity at Aberdeen Royal Infirmary is based on the following assumptions

total intervention rate of 2500 per million population (pmp) including CABG (assumes CABG rates will remain static), which would mean PCI activity of between 1,500 and 1,700 for the NoS

Each cardiac cath lab working 48 weeks per year x 10 sessions per week = 480 sessions per annum per lab + 1.5 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 2nd lab would undertake 480 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- 1.5 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 NHS

Scotland Capacity Review for CHD services

During 2010/11, 200 PCIs will transfer from other service providers (assumed 50 from Grampian and 150 from Lothian/Glasgow) 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

Table Six Required Cardiac Catheter Laboratory Capacity within ARI

Procedure 2004/05 2005/061 2006/07 2007/083 2008/09 2009/10 2010/11AngiogramActivitySessions

1671335

1858372

1988398

2127426

2276456

2435487

2605521

PCIActivitySessions

602201

774258

890297

1024342

1178393

1355452

15092

520Pacemaker & Generator ChangesActivitySessions

26388

29498

315105

337113

361121

386129

413138

ICDActivitySessions

4221

6834

7839

9045

10452

12060

13869

RFAActivitySessions

5235

6242

7148

8255

9463

10872

12483

EP StudiesActivitySessions

21

42

52

63

73

83

93

TotalActivitySessions

2632681

3060806

3347889

3666984

40201088

44121203

48481334

1 2005/06 activity is projected based on first 6 months activity

2 PCI activity has been adjusted to reflect PCIs being switched from ARI to the PCI centre in Raigmore in 2010/11 (50 cases).

3 Opportunities to move some angiogram activity from the Moray area (currently going in to ARI) to the new catheter laboratory at Raigmore Hospital in 2007/08 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

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 10 sessions per week = 480 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 480 + 72 = 552 sessions per annum and the 2nd cath lab would have 480 cath lab sessions per annum giving a total of 1032 sessions per annum.

The phased development plan of the proposed service is enclosed in section 5.4.2. Predicted growth and the plan to manage this are outlined below.

2005/06

During 2005/06 it is projected that 806 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 2005/06 to meet projected demand. This is subject to the reliability of the existing cardiac catheter laboratory.

20

Available Cardiac Cath Lab Sessions at ARIUtilising 2 Cath Labs

1032

552

0

200

400

600

800

1000

1200

1 2

Cath Lab

No

of

Ses

sio

ns

1 Cath Lab 2 Cath Labs

2006/07

During 2006/07 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 2006. 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 2006 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.

21

Cath Lab Capacity required at ARI during 2005/06

806

0

200

400

600

800

1000

1200

1

Cath Labs Required

No

of

Ses

sio

ns

1 Cath Lab 552 Sessions

2 Cath Labs 1032 Sessions


889

0

200

400

600

800

1000

1200

1

Cath Labs Required

No

of

Ses

sio

ns



2007/08

During 2007/08 it is projected that 984 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. A 2nd new cardiac catheter laboratory will become operational on 1st October 2007. This will work alongside the replacement cardiac catheter laboratory. The 2 cardiac catheter laboratories will have the capacity to deliver 1032 sessions but staffing etc will be adjusted to reflect actual demand.

2008/09

During 2008/09 it is projected that 1088 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The 2 cardiac catheter laboratories will have the capacity to deliver 1032 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.

22


984

0

200

400

600

800

1000

1200

1

Cath Labs Required

No

of

Ses

sio

ns




1088

500

700

900

1100

1

Cath Labs Required

No

of

Ses

sio

ns


It is recommended that a detailed review of cardiac catheterisation capacity/demand is undertaken during 2008/09 by the North of Scotland Cardiac Services Sub Group, to enable planning for the next 5-10 years.

2009/10

During 2009/10 it is projected that 1203 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. The 2 cardiac catheter laboratories will have the capacity to deliver 1032 sessions. The remaining 171 sessions (85.5 days) will be covered by a mobile or modular cardiac catheter laboratory depending on actual demand.

2010/11

During 2010/11 it is projected that 1334 cardiac catheter laboratory sessions will be required at Aberdeen Royal Infirmary. PCI activity has been adjusted to reflect 50 PCI’s being switched from ARI to the PCI centre in Raigmore in 2010/11.

The 2 cardiac catheter laboratories will have the capacity to deliver 1032 sessions. A decision will need to be made whether the remaining 302 sessions (151 days) will be covered by a modular cardiac catheter laboratory or a 4th 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 2008/09.

23


1203

500

700

900

1100

1300

1

Cath Labs Required

No

of

Ses

sio

ns



1334

500

700

900

1100

1300

1

Cath Labs Required

No

of

Ses

sio

ns


24

5.3 Predicted Growth at Raigmore Hospital

Table seven sets out the projected activity position at Raigmore Hospital for 2005/06.

Table Seven Cardiac Catheter Laboratory Activity at Raigmore Hospital 2003/04 to 2005/06 (2005/06 projected based on first 6 mths activity)

Procedure 2003/04 2004/05 2005/06Projected

Angiogram 273 334 344 Pacemaker + Generator Changes 107 93 152Total 380 427 496

Table eight sets out NHS Highland cardiac catheter laboratory activity by all providers for the period 2004/05 to 2005/06 (projected based on first 6 mths activity).

Table Eight Cardiac Catheter Laboratory Activity for Highland Patients by all Providers for the Period 2004/05 to 2005/06 (projected)

Procedure 2004/05 2005/06Projected

Angiogram 495 486 Percutaneous Coronary Intervention (PCI)

157 198


4 24


8 6

Electrophysiology Studies (EP) 8 10Pacemaker + Generator Changes 104 162 Total 776 886

* Angiogram activity will be restricted during 2005/06 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 increased numbers and increased capacity to sustain waiting time guarantees.

25

The required cardiac catheter laboratory capacity at Raigmore Hospital is based on the following assumptions

total intervention rate of 2500 per million population (pmp) including CABG (assumes CABG rates will remain static), which would mean PCI activity of between 1,500 and 1,700 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 1st April 2008 : 4 sessions per week x 42 weeks per annum = 168 session per annum. Excludes PCI.

From 1st April 2010 : 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- 1.5 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% per annum for PCI (predicted growth rates as set out in the NHS

Scotland Capacity Review for CHD services

Assumes 200 PCIs will transfer from other service providers to Raigmore Hospital from 1st April 2010 (assumed 50 from Grampian and 150 from Lothian/Glasgow). 86% 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

Table Nine Required Cardiac Catheter Laboratory Capacity for NHS Highland

Procedure 2004/05 2005/061 2006/07 2007/08 2008/09 2009/10 2010/112

Angiogram

RaigmoreActivitySessions

Other CentresActivitySessions

33467

16133

34469

14229

36974

15231

39579

16333

42385

17535

45391

18838

48597

20241

PCI



00

15753

00

19866

00

22876

00

26388

00

303101

00

349117

*20067

*20268

Pacemaker & Generator Changes



9331

114

15251

103

16355

114

17559

124

18863

135

20268

145

21773

155

ICD



00

42

00

2412

00

2814

00

3317

00

3819

00

4422

00

5126

27

Procedure 2004/05 2005/061 2006/07 2007/08 2008/09 2009/10 2010/112

RFA



00

86

00

64

00

75

00

96

00

118

00

139

00

1510

EP Studies



00

83

00

104

00

124

00

145

00

176

00

207

00

238

Total



42798

349101

496120

390118

532129

438134

570138

494153

611148

557174

655159

628198

902237

508158

1 2005/06 activity is projected based on first 6 months activity

2 PCI activity has been adjusted to reflect 200 PCIs being switched from other service providers to the PCI centre in Raigmore in 2010/11 (assumed 50 from Grampian and 150 from Lothian/Glasgow).

28

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 1st April 2008 : 4 sessions per week x 42 weeks per annum = 168 sessions per annum. Excludes PCI.

From 1st April 2010 : 6 sessions per week x 42 weeks per annum = 252 sessions per annum. Includes 200 PCIs.

Cath Lab Sessional Capacity at Raigmore Hospital

126168

252

0

50

100150

200

250

300

2005/06 2008/09 2010/11

Year

No

of

Ses

sio

ns

The phased development plan of the proposed service is enclosed in section 5.4.2. Predicted growth and the plan to manage this are outlined below.

2005/06

During 2005/06 it is projected that 120 cardiac catheter laboratory sessions will be required at Raigmore Hospital. The existing catheter laboratory will cover at all of these sessions.

29

2006/07

During 2006/07 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

2007/08

During 2007/08 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.

2008/09

During 2008/09 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.

2009/10

During 2009/10 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.

2010/11

During 2010/11 it is projected that 237 cardiac catheter laboratory sessions will be required at Raigmore Hospital. This assumes that 200 PCIs will be switched from other service providers (assume 50 from Grampian and 150 from Lothian/Glasgow) to the PCI centre at Raigmore Hospital. From 1st April 2010 : 6 sessions per week x 42 weeks per annum = 252 sessions per annum to includes 200 PCIs have been planned for. The remaining 15 sessions could be used to repatriate more patients from other service providers and to manage demand in the North of Scotland.

30

5.4 Proposed Service

5.4.1 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 2006/07

commissioning a new 2nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 2007/08;

commissioning a dedicated cardiac catheter laboratory at Raigmore Hospital during 2007/08 which will undertake Percutaneous Coronary Intervention (PCI) from 1st April 2010

This proposed service would build on the good clinical relationships that already exist across the North of Scotland, maximising clinical skills and expertise.

31

5.4.2 Phased Development Plan of the Proposed Service

Phase Action

Phase One :

0-12 mths

April 2006 to March 2007

Subject to approval of the business case,

July to Sept 2006 - replace the existing cardiac catheter laboratory at Aberdeen Royal Infirmary. The replacement catheter laboratory could be operational by 1st October 2006. 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 2006. A mobile catheter laboratory will also be required, 3 days a week, for a period of 3 months, between July and Sept 2006. It will work alongside the modular cardiac catheter laboratory. From October 2006, the modular cardiac catheter laboratory will work alongside the replacement cardiac catheter laboratory, 3 days per week.

August 2006 - 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 2006 - 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 2010/11. 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 1st April 2006 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 2nd 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

Phase Action

Phase Two :

13-24 mths


Subject to approval of the business case

Commission a new 2nd cardiac catheter laboratory at Aberdeen Royal Infirmary. This could be operational by 1st October 2007. Equipment and Build costs will be incurred during 2006/07 and 2007/08.

1st October 2007 - new 2nd cardiac catheter laboratory at Aberdeen becomes operational. It will operate 10 sessions per week, 48 weeks per annum.

April 2007 to March 2008 - commission a new dedicated cardiac catheter laboratory at Raigmore Hospital. This could be operational by 1st April 2008. Equipment and Build costs will be incurred during 2007/08.

August 2007 - 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 2008 – Appoint non-medical staff to work in the dedicated cardiac catheter laboratory at Raigmore Hospital. This will become operational on 1st April 2008. 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

25-37 mths



1st April 2008 - 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 2008/09 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 2008/09 by the North of Scotland Cardiac Services Sub Group, to enable planning for the next 5-10 years

33

Phase Action

Phase Four

38-62 mths



During 2009/10 a mobile cardiac catheter laboratory will be required for 171 sessions (85.5 days) to ensure there is sufficient capacity to meet demand.

During 2010/11 an additional 302 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 4th 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 2008/09

1st April 2010 - 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 2010 – 200 PCIs switched from other service providers (assumed 50 from Grampian and 150 from Lothian/Glasgow) 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

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

InstitutionsOperatorsCase selectionAudit (data collection & analysis, peer review, resources) Training

The indicators were updated by this joint working group in 2005 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 CHD 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 50 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

In summary the joint working group made the following recommendations

In the guidelines published in 2000, 200 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 400 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 200 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 90 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 90 minute rule can be met.

Although the majority of PCI in the UK is still undertaken in tertiary centres with on-site surgery, 11% of procedures were performed in centres without on-site surgery in 2002.

36

The concept of delivering cardiac care through a local clinical network has gained momentum. Representatives from the DOH, BCS and BCIS have developed guidelines for additional PCI centres within clinical networks which will have strong links with their local surgical centre. Thus, further expansion of PCI will occur on two fronts, within the existing surgical centres, and with the development of new PCI centres in limited numbers of district general hospitals that can fulfil the institutional and operator standards.

The option appraisal outlined in the next section will compare a range of options against the recommendations and criteria outlined above.

7. List of Options

37

7.1 Summary

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.

If a 3.5 hour session started at 6pm to allow clean up time from the day sessions, then patients, who are routinely discharged 2 hours after PCI, may require an overnight stay for logistical reasons or the length of the evening sessions and the number of patients seen would need to be shortened.

It would be costly to operate in comparison to operating a mobile cardiac catheter laboratory and a day unit during the routine working day.

Recruitment and retention would be difficult

7.2 Outline Benefit

38

The criteria were developed and weighted according to the consensus of the option appraisal group and this enabled the benefits of the options to be quantified and compared. The table below shows the agreed criteria and weightings.

Benefit Criteria WeightingTo provide services locally to support local communities 12To provide safe and effective services so achieving high standards and improving quality 39To provide sustainable services 20To provide quick access to treatment 16To reflect effective planning and use of resources 13

7.3 Scoring of Options

The “Weighted Benefit Scores” for each of the options are shown below:

Option Weighted Benefit ScoreA 196B 467C 507D 749E 539

8. Preferred Option

39

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 option D :-To

Replace the existing cardiac catheter laboratory at Aberdeen Royal Infirmary during 2006/07

To commission of a new 2nd cardiac catheter laboratory at Aberdeen Royal Infirmary during 2007/08; and

To commission of a dedicated cardiac catheter laboratory at Raigmore Hospital during 2007/08 which will undertake Percutaneous Coronary Intervention (PCI) from 1st April 2010

provides the following clinical gains.

a) Ability to maximise clinical skills and expertise across the North of Scotland

b) Provide safe and effective services to achieving high standards and improving quality for patients

40

9. Affordability

9.1 Methodology and Assumptions

The costing methodology and assumptions are used in line with the latest Scottish Executive Health Department guidance. The following pages set out the main conclusions. The detailed assumptions and methodology are included in Appendix Five and the attached excel spreadsheet.

9.2 Capital and Revenue Cost allocation between NHS Boards

Table Ten (overleaf) sets out the capital and revenue costs by NHS Board for the cardiac catheter development at Aberdeen Royal Infirmary. Table Eleven (overleaf) sets out the capital and revenue costs by NHS Board for the cardiac catheter development at Raigmore Hospital. Table Twelve (overleaf) sets out the total capital and revenue costs by NHS Board for the cardiac catheter developments at Aberdeen Royal Infirmary and Raigmore Hospital.

41

TABLE TEN : TOTAL COSTS FOR NoS BOARDS (£'000)

Contribution to capital and revenue costs from waiting times monies received in 2005/06 (Grampian and Highland) and expectation that further funding will be available from 2006/07 onwards but not factored into above (NoS Cardiac delivery plan being progressed).National tariffs may have an impact on fund flows between Boards – further information awaited.Highland 2010/11 figures assume reduction in CBF following repatriation of 200 cases from other centres (National Tariff rates used)

TOTAL COSTS (£'000) – ARI & RAIGMORE DEVELOPMENTS 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 £'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIAN 429 258 2,793 HIGHLAND 86 1,029 2,724 TAYSIDE 23 14 149 ORKNEY 6 3 37 SHETLAND 11 7 74 OTHERSTOTAL CAPITAL 555 1,311 5,777 REVENUEGRAMPIAN 1,078 1,530 2,033 2,293 2,847 3,692HIGHLAND 453 673 1,157 1,436 1,706 1,457 TAYSIDE 76 107 141 165 206 251 ORKNEY 51 69 90 110 136 165 SHETLAND 30 42 56 64 79 97 OTHERS 25 40 56 63 81 101

TOTAL REVENUE 1,713 2,461 3,533 4,131 5,055 5,763

TABLE ELEVEN : CARDIAC CATH LAB DEVELOPMENT AT ARI

CARDIAC CATH LAB DEVELOPMENT AT ABERDEEN ROYAL INFIRMARY 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 £'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIAN 75% 429 258 2,793 HIGHLAND 15% 86 51 559 TAYSIDE 4% 23 14 149 ORKNEY 1% 6 3 37 SHETLAND 2% 11 7 74 OTHERS 3%TOTAL CAPITAL 100% 555 333 3,612 97%REVENUEGRAMPIAN 1,078 1,530 2,033 2,293 2,847 3692 HIGHLAND 229 320 423 479 594 632 TAYSIDE 76 107 141 165 206 251 ORKNEY 51 69 90 110 136 165 SHETLAND 30 42 56 64 79 97 OTHERS 25 40 56 63 81 101

TOTAL REVENUE 1,489 2,108 2,799 3,174 3,943 4,938

Implementation of National tariffs may have an impact on funding flows – further information awaited.Contribution to capital and revenue cost expected from waiting times monies but not factored into above.

43

TABLE TWELVE : CARDIAC CATH LAB DEVELOPMENT AT RAIGMORE HOSPITAL

CARDIAC CATH LAB DEVELOPMENT AT RAIGMORE HOSPITAL 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

£'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIANHIGHLAND 100% 978 2,165 TAYSIDEORKNEYSHETLANDOTHERSTOTAL CAPITAL 978 2,165 REVENUEGRAMPIANHIGHLAND 100% 224 353 740 966 1,122 825TAYSIDEORKNEYSHETLANDOTHERS

TOTAL REVENUE 224 353 740 966 1,122 825

Revenue figures for2010/11 take into consideration reduction in cross boundary flow payments as 200 cases repatriated (£566k).Implementation of National tariffs may have an impact on funding flows – further information awaited.Contribution to capital and revenue cost expected from waiting times monies but not factored into above.

44

10. Risk Assessment

Risk Impact Mitigation

Level of current build costs High On-going refinement of build costs with the design teams

Correct sizing of the facilities in the NoS to meet demand

Medium Projections are underpinned by detailed activity analysis and demographic profiling. The new facilities will be staffed to meet the level of demand required.

Explicit agreement of the business case with NHS Board’s not yet reached

High Decision to be made by NHS Board’s through the NoS Planning Group

Achievement of new waiting time guarantees for cardiac catheter laboratory procedures

High Existing staffing and infrastructure would be unable to deliver this without additional capacity in the NoS.

Sustainability of the current service in the NoS

High The development of a regional strategy for the development of cardiac catheterisation services will provide long term sustainability if new investment in staffing and infrastructure runs parallel to this.

Recruitment and Retention of Clinical staff

Medium This new developments will be an important factor in attracting clinical staff to work in the NoS.

Delay in phased development plan

High Short term capacity can be brought in through a mobile cardiac catheter laboratory but the costs are not sustainable in the medium to long term.

11. NHS Boards Approval

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 the capital and revenue costs outlined in section 9.

46

APPENDIX ONE

REPORT ON CARDIOLOGY WORKSHOPS FOR THE DEVELOPMENT OF CARDIAC CATHETERISATION FACILITIES

IN THE NORTH OF SCOTLAND

47

NORTH OF SCOTLAND PLANNING GROUP

REPORT ON CARDIOLOGY WORKSHOPS FOR THE DEVELOPMENT OF CARDIAC CATHETERISATION FACILITIES IN THE NORTH OF SCOTLAND

1. PURPOSE

The purpose of this paper is to:

- Inform NoSPG of the outcome of the cardiology workshops- Recommend the acceptance of the option of three catheterisation laboratories (cath labs)

in the North of Scotland region, with two in Aberdeen and another in Inverness by 2010, subject to the development of a business case.

- Advise on the future steps and the development of a business case.

2. RECOMMENDATIONS

The Group is asked to:

- Note the content of the report.- Agree to the proposed option of 2 cath labs in Aberdeen and 1 in Inverness by 2010

subject to actual demand.- Agree on the appointment of a small, dedicated team with the requisite skills and

experience to complete the business case by the end of October 2005.

3. EXECUTIVE SUMMARY

A detailed report on each of the workshops is attached in the appendices. In brief the results of the two workshops are as follows:

3.1 First Workshop: The first workshop was held in November 2004. While options were identified, these were dependent on the commissioning of detailed work on activity projections. A number of action points were outlined as follows:

An urgent increase in cath lab capacity was required to meet waiting times guarantees. This was achieved on a temporary basis by the installation of a modular cath lab at Aberdeen Royal Infirmary, funded from slippage in CHD money.

Investigate new technology, specifically high resolution CT, to determine whether angiography could be performed without cath lab facilities.

Develop the clinical network to support cardiology services in the North of Scotland.

Commission detailed work on activity projections and patient flows.

The initial work on activity flows revealed significant differences between ISD and locally held data.

A huge amount of work was required to reconcile and explain the differences and to ensure that the data was sufficiently robust for the basis of future activity projections. This work was fraught with problems and took an inordinate time to complete satisfactorily, which delayed the second workshop until August 2005.

48

3.2 Second Workshop: The second workshop was held on 23/24 August 2005. The workshop was presented with detailed activity projections under a range of assumptions up to 2010. There was agreement that by 2010:

a) Planning should be based on 1,500-1,800 PCI activity, which approaches European rates of PCI, but growth would not continue along the current trend of c.17% per annum.

b) We could not foresee at this stage the impact of high resolution CT scanning for angiography, but this should be kept under review.

c) On this reckoning the North of Scotland would require 3 cath labs to meet demand.

Following the above agreement a number of options were identified for the placement of cath labs in the region by 2010. There was however unanimity that there should be:

- 2 cath labs in Aberdeen- 1 cath lab in Inverness

A number of important issues were raised:

4. Phasing of the developments5. Development of a fully costed business case to ensure affordability6. Workforce issues7. Support for and sustainability of the current service8. The need to implement solutions swiftly

However it was agreed that these issues could not be dealt with in the workshop forum. It was further agreed to recommend the formation of a small, dedicated team to prepare a business case by the end of October 2005 and following approval commence implementation thereafter.

4. FINANCIAL IMPLICATIONS

The financial implications will be detailed in the business case.

Cost sharing arrangements will be proposed in the business case.

5. RISK ASSESSMENT

Risks will be identified and set out in the business case. The main current risks identified were:

- Sustainability of current service in the region.- Meeting waiting times guarantees.- Correct sizing of facilities in the North of Scotland to meet demand.

6. IMPLICATIONS FOR HEALTH

Owing to the historic and projected growth in activity in PCI it is vital that cath lab facilities are sized and placed to meet projected need by the North of Scotland population

49

7. TIME TABLE AND LEAD OFFICER

The workshop members recognised the urgency of the situation and therefore recommend that the business case be completed by the end of October and, once approved, be implemented soon thereafter.

Owing to the importance and urgency of the recommended developments the lead officers need to be senior management.

8. CONSULTATION

There was a wide range of participants at the workshops including patient representatives.

David CarsonAugust 2005

50



LIST OF APPENDICES

APPENDIX 1: BACKGROUND

APPENDIX 2: DETAILED REPORT ON NOVEMBER 2004 WORKSHOP

APPENDIX 3: DETAILED REPORT OF AUGUST 2005 WORKSHOP

APPENDIX 4: ACKNOWLEDGEMENTS

NOTE: A file of information and presentations has been maintained and is available for review and reference.

51

APPENDIX 1 OF NoS CARDIOLOGY WORKSHOP REPORT



BACKGROUND

There are a number of existing cath lab facilities in the North of Scotland region:

Aberdeen Royal Infirmary: 1 permanent cath lab equipped for angiography and PCI. A temporary modular cath lab was added in November 2004, which performs angiography only. Aberdeen is the PCI centre for the North of Scotland currently.

Raigmore Hospital, Inverness: 1 permanent cath lab equipped for angiography. The lab is currently also used by other departments for various services.

Ninewells Hospital, Dundee: 1 permanent cath lab equipped for angiography. The lab is not dedicated to angiography.

The past few years has seen a large growth in PCI activity driven by several factors, such as demographics, changes in clinical practice, the introduction of troponin testing and reduction in waiting times. As a consequence the existing PCI facilities and equipment in Aberdeen, which are reaching the end of their useful lives, were recognised to be increasingly unreliable and unable to cope with increasing demand.

In 2004 Grampian independently developed a draft business case for a regional development of 2 new cath labs in Aberdeen, which was presented to the North of Scotland as the preferred solution. However there were a number of issues raised, which led to the formation of a wider group, drawn from the affected North of Scotland Boards, whose remit was to determine the prioritised list of options for cath lab facilities and report the preferred option to the North of Scotland Planning Group.

The wider group met on two occasions, November 2004 and August 2005, in a workshop format. The deliberations of the group and the issues arising are set out in the following appendices.

52

APPENDIX 2 OF NoS CARDIOLOGY WORKSHOP REPORTNORTH OF SCOTLAND PLANNING GROUP


FIRST WORKSHOP MEETING – NOVEMBER 2OO4RAIGMORE HOSPITAL, INVERNESS

1. ATTENDANCE

The workshop was well attended by a wide range of representatives:

David CarsonDerek LeslieDavid SullivanRoseanne UrquhartKen OatesIan CrozierMilne WeirClark PatersonStuart CaldwellFiona GrantSteve WaltonStephen Cross

2. CONTENT

2.1 Dr Steve Walton gave a presentation on the issues facing angiography and PCI services in the North of Scotland. The presentation gave reasons for the need to increase capacity to meet demand:

- Demand for PCI was increasing for several reasons. Waiting times were shortening; higher risk patients that were unsuitable for CABG were undergoing PCI; troponin testing was identifying more patients for treatment;

- The MCN was developing with rapid access chest pain clinics and the introduction of local cardiology clinics leading to identification of more need

- Demographics- There were recommendations to increase the rate of cardiac intervention to deal with

the prevalence of heart disease and reduce mortality- There was growing evidence that primary PCI should be the first

line of treatment for AMI- Improved survival of AMI patients through community

thrombolysis- Existing cath lab at Aberdeen was working over capacity and

there was no contingency in the event of breakdown.

2.2 The workshop identified and discussed a long list of options which could provide additional cath lab capacity:

53

a) Do nothing/status quob) Mobile unitc) High resolution CT for angiography to release cath lab capacityd) Expand and change use of Raigmore cath labe) Identify and use spare capacity elsewhere in Scotlandf) Expand hours of use of existing cath labs through shift workingg) 2 new cath labs in Aberdeen to replace the existing cath lab

The pros and cons of each option were identified using post-its and these were summarised after the workshop.

3. DISCUSSION

The main themes of the discussions are set out below. The detailed notes from the workshop are available if required.

3.1 As the discussion developed around the options, the clear issue was that there was insufficient information on activity, and where this originated geographically, to arrive at an informed decision on any of the options. There was also a desire to future proof the preferred option, otherwise if growth in activity continued the NoS would be in a similar situation in a few years. Consequently the workshop asked that work be commissioned to project activity, and therefore likely demand, several years into the future so that appropriate longer-term options could be developed.

3.2 There was also lack of clarity over the new technology, high resolution CT, that was available, which might replace angiography in the cath lab and therefore reduce total future cath lab requirements. More knowledge of the impact of the new technology was needed and the workshop asked that this be obtained.

3.3 Urgent increase in cath lab capacity was required as there were problems forecast in meeting waiting times guarantees. The workshop recommended the immediate replacement of old equipment in Aberdeen as a short-term solution.

3.4 There were extensive problems with recruitment of cardiologists with vacancies exceeding supply. New facilities and PCI developments would be more attractive for new candidates. The NoS needed to develop the cardiac MCN to innovate more efficient ways of working within the restrictions and opportunities arising from various directions such as Working Time Regulations, Junior Doctors, Modernising Medical Careers, etc. There were also restrictions imposed by BCIS to regulate PCI centres to ensure patient safety; an operator must perform 75 PCIs per annum, the PCI site should perform more than 200 PCIs and should be no more than 90 minutes from a cardiac surgery centre.

54

3.5 The placement of cath lab facilities dictated how efficient and safe they were likely to be. A larger central facility would be easier and more efficient to operate and would be a supportive environment for operators and support staff as experiences could be readily shared. Smaller geographically discrete facilities, without a strong MCN, might be less viable.

3.6 The patient perspective was discussed. Access was a key issue and there was a balance to be struck between local access and the viability of PCI units. A mobile unit might be a solution, but this was known to be expensive and might be exposed where complications arose. Travel and set up time was a major issue that reduced efficiency.

3.7 The efficiency of existing sites was discussed. If work patterns were changed, e.g. shift and weekend working, it may be possible to increase capacity of existing facilities. However there were restrictions in terms of Working Time Regulations, the attractiveness of posts where there was a shortage of people and increased maintenance costs.

3.8 Costs and affordability were not discussed, as no reliable and robust costs were available. The workshop needed to develop options with the best fit for clinical governance, access and viability and these options would be costed to allow NoSPG to make a decision.

3.9 The workshop advised that due to the requirement for more information about activity it could not progress further to prioritise the options identified.

4. ACTION POINTS

A number of action points were agreed:

4.1 There was agreement to an immediate increase in cath lab capacity in Aberdeen in order to meet waiting times guarantees. The workshop was advised that this could be achieved by replacing the old equipment in the existing cath lab. Subsequently it was found that the new equipment would not fit in the old cath lab and therefore a short-term temporary solution was implemented where a staffed modular cath lab was rented. The modular lab performs angiography only, which releases capacity from the old lab. The funding for the modular lab was secured from CHD money.

4.2 Investigation of high resolution CT scanning as a possible alternative to angiography was required. GE Medical was subsequently contacted to arrange demonstration of the possibilities.

4.3 The clinical network for cardiac services needed to be extended on a regional basis in order to sustain services in the region.

4.4 There was a recognition that PCI services needed to be future-proofed for several years, especially as the activity was rising and was expected to rise further.

55

4.5 `Work was therefore commissioned to project activity and patient flows several years into the future to inform decision making about the number and location of facilities required in several years time.

5. ADDENDUM

Following the workshop, work was commissioned on activity data. The common source of activity data was ISD, however it was quickly realised that there were major differences between locally held data and ISD. Doubts were therefore cast over the validity of the data and its robustness for performing projections. Because of the length of forecasting (5 to 10 years into the future) and the large historic percentage increases in activity, even a relatively small error in the baseline activity could have a large impact on the projections and lead to the wrong decisions. It was therefore necessary to undertake a huge task in reconciling ISD and local data and verifying the quality of the data.

The reconciliation took an inordinate length of time owing to resignation of several key Grampian data staff and the overall size and complexity of the task.

When the task had been completed it was calculated that about 11% of Grampian cardiac activity had been miscoded, which needed to be taken into account in the projections.

Action has been taken by Grampian to eliminate the causes of error.

The completion of the data work coincided with the start of the holiday season and it proved impossible to establish a second workshop with all the key people in attendance until late August.

56




SECOND WORKSHOP MEETING – AUGUST 2OO5ABERDEEN CONFERENCE CENTRE, ABERDEEN

1. ATTENDANCE

The workshop was well attended with representatives from most of the referring Boards. Patient representatives from Grampian and Highland also attended. A complete list of those present for the workshop proper is set out in a separate schedule.

2. CONTENT OF PRESENTATIONS

The workshop was spread over two days. On the evening of Tuesday 23 August 2005 a seminar was arranged for GE Medical to advise on the new technology that was available, which attracted not only the members of the workshop, but also a number of local clinicians and radiologists. The following day the workshop proper as held.

2.1 GE Medical Seminar: GE presented on several items and issues in respect of the abilities and use of the advanced equipment now available:

- Angiography equipment: The new generation of equipment was faster, more accurate and gave reduced dosage of radiation to the patient. Demonstrations of the abilities of the equipment were also available.

- The compatibility of the imaging equipment with current IT systems was demonstrated, with images transferable to PACS and suitable for viewing over NHSnet.

- The abilities of the high resolution (64-slice) CT for cardiology were demonstrated. The quality of imaging was impressive. However there were several technical problems raised by interventional cardiologists. It was not possible at this stage to estimate the diagnostic activity that could be removed from the cath lab using this new technology. The cost of the scanner was approximately £600,000.

- Lastly there was an introduction to the benefits of looking at process workflow, which was aimed at securing maximum benefits from the use of new technology.

2.2 Workshop: The workshop proper commenced on the morning of 24 August 2005. The workshop was divided into several phases:

2.2.1 David Carson introduced the session and gave a summarised refresher of the outcomes of the workshop held in November 2004 and advised of the changes in the intervening period, which included the publication of the Kerr Report and the updated draft of the BCIS guidelines for PCI sites

57

The key benefit criteria for the potential development based on the Kerr Report were ranked individually and averaged. The workshop ranked the criteria as follows:

First: Safe and effectiveSecond: SustainableThird: Quick accessFourth: Effectively plannedFifth: Local service

2.2.2 Susan Vaughan presented the work performed on activity projections using 3 rates of PCI activity growth mapped on to 3 possible options to 2010. 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:

2003/04 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 2000 interventions per million of population by 2010 which gave a percentage growth of 86%.

The activity projected ranged from 600 to 2,000 PCIs per annum. Following discussion the workshop concluded that the trend would ameliorate, but it was likely that we would move closer to European rates of intervention (total intervention rate including CABG: 2,500 pmp), which would mean a PCI activity of between 1,500 and 1,700 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 600 PCI per cath lab the NoS will require up to 3 cath labs to meet estimated demand by 2010.

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 0.29%. Therefore the requirement to meet the 90 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.

2.2.3 Ros Wilkinson 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.

2.2.4 The workshop agreed that activity by 2010 would require 3 cath labs.

58

3. EXPLORATION OF SERVICE OPTIONS

3.1 The high resolution CT was discussed. The advice from the clinicians experienced in their use was that there were still a number of issues to be resolved and that the technology was work in progress. The workshop agreed that this type of technology was developing and should be kept under review, but that it was not appropriate for it to be considered as a viable option or sub-option at this stage.

3.2 The options proposed from the November workshop were listed. The workshop agreed that the options did not fit the projected activity requirements and exploration of other options was required.

3.3 Following discussion a list of options was identified:

A: Do nothingB: 2 new cath labs in AberdeenC: 2 new cath labs in Aberdeen plus 1 mobileD: 2 new cath labs in Aberdeen plus equip the Inverness site for PCIE: 3 new cath labs in Aberdeen

3.4 The benefits and disadvantages of each option were identified and discussed. The detailed discussions were noted and are available in the workshop files. The main discussion points revolved around the options of having a 3 cath lab centre in Aberdeen and a more distributed model of 2 cath labs in Aberdeen with 1 in Inverness.

The central model of 3 cath labs in Aberdeen exhibited the advantages of being potentially safe and efficient. However there were several difficulties; patient access and associated travel and transport issues, Aberdeen would need additional infrastructure (labs and beds) to deal with the region’s activity and there was a potential knock on impact of making other services unviable in Inverness if cardiology was not retained and developed.

The mobile service met access demands for angiography, but could not be used for PCI and pacemakers. Staffing was potentially a problem as it was seen to be unpopular and was also expensive to operate.

The distributed model with PCI being performed in Aberdeen and Inverness was the most popular. The existing cath lab in Inverness could be used for PCI following re-equipping, which did not require new build and was therefore seen as cost effective. Access would be better than a regional centre in Aberdeen. An Inverness PCI centre would be more attractive for cardiologists and other staff. There might still however be recruitment difficulties for staff in short supply and there was considerable discussion over the numbers and types of cases. An out of hours service, while preferable might not be efficient or affordable and the limitations of the potential PCI service in Inverness needed to be fully explored.

While no option was a perfect solution the distributed model appeared to be the best fit to the criteria.

59

4. PRIORITISATION OF OPTIONS

The options were scored by the workshop individually to rank them in order, taking into account the weighting applied to the criteria. The ranking was as follows:

First: Option D – 2 new cath labs in Aberdeen plus equip the Inverness site for PCISecond Option E – 3 new cath labs in AberdeenThird Option C – 2 new cath labs in Aberdeen plus 1 mobile

The detailed scoring schedules are available.

5. NEXT STEPS

The workshop discussed several other issues:

5.1 Phasing: While there was agreement for the need for 3 cath labs by 2010 in NoS the timing of their introduction into each area was a complex issue. The existing equipment in Aberdeen required replacement, but that demanded new build. A new build would be more efficient if 2 labs were built at the same time.

Inverness has a cath lab that requires only to be re-equipped. This could be completed relatively quickly.

5.2 Urgency: The urgency of the situation was emphasised.

5.3 Workforce Issues: Richard Carey joined the workshop and asked about discussions regarding sustaining the existing service. There was recognition that this issue was crucial to the success of cardiology services in the NoS, but this forum was not constituted to take this forward. The MCN with appropriate support should be tasked with workforce issues and new ways of working to meet the requirements of the service.

5.4 There was acceptance that the workshop had identified an acceptable and practical preferred option, but there were many complexities and details to deal with, which the workshop was not equipped to discuss and resolve. The workshop proposed that a recommendation be made in the report to NoSPG to establish a dedicated team to develop a business case urgently and move to implement the preferred solution as soon as possible.

60




ACKNOWLEDGEMENTS

I am grateful to the following in particular for their help and support during this complex process:

Stuart Caldwell, who facilitated both workshops.Roseanne Urquhart, who provided support and guidance throughout the process.Susan Vaughan, who performed a huge amount of work on projections of activity and presented this complex work to the August workshop.Ros Watkinson, who provided a focused presentation on the issues.Milne Weir, who provided support and guidance and administered the second workshop.Clark Paterson, who provided the financial

61

APPENDIX TWO

CLINICAL BENEFITS OFPERCUTANEOUS CORONARY INTERVENTION (PCI)

Percutaneous Coronary Intervention (PCI) is an established and effective therapy for a defined group of patients with coronary artery disease. It is used to dilate narrowed arteries. A catheter with a deflated balloon at its tip is inserted into the narrowed part of the artery. The balloon is inflated, compressing the plaque and enlarging the inner diameter of the blood vessel so blood can flow more easily. The balloon is then deflated and the catheter removed. It is a less traumatic and less expensive alternative to coronary artery bypass surgery (CABG) for patients with coronary artery disease. About 95% of these procedures also involve the placement of at least one, and routinely more than one, stent.

New coronary devices have expanded the clinical and anatomical indications for revascularisation initially limited by Percutaneous Coronary Intervention (PCI). For example, stents reduce both the acute risk of major complications and long term restonosis. The success of new coronary devices in meeting these goals is in part represented by the less frequent use of balloon angioplasty alone (<10%) and the high (>90%) incidence of coronary stenting in the current practice of interventional cardiology Stents are small, spring-like metal devices which keep the artery "stretched" open and can significantly decrease the chances that a treated blockage will renarrow causing problems such as recurrent angina. Nowadays it is usually possible to directly insert a stent into a coronary artery without any pre-dilation. This is safer and more cost-effective. A stent, tightly mounted on a special angioplasty balloon is threaded over an ultra-thin guide wire to the site of the blockage. As the angioplasty balloon is inflated it stretches the stent open and implants it against the walls of the coronary artery. Because the stent is made of metal, it remains in this stretched-open position, keeping the artery stretched and open.

The major advantages of PCI are its safety, relative ease of use, avoidance of general anaesthesia and major surgery, brain complications, and prolonged convalescence. Repeat PCI can be performed more easily than repeat bypass surgery, and revascularization can be achieved more quickly in emergency situations. The disadvantages of PCI are early restenosis (renarrowing) and the inability to relieve many totally occluded arteries and/or those vessels with extensive atherosclerotic disease.

62

Technology continues to advance however and a new type of stent coated with a special chemical is now available – this is called a drug eluting stent. It appears to abolish the restenosis problem and will allow successful PCI of small arteries. The use of Drug Eluting stents (DES) was approved by NICE in October 2003 and endorsed by Quality Improvement Scotland (QIS) for use in Scotland. The Cardiac Intervention sub group conducted an analysis of the Scottish Angioplasty Register and have concluded that approximately 50% of all lesions treated in Scotland would meet the NICE criteria for a drug eluting stent and have requested the development of a national policy. The North of Scotland Cardiac Services Sub group put forward a paper to the North of Scotland Planning Group in January 2005 recommending that 30% of all stents put in during PCI procedures should be drug eluting stents (DES) – SEE Appendix Four. This was formally accepted by the North of Scotland Planning Group. The cost of a drug eluting stent (£950 each) is higher than bare metal stents (£250 each) currently used.

Usually the greater the extent of coronary atherosclerosis and its diffuseness, the more compelling the choice of coronary artery bypass surgery, particularly if cardiac function is depressed. Patients with lesser extent of disease and localized lesions are good candidates for PCI.

63

APPENDIX THREE

DEFINITION OF CARDIAC PROCEDURES

Procedure Definition

Angiogram An X-ray picture of the blood vessels which shows where the arteries are narrowed and how narrow they have become. A fine, hollow tube called a ‘catheter’ is introduced into an artery in the forearm or groin and is gently advanced through the blood vessels. A dye is then injected into the blood vessels and X-rays taken from several angles. This allows a ‘road map’ of the blood vessels to be drawn, showing where they are narrowed and how narrow they have become. This procedure may be carried out to examine the coronary arteries (a coronary angiogram)

Percutaneous Coronary Intervention (PCI).

Percutaneous Coronary Intervention (PCI). is a technique for treating coronary artery disease. It was first used in 1977 and has developed rapidly since then. Over 20,000 angioplasties are now done each year in the UK. PCI 'squashes' the atheroma (fatty tissue) in the narrowed artery, allowing the blood to flow more easily. Before you have PCI you will be given a local anaesthetic. A catheter (a fine, hollow tube) with a small inflatable balloon at its tip is passed into an artery in either your groin or your arm. The operator then uses X-ray screening to direct the catheter to a coronary artery until its tip reaches the narrowed or blocked section. The balloon is then gently inflated so that it squashes the fatty tissue responsible for the narrowing. As a result, this widens the artery. The catheter contains a 'stent' which is a short tube of stainless-steel mesh. As the balloon is inflated, the stent expands so that it holds open the narrowed blood vessel. The balloon is then let down and removed, leaving the stent in place.


A device which is implanted within the chest wall. It monitors the heart rhythm, senses if there is about to be a severe disturbance in heart rhythm and if necessary delivers an electrical impulse to stop the abnormal rhythm and allow the normal rhythm to resume

64

http://www.bhf.org.uk/hearthealth/index.asp?secondlevel=74&thirdlevel=257&artID=75

Procedure Definition

Radio Frequency Ablation (RFA)

Some disturbances of heart rhythm cause the heart to beat too quickly. Although sometimes no more than a nuisance, attacks may be life threatening. One of the most significant advances in the 1980s was treatment through the introduction of ablation techniques. A thin tube called a catheter is placed in the heart and gently warmed by radio frequency energy so that the electrical short-circuit in the heart that causes these problems is corrected

Electrophysiology Studies (EP)

A doctor will place fine tubes, called electrode catheters, into a vein, usually in the groin, but sometimes into a vein in the neck or under the collarbone. They are then gently moved into position in the heart where they stimulate the heart and record the electrical impulses. It may feel as if you are having palpitations. Most people need only a local anaesthetic (an injection which numbs the area being cut) before having this test.

Pacemaker Implantable pacemakers first became available in the mid 1960s. Their role is to stimulate an excessively slow heart rate which causes breathlessness and sometimes life-threatening loss of consciousness. Over the years, their use has been refined enabling thousands of heart patients to enjoy a better quality of life and return to active work

Generator Change

The part of a pacemaker that contains the electrical circuitry

65

APPENDIX FOUR

DRUG ELUTING STENT PAPER

66

North of Scotland Planning Group Meeting

DRUG ELUTING STENTS

This updated paper outlines for NoSPG members a proposed strategy for the use of Drug Eluting Stents in PCI in line with NICE Guidance and proposes a NoSPG approach.

BackgroundIn October 2003 NICE issued guidance for the use of Drug Eluting Stents (DES) Advisory Committee on CHD wrote to the Chair of each of the regional planning groups requesting an all-Scotland policy for the use of DES. The Regional Chief Executives resolved to raise the issue at the Chief Executives Business meeting with Trevor Jones in March 2004. In the interim, the cardiologists had raised concerns with SEHD regarding an uneven response by NHS Boards to the introduction of this new technology and requested the imposition of a time-limit for introduction.

The current position of SEHD is that NHS Boards should take account of NICE Guidance and NHS QIS advice in their planning, funding and provision of services, to ensure that newly-recommended drugs or treatments are made available to meet clinical need. SEHD have proposed a time-limit of 12 months and if not made available within this period then necessary follow-up action would be taken through performance management and accountability review arrangements.

Proposal

Attached to this paper is a paper prepared on behalf of the NoS Cardiac Services Sub-Group. The paper recommends that DES be introduced for patients with single vessel disease, where both efficiency and cost effectiveness can be demonstrated. For patients with multiple vessel disease the implementation of DES is being discussed nationally although no decisions have been reached on this to date.

In May 2003, the NoSPG established a Cardiac Services Sub-group. This sub-group has reviewed the SEAT Protocol and has made recommendations to NoSPG on:

1. The applicability of the SEAT Protocol for NoSPG;2. The likely patient numbers across NoSPG area;3. The identifiable costs for NoSPG Boards

Dr Annie K IngramRegional Planning & Workforce Co-ordinatorNorth of Scotland Planning Group

67

DRUG ELUTING STENTS

1. Purpose of the Report

1.1 The purpose of the report is to outline to consortium members the proposed strategy for expanding the use of the Drug Eluting Stents in PTCA in line with NICE recommendations and to propose that other member Boards consider the same approach

2. Background

2.1.1 Drug Eluting Stents have been being used within Aberdeen Royal Infirmary for over one year. Their use has been strictly controlled according to a protocol for their use, which was subsequently approved by the cardiac consortium in the NoS.

2.1.2 Adherence to the protocol is closely audited and the view taken is that that clinicians are adhering to the approved protocol.

3. Key Issues and Options

3.1 In October 2003 NICE approved the use of Drug Eluting Stents in angioplasty for two patient groups.

3.2 The first patient group was patients with single vessel disease where the vessel was long and/or very narrow. The efficiency data suggested that patients have a lower rate of re-stenosis and cost effectiveness data was estimated at £15,000 per QUALY.

3.3 The second group was patients with multiple vessel disease where there was no efficacy data available and so efficacy was not able to be established and the cost effectiveness data was not good coming out at £195,000 per QUALY. In this case, NICE recommended the use of drug eluting stents on the basis of strong clinical opinion and not efficacy data or cost effectiveness data. The implementation of DES for this group of patients is being discussed at a national level but no decisions have been reached on this to date.

3.4 The NoS Cardiac Services Sub-group has agreed to support a staged process for the introduction of these stents into use. This follows on from a local protocol and will extend the use of these stents from approximately 15% during 2004/05 to 30% during 2005/06. This is consistent with an agreement reached by SEAT on the use of drug eluting stents. Progress on this staged process has been restricted in the NoS over the last two years due to limited cardiac catheter laboratory capacity.

68

4. Resource Implications

4.1 The current projections suggest the resource implications for referring boards in the NoS consortium will be

PROJECTED DIFFERENTIAL COST OF DES. £757 Per Stent% of ACTIVITY (PROCEDURES) 15% 30% 30% 30%

2001/02 2002/03 2003/04 2004/05 2005/06 2006/07 2007/08Grampian 0 6,813 18,925 86,298 197,577 226,343 260,408Highland 0 0 1,514 18,168 42,392 49,962 56,775Orkney 0 0 0 2,271 4,542 6,056 6,056Shetland 0 0 757 1,514 2,271 2,271 2,271Tayside 0 0 0 2,271 6,056 6,056 7,570Others 0 0 0 3,785 7,570 8,327 9,841Grand Total 0 6,813 21,196 114,307 260,408 299,015 342,921

Average cost of a coronary stent is £193Average cost of a drug eluting stent is £950 giving an increased cost of £757Based on 2004/05 BPI price listsBased on average 1.6 stents per case

5. Recommendations

5.1 The NoS Cardiac Services Sub-Group recommends the introduction of drug eluting stents for patients with single vessel disease. A decision on the use of drug eluting stents for patients with multiple vessel disease is awaited at a national level.

5.2 The NoS Cardiac Services Sub-Group recommends that NHS boards in the NoS agree to this.

5.3 Aberdeen Royal Infirmary is taking part in a national procurement of drug eluting stents. It is envisaged that referring NHS Board will see the benefits in central purchasing of these stents for the whole of Scotland.

69

APPENDIX FIVE

DETAILED FINANCIAL ASSUMPTIONS AND METHODOLOGY

CAPITAL & REVENUE COST ALLOCATION BETWEEN NHS BOARDS (£'000)

CARDIAC CATH LAB DEVELOPMENT AT ABERDEEN ROYAL INFIRMARY 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 £'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIAN 75% 429 258 2,793 HIGHLAND 15% 86 51 559 TAYSIDE 4% 23 14 149 ORKNEY 1% 6 3 37 SHETLAND 2% 11 7 74 OTHERS 3%TOTAL CAPITAL 100% 555 333 3,612 97%REVENUEGRAMPIAN 1,078 1,530 2,033 2,293 2,847 3692 HIGHLAND 229 320 423 479 594 TAYSIDE 76 107 141 165 206 ORKNEY 51 69 90 110 136 SHETLAND 30 42 56 64 79 OTHERS 25 40 56 63 81

TOTAL REVENUE 1,489 2,108 2,799 3,174 3,943 4,938

Implementation of National tariffs may have an impact on funding flows – further information awaited.Contribution to capital and revenue cost expected from waiting times monies but not factored into above.

70

NOS CARDIAC CATH LAB DEVELOPMENT CARDIAC CATH LAB DEVELOPMENT AT ABERDEEN ROYAL INFIRMARYFINANCIAL PLAN - CAPITAL & REVENUE COSTS

CAPITAL £ £ £ £ £ £2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

Building Costs New Cath Lab Facilities 0 300,000 2,844,000 0 0 0 Medical Equipment New Cath Lab 0 0 644,000 0 0 0 General Equipment New Cath Lab 0 0 25,000 0 0 0 Medical Equipment Replacement Existing Cath Lab 549,000 33,000 0 0 0 0 Electromedical Equipment 6,000 0 99,000 0 0 0

TOTAL CAPITAL COSTS 555,000 333,000 3,612,000 0 0 0

REVENUE £ £ £ £ £ £2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

Lease of staffed Mobile/Modular Cath Labs 441,170 592,320 324,480 86,080 232,640 407,360 Staffing 0 94,143 256,970 311,245 311,245 311,245 General Overheads 0 0 11,883 23,766 23,766 23,766 Equipment Service Contracts 0 -31,000 14,000 36,500 59,000 59,000 Capital Charges 73,954 76,409 348,507 340,324 332,211 324,164

515,124 731,872 955,840 797,915 958,862 1,125,535 Consumables 973,873 1,376,043 1,843,364 2,376,292 2,984,121 3,671,790

TOTAL REVENUE COSTS 1,488,997 2,107,915 2,799,204 3,174,207 3,942,983 4,797,325 Reduction in Income from Highland (50 cases) 141,600

Net Costs 1,488,997 2,107,915 2,799,204 3,174,207 3,942,983 4,938,925

Assumptions/Notes

1. New Building operational October 20072. Existing Kit replaced March 20064. Commercial supplier staffed modular cath lab in use from April 05 to Sep'074. Day bed, Recovery Nurse and ODO appointed by April 20065. Cath Lab staff in post July 2007 with training for 3 month period 6. All equipment under warranty for 1 year with service contracts in place thereafter7. Building to be depreciated over 50 years and equipment to be replaced every 10 years8. Tube and detector replacement included in service contract9. Cost of existing Service contracts (£31k) offset new contract costs10. Capital building cost estimates provided by Atkins11. General Overheads include Rates, Cleaning, energy, building maintenance etc.12. All costs at 2005/06 pay (inc AfC 6% uplift) and price rates13. Consumables costs reflect cumulative cost increase from 2004/0514. National PCI tariff rate of £2,832 used to calculate loss of Highland income

72

CARDIAC CATH LAB AT ARI

NOTES FYC (£)

REVENUE COSTSStaffing: Medical (iii) - Sen 1 Radiographer x 2.4 82,894 MTO 2 x 1.2 27,725 ODO x 1.5 21,896 Nursing - Regrade F->G 4,985 Nursing - E Grade x 3 77,408 Nursing - D Grade x 1 24,090 Day Bed Nursing E Grade x 1.6 41,284 Recovery Nurse E Grade x 1.2 30,963 311,245

Rates (v) £

12.73 3,527

Energy (v) £

23.80 6,595

Building Maintenance (v) £

12.24 3,392

Waste (v) £

4.00 1,108

Cleaning (v) £

33.00 9,144SC - 2 Labs (vi) 90,000SC - Existing Budget (vi) -31,000Capital Charges (vii) 73,954

467,965

NOTES

(iii) Assumed medical staff fully funded but other Boards should contribute to costs.(v) Based on cost per squared metres 277.1 m2

(vi) Maintenance costs per GMck(vii) see capital charge costing sheet(viii) all pay & prices at 2005/06 rates(ix) pay includes assumed 6% uplift for AfC

Breakdown of Consumables and Capital Charges available

CAPITAL & REVENUE COST ALLOCATION BETWEEN NHS BOARDS (£'000)

CARDIAC CATH LAB DEVELOPMENT AT RAIGMORE HOSPITAL 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

£'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIANHIGHLAND 100% 978 2,165 TAYSIDEORKNEYSHETLANDOTHERSTOTAL CAPITAL 978 2,165 REVENUEGRAMPIANHIGHLAND 100% 224 353 740 966 1,122 825TAYSIDEORKNEYSHETLANDOTHERS

TOTAL REVENUE 224 353 740 966 1,122 825

Revenue figures for2010/11 take into consideration reduction in cross boundary flow payments as 200 cases repatriated (£566k).Implementation of National tariffs may have an impact on funding flows – further information awaited.Contribution to capital and revenue cost expected from waiting times monies but not factored into above.

NOS CARDIAC CATH LAB DEVELOPMENT CARDIAC CATH LAB DEVELOPMENT AT RAIGMORE HOSPITAL FINANCIAL PLAN - CAPITAL & REVENUE COSTS

CAPITAL £ £ £ £ £ £ £2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

Building Costs New Cath Lab Facilities 0 0 978,000 1,440,000 0 0 0 Medical Equipment New Cath Lab 0 0 0 600,000 0 0 0 General Equipment New Cath Lab 0 0 0 10,000 0 0 0 Medical Equipment Replacement Existing Cath Lab 0 0 0 0 0 0 0 Electromedical Equipment 0 0 0 115,000 0 0 0

TOTAL CAPITAL COSTS 0 0 978,000 2,165,000 0 0 0

REVENUE £ £ £ £ £ £ £2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11

Consultant Cardiologist + 1.0 Sec from Aug 07 0 0 0 86,287 129,431 129,431 129,431Cath Lab Staffing 2 days/wk April 2008 - 3days/wk April 2010 0 0 0 31,056 124,223 124,223 186,334 General Overheads 0 0 0 0 4,289 4,289 4,289 Equipment Service Contracts 0 0 0 0 0 50,000 50,000 Capital Charges 0 0 53,448 227,682 223,465 219,249 215,032

0 0 53,448 345,025 481,408 527,192 585,086Consumables 223,685 299,267 395,267 484,536 594,364 806,557

TOTAL REVENUE COSTS 0 223,685 352,715 740,292 965,944 1,121,556 1,331,737 Reduction in Service Agreements with other Boards (566,400)

Net Costs 0 223,685 352,715 740,292 965,944 1,121,556 825,243

75

Assumptions/Notes

1. New Building and equipment operational April 2008 - possibility that may be part paid from revenue but yet to be quantified Cost includes £978k enabling works for relocation of Cardio-Respiratory Department in 2006/07 for which a business case has already been submitted2. Additional consultant appointed Aug 2007 (assumed require 1.0wte med sec)3. Unit staffed for 2 days per week April 2008 - appointed Jan'08 for training4. Unit staffed for 3 days per week April 20105. All equipment under warranty for 1 year with service contracts in place therefter6. Building to be depreciated over 50 years and equipment to be replaced every 10 years7. Tube and detector replacement included in service contract - based on ARI equipment quote + uplift8. No saving on existing Service contracts as dual purpose kit9. Indicative capital building cost estimates provided by design Team10. General Overheads include Rates, Cleaning, energy, building maintenance etc.11. All costs at 2005/06 pay (inc AfC 6% uplift) and price rates12. Reduction in Service agreements based on proposed 2006/07 national tariff rates for PCI (£2,832 per case)13. Consumables costs reflect cumulative cost increase from 2004/05

76

CARDIAC CATH LAB AT RAIGMORE

NOTES FYC (£) FYC (£)

REVENUE COSTSConsultant 111,159 pt 4 on scale +1 EPA + lev 1 on-callMed sec x 0.5 9,136 120,295 mid -pt on scaleStaffing for 3 days per week: Medical (iii) - Sen 1 Radiographer x 1.4 48,355 mid -pt on scale MTO 2 x 0.75 17,328 mid -pt on scale ODO x 1.0 14,597 mid -pt on scale Nursing - Regrade F->G mid -pt on scale Nursing - E Grade x 1.8 46,445 mid -pt on scale Nursing - D Grade x 0.6 14,454 mid -pt on scale Day Bed Nursing E Grade x 1.0 25,803 mid -pt on scale Recovery Nurse E Grade x 0.75 19,352 186,334 mid -pt on scale

Rates (v) £

12.73 637

Energy (v) £

23.80 1,190

Building Maintenance (v) £

12.24 612

Waste (v) £

4.00 200

Cleaning (v) £

33.00 1,650SC - 2nd Lab (vi)SC - Existing Budget (vi)

310,918

NOTES

(iii) Assumes staff employed to cover 3 days per week

(v) Based on cost per squared metres ------------- 50 m2

(vi) Service contract costs based on ARI quotes(vii) see capital charge costing sheet(viii) all pay & prices at 2005/06 rates(ix) pay includes assumed 6% uplift for AfC

Breakdown of Consumables and Capital Charges available

Contribution to capital and revenue costs from waiting times monies received in 2005/06 (Grampian and Highland) and expectation that further funding will be available from 2006/07 onwards but not factored into above (NoS Cardiac delivery plan being progressed).National tariffs may have an impact on fund flows between Boards – further information awaited.Highland 2010/11 figures assume reduction in CBF following repatriation of 200 cases from other centres (National Tariff rates used)

TOTAL COSTS (£'000) – ARI & RAIGMORE DEVELOPMENTS 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 £'000 £'000 £'000 £'000 £'000 £'000CAPITALGRAMPIAN 429 258 2,793 HIGHLAND 86 1,029 2,724 TAYSIDE 23 14 149 ORKNEY 6 3 37 SHETLAND 11 7 74 OTHERSTOTAL CAPITAL 555 1,311 5,777 REVENUEGRAMPIAN 1,078 1,530 2,033 2,293 2,847 3,692HIGHLAND 453 673 1,157 1,436 1,706 1,457 TAYSIDE 76 107 141 165 206 251 ORKNEY 51 69 90 110 136 165 SHETLAND 30 42 56 64 79 97 OTHERS 25 40 56 63 81 101

TOTAL REVENUE 1,713 2,461 3,533 4,131 5,055 5,763

5.3 interventional cardiology business case

Documents

cardiac revascularisation

nhs tayside nhs tayside

regional service

nhs orkney

nhs highland

nhs shetland

nhs grampian

nhs boards activity