Working to improve the delivery of services for cardiac and stroke patients and their families across Cheshire and Merseyside

Transcription

1 Cardiac Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT) & Elective Percutaneous Coronary Intervention (PCI) Review 31 st August 2010 Working to improve the delivery of services for cardiac and stroke patients and their families across Cheshire and Merseyside Cheshire and Merseyside Cardiac and Stroke Networks

2 DOCUMENT INFORMATION Document Name Organisation / Further Information / Additional Copies Cardiac ICD, CRT & PCI Review Cheshire and Merseyside Cardiac and Stroke Networks Victoria House 490 Knutsford Road Warrington WA4 1DX Tel No: Luke Zaki Document Author Date of Issue 31 st August 2010 Status Final Version 2.0 File Name Cardiac ICD, CRT & PCI Review v2.0 PROJECT INFORMATION Workstream Cheshire & Merseyside Cardiac Work Programme 2010/11 Project Cardiac ICD, CRT & PCI Review Network Project Lead Luke Zaki Programme Lead Judy Arslanian Network Director Jan Vaughan VERSION HISTORY Version Type Document Name Authorised By Date Draft 1.0 Cardiac ICD, CRT & PCI Judy Arslanian 13/08/2010 Review Draft Draft 1.1 Cardiac ICD, CRT & PCI Judy Arslanian 16/08/2010 Review Draft Draft 1.2 Cardiac ICD, CRT & PCI Judy Arslanian 18/08/2010 Review Draft Draft (Shared with Stakeholders) 1.3 Cardiac ICD, CRT & PCI Review Draft Judy Arslanian 20/08/2010 Final (Shared with Stakeholders) 2.0 Cardiac ICD, CRT & PCI Review Judy Arslanian 31/08/2010 2

3 Contents 1. Executive Summary 1 2. Introduction 2 3. Objectives 4 4. Implantable Cardioverter Defibrillator (ICD) 5 4. A. Current Service 5 4. B. Cost Profile 5 4. C. Outcome Indicators 6 4. D. Current Activity 6 4. E. Guidance 9 Page 5. Cardiac Resynchronisation Therapy (CRT) A. Current Service B. Cost Profile C. Outcome Indicators D. Current Activity E. Guidance Elective Percutaneous Coronary Intervention (PCI) A. Current Service B. Cost Profile C. Outcome Indicators D. Current Activity E. Guidance Interested Hospital Trusts Conclusion Considerations Appendices: 28 i. Stakeholders 29 ii. Project Plan 30 iii. NECVN Guidance 31 iv. BCIS PCI Guidance 31 v. Questionnaire 32 3

4 1. Executive Summary The Cheshire & Merseyside Cardiac & Stroke Networks (CMCSN) conducted this review of Implantable Cardioverter Defibrillators (ICD), Cardiac Resynchronisation Therapy (CRT) and elective Percutaneous Coronary Intervention (PCI). This review took 2 months to carry out, involved representatives from Hospital Trusts and PCTs across Cheshire and Merseyside as well as the North West Specialised Commissioning Team. The aim of this review was to outline the delivery of each service, identify the current activity and detail the appropriate guidance for each service in order to deliver a safe and efficient service for patients in Cheshire & Merseyside. Each of these services are solely provided by Liverpool Heart and Chest Hospital for the Cheshire & Merseyside population. These services are currently commissioned by the North West Specialised Commissioning Team and this review was able to provide all stakeholders with a shared understanding of current provision. This review presents the current activity for each of the 3 services and compares them against the national targets, identifying the gaps for each PCT in Cheshire & Merseyside. This review identified the relevant guidance that details the necessary staff, equipment, and protocols needed to facilitate the safe delivery of an ICD, CRT or PCI service. This review highlights the aspirations of local Hospital Trusts that would be interested in providing these services in the future and provides an initial indication of the level of interest, current capacity, infrastructure and capability. Finally, the review raises some key considerations for PCTs with regard to the future of these services. With the help of this information, and through further consultation where necessary, it is hoped that commissioners will be able to make informed decisions regarding these services in the 2011/12 contracting round. I would like to thank all the stakeholders for their involvement throughout the course of the review and for their contribution to the production of this report. Luke Zaki Network Project Lead 31 st August

5 2. Introduction Case for Change The approved Cheshire and Merseyside Cardiac Work Programme (2010/11), included the need to undertake a review of defined cardiac interventions and procedures currently provided at the cardiac tertiary centre, in order to establish the required capacity and capability arrangements necessary for repatriating activity to local Hospital Trusts. Primary Care Trust (PCT) commissioners identified the need to carry out a review of cardiac services, specifically Implantable Cardioverter Defibrillators (ICD), Cardiac Resynchronisation Therapy (CRT) and elective Percutaneous Coronary Intervention (PCI). The procedures contained within this review are recognised as complex cardiac interventions and have only until recently been delivered from specialised Tertiary centres across the country.the network is aware that local Hospital Trusts have the aspiration to deliver these services, partly due to the fact that PCI is no longer defined as specialised, according to the Specialised Services National Definition Set 3 rd Edition. It is important to keep in mind the fact that both ICD and CRT remain within the Specialised Services National Definition Set, and are currently commissioned by the North West Specialised Commissioning Team. Equality & excellence: Liberating the NHS 1 outlines proposals for specialised services to be commissioned by a newly established NHS Commissioning Board in the future. QIPP & WCC The review will bear in mind the need to assess services in line with the QIPP agenda (Quality, Innovation, Productivity and Prevention) and the World Class Commissioning Competencies. This review will focus on the quality of services within the region, to assess need of those services by collaborating with clinicians, commissioners and managers to ultimately present information to commissioners to allow them to make informed decisions regarding the future services. Outcomes The major outcomes of conducting this review are to: Provide a shared understanding of current provision. Identify and address any inequities across the health economy. Inform commissioners of best practice, clinical guidance and workforce requirements. Provide commissioners with evidence to support future decisions relating to commissioning arrangements for 2011/

6 Stakeholders An invitation to be involved in this review was sent to representatives from Hospital Trusts and PCTs across Cheshire and Merseyside as well as the North West Specialised Commissioning Team. Expressions of interest were received from: Aintree University Hospitals Royal Liverpool & Broadgreen University Hospitals St Helens & Knowsley Teaching Hospitals Warrington & Halton Hospitals Wirral University Teaching Hospital The North West Specialised Commissioning Team Halton & St Helens PCT Liverpool PCT Sefton PCT Western Cheshire PCT Wirral PCT The detailed Stakeholder list is attached in Appendix 1. Review Conducted The review was conducted under a tight time scale of 2 months from initiation to reporting, therefore it was vital to have a strict project plan and achievable goals. The review followed the pathway in Diagram 1. Diagram 1 Background research and information gathering. Collation of a Stakeholder list. Distribution of the Terms of Reference to the Stakeholders. Incorporation of feedback in development of the Project Initiation Document. Distribution of the Project Initiation Document to all Stakeholders. Meetings with key stakeholders. Retrieval of information necessary to produce the final report. Distribution of draft final report to all Stakeholders. Collation of feedback on the report. Distribution of the final report. The detailed project plan is attached in Appendix 2. 3

7 Data Sources Population data in five- year age bands (for males and females) were obtained from the UK Statistics Authority. The data covered: Population estimates for the UK for the years 2000 to Population projection for the UK for the year The latest figures on access to the interventions have come from a number of sources, including: The Hospital Episode Statistics (HES) for PCI and CABG data and CISSU for PCI and CABG data The Central Cardiac Audit Database (CCAD) for ICD and CRT. The British Cardiovascular Intervention Society (BCIS) Audit Report Objectives The overall objective of the review is to outline how ICD, CRT & elective PCI services are currently delivered at Liverpool Heart & Chest Hospital NHS Foundation Trust (LHCH), identify the current activity and detail the guidance for each service in order to deliver a safe and efficient service within Cheshire & Merseyside. The objectives of this review are to: Detail the current service. Scope out the current activity of the selected cardiac procedures and recognise possible need within the region. Identify gaps, strengths & weaknesses of the current service. Identify the workforce requirements & national targets. Collate capacity data at possible hospital sites. Identify the benefits and risks associated with changing any services. Provide commissioners with the appropriate information to make informed decisions regarding these services in the 2011/12 contracting round. 4

8 4. Implantable Cardioverter Defibrillator (ICD) An implantable cardioverter defibrillator (ICD) is a small device that is put into the upper chest below the left shoulder. Leads from the device go into the heart to: Continually sense for an irregular heartbeat Deliver a small electric shock to return the heartbeat to its normal rhythm (defibrillate) if necessary A. Current Service Liverpool Heart and Chest Hospital (LHCH) provide a well established ICD service and is the only provider commissioned to perform these procedures within Cheshire & Merseyside. They are the largest single implanting site in the UK. The North West Specialised Commissioning Team (NWSCT) currently commissions the ICD service on behalf of all the Cheshire & Merseyside PCTs. ICD s are a specialised service and therefore will remain commissioned by NWSCT and in line with the Equity & excellence: Liberating the NHS 3 specialised services will be commissioned by the NHS Commissioning Board in the future. Catchment Population The current referral base for the ICD service provided at LHCH covers the whole of Cheshire and Merseyside, North Wales and the Isle of Man. Follow-up Appointments ICD patients on average have 4 follow-up appointments each year, LHCH are currently providing remote follow-up appointments to patients with new ICD implants and have been for the past 18 months. For those current patients where remote follow-up appointments are not possible due to their device not being compatible, conversion is undertaken when they undergo a battery change. Waiting Times There are currently no waiting time breaches in line with the 18 week initiative for the ICD service at LHCH 4. B. Cost Profile The tariff costs in line with Payment by Results (PbR) for the procedure to implant a device differs depending on the main Healthcare Resource Group (HRG) that is assigned to the procedure. The devices themselves are excluded from PbR and are therefore an additional cost to the tariff which is paid for on an individual basis. Depending on the type of device fitted the cost can range from 7,000 to 17,

9 However, follow-up appointments are paid through PbR tariff. LHCH have negotiated a reduced price with NWSCT for remote follow-up s based on that fact that it generally takes less time to perform them. 4. C. Outcome Indicators The outcomes that are measured by LHCH for ICD are: Lead Displacement Pneumothorax Haemothorax Haematoma Infection Puncture & Laceration Lead Perforation Cardiac Tamponade These outcomes are measured for audit purposes within LHCH. Not all of these outcomes are routinely monitored by commissioners, however through quality reports the outcomes of the service are examined. 4. D. Current Activity For ICD procedures the data is collected in calendar years, for evaluation 2009 data has been compared against 2005 to 2009 average. Chart 1 displays the number of procedures performed at Liverpool Heart & Chest for new ICD implants. Chart 1 Chart 1 clearly demonstrates that more patients from Liverpool PCT are being implanted than any other PCT in Cheshire & Merseyside. However, it is essential to assess this in terms of the rate for the population, this is shown in Chart 2. 6

10 Chart 2 The regions ICD implantation rate tracks closely to the national average with Liverpool PCT surpassing the national target of 100pmp. Chart 3 illustrates how the Cheshire & Merseyside Cardiac & Stroke Network performs in relation to the rest of the country. Chart 3 7

11 The projections for ICD implantation over the next 5 years is displayed in Chart 4. Chart 4 NICE guidance in January 2006 estimated that, when implemented, the ICD rate per million population (pmp) would need to increase to 100. For the Cheshire & Merseyside region a 7% increase would be required to reach this target by the year It should be noted that differential growth by individual PCT would apply. Chart 4 indicates the forecast that results from the application of a 7% year on year increase for each of the age/sex rates pmp from 2010 through to the year This is a lower rate of projected growth than the 9% which has occurred for England, Northern Ireland and Wales in the period Chart 5 clarifies the number of procedures that are needed in order for each PCT to reach the 2015 target. Chart 5 8

12 4. E. Guidance The North of England Cardiovascular Network (NECVN) has produced Standards for Implantation and Follow-up of Cardiac Rhythm Management Devices. Heart Rhythm UK is currently in consultation surrounding the production of their standards to be ratified in September Some of the key recommendations extracted from the NECVN document are: The implantation of ICDs and CRT carry higher immediate and long-term complication rates than do bradycardia pacemakers. As the indications for CRT and ICD overlap significantly, it would be expected that centres implanting ICDs should also be able to implant CRT-D devices. There should be at least 2 active implanting consultants per centre. There should be at least 2 cardiac physiologists actively involved in pacemaker implantation and follow-up in each centre. All implanters and physiologists must be fully competent in ICD/CRT followup. Each implanter and physiologist should perform 10 primary ICD implants / year and/or 10 primary CRT implants / year. Each centre should therefore perform 20 primary ICD implants / year and/or 20 primary CRT implants / year. All equipment for implantation and possible complications must be immediately available including external defibrillation. Implantation should be performed in a theatre appropriate for sterile procedures and all aspects of the procedure. Immediate anaesthetic support must be available for ICD implantation. Each trust should maintain a database of device activity to allow immediate tracing of patients with device advisories and timely electronic submission of data to CCAD. In order to assess patients for ICD/CRT therapy, centres must have access to: o echocardiography for accurate ejection fraction and dysynchrony o angiography o cardiac Magnetic Resonance Imaging (MRI) o electrophysiology studies o revascularisation before (CABG) or after (PCR) device implantation 9

13 o anaesthetic support for sedation and general anaesthesia Implantable Device follow-up standards: Patients with cardiac rhythm management devices require life-long follow-up with specialised medical and technical expertise and equipment. This should be performed in accordance with published Guidelines for follow-up of implantable cardiac devices for cardiac rhythm management, HRUK October Arrangements for 24-hour cover should be in place for all device patients. This is particularly important for ICD patients where device-related and arrhythmic complications occur frequently and can be life-threatening. Follow-up should be performed at nationally accepted intervals (within 2 months of implantation and then 6-12 monthly for bradycardia pacing and 3-6 monthly for CRT and ICD therapy). Remote monitoring of devices should be encouraged. Patients should have urgent follow up if they report symptoms which may be associated with their device. In-clinic follow-up should include: o Wound review o Recorded patient rhythm data (including atrial fibrillation or ventricular arrhythmias which may require medical input) o Device checks battery, lead impedance, pacing thresholds, sensitivity o Access to specialised echocardiography services for CRT optimisation when required o Access to specialised electrophysiology services for management of atrial and ventricular arrhythmias when required o Data recording in a form which can be transferred to another centre o Psychological support and early identification of distress o Communication with cardiologists, heart failure team and general practitioners as indicated The full document containing all the standards for implementation and follow-up s of ICD s is attached in Appendix 3. 10

14 5. Cardiac Resynchronisation Therapy (CRT) Cardiac resynchronisation therapy (also known as biventricular pacing) brings the pumping action of the heart chambers back in time with each other, to make the heart more efficient. It is suitable for some people with heart failure caused by left ventricular systolic dysfunction. The person has an operation to put a pacing device into their chest, this is known as a CRT-P This is attached to the heart chambers using three tiny leads. This device can also have a defibrillator added to deliver a small electric current to the heart if it starts beating irregularly, this is known as a CRT-D A. Current Service Liverpool Heart and Chest Hospital (LHCH) provide a well established ICD service and is the only provider commissioned to perform these procedures within Cheshire & Merseyside. They are the largest single implanting site in the UK have achieved National Mentor Status for CRT. The North West Specialised Commissioning Team (NWSCT) currently commissions CRT on behalf of all the Cheshire & Merseyside PCTs. CRT is a specialised service and therefore will remain commissioned by NWSCT and in line with the Equity & excellence: Liberating the NHS 5 specialised services will be commissioned by the NHS Commissioning Board in the future. Catchment Population The current referral base for the CRT service provided at LHCH covers the whole of Cheshire and Merseyside, North Wales and the Isle of Man. Follow-up Appointments CRT patients can have between 2-4 follow-up appointments each year, LHCH are currently providing CRT-D patients with remote follow-up appointments but this function is not currently available for CRT-P patients. Waiting Times There are currently no waiting time breaches in line with the 18 week initiative for the CRT service at LHCH 5. B. Cost Profile The tariff costs in line with Payment by Results (PbR) for the procedure to implant a device differs depending on the main Healthcare Resource Group (HRG) that is assigned to the procedure. The devices themselves are excluded from PbR and are therefore an additional cost to the tariff which is paid for on an individual basis. Depending on the type of device fitted the cost can range from 7,000 to 17,

15 However, follow-up appointments are paid through PbR tariff. LHCH have negotiated a reduced price with NWSCT for remote follow-up s based on that fact that it generally takes less time to perform them. 5. C. Outcome Indicators The outcomes that are measured by LHCH for CRT are: Lead Displacement Pneumothorax Haemothorax Haematoma Infection Puncture & Laceration Lead Perforation Cardiac Tamponade These outcomes are measured for audit purposes within LHCH. Not all of these outcomes are routinely monitored by commissioners, however through quality reports the outcomes of the service are examined. 5. D. Current Activity For CRT procedures the data is collected in calendar years, for evaluation 2009 data has been compared against 2005 to 2009 average. Chart 6 displays the number of procedures performed at Liverpool Heart & Chest for new CRT implants. Chart 6 The rate for new CRT implantation is exhibited overleaf in Chart 7. 12

16 Chart 7 Chart 7 makes it clear that all of the PCTs in the region are exceeding the national average and in some cases the 2015 target as well. Chart 8 illustrates how the Cheshire & Merseyside Cardiac & Stroke Network performs in relation to the rest of the country. Chart 8 13

17 No forecast has been produced for CRT because the region is already hitting the national target of 130pmp. Chart 9 clarifies the number of procedures that are needed in order for each PCT to reach the 2015 target. Chart 9 Further work needs to be undertaken in order to better understand the high rates of CRT implantation for certain PCTs. 5. E. Guidance (Please refer to page 9 for appropriate guidance.) The full document containing all the standards for implementation and follow-up s of CRT is attached in Appendix 3. 14

18 6. Elective Percutaneous Coronary Intervention (PCI) A coronary angioplasty is a surgical procedure that is used to widen blocked or narrowed coronary arteries. Coronary angioplasty is sometimes known as percutaneous transluminal coronary angioplasty (PTCA) or percutaneous coronary intervention (PCI) A. Current Service Liverpool Heart and Chest Hospital (LHCH) provide a well established ICD service and is the only provider commissioned to perform these procedures within Cheshire & Merseyside. The North West Specialised Commissioning Team (NWSCT) currently commissions elective PCI on behalf of all the Cheshire & Merseyside PCTs. Elective PCI is no longer defined as a specialised service within the 3 rd Edition of the National Specialised Definition Set, however it remains within the portfolio of services commissioned by NWSCT in 2010/11. Migration of commissioning responsibilities for PCI services is currently being considered by PCTs, via the North West Specialised Commissioning Group, as part of a wider migration programme. A decision regarding future commissioning arrangements will need to be made in the context of current NHS reforms. Catchment Population The current referral base for the ICD service provided at LHCH covers the whole of Cheshire and Merseyside, North Wales and the Isle of Man. Follow-up Appointments Elective PCI patients return to LHCH for a follow-up appointment within 4-6 months and dependent on the patient s recovery they may be asked to return for further appointments later in the year, otherwise they will be referred back to their GP. Waiting Times There are currently no waiting time breaches in line with the 18 week initiative for the PCI service at LHCH 6. B. Cost Profile The tariff costs in line with Payment by Results (PbR) differs depending on the main Healthcare Resource Group (HRG) that is assigned to the procedure. There are 2 types of stents used in PCI (Bare Metal Stents and Drug Eluting Stents) and these costs are covered by the PbR tariff price. Follow-up appointments are paid through Payment by Results (PbR) tariff

19 6. C. Outcome Indicators The outcomes that are measured by LHCH for PCI are: In-hospital mortality Cerebrovascular accident Emergency Coronary Artery Bypass Graft (CABG) Non Q-wave myocardial infarction Q-wave myocardial infarction Major bleed Reintervention Cardiac Tamponade Renal failure All new PCI services must submit complete procedural and in-hospital outcome data to Central Cardiac Audit Database (CCAD). These outcomes are measured for audit purposes within LHCH. Not all of these outcomes are routinely monitored by commissioners, however through quality reports the outcomes of the service are examined. 6. D. Current Activity For elective PCI procedures the data is collected in financial years, for evaluation 2009 /10 data has been compared against 2007 to 2010 average. Chart 10 displays the number of elective PCI procedures for Cheshire & Merseyside patients. A total of 938 elective PCI s were carried out in 2009/10. Chart 10 16

20 There is no national target for elective PCI, instead it is combined with Coronary Artery Bypass Graft (CABG) and non-elective PCI into the revascularisation rate. Therefore, Chart 11 displays how the PCTs compare to the revascularisation target. Chart 11 In order for all the Cheshire & Merseyside PCT s to reach this target by 2015 it requires an average increase of 8.1% year on year. However, to understand if an increase in elective PCI is needed the revascularisation rate must be split into its 3 components. Chart 12 displays what proportion of the revascularisation rate is made up from elective PCI. Chart 12 17

21 Chart 12 demonstrates that the percentage of elective PCI that contributes to the revascularisation rate has been decreasing since 2006/07. This can be further explained by understanding the trends between elective and non elective PCI which are illustrated in Chart 13. Chart 13 The forecast of future potential need in the year 2015 has been modelled using a possible growth assumption. This growth assumption is similar to, and based on, those used in the 2009 Access to Cardiac Care in the UK. 7 The revascularisation target has been adjusted by the Standardised Mortality Ratio (SMR) for Cheshire & Merseyside in line with common practice. The forecast in Chart 13 has been produced using the 2009/10 data for Cheshire & Merseyside. This data contains a current split between PCI:CABG of 2.2:1, and nonelective PCI accounts for 60% of the activity. This ratio falls below the national average between PCI:CABG of 4:1 but it should be noted that over time the Cheshire & Merseyside ratio may change. These trends align themselves with the change displayed in the breakdown of revascularisation rates. The introduction of the Primary PCI service in 2009 with patients from 3 PCTs but has since expanded to include the whole of Cheshire & Merseyside in 2010 will have contributed greatly to the increase of non-elective PCI procedures. 7 Access to Cardiac Care in the UK: A REPORT ON INVASIVE PROCEDURES IN CARDIAC CONDITIONS. Recent Trends,Variations in Access & Future Need; Dr Stephen Green and Dr Rebecca Miles; June

22 Chart 14 clarifies the number of procedures that are needed in order for each PCT to reach the 2015 target. Chart E. Guidance The British Cardiovascular Intervention Society (BCIS) has produced updated guidance earlier this year summarising their recommendations for the development of new PCI services. This document reports that the number of hospitals that are carrying out PCI has increased rapidly over the last few years and it is therefore even more important that these services comply with these recommendations in order to provide a high quality patient-centred service. Some of the key recommendations extracted from the BCIS document are: Consultation with all the relevant stakeholders at the planning stage. All new PCI services should plan to carry out at least 200 therapeutic coronary interventions in the first year and increase activity to at least 400 cases per annum within three years. Instrumentation of a coronary artery for diagnostic purposes (e.g. with a pressure wire or intravascular ultrasound catheter) should not be included in this number of interventions. If the local catchment population is unlikely to require 400 cases per annum there should be other explicit imperatives that justify the development of the new PCI service. All PCI services should have at least three independent PCI operators to ensure that an uninterrupted service can be provided. A service with only three independent operators may be difficult to sustain long-term and services should plan to increase the number of operators to four to six, depending on workload. 19

23 Independent operators must carry out at least 75 PCI cases as primary operator per annum to maintain competence. Cardiologists who have never been fully trained in PCI and who wish to start PCI must undergo formal PCI training. New PCI services must be supported by a range of other clinical staff with relevant nursing, radiography and physiology expertise. At least one dedicated cardiac catheter laboratory with high quality digital imaging, including freeze frame, zoom, road mapping, and immediate playback capability. All new PCI services must agree a written protocol for the provision of emergency cardiac surgical cover with a local cardiac surgical service. This requirement applies to PCI services at hospitals with and without on-site cardiac surgery. The protocol must describe clear lines of communication between the PCI service and the cardiac surgical service, and must ensure that surgical cover is available for all relevant PCI procedures. The time between a decision to refer a patient for emergency cardiac surgery and cardiopulmonary bypass being established should be as short as possible and less than 90 minutes. As a minimum, a consultant interventional cardiologist must be available on a formal on-call rota to provide overnight medical cover after all elective PCI procedures, including day-case procedures. As a minimum, all PCI services must provide access to the local catheter laboratory for six hours after completion of all elective PCI procedures. The laboratory should be fully operational within 60 minutes of a call. If uninterrupted access to the local catheter laboratory cannot be provided, arrangements for emergency transfer of a patient to another PCI service providing continuous catheter laboratory access must be agreed in writing between all relevant parties. All new PCI services must submit complete procedural and in-hospital outcome data to CCAD. This includes the recording of all major adverse cardiovascular and cerebrovascular events up to hospital discharge. These data will be used to assess the quality of individual PCI services using a range of metrics, including risk-adjusted outcomes, and call to balloon and door to balloon times for patients undergoing primary PCI. The full document containing all the requirements necessary for the development of a new PCI service is attached in Appendix 4. 20

24 7. Interested Hospital Trusts The Terms of Reference for the review were circulated to all NHS Hospital Trusts and PCTs within Cheshire and Merseyside. They were invited to submit an expression of interest in delivering the defined cardiac services. Interested Hospital Trusts were requested to complete a questionnaire (Appendix 5) which would provide an indication of the level of interest, current capacity, infrastructure and capability. The following Hospital Trusts declared their interest: Aintree University Hospitals Royal Liverpool & Broadgreen University Hospitals St Helens & Knowsley Teaching Hospitals Warrington & Halton Hospitals Wirral University Teaching Hospital The responses that have been received have been collated and summarised overleaf in Table 1. 21

25 Table 1 Question Which procedures would your Trust be interested in performing? Detail the reasons why Current capacity to perform the procedures Aintree ICD CRT Elective PCI The Trust has a long established and regularly audited local pacemaker implantation and followup service. The Trust is currently the largest implanting centre in the Region outside the LHCH. The current waiting time for out-patient pacing is less than 2 weeks and in-patients requiring a pacemaker wait no more than 48-72hours. This demonstrates that we are both committed to providing and able to provide a high quality and timely local bradycardia pacing service. Intention to implant 80 complex devices. This would require 1 catheter lab session per week. There is current capacity to accommodate this. Hospital Trust Royal Liverpool & Broadgreen St Helens & Knowsley Warrington & Halton Wirral CRT ICD ICD ICD CRT CRT CRT Elective PCI Elective PCI Elective PCI It is considered a mutually beneficial development to move CRT P to RLBUHT maintaining ICD therapy at LHCH. The development of bi- pacing at ventricular RLBUHT would be a natural progression of the pacing service, streaming the patient pathway and avoiding unnecessary handoffs, thereby improving quality of care for the patient. RLBUHT has currently three available sessions of cardiac catheter lab time not used for Cardiology which would be available for this expansion of service. The catheter lab is Our commissioning PCTs wish us to provide all of these interventions in order that patients have access to these interventions closer to home and for a lower cost. The Trust has new state of the art facilities. It is demonstrably safe to perform all of these interventions in the DGH setting. There are two catheter laboratories on the Whiston Hospital site with ample capacity for the estimated 6 or more sessions per week required. The Trust has an established Cardiac Catheter Suite with a st rong track record of delivering excellent outcomes as well as being highly efficient and well re garded by both clinicians and patients alike. The Trust would be very keen to repatriate PCI activity performed by their consultant at LHCH so it is delivered closer to our patients across Warrington and Halton. Warrington and Halton Hospitals have a strong track record in delivering the coronary angiography services for both the St Helens and Warrington and Halton populations (prior to Whiston opening). There is a fully equipped Cardiac Catheter Suite with capacity for an estimated 4 sessions per week to undertake this activity. There is further scope for providing sessions out of hours either through extending to 3 session days or weekend working. In order to streamline their patients pathway. Wirral PCT has recently conducted a cardiac review which recognised that there an amount of untreated heart disease and higher mortality amongst the local population as a result of undiagnosed and therefore untreated heart disease. Introduction of CT angiography a major part of BC that will free up existing slots. A revamp of the temporary pacing facility to deliver pacemaker fitting. 22

26 Question Aintree Details of staff At present there is one carrying out Consultant Cardiologist the who is fully trained in procedures device therapy and is HRUK accredited. Current support staff There are 3 other Consultant Cardiologists who undertake pacemaker implantation, one of whom will need to undergo a period of further training to become competent in complex device implantation. There are currently 2 Cardiac Clinical Physiologists in post who have HRUK accreditation, and experience in programming ICDs. These individuals will require some further training to become fully competent in all aspects of complex device implantation and follow up. Royal Liverpool & Broadgreen equipped for these procedures. This includes 2 consultant cardiologists who regularly undertake ICD and CRT implantation according to NECVN standards with a further consultant cardiologist currently performing brady implants. There are 2 clinical physiologists who are already HRUK accredited with at least 2 others to attain accreditation shortly. Current catheter nurses are experienced in supporting pacemaker implantation. Hospital Trust St Helens & Knowsley Warrington & Halton Wirral The Trust has adequate capacity to provide these services for their own population of approximately 350,000 and if necessary for Halton and Warrington; a total population of over 600,000. ICD and CRT implantations will be performed by Dr Martin Royle. Dr Royle is fully trained in implantation of ICDs and CRT and holds the Physicians IBHRE qualification. 8 members of staff, with several holding HRUK accreditation and others due to sit their exam. Staff have experience of ICD reactivation, deactivation and implantation. 2 Consultant Cardiologists currently undertaking pacemaker implantation p rocedures, one of whom is HRUK accredited. 1 Consultant Cardiologist currently undertaking PCI procedures at LHCH who also fo rms part of the primary PCI team at LHCH. 5 highly experienced cardiac physiologists 3 of whom are highly skilled in device therapy. 9 highly experienced dedicated Catheter Lab nurses. 3 highly experienced radiographers. 3 Cardiology Nurse Specialists undertaking post-pci review clinics. New appointments to be made and in addition existing Consultants to be trained as number 2's. Not received. 23

27 Question Supporting facilities Aintree The Cardiac Catheterisation Laboratory is already staffed with dedicated Nurses several of whom have experience in complex device implantation. Already established good relationships with the device companies. These links will allow the Trust to readily access training and support for implantation procedures for complex devices. Royal Liverpool & Broadgreen Anaesthetic cover is available and the infrastructure for physiologist support and follow-up are either available immediately or can be acquired relatively easily. CCU and HEC unit for ECG monitoring if required. Hospital Trust St Helens & Knowsley Warrington & Halton Wirral There are two brand new catheterisation laboratories available to perform device implants. There is a 9-bedded recovery area and a further 2-bedded recovery room for isolation patients if needed. 3 Heart Failure Nurse Specialists with strong community links. 3 Cardiology Specialist Registrars. 10-bedded cardiac catheter suite performing approximately 1500 coronary angiography procedures per year for the last 5 years. E xisting pacemaker follow-up clinics. 8 bedded Coronary Care Unit with daily consultant-led reviews. Not received. Physiologists trained in ICD interrogation and deactivation. There is a 17-bedded Coronary Care Unit attached directly to the CDC. There is consultant anaesthetic cover ready when required for device cases. 35 bedded Cardiology Ward. Specify the expansion required There will be a requirement for specific complex device follow-up All of the necessary equipment for programming devices is already provided and in use. I nitiation of complex Appointment of device clinics for followup. Interventional These would require Cardiologist. additional physiologist We would require further investment to expand our Consultant team to include an additional interventional / 2 consultants ; Ct scanner ; technicians. 24

28 Question clinics. Aintree To provide the service and staff the follow-up clinics it is likely that we would need to recruit at least one additional Cardiac Clinical Physiologist. We would need to recruit one additional Band 5/6 catheter laboratory Nurse to provide staffing to cover additional late shifts (not covered in current establishment). Royal Liverpool & Broadgreen s taffing and additional nursing sessional time for lab cover. Hospital Trust St Helens & Knowsley Warrington & Halton Wirral PCI will be performed by a specialist to be appointed as soon as possible. Training of catheter laboratory physiologists and nurses to support the PCI service as required. ICD companies are ready to provide support for the implantation service when necessary. device therapy cardiologist. We have already undertaken discussions with St Helens and Knowsley Hospitals to explore th e possibility of collaborative working across the Mid-Mersey region to deliver economies of scale to serve our joint population of 600,000+. This could involve PCI being centralised on one site and ICD / CRT services at the other. We would require Anaesthetic support for the implantation procedures. Remote monitoring facilities are available. Cost implications 2 further Cardiac Clinical Physiologists will require full training in complex device implantation and follow up. Initial costs of the additional training requirements for one Consultant Cardiologist and the Cardiac Clinical Physiologists and recruitment of additional staff. There will also be the additional cost of providing anaesthetic support. Additional staffing costs for physiologists and nurses Costs would be more than matched by income generated. To be determined depending on the above. Confidential at this moment in time. 25

29 8. Conclusion This review has provided commissioners with detail of the current ICD, CRT and elective PCI service s provided at LHCH, and identified the aspirations of other Hospital Trusts across Cheshire & Merseyside. The activity analysis has shown that the region is currently hitting the CRT target of 130pmp, however in line with the ICD forecast the majority of PCTs need to significantly improve their rate for ICD s implants. Similarly, it is forecast that the elective PCI rate will need to increase in order to achieve the national target of 1900pmp by In order to provide a quality safe service, that follows best practice and is safe for patients, it is vital that the provider has the correct facilities, equipment, staff and supporting services. This review has identified the necessary guidance to provide any of the services. The strengths & weaknesses and risks & benefits sections have been omitted from the final version of this review. Feedback received from the stakeholders on the draft highlighted that the comments within these sections lacked any accompanying evidence to substantiate their claims. Detailed discussions would need to take place between all stakeholders in order to draw together these facts and this was not possible within the timeframe of this report. It is vital when assessing a service that not only activity is considered but also that the outcomes are measured. If a Hospital Trust is looking to establish any of the services within this review, outcomes should be measured with targets set. The information collected notes the aspirations of several Hospital Trusts to set up services should be seen as an initial collection of information. There would be a clear need to fully identify the cost implications of establishing a new service and running it, with sufficient staff and facilities to cope with sickness and complex cases. With the help of this information and through further consultation where necessary, it is hoped that commissioners will be able to make informed decisions regarding these services in the 2011/12 contracting round. The Primary Care Trusts are asked to: Note the content of this report. Consider their performance against current national targets. Note the aspirations of local Hospital Trusts. Note the guidance. Liaise with the North West Specialised Commissioning Team in respect of the future commissioning arrangements for these services. 26

30 9. Considerations In line with the information supplied within this report the PCTs are asked to consider the subsequent points: There is a need to understand why current demand is below the recommended national targets. There is a need to consider if patients are not being refered from primary & secondary care, and if so why not. Further work needs to be undertaken in order to better understand the high rates of CRT implantation for certain PCTs. Take into account that fact tht there are currently joint consultant posts between LHCH and several Hospital Trusts. These arrangements seem to be beneficial for both parties involved. There are minimum procedure numbers needed to establish a local PCI service and the population of a PCT must be able to provide sufficient cases in order to reach these numbers. A proportion of patients for ICD, CRT & PCI are complex and would have to be referred to LHCH as the tertiary centre. Hospital Trusts that are aspiring to establish an ICD and/or CRT service should be evaluated on their adoption of bradycardia pacing, and whether they are performing to national targets for this service. Any new service will need support from LHCH as the region s tertiary centre. The responsible commissioner should ensure that services: Demonstrate value for money. Consider staff training implications within Hospital Trusts, both for existing staff and as part of regional medical training programmes. Deliver a full range of patient benefits and not solely geographical location. Have access to the appropriate infrastructure as indicated within the NECVN standards (Appendix 3). 27

31 10. Appendices 28

32 Appendix 1 Stakeholders This is a list of current stakeholders that have expressed their interest to be involved in the review. Hospital Trusts PCTs Aintree Halton & St Helens Aleem Khand Sarah Johnson Erwin Rodrigues Simon Banks Gershan Davis Homeyra Douglas Liverpool Karen Clarke Ruth Hunter Peter Wong Sue McGorry Liverpool Heart & Chest Sefton Ann-Marie Francis Deborah Jones Catherine Barton Mark Jackson Western Cheshire Jay Wright Laura Marsh Raphael Perry Wirral Royal Liverpool and Broadgreen Jane Hayes-Green Denise Pozzi Derek Cooke The North West Specialised Julian Hobbs Commissioning Team Karen Wardle Claire Jones Peter Williams Stephen Saltissi St Helens & Knowsley Jeff Ball Joanne MacLeod Martin Royle Warrington & Halton Daniel Grimes Helen Seddon Mohammed Andron Wirral Alistair Bardsley Nick Newall 29

33 Appendix 2 Project Plan Date(s) Key Deliverable Key Stakeholders Week 1 Conduct background research. CMCSN Collate stakeholder List. (5 th July) Produce draft Terms of Reference (ToR). Week 2 (12 th July) Week 3 (19 th July) Week 4 (26 th July) Week 5 (2 nd August) Week 6 (9 th August) Week 7 (16 th August) Week 8 (23 rd August) Contact stakeholders for involvement. Produce draft Project Initiation Document (PID). Collate feedback on ToR from stakeholders. Finalise ToR & PID. Define review objectives & deliverables. Confirm contents of final report internally. Update stakeholders on the review pathway. Collect data of current activity and produce data analysis. Collate background to current service with help of stakeholders. Identify workforce requirements. Identify national targets for procedure rates. Meet with commissioners to discuss the review and information needed to achieve the goals. Consider patient engagement. Collect capacity data from Hospital Trusts. Collect current workforce from Hospital Trusts. Continuation of data analysis. Meet with Hospital Trust representatives where appropriate to discuss the current service. Assess the strengths & weaknesses of current service. Assess the key performance indicators of the current service. Final version of data analysis & comparison. Compile views from stakeholders on the current service. Produce draft final report and circulate to stakeholders. Gather feedback form stakeholders on final report. Redraft final report. Approve final report internally. Distribute final report to stakeholders & wider community. CMCSN CMCSN CMCSN Commissioners CMCSN Hospital Trust representatives (in particular Liverpool Heart & Chest) CMCSN All stakeholders CMCSN CMCSN 30

34 Appendix 3 Please find the North of England Cardiovascular Network standards for implantation and follow-up of cardiac rhythm management devices in the embedded file below. NECVN Device Standards.pdf Appendix 4 Please find the British Cardiovascular Intervention Society Guidance in the embedded file below. BCIS PCI Guidance.pdf 31

35 Appendix 5 The questionnaire that was sent to interested Hospital Trusts: 1. Please indicate which procedures (ICD, CRT & elective PCI) your Trust is interested in performing. 2. Detail the reasons for the Trusts interest to perform the selected procedures Can you provide appropriate evidence as to your Trusts infrastructure to provide the service(s)? This could take the form of a business case, as long as the following areas are covered: a. Current capacity, e.g. catheter labs, sessions available per annum to perform the selected procedure(s). b. Details of current staff who will be undertaking the procedure(s). Please provide details of their training & experience currently held. c. Details of current support staff. d. Available supporting facilities. e. If necessary, specify the expansion required by the Trusts in order to provide the service(s). To include equipment, staff and facilities. f. Identify cost implications of providing any additional service(s). 4. Please highlight what your Trust believes to be the benefits and risks in developing a local service. 5. Please specify if you believe there are weaknesses or inequalities in the current service and provide evidence / patient feedback 32