NORTH OF SCOTLAND PLANNING GROUP

Transcription

1 Meeting: IPG Date: 21st December 2010 Item: (ii) NORTH OF SCOTLAND PLANNING GROUP Status Unapproved Version & Date Authors Dr Malcolm Metcalfe & Fiona MacDonald Introducing Optimal Reperfusion Therapy Services in the North of Scotland by March

2 Contents Page Executive Summary 2 Introduction/Background 4 Process 5 Strategic Objectives 5 Clinical Needs 6 Proposed Outcomes 7 Service Description 8 Current Service 8 Planning Assumptions 11 Proposed Service Objectives 16 Optimal Reperfusion Guidelines for Best Practice 17 List of Options 20 Preferred Option 21 Performance Measures 21 Affordability Capital and Revenue Costs 22 Risk Assessment 22 Partner Profile 23 SAS and NHS Boards Approval 25 Appendix A SAS Isochrones 26 Appendix B ORT Algorithm (i) 27 ORT Algorithm (ii) 28 2

3 Executive Summary This business case seeks approval from the North of Scotland Boards and the Scottish Ambulance Service, to introduce an Optimal Reperfusion Service for North of Scotland residents by: Expanding access to the newly introduced Percutaneous Coronary Intervention (PCI) service at Raigmore through the appointment of additional interventional cardiology expertise to provide PCI 5 days per week Monday to Friday, (in hours); Providing Primary PCI for NoS patients, 24/7 at ARI, and Monday to Friday (in hours) at Raigmore; Improving Pre hospital thrombolysis rates (PHT) through appropriate decision support; Providing timely patient transfer to a PCI capable centre. Proposals put forward within this business case are made on the understanding that Board specific recommendations will require approval from individual NHS Boards prior to implementation of ORT for north residents, if this business case is accepted. The Scottish Government now expects all boards to approve an Optimal Reperfusion Strategy 1 for the most severe type of heart attack (ST Elevation Myocardial Infarction STEMI). SIGN Guideline 93 recommends that, where possible, patients with STEMI should be treated immediately with primary percutaneous coronary intervention (PPCI). This type of heart attack is caused by prolonged blockage of the blood supplied to the heart through the coronary arteries. Because STEMI affects large areas of the heart muscle it causes changes in the ECG as well as in levels of key chemical markers in the blood. Where patients are unlikely to receive Primary PCI within 90 minutes 2 of diagnosis, they should receive immediate thrombolytic therapy to clear the blockage. Clearing the blockage (reperfusion) resolves pain and decreases the risk of death and heart failure immediately and later. Reperfusion treatment is most effective when it is administered early; there is a graded, time dependant worsening of outcomes associated with every minute of delay. PPCI (Primary Percutaneous Coronary Intervention) is the gold standard treatment and when it can be delivered rapidly is effective in the majority of cases. When it cannot, the next best option is immediate thrombolytic drug administered by the attending paramedic, GP or other healthcare professional with transfer to an interventional centre where rescue PCI can be performed if the patient does not reperfuse and next day PCI, if thrombolysis is successful. Current guidance states that patients living within 40 minutes drive time of a PCI capable centre should be provided with PPCI and the isochrones in Appendix A identify the relevant catchment area for the North. 1 Better Heart Disease and Stroke Care Action Plan, June SIGN Guideline 93 3

4 An extension to the treatment window is currently under discussion and if this is extended to 120 minutes, as expected, then a larger percentage of North of Scotland residents will have access to PPCI. Scotland, and in particular the north of Scotland, is often compared to Denmark with similar archipelago, however Scotland does not have access to the level of air transfer resources 3 required to be able to offer Primary PCI to all north residents due to the distances involved. For this reason, realistically, for the island populations, including Orkney and Shetland and the very north east and west of the Highlands, pre hospital thrombolysis (PHT) with immediate onward transfer to a PCI capable centre (Heart attack centre), by the most appropriate transport method is the next best option. The expanded catheter laboratory infrastructure within the north was designed to meet the increased demand for PCI. The tertiary centre at Aberdeen Royal Infirmary undertake between PCI procedures per annum and have with a team of 7 interventional cardiologists, there are 2 retirals pending. NHS Tayside undertake between 450 and?? with a team of 5 interventionalist who offer a 24/7 service. NHS Highland, up until May 2010, accessed a PCI service through referral to other centres, mainly ARI but also Edinburgh Royal Infirmary and Golden Jubilee Hospital. Following the commissioning of interventional capacity at Raigmore Hospital, NHS Highland have restricted capacity, with a team of 2 interventional cardiologists offering a limited number of sessions which does not meet current demand. Additional interventional expertise, with on call team support and extended catheter laboratory opening hours at Raigmore, would enable an ORT service incorporating a redesigned transport strategy, to be introduced for the benefit of North of Scotland residents, Monday to Friday (in hours). Introduction/Background As the Government made clear in Better Health, Better Care, heart disease and stroke continue to be clinical priorities for NHS Scotland. The Better Heart Disease and Stroke Care Action Plan published in June 2009, outlines recommendations for improving services including improved delivery of prehospital thrombolysis and consistency of approach across Scotland in relation to Optimal Reperfusion Therapy. Primary PCI is the treatment of choice recommended in Feb 2007 by SIGN 93. The European Society of Cardiology Guidelines on myocardial revascularisation 2010 [DN:ref?] reinforced this recommendation and is outlined in the new clinical standards for Heart Disease, published by NHS QIS in April It should be noted that air resources do transport patients from the west of Scotland Boards where necessary but the WoS Boards provided additional funding to SAS to fund this. 4

5 PPCI results in fewer deaths, fewer recurrent infarcts, reduction in recurrent severe pain and fewer strokes. Thrombolysis is a drug therapy which will dissolve the obstructing blood clot but usually leaves a residual severe narrowing of the artery, which often requires further treatment. Together these two options (PPCI and thrombolysis) form Optimal Reperfusion Therapy the national standard of care from which all Boards within Scotland have been tasked to introduce as a service improvement. The North of Scotland (NoSPG) region with a population of 1,323,410 comprises approximately 20% of the Scottish population and 65% of the land mass. It is thought that on average approximately 50% of this respective population (500,000) are within a suitably short (40 minute) 4 ambulance drive time and could benefit from PPCI. However while thrombolysis can be delivered almost anywhere by trained staff, primary/pci requires access to a cardiac catheterisation laboratory and a consultant led team. The Cardiac services sub group has been working closely with colleagues across the North and Scottish Ambulance Service to develop this business case to facilitate the roll out of ORT to all patients within the region. Optimal Reperfusion Therapy services rely upon a transport strategy that can deliver the outcomes required and there is recognition that this changes patient pathways and impacts on hospital and SAS resources. Process The North of Scotland Cardiac Services Sub group organised 2 planning events (February and June 2009) to inform the strategic direction for regional Cardiac services for the next 5 years. Introducing ORT services for NoS residents is identified as a major aim within the Regional Plan for Cardiac Services In addition, an ORT working group in partnership with Scottish Ambulance Service organised 2 multidisciplinary workshops, one in December 2009 in NHS Highland and one in January 2010 in NHS Grampian, to identify patient flows and service requirements. These workshops were underpinned by detailed postcode analysis of existing activity flows and modelling of drive times and population catchment areas to distinguish alterations to patient flows for patients who could access Primary PCI and those who, due to living beyond the recommended drive time, will be eligible for pre hospital thrombolysis and rescue PCI, if appropriate. Strategic Objectives Service Aims The Cardiac Services sub group has identified a need to improve services offered to patients who experience a heart attack through the introduction of an Optimal Reperfusion Therapy Service for North of Scotland residents. By providing Primary PCI for the local population and pre hospital 5

6 thrombolysis and rescue PCI for patients with STEMI in remote areas, this will bring services into line with national priorities and current clinical guidelines and will greatly enhance care of Acute Coronary Syndrome (ACS) in the North of Scotland. This business case is set within the strategic context of the Regional Plan for Cardiac Services which assesses interventional cardiac capacity in the North of Scotland against projected demand. It is consistent with future demand as outlined in the Access to Cardiac Care within the UK report which was commissioned by the British Cardiac Society and the British Heart Foundation and published by the Oxford Healthcare Associates in June Clinical Needs As stated above, one of the strategic priorities of the Regional Plan for NoS Cardiac services is to offer services which are designed to improve outcomes for people who have a heart attack. Introducing an Optimal Reperfusion Therapy service as described in this business case for north residents will both improve patient outcomes and comply with national objectives and clinical standards by supporting Boards and SAS to meet the challenges outlined in the Better Heart Disease and Stroke Care Action Plan, to provide a standardised approach to ORT 5. The West of Scotland (WoS) has been providing ORT services to all its boards since 2008/2009. Within South East and Tayside (SEAT), NHS Lothian has an ORT service for its population, NHS Forth Valley procure a 50% service from NHS Lothian and 50% from the WoS. North East Fife patients have a service provided by NHS Tayside. The remainder of Fife and NHS Borders have planned start dates to offer ORT service to patients within their board area. For many parts of Scotland ORT poses considerably logistical challenges as there is often no practical way of transporting a patient to a PCI centre within a short time frame. Close working with SAS, Air Ambulance and the Emergency Retrieval Service with a good point of contact and decision support at the PCI centre is an essential component of any Optimal Reperfusion service to achieve the best clinical outcomes for patients. The advantage of PPCI is clear up to a 90 minute delay, from the point of diagnosis (confirmatory ECG), to successful re opening of the infarct related artery and this interval may extend up to 120 minutes 6. There is no evidence of harm for PPCI after 120 minutes but expedient pre hospital thrombolysis will usually be more advantageous in this circumstance. Approximately one third of patients experiencing Acute Myocardial Infarction (AMI) and given thrombolysis will not reperfuse and therefore may not gain any significant advantage from this treatment. Conventionally, this group should be given the chance of rescue PCI and this should be 5 Better Heart Disease and Stroke Care Action Plan, June Danami 2 study, February

7 done as soon as possible and certainly within 12 hours. This has led to the logical development of drip and ship policies. This means that a patient out with the time frame for transfer to a PPCI centre should be given thrombolysis as soon as possible and then transferred directly to a PCI centre. The 30% who show no evidence of reperfusion on arrival would be taken immediately to a cardiac catherisation laboratory for emergency PCI. All other STEMI patients in this category should have cardiac catheterisation with appropriate revascularisation ideally within 24 hours of the event. Proposed Outcomes There are significant clinical and organisational gains to be achieved from the approval of this business case for NHS Boards and for the Managed Clinical Networks for CHD and Long Term conditions across the North of Scotland. Benefits of Primary PCI for patients with ST elevation acute coronary syndrome The National Infarct Project (NIAP) study collected data over 2 years on 2,245 patients, during the year April 2005 April 2006 and then follow up for 1 year. Of these patients 65% were admitted directly to a PPCI centre and 35% to a non PPCI centre. Of the 35% initially taken to a non PPCI centre, 58% were then transferred to a PPCI centre and underwent PPCI. The table below shows the mortality rates for those patients who either had PPCI or thrombolysis. Treatment 30 days 1 year 18 months PPCI 5.6% 8.7% 9.9% Thrombolysis 7.9% 12.4% 14.8% (Source: MINAP report October 2008) Aside from the reduced mortality rate expected from this proposed change, residual angina (underlying narrowed artery treated) and subsequent heart failure (less dead heart muscle) are reduced by more effective reperfusion strategies. 70% of patients treated in the proposed PPCI programme would have undergone angiography/pci at some point during the first year following STEMI, albeit during normal working hours through index admission resulting in an increased length of stay. It has been shown that the majority of MI s occur within daytime although a proportion will require to be performed out of hours. The Lothian study demonstrated that PPCI reduced the length of stay from 5 7 days to between 24 and 48 hours. CCU bed day costs per day 466 (blue book) resulting in estimated savings of between 2330 and 3262 per patient. Patients receiving PPCI are generally repatriated home or back to their local hospital the following day. 7

8 Research has shown that patients who have PPCI have better clinical outcomes over those who have thrombolysis alone and patients who have thrombolysis better outcomes than those who receive no reperfusion treatment. Benefits are evident both in the short term and longer term and positively impact on health and social services. The benefits have been shown to include: Reduction in stroke rate Reduction in reinfarction rate Reduction in cardiac bypass surgery Reduction in all cause readmission rates Reduction in readmission for elective catheter lab procedures Reduction in length of hospital stay By performing PPCI as soon as it is needed there is evidence that there will be a reduction in the mortality rates, therefore assisting with the achievement of the reduced mortality targets of the under 75 s, for CHD. In addition an ORT service for North of Scotland residents adds further value through: Patients having access to the best possible services as locally as possible Improved planning and integration of services/care Meeting established standards of care Reduced travelling times for patients Improved equity of access to service Staff being involved in developments and having access to high quality peer support Appropriate skill mix of professionals and improved multidisciplinary working Reduced lengths of stay and less likelihood of readmission to hospital Increased patient empowerment Patients being involved in developments and supported to self care, post procedure Service Description Current Service The NoS cardiac catheterisation infrastructure has expanded 7 and now includes 2 catheter laboratories at ARI and 1 at both Raigmore and Ninewells. An ORT service will require all STEMI patients to be transported to one of these sites for treatment either directly or following PHT, for intervention. Some patients may require cardiac surgery rather than PCI however these patient numbers will be minor in relation to overall demand for intervention. NHS Tayside Within the North of Scotland NHS Tayside commissioned a PCI service in 2007 and introduced a 24/7 ORT service 8 for its population and for residents of North East Fife, in February NHS Tayside can be looked on as a role model for this as a service development and are 7 Business Case to Expand Cardiac Catheterisation Laboratory Capacity within the NoS, NoSPG /7 ORT service introduced for NHS Tayside and North East Fife residents in February

9 virtually a stand alone service which is primarily PPCI, as 95% of the population can access the catheter laboratory at Ninewells, within the timescale. NHS Grampian has been offering a PCI service since?? and have provided a daytime PPCI service (Monday to Friday) for its population, since February This business case recommends that a 24/7 service is required. Over half of the population of Grampian now have access to PPCI (in hours) with an emergency on call service for PCI 24/7. Aberdeen Royal Infirmary provides this service to NHS Orkney and NHS Shetland also and is the PCI centre for Out of Hours STEMI care for all North of Scotland residents, excluding Tayside. NHS Highland introduced a part time PCI service (mornings, Monday to Thursday) for Highland residents with effect from May 2010 with access to the catheter laboratory available in hours, Monday to Friday. Projected increases in revascularisation within NoS are predicted to come from the NHS Highland population where rates have been below what is expected for the population demographic until recently. Primary PCI is not available from Raigmore and elective PCI cannot be carried out in the afternoons, at present. BCIS guidelines recommend that PCI services should have access to the on site catheter laboratory for emergency retreatment of patients for a minimum of 6 hours following index intervention. This means that currently the catheter laboratory in Raigmore is fully staffed from 8.30 am until 6pm Monday to Thursday and from 8.30 am to 1 pm on Fridays; however the PCI service is not being maximised as it cannot be undertaken beyond 12 noon and patients within the NHS Highland and West Moray catchment area cannot benefit from Primary PCI during catheter lab opening hours. The tables below outline PCI activity and trends for North of Scotland residents with benchmark comparisons. Any ORT service once implemented will address areas of under referral to identify underlying causes and ensure equity of service provision. 9

10 PCI trends for NoS residents (cases completed at ARI) / / / NHSG NHSH NHSO NHSS Total PCI activity completed for individual Health Boards at all centres (2008/09) benchmarked against expected rate per population million are outlined below. [ARI/Raigmore or Ninewells/other centres.] 2008/09 NHSG NHSH NHSO NHSS NHST Total PCI 714/3 208/196 25/1 11 2/413/ Expected Rate pmp Angiogram /558/ /1009/ Expected Rate pmp Source: NHSG Cardiac MMI, Scottish Cardiac Revascularization Register (SCRR) Notes: Recommended rates per population million = 1200 pmp* for PCI and 3215 pmp for Angiography. Total Health Board populations have been used to calculate rates pmp. * (now 1300/1400 pmp) NHS Shetland appears to have a lower than expected referral rate and this will benefit from closer scrutiny to identify underlying causes, if any. Breakdown of Angiography/PCI activity performed at other centres for NoS patients 2008/09 9 NHSGG&C NHSL Total W/Isles PCI Angiogram Source: SCRR 9 Western Isles included for information only 10

11 Decision support Diagnosis of STEMI is by ECG (Sign 93) and decision support with a good point of contact to decide the best patient pathway is a vital component of a successful ORT service. Decision support introduced in NHS Highland in 2009 has proved to be very successful showing an improved PHT rate for NHS Highland patients. Decision support is also now available in ARI although PHT rates are unknown and appear to remain variable. Trained CCU nurses at Raigmore and SpR s at ARI provide the link for SAS Paramedics to decide optimum treatment for STEMI patients in the respective Board areas. New defibrillator kit deployed within the SAS is being rolled out and some technical issues have been identified. These are being addressed. Activity completed at ARI prior to PCI start up at Raigmore Postcode breakdown of all current NoS PCI activity (excludes Tayside) by treatment category NoS 2008/09 AB IV KW OS PH ZE Total 1=emergency = urgent = elective AB = Grampian; IV = Highland and Moray; KW = Wick/Caithness & Orkney; OS = Orkney; ZE = Shetland West Moray breakdown IV30 = W Elgin, IV36 = Forres NoS W/Moray IV30 IV36 Total 1=emergency =urgent =elective NHS Highland PCI activity completed elsewhere Fort William Skye Mull Tiree Coll Total Planning Assumptions for a NoS ORT service showing altered patient flows An Optimal reperfusion Service will increase emergency transfers as all STEMI s are taken to an interventional centre by passing local District General Hospitals (DGH s). This has an impact on SAS resources. Longer transport times result in ambulances being unavailable for extended periods. The impact on Category A response times and next day compensatory rest periods have been factored in to the transport strategy to introduce an ORT service within north. The following pathways have been designed in partnership with SAS and offer best outcomes for patients in a sustainable way, by maximising use of resources without causing unacceptable pressure or risk to SAS Category A response services. Patient Pathways & Transport Strategy including Cross Boundary Flows 11

12 The SAS isochrones in Appendix A, outline the catchment areas for PPCI for north residents if PPCI becomes available at Raigmore (in hours Monday to Friday) and at ARI 24/7. It is estimated that repatriation of elective PCI to Raigmore will see a reduction of 220 SAS journeys (road and air) between Raigmore and Aberdeen and this impacts on patient discharges also. Since PCI start up in Highland in May, SAS report significant reductions in patient transfers between Raigmore and Aberdeen. Emergency patients from Skye and Caithness will continue to be transferred by air, to a PCI centre and this would now be to Raigmore. Patients from the Fort William area have traditionally remained at the Belford or been transferred to Edinburgh Royal Infirmary and the pathway for STEMI patients (in hours) should now be direct transfer to the PCI centre at Raigmore. Western Isles patients traditionally transfer to Glasgow Golden Jubilee Hospital and these patients could be offered access the catheter laboratory and PCI services available within north. Western Isles patients are currently flown off island and so this would involve a change of service location rather than additional journeys. Emergency transfer off island for NHS Orkney and NHS Shetland would continue using emergency response services with transfer to a PCI centre, normally Aberdeen Royal Infirmary. West Moray patients The briefing paper competed by NHS Highland colleagues in suggests that the average journey time between Raigmore and Aberdeen is 2 hours and 35 minutes and it is important to clarify the expected patient flows from the Moray area to Raigmore and ARI. Average journey times based on road types and travel speeds to selected locations are outlined in the table below: Estimated travel time to Raigmore Estimated travel time to Aberdeen Royal Infirmary Elgin 55 minutes > 90 minutes Fochabers 71 minutes 84 minutes Lossiemouth 65 minutes > 90 minutes Keith 82 minutes 73 minutes Dufftown 84 minutes 78 minutes 39,505 of the population of the Moray Council area are within the 60 minutes isochrones of Raigmore. The area includes the town of Elgin but not it s hinterland to the Moray coast or the south and east. A further 45,611 residents in the Moray area are within the minutes drive time isochrones of Raigmore. In total 98% of the population of the Moray Council area are within 90 minutes travel time of Raigmore. 12

13 No area in Moray is with 0 60 minutes drive time of Aberdeen Royal Infirmary. However 14,859 (17% of the population) in the Moray area are within a drive time of 90 minutes of Aberdeen. An area including Keith and Dufftown has a total population of 13,512 and is within the 90 minute isochrones where the choice of service location would not be influenced by travel time. Out of area referrals As stated above, it is anticipated that activity currently being referred out with NHS Highland e.g. Skye, Lochaber will be referred to the PCI service at Raigmore and this will impact on current SAS transfers. Projected Demand (general) The tables below outline the demand for cardiac intervention at present with projected activity at low, medium and high growth rates for the different Health Boards. It is acknowledged that due to unmet need the largest increase in demand will be for patients within the NHS Highland and West Moray catchment areas. Revascularisation rates (PCI + CABG) by Health board, actual for 2008/09 versus projected demand for 2010, lowest growth rate of 1900 pmp, medium growth 2200 pmp, high growth 2500 pmp Revasc rates 2010 NHSG NHSH NHSO NHSS NHST Actual ORT Service Projections Projected STEMI activity by CHP population catchment area (based on 700 pmp) ARI CHP Populations yrs 65+ Total 700 pmp Total NHSG + Moray Net inc post ORT Aberdeen city 146,402 32, , Aberdeenshire 158,762 37, , Orkney 12,930 3,697 19, Shetland 14,429 3,500 22, Moray 56,537 15,559 86, Exploring Patient Travel Times, Alasdair MacLennan and Ian Douglas, Health Intelligence & Knowledge Unit, Directorate of 13

14 Raigmore CHP Populations yrs 65+ Total 700pmp North Highland 24,112 7,748 37, Total NHSH + WMoray Net inc post ORT Mid Highland 59,302 16,141 90, SE Highland 58,851 14,938 88, W/Moray 56,537 15,559 86,870 61/28* 28 New 28 Notes: It is assumed that all emergency and some urgent activity completed in 2008/09 was for STEMI patients and this has been used as the baseline West Moray projections are based on 39,000 populations of Forres, West Elgin area (patients would transfer to Raigmore in hours Monday to Friday (previously went to ARI) The remaining Moray patients would receive pre hospital thrombolysis and be transferred to ARI for angiography and rescue PCI, if required It is estimated that the impact of PPCI 24/7 at ARI will mean an additional 42 caths/pci OOHs per annum i.e. 1 per week of which 50% may occur after midnight with the resulting impact on staff availability (this would be managed by the on call team in place) For Raigmore the impact is estimated at 30 additional caths/pci per annum. Patients would be triaged with onward transfer to ARI 24/7 service as appropriate for OOHs referrals i.e. 1 per fortnight approximately (includes West Moray) and anticipates 50% after midnight. As a PCI service is already in place in Raigmore and Aberdeen, it is worth noting that introducing an Optimal Reperfusion Therapy service expands the number of patients currently accessing this service by providing an earlier response to treatment for a greater number of people. Any ORT service therefore changes the time of presentation and the mix of emergency and urgent cases. It may impact on elective capacity and clear protocols need to be in place to maintain continuity of service provision. Projected Demand for all PCI (excludes CABG) Projected demand for PCI (including PPCI) within the NoS is 2247 in 2010 rising to 2551 by P/PCI projections 2010/2011 (NoS ORT Service) /11p PPCIp Totals NHSG NHSH NHSO NHSS Performance and Planning, NHS Highland, August

15 The table below outlines demand from each individual Board. PCI NHSG NHSH NHSO NHSS NHST NHSWI 2010/ / Estimated sessions required per annum NOSPG 010/ /16 Comments ARI (NHSG, NHSO, NHSS, NHSH OOH s) Raigmore (NHSH + WM) Raigmore (NHSH + WM + WI) Additional interventional capacity at Raigmore will assist full repatriation. Lab capacity at ARI is at it s limit An additional interventional consultant at Raigmore is required to address demand for PCI and offer PPCI in hours Monday to Friday. Lab capacity is available (dedicated permanent cath lab in progress) For information Current staffing profile Interventional cardiologists in post by location (catchment population) and age range, December (Average number of procedures per operator (ARI) = 140 per annum) No < Aberdeen (544,980) 7** Raigmore (260,490*) Ninewells (399,550) 5 *excluding A&B and including West Moray ** 2 retirals pending March 2011, in the ARI team As there are currently only 2 interventional cardiologists within the team at Raigmore, consultant capacity is severely restricted and certainly will not meet projected demand for patient activity. With some investment in workforce, daytime (P)PCI could be offered at Raigmore for NHS Highland and West Moray residents who can access the catheter laboratory within the timeframe. 12 In approving service start up at Raigmore, BCIS made the following recommendations: Extract from the BCIS site visit to Raigmore report th February 2010: BCIS guidance recommends that all PCI services should be provided by a minimum of three interventional cardiologists and that a consultant interventional cardiologist is available on a formal on call rota to provide overnight medical cover after all PCI procedures, including day 11 Regional Plan for Cardiac Services , Cardiac Sub Group, NoSPG Briefing Paper: Exploring Patient Travel Times, Alasdair MacLennan and Ian Douglas, Health Intelligence and Knowledge Unit, Directorate of Performance and Planning, NHS Highland, August Percutaneous Coronary Intervention at Raigmore Hospital, Inverness, Dr Jim Nolan, University Hospital of North Stafford, Dr Ian Starkey, Royal Infirmary Edinburgh 15

16 case procedures. The planned service in Inverness is currently based upon two interventional cardiologists. We recommend that plans for the appointment of a third interventional cardiologist are accelerated to support the PCI programme as it stands and to facilitate compliance with BCIS guidance for post PCI medical cover. BCIS guidance recommends that PCI services should have access to the on site catheter laboratory for emergency re treatment of patients for a minimum of 6 hours following the index intervention. Plans to provide full 24 hour on site catheter laboratory access should be in place within 3 years. We recommend that the Trust develops plans to provide a full 24/7 service at Raigmore hospital. A continuous PCI service would allow provision of primary PCI for the local population and rescue PCI for patients with STEMI in remote areas, greatly enhancing the care of Acute Coronary Syndrome (ACS). Evidence suggests that 68% of STEMI patients in NHS Highland were within the 90 minutes timeframe for accessing PPCI should it be offered from Raigmore, (Cardiac MMI 2008/09). Prior to the introduction of PCI at Raigmore, patients were managed in their local hospital and some may have received thrombolysis before being transferred to Raigmore. The majority were then transferred to Aberdeen Royal Infirmary for angiography and PCI, if appropriate, with some referrals also made to Edinburgh Royal Infirmary and Golden Jubilee Hospital (Argyll and Bute). This often resulted in lengthy delays while patients remained in hospital prior to treatment. It also impacted on ambulance resources due to time taken to transfer patients. This business case seeks to demonstrate that the introduction of an ORT service would enable patients to access optimum treatment by being transferred to a PCI centre for either PPCI or catheterisation and revascularisation if appropriate, following thrombolysis, at the earliest opportunity. At present due to the lack of interventional capacity and restricted access to the catheter laboratory at Raigmore, a large proportion of patients within the NHS Highland area will not benefit from ORT as they cannot access either ARI or Ninewells within the recommended drive time. In addition Laboratory capacity at other centres e.g. Ninewells, Edinburgh and Aberdeen is at maximum. This presents a major drawback in introducing an ORT service within the north unless workforce issues are addressed. With a projected demand of 540 procedures in 2010 for NHS Highland and taking into account the fact that repatriation has only been partially achieved, NHS Highland are not yet able to maximise the newly introduced PCI service at Raigmore by undertaking all PCI procedures for their own population. The result of this is continuing financial outflow to other centres in addition to in house costs already being incurred. 16

17 Proposed Service Objectives: 1. To treat patients with STEMI in line with SIGN 93 and clinical standards for Heart Disease by providing equitable access to Optimal Reperfusion Therapy within the expanded catheter laboratory capacity in the NoSPG area. 2. To provide Primary PCI at ARI 24/7 for the patients of NHS Grampian and NHS Orkney and NHS Shetland and those from NHS Highland requiring emergency treatment, Out of Hours. 3. To provide Primary PCI at Raigmore Monday to Friday (in hours) for NHS Highland and West Moray patients by expanding access to the catheter laboratory and increasing interventional capacity at Raigmore to provide a PCI service for NHS Highland patients, as per BCIS recommendations. 4. To implement a transport plan which supports the redesigned patient flows to transfer patients to a PCI capable centre for Primary/Rescue PCI within the recommended timeframe. 5. To maximize income from out of area referrals by using capacity at each PCI centre fully. 6. To improve pre hospital thrombolysis rates by utilising decision support with timely patient transfer from remote locations. 7. To enhance and maximize team expertise and capacity at each PCI centre and within SAS. 8. To streamline patient pathways by complying with drive time recommendations resulting in patients being treated closer to home. 9. To discharge patients following procedure within hours, as appropriate to release bed capacity and assist patients return home or to local community hospital. 10. To adjust the current SLA to incorporate the proposed changes to patient flows, over a 3 year period. 11. To co ordinate and standardize the NoS ORT service with the rest of Scotland. Optimal Reperfusion Guidelines for Best Practice SIGN 93: Acute Coronary Syndromes (February 2007) Recommend: Patients with an ST elevation acute coronary syndrome should be treated immediately with PCI When PCI cannot be provided within 90 minutes of diagnosis, patients with an ST elevation acute coronary syndrome should receive immediate thrombolytic therapy and be transferred directly to a PCI centre. 17

18 Reperfusion strategies 14 PPCI (ESC Extract) Randomised control Trials and meta analysis comparing primary PCI with in hospital fibrinolysis (thrombolysis) therapy in patients within 6 12 hours after symptom onset treated in high volume, experienced centres, have shown more effective restoration of vessel patency, less re occlusion, improved residual LV function and better clinical outcomes with primary PCI. Cities and countries switching from fibrolinysis to primary PCI have observed a sharp decrease in mortality after STEMI. The American College of Cardiology/American Heart association (ACC/AHA) and BCIS guidelines specify that primary PCI should be performed by operators who perform > 75 elective procedures per year and at least 11 procedures for STEMI in institutions with an annual volume of > 400 elective and > 36 primary PCI procedures. The latest ESC guidance reinforces the message that it is essential to make every effort to minimise all time delays, especially within the first 2 hours after onset of symptoms, by the implementation of a system of care network. As illustrated in the flow diagram below, the preferred pathway is immediate transfer of STEMI patients to a PCI capable centre offering an uninterrupted primary PCI service by a team of high volume operators. While it is appreciated that continuous PPCI (24/7) may take some time to achieve for the Raigmore unit, the proposals outlined in this business case favour an approach which will enable a full ORT service to be delivered from 2 centres (3 including Tayside) for NoS residents within an acceptable timeframe. Patients admitted to hospital without PCI facilities should be transferred to a PCI capable centre and no fibrinolysis (thrombolysis) administered if the expected time delay between first medical contact (FMC) and balloon inflation is < 2 hours. If the expected time delay is > 2 hours (or > 90 minute in patients < 75 years old with large anterior STEMI and recent onset of symptoms) patients admitted to a non PCI centre should receive fibrolinysis (thrombolysis) and then be transferred to a PCI capable centre where angiography and PCI should be performed in a time window of 3 24 hours. Patients with STEMI in the community should receive pre hospital thrombolysis if out with the timeframe with direct onward transfer to the PCI capable centre otherwise they should be taken directly to the PCI capable centre for PPCI. 14 ESC/EACTS Guidelines, European Heart Journal; Guidelines on myocardial revascularisation, European Society of Cardiology,

19 Symptoms of STEMI SAS Transport Strategy ORT Algorithm Appendix B (i) (ii) 1) Direct transfer to ARI for all patients who can access PPCI at the catheter laboratory within 90 minutes of confirmation of diagnosis (likely to be Grampian patients only) until PPCI is available 24/7 in all centres (for future consideration) 2) Direct transfer (in hours, Monday to Friday) for all patients who can access PPCI at Raigmore (NHS Highland and West Moray patients) 3) PHT and transfer to Raigmore or ARI for appropriate cardiac catheterisation/rescue PCI at the earliest opportunity (patients out with the 90 minute timeframe (all boards with the exception of NHS Tayside). 4) PHT and transfer to Raigmore or ARI for cardiac catheterisation/rescue PCI within 3 24 hours (stable patients), 5) OOH s patients who do not reperfuse transfer directly to ARI for immediate rescue PCI British Cardiac Intervention Society Guidelines 15 Recommend: A minimum of 3 interventional cardiologists are required to offer a PCI service Each operator should undertake a minimum of 75 procedures with 150 being the preferred number of procedures 15 Percutaneous Coronary Intervention; Recommendations for Good Practice, Joint Working Group on PCI, BCIS and BCS, Heart

20 A centre which is able to undertake 400 cases + per annum is deemed to have sufficiently high volume 16 to maintain skills Centres should aim to provide a 24/7 service within 3 years of start up List of Options for Delivering ORT in NoS Option Description Comment/Impact 1 Do nothing status quo NoSPG residents will not benefit from ORT 2 Introduce Primary PCI 24/7 at Aberdeen Royal Infirmary using the existing on call team and Primary PCI in hours Monday to Friday at Raigmore by appointing a third interventionalist to expand PCI capacity within NHS Highland and extending the cath laboratory hours until 11pm with on call team support at Raigmore. New pathways supported by redesigned patient transport plan. Pre Hospital thrombolysis and direct transfer to a PCI centre for all patients with ACS who are out with the drive time. Increased mortality; More frequent hospital admissions; Non compliance with BCIS guidance, Sign 93, Clinical Standards for HD, Scottish Government BHD&SC Action Plan No benefit from service plans A third interventionist is required for NHS Highland with on call team support to enable PCI and PPCI in hours, Monday to Friday; Clear protocols will be required between SAS and NHS decision support teams at the PCI centre; NHS Grampian, Highland and West Moray patients will have access to Primary PCI; Island patients and remote north west and east patients will have PHT and the choice of rescue PCI Improved mortality rates; Reduced hospital admissions; Patients treated closer to home; Capacity is maximised; SAS and Health Board resources are streamlined; 3 Introduce a partial ORT service by offering Primary PCI on certain days of the week, for NHS Highland and West Moray residents and offer Primary PCI 24/7 for NHS Grampian, PHT and rescue PCI for NHS Orkney, NHS Shetland and NHS Highland patients not able to access PPCI at Raigmore in hours, or ARI 24/7 due to distances involved Hybrid systems are not recommended as they cause confusion and tend to be wasteful of resources; NHS Highland would require to purchase PCI services from other centres; Iniquitous to patients Reduced numbers of patients would benefit from PPCI; Increased mortality; Longer lengths of hospital stay; Longer transfer journeys with resultant impact on SAS resources; Capacity at other centres is at it s limit; Underused resource (dedicated cath lab being built at Raigmore; Increased financial burden on PCI centres; 16 BCIS Audit 2008/09 20

21 Preferred Option Option 2 is the option recommended in this business case as providing the best outcome for patients and service delivery by introducing Optimal Reperfusion Therapy services in a step change way, for all North of Scotland residents. Performance Measures All Boards are required to demonstrate how they are achieving the new clinical standards for Heart Disease and for clinical governance purposes the table below highlights how an ORT service can be measured. Objective Evaluation Timescale Responsibility 1 MMI, QIS benchmarking Continuous Monitoring ARI, Raigmore, Ninewells, SAS 2 Cardiology dept ARI Early 2011 UOM/Head of Service 3 Cardiolgy dept Early 2011 Assistant Divisional Manager/Head of Raigmore/workforce issues Service/BCIS review addressed 4 Emergency response & Call to Balloon times 5 Service planning, patient management system, financial reporting 6 Decision support reports/appropriate referrals/pht levels Quarterly reports, Ongoing SAS, Cath Labs, monitoring QIS SET Quarterly reports Ongoing Referring & Receiving board, Dept monitoring Managers Finance teams, SIM Ongoing monitoring, SAS, Receiving units exception reporting, MDT case review, SEA 7 Staff trained and fully competent Ongoing Joint training SAS & Health 8 Postcode analysis of referrals, Quarterly reports, Cardiology depts, MCN s, SIM patient stories 9 Delayed discharge reports, Monthly reports Discharge coordinators SAS, postcode analysis, SAS transport receiving PCI centre, PMS planning 10 SLA s review Annual Finance & Service planning 11 National & Regional comparisons Meet BHD&SC Action plan, SIGN guidelines and Clinical standards ongoing monitoring Regional SIMS Affordability Capital and Revenue costs Costs per case for PCI are 2960 and for PPCI estimated to be 3900/ 4000 and at present there are service level agreements in place between Raigmore and ARI and ERI? Plus GJH? Options for managing future demand can be either within each PCI centre or by referral to other centres with the resultant impact on costs. Once a service becomes established reliance on other centres tends to diminish in favour of sustainability of service within the referring Board. It can however be prudent to maintain links with other centres to manage caseloads in times of equipment breakdown, staffing shortage and to meet RTT if required. 21

22 Catheter laboratory staffing costs: Post Daytime On call 6pm 10/11/12pm? Consultant 2 nd Operator/SpR Nurse scrub Nurse floor Radiographer Physiologist CCU nurses On call OOH s Resource requirements to provide PPCI in hours at Raigmore and PPCI 24/7 at ARI: PPCI centre Consultant & MDT team Cath Lab CCU Gap ARI Staffed daytime, on call Team in place + on Staffed for PPCI in On call team will set rota in place for OOHs call rota hours, Decision up lab support via SpR Raigmore Staffed daytime MDT, Staffed 8 6pm Staff in post, trained On call 6 11pm? for consultants job plans Consultants 8 5pm in decision support MDT, limited to mornings only 1 additional PCI + on call interventional Additional interventional cardiologist to Cardiologist required facilitate daytime P/PCI + on call Overall cost of providing an ORT service for North residents with individual Health Board contribution highlighted. NB (Financial costings have been requested) Risk Assessment Implement the ORT proposal for NoS (Option 2) Costs: Additional interventional Cardiologist for NHS Highland Cath lab support staffing for on call e.g. OOH 6 11 pm Raigmore, Decision support training SAS & GP training (thrombolysis) SAS resource Benefits: Consultant on call rotas in place, (ARI & Raigmore) Cath lab staff on call rota in place ARI 24/7 Cath lab team in place Raigmore (in hours) Parity with the rest of Scotland Achieve best practice (SIGN) & SGHD Action plan (Better Heart Risks: PPCI 24/7 not guaranteed for all (drive times, transport availability, adverse weather) PHT uptake patchy Compensatory rest impact on elective capacity & SAS Sub standard care if not introduced Costs of greater lengths of hospital stay 22

23 Disease and Stroke Care) Reduced length of stay SAS new defib kit in place for decision support More appropriate use of resources Service plans streamlined Financial outlays from outsourcing to other centres reduced SAS reduction in journeys between Raigmore & ARI & Dr Grays & ARI Risk of readmission Higher mortality rates Non compliance with SG health targets & QIS HD standards Consultation: The successful introduction of an ORT service for North of Scotland residents requires consultation with patients, public and all staff groups involved. It will be important to identify acceptable and sustainable patterns of working. Patients and the public will require information on how the proposed service change will affect them including post procedure and repatriation arrangements. Local MCN s are well placed to promote the benefits to patients through their extended networks and it is recommended that in view of the geographical challenges and remote and rural nature of the area an Equality Impact Assessment is undertaken to assess accessibility to the service. Initial EIA screening identifies this service development as low impact and therefore a full EIA should be undertaken within the first year. Audit and Evaluation. As this is a new service being introduced it will be important to carry out audit to ensure that service aims are achieved. In particular standard 8 of the new clinical standards for Heart Disease should be monitored to assess compliance with SIGN and European guidelines. PCI capable hospitals will require to demonstrate robust systems for data capture and analysis. Partner Profile The North of Scotland Planning Group (NoSPG) is collaboration between NHS Grampian, NHS Highland, NHS Orkney, NHS Shetland, NHS Tayside and NHS Western Isles. With a recently revised population of 1,323,410 million (including Western Isles) NoSPG represents 66% of Scotland s landmass but only 26% of the total population. The table below provides a partner profile: 23

24 Est. population 30 June 2004 Area Persons per sq km Scotland 5,078,400 77, NHSG 544, (City) 1,107 87,660 6,313 (Shire) 37 Moray 2,238 (Moray) 39 Highland Argyll & Bute 310,530 90,040] 25,659 6, Orkney 19, Shetland 22,210 1, Tayside 399,550 2,182 (Dundee) 60 (P&K) 5,286 (Angus) 50 2, Western Isles 26,180 3,071 9 Total 1,323,419 Scottish Ambulance Service A significant feature of this ORT business case is the collaboration between SAS to provide a transport plan which supports delivery of the proposed service. ORT services requires close partnership working from the point of first medical contact to the patient receiving treatment and systems in place which facilitate transfer of patients to receive the most appropriate care in the most appropriate setting. An extract from the newly published SAS Strategic Vision Working together for Better Patient Care establishes the SAS vision to deliver the best patient care for people in Scotland, when they need us, where they need us with 3 main goals: To improve patient access and referral to the most appropriate care To deliver best services for patients To engage with all our partners and communities to deliver improved healthcare Summary: The infrastructure and catheter laboratory capacity is in place within north now with 2 catheter laboratories in Aberdeen, 1 in Inverness and 1 in Dundee. Clinical expertise is available in all board areas however, projected demand and clinical governance outline the need for an additional interventional consultant at Raigmore and on call cath lab team support to enable PCI and PPCI to be offered in hours. As NHS Tayside has a stand alone ORT service this business case outlines an ORT service for the remainder of the NoSPG area. It is anticipated that where patient flows cross health board 24

25 boundaries then an inter board contribution will be made to support the ORT service and this will involve review and may require adjustment to current SLA arrangements. This business case recommends: 1. Introducing an ORT service for north residents by offering PPCI at Raigmore in a step change way Monday to Friday (day time) within the proposed extended catheter laboratory access and increased workforce as outlined above. 2. Extending the current PPCI daytime service offered at ARI to 24/7 with an agreed planned start date. 3. Implementation of SAS transport strategy to support the introduction of ORT for north residents. 4. Adjusting the current SLA to incorporate the proposed changes to patient flows, over a 3 year period. Approval is sought from NoS NHS Boards and SAS for this business case proposal: Organisation Authorised Signatory Date NHS Grampian NHS Highland NHS Orkney NHS Shetland NHS Tayside NHS Western Isles SAS 25

26 Appendix A All Scotland Optimal Reperfusion Sites drive times (40, , 70 mins) Copyright and (P) Microsoft Corporation and/or its suppliers. All rights reserved. Certain mapping and direction data 2008 NAVTEQ. All rights reserved. NAVTEQ and NAVTEQ ON BOARD are trademarks of NAVTEQ Tele Atlas. All rights reserved. Certain postcode data licensed from Ordnance Survey with the permission of Her Majesty s Stationary Office. Crown Copyright and/or database All Rights Reserved. License Number Certain Demographic data 2008 Acxiom Corp. All rights reserved. 26