1. PRIMARY PCI - MAKING IT HAPPEN UK Proposals (BCS/DoH) Advanced Angioplasty 2005 Huon Gray Consultant Cardiologist, Southampton President, British Cardiac Society

2. Background June 2003June 2003 –Heart Team asked to report to the Prime Minister’s Delivery Unit (PMDU) on ‘The impact of early thrombolysis’ July 2003July 2003 –Meeting of DoH and PMDU at the Treasury to review ‘The early treatment of myocardial infarction’ PresentPresent –Roger Boyle National Clinical Director –Heather Gwynn CHD Programme Manager –Maree Barnett DoH Nurse Adviser –Daniel Scheffer DoH Head of Ambulance Policy –Robert Anderson DoH Economic Adviser –Tom QuinnNHS Modernisation Agency –Janet Davies CE Mersey Ambulance Services –Katherine Henderson A&E Consultant –Nick Curzen Cardiologist, MRI –Gordon Murray Cardiologist, Birmingham & Clinical Lead CHDCollaborative Site visits proposedSite visits proposed

3. Background August 2003August 2003 –Visits to 3 Acute Trusts and 2 Ambulance Trusts Kings College LondonKings College London St Mary’s LondonSt Mary’s London South Manchester University HospitalSouth Manchester University Hospital London Ambulance ServiceLondon Ambulance Service Greater Manchester Ambulance ServiceGreater Manchester Ambulance Service PMDU concluded: –“ DoH should develop a clear policy for expanding primary angioplasty” –Up to £1m of funding allocated for data collection (not service delivery) in England September 2003September 2003 –Heart Team approach BCS & BCIS for collaboration October 2003October 2003 –Working Group approved by BCS Council

4. Working Group Huon Gray (co-chair)Huon Gray (co-chair) Mark de BelderMark de Belder Martin ThomasMartin Thomas Keith DawkinsKeith Dawkins Martin RothmanMartin Rothman Tony GershlickTony Gershlick David SmithDavid Smith Kevin BeattKevin Beatt Rodney FoaleRodney Foale Roger Boyle (co-chair) Sue Dodd Heart Team Steve Campbell CHD Collaborative John Birkhead MINAP Mark Whitbread Ambulance Service Janet Davies Ambulance Service Nick Boon / Ross Lorrimer Scotland Mark Sculpher Health Economist

5. Working Group 4 meetings in 20044 meetings in 2004 –January:Define scope of pilot project and discuss overall concepts –June:More detailed discussion of governance framework, pre-hospital & in-hospital issues, data collection Dataset sub-group established (Mark de Belder) –Sept:Discussion of possible sites, protocols, draft dataset, method of data collection/analysis Sept-Dec Meetings with NHS Service Delivery & Organisation (SDO) R&D programme –Dec:Dataset (v 1.0) & Scoping Document agreed CCAD presentation Pilot to be ‘National Infarct Angioplasty Project (NIAP)’ Selected centres invited to submit expressions of interest Coverage at BCS Annual Conference and on BCS web site

6. Scope of NIAP Not to research efficacy of PCI vs. LysisNot to research efficacy of PCI vs. Lysis Address feasibility of rolling out a national ‘PCI for AMI’ programmeAddress feasibility of rolling out a national ‘PCI for AMI’ programme Ensure assessment of different (English) modelsEnsure assessment of different (English) models –Geography –Single centre –Networks –Inter-hospital transfers –Non-A&E units Make cost analysis and comparison with lysis (MINAP)Make cost analysis and comparison with lysis (MINAP) Assessment of patient experienceAssessment of patient experience 24 x 7 service delivery24 x 7 service delivery Data collection on all AMI’s in catchment population over pilot period to be includedData collection on all AMI’s in catchment population over pilot period to be included Follow-up for at least 1 yearFollow-up for at least 1 year

7. Scoping Document General guidance but protocols locally determinedGeneral guidance but protocols locally determined –Pre-hospital (ambulance service) –Inter-hospital transfer –In-hospital (receiving arrangements, cath lab, discharge) –BCIS/BCS recommendations on PCI (Heart 2005, in press) Guide times (subject to clinical discretion)Guide times (subject to clinical discretion) –‘Diagnosis’ to ‘arrival PCI centre’ < 60 minutes –‘Patient call for help’ to ‘balloon’ time < 3 hours –Not enrolled if ‘onset of pain’ to diagnosis > 9 hours –Discharge < 72 hours if uncomplicated Patient experience (2 centres)Patient experience (2 centres) Data collectionData collection

8. Courtesy of Dr David Cunningham (CCAD) Government funded Government funded Patient confidentiality / ethical considerations Patient confidentiality / ethical considerations Potential cross-population / validation of datasets (MINAP, BCIS) Potential cross-population / validation of datasets (MINAP, BCIS) ONS mortality tracking ONS mortality tracking Currently single-tender exercise (CCAD) Dataset covers key elements (particularly cost drivers) from recruitment to follow-up Local data collection and download or online data input

9. Courtesy of Dr David Cunningham (CCAD)

14. Timetable 2005 FebruaryFebruary –Working Group meets to consider: Expressions of interest & potential fundingExpressions of interest & potential funding Dataset and data collection systemDataset and data collection system Final revision of scoping documentFinal revision of scoping document –SDO invites tenders (up to £250k) from research units to undertake: Assessment of patient and carer experience Workforce implications Description of different models of service delivery Assessment of potential implementation and feasibility Economic evaluation AprilApril –Proposed start of pilot project –Establish Steering Group and Data Monitoring Group

15. Conclusions Welcome feasibility exercise (2 years)Welcome feasibility exercise (2 years) –Assessment of costs –Identification of cost savings –Observation of outcomes Centres selectedCentres selected –Perceived likelihood of data delivery –Requirement for different service models & geographical spread –Centres not centrally funded for data collection can still participate if meet scoping criteria Project should not be used to inhibit local service developmentsProject should not be used to inhibit local service developments