1. 1 Development of heart attack services in the east of England Julie Garbutt Chair of Specialised Commissioning Group Dr Sarah Clarke Acute Programme Board lead for PPCI Sally Standley Chair of PPCI Steering Group

2. 2 The clinical case for PPCI Dr Sarah Clarke

3. 3 Introduction: The objective: To develop plans to deliver the best possible service for all heart attack patients in the east of England This presentation covers: - the case and evidence for PPCI for all - the decision making processes - addressing the key Suffolk issues

4. 4 Background: Cardiovascular disease is our biggest killer accounting for 2/3rds of premature deaths. In 2008 (Source: HES data): 8,084 people in the region admitted to hospital with heart attacks. 1,180 were ST Elevation Myocardial Infarction (STEMI) Of the 760 heart attacks in Suffolk, 269 were STEMI (MINAP) Current treatment of thrombolysis which has been very successful, especially across Anglia. 1,062 Anglia patients 2003/7 treated with PHT mortality rate National Thrombolysis (PHT& IHT) mortality rate 6%7.9%

5. 5 Clinical advances for heart attack patients Primary Angioplasty (PPCI) should be the first treatment of choice for STEMI heart attacks: –it will save even more lives than thrombolysis –It will be available to people who cannot receive thrombolysis –It will lead to fewer future heart attacks and strokes. But there are conditions to be met: –time taken for PPCI above that for delivering PHT –specialist catheter laboratory staff and consultants –access to specialist equipment needed –minimum number of cases needed to maintain skills and optimise outcomes December 2006, ‘Mending Hearts and Brains: the clinical case for change’.

6. 6 There is clinical consensus, based on evidence from around the world, that PPCI, if delivered in time, is a better treatment for STEMI heart attacks than Thrombolysis.

7. 7 Facts and figures for PPCI 30 day1 year18 months PPCI5.6%8.7%9.9% Thrombolysis7.9%12.4%14.8% Source: Final NIAP Guidance Oct 08 CTB TimeIn - hospital30 days1 year 60-120 mins2.7%2.9%5.1% 120 – 180 mins4.5%4.9%8.7% 180 mins +11.4%12.2%15.9% Death rates are lower for PPCI But time for delivering PPCI is crucial Better results for PPCI over Thrombolysis Worse results for PPCI over Thrombolysis

8. 8 The process Mending Hearts and Brains Dec 2006 Looking to the Future Clinical Workstream May 2007 Next Stage Review Clinical Programme Board – Spring 2008 Towards the Best, Together consultation Summer 2008 Specialist Heart Attack Centres agreed in Principle Summer 2008 Papworth pilot Launched September 2008 Cardiac Networks Makes whole region proposals October 2008 External Clinical Advisory Group comment October 2008 Final NIAP guidance October 2008 Further national expert advice sought December 2008 Wider Clinical Group Consider guidance December 2008 Specialised Commissioning Group Make decision December 2008 Evidence gathering and discussion Commissioning the service

9. 9 May 2007 –work began on service development as ‘Looking to the Future’. –Clinical workstream on emergency care, with subgroup on PPCI to address issues from ‘Mending Hearts and Brains’. –worked with the Eastern Regional Public Health Observatory to: map travel times across the region (subsequently Ambulance Trust) agree standards for PPCI delivery July 2007 -PPCI subgroup developed comprehensive document with detailed input from cardiac networks -Questionnaire of hybrid PPCI/PHT model sent to all regional providers Looking to the Future Clinical Workstream May 2007

10. 10 Emerging Themes PPCI centres should provide 24/7 services high volume: –over 50 per operator –and over 200 per centre per year located to maximise opportunity for patients to receive PPCI within 150 minutes interventional cardiologists to provide 24/7 service, rota not less than 1 in 6 catheter laboratories staffed 24/7 by a multi-skilled team, including anaesthetic cover. patients discharged in 4 days, follow up and cardiac rehabilitation services established locally. Looking to the Future Clinical Workstream May 2007

11. 11 Looking to the Future Emergency Care workstream and sub groups incorporated into an Acute Clinical Pathway Group (CPG) made recommendations based on evidence of good practice, nationally and internationally –Recommendation was: “Create new specialist centres for stroke, primary angioplasty and major trauma” work of all eight CPGs came together in ‘Towards the best, together, the clinical vision for NHS in the east of England’. vision launched for consultation in May 2008. Next Stage Review Clinical Programme Board – Spring 2008

12. 12 three months extensive consultation directly involving: –more than 7,000 people; all NHS organisations in region; unions; patient representatives; voluntary sector; local councils etc. –Included local meetings, structures sample surveys, staff surveys, a week of hearings by the Joint Overview and Scrutiny Committees Support from public and staff responses The principle was supported by Regional Health Overview and Scrutiny Committee (HOSC): –recognition that further discussion might be needed on detail Towards the Best, Together consultation Summer 2008 Specialist Heart Attack Centres agreed in Principle Summer 2008

13. 13 Commenced September 2008 with audit after 3 months STEMIs (in hospital and in community) in catchment area Addenbrooke’s, Hinchingbrooke and Peterborough Hospitals, served by east of England ambulance service. Direct admission to catheter laboratory at Papworth for PPCI Papworth Heart Attack Centre pilot launched September 2008 Review of results showed: 127 referrals 50% direct admissions via ambulance 70% of admitted patients had a PPCI procedure Av. call to balloon (CTB) 112 minutes Av. door to balloon (DTB) 40 minutes majority of patients discharged home In hospital mortality: NIAP national 5.2%, Papworth 4% 30 day mortality: NIAP national 5.6%, Papworth 4%

14. 14 Sally Standley Commissioning a PPCI Service for east of England

15. 15 Cardiac Networks make proposals October 2008 Essex: –PPCI in 24/7 centre Essex CTC at Basildon Beds and Herts: –24/7 PPCI at Papworth and Harefield, supported by Lister and Watford providing a five day 9-5 service. Anglia two 24/7 PPCI centres: –Papworth (Peterborough, Cambridgeshire, West Suffolk) –Norfolk and Norwich (Norfolk, North and Central Suffolk) for those with journey time of over 75 minutes: short term: thrombolysis followed by early angiography and PCI or rescue PCI longer term: PPCI in Ipswich and Peterborough

16. 16 Membership: British Cardiovascular Intervention Society (BCIS): Dr Jim Hall, interventional cardiologist from South Tees Hospital British Cardiovascular Society (BCS): Dr David Hackett, cardiologist from the West Herts Hospital user representative ambulance trust public health three cardiac and stroke networks NHS EoE External Clinical Advisory Group comment October 2008 Networks’ proposals considered in light of national guidance and advice Group recommended: single model of PPCI preferred (i.e. no PHT), but this does not preclude PHT followed by rescue PCI three 24/7 centres (Papworth, Basildon, and NNUH) plus Harefield no part time centres upper travel time of 90 minutes standard for door to balloon of 30 minutes

17. 17 30 day1 year18 months PPCI5.6%8.7%9.9% Thrombolysis7.9%12.4%14.8% CTB TimeIn - hospital30 days1 year 60-120 mins2.7%2.9%5.1% 120 – 180 mins4.5%4.9%8.7% 180 mins +11.4%12.2%15.9% Death rates are lower for PPCI But time for delivering PPCI is crucial Better results for PPCI over Thrombolysis Worse results for PPCI over Thrombolysis Final NIAP guidance October 2008 Source: Final NIAP Guidance Oct 08

18. 18 National roll-out feasible within 3 years but may be logistically challenging Times of treatment within 120 minutes are achievable but must be achieved reliably regardless of the time of day or week Hybrid services offering day time PPCI and OOH thrombolysis not satisfactory 24/7 centres, with sufficiently high volume to maintain and develop skills If acceptable PPCI service cannot be established: –pre hospital thrombolysis (PHT) is preferable to in-hospital thrombolysis. Final NIAP guidance October 2008

19. 19 85% of population within 120minutes CTB, and 100% within 165 minutes CTB concerns about arrangements for areas with longer travel times wanting to take account of Professor Steven Goodacre’s evaluation of NIAP: –‘if the PCI related delay exceeds 90 mins the benefits of PCI would be lost.’ Advice sought, esp. on: –120 minute CTB time –calculation of the ‘PCI related delay’ (i.e. point where benefits of PPCI are outweighed by benefits of PHT). On these issues: Further national expert advice sought December 2008

20. 20 Basildon 90 Min

21. 21 Harefield 90 Min

22. 22 Norfolk & Norwich 90 Min

23. 23 Papworth 90 Min

24. 24 Papworth – Red N & N – Green Basildon – Blue Harefield - Yellow

25. 25 BCIS: Dr Jim Hall Noted: –Anglia’s excellent PHT service of between 60-90 minutes call to needle (CTN) time –and Prof Goodacre’s conclusion that max PPCI related delay must not exceed 90 mins Calculated: –assumed CTN of 75min (median between performance of PHT service of 60 and 90) –CTB minus CTN = PPCI related delay CTB minus 75 minutes = PPCI related delay CTB must therefore be max 165 mins (ie 165-75=90) And therefore advised: –EOE “PPCI service would need to operate with an upper confidence limit of 165 mins to be cost-effective”. Further national expert advice sought December 2008

26. 26 BCS: Dr Mark deBelder British Cardiovascular Society commented on Dr Jim Hall advise “… DTB and CTB times… in NIAP report are aspirations, and it would be unlikely that new PPCI services will immediately fulfil them … If you really feel some of your population are further from a PPCI centre than this, the use of prehospital lysis and immediate transfer to a high volume centre will probably be better, but from what I understood was not really the issue” [as 100% within 165 minutes travel time]. Further national expert advice sought December 2008

27. 27 Department of Health: DH clarified NIAP by saying: 120 minutes an aspiration not a target DANAMI research shows benefit for PCI vs thrombolysis even when transfers took 3 hours (180min) or more concern about the viability of small volume PHT for rural areas with longer travel times, favouring 100% PPCI services even if longer transfers and some patients > 120 minutes inverse relationship between travel time and door to balloon (DTB) time: –i.e. longer travel time leads to shorter DTB time at specialist centre due to more setting up time prior to patient arrival Further national expert advice sought December 2008

28. 28 Membership: –representatives of cardiac networks –external advisors –provider organisations –Ambulance Service Trust, –Ambulance Commissioner –east of England Specialist Commissioning Group –SHA total of 24 people (15 clinicians) considered the recommendations from External Expert Advisory Group and expressed concern about… Wider Clinical Group Consider guidance December 2008 - the number of centres proposed - working to a max 165 mins CTB time

29. 29 Single model of PPCI in 24/7 centres: –no supporting role for PHT –a mixed model would generate confusion, and reduce skill base for PHT delivery –impact on volume and hence outcome if more centres developed No small volume centres: –100% EOE covered by the 24/7 centres in 90 min travel time –small volume centres would fail to achieve necessary levels of activity for operator or institutional competence 24/7 centres operational from 1 April 2009 Target of 120 minutes CTB but, as PPCI remains the recommended clinically effective treatment at 165 minutes supporting operating within a maximum CTB of 165 minutes Wider Clinical Group Consider guidance December 2008 After debate, they recommended…

30. 30 Wider Clinical Group Consider guidance December 2008 –“The model was agreed in the light of current evidence and guidance, with recognition that the evidence base is in parts incomplete, but that failure to make a decision to act on the evidence that is available would be to the detriment of patient care. –Should further evidence of cost or clinical effectiveness become available either nationally to from audit at the 3 EOE Centres, these arrangements may be reviewed e.g. regarding the appropriateness of in hours provision.” Minutes recorded:

31. 31 SCG discussed recommendation of Wider Clinical Group and formally agreed : support for a single model of care for PPCI PPCI centres at Basildon, Papworth and NNUH hospitals support for a maximum call to balloon time of 165 minutes, to ensure that total population coverage for primary PCI, subject to a comprehensive audit programme over the fist year to measure comparable outcomes 1 April 2009 start date. Specialised Commissioning Group Make decision December 2008

32. 32 Since that decision…

33. 33 Jan 2009, 3 Networks each asked to identify any remaining concerns points were considered against national guidance and expert advice to identify if any new issues –most related to issues already considered –issues of communication which needed to be addressed by SCG and Networks –others related to operational implementation which needed to be addressed by PPCI Steering Group Preparing for Implementation Jan 09 – present

34. 34 Ambulance Trust modelling to calculate the resource implications to avoid PPCI transfers having an adverse impact on other emergency calls SCG, EAAST and 3 Networks begin preparing for roll out, supported by PPCI Steering Group: –communication –training –audit –policies and procedures e.g.: repatriation contingency planning cross boundary issues Preparing for Implementation Jan 09 – present

35. 35 PPCI Steering Group established Membership: Cardiac and Stroke Network public health specialist Ambulance Service Trust GP from Suffolk interventional cardiologists from each PPCI providers, including existing part time providers Specialised Commissioning Group Ambulance Commissioner NHS East of England Preparing for Implementation Jan 09 – present Sought further national advice in response to concerns: part time centres can have a role as part of a 24/7 ‘service’ must be agreed with the ambulance service cardiologists must support the 24/7 service at the tertiary centre evaluated after two years DH will be providing monitoring arrangements re outcomes

36. 36 Specialised Commissioning Group In March 2009: In the light of specific national advice the SCG updated the model for east of England to include two 9-5 units in Hertfordshire Excluded an extra step of PHT in Suffolk and NE Essex Agreed communication to GPs outlining advice and decisions made Implementation arrangements: –Specialised Commission Group to commission the service: Contracts Communication –Ambulance Commissioners: Commission from Ambulance service based on travel times –PPCI Steering Group to work up implementation inc: implementation, including phasing audit arrangement protocols Preparing for Implementation Jan 09 – present

37. 37 Roll Out: 6 April: PPCI continued at Papworth and introduced at NNUH for the areas normally served by hospital May 08: Introduction to Suffolk postponed 1 June: Papworth and NNUH expanded areas covered 6 July: Roll out to Queen Elizabeth Hospital area 1 September: agreed date for roll out to Essex Preparing for Implementation Jan 09 – present

38. 38 PPCI procedures undertaken: –274 at Papworth since Sept 08 all discharged back home CTB range 72 and 124 minutes average DTB 35 minutes –65 at NNUH since 6 April 09 audit report after first three months Ambulance crews involved very supportive No major issues have been identified Detailed audit underway Implementation To date…

39. 39 Issues around this review for Suffolk: Clear local concern that service will be worse than currently: –Is the CTB time too long at 165 minutes? –Can rural and coastal areas be serviced effectively? –What does this mean for the future of Ipswich Hospital? –Why weren’t local people asked?

40. 40 Is the travel time too long at 165 minutes? Best advice, nationally from experts, is that 165 minutes is well within the 180 minutes identified in Final NIAP guidance where PPCI is more effective than Thrombolysis As journey times increase, the door to balloon time at the specialist centre decreases, making the process quicker at the end than the 120 minute calculation allows.

41. 41 Can rural and coastal areas be served effectively? Ambulance Trust modelling and blue light testing shows that all parts of the east of England can reach a specialist heart attack centre within 165 CTB DTB time is shorter the longer the journey Real time traffic management gives Ambulance staff choices of where best to take patients based on conditions PHT will be kept on ambulances for three months as a precaution, and longer if need is proved.

42. 42 What does this mean for the future of Ipswich Hospital? Regional vision is clear: all Acute Trusts, including Ipswich, have a sustainable future with A&E and Maternity Ipswich does not currently do Elective Angioplasty and does not have the equipment or staff to undertake PPCI Ipswich is an excellent hospital and will be in line for future specialist commissioning decisions like all other trusts Ipswich is recruiting new cardiologists to its team, and will continue to deal with the majority of heart attacks, and post PPCI care.

43. 43 Why weren’t local people asked? The principle was agreed by clinicians and stakeholders across the region, and then ratified by regional consultation, including in Suffolk The Chairs of HOSCs were asked if further consultation was needed and they advised the NHS that is was not BUT, the NHS should have done more to talk to and listen to local people, we will learn from this and we apologise However, we firmly believe that this change is in the best interests of all people in the east of England; it will save lives.