1. Interventional Registries The Audit and Research Potential of the BCIS CCAD Registry Peter F Ludman

2. NO CONFLICT OF INTEREST TO DECLARE

3. Audit: Background Clinical Governance –The systematic approach to maintaining and improving the quality of patient care in a health system Recognisably high standards of care Transparent responsibility and accountability for those standards A constant dynamic of improvement

4. Clinical Governance Education and training –continued professional development Clinical effectiveness –the appropriateness, efficacy, cost effectiveness and safety of different therapies. Research and development –the application of new research findings into clinical practice and guideline development. Openness –Poor practice can thrive if it occurs out of the scrutiny of peers, and while openness is important, it must respect appropriate individual patient and practitioner confidentiality. Risk management –addressing and minimising risks to patients, physicians and organisations. Clinical audit

5. Clinical Audit Greatest potential to assess quality of care Domains –Structure –Appropriateness –Process –Outcomes

6. SCTS Aim: Harmonise datasets Design medical audit system Based on principles of quality assurance To be used Nationally BPEG British Paediatric Cardiac Association CCAD formed May 1996 DoH funding Pilot for 3 years 6 Specialist Groups 1999 onwards Funding via NHS IA

7. Data Collection BCIS-CCAD dataset 5.5.6 (113 fields) Spreadsheet csv file spec

8. CCAD Mechanism Hospital 1 Hospital 2 Hospital 3 Hospital n CCAD Server encryption Internet encryption....

9. Central Cardiac Audit Database Domains PCIMINAPAdult Surgery Paedtrc Surgery Heart Failure EP Pacing ICD RehabAmbulance audit BCISRCPSCTSBPCABSHHRUKBACR / BHF ASA CCAD NHS Central Register Heart Valve registry

10. Central Cardiac Audit Database Domains PCIMINAPAdult Surgery Paedtrc Surgery Heart Failure EP Pacing ICD RehabAmbulance audit BCISRCPSCTSBPCABSHHRUKBACR / BHF ASA CCAD NHS Central Register Heart Valve registry

11. Procedure Specific Analysis Participation in CCAD 2009 data: Ludman Total No. of Centres Data to CCAD Participation EnglandNHS777496% Private16531% Wales33100% N Ireland3267% ScotlandNHS7686% Private100%

12. CCAD data UK PCI data in CCAD as % of Reported Totals 2009 data: Ludman As August 2010

13. CCAD data UK PCI data in CCAD as % of Reported Totals 2009 data: Ludman As August 2010 UKE&W (NHS) Scotland (NHS) N. Ireland PCIs 83,13071,2777,1533,049 In CCAD 77,57869,0745,8961,577 Missing 5,5522,2031,2571,472 % Missing6.7%3.1%17.6%48.3%

14. % Completeness 12 fields required for risk adjusted outcome NWQIP Top score potential = 1200

15. 200620072008 2009

16. Audit Potential Structure Appropriateness Process Outcome

17. Audit Potential Structure Appropriateness Process Outcome

18. No PPCI PPCI day PPCI 24/7 Angiography (76) PCI (105)

19. No PPCI PPCI day PPCI 24/7 Angiography (76) PCI (105)

20. Audit Potential Structure Appropriateness Process Outcome

21. Appropriateness

22. Primary PCI - ? Case selection % Cases over 80 (2009 data) 2009 data: Ludman 11.7% Number of PPCI procedures % of cases with age over 80 yrs

23. Primary PCI - ? Case selection % Cases over 80 (2009 data) 2009 data: Ludman 11.7% Number of PPCI procedures % of cases with age over 80 yrs

24. Appropriateness 2008 data: Ludman Under analysis Accepted as appropriate

25. Appropriateness 2008 data: Ludman Acute

26. Appropriateness 2008 data: Ludman

27. Appropriateness 2008 data: Ludman

28. Appropriateness 2008 data: Ludman

29. Appropriateness 2008 data: Ludman

30. Appropriateness 2008 data: Ludman

31. Appropriateness 2008 data: Ludman

32. Appropriateness 2008 data: Ludman Number% ? Inappropriate24353.3 % Unknown65878.8 % Stable CCS 0/1 no non invasive testing no invasive testing for ischaemia

33. Audit Potential Structure Appropriateness Process Outcome

34. Admitted from the community Direct admission to PCI centre Transfer to PCI centre Admission to Non-PCI centre Primary PCI device D1 D2

35. Primary PCI Direct and IHT: Call to Balloon times < 150 min Number of Cases % CTB < 150 min 2009 data: Ludman 75.3% 3 SD 2 SD

36. Audit Potential Structure Appropriateness Process Outcome

37. All as % No.Success Partial success Fail no comp Re-PCIQMI Em CABG CVA Death In hosp Death 30/7 ONS NSTEMI / UA no shock 26,55592.92.34.00.30.20.090.070.561.3 All STEMI no shock 14,48592.02.03.50.60.110.212.33.8 *Primary PCI13,18989.82.13.70.60.110.184.36.2 *Rescue PCI1,69592.01.62.40.90.120.74.05.8 Shock141666.22.54.00.90.140.4326.634.0 Outcome 2009 2009 data: Ludman *all PPCI (includes shock / ventilation etc)

38. Primary PCI (includes shock/vent) 30 day ONS tracked Mortality 2009 data: Ludman Number of PPCI procedures % Mortality at 30 days 6.2% Shock and ventilation INCLUDED

39. +3 σ +2 σ -2 σ -3 σ Observed MACCE Predicted MACCE NWQIP Model 2009 data: Ludman

40. Feedback to units Live view in Lotus Notes emailed reports Annual reports

41. National PCI Unit

42. QEB National 0.9% 2.0% 60% 35% 66% 55%

43. Delays Reports Monthly

44. Cumulative Funnels Quarterly

45. AuditResearch

46. AuditResearch RegistryRCT

47. Randomised Control Trials Strengths –Randomisation –Ability to test hypotheses –Cause and effect conclusions –Precise and robust analysis Weakness –Focused entry criteria –costs limit patient number and FU duration ESC STEMI Guidelines 13% based on RCTs (Tricoci P JAMA 2009;301:831) Euro Heart Survey up to 89% wld be excluded from RCTs (Hordijk_Trion M EHJ 2006;27:671)

48. Registry Strengths –Generalised entry full spectrum including high risk patients included –Population outcomes –Long follow up –Large numbers of patient assessed –Suited to Risk Modelling Weaknesses –Non randomised –Observational –Hypothesis generating (cause v effect uncertain)

49. SCAAR scare ? 32%  Mortality James S. EuroInt 2009;5:501

50. SCAAR scare James S. EuroInt 2009;5:501

51. BCIS-CCAD Research Strategy NICOR –National Institute for Outcomes Research –Within the Institute of Cardiovascular Science at UCL –Links with Cardiovascular prevention unit –Newly appointed analyst UK research groups –Data governance framework –Data applications review group –6 projects about to start, 2 await approval

52. Research: BCIS-CCAD Exploratory analyses

53. 030/76/121 yr Mortality: PCI Success0.4%0.9%1.8% Number at risk2344233123142292 Mortality: PCI failed0.7%2.1%3.7% Number at risk1101108910721054 Chronic Total Occlusions 2008 Data with ONS track to May 2010 2009 data: Ludman PCI Success PCI Failure

54. 2009 data: Ludman Complication by Access route Complications to hospital Dx: False aneurysm Haemorrhage (retroperitoneal, delay Dx, surgery) Art occlusion / dissection Any need for surgery

55. 2009 data: Ludman Complication by Access route CVA

56. Diabetes Diabetes by Ethnicity 2008 data: Ludman

57. BMI BMI by Ethnicity 2008 2008 data: Ludman

58. Diabetes Diabetes by Ethnicity 2008 data: Ludman Outcomes from PCI in South Asians?

59. Risk Models Large unselected population Validated mortality Potential to cross link datasets –MINAP: ACS / re-MI –SCTS: CABG –HES: re-admission BUT ….

60. Outcome Data for 2007, 2008 and 2009 2009 data: Ludman Risk Adjusted MACCE Number of PCI procedures % MACCE

61. Outcome Data for 2007, 2008 and 2009 2009 data: Ludman Risk Adjusted MACCE Number of PCI procedures % MACCE MOUMOU

62. Outcome Data for 2007, 2008 and 2009 2009 data: Ludman Risk Adjusted MACCE Number of PCI procedures % MACCE Model out of date Over report procedural risk Under report adverse outcome

63. Cardiogenic Shock % Cases with shock by PCI unit 2009 data: Ludman Shock in 1.8% of cases (1416 of 77,660)

64. Cardiogenic Shock % Cases with shock by PCI unit 2009 data: Ludman Shock in 1.8% of cases (1416 of 77,660)

65. Model out of date Recalibrate New model Over report procedural risk Avoid subjective measures Peer review Under report adverse outcome Mortality only

66. Research: Current potential projects Outcomes –in South Asians –by access route –after CTO intervention HES v BCIS for revalidation Variation in outcomes by unit –Unit features (volume / organisation…) –Patient presentation and demographics Models for mortality after PCI

67. Conclusions Audit potential –Valuable contribution –Evolving analyses and feedback systems Research potential –Dataset quantity and quality improving –Huge potential for registry based investigation –Strategy NICOR UK Research groups

68. The End