Non-Coronary Intervention Circulatory Support

1. Non-Coronary InterventionCirculatory Support Advanced Angioplasty 2003 Andreas Baumbach Bristol Royal Infirmary

2. Circulatory Support PCI / Acute MI Cardiogenic shock • Cardiac Surgery • High risk CABG • Weaning • Bridge to transplant • Chronic Heart Failure ?

3. Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments

4. Intra-Aortic Balloon Pump • Inflatable 32-40 cc balloon • Triggered to inflate with helium immediately after aortic valve closure • Triggered to deflate with opening of the aortic valve

5. Intra-Aortic Balloon Pump

6. Intra-Aortic Balloon Pump Decreases Afterload Increases Diastolic Aortic Pressure Increases Coronary Flow Velocity Reduces Myocardial Oxygen Demand

7. Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments

8. Intra-Aortic Balloon PumpCurrent Practice Results from the Benchmark Registry Ferguson et al. J Am Coll Cardiol 2001; 38:1456

9. Benchmark Registry • June 96-August 2000 • 203 Hospitals (90%US) • 16909 patient case records • Verified by external audit Ferguson et al. J Am Coll Cardiol 2001; 38:1456

10. Benchmark Registry: Indication • Hemodynamic support during/after catheterisation 20.6% • Cardiogenic shock 18.8% • Weaning from CP bypass 16.1% • Preoperative use in high risk pts 13% • Refractory unstable angina 12.3% Ferguson et al. J Am Coll Cardiol 2001; 38:1456

11. Benchmark Registry: Complications • Major: Limb ischemia, severe bleeding, balloon leak, death due to IABP 2.6% • In –hospital mortality 21.2% • Failed IABP insertion 2.3% • Increased risk for major complications: • Women • Low BSA • Older patients • PVD Ferguson et al. J Am Coll Cardiol 2001; 38:1456

12. IABP Evidence A prospective randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute MI treated with primary angioplasty Stone et al. J Am Coll Cardiol 1997

13. IABP in direct angioplasty Hypothesis: routine use of IABP after primary PCI reduces infarct related artery reocclusion Multicentre, randomised trial High risk patients randomised to 36 to 48hrs IABP or standard care Stone et al. J Am Coll Cardiol 1997

14. IABP in direct angioplasty High risk Age>70yrs 3 vessel disease LVEF<45% SVG occlusion Persistent malignant arrhythmia Subotpimal result* *Stents 1.3% Stone et al. J Am Coll Cardiol 1997

15. IABP in direct angioplasty N:1100 Angio for MI N: 908 randomised N: 437 high risk IABP 211 no IABP 226 Established 86% Crossover 13% Stone et al. J Am Coll Cardiol 1997

16. IABP in direct angioplasty Stone et al. J Am Coll Cardiol 1997

17. IABP in direct angioplasty Complications No difference in hemorrhagic complications or vascular complications Significant difference in stroke ‘This finding may be due to chance ….. One intracranial hemorrhage developed after a postinfarction patient was hit in the head with a shovel while robbing the hospital nursery ‘ Stone et al. J Am Coll Cardiol 1997

18. IABP Evidence A randomized comparison of intraaortic balloon pumping after primary coronary angioplasty in high risk patients with acute MI treated Van ‘t Hoft 1999, Eur Heart J

19. IABP Evidence N 238 over 3.5 years 118 IABP 120 no IABP Primary endpoint: Death, Re-MI, stroke, EF<30% at 6 months FU -> 26% vs 26% No difference in EF 8% major complications in IABP group Van ‘t Hoft 1999, Eur Heart J

20. IABP Evidence: SHOCK Impact of thrombolysis, intra-aortic balloon pump counterpulsation, and their combination in cardiogenic shock complicating acute myocardial infarction A report from the SHOCK trial registry Sanborn et al. J Am Coll Cardiol 2000;

21. IABP Evidence: SHOCK Background: National registry of MI suggests lower mortality in pts treated with thrombolysis followed by IABP (49%) compared with thrombolysis alone (69%) GUSTO trend towards better outcome Sanborn et al. J Am Coll Cardiol 2000; 36:1123

22. SHOCK Registry • N: 856 patients with cardiogenic shock in acute MI • 36 participating centres • Treatment: • No thrombolysis / no IABP 33% • IABP only 33% • Thrombolysis only 15% • Thrombolysis and IABP 19% Sanborn et al. J Am Coll Cardiol 2000; 36:1123

23. SHOCK Registry: Mortality p=.005 p<.0001 Sanborn et al. J Am Coll Cardiol 2000; 36:1123

24. SHOCK Result IABP vs. no IABP mortality after adjustement for revascularisation p=0.313 Use of IABP with or without thrombolysis improves survival in pts with cardiogenic shock because of the higher rate of attempted revascularisation in the IABP group Sanborn et al. J Am Coll Cardiol 2000; 36:1123

25. Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments

26. Guidelines “Emergency high risk PCI such as direct PCI for acute MI can usually be performed without IABP or CPS. … However, it should be noted that in patients with borderline hemodynamics, ongoing ischemia, or cardiogenic shock, insertion of an intra-aortic balloon just prior to coronary instrumentation has been associated with improved outcomes. Furthermore it is reasonable to obtain vascular access in the contralateral femoral artery prior to the procedure in patients in whom the risk of hemodynamic compromise is high…” AHA/ACC Guidelines for PCI, Circulation 2001

27. Guidelines • Recommendations for the use of IABP in the treatment of AMI • Class I • Cardiogenic shock not quickly reversed with pharmacological therapy as a stabilising measure for angiography and prompt revascularisation • Acute MR or VSD – as a stabilising therapy for angio and repair/ revascularisation • Recurrent intractable ventricular arrhythmias with hemodynamic instability • Refractory post –MI angina as a bridge to revascularisation AHA/ACC Guidelines for AMI, JACC 1996, Web update 1999

28. Guidelines Recommendations for the use of IABP in the treatment of AMI Class IIa Signs of hemodynamic instability, poor LV , or persistent ischemia in patients with large areas of myocardium at risk Class IIb Following successful angioplasty to prevent reocclusion Large areas at risk w/o active ischemia AHA/ACC Guidelines for AMI, JACC 1996

29. Summary IABP Intra-Aortic Balloon Pump is an excellent tool for the management of hemodynamically unstable patients especially in the setting of acute MI

30. Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments

31. Assist Devices: Indications • Cardiogenic shock in AMI • Postsurgical myocardial dysfunction • Acute cardiac failure from myocarditis • Decompensated chronic heart failure

32. Assist Devices: Goals • Bridge to transplantation • Bridge to recovery • Alternative to heart transplantation Delgado et al Circulation 2002;106:2046

33. Devices • Extracorporeal Assist (e.g.Thoratec/Abiomed) • Implantable LV assist devices (Heartmate) • Axial Flow pumps • Totally implantable LVAD (Lion Heart) • Total Artificial Heart (ABIOCOR) Delgado et al Circulation 2002;106:2046

34. HeartmateTM

35. Heartmate

36. Heartmate N:129 Quality of life

37. AbiocorTM

38. AbiocorTM

39. AbiocorTM

40. AbiocorTM

41. Assist Devices Progress in technology promises new surgical treatment options for end stage heart failure Our surgical colleagues should be pleased to finally have hearts that we won’t fix with percutaneous intervention