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Advanced Angioplasty 2003 Non-Coronary Intervention Circulatory Support Andreas Baumbach Bristol Royal Infirmary AB 1/03 Circulatory Support PCI / Acute MI Cardiogenic shock Cardiac Surgery High risk CABG Weaning Bridge to transplant Chronic Heart Failure ? AB 1/03 Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments AB 1/03 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 AB 1/03 Intra-Aortic Balloon Pump AB 1/03 Intra-Aortic Balloon Pump Decreases Afterload Increases Diastolic Aortic Pressure Increases Coronary Flow Velocity Reduces Myocardial Oxygen Demand AB 1/03 Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments AB 1/03 Intra-Aortic Balloon Pump Current Practice Results from the Benchmark Registry Ferguson et al. J Am Coll Cardiol 2001; 38:1456 AB 1/03 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 AB 1/03 Benchmark Registry: Indication • Hemodynamic support during/after catheterisation • Cardiogenic shock • Weaning from CP bypass • Preoperative use in high risk pts • Refractory unstable angina 20.6% 18.8% 16.1% 13% 12.3% Ferguson et al. J Am Coll Cardiol 2001; 38:1456 AB 1/03 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: – – – – AB 1/03 Women Low BSA Older patients PVD Ferguson et al. J Am Coll Cardiol 2001; 38:1456 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 AB 1/03 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 AB 1/03 IABP in direct angioplasty *Stents 1.3% High risk Age>70yrs 3 vessel disease LVEF<45% SVG occlusion Persistent malignant arrhythmia Subotpimal result* Stone et al. J Am Coll Cardiol 1997 AB 1/03 IABP in direct angioplasty N:1100 Angio for MI N: 908 randomised N: 437 high risk IABP 211 Established 86% no IABP 226 Crossover 13% Stone et al. J Am Coll Cardiol 1997 AB 1/03 IABP in direct angioplasty 28.9 29.2 30 25 20 23 IABP no IABP 19.9 15 8 10 5 4.3 3.1 6.2 6.7 5.5 2.4 0 0 Death AB 1/03 Re-MI Reoccl Stroke CHF Hypo Endpoint Stone et al. J Am Coll Cardiol 1997 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 ‘ AB 1/03 Stone et al. J Am Coll Cardiol 1997 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 AB 1/03 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 AB 1/03 Van ‘t Hoft 1999, Eur Heart J 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; AB 1/03 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 AB 1/03 Sanborn et al. J Am Coll Cardiol 2000; 36:1123 SHOCK Registry N: 856 patients with cardiogenic shock in acute MI 36 participating centres Treatment: • No thrombolysis / no IABP • IABP only • Thrombolysis only • Thrombolysis and IABP AB 1/03 33% 33% 15% 19% Sanborn et al. J Am Coll Cardiol 2000; 36:1123 SHOCK Registry: Mortality Cardiogenic shock (LV Failure) No thrombolysis n=564 64% No IABP n=285 77% no revasc n=233 83% AB 1/03 revasc n=52 48% Thrombolysis n=292 54% IABP n=279 52% no revasc n=84 76% No IABP n=132 63% revasc n=195 41% no revasc n=105 74% revasc n=27 19% p=.005 IABP n=160 p<.0001 47% no revasc n=51 69% revasc n=109 37% Sanborn et al. J Am Coll Cardiol 2000; 36:1123 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 AB 1/03 Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments AB 1/03 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 AB 1/03 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 AB 1/03 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 AB 1/03 Summary IABP Intra-Aortic Balloon Pump is an excellent tool for the management of hemodynamically unstable patients especially in the setting of acute MI AB 1/03 Circulatory Support Balloon Counterpulsation Results & Evidence Guidelines Assist Devices: Developments AB 1/03 Assist Devices: Indications • • • • AB 1/03 Cardiogenic shock in AMI Postsurgical myocardial dysfunction Acute cardiac failure from myocarditis Decompensated chronic heart failure Assist Devices: Goals • Bridge to transplantation • Bridge to recovery • Alternative to heart transplantation Delgado et al Circulation 2002;106:2046 AB 1/03 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 AB 1/03 HeartmateTM AB 1/03 Heartmate AB 1/03 Heartmate N:129 Quality of life AB 1/03 AbiocorTM AB 1/03 AbiocorTM AB 1/03 AbiocorTM AB 1/03 AbiocorTM AB 1/03 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 AB 1/03