THE ROLE OF ICD THERAPY FOR PRIMARY PREVENTION Leonard Ganz, M.D. Pittsburgh, PA
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1 THE ROLE OF ICD THERAPY FOR PRIMARY PREVENTION Leonard Ganz, M.D. Pittsburgh, PA Speakers Bureau: Zoll / Lifecore, Sanofi Aventis, Cardionet Consultant: Boston Scientific, St. Jude Medical, Biotronik, Boehringer Ingleheim
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3 ANNUAL DEATHS IN U.S. 1 NASPE, May , , , , , , , , ,000 50, American Heart Association 2000 SCD CVA Lung CA Breast CA Auto Acc. AIDS Fires 3 National Cancer Institute National Transportation Safety Board, Center for Disease Control NFPA, US Facts & Figures, MMWR, Feb. 2002
4 Callans DJ. New Engl J Med 2004; 351: 632.
5 Callans DJ. New Engl J Med 2004; 351: 632.
6 MADIT II MADIT / MUSTT Huikuri et al, NEJM 2001; 345:1473.
7 PHARMACOLOGIC THERAPY β blockers ACE inhibitors Statins Eplenerone ARB s Aspirin
8 PREVENTION OF SCD Optimal Rx of heart disease and risk factors Put ß - blockers in water supply Improving acute response to SCD AEDs CPR First responder response time Implanting ICD s in high risk patients prior VT / VF high risk primary prevention
9 THEN NOW
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12 RANDOMIZED PROPHYLACTIC ICD TRIALS ISCHEMIC CMP CABG Patch MADIT MUSTT MADIT - II NONISCHEMIC CMP AMIOVERT CAT DEFINITE HEART FAILURE SCD - HeFT COMPLETED COMPANION COMPLETED
13 ICD THERAPY AND TOTAL MORTALITY 80 % Mortality Reduction w/ ICD Rx % Mortality Reduction w/ ICD Rx % 55% 31% 1 2 MADIT MUSTT MADIT-II 27 months 39 months 20 months 31% 28% 20% 3 ICD mortality reductions in primary prevention trials are equal to or greater than those in secondary prevention trials. 1 Moss AJ. N Engl J Med. 1996;335: Buxton AE. N Engl J Med. 1999;341: Moss AJ. N Engl J Med. 2002;346: AVID CASH CIDS 3 Years 3 Years 3 Years 4 The AVID Investigators. N Engl J Med. 1997;337: Kuck K. Circ. 2000;102: Connolly S. Circ. 2000:101:
14 MADIT-II TRIAL Prior MI INCLUSION CRITERIA LV EF < 30 % No requirement for NSVT or EP studies EXCLUSION CRITERIA MADIT-I ICD indication NYHA IV at enrollment MI < 1 month CABG < 3 months advanced organ system disease
15 MADIT-II SURVIVAL RESULTS 1.0 Probability of Survival P = Conventional Defibrillator Hazard Ratio Year Number At Risk Mortality Defibrillator (0.91) 274 (0.84) 110 (0.78) (14.2%) Conventional (0.90) 170 (0.78) 65 (0.69) 3 97 (19.8%) Moss AJ. N Engl J Med. 2002;346:
16 SUBSET ANALYSES No subgroups failed to benefit from ICD
17 NUMBER TO TREAT TO SAVE A LIFE MUSTT MADIT AVID MADIT-II MADIT-II SAVE SOLVD CIBIS-II ISIS-2 Merit-HF 4S (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (1.7 Yr) (3 Yr) (4 Yr) (1 Yr) (2 Yr) (1 Yr) (6 Yr) NNT x years = 100 / (%Mortality in Control Group %Mortality in Treatment Group)
18 MADIT-II 8 YEAR FOLLOW-UP 34% reduction in mortality Goldenberg I et al. Circulation 2010; 122: 1265.
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20 SCD-HeFT 2521 patients enrolled NYHA II - III, EF < 35%, no ICD indication All patients receive standard CHF Rx Randomization to placebo, amiodarone, ICD Endpoint - all cause mortality; QOL, cost effectiveness, morbidity Results presented at ACC 3/8/04
21 SCD-HeFT Age 60.1 yrs Female 23% CHF duration 24.5 months NYHA II, III 70%, 30% Ischemic, nonisch CMP 52%, 48% LV EF 25% QRS duration 112 msec ACE-I 85%, 72% ACE-I / ARB 96%, 87% Beta-blocker 69%, 78% Bardy G. ACC Annual Scientific Sessions 3/8/04
22 SCD-HeFT TOTAL MORTALITY Bardy, G. H. et al. N Engl J Med 2005;352:
23 SCD-HeFT Bardy, G. H. et al. N Engl J Med 2005;352:
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25 Medicare to Expand Coverage of Heart Devices By ROBERT PEAR Published: January 20, 2005 ASHINGTON, Jan Federal health officials said on Wednesday that they planned a major expansion of Medicare coverage for implantable devices that can help prevent sudden death from heart failure and certain types of heart disease. Dr. Mark B. McClellan, administrator of the federal Centers for Medicare and Medicaid Services, said the agency was "poised to expand" coverage of the devices, implantable cardioverter-defibrillators, based on new research showing that they could increase the chances of survival in substantial numbers of elderly people on Medicare. The move by the agency was reported on Wednesday night by The Washington Post.
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27 DEFINITIONS Class I Class IIa Class IIb Class III indicated reasonable may be considered not indicated
28 ICD CLASS I Survivors of cardiac arrest or unstable VT (exclude reversible causes) Sustained VT with structural heart disease Syncope with inducible sustained VT / VF Prior MI, EF < 35 %, NYHA II / III, > 40 days post MI
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30 IS THERE A DOWNSIDE? Procedural risks Inappropriate shocks Lifestyle modifications Quality of Life
31 INAPPROPRIATE SHOCKS Substantial source of morbidity in ICD patients Thoughtful program significantly decreases inappropriate shock frequency Wilkoff BL, et al. PREPARE Trial. JACC 2008; 52:541. Decreased morbidity index (0.26 vs 0.69 events/pt yr) Decreased likelihood of shock in 1 st year (9% vs 17% No significant change in untreated VT and syncope
32 DISCUSSION PRIOR TO IMPLANT Rationale for ICD (clinical trial data) Difference between heart attack and cardiac arrest Negligible effect on QOL, functional capacity (unless CRT-D) Procedural risks, recovery Lifestyle modifications Inappropriate shocks
33 LIFESTYLE MODIFICATIONS No driving for 1 week (primary prevention) Limited arm movement for 4 weeks Avoidance of powerful magnetic fields Microwaves, household appliances, hand tools all okay
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36 ICD s SAVE LIVES
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Implantable Cardioverter Defibrillators Page 1 of 44 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Implantable Cardioverter Defibrillators Wearable Cardioverter
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