Response to the Center for Medicare & Medicaid Services coverage with evidence development request for primary prevention implantable cardioverter-defibrillators: Data from the OMNI study

Heart Rhythm

Volumn 9, Issue 7, 2012, Pages 1058-1066

  Sweeney, Michael O ^a   Sakaguchi, Scott ^b   Simons, Grant ^c   Machado, Christian ^d   Connett, John E ^e   Yang, Fang ^f  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c ENGLEWOOD HOSPITAL AND MEDICAL CENTER   (United States)

^d PROVIDENCE HOSPITAL   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

^f MEDTRONIC INC   (United States)

Author keywords

Heart failure; Implantable cardioverter defibrillator; Mortality

Indexed keywords

AGED; ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY; CONGESTIVE CARDIOMYOPATHY; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEFIBRILLATOR; FEMALE; HEALTH CENTER; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART VENTRICLE TACHYCARDIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAID; MEDICARE; MORTALITY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SURVIVAL;

AGED; CARDIAC RESYNCHRONIZATION THERAPY; CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); DEFIBRILLATORS, IMPLANTABLE; FEMALE; HEART FAILURE; HUMANS; INSURANCE COVERAGE; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PRIMARY PREVENTION; REGISTRIES; TACHYCARDIA, VENTRICULAR; UNITED STATES;

EID: 84862902600     PISSN: 15475271     EISSN: 15563871     Source Type: Journal    
DOI: 10.1016/j.hrthm.2012.02.027     Document Type: Article

References (21)

1. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-883. (Pubitemid 34984635)
2. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350:2140-2150.
3. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverterdefibrillator for congestive heart failure. N Engl J Med 2005;352:225-237. (Pubitemid 40110811)
4. Bansch D, Antz M, Boczor S, et al. Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: the Cardiomyopathy Trial (CAT). Circulation 2002;105:1453-1458. (Pubitemid 34263277)
5. Strickberger SA, Hummel JD, Bartlett TG, et al. Amiodarone vs. implantable defibrillator: randomized trial in patients with nonischemic cardiomyopathy and asymptomatic nonsustained ventricular tachycardia-AMIOVIRT. J Am Coll Cardiol 2003;41:1707-1712. (Pubitemid 36584239)
6. Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;351:2151-2158. (Pubitemid 38637995)
7. Hamill SC, Stevenson LW, Kadish AH, et al. Review of the registry's first year, data collected, and future plans. Heart Rhythm 2007;4:1260-1263. (Pubitemid 47324135)
8. Hamill SC, Kremers MS, Stevenson LW, et al. Review of the registry's fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm 2010;7:1340-1345.
9. Singh JP, Hall JW, McNitt S, et al. Factors influencing appropriate firing of the implanted defibrillator for ventricular tachycardia/fibrillation: findings from the Multicenter Automatic Defibrillator Trial II (MADIT-II). J Am Coll Cardiol 2005;46:1712-1720. (Pubitemid 41531628)
10. Saxon LA, Bristow MR, Boehmer J, et al. Predictors of sudden cardiac death and appropriate shock in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial. Circulation 2006;114:2766-2722.
11. Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008;359:1009-1017.
12. Daubert JP, Zareba W, Cannom DS, et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51:1357-1365. (Pubitemid 351443082)
13. Wilkoff BL, Williamson BD, Stern RS, et al. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol 2008;52:541-550.
14. Volosin KJ, Exner DV, Wathen MS, et al. Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling. J Cardiovasc Electrophysiol 2011;22:280-290.
15. Ellenbogen KA, Levine JH, Berger RD, et al. Are implantable cardioverterdefibrillator shocks a surrogate for sudden cardiac death in patients with nonischemic cardiomyopathy? Circulation 2006;113:776-782.
16. Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (Pain-FREE Rx II) trial results. Circulation 2004;110:2592-2596.
17. Goldenberg I, Moss AJ, Hall WJ, et al. Causes and consequences of heart failure after prophylactic implantation of a defibrillator in the Multicenter Automatic Defibrillator Implantation Trial II. Circulation 2006;113:2810-2817. (Pubitemid 44305293)
18. Sweeney MO, Sherfesee L, DeGroot P, et al. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in ICD patients. Heart Rhythm 2010;7:353-360.
19. Dorian P, Hohnloser SH, Thorpe KE, et al. Mechanisms underlying the lack of effect of implantable cardioverter-defibrillator therapy on mortality in high-risk patients with recent myocardial infarction: insights from the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT). Circulation 2010;122:2645-2652.
20. Larsen GK, Evans J, Lambert WE, et al. Shocks burden and increased mortality in implantable cardioverter-defibrillator patients. Heart Rhythm 2011;8:1881-1886.
21. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2008;117:2820-2840.