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Original Investigation |

Association Between Prophylactic Implantable Cardioverter-Defibrillators and Survival in Patients With Left Ventricular Ejection Fraction Between 30% and 35%

Sana M. Al-Khatib, MD, MHS1,3; Anne S. Hellkamp, MS1; Gregg C. Fonarow, MD5; Daniel B. Mark, MD, MPH1,3; Lesley H. Curtis, PhD1,2,4; Adrian F. Hernandez, MD, MHS1,3; Kevin J. Anstrom, PhD1; Eric D. Peterson, MD, MPH1,3; Gillian D. Sanders, PhD1; Hussein R. Al-Khalidi, PhD1; Bradley G. Hammill, MS1; Paul A. Heidenreich, MD6; Stephen C. Hammill, MD1,2,7
[+] Author Affiliations
1Duke Clinical Research Institute, Department of Medicine, Duke University Medical Center, Durham, North Carolina
2Center for Clinical and Genetic Economics, Department of Medicine, Duke University Medical Center, Durham, North Carolina
3Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina
4Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, North Carolina
5Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, California
6Stanford University, Palo Alto Veteran’s Health Care System, Palo Alto, California
7Mayo Clinic, Rochester, Minnesota
JAMA. 2014;311(21):2209-2215. doi:10.1001/jama.2014.5310.
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Importance  Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are implanted in such patients, it is important to study survival associated with this therapy.

Objective  To characterize patients with LVEF between 30% and 35% and compare the survival of those with and without ICDs.

Design, Setting, and Participants  Retrospective cohort study of Medicare beneficiaries in the National Cardiovascular Data Registry ICD registry (January 1, 2006, through December 31, 2007) with an LVEF between 30% and 35% who received an ICD during a heart failure hospitalization and similar patients in the Get With The Guidelines–Heart Failure (GWTG-HF) database (January 1, 2005, through December 31, 2009) with no ICD. The analysis was repeated in patients with an LVEF less than 30%. There were 3120 patients with an LVEF between 30% and 35% (816 in matched cohorts) and 4578 with an LVEF less than 30% (2176 in matched cohorts). Propensity score matching and Cox models were applied.

Main Outcomes and Measures  The primary outcome was all-cause mortality; data were obtained from Medicare claims through December 31, 2011.

Results  There were no significant differences in the baseline characteristics of the matched groups (n = 408 for both groups). Among patients with an LVEF between 30% and 35%, there were 248 deaths in the ICD Registry group, within a median follow-up of 4.4 years (interquartile range, 2.7-4.9) and 249 deaths in the GWTG HF group, within a median follow-up of 2.9 years (interquartile range, 2.1-4.4). The risk of all-cause mortality in patients with an LVEF between 30% and 35% and an ICD was significantly lower than that in matched patients without an ICD (3-year mortality rates: 51.4% vs 55.0%; hazard ratio, 0.83 [95% CI, 0.69-0.99]; P = .04). Presence of an ICD also was associated with better survival in patients with an LVEF less than 30% (3-year mortality rates: 45.0% vs 57.6%; 634 and 660 total deaths; hazard ratio, 0.72 [95% CI, 0.65-0.81]; P < .001) (P = .20 for interaction).

Conclusions and Relevance  Among Medicare beneficiaries hospitalized for heart failure and with an LVEF between 30% and 35% and less than 30%, survival at 3 years was better in patients who received a prophylactic ICD than in comparable patients with no ICD. These findings support guideline recommendations to implant prophylactic ICDs in eligible patients with an LVEF of 35% or less.

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Figure.
Unadjusted Kaplan-Meier Estimates of Mortality, and Cox Model-Derived Adjusted Mortality Rates, for Patients With an LVEF Between 30% and 35% With and Without an Implantable Cardioverter-Defibrillator (ICD)

Adjusted rates, hazard ratios, and P values are from Cox models that include age, sex, race, left ventricular ejection fraction, ischemic heart disease, prior atrial arrhythmia, systolic blood pressure, diabetes, hypertension, and baseline use of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, digoxin, diuretic, or statin.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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