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New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials.

Publication ,  Conference
Friedman, DJ; Al-Khatib, SM; Zeitler, EP; Han, J; Bardy, GH; Poole, JE; Bigger, JT; Buxton, AE; Moss, AJ; Lee, KL; Steinman, R; Dorian, P ...
Published in: Am Heart J
September 2017

BACKGROUND: Primary prevention implantable cardioverter defibrillator (ICD) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure derive ICD benefit owing to the competing risk of nonsudden death. METHODS: We performed a patient-level meta-analysis of New York Heart Association (NYHA) class II/III heart failure patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian-Weibull survival regression models were used to assess the impact of NYHA class on the relationship between ICD use and mortality. RESULTS: Of the 2,763 patients who met study criteria, 68% (n=1,867) were NYHA II and 52% (n=1,435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality (hazard ratio [HR] 0.65, 95% posterior credibility interval [PCI]) 0.40-0.99). The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35-0.85), and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48-1.24), although this was not statistically significant. CONCLUSIONS: Primary prevention ICDs reduce mortality in NYHA class II patients and trend toward reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

September 2017

Volume

191

Start / End Page

21 / 29

Location

United States

Related Subject Headings

  • Survival Rate
  • Societies, Medical
  • Randomized Controlled Trials as Topic
  • Primary Prevention
  • New York
  • Humans
  • Heart Failure
  • Global Health
  • Defibrillators, Implantable
  • Death, Sudden, Cardiac
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Friedman, D. J., Al-Khatib, S. M., Zeitler, E. P., Han, J., Bardy, G. H., Poole, J. E., … Sanders, G. D. (2017). New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials. In Am Heart J (Vol. 191, pp. 21–29). United States. https://doi.org/10.1016/j.ahj.2017.06.002
Friedman, Daniel J., Sana M. Al-Khatib, Emily P. Zeitler, JooYoon Han, Gust H. Bardy, Jeanne E. Poole, J Thomas Bigger, et al. “New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials.” In Am Heart J, 191:21–29, 2017. https://doi.org/10.1016/j.ahj.2017.06.002.
Friedman DJ, Al-Khatib SM, Zeitler EP, Han J, Bardy GH, Poole JE, Bigger JT, Buxton AE, Moss AJ, Lee KL, Steinman R, Dorian P, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Inoue LYT, Sanders GD. New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials. Am Heart J. 2017. p. 21–29.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

September 2017

Volume

191

Start / End Page

21 / 29

Location

United States

Related Subject Headings

  • Survival Rate
  • Societies, Medical
  • Randomized Controlled Trials as Topic
  • Primary Prevention
  • New York
  • Humans
  • Heart Failure
  • Global Health
  • Defibrillators, Implantable
  • Death, Sudden, Cardiac