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Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.

Publication ,  Journal Article
Steinberg, BA; Al-Khatib, SM; Edwards, R; Han, J; Bardy, GH; Bigger, JT; Buxton, AE; Moss, AJ; Lee, KL; Steinman, R; Dorian, P; Hallstrom, A ...
Published in: JACC Heart Fail
December 2014

OBJECTIVES: The aim of this study was to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. BACKGROUND: Primary prevention ICDs improve survival in patients at risk for sudden cardiac death. Their benefit in patients with significant comorbid illness has not been demonstrated. METHODS: Original, patient-level datasets from MADIT I (Multicenter Automatic Defibrillator Implantation Trial I), MADIT II, DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were combined. Patients in the combined population (N = 3,348) were assessed with respect to the following comorbidities: smoking, pulmonary disease, diabetes, peripheral vascular disease, atrial fibrillation, ischemic heart disease, and chronic kidney disease. The primary outcome was overall mortality, using the hazard ratio (HR) of time to death for patients receiving an ICD versus no ICD by extent of medical comorbidity, and adjusted for age, sex, race, left ventricular ejection fraction, use of antiarrhythmic drugs, beta-blockers, and angiotensin-converting enzyme inhibitors. RESULTS: Overall, 25% of patients (n = 830) had <2 comorbid conditions versus 75% (n = 2,518) with significant comorbidity (≥2). The unadjusted hazard of death for patients with an ICD versus no ICD was significantly lower, but this effect was less for patients with ≥2 comorbidities (unadjusted HR: 0.71; 95% confidence interval: 0.61 to 0.84) compared with those with <2 comorbidities (unadjusted HR: 0.59; 95% confidence interval: 0.40 to 0.87). After adjustment, the benefit of an ICD decreased with increasing number of comorbidities (p = 0.004). CONCLUSIONS: Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex patients is warranted.

Duke Scholars

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Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

December 2014

Volume

2

Issue

6

Start / End Page

623 / 629

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Randomized Controlled Trials as Topic
  • Prospective Studies
  • Primary Prevention
  • Multicenter Studies as Topic
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
 

Citation

APA
Chicago
ICMJE
MLA
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Steinberg, B. A., Al-Khatib, S. M., Edwards, R., Han, J., Bardy, G. H., Bigger, J. T., … Sanders, G. D. (2014). Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials. JACC Heart Fail, 2(6), 623–629. https://doi.org/10.1016/j.jchf.2014.06.007
Steinberg, Benjamin A., Sana M. Al-Khatib, Rex Edwards, JooYoon Han, Gust H. Bardy, J Thomas Bigger, Alfred E. Buxton, et al. “Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.JACC Heart Fail 2, no. 6 (December 2014): 623–29. https://doi.org/10.1016/j.jchf.2014.06.007.
Steinberg BA, Al-Khatib SM, Edwards R, Han J, Bardy GH, Bigger JT, et al. Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials. JACC Heart Fail. 2014 Dec;2(6):623–9.
Steinberg, Benjamin A., et al. “Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.JACC Heart Fail, vol. 2, no. 6, Dec. 2014, pp. 623–29. Pubmed, doi:10.1016/j.jchf.2014.06.007.
Steinberg BA, Al-Khatib SM, Edwards R, Han J, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Steinman R, Dorian P, Hallstrom A, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Inoue LYT, Sanders GD. Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials. JACC Heart Fail. 2014 Dec;2(6):623–629.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

December 2014

Volume

2

Issue

6

Start / End Page

623 / 629

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke Volume
  • Randomized Controlled Trials as Topic
  • Prospective Studies
  • Primary Prevention
  • Multicenter Studies as Topic
  • Middle Aged
  • Male
  • Humans
  • Heart Failure