Gender differences in clinical outcome and primary prevention defibrillator benefit in patients with severe left ventricular dysfunction

A systematic review and meta-analysis

Pasquale Santangeli, Gemma Pelargonio, Antonio Dello Russo, Michela Casella, Caterina Bisceglia, Stefano Bartoletti, Pietro Santarelli, Luigi Di Biase, Andrea Natale

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Background: Women are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial. Objective: The purpose of this study was to better evaluate the benefit of prophylactic ICD in women by performing a meta-analysis of primary prevention ICD trials that assessed gender differences on the end-points of total mortality, appropriate ICD intervention, and survival benefit of ICD compared with placebo. Methods: PubMed, CENTRAL, and other databases were searched in October 2009. Studies were included only if they examined gender differences in the specified end-points, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables. Results: We retrieved five studies (MADIT-II, MUSTT, SCD-HeFT, DEFINITE, COMPANION) that enrolled 7,229 patients (22% women) with dilated cardiomyopathy (74% ischemic). Compared to men, women had no significant difference in overall mortality (HR 0.96, 95% confidence interval [CI] 0.67-1.39, P = .84) but experienced significantly less appropriate ICD interventions (HR 0.63, 95% CI 0.49-0.82, P ≤.001). The benefit of ICD on mortality was significantly higher in men (HR 0.67, 95% CI 0.58-0.78, P <.001) but did not reach statistical significance in women (HR 0.78, 95% CI 0.57-1.05, P = .1). Conclusion: Women enrolled in primary prevention ICD trials have the same mortality compared to men while experiencing significantly less appropriate ICD interventions, thus suggesting a smaller impact of sudden cardiac death on overall mortality in women with dilated cardiomyopathy. These findings may explain the smaller ICD survival benefit among women.

Original languageEnglish (US)
Pages (from-to)876-882
Number of pages7
JournalHeart Rhythm
Volume7
Issue number7
DOIs
StatePublished - Jul 2010
Externally publishedYes

Fingerprint

Defibrillators
Implantable Defibrillators
Left Ventricular Dysfunction
Primary Prevention
Meta-Analysis
Mortality
Confidence Intervals
Dilated Cardiomyopathy
Confounding Factors (Epidemiology)
Survival
Sudden Cardiac Death
PubMed
Placebos
Regression Analysis
Databases

Keywords

  • Dilated cardiomyopathy
  • Gender differences
  • Implantable cardioverter-defibrillator
  • Sudden cardiac death

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Gender differences in clinical outcome and primary prevention defibrillator benefit in patients with severe left ventricular dysfunction : A systematic review and meta-analysis. / Santangeli, Pasquale; Pelargonio, Gemma; Russo, Antonio Dello; Casella, Michela; Bisceglia, Caterina; Bartoletti, Stefano; Santarelli, Pietro; Di Biase, Luigi; Natale, Andrea.

In: Heart Rhythm, Vol. 7, No. 7, 07.2010, p. 876-882.

Research output: Contribution to journalArticle

Santangeli, Pasquale ; Pelargonio, Gemma ; Russo, Antonio Dello ; Casella, Michela ; Bisceglia, Caterina ; Bartoletti, Stefano ; Santarelli, Pietro ; Di Biase, Luigi ; Natale, Andrea. / Gender differences in clinical outcome and primary prevention defibrillator benefit in patients with severe left ventricular dysfunction : A systematic review and meta-analysis. In: Heart Rhythm. 2010 ; Vol. 7, No. 7. pp. 876-882.
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abstract = "Background: Women are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial. Objective: The purpose of this study was to better evaluate the benefit of prophylactic ICD in women by performing a meta-analysis of primary prevention ICD trials that assessed gender differences on the end-points of total mortality, appropriate ICD intervention, and survival benefit of ICD compared with placebo. Methods: PubMed, CENTRAL, and other databases were searched in October 2009. Studies were included only if they examined gender differences in the specified end-points, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables. Results: We retrieved five studies (MADIT-II, MUSTT, SCD-HeFT, DEFINITE, COMPANION) that enrolled 7,229 patients (22{\%} women) with dilated cardiomyopathy (74{\%} ischemic). Compared to men, women had no significant difference in overall mortality (HR 0.96, 95{\%} confidence interval [CI] 0.67-1.39, P = .84) but experienced significantly less appropriate ICD interventions (HR 0.63, 95{\%} CI 0.49-0.82, P ≤.001). The benefit of ICD on mortality was significantly higher in men (HR 0.67, 95{\%} CI 0.58-0.78, P <.001) but did not reach statistical significance in women (HR 0.78, 95{\%} CI 0.57-1.05, P = .1). Conclusion: Women enrolled in primary prevention ICD trials have the same mortality compared to men while experiencing significantly less appropriate ICD interventions, thus suggesting a smaller impact of sudden cardiac death on overall mortality in women with dilated cardiomyopathy. These findings may explain the smaller ICD survival benefit among women.",
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AU - Pelargonio, Gemma

AU - Russo, Antonio Dello

AU - Casella, Michela

AU - Bisceglia, Caterina

AU - Bartoletti, Stefano

AU - Santarelli, Pietro

AU - Di Biase, Luigi

AU - Natale, Andrea

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N2 - Background: Women are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial. Objective: The purpose of this study was to better evaluate the benefit of prophylactic ICD in women by performing a meta-analysis of primary prevention ICD trials that assessed gender differences on the end-points of total mortality, appropriate ICD intervention, and survival benefit of ICD compared with placebo. Methods: PubMed, CENTRAL, and other databases were searched in October 2009. Studies were included only if they examined gender differences in the specified end-points, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables. Results: We retrieved five studies (MADIT-II, MUSTT, SCD-HeFT, DEFINITE, COMPANION) that enrolled 7,229 patients (22% women) with dilated cardiomyopathy (74% ischemic). Compared to men, women had no significant difference in overall mortality (HR 0.96, 95% confidence interval [CI] 0.67-1.39, P = .84) but experienced significantly less appropriate ICD interventions (HR 0.63, 95% CI 0.49-0.82, P ≤.001). The benefit of ICD on mortality was significantly higher in men (HR 0.67, 95% CI 0.58-0.78, P <.001) but did not reach statistical significance in women (HR 0.78, 95% CI 0.57-1.05, P = .1). Conclusion: Women enrolled in primary prevention ICD trials have the same mortality compared to men while experiencing significantly less appropriate ICD interventions, thus suggesting a smaller impact of sudden cardiac death on overall mortality in women with dilated cardiomyopathy. These findings may explain the smaller ICD survival benefit among women.

AB - Background: Women are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial. Objective: The purpose of this study was to better evaluate the benefit of prophylactic ICD in women by performing a meta-analysis of primary prevention ICD trials that assessed gender differences on the end-points of total mortality, appropriate ICD intervention, and survival benefit of ICD compared with placebo. Methods: PubMed, CENTRAL, and other databases were searched in October 2009. Studies were included only if they examined gender differences in the specified end-points, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables. Results: We retrieved five studies (MADIT-II, MUSTT, SCD-HeFT, DEFINITE, COMPANION) that enrolled 7,229 patients (22% women) with dilated cardiomyopathy (74% ischemic). Compared to men, women had no significant difference in overall mortality (HR 0.96, 95% confidence interval [CI] 0.67-1.39, P = .84) but experienced significantly less appropriate ICD interventions (HR 0.63, 95% CI 0.49-0.82, P ≤.001). The benefit of ICD on mortality was significantly higher in men (HR 0.67, 95% CI 0.58-0.78, P <.001) but did not reach statistical significance in women (HR 0.78, 95% CI 0.57-1.05, P = .1). Conclusion: Women enrolled in primary prevention ICD trials have the same mortality compared to men while experiencing significantly less appropriate ICD interventions, thus suggesting a smaller impact of sudden cardiac death on overall mortality in women with dilated cardiomyopathy. These findings may explain the smaller ICD survival benefit among women.

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KW - Gender differences

KW - Implantable cardioverter-defibrillator

KW - Sudden cardiac death

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