Meta-analysis

Age and effectiveness of prophylactic implantable cardioverter-defibrillators

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

Research output: Contribution to journalArticle

113 Citations (Scopus)

Abstract

Background: Implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death have been proven effective in several clinical trials. Purpose: To summarize evidence about the effectiveness of ICDs versus standard medical therapy for the primary prevention of sudden cardiac death in different age groups of patients with severe left ventricular dysfunction. Data Sources: MEDLINE, Embase, CENTRAL, BioMed Central, Cardiosource, ClinicalTrials.gov, and ISI Web of Science (January 1970 to April 2010) were searched with no language restrictions. Study Selection: Two independent reviewers screened titles and abstracts to identify randomized, controlled trials of prophylactic ICD versus medical therapy in patients with severe left ventricular dysfunction that provided data about mortality outcomes for different age groups. Data Extraction: Two independent reviewers assessed risk for bias of trials and extracted patient and study characteristics and hazard ratios (HRs) relevant to all-cause mortality. Data Synthesis: Five trials (MADIT-II, DEFINITE, DINAMIT, SCDHeFT, and IRIS) that enrolled 5783 patients (44% were elderly) were included. The primary analysis, which excluded the 2 trials enrolling patients early after acute myocardial infarction (DINAMIT and IRIS), found that prophylactic ICD therapy reduced mortality in younger patients (HR, 0.65 [95% Cl, 0.50 to 0.83]; P < 0.001). A smaller and statistically nonsignificant survival benefit was found in elderly patients (HR, 0.81 [Cl, 0.62 to 1.05]; P = 0.11). The inclusion of data from DINAMIT and IRIS did not change these results. Limitations: Four potentially eligible trials were not included in the meta-analysis because mortality data by age group were not available. Adjustment for differences in comorbid conditions and medical therapies among patients enrolled in the trials was not possible. Conclusion: Available data do not conclusively show that prophylactic ICD therapy improves survival in elderly patients with severe left ventricular dysfunction. Primary Funding Source: None.

Original languageEnglish (US)
Pages (from-to)592-599
Number of pages8
JournalAnnals of Internal Medicine
Volume153
Issue number9
StatePublished - Nov 2 2010
Externally publishedYes

Fingerprint

Implantable Defibrillators
Meta-Analysis
Left Ventricular Dysfunction
Mortality
Age Groups
Sudden Cardiac Death
Primary Prevention
Therapeutics
Survival
Information Storage and Retrieval
MEDLINE
Language
Randomized Controlled Trials
Myocardial Infarction
Clinical Trials

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Santangeli, P., Di Biase, L., Dello Russo, A., Casella, M., Bartoletti, S., Santarelli, P., ... Natale, A. (2010). Meta-analysis: Age and effectiveness of prophylactic implantable cardioverter-defibrillators. Annals of Internal Medicine, 153(9), 592-599.

Meta-analysis : Age and effectiveness of prophylactic implantable cardioverter-defibrillators. / Santangeli, Pasquale; Di Biase, Luigi; Dello Russo, Antonio; Casella, Michela; Bartoletti, Stefano; Santarelli, Pietro; Pelargonio, Gemma; Natale, Andrea.

In: Annals of Internal Medicine, Vol. 153, No. 9, 02.11.2010, p. 592-599.

Research output: Contribution to journalArticle

Santangeli, P, Di Biase, L, Dello Russo, A, Casella, M, Bartoletti, S, Santarelli, P, Pelargonio, G & Natale, A 2010, 'Meta-analysis: Age and effectiveness of prophylactic implantable cardioverter-defibrillators', Annals of Internal Medicine, vol. 153, no. 9, pp. 592-599.
Santangeli P, Di Biase L, Dello Russo A, Casella M, Bartoletti S, Santarelli P et al. Meta-analysis: Age and effectiveness of prophylactic implantable cardioverter-defibrillators. Annals of Internal Medicine. 2010 Nov 2;153(9):592-599.
Santangeli, Pasquale ; Di Biase, Luigi ; Dello Russo, Antonio ; Casella, Michela ; Bartoletti, Stefano ; Santarelli, Pietro ; Pelargonio, Gemma ; Natale, Andrea. / Meta-analysis : Age and effectiveness of prophylactic implantable cardioverter-defibrillators. In: Annals of Internal Medicine. 2010 ; Vol. 153, No. 9. pp. 592-599.
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abstract = "Background: Implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death have been proven effective in several clinical trials. Purpose: To summarize evidence about the effectiveness of ICDs versus standard medical therapy for the primary prevention of sudden cardiac death in different age groups of patients with severe left ventricular dysfunction. Data Sources: MEDLINE, Embase, CENTRAL, BioMed Central, Cardiosource, ClinicalTrials.gov, and ISI Web of Science (January 1970 to April 2010) were searched with no language restrictions. Study Selection: Two independent reviewers screened titles and abstracts to identify randomized, controlled trials of prophylactic ICD versus medical therapy in patients with severe left ventricular dysfunction that provided data about mortality outcomes for different age groups. Data Extraction: Two independent reviewers assessed risk for bias of trials and extracted patient and study characteristics and hazard ratios (HRs) relevant to all-cause mortality. Data Synthesis: Five trials (MADIT-II, DEFINITE, DINAMIT, SCDHeFT, and IRIS) that enrolled 5783 patients (44{\%} were elderly) were included. The primary analysis, which excluded the 2 trials enrolling patients early after acute myocardial infarction (DINAMIT and IRIS), found that prophylactic ICD therapy reduced mortality in younger patients (HR, 0.65 [95{\%} Cl, 0.50 to 0.83]; P < 0.001). A smaller and statistically nonsignificant survival benefit was found in elderly patients (HR, 0.81 [Cl, 0.62 to 1.05]; P = 0.11). The inclusion of data from DINAMIT and IRIS did not change these results. Limitations: Four potentially eligible trials were not included in the meta-analysis because mortality data by age group were not available. Adjustment for differences in comorbid conditions and medical therapies among patients enrolled in the trials was not possible. Conclusion: Available data do not conclusively show that prophylactic ICD therapy improves survival in elderly patients with severe left ventricular dysfunction. Primary Funding Source: None.",
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AU - Santangeli, Pasquale

AU - Di Biase, Luigi

AU - Dello Russo, Antonio

AU - Casella, Michela

AU - Bartoletti, Stefano

AU - Santarelli, Pietro

AU - Pelargonio, Gemma

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