• Michalina Kolodziejczak, Felicita Andreotti, Mariusz Kowalewski, Antonino Buffon, Marco Matteo Ciccone, Gianfranco Parati, Pietro Scicchitano, Julia M Uminska, Stefano De Servi, Kevin P Bliden, Jacek Kubica, Alessandro Bortone, Filippo Crea, Paul Gurbel, and Eliano P Navarese.
• From Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Collegium Medicum in Bydgoszcz, Dr Antoni Jurasz Memorial University Hospital, and Nicolaus Copernicus University, Bydgoszcz, Poland; University of Nicolaus Copernicus, Torun, Poland; Catholic University, Rome, Italy; University of Bari, Bari, Italy; Inova Heart and Vascular Institute and SIRIO MEDICINE Research Network, Falls Church, Virginia; and George Mason University, Fairfax, Virginia.
• Ann. Intern. Med. 2017 Jul 18; 167 (2): 103-111.

BackgroundImplantable cardioverter-defibrillators (ICDs) have a role in preventing cardiac arrest in patients at risk for life-threatening ventricular arrhythmias.PurposeTo compare ICD therapy with conventional care for the primary prevention of death of various causes in adults with ischemic or nonischemic cardiomyopathy.Data SourcesMEDLINE, Cochrane Central Register of Controlled Trials, Google Scholar, and EMBASE databases, as well as several Web sites, from 1 April 1976 through 31 March 2017.Study SelectionRandomized controlled trials, published in any language, comparing ICD therapy with conventional care and reporting mortality outcomes (all-cause, sudden, any cardiac, or noncardiac) in the primary prevention setting.Data Extraction2 independent investigators extracted study data and assessed risk of bias.Data SynthesisIncluded were 11 trials involving 8716 patients: 4 (1781 patients) addressed nonischemic cardiomyopathy, 6 (4414 patients) ischemic cardiomyopathy, and 1 (2521 patients) both types of cardiomyopathy. Mean follow-up was 3.2 years. An overall reduction in all-cause mortality, from 28.26% with conventional care to 21.37% with ICD therapy (hazard ratio [HR], 0.81 [95% CI, 0.70 to 0.94]; P = 0.043), was found. The magnitude of reduction was similar in the cohorts with nonischemic (HR, 0.81 [CI, 0.72 to 0.91]) and ischemic (HR, 0.82 [CI, 0.63 to 1.06]) disease, although the latter estimate did not reach statistical significance. The rate of sudden death fell from 12.15% with conventional care to 4.39% with ICD therapy (HR, 0.41 [CI, 0.30 to 0.56]), with a similar magnitude of reduction in patients with ischemic (HR, 0.39 [CI, 0.23 to 0.68]) and those with nonischemic disease (HR, 0.44 [CI, 0.17 to 1.12]). Noncardiac and any cardiac deaths did not differ significantly by treatment.LimitationHeterogeneous timing of ICD placement; heterogeneous pharmacologic and resynchronization co-interventions; trials conducted in different eras; adverse events and complications not reviewed.ConclusionOverall, primary prevention with ICD therapy versus conventional care reduced the incidence of sudden and all-cause death.Primary Funding SourceNone.

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