AIMS: This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted withdual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced. METHODS AND RESULTS: Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated. CONCLUSION: In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.
RCT Entities:
AIMS: This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced. METHODS AND RESULTS:Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated. CONCLUSION: In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.
Authors: Emily P Zeitler; Gillian D Sanders; Kavisha Singh; Ruth Ann Greenfield; Anne M Gillis; Bruce L Wilkoff; Jonathan P Piccini; Sana M Al-Khatib Journal: Europace Date: 2018-10-01 Impact factor: 5.214
Authors: Dan D Matlock; Pamela N Peterson; Yongfei Wang; Jeptha P Curtis; Matthew R Reynolds; Paul D Varosy; Frederick A Masoudi Journal: Arch Intern Med Date: 2012-04-23
Authors: Sana M Al-Khatib; Jennifer M Gierisch; Matthew J Crowley; Remy R Coeytaux; Evan R Myers; Amy Kendrick; Gillian D Sanders Journal: J Gen Intern Med Date: 2015-12 Impact factor: 5.128
Authors: Pamela N Peterson; Paul D Varosy; Paul A Heidenreich; Yongfei Wang; Thomas A Dewland; Jeptha P Curtis; Alan S Go; Robert T Greenlee; David J Magid; Sharon-Lise T Normand; Frederick A Masoudi Journal: JAMA Date: 2013-05-15 Impact factor: 56.272