HealthDay News — For patients with an indication for an implantable cardioverter defibrillator (ICD) but no indication for pacing, subcutaneous ICD is noninferior to transvenous ICD, according to a study published in the Aug. 6 issue of the New England Journal of Medicine.

Reinoud E. Knops, M.D., Ph.D., from the University of Amsterdam, and colleagues conducted a noninferiority trial involving patients with an indication for an ICD but not for pacing who were randomly assigned to receive either a subcutaneous ICD or transvenous ICD (426 and 423 patients, respectively). The composite of device-related complications and inappropriate shocks was examined as the primary end point.

The researchers found that a primary end point event occurred in 68 patients in the subcutaneous ICD group and 68 in the transvenous ICD group at a median follow-up of 49.1 months (48-month Kaplan-Meier estimated cumulative incidence, 15.1 and 15.7 percent, respectively; hazard ratio, 0.99; 95 percent confidence interval, 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 and 44 patients in the subcutaneous and transvenous ICD groups, respectively (hazard ratio, 0.69; 95 percent confidence interval, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95 percent confidence interval, 0.89 to 2.30).

“The trial provides data to aid patients and providers in their shared decision making regarding ICD selection,” write the authors of an accompanying editorial.


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Several authors disclosed ties to pharmaceutical companies, including Boston Scientific, which supported the study.

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