EP News: Clinical

Published:September 02, 2022DOI:
      Friedman et al (N Engl J Med August 28, 2022; doi: 10.1056/NEJMoa2206485, PMID 36036522) conducted a prospective, nonrandomized, clinical study of an extravascular implantable cardioverter-defibrillator (ICD). The primary efficacy end point was successful defibrillation at implantation. The primary safety end point was freedom from major complications at 6 months. Among the 302 patients who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7%. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6%. No major intraprocedural complications were reported. At 6 months, 25 major complications were observed in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing was 50.8%. A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement. The authors conclude that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation.
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