Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study.
Extravascular implantable cardioverter defibrillators (EV-ICDs) show 89.1% one-year freedom from major complications in a large global cohort.
- Why it matters: Understanding real-world safety and efficacy of EV-ICDs is crucial as premarket trials only cover limited periods and controlled settings, leaving a gap in long-term, practical data.
- What they did: The study prospectively followed 787 patients across multiple centers, assessing complication rates, therapy effectiveness, and sensing accuracy over one year using the Aurora EV-ICD system.
- The result: Findings confirm high safety and effectiveness, with 7.3% experiencing appropriate therapy and 7.1% receiving inappropriate shocks, supporting EV-ICD use in everyday clinical practice.