Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study
Lucas V.A. Boersma, Anish Amin, Francis Murgatroyd, Maciej Sterliński, Jens Brock Johansen, Karim Saleh, Pamela K. Mason, Jaime Casares, Gregory Engel, David Duncker, Alexander Breitenstein, Theodore Takata, Laurence M. Epstein, Jurren M. van Opstal, Nicolas Clémenty, Paul Friedman, Oliver Monfredi, Marianne Gwechenberger, Nobuhiro Nishii, Christopher Wiggenhorn, Jeff D. Lande, Jennifer Lee, Amy E. Thompson, Thomas R. Holmes, Ian Crozier,BACKGROUND:
The extravascular implantable cardioverter defibrillator (EV-ICD) was developed to provide defibrillation and antitachycardia pacing therapy without the need for intravascular lead placement. Premarket clinical trials reported EV-ICD safety and efficacy through 3 years, but a real-world assessment of the Aurora EV-ICD system, which includes a novel sensing discriminator, is needed. The objective of this analysis was to assess real-world therapy efficacy and safety of the EV-ICD through 1 year.
METHODS:
Enlighten: The EV-ICD Post Approval Registry is a prospective, global, real-world registry that included patients who underwent an EV-ICD implantation attempt. The main safety analysis was freedom from all system- or procedure-related major complications through 1 year. Event rates at 1 year were calculated using the Kaplan-Meier method.
RESULTS:
EV-ICD system implantation was attempted by 168 implanters in 787 patients (49.1±15.2 years old; 28.7% women; 34.1% secondary prevention). Tunneling and lead placement in the substernal space were achieved in 781 of 787 patients (99.2%), with 758 patients (96.3%) remaining implanted following defibrillation and electrical testing. One-year freedom from major system- or procedure-related complications was 89.1% (95% CI, 86.3%–91.3%). The 1-year rate of first appropriate therapy (shock, antitachycardia pacing, or both) was 7.3% (95% CI, 5.5–9.6). Shock success for discrete spontaneous episodes was 100% (61 of 61), and the generalized estimating equations antitachycardia pacing success rate, to account for multiple episodes per patient, was 74.2% for monomorphic ventricular tachycardia. The 1-year rate of first inappropriate shock was 7.1% (95% CI, 5.4–9.4), with noncardiac oversensing as the main cause (40.5% of inappropriately shocked episodes).
CONCLUSIONS:
In the largest prospective worldwide cohort of patients with an EV-ICD to date, both antitachycardia pacing and shock therapy were effective, while the rate of major complications agreed with the premarket experience through 1 year. These data demonstrate that positive outcomes of the EV-ICD are retained in everyday clinical practice in a large, global cohort with an expanded number of implanters.
REGISTRATION:
URL: