Document Type
Article
Publication Title
Circulation
Abstract
BACKGROUND: Substernal lead placement of the extravascular implantable cardioverter defibrillator (EV ICD) permits both defibrillation at thresholds similar to those seen with transvenous implantable cardioverter defibrillators and effective anti-tachycardia pacing (ATP) while avoiding the vasculature and associated complications. The global Pivotal study has shown the EV ICD system to be safe and effective through 6 months, but long-term experience has yet to be published. Our aim was to report the performance and safety of the EV ICD system throughout the study.
METHODS: The EV ICD Pivotal study was a prospective, global, single-arm, premarket clinical study. Individuals with a Class I or IIa indication for a single-chamber implantable cardioverter defibrillator per guidelines were enrolled. Freedom from major system- or procedure-related complications and appropriate and inappropriate therapy rates were assessed through 3 years with the Kaplan-Meier method. ATP success was calculated from simple proportions.
RESULTS: An implantation was attempted in 316 patients (25.3% female; 53.8±13.1 years of age; 81.6% primary prevention; left ventricular ejection fraction, 38.9±15.4%). Of 299 patients with a successful implantation, 24 experienced 82 spontaneous arrhythmic episodes that were appropriately treated with ATP only (38, 46.3%), shock only (34, 41.5%), or both (10, 12.2%) for a Kaplan-Meier-estimated rate of first any appropriate therapy of 9.2% at 3 years. ATP was successful in 77.1% (37/48) of episodes, and ATP use significantly increased from discharge to last follow-up visit (
CONCLUSIONS: From implantation to study completion, the EV ICD Pivotal study demonstrated that a single integrated system with an extravascular lead placed in the substernal space maintains high ATP success, effective defibrillation, and a consistent safety profile.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04060680.
First Page
322
Last Page
332
DOI
10.1161/CIRCULATIONAHA.124.071795
Publication Date
1-28-2025
Recommended Citation
Friedman, Paul; Murgatroyd, Francis; Boersma, Lucas V A; Manlucu, Jaimie; Knight, Bradley P; Clémenty, Nicolas; Leclercq, Christophe; Amin, Anish; Merkely, Béla; Birgersdotter-Green, Ulrika Maria; Chan, Joseph Yat Sun; Biffi, Mauro; Knops, Reinoud Elwin; Engel, Gregory; Muñoz Carvajal, Ignacio; Epstein, Laurence M; Sagi, Venkata; Johansen, Jens Brock; Sterliński, Maciej; Steinwender, Clemens; Hounshell, Troy; Abben, Richard; Thompson, Amy E; Zhang, Yan; Wiggenhorn, Christopher; Willey, Sarah; and Crozier, Ian, "Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study." (2025). Heart and Vascular Articles. 85.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/85