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 P, Murgatroyd F, Boersma LVA, Manlucu J, Knight BP, Clémenty N, Leclercq C, Amin A, Merkely B, Birgersdotter-Green UM, Chan JYS, Biffi M, Knops RE, Engel G, Muñoz Carvajal I, Epstein LM, Sagi V, Johansen JB, Sterliński M, Steinwender C, Hounshell T, Abben R, Thompson AE, Zhang Y, Wiggenhorn C, Willey S, Crozier I; Extravascular ICD Pivotal Study Investigators. Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study. Circulation. 2025 Jan 28;151(4):322-332. doi: 10.1161/CIRCULATIONAHA.124.071795. Epub 2024 Sep 26. PMID: 39327797; PMCID: PMC11771354.