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Observational Study
. 2026 Jan;23(1):180-185.
doi: 10.1016/j.hrthm.2025.02.012. Epub 2025 Apr 2.

Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis

Ian Crozier  1 , Francis Murgatroyd  2 , Anish Amin  3 , Nicolas Clementy  4 , David Duncker  5 , Emily Kotschet  6 , Christopher Wiggenhorn  7 , Lucas V A Boersma  8
Affiliations
Observational Study

Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis

Ian Crozier et al. Heart Rhythm. 2026 Jan.

Abstract

Background: Premarket clinical trials have shown the extravascular implantable cardioverter-defibrillator (EV-ICD) system to provide effective therapy with a low complication rate, but its performance in the real world is unknown.

Objective: We report on the periprocedural safety and performance of the EV-ICD system from the postmarket Enlighten (EV-ICD Post-Approval Registry) Study.

Methods: Enlighten is an ongoing, global, prospective, postmarket registry study, enrolling patients guideline indicated for an ICD with a planned implantation of the Aurora EV-ICD system (Medtronic, Mounds View, MN). Procedure characteristics and outcomes, defibrillation testing details, system- or procedure-related major complications, electrical measurements, and pacing therapy programming through discharge were analyzed. A meta-analysis of premarket EV-ICD studies is included in the Supplemental Material for comparison with postmarket Enlighten Study data.

Results: In total, 228 Enlighten patients underwent an Aurora EV-ICD implant attempt (49.4 ± 15.4 years old; 27.9% female; 43.5 ± 16.1 mean left ventricular ejection fraction). Tunneling and substernal lead placement were successful in 227 of 228 (99.6%) patients. After electrical testing, 221 (96.9%) patients remained implanted with the EV-ICD and proceeded to follow-up. Defibrillation testing, if performed, was successful in 191 of 193 (99.0%) patients. The rate of system- or procedure-related major complications at discharge was 3.9%. Electrical measurements were stable at discharge.

Conclusion: In a global, real-world cohort, the EV-ICD system demonstrated a high success rate for terminating induced ventricular arrhythmia episodes at implant and a low rate of periprocedural major complications at discharge, comparable with the premarket experience.

Gov id: NCT06048731 (Enlighten Study: The EV-ICD Post-Approval Registry).

Keywords: Defibrillation testing; Extravascular implantable cardioverter-defibrillator; Postapproval; Sudden cardiac death; Ventricular tachycardia/fibrillation.

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Conflict of interest statement

Disclosures Dr Crozier has received research funding for the EV-ICD Pivotal study from Medtronic, grants from Medtronic for fellowship funding, and consulting fees from Medtronic. Dr Murgatroyd has received EV-ICD Pivotal study participation support, paid to his institution, from Medtronic; consulting fees from Medtronic for advisory board and steering committee participation; consulting fees from Boston Scientific for steering committee participation; and speaker fees from Medtronic. Dr Amin has received EV-ICD Pivotal Study participation support from Medtronic; an institutional grant from Biosense Webster; consulting fees from Medtronic, Boston Scientific, Biosense Webster, Atricure, and Philips; honoraria from Medtronic, Boston Scientific, Biosense Webster, Atricure, and Philips; travel support from Boston Scientific, Medtronic, and Philips; and has had advisory board participation at Boston Scientific, Medtronic, Atricure, and Philips. Dr Clementy has received consulting fees, honoraria, travel support, and has had advisory board participation at Medtronic. Dr Duncker has received lecture honoraria, travel grants, and/or fellowship grants from Abbott, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Medtronic, Microport, Pfizer, Sanofi, and Zoll. Dr Kotschet has received consultation fees from Medtronic, Inc. Dr Wiggenhorn is an employee of Medtronic Inc; Dr Boersma has received EV-ICD Pivotal study participation support, paid to his institution, from Medtronic, and consulting fees and grant support from Medtronic and Boston Scientific, paid to the cardiology department at his institution.

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