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

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).