TOPLINE

Patients implanted with an extravascular implantable cardioverter defibrillator (EV-ICD) had all discrete spontaneous ventricular tachycardia/ventricular fibrillation episodes successfully terminated by shock therapy through 1 year, with freedom from major complications being 89.1%.

METHODOLOGY

• The Aurora EV-ICD is a defibrillator with a substernal lead placed outside the blood vessels, and it uses a discriminator to cut down inappropriate shocks caused by P-wave oversensing.
• The Enlighten study was a global, prospective postapproval registry conducted across 23 countries between September 2023 and March 2025, evaluating real-world safety and effectiveness of the Aurora EV-ICD.
• Researchers reported findings from 787 patients who underwent an EV-ICD implantation attempt. The mean age of patients was 49.1 years, 28.7% were women, and 34.1% had an indication for secondary prevention.
• Overall safety was determined as freedom from all major complications related to the device or procedure over a period of 1 year. Other assessments included the success rate of shocks and antitachycardia pacing for discrete spontaneous ventricular tachycardia or ventricular fibrillation.
• The mean clinical follow-up duration was 10.5 months for patients still implanted, and the mean device follow-up duration was 12.9 months for 706 patients with available device data.

TAKEAWAY

• Tunneling and placement of lead were successful in 99.2% of patients, and a system remained in place for 96.3% after electrical and defibrillation testing.
• By 1 year, the estimated rate of any first appropriate therapy was 7.3%, and the estimated rate of first inappropriate shock was 7.1% in 706 patients with device data.
• An appropriate shock terminated all discrete spontaneous episodes of ventricular tachycardia or ventricular fibrillation (first-shock success, 93.4%), while antitachycardia pacing was successfully given in 74.2% of monomorphic ventricular tachycardia episodes, avoiding shocks in 22 patients.
• The estimated 1-year freedom from major complications related to the device or procedure was 89.1%; 5.7% of patients underwent system revision or removal. Of 16 deaths, none were device-related (three undetermined), yielding an estimated 1-year freedom from all-cause mortality of 97.1%.

IN PRACTICE

"The EV-ICD system provides a clinically impactful therapeutic option for sudden cardiac death prevention for both primary and secondary prevention patients who do not require bradycardia pacing," the researchers wrote.

SOURCE

The study was led by Lucas V.A. Boersma, MD, PhD, of St Antonius Hospital in Nieuwegein, Netherlands. It was published online on September 22 in Circulation.

LIMITATIONS

The study was not randomized and had no comparison to other ICDs or standard treatment. The registry lacked a prespecified protocol for testing. Follow-up lasted for only 1 year, and the complete 12-month follow-up data were absent for many patients.

DISCLOSURES

The study received funding from Medtronic Inc. Several authors reported receiving consulting fees, honoraria, research support, or grants and having other financial ties with Medtronic and other medical device companies. Multiple authors reported being employees of Medtronic. Detailed author disclosures are reported in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.