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Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study
Key result
Extravascular ICDs demonstrate ~89% freedom from major system or procedure complications at one year.
- 95% CI 86.3-91.3
- n=787
Why the study?
A real-world assessment of the Aurora EV-ICD system, including its novel sensing discriminator, is needed to evaluate therapy efficacy and safety through 1 year.
Key Points
- Assess the real-world safety and therapy efficacy of the extravascular implantable cardioverter defibrillator through one year of follow-up.
- Conducted a prospective, global, interventional registry (NCT06048731) evaluating the Aurora extravascular implantable cardioverter defibrillator system.
- Enrolled 787 patients (mean age 49.1±15.2 years; 28.7% women; 34.1% secondary prevention) with implantation attempts by 168 implanters across real-world clinical sites.
- Assessed the primary safety endpoint of freedom from system- or procedure-related major complications and therapy efficacy at 1 year using the Kaplan-Meier method.
- Substernal tunneling and lead placement succeeded in 99.2% of patients (781/787), with 96.3% (758/787) remaining implanted, yielding a 1-year freedom from major complications of 89.1% (95% CI, 86.3%–91.3%).
- The 1-year rate of first appropriate therapy was 7.3% (95% CI, 5.5%–9.6%), with 100% shock success (61 of 61 spontaneous episodes) and 74.2% antitachycardia pacing success for monomorphic ventricular tachycardia.
- The 1-year rate of first inappropriate shock was 7.1% (95% CI, 5.4%–9.4%), primarily caused by noncardiac oversensing in 40.5% of inappropriately shocked episodes.
Study Design
Type
Cohort (n=787)
Multicenter
Yes
Structured PICO
P
Population
787 patients (mean age 49.1 years, 28.7% women) who underwent an extravascular implantable cardioverter defibrillator implantation attempt, followed for 1 year.
E
Exposure
Extravascular implantable cardioverter defibrillator (Aurora EV-ICD system) implantation
O
Outcome
Freedom from all system- or procedure-related major complications through 1 yearsafety
In a real-world global registry, the extravascular ICD demonstrated high implant success, effective antitachycardia pacing and shock therapy, and an acceptable safety profile at 1 year.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
DJDaniel J. FriedmanElectrophysiologist, Duke University Medical Center
“The primary results of the pivotal single arm EV-ICD trial reassuringly demonstrated acceptable rates of defibrillation efficacy and freedom from major system or procedure related complications, although inappropriate shocks occurred in 29 of 299 patients (9.7%) and the Kaplan-Meier estimate for inappropriate shocks was 8.5% at 6 months. This elevated rate of inappropriate shocks is similar to early reports of the S-ICD. Interestingly and in contrast with the S-ICD, PWOS was the most common adjudicated mechanism for inappropriate shocks.”
“We are seeing Aurora EV-ICD continue to perform as well in real-world settings as it did in the clinical trial, if not better in some areas. These longer-term outcomes demonstrate consistently strong performance across age groups. Based on the growing body of evidence, the Aurora EV-ICD should be a first-line consideration for patients who haven't had a prior sternotomy and don't require pacing but can benefit from a defibrillator.”
“The strong safety profile and consistent performance of the Aurora EV-ICD in real-world settings reinforces the benefit that patients are experiencing with a defibrillator outside of the vasculature that avoids unnecessary shocks. These real-world outcomes confirm the results observed in the Pivotal Trial showing high defibrillation and ATP success, a low system-related major complication rate, and a reduced rate of inappropriate shocks compared to the Pivotal Trial. We look forward to continued follow up of these patients out to five years.”
Implication
Real-world EV-ICD performance data remain limited; leaves open whether premarket safety and efficacy generalize to routine practice.
Abstract
BACKGROUND: The extravascular implantable cardioverter defibrillator (EV-ICD) was developed to provide defibrillation and antitachycardia pacing therapy without the need for intravascular lead placement. Premarket clinical trials reported EV-ICD safety and efficacy through 3 years, but a real-world assessment of the Aurora EV-ICD system, which includes a novel sensing discriminator, is needed. The objective of this analysis was to assess real-world therapy efficacy and safety of the EV-ICD through 1 year. METHODS: Enlighten: The EV-ICD Post Approval Registry is a prospective, global, real-world registry that included patients who underwent an EV-ICD implantation attempt. The main safety analysis was freedom from all system- or procedure-related major complications through 1 year. Event rates at 1 year were calculated using the Kaplan-Meier method. RESULTS: EV-ICD system implantation was attempted by 168 implanters in 787 patients (49.1±15.2 years old; 28.7% women; 34.1% secondary prevention). Tunneling and lead placement in the substernal space were achieved in 781 of 787 patients (99.2%), with 758 patients (96.3%) remaining implanted following defibrillation and electrical testing. One-year freedom from major system- or procedure-related complications was 89.1% (95% CI, 86.3%–91.3%). The 1-year rate of first appropriate therapy (shock, antitachycardia pacing, or both) was 7.3% (95% CI, 5.5–9.6). Shock success for discrete spontaneous episodes was 100% (61 of 61), and the generalized estimating equations antitachycardia pacing success rate, to account for multiple episodes per patient, was 74.2% for monomorphic ventricular tachycardia. The 1-year rate of first inappropriate shock was 7.1% (95% CI, 5.4–9.4), with noncardiac oversensing as the main cause (40.5% of inappropriately shocked episodes). CONCLUSIONS: In the largest prospective worldwide cohort of patients with an EV-ICD to date, both antitachycardia pacing and shock therapy were effective, while the rate of major complications agreed with the premarket experience through 1 year. These data demonstrate that positive outcomes of the EV-ICD are retained in everyday clinical practice in a large, global cohort with an expanded number of implanters. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06048731.
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Cite This Study
Boersma et al. (2026) conducted a cohort in Indication for implantable cardioverter defibrillator (n=787). Extravascular implantable cardioverter defibrillator (EV-ICD) was evaluated on Freedom from all system- or procedure-related major complications through 1 year (95% CI 86.3-91.3). The extravascular implantable cardioverter defibrillator demonstrated an 89.1% (95% CI, 86.3%-91.3%) freedom from major system- or procedure-related complications at 1 year in a real-world cohort.