Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study
20 affiliations
- 1Department of Cardiology, St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands (L.V.A.B.).
- 2Department of Cardiology, Amsterdam University Medical Center, Amsterdam, North Holland, the Netherlands (L.V.A.B.).
- 3Heart Health and Cardiac Arrhythmias, Riverside Methodist Hospital, Columbus, OH (A.A.).
- 4Department of Cardiology, King’s College Hospital, London, United Kingdom (F.M.).
- 5I Klinika Zaburzeń Rytmu Serca, Narodowy Instytut Kardiologii, Warszawa, Masovian Voivodeship, Poland (M.S.).
- 6Department of Cardiology, Odense University Hospital, Odense, Syddanmark, Denmark (J.B.J.).
- 7Department of Cardiology and Medical Intensive Care, Kepler University Hospital, Linz, Upper Austria, Austria (K.S.).
- 8Department of Cardiovascular Medicine, University of Virginia School of Medicine, Charlottesville, VA (P.K.M., O.M.).
- 9Department of Cardiovascular Surgery, Hospital Universitario Reina Sofia, Cordoba, Cordoba, Spain (J.C.).
- 10Sutter Health, Redwood City, CA (G.E.).
- 11Department of Cardiology and Angiology, Hannover Medical School, Hannover, Lower Saxony, Germany (D.D.).
- 12University Heart Center, University Hospital Zurich, Zurich, Switzerland (A.B.).
- 13Heart and Vascular Specialists, Texas Health Harris Methodist Hospital, Fort Worth, TX (T.T.).
- 14Electrophysiology, Northwell Health, New Hyde Park, NY (L.M.E.).
- 15Cardiology Department, Medical Spectrum Twente, Enschede, Overijssel, the Netherlands (J.M.v.O.).
- 16Clinique du Millénaire, Montpellier, Occitania, France (N.C.).
- 17Division of Cardiology, Medical University of Vienna, Vienna, Austria (M.G.).
- 18Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Chugoku, Japan (N.N.).
- 19Cardiac Rhythm Management, Medtronic Inc, Mounds View, MN (C.W., J.D.L., J.L., A.E.T., T.R.H.).
- 20Department of Cardiology, Christchurch Hospital, Christchurch, Canterbury, New Zealand (I.C.).
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.
Related
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BibTeX
@article{boersma2026realworld,
title = {{Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study}},
author = {Lucas V.A. Boersma and Anish Amin and Francis Murgatroyd and Maciej Sterliński and Jens Brock Johansen and Karim Saleh and Pamela K. Mason and Jaime Casares and Gregory Engel and David Duncker and Alexander Breitenstein and Theodore Takata and Laurence M. Epstein and Jurren M. van Opstal and Nicolas Clémenty and Paul Friedman and Oliver Monfredi and Marianne Gwechenberger and Nobuhiro Nishii and Christopher Wiggenhorn and Jeff D. Lande and Jennifer Lee and Amy E. Thompson and Thomas R. Holmes and Ian Crozier},
journal = {Circulation},
year = {2026},
month = sep,
doi = {10.1161/circulationaha.126.080942},
url = {https://doi.org/10.1161/circulationaha.126.080942},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study
AU - Lucas V.A. Boersma
AU - Anish Amin
AU - Francis Murgatroyd
AU - Maciej Sterliński
AU - Jens Brock Johansen
AU - Karim Saleh
AU - Pamela K. Mason
AU - Jaime Casares
AU - Gregory Engel
AU - David Duncker
AU - Alexander Breitenstein
AU - Theodore Takata
AU - Laurence M. Epstein
AU - Jurren M. van Opstal
AU - Nicolas Clémenty
AU - Paul Friedman
AU - Oliver Monfredi
AU - Marianne Gwechenberger
AU - Nobuhiro Nishii
AU - Christopher Wiggenhorn
AU - Jeff D. Lande
AU - Jennifer Lee
AU - Amy E. Thompson
AU - Thomas R. Holmes
AU - Ian Crozier
PY - 2026
DA - 2026/09/22
JO - Circulation
DO - 10.1161/circulationaha.126.080942
UR - https://doi.org/10.1161/circulationaha.126.080942
AB - 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.
SN - 0009-7322
SN - 1524-4539
ER -