Trial reportCirculation2025
Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study.
Trial report in Circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04060680 (Extravascular ICD Pivotal Study), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Extravascular ICD Pivotal Study (EV ICD)
Who cites it
44 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Retrosternal extravascular implantable cardioverter-defibrillators: a systematic review of implant characteristics, defibrillation testing, and acute safety.Future cardiology · 2026Pooled it
- One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator.Circulation. Arrhythmia and electrophysiology · 2026Trial
- Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Trial
- Beyond one-size-fits-all: personalized selection of contemporary implantable cardioverter-defibrillator therapies.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Review
- Athletes with Implantable Cardioverter-Defibrillators: A Practical Framework for Device Selection, Programming, and Return-to-Sport Risk Mitigation.Journal of clinical medicine · 2026Review
- Safety and Efficacy of the Extravascular Implantable Cardioverter-Defibrillator (EV-ICD) in Japanese Patients: Final Results From the EV ICD Japan Study.Circulation reports · 2026Article
- Similarities and Differences Between the Extravascular and the Subcutaneous Implantable Cardioverter-Defibrillator: Clinical Selection and Implantation (Part 1).Current cardiology reports · 2026Review
- Cardiac implantable electronic devices in heart failure: needs, challenges, and real-world implementation.Heart failure reviews · 2026Review
- Innovations in cardiac device therapy in the era of advanced rhythm management: implantable defibrillators and conduction system pacing.Heart (British Cardiac Society) · 2026Review
- Extravascular implantable cardioverter defibrillator lead fracture and challenges with revision.HeartRhythm case reports · 2026Article
- Initial Experience of the Medtronic Aurora Extravascular Implantable Cardioverter in Children in a UK Centre.Pediatric cardiology · 2026Article
- First Reported Extravascular-ICD Insertion in a Patient With Prior Sternotomy for Valvular Surgery.JACC. Case reports · 2026Article
- Extravascular Implantable Cardioverter-Defibrillator Therapy for Malignant Ventricular Arrhythmias in a Child with Congenital Long QT Syndrome: A Case Report.Journal of cardiovascular development and disease · 2026Article
- Extravascular implantable cardioverter-defibrillator implantation strategies following transvenous or subcutaneous device infections: a case series.European heart journal. Case reports · 2026Article
- Article
- An Individualized Right-to-Left Tunneling "Bail-Out" for Complex ICD Upgrade in a Pacemaker-Dependent Patient: A Case Report and Literature Review.Journal of personalized medicine · 2026Review
- CT-guided lead placement prevents P-wave oversensing in extravascular ICD.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Single-Pocket-Incision Generator Exchange From a Subcutaneous to an Extravascular Implantable Cardioverter-Defibrillator.Journal of arrhythmia · 2026Article
- Preservation of an extravascular implantable cardioverter-defibrillator during sternotomy and surgical myectomy.HeartRhythm case reports · 2026Article
- Extravascular versus subcutaneous ICD: a propensity score-matched analysis of procedural outcomes.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSubsternal lead placement of the extravascular implantable cardioverter defibrillator (EV ICD) permits both defibrillation at thresholds similar to those seen with transvenous implantable cardioverter defibrillators and effective anti-tachycardia pacing (ATP) while avoiding the vasculature and associated complications. The global Pivotal study has shown the EV ICD system to be safe and effective through 6 months, but long-term experience has yet to be published. Our aim was to report the performance and safety of the EV ICD system throughout the study.
methodsThe EV ICD Pivotal study was a prospective, global, single-arm, premarket clinical study. Individuals with a Class I or IIa indication for a single-chamber implantable cardioverter defibrillator per guidelines were enrolled. Freedom from major system- or procedure-related complications and appropriate and inappropriate therapy rates were assessed through 3 years with the Kaplan-Meier method. ATP success was calculated from simple proportions.
resultsAn implantation was attempted in 316 patients (25.3% female; 53.8±13.1 years of age; 81.6% primary prevention; left ventricular ejection fraction, 38.9±15.4%). Of 299 patients with a successful implantation, 24 experienced 82 spontaneous arrhythmic episodes that were appropriately treated with ATP only (38, 46.3%), shock only (34, 41.5%), or both (10, 12.2%) for a Kaplan-Meier-estimated rate of first any appropriate therapy of 9.2% at 3 years. ATP was successful in 77.1% (37/48) of episodes, and ATP use significantly increased from discharge to last follow-up visit (
conclusionsFrom implantation to study completion, the EV ICD Pivotal study demonstrated that a single integrated system with an extravascular lead placed in the substernal space maintains high ATP success, effective defibrillation, and a consistent safety profile. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04060680.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.