Observational studyEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2026
The evolution of extravascular cardioverter defibrillator implantation: feasibility without general anaesthesia.
Observational study in 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, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
aimsExtravascular implantable cardioverter-defibrillator (EV-ICD) is a novel non-transvenous system delivering defibrillation shocks and anti-tachycardia pacing through a substernal lead. Despite proven efficacy, implantation has traditionally required general anaesthesia and cardiothoracic surgical backup, limiting widespread adoption.
objectivesTo evaluate feasibility, safety, and workflow efficiency of EV-ICD implantation under cardiologist-directed sedation without anaesthesiology support. METHODS AND
resultsProspective observational study including 115 consecutive patients undergoing EV-ICD implantation across two European centres. Three procedural settings were explored sequentially: general anaesthesia (GA, n = 46), analgosedation without anaesthesiology supervision (AS, n = 28) and regional block with limited sedation (RBS, n = 41). The primary endpoint was successful implantation without conversion to respiratory or circulatory support. Secondary endpoints included procedure duration, procedure-related complications, and device performance at follow-up. Overall implantation success was 97% (112/115) in a predominantly young population (50 ± 17 years; 70% male). All procedures performed without anaesthesiology supervision were completed without conversion to GA or emergency support, with comparable complication rates across groups. RBS was associated with a 27-minute reduction in procedural duration vs. GA (P < 0.001) and earlier mobilization (97% ambulating within 3 h vs. 65% after 6 h with GA; P < 0.001). Over a median follow-up of 20 [10-30] months, appropriate ICD therapy was delivered in 13% of patients with 100% arrhythmia termination. Inappropriate therapy occurred in 8.9%, predominantly during the early learning phase.
conclusionEV-ICD implantation can be safely and effectively performed under cardiologist-directed sedation without anaesthesiology supervision, achieving a fully electrophysiology-driven workflow. Procedural simplification substantially reduces resource utilization and may facilitate broader adoption of this technology.
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