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Updated: Aug 21, 2026
A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
The evolution of extravascular cardioverter defibrillator implantation: feasibility without general anaesthesia
Mauro Biffi1, Hans Römers2,3, Andrea Quaranta4
1IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti 9, 40138 Bologna, Italy.
Aims:
Extravascular 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.
Objectives:
To evaluate feasibility, safety, and workflow efficiency of EV-ICD implantation under cardiologist-directed sedation without anaesthesiology support.
Methods And Results:
Prospective 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.
Conclusion:
EV-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.
