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
October 1, 2026 · via Europe PMC
The evolution of extravascular cardioverter defibrillator implantation: feasibility without general anaesthesia.
Biffi M, Römers H, Quaranta A, +8 more, Boersma LVA.
AI summary — for doctors, generated from the abstract only
EV-ICD implantation appears feasible and safe under cardiologist-directed sedation or regional block without anaesthesiology support.
What was studied
Prospective observational study of 115 consecutive EV-ICD implants at two European centres across three sequential settings: general anaesthesia (46), analgosedation without anaesthesiology (28) and regional block with limited sedation (41).
Key findings
- Overall implantation success was 97% (112/115)
- All procedures done without anaesthesiology supervision were completed without conversion to GA or emergency support, with comparable complication rates
- Regional block with limited sedation shortened procedures by 27 minutes versus GA
Clinical relevance
Removing the need for general anaesthesia simplifies workflow and resource use, which could widen access to extravascular ICDs.
Who should care
Limitations
Non-randomized, sequential groups at two experienced centres, so learning curve and patient selection may influence results.
Centres with EV-ICD experience can consider sedation or regional block pathways rather than defaulting to general anaesthesia.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
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.
DOI
10.1093/europace/euag217
PMID
42615922
PMCID
PMC13669631
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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