The evolution of Extravascular Cardioverter Defibrillator implantation: feasibility in a purely electrophysiologic setting
Key result
EV-ICD implantation under cardiologist-directed sedation achieves 100% procedural success without conversion to general anesthesia.
- n=115
Why the study?
EV-ICD implantation traditionally required general anesthesia and cardiothoracic surgical backup, limiting widespread adoption.
Does EV-ICD implantation under cardiologist-directed sedation without anesthesiology supervision maintain safety and improve workflow compared to general anesthesia in patients requiring EV-ICD?
Population
115 consecutive patients undergoing EV-ICD implantation across two European centers
Comparison
General anesthesia vs analgosedation without anesthesiology supervision vs regional block with limited sedation
Design
Prospective observational study
Follow-up
Median 20 [10-30] months
Authors
Discussion
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Implication
Cardiologist-directed sedation for EV-ICD implantation appears feasible and safe; leaves open whether this extends to routine practice without further prospective data.
Key Points
- To evaluate the feasibility, safety, and workflow efficiency of extravascular implantable cardioverter-defibrillator (EV-ICD) implantation under cardiologist-directed sedation without anesthesiology supervision.
- Prospective observational study of 115 consecutive patients (mean age 50±17 years; 70% male) undergoing EV-ICD implantation across two European centers.
- Evaluated three sequential procedural approaches: general anesthesia (n=46), analgosedation without anesthesiology supervision (n=28), and regional block with limited sedation (n=41).
- Overall implantation success reached 97% (112/115), with zero conversions to general anesthesia or emergency respiratory/circulatory support in procedures without anesthesiology supervision.
- Regional block with limited sedation reduced procedure duration by 27 minutes compared to general anesthesia (p<0.001) and improved early ambulation (97% ambulating within 3 hours vs. 65% after 6 hours with general anesthesia; p<0.001).
- Over a median follow-up of 20 [10-30] months, appropriate shock therapy occurred in 13% of patients with 100% arrhythmia termination, while inappropriate therapy occurred in 8.9%.
Study Design
Type
Observational (n=115)
Multicenter
Yes
Structured PICO
Does EV-ICD implantation under cardiologist-directed sedation without anesthesiology supervision maintain safety and improve workflow compared to general anesthesia in patients requiring EV-ICD?
P
Population
115 consecutive patients (mean age 50 years, 30% female) undergoing EV-ICD implantation across two European centers, followed for a median of 20 months.
E
Exposure
EV-ICD implantation under cardiologist-directed sedation without anesthesiology supervision (analgosedation [n=28] or regional block with limited sedation [n=41])
C
Comparator
EV-ICD implantation under general anesthesia (n=46)
O
Outcome
Successful implantation without conversion to respiratory or circulatory supportsafety
EV-ICD implantation can be safely and effectively performed using cardiologist-directed sedation or regional block without anesthesiology support, reducing procedure time and facilitating earlier mobilization compared to general anesthesia.
Cite This Study
Biffi et al. (2026) conducted an observational in Patients undergoing EV-ICD implantation (n=115). Cardiologist-directed sedation without anesthesiology supervision (analgosedation or regional block) vs. General anesthesia was evaluated on Successful implantation without conversion to respiratory or circulatory support. EV-ICD implantation under cardiologist-directed sedation achieved 100% procedural success without conversion to general anesthesia or emergency support.