What does this research mean for the field?

Extravascular defibrillator implantation performed under deep sedation showed no serious complications and shorter implant duration than other anesthetic methods in 50 patients. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

The aim is to assess the feasibility and safety of extravascular defibrillator implantation using deep sedation.

February 6, 2026European Heart Journal

Feasibility of extravascular defibrillator implantation in a fully cardiological setting: from general anesthesia to deep sedation, and relevance of surgical back-up

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Patients requiring extravascular defibrillator (EV ICD) implantation (n=50). Intervention: Extravascular defibrillator implantation under deep sedation without surgical back-up vs. General anesthesia with oral intubation or laryngeal mask. Primary outcome: Complications requiring surgical back-up.

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Key result

EV ICD implantation under deep sedation without surgical back-up is feasible with 0 complications requiring surgery.

n=50

Why the study?

EV ICD implantation commonly requires general anesthesia with oral intubation and cardiac surgery back-up, limiting broad adoption in electrophysiology laboratories.

Does EV ICD implantation under deep sedation without surgical back-up maintain safety and improve procedural efficiency compared to general anesthesia in patients requiring an ICD?

Population

50 patients undergoing EV ICD implantation attempt

Comparison

General anesthesia vs laryngeal mask vs sedation without arterial monitoring, with or without surgical back-up

Design

Single-centre observational study

Authors

AQA QuarantaIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola CMCristian MartignaniElectrophysiology MZMatteo ZiacchiElectrophysiology

Discussion

Member takes

Implication

Suggests extravascular ICDs may be safely implanted using deep sedation without routine surgical standby; leaves.

Key Points

The aim is to assess the feasibility and safety of extravascular defibrillator implantation using deep sedation.
Fifty patients underwent EV ICD implantation in a hybrid room from November 2020 to February 2025.
General anesthesia with oral intubation was used for the initial cases, transitioning to deep sedation.
Surgical back-up was minimized, ending after the PIVOTAL trial.
No complications requiring surgical back-up occurred during the procedures.
Shorter implant duration was noted under deep sedation compared to other anesthesia methods.
Ambulation was permitted within 5 hours post-procedure for all groups.

Study Design

Type

Observational (n=50)

Multicenter

Structured PICO

Does EV ICD implantation under deep sedation without surgical back-up maintain safety and improve procedural efficiency compared to general anesthesia in patients requiring an ICD?

Population

50 patients undergoing extravascular defibrillator (EV ICD) implantation attempt

Intervention

EV ICD implantation under deep sedation without arterial monitoring and without routine cardiothoracic surgical back-up

Comparator

EV ICD implantation under general anesthesia with oral intubation or laryngeal mask, with surgical back-up (historical/earlier cases in the same center)

Outcome

Procedural safety and feasibility (complications requiring surgical back-up, conversion to intubation, and implant duration)safety

Extravascular ICD implantation is feasible and safe when performed under deep sedation in a fully cardiological setting without routine cardiothoracic surgical back-up.

Limitations

Single-center experience requiring larger multicenter studies to confirm broad adoption in hospitals without cardiothoracic surgery back-up
Single-center experience
Requires larger multicenter studies to confirm broad adoption

Cite This Study

Quaranta et al. (2025) conducted an observational in Patients requiring extravascular defibrillator (EV ICD) implantation (n=50). Extravascular defibrillator implantation under deep sedation without surgical back-up vs. General anesthesia with oral intubation or laryngeal mask was evaluated on Complications requiring surgical back-up. Extravascular defibrillator implantation transitioning to deep sedation without surgical back-up was feasible, with 0 complications requiring surgical back-up across 50 procedures.

synapsesocial.com/papers/698586238f7c464f2300a1ef https://doi.org/10.1093/eurheartj/ehaf784.667

Topics

Subcutaneous and Extravascular ICDs Cardiac device therapy

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Feasibility of extravascular defibrillator implantation in a fully cardiological setting: from general anesthesia to deep sedation, and relevance of surgical back-up

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

Topics

Feasibility of extravascular defibrillator implantation in a fully cardiological setting: from general anesthesia to deep sedation, and relevance of surgical back-up

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

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