First Experience With Extravascular Implantable Cardioverter-Defibrillator Under Deep Sedation.
Pacing Clin Electrophysiol 2026 Jun 20. [Online ahead of print]

Abstract

BACKGROUND

The Extravascular Implantable Cardioverter-Defibrillator (EV-ICD) utilizes a substernal lead to provide defibrillation and anti-tachycardia pacing (ATP) while avoiding transvenous complications. General anesthesia (GA) was applied for implantation procedures in the EV-ICD pivotal trial and is currently recommended by the manufacturer. However, GA carries specific risks and consumes significant resources. This study evaluates the feasibility, safety, and procedural efficiency of EV-ICD implantation performed under cardiologist-administered deep sedation with noninvasive ventilation (DS-NIV) compared to standard GA.

METHODS

We retrospectively analyzed 24 consecutive patients undergoing EV-ICD implantation in our center. Patients received either GA (n = 14) or DS-NIV (n = 10) using a propofol-ketamine protocol delivered by cardiologists. Analyses focused on peri-procedural feasibility and safety, procedural workflow and anesthesia characteristics, and early device electrical performance.

RESULTS

No anesthesia-related complications occurred in either group. The DS-NIV group demonstrated significantly shorter wheels-to-incision times (median: 45 vs. 70 min, p = 0.022), whereas the procedural duration did not differ significantly from the GA group. Patients receiving DS-NIV required fewer vasopressors (60% vs. 100%, p = 0.024) despite higher propofol infusion rates (800 vs. 350 mg/h, P<0.001). Defibrillation testing success and electrical parameters were comparable. In a median follow-up of 182 days two patients received appropriate EV-ICD therapies and no inappropriate ATP or shocks were delivered.

CONCLUSION

EV-ICD implantation under cardiologist-administered DS-NIV appears to be feasible and safe, offering improved workflow efficiency compared to GA. These findings support deep sedation as a practical alternative in experienced centers, potentially expanding access to EV-ICD therapy.

Authors+Show Affiliations

Soubh N0000-0002-0272-0525Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Danner BCDZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany. Department of Thoracic and Cardiovascular Surgery, University Medical Center in Göttingen (UMG), Göttingen, Germany.
Krause UDZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany. Division of Pediatric Cardiology, Department of Pediatric and Adolescent Medicine, University Medical Center in Göttingen (UMG), Göttingen, Germany.
Müller MJDZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany. Division of Pediatric Cardiology, Department of Pediatric and Adolescent Medicine, University Medical Center in Göttingen (UMG), Göttingen, Germany.
Zabel MDepartment of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Hasenfuβ GDepartment of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Schmidt C0000-0001-5897-237XDepartment of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Haarmann H0009-0000-0566-5827Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Rasenack EDepartment of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.
Bergau L0000-0001-7025-9315Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Lower Saxony, University of Göttingen, Göttingen, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

42322111