First Experience With Extravascular Implantable Cardioverter‐Defibrillator Under Deep Sedation
Nibras Soubh, Bernhard C. Danner, Ulrich Krause, Matthias J. Müller, Markus Zabel, Gerd Hasenfuß, Constanze Schmidt, Helge Haarmann, Eva Rasenack, Leonard BergauABSTRACT
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.