CONVENTIONAL VS. OPTIMIZED PERIPROCEDURAL ANALGOSEDATION VS. TOTAL INTRAVENOUS ANAESTHESIA FOR PULSED-FIELD ABLATION: A RANDOMIZED CONTROLLED TRIAL (COOPERATIVE-PFA)

Introduction: Deep analgosedation (DAS) or general anaesthesia (GA) is mandatory for pulsed-field ablation (PFA) of atrial fibrillation (AF). In contrast to DAS, GA (conventional or total intravenous anaesthesia [TIVA]) requires airway management. This study compared ketamine-remimazolam DAS and propofol-opioid TIVA to propofol-opioid DAS, focusing on sedation-related adverse events.

Methods: Patients indicated for AF catheter ablation were randomly assigned in a 1:1:1 ratio to (1) DAS using intermittent propofol-opioid boluses (arm P), (2) continuous remimazolam-ketamine DAS (arm R), or (3) continuous propofol-opioid TIVA with secured airways (arm TIVA). Catheter ablation was performed using the FARAPULSE system (Boston Scientific, MA, USA). The primary endpoint was defined as a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or leading to procedure discontinuation. Secondary endpoints included hemodynamic instability events, procedure time, serious adverse events, and patient satisfaction.

Results: One-hundred and twenty-seven patients (mean age 62.9 ± 10.3 years, 35.1% female, 47.2% with paroxysmal AF) were enrolled and randomised to the P (N = 42), R (N = 43) or TIVA (N = 42) arms. The primary endpoint occurred in 85.7% of P pts., 27.9% of R pts., and 66.7% of TIVA pts. (P < 0.001), driven by hypoxemia in the P (100 % of pts. with the primary endpoint) and by hypotension in the TIVA arm (100 %). The R arm showed a similar distribution of hypoxemia (50 %) and hypotension (66.7 %) events. No differences were observed in mean procedural times, serious adverse event rates, and assessment of patient satisfaction.

Conclusions: In PFA procedures for AF, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events.