The Effectiveness and Safety of Deep Sedation Protocols for Pulsed Field Ablation of Atrial Fibrillation

BACKGROUND: Deep sedation (DS) is increasingly utilized during pulsed field ablation (PFA) for atrial fibrillation (AF), but the optimal electrophysiologist-led sedation regimen remains unclear. OBJECTIVE: To compare sedative effectiveness and safety of three electrophysiologist-led DS protocols. METHODS: In this prospective, single-center study, AF patients undergoing focal-form PFA received (1) midazolam + fentanyl (Midazolam group), (2) flurbiprofen axetil + midazolam + fentanyl (Flurbiprofen group), or (3) dexmedetomidine + fentanyl (Dexmedetomidine group). The primary endpoint was the achievement of the target sedation level at ablation initiation (Ramsay Sedation Score ≥3). Secondary endpoints included intraoperative pain, sedation difficulty, operator satisfaction, and sedation-related adverse events. RESULTS: 166 patients (mean age, 62.2 ± 10.8 years; 62.7% male; 48.2% with paroxysmal AF) were enrolled, with 53, 67, and 46 patients included in the Midazolam, Flurbiprofen, and Dexmedetomidine groups, respectively. The primary outcome occurred more frequently in the Flurbiprofen (73.1%) and Dexmedetomidine (82.6%) groups compared to Midazolam (47.2%) (overall p < 0.001); Flurbiprofen and Dexmedetomidine group did not differ significantly. Intraoperative pain scores were lowest with Dexmedetomidine (overall p < 0.001). Both Flurbiprofen and Dexmedetomidine groups showed lower sedation difficulty and higher operator satisfaction than the Midazolam group (both overall p < 0.001). Dexmedetomidine was associated with more intraoperative hypotension (overall p = 0.047). CONCLUSION: Electrophysiologist-led DS protocols with Flurbiprofen and Dexmedetomidine were associated with higher target sedation attainment than the specific low-dose Midazolam regimen during PFA, but Dexmedetomidine is linked to higher hypotension rates, warranting caution.