Safety and feasibility of a standardized deep sedation protocol with primarily nurse-led management in patients undergoing pulsed field ablation

Abstract Background Pulsed field ablation (PFA) has emerged as a widely adopted non-thermal energy source for the treatment of atrial fibrillation (AF). However, a standardized sedation protocol for PFA procedures has not yet been established with few preliminary experiences using a ketamine-based sedation approach reported in literature. Purpose The present study reports our experience with a deep sedation protocol performed under spontaneous respiration using ketamine in a high-volume electrophysiology center. Methods We prospectively analyzed 108 consecutive patients who underwent PFA ablation for AF or atrial flutter utilizing three different PFA systems (Farapulse, Boston Scientific; Varipulse, Biosense Webster; and PulseSelect, Medtronic). The sedation protocol included intravenous administration of midazolam (2 mg), fentanyl (0.5 µg/kg), and droperidol (0.6 mg) prior to local anesthesia with lidocaine (200 mg). Patients were maintained under spontaneous respiration with oxygen supplementation (4–6 L/min) via face mask. Additional midazolam (0.05 mg/kg) was titrated as needed based on clinical assessment. Following transseptal puncture, heparin (100 U/kg) was administered. At the time of PFA delivery, patients received midazolam (1–2 mg), atropine (1 mg), and ketamine (1 mg/kg) administered over 60–90 seconds; ablation commenced approximately two minutes later. Supplemental doses of ketamine (0.5 mg/kg), fentanyl (0.5 µg/kg), and midazolam (1–2 mg) were given during repositioning from left to right pulmonary veins. Flumazenil (1 mg) was administered at the end of each procedure. Results The study population had a mean age of 63 ± 10 years, and 76% were male. The mean CHA2DS2-VASc score was 1.9 ± 1.4, and the median BMI was 25.8 ± 3.5 kg/m²; 36% had underlying respiratory disease (asthma, obstructive sleep apnea, or COPD). PFA systems used included Farapulse (71%), Varipulse (22%). and PulseSelect (13%). Pulmonary vein isolation was performed in 93.5% of procedures, with additional lesions as required (cavo-tricuspid isthmus 16.7%, posterior wall 13%, roof line 10.2%, anterior wall 3.7%, mitral isthmus 2.8%, left atrial appendage 1.9%). The mean skin-to-skin time was 101.6 ± 40.9 minutes (including complex mapped procedures). In one case, propofol administration under anesthesiologist supervision was necessary to control patient movement. Sedation requirements did not differ among PFA systems. No intraprocedural complications occurred. Both patient and operator satisfaction were rated as high across all procedures. Conclusion A standardized deep sedation protocol, jointly managed by a trained nurse and electrophysiologist and incorporating low-dose, short-acting agents with minimal respiratory depression, was safe and effective for PFA procedures. The protocol provided excellent procedural conditions and satisfaction for both patients and operators, with consistent performance across three different PFA systems.