Sedation protocols for atrial fibrillation ablation using pulsed-field ablation: patient and operator-reported outcomes from a large nationwide study

Abstract Background General anesthesia (GA) or monitored anesthesia with deep sedation (DS) are the preferred sedation protocols used during thermal ablation of atrial fibrillation (AF). However, each approach may have advantages and disadvantages with variability in operator preferences and patient’s feedback. Purpose We aimed to evaluate the procedural workflow of AF ablation using the Farapulse PFA technology, as well as assess patient- and operator-reported outcomes (including primary operator, anesthesiologist, and nursing staff), in procedures performed under GA versus DS, within a large, nationwide clinical practice. Methods All consecutive patients undergoing AF ablation with PFA at 16 Italian centers were included. Anesthesia protocol was performed at the operator’s discretion. At the end of ablation, Likert Scale Questionnaires (LSQ) and Visual-Analog Scales (VIS, from 0 -low- to 100 -maximum-) were used to assess the patients’ and operators’ satisfaction with intraoperative analgesia-sedation. Results A total of 478 patients were enrolled: GA protocol was applied in 341 (71%) procedures and DS protocol in 137 (29%) procedures. Positive answers to LSQs were obtained in almost all patients and operators without differences between GA and DS. The primary operator reported being satisfied (9.0%) or very satisfied (90.4%) in 99.4% of the cases (GA: 99.1% vs DS: 100%, p=0.561), the anesthetist was satisfied (7.3%) or very satisfied (90.8%) in 98.1% of the cases (97.4% vs 100%, p=0.066) and the nursing staff reported satisfaction (7.5%) or very high satisfaction (91.2%) in 98.7% of the cases (98.2% vs 100%, p=0.189). Similarly, the patient reported satisfaction (7.5%) or very high satisfaction (91.4%) in 99.0% of the cases (98.5% vs 100%, p=0.328). Sedation scores indicated highly positive outcomes in terms of procedural management. In 94.6% of the cases patients did not recall experiencing pain during the procedure (99.4% vs 82.5%, p<0.001), were not anxious in 97.3% of the cases (98.8% vs 93.4%, p=0.003) and reported no discomfort in 97.7% of the cases (99.1% vs 94.2%, p=0.003). At the end of the procedure, overall patient feedback, rated on the VIS was extremely positive: patient’ satisfaction was ranked 93.6±12 (91.7±13 vs 98.2±6, p<0.001), anxiety level=6.9±13 (8.8±13 vs 2.3±11, p<0.001), discomfort=9.8±18 (13.6±20 vs 0.3±2, p<0.001) and pain level=6.7±12 (8.9±13 vs 1.1±4, p<0.001). Two (0.4%) minor anaesthesia-related complications were reported (GA: 0.3% vs DS: 0.7%, p=0.492). Conclusion Adoption of both general anesthesia and deep sedation protocol during ablation of AF with the Farapulse PFA system led to a safe and effective anesthesia, achieving favorable sedation parameters as evidenced by positive feedback from both patients and operators. Patients reported a more positive procedural experience under general anesthesia, while deep sedation was associated with greater comfort during the immediate post-awakening phase.