Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, which severely impairs patients' quality of life and is closely associated with an elevated risk of complications including thromboembolism and heart failure. Rhythm control, particularly catheter ablation, has become a cornerstone of AF management. In recent years, pulsed-field ablation (PFA) has emerged as a novel catheter ablation technique for AF. It demonstrates non-inferior ablation efficacy to conventional radiofrequency ablation, with the advantages of minimal injury to peri-myocardial tissues, high procedural efficiency and a low incidence of complications, thus serving as a promising alternative for AF catheter ablation. Unlike radiofrequency ablation, PFA delivers high-voltage electric fields during the procedure, for which local anesthesia fails to achieve satisfactory sedation and analgesia. General anesthesia (GA) is currently the main anesthetic approach for PFA to ensure adequate intraoperative immobilization and provide stable conditions for precise procedural manipulation. However, GA has notable limitations: first, the central inhibitory effects of general anesthetics and procedural stress-induced responses are prone to cause perioperative hemodynamic instability, leading to adverse events such as hypotension and hypoxemia, which not only increase procedural risks but also exert adverse impacts on short- and long-term patient prognosis; second, GA usually requires endotracheal intubation or laryngeal mask ventilation, which may cause retropharyngeal injury and raise the risk of complications like bleeding or hematoma; third, GA incurs relatively high medical costs, further increasing the economic burden on patients. In light of these unmet clinical needs, several observational studies have demonstrated the feasibility of deep or conscious sedation during PFA procedures. Nevertheless, sedation strategies vary across centers, and most findings are based on single-center, small-sample empirical summaries, lacking high-quality evidence from large-sample, rigorously designed randomized controlled trials (RCTs). Our team has previously explored a conscious sedation strategy in over 200 patients, and the results showed that this strategy could achieve satisfactory sedation and analgesia for PFA, significantly reduce the risk of GA-related hemodynamic instability, and yield favorable postoperative feedback from patients. Given the sufficient evidence supporting the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (PAF), this study intends to conduct a single-center, 1:1 randomized, single-blind controlled trial to compare the safety and efficacy of conscious sedation and GA in PFA for PAF, aiming to provide an evidence-based basis for the selection of an optimal sedation regimen for PFA procedures.