Outcomes and patient satisfaction of deep sedation versus general anesthesia during dual-energy catheter ablation for paroxysmal atrial fibrillation: a randomized clinical trial
M Suleiman, W Darawsha, M Blich, R Suleiman, R Shinawi, L Gepstien, A EyalAbstract
Background
Pulsed Field (PF) ablation offers superior procedural efficiency and a favorable safety profile for adjacent structures compared to thermal ablation. However, high-voltage pulses can trigger significant muscle contraction and transient cough, often necessiting General Anesthesia (GA). While GA ensures stability, it imposes a logistical burden and increases "room time." The Dual-Energy (DE) catheter allows for seamless switching between PF and radiofrequency (RF) energy. The feasibility of Pulmonary Vein Isolation (PVI) with DE under Deep Sedation (DS) without compromising patient comfort or procedural success has not been established in randomized clinical trial.
Objectives
To compare patient satisfaction and procedural outcomes of DS versus GA in patients undergoing PVI for paroxysmal atrial fibrillation (PAF) using the DE catheter.
Methods
Forty-five patients (73% male, age 59 ±11 years) with symptomatic PAF were randomized to either DS group (n=22) or GA group (n=23). Index guided ablation was performed using PFA for posterior/inferior segments (450 index) and RF for anterior/ridge/carina segments (550 index). Patient and physician satisfaction were assessed using a 100-mm Visual Analog Scale (VAS; 0 = least, 100 = most satisfied) and Likert scales regarding the likelihood of recommending the sedation method.
Results
Baseline characteristics were comparable between groups. Patient satisfaction levels were high and similar in both groups (96 ± 6 in the GA vs. 92±10 in DS, p=0.2) with no differences in Likert scale scores. However, operator satisfaction was significantly higher in the GA group (98±6 vs. 90±10, p=0.01). Patient movement due to coughing occurred in 23% (n=5) of the DS group vs. 0% in the GA group (p=0.0001), resulting in monor, non-clinically significant map shifts in four cases. Acute PVI was achieved in 100% of veins in both groups. Mean left atrial dwelling time was longer in the DS group (66± 13 vs 52± 13 min, p=0.001), whearse total "room time" trended higher in the GA group (123 ± 15 vs 110±24 min, p=0.08). No major procedural or anesthesia-related complications occurred.
Conclusion
In DE catheter ablation for PAF using, deep sedation provides patient satisfaction, safety, and acute procedural success comparable to general anesthesia. While DS is associated with increased patient movement and longer LA dwelling times, it may offer a more efficient "room time" workflow. DS is a viable alternative to GA for DE ablation, provided operators account for potential map shifts during ablation delivery.