Sedation strategies for pulsed field ablation: a FARADISE registry sub-analysis
L Eckardt, J Vijgen, G Szeplaki, A Dello Russo, I Garcia-Bolao, M Efremidis, N Szegedi, S Willems, H Haqqani, E Gandjbakhch, C Martin, S Bianchi, A Elfstrum, L BoersmaAbstract
Introduction
Deep sedation has gained popularity as an anesthetic method used during pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF). While general anesthesia offers controlled ventilation, deep sedation presents notable advantages such as avoiding intubation-related complications, faster patient recovery, and shorter procedures. Deep sedation and general anesthesia are accepted as safe anesthetic options; however, few studies have evaluated these sedation strategies for safety and clinical outcomes in the context of PFA. FARADISE is a global registry offering real-world data to address this evidence gap.
Purpose
To assess patient safety and long-term outcomes in AF patients undergoing PFA under deep sedation or general anesthesia.
Methods
The FARADISE registry is a prospective, real-world registry enrolling AF patients clinically indicated for a pentaspline PFA procedure. Safety and one-year clinical effectiveness were assessed in patients receiving ablation under deep sedation or general anesthesia. Clinical effectiveness was defined as freedom from arrhythmia recurrence, repeat procedure, or cardioversion.
Results
The FARADISE registry included 1158 patients, 1155 of which were treated under deep sedation (39%) or general anesthesia (61%). Comparing deep sedation to general anesthesia patients, patient age (63±11 years vs. 64±11 years, p=0.52) and CHA2DS2-VA scores (1 [1, 2] vs. 1 [1, 2], p=0.34) were similar. The deep sedation group had a lower proportion of paroxysmal AF patients (61% vs. 68%, p=0.03). Procedural characteristics in the deep sedation and general anesthesia groups were largely similar, but the deep sedation group had more 3D mapping utilization during procedures (20% vs. 11%, p<0.01) and less intracardiac echocardiography (ICE) usage (9% vs. 21%, p<0.01). The pulmonary vein isolation (PVI)-only ablation strategy was widely used in both groups (72% vs. 73%, p=0.73). Serious adverse events, including stroke, were similarly low in deep sedation and general anesthesia patients (1.8% vs. 1.3%, p=0.47). Clinical effectiveness was comparable in PFA patients sedated under both deep sedation and general anesthesia techniques (74% vs. 78%, p=0.24).
Conclusion
Deep sedation and general anesthesia methods yielded similarly safe and effective PFA procedures. These findings demonstrate that PFA can be performed safely and reliably across sedation techniques, offering flexibility in the catheterization laboratory.