General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping system

Andreas Rillig; Jun Hirokami; Fabian Moser; Stefano Bordignon; Laura Rottner; Shota Tohoku; Ilaria My; Andrea Urbani; Marc D. Lemoine; Joseph Kheir; Niklas Schenker; Lukas Urbanek; K Govorov; David Schaack; Julius Obergassel; Djemail Ismaili; Paulus Kirchhof; Feifan Ouyang; Boris Schmidt; Bruno Reißmann; K. R. Julian Chun; Andreas Metzner

doi:10.1093/europace/euae270

Why the study?

Does deep sedation reduce lab occupancy time or affect acute efficacy compared to general anaesthesia during monopolar pulsed field ablation for atrial fibrillation?

Key Points

To assess the feasibility, safety, and procedural efficiency of deep sedation compared with general anaesthesia for monopolar pulsed field ablation using a lattice-tip catheter and a 3D mapping system.
Enrolled 63 patients (mean age 64 ± 9 years, 35% female, 75% persistent AF) with symptomatic paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation and linear ablation.
Compared acute outcomes and procedural timeframes between patients managed under general anaesthesia (n = 23) and deep sedation (n = 40) using a catheter capable of pulsed field ablation and radiofrequency delivery.
Acute pulmonary vein isolation was achieved in 100% of patients across both arms, with procedure durations of 96 ± 24 min in the general anaesthesia group versus 100 ± 23 min in the deep sedation group (P = 0.52).
Lab occupancy time was significantly reduced with deep sedation compared to general anaesthesia (131 ± 35 min vs. 165 ± 40 min; P = 0.0008), while radiation exposure remained comparable (452 vs. 489 cGycm2; P = 0.82).
Observed zero mapping shifts in either group, one crossover from deep sedation to general anaesthesia, and one case of pericardial tamponade in the deep sedation cohort.

Structured PICO

Does deep sedation reduce lab occupancy time or affect acute efficacy compared to general anaesthesia during monopolar pulsed field ablation for atrial fibrillation?

P

Population

63 patients with symptomatic paroxysmal or persistent atrial fibrillation (35% female, 75% persistent AF, mean age 64 ± 9 years)

I

Intervention

Monopolar pulsed field ablation (PFA) for pulmonary vein isolation (PVI) and additional linear lesions using a lattice-tip catheter combined with a novel three-dimensional mapping system, performed under deep sedation (n=40)

C

Comparator

The same monopolar pulsed field ablation procedure performed under general anaesthesia (GA) (n=23)

O

Outcome

Acute efficacy (pulmonary vein isolation rate) and lab occupancy timesurrogate

Performing monopolar pulsed field ablation using a lattice-tip catheter under deep sedation is feasible, maintains 100% acute efficacy, and significantly reduces lab occupancy time compared to general anaesthesia.

Implication

May enable deep sedation for lattice-tip PFA/RF in AF; leaves open randomized comparison to general anesthesia.

Abstract

AIMS: A novel three-dimensional mapping platform combined with a lattice-tip catheter that can toggle between monopolar pulsed field ablation (PFA) and radiofrequency energy delivery was recently launched. So far, the system was predominantly applied in general anaesthesia (GA), not in deep sedation. METHODS AND RESULTS: Patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) were enrolled, and pulmonary vein isolation (PVI) and ablation of additional linear lesion sets were performed either in GA or in deep sedation. Pulsed field ablation was applied exclusively to perform ipsilateral PVI. A total of 63 patients (35% female, 75% persistent AF, mean age 64 ± 9 years) were included in the analysis with 23 patients treated in GA and 40 patients in deep sedation. Acute efficacy was comparable in both groups with a PVI rate of 100%. Additional 74 lesion sets were performed in the total cohort. Mean procedure and lab occupancy time in the GA and deep sedation group was 96 ± 24 min vs. 100 ± 23 min (P = 0.52) and 165 ± 40 min vs. 131 ± 35 min (P = 0.0008). Mean dose area product was 489 (216;1093) vs. 452 (272;882) cGycm2 in the GA and the deep sedation group (P = 0.82). There was one conversion from deep sedation to GA. There were no map shifts observed in any group. Pericardial tamponade occurred in one patient of the deep sedation group. CONCLUSION: The use of a novel ablation platform in conjunction with a lattice-tip catheter in deep sedation is feasible, effective, and associated with significantly shorter lab occupancy time when compared with GA.