Safety and efficacy outcomes in 100 consecutive cases of pulsed field ablation

Abstract

Abstract Background Pulsed field ablation (PFA) an emerging technology for ablation of atrial fibrillation (AF). This non-thermal ablation modality uses ultrarapid electrical pulses to destabilise cell membranes and can selectively ablate myocardial tissue. Successful pulmonary vein isolation (PVI) and reductions in procedure times compared to other modalities have been observed in initial studies. Aim To report initial outcomes and fluoroscopic times in the first 100 consecutive cases using PFA in AF ablation. Methods The first 100 consecutive PFA cases carried out by a single operator in a single centre were examined. All cases were performed under general anaesthesia, using ultrasound-guided vascular access and TOE-guided transseptal puncture. Outcomes were recorded from the first case in June 2022 to the present day. Electroanatomic mapping (EAM) was carried out using two proprietary systems. Results Procedural information and follow-up was achieved in all 100 patients (see table). The majority (77) were male. Mean age 61. Cardiovascular comorbidities included: hypertension (41), heart failure (12), ischaemic heart disease (10), stroke (4), diabetes mellitus (3). Antiarrhythmic drugs were used by 45 patients (Amiodarone in 22, Dronedarone in 18, Flecainide in 10, Sotalol in 8, Mexiletine in 1) with 55 taking beta blockers only or no rhythm control drugs. Persistent AF accounted for 57 cases, and 91 patients had no prior ablation procedure. Median CHA2DS2VASC 1. Warfarin was used on 1 patient, the other 99 patients underwent ablation on uninterrupted DOAC, most commonly Apixaban. EAM was conducted in 59 patients. Stand-alone PVI was carried out in 68, while 30 underwent an additional posterior wall box isolation, and a mitral isthmus line was added in a further 2 who had atrial flutter (AFl) during the procedure following successful PVI. There were no serious peri-procedural complications. (vascular access complications, pericardial effusion, stroke or death). All 100 patients were discharged following a one-night stay. Clinical pericarditis without effusion occurred in 1 patient on day 2, and resolved with a short course of Colchicine. Mean fluoroscopy time was 9minutes, 12seconds, and reductions in fluoroscopy times correlated significantly with case number (see figure). Mean fluoroscopy time was 2mins, 30secs higher where EAM was used. Sinus rhythm was achieved in 100%. Atrial arrhythmia recurred in 12 patients, 7 with AF and 3 atrial flutter, 2 with typical symptoms which could not be documented. Two of the recurrences were within 24 hours of the procedure. Conclusions This registry data shows that PFA was used to achieve PVI safely, with effective additional substrate ablation also demonstrated. There were no serious peri-procedural complications, and procedural improvements in fluoroscopic times were observed throughout the 100 cases. Long term follow-up data is required to validate the safety and efficacy of this new technology.