Quantitative assessment of transient autonomic modulation after single‐shot pulmonary vein isolation with pulsed‐field ablation

Abstract

IntroductionPulmonary vein isolation (PVI) with thermal energy is characterized by concomitant ablation of the surrounding ganglionated plexi (GP). Pulsed‐field ablation (PFA) selectively targets the myocardium and seems associated with only negligible effects on the autonomic nervous system (ANS). However, little is known about the dynamic effects of PFA on the GP immediately after PVI. This study sought to investigate the degree and acute vagal modulation induced by the FarapulseTM PFA system during PVI compared with single‐shot thermal ablation.MethodsA total of 76 patients underwent first‐time PVI with either FarapulseTM PFA (PFA group, n = 40) or cryoballoon ablation (thermal ablation group, n = 36) for paroxysmal atrial fibrillation (AF). The effect on the ANS in the two groups was assessed before and after PVI with extracardiac vagal stimulation (ECVS). To capture any transient effects of PFA on the ANS, in a subgroup of PFA patients ECVS was repeated at three predefined timepoints: (1) before PVI (T0); (2) immediately after PVI (T1); and (3) 10 min after the last energy application (T2).ResultsDespite similar baseline values, the vagal response induced by ECVS after PVI almost disappeared in the thermal ablation group but persisted in the PFA group (thermal group: 840 [706–1090] ms, p < .001 compared to baseline; PFA group: 11 466 [8720–12 293] ms, p = .70 compared to baseline). Intraprocedural vagal reactions (defined as RR increase >50%, transitory asystole, or atrioventricular block) occurred more frequently with PFA than thermal ablation (70% vs. 28%, p = .001). Moreover, heart rate 24 h post‐PVI increased more with thermal ablation than with PFA (16.5 ± 9.0 vs. 2.6 ± 6.1 beats/min, p < .001). In the subgroup of PFA patients undergoing repeated ANS modulation assessment (n = 11), ECVS demonstrated that PFA determined a significant acute suppression of the vagal response immediately after PVI (p < .001 compared to baseline), which recovered almost completely within 10 min.ConclusionPVI with the FarapulseTM PFA system is associated with only transitory and short‐lasting vagal effects on the ANS which recover almost completely within a few minutes after ablation. The impact of this phenomenon on AF outcome needs to be further investigated.

Meta‐analysis of pulsed‐field ablation versus cryoablation for atrial fibrillation

“…The PRISMA flow chart provides a systematic description of the literature selection process (Figure 1). Ultimately, this study encompassed 15 trials involving a total of 1880 patients (1036 patients in the PFA group vs. 844 patients in the CBA group) published between 2021 and 2023, 7,12–25 comprising of 14 observational studies (7 prospective cohort, 7,12,16,17,19,23,25 6 retrospective cohort, 13,14,18,20,22,24 and 1 cross‐sectional study 15 ), along with one RCT 21 …”

“…Five studies included patients with paroxysmal AF, 7,17–19,21 while the remaining studies enrolled a broader population of AF patients. Many participants had previously failed anti‐arrhythmic medications, and none had undergone prior AF ablation procedures.…”

“…Of the 13 cohort studies, 3 (23%) were rated as having moderate quality, 13,16,17 while the remaining studies demonstrated high quality; specifically, 38% of the cohort studies did not mention adjusting for confounding factors 13,16–18,22 . For the RCT conducted by Reddy et al., 21 there was a low risk of bias in terms of selection (random sequence generation and allocation concealment), performance (blinding of participants), detection (blinding of outcome assessment), attrition (relatively complete outcome data), and reporting bias (all prespecified outcomes were reported according to the study protocol).…”

“…There were five studies which only included paroxysmal AF, 7,17–19,21 two study which provided separate outcome data for patients with paroxysmal AF 12,24 . A total of 1256 patients from these seven studies (704 in the PFA and 552 in the CBA) were included in the subgroup analysis of paroxysmal AF.…”