Prophylactic administration of glycopyrrolate prevents vasovagal responses induced by pulsed field ablation in patients with atrial fibrillation

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Abstract Background The FarapulseTM system was the first pulsed field ablation device to receive regulatory approval. Vagal Responses (VR) during pulmonary vein isolation (PVI) with this pentaspline device are frequent and often require back-up pacing or the administration of parasympathetic drugs. Glycopirrolate (GLY) is a medication of the muscarinic anticholinergic group; its efficacy for VR prevention when administered prophylactically before PVI has never been reported. Objective To evaluate the effectiveness of prophylactic intravenous administration of GLY on VRs induced by PFA. Methods Consecutive AF patients undergoing first-time PVI with PFA via the FarapulseTM system between April and October 2023 were prospectively enrolled in 3 European centers. Prophylactic administration of GLY (0.2 mg intravenous administration before femoral vein puncture) [Group GLY(+)] was adopted based on operator’s preference. VR was defined as at least one of the following: sinus bradycardia (<40 beats/min), asystole (>6 sec), or atrioventricular block (AVB) occurring immediately after a pulsed electric field application. VRs and maximum pause duration (maximum RR interval) were determined for each PV. Temporary backup pacing was performed as per the operator's preference. Results We enrolled 141 patients [GLY(+): 64 patients; GLY(-): 77 patients] undergoing PVI with the pentaspline FarapulseTM system. Median age was 54.1 years (54.1- 70), and 76 (54%) patients were males with an average CHA2DS2-VASc Score of 1.0 (0 – 2). A total of 563 PVs, including 3 left common PVs and 2 accessory middle PVs, were successfully isolated with the FarapulseTM PFA system. There were no statistically significant differences in baseline and procedural characteristics between two groups. VRs during PVI occurred in a total of 53 (37.6%) patients. GLY administration reduced significantly the incidence of any VRs (4.7% vs 64.9%; p<0.001) (Figure 1A). Additionally, GLY resulted in a lower incidence of VRs during LSPV (4.7% vs 62.3%; p<0.001) and LIPV (1.6% vs 9.1%; p<0.001) (Figure 1B) isolation and the need for temporary backup pacing during LSPV (24.7% vs 1.6%; p<0.001) isolation. Maximum pause duration was significantly shorter in the GLY(+) group after PFA of LSPV (1195 vs 3459 sec; p<0.001), LIPV (1128 vs 1556 sec; p<0.001), RSPV (1138 vs 1607 sec; p<0.001) and RIPV (1103 vs 1343 sec; p<0.001) compared to GLY(-) group (Figure 1C). Conclusions Glycopyrrolate is highly effective in the prevention of VRs induced by PFA ablation in AF patients undergoing first-time PVI.Figure 1