Title Paroxysmal atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter integrated with a 3D mapping system: 1-year outcomes of the multicenter inspIRE study /
Authors Duytschaever, Mattias ; De Potter, Tom ; Grimaldi, Massimo ; Anic, Ante ; Vijgen, Johan ; Neuzil, Petr ; Van Herendael, Hugo ; Verma, Atul ; Skanes, Allan ; Scherr, Daniel ; Pürerfellner, Helmut ; Račkauskas, Gediminas ; Jaïs, Pierre ; Reddy, Vivek Y
DOI 10.1161/CIRCEP.122.011780
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Is Part of Circulation. Arrhythmia and electrophysiology.. Philadelphia : Lippincott Williams & Wilkins. 2023, vol. 16, no. 3, art. no. e011780, p. 119-128.. ISSN 1941-3149. eISSN 1941-3084
Abstract [eng] Background - The inspIRE study evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation (AF). Methods - Subjects underwent pulmonary vein isolation (PVI) with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions (SCLs), and PV stenosis. Wave II (pivotal phase) tested i) primary safety - incidence of early onset primary adverse events (PAEs), and primary effectiveness - confirmed PVI with freedom from documented atrial arrhythmia at 12-months (12M). The study design specified an interim analysis to determine early success once 30 subjects reached 12M follow-up (FU) and all subjects reached 3M FU. Results - Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations and received PFA (Wave I: 40; Wave II: 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral MRI, SCLs were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10s pause between PFA applications was implemented; subsequently, only 4 of 33 subjects had SCLs. In the Wave II phase, no PAE was reported. Upon declaring early success, 83 subjects reached 12M FU. With 100% entrance block, PVI without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness endpoint per Kaplan Meier at the time of interim analysis was 70.9%; 12M freedom from symptomatic AF/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1 ± 27.7 min and 26.7 ± 14.0 min, respectively. Conclusions - The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.
Published Philadelphia : Lippincott Williams & Wilkins
Type Journal article
Language English
Publication date 2023
CC license CC license description