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Multicenter Study
. 2023 Mar;16(3):e011780.
doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.

Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study

Mattias Duytschaever  1 , Tom De Potter  2 , Massimo Grimaldi  3 , Ante Anic  4 , Johan Vijgen  5 , Petr Neuzil  6 , Hugo Van Herendael  7 , Atul Verma  8 , Allan Skanes  9 , Daniel Scherr  10 , Helmut Pürerfellner  11 , Gediminas Rackauskas  12 , Pierre Jaïs  13 , Vivek Y Reddy  4   6 ; inspIRE Trial Investigators
Collaborators, Affiliations
Multicenter Study

Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study

Mattias Duytschaever et al. Circ Arrhythm Electrophysiol. 2023 Mar.

Abstract

Background: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) 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.

Methods: Subjects underwent pulmonary vein (PV) isolation 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, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up.

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 magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/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 and 26.7±14.0 minutes, respectively.

Conclusions: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.

Registration: URL: https://www.

Clinicaltrials: gov; unique identifier: NCT04524364.

Keywords: atrial fibrillation; catheter ablation; efficacy; electroporation; radiofrequency ablation.

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Conflict of interest statement

Dr Duytschaever has served on the speaker’s bureau, is a consultant for Biosense Webster, Inc, and has received research support from Biosense Webster, Inc. Dr De Potter has received consulting fees, honorarium for lectures, and presentation fees from Biosense Webster and Adagio Medical (all payments were directed to the institution). Dr Anic has received consulting fees and has contracted research with Farapulse, Boston Scientific, Galaxy Medical, and Biosense Webster. Dr Grimaldi has an unrelated patent agreement with Biosense Webster, Inc. Dr Neuzil has received grant support from Biosense Webster, Inc. Dr Van Herendael has received support from Biosense Webster for congress-related activities. Dr Verma has received grants from Biosense Webster, Medtronic, Bayer, and Biotronik; has received consulting fees from Biosense Webster, Medtronic, Adagio Medical, Galaxy Medical, Ablacon, and Thermedical; and has received honorarium for lectures from Biosense Webster and Medtronic. Dr Skanes has served on the speaker’s bureau for Biosense Webster and has received research support from Biosense Webster, Inc. Dr Scherr has received grant support from Biosense Webster. Dr Pürerfellner has received consulting fees from Biosense Webster, Abbott, Boston Scientific, Biotronik, and Medtronic and has received payment or honorarium for lectures or presentations from Biosense Webster, Abbott, Boston Scientific, Biotronik, and Medtronic. Dr Jais has received a LIRYC research grant from Biosense Webster; has received speaker fees from Biosense Webster; is a share holder of Farapulse/Affera; and has also received speaker fees and research grants from Boston Scientific, Medtronic, and Abbott. Dr Reddy is a consultant for Biosense Webster, Inc; he also has additional disclosures unrelated to this article that are listed in the Supplemental Material. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Pre- and postablation voltage maps using the variable-loop circular catheter (VLCC). A, The variable-loop circular catheter (VLCC). B, The VLCC as visualized under the 3-dimensional mapping system. C, Preablation (top) and postablation (bottom) voltage map showing the level of isolation (red) for the pulmonary veins with corresponding electrogram signals in the same subject. Reprinted from Biosense Webster, Inc. with permission. Copyright ©, Biosense Webster, Inc. (A).
Figure 2.
Figure 2.
inspIRE trial (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) patient population flowchart. inspIRE indicates Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE); mITT, modified intention to treat; PFA, pulsed field ablation; and PV, pulmonary vein.
Figure 3.
Figure 3.
Freedom from primary effectiveness and documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter recurrence (clinical success) in the per-protocol population. Kaplan-Meier analysis in the per-protocol population of (A) primary effectiveness in Wave II subjects and (B) freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter recurrence in Wave I and Wave II subjects. PG indicates performance goal.
See this image and copyright information in PMC

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