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Clinical Trial
. 2024 May;17(5):e012667.
doi: 10.1161/CIRCEP.123.012667. Epub 2024 Apr 24.

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE

Tom De Potter  1 , Massimo Grimaldi  2 , Mattias Duytschaever  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 Jais  13 , Vivek Y Reddy  14 ; inspIRE Trial Investigators
Affiliations
Clinical Trial

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE

Tom De Potter et al. Circ Arrhythm Electrophysiol. 2024 May.

Abstract

Background: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success.

Methods: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success.

Results: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA2DS2-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications.

Conclusions: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.

Keywords: atrial fibrillation; catheters; electroporation; pulmonary veins.

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Conflict of interest statement

Disclosures Dr De Potter has received consulting fees and honoraria for lectures and presentations from Biosense Webster and Adagio Medical (all payments were directed to the institution). Dr Grimaldi has an unrelated patent agreement with Biosense Webster, Inc. Dr Duytschaever has served on the speakers’ bureau and as a consultant for Biosense Webster, Inc, and has received research support from Biosense Webster, Inc. Dr Anic has received consulting fees and has contracted research with Farapulse, Boston Scientific, Galaxy Medical, and Biosense Webster, Inc. Dr Vijgen has received grant support from Biosense Webster, Inc. Dr Neuzil has received grant support from Biosense Webster, Inc. Dr Van Herendael has received support from Biosense Webster, Inc, for congress-related activities. Dr Verma has received grants from Biosense Webster, Inc, Medtronic, Bayer, and Biotronik; has received consulting fees from Biosense Webster, Inc, Medtronic, Adagio Medical, Galaxy Medical, Ablacon, and Thermedical; and has received honoraria for lectures from Biosense Webster, Inc, and Medtronic. Dr Skanes has served on the speakers’ bureau for Biosense Webster, Inc, and has received research support from Biosense Webster, Inc. Dr Scherr has received grant support from Biosense Webster, Inc. Dr Pürerfellner has received consulting fees from Biosense Webster, Inc, Abbott, Boston Scientific, Biotronik, and Medtronic, and has received payment or honoraria for lectures or presentations from Biosense Webster, Inc, Abbott, Boston Scientific, Biotronik, and Medtronic. Dr Jais has received research grants from Biosense Webster, Inc; has received speaker fees from Biosense Webster, Inc; is a shareholder of Farapulse/Affera; and has received speaker fees and research grants from Boston Scientific, Medtronic, and Abbott. Dr Reddy is a consultant for Biosense Webster, Inc; and unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for Abbott, AtriAN, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Johnson & Johnson MedTech has an agreement with the Yale Open Data Access Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant-level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the Yale Open Data Access Project site at http://yoda.yale.edu. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Effectiveness analysis in the per-protocol population. A, The primary effectiveness end point, which is 12-month freedom from AF/AT/AFL asymptomatic/symptomatic recurrences, and (B) clinical success, which is 12-month freedom from AF/AT/AFL symptomatic recurrences. AF indicates atrial fibrillation; AFL, atrial flutter; and AT, atrial tachycardia.
Figure 2.
Figure 2.
Predictors of primary effectiveness in Wave II. LVEF indicates left ventricular ejection fraction; OR, odds ratio; PAF, paroxysmal atrial fibrillation; and PFA, pulsed-field ablation.
Figure 3.
Figure 3.
Primary effectiveness success rate versus number of PFA applications per patient and per vein (post hoc analysis of Wave II cohort, n=158). PFA indicates pulsed-field ablation.
Figure 4.
Figure 4.
Frequency of PV reconnection by location at repeat procedure. LIPV indicates left inferior pulmonary vein; LSPV, left superior pulmonary vein; PV, pulmonary vein; RIPV, right inferior pulmonary vein; and RSPV, right superior pulmonary vein.
Figure 5.
Figure 5.
Freedom from atrial arrhythmia at 1 year in patients with paroxysmal AF reported among recently published multicenter studies of pulsed-field ablation. AF indicates atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia; EU-PORIA, EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation; FIH, first in human; IMPULSE, A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation; inspIRE, Study for Treatment of PAF by Pulsed-field Ablation System With Irreversible Electroporation; MANIFEST-PF, Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation; PAF, paroxysmal atrial fibrillation; PEFCAT, A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation; PEFCAT II, Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation; PF, pulsed field; Q-FFICIENCY, Evaluation of QDOT MICRO Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation; RF, radiofrequency; SPHERE-9 FIH, Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; and TTM, transtelephonic monitoring. *MANIFEST reported single-procedure freedom from AF/AT/AFL. †MANIFEST repeat procedure rate calculated based on a study manuscript reporting 87 repeat ablations among 1021 patients with PAF. ‡EU-PORIA repeat procedure rate calculated based on a study manuscript reporting 78 repeat ablations among 742 patients with PAF.
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