Article ; Online: 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.
Circulation. Arrhythmia and electrophysiology
2024 , Page(s) e012667
Abstract: Background: We previously presented the safety and early efficacy of inspIRE study (Pulsed-Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation by Irreversible Electroporation). With the study's conclusion, we report the ... ...
Abstract | Background: We previously presented the safety and early efficacy of inspIRE study (Pulsed-Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation by Irreversible Electroporation). 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 CHA 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. |
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Language | English |
Publishing date | 2024-04-24 |
Publishing country | United States |
Document type | Journal Article |
ZDB-ID | 2426129-4 |
ISSN | 1941-3084 ; 1941-3149 |
ISSN (online) | 1941-3084 |
ISSN | 1941-3149 |
DOI | 10.1161/CIRCEP.123.012667 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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