October 1, 2021Open Access
View Full PaperAcute safety and performance outcomes from the inspIRE trial using a novel pulsed field ablation system for the treatment of paroxysmal atrial fibrillation
Key Result
A novel integrated biphasic pulsed field ablation system achieved 100% acute procedural success for pulmonary vein isolation with zero primary adverse events in 35 patients with paroxysmal AF.
Structured PICO
Does a novel fully integrated biphasic pulsed field ablation system safely and effectively achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation?
P
Population
35 patients with paroxysmal atrial fibrillation treated across 5 European sites to assess the acute safety and performance of a novel pulsed field ablation system.
I
Intervention
Pulmonary vein isolation (PVI) using a novel fully integrated biphasic pulsed field ablation (PFA) system (multi-channel generator, variable decapolar irrigated loop circular catheter, and mapping system).
O
Outcome
Acute procedural effectiveness (entrance block in all clinically targeted PVs post adenosine/isoproterenol challenge) and incidence of primary adverse events (PAEs).safety
A novel fully integrated biphasic pulsed field ablation system demonstrated 100% acute procedural success for pulmonary vein isolation with no primary adverse events in an initial cohort of 35 patients with paroxysmal atrial fibrillation.
Abstract
Abstract Background/Introduction The inspIRE clinical trial was designed to assess the safety and efficacy of a fully integrated biphasic pulsed field ablation (PFA) system comprised of a multi-channel generator, variable decapolar irrigated loop circular catheter, and mapping system (Figure A) for the treatment of paroxysmal atrial fibrillation (PAF). Purpose Using this novel PFA system in a multicentre clinical trial, we present the initial feasibility of electrical pulmonary vein isolation (PVI), procedural performance, and acute safety results. Methods inspIRE is a prospective, non-randomized, multi-centre study, planned to enrol up to 550 patients. PVI is performed with the novel, variable loop circular catheter, compatible mapping system and generator. Acute procedural effectiveness (entrance block in all clinically targeted PVs post adenosine/isoproterenol challenge) and the incidence of primary adverse events (PAEs) were assessed. PAEs are defined as the occurrence of cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack, permanent phrenic nerve paralysis, pulmonary edema, pericarditis, and any major vascular access complications within 7 days of the ablation procedure. Additionally, any incidence of procedure or device related death, atrio-esophageal fistula, or PV stenosis (related to the ablation procedure or study catheter) within the 12M follow-up period is classified as a PAE. Results A total of 35 PAF subjects (age 59.7±10.7 years, 54.3% male) were treated across 5 European sites by 6 operators. Acute procedural success was achieved in 100% of study subjects (Figure B) with zero incidence of PAEs. Mean total procedure time was 82.9±19.9 minutes with 27.0±11.9 minutes of PFA from first to last application. Average fluoroscopy use was 10.6±6.8 minutes and LA dwell time was 45.6±15.3 minutes. Conclusion Initial results of the inspIRE trial demonstrate the acute safety and effectiveness of the new integrated IRE circular catheter, mapping system and generator for PVI in PAF patients. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): inspIRE is a company-sponsored study funded by Biosense Webster, Inc. Figure 1. (A) PFA System; (B) PVI Voltage Map