Novel mapping-integrated pulse field ablation system meets feasibility, pivotal endpoints
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A novel mapping-integrated pulsed field ablation system for treatment of paroxysmal atrial fibrillation met safety and performance goals in the feasibility and pivotal phases of a trial, researchers reported at AF Symposium.
Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and The Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, and colleagues conducted the inspIRE study of the fully integrated biphasic pulsed field ablation system (Varipulse catheter and Trupulse generator, Biosense Webster) to determine whether it could safely and effectively treat symptomatic, drug-refractory recurrent paroxysmal AF. The results were simultaneously published in Circulation: Arrhythmia and Electrophysiology.
“This was the first-in-human experience with this technology,” Reddy told Healio. “We wanted to understand the safety with ablation, whether there were any effects on the esophagus or narrowing of the pulmonary vein, and to understand the effectiveness.”
For the single-arm study conducted in 13 European centers, the researchers enrolled 226 patients, of whom 40 were in the first wave to assess for initial safety and the remainder were in the second wave to assess for the primary safety endpoint of early-onset primary adverse events and the primary effectiveness endpoint of freedom from atrial arrhythmias at 12 months.
In the first wave, there were no esophageal thermal lesions or pulmonary vein stenosis, according to the researchers.
Of the first six patients in the first wave, four had silent cerebral lesions, after which the researchers made adjustments to the procedure’s workflow, including a 10-second pause between pulsed field ablation applications. Following that, of the remaining 33 patients who had a cerebral MRI, four had a silent cerebral lesion.
In the second wave, there were no cases of silent cerebral lesions or other primary adverse events.
Among the 83 patients who reached 12-month follow-up, 97.1% of targeted pulmonary veins were achieved without acute reconnection. The primary effectiveness endpoint was achieved in 70.9% of patients, whereas freedom from recurrence of symptomatic AF/atrial flutter/atrial tachycardia was achieved in 78.9% and freedom from repeat ablation was achieved in 92.3%, according to the researchers.
The mean total procedure time was 70.1 minutes and the mean transpired pulsed field ablation time was 26.7 minutes, Reddy and colleagues found.
“What’s unique about this pulsed field ablation system is that it’s linked to a mapping system, which worked very well,” Reddy told Healio. “It was also very efficient. Every operator was using this for the first time, so a mean skin-to-skin procedure time of 70 minutes in the second wave is pretty extraordinary.”
A parallel trial in U.S. centers, admIRE, is ongoing, with results expected in 2024, Reddy told Healio.
The system is not yet approved for commercial use in the United States.
Reference:
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Reddy VY, et al. Late Breaking Clinical Trials and First Report Investigations and Best Abstract Award. Presented at: AF Symposium; Feb. 2-4, 2023; Boston.
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