Twelve-month results of the inspire study investigating predictors of successful pulmonary vein isolation with pulsed-field ablation (PFA) using a variable-loop catheter with 3D mapping integration were presented as an updated presentation at AF Symposium 2024. (1-3) February, Boston, USA).
Interim results from the admIRE study evaluating PFA using a variable loop circular catheter with 3D mapping integration were also shared in the conference’s latest presentation. Both trials were sponsored by his Biosense Webster.
Both the inspire and admIRE studies were conducted using the Biosense Webster Varipulse platform, which consists of the Varipulse catheter, a fully integrated variable loop multielectrode catheter. Trupulse Generator – Multichannel PFA generator. The Carto 3 System Varipulse Service Pack software provides complete integration with 3D cardiac mapping systems.
“BioSense Webster is committed to advancing our portfolio of versatile and differentiated PFA solutions designed to help electrophysiologists deliver safe, effective and efficient cardiac ablation procedures. ” said Jasmina Brooks, President of Biosense Webster. “The encouraging results from the Varipulse clinical trial make us even more excited as we continue to deliver innovations that meet the diverse needs and ablation strategies needed to successfully treat atrial fibrillation. .”
The inspire study evaluated the safety and efficacy of the Varipulse platform in the treatment of drug-resistant paroxysmal atrial fibrillation in Europe and Canada. In this study, the primary efficacy endpoint of acute pulmonary vein isolation and absence of atrial arrhythmia recurrence (AF, atrial tachycardia, or atrial flutter) over a 12-month period was 75.6%.
Of the participants who received the optimal PFA application, 80% met the primary efficacy endpoint. This study reported that integrating the Varipulse platform into the Carto 3 system reduced fluoroscopy time to 7.8 minutes. Safety results demonstrated a primary adverse event rate of 0.0%.
“The high efficacy and strong safety profile of 80% freedom from atrial recurrence at 12 months of age are encouraging evidence of the power of the Varipulse platform,” said corresponding author Vivek Reddy, PhD, PhD, PhD, PhD, PhD, at Mount Sinai, New York, USA. (Icahn School of Medicine) said. “The Varipulse platform is designed to seamlessly integrate with his Carto 3 mapping system, allowing the technology to reduce radiation exposure to both patients and laboratory staff while minimizing radiation exposure to atrial cells,” he told the inspire research publication. We should be able to effectively treat dynamic patients.”
Twelve-month outcome data from the pilot phase of the admIRE study evaluating the safety and efficacy of the Varipulse platform in U.S. patients was presented as an update at the AF Symposium. Of the 20 patients who completed the 12-month follow-up visit, 100% had acute success from the ablation procedure, and 80% had no recurrence of atrial arrhythmia after 1 year.
No major adverse events related to the procedure or device were reported during the pilot phase of the study. For patients undergoing ablation, Carto integration resulted in median procedure and fluoroscopy times of 90 minutes and 3.5 minutes, respectively.
“The results observed in the pilot phase of the admIRE study demonstrate the promise of the Varipulse platform in the treatment of patients with paroxysmal AF,” said David Newton (Memorial Health University Medical Center, Savannah, USA). “These initial results are encouraging and demonstrate the potential of the Varipulse platform to become a key component of the suite of tools at electrophysiologists’ disposal to perform catheter ablations.”
