Twelve-month results from the inspIRE study, investigating predictors of success for pulmonary vein isolation with pulsed field ablation (PFA) using a variable loop catheter with 3D mapping integration have been presented as a late-breaking presentation at AF Symposium 2024 (1–3 February, Boston, USA).
Interim results from the admIRE study, assessing PFA using a variable loop circular catheter with 3D mapping integration were also shared in a late-breaking presentation at the meeting. Both trials were sponsored by Biosense Webster.
Both the inspIRE and admIRE studies were conducted using the Biosense Webster Varipulse platform, consisting of the Varipulse catheter—a fully integrated variable-loop multielectrode catheter; the Trupulse generator —a multichannel PFA generator; and the Carto 3 system Varipulse service pack software, which provides full integration with the 3D cardiac mapping system.
“Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures,” said Jasmina Brooks, president, Biosense Webster. “The encouraging outcomes from clinical trials with Varipulse fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation.”
The inspIRE study evaluated the safety and effectiveness of the Varipulse platform for the treatment of drug-refractory paroxysmal AF in Europe and Canada. In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, atrial tachycardia, or atrial flutter) was 75.6%.
Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint. The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the Varipulse platform to the Carto 3 system. The safety results demonstrated a primary adverse event rate of 0.0%.
“High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the Varipulse platform,” said Vivek Reddy (Icahn School of Medicine at Mount Sinai, New York, USA), corresponding author for the inspIRE study publication “As the Varipulse platform was designed to integrate seamlessly with the Carto 3 mapping system, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike.”
Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the Varipulse platform among US patients, were presented as a late-breaker at the AF Symposium. Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.
No procedure or device-related primary adverse events were reported in the pilot phase of the study. For patients who had received ablation, median procedure and fluoroscopy times were 90 and 3.5 minutes, respectively, as a result of the Carto integration.
“The results observed in the pilot phase of the admIRE study point to the promise of the Varipulse platform in treating patients with paroxysmal AF,” said David Newton (Memorial Health University Medical Center, Savannah, USA). “These initial results are encouraging and demonstrate the potential for the Varipulse platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations.”
