Late-breaking results from the pivotal phase of the admIRE pivotal clinical trial, alongside results from the VIRTUE study—both assessing the Varipulse (Biosense Webster) pulsed field ablation (PFA) system— were presented at the Heart Rhythm Society (HRS) annual meeting (16–19 May, Boston, USA).
Twelve-month data from the pivotal phase of the admIRE study assessed the safety and efficacy of the Varipulse platform among 277 participants with paroxysmal atrial fibrillation (AF) treated across 30 healthcare centres in the USA by 39 operators.
Presentation highlights included 75% overall primary effectiveness success, 85% peak primary effectiveness for participants receiving 73–96 PFA applications for pulmonary vein isolation (PVI) and a 2.9% overall primary adverse event rate.
There were no reported incidents of device or procedure-related death, atrioesophageal fistula, coronary spasm, or haemolysis-related renal failure requiring haemodialysis. All patients achieved acute procedural success, with 98% first-pass isolation recorded per vein. The investigators noted a median procedure time of 81 minutes in PVI-only procedures, 90 minutes in all procedures, and a fluoroscopy time of 7 minutes.
Almost half—43%—of patients were able to leave the healthcare facility on the same day as their procedure. Additionally, 25% of procedures were performed without fluoroscopy, with no impact to safety or efficacy.
The admIRE study evaluated the safety and efficacy of the Varipulse platform to treat paroxysmal atrial fibrillation (PAF), and supported the premarket approval application to the US Food & Drug Administration (FDA) for the Varipulse platform.
“The admIRE study demonstrated good safety and effectiveness results. The primary effectiveness success was 74.6%, and among the subset of participants receiving 73–96 PFA applications for PVI, 85% achieved success. Primary safety events occurred in 2.9%, demonstrating promising evidence of the capabilities of the VARIPLUSE Platform,” said Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York, USA). “Differentiated by its unique Carto 3 system integration, this was the first PFA IDE [investigational device exemption] study to support a substantial number of fluoro-free procedures; 25% of procedures were performed with zero fluoroscopy.”
