Biosense Webster Varipulse PFA system performs well with minimal adverse events
The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. The positive data was used by the vendor to support its recent premarket approval application for the device to the U.S. Food and Drug Administration.
Twelve-month data presented from the admIRE study assessed 277 patients treated at 30 U.S. 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).
- 2.9% overall primary adverse event rate.
- 100% of patients achieved acute procedural success.
- 98% first-pass isolation recorded per vein.
- 43% of patients were discharged the same day as their procedure.
- 25% of procedures were performed without fluoroscopy due to full integration of the Varipulse with the Carto 3 mapping system.
There were no reported incidents of device- or procedure-related death, atrio-esophageal fistula, coronary spasm, or hemolysis-related renal failure requiring hemodialysis,
"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 Varipulse platform," Vivek Reddy, MD, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York, explained in a statement. "Differentiated by its unique Carto 3 system integration, this was the first PFA IDE study to support a substantial number of fluoro-free procedures."
The study found, overall, the median procedure time was 81 minutes for PVI-only procedures, 90 minutes in all procedures, and a fluoroscopy time was and average of 7 minutes.
Data from the VIRTUE study were also presented at the HRS annual meeting. This study evaluated the use of the Varipulse PFA system in a more real-world patient treatment population with paroxysmal and persistent AFib, as well atypical atrial flutter. The study includes both first-time and redo procedures. Of the 125 patients in the VIRTUE trial, only 23% would have met the criteria for the admIRE trial. Ablation beyond PVI was performed in 80% of study participants. PFA was demonstrated to be able to treat a variety of paroxysmal and persistent AFib patients, as well as those with atypical atrial flutter, with lesions beyond PVI.
PFA was the hottest topic at HRS 2024
The admIRE study was among five late-breaking trials on PFA technology. Numerous other PDA presentations were made in sessions. PFA was by far the hottest topic at HRS 2024. The first two vendors to gain FDA clearance for their PFD devices, Medtronic and Boston Scientific, had large models of their PFA catheters in the front of their booths. Boston's booth was covered in the flower shapes that its PFA catheter makes when deployed for ablations. Both vendors also had training areas to show EPs how the technology works on simulators.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com