J&J study shows 25% of pulsed field ablation procedures performed with zero X-ray guidance

Johnson & Johnson MedTech’s Biosense Webster division presented new clinical data backing up its pulsed field ablation approach for treating atrial fibrillation, which was submitted for FDA review earlier this year.

The Varipulse system—including its multielectrode catheter, generator and J&J’s Carto 3 three-dimensional heart mapping software—aims to target the specific cells responsible for abnormal heartbeats, while sparing others by using short bursts of electric fields. 

At the annual meeting of the Heart Rhythm Society in Boston, the company presented additional, late-breaking results from the pivotal trial that laid the groundwork for its FDA submission delivered to the agency in March.

One-year data from the admIRE trial’s pivotal phase evaluated over 250 participants with intermittent AFib, demonstrating 100% acute procedural success in isolating the pulmonary vein, including 98% on the first pass per vein.

Overall, the study showed that 75% of treated patients were able to go 12 months without logging symptomatic or asymptomatic irregular heartbeats lasting longer than 30 seconds, including atrial fibrillation episodes as well as atrial tachycardia or flutter. 

In terms of safety, 2.9% of patients reported complications, with zero reports of procedure-related deaths, while 43% of patients were discharged the same day as their procedure.

Additionally, Biosense Webster pegged Varipulse’s median procedure time at about 90 minutes, including about 7 minutes of real-time fluoroscopy imaging, while some were able to avoid X-ray radiation altogether. 

“Differentiated by its unique Carto 3 System integration, this was the first PFA IDE study to support a substantial number of fluoro-free procedures; 25% of procedures were performed with zero fluoroscopy,” admIRE study co-investigator Vivek Reddy, director of electrophysiology at Mount Sinai Fuster Heart Hospital, said in the company’s announcement

J&J secured a groundbreaking approval from the FDA last year allowing several of its previous afib treatments to be used entirely with ultrasound and other heart-mapping hardware. The zero-fluoroscopy green light relied upon real-world evidence that showed therapies could still be safe and effective.

Meanwhile, the company recently launched the latest version of its Carto 3 system, its first to include artificial intelligence capabilities

Biosense Webster previously presented topline data from admIRE’s pilot phase, including fewer patients, earlier this year at the International AF Symposium.