Novel Pulsed Field Ablation System Turns to High-Energy, Ultra-Short Zaps

The future of pulsed field ablation (PFA) technology could go in the direction of high-voltage nanosecond energy bursts, according to early results of a novel device. With CellFX nsPFA-360 PFA for paroxysmal atrial fibrillation (Afib or AF), acute electrical isolation of all pulmonary veins (PVs) was achieved in 100% of cases in a 177-person first-in-human study from a group led by Vivek Reddy, MD, of Mount Sinai Fuster Heart Hospital in New York City. The main safety result was a "reasonable" 1.7% incidence of device- or procedure-related serious adverse events: one each of inflammatory pericardial effusion, hemolysis with acute kidney injury, and stroke. Of note, there were no instances of phrenic nerve palsy, PV stenosis, esophageal complications, or death. The study was presented at the annual Heart Rhythm Society meeting and its manuscript published in JACC: Clinical Electrophysiology. Based on invasive remapping at 2-3 months, PV isolation (PVI) lesion durability reached 91% with 5-second applications with the CellFX system; this was notably better than the 79% durability seen with 2.5-second applications also tested. Additional nanosecond PFA was performed for incomplete lesions at this point. "It is well accepted that achieving durable PVI is essential for enhancing long-term freedom from atrial