BOSTON — In this video, Vivek Y. Reddy, MD, director of electrophysiology at Mount Sinai Medical Center in New York, presents results of the HEARTLIGHT study, which compared a visually guided laser balloon with radiofrequency ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
The prospective, randomized trial was the first to assess the visually guided laser ablation catheter (HeartLight Endoscopic Ablation System, CardioFocus) in the United States. The trial involved nearly 400 patients across more than 20 centers nationwide.
Reddy presented findings at the Heart Rhythm Society Annual Scientific Sessions showing that the overall rate of adverse events was low among patients assigned the visually guided laser ablation catheter or radiofrequency ablation. He noted that more patients experienced phrenic nerve injury in the laser group, but that virtually all patients recovered from the injury. No patients in the laser group experienced pulmonary vein stenoses.
Device success at 1 year, defined as freedom from AF and procedural success, was similar between the groups and in the mid-60% range. Reddy noted that the similar success rate between the treatments was particularly interesting due to the relative inexperience the operators had with the new technology: Few of the operators had performed more than 15 procedures with the laser balloon catheter, but all had extensive experience with radiofrequency ablation.
He concluded that the trial achieved both its efficacy and safety endpoints for noninferiority, and that the results provide a basis for the FDA to evaluate this technology for potential future approval in the United States.