Light-driven endoscopic ablation isolates pulmonary veins for AF treatment

July 22, 2011

A recent study suggests that the HeartLight endoscopic ablation system from CardioFocus for transcatheter treatment of atrial fibrillation (AF) enables a pulmonary vein (PV) acute isolation rate of nearly 99%, with approximately 86% of PVs remaining persistently isolated after three months.

The HeartLight endoscopic ablation system received the European CE Mark in 2009, and is currently investigational in the U.S.

A recent study suggests that the HeartLight endoscopic ablation system from CardioFocus (Marlborough, MA) for transcatheter treatment of atrial fibrillation (AF) enables a pulmonary vein (PV) acute isolation rate of nearly 99%, with approximately 86% of PVs remaining persistently isolated after three months. Additional research also suggests that 65% of patients achieve durable freedom from AF after one procedure.

New clinical results supporting the safety and efficacy of the HeartLight system—which includes endoscopic visualization, a compliant balloon catheter and the delivery of light energy—were presented at Heart Rhythm 2011 in San Francisco, CA. The presentations included data from both a 200-patient international, multicenter clinical experience with the CardioFocus device (15 sites across four countries) and from a unique study that employed intracardiac diagnostic remapping on 56 paroxysmal AF patients, whether or not they were symptomatic, to determine the rate of persistent PV isolation.

In the 200-patient study, titled "Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience" and presented on May 6, researchers reported nearly 99% of all PVs were isolated following the HeartLight ablation procedure. Of the 107 patients that reached at least six months follow-up, 65% remained free from AF after a single ablation procedure. The procedure also demonstrated low complication rates including freedom from strokes, PV stenosis or atrial esophageal fistulae.

Catheter ablation therapy for paroxysmal AF has had the inability to create durable lesions in a single procedure to adequately isolate the pulmonary veins, says lead investigator Vivek Y. Reddy, MD, of Mount Sinai School of Medicine in New York. But the study using CardioFocus' HeartLight demonstrates that a high rate of PV isolation can be reproducibly achieved across multiple sites with a visually guided laser balloon catheter.

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