Endoscopic Ablation For AF Gains Study Support

In short

Endoscopic ablation for atrial fibrillation (AF) is a new technique that is generating a lot of excitement. CardioFocus, Inc., developer of the ground-breaking HeartLight® Endoscopic Ablation System (EAS), announced at Cardiostim 2012 last week that a unique study in the journal Heart Rhythm demonstrated high acute success (98%) and durable pulmonary vein (PV) isolation rates achievable with a single, visually-guided HeartLight EAS ablation procedure.

To determine durability, the study involved a subsequent diagnostic remapping procedure that found 86% of PVs remained electrically isolated after three months. Furthermore outcomes improved after only ten cases, suggesting a short learning curve.

Background

CardioFocus, Inc. is a medical device manufacturer specialising in ablation treatment for cardiac disorders such as atrial fibrillation. Its novel HeartLight® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to actually see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.

HeartLight EAS incorporates an endoscope for direct visualization of a beating heart and a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium irrespective of individual patient anatomy. The company claims its system, by utilising laser energy provides more efficient, durable and precise ablation treatment, presumably than its RF-based competition.

The study

The multicentre study, entitled “The Durability of Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon Catheter: Multicenter Results of Pulmonary Vein Remapping Studies” and authored by Srinivas R. Dukkipati, MD, Mount Sinai School of Medicine, New York, is published in the June 2012 issue of the journal Heart Rhythm.

Researchers looked at the first 56 patients treated with HeartLight EAS by 10 primary operators at three European sites, resulting in an acute PV isolation rate of 98% (202/206). At approximately three months follow-up (105 +/= 44 days), 52 patients returned for a remapping procedure to reconfirm electrical isolation, in which researchers found 86% (162/189) of PVs remained isolated. During the remapping, if a PV had reconnected, physicians performed repeat ablation. At an average follow-up of one year (12.0 +/= 1.8 months post remapping), 71% of patients remained free from AF and off anti-arrhythmic drugs.

Notably, after performing only 10 cases, physicians began to see improved outcomes. Data from the remapping shows physicians who performed fewer than 10 cases achieved a durable PV isolation rate of 73% (38/52), while physicians who had performed 10 or more cases achieved a rate of 89% (127/142).

Clinician comments

“The goal of catheter ablation for paroxysmal AF is durable PV isolation, and this study demonstrates that the unique compliant, variable-diameter balloon catheter and laser energy source of the HeartLight EAS enables the placement of circumferential and continguous lesions for high rates of acute and persistent PV isolation,” said Dr. Dukkipati. “Through the insights gleaned in the remapping procedures we have been able to hone our techniques for energy application, catheter positioning and other procedural elements and are continuing to obtain impressive clinical outcomes with the system.”

Company comments

“This data continues to contribute to the growing body of research supporting HeartLight EAS as an effective treatment option for AF with a remarkably quick learning curve,” said Stephen Sagon, President and CEO of CardioFocus. “As adoption continues throughout Europe and momentum builds in our U.S. pivotal trial, we are excited that such positive clinical experiences are being documented by leading electrophysiologists and shared in prominent forums such as the journal Heart Rhythm.”

Regulatory status

The device is CE marked and commercially available in Europe. It is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012.

Source: Cardiofocus Inc., PR Newswire