January 25, 2012 — CardioFocus, Inc. developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF) announced that a new study in the Journal of Cardiovascular Electrophysiology demonstrated the high acute and chronic success rates achievable with a single AF ablation procedure using HeartLight EAS. The study was conducted by Boris Schmidt, M.D., and colleagues at Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
The HeartLight EAS is a catheter ablation system that incorporates an endoscope for direct visualization of a beating heart, in real-time and without radiation. It also includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the pulmonary vein (PV) ostium (opening) irrespective of the individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation treatment.
"In this study we set out to examine the feasibility of performing a streamlined, visually-guided ablation procedure and record best practices to achieve endpoints of acute and chronic success. Our findings demonstrate that this unique approach to ablation may prove highly effective in treating AF patients," said Schmidt.
In the study, "Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success," physicians performed ablation with a single HeartLight EAS and single transseptal puncture on 35 patients with drug-refractory paroxysmal or persistent AF. PV isolation was achieved in 70% (96/137) of veins with an initial ablation. After assessment with a circular mapping catheter, continued ablation with the same HeartLight EAS device resulted in an overall 98% single procedure PV isolation rate.
Procedures were performed in a mean time of 154+ 38 min, with the ablation stage lasting an average of 89+ 16 min and mean fluoroscopy time of 16 + 6 min. Notably, between the first and last 12 cases a reduction in procedure time was observed (175 + 48 min vs. 138 + 26 min). The primary efficacy endpoint of the study was acute PVI, with a secondary endpoint of freedom from AF between 90 and 365 days post-ablation and off antiarrythmic drugs. During a median follow-up of 266 days, 77% (27/35) of patients remained free of any tachyarrhythmia recurrence and off drugs.
"With the increasing use of catheter ablation as a treatment option for AF patients, the short learning curve and simplified approach enabled by the HeartLight EAS makes this a very promising system, especially as the technique continues to be adopted outside specialized ablation centers," continued Schmidt. "In the paper we documented our approach to performing ablation on our center's first series of patients to undergo treatment with the HeartLight EAS, and we believe that as the procedure continues to be standardized, additional centers will experience these impressive, reproducible results."
For more information: www.cardiofocus.com