CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces new worldwide data with its technology was presented during the scientific sessions at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions, in Boston, MA last month. The research, representing the first 400 patients treated solely with the HeartLight system, demonstrates an overall 98% acute pulmonary vein (PV) isolation rate, further supporting the high reproducibility of the procedure in clinical practice.
Lead author Boris Schmidt, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, said, "The positive results reported in this multicenter study remain consistent with those of numerous smaller-scale experiences, demonstrating that ablation with HeartLight EAS can be performed with high acute success even by those with limited experience, and helping to validate the continued application of the system in clinical practice. While this presentation focused on acute treatment and initial cases at these worldwide centers, research is ongoing to further evaluate long-term outcomes with a single procedure."
Titled "Worldwide Experience Using the Endoscopic Ablation System for Ablation of Atrial Fibrillation," the aim of the study was to analyze feasibility and safety of AF ablation using the HeartLight EAS, with the primary endpoint being acute PV isolation. It collected data on 406 patients, drawn both from registries (n=170) and clinical studies (n=236), treated by 33 physicians at 16 medical centers throughout the world. Overall, physicians achieved an acute PV isolation rate of 98%, with 79% of veins being isolated on the very first visually-guided attempt. At 12 months following the single procedure, approximately 60% of patients remained in sinus rhythm.
Average procedure time overall was 180+/-58 min including 107+/-36 min in the left atrium (LA), with average fluoroscopy time of just 29+/-19 min. Notably, procedure time decreased dramatically after about 15 cases, suggesting a short learning curve associated with the technology.
International experiences with the device were also highlighted at a private academic symposium held in conjunction with the meeting. Electrophysiology thought leaders from the Czech Republic, Germany, the Netherlands and the UK presented on topics regarding the adoption of the system in clinical practice. The physicians also highlighted their experiences refining the new visually-guided laser balloon ablation technique, including continued advances in standardizing variables such as device positioning and energy titration for improved clinical results. Recent published data referenced at the symposium suggest approximately 77% of patients may achieve durable freedom from AF after a single procedure.
Stephen Sagon, President and CEO of CardioFocus, said, "Last year at this meeting, physicians presented data on the first 200 patients treated with the HeartLight EAS. This year's even more comprehensive 400-patient study provides comparable data, further supporting the reproducibility of the procedure and its increasingly widespread utility in the treatment of AF."
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