A new study demonstrates the high acute and chronic success rates achievable with a single atrial fibrillation ablation procedure using the HeartLight endoscopic ablation system (CardioFocus). The study was conducted by Boris Schmidt and colleagues at Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, and was published online in the Journal of Cardiovascular Electrophysiology, in January 2012.
In the study, “Visually guided sequential pulmonary vein isolation: Insights into techniques and predictors of acute success,” Schmidt and colleagues performed ablation with a single HeartLight endoscopic ablation system (CardioFocus) and single transseptal puncture on 35 patients with drug-refractory paroxysmal or persistent atrial fibrillation. Pulmonary vein 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 device resulted in an overall 98% single procedure pulmonary vein isolation rate.
“Pulmonary vein isolation is a critical indicator of success in catheter ablation procedures for atrial fibrillation; however, this has traditionally been a very challenging and complex endeavor requiring an experienced operator, multiple ablation devices to account for varied patient anatomy, and even multiple transseptal punctures for access,” said Schmidt. “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 atrial fibrillation patients.”
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 pulmonary vein isolation, with a secondary endpoint of freedom from atrial fibrillation 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 atrial fibrillation 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 specialised ablation centres,” said Schmidt. “In the paper we documented our approach to performing ablation on our centre’s first series of patients to undergo treatment with the HeartLight EAS, and we believe that as the procedure continues to be standardised, additional centres will experience these impressive, reproducible results.”
About the HeartLight endoscopic ablation system
The HeartLight EAS is a catheter ablation system that incorporates, for the first time, an endoscope for direct visualisation 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 ostium (opening) irrespective of the individual patient anatomy, and utilises laser energy for more efficient, durable and precise ablation treatment.
HearhLight is commercially available in Europe. The device is investigational in the USA, with a pivotal study expected to commence in 2012.