A shorter learning curve, more procedural flexibility and direct visual guidance were all design factors for researchers while designing the HeartLight® Endoscopic Ablation System that recently received premarket approval from the FDA. It is intended for treatment of paroxysmal atrial fibrillation patients.
To learn more about the system and the corresponding study, Surgical Products connected with Dr. Frank Cuoco, an associate professor of medicine, division of cardiology at the Medical University of South Carolina, and study contributor.
What was your first impression of the Cardiofocus Heartlight System?
Cuoco: It seemed intuitive. The ability to actually visualize the pulmonary veins and see where we were going to ablate was exciting and novel. It expands on other technologies because of this unique feature (the direct visualization) as well as its flexibility. Unlike other balloon catheters (i.e. cryo or hot ballon) the Heartlight balloon is compliant and can be “sized” to fit a variety of pulmonary veins. This helps make the ablation procedure easier and more efficient, as you do not have to “work as hard” to fit the balloon into the antrum of the vein and get occlusion. It also obviates the need to switch out catheters for different sized balloons during the procedure. It also flexible in that it allows the operator to titrate power along different areas of the vein – this enabling the proceduralist to use more power in regions where the pulmonary vein tissue is thicker and less power where it is thinner and/or there are ancillary structures that we are trying to avoid injuring (i.e. the esophagus or phrenic nerve).
My first experience with the catheter confirmed these features. It’s flexibility and intuitiveness made even my initial procedures straightforward and efficacious with a short learning curve. In short, it made sense and was relatively easy to use (and i had no prior balloon catheter experience with this system or with cryo).
What did you take away from the study?
Cuoco: With more use of the system I found that this procedure was clearly safe – which is key with any new technology – it HAS to be safe as well as efficacious. The data from the trial confirmed this – showing, in fact, that once operators reached the “learning curve” the safety of the Heartlight system was actually trending better than traditional RF. I felt very comfortable offering this new technology to patients because I felt comfortable that its safety profile was excellent, and additionally the durability of the PV isolation was very good. I knew from my own patients that our success rates were very good as the recurrence rate was low. I am excited to offer this technology to our patients going forward.
