Visually-guided laser balloon ablation is as effective as standard ablation in treating paroxysmal atrial fibrillation, researchers announced today at the Heart Rhythm Society’s annual meeting in Boston.
Subjects in the 353-patient pivotal study of CardioFocus’s Heartlight device were randomly assigned to treatment with either the laser balloon or standard RF ablation.
Data showed that the treatments were similar, although treatment time was much higher for the VGLB arm and required more time under fluoroscopy. Principal investigator Dr. Vivek Reddy of the Mt. Sinai Hospital in New York said that was most likely due to the novelty of the Heartlight device.
"I was pleased. On 1 hand, I’d love to see the laser work better than point-by-point ablation; on the other hand, the majority of these operators have never touched this device and were expected to perform as well as a technology they’ve used hundreds of times," Reddy said today.
As the technology becomes more standard and physicians gain more experience with it, efficacy, safety and treatment times would all improve, he added
"One important point is you have to remember the physicians that performed the RF ablation procedures had a lot of experience with RF ablation. Each of them had performed hundreds, if not thousands, of RF ablations. In contrast, the physicians in the study had relatively little experience using the laser balloon. Even at the conclusion of the study they had relatively little experience – none of the operators had performed more than 15 procedures. Despite that, again, there was similar efficacy. Why does that matter? If we look at European experience where this device has been approved, just as with the cryoballoon, you have improvements in efficacy, you have improvements in safety."
The rate of phrenic nerve palsy in VGLB treatments was higher than in standard ablation, at 3.5% versus 0.6%. Reddy said that although phrenic nerve injuries should be treated seriously, most cases were asymptomatic and all but 1 case in the study had recovered within 12 months.
Also released this week was non-inferiority data on cryoballoon ablation. Reddy reported that VGLB was non-inferior to cryoablation in terms of efficacy, and superior in terms of safety, noting that the study did not have data from next-generation cryoballoons.
"This has truly been a tremendous effort from everyone involved including our dedicated employees and esteemed clinical investigators. As the developers of a completely new technique to treat atrial fibrillation, it is a significant honor to have our data presented as a late-breaking clinical trial to the greater community of arrhythmia specialists. We look forward to continuing our favorable progress for this potentially important treatment for atrial fibrillation," CardioFocus president Stephen Sagon said in prepared remarks.
CardioFocus said it plans to submit the pivotal study data to the FDA as part of an ongoing pre-market approval process for Heartlight.