ESC Data Points To Reduced AF Ablation Redo’s With HeartLight® When Compared With Cryoballoon

 

In short

New data presented at the European Cardiology congress last week shows pulmonary vein isolation (PVI) using the CardioFocus HeartLight® device leads to a 99% acute success rate and up to an 82% chronic success rate at 12 months follow-up.

In addition, the research indicates the HeartLight laser balloon technology resulted in improved long-term outcomes after a single procedure as compared with the cryothermal balloon catheter although the device tested was no doubt the previous iteration of Medtronic’s Arctic Front.

Background

Only last week we covered Medtronic’s announcement that its Arctic Front® Advance™ next generation Cryoballoon had gained CE Mark and FDA approval, with the company claiming improved performance in the treatment of paroxysmal atrial fibrillation (PAF) compared with its predecessor and its competitors. Almost simultaneously CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) was preparing a press release to trumpet data presented at last week’s ESC congress in Munich.

We’ve covered HeartLight quite extensively on our pages, not least because it represents a departure from the approaches to PV isolation adopted by its competitors. Firstly it delivers laser energy and secondly it does so using a combination of a locating balloon and direct visualisation, which has the added benefit of reducing the need for extended fluoroscopy. So in theory the device has a few good cards in its hand and it’s not difficult to imagine the combination of features delivering solid results. And so it seems this is the case, although the company press release is at pains to point out that the scientific information discussed in its news release is preliminary and investigative. Notably too the CardioFocus HeartLight Endoscopic Ablation System is not FDA approved.

The studies

In the presented study titled, “Laser or Cryo? Prospective comparison of balloon based PVI technologies,” researchers from Cardioangiologisches Centrum Bethanien (CCB), Frankfurt, Germany allocated 140 patients 1:1 to undergo catheter ablation with the HeartLight laser balloon or the cryothermal balloon (Medtronic Arctic Front®). Acute isolation rates were comparable (98.9% vs. 99.6%, respectively). However, during 12-months follow-up, 37% of patients treated with the cryoballoon experienced AF recurrence vs. only 27% treated with a single HeartLight system procedure.

After repeat procedures with radiofrequency ablation as needed, both technologies demonstrated a chronic success rate of approximately 80%, though notably, the number of redo procedures was twice as high with the cryothermal balloon vs. HeartLight (22 vs. 11). Analysis of the veins themselves also demonstrated a 37% relative risk reduction of PV reconnection using the HeartLight technique.

In a second presentation, titled “Pulmonary vein isolation for paroxysmal atrial fibrillation with the laser balloon,” researchers at Na Homolce Hospital in Prague, Czech Republic, highlighted outcomes of three years (2009-2011) of HeartLight cases at their centre. They found that at a mean 12 months follow-up, 82% of patients remained free from AF. In addition, acute PVI was documented at 100% for all of 2011, supporting the short learning curve and high reproducibility of the procedure

Company comments

Stephen Sagon, President and CEO of CardioFocus, said, “The presented outcomes data with the HeartLight system are particularly impressive because high chronic success rates have been elusive, let alone from a single procedure.  We are encouraged by the continued performance of our system and its positive impact on patient care, especially as compared with alternative ablation technologies. As physicians hone their technique with endoscopically guided ablation, we anticipate further studies reinforcing these durable success rates.”

Clinician comments

“We were interested in prospectively evaluating the outcomes achievable with HeartLight compared to the established cryothermal balloon catheter,” said Boris Schmidt, MD, of CCB. “While we found the systems to have comparable safety and acute efficacy outcomes, the HeartLight system, in fact, led to a higher rate of longer-term freedom from AF after a single procedure. We look forward to further, multicenter study on this comparison.”

On the Czech study, Prof. Petr Neuzil, MD, of Na Homolce Hospital said; “These data are a testament to our positive experiences with the HeartLight Endoscopic Ablation System since its incorporation into our practice over three years ago. Our research demonstrates the laser balloon PV isolation procedure to be safe, with acute results comparable to those of radiofrequency ablation procedures and longer-term results showing a compelling degree of continued isolation.”

Regulatory status

The HeartLight Endoscopic Ablation System is CE marked and commercially available at leading institutions throughout Europe and in Australia. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012.

Source: CardioFocus, PR Newswire