Unlike traditional ablation treatments that use radiofrequency, or heat, to destroy faulty electrical circuits in the heart, the balloon-based technology of Arctic Front is novel because it ablates cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.
Dr. Kevin Wheelan, medical director of Baylor Hamilton's electrophysiology program, says "The value of the new cryoablation technology over existing ablation methods is that it enables physicians to safely and effectively isolate the pulmonary veins via a simple, efficient approach. This minimally invasive procedure gives patients peace-of-mind that their heart may be restored to an appropriate rhythm and they can resume their normal, daily activity following the treatment."
According to the STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which served as the basis for FDA approval, 69.9 percent of patients treated with Arctic Front achieved treatment success at 12 months, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1 percent), and a reduction in adverse events caused by atrial fibrillation when compared to drug therapy. Additionally, patients treated with Arctic Front displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors. Baylor Hamilton Heart and Vascular Hospital was the lead enrolling site in the STOP-AF study in the United States and Canada.
About Atrial Fibrillation
Atrial fibrillation is the most common and one of the most undertreated heart rhythm disorders in America. Approximately 3 million Americans are estimated to have the disease, and about 40 percent don't exhibit symptoms and may be under-diagnosed.
Half of all diagnosed atrial fibrillation patients fail drug therapy, and if left untreated patients have up to a five times higher risk of stroke and an increased chance of developing heart failure. Additionally, since atrial fibrillation is often age-related, as the U.S. population continues to grow older, the need for more effective treatment options is escalating.
Paroxysmal atrial fibrillation (PAF) is a type of atrial fibrillation in which irregular heartbeats in the upper chambers start and stop suddenly on their own, usually for minutes or days at a time.
