January 13, 2011 – St. Joseph's Hospital in Tampa, Fla., and the Baylor Jack and Jane Hamilton Heart and Vascular Hospital in Dallas, Texas, are among the first U.S. hospitals to treat patients with atrial fibrillation (A-fib) using a new freezing balloon technology. The minimally-invasive catheter system is the first of its kind in the United States and was approved by the U.S. Food and Drug Administration (FDA) just a few weeks ago.
The Arctic Front Cardiac CryoAblation Catheter system, by Medtronic, is the first and only cryoballoon in the United States indicated to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF).
Unlike traditional ablation treatments that use radiofrequency, or heat, to destroy faulty electrical circuits in the heart, the balloon-based technology ablates cardiac tissue through the use of a coolant, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater stability.
"The value of the new cryoablation technology over existing ablation methods is that it enables physicians to more safely isolate the pulmonary veins using a simple, efficient approach,” said Kevin Wheelan, M.D., medical director of Baylor Hamilton's electrophysiology program. “This minimally invasive procedure may give 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."
St. Joseph's Hospital electrophysiologist James M. Irwin, M.D., participated in all three stages of the STOP-AF trial that tested the safety and efficacy of the device. St. Joseph's Hospital in Tampa was one of 23 centers in the United States that enrolled patients for the trial, and quickly grew to become the largest enrolling center in all of North America.
"About three million Americans have A-fib, and I've been lucky enough to work with dozens over the past few years who now are considered to be cured, thanks to this procedure," Irwin said. "I have never seen more grateful patients than those who no longer have to live with the risk, uncertainty and discomfort of A-fib."
The cryoballoon treatment involves a minimally invasive procedure that creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.
Irwin says this new technology can cure A-fib. It is an option for patients who have found that medication alone does not control their episodes of rapid heart rhythm that start and stop suddenly for minutes or days at a time.
Clinical trials found that 70 percent of patients treated with the cryoballoon were free from A-fib after one year. Patients in the hands of physicians with more extensive experience with the procedure fared even better with a 90 percent cure rate. Patients experienced 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.
For more information: www.BaylorHeartHospital.com, www.BayCare.org