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Doctors at St. Joseph’s Hospital Stopping Atrial Fibrillation Cold|
For years, Tampa resident Catherine DeMare had atrial fibrillation (AF) and lived with the irregular heartbeat and uncertainty that affects approximately three million Americans. That is, until a procedure stopped her AF cold, literally.
On January 10, 2011, just one day after the FDA approved the Arctic Front cryoballoon catheter for the treatment of AF, DeMare reported to St. Joseph’s Hospital in Tampa for surgery, hoping she would soon have the quality of life she had prior to being diagnosed with AF. She was one of the first patients in the country to undergo cryoballoon ablation, or “freezing,” of the pulmonary veins using the FDA-approved device.
“I waited for nearly three years because the procedure sounded so promising,” said DeMare. It worked; it was worth the wait. “Three months after my surgery, I was able to stop taking my medication,” said DeMare. “I was waiting to see if my irregular heartbeat would happen again and it didn’t. I actually forgot all about it.”
Her doctor, St. Joseph’s Hospital Electrophysiologist James Irwin, M.D., has worked with dozens of patients over the past few years who are now considered to be cured thanks to the Arctic Front.
“I have never seen more grateful patients than those who no longer have to live with the risk, uncertainty and discomfort of AF,” said Dr. Irwin.
How does it work? The Arctic Front catheter includes a balloon-like device that goes into the opening of the pulmonary veins. Dye is injected to assure that the opening of the pulmonary vein is closed off. Then a liquid refrigerant is used to scar the tissue so that it no longer spreads the electrical current that causes AF. Compared with spot (or radiofrequency) ablations, which have a 50 percent recurrent rate, the cryoablation boasts a seven percent recurrent rate for AF.
As one of the first doctors to utilize the Arctic Front, Dr. Irwin is one of the nation’s most experienced users of the device. He participated in all three stages of the FDA’s investigational trial, STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation), which tested the safety and efficacy of the Arctic Front. 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 North America.
The clinical trials found that 70 percent of patients treated with the cryoballoon were free from AF 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. The study further demonstrated that treatment with the device is safe. 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 most patients who qualify for the procedure, the Arctic Front is a cure for AF.
St. Joseph’s Hospital is the nation’s largest user of the Arctic Front, with two electrophysiologists specially trained to use the technology. Dr. Irwin, along with Electrophysiologist Kevin Makati, M.D., has helped cure AF in more than 350 patients. The team has averaged 6-8 procedures per week since the device was approved by the FDA.
“It’s really special to be able to cure someone,” said Dr. Irwin. I’m excited to see these patients for their follow up visits and hear how they’re enjoying life with no symptoms of AF.”
“I’m not worried about AF anymore, my husband isn’t worried about it, either,” said DeMare. “We don’t have to wonder about the ‘what ifs.’ I really feel good.”
As one of the first Arctic Front patients, DeMare has enjoyed the platform to share her story with others who suffer from AF. “People have seen my name in the news stories that I’ve done and they look me up and they call me. I just find that amazing. And then I tell them my experience,” said DeMare. “I kind of wonder why their doctor isn’t telling them.”
Meanwhile, Dr. Irwin’s feedback from the last 18 months was used in a redesign of the device, which was recently approved for use in the United States and Europe. The new Arctic Front Advance is now being tested at 10 hospital sites, including St. Joseph’s, prior to full market release in September.
“The benefit of the newest version of the cryoballoon, Arctic Front Advance, is that it freezes even more surface area, providing a more effective procedure with a shorter treatment time,” Dr. Irwin said. “The early results are very promising.
"In some of the cases I’ve done, I was delighted to see that the cooling and the effect were so quick. I’ve noticed a very different result than what I experienced with the older balloon,” said Makati. “We’re privileged at St. Joseph’s to be able to provide the early feedback on the redesigned Arctic Front Advance before it is available nationwide.”
St. Joseph’s Hospital Advanced Center for Atrial Fibrillation will set up a free one-on-one consultation with a cardiac RN to discuss your history with AF and help determine if you meet the clinical criteria for one of the procedures offered at St. Joseph’s Hospital. Call (813) 877-2342 for more information.