Jan. 18, 2011 - Bethesda North Hospital is the first hospital in the Greater Cincinnati region to offer patients an innovative cryoablation treatment option using the only cryoballoon in the United States indicated to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF), a serious heart rhythm disorder that affects millions of Americans.
Recently approved by the U.S. Food and Drug Administration, the Arctic Front® Cardiac CryoAblation Catheter system is used to perform a minimally-invasive procedure that efficiently creates lesions around the pulmonary veins, which is the source of erratic electrical signals that cause the irregular heartbeat.
Bethesda North's first patient received the treatment in January 2011.
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 catheter stability.
“This technology gives cardiologists who treat atrial fibrillation another effective, safe, minimally invasive approach for patients who are not helped by medication,” said Gaurang Gandhi MD, electrophysiologist at Bethesda North. “This puts Bethesda North at the forefront of technology to treat this growing medical concern. It gives patients an option that may restore their heart to an appropriate rhythm so 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.