Cryoballoon ablation did not prove less effective than radiofrequency ablation among patients suffering from drug-refractory paroxysmal atrial fibrillation or irregular and very fast heartbeat, a new study found.
The two established techniques for treating the underlying cause of a heart rhythm disorder called atrial fibrillation, showed similar efficacy and safety outcomes.
A team of researchers from Germany described the findings of the study in the American College of Cardiology (ACC) 2016 Scientific Sessions and published it in the New England Journal of Medicine.
Dubbed Fire And Ice, the study is considered the largest randomized trial to compare radiofrequency and cryoballoon ablation, two techniques used to disable small portions of the heart that generate irregular and erratic electric signals.
Atrial fibrillation or otherwise known as AFib, is an irregular heartbeat that could lead to blood clots, heart failure, stroke and other heart-related complications. According to the American Heart Association, about 2.7 million Americans are living with AFib. Worldwide, there is an estimated 33 million people with this illness.
Resolution of the heart rhythm is vital to prevent serious complications. Radiofrequency ablation is an older technique that uses heat energy to disable the tissue causing the problem. Cryoballoon, on the other hand, is a newer treatment procedure that uses extreme cold temperature to disable the same portions of the heart.
Among 762 patients suffering from AFib, 378 were subjected with cryoballoon ablation while the remaining 384 were treated with radiofrequency ablation. The average duration of the treatment was 1.5 years. The primary efficacy endpoint occurred in 138 patients in the cryoballoon group and 143 people in the radiofrequency group.
After the patients were subjected to the procedures, clinic visits were scheduled at three, six and 12 months, then every six months thereafter. During visits, an electrocardiogram (ECG) tests were done to assess the heart rhythm and function. A Holter monitor, wherein a patient wears a cardiac monitor for 24 hours to check any abnormal rhythm, was also used.
On average, the results show no significant difference in the rates of recurring irregular heart rhythm. In terms of safety, the primary safety endpoint happened in 40 participants in the cryoballoon group and 51 patients in the radiofrequency group.
"In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety," the researchers concluded.
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