Patients with atrial fibrillation who received cryoballoon catheter ablation had lower healthcare costs and fewer rehospitalizations and repeat ablations compared with those who received radiofrequency ablation, according to a health economic analysis.
The findings were presented Oct. 13 during a late-breaking clinical trial session at the Asia Pacific Heart Rhythm Society's Scientific Sessions in Seoul, South Korea.
The primary results of the study, which enrolled 762 patients with drug-refractory paroxysmal atrial fibrillation, were published in the New England Journal of Medicine in April. Medtronic, which manufactures the Arctic Front cardiac cryoablation catheter, funded the study.
The FDA approved the Arctic Front advance ST cryoablation catheter in May 2015 for patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
After a mean follow-up period of 1.5 years, the primary efficacy endpoint occurred in 138 patients randomized to the cryoballoon group and in 143 patients randomized to the radiofrequency group. The primary safety endpoint occurred in 40 and 51 patients, respectively. Neither difference was statistically significant.
The primary efficacy endpoint was the recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs or repeat ablation following a 90-day period after the index ablation. The primary safety endpoint was a composite of death, cerebrovascular events or serious treatment-related adverse events.
The data presented at the Asia Pacific Heart Rhythm Society's Scientific Sessions showed that the cryoablation group used fewer post-procedure healthcare resources and had fewer repeat ablations and reinterventions than the radiofrequency ablation group, according to a Medtronic news release.
The company said that the cryoablation group saved $355,000 compared with the radiofrequency ablation group. The cryoablation group also had significant savings when assessed using Euros and British pounds.
In addition, they found that patients with a CHA 2DS2-VASC score of 0 or 1 and/or patients with prior direct current cardioversion were associated with a significantly lower risk of cardiovascular rehospitalization with cryoablation as opposed to radiofrequenct ablation.