Safety and Efficacy Analysis of Balloon Cryoablation vs Radiofrequency Ablation in Atrial Fibrillation: A Retrospective Analysis. (SECARA AFib TRIAL)

Abstract

Background: According to the ACC/AHA/HRS guidelines, Pulmonary-Vein Isolation has become the cornerstone approach in ablation for patients with medication refractory paroxysmal atrial fibrillation. (Class 1). Radiofrequency ablation is the most frequently employed technology followed by balloon cryoablation. According to multiple, smaller studies in recent past, both procedures have similar efficacy in terms of recurrence with little difference in complication rate. The FreezeAF trial, a 5-year observational study from 2011-2016 involving 4,073 patients, showed a better safety profile with radiofrequency ablation with lower rates of phrenic-nerve injuries in comparison to those of balloon cryoablation. However, some studies have shown that the rate of perforation was higher with thermal ablation. The landmark FIRE AND ICE Trial, a multicenter randomized controlled noninferiority trial of almost 800 patients published in 2016 in NEJM by Karl Heinz et al. showed a similar result in terms of efficacy and end safety result between the two. A systematic review of 7200 patients by Yi-He Chen et al. concluded that cryoablation has fewer rates of atrial fibrillation recurrence, shorter procedural duration and similar fluoroscopy times. Similar other studies are favoring the use of balloon cryoablation due to lower rate of hospitalizations, repeat ablation, and cardioversions. Methods: Retrospective single center chart review. Results: Cryoablation ( n -139 ) vs RF ( n -507) MACE - ( OR 2.62, p: 0.045, CI: 1.1 - 6.28) Non cardiac ADEs (OR 6.47, p: 0.0029, CI 2.3098 - 18.1395) Death: ( 1 vs 2, OR 1.84, p: 0.52, CI: 0.16-20.28) Efficacy: Persistent afib at discharge: ( OR 1.69, p: 0.08, CI: 0.85-3.07 ) Mean Contrast volume: (78 cc vs 4.48 cc, p Mean LA volume: (3.94 vs 4.59) Mean Fluoroscopy time: ( 31 vs 32 mins, p: 0.86) Conclusion: In our retrospective single-center study, patients who underwent cryoablation for pAF had a statistically significant higher incidence of MACE and noncardiac ADEs. There was no significant difference in mortality rates or primary efficacy.