Pulmonary vein isolation using cryoballoon ablation versus RF ablation using ablation index following the CLOSE protocol: A prospective randomized trial

BACKGROUND: The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) vary between 80% and 90%. This prospective, randomized study investigated the efficacy of cryoballoon PVI (CBA) versus PVI with radio-frequency (RF)-energy following the CLOSE protocol (ablation index [AI], interlesion distance ≤6 mm, surround flow catheter) in terms of single-procedure arrhythmia-free outcome and safety. METHODS AND RESULTS: A total number of 150 patients undergoing de novo catheter ablation for paroxysmal AF were randomized to two different treatment arms. In group A patients, PVI was performed with the 23 or 28 mm cryoballoon (Artic Front™ Balloon in conjunction with an Achieve Mapping Catheter, Medtronic Inc.). The ablation procedure in group B was performed with RF-energy, using AI and following the CLOSE protocol. PVI using AI incorporates stability, contact force (CF), time, and power. The CLOSE protocol combines AI and ≤6 mm interlesion distance using a surround flow catheter (Biosense Webster Thermocool STSF). A total of 75 patients were randomized into each group without significant differences in baseline characteristics. During a mean follow-up of 12 ± 4.5 months after a single procedure, 64 (85.33%) patients of group A were free of arrhythmia recurrence versus 65 (86.67%) patients in group B (p = ns). A total of 14 patients (group A: 7 [9.33%]; group B: 7 [9.33%]; p = ns) underwent a redo-procedure. No significant difference between both groups was observed in terms of PV recovery (group A: 4 [5.33%] vs. group B: 3 [4%]; p = ns). In two patients of group A and four patients of group B, the PVs were durably isolated, whereas the patients had AF recurrence caused by extra-PV AF sources. Two patients of each group had continued paroxysmal AF but did not undergo redo-procedure. Patients of group A showed significantly more AF recurrence during the blanking period of 3 months (group A: 14 [18.67%] vs. group B: 6 [8%]; p < .05). With regard to the procedural data, the procedure time was significantly shorter in group A (70.53 ± 16.13 vs. 115.35 ± 15.38; p < .01); the flouroscopy time and dose area product showed no significant differences (Table 2). Both procedures were performed with a low number of complications; no pericardial effusion was seen in either group; in group A two patients had a significant hematoma of the groin with the need for surgical repair. CONCLUSIONS: Cryoballoon PVI and PVI using ablation index following the CLOSE protocol are equally efficient in achieving durable PV isolation. In this study, cryoballoon ablation led to significantly more AF recurrence during the blanking period.