Pulmonary vein isolation using Cryoballoon ablation versus RF ablation
using ablation index following the CLOSE protocol: a Prospective
Randomized Trial
Abstract
Background The single procedure success rates of durable pulmonary vein
isolation (PVI) for paroxysmal atrial fibrillation (AF) varies between
80 and 90 %. This prospective, randomized study investigated the
efficacy of Cryoballoon PVI (CBA) versus pulmonary vein isolation with
RF-energy following the CLOSE protocol 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 a 1:1 fashion. In
group-A patients, PVI was performed with the Cryoballoon (Articfront
Balloon, Medtronic Inc). The ablation procedure in group B was performed
with RF-energy (CARTO 3, Biosense Webster Thermocool STSF), following
the CLOSE protocol. 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). Patients of group A showed significantly more
AF recurrence during the blanking period of three months (group A: 14
(18.67 %) versus group B: 6 (8 %); p<0.05. Conclusions
Cryoballoon PVI and PVI using ablation index following the CLOSE
protocol are equally efficient in achieving durable PV-isolation.
Cryoballoon ablation leads to significantly more AF recurrence during
the blanking period.