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Pulmonary vein isolation using Cryoballoon ablation versus RF ablation using ablation index following the CLOSE protocol: a Prospective Randomized Trial
  • +4
  • Cathrin Theis,
  • Bastian Kaiser,
  • Philipp Kaesemann,
  • Felix Hui,
  • Giancarlo Pirozzolo,
  • Raffi Bekeredjian,
  • Carola Huber
Cathrin Theis
Robert Bosch Hospital
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Bastian Kaiser
Robert Bosch Hospital
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Philipp Kaesemann
Robert Bosch Hospital
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Felix Hui
Robert Bosch Hospital
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Giancarlo Pirozzolo
Robert Bosch Hospital
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Raffi Bekeredjian
Robert Bosch Hospital
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Carola Huber
Robert Bosch Hospital
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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.

Peer review status:IN REVISION

20 Jul 2021Submitted to Journal of Cardiovascular Electrophysiology
28 Jul 2021Assigned to Editor
28 Jul 2021Submission Checks Completed
09 Aug 2021Reviewer(s) Assigned
07 Sep 2021Review(s) Completed, Editorial Evaluation Pending
13 Sep 2021Editorial Decision: Revise Minor