Pulmonary vein isolation: cryoballoon non-inferior to radiofrequency ablation

A prospective, randomised study evaluated the efficacy of cryoballoon ablation in comparison with the standard radiofrequency ablation in patients undergoing pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) [1]. Both protocols were equally efficient in achieving PVI. However, cryoballoon ablation was associated with higher rates of recurrence in the first 3 months.

The single procedure success rates of durable PVI for paroxysmal AF varies between 80% and 90%. This prospective, randomised controlled, non-inferiority study (NCT00774566), presented by Dr Bastian Kaiser (Robert-Bosch-Hospital Bad Cannstatt, Germany), investigated the efficacy of cryoballoon PVI versus PVI with radiofrequency energy following the CLOSE protocol in terms of single-procedure, arrhythmia-free outcome, safety, and procedural time.

The study enrolled and randomised 150 patients undergoing de-novo PVI for paroxysmal AF. In group A (n=75), PVI was performed using a 23 or 28 mm cryoballoon. In group B (n=75), ablation was performed with radiofrequency energy according to the CLOSE protocol. Follow-up was after 3 months and at the end of the study period (mean 14±2 months). The primary endpoint was arrhythmia-free survival.

The procedural time in group A was statistically significantly shorter than in group B (70.53 min vs 115.35 min; P<0.01), while fluorescence time and dose area product did not differ between groups. Both procedures were performed with a low number of complications.

Results showed that cryoballoon PVI and PVI using ablation index following the CLOSE protocol are equally efficient in achieving durable PVI (PV recovery in 2.67% vs 4%; P=ns). Cryoballoon ablation led to significantly more AF recurrence during the blanking period of 3 months (P=0.048), most likely due to the higher myocardial damage by the cryoballoon, a theory supported by higher corresponding troponin levels. At the end of the 14-month follow-up, the difference between treatment group was not detectable anymore (P=0.110).

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   1. Kaiser B. Pulmonary vein isolation using cryoballoon ablation versus RF ablation using ablation index following the CLOSE protocol: a prospective randomised trial. EHRA 2021 Congress, 23-25 April.

 

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Posted on 16 June 202128 March 2024