Key result
Cryoballoon pulmonary vein isolation had similar clinical AF recurrence (log-rank P=0.840) but shorter procedure times (78.5 vs 124.5 min; P<0.001) compared to HPSD radiofrequency ablation.
Why the study?
Although cryoballoon pulmonary vein isolation is known to be equivalent to radiofrequency ablation for paroxysmal AF, comparisons of its efficacy and safety against high-power, short-duration radiofrequency catheter ablation were needed.
Does cryoballoon pulmonary vein isolation reduce atrial fibrillation recurrence compared to high-power, short-duration radiofrequency ablation in patients with paroxysmal atrial fibrillation?
RCT (n=314)
randomized
Does cryoballoon pulmonary vein isolation reduce atrial fibrillation recurrence compared to high-power, short-duration radiofrequency ablation in patients with paroxysmal atrial fibrillation?
p-value: p=0.840
Cryoballoon pulmonary vein isolation offers similar efficacy for rhythm control in paroxysmal AF compared to high-power, short-duration radiofrequency ablation, but with a significantly shorter procedure time.
Positions cryoballoon as a time-saving alternative with equivalent efficacy; confirms.
Background: The efficacy of cryoballoon pulmonary vein isolation (Cryo-PVI) is equivalent to that of radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation (AF). We aimed to compare the efficacy and safety profile of Cryo-PVI and high-power, short-duration (HPSD) radiofrequency catheter ablation (RFCA) in patients with AF. Methods: We prospectively randomized 314 patients with paroxysmal AF (men, 71.3%; 59.9±10.9 years old) to either the Cryo-PVI group (n=156) or HPSD-RFCA group (n=158). Cavotricuspid isthmus ablation and linear ablation from the superior vena cava to the right atrial septum in addition to pulmonary vein isolation were carried out in the majority of patients in the HPSD-RFCA group. The primary end point was AF recurrence after a single procedure; secondary end points were the recurrence pattern, cardioversion rate, follow-up heart rate variability, and response to antiarrhythmic drugs. Results: After a mean follow-up of 9.8±5.1 months, the clinical recurrence rate did not significantly differ between the two groups (log-rank P =0.840). The rate of recurrence as atrial tachycardia ( P >0.999), cardioversion ( P =0.999), and 3-month heart rate variability (high frequency; P =0.506) did not significantly differ. During the final follow-up, sinus rhythm was maintained without antiarrhythmic drugs in 70.5% of the Cryo-PVI group and 73.4% of the HPSD-RFCA group ( P =0.567). No significant difference was found in the major complication rate between the two groups (3.8% versus 0.6%; P =0.066), but total procedure time was significantly shorter in the Cryo-PVI group (78.5±20.2 versus 124.5±37.1 minutes; P <0.001). Conclusions: In patients with paroxysmal AF, the Cryo-PVI is an effective rhythm-control strategy with a shorter procedure time compared with the HPSD-RFCA. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03920917.
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Pak et al. (2021) conducted an RCT in paroxysmal atrial fibrillation (n=314). Cryoballoon pulmonary vein isolation (Cryo-PVI) vs. High-power, short-duration (HPSD) radiofrequency catheter ablation (RFCA) was evaluated on AF recurrence after a single procedure (p=0.840). Cryoballoon pulmonary vein isolation had similar clinical AF recurrence (log-rank P=0.840) but shorter procedure times (78.5 vs 124.5 min; P<0.001) compared to HPSD radiofrequency ablation.
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