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.
Bibliographical noteFunding Information:
This work was supported by a grant (HI19C0114) from the Ministry of Health and Welfare and a grant (NRF-2020R1A2B0100169) from the Basic Science Research Program run by the National Research Foundation of Korea, which is funded by the Ministry of Science, ICT and Future Planning, and a Severance Hospital Research Fund for Clinical Excellence (C-2021-0019).
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All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
- Physiology (medical)