Key result
Extended cryoballoon ablation shows no benefit over standard cryoablation for persistent AF.
Why the study?
The study evaluated the effectiveness of extended cryoballoon ablation in patients with persistent AF and investigated risk factors for post-ablation AF recurrence.
Does extended cryoballoon ablation (PV + posterior wall) improve effectiveness compared to standard PV cryoablation in patients with persistent atrial fibrillation?
RCT (n=89)
randomized
Does extended cryoballoon ablation (PV + posterior wall) improve effectiveness compared to standard PV cryoablation in patients with persistent atrial fibrillation?
Extended cryoballoon ablation (PV + posterior wall) does not significantly improve 12-month efficacy compared to standard PV isolation in patients with persistent atrial fibrillation.
Answers are grounded in this paper and cite their sources.
Standard PV isolation suffices for persistent AF; challenges addition of posterior wall ablation and guides future trial design.
Aim. To study the effectiveness of “extended” cryoballon ablation in patients with a persistent form of atrial fibrillation (AF) and to determine the risk factors for AF recurrence after cryoablation. Methods. The study included 89 patients (62±10 years, 24 [27%] men) with a persistent form of AF. The patients were randomized into two groups: in the 1st, the pulmonary veins (PV) cryoablation was performed (n=48 [53.9%]); in the 2nd, the PV cryoablation was performed in combination with cryoablation of the posterior wall of the left atrium (n=41 [46.1%]). The number of patients at high risk of thromboembolic events predominated in Group 2 (p=0,03). There is a high frequency of taking antiarrhythmic drugs of class III in this group (p=0.018). The follow-up period was 12 months. Clinical efficacy was assessed during a survey and daily ECG monitoring at face-to-face visits after 3, 6 and 12 months. Results. Antral isolation of PV was achieved in all 89 (100%) patients in both groups. In group 2, the average number of applications in the posterior wall of the PV was 10 [9; 13]. The effectiveness of cryoablation in group 1 by the end of the 12-month follow-up period was 54.2%, in group 2 - 56.1%. The complication rate (6.7%) in both groups did not differ statistically (p=0.683). The risk of arrhythmia recurrence didn’t depend on the strategy of cryoablation in postablation period (p=0.834). When conducting a single-factor analysis, a statistically significant effect on the probability of AF recurrence in the period of 3-12 months in group 1 was caused by AF recurrence in the blind period (95% confidence interval (CI): 1.5-27.7, p=0.013), in group 2 belonging to the female sex (95% CI: 1.2-24.6, p=0.032) and AF relapse in the blind period (95% CI: 1.5-128.5, p=0.020). During multivariate analysis in group 2, a statistically significant influence on the risk of AF recurrence in the period of 3-12 months was exerted by belonging to the female sex (hazard ratio (HR) 7.84; 95% CI 1478-42,23; p=0.016) and the presence of early AF recurrence (HR 20.36; 95% CI 1.99-208.23; p=0.011). Conclusion. Extended cryoablation in terms of efficiency and safety was comparable with the standard cryoablation. Early recurrence of AF (in the first 3 months after the intervention) turned out to be an independent risk factor for AF recurrence in the long-term period up to 12 months after cryoablation in both groups.
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Kirilova et al. (2023) conducted an RCT in persistent atrial fibrillation (n=89). PV cryoablation in combination with cryoablation of the posterior wall of the left atrium vs. pulmonary veins (PV) cryoablation was evaluated on effectiveness of cryoablation at 12 months (p=0.834). Extended cryoballoon ablation (pulmonary vein and posterior wall) was comparable to standard pulmonary vein cryoablation for persistent AF, with 12-month efficacy of 56.1% vs 54.2% (p=0.834).
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