Key result
Female sex linked to ~21% higher atrial arrhythmia recurrence risk after cryoballoon ablation.
Why the study?
Cryoballoon ablation is an established AF treatment, but evidence regarding the impact of sex on outcomes remains sparse.
Does cryoballoon ablation prevent atrial arrhythmia recurrence similarly in female and male patients with atrial fibrillation?
Observational (n=3,089)
Yes
Does cryoballoon ablation prevent atrial arrhythmia recurrence similarly in female and male patients with atrial fibrillation?
While cryoballoon ablation is safe and effective in both sexes, females have a slightly higher risk of atrial arrhythmia recurrence and rehospitalization at 24 months compared to males.
Introduction Cryoballoon ablation (CBA) is a well-established treatment for atrial fibrillation (AF). However, evidence on the impact of sex on outcome is sparse. This real-world analysis aims to describe outcome after CBA in both sexes. Methods This registry is an ongoing, global evaluation of CBA procedures in standard-of-care practice. Females undergoing CBA were compared to males at baseline and 12-, and 24-months post-ablation. Serious procedure-related adverse event rate, rate of atrial arrhythmia (AA) recurrence, repeat ablation, hospitalization, cardioversion, and quality-of-life (QoL; EQ-5D-3l) were compared. Results Of 3,089 patients with 12-month follow-up, 1,136 (36.8%) were female; and a subset of 1,099 patients (400 female) were followed through 24 months. Females presented with different comorbidities at baseline. The complication rate was low overall in females (3.9%) and males (2.7%, p = 0.07). At 24-month follow-up, the rate of AA recurrence was 25.0% in females and 22.1% in males and female sex was a predictor of AA recurrence (HR adj = 1.21, p = 0.047) and rehospitalizations (HR adj = 1.25, p = 0.03) in a propensity score adjusted analysis. In addition, females stayed in the hospital longer compared to males during the index ablation procedure (47.9% with 2 or more days in hospital vs. 39.3% in males, p < 0.01), as well as during the first hospital stay post-ablation (78.2% with 2 or more days in hospital vs. 60.2% in males, p < 0.01). QoL improved from baseline to 12 months in females (0.85 ± 0.15–0.90 ± 0.13) and males (0.91 ± 0.13–0.94 ± 0.11) and remained high at 24 months. Discussion CBA performed according to standard-of-care practice was safe in both sexes. The efficacy of CBA is marginally lower in females, but 75% of females remained free from AA recurrence at 24-months and reported a meaningful improvement in QoL post ablation. Systematic Review Registration https://clinicaltrials.
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Khelae et al. (2025) conducted an observational in Atrial fibrillation (n=3,089). Cryoballoon ablation (Female sex) vs. Cryoballoon ablation (Male sex) was evaluated on Atrial arrhythmia recurrence at 24 months (HR 1.21, 95% CI 1.002-1.46, p=0.047). Female sex was associated with a 21% increased risk of atrial arrhythmia recurrence (HR 1.21) and a 25% increased risk of rehospitalization at 24 months after cryoballoon ablation compared to males.
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