Prospective randomized controlled trial evaluating the efficacy of cryoballoon and radiofrequency pulmonary vein isolation in patients with different forms of atrial fibrillation

Abstract

Objective: compare the effectiveness of cryoballoon and radiofrequency pulmonary vein isolation in patients with different forms of atrial fibrillation (AF), as well as to identify factors predisposing to arrhythmia recurrence.

Material and methods. In 2023–2024, a single-center prospective study was conducted involving 120 patients with AF who underwent pulmonary vein isolation using either cryoballoon (CBA) or radiofrequency (RFA) ablation. The mean follow-up period was 18.4±1.8 months. Patients were divided into two groups: those with AF recurrence (n=29) and those without recurrence (n=91). The analysis included the impact of comorbidities (diabetes mellitus (DM), arterial hypertension (AH), chronic heart failure (CHF)) and structural changes of the left atrium assessed by echocardiography (EchoCG) and multidetector computed tomography (MDCT) of the left atrium and pulmonary veins on the risk of AF recurrence. Recurrence-free survival was evaluated using the Kaplan–Meier method, and recurrence risk was assessed using Cox regression. The prognostic significance of quantitative parameters was evaluated using ROC analysis.

Results. Patients with recurrence had a higher body mass (p=0.049), a higher prevalence of long-standing persistent AF (27.6% vs 0%, p<0.001), and more frequent comorbidities: DM (48.3% vs 13.2%, p<0.001), AH (79.3% vs 57.1%, p=0.032), and CHF (69.0% vs 26.4%, p<0.001). Left atrial volume by EchoCG (51 mL vs 47 mL, p=0.034) and indexed left atrial volume by MDCT (69.5 mL/m2 vs 62.4 mL/m2, p=0.015) were also higher in patients with recurrence. Survival analysis showed that freedom from recurrence was 80.5% after navigated RFA and 65.7% after CBA (p=0.032). In patients without DM, recurrence-free survival reached 86.5%, whereas the presence of diabetes reduced this value to 50.0% (p=0.001). In the absence of CHF, freedom from recurrence was 86.3%, while in patients with CHF it decreased to 55.7% (p=0.001).

Conclusion. Radiofrequency ablation provides a higher rate of freedom from AF recurrence compared with cryoballoon ablation; however, the choice of ablation technique should be individualized.