Background: Single-shot ablation technologies, mainly cryo-balloon (CB) and pulsed field ablation (PFA), are increasingly favored for first-time pulmonary vein isolation (PVI) due to their procedural efficiency and ability to achieve rapid, safe, and durable PVI. However, comparative data from large real-world cohorts remain limited.
Methods: Patients undergoing a first-time PVI at a German high-volume center between 2021 and 2025 were retrospectively analyzed. Baseline, acute safety, and readmission for re-PVI were systematically collected. A total of 1,961 patients were included, comprising 1,369 treated with CB and 592 with PFA using the penta-spline catheter.
Results: Baseline demographics were comparable between groups with respect to age (67 [59–74] vs. 67 [60–74] years, p = 0.72), sex (female 39% vs. 36%, p = 0.06), and AF type (persistent AF 53.9% vs. 54.4%, p = 0.88). The CB cohort demonstrated a higher prevalence of comorbidities including arterial hypertension (56.2% vs. 45.3%, p < 0.001), heart failure (6.4% vs. 2.9%, p < 0.001), diabetes mellitus (12.2% vs. 5.6%, p < 0.001), coronary artery disease (16.8% vs. 8.6%, p < 0.001) and peripheral artery disease (1.4% vs. 0.3%, p = 0.05)). Left ventricular ejection fraction, history of stroke/TIA, antiarrhythmic drug use, and anticoagulation rates were similar between groups. Acute overall complications occurred in 8.9% of CB and 3.7% of PFA procedures (p < 0.001). Major complication rates (death, tamponade, stroke/TIA, phrenic nerve injury, atrioesophageal fistula) did not differ significantly (0.8% vs. 0.5%, p = 0.6), whereas minor complications (vascular access, infection, acute kidney injury) were more frequent in the CB group (8.1% vs. 3.2%, p < 0.001). In multivariate regression analysis, higher age (OR 2.7, p = 0.007), female sex (OR 2.4, p = 0.017), and diabetes mellitus (OR 2.1, p = 0.036) independently predicted minor complications, while no variable predicted major events. During follow-up, patients were readmitted for re-PVI procedures in 169/1369 (12.3%) CB patients versus 35/592 (5.9%) PFA patients (p < 0.001). The data analysis of a structured clinical and holter ECG follow-up is currently ongoing.
Conclusion: In this large real-world cohort, both cryo-balloon and pulsed field ablation demonstrated high acute safety, but pulsed field ablation was associated with fewer minor complications and a reduced need for repeat procedures.
