Long-Term Outcomes of Cryoballoon Pulmonary Vein Isolation Freeze Using a Modified ICE-T Protocol With a Double 120 s Applications (ICE-T 2 × 2).

Background: Cryoballoon (CB) pulmonary vein isolation (PVI) is a well-established treatment for symptomatic atrial fibrillation (AF). Most centers use application durations of 180 or 240 s. Since freezing-related complications tend to occur later during the application, empirically shortening the duration may reduce procedural risks. A protocol using two consecutive 120-s freezes was proposed. Here, we report its long-term outcomes.

Methods: We performed a long-term follow-up comparison of patients with symptomatic AF undergoing PVI with second-generation CB between 2019 and 2020. The conventional single 240-s freeze protocol (CB240) was compared to a modified double 120-s freeze protocol (CB120). Among 160 consecutive patients, 80 received CB120 and 80 CB240. A total of 140 patients (70/group) completed follow-up. The primary endpoint was freedom from atrial tachyarrhythmia.

Results: Persistent AF was more common in the CB240 group (32%) than in the CB120 group (20%), (p < 0.05). After a mean follow-up of 948 ± 517 days, freedom from any atrial tachyarrhythmia at 1 year was 90% in the CB120 group and 82% in the CB240 group (log-rank p = 0.122). The primary outcome was assessed after a single procedure, including antiarrhythmic drug (AAD) use.

Conclusions: The CB120 protocol appears noninferior to the standard CB240 protocol regarding long-term efficacy, while offering a potentially more favorable safety profile. This protocol may represent a viable alternative for optimizing the balance between effectiveness and safety.