Lesion durability in pentaspline pulsed field ablation vs. cryoballoon ablation - results from the PULSED-ICE-MRI Randomized Trial

Background Pulsed-field ablation (PFA) has emerged as a safe and highly efficient ablation technology for pulmonary vein isolation (PVI). However, data on lesion quality and durability are somewhat ambiguous. We performed a randomized trial to compare lesion durability of a pentaspline PFA single-shot device with cryoballoon ablation as assessed by post-ablation late gadolinium enhancement (LGE)-MRI. Methods and Results 106 patients with paroxysmal or persistent atrial fibrillation (AF) were randomized in a 2:1 fashion to undergo PVI using PFA (Farapulse, Boston Scientific) versus cryoballoon ablation (Arctic Front Advance, Medtronic) (Figure 1). Patients with long-standing persistent AF, LVEF <45%, left atrial diameter >55 mm, GFR < 30 ml/min, or BMI >35 were excluded. All patients received an LGE-MRI three months post-ablation. Here we present a prespecified interim analysis of the first 53 patients who completed 6-months follow-up. Patients were on average 64 years old, the majority (78%) with paroxysmal AF. The primary endpoint of complete PV-encircling LGE-lesions at 3 months was accomplished in 17% of the PFA and 43% of the cryoballoon group (p<0.01) (Figure 2). The average number of gaps was 3.1 in patients who received PFA and 2.1 in patients who received cryoballoon ablation (p<0.05). Six-months arrythmia-free survival did not differ between the two groups (PFA: 88.9%; Cryo: 85.7%; p=0.76). Conclusion While PFA and cryoballoon ablation resulted in similar arrhythmia-free survival, lesion durability was considerably higher with cryoballoon ablation. The heterogeneous LGE patterns with PFA suggest minor lesion durability, but it must be considered that they may also reflect a different, less detectable kind of remodeling compared to thermal ablation.