Concomitant cryoballoon pulmonary vein and posterior wall isolation in persistent atrial fibrillation: Results from the Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) IDE trial.

Background: Pulmonary vein isolation (PVI) remains the cornerstone of atrial fibrillation (AF) ablation, but its efficacy in patients with persistent AF (PersAF) remains suboptimal compared with those with paroxysmal AF.

Objective: This study investigated the outcomes of cryoballoon PVI with concomitant "direct" posterior wall isolation (PWI) vs PVI alone in patients with symptomatic PersAF.

Methods: The PIVoTAL IDE was a prospective, multicenter trial (NCT04505163) that randomized patients with symptomatic antiarrhythmic drug-refractory PersAF to cryoballoon PVI vs PVI + PWI. The design was double blind until randomization after PVI. AF recurrence at 12 months was the primary efficacy endpoint. The study planned to enroll 366 patients, but funding constraints prompted early termination.

Results: The cohort consisted of 153 patients randomized to PVI alone (n = 77) vs PVI + PWI (n = 76). Baseline demographics were similar. PVI was achieved in all patients and PWI in 75 of 76 patients (98.7%). PVI + PWI required more cryoapplications (21 ± 6 vs 9 ± 4; P < .001) and longer procedure times (162 ± 60 minutes vs 112 ± 43 minutes; P < .001). Adjunct radiofrequency ablation was required in 22 of 76 patients (28.9%) to complete PWI. Although there was a nonsignificant trend in AF recurrence at 12 months with PVI + PWI (29.0% vs 43.3%; P = .12), an atrial arrhythmia burden of >0.1% was significantly lower with PVI + PWI than PVI alone (19.2% vs 31.6%; P = .02), as was the need for antiarrhythmic drug therapy at 12 months (5.3% vs 15.6%; P = .04).

Conclusion: Despite early termination rendering the trial statistically underpowered, cryoballoon PVI with "direct" PWI was associated with a trend toward reduction in AF recurrence at 12 months and a significant reduction in atrial arrhythmia burden vs PVI alone.