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Cryoballoon Versus Laserballoon: Insights from the First Prospective Randomized Balloon Trial in Catheter Ablation of Atrial Fibrillation.

Background - Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon (CB) and laser balloon (LB) catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal AF. Methods - Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either CB or LB PVI (CB: n=100: 50 PAF + 50 persistent AF vs. LB: n=100: 50 PAF + 50 persistent AF). All antiarrhythmic drugs (AAD) were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6 and 12 months. Primary efficacy endpoint was defined as freedom from atrial tachyarrythmia (ATa) between 90 and 365 days after a single ablation. Secondary endpoints included procedural parameters and peri-procedural complications. Results - Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (CB) vs. 95% (LB) requiring focal touch up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the CB group (50.9±21.0min vs. 96.0±20.4 min; p<0.0001 and 7.4±4.4 min vs. 8.4±3.2min, p=0.083). Overall, the primary endpoint of no ATa reccurence was met in 79% (CB: 80.0% vs LB: 78.0%, p=ns). No death, atrio-esophageal fistula, tamponade or vascular laceration requiring surgery occurred. In the CB group, 8 transient but no persistent phrenic nerve palsy (PNP) were noted compared to 2 persistent PNP and 1 TIA in the LB group. Conclusions - Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.