PO-02-193 A COMPARISON OF THIRD GENERATION CRYOABLATION VERSUS X3 LASER BALLOON SYSTEMS FOR PULMONARY VEIN ISOLATION FOR TREATMENT OF ATRIAL FIBRILLATION

Abstract

As the incidence of atrial fibrillation (AF) increases operators are looking to improve the efficiency of pulmonary vein isolation (PVI) with similar clinical outcomes. In a recent study the 2nd generation cryo-balloon (CB) and the 1st and 2nd generation laser balloon (LB) was compared with similar clinical efficacy but with shorter procedure time in the CB group. Improvements were made to both modalities in subsequent generation catheters. The 3rd generation CB (CB3) has a 40% shorter tip that allows for improved stability during cryo-applications. The X3 LB (LB3) introduced a “rapid” ablation mode which utilizes a motorized handle to allow for continuous 360-degree energy delivery to decrease ablation time and improve lesion effectiveness We sought to compare if these improvements impacted the overall efficacy, procedural and/or fluoroscopy time between the two modalities. To compare clinical outcomes of CB3 and X3 LB ablation in patients with AF in a multi-center prospective registry. Between November 2019 and November 2020, 69 patients with atrial fibrillation underwent ablation with either CB3 or LB3 at two large US medical centers. Patients were followed for at least 180 days after index procedures. The primary outcome was time to recurrence of AF. Secondary outcomes included time to anti-arrhythmic drug (AAD) therapy after the 90-day blanking period, and procedural characteristics. A total of 69 patients were enrolled in the study (baseline characteristics in Table 1). Forty patients (58%) underwent PVI ablation with CB3, and 29 patients (42%) underwent PVI ablation with LB3. There was no significant difference in the time to recurrent AF between treatment groups (p=0.865) (Figure 1). There was also no significant difference in the time to treatment with AAD therapy after the 90-day blanking period (p=0.125). Both procedural and fluoroscopy time were significantly shorter in the LB group (mean procedure time was 122 minutes in CB3 group versus 104 minutes in LB3 group and mean fluoroscopy time of 19.4 minutes in CB3 group versus 6.7 minutes in LB3 group) which was statistically significant for both parameters (p<0.001). There was no significant difference in adverse events between the two groups. LB and CB are safe and effective PVI modalities. Using the X3 LB system, procedure and fluoroscopy time were shorter than with the CB3 system with similar efficacy and safety. Larger prospective randomized studies are needed to confirm these results.