Effectiveness of a novel integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures

Abstract

Abstract Background In cryoballoon ablation (CBA) procedures, left atrial (LA) access is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events in CBA procedures. A novel integrated dilator-needle system, that can be combined with the cryoballoon delivery sheath allowing direct LA transseptal access, was recently introduced. Figure. Objective The purpose of this study is to evaluate the efficacy and safety of this new integrated transseptal access tool compared with the traditional approach in CBA procedures. Methods In this prospective single-center study, consecutive patients who underwent AF CBA procedures were randomly assigned 1:1 to undergo traditional transseptal access (t-TSA) or integrated transseptal access (i-TSA). Patients with foramen ovale or interatrial communication, detected on transesophageal echocardiogram prior to the procedure, were excluded. Transseptal access time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). Results We evaluated 82 patients (63 males, mean age 59 ± 10 years) indicated to CBA of atrial fibrillation, 42 patients underwent t-TSA and 40 i-TSA. The baseline characteristics of the study population were comparable between groups. Table. Mean CBS transseptal access time was 5 min 6 sec ± 2 min 5 sec in the t-TSA group and 3 min 5 sec ± 2 min 23 sec in the i-TSA group, P < 0.001. Challenging interatrial septa were noted in 3 patients: 1 in t-TSA (1 aneurysmal/elastic) and 2 in i-TSA group (1 lipomatous hypertrophy, and 1 abnormally thickened/fibrotic). No acute complications related to transseptal access were noted in both cohorts. The CBA procedure time and fluoroscopy time were lower in the i-TSA group. Table. There were 1 temporary phrenic nerve injury and 1 vascular complication, both in the t-TSA group. Importantly, no signs of clinical air embolism were noted in both groups. Conclusion This is the first randomized study comparing the traditional approach and the use of a new integrated dilator-needle system. Transseptal crossing in CBA procedures using this integrated tool enables a safe and more efficient workflow, reducing time for transseptal access and avoiding sheath exchange.FigureTable