Integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures.

Abstract

In cryoballoon ablation (CBA) procedures, transseptal access (TSA) 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. Recently, an integrated dilator-needle system assembled to the cryoballoon sheath was introduced. We aimed to evaluate the efficacy and safety of an integrated TSA tool compared with the traditional approach in atrial fibrillation CBA procedures. Patients scheduled for CBA procedures were randomized 1:1 to traditional TSA (t-TSA) or integrated TSA (i-TSA). TSA 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). Ninety-seven patients (76 males, mean age 59 ± 10 years) were randomized, 48 patients underwent t-TSA, and 49 i-TSA. Mean TSA time was 5 min 59 s ± 5 min 36 s in the t-TSA group and 2 min 59 s ± 2 min 14 s in the i-TSA group (p < .001). Total fluoroscopy time, skin-to-skin procedure time, and LA dwell time were respectively 15 ± 6, 69 ± 16, and 44 ± 12 min in the t-TSA group and 13 ± 6, 65 ± 15, and 43 ± 11 min in the i-TSA group (p = ns). No clinically significant acute complications related to TSA were noted in both cohorts. This is the first randomized study comparing both TSA approaches. TSA in CBA procedures using this integrated tool enables a safe andefficient workflow, reducing TSA time and avoiding sheath exchange.