TRUST-AF: comparison of conventional SL0 sheath exchange versus direct large-bore faradrive sheath access for fluoroscopy-guided transseptal puncture in pulsed field ablation

Transseptal puncture (TSP) is a critical step in Pulsed field ablation (PFA) procedures. Conventional workflows often require initial septal access using a standard transseptal sheath followed by exchange to accommodate large-bore PFA delivery systems. Direct large-bore sheath access may simplify the workflow and reduce procedural resource utilization. To compare procedural efficacy, safety, and cost-effectiveness of a conventional SL0 sheath exchange strategy versus direct Faradrive sheath access for fluoroscopy-guided TSP in PFA-guided pulmonary vein isolation (PVI). In this prospective, single-center study, 140 consecutive patients undergoing first-time PFA-guided PVI were included. The first 70 patients underwent TSP using an SL0 sheath followed by sheath exchange to a Faradrive sheath. The subsequent 70 patients underwent direct TSP using Faradrive sheath without exchange. All procedures were performed under fluoroscopic guidance without intracardiac or transesophageal echocardiography. The primary endpoint was total procedural time prespecified as one objective marker of workflow efficiency. Secondary endpoints included fluoroscopy duration, radiation exposure, number of transseptal puncture (TSP) attempts, sheath crossovers, acute procedural success, complication rates, and procedural cost analysis. Total procedural time was shorter in the direct Faradrive group compared with the SL0 exchange group (35.0 [30.0–40.0] min vs. 40.0 [34.3–50.0] min; p = 0.001). Fluoroscopy time (5.98 [4.57–7.94] min vs. 8.63 [6.04–11.7] min; p < 0.001) and radiation dose (567 [302–730] vs. 715 [434–1002] cGy·cm²; p = 0.001) were also lower with direct access. Time to septal crossing, number of puncture attempts, first-pass success, and acute PVI success were comparable between groups. One air embolism occurred during sheath exchange in the SL0 group without long-term sequelae. No hemolysis, acute kidney injury, stroke, tamponade, or deaths were observed. Estimated per-case cost reduction with direct access was €171. In a fluoroscopy-guided workflow, direct large-bore Faradrive sheath access for transseptal puncture during PFA-guided pulmonary vein isolation was associated with shorter procedural and fluoroscopy times and lower procedural costs without compromising acute procedural safety or success. These findings support procedural workflow simplification by eliminating sheath exchange in experienced operators.