David Schaack, K R Julian Chun, Kars Neven, Andreas Metzner, Christian‐Hendrik Heeger, Reza Wakili, Arian Sultan, Andrea Urbani, Nico Reinsch, Andreas Rillig, Henning Rolfes, Laura Rottner, Julia Vogler, Lukas Urbanek, Stefan Hartl, Joseph Kheir, Julia Alexandra Marx, Julia Lurz, Melanie Gunawardene, Stefano Bordignon, A Fueting, Katharina Govorov, Fariba Rafiee, Matthias Hölzl, Matteo Rocchetti, Shota Tohoku, Boris Schmidt
BACKGROUND AND AIMS: Vascular access site complications are the most common procedure-related adverse event of atrial fibrillation catheter ablation. Whether ultrasound-guided femoral venous puncture reduces these vascular access complications remains uncertain. METHODS: In this investigator-initiated, multicenter, open-label, superiority trial, patients undergoing atrial fibrillation or left atrial tachycardia catheter ablation were randomized to an ultrasound-guided venous puncture strategy (intervention group) or to a conventional venous puncture group guided by palpation (control group). The composite primary outcome was occurrence of venous access site complications until 30 days after the procedure defined as arteriovenous fistula, false aneurysm or access site bleeding requiring intervention or leading to prolonged hospitalization. Secondary endpoints included procedure duration, puncture duration, procedure related stroke/transient ischemic attack within 30 days, number of unintended arterial punctures and number of failed venous access attempts as well as hospital stay duration. RESULTS: In six centers, 986 patients were randomized. A total of 496 patients were assigned to the ultrasound-guided puncture group and 490 patients to the conventional puncture group. The trial was stopped for efficacy following the first interim analysis after enrollment of half of the planned patients. The composite primary outcome occurred in 3 patients (0.6%) in the intervention group and 16 patients (3.3%) in the control group (risk ratio 0.19; 95% confidence interval 0.05-0.63; P = 0.002). Additionally, ultrasound-guided venous puncture significantly reduced the rate of an unintended arterial puncture (2% vs 16%, P < 0.0001) and the rate of unsuccessful venous access attempts requiring crossover to the other group (0.2% vs 8.2%, P < 0.0001). CONCLUSIONS: Ultrasound-guided venous access for atrial fibrillation ablation procedures significantly reduced vascular access site complications.(ULYSSES ClinicalTrials.gov number: NCT06403527).