Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial).

Aims: Complications of catheter ablation for atrial fibrillation (AF) are frequently related to vascular access. We hypothesized that ultrasound-guided (USG) venipuncture may facilitate the procedure and reduce complication rates. Methods and results: We conducted a multicentre, randomized trial in patients undergoing catheter ablation for AF on uninterrupted anticoagulation therapy. The study enrolled consecutive 320 patients (age: 63 ± 8 years; male: 62%) and were randomized to USG or conventional venipuncture in 1:1 fashion. It was prematurely terminated due to substantially lower-than-expected complication rates, which doubled the population size needed to maintain statistical power. While the complication rates did not differ between two study arms (0.6% vs. 1.9%, P = 0.62), intra-procedural outcome measures were in favour of the USG approach (puncture time, 288 vs. 369 s, P < 0.001; first pass success, 74% vs. 20%, P < 0.001; extra puncture attempts 0.5 vs. 2.1, P < 0.001; inadvertent arterial puncture 0.07 vs. 0.25, P < 0.001; unsuccessful cannulation 0.6% vs. 14%, P < 0.001). Though these measures varied between trainees (49% of procedures) and expert operators, between-arm differences (except for unsuccessful cannulation) were comparably significant in favour of USG approach for both subgroups. Conclusions: Ultrasound-guided puncture of femoral veins was associated with preferable intra-procedural outcomes, though the major complication rates were not reduced. Both trainees and expert operators benefited from the USG strategy. (www.clinicaltrials.gov ID: NCT02834221).

RCT Entities:   Population Interventions Outcomes