Axillary vein puncture guided by ultrasound versus cephalic vein dissection in pacemaker and defibrillator implant: a multicenter randomized clinical trial

Abstract Background Although still not standard, axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator leads insertion. Objective To evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant. Methods Prospective, multicenter clinical trial including 88 adult patients randomized 1:1 to US-Ax (n=44) or CV (n=44). All procedures were performed by operators with no previous experience in axillary approach. Primary endpoint was defined as success rate. Secondary endpoints were venous access site change, time to obtain venous access, total procedural time, and early complication rate. Analyzes were carried out using the intention-to-treat principle. Results Median age was 70.5 years (58.2–79.7), and 60.2% were males. Considering the primary outcome, a higher success rate was observed in axillary group (97.7% vs. 54.5%; p Conclusion To the best of our knowledge, this is the first randomized trial comparing self-learned US-Ax to CV in cardiac leads implantation. Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.