Background: Axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator lead insertion.
Objective: The purpose of this study was to evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant.
Methods: This prospective, multicenter clinical trial included 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. Analyses were performed using the intention-to-treat principle.
Results: Median age was 70.5 years (58.2-79.7), and 60.2% were male. For the primary outcome, a higher success rate was observed in the axillary group (97.7% vs 54.5%; P <.001), as well as a lower rate of venous access site change (2.3% vs 40.9%; P <.001) and shorter time to obtain venous access (5 vs 15 minutes; P <.001) and procedural time (40 vs 51 minutes; P = .010), with no difference in complication rate (2.3% vs 11.4%; P =.20). In multivariate analysis, US-Ax (P <.001), single-chamber device (P = .015), and body mass index (P = .015) were independent predictors of overall success.
Conclusion: This is the first randomized trial comparing self-learned US-Ax to CV in cardiac lead 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.
Keywords: Axillary vein; Cephalic vein; Implantable cardioverter-defibrillator; Pacemaker; Randomized clinical trial; Ultrasound-guided venous puncture.
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