Long-term outcomes and the possibility of repeat puncture after suture-mediated closure device for femoral vein access.

Abstract

Background: Long-term safety and reaccessibility following the use of suture-mediated vascular closure systems (SMC) for femoral vein access are not well documented. This study aimed to assess the long-term outcomes and feasibility of repeated femoral vein punctures after SMC.

Methods: We analyzed 282 patients who underwent elective catheter ablation via femoral vein access using an 8-13 Fr sheath. Patients were randomized into the pre-close or post-close groups using the ProGlide/ProStyle single-suture technique (Abbott Vascular). Duplex ultrasound evaluations were performed on day 1, day 90, and at 1 year to evaluate vascular complications. The primary and secondary endpoints included major and minor complications within 1 year. Reaccessibility was assessed in patients who required repeated procedures.

Results: Successful re-access was achieved in 21 patients (14.9%) in the pre-close group and 16 patients (11.3%) in the post-close group who underwent repeat procedures. Long-term safety was analyzed in 91 (64.5%) and 98 (69.5%) patients in the pre-close and post-close groups, respectively. The major complication rate was 2/189 (1.1%), and the minor complication rate was 28/189 (14.8%). No difference in complication rates was observed between the pre-close group (0/91, 0.0% major, 12/91, 13.2% minor) and post-close group (2/98, 2% major, 16/98, 16.3% minor), with P-values of 0.50 and 0.68, respectively. No new vascular stenosis occurred during the chronic phase in either group.

Conclusion: In the long-term follow-up after femoral vein access using SMC, new-onset chronic stenosis was not observed, and reaccess was possible in repeat procedures.

Clinical trial registration: UMIN000049174.