Re-accessibility and the long-term safety after suture-mediated vascular closure systems usage for femoral vein access

Long-term safety and re-accessibility 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 the feasibility of repeat punctures in the femoral vein after the application of SMC.

We analyzed 282 patients undergoing elective catheter ablation via femoral vein access with an 8–13 F sheath. Patients were randomized into pre-close or post-close groups using the ProGlide/ProStyle single-suture technique. Duplex ultrasound evaluations were performed on Day 1, Day 90, and at 1 year to evaluate vascular complications. Primary and secondary endpoints included major and minor complications within 1 year. Re-accessibility was assessed in patients requiring repeat procedures.

Twenty-one patients (14.9%) in the pre-close group and 16 patients (11.3%) in the post-close group underwent repeat procedure, achieving successful re-access in all cases. The long-term safety analysis included 91 patients (64.5%) from the pre-close group and 98 patients (69.5%) from the post-close group. Major complications rate was 2/189 (1.1%) and minor complications rate was 28/189 (14.8%) in total. There was no difference in complication rates 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.

In long-term follow-up after femoral vein access using SMC, new onset of chronic stenosis was not observed and re-access was possible in multiple procedures.