Long-term outcomes and the possibility of repeat puncture after suture-mediated closure device for femoral vein access
摘要
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.
MethodsWe 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.
ResultsSuccessful 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.
ConclusionIn 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.
Graphical Abstract