FemoSeal ® Device Use for Femoral Artery Closure by Different Techniques.

BACKGROUND: Common femoral artery is still the most frequently used site for vascular access, mostly for peripheral arterial interventions, and its puncture remains a significant source of patient's morbidity. Manual compression (MC) has been the gold standard for hemostasis after femoral catheterization until recently, but only in the last few years, vascular closure devices (VCDs) are replacing MC due to their rapid development. Nowadays, vascular surgeons (VSs) are also becoming familiar with VCDs. The purpose of this study was to investigate FemoSeal® arterial closure system use in terms of safety and efficacy in patients undergoing transfemoral peripheral procedure and evaluate the complication risk factors.

METHODS: A retrospective analysis to compare 2 different specialists and technique with systematic implantation of FemoSeal® VCD was performed in a cohort of vascular patients treated by endovascular procedure with femoral artery access site over a 2-year period and sheaths ranged from 6F to 8F. All the patients were on antiplatelet therapy and received heparin during the procedure. The FemoSeal® was deployed in common femoral arteries. All patients were examined for access site complication by VS in both groups 20-24 hrs after VCD deployment and 1 and 6 weeks after the procedure with clinical visit and ultrasound duplex scan. Complications, as minor and major hematomas, pseudoaneurysm formation, vessel occlusion or dissection, and infection were recorded.

RESULTS: During the study period, 130 FemoSeal® were deployed in 114 patients, 102 FemoSeal® in VS group, and 28 in interventionalist group. Mean age was 57 ± 24 years. There was no significant difference between the 2 groups in terms of comorbidities. Patient follow-up ranged from 1 to 15 months. All but 3 of the FemoSeal® devices were successfully deployed (all 3 cases in group 2). Mobilization time was 6 ± 4 hrs following interventions, and the discharge time ranged from 6 hrs to 7 days after procedure. Early discharge (within 6 hrs) was obtained in 23% of group 1 and in 0 cases of group 2 (P = 0.008). Delayed discharge was obtained in 74% of group 1 (67 pts) and in 70% of group 2 (18 pts) on postoperative day 1 (P = 0.47). Technical success was achieved in 99% of group 1 and in 93% of group 2 (P = 0.87). There were no perioperative deaths. There were no significant differences in terms of minor bleeding complications (P = 0.21) or infections or transfusion needing (P 0.06) in both groups. FemoSeal® -related complications occurred in 6 patients (1 in group 1 and 5 in group 2; P = 0.0017). All complications occurred following therapeutic intervention with 6F sheath introducer. Complication rate resulted significatively higher in group 2 in terms of pseudoaneurysm development (P < 0.0001) and transfusion needing (P = 0.03) in a subgroup analysis on peripheral arterial disease (Rutherford 3-5). Only chronic limb ischemia was found to be independent predictor of complications due to VCD use.

CONCLUSIONS: Our data suggest that when simple guidelines are observed, the device is safe, effective, and easy to deploy and allows for early ambulation and discharge. However, appropriate randomized clinical trials could clarify the correct guideline to minimize the complication rates.