Abstract:Background and Aims: Interventional procedures have become the main part of vascular surgery practice. The closure of the femoral arterial puncture site directly related to the operation is an essential step at the end of surgical procedures. Considering the lack of high-level evidence on the application effect of the simulator training for occlusion and hemostasis system at home and abroad, this study aimed to evaluate the clinical application effect of the simulator training in implementation of femoral arterial puncture point closure using ExoSealTM vascular closure device and the application value of the simulator training in the basic teaching and training of vascular intervention operation.
Methods: Using a prospective controlled design, 8 interventional vascular surgeons from 7 centers were selected during May 2020 to October 2020 to receive two different approaches for closure operation training. Four interventional surgeons were trained by reading the instructions of ExoSealTM vascular closure device and watching the videos (control group), and the training method for the other 4 interventional surgeons was the use of simulator under the guidance of professionals in addition to the training for control group (study group). After completion of the training, under the supervision of the attending surgeons, each participant performed puncture site closure using the ExoSealTM vascular closure device in patients undergoing endovascular interventional procedures and with 6-F sheaths in the common femoral artery. After this operation was performed in 50 cases by each group, the operative time, blood loss, equipment success rate, incidence of femoral artery embolism, secondary intervention rate and incidence of 24-h hematoma formation were compared between the two groups.
Results: During the operation of ExoSealTM vascular closure device, the operative time and blood loss in study group were significantly less than those in control group (24.50 s vs. 30.00 s, P=0.003; 8.60 mL vs. 11.22 mL, P=0.019). The equipment success rate in study group (98%) was higher than that in control group (96%), but it did not reach a statistical significance (P=0.558). There were no arterial embolism, second intervention 24-h hematoma formation in both groups.
Conclusion: The training of ExoSealTM vascular closure device simulator can improve the safety and effectiveness of femoral arterial puncture site sealing. The training of the simulator is recommended to be routinely used in the basic teaching and training of vascular intervention operation.