A Novel Femoral Artery Compression Device Compared with Manual Compression for Hemostasis After Femoral Artery Access in Coronary Artery Catheterizations.

Background

Femoral arterial access remains widely used in contemporary coronary catheterization procedures. Following the removal of the femoral sheath, hand compression is commonly employed to achieve hemostasis. Nevertheless, this method is time-consuming and imposes a burden on both the operator and the patient.

Objective

This study aims to investigate the hemostatic efficacy of the novel external femoral artery compression device (the TU device).

Materials And Methods

Patients enrolled in this study were randomly assigned in a 1:1 ratio to either the TU device (with a 3-2-1 protocol for compression) or the conventional hand compression group. The primary efficacy outcome was the time to achieve hemostasis within 15 minutes, and the safety outcomes were major vascular complications. Other secondary outcomes included minor vascular complications, time to hospital discharge, reports of vasovagal symptoms, discomfort levels, as well as user and patient satisfaction.

Results

A total of 52 patients were included in this study (TU device, n = 26 vs. hand compression, n = 26). The baseline characteristics of the groups were mostly similar. We found that achieving hemostasis within 15 minutes was successful in the TU device group more than in the hand compression group (84.6% vs. 46.2%, p = 0.004). Small hematomas were reported more frequently in the device group (34.6% vs. 7.7%, p = 0.017). Interestingly, there was an absence of any vasovagal response in patients using the device (0% vs. 15.4%, p = 0.037). There were no significant differences in major vascular complications, time to hospital discharge, patient discomfort, and satisfaction scores between the groups.

Conclusions

The TU device is effective for achieving femoral artery hemostasis with an acceptable rate of access site complications compared to conventional hand compression.