FemoSeal Evaluation Registry (FER). Prospective study of femoral arterial closure with a mechanical system on 100 patients who underwent angioplasty procedures

Background: The objective of this study is to evaluate the effectiveness and the safety of the FemoSeal mechanical closure system in order to obtain hemostasis of the puncture site following angioplasty procedures performed through femoral arterial approach.

Method: A single-centre prospective registry was conducted from November 2010 to April 2011, comparing the results of manual compression (n=111 patients), hemostatic bandages compression (n=43 patients) and FemoSeal mechanical closure (n=100 patients). The end points evaluated were the following: successful hemostasis, major and minor complications right after the procedures and major and minor complications at 1 month follow-up. The patients' feedback about their comfort was also collected right after the procedure and after one month.

Results: Successful hemostasis with FemoSeal was obtained in 93% of the patients (n=93). Seven patients required additional slight manual compressions or compression bandages. The use of FemoSeal was not associated with any major complications, significantly reducing (P<0.05) the number of complications compared to other compression techniques over the studied period. Only one minor complication was observed with FemoSeal (a 1.5-cm-hematoma, which reabsorbed spontaneously without any issue).

Conclusion: In our experience, the use of FemoSeal is effective in achieving hemostasis performed through femoral arterial approach up to 7F and is associated with a very low rate of complications.