Venous Access Closure Using the Double-ProGlide Preclose Technique After MitraClip Implantation: Long-Term Clinical and Duplex Ultrasound Outcomes.

OBJECTIVE

This study evaluates the safety and efficacy of the double-ProGlide preclose technique to secure hemostasis in patients with 24 Fr venous access.

METHODS

Consecutive patients with severe mitral regurgitation undergoing the MitraClip procedure were included. All patients underwent the double-ProGlide preclose technique for closure of the femoral vein access site. Duplex ultrasound was performed at 1 month to 1 year after the procedure. The primary study outcome was a composite of major vascular complications, including: (1) the presence of >50% stenosis of the femoral vein; (2) presence of proximal deep vein thrombosis (DVT); and (3) significant venous bleeding as evidenced by >1 unit packed red blood cell transfusion within 48 hours of the procedure.

RESULTS

A total of 42 patients (age, 72.5 ± 9.8 years; 26 males) were included. The device was successfully deployed in all cases with successful hemostasis. No transfusions were required and no major vascular complications were noted. Thirty-five patients (83%) underwent duplex ultrasound. No femoral vein stenosis was noted on duplex ultrasound.

CONCLUSIONS

Off-label use of the double-ProGlide preclose technique after MitraClip therapy for closure of large-caliber femoral vein sites is both safe and efficacious.