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.
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.