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Evaluate the safety and performance of ProGlide in closure of venous access site in subjects with a large-caliber femoral vein sheath (24F).
Materials and Methods
This was a prospective analysis of retrospective data from the EVEREST II REALISM (REALISM) MitraClip study population who had received either ProGlide or manual compression (MC) as the intended method for venous accesssite closure. Seven (7) high frequency vessel closure device usage sites from the REALISM study were selected as the study sites. The primary analysis cohort (ProGlide group) was defined as subjects who received at least one (1) ProGlide as the intended femoral vein access-site closure device. The primary analysis was the evaluation of ProGlide against an acceptance criterion of ≥90% for the rate of freedom from major femoral vein access-site related complications at 30 days post-procedure.
A total of 159 subjects from five of the seven high-frequency VCD sites were included in this analysis. Two high-frequency VCD sites did not use any ProGlide for the femoral vein access site closure. The subjects enrolled were elderly with a mean age of 76 years, 53% were male with multiple comorbidities. The largest venous sheath for the MitraClip access site was 24 French (F). The primary endpoint of the rate of freedom from major femoral vein access-site related complication at 30 days was 98.1% (95% CI [94.6%, 99.6%]), meeting the predefined acceptance safety criterion of 90%. Of the 159 cases in which ProGlide was used, 144 used 2 ProGlides and 15 used 1 ProGlide. In the ProGlide cohort, 69.2% (110/159) of the subjects received ProGlide only as the intended hemostasis method; 17.6% achieved hemostasis with ProGlide plus MC, and 12.6% used secondary closure methods (subcutaneous stitch) along with ProGlide. Hemostasis at the time of the index procedure using ProGlide was achieved in an average time of 5.92 ± 6.19 minutes.
The study results have demonstrated that the safety assessment of ProGlide met the predefined acceptance safety criterion. The use of ProGlide in venous closure of 24F was associated with a low 30-day major complication rate.