C-66 | Femoral Hemostasis After Transcatheter Aortic Valve Replacement with use of Single Perclose Delivery with a Potassium Ferrate Hemostatic Patch

Closure for large bore femoral vascular access commonly involves the use of two Perclose ProglideTM in a "preclose" technique. Prior observational studies suggest that use of a single perclose device for trans-femoral TAVR closure is safe and may have clinical benefits compared to a two-device technique, however a protocol for use of a single perclose has not been established. The potassium ferrate hemostatic patch (PFHP, Statseal) has been shown to reduce time to hemostasis as an adjunct for transradial closure. The aim of this trial was to test whether the PFHP as an adjunct to use of a single perclose for trans-femoral transcatheter aortic valve replacement (TAVR) closure facilitated earlier hemostasis. 50 patients at a single high-volume TAVR center undergoing transfemoral implantation were randomized 1:1 to closure with a single Perclose device (SP) or SP + PFHP with manual pressure for 3 additional minutes after SP cinching. All patients received protamine prior to arteriotomy closure. Those on oral coagulants within 24 hours of the procedure were not included. The primary outcome was total time to hemostasis and the secondary safety outcome was post-procedure hematoma formation. No difference in successful time to hemostasis was seen between the SP vs PFHP groups (5.3 vs 4.3 minutes, p=0.50) or hematoma formation (3.8 vs 4.2%, p=0.95) with 2 hematoma complications occurring in the study. In univariate analysis, procedural characteristics of sheath size (14 vs 16 French), heparin dose, anti-platelet usage, and last systolic blood pressure were not found to be predictive of time to hemostasis or hematoma formation. In this small randomized trial, compared with the use of SP alone, the PFHP did not appear to reduce time needed to hemostasis or hematoma formation. Use of a single Perclose ProglideTM device, delivered in a preclose fashion, with 3 minutes of manual compression and protamine administration was found to have a low hematoma complication rate in transfemoral large bore TAVR access closure. (NCT05637970)