SS15 - The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux

Objectives: Chronic venous ulcers (VU) remain a challenging vascular condition despite advances in wound care and surgical therapy. Deep venous reflux (DVR) is present in approximately a third of patients with VU and is thought to be a factor contributing to non-healing and recurrence. The VenoValve is a bioprosthetic valve that is implanted into the femoral vein of the upper thigh and has demonstrated success promoting VU healing in a pilot single center study. This report will present data of the multicenter SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) trial highlighting the impact of the VenoValve after one year of implantation in patients treated for VU.

Methods: The SAVVE trial is a prospective, multi-center study that enrolled patients with DVR and symptomatic advanced venous disease CEAP C4b–C6 despite standard of care therapy. Patient characteristics were recorded and the revised Venous Clinical Severity Score (rVCSS), wound surface area, VU healing as well as improvement defined by reduction of area were assessed at preoperative baseline and at 3, 6, and 12 months. This abstract contains the available data on patients treated for VU (C6 disease). At VAM 2024, updated data on all patients who have reached 1-year follow up will be presented.

Results: A total of 75 patients enrolled in the study and 41 patients (54.7%) were treated for VU and are the focus of this report. The mean age was 64 with 78% males and 93% White. Most VU had a duration of more than 12-month 70.7% (N=29/41) and only 5 patients (12.2%) had ulcers of less than one month duration. The mean baseline rVCSS was 19 and significantly decreased after VenoValve implantation at 3, 6, and 12 months to 13.8, 12.5, and 12.4, respectively (all P< 0.05). (Figure1) Total VU healing was achieved by 26.8% at 3-month and continued to increase up to 43% at 12-month with more than 80% of patients achieving VU healing or improvement at all time points. (Figure2) Based on currently available data, the mean VU surface area in this patient population decreased from 12.58 cm2 prior to surgery to 5.09 cm2 at 3-month and continued to decrease down to 3.85 cm2 at 12-month. The total area of VU combined at baseline was 264.14 cm2and decreased to 84.79 cm2 at 12-month after surgery.

Conclusions: VenoValve implantation provides sustainable improvement in VU healing that continues for a year after surgery in patients who have exhausted all current standard of care treatments.