RS20 - Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve

Objectives: Patients with advanced venous disease and deep venous reflux (DVR) have no surgical options for treatment. The VenoValve is a bioprosthetic monocusp valve surgically implanted into the Femoral vein and being tested currently in a clinical trial. The 1-year results showed significant improvement in clinical endpoints and quality of life measures. The 1-year Ulcer healing data was presented prior showing 91% ulcer healing or improvement in that subgroup of patients. The current abstract will present the 2-year results of the total cohort of patients.

Methods: The SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) is a prospective, multicenter trial assessing the safety and efficacy of the VenoValve device. Patients with DVR and no superficial venous reflux or venous outflow obstruction underwent surgery for symptoms of advanced venous disease consistent with CEAP C4b-C6. The revised Venous Clinical Severity Score (rVCSS), Quality of life measures (VEINES qol/sym and EQ5-D), wound size, and DVR on ultrasound were assessed at preoperative baseline and continue to be followed on a yearly basis.

Results: A total of 43 patients in this study have reached the 2-year follow up milestone. Clinical improvement measured by rVCSS showed sustained benefit at 2-year. The mean rVCSS at 2-year was 9.8 similar to 1-year (10.0) but significantly lower than baseline (15.6). (Figure 1) Those patients with clinically meaningful benefit (greater than 3-point improvement) continue to show rVCSS improvement at 2-year of 8.2 points. Pain scores assessed by Visual Analogue Scale (VAS) decreased slightly to 1.9 at 2-year compared to 2.2 at 1-year but were significantly lower than baseline (4.3). (Figure 2) Overall, patients had improvement in quality-of-life measures represented by EQ-5D that remained stable and similar to 1-year. The mean EQ-5D score was 0.76 at 2-year from 0.78 at 1-year but was higher than baseline (0.69). Secondary patency rates at 2 years appear to be stable. Over the past year, one device occluded but the patient underwent successful aspiration thrombectomy. This patient had been non-compliant with their anticoagulation medication during the first year of the study. Data continue to be collected and will be updated at the time of VAM2025.

Conclusions: VenoValve implantation continues to promote stabilization of symptoms in patients at 2-year. These results are consistent with the findings of the smaller first in-human pilot study that was completed. Patients demonstrated stable improvement in clinical assessment and quality of life measures compared to baseline.