SAVVE US pivotal study of patients with severe chronic insufficiency due to deep valvular venous reflux: One-year results after VenoValve implantation.

Abstract

Objective: Failure of deep venous valves and associated reflux leads to the progression of chronic venous insufficiency (CVI), culminating in painful, clinically challenging, and costly leg ulcers. Traditional CVI treatments have primarily focused on symptom management, or interventions for superficial veins. This study aimed to show that bioprosthetic valve implantation yields clinically meaningful health improvements and offers a safe and effective treatment for deep venous CVI by addressing the root cause of the condition.

Methods: SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) was a prospective, single-arm, multicenter study to evaluate the performance of a bioprosthetic venous valve device (VenoValve; enVVeno Medical), for femoral vein implantation in patients with venous disease (Clinical-Etiology-Anatomy-Pathophysiology clinical classifications C4b, C4c, C5, and C6) unresponsive to standard care. Outcome measures included duplex-derived reflux time, the Revised Venous Clinical Severity Score (rVCSS), pain, disease-specific (VEINES-QoL/Sym) and general health-related quality of life (EuroQol 5 Dimensions) measures, technical success of device implantation, ulcer healing (C6 patients), and ulcer recurrence (in C5 and C6 patients). Clinically meaningful improvement was defined as a decrease in rVCSS of at least 3 points.

Results: Between October 2021 and September 2023, 75 patients were enrolled (median age, 65 years; interquartile range, 57-70 years) at 23 institutions. Of the enrolled patients, 61 (81.3%) were men and 16 (21.3%) were Black, Hispanic, or Latino. The device was implanted in 73 patients (97.3%). At 6 months, 23 of 67 implanted patients (34.3%) had a 30% or greater improvement in duplex-derived reflux time. Average rVCSS score improvements were clinically meaningful and statistically significant at 3, 6, and 12 months. At 12 months, 84.6% of implanted patients achieved clinically meaningful improvement, with an average improvement of 7.9 points in rVCSS. Statistically significant improvements in pain and health-related quality of life were reported through 12 months of follow-up. Among patients with C6 disease, healing was observed for 91.6% of ulcers that had a duration of less than 12 months. No unanticipated device-related adverse events were reported. The perioperative major adverse events rate was 30.7% with no mortality. Most patients with major adverse events achieved clinically meaningful improvement in symptoms.

Conclusions: Implantation of the bioprosthetic venous valve yielded important clinical and health-related quality of life benefits in patients with severe CVI.