Implantation of the VenoValve (enVVeno Medical) continues to promote stabilization of symptoms in patients with deep venous reflux at two-year follow-up. This is the headline finding of data shared yesterday during Plenary Session 6 at VAM 2025.
In the abstract outlining their findings, submitting and presenting author Cassius Iyad Ochoa Chaar, MD, associate professor of surgery at Yale School of Medicine in New Haven, Connecticut, and colleagues highlight that patients with advanced venous disease and deep venous reflux have no surgical options for treatment.
The VenoValve, they note—a bioprosthetic monocusp valve surgically implanted into the femoral vein—is currently being tested in a clinical trial to address this clinical need.
In the prospective, multicenter SAVVE trial, patients with deep venous reflux and no superficial venous reflux or venous outflow obstruction underwent surgery for symptoms of advanced venous disease consistent with CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification C4b–C6.
“The one-year results showed significant improvement in clinical endpoints and quality-of-life measures,” the authors share. The goal of their present paper was to outline the two-year results of the total cohort of patients.
At VAM 2025, Chaar and colleagues reported that clinical improvement—as measured by revised Venous Clinical Severity Score (VCSS)—showed sustained benefit at two years in the 43 patients who reached this follow-up milestone. Specifically, the mean rVCSS at two years was 9.8, which was slightly lower than the mean score at one year, but “significantly lower” than the baseline score of 15.6. Among several other data points, Chaar and colleagues will report on pain scores. The authors note in their abstract a slight decrease in Visual Analogue Scale (VAS) score from 2.2 at one-year follow-up to 1.9 at the two-year mark. Again, however, this was “significantly lower” than the baseline of 4.3.
Excellent results