A new paper that drills into the impact of a novel bioprosthetic venous valve replacement by CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classification shows sustained clinical improvement regardless of grading, with patients classed as C4b exhibiting greater resolution of symptoms and quicker ulcer healing within the first three months after implantation than those with more advanced disease.
The findings emerged during the 2024 Midwestern Vascular Surgical Society (MVSS) annual meeting in Chicago (Sept. 12–14) in the latest analysis of the SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) multicenter pivotal trial assessing the safety and efficacy of the VenoValve (enVVeno Medical) in patients with chronic venous insufficiency.
The fully enrolled trial—made up of 75 patients across 21 sites in the U.S.—measures disease in CEAP categories C4b, C4c, C5 and C6. The paper presented at MVSS 2024 sought to elucidate how the valve affects disease severity, pain levels, quality of life and ulcer healing at the point of enrollment out to 12-month follow-up.
C6 patients comprised 50% of the study population. “What was interesting to see here was that 70% of the patients who were enrolled in the study had a nonhealing ulcer for more than a year or so,” Raghu Motaganahalli, MD, a SAVVE trial principal investigator who is chief of vascular surgery and program director at Indiana University in Indianapolis, told MVSS 2024. He reported primary and secondary patency rates for the valve of 87% and 96%, respectively, adding that there were four reinterventions and no procedural-related deaths or device-related infections. Benefits from device implantation in terms of venous reflux time were seen after three months and significantly decreased, he added.
In terms of clinical improvement by CEAP classification, Motaganahalli reported improvements in revised Venous Clinical Severity Score (rVCSS) across CEAP categories at three- and six-month follow-up. Compared to the baseline, he said there was an overall 9-point gain in rVCSS at 12-month follow-up after valve implantation. Visual Analogue Score (VAS) for pain assessment improved by almost 50% at one year, Motaganahalli continued, and quality of life, as measured by the VEINES-QOL/Sym instrument, also “significantly improved” across the CEAP spectrum.
Motaganahalli also noted a decrease in the use and need for compression stockings in tandem with the increase in patient quality of life. Meanwhile, ulcer area was reduced from 18.16cm2 at baseline to 3cm2. “It was also interesting to see that if a patient has an ulcer for less than three months, they have a 100% resolution of the ulceration over time,” Motaganahalli added.
Concluding, he said: “For patients with chronic venous insufficiency, the VenoValve was a novel treatment option. It has shown improvement by rVCSS, we have seen a reduction in pain as evidenced by VAS, ulcers heal, limb swelling is improved by the VEINES-QOL/Sym score, and all improvements are shown within the first three months of the clinical period.”
During discussion, Motaganahalli highlighted how the paper helps draw attention to optimal intervention points. “By the time you transition from a C4b, or a C4c, to a C6 category, you have a lot of damage in those patients,” he said. “That is exactly the purpose of this paper: to see where to intervene and when to intervene. In fact, the C4b category patients had more resolution of their symptoms. Ulcers heal much more quickly in that group of patients—they were the ones to improve within the three-month window—as opposed to much more advanced disease.”
