Annals of vascular surgery · 2025
Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux.
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Cifuentes Sebastian, Figueroa Andres V, Glickman Marc H, Ulloa Jorge H
Аннотация
BACKGROUND: Chronic venous insufficiency (CVI) affecting the deep venous system is most often caused by postthrombotic syndrome (PTS), which leads to reflux, blood pooling, and venous hypertension in the lower extremities. Researchers have sought to restore deep valvular competence, with numerous attempts at primary repair and valve replacement yielding limited results. This article presents the mid-term outcomes (3 years) of the first-in-human study of the bioprosthetic VenoValve surgically implanted in patients with CVI.
METHODS: The VenoValve is a 10-mm × 21-mm monocusp bioprosthetic valve crafted from porcine aortic wall and noncoronary aortic valve leaflet, sewn onto a stainless-steel frame and designed to restore deep venous competence. In a first-in-human study conducted in Colombia, the VenoValve was implanted in patients with PTS unresponsive to conservative management and with deep venous reflux ≥1 sec, measured at the popliteal vein. Technical results and 3-year clinical outcomes were analyzed and reported.
RESULTS: Between February and December 2019, 11 patients (5 males and 6 females; mean age 67 ± 14.8) underwent surgical implantation of the valve in the femoral vein. All patients had clinical and sonographic evidence of postthrombotic changes, and a self-reported history of deep venous thrombosis was positive in 6 patients (55%). According to the clinical, etiologic, anatomic, and pathophysiologic classification, 6 patients (55%) were classified as C6, and 5 patients (45%) were classified as C5. The technical success rate was 100%. Three patients were lost to follow-up after 1 year. At the 3-year follow-up, the VenoValve showed a primary patency rate of 79%, with patients experiencing a mean reduction of 62% in reflux times, 52% in the revised Venous Clinical Severity Score (7-point reduction), and 84% in pain levels (visual analog scale). Valve thrombosis occurred in 2 patients, 1 at 3 months and the other at 3 years postimplantation; both events occurred after the patient discontinued anticoagulation. No serious device-related adverse events were observed.
CONCLUSION: VenoValve implantation demonstrated mid-term safety and efficacy in restoring deep venous competence in patients with refractory PTS, leading to sustained improvement and stabilization of the disease for 3 years. Nonetheless, long-term anticoagulation therapy may be necessary to maintain these benefits. This first-in-human study provides evidence of the device's performance, informing regulatory deliberations and supporting further evaluation in a larger cohort in an ongoing pivotal trial in the United States.
METHODS: The VenoValve is a 10-mm × 21-mm monocusp bioprosthetic valve crafted from porcine aortic wall and noncoronary aortic valve leaflet, sewn onto a stainless-steel frame and designed to restore deep venous competence. In a first-in-human study conducted in Colombia, the VenoValve was implanted in patients with PTS unresponsive to conservative management and with deep venous reflux ≥1 sec, measured at the popliteal vein. Technical results and 3-year clinical outcomes were analyzed and reported.
RESULTS: Between February and December 2019, 11 patients (5 males and 6 females; mean age 67 ± 14.8) underwent surgical implantation of the valve in the femoral vein. All patients had clinical and sonographic evidence of postthrombotic changes, and a self-reported history of deep venous thrombosis was positive in 6 patients (55%). According to the clinical, etiologic, anatomic, and pathophysiologic classification, 6 patients (55%) were classified as C6, and 5 patients (45%) were classified as C5. The technical success rate was 100%. Three patients were lost to follow-up after 1 year. At the 3-year follow-up, the VenoValve showed a primary patency rate of 79%, with patients experiencing a mean reduction of 62% in reflux times, 52% in the revised Venous Clinical Severity Score (7-point reduction), and 84% in pain levels (visual analog scale). Valve thrombosis occurred in 2 patients, 1 at 3 months and the other at 3 years postimplantation; both events occurred after the patient discontinued anticoagulation. No serious device-related adverse events were observed.
CONCLUSION: VenoValve implantation demonstrated mid-term safety and efficacy in restoring deep venous competence in patients with refractory PTS, leading to sustained improvement and stabilization of the disease for 3 years. Nonetheless, long-term anticoagulation therapy may be necessary to maintain these benefits. This first-in-human study provides evidence of the device's performance, informing regulatory deliberations and supporting further evaluation in a larger cohort in an ongoing pivotal trial in the United States.