Systematic Review of Devices, Designs, and Trials for the Treatment of Deep Venous Reflux.

OBJECTIVE: Chronic venous insufficiency (CVI) is driven primarily by venous reflux and affects nearly one-third of adults. While superficial reflux is effectively treated with ablation, therapeutic options for deep venous reflux (DVR) remain limited. Despite decades of innovation, no prosthetic or bioprosthetic venous valve has achieved U.S. regulatory approval. We systematically reviewed device strategies, clinical and hemodynamic outcomes, complications, and barriers to translation for devices designed to treat DVR.

METHODS: We conducted a PROSPERO-registered systematic review (CRD420251101761) of six databases from inception through February 2026, including in vivo animal and human studies evaluating prosthetic or bioprosthetic devices for DVR. Studies of native valve repair or autotransplantation were excluded. The primary outcome for human studies was clinical improvement, and secondary outcomes included patency, procedural complications, valvular function, and thrombosis.

RESULTS: Of 516 records identified, 15 met inclusion criteria: 8 human and 7 animal studies. Two principal strategies were identified: intraluminal valve restoration (VR) and external compression (EC), with approximately 40% of devices delivered percutaneously or endovenously. In human studies, technical success ranged from 87.7%-100%, patency from 67%-100%, and perioperative complication rates from 0%-44%, consisting primarily of bleeding, wound infection, and valve thrombosis. Valve occlusion occurred in up to 28% of animal implants and 18%-22% of select human cohorts. Two perioperative deaths occurred in animal studies; none were reported in human studies. Among human studies, valve competency assessment methods varied substantially. Reported competency ranged from 0%-92%, reflecting heterogeneity in imaging modalities and definitions. Discordance between anatomic patency, duplex-derived reflux reduction, and clinical improvement was frequently observed. In contemporary multicenter trial data, fewer than half of patients met predefined reflux-reduction endpoints despite high device patency and substantial clinical improvement, highlighting discordance between anatomic, hemodynamic, and patient-centered outcomes. By one year, pain had improved in 75%-97% of patients; rVCSS decreased by 37%-81%, with clinically meaningful (≥3-point) improvement in up to 84.6%; and ulcer healing ranged from 67%-100%. Longer follow-up extended to 2 years in animal studies and up to 11 years in human series with various outcomes reported.

CONCLUSION: Several devices developed for DVR have demonstrated technical feasibility and symptom improvement. However, the risk of thrombosis, the marginal impact on valvular function, and the lack of standardization and selection of adequate endpoints in the measurement of results remain major barriers to regulatory approval. Standardized composite endpoints integrating objective hemodynamic measures with patient-centered outcomes are essential to advance durable DVR device development and clinical translation.