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Published on: November 19, 2019
Endovenous valve transfer for chronic deep venous insufficiency
M N Phillips1, M L Dijkstra, N Y Khin
1Royal North Shore Hospital, Department of Vascular Surgery, Sydney, NSW, Australia.
A novel endovenous valve transfer stent demonstrated excellent safety and efficacy in animal models. This innovative approach showed promising results for treating venous ulcers in a small human pilot study.
Area of Science:
- Vascular Surgery
- Biomedical Engineering
- Regenerative Medicine
Background:
- Venous valve insufficiency is a common condition leading to chronic venous ulcers.
- Current treatments for severe venous insufficiency have limitations.
- Endovenous valve transfer offers a potential new therapeutic strategy.
Purpose of the Study:
- To evaluate the safety and efficacy of a custom-made endovenous valve transfer stent and delivery system.
- To assess the feasibility of endovenous valve transfer in both animal models and human subjects.
Main Methods:
- Sheep internal jugular veins were used to test the stent, with valves enclosed in a barbed stent and remotely deployed.
- Histological and scanning electron microscopic (SEM) examinations were performed at various postoperative intervals.
- A small pilot study involved transferring axillary veins from the popliteal vein in four human patients with recalcitrant ulcers.
Main Results:
- In sheep, all transferred venous valves remained competent postoperatively, with no thrombosis, tilting, endoleak, or migration observed.
- Macroscopic and SEM findings in sheep were normal.
- In humans, 50% of ulcers healed completely, with the remainder showing improvement. All transferred valves remained competent and patent.
Conclusions:
- The custom-made circumferential stent for endovenous valve transfer demonstrated near-perfect outcomes in sheep.
- The technique yielded encouraging results in a small human pilot study for venous ulcer treatment.
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