In Vitro Evaluation of a New Autologous Valve-Stent for Deep Venous Incompetence

• Published in: Journal of endovascular therapy Vol. 13; no. 6; pp. 762 - 769
• Main Authors: Geselschap, Jim H., van Zuiden, Jorrit M., Toonder, Irwin M., Wittens, Cees H.A.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.12.2006; Allen Press Inc
• Subjects: Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - methods; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - methods; Clinical trials; Equipment Failure Analysis; Hemodialysis; Humans; Hydrostatic Pressure; Informed consent; Leg - blood supply; Materials Testing; Mechanical properties; Medical treatment; Models, Anatomic; Models, Cardiovascular; Patients; Polyvinyl chloride; Prosthesis Design; Saphenous Vein - diagnostic imaging; Saphenous Vein - transplantation; Stents; Stents - adverse effects; Stents - standards; Studies; Time Factors; Transplantation, Autologous - methods; Ultrasonography, Doppler, Duplex; Varicose veins; Veins & arteries; Venous Insufficiency - diagnostic imaging; Venous Insufficiency - therapy; deep venous incompetence; autologous vein; saphenous vein; venous valve; venous reflux; endovascular treatment; Palmaz stent
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/04-1208R.1

Purpose: To report the results of in vitro hydrostatic bench testing of a new vein-stent combination to correct deep venous incompetence. Methods: Twelve valves were constructed from a modified Palmaz stent encased in a segment of great saphenous vein harvested from patients during routine varicose vein surgery. An in vitro flow circuit was set up to evaluate opening and closing pressures (in cm H2O), and the valve was subsequently subjected to repetitive cycles of increasing prograde flow and reflux pressures. Duplex scanning was used to evaluate valve closure time and detect any possible reflux. Results: The valve mechanism required only 1 to 3 cm H2O for opening and 2 to 4 cm H2O for closing. Prograde flow of up to 1000 mL/min passed easily through this valve, which remained competent with reflux pressures up to 180 cm H2O. Mean valve closure time was 0.15±0.07 seconds. Unligated side branches or damage from dissection impaired the competence of 3 valves. Conclusion: This new vein-stent valve functions as a normal deep vein valve, requiring only minimal pressures for opening and closing. It allows high flow passage and still remains competent at high reflux pressures. This valve may provide a minimally invasive solution for the correction of deep venous incompetence using autologous material. Further in vivo evaluation will be mandatory.