Wei-Hsin Tien1, Xuefeng Zhao2, Henry Y Chen3, Zachary C Berwick3, Joshua F Krieger4, Sean Chambers4, Dana Dabiri5, Ghassan S Kassab6. 1. Department of Mechanical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan. 2. California Medical Innovations Institute, San Diego, Calif. 3. Research and Development, 3DT Holdings, LLC, San Diego, Calif. 4. Research Engineering, Cook Medical, Bloomington, Ind. 5. Department of Aeronautics and Astronautics, University of Washington, Seattle, Wash. 6. California Medical Innovations Institute, San Diego, Calif. Electronic address: gkassab@calmi2.org.
Abstract
BACKGROUND: Efforts to treat chronic venous insufficiency have focused on the development of prosthetic venous valves. The role of prosthetic valve-to-vessel size matching has not been determined. The purpose of this investigation was to assess the effect of size mismatching on venous valve function and to establish a mismatch limit that affects valve hemodynamic performance and venous wall stress to improve future valve designs and implants. METHODS: Flow dynamics of prosthetic venous valves were studied in vitro using a pulse duplicator flow loop. Valve performance based on flow rate and pressure measurements was determined at oversizing ratios ranging from 4.2% to 25%. Valve open area ratios at different size mismatching ratios were investigated by image analysis. Finally, a wall stress analysis was used to determine the magnitude of circumferential (hoop) stress in the venous wall at various degrees of oversizing. RESULTS: Our findings indicate that valve regurgitate volume, closing time, and pressure difference across the valve are significantly elevated at mismatch ratios greater than ∼15%. This is supported by increases in regurgitate velocity and open area relative to valves tested at near-nominal diameters. At this degree of size mismatch, the wall stress is increased by a factor of two to three times relative to physiologic pressures. CONCLUSIONS: These findings establish a relationship between valve size matching and valve hemodynamic performance, including vessel wall stress, which should be considered in future valve implants. The size of the prosthetic valve should be within 15% of maximum vein size to optimize venous valve hemodynamic performance and to minimize the hoop wall stress.
BACKGROUND: Efforts to treat chronic venous insufficiency have focused on the development of prosthetic venous valves. The role of prosthetic valve-to-vessel size matching has not been determined. The purpose of this investigation was to assess the effect of size mismatching on venous valve function and to establish a mismatch limit that affects valve hemodynamic performance and venous wall stress to improve future valve designs and implants. METHODS: Flow dynamics of prosthetic venous valves were studied in vitro using a pulse duplicator flow loop. Valve performance based on flow rate and pressure measurements was determined at oversizing ratios ranging from 4.2% to 25%. Valve open area ratios at different size mismatching ratios were investigated by image analysis. Finally, a wall stress analysis was used to determine the magnitude of circumferential (hoop) stress in the venous wall at various degrees of oversizing. RESULTS: Our findings indicate that valve regurgitate volume, closing time, and pressure difference across the valve are significantly elevated at mismatch ratios greater than ∼15%. This is supported by increases in regurgitate velocity and open area relative to valves tested at near-nominal diameters. At this degree of size mismatch, the wall stress is increased by a factor of two to three times relative to physiologic pressures. CONCLUSIONS: These findings establish a relationship between valve size matching and valve hemodynamic performance, including vessel wall stress, which should be considered in future valve implants. The size of the prosthetic valve should be within 15% of maximum vein size to optimize venous valve hemodynamic performance and to minimize the hoop wall stress.