All present day prosthetic heart valves have issues regarding blood compatibility and risk of thromboembolic complications. India's low cost Chitra mechanical heart valve that requires strong life-long anti-coagulation therapy is the only valve that presently caters to the predominantly young heart valve patient in India. Therefore, most Indian patients have no choice but to face the risks of life long anti-coagulation therapy. Bio-prosthetic heart valves are either too expensive or the patients do not prefer the prospect of re-operation secondary to relatively poor durability of these valves and high rate of infection in Indian hospitals. Further there exists concern arising from personal religious preference related to use of porcine or bovine tissue. Recent development of minimally invasive technology in the United States is not as attractive to India due to the patient age, and more severe durability concerns. What is needed is a low-cost non-tissue based biocompatible tri-leaflet heart valve. Polymeric heart valves have the promise to bring the best of mechanical valves and bio-prosthetic heart valves. Our lab has developed a novel biomaterial, Bio-Poly, which involves the engineering of polymeric materials that are, at a molecular level, interlocked with hyaluronan (HA, a naturally occurring polysaccharide) to make highly hydrophilic hemo- and bio-compatible polymer leaflets with the durability of engineered synthetic polymers. Preliminary work has shown that Bio-Poly leaflets have a remarkably hemo-compatible compared to plain polymer leaflets. Further, we have already demonstrated the feasibility of assembling Bio-Poly leaflets into implantable tri-leaflet valve prosthesis with excellent hemodynamic characteristics. The present R03 study aims to test and optimize Bio-Poly valves as the next generation low-cost and superior heart valve. Our central hypothesis is: that Bio-poly is an effective and low-cost biomaterial for tri-leaflet heart valve prosthesis with aspirin regimen anticoagulation only. This is tested in three aims.
Aim 1 focuses on hemodynamic and durability testing of the new valves while optimizing leaflet cooptation characteristics.
Aim 2 focuses on optimizing the materials manufacturing process to maximize hemo-compatibility of these valves.
Aim 3 focuses on commencing animal trials to validate hemocompatibility and calcification in vivo and lay the groundwork for commercialization in India. These studies are jointly conducted by the US and Indian teams in collaboration with our commercial partner, TTK Healthcare. TTK Healthcare is a major valve manufacturer in India that is committed to commercialize our low-cost technology to cater to the Indian market. Our approach is innovative with the use of HA, as the agent that brings hemo-compatibility to otherwise non-compatible, durable hydrophobic polymer leaflets that have the potential for scaling towards mass production at low-cost and high design tolerance.

Public Health Relevance

We have developed an advanced polymeric heart valve that is engineered for maximum biocompatibility through the use of cross-linked Hyaluronan. Testing, validation, and optimization of this novel low-cost technology is proposed as a joint effort between the US and Indian teams, while laying the ground work towards commercialization in India through TTK Healthcare (India's largest heart valve manufacturer).

National Institute of Health (NIH)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Small Research Grants (R03)
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Special Emphasis Panel (ZRG1)
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Pai, Vinay Manjunath
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Ohio State University
United States
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Yousefi, Atieh; Bark, David L; Dasi, Lakshmi P (2017) Effect of Arched Leaflets and Stent Profile on the Hemodynamics of Tri-Leaflet Flexible Polymeric Heart Valves. Ann Biomed Eng 45:464-475