Project Summary: All present day prosthetic heart valves suffer from complications. Mechanical heart valves (HVs) require life-long anti-coagulation therapy, while bioprosthetic heart valves based on fixed tissue are plagued with durability, immunogenic and calcification issues. Superhydrophobic (SH) bileaflet mechanical heart valves with vortex generator (VG) technology promise to eliminate the need for anti-coagulation therapy. Our lab has developed a SH bileaflet mechanical heart valve (BMHV) with VGs that drastically improve surface hemocompatibility as well as eliminate turbulent stresses, thus reducing platelet activation. Preliminary work has shown that SH surfaces remarkably reduced thrombogenic potential relative to plain pyrolytic carbon leaflets. Further, we have already demonstrated the feasibility of manufacturing BMHVs and assembling them with VGs into an implantable BMHV. The present R01 study aims to gauge the efficacy of SH BMHV with VG as a potential alternative to current heart valve technology by fine tuning material composition and processing to meet the durability and antithrombogenic requirements for heart valves. Our central hypothesis is: superhydrophobic BMHVs with vortex generator flow control technology will require significantly less anti-coagulation therapy. This is tested in three aims. Aim 1 focuses on elucidating the effects of leaflet composition and processing on hemocompatibility while optimizing the strength and hemocompatibility of the coating. Aim 2 quantifies heart valve hemodynamic performance of SH with VG BMHVs to identify the ideal SH+VG configuration for superior hemodynamics and minimum blood damage. Aim 3 focuses on understanding the in vivo hemocompatibility of SH with VG BMHV in a pilot ovine study. This proposal is led by Dr. Lakshmi Prasad Dasi, who is a well trained young investigator with expertise in heart valve engineering and cardiovascular biomechanics, and inventor of several heart valve technologies including VGs and novel biomolecule polymer leaflets. Multi-PIs are Dr. Kota, who is an established superhydrophobic materials expert; Dr. Popat whose expertise lies in bio-compatibility and surface nano-engineering. Co-Is include Dr. Brueur, Dr. Bark, Dr. Crestanello, Dr. Shinoka, and Dr. Hor who form an experienced team with expertise in in-vivo models, platelet biology, surgery, and imaging. If the proposed work demonstrates that SH with VG BMHVs do not require anti-coagulation, elicit excellent hemodynamics, and are durable, this R01 grant may lead to breakthrough technology for mechanical HVs that require little or no anticoagulation.

Project Narrative: The objective of this project is to develop an advanced superhydrophobic mechanical heart valve that is engineered with flow control technology for maximum blood compatibility. State-of-the-art manufacturing and experimental studies in the areas of materials sciences and flow control theory are utilized to construct this novel heart valve. The proposed innovative approach combines these methods and techniques in a unique interdisciplinary effort to produce high performance mechanical heart valves. This research will lead to a dramatic improvement in heart valve and other mechanical support technology.