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Center for Research & Breakthroughs (R&B)

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Center for Research & Breakthroughs (R&B)
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R&B Advanced Cardiovascular Research

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Introduction

Cardiovascular diseases are one of the main reasons behind deaths according to recent reports. Approximately, 92.1 million American adults have at least one type of cardiovascular disease [1]. 30% of adults with an existing cardiovascular condition suffer from heart disease. For the last century, cardiovascular diseases have been considered the main cause of death in the United States. Depending on the severity and type of the condition, treatment or countermeasure options may vary. Altering lifestyle habits, such as weight control, increasing physical activity, quitting the consumption of tobacco products, moderating alcohol intake, and decreasing saturated fat and sodium in the diet, are shown to be beneficial to improving cardiovascular health. Moreover, assistive medication for high blood pressure or high cholesterol is also beneficial. For people who have been diagnosed with severe conditions, lifestyle changes, and assistive medication may not be enough. Heart transplantation could be considered the best possible treatment. Yet, the ratio of available heart donors to people on the transplantation waitlist is not promising [2]. The World Health Organization’s “Atlas of Heart Disease and Stroke [3]” foresees a grim future for the World’s population. One of the predictions of the report is that by 2030 globally 32.5 % of all deaths would be caused by cardiovascular diseases. The report also plants hope by stating that cardiovascular diseases could be prevented considering research conducted for the last 50 years. Therefore, there is an imminent need for the development of new treatments for cardiovascular diseases and the development and testing of proposed future treatments. The development of a novel Cardiovascular Performance Benchmark platform (CPSP) would be a perfect candidate to meet the requirements of such a need.

Goal

The goal of this research is to empower the development of technologies and simulation models supporting health and medical research through computational science, engineering, bioscience, and health science research. This innovative hands-on cardiovascular performance benchmark simulation platform provides transformative research and learning process that enables the integration of knowledge, methods, and expertise from different disciplines through convergence research across diverse perspectives.

Equipping the Healthcare Industry to Achieve Innovative Design Breakthrough

We will test the hypothesis using the following specific aims as shown in Figure 1: (1) 3D printing customized specialized biocompatible, silicone-based heart valvemanufacturing (2) Silicone heart valve testing using the MCL system for functionality and performance. (3) using validated heart valve with the CPSP for cardiovascular performance simulation platform that will serve as a design and monitoring tool for better and physiologically accurate research and development efforts.

01. Design and Development of a 3D Printing Machine to Manufacture Customized Silicon Heart Valve

Heart valve diseases, such as aortic stenosis, are considered a common illness in the US, resulting in hundreds of thousands of heart valve replacement operations. . In severe cases, either mechanical or prosthetic heart valves are used to replace the damaged heart valve. Current heart valve solutions are costly and labor-intensive for fabrication, have relatively short life spans, and include animal-derived tissue (bioprosthetic) or metallic elements that require immunosuppression or anti-thrombogenic drugs, which have significant undesirable side effects. Moreover, the replacement valves presently used are circular and may not fit perfectly into the patient's aorta which is different for each patient. Additive manufacturing (AM) is becoming increasingly capable of redefining the manufacturing landscape. High accuracy, reliable, and capable of using silicon material 3D printing machine for manufacturing customized heart valves is designed and built (see Fig. 2).
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Fig.2 3D silicone printing machine final product (Ertas et al., 2023).

02. Mock Circulation Loops (MCL) to Test Heart Valve Functionality

As shown in Figure 3, mock circulation loops are closed-loop piping systems whose sole purpose is to regenerate physiological circulatory parameters. MCLs consist of compliance chambers, resistance valves, artificial heart valves or flip valves, and more importantly, a pump to act as actuators mimicking the ventricles. The use of expandable sacs, pneumatically actuated chambers, and an artificial heart could be found as examples of a pump for an MCL.
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Fig. 3 Prototyped MCL system (adapted from Baturalp and Ertas, 2015).

03 Cardiovascular Performance Simulation Platform (CPSP)

CPSP will consist of a multistage computational model and an experimental setup for not only validation of the computational counterpart, but also serving as a test bed for cardiovascular assistance devices. General stages of the computational part of CPSP could be listed as follows (see Figure 4): finite element analysis to identify mechanical deformation characteristics of the left ventricular simulator, fluid-structure interaction model to predict cardiac output and flow through valves, and computational fluid dynamics model to monitor flow from aorta to left atrium, excluding pulmonary flow.
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Fig. 4 Proposed Cardiovascular Performance Simulation Platform. (adapted from Gulbulak and Ertas, 2019).

Concluding Remarks

The results of this study will be a stepping- stone for researchers all around the globe who have been working on a better understanding of cardiovascular diseases and effective long-term cardiovascular treatments by means of either clinical, computational, or experimental. CPSP will accelerate the mentioned research efforts by offering a benchmark strategy that will be physiologically accurate as much as possible. The design of cardiovascular assistance devices (LVADs) has not reached its perfection and is yet to even deliver its initial promises. The complex and sensitive nature of working conditions of cardiovascular assistance devices is the main reason for their decelerated progress. Yet, future treatments seem to be the only viable option as destination therapy for World's population. The proposed research will have an impact on the direction of the development of new solutions for cardiovascular diseases and will be a focal point for medical doctors, engineers, and scientists by creating a transdisciplinary research effort. Mock Circulation Loops (MCLs) play an essential role not only in vitro testing (not in a body) and development of LVADs and heart valves but also in other circulation-related devices, such as total artificial hearts, artificial lungs, vascular grafts, bioreactors for tissue-engineered heart valves.

References

  1. Benjamin, E. J., et al., “Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association.” Circulation 135, no. 10 (2017): e146–e603. doi:10.1161/CIR.0000000000000485, Available at http://circ.ahajournals.org/lookup/doi/10.1161/CIR.0000000000000485

  2. Califano, S., Pagani, F. D., and Malani, P. N. “Left Ventricular Assist Device–Associated Infections.” Infectious Disease Clinics of North America 26, no. 1 (2012): 77–87. doi:10.1016/j.idc.2011.09.008, Available at http://www.ncbi.nlm.nih.gov/pubmed/22284377

  3. “WHO | The Atlas of Heart Disease and Stroke.” WHO (2010): Available at http://www.who.int/cardiovascular_diseases/resources/atlas/en/

Related Published Articles

Ertas, A., Erik Farley-Talamantes, H. Saker, A. Rajan, C. Lamb, D. Flores, B. Norton. Innovative Approach to Design and Development of a 3D Silicone Printing Machine Using Transdisciplinary Integrated Design Tools. Transdisciplinary Journal of Engineering & Science, Vol. 14, pp. 19-63, 2023.

Gulbulak, U., Gecgel, O., and Ertas, A. A Deep Learning Framework to Approximate the Geometric Orifice and Coaptation Area of Polymeric Heart Valves Under Time-Varying Transvalvular Pressure. Journal of the Mechanical Behavior of Biomedical Materials, 2021, 117:104371. doi: 10.1016/j.jmbbm.2021.104371.

Gulbulak, U., Ertas, A., Pavelka, T., Baturalp, T. The Effect of Fundamental Curves on Geometric Orifice Area of Polymeric Bioprosthetic Heart Valves.  Journal of the Mechanical Behavior of Biomedical Materials, 112, 104039. https://doi.org/10.1016/j.jmbbm.2020.104039.

Gulbulak, U., Ertas, A. Finite Element Driven Design Domain Identification of a Beating Left Ventricular Simulator. Bioengineering, 2019, 6, 83; doi:10.3390/bioengineering6030083

Gulbulak U., and Ertas, A., and Students from Additive Manufacturing class. Boosting Just-in-Time Supply Chain Innovation through Additive Manufacturing: A Transdisciplinary Educational Experience. Transdisciplinary Journal of Engineering & Science, Vol. 10, pp. 199-223, 2019. doi: 10.22545/2020/00137

Pavelka, T., Gulbulak, U., Baturalp, T., Ertas, A. Performance Evaluation of a Mock Circulation Loop with Bioprosthetic Heart Valves and a Beating Left Ventricle Simulator. Rice University, Houston, Texas, "Gold Coast Undergraduate Research Symposium," National, peer-reviewed/refereed. (2019).

Baturalp, T. B., Ertas, A. State of the Art Mock Circulation Loop and a Proposed Novel Design (pp. 23-29, 2015). Proceedings of the International Conference on Biomedical Engineering and Science (BIOENG'15).

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