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      Review of Systemic Mock Circulation Loops for Evaluation of Implantable Cardiovascular Devices and Biological Tissues

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          Abstract

          Implantable cardiovascular devices must undergo evaluation prior to animal testing and clinical trials to ensure their performance and efficiency. Mock circulation loops (MCLs) are on-demand tools capable of reproducing physiological conditions in vivo and are also devices for preventative testing. Recognition of their success as useful tools comes from the fact that over 100 MCLs have been submitted for device assessment in recent years. Mock circulation loops could detect malfunctions that patients might otherwise experience. Thus, MCLs can complement preclinical and prototype evaluation rather than being mutually exclusive. In this review, we emphasize the experimental value of MCLs while providing a brief overview of the history of the field. In addition, the necessary hemodynamic parameters are analyzed to reproduce physiological scenarios in vitro. We also discuss the relevant setups when evaluating devices to assist heart failure and aortic pathologies, namely artificial hearts, left ventricular assist devices, stent-grafts, and artificial heart valves. Finally, we report novel setups developed to evaluate soft biological tissues for translational research.

          Clinical Impact

          On needs-based ex vivo monitoring of implantable devices or tissues/organs in cardiovascular simulators provides new insights and paves new paths for device prototypes. The insights gained could not only support the needs of patients, but also inform engineers, scientists and clinicians about undiscovered aspects of diseases (during routine monitoring). We analyze seminal and current work and highlight a variety of opportunities for developing preclinical tools that would improve strategies for future implantable devices. Holistically, mock circulation loop studies can bridge the gap between in vivo and in vitro approaches, as well as clinical and laboratory settings, in a mutually beneficial manner.

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          Most cited references125

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          Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019

          Cardiovascular diseases (CVDs), principally ischemic heart disease (IHD) and stroke, are the leading cause of global mortality and a major contributor to disability. This paper reviews the magnitude of total CVD burden, including 13 underlying causes of cardiovascular death and 9 related risk factors, using estimates from the Global Burden of Disease (GBD) Study 2019. GBD, an ongoing multinational collaboration to provide comparable and consistent estimates of population health over time, used all available population-level data sources on incidence, prevalence, case fatality, mortality, and health risks to produce estimates for 204 countries and territories from 1990 to 2019. Prevalent cases of total CVD nearly doubled from 271 million (95% uncertainty interval [UI]: 257 to 285 million) in 1990 to 523 million (95% UI: 497 to 550 million) in 2019, and the number of CVD deaths steadily increased from 12.1 million (95% UI:11.4 to 12.6 million) in 1990, reaching 18.6 million (95% UI: 17.1 to 19.7 million) in 2019. The global trends for disability-adjusted life years (DALYs) and years of life lost also increased significantly, and years lived with disability doubled from 17.7 million (95% UI: 12.9 to 22.5 million) to 34.4 million (95% UI:24.9 to 43.6 million) over that period. The total number of DALYs due to IHD has risen steadily since 1990, reaching 182 million (95% UI: 170 to 194 million) DALYs, 9.14 million (95% UI: 8.40 to 9.74 million) deaths in the year 2019, and 197 million (95% UI: 178 to 220 million) prevalent cases of IHD in 2019. The total number of DALYs due to stroke has risen steadily since 1990, reaching 143 million (95% UI: 133 to 153 million) DALYs, 6.55 million (95% UI: 6.00 to 7.02 million) deaths in the year 2019, and 101 million (95% UI: 93.2 to 111 million) prevalent cases of stroke in 2019. Cardiovascular diseases remain the leading cause of disease burden in the world. CVD burden continues its decades-long rise for almost all countries outside high-income countries, and alarmingly, the age-standardized rate of CVD has begun to rise in some locations where it was previously declining in high-income countries. There is an urgent need to focus on implementing existing cost-effective policies and interventions if the world is to meet the targets for Sustainable Development Goal 3 and achieve a 30% reduction in premature mortality due to noncommunicable diseases.
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            Global Public Health Burden of Heart Failure.

            Heart failure (HF) is a global pandemic affecting at least 26 million people worldwide and is increasing in prevalence. HF health expenditures are considerable and will increase dramatically with an ageing population. Despite the significant advances in therapies and prevention, mortality and morbidity are still high and quality of life poor. The prevalence, incidence, mortality and morbidity rates reported show geographic variations, depending on the different aetiologies and clinical characteristics observed among patients with HF. In this review we focus on the global epidemiology of HF, providing data about prevalence, incidence, mortality and morbidity worldwide.
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              Large-Artery Stiffness in Health and Disease

              A healthy aorta exerts a powerful cushioning function, which limits arterial pulsatility and protects the microvasculature from potentially harmful fluctuations in pressure and blood flow. Large-artery (aortic) stiffening, which occurs with aging and various pathologic states, impairs this cushioning function, and has important consequences on cardiovascular health, including isolated systolic hypertension, excessive penetration of pulsatile energy into the microvasculature of target organs that operate at low vascular resistance, and abnormal ventricular-arterial interactions that promote left ventricular remodeling, dysfunction, and failure. Large-artery stiffness independently predicts cardiovascular risk and represents a high-priority therapeutic target to ameliorate the global burden of cardiovascular disease. This paper provides an overview of key physiologic and biophysical principles related to arterial stiffness, the impact of aortic stiffening on target organs, noninvasive methods for the measurement of arterial stiffness, mechanisms leading to aortic stiffening, therapeutic approaches to reduce it, and clinical applications of arterial stiffness measurements.
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                Author and article information

                Contributors
                (View ORCID Profile)
                Journal
                Journal of Endovascular Therapy
                J Endovasc Ther
                SAGE Publications
                1526-6028
                1545-1550
                March 25 2024
                Affiliations
                [1 ]Institute of Biomechanics, Graz University of Technology, Graz, Austria
                [2 ]Division of Cardiac Surgery, Medical University of Graz, Graz, Austria
                [3 ]Department of Structural Engineering, Norwegian University of Science and Technology, Trondheim, Norway
                Article
                10.1177/15266028241235876
                941c1c22-7b7b-4697-998c-0f8ed62dda69
                © 2024

                https://journals.sagepub.com/page/policies/text-and-data-mining-license

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