دورية أكاديمية
Using a Mock Circulatory Loop as a Regulatory Science Tool to Simulate Different Heart Failure Conditions.
| العنوان: | Using a Mock Circulatory Loop as a Regulatory Science Tool to Simulate Different Heart Failure Conditions. |
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| المؤلفون: | D'Souza GA; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Rinaldi JE; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Meki M; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Crusan A; Circulatory Support Devices Team, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Richardson E; Circulatory Support Devices Team, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Shinnar M; Circulatory Support Devices Team, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993., Herbertson LH; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993. |
| المصدر: | Journal of biomechanical engineering [J Biomech Eng] 2024 Jan 01; Vol. 146 (1). |
| نوع المنشور: | Journal Article; Research Support, U.S. Gov't, P.H.S. |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society Of Mechanical Engineers Country of Publication: United States NLM ID: 7909584 Publication Model: Print Cited Medium: Internet ISSN: 1528-8951 (Electronic) Linking ISSN: 01480731 NLM ISO Abbreviation: J Biomech Eng Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York Ny : American Society Of Mechanical Engineers Original Publication: [New York] American Society of Mechanical Engineers. |
| مواضيع طبية MeSH: | Heart-Assist Devices* , Cardiovascular System* , Heart Failure*/therapy, Humans ; Adult ; Hemodynamics/physiology ; Heart |
| مستخلص: | Mechanical circulatory support (MCS) device therapy is one of the primary treatment options for end-stage heart failure (HF), whereby a mechanical pump is integrated with the failing heart to maintain adequate tissue perfusion. The ISO 14708-5:2020 standard prescribes generic guidelines for nonclinical device evaluation and system performance testing of MCS devices using a mock circulatory loop (MCL). However, the utility of MCLs in premarket regulatory submissions of MCS devices is ambiguous, and the specific disease states that the device is intended to treat are not usually simulated. Hence, we aim to outline the potential of MCLs as a valuable regulatory science tool for characterizing MCS device systems by adequately representing target clinical-use HF conditions on the bench. Target pathophysiologic hemodynamics of HF conditions (i.e., cardiogenic shock (CS), left ventricular (LV) hypertrophy secondary to hypertension, and coronary artery disease), along with a healthy adult at rest and a healthy adult during exercise are provided as recommended test conditions. The conditions are characterized based on LV, aorta, and left atrium pressures using recommended cardiac hemodynamic indices such as systolic, diastolic, and mean arterial pressure, mean cardiac output (CO), cardiac cycle time, and systemic vascular resistance. This study is a first step toward standardizing MCLs to generate well-defined target HF conditions used to evaluate MCS devices. (Copyright © 2024 by ASME.) |
| معلومات مُعتمدة: | Critical Path Program U.S. Food and Drug Administration |
| فهرسة مساهمة: | Keywords: cardiovascular hemodynamics; heart failure; mechanical circulatory support (MCS); medical device; mock circulatory loop (MCL); nonclinical testing; regulatory science tool |
| تواريخ الأحداث: | Date Created: 20231013 Date Completed: 20231106 Latest Revision: 20240618 |
| رمز التحديث: | 20240618 |
| DOI: | 10.1115/1.4063746 |
| PMID: | 37831143 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1528-8951 |
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| DOI: | 10.1115/1.4063746 |