Key result
Standardized mock circulatory loops successfully simulate target heart failure conditions for bench testing MCS devices.
Why the study?
The utility of mock circulatory loops (MCLs) in premarket regulatory submissions for mechanical circulatory support devices is ambiguous, and specific target clinical-use heart failure disease states are not usually simulated on the bench.
Standardizing mock circulatory loops to simulate specific heart failure conditions could improve the preclinical regulatory evaluation of mechanical circulatory support devices.
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.
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D’Souza et al. (2023) studied Heart failure. Mock circulatory loop (MCL) simulation was evaluated on Target pathophysiologic hemodynamics of heart failure conditions. Mock circulatory loops can be standardized to generate well-defined target heart failure conditions to evaluate mechanical circulatory support devices on the bench.
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