Using a Mock Circulatory Loop as a Regulatory Science Tool to Simulate Different Heart Failure Conditions.

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Regulatory Science

Background:

• Mechanical circulatory support (MCS) devices are crucial for end-stage heart failure (HF).
• Current ISO standards for MCS device testing using mock circulatory loops (MCLs) lack specificity for disease states.
• The utility of MCLs in premarket regulatory submissions for MCS devices remains ambiguous.

Purpose of the Study:

• To outline the potential of MCLs as a regulatory science tool for MCS device characterization.
• To demonstrate the capability of MCLs in simulating target clinical-use heart failure (HF) conditions.
• To standardize bench testing for MCS devices under specific HF pathophysiologies.

Main Methods:

• Defined target pathophysiologic hemodynamics for HF conditions including cardiogenic shock (CS), left ventricular (LV) hypertrophy, and coronary artery disease.
• Included healthy adult conditions at rest and during exercise as recommended test scenarios.
• Characterized conditions using LV, aorta, and left atrium pressures, and key hemodynamic indices (e.g., mean arterial pressure, cardiac output, systemic vascular resistance).

Main Results:

• Provided a framework for simulating specific HF hemodynamic conditions on a mock circulatory loop (MCL).
• Established recommended test conditions representing diverse cardiovascular states relevant to MCS device use.
• Detailed characterization of hemodynamic parameters for each simulated condition.

Conclusions:

• Mock circulatory loops (MCLs) can be optimized to represent specific heart failure (HF) conditions for device evaluation.
• Standardized MCL testing provides a valuable regulatory science approach for MCS device characterization.
• This study represents a foundational step towards well-defined HF conditions for MCS device assessment.