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In-Vitro Hemocompatibility Evaluation of the HeartMate 3 Under Realistic Operating Conditions.
IEEE Transactions on Bio-Medical Engineering
|April 11, 2025
Summary
Pulsatile flow conditions in rotodynamic blood pumps (RBPs) did not significantly alter hemolysis or von Willebrand Factor (vWF) degradation. Pump speed and flow rate, not pulsatility, are key factors influencing RBP hemocompatibility.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Hemodynamics
Background:
- Rotodynamic blood pumps (RBPs) are crucial for patients with heart failure.
- Clinical RBP performance is affected by fluctuating flow rates due to residual cardiac function.
- Understanding hemolysis and von Willebrand Factor (vWF) degradation under pulsatile conditions is vital for optimizing RBP hemocompatibility.
Purpose of the Study:
- To investigate the impact of pulsatile operating conditions on hemolysis and vWF degradation in the HeartMate 3 (HM3) RBP.
- To compare hemolysis and vWF degradation under varying levels of pulsatility and pump speeds.
- To determine the primary drivers of hemocompatibility in RBPs during simulated clinical use.
Main Methods:
- Pulsatile flow experiments were conducted for 12 hours using the HM3 RBP in a mock circulatory loop with human blood.
- Three pulsatility conditions (high, low, no residual cardiac function) were tested at normal (5400rpm) and low (4800rpm) pump speeds.
- Hemolysis was quantified by measuring delta free hemoglobin (dfHb30min) and calculating the normalized index of hemolysis (NIH); vWF degradation was assessed via immunoblotting.
Main Results:
- No significant differences in dfHb30min, NIH, or HMW vWF multimer degradation were found across the three pulsatility conditions.
- Significant differences in hemolysis parameters were observed between the normal and low pump speed settings.
- A trend of slightly elevated hemolysis was noted under no and high pulsatility conditions at both speed settings.
Conclusions:
- In vitro evaluation indicates that the hemocompatibility of the HM3 RBP is not significantly impacted by periodic high/low flow or backflows.
- Pump operating conditions, specifically flow rate and pump speed, are the primary determinants of hemolysis generation.
- These findings highlight the importance of pump speed and flow rate management for ensuring RBP hemocompatibility in clinical applications.
