Long-Term Durability Test for the Left Ventricular Assist System EVAHEART under the Physiologic Pulsatile Load

Area of Science:

• Biomedical Engineering
• Cardiovascular Technology

Background:

• Severe heart failure necessitates long-term circulatory support.
• Left Ventricular Assist Systems (LVAS) are crucial for managing end-stage heart failure.
• Component wear is a critical failure mode in LVAS.

Purpose of the Study:

• To evaluate the durability and wear performance of the EVAHEART LVAS.
• To assess the effectiveness of its unique water lubrication system.
• To determine the reliability of the EVAHEART blood pump under simulated long-term use.

Main Methods:

• Development of a durable mock loop simulating physiologic pulsatile flow.
• Testing 18 EVAHEART blood pumps for 2 years under severe pulsatile conditions.
• Continued testing with six pumps to an average of 8.6 years.

Main Results:

• All 18 pumps completed 2 years without failure, indicating >90% reliability.
• Extended testing showed no catastrophic, critical, or minor failures.
• Seal performance and surface integrity remained intact, demonstrating no abnormal wear.

Conclusions:

• The EVAHEART LVAS, with its water lubrication system, exhibits excellent wear resistance.
• The device is suitable for long-term bridge-to-transplant and destination therapy applications.
• The system provides reliable support for patients with severe heart failure.