Extended clinical support with an implantable left ventricular assist device.

Area of Science:

• Cardiovascular Engineering
• Medical Devices
• Transplantation Medicine

Background:

• Heart failure necessitates advanced support systems for patients awaiting transplantation.
• Current left ventricular assist devices (LVADs) present challenges with long-term use and antithrombotic therapy.
• Intracorporeal LVADs offer a potential solution for prolonged cardiac support.

Purpose of the Study:

• To evaluate the safety and efficacy of an intracorporeal pulsatile left ventricular assist device (LVAD) for extended support (>30 days) in heart transplant candidates.
• To assess the requirement for antithrombotic therapy with LVADs featuring textured blood-contacting surfaces.
• To determine the impact of LVAD support on hemodynamic and secondary organ function.

Main Methods:

• Clinical evaluation of an abdominally positioned pulsatile LVAD with textured blood-contacting surfaces.
• LVADs operated in a fixed-rate mode (4-8 L/min) in 11 bridge-to-transplantation patients.
• Gradual reduction of postoperative anticoagulation, with recent patients receiving dipyridamole and aspirin only.

Main Results:

• Extended support (35-132 days) was provided to four patients, with three showing positive post-transplant outcomes.
• Hemodynamic and secondary organ function stabilized in all patients during LVAD support.
• Minimal antithrombotic therapy (dipyridamole and aspirin) resulted in normal coagulation times and acceptable plasma hemoglobin levels without thromboembolism.

Conclusions:

• The intracorporeal LVAD with textured surfaces effectively supports failing hearts for extended durations (>30 days).
• Minimal antithrombotic therapy is feasible and safe with this device.
• This LVAD technology shows promise as a bridge to heart transplantation.