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Cleveland clinic CorAide blood pump circulatory support without anticoagulation
Yoshie Ochiai1, Leonard A R Golding, Alex L Massiello
1Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Ohio 44195, USA.
Insights
The CorAide left ventricular assist system demonstrated safe operation in calves with minimal or no anticoagulation. This centrifugal pump showed stable hemodynamics and clean blood pump surfaces, indicating reduced thrombotic risk.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Medical Technology
Background:
- Left ventricular assist devices (LVADs) are crucial for managing heart failure.
- Anticoagulation therapy is often required to prevent thrombosis with LVADs, posing bleeding risks.
- The CorAide system utilizes a noncontact, suspended rotating assembly, potentially reducing thrombogenicity.
Purpose of the Study:
- To evaluate the biologic effects and safety of the CorAide LVAD in a chronic animal model.
- To assess the necessity and efficacy of anticoagulation therapy with the CorAide system.
- To determine the thrombotic potential of the CorAide pump without continuous anticoagulation.
Main Methods:
- Chronic implantation of the CorAide centrifugal pump in six calves.
- Varying durations of heparin administration post-surgery, with extended periods without anticoagulation.
- Hemodynamic monitoring (pump flow, mean arterial pressure) and post-mortem examination for thrombus, device integrity, and adverse events.
Main Results:
- Stable hemodynamics were maintained across all animals (mean pump flow 5.6 L/min, mean arterial pressure 100 mm Hg).
- Blood pump surfaces remained free of thrombus in all six calves.
- No mechanical failures, bleeding complications, or device infections occurred; one case of renal infarction was noted.
Conclusions:
- The CorAide left ventricular assist system can be safely operated with minimal or no anticoagulation therapy.
- The noncontact design of the CorAide pump appears to mitigate thrombus formation.
- These findings support the potential for reduced anticoagulation burden in patients using the CorAide LVAD.
Abstract:
The Cleveland Clinic CorAide left ventricular assist system consists of a permanently implantable centrifugal pump in which the rotating assembly is completely suspended and noncontacting. A series of chronic animal in vivo studies were conducted to evaluate the biologic effects of CorAide circulatory support without the use of anticoagulation therapy. The CorAide pump was implanted in six calves (five calves for 21 to 32 days and one calf for 95 days). The first five calves received intravenous heparin during the early postoperative periods (2-7 days). Heparin administration was then discontinued and no other anticoagulant drugs were used for the duration of the experiments. The last calf did not receive any anticoagulant except for a bolus dose of heparin (200 U/kg) during surgery. Hemodynamics were stable in all six calves, with a mean pump flow of 5.6+/-1.2 L/min and mean arterial pressure of 100+/-4 mm Hg. The blood pump surfaces were clean of thrombus in all six calves. Significant findings at autopsy were limited to one case of renal infarction. There was no incidence of mechanical failure, bleeding, or device infection. The CorAide pump can be safely run with minimal or no anticoagulant therapy.