Division of Cardiovascular Diseases Strategic Plan

Goals in Enabling Technologies and Methodologies for Cardiovascular Disease

1.4. Improve biocompatibility and durability of cardiovascular devices

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Overview

The goals are to minimize the risk of thrombosis and improve the durability associated with blood-contacting prosthetic CV devices such as heart valves, stents, vascular grafts, and ventricular assist devices.

Each year an estimated 100,000 heart valves, 1.5 million coronary stents, 300,000 vascular grafts, and 2000 ventricular assist devices are implanted in the U.S.  Patients with prosthetic devices such as these experience substantial risk of adverse events related to thrombosis, thromboembolism, infection, and device failure.  In spite of anticoagulant therapy, thrombosis remains a leading and substantial serious adverse event, as is the problem of hemorrhage resulting from the anticoagulant therapy.  Although bioprosthetic devices nearly eliminate thrombosis risk, their durability is limited to 10-20 years, requiring eventual replacement. Improvements in biocompatibility and durability of these devices to minimize the risk of thrombosis or mechanical failure should result in a substantial reduction in serious adverse events and reoperations and improvements to health-related quality of life.

Strategies to Accomplish this Goal May Entail:

Basic Research:

  • Characterize key endothelial cell processes linked to thrombogenesis.
  • Characterize key prosthetic material properties that influence thrombogenicity.
  • Develop novel methods to block clotting cascades associated with blood-contacting prosthetic surfaces, including nanotexturing to prevent platelet adhesion.
  • Investigate native and bioprosthetic valve tissues to characterize properties linked to valve durability.
  • Understand the mechanisms of device degradation, such as in bioprosthetic valves in younger patients.

Translational Research:

  • Develop computational methods to predict biocompatibility.
  • Develop novel blood-material interfaces for devices, including endothelial-mimetic coatings or surfaces.
  • Develop additional anticoagulation agents targeted at inhibiting specific clotting cascade factors associated with blood-contacting CV devices.
  • Incorporate developed technology into existing and new CV devices.
  • Perform in vitro and animal testing to assess the efficacy of novel device designs and biomaterials resulting from basic studies to mitigate the problems of thrombosis and limited durability.

Clinical Research:

  • Evaluate novel improved device designs that incorporate novel biomaterial surfaces in humans for reduced thrombogenicity and/or improved durability.
  • Evaluate targeted clotting cascade inhibiting factors in humans.

Contributing Sources:

September 2008

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