Division of Cardiovascular Diseases Strategic Plan

Goals in Cardiovascular Clinical Problems or Disease States

2.4d. Expand the application of mechanical cardiac support devices to improve clinical outcomes in patients with heart failure

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The use of chronic mechanical circulatory support (MCS) devices is currently primarily limited to late-stage heart failure (HF) patients as permanent long-term support, as a bridge to transplant, or, in a very limited number of cases, as a bridge to myocardial recovery. Its use has been chiefly limited by the morbidity and mortality associated with earlier generations of the devices.

More than 250,000 Americans experience HF so advanced that they suffer severe functional limitation.  Although symptoms can be abated through various therapies, the disease will advance in a large majority of these patients and at a substantial cost to the health care system.  The greatest promise appears to be in MCS applications in patients who can benefit from the devices, are healthy enough to undergo the surgical procedures, and potentially experience myocardial recovery.  Another important but much smaller group of patients (approximately 100/year) is children with advanced congenital or acquired heart disease.   The expansion and application of MCS may provide the needed support to enable these fragile young patients to recover or, at least, improve their chances to be successfully bridged to transplant or undergo palliative surgeries.

Developing novel devices specifically designed to enhance recovery in conjunction with adjunctive therapies may allow some HF patients to regain independent cardiac function.  All patients on MCS could also benefit from improvements in technology to minimize or eliminate the risks of serious adverse events. Such advances would result in much improved longevity, function, and quality of life for patients who need MCS.

Strategies to Accomplish this Goal May Entail:

Basic Research:

  • Investigate stress-induced signaling pathways.
  • Investigate the mechanical forces and mechanical-molecular linkages that drive:
    • pathologic vs. physiologic myocyte hypertrophy.
    • programmed cell death. • pathologic changes in the extra-cellular matrix.
  • Investigate means to reverse myocyte hypertrophy through mechanical and molecular manipulation.

Translational Research:

  • Facilitate the development of MCS devices that:
    • specifically enhance myocardial recovery.
    • incorporate biosensors into devices to tailor feedback to need.
    • can be applied to broader (e.g., NYHA Class III) or alternative (e.g., pediatric) populations.
    • have greater mechanical reliability.
    • improve ease of implant.
    • have characteristics that may reduce morbidity (e.g., require little or no anticoagulation).
  • Examine the ability of mechanical devices to reverse CV pathology and/or improve function in animal models of heart failure.
  • Identify critical biologic parameters that help to predict early survival or death in advanced animal models of HF on MCS.

Clinical Research:

  • Expand ventricular assist device therapy appropriately to less sick populations (compared to the NHLBI trial, REMATCH—Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure).
  • Examine the impact on credible surrogates and clinical outcomes of novel devices and/or within novel populations.
  • Apply advanced circulatory support therapy in neonates, infants, and young children with advanced heart disease.
  • Provide right ventricular support in children and adults with failing Fontan repair.
  • Facilitate cardiac recovery through use of MCS devices.
  • Compare the progression of HF in patients with and without circulatory support.

Contributing Sources:

September 2008

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