Background:

No biochemical test currently exists for assessing the health of myocardial tissue or risk of cardiac mortality in heart failure patients. Frequent cardiac catheterization and echocardiography are costly and labor intensive yet can only provide a rough estimate of heart status. BNP serum tests can indicate recent stress on the heart and help diagnose acute failure, but cannot assess the biochemical state of the heart and cannot offer prognostic information. 

Mechanical assist devices, such as the LVAD, traditionally implanted while a patient is waiting for transplant, are now being used as a “destination therapy” in place of a heart transplant. However, no existing test informs clinicians about which patients require transplant, which patients will thrive on LVAD alone, and which patient only need temporary LVAD use before recovery. Also, no test can monitor improvement of intrinsic heart health while on an LVAD. Such tests would aid in critical clinical decision making about patients with end-stage heart failure. More patients could move directly to assist devices without spending time on the transplant list. Total hospitalization time would be reduced while patients would benefit from rapid improvements in quality of life. 

Invention:

UCSF investigators have discovered a novel biomarker for prognostic and diagnostic assessment of heart tissue health and risk of cardiac mortality in end-stage heart failure patients. Measurement of biomarker levels could identify patients requiring transplant versus those that are candidates for LVAD implantation. Biomarker levels can also be used to monitor therapeutic effectiveness of LVAD implantation and potentially guide the decision to remove an LVAD device. This cardiac biomarker is not a marker of recent stress or tissue damage but rather a marker of longer-term health. No other test in use or in development can provide the same type of clinical and diagnostic information. This first-of-its-kind test would directly assess the strength and health of the heart muscle itself. 

End-stage heart failure patients face few options: heart transplant, or LVAD implantation. Patients who will be undergoing such procedures are often hospital-bound and are frequently sent to the cardiac catheterization lab for evaluation and testing. UCSF’s diagnostic assay would take advantage of the fact that these patients will already be in the cardiac catheterization lab. The test requires a small biopsy of heart tissue that can easily be done in the cardiac catheterization lab. The biomarker can be assayed by detection of RNA or protein.

File Number: 20840 

Web site: http://techtransfer.universityofcalifornia.edu/...

Disease: Cardiovascular and Circulatory System