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The Heartsbreath^TM test is a non-invasive breath test for markers which may predict the probability of grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. It consists of a breath collection apparatus (BCA) for collection of volatile organic compounds in breath onto a sorbent trap, as well as for the collection of a separate sample of room air.

Analysis of the organic compounds in breath and room air is performed by gas chromatography and mass spectroscopy, which are laboratory tests.

Current test sites
The National Heart, Lung, and Blood Institute (of the National Institutes of Health) is currently funding Menssana Research, Inc. to perform a reevaluation of the Heartsbreath^TM test for heart transplant rejection at the following sites:

Cedars-Sinai Medical Center

Columbia - New York Presbyterian Hospital

Drexel University College of Medicine

Newark Beth Israel Medical Center

Stanford University Medical Center

The Menssana Heartsbreath^TM is designated as a Humanitarian Device authorized by Federal law for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart transplant recipients. The effectiveness of this device for this use has not yet been demonstrated.

Intended use/Indications for use
The Heartsbreath^TM test is indicated for use as an aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. The Heartsbreath^TM test is intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

Warnings and precautions
Heartsbreath^TM is not a substitute for endomyocardial biopsy - both tests should be used in combination to detect grade 3 heart transplant rejection.

The Heartsbreath^TM test result should be compared to biopsy performed within the previous month.

The Heartsbreath^TM test should not be used for patients who have received a heart transplant more than one year ago.

The Heartsbreath^TM test should not be used for patients who have grade 4 transplant rejection because Heartsbreath^TM has not been evaluated in these patients.

Publications

(PDF Document) Prediction of Heart Transplant Rejection With a Breath Test for Markers of Oxidative Stress.

Phillips M, Boehmer JP, Cataneo RN et al.

The American Journal of Cardiology (2004); 94: 1593-1594.

(PDF document) Heart Allograft Rejection: Detection with Breath Alkanes in Low Levels (the HARDBALL study).

Phillips M, Boehmer JP, Cataneo RN et al.

The Journal of Heart and Lung Transplantation (2004); 23: 701-8

(PDF document) Heart Allograft Rejection: Detection with Breath Alkanes in Low Levels (the HARDBALL study).

Phillips M, Boehmer JP, Cataneo RN, Cheema T, Eisen HJ, Fallon JT, Fisher PE, Gass A, Greenberg J, Kobashigawa J, Mancini D, Rayburn B and Zucker MJ

Journal of the American College of Cardiology (2002); 1(40): 12-13