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Point-of-care breath test - Heart Transplant Rejection (HeartsbreathTM) | Menssana Products

The HeartsbreathTM 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 HeartsbreathTM test for heart transplant rejection as a point of care screening 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 HeartsbreathTM 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 HeartsbreathTM 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 HeartsbreathTM 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
HeartsbreathTM is not a substitute for endomyocardial biopsy - both tests should be used in combination to detect grade 3 heart transplant rejection.

The HeartsbreathTM test result should be compared to biopsy performed within the previous month.

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

The HeartsbreathTM test should not be used for patients who have grade 4 transplant rejection because HeartsbreathTM 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


View part of our news segment from "Beyond Tomorrow,"
on Australia's Channel 7 (may require downloading Quicktime 7)


Point of care breath test for heart transplant rejection in development http://www.flickr.com/photos/cygnus921/2652831429/