Background: Heart failure (HF) is a healthcare problem burdening patients, care teams, and health care systems. A relentless, downward spiral of decompensation, hospital admission, and functional deterioration is challenging to break, partly because of the lack of an objective, inexpensive tool to aid the clinicians physical examination. We studied performance of a shortwave infrared (SWIR) molecular chemical imaging (MCI) tool to measure relative tissue congestion (TC) in HF patients shins, compared to MRI Dixon sequence TC measurements as ground truth. Methods: Forty-seven (47) subjects underwent paired SWIR MCI and MRI measurements of their lower extremities. Thirty-six (36) subjects were hospitalized with decompensated HF while 11 healthy outpatients served as controls. A partial least squares (PLS) regression model was trained to ingest the SWIR MCI spectra and produce a CardioVerification Index (CVI) that mirrored MRI measurements. Results: The SWIR MCI model reflected MRI TC measurements accurately for all subjects with a 0.743 linear correlation coefficient. Surprisingly, the MRI results identified a significant fraction of non-HF subjects with elevated TC levels, so a sub-analysis was performed on these Low TC subjects with low and undetectable levels of extremity edema. This subpopulations linear correlation between MRI and CVI was 0.674. A logistic classifier model differentiated HF from non-HF subjects; the area under the receiver operating characteristic curves was 0.906 for the entire subject group and 0.821 for the Low TC subpopulation. Conclusion: SWIR MCI techniques can be used in a TC-measuring tool that replicates MRI TC measurements. Clinicians could use such tools to help guide therapy for HF patients during in-hospital management of acute HF decompensation and for outpatient monitoring. SWIR MCIs ability to identify elevated TC in otherwise normal subjects may also meet the unmet need for a novel, widely applicable HF screening tool.

Michael Chappuis and Maurice Enriquez-Sarano are paid consultants of ChemImage. Adam Saltman, Richik Ghosh, Shawna Tazik, Heather Gomer, Matthew Nelson, and Patrick Treado are paid, full-time employees of ChemImage Corporation. Robert Schweitzer was a paid, full-time employee of ChemImage Corporation during the time the study was conducted.

This study was funded entirely by ChemImage Corporation.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Institutional Review Board of Advarra and Allina Abbott Northwestern Hospital.

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