Journal of Preventive Medicine

Clinical Evaluation of Volume Plethysmography as an aid for Diagnosis of Heart Failure in the Primary Care Setting

Approximately 6.2 million persons ≥ 20 years of age in the U.S have been diagnosed with Heart Failure (HF) and about 1 million new HF cases are diagnosed annually. HF remains primary diagnosis in >1 million hospitalizations annually, with the total cost of HF care in US exceeding $30 billion annually. Mortality rates after hospitalization for HF remain high; approximately 20%-25% within one year after diagnosis and mortality rates are similar for both HF with preserved Ejection Fraction (HFpEF) and HF with reduced Ejection Fraction (HFrEF). The most common way to diagnose HF is with transthoracic echocardiography (echo), which requires referral to a cardiologist and a cardiovascular technician. There is currently no low-cost method to identify HF, other than measuring Brain Natriuretic Peptides (BNP) in blood. QuantaFlo® HD (QFHD), a volume plethysmographic, point-of-care test performed by a medical aide in the primary care setting, presents real-time results to providers to aid in diagnosis of cardiovascular disease. Study objective was to measure the accuracy of QFHD as judged by echo determination of the diagnosis of HF.

Methods: QFHD and echo data were prospectively collected under an Institutional Review Board (IRB)-approved, multi- center, single-arm study. Test results for each technology were analyzed and used to design the algorithm to optimize accuracy. The algorithm was then prospectively validated in a second subject cohort from the same practices. Two separate metrics were computed and separate analyses were done to determine a diagnosis of HF. IRB approval of the study protocol was obtained through WIRB Copernicus Group (WCG) IRB. Written informed consent was obtained from each subject.

Results: A total of 414 subjects were enrolled in the first cohort used to create the algorithm. A total of 54 subjects were enrolled in second validation cohort. There was a significant correlation between QFHD and echo for diagnosing HF (p<0.01).

Conclusion: This study demonstrated QFHD is significantly correlated with echo for the diagnosis of HF in the primary care setting.

Author(s): Scott C Howell

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