Noninvasive Venous Waveform Analysis Correlates With Pulmonary Capillary Wedge Pressure and Predicts 30-Day Admission in Patients With Heart Failure Undergoing Right Heart Catheterization
Graphical abstract
The noninvasive venous waveform analysis in heart failure (NIVAHF) device is a noninvasive technology that records venous raw signal harmonics (A) of the pulse rate from the volar aspect of the wrist. These raw signals are transformed into the frequency domain (B) using a fast Fourier transformation and then used to train, validate, and test a NIVAHF algorithm to output a NIVA score based on the harmonic patterns recorded. A Pearson correlation (C) of NIVA scores to the measured pulmonary capillary wedge pressure (in millimeters of mercury) demonstrated a significant correlation (r = 0.92, n = 106, P < .0001). A secondary analysis of 30-day admissions owing to heart failure exacerbation, a receiver operator characteristic curve (D) demonstrated an area under the curve of 0.84 (P < .0001). A NIVA score of more than 18 had a sensitivity of 91% and specificity of 56% at predicting the need for hospitalization secondary to heart failure exacerbation in 30 days.
Section snippets
Methods
This observational study was approved by the University of Alabama Birmingham Institutional Review Boards through Vanderbilt University Medical Center Institutional Review Board secondary to institutional conflict of interest. Patients who were at least 18 years old and had a scheduled RHC were enrolled. One hundred six patients with adequate PCWP tracings and NIVA signals were used for analysis, training, validation, and testing (Fig. 3) of the NIVAHF algorithm. This process is completed after
Results
Demographic information for the algorithm analysis, training, validation, and testing cohorts (n = 106) are displayed in Table 1. Median age was 63 years (IQR 50–67 years), 61.3% of patients were male, and 81.3% were White. Indications for RHC included heart failure diagnostic evaluation in 39 (37%), post-transplant graft evaluation in 38 (36%), and heart failure maintenance of care evaluation in 29 (27%). Of those patients with heart failure who had an echocardiogram within the preceding year (
Discussion
The NIVA score is a numerical value generated from analysis of peripheral venous waveforms acquired using a noninvasive piezoelectric sensor in a housing applied over the volar aspect of the wrist and secured via a wristband. This study demonstrates the ability to train and test in situ the NIVA score to estimate the PCWP with a high degree of accuracy (r = 0.92). This method of analysis, training, validation, and testing was performed to produce the best possible correlative results. Compared
Conclusions
Results from this study suggest that NIVAHF is a promising noninvasive technology that estimates PCWP over a wide range of values and in a medically diverse population. These results also demonstrate that NIVAHF is as effective as the gold standard PCWP49 at identifying patients with elevated filling pressures, who are at risk for hospital admission. The ease of use and noninvasive nature of the NIVAHF allows for use in multiple settings (hospital, clinic, home). This information also provides
Acknowledgments
The investigators appreciate the assistance of the cardiologists at Vanderbilt University Medical Center.
Funding
Supported by 2 grants from the National Institutes of Health (BA: R01HL148244) and (KH: R44HL140669). Research reported in this study was supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award numbers, R44HL140669 & R01HL148244. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Lay Summary
NIVAHF is a noninvasive technology that estimates PCWP over a wide range of values. In 106 patients having RHC, NIVA scores demonstrated a significant correlation to the measured PCWP (r = 0.92, n = 106, P < .0001). A secondary analysis of the subset (n = 84) that went home immediately after their RHC demonstrated that elevated NIVA scores predicted 30-day admission (AUC=0.84, P < .0001). Using a trained, validated, and tested algorithm the automated analysis of a patients’ venous harmonics can
Disclosures
Kyle Hocking, PhD, is Founder, CEO, and President of VoluMetrix and an inventor on intellectual property in the field of venous waveform analysis assigned to Vanderbilt University and licensed to VoluMetrix. Colleen Brophy, MD, is Founder and CMO of VoluMetrix and an inventor on intellectual property in the field of venous waveform analysis assigned to Vanderbilt and licensed to VoluMetrix. Bret Alvis, MD, is CSO and is an inventor on intellectual property in the field of venous waveform
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