Elsevier

Journal of Cardiac Failure

Volume 28, Issue 12, December 2022, Pages 1692-1702
Journal of Cardiac Failure

Noninvasive Venous Waveform Analysis Correlates With Pulmonary Capillary Wedge Pressure and Predicts 30-Day Admission in Patients With Heart Failure Undergoing Right Heart Catheterization

https://doi.org/10.1016/j.cardfail.2021.09.009Get rights and content

Highlights

  • Noninvasive venous waveform analysis in heart failure (NIVAHF) is a noninvasive, wristband, remote monitoring technology that is designed to provide a real-time estimate of pulmonary capillary wedge pressure.

  • NIVA scores correlated with pulmonary capillary wedge pressures obtained during right heart catheterization (r = 0.92, n = 106, P < .0001).

  • A NIVA score of more than 18 at time of discharge after right heart catheterization demonstrated a sensitivity for predicting 30-day hospital admission for heart failure exacerbation of 91% (AUC 0.84, P < .0001).

ABSTRACT

Background

Heart failure is the leading cause of hospitalization in the elderly and readmission is common. Clinical indicators of congestion may not precede acute congestion with enough time to prevent hospital admission for heart failure. Thus, there is a large and unmet need for accurate, noninvasive assessment of congestion. Noninvasive venous waveform analysis in heart failure (NIVAHF) is a novel, noninvasive technology that monitors intravascular volume status and hemodynamic congestion. The objective of this study was to determine the correlation of NIVAHF with pulmonary capillary wedge pressure (PCWP) and the ability of NIVAHF to predict 30-day admission after right heart catheterization.

Methods and Results

The prototype NIVAHF device was compared with the PCWP in 106 patients undergoing right heart catheterization. The NIVAHF algorithm was developed and trained to estimate the PCWP. NIVA scores and central hemodynamic parameters (PCWP, pulmonary artery diastolic pressure, and cardiac output) were evaluated in 84 patients undergoing outpatient right heart catheterization. Receiver operating characteristic curves were used to determine whether a NIVA score predicted 30-day hospital admission. The NIVA score demonstrated a positive correlation with PCWP (r = 0.92, n = 106, P < .0001). The NIVA score at the time of hospital discharge predicted 30-day admission with an AUC of 0.84, a NIVA score of more than 18 predicted admission with a sensitivity of 91% and specificity of 56%. Residual analysis suggested that no single patient demographic confounded the predictive accuracy of the NIVA score.

Conclusions

The NIVAHF score is a noninvasive monitoring technology that is designed to provide an estimate of PCWP. A NIVA score of more than 18 indicated an increased risk for 30-day hospital admission. This noninvasive measurement has the potential for guiding decongestive therapy and the prevention of hospital admission in patients with heart failure.

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.

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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

References (49)

  • H Humphrey et al.

    Improved survival in ARDS patients associated with a reduction in pulmonary capillary wedge pressure

    Chest

    (1990)
  • DM Brinkley et al.

    The prognostic value of the relationship between right atrial and pulmonary capillary wedge pressure in diverse cardiovascular conditions

    Am Heart J

    (2018)
  • NA Gilotra et al.

    Usefulness of noninvasively measured pulse amplitude changes during the valsalva maneuver to identify hospitalized heart failure patients at risk of 30-day heart failure events (from the PRESSURE-HF Study)

    Am J Cardiol

    (2020)
  • SR Ommen et al.

    Assessment of right atrial pressure with 2-dimensional and Doppler echocardiography: a simultaneous catheterization and echocardiographic study

    Mayo Clin Proc

    (2000)
  • SC Chase et al.

    Influence of thoracic fluid compartments on pulmonary congestion in chronic heart failure

    J Card Fail

    (2017)
  • PB Adamson et al.

    Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system

    J Am Coll Cardiol

    (2003)
  • JL Grodin et al.

    A disproportionate elevation in right ventricular filling pressure, in relation to left ventricular filling pressure, is associated with renal impairment and increased mortality in advanced decompensated heart failure

    Am Heart J

    (2015)
  • CW Yancy et al.

    2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

    J Am Coll Cardiol

    (2013)
  • WT Abraham et al.

    Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial

    Lancet

    (2011)
  • KS Parikh et al.

    Characteristics of acute heart failure hospitalizations based on presenting severity

    Circ Heart Fail

    (2019)
  • H. Saleh

    Machine Learning Fundamentals: Use Python and scikit-learn to get up and running with the hottest developments in machine learning

    (2018)
  • AP Ambrosy et al.

    Clinical course and predictive value of congestion during hospitalization in patients admitted for worsening signs and symptoms of heart failure with reduced ejection fraction: findings from the EVEREST trial

    Eur Heart J

    (2013)
  • S. Gelman

    Venous function and central venous pressure: a physiologic story

    Anesthesiology

    (2008)
  • BD Alvis et al.

    Observational study of noninvasive venous waveform analysis to assess intracardiac filling pressures during right heart catheterization

    J Card Fail

    (2019)
  • View full text