Key result
Non-invasive NIVA Score tracks acute decongestion, dropping significantly after IV diuresis in ADHF.
Why the study?
Static agreement between the NIVA Score and invasively measured pulmonary capillary wedge pressure does not establish whether the NIVA Score tracks dynamic decongestion.
Does the wrist-worn NIVAHF device accurately track acute changes in volume status (decongestion) in adults with acute decompensated heart failure and in a preclinical porcine model?
Observational (n=11)
Single-blind (Treating clinicians blinded to NIVA Scores)
No
Does the wrist-worn NIVAHF device accurately track acute changes in volume status (decongestion) in adults with acute decompensated heart failure and in a preclinical porcine model?
A novel wrist-worn non-invasive venous waveform analysis device (NIVAHF) successfully tracked acute changes in volume status during diuresis in both a clinical heart failure cohort and a controlled animal model, establishing feasibility for serial non-invasive congestion monitoring.
Answers are grounded in this paper and cite their sources.
Supports noninvasive decongestion tracking in ADHF; extends static validation but leaves open clinical utility pending prospective trials.
device), which produces an integer-scaled estimate of pulmonary capillary wedge pressure termed the NIVA Score, responds to acute changes in volume status. Agreement between the NIVA Score and invasively measured pulmonary capillary wedge pressure at single time points has been established in a separate prospective, multi-site study; however, such static agreement does not establish whether the measure tracks dynamic decongestion. We therefore evaluated the directional responsiveness of the locked NIVA Score in two prespecified cohorts: hospitalized adults with acute decompensated heart failure undergoing routine intravenous diuresis, and a controlled porcine model of volume overload followed by diuresis. In eleven patients contributing thirteen paired measurements (mean net fluid balance -2.1 ± 1.0 L), NIVA Scores decreased significantly after diuresis (paired t-test, P = 0.04). In five pigs contributing twenty-four paired measurements, NIVA Scores decreased significantly after intravenous furosemide following crystalloid loading (P < 0.01), and the direction of change was concordant with measured urine output in every animal. Statistical significance was reached in both cohorts despite modest sample sizes, indicating a measurable NIVA Score reduction with volume removal. In an exploratory analysis, the discharge NIVA Score yielded an area under the receiver-operating-characteristic curve of 0.85 (95% confidence interval 0.575-1.00; P = 0.04) for thirty-day readmission. Together, the significant, directionally concordant NIVA Score reductions across independent clinical and preclinical cohorts demonstrate that the device tracks acute decongestion and support its use for serial, non-invasive congestion monitoring; an adequately powered prospective study is the planned next step.
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Alvis et al. (2026) conducted an observational in Acute decompensated heart failure (n=11). Intravenous diuresis vs. Pre-diuresis baseline was evaluated on Change in NIVA Score following diuresis (p=0.04). In hospitalized adults with acute decompensated heart failure, the non-invasive NIVA Score decreased following intravenous diuresis, demonstrating that the device tracks acute decongestion.
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