Retrospective Analysis Using the VoluMetrix NIVA|HF Investigational Algorithm to Assess Patients With Heart Failure Predicts Hospitalization

VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced publication of a study showing that, in patients with heart failure, its investigational NIVAHF algorithm predicted hospitalization 30 days after outpatient right heart catheterization (RHC) with 91% sensitivity.1
Heart failure affects about 6.2 million Americans2 and is the most common reason for hospitalization of elderly patients. VoluMetrix developed the investigational NIVAHF device, a remote monitoring technology worn on the wrist, to provide non-invasive estimates of pulmonary capillary wedge pressure (PCWP), a metric currently obtained only through invasive catheterization of the heart and vasculature in the hospital setting. PCWP can predict the exacerbation of heart failure that leads to hospitalization, but patients are not routinely monitored with PCWP after outpatient RHC because of the invasive nature of PCWP monitoring.
In a study published in Journal of Cardiac Failure, 84 patients undergoing outpatient RHC were evaluated using a NIVAHF prototype at the time of discharge. Using the NIVA signals captured on these patients, a NIVAHF algorithm was developed, trained, validated, and tested. The investigational NIVAHF algorithm produced a proprietary NIVA Score which is an estimate of PCWP. Follow-up showed that, within 30 days, a NIVA Score above 18 predicted acute worsening of heart failure and hospital admission with a sensitivity of 91% and specificity of 56%. The study’s authors concluded, “This non-invasive measurement has potential for guiding decongestive therapy and prevention of hospital admission in heart failure patients.”
“This study is exciting news for everyone at VoluMetrix. We are dedicated to improving the lives of millions of people with heart failure, and the relationship between NIVA Score and hospitalization shows the potential of our technology to advance this goal,” said Kyle Hocking, Ph.D., President and CEO of VoluMetrix. “Studies of the NIVA vital monitoring platform have been advancing quickly since NIVAHF received FDA Breakthrough Device designation in May; this new study is one more milestone in our journey to delivering important prospective clinical applications.”
What is NIVA Technology?
NIVA is a proprietary venous waveform technology from VoluMetrix, representing a major innovation in vital monitoring technology. The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate and respiration, as well as intravascular and extravascular dynamics. NIVA was developed to optimize hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient’s waveform), and signal decoding.
About VoluMetrix
VoluMetrix is a Nashville-based company, closely aligned with Vanderbilt University and Medical Center in Nashville, Tennessee, and a member of the Mayo Clinic Innovation Exchange in Jacksonville, Florida, that is dedicated to creating a new wave of solutions for vital monitoring to enhance well-being. As pioneers of non-invasive venous waveform technology, we are partnering closely with patients and practitioners to develop the pathway towards the optimal implementation and utilization of our technology, from hospital to home.
NIVA technology is investigational and is not available for sale in the United States.
Research and development reported in this press release was supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award numbers, R44HL140669 and R01HL148244. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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1Alvis B, Huston J, Schmeckpeper J, et al. Non-Invasive Venous waveform Analysis (NIVA) correlates with pulmonary capillary wedge pressure (PCWP) and predicts 30-day admission in heart failure patients undergoing right heart catheterization: NIVA Scores correlate with PCWP and predicts 30-day admission. J Card Fail. 2021 Sep 20;S1071-9164(21)00385-7.
2Centers for Disease Control and Prevention. Interactive Atlas of Heart Disease and Stroke.
Source: VoluMetrix