PURPOSE: Echo derived Doppler indices provide reliable noninvasive assessment of left ventricular (LV) filling pressures and global myocardial function. However, the clinical use of standard echo as a continuous monitoring tool is limited by the need for expertise in acquiring and interpreting the data and its inability to give real time reproducible readings. The NICHE™ monitoring system is a new Doppler-based device that uses proprietary technology. It continuously acquires and displays simultaneous blood-flow and tissue-Doppler measurements. The clinical parameters are measured automatically in a 'hands free' manner using three miniature ultrasound probes that are attached to the chest wall with special adhesive pads. This study was designed to evaluate NICHE™ performance in comparison with standard echo.
METHODS: 30 patients were included in this study: A group of 10 healthy volunteers with no structural heart disease and a group of 20 subjects with known heart disease. Each subject had an initial reference echo study according to the American Society of Echocardiography (ASE) guidelines that was followed by measurements using NICHE™. Study measures included: transmitral early-wave peak velocity (E) associated with blood volume & diastolic pressures; tissue Doppler mitral annular early-wave peak velocity (E’), a Doppler index for myocardial function during diastole; and the ratio E/E’ for the assessment of LV diastolic pressure. Echo and NICHE™ measurements were compared for each subject.
RESULTS: The correlations between NICHE™ and standard echo (SE) measurements were: 1) E velocity r=0.93 (95% CI: [0.84, 0.96], p<0.0001); 2) E’ velocity (SE averaged lateral and medial velocities) r=0.91 (95% CI: [0.80, 0.96], p<0.0001); and 3) E/E’ r=0.91 (95% CI: [0.81, 0.96], p<0.0001).
CONCLUSIONS: The study demonstrates NICHE™ ability to measure echo Doppler parameters with good correlation to standard echo, and with similar inter reader variability to that reported in the literature.
CLINICAL IMPLICATIONS: NICHE™ offers hands free, continuous, real-time non-invasive hemodynamic monitoring with potential for use on patients in ICU and other clinical settings who require such monitoring.
DISCLOSURE: Gilead Lancaster: Consultant fee, speaker bureau, advisory committee, etc.: I am a paid consultant and shareholder in Cardiogal LTD
The following authors have nothing to disclose: Ilan Hay, Michael Eldar
We will be discussing the results of the first clinical trials of a new noninvasive device that has been developed by Cardiogal, LTD. NICHE™ was designed to offer a fully noninvasive, hands free, continuously monitoring device of multiple well validated echo-Doppler derived hemodynamic parameters. The purpose of this research is to show feasibility as well as comparison to the 'gold standard' echo-Doppler derived noninvasive measurements.