Research Papers

Continuous, Real-Time, Noninvasive Hemodynamic Cardiac Doppler Monitoring With a Novel Hands-Free Device: A Feasibility Study Compared to Standard Echo

[+] Author and Article Information
Gilead I. Lancaster

Department of Medicine (Cardiology),
Bridgeport Hospital/Yale
University School of Medicine,
Bridgeport, CT 06610;
Department of Echocardiography,
Joel E. Smilow Heart Institute at
Bridgeport Hospital,
267 Grant Street,
Bridgeport, CT 06610
e-mail: Gilead.Lancaster@ynhh.org

Ilan Hay

Cardiac Rehabilitation Institute,
Sheba Medical Center,
Tel Hashomer,
Ramat-Gan, Israel

Michael Eldar

Leviev Heart Center,
Sheba Medical Center,
Tel Hashomer,
Ramat-Gan, Israel

1Corresponding author.

Manuscript received October 7, 2015; final manuscript received December 27, 2016; published online June 27, 2017. Assoc. Editor: John LaDisa.

J. Med. Devices 11(3), 031001 (Jun 27, 2017) (6 pages) Paper No: MED-15-1272; doi: 10.1115/1.4036024 History: Received October 07, 2015; Revised December 27, 2016

This study sought to determine the feasibility of using noninvasive cardiac hemodynamics (NICHE), a new noninvasive Doppler-based device, to monitor real-time, simultaneous tissue and blood-flow Doppler measurements in a clinical setting, and to obtain preliminary performance data compared to a commercially available system. Doppler-based measurements have been shown to correlate well with invasive hemodynamic data and diastolic function, but their use in clinical applications has been limited by various technical issues. The NICHE device was developed to obtain simultaneous tissue and blood-flow Doppler measurements automatically, in real-time and in a hands-free manner. Thirty participants (ten normal volunteers and 20 patients in a cardiac rehab program) underwent standard echocardiographic/Doppler studies followed immediately by NICHE monitoring. Early diastolic transmitral blood-flow velocity (E) and tissue Doppler myocardial wall velocity during early relaxation (E′) were acquired using a standard echo device; and E/E′ was derived post hoc. NICHE measurements included E, E′, and directly measured instantaneous E/E′. NICHE was successfully used in 28 participants. Measurements of ENICHE ranged from 40 cm/s to over 120 cm/s and correlated well with Eecho (R = 0.93). ENICHE ranged from 2 to 23 cm/s and correlated well with the averaged Eecho (R = 0.91). Directly measured E/ENICHE ratios ranged from 3 to 23 and correlated well with derived E/Eecho (R = 0.91). The NICHE device can monitor patients in a hands-free manner and can supply real-time Doppler derived measurements of hemodynamic parameters and diastolic function that correlate well with measurements from standard echo devices.

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Grahic Jump Location
Fig. 3

Correlation of E′ velocities (in cm/s) obtained by NICHE with averaged E′ velocities (〈E′〉) obtained from the septum and lateral annulus by standard echo. R = 0.91. E′ = tissue Doppler myocardial wall velocity during early relaxation.

Grahic Jump Location
Fig. 4

Correlation of directly measured E/E′ velocities ratio obtained by NICHE with standard echo E/〈E′〉 ratio calculated post hoc. R = 0.91.

Grahic Jump Location
Fig. 5

Bland Altman analysis of E/E′ showing agreement between NICHE and standard echo over a large range of values

Grahic Jump Location
Fig. 2

Correlation of NICHE derived E velocities (in cm/s) with E velocities derived by standard echo. R = 0.93. E = early diastolic transmitral blood-flow velocity.

Grahic Jump Location
Fig. 1

NICHE transducer attachment on chest wall. Note that each transducer is attached using disposable adhesive pads and equipped with a steering rod to optimize Doppler signal. Once the signal is optimized, the rods are locked and do not need further manipulation.

Grahic Jump Location
Fig. 6

NICHE derived spectral tracing demonstrating simultaneous diastolic blood-flow Doppler signals (E and A) and tissue Doppler signals (E′ and A′)



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