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Research Papers

Validation of Cardiac Output as Reported by a Permanently Implanted Wireless Sensor

[+] Author and Article Information
Michael Tree

The George W. Woodruff School of Mechanical Engineering,
Georgia Institute of Technology,
387 Technology Circle, Suite 200,
Atlanta, GA 30313
e-mail: treem22@gatech.edu

Jason White

Mem. ASME
St. Jude Medical, Inc.,
387 Technology Circle, Suite 500,
Atlanta, GA 30313
e-mail: JWhite2@sjm.com

Prem Midha

The George W. Woodruff School of Mechanical Engineering,
Georgia Institute of Technology,
387 Technology Circle, Suite 200,
Atlanta, GA 30313
e-mail: prem@gatech.edu

Samantha Kiblinger

Coulter Department of Biomedical Engineering,
Georgia Institute of Technology,
387 Technology Circle, Suite 200,
Atlanta, GA 30313
e-mail: skiblinger3@gatech.edu

Ajit Yoganathan

Mem. ASME
Coulter Department of Biomedical Engineering,
Georgia Institute of Technology,
387 Technology Circle, Suite 200,
Atlanta, GA 30313
e-mail: ajit.yoganathan@bme.gatech.edu

1Corresponding author.

Manuscript received April 21, 2015; final manuscript received October 1, 2015; published online November 5, 2015. Editor: Rupak K. Banerjee.

J. Med. Devices 10(1), 011001 (Nov 05, 2015) (7 pages) Paper No: MED-15-1168; doi: 10.1115/1.4031799 History: Received April 21, 2015; Revised October 01, 2015

The CardioMEMS heart failure (HF) system was tested for cardiac output (CO) measurement accuracy using an in vitro mock circulatory system. A software algorithm calculates CO based on analysis of the pressure waveform as measured from the pulmonary artery, where the CardioMEMS system resides. Calculated CO was compared to that from reference flow probe in the circulatory system model. CO measurements were compared over a clinically relevant range of stroke volumes and heart rates with normal, pulmonary hypertension (PH), decompensated left heart failure (DLHF), and combined DHLF + PH hemodynamic conditions. The CardioMEMS CO exhibited minimal fixed and proportional bias.

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References

Figures

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Fig. 1

CardioMEMS HF system with wireless PA pressure sensor implant (left) and patient home electronics unit (right)

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Fig. 2

In Vitro mock circulation used to validate the CardioMEMS HF system CO measurement

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Fig. 3

o Patient-specific pulmonary artery anatomy acquired from CT angiogram. The CardioMEMS pressure sensor location is highlighted by the circle.

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Fig. 4

An example of pulmonary artery pressure waveform from an implanted CardioMEMS sensor with relevant parameters. Pd, diastolic pressure; mSPAP, mean systolic pulmonary artery pressure; Pi, pressure at RV incident; and Ps, pressure at peak systole.

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Fig. 5

Pressure waveforms from each of the modeled physiological conditions as recorded by the CardioMEMS HF system. DLHF, decompensated left heart failure and PH, pulmonary hypertension.

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Fig. 6

Bland–Altman plot indicating the fixed and proportional bias between the reference CO measurement and the CO estimated by the CardioMEMS system, over the presented range of simulated benchtop hemodynamic conditions, with three repetitions. The dashed lines indicate the 95% limits of agreement.

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Fig. 7

Bland–Altman analyses of CardioMEMS HF system CO measurement per simulated physiological condition. PH, pulmonary hypertension; DLHF, decompensated left heart failure; and CMHFS, CardioMEMS heart failure system.

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Fig. 8

CO change analysis. The baseline calibration set point (CO = 4.9 l/min) is used as the origin.

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