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Noninvasive Blood Pressure Monitor Designed for Patients With Heart Failure Supported with Continuous-Flow Left Ventricular Assist Devices

Sajgalik, Pavol*; Kremen, Vaclav†,‡; Fabian, Vratislav§; Maltais, Simon; Stulak, John M.; Kushwaha, Sudhir S.*; Joyce, Lyle D.; Schirger, John A.*; Johnson, Bruce D.*

doi: 10.1097/MAT.0000000000000775
Adult Circulatory Support
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The gold standard for noninvasive blood pressure (BP) measurement, the Doppler technique, does not provide systolic blood pressure (SBP) and diastolic blood pressure (DBP) and may limit therapy outcomes. To improve patient care, we tested specifically designed experimental BP (ExpBP) monitor and the Doppler technique by comparing noninvasive measures to the intraarterial (I-A) BP in 31 patients with end-stage heart failure (4 females) 2.6 ± 3.4 days post-LVAD implantation (20 HeartMate II and 11 HeartWare). Bland–Altman plots revealed that the ExpBP monitor overestimated mean arterial pressure (MAP) by 1.2 (4.8) mm Hg (mean difference [standard deviation]), whereas the Doppler by 6.7 (5.8) mm Hg. The ExpBP SBP was overestimated by 0.8 (6.1) mm Hg and DBP by 1.9 (5.3) mm Hg compared with the respective I-A pressures. Both techniques achieved similar measurement reliability. In the measurement “success rate” expressed as a frequency (percent) of readable BP values per measurement attempts, Doppler accomplished 100% vs. 97%, 97%, and 94% of successful detections of MAP, SBP, and DBP provided by the ExpBP monitor. The ExpBP monitor demonstrated higher accuracy in the MAP assessment than the Doppler in addition to providing SBP and DBP in majority of subjects. Improved BP control may help to mitigate related neurologic adverse event rates.

From the *Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota

Czech Institute of Informatics, Robotics, and Cybernetics, Czech Technical University in Prague, Czech Republic

Department of Neurology, Mayo Clinic, Rochester, Minnesota

§Department of Physics, Faculty of Electrical Engineering, Czech Technical University in Prague, Czech Republic

Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota

Division of Cardiothoracic Surgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin.

Submitted for consideration October 2017; accepted for publication in revised form January 2018.

Disclosure: The authors have no conflicts of interest to report.

Supported by the Mayo Clinic Cardiovascular Prospective Project Award and the National Institutes of Health grant HL71478 (B.D.J.) and institutional resources for research by Czech Technical University in Prague, Czech Republic.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Off-label use/unapproved drugs or products: This article includes data from investigational use of the device (experimental blood pressure monitor). Use of the non–Food and Drug Administration–approved device was approved by the Mayo Clinic Ethic Committee (Institutional Review Board) for purpose of this study.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.asaiojournal.com).

Correspondence: Pavol Sajgalik, Department of Cardiovascular Diseases, 200 First St SW, Mayo Clinic, Rochester, MN 55905. Email: sajgalik.pavol@mayo.edu.

Copyright © 2019 by the American Society for Artificial Internal Organs