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Wireless Blood Pressure Monitoring with a Novel Implantable Device: Long-Term In Vivo Results

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Abstract

Purpose

Devices constantly tracking the blood pressure (BP) of hypertensive patients are highly desired to facilitate effective patient management and to reduce hospitalization. We report on experiences gathered in a pilot study that was designed to evaluate the prototype of a newly developed, minimally invasive implantable sensor system for long-term BP monitoring.

Methods

The device was implanted in the femoral artery (FA) of 12 sheep via standard FA catheterization under fluoroscopic control. Accuracy of the recorded blood pressure was determined by comparison with a reference catheter, which was positioned in the contralateral FA immediately after implantation. Regular follow-up included angiography, computed tomography (CT), and control of functionality and position of the BP sensor. Animals were euthanized after 6 months. FA segments with in situ pressure sensor underwent macroscopic and histopathologic examinations.

Results

All implantations of the novel sensor device in the FA were successful and uneventful. High-quality BP recordings were documented. Bland–Altman plots indicate very good agreement. Comparison with measurements taken from the reference sensor revealed mean differences and standard deviations of −0.56 ± 0.85, 0.29 ± 1.44, and 0.85 ± 2.27 mmHg (diastolic, systolic, and pulse pressure, respectively) after exclusion of one outlier. CT uncovered deficiencies in cable stability that were addressed in a redesign. No thrombus formation, necrosis, or apoptosis were detected.

Conclusions

The pilot study proved the technical feasibility of wireless BP measurement in the FA via a novel miniature sensor device.

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Acknowledgments

The study was financially supported by the German Federal Ministry for Education and Research, Grant 16SV5000. The authors would like to thank the Osypka AG, Rheinfelden, Germany; the Fraunhofer Institute for Microelectronic Circuits and Systems, Duisburg, Germany; the Institute of Materials in Electrical Engineering - Chair 1, RWTH Aachen University, Germany and all coworkers for their support and cooperation.

Conflict of interest

Nina J. Cleven, Peter Isfort, Tobias Penzkofer, Anna Woitok, Benita Hermanns-Sachweh, Ulrich Steinseifer, and Thomas Schmitz-Rode declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz-Institute, RWTH Aachen University, Pauwelsstraße 20, 52074, Aachen, Germany

    Nina J. Cleven, Ulrich Steinseifer & Thomas Schmitz-Rode

  2. Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Pauwelsstr. 30, 52074, Aachen, Germany

    Peter Isfort & Tobias Penzkofer

  3. Surgical Planning Laboratory, Department of Radiology, Harvard Medical School, Brigham and Women’s Hospital, 75 Francis St., Boston, MA, 02115, USA

    Tobias Penzkofer

  4. Institute for Laboratory Animal Science, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany

    Anna Woitok

  5. Institute of Pathology, RWTH Aachen University Hospital, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany

    Benita Hermanns-Sachweh

Authors
  1. Nina J. Cleven
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  2. Peter Isfort
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  3. Tobias Penzkofer
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  4. Anna Woitok
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  5. Benita Hermanns-Sachweh
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  6. Ulrich Steinseifer
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  7. Thomas Schmitz-Rode
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Corresponding author

Correspondence to Nina J. Cleven.

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Cleven, N.J., Isfort, P., Penzkofer, T. et al. Wireless Blood Pressure Monitoring with a Novel Implantable Device: Long-Term In Vivo Results. Cardiovasc Intervent Radiol 37, 1580–1588 (2014). https://doi.org/10.1007/s00270-014-0842-0

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  • DOI: https://doi.org/10.1007/s00270-014-0842-0

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