Mullens, W., Sharif, F., Dupont, M. et al. (2 more authors) (2020) Digital health care solution for proactive heart failure management with the Cordella Heart Failure System : results of the SIRONA first‐in‐human study. European Journal of Heart Failure, 22 (10). pp. 1912-1919. ISSN 1388-9842
Abstract
Aims Incorporation of remote monitoring of pulmonary artery pressure and vital signs has been demonstrated to reduce heart failure (HF) hospitalization and all‐cause mortality in selected symptomatic HF patients. The aim of this study is to investigate the safety and accuracy of the new CordellaTM Pulmonary Artery Pressure Sensor (Endotronix, Inc., Chicago, IL, USA) and the usability of the comprehensive CordellaTM Heart Failure System (CHFS).
Methods and results Multicentre, open‐label, first‐in‐human, feasibility study to evaluate the CHFS and the safety and accuracy of the Cordella™ Pulmonary Artery Pressure Sensor in 15 patients with New York Heart Association class III HF. All patients were successfully implanted with the Cordella Pulmonary Artery Pressure Sensor, without sensor failure. No device system‐related complications, defined as invasive treatment, device explant or death, occurred. The primary efficacy endpoint of a mean pulmonary artery pressure at 90 days was met in all but one patients with a cohort difference of 2.7 mmHg (Cordella Sensor 22.5 ± 11.8 mmHg, Swan–Ganz catheter 25.2 ± 8.5 mmHg). One patient did not go through the 90‐day right heart catheterization for safety reasons. Patient adherence to daily measurement, transmission of vital signs and pulmonary artery pressure sensor readings were recorded 99% of the time.
Conclusion The initial experience of the CHFS incorporating comprehensive vital signs and pulmonary artery pressure monitoring enables safe and accurate monitoring of HF status.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. https://creativecommons.org/licenses/by-nc/4.0/ |
Keywords: | Pulmonary artery pressure sensor; Heart failure |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Sheffield Teaching Hospitals |
Funding Information: | Funder Grant number WELLCOME TRUST (THE) 206632/Z/17/Z |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 16 Jun 2020 12:42 |
Last Modified: | 28 Oct 2021 13:34 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/ejhf.1870 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:161838 |