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http://hdl.handle.net/1942/31840
Title: | Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study | Authors: | MULLENS, Wilfried Sharif, Faisal DUPONT, Matthias Rothman, Alexander M. K. Wijns, William |
Issue Date: | 2020 | Publisher: | WILEY | Source: | EUROPEAN JOURNAL OF HEART FAILURE, 22(10), p. 1912-1919 | 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 Cordella(TM) Pulmonary Artery Pressure Sensor (Endotronix, Inc., Chicago, IL, USA) and the usability of the comprehensive Cordella(TM) 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 (TM) 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. | Notes: | Mullens, W (corresponding author), Ziekenhuis Oost Limburg, Dept Cardiovasc Med, Schiepse Bos 6, B-3600 Genk, Belgium. wilfried.mullens@zol.be |
Other: | Mullens, W (corresponding author), Ziekenhuis Oost Limburg, Dept Cardiovasc Med, Schiepse Bos 6, B-3600 Genk, Belgium. wilfried.mullens@zol.be | Keywords: | Pulmonary artery pressure sensor;Heart failure | Document URI: | http://hdl.handle.net/1942/31840 | ISSN: | 1388-9842 | e-ISSN: | 1879-0844 | DOI: | 10.1002/ejhf.1870 | ISI #: | WOS:000536479000001 | Rights: | 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 License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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European J of Heart Fail - 2020 - Mullens - Digital health care solution for proactive heart failure management with the.pdf | Published version | 7.7 MB | Adobe PDF | View/Open |
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