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Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first‐in‐human study
Author(s) -
Mullens Wilfried,
Sharif Faisal,
Dupont Matthias,
Rothman Alexander M.K.,
Wijns William
Publication year - 2020
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.1870
Subject(s) - medicine , pulmonary artery , heart failure , vital signs , cardiology , blood pressure , pulmonary hypertension , surgery
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™ 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.