Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first‐in‐human study

Wilfried Mullens,Matthias Dupont,William Wijns,Faisal Sharif,Alexander M.K Rothman

doi:10.1002/ejhf.1870

Abstract

AimsIncorporation 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 resultsMulticentre, 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.ConclusionThe initial experience of the CHFS incorporating comprehensive vital signs and pulmonary artery pressure monitoring enables safe and accurate monitoring of HF status.

Highlights

Incorporation of remotely monitored pulmonary artery pressure (PAP)-guided treatment algorithm with the aim of maintaining normal PAP range proved to be more effective in reducing heart failure (HF) hospitalizations in selected patients with HF than management based on symptoms and clinical signs.[1,2]
Sensor (Endotronix, Inc., Chicago, IL, USA) provide comprehensive clinical information including PAP, body weight, blood pressure, heart rate and oxygen saturations of HF patients to their physicians, allowing HF patients to be an integral part of the team and provide a proactive HF management platform
SIRONA sought to examine for the first time the safety and accuracy of the Cordella Pulmonary Artery Pressure Sensor and the usability of the CordellaTM Heart Failure System (CHFS)

Summary

Introduction

Incorporation of remotely monitored pulmonary artery pressure (PAP)-guided treatment algorithm with the aim of maintaining normal PAP range proved to be more effective in reducing heart failure (HF) hospitalizations in selected patients with HF than management based on symptoms and clinical signs.[1,2] it has been demonstrated that structured and protocol-driven remote monitoring of daily weights, blood pressure, heart rate and rhythm, oxygen saturations and a self-rated health status score through a telemedical centre management leads to a reduction in unplanned cardiovascular admissions and all-cause mortality.[3] Together, the approved CordellaTM Heart Failure System (CHFS) and the investigational CordellaTM Pulmonary Artery Pressure. Sensor (Endotronix, Inc., Chicago, IL, USA) provide comprehensive clinical information including PAP, body weight, blood pressure, heart rate and oxygen saturations of HF patients to their physicians, allowing HF patients to be an integral part of the team and provide a proactive HF management platform.

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Conclusion