Digital Health Care Solution for Proactive Heart Failure Management with the Cordella Heart Failure System: Results of the SIRONA First-in-Human Study

Figures

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  Figure 1. The Cordella™ Heart Failure System. (A) The Cordella™ System securely transmits daily health information (weight, blood pressure, saturations, heart rate) as well as pulmonary artery pressure (PAP) data to clinicians from the patient's home. (B) The Cordella™ Pulmonary Artery Pressure Sensor.

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  Figure 2. The CordellaTM Pulmonary Artery Pressure Sensor. (A) Schematic of the sensor implanted in the right pulmonary artery in anterior‐posterior view: target implant zone and three‐dimensional reconstruction of the Cordella Sensor deployed at the target zone. (B) Implantation technique. Pulmonary angiography in the (A) antero‐posterior (PA) and (B) left anterior oblique caudal (LAO‐CAU) views. (C) 0.025” × 260 cm Amplatz extra support wire in a side branch of the right pulmonary artery over which the delivery system is advanced, (D) positioning of the Cordella Sensor in the right pulmonary artery, (E) withdrawal of release wires allows nitinol anchors to expand securing the sensor within the vessel, and (F) final positioning of the Cordella Sensor in the right pulmonary artery.

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  Figure 3. Enrolment diagram (consort diagram).

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  Figure 4. Pulmonary artery pressure measurement: (A) Bland–Altman plot of mean pulmonary artery pressure 90 days following implantation. The Cordella Pulmonary Artery Pressure Sensor readings are compared to fluid‐filled catheter. (B) The Cordella Pulmonary Artery Pressure Sensor‐derived waveform.

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  Figure 5. Patient adherence, quality of life and New York Heart Association (NYHA) classification. (A) Patient adherence with daily CordellaTM Heart Failure System (CHFS) and Cordella™ Pulmonary Artery Pressure Sensor (CPAS) readings over the first 90 days following implantation. (B) Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and 90 days following implantation. (C) NYHA classification at baseline and 90 days following implantation.