Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease by Unknown

Author:Unknown
Language: eng
Format: epub
ISBN: 9783030117481
Publisher: Springer International Publishing

Pulmonary Artery Pressure Continuous Monitoring

This device/sensor (CardioMems - Abbott, Chicago, IL, USA) provides continuous telemetry on intravascular pressures in the pulmonary artery and it is of special interest in the context of chronic heart failure. In the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association (NYHA) Class III Heart Failure Patients) study, use of the device in patients with chronic heart failure resulted in a 30% reduction of heart failure re-hospitalizations compared to controls [64]. This suggests that the close monitoring of patients is of great importance to assess response to treatment, as the investigators were able to make corrections of the chronic heart failure therapy decreasing the need for the subject to visit the hospital because of clinical decompensation. It can be used as a hemodynamic marker assessing blood pressure changes by a drug or a device in a real-world fashion allowing variations throughout the day and night to be observed.

The system consists of a wireless chronic implantable sensor that is deployed in the lumen of the pulmonary artery using catheterization. The device will remain in the artery thanks to its anchoring wires (Fig. 11.5). This procedure typically takes 10–20 min depending on the operator skills and familiarity with the device and requires a cardiac catheterization laboratory for implantation. The device registers data on systolic and diastolic blood pressure, mean (time point) and mean baseline blood pressure. All data are remotely captured and made available in real time to the investigator. It is possible to set alerts with pre-specified systolic or diastolic blood pressure readings in the system. The system is compliant with the 1996 U.S. Health Insurance Portability and Accountability Act (HIPAA) and is cloud-based. A smartphone app is also available for subjects and or investigators unless data blinding is required. This technology has extensive applications into further characterizations of the vascular effects of novel drugs that affect hemodynamics in subjects with diabetes and congestive heart failure (CHF), for example the sodium-glucose cotransporter (SGLT)-2 inhibitors, as pulmonary blood pressure is a good indicator and/or a biomarker of the hemodynamic response and vascular function in subjects with CHF and/or chronic kidney disease (CKD) [65]. Increases in pulmonary blood pressure is also a predictor of rehospitalisation for CHF [65, 66]. Number of excursions and the intensity are valuable endpoints for continuous monitoring during and after the exposure of an investigational product (IP). The technology is scalable for phase IIa, IIb, III and mechanistic studies.

Fig. 11.5CardioMEMS. (a) Implantable device. (b) 24 h readings with intervention annotations

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