In the past year, the FDA has approved use of an implantable device to monitor heart failure management via measurement of the pulmonary artery pressure. Approved for use in HF patients at a NYHA Class III-IV level.
NYHA Class III – Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). The patients are comfortable only at rest.
In a retrospective analysis of the CHAMPION clinical data for heart failure, reduced ejection fraction (HFrEF) patients already on guideline-directed medical therapy, pulmonary artery pressure guided management reduced HF hospitalization by 43% and mortality by 57%.
- The PA Sensor is permanently implanted in the distal pulmonary artery during a right heart catheterization.
- Is MRI compatible
- Pacemakers, ICDs, and Ventricular Assist Devices (VAD) can work in conjunction with the PA Sensor and will not affect the performance of the system.
- The sensor does not require removal before cremation.
Indications The CardioMEMS HF System is indicated for wireless measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.
Contraindications The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
Cautions Medical procedures including radiofrequency ablation, ionizing radiation, and diagnostic ultrasound CAN also be performed while the sensor is implanted if precautions are taken to avoid direct contact with the sensor.