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Tiny Devices, Big Impact

Tiny device lets providers, patients manage heart failure proactively

CardioMEMS, a miniaturized, wireless monitoring sensor, is the first FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure.

The device, which is about the size of a dime, is implanted in the pulmonary artery during a cardiac catheterization procedure. The device directly measures pulmonary artery pressure, which gives a direct indication of worsening heart failure. The system transmits daily sensor readings from the home to King's Daughters Heart Failure Clinic, allowing for personalized, proactive management to reduce the likelihood of complications and hospitalization.

With the data provided by the CardioMEMS device, Heart Failure Clinic providers are able to make adjustments to medications and advise patients on lifestyle changes that they can make in the moment.

The CardioMEMS sensor is designed to last the lifetime of the patient and doesn’t require batteries. Once implanted, the wireless sensor sends pressure readings to an external patient electronic system. There is no pain or sensation for the patient during the readings. The CardioMEMS HF System allows patients to transmit critical information about their heart failure status to the Heart Failure Clinic on a regular basis, without the need for additional clinic or hospital visits. This provides clinicians with the ability to detect worsening heart failure sooner and adjust treatment to reduce the likelihood that the patient will need to be hospitalized.

In 2018, King’s Daughters was the first facility in the area to offer the CardioMEMS HF System to patients.

The CardioMEMS device was approved by the FDA following the results of the CHAMPION Clinical Trial, in which King's Daughters participated. The research, sponsored by CardioMEMS, studied the safety and effectiveness of the system, following patients with class III heart failure who had been hospitalized for heart failure in the prior 12 months.

Data from a clinical trial showed that the CardioMEMS technology reduces heart failure hospital admissions by up to 37 percent. The CHAMPION trial studied the effectiveness of the CardioMEMS HF System in New York Heart Association (NYHA) Functional Classification System class III heart failure patients who had been hospitalized for heart failure in the previous 12 months. The CHAMPION Trial demonstrated a statistically significant 28 percent reduction in the rate of heart failure hospitalizations at six months, and 37 percent reduction in heart failure hospitalizations during an average follow-up duration of 15 months.

Roughly 1.4 million patients in the U.S. have NYHA Class III heart failure, and historically these patients account for nearly half of all heart failure hospitalizations. According to the American Heart Association, the estimated direct and indirect cost of heart failure in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030.

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. According to the U.S. Centers for Disease Control and Prevention, more than 5.1 million Americans have heart failure, with 670,000 new cases diagnosed each year. Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death.

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