Emory Healthcare is the first health care system in Atlanta offering patients a miniaturized, wireless monitoring sensor, implanted in the pulmonary artery (PA), to help remotely manage heart failure (HF).
The CardioMEMS HF System is the first and only FDA-approved heart failure monitoring device that has demonstrated in clinical trials to reduce hospital admissions when used by physicians to manage heart failure.
During a non-surgical procedure, the CardioMEMS device is delivered to the heart via catheter and implanted in the PA. The paper clip-sized sensor directly measures pressure inside the PA.
Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure.
Once implanted, the wireless sensor sends regular PA pressure readings to an external patient electronic system, allowing physicians to monitor the patient’s heart failure status and offer proactive management of the disease. There is no pain or sensation for patients during the readings.
“This is a breakthrough development in the monitoring of our heart failure patients,” says cardiologist Rob Cole, MD, assistant professor of medicine (cardiology), Emory University School of Medicine.
“We’re able to detect changes from a distance and, if needed, adjust a patient’s medication regimen to stabilize PA pressures, ultimately reducing thier likelihood of visiting a hospital.”
Cole and his Emory colleagues recently implanted Metro Atlanta’s first CardioMEMS device since FDA approval was granted last year. Emory Healthcare has been implanting the device for several years during a national clinical trial for the new technology.
“Our study findings showed a statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to this critically important pulmonary artery pressure data,” says Cole.
The CHAMPION clinical 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.
Results of the 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.
Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. According to the 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.
The CardioMEMS HF System, from device manufacturer St. Jude Medical, was invented at Georgia Tech using technology created to sense the pressure changes in jet engines. The CardioMEMS sensor is designed to last the lifetime of the patient and does not require batteries.