For 6 million heart failure patients in the United States, hospitalizations are often a way of life. But a new battery-free at-home monitoring system may help keep patients healthy.
At 72, Rose-Marie Stewart is always itching to travel. And it was on a trip in 2008 the 72- year retired equal employment opportunity investigator first noticed something wasn't right. Stewart says, "I went on a cruise and when my friends and I came back my ankles looked like elephant legs and I thought it was because of the driving."
But tests showed Rose-Marie has congestive heart failure. Her heart is too weak or stiff to pump the way it should, leaving her out of breath, and swollen. She says, "I would retain fluid like nobody's business, just swell up like a balloon."
In January of 2013, Rose-Marie was hospitalized for 17 days straight with complications. She says, "It was almost like every month thereafter I was in the hospital for 4 days, 3 days, 5 days, 7 days."
That's when Dr. Robert Cole, Assistant Professor of Cardiology at Emory School of Medicine, told Rose-Marie about a new heart-failure monitoring system known as the CardioMEMS HF System. It was approved in April of 2015 by the Food and Drug Administration. And it's designed to keep heart failure patients like Rose-Marie out of the hospital, allowing them to be monitored in real time from their homes.
Rose-Marie had a tiny battery-free sensor implanted in her pulmonary artery. Once a day, she rests her head on a special pillow, fitted with a sensor that monitors her lung pressures. Dr. Cole explains, "Anytime the patient lays down on the pillow, it transmits information to a small box next to the bedside. That's how the information comes to us."
If Rose-Marie's pressures are off, Dr. Cole is alerted, and calls her, telling her to cut back on or increase her medication. He's only had to do that twice. She hasn't been been hospitalized once since April, when she started using the system.
The system is designed for heart failure patients who've been experiencing complications and have spent time in the hospital over the last year. The device costs about $25,000. Rose-Marie says her insurance company paid for it. She says, "If anybody is going through what I went through, to stay out of the hospital, it's worth the investment, do it."
Last week, the Food and Drug Administration sent a warning letter to the Atlanta facility that makes the CardioMEMS system. The agency cited "non-conformities" at the Georgia plant.
The FDA says the plant had not met deadlines to address concerns about problems including incorrect serial numbers and possible defects in the coating of the devices.
The company says it's addressing the concerns.