Portsmouth Regional Hospital
October 27, 2015

Portsmouth Regional Hospital is the first facility in the seacoast region to implant a new miniaturized, wireless monitoring sensor to manage heart failure (HF). The CardioMEMS HF System is the first and only FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure.

The CardioMEMS HF System features a sensor that is implanted in the pulmonary artery (PA) during a non-surgical procedure to directly measure PA pressure. Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure. The new system allows patients to transmit daily sensor readings from their homes to their health care providers allowing for personalized and proactive management to reduce the likelihood of hospitalization.

"The CardioMEMS is about the size of a paper clip, with wires extending from it," said cardiologist, Dr. Jeffrey Colnes, MD, FACC. “Monitoring changes makes for easier adjustments to medications and will mean less need for repeat hospitalizations.

"It's very exciting and a new option for CHF patients," Colnes said. "CHF is a very frustrating problem. It's very common and difficult to treat. It consumes large resources and I think this is going to make a very big difference for patients."

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 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 the patients to transmit critical information about their heart failure status to a clinician 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.

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. 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. 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.

"We are committed to improving patient care and investing in innovative medical technology such as the CardioMEMS HF System," said Cindy Fielders, Director of Portsmouth Regional Hospital’s Heart & Vascular Institute. "This new technology allows for proactive management of heart failure and will greatly benefit patients, caregivers, their families and the greater health care economy."

The CardioMEMS HF System, from global medical device manufacturer St. Jude Medical, is approved by the U.S. Food and Drug Administration (FDA) for commercial use in the U.S. For more information, visit Abbott's heart failure answers site.

CardioMEMS Technology Fact Sheet

 

CHAMPION Clinical Trial Fact Sheet

 

Heart Failure Fact Sheet

 

News Release – FDA Approval