Ohio State First to Implant Newly-Approved Wireless Heart Failure Monitor
Ohio State's Heart and Vascular Center was the first in the country to begin treating some heart failure patients with a new wireless, implantable hemodynamic monitor just approved by the FDA. The CardioMEMS HF monitoring system will help physicians observe pulmonary artery pressures, optimize treatment and prevent hospitalizations. Dr. William Abraham, director of the Division of Cardiovascular Medicine, was the national co-principal investigator on the clinical trials of the new device. "I consider this to be the first major breakthrough in heart failure management in more than a decade," Abraham says. "For the first time, cardiologists can directly manage a patient's pulmonary pressures rather than managing their symptoms or weight gain.
The CardioMEMS heart sensor is approved for NYHA Class III patients with a history of hospitalizations within the past year. Results from studies show the device has reduced hospital readmissions by more than 30 percent, when compared with standard care. The study also determined the device to be cost-effective, with implant procedures costing approximately $15,000—the same cost as one average hospitalization for heart failure.
The device is about the size of a large paper clip and is implanted in the pulmonary artery using a simple, catheter-based procedure. It takes real-time measurements of pulmonary artery pressure and transmits them to a secure website where cardiologists can review the data and make adjustments to medication, if needed.
"An increase in pulmonary artery pressure is the most direct sign of congestion," Abraham says. "By identifying these elevated pressures early, we can treat patients before they get sick and avoid episodes that lead to repeated hospitalizations."
Dr. Ayesha Hasan, a heart failure cardiologist at Ohio State's Richard M. Ross Heart Hospital, was the study's lead principal investigator at Ohio State.
"I've seen several patients in the clinical trials go from numerous hospitalizations down to zero. Now with federal approval, we're excited that many more people with heart failure can have the monitor and a better quality of life," Hasan says.
Next, Abraham says, he is planning follow-up studies to evaluate the long-term effects of the monitoring system.