Doctors at The Ohio State University Wexner Medical Center are the first in the country to begin treating some heart failure patients with a new wireless, implantable hemodynamic monitor that was just approved by the U.S. Food and Drug Administration. The monitor will help physicians observe pulmonary artery pressures, optimize treatment, and prevent hospitalizations.
Dr. William Abraham, director of the Division of Cardiovascular Medicine at Ohio State’s Wexner Medical Center, has devoted 20 years of his career to researching hemodynamic monitoring. He was the national co-principal investigator on the clinical trials of the new device with Dr. Philip B. Adamson at the Oklahoma Heart Hospital Research Foundation, which is also planning its first implant for today.
“I consider this to be the first major breakthrough in heart failure management in more than a decade,” Abraham said. “For the first time, cardiologists can directly manage a patient’s pulmonary pressures rather than managing their symptoms or weight gain.”
The CardioMEMS HF system is approved for people with moderate (NYHA class III) heart failure who have had hospitalizations within the last year. About the size of a large paper clip, the device is implanted into 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 doctors can review the data and make medication adjustments, if needed.
“An increase in pulmonary artery pressure is the most direct sign of congestion,” Abraham said. “By identifying these elevated pressures early, we can treat patients before they get sick and avoid episodes that lead to repeated hospitalizations.”
Results from studies show the monitor has reduced hospital readmissions by 37 percent, when compared to standard care. The study also determined the device to be safe and cost-effective, with implant procedures costing approximately $15,000 or roughly the same cost as one average hospitalization for heart failure.
Nearly 5 million Americans have heart failure and it’s often under recognized. Symptoms can be mistaken for normal signs of aging. They include: shortness of breath, even during mild activity; difficulty breathing when lying down; weight gain with swelling in the legs and ankles from fluid retention; fatigue; and weakness.
Dr. Ayesha Hasan, director of the cardiac transplant program at Ohio State’s Richard M. Ross Heart Hospital, was the lead principal investigator at Ohio State and did today’s implant procedure.
“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 said.
Next, Abraham says he is planning follow-up studies to evaluate the long-term effects of the monitoring system.