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Ohio State First in Ohio to Implant Novel Device, FIRE1 System, for Monitoring Heart Failure
COLUMBUS, Ohio – About 60 million people worldwide are living with heart failure, including more than 6 million in the United States. Many are hospitalized because of symptoms like excess fluid retention, which can result in shortness of breath. The Ohio State University Wexner Medical Center is the first in Ohio to participate in the clinical trial of a novel sensor designed to help patients better monitor their fluid levels, which may reduce the need for hospitalization.
“This technology directly measures the volume of fluid buildup and alerts the patient and healthcare provider of a change. Heart failure patients begin to retain fluid a few weeks before experiencing symptoms. Early intervention can help prevent emergency department visits and hospitalization,” said Rami Kahwash, MD, director of Ohio State’s heart and vascular research and professor of clinical medicine.
The FIRE1 device was implanted Jan. 18 in Wes Vollrath, 72, of Marysville, who started retaining fluid over a year ago, resulting in a heart attack. He was last hospitalized in December because of fluid buildup. During the minimally invasive procedure, a small device was implanted via a catheter in the inferior vena cava, the body’s largest vein and a crucial pathway that moves blood from the body to the heart.
“The procedure is performed in the cath lab with mild sedation and is the same method used for standard heart catheterizations. Patients can usually be discharged on the same day,” said Scott Lilly, MD, who implanted the sensor as part of an early feasibility trial in the United States. He is an interventional cardiologist and director of the structural heart disease program at Ohio State.
After Vollrath returned home, he started wearing a special belt across the abdomen for a few minutes each day to download data on how his fluid volume is trending and transmit it to a cloud-based computer application that can be viewed by clinicians at Ohio State’s heart failure clinic. Based on readings, he may need to adjust his medication or see Kahwash, who manages his care.
“This is the only technology that directly measures volume of fluid. Current technology has mainly focused on measuring lung pressures, which has numerous obstacles since fluid retention often does not align with changes in pressure readings in many instances,” Kahwash said. “This type of sensor represents a significant milestone in the remote management of heart failure, which is the world’s leading cause of hospitalization.”
More information about the First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF) can be found at clinicaltrials.gov.
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