Advocate Aurora Health researchers contributed to a recent U.S. Food and Drug Administration (FDA) approval of the Abbott CardioMEMS™ HF System, a remote heart failure monitoring technology. This is the second FDA approval for CardioMEMS, and it expands the monitoring system’s use to include people with an earlier stage of heart failure.
FDA approval was granted after findings from the GUIDE-HF clinical trial showed that CardioMEMS was effective in reducing hospitalizations for people who live with Class II heart failure or those who have higher blood levels of natriuretic peptide, a hormone produced by the heart when failure develops or worsens. The Class II New York Heart Association (NYHA) designation is given to people whose heart failure only slightly limits their abilities to perform routine physical activities.
Nine Advocate Aurora Research Institute cardiovascular research teams joined the GUIDE-HF clinical trial, offering participation to eligible patients across Illinois and Wisconsin.
The Abbott CardioMEMS HF System includes a device that is implanted inside a person’s pulmonary artery, the major blood vessel that carries blood from the heart to the lungs. The device enables the system to monitor blood pressure inside the artery. Higher blood pressure indicates an increase of fluid, which may signify worsening heart failure. When the sensor picks up elevated blood pressure, the system remotely sends an alert to the patient’s health care team.
“CardioMEMS is part of an early warning system that gives us the opportunity to make treatment changes for our patients that may prevent hospitalization and worsening heart failure,” said Ali Valika, MD, cardiologist and the study’s principal investigator for the Research Institute’s Illinois sites.
More than 100 research participants volunteered to enter the GUIDE-HF clinical trial at Advocate Aurora Health sites.
“Early intervention is critical to maintaining a person’s health and preventing hospitalization, and CardioMEMS may alert the health care team before a patient even begins to experience physical symptoms,” said Nasir Sulemanjee, MD, cardiologist and principal investigator at Aurora St. Luke’s Medical Center in Milwaukee.
Advocate Aurora researchers also contributed to the clinical trial that led to the 2014 FDA approval of Abbott’s CardioMEMS HF System for use in people living with NYHA Class III heart failure. People with Class III failure often are unable to perform ordinary physical activities without significant symptoms, such as difficulty breathing, heart palpitations and fatigue.
“We’re grateful to our many patients who participated in the CardioMEMS GUIDE-HF clinical trials conducted at Advocate Aurora,” said Laura Wrona, MSN, director of cardiovascular clinical trials at the Research Institute. “Together, we’re helping to make a difference for the more than half a million people who are newly diagnosed with heart failure each year and the people who now qualify for earlier access to remote heart failure monitoring.”
Abbott is the manufacturer of the CardioMEMS HF system.
To learn more about Advocate Aurora’s research, visit aah.org/research.
About Advocate Aurora Research Institute
Advocate Aurora Research Institute is a not-for-profit, limited liability company of Advocate Aurora Health. Advocate Aurora has emerged as a national destination for patient-centered bench, translational and clinical research, and the Research Institute unifies the innovative research efforts throughout the health system. Advocate Aurora researchers focus on rapidly translating new discoveries from the scientist’s bench to the patient’s bedside and into the community we serve to improve options and outcomes that change not only the lives of individuals, but transform the health of populations.