Published on November 11, 2019

Local Medical Center Enrolls First Patient in Largest Heart Failure Clinical Trial in the U.S.

Photo of the CardioMEMS System.

The CardioMEMS System consists of a small pressure-sensing device that is implanted directly into the pulmonary artery. Once implanted, the sensor measures and transmits blood flow pressure and heart rate. A special electronic receiving unit allows patients to take daily readings and wirelessly transmit this data to MidMichigan’s Heart Failure Clinics.

MidMichigan Medical Center- Midland recently implanted their first patient with the CardioMEMS™ HF System as part of the landmark GUIDE-HF clinical trial. The Medical Center is one of 140 centers currently participating in this study. The trial itself will evaluate improved survival and quality of life of patients who have been implanted with the Abbott CardioMEMS™ HF System.

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s needs. It is the leading cause of hospitalization for Americans over age 65. According to the American Heart Association, nearly 6 million Americans have heart failure and 900,000 new patients are diagnosed each year. The estimated direct and indirect cost of heart failure in the U.S. in 2012 was $31 billion and that number is expected to more than double by 2030. Ongoing management of heart failure is necessary to monitor a patient’s condition, prevent hospitalizations and to improve a patient’s overall quality of life.

“To me, the idea of using technology to be proactive in the management of heart failure, identifying early physiologic changes within the heart, and ultimately keeping people feeling well and out of the hospital is the future of medicine,” said Cardiologist and Director of MidMichigan’s Heart Failure Program Jeffrey Martindale, D.O., F.A.C.C., who performed the procedure. “Our involvement in the GUIDE-HF study is fostering opportunities for patients within our communities to have access to this kind of leading-edge innovation in heart failure care.”

The GUIDE-HF clinical trial is the largest heart failure medical device trial in the U.S. The trial uses Abbott’s CardioMEMS HF System, which supports heart failure management by measuring pulmonary artery pressure (PAP) from within the body. Building on previous clinical trials, the GUIDE-HF trial will study whether the CardioMEMS device can reduce heart failure hospitalization, and improve survival and quality of life for people living with Class II-IV heart failure, based on the New York Heart Association (NYHA) Class guidelines. This investigational device exemption (IDE) study will continue through 2023. GUIDE-HF will enroll more than 3,600 patients at 140 hospitals around the U.S. If successful, the study will expand coverage to a larger group of at-risk heart failure patients.

“MidMichigan Health is committed to improving patient care and investing in innovative medical technology such as the CardioMEMS HF System,” said Sunita Vadakath, M.D., F.R.C.A., M.P.A., vice president of service lines for MidMichigan Health. “Our Clinical Research Department and physicians are very excited to be on the forefront of bringing new pharmaceutical and advanced medical technologies to patients in our community. Additionally, MidMichigan Health offer a heart failure program with clinic locations in Midland, Alma, Alpena, Clare, Gladwin and Mt. Pleasant. Our program is based on best practices from the University of Michigan and is designed to assist patients in monitoring responses to treatment, modifying behaviors, adjusting medications and coordinating care.”

About the CardioMEMS HF System
The CardioMEMS HF System, from global medical device manufacturer Abbott, is approved by the U.S. Food and Drug Administration (FDA) for commercial use in the U.S. 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.

Those who would like more information on the CardioMEMS HF System may visit www.midmichigan.org/cardiomems.  Additional information about clinical trials can be found at www.midmichigan.org/clinicaltrials.