MidMichigan Medical Center-Midland Implants First Patient with CardioMEMS™ as part of the landmark GUIDE-HF clinical trial. One of 140 centers participating in the study, the trials’ investigators are evaluating improved survival and quality of life of patients who have been implanted with the Abbott CardioMEMS™ HF System.
The Problem of Heart Failure
Heart failure represents a big problem as nearly 6 million will be hospitalized at some point. It occurs when the heart can’t pump sufficient amounts of blood to meet the body’s needs. 900,000 new patients are diagnosed each year. Direct and indirect costs represented $31 billion back in 2012 and that number will double by 2030 according to the American Heart Association.
Such a potentially dangerous condition must be managed on an ongoing basis by monitoring a patient’s condition—this helps to prevent hospitalizations and improve overall quality of life.
The GUIDE-HF Clinical Trial
Sponsored by Abbott, this endeavor is the largest heart failure medical device trial in the United States. By using the CardioMEMS HF System, which supports heart failure management by measuring pulmonary artery pressure (PAP) from within the body, this system supports a heart failure management.
The study exists to determine if the CardioMEMS device can reduce heart failure hospitalization, and improve survival and quality of life for patients living with Class II-IV heart failure—in alignment with New York Heart Association (NYHA) Class guidelines.
An investigational device exemption (IDE) study, it continues through 2021 and is planned to involve more than 3,600 patients at 140 research sites (hospitals and health centers) around the country.
If the CardioMEMS HF System clinical trial system is successful the study sponsor will expand coverage to broader groups of at-risk heart failure patients.
Clinical Investigator Comments
Sunita Vadakath, MD, FRCA, MPA, vice president of service lines for MidMichigan Health noted “MidMichigan Health is committed to improving patient care and investing in innovative medical technology such as CardioMEMS HF system.” He continued, “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, Mid-Michigan Health offer a heart failure program with clinic locations in Midland, Alpena, Gratiot, Clare, Gladwin and Mount 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.”
Jeffrey Martindale, DO, FACC, Cardiologist and Director of MidMichigan’s Heart Failure Program, also performed the procedure. He noted, “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.” After all he concluded, 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 CardioMEMS device is the first and only FDA—approved heart failure monitor proven to significantly reduce heart failure in hospital admissions and improve quality of life—it has been clinically proven to reduce hospital admission by 58% over an average of 12 months according to one year outcomes from the CardioMEMS Post Approval Study which was presented at ACC; March 17, 2019.
Sunita Vadakath, MD, FRCA, MPA, vice president of service lines for MidMichigan Health
Jeffrey Martindale, DO, FACC, Cardiologist and Director of MidMichigan’s Heart Failure Program
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