Approval of the CardioMEMS HF System represents the beginning of a new era of treatment for certain patients with heart failure.
Oklahoma City (PRWEB) June 10, 2014
The CardioMEMS HF System features a sensor that is implanted in the pulmonary artery (PA) during a non-surgical procedure to directly measure PA pressure. Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure. The new system allows patients to transmit daily sensor readings from their homes to their health care providers allowing for personalized and proactive management to reduce the likelihood of hospitalization.
Dr. Philip B. Adamson, director of the Heart Failure Institute of the Oklahoma Heart Hospital, and Dr. William T. Abraham, director of the Division of Cardiovascular Medicine at Ohio State’s Wexner Medical Center, were national co-investigators on the clinical research studies of the CardioMEMS HF System. Dr. Adamson performed today’s implant at the Oklahoma Heart Hospital, in Oklahoma City, Oklahoma, and Dr. Abraham oversaw the procedure at Ohio State, performed by Dr. Ayesha Hasan, director of the cardiac transplant program.
This event marks the culmination of a 17-year collaboration between Dr. Adamson and Dr. Abraham that started in 1997 when these two physicians helped assemble a team of physician-scientists to investigate the concepts of implantable hemodynamic monitoring in patients with heart failure. Later, they would both work as the national co-principal investigators on the clinical trials that ultimately carried this device through to FDA approval.
The research for the CardioMEMS HF System was conducted at more than 64 clinical research sites across the United States including: the Oklahoma Heart Hospital Research Foundation, and The Ohio State University Wexner Medical Center.
“Approval of the CardioMEMS HF System represents the beginning of a new era of treatment for certain patients with heart failure. The remarkable technology in the sensor measures the very problem that leads to worsening symptoms and instability. We now have the opportunity to promote wellness and stability rather than react to problems after they develop,” said Dr. Adamson.
Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. According to the Centers for Disease Control and Prevention, more than 5.1 million Americans have heart failure, with 670,000 new cases diagnosed each year. Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death.
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.
Data from a clinical trial showed that the CardioMEMS technology reduces heart failure hospital admissions by up to 37 percent. The CHAMPION trial studied the effectiveness of the CardioMEMS HF System in New York Heart Association (NYHA) Functional Classification System class III heart failure patients who had been hospitalized for heart failure in the previous 12 months. Results of the trial demonstrated a statistically significant 28 percent reduction in the rate of heart failure hospitalizations at six months, and 37 percent reduction in heart failure hospitalizations during an average follow-up duration of 15 months.
Roughly 1.4 million patients in the U.S. have NYHA Class III heart failure, and historically these patients account for nearly half of all heart failure hospitalizations. According to the American Heart Association, the estimated direct and indirect cost of heart failure in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030.
After extensive clinical trials, the U.S. Food and Drug Administration (FDA) approved the CardioMEMS HF System for commercial use in patients in the United States, on May 28th, 2014, less than two weeks ago. Speaking of the short turn-around time from approval to use of this new therapy, Dr. John Harvey, CEO of the Oklahoma Heart Hospital said:
“In order to provide cardiovascular medicine of the highest quality, our staff has consistently sought to provide those treatments that are on the forefront of new science. In this case, we are fortunate to have one of the top physician-scientists involved in the development of this product on our staff, and it is safe to say that there are few people in the nation who know more about this new medical device than Drs. Adamson and Abraham.”
The CardioMEMS HF System, from global medical device manufacturer St. Jude Medical, is approved by the U.S. Food and Drug Administration (FDA) for commercial use in the United States. For more information, visit http://www.heartfailureanswers.com/.
About the Oklahoma Heart Hospital:
Known for focusing on the patient and family experience, the Oklahoma Heart Hospital (OHH) is consistently recognized as a national leader in patient satisfaction. In addition, OHH ranks in the top 1% in the nation in cardiac procedural volumes, and the top 6% in quality outcomes for cardiac surgery. As a physician owned hospital, OHH is better empowered to connect the practices of the organization to the needs of the patient.
Through a long-standing integrated partnership with the Oklahoma Heart Hospital Research Foundation, OHH provides its patients with access to unique medicines and devices not readily available at other hospitals around the world.
Founded in 2002, expanded in 2010, Oklahoma Heart Hospital’s network is one of the largest cardiovascular programs in the United States, consisting of 2 hospitals, 67 cardiovascular specialists, and 60 clinics in rural and metro locations across the great state of Oklahoma.
About the Oklahoma Heart Hospital Research Foundation:
A non-profit organization founded in 1993, the Oklahoma Heart Hospital Research Foundation (OHHRF) works to reduce mortality from heart disease and to improve the quality of life of those who suffer from this disease. To accomplish this end, the foundation participates in clinical research, educational programs for mid-level providers, philanthropy, and supports a free clinic based in Midwest City, Oklahoma. OHHRF is currently participating in over 75 clinical trials utilizing a longstanding integrated partnership with the Oklahoma Heart Hospital’s network of 67 cardiovascular specialists in more than 60 clinic locations across the state.