A new clinical trial at the Massachusetts General Hospital Heart Center gives patients the power to monitor their hearts and change their medication dosing daily to prevent the symptoms of heart failure.
At home heart failure care
New device aims to keep patients out of the hospital
A new trial gives patients the power to monitor their hearts
Raymond Racette enjoys his quiet life. Thirteen years ago he built his dream house in western Massachusetts. However, repeated hospitalizations resulting from congestive heart failure often keep him away from the lakeside chalet. After being discharged from his most recent stay, Racette was hopeful he would not be back soon.
In June, Racette, 67, was the first patient at the Massachusetts General Hospital Heart Center implanted with a new device that doctors hope will reduce hospitalizations for heart failure. The Homeostasis Trial is evaluating the effectiveness of the HeartPOD System, which gives patients the power to monitor their hearts and change their medication dosing daily to prevent more serious symptoms.
"This device could change the playing field of how we monitor and treat patients with heart failure," said Jagmeet Singh, MD, PhD, director of the Cardiac Resynchronization Therapy Program and co-investigator on the study. "This study will help us determine if daily optimization of drug therapy can improve the clinical outcomes of patients with congestive heart failure."
Heart failure’s cost
Hospitalization rates for people with heart failure have increased dramatically in the past three decades, evidence of a growing epidemic in the United States. An estimated 5.7 million Americans are living with heart failure and another 670,000 cases are diagnosed annually, according to the American Heart Association (AHA).
Heart failure occurs when the heart muscle can not pump enough blood to the body. When the flow out of the heart slows, blood retuning to the heart through the veins causes congestion in the tissues. This can lead to fluid build-up and swelling in the legs and ankles, and fluid build-up in the lungs can make it difficult to breathe.
"Most people with heart failure manage their symptoms with a number of medications that work in different ways," said Stephanie Moore, MD, a heart failure specialist and primary investigator for the Homeostasis Trial. "Unfortunately, fluid balance can be difficult to maintain. Multifactorial patients end up hospitalized with increased fluid as we try to re-establish their medical regimen and manage their symptoms. These frequent hospitalizations are a burden for the patients and their family and friends and can likely be avoided."
The next step in heart failure care
Repeated hospitalizations for heart failure are also a burden on the health care system, with the total cost of care in the billions of dollars annually. Home monitoring systems are already in use in the Heart Center's Cardiac Resynchronization Therapy Program and Heart Failure and Cardiac Transplant Program, alerting doctors when a patient's condition changes. The Homeostasis Trial takes the concept a step further by allowing patients to monitor their heart function themselves.
In mid-June, Dr. Singh implanted a sensor - about the size of a dime - in the left ventricle of Racette’s heart. This sensor monitors his left atrial pressure and sends the information twice daily to a small hand-held computer. Using Dr. Moore's prescriptive instructions, Racette will be able to adjust his medications on a dose-by-dose basis, similar to how diabetics can adjust their insulin dosage based on the results of at-home glucose monitoring.
"As the study progresses, we will work together to determine his dosing instructions based on the sensor's readings," said Moore. "The hope is that Raymond and future patients will be able to take their care into their own hands."
Racette will also be able to judge if he should make changes like reducing salt and fluid intake to prevent further symptoms.
Currently, doctors are guided by a heart failure patient's symptoms, such as sudden weight changes caused by fluid buildup, swelling or shortness of breath. The Homeostasis Trial is evaluating whether left atrial pressure measured from within the heart can indicate impending problems hours or days before these more serious symptoms occur.
"In the past the only time I knew I was having a problem was when I would start having difficulty breathing," said Racette, who was diagnosed with congestive heart failure in 2002. "I was being considered for a heart transplant. Hopefully this will carry me through so I won’t need to go down that road."
Mass General is one of six hospitals in the United States participating in the trial, which is sponsored by St. Jude Medical. Patients may qualify to participate if they have congestive heart failure that has not responded to conventional treatments.
"For many patients listed for a heart transplant, this device could help them turn the corner while waiting," said Singh. "And for those who are not candidates for transplants, it could provide renewed hope."
The Corrigan Minehan Heart Center is a multidisciplinary care center made up of specialists from cardiology, cardiac surgery, cardiac imaging, cardiac anesthesia and cardiac nursing.
Massachusetts General Hospital is recognized as a leader in patient care, education and research, ranking among the most prestigious medical institutions.