One of several ongoing trials under SHI research program
AUSTIN, Texas - (October 29, 2012) - The Seton Heart Institute (SHI) is studying a new, implantable monitoring device that may allow physicians the ability to better personalize and optimize treatment for heart failure patients and give patients better management of their chronic condition.
The clinical trial is called LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy). SHI is one of 75 sites in the U.S. chosen to evaluate how safely and effectively the physician-directed, patient self-management system improves outcomes for heart failure patients. The device was developed by St. Jude Medical.
"Millions of Americans suffer from heart failure and must often be readmitted to the hospital because of worsening of symptoms," explained Dr. Jason Zagrodzky, an electrophysiologist with Seton Heart Institute. "We hope this new technology will transform the way heart failure is managed, giving patients more control over their treatment while at the same time reducing hospital visits."
According to the American Heart Association, approximately five million Americans live with heart failure, which carries an estimated burden of $37.2 billion of direct and indirect costs in the United States.
The investigational system allows patients to make
adjustments to their diet and medication similar to how
diabetic patients self-monitor their insulin levels. A patient
will receive instructions by simply waving the wireless monitor
over the implantable device.
Traditionally, the only way to measure a patient's left atrial pressure is to undergo heart catheterization in a hospital setting.
Barbara Organ, a 68-year-old heart failure patient, has suffered from seven heart attacks in the past 20 years. Her disease, she says, has taken a toll on her quality of life. In addition to heart attack treatment, she has been hospitalized numerous times because of fluid buildup around her heart.
"I feel so fortunate to be a part of this study," said
Organ. "I use the monitor four times a day and it gives me
important information I need to know about my medication."
Dr. Zagrodzky implanted a small generator into Organ's chest. Using a hand-held, wireless device, Organ can externally monitor elevated left atrial pressure (LAP) of her heart (see image below). Depending on her pressure readings, Organ can adjust her medication based on her physician-directed prescription plan and her current LAP.
"By bringing cutting edge therapies to central Texas and advancing medical research, Seton Heart is helping to improve the cardiovascular health of our region," said Dr. Mark Pirwitz, president and chief executive officer of SHI.
Investigators are still enrolling patients for the
LAPTOP-HF study. For more information, go to www.setonheart.com/research.