Long-term monitoring of pulmonary artery pressure could significantly lower the risk of heart failure for patients with moderate to severe heart disease, according to a recent study conducted by Allegheny General Hospital (AGH) and other leading heart centers across the United States.
The CHAMPIOM trial (CardioMems Heart sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III patients) studied the effects of measuring pulmonary artery pressure with an implantable device in 550 patients at 64 US heart centers.
The study showed that patients who were monitored with the sensor had a 30 percent reduction in heart failure hospitalizations over a six month period.
“Patient outcomes from the CHAMPION study have been very encouraging,” said Raymond Benza, Medical Director, Pulmonary Hypertension Program, and Director, Center for Research and Innovation at the Gerald McGinnis Cardiovascular Institute at Allegheny General.
“The study has shown that regular monitoring yields valuable information that helps us detect early congestive heart failure symptoms and enables the health care team to modify the patient’s treatment to prevent disease progression.”
The trial was sponsored by CardioMems, Inc., creators of a wireless, battery-less, system that is implanted into the patient’s pulmonary artery through a catheter and allows patients to take measurements of their pulmonary artery pressure from home.
The sensor, which is about the size of a paper clip, is activated by radiofrequency when the patient places a wand-like device over the implant area or lies on the wand. The pulmonary pressure readings are immediately transferred to an online database for the patient’s physician to review.
“The monitor actually talks to you and says if you need to reposition yourself, or music plays when it’s right,” said Barbara Yakelis, a patient enrolled in the study at AGH. “It takes about 15 seconds.”
Participants in the study were NYHA Class III patients who experience heart failure symptoms with only minimal exertion. About 1.5 million of the six million heart failure patients in the US fall into the category of NYHA Class III patients.
During the trial, all patients in the study were implanted with the device, but only half had active monitoring with the sensor. Patients enrolled in active monitoring would receive a variety of treatments, including modification of medication dosages, in response to changes in their daily pressure readings.
Ms. Yakelis received her activated CardioMems sensor as part of the CHAMPION study in January 2008 and hasn’t been hospitalized for heart failure in 18 months. Prior to the study, she typically ended up in the hospital with heart failure every three to four months.
“I know Dr. Benza is notified when I submit my data and that makes me feel good,” said Ms. Yakelis, 57, of Bellevue. “If something was drastically wrong, he would know it. It’s amazing they can keep a watch on me that close.”
Physicians and researchers predict that the study will spur major changes in the way patients with congestive heart failure are treated. In light of the study results, all of the patients enrolled are being switched to active monitoring mode.
Other Allegheny General Hospital physicians who participated in the trial included Srinivas Murali, MD, Director, Division of Cardiology, and George Sokos, DO.
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