February 14, 2011 – Results from the CHAMPION study have been published online in The Lancet. The study demonstrated a significant reduction in heart failure hospitalization rates for patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor.
Specifically, it demonstrated a 30 percent reduction in the primary efficacy endpoint of heart failure hospitalization rates at six months, and a 39 percent reduction in heart failure hospitalization rates at 15 months. The trial also met all of its safety and secondary efficacy endpoints.
The CHAMPION trial was a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the United States. The trial was led by William Abraham, M.D., at The Ohio State University Medical Center and Philip Adamson, M.D., at the Oklahoma Heart Hospital. It evaluated the safety and effectiveness of CardioMEMS' heart failure pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients. NYHA Class III patients represent approximately 30 percent of heart failure patients in the United States and account for nearly half of all heart failure hospitalizations.
All subjects in the CHAMPION trial had the CardioMEMS heart failure sensor permanently implanted in the pulmonary artery using a simple, catheter-based technique. All patients took daily pulmonary artery pressure readings from home that were transmitted to CardioMEMS' secure patient database. For patients in the treatment group only, healthcare providers were provided access to the pressure readings, which were used in the treatment of their heart failure condition. For control group patients, health care providers were denied access to the pressure readings and they continued to receive standard care.
"The results from the CHAMPION study are very significant and provide a valuable new tool in the battle against heart failure,” Abraham said. “Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy."
"The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life,” Adamson added. “These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The 'hemodynamic era' is a major advancement with promise for profound long-term impact on heart failure morbidity."
"Hospitalizations are very traumatic for heart failure patients and costly to the health care system," said Jay Yadav, M.D., founder and CEO of CardioMEMS and a cardiologist at the Piedmont Heart Institute. "With the CardioMEMS heart failure monitoring system, frequent hemodynamic monitoring can allow doctors and nurses to more efficiently manage their patients and produce meaningful reductions in their patients' heart failure related hospitalizations."
For more information: www.cardiomems.com