An investigational wireless blood pressure sensor implanted into the pulmonary arteries of patients with heart failure significantly reduced their rate of hospitalization, according to a groundbreaking study published today in The Lancet. The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial was conducted at 64 leading heart centers in the United States, including Pittsburgh’s Allegheny General Hospital (AGH)
The CHAMPION trial demonstrated a 30% reduction of heart failure hospitalization rates at 6 months and a 39% reduction in heart failure hospitalization rates at 15 months among heart failure patients whose treatment was guided by pulmonary artery pressures obtained through the sensor, compared to control patients receiving standard heart failure treatment. The trial also met all of its safety and secondary efficacy endpoints. A total of 550 patients nationwide were enrolled in the study, including seven from the western Pennsylvania region at AGH.
Investigators in the trial 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% of the over six million heart failure patients in the U.S. and account for nearly half of all heart failure hospitalizations.
The CardioMEMS’ device is implanted by catheter through the groin and into the pulmonary artery. Each day, patients lie on a pad in their home that uses radio frequency to collect information from the sensor. This information is then transmitted to a secure website where the physician can access it.
If blood pressure in the pulmonary artery is rising, physicians can take steps to correct the problem before a crisis emerges by adjusting the patient’s medication.
“We are extremely excited about the results of this trial. Typically we have to rely on patients reporting symptoms to alert us to a worsening of their condition and by that time it has often progressed to the point where hospitalization is necessary,” said Raymond Benza, MD, AGH’s lead researcher in the CHAMPION trial and Medical Director of the hospital’s Advanced Heart Failure, Transplantation, Mechanical Circulatory Support and Pulmonary Hypertension Program.
“This new device could revolutionize how we manage heart failure, greatly improving patient quality of life and helping reduce the enormous cost to the healthcare system associated with this complex disease,” Dr. Benza said.