St Jude Medical has announced a new data analysis from the CHAMPION clinical trial-in a subgroup of patients with renal failure-that showed reduced heart failure hospitalisation by 42% for patients managed with pulmonary artery pressure based technology compared to a control group. Renal function was not adversely affected.
The CHAMPION trial looked at the safety and effectiveness of the CardioMEMS HF System for patients with New York Heart Association (NYHA) Class III heart failure who had been hospitalised for heart failure in the previous 12 months.
The subgroup data analysis of 297 patients followed for 18 months, presented during the Heart Failure Society of America (HFSA) 18th annual scientific meeting (14–17 September, Las Vegas, USA) looked at the potential benefit for patients with NYHA Class III hear failure and chronic kidney disease using the CardioMEMS system to measure pulmonary artery pressure without adversely affecting renal function.
These data show that management based on pulmonary artery pressure reduced heart failure hospitalisation in this patient population by 42% compared to the control group and did not adversely affect renal function.
The CardioMEMS system uses a miniaturised, wireless monitoring sensor that is implanted in the pulmonary artery during a minimally invasive procedure to directly measure pulmonary artery pressure. Measuring pulmonary artery pressure allows clinicians to proactively manage treatment for patients with worsening heart failure before visible symptoms, such as weight and blood pressure changes, occur. The system allows patients to transmit pulmonary artery pressure data from their homes to their health care providers, who then manage appropriate medication changes to reduce the likelihood of hospitalisation.
“Patients who have heart failure often also suffer from chronic kidney disease and the worry is that medical therapies to avoid hospitalisation will adversely affect renal function,” said William Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center, Columbus, USA, and primary investigator for the CHAMPION trial. “Our goal in analysing this group of patients was to demonstrate that monitoring pulmonary artery pressure with the CardioMEMS HF System can reduce hospitalisations without adversely affecting renal function and the data shows this to be true.”
The Center for Disease Control and Prevention reports that more than five million Americans suffer from heart failure with 670,000 new cases diagnosed each year. Roughly 1.4 million patients in the USA have NYHA Class III heart failure, and historically these patients account for nearly half of all heart failure hospitalisations. According to the American Heart Association, the estimated direct and indirect cost of heart failure in the USA for 2012 was US$31 billion and that number is expected to more than double by 2030.
The CardioMEMS HF System was approved by the US Food and Drug Administration (FDA) in May 2014.