St Jude Medical has announced a new data analysis from the CHAMPION trial showing that heart failure patients with reduced ejection fraction on optimal doses of guideline directed medical therapy managed by pulmonary artery pressure monitoring with the CardioMEMS heart failure system had a 57% reduction in mortality and a 43% reduction in heart failure hospitalisations compared with patients on guideline directed medical therapy managed by the standard of care. These data show a strong improvement for patients managed by optimal guideline directed medical therapy and the CardioMEMS system in both mortality and hospitalisations over currently defined best practices.
The analysis looked at patients with heart failure and reduced ejection fraction over an average of 17 months who were on optimal guideline directed medical therapy and compared those managed by pulmonary artery pressure monitoring with the CardioMEMS system to those managed by standard of care. The CHAMPION trial retrospective analysis demonstrated that pulmonary artery pressure monitoring, in addition to guideline directed medical therapy, significantly reduced heart failure hospitalisations and mortality in patients with reduced ejection fraction.
This new retrospective data analysis was presented during the American College of Cardiology 64th Annual Scientific Sessions (14–16 March, San Diego, USA).
“For heart failure patients whose hearts do not contract effectively, the risk for hospitalisation and mortality is very high, even with appropriate evidence-based medical therapy. The findings from this analysis show us that use of the CardioMEMS system in addition to guideline directed medical therapy can significantly reduce hospital admissions for these heart failure patients and for the first time, we also see a significant improvement in survival,” said William Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center, USA, and presenter of these data.
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 this 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 and improve survival.
The CardioMEMS system is supported by clinical evidence, including data from the CHAMPION trial published in The Lancet. The CHAMPION trial evaluated the overall safety and effectiveness of the CardioMEMS system for New York Heart Association Class III heart failure patients who had been hospitalised for heart failure in the previous 12 months. The CHAMPION trial demonstrated a 37% reduction in hospitalisations during an average follow-up duration of 15 months.