Long-Term CHAMPION Data Published for St. Jude Medical's CardioMEMS HF System

November 9, 2015—St. Jude Medical, Inc. announced the publication of prospective data in The Lancet by Prof. William T. Abraham, MD, et al that further support the long-term effectiveness of the company’s CardioMEMS HF system at reducing heart failure (HF) hospitalizations for patients with New York Heart Association (NYHA) class 3 HF.

The CardioMEMS HF system uses a miniature wireless monitoring sensor implanted in the pulmonary artery to directly measure blood pressure and heart rate data. Patients can transmit this data from home to their health care providers, allowing providers to stabilize pulmonary artery pressure by managing the patient’s medications more effectively. The system has been shown to significantly reduce HF hospital admissions and improve the quality of life in NYHA class 3 patients, stated St. Jude Medical.

The CardioMEMS HF system was approved by the US Food and Drug Administration in May 2014, based on clinical data from the landmark CHAMPION clinical study, which had an average follow-up duration of 15 months. 

The newly published analysis shows that after moving from standard HF therapy to management based on information from the CardioMEMS HF system, patients from the study’s control group had a 48% reduction in HF hospitalizations. In addition, hospitalization rates continued to remain low in the treatment group during the open access period, demonstrating the durability of the effect of home hemodynamic monitoring. The data provide results over an extended time period, demonstrating the long-term benefit of hemodynamic monitoring in reducing heart failure hospitalization in these high-risk patients.

In the CHAMPION study, all patients were implanted with the CardioMEMS sensor at the beginning of the study. The treatment group was monitored with the CardioMEMS HF system throughout the study with an average of 31 months of follow-up. For the first 18 months, physicians treating patients in the control group were blind to the pulmonary artery pressure readings and did not take readings into account when determining their treatment plan. 

When physicians had access to the sensor readings for patients in the control group (open access period), they made patient management decisions based on pulmonary artery pressure data received from the CardioMEMS sensor, rather than decisions based on signs and symptoms of worsening HF. This portion of the study represented a “real-world” experience because—based on the protocol—the study sponsor no longer provided communication with the study centers.

In the company’s press release, Prof. Abraham commented, “Despite advances in medical care, a significant number of HF patients are readmitted to the hospital within a relatively short period of time, and every hospitalization is very traumatic for those patients and their families. The longitudinal analysis shows an important reduction in these admission rates when patients are monitored with the CardioMEMS HF system.” Prof. Abraham is Chief of Cardiovascular Medicine at The Ohio State University Wexner Medical Center in Columbus, Ohio.

The CHAMPION study originally demonstrated a statistically and clinically significant 28% reduction in the rate of HF hospitalizations at 6 months, and a 37% reduction in HF hospitalizations during an average follow-up duration of 15 months. These new long-term, prospective data further support the effectiveness of the CardioMEMS system at reducing HF hospitalizations by demonstrating that the system can provide physicians the opportunity to proactively manage their HF patients, stated St. Jude Medical.