By Van Selby, MD
Assistant Professor of Medicine, UCSF Cardiology Division, Advanced Heart Failure Section, San Francisco
Dr. Selby reports no financial relationships relevant to this field of study.
SYNOPSIS: Remote pulmonary artery pressure monitoring in NYHA class III heart failure patients resulted in fewer subsequent hospitalizations and was well tolerated.
SOURCE: Abraham WT, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomized trial. Lancet 2015 Nov 6 pii: S0140-6736(15)00723-0. doi: 10.1016/S0140-6736(15)00723-0. [Epub ahead of print].
Remote hemodynamic monitoring is a novel strategy for treating chronic heart failure (HF). The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association (NYHA) Class III Heart Failure Patients (CHAMPION) trial enrolled 550 patients with class III heart failure and at least one HF hospitalization in the previous year. Most the patients had a reduced left ventricular ejection fraction and about 20% had an ejection fraction > 40%. All patients had a wireless pulmonary artery pressure sensor (CardioMEMS) implanted. Of those implanted, 270 patients were randomized to CardioMEMS-guided management while the other 280 were randomized to standard guideline-based therapy, with treating clinicians blinded to the hemodynamic data. After 6 months of follow-up, there was a 33% reduction in HF hospitalizations among patients randomized to CardioMEMS-guided therapy.
Following the 6-month randomization period, the remaining 347 patients were transitioned to a 13-month open-access period. During this time, hemodynamic data became available to the treating clinician for all patients, and there was no communication with the study sponsor related to patient management.
During the open-access period, the CardioMEMS-guided therapy group experienced a 48% reduction in the rate of HF hospitalization (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.40-0.69; P < 0.0001) and a 47% decreased risk of death or first HF hospitalization (HR, 0.53; 95% CI, 0.38-0.73; P < 0.0001). Among patients originally randomized to guideline-based management alone, making hemodynamic data available to the treating clinician was associated with a similar 48% reduction in HF hospitalizations (P < 0.0001). The CardioMEMS-guided strategy was also associated with improvements in quality of life scores.
There were eight device-related or system-related complications and seven procedure-related adverse events, all occurring within the original 6-month period. No sensor failures occurred over an average 31 months of follow-up. The authors concluded that management of functional class III heart failure using home transmission of pulmonary artery pressure measurements has significant long-term benefit in reducing hospital admission rates.
Based on the results of the CHAMPION trial randomization period, the FDA approved the CardioMEMS device in May 2014 for patients with NYHA class III HF and at least one HF hospitalization in the previous year. At the time, the CHAMPION trial was criticized for communication between the study sponsor and individual sites regarding management of patients in the treatment group. To better evaluate the effects of remote hemodynamic monitoring in the “real world,” there was no communication between the sponsor and the treating clinicians during the open-access period reported in this follow-up publication. Although a clinical trial cannot perfectly reproduce real-world clinical care, these findings provide strong evidence that using an implantable hemodynamic monitor to guide therapy leads to a sustained reduction in HF hospitalizations. The magnitude of the reduction observed in CHAMPION is greater than what has been reported for nearly any other HF treatment available today.
For providers considering the CardioMEMS device for a patient, it is important to understand the reality of managing patients post-implant. Remote monitoring generates substantial new patient data. Providers and office staff must be ready to receive these data, use the information to make medication adjustments, and communicate these changes to patients, all in a timely manner. Patients who receive hemodynamic-guided therapy have better outcomes, in part, because knowledge of hemodynamic data leads to more frequent adjustments (during the initial randomization period, patients in the CardioMEMS group had more than twice as many HF medication adjustments compared to those in the medical-therapy arm). As remote monitoring becomes more widespread, healthcare payers will need to determine how best to reimburse for this extra workload. Patient selection is equally important. The successful use of the technology requires that patients transmit pressure measurements regularly and adhere to the recommended medication adjustments.
The additional information from this open access extension period strengthens the evidence supporting remote hemodynamic monitoring for patients with NYHA class III HF and a recent HF hospitalization, and suggests this technology can be successfully used in real world clinical practice. Importantly, the CardioMEMS device is effective regardless of ejection fraction, making it one of the few interventions with proven efficacy in HF with preserved ejection fraction. With careful patient selection and a clear plan for ongoing patient follow-up, remote hemodynamic monitoring is a promising option for patients with HF and prior hospitalizations.