A model-based study found that patients with chronic heart failure who used the CardioMEMS device had reductions in hospitalizations and increases in quality-adjusted life-years (QALYs) and costs.
Based on the analysis, the CardioMEMS device (St. Jude Medical) had a cost per QALY gained of $82,301 in patients with reduced ejection fraction and $47,768 in patients with preserved ejection fraction.
Lead researcher Alexander T. Sandhu, MD, of Stanford University, and colleagues published their results online in the Journal of the American College of Cardiology: Heart Failure on Feb. 10.
In May 2014, the FDA approved the CardioMEMS device, which includes a small wireless sensor and portable electronic transmitter, to allow patients to wirelessly transmit pulmonary artery pressure readings to an online database.
The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial found that patients who received the CardioMEMS device had fewer hospitalizations for heart failure and an improved quality of life. However, the researchers noted that the device is expensive and has a list price of $17,750 for Medicare patients.
In this analysis, the researchers developed a Markov model based on data from the CHAMPION trial. The patients had New York Heart Association functional class III heart failure and had a mean age of 62 years. Of the patients, 21.7 percent had preserved ejection fraction and 78.3 percent had reduced ejection fraction.
The model assumed all patients had a CardioMEMS device implanted. Afterward, patients could have hospitalizations for heart failure, hospitalizations not related to heart failure, device complications and all-cause mortality. The researchers matched the mortality rates for 17 months, which was the mean duration of the control group in the CHAMPION trial.
Compared with the control group, patients who received the CardioMEMS device had fewer lifetime hospitalizations (2.18 vs. 3.12) but more QALYs (2.74 vs. 2.46) and higher costs ($176,648 vs. $156,569).
The device clocks in at less than $50,000 per QALY gained—the oft-cited threshold for cost-effectiveness in health policy discussion—if it costs less than $9,798 in patients with reduced ejection fraction and less than $18,657 in patients with preserved ejection fraction. The price per QALY exceeds $150,000 if the device costs more than $34,418 in patients with reduced ejection fraction and more than $59,296 for patients with preserved ejection fraction.
The researchers noted the CardioMEMS device costs $62,121 per QALY gained in a large, urban, public teaching hospital with a higher predicted cost of hospitalization ($16,750) and costs $82,169 per QALY gained in a small, rural, private nonteaching hospital with lower predicted costs of hospitalization ($8,341).
The study had a few limitations, according to the researchers, including that the CHAMPION trial was the only study to evaluate the device and that the model may not have captured all of the device’s treatment benefits. They also mentioned that long-term safety data was not available and the average national cost of the device’s monitoring program was not known.
“This analysis shows that the use of the CardioMEMS device is a cost-effective means of improving quality of life and reducing rehospitalizations in patients with heart failure,” the researchers wrote. “It is a better value in patients with preserved ejection fraction, a group with few effective therapies. The cost-effectiveness of CardioMEMS is most sensitive to the duration of effectiveness; therefore, further research on the continued hospitalization trends of patients with the device will be important for future evaluations.”