The FDA approved the CardioMEMS system in 2014, three years after an FDA panel voted against the device’s approval. Since then, two trials have estimated the cost-effectiveness of the system, which is indicated to monitor patients with heart failure.

Two prominent cardiologists, however, argue that determining whether the CardioMEMS is effective is of more pressing concern than figuring out if it’s cost-effective.

Sanket S. Dhruva, MD, and Harlan M. Krumholz, MD, SM, of the Yale School of Medicine in New Haven, Conn., expressed their opinion in an editorial in the Journal of the American College of Cardiology: Heart Failure on May 1.

“Important uncertainties remain about the ability of the CardioMEMS device to reduce [heart failure]-related hospitalizations, improve quality of life, and decrease mortality,” they wrote.  

The authors noted that the multicenter, single-blind CHAMPION trial found that patients who were implanted with the CardioMEMS device and had pulmonary artery pressure targets and treatment algorithms had a statistically significant 12 percent absolute reduction in heart-failure related hospitalizations up to six months. Patients in the other group were implanted with the CardioMEMS device and received routine care.

The study enrolled 550 patients with New York Heart Association (NYHA) class III heart failure who were hospitalized for heart failure at least once in the past year.

Dhruva and Krumholz wrote that the CardioMEMS device (St. Jude Medical) has a list price of approximately $17,750 as well as a device management fee of $68 per month. In 2016, St. Jude Medical expects $65 million in sales, according to the authors. They also mentioned that the company plans on applying for a Medicare national coverage determination this year, which could lead to increased sales in the coming years. In April, Abbott agreed to acquire St. Jude Medical for approximately $25 billion.

“Given the large eligible population of hospitalized NYHA functional class III patients, the device could lead to enormous societal costs,” Dhruva and Krumholz wrote.

The authors cited three cost-effectiveness analyses of the CardioMEMS device. The first group, which included company employees, calculated a cost of $13,979 per quality-adjusted life-year (QALY) gained. In December 2015, the Institute for Clinical and Economic Review found a cost of $57,933 per QALY gained.

Most recently, researchers examined 17-month follow-up data from the CHAMPION trial and found the CardioMEMS device had a cost of $71,462 per QALY gained.

“Confidence in the value of CardioMEMS, however, depends on assumptions regarding the device’s effectiveness, which has been questioned,” Dhruva and Krumholz wrote. “Sensitivity analyses allow one to vary assumptions regarding effectiveness, but if there is no effectiveness, there is no need to calculate cost-effectiveness.”

The authors said St. Jude Medical is conducting a 1,200-patient, post-marketing, observational cohort study with an estimated completion date of June 2020, which they said would not determine whether the CardioMEMS device reduces heart failure-related hospitalizations, improves quality of life and decreases mortality. No other studies are planned to evaluate the CardioMEMS device.

“We believe that a prospective, randomized trial free of sponsor contact with individual study investigators is required to identify, with more certainty, what the device can do,” Dhruva and Krumholz wrote. “Until then, any cost-effectiveness calculations are only helpful in showing what the value would be if we knew that the device had benefit. Conviction in CardioMEMS’ cost-effectiveness requires conviction in its effectiveness.”