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“If you had a drug that reduced rehospitalization rates it would be pretty clear how to proceed, but in this case it is not the device that reduces readmissions, it just gives you data and you need to act on the data,” Dr. Butler added. He acknowledged that the CHAMPION investigators used a relatively simple, straightforward management algorithm for patients whose PAP fell out of the target range, such as a diastolic PAP greater than 20 mm Hg or less than 8 mm Hg. The first management step is to raise or reduce the patient’s diuretic dosage, and if that fails to quickly normalize PAP the next step is to adjust the vasodilator dosage.
Managing patients in CHAMPION was “not totally an art” but neither was it “totally a science,” Dr. Butler said. Managing patients based on daily data collected using a CardioMEMS device will “require a little finesse,” he said. “It’s not straight science.”
Programs that have already used PAP monitoring on a routine basis, like those in Denver and at Brigham and Women’s, consider their experience too small in size and short in duration to draw any substantive conclusions regarding their success compared with the CHAMPION results. But Dr. Abraham, whose program has now placed CardioMEMS routinely in a few dozen patients and followed them for as long as a year, said that in his center’s patients the device and management system has produced outcomes that roughly match what he saw in the pivotal trial.
“The ongoing concern is that what was achieved in the CHAMPION trial may not be what is achieved in routine practice,” said Dr. Desai. The care that patients received in the trial is “a little of a black box,” he said, and during the FDA’s approval process some reviewers raised concerns that patients in the active-treatment arm simply received more intensive surveillance, although this concern eventually resolved. “There is not a lot of skepticism” among clinicians about this treatment, but there is uncertainly about exactly whom are the best patients to treat and whether their responses be as good as in CHAMPION, Dr. Desai said in an interview.
“The proof [of efficacy] will be in each individual center’s experience” using CardioMEMS, Dr. Altman said.
CHAMPION was initially funded by CardioMEMS, which then was acquired by St. Jude which is the company marketing the CardioMEMS device and associated hardware. Dr. Butler said that he had no current relevant disclosures, although in the past he had been a consultant to CardioMEMS (prior to its acquisition by St. Jude). Dr. Parks and Dr. Altman had no disclosures. Dr. Desai has been a consultant to and has received honoraria as a speaker on behalf of CardioMEMS and St. Jude. Dr. Abraham has been a consultant to CardioMEMS and St. Jude, was co-principal investigator on the CHAMPION trial, and is the principal investigator on a new St. Jude-funded trial studying CardioMEMS.
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