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In an era when rehospitalization of patients with heart failure for episodes of acute decompensation has become a top target for reduction in the U.S. health care system via Medicare’s Readmissions Reduction Program CardioMEMS looks like the tool that every U.S. health care system and medical center has dreamed of having.
A wireless and battery-less implanted device, CardioMEMS guides management of stage III heart failure patients by allowing daily monitoring of patients’ pulmonary-artery pressure (PAP). Using these measures to fine-tune patient treatment with diuretics and vasodilators led to a statistically significant and clinically meaningful 37% relative reduction in heart failure rehospitalizations over an average 15-month follow-up, based on results from CardioMEMS’ pivotal U.S. trial as well as from subsequent secondary analyses. All-cause mortality was reduced and patients’ quality of life improved. And device-driven therapy yielded these benefits equally well in patients with either preserved or reduced left ventricular function as well as in a variety of other subgroups including patients with cardiac resynchronization devices or implantable cardioverter defibrillators, chronic obstructive pulmonary disease, chronic kidney disease, atrial fibrillation, pulmonary hypertension, or a history of myocardial infarction.
Yet in the first year after CardioMEMS received Food and Drug Administration approval and came onto the U.S. market, the device has taken a strikingly slow path into routine heart failure practice, according to heart failure cardiologists at several U.S. centers. A representative of St. Jude, the company that markets CardioMEMS, saidin July that sales of the device during the first half of 2015 had involved more than 200 U.S. customers and slightly surpassed earlier expectations, and the company now anticipated full 2015 sales to run roughly 25% ahead of projections made at the start of this year. Despite that, the company’s second quarter report acknowledged the challenges that CardioMEMS faced during its first year on the U.S. market.
Numbers show a slow rollout
“I belong to a consortium of academic heart failure physicians who come from many of the major U.S. academic medical centers, and a recent straw poll of the members showed that close to no one was using it [CardioMEMS] on a regular basis, and the majority said they were not yet using it at all or in the process of starting their program,” said Dr. Javed Butler, a heart failure specialist who is professor of medicine, chief of cardiology, and codirector of the Stony Brook (N.Y.) University Heart Center.
Dr. Javed Butler
At Stony Brook, no heart failure patient had received the device as of July 2015, although Dr. Butler said that his program’s use of CardioMEMS will probably start soon. Cardiologists at a handful of other U.S. centers report similarly slow starts.
At Massachusetts General Hospital (MGH) in Boston not a single patient has received CardioMEMS, though the heart failure staff there hopes to soon launch pilot use in 10 patients, said Dr. Kimberly A. Parks, associate director of the resynchronization and advanced cardiac therapeutics program. At the University of Colorado Hospital in Aurora, three patients have received the device since their first implant in the late winter, and the program is now on track to place devices in another one or two patients each month, said Dr. Natasha L. Altman, a cardiologist who heads the center’s CardioMEMS program. At Brigham and Women’s Hospital in Boston, which participated in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) pivotal trial that led to CardioMEMS approval, so far a “handful, fewer than 10 patients” received the device since marketing began, said Dr. Akshay S. Desai, associate director of Brigham Cardiovascular Consultants. Even at Ohio State’s Wexner Medical Center in Columbus, the program run by Dr. William T. Abraham, coprincipal investigator for CHAMPION, a relatively modest number of roughly 50 patients had received CardioMEMS in routine practice since the first patient received a device there in June 2014 following the FDA’s approval, Dr. Abraham said in an interview.
Dr. Kimberly A. Parks
Contrasting with this level of use is the substantial number of patients who meet the CHAMPION enrollment criteria of New York Heart Association class III heart failure and a heart failure hospitalization within the prior year. Experts estimate that throughout the United States this group must number at least a half-million patients, and at the level of individual medical centers that provide advanced heart failure care, the numbers likely reach several hundred patients at each site.
Several challenges slow CardioMEMS implantation
Why such a slow start for what seems to be such an attractive device that clinicians uniformly praise for having a strong evidence base in CHAMPION and a compelling medical rationale? The answer seems multifactorial, including the need to convince skeptical hospital administrators and insurance payers to provide and pay for the device and follow-up care, a requirement to ramp up the patient-monitoring and management infrastructure, and the challenge of transitioning a relatively complex therapeutic formula from a successful clinical trial model into routine care.