Fewer HF Hospitalizations With CardioMEMS-Guided Med Management: Medicare Data

Larry Hand

March 20, 2017

WASHINGTON, DC — Medicare patients with heart failure who were implanted with the CardioMEMS pulmonary-artery (PA) pressure monitor (Abbott/St Jude Medical) over an 18-month period had fewer HF hospitalizations and showed a reduction in healthcare costs, according to an observational study[1].

"In this retrospective, Medicare claims-based analysis, cumulative HF hospitalizations were 45% lower in the 6 months following PA-pressure sensor implantation than in the 6 months before sensor implantation," Dr Akshay S Desai (Brigham and Women's Hospital, Boston, MA) said during his presentation of the study here at the American College of Cardiology (ACC) 2017 Scientific Sessions.

Dr Akshay Desai

The reduced reliance on healthcare resources translated into estimated mean cost savings of $13,190 after 1 year, Desai added. He is lead author on the study's publication in the Journal of the American College of Cardiology, which was released at about the time of his presentation.

A recent observational study based on 2000 patients demonstrated that HF management in clinical practice guided by readings from the sensor can lead to significant reductions in PA pressure. The reductions were consistent with those in the randomized CHAMPION trial on which the device's FDA approval was based. In that trial, HF management guided by the remote-monitoring device led to substantial reduction in heart-failure hospitalizations.

The FDA first turned down the device, as reported previously by heartwire from Medscape, but approved it after patients were monitored for an extended period. But the agency required postmarketing studies to show that the CHAMPION results could be repeated in clinical practice outside of a clinical trial. Abbott's postmarketing study is ongoing.

For now, however, the current analysis suggests that the outcomes achieved in CHAMPION can be replicated in clinical practice, according to the authors.

The group analyzed claims data from 1114 Medicare patients who were implanted with the device from 2014 to 2015 upon its first availability in the US; 480 had complete data for 12 months after implantation.

At the time of implantation, patient mean age was 71, with 40% of them at least 75; just over a third were women, 14% were black, and many carried a heavy burden of comorbidities, the group reported.

Overall there were 1899 hospitalizations from any cause, including 1020 for heart failure during the preimplantation period. In the 6 months after implantation, there were 1119 all-cause hospitalizations, 381 for heart failure, 17 ventricular-assist–device (VAD) implantations, and 139 deaths. Compared with 88% of HF patients hospitalized during the preimplantation period, 50% of patients were hospitalized during the 6 months after implantation.

Almost 60% of patients experienced at least one HF hospitalization preimplantation, compared with 22% afterward. The median number of HF hospitalizations per patient before implantation came to 0.92/patient–6-months, compared with 0.37/patient–6-months afterward.

The researchers found HF-hospitalization reductions were associated with estimated cost reductions of $7433/patient–6-months after implantation (95% CI $7000–$7884/patient–6- months; P<0.001). For all-cause hospitalizations, the hazard ratio during the period came to 0.69 (95% CI 0.64–0.75; P<0.001).

They found that healthcare costs decreased from $47,690 preimplantation to $34,500 for the 1-year period postimplantation, for a $13,190 decrease.

"These data from an unselected population support the 'real-world' effectiveness of this approach to heart-failure management," Desai said at the presentation.

In an accompanying editorial[2], Dr Harlan M Krumholz (Yale University School of Medicine, New Haven, CT) and Dr Sanket S Dhruva (Veterans Affairs Connecticut Healthcare System, West Haven) call for caution in interpreting the results of the study.

They first point out that, among other issues, the study is observational and so lacks a control group and that the database from which information was drawn does not sufficiently describe patient characteristics. And they noted that the CardioMEMS device is not part of the ACC/AHA Guidelines.

"This paper responds to the great need for evidence about CardioMEMS but unfortunately does not have the evidentiary strength to inform clinical decisions," they write.

"The low adoption of the device may be a signal to the manufacturer that the initial industry-sponsored and potentially biased study is insufficient to fundamentally shift practice. There is a need for additional independent trials—and more detailed observational studies—to fill the gaps in knowledge that remain."

Speaking with heartwire , Desai said, "There is no question that these are observational data. Correlation is not causation." All that is certain, he said, "is that, for this cohort of patients, the hospitalization rates were lower in the period after implant, as opposed to before. To draw the conclusion that that reduction is specifically related to the effect of hemodynamic monitoring is a stretch.

"There are other potential explanations," he added. "It might be that there are other enhancements to disease management postimplant. It might be that there were medication changes in the period after that would account for that. We can't account for medication changes, and we can't account for other changes in clinical care.

"That said, these observational data are at least reassuring and support the observations from the [CHAMPION] clinical trial," he concluded.

Desai reports receiving honoraria for consulting for St Jude Medical, which recently became Abbott; the company funded the study. Disclosures for the coauthors are listed in the paper. Krumholz reports research support through Yale from Medtronic and Johnson & Johnson. Dhruva has no relevant financial relationships.

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