ACC.17: Medicare beneficiaries implanted with CardioMEMS system have lower rate of heart failure hospitalizations

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 - CardioMEMS
The FDA approved CardioMEMS in 2014 for monitoring heart failure patients.
Source: St. Jude Medical

Medicare beneficiaries who received an implantable pulmonary artery pressure (PAP) sensor had a statistically significant 45 percent lower rate of heart failure hospitalizations and reduced costs at six months, according to a retrospective cohort study.

All of the patients were implanted with the CardioMEMS heart failure system, a miniaturized implantable system for monitoring patients with heart failure that the FDA approved in May 2014.

Lead researcher Akshay S. Desai, MD, MPH, of Brigham and Women’s Hospital in Boston, presented results of the study in a featured clinical research session at the ACC scientific session on March 19 in Washington, D.C.

The findings were simultaneously published in the Journal of the American College of Cardiology. Abbott, which markets the CardioMEMS heart failure system, funded the study.

“These results support the clinical effectiveness and potential cost savings of using an implantable hemodynamic monitor to help with heart failure management,” Desai said in a news release. “Reducing heart failure hospitalizations is an important goal for patients and hospitals alike, and may help to improve long-term clinical outcomes and quality of life for our patients.”

The researchers noted that the CHAMPION trial previously found that patients who received the CardioMEMS system had a significant reduction in heart failure hospitalizations compared with patients who received usual care.

In this study, the researchers examined administrative claims data from CMS and identified 1,114 patients who were implanted with the CardioMEMS system from June 1, 2014 through 2015.

All of the patients had continuous, fee-for-service Medicare insurance for at least six months before and after implantation. Of those patients, 480 had data available 12 months before and after implantation.

The mean age was 71 years old, and 36 percent of patients were women and 14 percent were black. A large percentage of patients had diabetes, hypertension and chronic obstructive pulmonary disease. In addition, 74.7 percent of the implants occurred in the ambulatory setting.

The researchers found there were 1,899 all-cause hospitalizations and 1,020 heart failure hospitalizations in the six months before implantation. Meanwhile, there were 1,119 all-cause hospitalizations, 381 heart failure hospitalizations, 17 ventricular assist device or transplants and 139 deaths in the six months.

In addition, 59 percent of patients had at least one heart failure hospitalization before the implant and 22 percent had at least one heart failure hospitalization in the six months after implantation. The researchers noted that the cumulative incidence of heart failure hospitalization was 45 percent lower following device implantation and was consistent in subgroups based on age, sex, Medicare contractors and outpatient implants.

The reductions in heart failure hospitalizations were associated with a mean $7,433 per patient reduction in costs related to heart failure care in the period following implantation compared with the period before implantation. There was also a 31 percent reduction in all-cause hospitalizations in the six months after implantation.

Among the 480 patients who had 12-month data, there were 1,387 all-cause hospitalizations and 696 heart failure hospitalizations in the 12 months before implantation compared with 859 all-cause hospitalizations, 300 heart failure hospitalizations, 15 ventricular assist device or transplants and 106 deaths in the 12 months after implantation. The cumulative incidence of heart failure hospitalizations was 34 percent lower in the 12 months following implantation compared with the 12 months before implantation.

During the 12 months after implantation, there was an estimated $11,260 per patient reduction in comprehensive heart failure costs compared with the pre-implant period. In addition, there was a 23 percent reduction in all-cause hospitalizations in the 12 months after implantation.

The researchers cited a few limitations of the study, including that they used Medicare claims data and had no information on medical history, ejection fraction, indication for PAP sensor implantation, quality of life and device safety. They also mentioned there was no clinical event adjudication, and they could not account for personnel costs associated with remote management. In addition, they could not rule out the possibility of selection bias or enhancements of heart failure disease management in the period after device implant could have confounded the results.

“These data from the ‘real world’ experience of Medicare implants of PAP sensors during the period following CardioMEMS device approval support the efficacy of ambulatory hemodynamic monitoring in reducing [heart failure] hospitalization and overall costs associated with [heart failure] care,” the researchers wrote. “In tandem with data suggesting effective reductions in [pulmonary artery] pressures among general use patients implanted with the CardioMEMS [heart failure] system since FDA approval, these observations support the generalizability of the CHAMPION trial results to clinical practice and argue for clinical effectiveness of ambulatory hemodynamic monitoring as a strategy for heart failure management.”