By Van Selby, MD
Assistant Professor of Medicine, University of California, San Francisco Cardiology Division, Advanced Heart Failure Section
Dr. Selby reports no financial relationships relevant to this field of study.
SYNOPSIS: In a retrospective study of Medicare claims data, use of the CardioMEMS implantable pulmonary artery pressure sensor was associated with reductions in both heart failure hospitalizations and comprehensive heart failure costs.
SOURCE: Desai AS, Bhimaraj A, Bharmi R, et al. Reduction in heart failure hospitalizations with ambulatory hemodynamic monitoring seen in clinical trials is maintained in the ‘real world.’ J Am Coll Cardiol 2017. pii: S0735-1097(17)35978-8. doi: 10.1016/j.jacc.2017.03.009. [Epub ahead of print].
The CHAMPION trial demonstrated that an implantable pulmonary artery pressure (PAP) sensor (CardioMEMS) reduced heart failure (HF) hospitalizations in patients with New York Heart Association (NYHA) functional class III chronic HF and a history of hospitalization for HF. Based on these data, the FDA approved the CardioMEMS device in 2014. However, it is unknown whether the HF hospitalization reduction observed in CHAMPION extends to non-trial, “real-world” HF patients.
Desai et al conducted a retrospective cohort study using Medicare claims data from patients who underwent CardioMEMS implantation between June 1, 2014, and Dec. 31, 2015. To evaluate the effectiveness of CardioMEMS, they compared rates of HF hospitalization during the six months before and after implantation in all patients with available data. Comprehensive HF-related costs were a secondary outcome.
A total of 1,114 implanted patients were included in the analysis. There were 1,020 HF hospitalizations in the six months before implantation, compared to 381 during the six months after implantation (hazard ratio [HR], 0.55; P < 0.001). All-cause hospitalizations also were reduced in the post-implantation period (HR, 0.69; P < 0.001). The findings were similar when the analysis was extended to 12 months pre- and post-implant in the subset of 480 patients with data available (HR, 0.66; P < 0.001). The reduction in HF hospitalizations resulted in a comprehensive HF cost reduction of $7,433 per patient at six months and $13,190 per patient at one year. The authors concluded that use of ambulatory hemodynamic monitoring in clinical practice reduces both HF hospitalizations and comprehensive HF costs, supporting the “real-world” effectiveness of this therapy for HF management.
COMMENTARY
Most HF hospitalizations are preceded by a progressive rise in cardiac filling pressures. The CHAMPION trial demonstrated that remote hemodynamic monitoring using a PAP sensor can identify these changes early, often before the onset of symptoms or weight gain. This allowed targeted interventions to treat the rising filling pressures, and ultimately resulted in reduced HF hospitalizations. Although the device was approved by the FDA, there were concerns regarding the conduct of the trial and the applicability of these findings outside the tightly controlled environment of a clinical trial. A subsequent study showed that remote hemodynamic monitoring effectively lowers PAP in non-trial, “real-world” patients. Desai et al used Medicare claims data to show this is associated with an improvement in relevant clinical endpoints as well.
The 45% observed reduction in HF hospitalizations at six months is impressive, and actually greater than the 28% reduction seen over six months in CHAMPION. This fits with the previous observation that patients implanted with CardioMEMS outside the trial setting experienced greater reductions in PAP than those implanted during the CHAMPION trial. The reduction in all-cause hospitalizations also is noteworthy, demonstrating the reduction in HF hospitalizations is not offset by an increase in non-HF hospitalizations.
The data regarding comprehensive HF-related costs suggest the true cost-effectiveness of CardioMEMS may be even more favorable than estimates based on the CHAMPION data. Using an average Medicare reimbursement of $23,122 for CardioMEMS, the authors calculated it would take approximately two years to recoup the initial cost of implantation.
When interpreting these findings, there are several important limitations to keep in mind. This was an observational study without a true control group. Essentially, patients served as their own control in this pre/post-analysis. It is possible that other interventions were implemented around the same time as CardioMEMS implantation as part of a comprehensive HF management program. Perhaps it is just closer follow-up, rather than the availability of hemodynamic data, that reduces hospitalizations. Second, of all Medicare patients hospitalized for HF during the study period, only 1,114 received CardioMEMS. Even this “real-world” cohort may be highly selected, and we must use caution when generalizing to the broader HF population.
When taking these limitations into consideration, the results reported by Desai et al may overestimate the benefit associated with CardioMEMS in the real world. That said, the evidence of reductions in both PAP and hospitalizations continues to grow, and CardioMEMS certainly is a reasonable option for patients with class III heart failure and recent hospitalization. The CardioMEMS system received a class IIB recommendation in the 2016 European Society of Cardiology heart failure guidelines (usefulness/efficacy is less well established by evidence/opinion), but there currently is no recommendation in American guidelines. Given the limitations of the current study, it is not clear whether this will change any time soon. Further clinical trials and an ongoing CardioMEMS postmarketing registry hopefully will provide further insights into the real-world benefit, safety, and optimal use of CardioMEMS.
In a retrospective study of Medicare claims data, use of the CardioMEMS implantable pulmonary artery pressure sensor was associated with reductions in both heart failure hospitalizations and comprehensive heart failure costs.
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