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Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study
Mandeep R Mehra1, Christopher Salerno2, Joseph C Cleveland3
1Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.R.M.).
Insights
The HeartMate 3 (HM3) left ventricular assist system led to fewer hospitalizations and significant cost savings compared to the HeartMate II (HMII) in advanced heart failure patients. This economic analysis shows HM3
Area of Science:
- Cardiovascular Medicine
- Health Economics
- Medical Device Technology
Background:
- The MOMENTUM 3 trial compared the centrifugal HeartMate 3 (HM3) and axial HeartMate II (HMII) continuous-flow left ventricular assist systems.
- The HM3 demonstrated superiority in the primary endpoint of survival free of disabling stroke or reoperation at 2 years.
Purpose of the Study:
- To evaluate the health resource utilization and economic implications of the HM3 versus HMII.
- To assess cost differences between the two devices in patients with advanced heart failure.
Main Methods:
- Analysis of hospitalizations and associated costs post-discharge until censoring.
- Calculation of device-attributable and non-device-attributable costs using trial data and claims databases.
- Stratified cost savings analysis based on subgroups.
Main Results:
- The HM3 arm had fewer hospitalizations (2.1 vs. 2.7 per patient-year) and hospital days (17.1 vs. 25.5 per patient-year) compared to HMII.
- Significant reductions in pump thrombosis (0.6% vs. 12.5%) and stroke (2.8% vs. 11.3%) were observed with HM3.
- Post-discharge costs were 51% lower for HM3 ($37,685) versus HMII ($76,599) per patient-year.
Conclusions:
- The HM3 left ventricular assist system resulted in reduced rehospitalizations and significant cost savings post-discharge compared to the HMII.
- These economic benefits were consistent regardless of the intended therapy goal (bridge to transplant or destination therapy).
Background:
The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial's 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial.
Methods:
We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non-device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed.
Results:
In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P=0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P=0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P<0.001) and stroke (HM3: 2.8% versus HMII: 11.3%; P=0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P<0.001) and similar in either bridge to transplant or destination therapy intent.
Conclusions:
In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy.
Clinical Trial Registration:
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.
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