Health Care Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study: A Randomized Controlled Trial of a Magnetically Levitated Cardiac Pump in Advanced Heart Failure
Background: MOMENTUM 3 compares the centrifugal HeartMate 3 (HM3) to the axial HeartMate II (HMII) continuous-flow Left Ventricular Assist System (LVAS) 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 endpoint (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 two 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, pump exchange with a non-study device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device attributable and non-device attributable event costs), estimated 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 gender) were also assessed.
Results: In 366 randomized patients, 361 comprised the as-treated group (189 the HM3 and 172 the HMII), of whom 337 (177 the HM3 and 160 the HMII) 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), post-discharge HM3 arm costs were 51% lower than with the HMII (HM3: $37,685±4,251 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 re-hospitalizations, hospital days spent during rehospitalizations, and a significant cost saving following discharge when compared with the HMII LVAS, irrespective of the intended goal of therapy.
Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02224755.
- cost-benefit analysis
- health economics
- heart surgery
- ventricular assist device
- mechanical circulatory support
- Received May 3, 2018.
- Accepted May 21, 2018.