Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study

Abstract

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.

Using left ventricular assist devices in advanced heart failure patients

“…This improvement in outcome was due to a lower rate of reoperation for pump malfunction. Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (P < 0.001) [9]. However, there were no significant differences in the rates of disabling stroke or death.…”

“…In conclusion, a fully magnetically levitated centrifugal-flow pump was superior to a mechanicalbearing axial-flow pump with regard to survival free from disabling stroke or re-operation to replace or remove a malfunctioning device in patients with AHF, demonstrating a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost-savings following discharge [9]. However, while advances in technologies have helped elucidate many aspects of these diseases, many questions remain unanswered.…”

“…As a result, LVADs strengthen peripheral circulation, alleviate end-organ dysfunction, reduce heart failure symptoms, and improve quality of life [7,8] 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. The primary end point, a composite of survival free of disabling stroke or reoperation to remove or replace a malfunctioning device, occurred significantly more often among patients who received the HeartMate 3 (centrifugal-flow) than among those who received the HeartMate II (axial-flow) [9]. In the intention-totreat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal flow pump group, as compared with 106 (60.2%) in the axialflow pump group [P < 0.001 for noninferiority]; [P < 0.001 for superiority]) [9].…”

“…The primary end point, a composite of survival free of disabling stroke or reoperation to remove or replace a malfunctioning device, occurred significantly more often among patients who received the HeartMate 3 (centrifugal-flow) than among those who received the HeartMate II (axial-flow) [9]. In the intention-totreat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal flow pump group, as compared with 106 (60.2%) in the axialflow pump group [P < 0.001 for noninferiority]; [P < 0.001 for superiority]) [9]. This improvement in outcome was due to a lower rate of reoperation for pump malfunction.…”

“…However, there were no significant differences in the rates of disabling stroke or death. The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the HeartMate 3 group than in the HeartMate II group (10.1% vs. 19.2%; P = 0.02) [9]. Patients were regarded as having a 'disabling stroke' if their National Institutes of Health Stroke Scale (NIHSS) score was greater than 5 [10].…”