Sanjeev K. Gulati

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure

Background In an early analysis of this trial, use of a magnetically levitated centrifugal continuous‐flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical‐bearing axial continuous‐flow pump, at 6 months in patients with advanced heart failure. Methods In a randomized noninferiority and superiority trial, we compared the centrifugal‐flow pump with the axial‐flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal‐flow pump group minus axial‐flow pump group) was ‐10 percentage points. Results Of 366 patients, 190 were assigned to the centrifugal‐flow pump group and 176 to the axial‐flow pump group. In the intention‐to‐treat 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 axial‐flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal‐flow pump group than in the axial‐flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal‐flow pump group than in the axial‐flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). Conclusions In patients with advanced heart failure, a fully magnetically levitated centrifugal‐flow pump was superior to a mechanical‐bearing axial‐flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)

Improving quality of life and decreasing readmissions in heart failure patients in a multidisciplinary transition-to-care clinic.

Objectives The purpose was to pilot the feasibility and impact of a 4‐week transition‐to‐care program on quality of life for heart failure patients. Background The transition from the acute care to the outpatient setting has been shown to be a critical time with heart failure patients. Methods A pre‐ and post‐test design was used. Quality of Life, measured by the Minnesota Living with Heart Failure Questionnaire, and hospital readmissions were the outcomes. A convenience sample of 50 persons was recruited into a multidisciplinary transition‐to‐care program for heart failure patients following hospitalization. Thirty‐six (72%) completed the study. Results There was a significant improvement in quality of life. Men reported greater improvement in physical symptoms and less emotional distress when compared to women. Only 2 participants were readmitted within 30 days. Conclusions Study findings support improved quality of life and decreased readmission rates following a multidisciplinary transition‐to care program for heart failure patients. HighlightsA transitional care program enhances quality of life and decreases readmissions.The needs of women with heart failure deserve additional attention.

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: 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:

Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients

37 685±4251 versus HMII:

Device Measured Physical Activity: Is It the New 6-Minute Hall Walk?

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.