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

Mehra, Mandeep R.; Goldstein, Daniel J.; Uriel, Nir; Cleveland, Joseph C.; Yuzefpolskaya, M.; Salerno, Christopher T.; Walsh, Mary Norine; Milano, Carmelo A.; Patel, Chetan B.; Ewald, Gregory A.; Itoh, Akinobu; Dean, David A.; Krishnamoorthy, Arun; Cotts, William; Tatooles, Antone; Jorde, Ulrich P.; Bruckner, Brian A.; Estep, Jerry D.; Jeevanandam, Valluvan; Sayer, Gabriel; Horstmanshof, Douglas; Long, James W.; Gulati, Sanjeev; Skipper, Eric; O’Connell, John B.; Heatley, Gerald J.; Sood, Poornima; Naka, Yoshifumi

doi:10.1056/nejmoa1800866

Cited by 623 publications

(491 citation statements)

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“…The first 2 analyses have been reported, and the final analysis is expected to be reported in 2019. 9,10 The trial also prespecified the collection of health resource use data by use of hospital billing information provided prospectively by centers. All patients (or their authorized representatives) provided written informed consent, and each institutional ethics review board approved the trial conduct.…”

Section: Methodsmentioning

confidence: 99%

“…Outflow graft twist is a known complication after HM3 placement, and was previously reported in the pivotal trial. 10 The Food and Drug Administration terminology for a Field Safety Corrective Action is Recall, which was issued as a Class I Recall (reasonable probability that the use of, or exposure to a product can cause serious adverse health consequences or death). The Food and Drug Administration did not recommend the return of products or avoidance of using the product with new patients.…”

Section: Original Research Articlementioning

confidence: 99%

“…[4][5][6][7][8] The HeartMate 3 (HM3), a fully magnetically levitated LVAS, has demonstrated its clinical superiority in comparison with the axial flow HeartMate II (HMII) pump in the short term (at 6 months), and in the long term (at 2 years), in the pivotal MOMENTUM 3 trial. 9,10 This study, a randomized comparative effectiveness investigation of these 2 pumps, reported that the HM3 LVAS was superior in meeting its primary end point of survival free of a disabling stroke or the need for reoperation to replace or remove a malfunctioning device (hazard ratio, 0.46; 95% confidence interval, 0.31-0.69 [P<0.001 for superiority]). 10 These benefits were driven by the absence of need for pump exchanges because of pump thrombosis and, importantly, a halving of overall stroke rates with the HM3 pump (hazard ratio, 0.47; 95% confidence interval, 0.27-0.84; P=0.02), suggesting greater hemocompatibility between the patient and the device interface with this LVAS.…”

mentioning

confidence: 99%

“…9,10 This study, a randomized comparative effectiveness investigation of these 2 pumps, reported that the HM3 LVAS was superior in meeting its primary end point of survival free of a disabling stroke or the need for reoperation to replace or remove a malfunctioning device (hazard ratio, 0.46; 95% confidence interval, 0.31-0.69 [P<0.001 for superiority]). 10 These benefits were driven by the absence of need for pump exchanges because of pump thrombosis and, importantly, a halving of overall stroke rates with the HM3 pump (hazard ratio, 0.47; 95% confidence interval, 0.27-0.84; P=0.02), suggesting greater hemocompatibility between the patient and the device interface with this LVAS. Whether these clinical findings also translate into benefits in the domain of medical resource use (principally adverse event-driven hospitalizations) and cost of care remains unknown.…”

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confidence: 99%

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

et al. 2018

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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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Section: Methodsmentioning

confidence: 99%

Section: Original Research Articlementioning

confidence: 99%

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confidence: 99%

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“…In an extended population of 366 patients followed to 2 years, the primary endpoint occurred in 151 of 190 patients in the centrifugal-flow pump group and 106 of 176 patients in the axial-flow pump group (absolute difference, 19%, 95% lower confidence boundary 10%; p<0.001 for non-inferiority; HR 0.46, 95% CI 0.31 to 0.69; p<0.001 for superiority). Although this difference was driven by pump reoperation rates, the overall rate of stroke was also significantly lower among patients assigned to the centrifugal-flow pump 52. Furthermore, the use of HeartMate 3 appeared to be cost-effective 53…”

Section: Introductionmentioning

confidence: 99%

Nine contemporary therapeutic directions in heart failure

et al. 2019

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The global burden of heart failure has continued to increase dramatically with 26 million people affected and an estimated health expenditure of $31 billion worldwide. Several practice-influencing studies were reported recently, bringing advances along many frontiers in heart failure, particularly heart failure with reduced ejection fraction. In this article, we discuss nine distinct therapeutic areas that were significantly influenced by this scientific progress. These distinct areas include the emergence of sodium-glucose cotransporter-2 inhibitors, broadening the application of angiotensin-neprilysin inhibition, clinical considerations in therapy withdrawal in those patients with heart failure that ‘recover’ myocardial function, benefits of low-dose direct oral anticoagulants in sinus rhythm, targeted therapy for treating cardiac amyloidosis, usefulness of mitral valve repair in heart failure, the advent of newer left ventricular assist devices for advanced heart failure, the role of ablation in atrial fibrillation in heart failure, and finally the use of wearable defibrillators to address sudden death.

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Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure

Yau

Pagani

Mancini

et al. 2019

JAMA

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IMPORTANCE Left ventricular assist device (LVAD) therapy improves myocardial function, but few patients recover sufficiently for explant, which has focused attention on stem cells to augment cardiac recovery. OBJECTIVE To assess efficacy and adverse effects of intramyocardial injections of mesenchymal precursor cells (MPCs) during LVAD implant. DESIGN, SETTING, AND PARTICIPANTS A randomized phase 2 clinical trial involving patients with advanced heart failure, undergoing LVAD implant, at 19 North American centers (July 2015-August 2017). The 1-year follow-up ended August 2018. INTERVENTIONS Intramyocardial injections of 150 million allogeneic MPCs or cryoprotective medium as a sham treatment in a 2:1 ratio (n = 106 vs n = 53). MAIN OUTCOMES AND MEASURES The primary efficacy end point was the proportion of successful temporary weans (of 3 planned assessments) from LVAD support within 6 months of randomization. This end point was assessed using a Bayesian analysis with a predefined threshold of a posterior probability of 80% to indicate success. The 1-year primary safety end point was the incidence of intervention-related adverse events (myocarditis, myocardial rupture, neoplasm, hypersensitivity reactions, and immune sensitization). Secondary end points included readmissions and adverse events at 6 months and 1-year survival. RESULTS Of 159 patients (mean age, 56 years; 11.3% women), 155 (97.5%) completed 1-year of follow-up. The posterior probability that MPCs increased the likelihood of successful weaning was 69%; below the predefined threshold for success. The mean proportion of successful temporary weaning from LVAD support over 6 months was 61% in the MPC group and 58% in the control group (rate ratio [RR], 1.08; 95% CI, 0.83-1.41; P = .55). No patient experienced a primary safety end point. Of 10 prespecified secondary end points reported, 9 did not reach statistical significance. One-year mortality was not significantly different between the MPC group and the control group (14.2% vs 15.1%; hazard ratio [HR], 0.89; 95%, CI, 0.38-2.11; P = .80). The rate of serious adverse events was not significantly different between groups (70.9 vs 78.7 per 100 patientmonths; difference, −7.89; 95% CI, −39.95 to 24.17; P = .63) nor was the rate of readmissions (0.68 vs 0.75 per 100 patient-days; difference, −0.07; 95% CI, −0.41 to 0.27; P = .68). CONCLUSIONS AND RELEVANCE Among patients with advanced heart failure, intramyocardial injections of mesenchymal precursor cells, compared with injections of a cryoprotective medium as sham treatment, did not improve successful temporary weaning from left ventricular assist device support at 6 months. The findings do not support the use of intramyocardial mesenchymal stem cells to promote cardiac recovery as measured by temporary weaning from device support.

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

Cited by 623 publications

References 17 publications

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

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

Nine contemporary therapeutic directions in heart failure

Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure

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