Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months

Abstract

BACKGROUND:The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibilityrelated clinical adverse events (HRAEs) between the 2 LVAS. METHODS:We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. RESULTS:In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P<0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/ patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065). CONCLUSIONS:In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months. CLINICAL TRIAL REGISTRATION: 2004H emocompatibility-related adverse events (HRAEs) are the Achilles heel of the interaction between a left ventricular assist system (LVAS) and its biological circulatory interface.1 The constellation of device-related hemolysis, pump thrombosis leading to malfunction, neurological events (predominantly stroke and bleeding), and nonsurgical bleeding (particularly gastrointestinal bleeding) are the principal concerns that influence outcomes in mechanical circulatory support. These frequent complications are noted to occur with all contemporary centrifugal and axial continuous-flow devices, the HeartWare ...

Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States

“…A tiered hierarchal score (hemocompatibility score; HCS) was calculated for each patient by weighting each event considering its escalating clinical relevance, as detailed previously [6,7], to determine the aggregate net burden of HRAEs, instead of assessing individual types of event. The definitions of each tier and the corresponding weighted score are shown in Table A1.…”

“…Considering that age is a well-known critical determinant of HCS [7], a propensity score matching analysis was performed to select age-matched populations with a ratio of 1:2 of the J-MACS group and US group. A propensity score was calculated using logistic regression modeling and paired participants within 0.2 * standard deviation of all propensity scorings were selected.…”

“…Age is an established risk factor of HRAEs. In the subanalysis of MOMENTUM 3 study, age was a significant predictor of death or any HRAEs during HeartMate 3 or HeartMate II support [7]. To focus more on other background differences between countries beyond age, we propensity-matched only age among the two groups in this study.…”

Antithrombotic therapy in ventricular assist device (VAD) management: From ancient beliefs to updated evidence. A narrative review

“…The clinical consequences of thrombotic and bleeding complications can be devastating, with ischemic and hemorrhagic stroke remaining among the most common causes of death in these patients (adjusted hazard ratio 6.1; 95% CI, 4.6–7.9) [ 11 ]. Even if an increase in pump thrombosis reported in previous studies [ [12] , [13] , [14] ] has been mitigated in recently published trials [ 15 , 16 ], pump thrombosis may be a vexing problem because of older patients and longer duration of life after implantation. Device manufacturers usually suggest the use of a specific antiplatelet or anticoagulant agent, without any strong evidence supporting their indication.…”

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

“…1 First, although continuous-flow LVASs have now become commonly used in situations of bridge to transplantation, and destination therapy, wider dissemination is often curtailed by clinical concerns related to the aggregate burden of hemocompatibility-related adverse events such as strokes, bleeding, infection, and pump thrombosis, a dreaded complication that often requires pump exchange. 2,3 Second, not only is the initial decision to implant a pump associated with considerable cost to the healthcare system, but the subsequent postimplant management of adverse events and the antecedent need for aggressive and frequent hospital-based care adds a prominent layer of economic concern that serves to decrease the net cost-effectiveness of this otherwise valuable therapy. [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.…”