Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF

Netuka, Ivan; Sood, Poornima; Pya, Yuriy; Zimpfer, Daniel; Krabatsch, Thomas; Garbade, Jens; Rao, Vivek; Morshuis, Michiel; Marasco, Silvana; Beyersdorf, Friedhelm; Damme, Laura; Schmitto, Jan D.

doi:10.1016/j.jacc.2015.09.083

Cited by 216 publications

(153 citation statements)

References 35 publications

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“…The absence of suspected or confirmed pump thrombosis with the centrifugal-flow pump was similar to the results with the same device in the nonrandomized CE Mark study (13). A recent analysis has also shown that the centrifugalflow device does not cause loss of high-molecular-weight multimers of von Willebrand factor to the same degree that the axial-flow pump does (14).…”

supporting

confidence: 75%

HeartMate 3—a “Step” in the right direction

Alvarez

Rao

2017

J. Thorac. Dis.

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supporting

confidence: 75%

HeartMate 3—a “Step” in the right direction

Alvarez

Rao

2017

J. Thorac. Dis.

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“…2,3 The HeartMate 3 (HM3) LVAS (Abbott) is a continuous-flow centrifugal pump, with a fully magnetically levitated rotor, wide blood flow passages, and an intrinsic pulse designed to avert stasis within the pump. 4 This novel LVAS is currently being evaluated in a prospective, randomized, controlled trial comparing it with the HMII pump in patients with advanced heart failure who are refractory to optimal medical therapy (MOMENTUM 3 trial [Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3]). 5 The primary analysis of the short-term cohort in this study (n=294 [intention-to-treat population], 6-month follow-up) was recently published.…”

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confidence: 99%

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

et al. 2017

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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 ...

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“…17 Ambulatory patients with advanced systolic heart failure on oral medical therapy will increasingly be considered for elective LVAD therapy. As LVAD use expands into the less sick advanced heart failure population, the challenge and importance of integrating HRQOL into decision making will only grow.…”

Section: Stewartmentioning

confidence: 99%

Putting Life in the Years

Stewart

2016

Circ: Heart Failure

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Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF

Cited by 216 publications

References 35 publications

HeartMate 3—a “Step” in the right direction

HeartMate 3—a “Step” in the right direction

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

Putting Life in the Years

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