One-year outcomes with the HeartMate 3 left ventricular assist device

Hanke, Jasmin S.; Doğan, Güneş; Zoch, Amelie; Ricklefs, Marcel; Wert, Leonhard; Feldmann, C.; Bara, Christoph; Shrestha, Malakh; Tillmanns, Jochen; Kempf, Tibor; Bauersachs, Johann; Haverich, Axel; Schmitto, Jan D.

doi:10.1016/j.jtcvs.2018.01.083

Cited by 41 publications

(31 citation statements)

References 14 publications

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“…(5,6) However, recent data from HeartMate 3 patients has shown an increased rate of 22%-36%. (3,7) VAD-related complications are thought to be the result of non-physiological shear stress patterns causing activation and damage of blood cells and proteins. (8) Red blood cells (RBCs) can tolerate relatively high shear stress in comparison to other blood cell types with hemolysis occurring due to deformation and fragmentation around 200 Pa-300 Pa. (9,10) Flow conditions within VADs disrupt natural hemodynamics through briefly exerting high shear stresses (10 Pa-800 Pa) on platelets.…”

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confidence: 99%

Artificial shear stress effects on leukocytes at a biomaterial interface

et al. 2019

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Medical devices, such as ventricular assist devices (VADs), introduce both foreign materials and artificial shear stress to the circulatory system. The effects these have on leukocytes and the immune response are not well understood. Understanding how these two elements combine to affect leukocytes may reveal why some patients are susceptible to recurrent device‐related infections and provide insight into the development of pump thrombosis. Biomaterials—DLC: diamond‐like carbon‐coated stainless steel; Sap: single‐crystal sapphire; and Ti: titanium alloy (Ti6Al4V) were attached to the parallel plates of a rheometer. Whole human blood was left between the two discs for 5 minutes at +37°C with or without the application of shear stress (0 s–1 or 1000 s–1). Blood was removed and used for complete blood cell counts, flow cytometry (leukocyte activation, cell death, microparticle generation, phagocytic ability, and reactive oxygen species [ROS] production), and the production of pro‐inflammatory cytokines. L‐selectin expression on monocytes was decreased when blood was exposed to the biomaterials both with and without shear. Applying shear stress to blood on a Sap and Ti surface led to activation of neutrophils shown as decreased L‐selectin expression. Sap and Ti blunted the LPS‐stimulated macrophage migration inhibitory factor (MIF) production, most notably when sheared on Ti. The biomaterials used here have been shown to activate leukocytes in a static environment. The introduction of shear appears to exacerbate this activation. Interestingly, a widely accepted biocompatible material (Ti) utilized in many different types of devices has the capacity for immune cell activation and inhibition of MIF secretion when combined with shear stress. These findings contribute to our understanding of the contribution of biomaterials and shear stress to recurrent infections and vulnerability to sepsis in some VAD patients as well as pump thrombosis.

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confidence: 99%

Artificial shear stress effects on leukocytes at a biomaterial interface

et al. 2019

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“…207,234,247 For HM3, all publications on follow-up have shown low incidence of pump thrombosis. [216][217][218][219][220][248][249][250][251][252] There is one reported case of outflow graft occlusion. 253…”

Section: Thrombosismentioning

confidence: 99%

Acoustic and afterload evaluation of left ventricular assist devices

Sundbom

2019

Linköping University Medical Dissertations

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Pulse width modulation RAAS Renin-Angiotensin Aldosterone system ROS Reactive oxygen species RPM Revolutions per minute RV Right ventricular TGF-β Transforming growth factor-β vWf Von Willebrand factor HF Unable to carry on any physical activity without symptoms of HF, or symptoms of heart failure at rest Hypertension Arrythmias Tachyarrythmias Atrial and ventricular arrythmias Bradyarrythmias Sinus node dysfunction, conduction disorders Valve disease Congentinal Atrial and ventricular septum defects Acquired Aortic, mitral, pulmonary and tricuspid valve disease High output Anemia, pregnancy, thyreotoxicosis, sepsis Volume overload Renal failure, iatrogen volume overload Others Pericardial Constrictive pericarditis, pericardial effusion Endomyocardial

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“… 3 More recently, an analysis from the multicenter study of maglev technology in patients undergoing mechanical circulatory support therapy with heartmate 3 (MOMENTUM 3) trial comparing centrifugal flow HeartMate III with the axial flow HeartMate II demonstrated excellent two years' outcomes with respect to the disabling stroke or malfunctioning of the device. 4 However, nearly two-thirds of the patients experience major adverse events within the first year after LVAD implantation. 5 Among them, stroke (both ischemic and hemorrhagic) is a significant adverse event associated with higher morbidity and mortality.…”

Section: Introductionmentioning

confidence: 99%

Incidence and impact of ischemic and hemorrhagic stroke after left ventricular assist device implantation: A nationwide study

Thakkar

Rupareliya

Doshi

2019

Indian Heart Journal

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Background Despite noteworthy advancements in the design of the left ventricular assist device (LVAD), stroke remains one of the most significant adverse events. This study aims to analyze the incidence and short-term outcomes associated with stroke (ischemic and hemorrhagic) after implantation of LVAD. Methods Study cohorts were identified from the National Inpatient Sample database from January 2009 to September 2015 using the International Classification of Diseases, Ninth Revision codes. The primary outcome was an incidence of stroke, and secondary outcomes were the associated mortality, length of stay, and cost of hospitalization. A multivariate logistic regression analysis was performed to analyze adjusted in-hospital mortality. Results Use of LVADs increased significantly from 2009 to 2014 (2278 in 2009 to 3730 in 2014 [ P trend <0.001]). From a total of 20,656 admissions who underwent LVAD implantation, 1518 (7.4%) developed stroke, among whom 1177 (5.7%) had an ischemic stroke and 426 (2.1%) had a hemorrhagic stroke. Adjusted in-hospital mortality was highest with hemorrhagic stroke. Incidence of stroke was associated with significantly longer length of stay and cost of hospitalization. Conclusion The incidence of stroke was ~7% after LVAD placement, and it was associated with significantly higher in-hospital mortality and resource utilization.

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One-year outcomes with the HeartMate 3 left ventricular assist device

Abstract: The novel LVAD HM3 has already shown excellent Conformité Européenne mark trial results. Within this cohort, 1-year survival after HM3 implantation was 85%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 1 year after implantation.

Cited by 41 publications

References 14 publications

Artificial shear stress effects on leukocytes at a biomaterial interface

Artificial shear stress effects on leukocytes at a biomaterial interface

Acoustic and afterload evaluation of left ventricular assist devices

Incidence and impact of ischemic and hemorrhagic stroke after left ventricular assist device implantation: A nationwide study

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