Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure

Netuka, Ivan; Kvasnička, Tomáš; Kvasnička, Jan; Hrachovinová, Ingrid; Ivák, Peter; Mareček, František; Bílková, Jana; Malíková, Ivana; Jančová, Michaela; Malý, Jiří; Sood, Poornima; Sundareswaran, Kartik S.; Connors, Jean M.; Mehra, Mandeep R.

doi:10.1016/j.healun.2016.05.019

Cited by 123 publications

(62 citation statements)

References 23 publications

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“…Our results concur with a recent multicenter study demonstrating excellent survival and low adverse event rates in HM III patients and with the study of Netuka et al, who showed greater preservation of VWF HMW multimers in the HM III group (n=15) compared with the HM II group (n=11). 24,25 Nevertheless, they could not detect a difference regarding the VWF ristocetin cofactor/VWF:Ag ratio in these patients. This phenomenon may be due to the higher sensibility of the in-house VWF:CB test used in our study compared with the VWF ristocetin cofactor test.…”

Section: Discussionmentioning

confidence: 76%

Platelet secretion defects and acquired von Willebrand syndrome in patients with Ventricular Assist Devices

et al. 2019

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Background--The number of implanted ventricular assist devices (VADs) has increased significantly recently. Bleeding, the most frequent complication, cannot be solely attributed to anticoagulation therapy. Acquired von Willebrand syndrome (AVWS) caused by increased shear stress is frequent in VAD patients and can increase the bleeding risk. The HeartMate III (HM III) is a novel left VAD featuring potential improvements over the HeartMate II.Methods and Results--In this study, we investigated the prevalence and onset of AVWS in 198 VAD patients. To our knowledge, this is the largest cohort of VAD patients whose longitudinal data on AVWS have been collected. We also analyzed whether AVWS is less severe in HM III patients than in HeartMate II patients. Because platelet dysfunction can raise the bleeding risk, we investigated platelet function in a subset of patients. In total, 198 VAD patients and 60 patients with heart transplants as controls were included in this study. The ratio of von Willebrand factor collagen binding capacity to von Willebrand factor:antigen, multimer analyses, and platelet function (especially secretion of aand d-granules) were investigated. All 198 VAD patients developed AVWS. As soon as the VAD was explanted, the AVWS disappeared within hours. AVWS was less severe in the HM III patients than in the HeartMate II patients. The HM III patients had fewer bleeding symptoms. In addition, VAD patients exhibited a platelet aand d-granule secretion defect.Conclusions--AVWS develops in VAD patients and may increase the bleeding risk. The HM III device causes less severe AVWS. Platelet secretion defects should be investigated in VAD patients because they also raise the bleeding risk.Clinical Trial Registration--https://www.drks.de/drks_web.

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Section: Discussionmentioning

confidence: 76%

Platelet secretion defects and acquired von Willebrand syndrome in patients with Ventricular Assist Devices

et al. 2019

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“…12 There is now preliminary evidence from an observational in vivo investigation that the HM3 LVAS prevents shearing of the high-molecular-weight multimers compared with the HMII device, which results in more predictable loss of this biomarker. 13 Whether these mechanisms directly correlate with improved hemocompatibility or merely represent an epiphenomenon, remains uncertain. However, it is very reassuring to note that, although only half of the HMII LVAStreated patients are free of a HRAE at 6 months, over two-thirds of HM3 patients demonstrate freedom of this morbidity.…”

Section: Discussionmentioning

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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“…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).…”

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confidence: 98%