Blood trauma potential of the HeartWare Ventricular Assist Device in pediatric patients

Granegger, Marcus; Thamsen, Bente; Schlöglhofer, Thomas; Lach, Selina; Escher, Andreas; Haas, Thorsten; Meboldt, Mirko; Schweiger, Martin; Hübler, Michael; Zimpfer, Daniel

doi:10.1016/j.jtcvs.2019.06.084

Cited by 32 publications

(43 citation statements)

References 41 publications

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“…Even if the absolute values of the in-silico study overestimate the actual hemolysis, they allow for the identification of the increased recirculation during operation at low-flow rates as a plausible explanation for increased hemolysis. Prognosis by CFD is complex and in this study underestimated the relative increase in blood damage [9]. An influence of the slightly higher resistance on hemolysis cannot be avoided in the low-flow experiments at the same speed and could strengthen the trend for increased hemolysis compared to high-flow.…”

Section: Discussionmentioning

confidence: 73%

“…In combination with the previous studies of Gross-Hardt et al [10] and Granegger et al [9], it appears that current centrifugal blood pumps, such as the DP3 (Xenios AG, Heilbronn, Germany), Rotaflow (Maquet GmbH Getinge Group, Rastatt, Germany), Revolution (LivaNova PLC, London, United Kingdom) or HVAD (Medtronic, Minneapolis, USA), are not recommended for operation at flow rates below 2 L/min. In the manufacturer's manual, pumps are often assigned a much larger operating range compared to the operating points which are mandatory to test during the approval process.…”

Section: Discussionmentioning

confidence: 85%

“…These low-flow operating points contribute to adverse events such as increased hemolysis, platelet activation and bleeding complications [7,8]. Furthermore, this may be a particularly important issue in vulnerable pediatric patients, where blood trauma should be carefully avoided [6,[9][10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

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Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump

et al. 2021

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Background Treating severe forms of the acute respiratory distress syndrome and cardiac failure, extracorporeal membrane oxygenation (ECMO) has become an established therapeutic option. Neonatal or pediatric patients receiving ECMO, and patients undergoing extracorporeal CO2 removal (ECCO2R) represent low-flow applications of the technology, requiring lower blood flow than conventional ECMO. Centrifugal blood pumps as a core element of modern ECMO therapy present favorable operating characteristics in the high blood flow range (4 L/min–8 L/min). However, during low-flow applications in the range of 0.5 L/min–2 L/min, adverse events such as increased hemolysis, platelet activation and bleeding complications are reported frequently. Methods In this study, the hemolysis of the centrifugal pump DP3 is evaluated both in vitro and in silico, comparing the low-flow operation at 1 L/min to the high-flow operation at 4 L/min. Results Increased hemolysis occurs at low-flow, both in vitro and in silico. The in-vitro experiments present a sixfold higher relative increased hemolysis at low-flow. Compared to high-flow operation, a more than 3.5-fold increase in blood recirculation within the pump head can be observed in the low-flow range in silico. Conclusions This study highlights the underappreciated hemolysis in centrifugal pumps within the low-flow range, i.e. during pediatric ECMO or ECCO2R treatment. The in-vitro results of hemolysis and the in-silico computational fluid dynamic simulations of flow paths within the pumps raise awareness about blood damage that occurs when using centrifugal pumps at low-flow operating points. These findings underline the urgent need for a specific pump optimized for low-flow treatment. Due to the inherent problems of available centrifugal pumps in the low-flow range, clinicians should use the current centrifugal pumps with caution, alternatively other pumping principles such as positive displacement pumps may be discussed in the future.

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Section: Discussionmentioning

confidence: 73%

Section: Discussionmentioning

confidence: 85%

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Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump

et al. 2021

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“…However, some studies revealed that blood trauma and hemolysis are elevated in pediatric patients treated with continuous flow VAD even at lower pump flows and speeds compared with the adult population. 3 The presence of hemolysis is associated with a high risk of morbidity and mortality. 2,4–6…”

Section: Introductionmentioning

confidence: 99%

Hemolysis and methemoglobinemia in a child with left ventricular assist Levitronix PediMag

et al. 2020

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A 5-month-old male was treated with left ventricular assist device due to cardiac failure secondary to dilated cardiomyopathy. The patient developed acute severe intravascular hemolysis with methemoglobinemia and renal failure, related to a mechanical problem due to pump cylinder misalignment. Secondary severe methemoglobinemia has not been previously described in patients undergoing ventricular assist device. Early detection of the signs and symptoms of hemolysis is crucial to prevent further complications.

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“…5 Unfortunately, the consequences of running these adult pumps at lower flows and in smaller ventricular cavities remains uncertain.The study by Granegger and colleagues in this issue of the Journal demonstrates the pitfalls of assuming that outcomes will be the same in children as in adults. 6 The authors used a combination of in vivo, in silica, and in vitro studies to examine the effect of the lower flows used in children on blood trauma with the HeartWare HVAD VAD pump. The clinical information from the in vivo studies is of limited value, but it does demonstrate that measures of blood trauma, most notably lactate dehydrogenase, appear to remain elevated for longer periods following VAD implantation in pediatric patients.…”

mentioning

confidence: 99%

Commentary: Not safe at any flow: The challenges of low-flow pediatric operation of adult continuous-flow ventricular assist devices

Davies

2020

The Journal of Thoracic and Cardiovascular Surgery

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With the exception of the Berlin Heart EXCOR ventricular assist device (VAD), 1 no durable VAD has yet been approved by the Food and Drug Administration for use in children. However, over the past 20 years, VADs approved for use in adults have demonstrated marked improvement in clinical outcomes while also being drastically reduced in physical size. [2][3][4] These factors, along with a design enabling potential discharge and long-term out-of-hospital support, have led to increasing enthusiasm for the use of these adult VADs in smaller children. 5 Unfortunately, the consequences of running these adult pumps at lower flows and in smaller ventricular cavities remains uncertain.The study by Granegger and colleagues in this issue of the Journal demonstrates the pitfalls of assuming that outcomes will be the same in children as in adults. 6 The authors used a combination of in vivo, in silica, and in vitro studies to examine the effect of the lower flows used in children on blood trauma with the HeartWare HVAD VAD pump. The clinical information from the in vivo studies is of limited value, but it does demonstrate that measures of blood trauma, most notably lactate dehydrogenase, appear to remain elevated for longer periods following VAD implantation in pediatric patients. This is consistent with preliminary data regarding other continuous-flow devices used in children (ACTION network, personal communication). The in silica studies using computational fluid dynamics are more compelling regarding the predicted differences in both stasis and shear stress within the pump during pediatric and adult operating conditions. The larger volume of static blood and longer time for blood exchange at lowspeed operation may predispose to thrombus formation and contribute to pump inefficiency and blood trauma. The in vitro studies support an important clinical effect from lower-speed operation with increased measures of hemolysis compared with adult settings.All these data provide a compelling story that suggests that we should not expect the same clinical behavior and outcomes under low-flow pediatric operation, as has been reported in standard-flow adult operation. This is likely part of the explanation for the trend toward poorer outcomes when the HVAD is used in pediatric patients with body surface area<1 m 2 . 5 Challenges with pump positioning, the influence of smaller ventricles, and the position of the papillary muscles, as well as the difficulty reaching hospital discharge, 5 and full rehabilitation may also play a role.The data in this issue of the Journal demonstrates the importance of careful consideration before simply using an adult pump in small pediatric patients under operating conditions that have not been evaluated. It reinforces the need to continue to evaluate these pumps in children to identify whether changes to anticoagulation regimens and alterations in standard clinical practices derived from adults are necessary to optimize outcomes in pediatric operating conditions. Finally, it suggests that ongoing develop...

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Blood trauma potential of the HeartWare Ventricular Assist Device in pediatric patients

Cited by 32 publications

References 41 publications

Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump

Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump

Hemolysis and methemoglobinemia in a child with left ventricular assist Levitronix PediMag

Commentary: Not safe at any flow: The challenges of low-flow pediatric operation of adult continuous-flow ventricular assist devices

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