Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group

Miera, Oliver; Schmitt, Katharina L; Akintuerk, Hakan; Boët, Angèle; Cesnjevar, Robert; Chila, Teresa; Fleck, Thilo; Goldwasser, Ranny; García-Guereta, Luis; Heineking, Beatrice; Hoerer, Juergen; Horke, Alexander; Hsia, Tain Yen; Huebler, Michael; Kansy, Andrzej; Karimova, Ann; Maruszewski, Bohdan; Medrano, Constancio; Pawlak, Szymon; Reinhardt, Zdenka; Romlin, Birgitta; Sandica, Eugen; Schmidt, Florian; Schramm, René; Schweiger, Martin; Śliwka, Joanna; Stiller, Brigitte; Thul, Josef; Amodeo, Antonio

doi:10.1177/0391398818773040

Cited by 14 publications

(5 citation statements)

References 31 publications

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“…The stroke rates in children on EXCOR and on continuous flow VADs reported in the EUROMACS registry are remarkably low. However, a recent survey addressing the antithrombotic protocols for children on EXCOR VADs in European centres revealed many modifications of the recommended Edmonton protocol with a trend towards more aggressive antithrombotic therapy [14]. Whether these modifications have contributed to lower stroke rates compared to the investigational device exemption trial is under investigation.…”

Section: Adverse Eventsmentioning

confidence: 99%

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report

By¹,

Antonides

Schweiger

et al. 2018

European Journal of Cardio-Thoracic Surgery

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Section: Adverse Eventsmentioning

confidence: 99%

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report

By¹,

Antonides

Schweiger

et al. 2018

European Journal of Cardio-Thoracic Surgery

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“…This shift from thrombotic complications to haemorrhagic complications might reflect the evolving and poorly understood coagulation system in early childhood, whereas the most used anticoagulation protocol for BHE-supported children, the Edmonton protocol, is the same for all patients above 1 year of age [ 19 ]. Although many centres deviate from the Edmonton protocol, there is often a dichotomy between children below 6, 8, 12 or 24 months and older paediatric patients [ 20 ]. Perhaps the ‘one approach fits all’ protocol should be revised because great differences exist within the paediatric population.…”

Section: Discussionmentioning

confidence: 99%

Outcomes in small children on Berlin Heart EXCOR support: age and body surface area as clinical predictive factors

Rohde

Sandica

Veen

et al. 2022

European Journal of Cardio-Thoracic Surgery

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Introduction The Berlin Heart EXCOR offers circulatory support across all paediatric ages. Clinically, the necessary care as well as outcomes differ in various age groups. The EUROMACS database was used to study age and size-related outcomes for this specific device. Methods All patients <19 years of age from the EUROMACS database supported with a Berlin Heart EXCOR between 2000 and November 2021 were included. Maximally Selected Rank statistics were used to determine BSA cut-off values. Multivariable Cox Proportional-Hazard Regression using ridge penalization was performed to identify factors associated with outcomes. Results In total, 303 patients were included (mean age: 2.0 years (interquartile range: 0.6–8.0, males: 48.5%)). Age and BSA were not significantly associated with mortality (n = 74, p = 0.684, p = 0.679). Factors associated with transplantation (n = 175) were age (HR 1.07, p = 0.006) and aetiology other than congenital heart disease (HR 1.46, p = 0.020). Recovery rates (n = 42) were highest in patients with a BSA <0.53 m2 (21.8% vs 4.3–7.6% at 1 year, p = 0.00534). Patients with a BSA ≥0.73 m2 had a lower risk of early pump thrombosis, but a higher risk of early bleedings compared to children with a BSA <0.73 m2. Conclusions Mortality rates in Berlin Heart supported patients cannot be predicted by age or BSA. Recovery rates are remarkably high in the smallest patient category (BSA <0.53 m2). This underscores that the Berlin Heart EXCOR is a viable therapeutic option, even for the smallest and youngest patients.

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“…Most of the patients were within the therapeutic range of both APTT and antithrombin at the time of the thrombosis and over the 2 days prior to the event. Although a subtherapeutic APTT is clearly undesirable, and the large fluctuations in APTT levels we regularly see in our daily practice make management of the heparin therapy difficult, it appears that the question of thrombosis and anticoagulation is not a simple matter of cause and effect 20‐22 …”

Section: Discussionmentioning

confidence: 99%

Clinical course and outcome after treatment with ventricular assist devices in paediatric patients: A single‐centre experience

Romlin

Dahlin

Hallhagen

et al. 2021

Acta Anaesthesiol Scand

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Background Heart failure is a rare condition in the paediatric population, associated with high morbidity and mortality. When medical therapy is no longer sufficient, mechanical circulatory support such as a ventricular assist device can be used to bridge these children to transplant or recovery. Coagulation‐related complications such as thrombi, embolism and bleeding events represent the greatest challenge in paediatric patients on mechanical support. We aimed to describe the outcomes and coagulation‐related complications in this patient population at our institution. Methods A total of 20 patients with either Berlin Heart EXCOR® or HeartWare® implantation were reviewed in this retrospective study. Study endpoints were survival to heart transplant, weaning due to recovery or death. Thrombotic events were defined as thrombus formation in the device or in the patient, or cardioembolic strokes. Bleeding events were defined as events requiring interventional surgery or transfusion of red blood cells. Results The aetiology of heart failure included cardiomyopathy (n = 12), end‐stage congenital heart disease (n = 6) and myocarditis (n = 2). Of the 20 patients, 12 were bridged to transplant, 7 recovered and could be weaned and 1 died. The median duration of mechanical support was 84 days (range: 20‐524 days). At least one major or minor bleeding event occurred in 45% of the patients. Thrombotic events occurred 21 times in 10 patients. Four of the patients (20%) had no bleeding or thromboembolic event. Conclusion In all, 95% of the patients were successfully bridged to transplant or recovery. Bleeding events and thrombotic events were common.

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Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group

Cited by 14 publications

References 31 publications

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report

Outcomes in small children on Berlin Heart EXCOR support: age and body surface area as clinical predictive factors

Clinical course and outcome after treatment with ventricular assist devices in paediatric patients: A single‐centre experience

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