Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device
Section snippets
Study population
All children <18 years of age implanted with a Berlin Heart EXCOR pediatric VAD at Stanford University between January 2009 and June 2014 were included in our investigation. The study dates were chosen based on when there was consistent use of either the EG (before September 2012) or the Stanford Anti-thrombotic Guideline (SG) (September 2012 or after) in all EXCOR recipients (Table 1). Patients were excluded if they were implanted before 2009 (N = 8) to avoid introducing an era bias related to
Results
Between January 2009 and March 2014, 27 children underwent implantation of a Berlin Heart EXCOR pediatric VAD as a bridge to heart transplant at Stanford. Of these, 16 (59%) patients were implanted before September 2012 when the EG was used, whereas 11 (41%) were implanted after September 2012 when the SG was used as the anti-thrombotic guideline. The baseline characteristics of the study cohort are summarized in Table 2. There were no significant baseline differences between the EG and SG
Discussion
In this study, we found that use of a modified anti-thrombotic guideline, consisting of triplet anti-platelet therapy titrated to high, weight-based target doses—rather than values derived from TEG/PM—combined with prophylactic steroids as needed for inflammation was associated with a substantially lower incidence of stroke and device-related thromboembolism compared with usual care. We also found that the frequency of bleeding adverse events, defined according to standard pediatric INTERMACS
Disclosure statement
David N. Rosenthal has received research support from Berlin Heart, subsequently to the preparation of this manuscript, for the purpose of planning a larger trial of this protocol. This study was supported by a generous grant from the Kate Marra Family. The abstract was presented at the 38th annual meeting and scientific sessions of the International Society for Heart and Lung Transplantation, April 2015, Nice, France. The authors thank the inpatient and outpatient clinical teams for their
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Platelet function in neonates and children
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2022, Progress in Pediatric CardiologyCitation Excerpt :Adjustments were made according to platelet function tests, thromboelastogram, and clinical signs and symptoms (the patient had a hemothorax that required thorax drainage and the antiaggregation treatment was removed until the bleeding had stopped, after that it was reintroduced again). He also presented a procoagulant systemic inflammatory syndrome that required multiple courses of steroids based on Standford's publication [9], according to PCR, Leukocytes, and fever data. Table 2 shows the evolution of these analytical parameters.
Hemostasis in Pediatric Extracorporeal Life Support: Overview and Challenges
2022, Pediatric Clinics of North AmericaCitation Excerpt :The Berlin Heart EXCOR protocol list two antiplatelet regimens (aspirin and dipyridamole), while the Stanford protocol lists triple antiplatelet therapy (aspirin, dipyridamole, clopidogrel). Both protocols use UFH for anticoagulation.63,64 The recent Advanced Cardiac Therapies Improving Outcomes Network (ACTION) protocol does not specify the antiplatelet regimen but uses bivalirudin as its main antithrombotic therapy.65
ISHLT consensus statement for the selection and management of pediatric and congenital heart disease patients on ventricular assist devices Endorsed by the American Heart Association
2021, Journal of Heart and Lung TransplantationPulsatile ventricular assist device as a bridge to transplant for the early high-risk single-ventricle physiology
2021, Journal of Thoracic and Cardiovascular SurgeryCitation Excerpt :The patient was too unstable to obtain imaging and slowly recovered end-organ function with no confirmatory data obtained on later imaging. Since this sentinel event, the approach to antiplatelet therapy has been modified based on the protocol by Rosenthal and colleagues.16 The 2 major complications observed in our cohort were hemolysis needing frequent transfusion and recurrent periods of inflammation/infection.
Commentary: How to VAD to avoid BAD in high-risk single ventricle
2021, Journal of Thoracic and Cardiovascular Surgery
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The first 2 authors (D.N.R. and C.N.L.) contributed equally to this study.