Lessons Learned from Managing Antithrombotic Therapy in Children Supported with Pediatric Ventricular Assist Devices.

Stroke, thromboembolism, and bleeding are the most recognized complications associated with pediatric ventricular assist devices (VADs) and the leading cause of death and disability on VAD support. Recently, newer antithrombotic strategies like bivalirudin have emerged that appear to be associated with a reduction in the neurologic event rates, especially for smaller pediatric-specific VADs like the Berlin Heart and PediMag/CentriMag systems where the risk of stroke is the highest. While contemporary antithrombotic therapies have likely contributed to lowering adverse event rates, we speculate that clotting and bleeding adverse events may have dropped because of a variety of other seemingly small changes to antithrombotic management that are independent of the antithrombotic agents used. This view is supported by recent reports documenting low stroke rates with anticoagulants other than bivalirudin, a drug that may have a wider therapeutic window but is not available in all locations throughout the world. The primary purpose of this report is 1) to summarize contemporary antithrombotic regimens used for smaller pediatric VADs today associated with low event rates in the United States and abroad and () to review 10 practical lessons learned and pitfalls to avoid that we believe to be important to reducing bleeding and clotting events based on our collective experience managing pediatric VADs over the past 20 years irrespective of the antithrombotic agents used.

[1]  R. Thiagarajan,et al.  Hemostatic Challenges in Pediatric Critical Care Medicine—Hemostatic Balance in VAD , 2021, Frontiers in Pediatrics.

[2]  P. Eghtesady,et al.  Berlin Heart EXCOR and ACTION post-approval surveillance study report. , 2021, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[3]  A. Michelson,et al.  Usefulness of anti-platelet therapy testing in children supported with a ventricular assist device. , 2019, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[4]  J. Kirklin,et al.  Third Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: Preimplant Characteristics and Outcomes. , 2019, The Annals of thoracic surgery.

[5]  C. Almond,et al.  Characteristics of deposits and pump exchange in the Berlin Heart EXCOR ventricular assist device: Experience with 67 cases , 2018, Pediatric transplantation.

[6]  D. McElhinney,et al.  Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device. , 2017, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[7]  M. Steiner,et al.  Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device , 2016, ASAIO journal.

[8]  N. Ghanayem,et al.  Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). , 2015, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[9]  A. Bhutta,et al.  Steroid therapy attenuates acute phase reactant response among children on ventricular assist device support. , 2015, The Annals of thoracic surgery.

[10]  R. Ichord,et al.  Neurological Complications and Outcomes in the Berlin Heart EXCOR® Pediatric Investigational Device Exemption Trial , 2015, Journal of the American Heart Association.

[11]  J. Jefferies,et al.  Pediatric heart transplant waiting list mortality in the era of ventricular assist devices. , 2014, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[12]  Ioanna Kougioumtzi,et al.  Right heart failure post left ventricular assist device implantation. , 2014, Journal of thoracic disease.

[13]  E. Blackstone,et al.  Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children , 2013, Circulation.

[14]  Eugene H Blackstone,et al.  Prospective trial of a pediatric ventricular assist device. , 2012, The New England journal of medicine.

[15]  A. Wolberg,et al.  Causal relationship between hyperfibrinogenemia, thrombosis, and resistance to thrombolysis in mice. , 2011, Blood.