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Updated: Sep 20, 2025

In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist
Kriti Puri1,2, Hari P Tunuguntla2, Lisa A Hensch3
1Division of Pediatric Critical Care Medicine, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
Insights
Bivalirudin use in pediatric continuous flow ventricular assist device (VAD) patients showed fewer bleeding complications than unfractionated heparin (UFH). Bivalirudin also helped manage pump thrombosis in most cases.
Area of Science:
- Pediatric cardiology
- Cardiovascular surgery
- Pharmacology
Background:
- Bivalirudin is increasingly used for anticoagulation in children with ventricular assist devices (VADs).
- Limited data exist on bivalirudin use in continuous flow (CF) VADs and its comparison to unfractionated heparin (UFH).
Purpose of the Study:
- To compare the safety and efficacy of bivalirudin versus UFH for anticoagulation in pediatric patients with CF-VADs.
- To evaluate outcomes including bleeding, thrombosis, and hemolysis.
Main Methods:
- Retrospective cohort study of pediatric patients (<21 years) on CF-VADs from 2016-2020.
- Compared clinical characteristics and adverse events between patients receiving bivalirudin or UFH.
- Analyzed time to therapeutic anticoagulation, hemolysis markers, and hemocompatibility-related events.
Main Results:
- Bivalirudin use was associated with significantly lower odds of major bleeding complications compared to UFH (OR, 0.29; p=0.038).
- No significant difference was found in the odds of major thrombotic complications between the two anticoagulants (OR, 2.53; p=0.450).
- Bivalirudin was effective as a "washout" strategy, resolving pump thrombosis in 6 of 8 cases.
Conclusions:
- Bivalirudin is associated with reduced hemorrhagic complications in pediatric CF-VAD patients compared to UFH.
- Bivalirudin serves as a viable option for anticoagulation and management of potential pump thrombosis in this population.
Objectives:
Bivalirudin is a direct thrombin inhibitor that is being increasingly used for anticoagulation in children after ventricular assist device (VAD) implantation. While the data on bivalirudin use in pulsatile flow VADs are growing, reports on its use in patients on continuous flow (CF) VAD as well as comparisons of associated outcomes with unfractionated heparin (UFH) remain limited.
Design:
Retrospective cohort study.
Setting:
Single tertiary-quaternary referral center.
Patients:
All patients less than 21 years old on CF-VAD support who received bivalirudin or UFH for anticoagulation between the years 2016 and 2020.
Interventions:
Not applicable.
Measurements And Main Results:
Clinical characteristics compared between the cohorts included time to target range of anticoagulation, markers of hemolysis, and prevalence of hemocompatibility-related adverse events such as major hemorrhagic complications, ischemic stroke, and pump thrombosis. In 42 unique patients (41 HeartWare HVAD [Medtronic, Minneapolis, MN], one HeartMate 3 LVAD [Abbott Laboratories, Abbott Park, IL]) during the study period, a total of 67 encounters of IV anticoagulation infusions (29 UFH and 38 bivalirudin) were retrospectively reviewed. In comparison with use of UFH, bivalirudin was associated with lesser odds of major bleeding complications (odds ratio [OR], 0.29; 95% CI, 0.09-0.97; p = 0.038). We failed to identify any difference in odds of major thrombotic complications (OR, 2.53; 95% CI, 0.47-13.59; p = 0.450). Eight of the patients (28%) on UFH were switched to bivalirudin due to hemorrhagic or thrombotic complications or inability to achieve therapeutic anticoagulation, while two of the patients (5%) on bivalirudin were switched to UFH due to hemorrhagic complications. Bivalirudin was used for a "washout" in eight cases with concern for pump thrombosis-six had resolution of the pump thrombosis, while two needed pump exchange.
Conclusions:
Use of bivalirudin for anticoagulation in patients on CF-VAD support was associated with lesser odds of hemorrhagic complications compared with use of UFH. Bivalirudin "washout" was successful in medical management of six of eight cases of possible pump thrombosis.
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