Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective Cohort Study
Retrospective cohort published in Pediatr Crit Care Med (2022)
Abstract
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Bivalirudin in 38 pediatric continuous-flow VAD encounters showed reduced major bleeding (OR 0.29) versus heparin; bivalirudin washout resolved 6/8 pump thrombosis cases.
Why This Matters for Hirudotherapy
This retrospective cohort study compared outcomes associated with bivalirudin versus unfractionated heparin in 42 patients under 21 on continuous-flow ventricular assist device support across 67 anticoagulation encounters, evaluating major bleeding, thrombotic complications, hemolysis markers, ischemic stroke, and pump thrombosis. The authors report that bivalirudin was associated with significantly lower odds of major bleeding complications compared to UFH (OR 0.29, 95% CI 0.09–0.97, p = 0.038), with no statistically significant difference in thrombotic complications, and that bivalirudin 'washout' resolved suspected pump thrombosis in six of eight cases. The abstract describes bivalirudin as a direct thrombin inhibitor but does not mention hirudin, leeches, or any leech-derived compound, so no defensible hirudotherapy link exists. This is a single-center retrospective study with a relatively small sample and does not involve leeches or hirudotherapy.
Citation
Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective Cohort Study.
Puri K et al. · Pediatric critical care medicine, 2022
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