TY - JOUR
T1 - Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support
T2 - Single-Center Retrospective Cohort Study
AU - Puri, Kriti
AU - Tunuguntla, Hari P.
AU - Hensch, Lisa A.
AU - Loh, Jia Hoi
AU - Hui, Shiu Ki
AU - Razavi, Asma
AU - Tume, Sebastian C.
AU - Humlicek, Timothy J.
AU - Denfield, Susan W.
AU - Spinner, Joseph A.
AU - Choudhry, Swati
AU - Price, Jack F.
AU - Dreyer, William J.
AU - Adachi, Iki
AU - Teruya, Jun
N1 - Funding Information:
Drs. Puri, Tunuguntla, Spinner, and Adachi disclosed the off-label product use of HeartWare HVAD for ventricular assist device support. Drs. Puri, Tunuguntla, Hensch, and Teruya disclosed the off-label product use of bivalirudin for first-line anticoagulation. Dr. Adachi reported consultant/proctor for Berlin Heart, Medtronic, Abbott, Abiomed, Jarvik, BiVACOR, and Sony-Olympus Medical Solutions. Dr. Teruya received funding from Hemosonics and UptoDate. The remaining authors have disclosed that they do not have any potential conflicts of interest.
Publisher Copyright:
Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - 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.
AB - 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.
KW - anticoagulation
KW - direct thrombin inhibitor
KW - pediatric
KW - ventricular assist device
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U2 - 10.1097/PCC.0000000000003003
DO - 10.1097/PCC.0000000000003003
M3 - Article
C2 - 35687091
AN - SCOPUS:85139562093
SN - 1529-7535
VL - 23
SP - E465-E475
JO - Pediatric Critical Care Medicine
JF - Pediatric Critical Care Medicine
IS - 10
ER -