PMID- 35687091
OWN - NLM
STAT- MEDLINE
DCOM- 20221005
LR  - 20221116
IS  - 1529-7535 (Print)
IS  - 1529-7535 (Linking)
VI  - 23
IP  - 10
DP  - 2022 Oct 1
TI  - Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients 
      on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective 
      Cohort Study.
PG  - e465-e475
LID - 10.1097/PCC.0000000000003003 [doi]
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.
CI  - Copyright (c) 2022 by the Society of Critical Care Medicine and the World 
      Federation of Pediatric Intensive and Critical Care Societies.
FAU - Puri, Kriti
AU  - Puri K
AD  - Division of Pediatric Critical Care Medicine, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Tunuguntla, Hari P
AU  - Tunuguntla HP
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Hensch, Lisa A
AU  - Hensch LA
AD  - Division of Transfusion Medicine & Coagulation, Departments of Pathology & 
      Immunology and Anesthesiology, Baylor College of Medicine, Texas Children's 
      Hospital, Houston, TX.
FAU - Loh, JiaHoi
AU  - Loh J
AD  - Division of Transfusion Medicine & Coagulation, Departments of Pathology & 
      Immunology and Pediatrics, Baylor College of Medicine, Texas Children's Hospital, 
      Houston, TX.
FAU - Hui, Shiu-Ki
AU  - Hui SK
AD  - Division of Transfusion Medicine & Coagulation, Departments of Pathology & 
      Immunology and Pediatrics, Baylor College of Medicine, Texas Children's Hospital, 
      Houston, TX.
FAU - Razavi, Asma
AU  - Razavi A
AD  - Division of Pediatric Critical Care Medicine, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Tume, Sebastian C
AU  - Tume SC
AD  - Division of Pediatric Critical Care Medicine, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Humlicek, Timothy J
AU  - Humlicek TJ
AD  - Department of Clinical Pharmacology, Baylor College of Medicine, Texas Children's 
      Hospital, Houston, TX.
FAU - Denfield, Susan W
AU  - Denfield SW
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Spinner, Joseph A
AU  - Spinner JA
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Choudhry, Swati
AU  - Choudhry S
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Price, Jack F
AU  - Price JF
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Dreyer, William J
AU  - Dreyer WJ
AD  - Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Baylor 
      College of Medicine, Texas Children's Hospital, Houston, TX.
FAU - Adachi, Iki
AU  - Adachi I
AD  - Section of Congenital Cardiac Surgery, Department of Surgery, Baylor College of 
      Medicine, Texas Children's Hospital, Houston, TX.
FAU - Teruya, Jun
AU  - Teruya J
AD  - Division of Transfusion Medicine & Coagulation, Departments of Pathology & 
      Immunology, Pediatrics, and Medicine, Baylor College of Medicine, Texas 
      Children's Hospital, Houston, TX.
LA  - eng
PT  - Journal Article
DEP - 20220610
PL  - United States
TA  - Pediatr Crit Care Med
JT  - Pediatric critical care medicine : a journal of the Society of Critical Care 
      Medicine and the World Federation of Pediatric Intensive and Critical Care 
      Societies
JID - 100954653
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Adult
MH  - Anticoagulants/adverse effects
MH  - Antithrombins/adverse effects
MH  - Child
MH  - *Heart-Assist Devices/adverse effects
MH  - Hemorrhage/chemically induced/epidemiology
MH  - Heparin/adverse effects
MH  - Hirudins/adverse effects
MH  - Humans
MH  - Peptide Fragments/adverse effects
MH  - Recombinant Proteins/adverse effects
MH  - Retrospective Studies
MH  - *Thrombosis/epidemiology/etiology/prevention & control
MH  - Treatment Outcome
MH  - Young Adult
COIS- 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.
EDAT- 2022/06/11 06:00
MHDA- 2022/10/06 06:00
CRDT- 2022/06/10 11:02
PHST- 2022/06/11 06:00 [pubmed]
PHST- 2022/10/06 06:00 [medline]
PHST- 2022/06/10 11:02 [entrez]
AID - 00130478-202210000-00019 [pii]
AID - 10.1097/PCC.0000000000003003 [doi]
PST - ppublish
SO  - Pediatr Crit Care Med. 2022 Oct 1;23(10):e465-e475. doi: 
      10.1097/PCC.0000000000003003. Epub 2022 Jun 10.