Pediatric catheterization laboratory anticoagulation with bivalirudin

Forbes, Thomas J.; Hijazi, Ziyad M.; Young, Guy; Ringewald, Jeremy M.; Aquino, Paolo M.; Vincent, Robert; Qureshi, Athar M.; Rome, Jonathan J.; Rhodes, John F.; Jones, Thomas K.; Moskowitz, William B.; Holzer, Ralf; Zamora, Rolando

doi:10.1002/ccd.22817

Cited by 56 publications

(40 citation statements)

References 16 publications

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“…[10][11][12] Disadvantages include the lack of an available antidote, although it can be removed by dialysis or ultrafiltration after CPB, 14 and limited pediatric experience. 8,[13][14][15][16][17] The initial bivalirudin dose in our patients was based on estimates of the glomerular filtration rate as measured by the Schwartz formula and following suggestions by Warkentin et al 10 All patients had normal renal function, with the exception of Patient 2. Once therapeutic levels were achieved as determined by PTT, few dosage adjustments were required.…”

Section: Discussionmentioning

confidence: 99%

Antithrombotic strategies in children receiving long-term Berlin Heart EXCOR ventricular assist device therapy

Rutledge¹,

Chakravarti²,

Massicotte³

et al. 2013

The Journal of Heart and Lung Transplantation

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Section: Discussionmentioning

confidence: 99%

Antithrombotic strategies in children receiving long-term Berlin Heart EXCOR ventricular assist device therapy

Rutledge¹,

Chakravarti²,

Massicotte³

et al. 2013

The Journal of Heart and Lung Transplantation

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“…Similar to argatroban, bivalirudin is a selective, reversible direct thrombin inhibitor. Recent pediatric investigations have begun to define the dose and safety profile of bivalirudin for neonatal VTE [46] as well as its efficacy in pediatric interventional cardiology [47]. An additional Phase I study investigating the safety and efficacy of bivalirudin in children up to age 18 has recently completed accrual [48].…”

Section: New Anticoagulant Agentsmentioning

confidence: 99%

Current and future management of pediatric venous thromboembolism

Kerlin

2012

American J Hematol

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Venous thromboembolism (VTE) is an increasingly common complication encountered in tertiary care pediatric settings. The purpose of this review is to summarize the epidemiology, current and emerging pharmacotherapeutic options, and management of this disease. Over 70% of VTE occur in children with chronic diseases. Although they are seen in children of all ages, adolescents are at greatest risk. Pediatric VTE is associated with an increased risk of in-hospital mortality; recurrent VTE and post-thrombotic syndrome are commonly seen in survivors. In recent years, anticoagulation with low molecular weight heparin has emerged as the mainstay of therapy, but compliance is limited by its onerous subcutaneous administration route. New anticoagulants either already approved for use in adults or in the pipeline offer the possibility of improved dose stability and oral routes of administration. Current recommended anticoagulation course durations are derived from very limited case series and cohort data, or extrapolations from adult literature. However, the pathophysiologic underpinnings of pediatric VTE are dissimilar from those seen in adults and are often variable within groups of pediatric patients. Clinical studies and trials in pediatric VTE are underway which will hopefully improve the quality of evidence from which therapeutic guidelines are derived.

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“…As outlined before, bivalirudin dose response in non-neonate pediatric patients (the group of interest in the present study) has been shown to be comparable to adults. 6 Of note, the target ACT value 4480 seconds for the ACT Plus device (eg, standard kaolin-activated assay) used in Dr. Hasija's study was rather high, when compared to previous investigations in adults and other reported pediatric cases. 5,9 In most articles, values of approximately 300 to 400 seconds showed a good correlation with the targeted bivalirudin concentrations of 10 to 15 mg/mL during CPB.…”

mentioning

confidence: 61%

“…the fact that the pharmacokinetic profile of bivalirudin, using the established dosing protocols for percutaneous intervention in adults, only has been assessed in small groups of pediatric patients with congenital heart disease undergoing percutaneous intravascular procedures. 6 These data suggest that the pharmacokinetics of bivalirudin in small infants and older children is predictable and comparable to adults, while neonates present a different dose-response profile.…”

mentioning

confidence: 79%

Bivalirudin for Anticoagulation During Cardiopulmonary Bypass in Children With Congenital Heart Disease: Are We Ready Yet?

Faraoni

Koster

2018

Journal of Cardiothoracic and Vascular Anesthesia

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Even though unfractionated heparin (UFH) remains the gold standard for the management of anticoagulation during cardiopulmonary bypass (CPB), alternatives to UFH are required in some rare circumstances (eg, heparin-induced thrombocytopenia [HIT] or heparin resistance). When UFH is contraindicated or needs to be avoided, parenteral direct thrombin inhibitors (DTIs), argatroban and bivalirudin, are considered the first-line alternatives. The use of these agents requires additional understanding of their background, pharmacology, monitoring, and potential side effects. Following the publication of large clinical trials in early 2000s, bivalirudin became an alternative to UFH during percutaneous coronary intervention. 1 In 2004, a pilot investigation compared bivalirudin to UFH in patients undergoing off-pump coronary artery bypass grafting (OPCABG) surgery. 2 Dosing of bivalirudin followed the percutaneous coronary intervention protocols. Although the safety profile in both arms was comparable (eg, bleeding, blood products transfusion, and myocardial infarction), an improved graft patency after 3 months was observed in patients anticoagulated with bivalirudin. Based on these results, bivalirudin was studied further in patients undergoing OPCAB and on-pump CAGB surgery employing a new dosing regimen. 3 Although bivalirudin never has been approved by the Federal Drug Agency, bivalirudin anticoagulation has been recommended since 2008 as the first-line strategy in patients with acute HIT requiring urgent cardiac surgery. 4 A large number of case reports and case series also have described the use and further development of the drug under special conditions, like with extracorporeal membrane oxygenation (ECMO) or ventricular assist device. Not surprisingly, there are currently no Federal Drug Agency-approved indications for the use of DTIs in the pediatric population. 5 However, DTIs sometimes are used for anticoagulation during CPB or ECMO in the pediatric cardiac population. The increase in utilization occurred despite Contents lists available at ScienceDirect

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Pediatric catheterization laboratory anticoagulation with bivalirudin

Cited by 56 publications

References 16 publications

Antithrombotic strategies in children receiving long-term Berlin Heart EXCOR ventricular assist device therapy

Antithrombotic strategies in children receiving long-term Berlin Heart EXCOR ventricular assist device therapy

Current and future management of pediatric venous thromboembolism

Bivalirudin for Anticoagulation During Cardiopulmonary Bypass in Children With Congenital Heart Disease: Are We Ready Yet?

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