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Background: Pediatric physicians regularly face the problem of uncertain procedural anticoagulation in children, especially in neonates. We sought to evaluate the safety, plasma concentration (pharmacokinetics, PK), pharmacodynamics (PD), and dosing guidelines of bivalirudin when used as a procedural anticoagulant in pediatric percutaneous intravascular procedures., Methods and Results: Pediatric subjects undergoing percutaneous intravascular procedures for congenital heart disease were enrolled and received the current weight-based dose used in percutaneous coronary interventions (0.75 mg/kg bolus, 1.75 mg/kg/hr infusion). Blood samples for PK/PD analyses were drawn, and safety was evaluated by monitoring bleeding and thrombosis events. A total of 110 patients (11 neonates, 33 infants, 32 young children, and 34 older children) were enrolled; 106 patients received the protocol dose. The PK/PD response of bivalirudin was predictable and behaved in a manner similar to that in adults. Weight-normalized bivalirudin clearance rates were more rapid in neonates and decreased with increasing age. Bivalirudin concentrations were slightly lower in neonates, with a trend to an increase with age. Activating clotting time response was consistent with adult studies and prolonged in all age groups, and there was reasonable correlation between activating clotting time and bivalirudin plasma concentrations across all age groups. There were few major bleeding (2 of 110, 1.8%) or thrombotic events (9 of 110, 8.2%) reported., Conclusions: PK/PD response of bivalirudin in the pediatric population is predictable and behaves in a manner similar to that in adults. Using adult dosing, bivalirudin safely provided the expected anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease., (Copyright © 2010 Wiley-Liss, Inc.)

Background and Objectives: The prognosis for infants with pulmonary atresia and intact ventricular septum (PA/IVS) is poor and they present a major management challenge. Mechanical penetration of the atretic pulmonary valve is an applicable option for decompression of the right ventricle and optimization of left ventricular function. The utilization of laser energy for debulking and vaporization of the atretic valve tissue is a relevant approach due to the potential for controlled, precise mode of energy distribution., Study Design/patients and Methods: A 4-month-old female with PA/IVS whose failure to thrive was accompanied by critical hemodynamic abnormalities received successful percutaneous pulmonary valve plate ablation by a 0.9 mm pulsed-wave ultraviolet excimer laser catheter (308 nm wavelength, fluence 50 mJ/mm(2); 30 Hz). A "step-by-step" lasing technique was applied whereby the tip of the emitting laser catheter is advanced ahead of a guide wire that serves mainly as support for positioning of that catheter., Results: Adequate penetration of the atretic tissue enabled introduction of balloon dilations resulting in patency of the atretic valve, decompression of the right ventricle, improved right and left ventricular hemodynamics, and oxygenation. To further investigate the effect of excimer laser energy on atretic valvular tissue this laser was applied in a specimen of heart from an infant who died because of PA/IVS. Histopathologic examination of the irradiated tissue revealed no laser-induced injury to the pulmonary valve., Conclusions: Thus, laser ablation and penetration of an atretic pulmonary valve is feasible and safe. The penetration of the atretic valve with the laser catheter enables subsequent introduction of various sizes balloon dilations. The application of available laser sources for treatment of congenital heart diseases is reviewed., ((c) 2004 Wiley-Liss, Inc.)

Percutaneous therapeutic embolization may be an effective strategy to manage distal coronary perforations or inadvertent iatrogenic coronary arteriovenous fistula complicating revascularization procedures. We present two cases in which embolization techniques were used to manage these patients and avoid the need for surgical intervention.