RESUMEN
The very limited options available to treat ventricular failure in patients with congenital and acquired heart diseases have motivated the development of a pediatric ventricular assist device (VAD). Our effort involves a consortium consisting of the University of Pittsburgh, Carnegie Mellon University, Children's Hospital of Pittsburgh, World Heart Corporation, and LaunchPoint Technologies, LLC. The overall aim of our program is to develop a highly reliable, biocompatible VAD for chronic support (6 months) of the unique and high-risk population of children between 3 kg and 15 kg (patients from birth to 2 years of age). The innovative pediatric VAD we are developing (PediaFlow) is based on a miniature mixed-flow turbodynamic pump featuring magnetic levitation, with the design goal being to assure minimal blood trauma and risk of thrombosis. This article discusses the limitations of current pediatric cardiac assist treatment options and the work to date by our consortium toward the development of a pediatric VAD.
Asunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Materiales Biocompatibles/uso terapéutico , Preescolar , Simulación por Computador , Diseño de Equipo , Cardiopatías Congénitas/complicaciones , Cardiopatías/complicaciones , Insuficiencia Cardíaca/etiología , Humanos , Lactante , Modelos CardiovascularesRESUMEN
Improvements in implantable ventricular assist device (VAD) performance will be required to obtain patient outcomes that are comparable with those of heart transplantation. The HeartQuest VAD (WorldHeart, Oakland, CA, U.S.A.) is an advanced device, with full magnetic suspension of the rotor, designed to address specific clinical shortcomings in existing devices and to maximize margins of safety and performance for an implantable assist device. The device dimensions are 35 x 75 mm, with a total weight of 440 g. The system was designed using extensive computer modeling of device function; a total of two iterations of device prototypes were built before building the clinical version. Animal study results have been very promising, with over 30 calf studies completed. Plasma-free hemoglobin levels returned to preoperative levels, and other hematology results were in the normal ranges. Highlights include clean surfaces seen in a 116-day experiment with no anticoagulation after day 43. Feasibility clinical trials are planned to start in 2006.