Right ventricular outflow tract reconstruction with bicuspid valved polytetrafluoroethylene conduit.

BACKGROUND: In general, all conduits available for right ventricular outflow tract (RVOT) reconstruction eventually become stenotic or insufficient. Owing to the lack of an ideal conduit and with the hope of reducing the incidence of reoperations, we have developed and utilized a bicuspid valved polytetrafluoroethylene (PTFE) conduit for the reconstruction of the RVOT. The purpose of this study was to review our early experience with this conduit. METHODS: From October 2008 to September 2009, we have implanted bicuspid valved PTFE conduits in 18 patients with a median age of 1.7 years (range 6 days to 16 years). Their diagnoses include tetralogy of Fallot with pulmonary atresia in 8, truncus arteriosus in 6, congenital aortic stenosis in 2, transposition of great arteries in 1, and interrupted aortic arch with a ventricular septal defect in 1. In 16 patients, a complete biventricular repair was performed. In another 2 cases, the conduit was used for palliative RVOT reconstruction. The conduit sizes varied from 10 mm to 24 mm in diameter. Three-dimensional flow fields obtained from computational fluid dynamics studies were utilized in the conduit design process. RESULTS: There was no surgical mortality or reinterventions associated with the PTFE conduit placement in our series. At the time of discharge, none of the patients had any echocardiographic findings consistent with significant conduit stenosis or insufficiency. During the follow-up period of 6.2 ± 3.9 months, all patients were alive and only 3 had more than mild pulmonary insufficiency. CONCLUSIONS: Our bicuspid valved PTFE conduit has an acceptable early performance, with a low incidence of valve insufficiency and no conduit stenosis. Certainly, longer follow-up is necessary to fully assess its long-term benefits.</p

Total cavopulmonary connection in patients with apicocaval juxtaposition: optimal conduit route using preoperative angiogram and flow simulation.

OBJECTIVES: Single ventricle with apicocaval juxtaposition (ACJ) is a rare, complex anomaly, in which the optimal position of the conduit for completion of total cavopulmonary connection (TCPC) is still controversial. The purpose of this study was to identify a preoperative method for optimal conduit position using the IVC anatomy and computational fluid dynamics (CFD). METHODS: Twenty-four patients with ACJ (5.3 ± 5.7 years) who underwent TCPC were enrolled. A conduit was placed ipsilateral to the cardiac apex in each of 11 patients, of which 9 were intra-atrial and 2 extracardiac (group A) and, in a further 13 patients, extracardiac on the contralateral side (group B). As control, 10 patients with tricuspid atresia were also enrolled (group C). The location of the IVC in relation to the spine was evaluated from the frontal view of preoperative angiogram, using the following index: IVC-index = IVC width overlapping the vertebra/width of the vertebra × 100%. Energy loss was calculated by CFD simulation. RESULTS: IVC-index of group B was larger than groups A and C (45 ± 26 vs. 20 ± 21 and 28 ± 19%, P = 0.03). Postoperative catheterizations showed that, due to its curvature, conduit length in group B was significantly longer than the others (65 ± 12 vs. 36 ± 14 and 44 ± 10 mm, P CONCLUSIONS: In patients with ACJ, placement of a straighter and shorter conduit on the ventricular apical side provides better laminar blood flow with less energy loss. However, conduit compression and kinking are far more detrimental to the Fontan circulation. A preoperative IVC-index is pivotal for avoiding these factors and deciding the optimal conduit route.</p

PediaFlow™ Maglev Ventricular Assist Device: A Prescriptive Design Approach.

This report describes a multi-disciplinary program to develop a pediatric blood pump, motivated by the critical need to treat infants and young children with congenital and acquired heart diseases. The unique challenges of this patient population require a device with exceptional biocompatibility, miniaturized for implantation up to 6 months. This program implemented a collaborative, prescriptive design process, whereby mathematical models of the governing physics were coupled with numerical optimization to achieve a favorable compromise among several competing design objectives. Computational simulations of fluid dynamics, electromagnetics, and rotordynamics were performed in two stages: first using reduced-order formulations to permit rapid optimization of the key design parameters; followed by rigorous CFD and FEA simulations for calibration, validation, and detailed optimization. Over 20 design configurations were initially considered, leading to three pump topologies, judged on the basis of a multi-component analysis including criteria for anatomic fit, performance, biocompatibility, reliability, and manufacturability. This led to fabrication of a mixed-flow magnetically levitated pump, the PF3, having a displaced volume of 16.6 cc, approximating the size of a AA battery and producing a flow capacity of 0.3-1.5 L/min. Initial in vivo evaluation demonstrated excellent hemocompatibility after 72 days of implantation in an ovine. In summary, combination of prescriptive and heuristic design principles have proven effective in developing a miniature magnetically levitated blood pump with excellent performance and biocompatibility, suitable for integration into chronic circulatory support system for infants and young children; aiming for a clinical trial within 3 years.</p

Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device.

The PediaFlow pediatric ventricular assist device is a miniature magnetically levitated mixed flow pump under development for circulatory support of newborns and infants (3-15 kg) with a targeted flow range of 0.3-1.5 L/min. The first generation design of the PediaFlow (PF1) was manufactured with a weight of approximately 100 g, priming volume less than 2 mL, length of 51 mm, outer diameter of 28 mm, and with 5-mm blood ports. PF1 was evaluated in an in vitro flow loop for 6 h and implanted in ovines for three chronic experiments of 6, 17, and 10 days. In the in vitro test, normalized index of hemolysis was 0.0087 ± 0.0024 g/100L. Hemodynamic performance and blood biocompatibility of PF1 were characterized in vivo by measurements of plasma free hemoglobin, plasma fibrinogen, total plasma protein, and with novel flow cytometric assays to quantify circulating activated ovine platelets. The mean plasma free hemoglobin values for the three chronic studies were 4.6 ± 2.7, 13.3 ± 7.9, and 8.8 ± 3.3 mg/dL, respectively. Platelet activation was low for portions of several studies but consistently rose along with observed animal and pump complications. The PF1 prototype generated promising results in terms of low hemolysis and platelet activation in the absence of complications. Hemodynamic results validated the magnetic bearing design and provided the platform for design iterations to meet the objective of providing circulatory support for young children with exceptional biocompatibility.</p