An In Vitro Protocol for Evaluation and Comparison of Membrane Oxygenators

With the trend in open heart surgery toward normothermic bypass and warm blood cardioplegia, greater demand is being placed on the perfusionist to select an oxygenator that will perform safely and efficiently under a variety of conditions. While manufacturers report performance parameters for their products, the data is often not comparable due to widely differing conditions. Recent in vitro evaluation techniques employed to characterize membrane oxygenators do not simulate the actual oxygenator conditions observed during cardiopulmonary bypass. Biocompatibility and drug delivery are reported but comparisons of different oxygenator performance parameters are not completely addressed. We have designed a test circuit and an evaluation protocol to simultaneously characterize the performance of multiple oxygenators under identical conditions. The test circuit is designed to simulate clinical conditions and to evaluate gas exchange, blood path pressures, gas path pressures, and hemolysis. Previously reported studies have relied on a comparison of a single membrane oxygenator and a single bubble oxygenator. Our protocol will compare multiple membrane oxygenators, in vitro, under similar clinically relevant conditions. Such testing would be done prior to animal or clinical trials. Furthermore in vitro tests should be more reproducible and more discriminating than are ex vivo tests

Fluid-Structure Interaction Analysis of Subject-Specific Mitral Valve Regurgitation Treatment with an Intra-Valvular Spacer

Mitral regurgitation imposes a significant symptomatic burden on patients who are not candidates for conventional surgery. For these patients, transcatheter repair and replacement devices are emerging as alternative options. One such device is an intravalvular balloon or spacer that is inserted between the mitral valve leaflets to fill the gap that gives rise to mitral regurgitation. In this study, we apply a large-deformation fluid-structure interaction analysis to a fully 3D subject-specific mitral valve model to assess the efficacy of the intra-valvular spacer for reducing mitral regurgitation severity. The model includes a topologically 3D subvalvular apparatus with unprecedented detail. Results show that device fixation and anchoring at the location of the subject’s regurgitant orifice is imperative for optimal reduction of mitral regurgitation