The Annals of thoracic surgery
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Centrifugal pumps have been employed most commonly for postcardiotomy mechanical support after intraaortic balloon pumping has failed. Despite their effectiveness in some patients, morbidity remains high. ⋯ Increasing clinical experience with centrifugal mechanical assist appears to result in a clinically relevant decrease in morbidity.
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In this article, based on a presentation before The Society of Thoracic Surgeons, D. Bruce Burlington, MD, director of the United States Food and Drug Administration's Center for Devices and Radiological Health, describes the role of the Center in regulating medical devices. ⋯ He focuses this discussion on circulatory support devices and therapies for cardiac patients. Throughout the discussion, Dr Burlington encourages manufacturers of new devices to discuss their plans and protocols with the agency before beginning their studies.
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The University of Alabama at Birmingham experience with investigational ventricular assist devices (VADs) used as a bridge to transplantation has increased over the past several years; it now includes 27 VAD implantations with 13 VAD runs lasting for extended periods (ie, > 30 days). A review of complications experienced by patients during extended VAD runs is warranted before the further development and testing of chronically implanted mechanical circulatory support devices. ⋯ Infection during VAD support pending cardiac transplantation is an important cause of morbidity and mortality in patients maintained for longer than 30 days by circulatory assist. Infectious complications will probably be a prominent component of the risk associated with the use of chronically implanted mechanical circulatory assist devices and will likely have an important effect on the quality of life experienced by these patients.
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A 51-year-old woman underwent resection of a renal tumor with intracaval and intracardiac extension. Histologic examination demonstrated an adult Wilm's tumor. Cardiopulmonary bypass and deep hypothermic circulatory arrest were used in a combined abdominal and thoracic procedure to remove the tumor and extension in its entirety without complication.