The Annals of thoracic surgery
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Bio-Medicus centrifugal ventricular support has been used widely for postcardiotomy cardiac failure. The purpose of this study was to review a large series of support patients examining complications and outcomes. ⋯ Bio-Medicus centrifugal ventricular support can be implemented rapidly and relatively easily. There are few device-related complications and the cost is relatively inexpensive compared with other assist systems. This series demonstrates that a substantial number of patients who experience reversible postcardiotomy myocardial injury will benefit from temporary centrifugal ventricular support.
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Extracorporeal membrane oxygenation (ECMO) support for cardiac failure has been used in children since 1981 at the Children's Hospital in Pittsburgh. Most children required support after cardiac operations. Recently, however, a larger number of patients with decompensated cardiomyopathy or myocarditis have been supported with ECMO, which was used as a bridge to transplantation in most. ⋯ We conclude that ECMO support for severe cardiac failure is effective. Patient selection and the use of heart transplantation for intractable heart failure have improved the overall survival.
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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.