The Annals of thoracic surgery
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New volume requirements for coronary artery bypass grafting are being imposed on cardiac surgeons by hospitals, managed care groups, and others. The rationale for this is unclear. The available literature as well as additional sources relating volume and outcomes in cardiac surgery were extensively reviewed and reexamined. ⋯ Each cardiothoracic surgeon should participate in a national database that permits comparison of his or her outcomes on a risk-adjusted basis with other surgeons. Until conclusive data become available that link volume to outcome, volume should not be used as a criterion for credentialing of cardiac surgeons by hospitals, managed care groups, or others. Instead, each surgeon should be evaluated on his or her individual results.
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Postcardiotomy cardiogenic shock remains a challenging situation. Many devices can be used although none of them directly unload the left ventricle except for the Hemopump. We report our clinical experience with the Hemopump 31 or sternotomy Hemopump. ⋯ Factors showing adverse effect are biventricular failure, vasoconstrictor requirement, and delayed insertion. We believe the Hemopump is a more efficient device than the intraaortic balloon pump, and that early use after onset of heart failure achieves better results.
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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.