ASAIO journal : a peer-reviewed journal of the American Society for Artificial Internal Organs
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Polymyxin B-immobilized fiber (PMX-F) hemoperfusion is reported to be safe and effective in septic shock patients. Because atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) may have pathophysiologic significance in the cardiac dysfunction of septic shock patients, we conducted a study to determine whether PMX-F treatment affects plasma ANP and BNP levels in patients with septic shock. Fifty septic shock patients (34 men and 16 women; mean age 60.0 years) and 30 healthy volunteers (18 men and 12 women; mean age 56.0 years) were included in this study. ⋯ After the second PMX-F treatment, plasma levels of endotoxin (p < 0.01), IL-6 (p < 0.01), ANP (p < 0.01), and BNP (p < 0.01) were reduced significantly. Values decreased further the following day. Both plasma ANP and BNP levels are increased in septic shock patients and PMX-F treatment is effective in reducing these natriuretic peptide levels.
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Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients. However, because of the larger size of the approved devices, many pediatric patients are underserved by this approach. ⋯ FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application. Pediatric device development is challenging and early communication with FDA to develop an appropriate regulatory and scientific pathway for device submission is advised and warranted. This early interaction can facilitate the development of a small but necessary trial for these life-sustaining pediatric cardiac assist devices.
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Randomized Controlled Trial
Reducing the effects of the systemic inflammatory response to cardiopulmonary bypass: can single dose steroids blunt systemic inflammatory response syndrome?
The use of cardiopulmonary bypass (CPB) is associated with the development of a significant systemic inflammatory response syndrome (SIRS) which can affect patient outcomes. Multiple pathways are involved in initiating and maintaining SIRS. We studied whether a single dose of steroids (dexamethasone) after the induction of anesthesia could blunt the SIRS from CPB. ⋯ A single dose of dexamethasone reduces IL-6 and PNE levels associated with CPB. Despite the significant reductions in IL-6 and PNE, there was no effect on clinical outcomes. Additional studies are needed to demonstrate a clinically significant effect on patient outcomes.
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Although microporous polypropylene hollow fiber oxygenators are standard devices used for extracorporeal membrane oxygenation (ECMO), they have limitations such as development of plasma leakage. Poly-methylpentene (PMP) is a new material used for the last generation of oxygenators. We reviewed our experience with a new PMP oxygenator (Quadrox D) and a centrifugal pump (RotaFlow) used to support adult patients with refractory cardiogenic shock. ⋯ Twelve patients (66.7%) survived on ECMO and five patients (27.8%) were discharged. Our results indicate the PMP oxygenator and the centrifugal pump provided acceptable results in terms of surviving on ECMO and discharge. Patients with an initial catastrophic hemodynamic status could benefit by means of a rapid institution of ECMO with PMP oxygenators.
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On March 22, 2006, the first Interventional Lung Assist (ILA) Consensus Meeting was held in Hannover, Germany, hosted by the Hannover Thoracic Transplant and Cardiac Assist Program at the Hannover Medical School. Leading experts in the field of lung transplantation, respiratory and critical care medicine, lung injury, mechanical ventilation, extracorporeal life support, and oxygenator engineering were formally invited to participate. The main goal was to translate previous clinical experience with the ILA into a consensus for the use of the ILA as a bridge to lung transplantation.