ASAIO journal : a peer-reviewed journal of the American Society for Artificial Internal Organs
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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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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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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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Meta Analysis
Systemic leukofiltration does not attenuate pulmonary injury after cardiopulmonary bypass.
Pulmonary injury mediated by activated leukocytes is a recognized complication of cardiopulmonary bypass. The aim of this paper is to systematically analyze the effects of systemic leukofiltration within the cardiopulmonary bypass circuit on pulmonary injury and related clinical outcomes. We performed a systematic search to identify randomized controlled trials reporting on the effects of systemic leukofiltration on respiratory parameters. ⋯ Leukofiltration significantly reduced the duration of ventilatory support postoperatively (WMD, -2.11 hours; 95% CI, -0.65 to -3.58; p = 0.005), but had no impact on postoperative chest infection, intensive care length of stay or hospital length of stay. The heterogeneity of the included studies was high, due to poor quality study design and failure to include patients at high risk of pulmonary complications. Systemic leukofiltration may attenuate bypass-related lung injury in the early postoperative period, but this does not seem to translate to clinically significant differences in outcomes.