ASAIO journal : a peer-reviewed journal of the American Society for Artificial Internal Organs
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We describe a 2 year-old girl with end-stage dilated cardiomyopathy in whom extracorporeal membrane oxygenation (ECMO) was used for mechanical cardiac assistance. After 4 weeks, ECMO-related complications necessitated change to a Berlin Heart Left Ventricular Assist Device (LVAD), and she received a successful cardiac transplant after a total of 106 days on mechanical cardiac support.
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Case Reports
Duration of cardiopulmonary resuscitation before extracorporeal rescue: how long is not long enough?
Despite the extensive resources required, extracorporeal cardiopulmonary resuscitation (ECPR) has been recognized as an extension of traditional CPR. The reported duration of CPR before ECPR initiation is similar between survivors and nonsurvivors, but the duration of CPR that results in futility of care is unknown. We report two cases of prolonged CPR followed by ECPR resulting in acceptable neurologic outcomes. ⋯ The Extracorporeal Life Support Organization registry is a plausible forum to collect data regarding ECPR. We suggest that possible predictive variables be collected. Until then, practitioners must rely on experience and judgment regarding the value of ECPR in children.
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Comparative Study
Precise quantification of pulsatility is a necessity for direct comparisons of six different pediatric heart-lung machines in a neonatal CPB model.
Generation of pulsatile flow depends on an energy gradient. Surplus hemodynamic energy (SHE) is the extra hemodynamic energy generated by a pulsatile device when the adequate pulsatility is achieved. The objective of this study was to precisely quantify and compare pressure-flow waveforms in terms of surplus hemodynamic energy levels of six different pediatric heart-lung machines in a neonatal piglet model during cardiopulmonary bypass (CPB) procedures with deep hypothermic circulatory arrest (DHCA). ⋯ The PPP produced the greatest surplus hemodynamic energy. Most of the pediatric pulsatile pumps (except Mast-PR) generated significant surplus hemodynamic energy. None of the nonpulsatile roller pumps generated adequate surplus hemodynamic energy.
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The Department of Health and Human Services, at the direction of Congress, has recently begun to address concerns regarding the development of medical devices designed specifically for the pediatric population, including devices for pediatric mechanical circulatory support, as evidenced by the National Institutes of Health's (NIH) funding of several development contracts. Food and Drug Administration (FDA) approval for marketing of these devices will typically follow either of two regulatory pathways: the Humanitarian Device Exemption (HDE) or the Premarket Application (PMA). An HDE is limited both in the extent of clinical use and economic benefit to the manufacturer, but does not require data derived from a clinical trial for market approval. ⋯ In addition, an HDE requires a demonstration of probable benefit, whereas a PMA requires a demonstration of a reasonable assurance of effectiveness. The evidence that can be used to support an HDE or a PMA approval may include both preclinical and clinical data. Types of preclinical tests needed depend upon the device design and its intended use, because circulatory support devices are all unique.
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An 84-year-old woman with septic shock caused by pyelonephritis is described herein. She was admitted for severe back pain and high fever. Her white blood cell (WBC) count and C-reactive protein (CRP) and endotoxin levels were elevated at 38,000/microl, 40.0 mg/dl, and 8,400 pg/ml, respectively. ⋯ Her blood pressure increased to 92/60 mm Hg after the first treatment and to 118/76 mm Hg after the second treatment. The patient was discharged on day 26 after admission. Our experience in this case suggests that PMX-F treatment with a low priming volume may be beneficial in elderly patients with septic shock and marked endotoxemia.