The Annals of thoracic surgery
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A new multisite registry for congenital cardiac anesthesia patients has now been incorporated into The Society of Thoracic Surgeons Congenital Heart Surgery Database. This new registry, "The Joint Congenital Cardiac Anesthesia Society-Society of Thoracic Surgeons Congenital Cardiac Anesthesia Database," is part of the Congenital Cardiac Anesthesia Society's commitment to patient care and research on outcomes improvement. This report will review the planning and funding of the initial start-up as well as the data elements being used in the registry. ⋯ Initial results from the first data harvests are reported, including site participation, patient population submitted, and adverse outcomes observed. These initial results validate the concept and serve as a benchmark for further development and implementation of the registry. Because of the relative infrequency of anesthesia-related events in this low-volume procedure, a multisite data harvest is the most reasonable approach to capture a sufficient number of patient encounters in a timely manner to support outcomes analysis, quality assessment, and quality improvement.
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The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. ⋯ Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.
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Prevention of brain injury during congenital heart surgery has focused on intraoperative and perioperative neuroprotection and neuromonitoring. Many strategies have been adopted as "standard of care." However, the strength of evidence for these practices and the relationship to long-term outcomes are unknown. We performed a systematic review (January 1, 1990 to July 30, 2010) of neuromonitoring and neuroprotection strategies during cardiopulmonary bypass (CPB) in infants of age 1 year or less. ⋯ Data supporting use of current neuromonitoring and neuroprotective techniques are limited. The level of evidence is insufficient to support effectiveness of most of these strategies. Well-designed studies with correlation to clinical outcomes and long-term follow-up are needed to develop guidelines for neuromonitoring and neuroprotection during CPB in infants.
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Acute kidney injury (AKI) after cardiac surgery confers a significant increased risk of death. Several risk models have been developed to predict postoperative kidney failure after cardiac surgery. This systematic review evaluated the available risk models for AKI after cardiac surgery. ⋯ A validated score to predict AKI not requiring dialysis is lacking. Further studies are required to develop risk models to predict milder AKI not requiring dialysis after cardiac surgery. Standardizing risk factor and AKI definitions will facilitate the development and validation of risk models predicting AKI.
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Acute kidney injury (AKI) occurs in as many as 40% of patients after cardiac surgery and requires dialysis in 1% of cases. Acute kidney injury is associated with an increased risk of mortality and morbidity, predisposes patients to a longer hospitalization, requires additional treatments, and increases the hospital costs. ⋯ Recently, several novel biomarkers have emerged, showing reasonable sensitivity and specificity for AKI prediction and protection. The development and implementation of potentially protective therapies for AKI remains essential, especially for the relevant impact of AKI on early and late survival.