Elective aortic-root replacement has a low operative mortality. In contrast, emergency repair, usually for acute aortic dissection, is associated with a much higher early mortality. Because nearly half the adult patients with aortic dissection had an aortic-root diameter of 6.5 cm or less at the time of operation, it may be prudent to undertake prophylactic repair of aortic aneurysms in patients with Marfan's syndrome when the diameter of the aorta is well below that size.
Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Necrotizing fasciitis has been associated with significant morbidity and mortality. Thirty-three patients were studied over a 3-year period. Predisposing factors included intravenous drug abuse (30%), diabetes (21%), and obesity (18%). Severe pain (94%) and abnormal temperature (88%) were present, whereas laboratory data and x-ray were nonspecific. Gram-positive organisms were most frequently recovered (B-hemolytic streptococcus 45%). Treatment consisted of antibiotics, surgical debridement, re-exploration 24 hours before surgery, nutritional support, and early soft tissue coverage as needed. Mean duration from admission to operation was 43 hours. The average number of operative debridements was three and the average length of hospitalization was 47 days. Patients operated on less than 12 hours from admission or greater than 48 hours had shorter hospital stays (36 and 38 days). The critical time period was 12-48 hours after admission; all deaths and amputations were in this group and the average hospital stay was 62 days (p less than 0.05). The number of operations did not correlate to hospital stay. Despite antibiotics and aggressive debridement, significant morbidity exists if operation is delayed more than 12 hours. Methods of early detection such as local bedside diagnostic incision and fascial inspection may be needed in high risk patients to further reduce the morbidity and mortality.
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