Individualized Mycophenolate Mofetil Dosing Based on Drug Exposure Significantly Improves Patient Outcomes After Renal Transplantation

Efficacy and safety of mycophenolate mofetil (MMF) may be optimized with individualized doses based on therapeutic monitoring of its active metabolite, mycophenolic acid (MPA). In this 12-month study, 137 renal allograft recipients from 11 French centers receiving basiliximab, cyclosporine A, MMF and corticosteroids were randomized to receive either concentration-controlled doses or fixed-dose MMF. A novel Bayesian estimator of MPA AUC based on three-point sampling was used to individualize doses on posttransplant days 7 and 14 and months 1, 3 and 6. The primary endpoint was treatment failure (death, graft loss, acute rejection and MMF discontinuation). Data from 65 patients/group were analyzed. At month 12, the concentration-controlled group had fewer treatment failures (p = 0.03) and acute rejection episodes (p = 0.01) with no differences in adverse event frequency. The MMF dose was higher in the concentration-controlled group at day 14 (p < 0.0001), month 1 (p < 0.0001) and month 3 (p < 0.01), as were median AUCs on day 14 (33.7 vs. 27.1 mg*h/L; p = 0.0001) and at month 1 (45.0 vs. 30.9 mg*h/L; p < 0.0001). Therapeutic MPA monitoring using a limited sampling strategy can reduce the risk of treatment failure and acute rejection in renal allograft recipients 12 months posttransplant with no increase in adverse events.     

Endovascular treatment (EVT) of acute traumatic lesions of the descending thoracic aorta--7 years' experience.

OBJECTIVES: To present a single centers' 7-year experience in the endovascular treatment of acute traumatic lesions of the descending thoracic aorta (ATL of the DTA). MATERIALS & METHODS: Between March 1999 and December 2006, 34 consecutive acute traumatic lesions of the descending aorta (23 men, mean age 44 years) were treated endovascularly. Stentgrafts used were TAG Excluder, Zenith TX2 and Talent. In 23 patients the Left Subclavian Artery (LSA) was covered. Mean procedural duration was 20 to 75 minutes. RESULTS: Exclusion of the rupture site was achieved in all cases with no conversion to open surgery. Overall 30-day mortality was 8.8%. Two patients died on post operative day (pod) 1 and one on pod 22 from cranial injuries. No death or neurological deficit related to the endovascular treatment was reported. Four type I endoleaks required treatment either by balloon reexpansion (n=2) or by additional stentgraft implantation (n=2). In two patients the stentgraft collapsed totally several days postoperatively. Two patients required secondary surgical procedures (iliac access complication and revascularisation of the left subclavian artery n=1). The average follow-up was 43.8 months (1-93 months). No stentgraft related abnormality has been subsequently documented. CONCLUSIONS: The endovascular treatment of ATL of the DTA may offer the best means of therapy in a polytrauma patient.     

Traumatic injuries associated with horseback riding.

BACKGROUND: According to the Center for Disease Control and Prevention (CDC), an estimated 30 million people ride horses each year in the United States. Horseback riding related injuries are common, with an estimated 50,000 emergency room visits annually. The popularity of recreational horseback riding has increased in South Florida and the incidence of associated traumatic injuries is a reflection of this. MATERIAL AND METHODS: Retrospective review of patients admitted to a state designated Level I trauma center that sustained horseback riding associated injuries between January 2000 and December 2003. Information extracted from the Trauma Center's data base included demographics, mechanism of injury and toxicology screening. RESULTS: During the review period, twenty-seven patients were identified. There were 12 men and 15 women. The average age was 36 years. The injuries occurred during pleasure riding in 23 patients and thoroughbred related activities in 4 patients. Multiple severe injuries were common and documented in 24 patients. All patients required hospitalization with an average stay of 5 days. Five patients had a positive toxicology screen on admission. No deaths were documented in this review. CONCLUSION: Horseback riding related injuries tends to be serious. Alcohol and recreational drugs may contribute to exacerbate the extent of these injuries. The use of proper protective equipment, instructions for safe riding, and discouraging drug and alcohol use during riding activities should be emphasized.     

Das Cinderella-Schuh-Syndrom

The Cinderella shoe syndrome specifies a commonly observed, not yet labeled disproportion of footwear and the morphologic conditions of the wearer. Disproportioned shoes and socks are worn–frequently unconsciously–due to personal reasons, fashion trends, misinformation and wrong advice; they can induce severe foot disorders. The Cinderella shoe syndrome has an important significance within the development, the treatment and the recurrence-prophylaxis of foot disorders, as well as in the assessment of possible reasons for recurrence after foot surgery. To recognize it, to treat individual psychologic reasons, to give support in the choice of footwear, to inform about and to change social reasons are all challenges of the foot surgeon.     

Development of bariatric surgery-specific risk assessment tool.

BACKGROUND: Administrative databases have increasingly been used to assess bariatric surgery outcomes, resulting in policy recommendations about bariatric practice. However, surgical outcomes must be risk adjusted to compare patients of varying potential risk fairly with those to whom the policies will apply. To date, the risk adjustment tools used for database analysis of bariatric surgical outcomes have been those designed for other purposes, and their sensitivity for bariatric outcomes has not been established. METHODS: Bariatric surgical procedures contained in the National Hospital Discharge Summary for 1993-2003 were assembled into a database. The standard set of Elixhauser co-morbidity variables used by the Agency for Healthcare Research and Quality were entered into the database. Those variables that were significantly associated with adverse outcomes were entered into a stepwise-elimination logistic regression equation, yielding a set of variables related to adverse outcomes from bariatric surgery. These were then prospectively applied to another database (the National Inpatient Survey) to determine their sensitivity for predicting outcomes and were compared with the commonly used Charlson score. RESULTS: The variables significantly correlating with bariatric adverse events included chronic pulmonary disease, hypertension, diabetes with chronic complications, fluid and electrolyte disorders, deficiency anemias, and depression. Age and male gender were also signficantly related to adverse events. The c-index (a correlative index, with .5 showing no, and 1, a perfect, relationship) for bariatric surgery mortality with the Charlson index is .52. For the Elixhauser-based system we developed, it is .72. CONCLUSIONS: We have developed a new risk-adjustment tool for bariatric surgery outcomes studies that use administrative databases. Its performance was clearly better than that of the commonly used Charlson co-morbidity score. Bariatric studies that have used the Charlson index should not be considered adequately risk adjusted.