Citations

Abstract. Acute limb ischemia (ALI), a subclass of critical limb ischemia, is a medical emergency. The cause of ALI is usually thrombotic or embolic in nature, and the specific etiology often dictates the appropriate therapy. While the diagnosis is a clinical with common presenting symptoms, advances in ultrasound, computed tomography, and magnetic resonance technology have impacted the diagnosis and subsequent therapy. In ALI, the time to revascularization is critical and computed tomography angiography (CTA) provides a highly sensitive and specific technique for rapidly identifying occlusions and precisely defining vascular anatomy prior to interventions. In patients with significant renal disease, magnetic resonance angiography with or without contrast provides effective alternatives at the expense of imaging time. Treatment can include a variety of endovascular or surgical interventions, including thromboembolectomy, angioplasty, or bypass. Proper evaluation of the etiology of the ischemia, affected vasculature, and medical history is critical to select appropriate treatment and improve patient outcomes. Here, we examine the presentation, evaluation, and treatment of ALI and the role of CTA in diagnosis and therapy.

Purpose: To examine the association of obesity with in-hospital mortality and complications during critical illness. Methods: We performed a retrospective analysis of a multiethnic cohort of 699 patients admitted to medical intensive care unit between January 2010 and May 2011 at Mount Sinai St. Luke’s and Mount Sinai West Hospitals, tertiary care centers in New York City. Multivariate logistic regression analysis was used to evaluate the association between obesity (body mass index [BMI] ≥ 30] and in-hospital mortality. Subgroup analysis was performed in elderly patients (age ≥65 years). Results: Compared to normal BMI, obese patients had lower in-hospital mortality (24.4% vs 17.6%, P = .04). On multivariate analysis, obesity was independently associated with lower in-hospital mortality (odds ratio [OR]: 0.49, 95% confidence interval [CI]: 0.27-0.89, P = .018). There was no significant difference in rates of mechanical ventilation, reintubation, and vasopressor requirement across BMI categories. In subgroup analysis, elderly obese patients did not display lower in-hospital mortality (adjusted OR: 0.85, 95% CI: 0.40-1.82, P = .68). Conclusion: Our study supports the hypothesis that obesity is associated with decreased mortality during critical illness. However, this finding was not observed among elderly obese patients. Further studies should explore the interaction between age, obesity, and outcomes in critical illness.

Abstract Learning Objectives Discuss methods for improving the efficiency of global clinical trials. Explain the need for national regulatory authorities and collaborative cancer groups to initiate efforts to quicken the activation process in their countries. Describe the activation process of phase III studies and its complex and heterogeneous regulation across different geographic and economic regions. Purpose. This study measured the time taken for setting up the different facets of Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), an international phase III study being conducted in 44 participating countries. Methods. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected in the ALTTO study. Analyses were conducted by grouping countries into either geographic regions or economic classes as per the World Bank's criteria. Results. South America had a significantly longer time to RA approval (median: 236 days, range: 21–257 days) than Europe (median: 52 days, range: 0–151 days), North America (median: 26 days, range: 22–30 days), and Asia-Pacific (median: 62 days, range: 37–75 days). Upper-middle economies had longer times to RA approval (median: 123 days, range: 21–257 days) than high-income (median: 47 days, range: 0–112 days) and lower-middle income economies (median: 57 days, range: 37–62 days). No significant difference was observed for time to EC/IRB approval across the studied regions (median: 59 days, range 0–174 days). Overall, the median time from EC/IRB approval to first recruited patient was 169 days (range: 26–412 days). Conclusion. This study highlights the long time intervals required to activate a global phase III trial. Collaborative research groups, pharmaceutical industry sponsors, and regulatory authorities should analyze the current system and enter into dialogue for optimizing local policies. This would enable faster access of patients to innovative therapies and enhance the efficiency of clinical research.