SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.
This study demonstrates that the addition of AVF Qa monitoring to clinical screening for AVF stenosis resulted in a non-significant doubling in the detection of angiographically significant AVF stenosis. Further, large multi-centre randomized trials are feasible and will be necessary to confirm whether Qa surveillance and the correction of detected AVF stenosis will lead to a reduction in AVF thrombosis and increased AVF survival.
Despite the increasing number of patients with the human immunodeficiency virus (HIV) infection. surgical experience with these patients remains limited. A retrospective review over a 9 year period (January 1985 to December 1993) was undertaken to determine the indications, operative management. pathologic findings and outcome of major abdominal surgery in these patients. A total of 51 procedures were performed in 45 patients; 30 patients had acquired immunodeficiency syndrome (AIDS) and IS patients had asymptomatic HIV infection. Indications included gastrointestinal bleeding. complicated pancreatic pseudocysts. cholelithiasis. bowel obstruction, immune disorders, acute abdomens. elective laparotomy. colostomy formation. menorrhagia and Caesarean section. Pathologic findings directly related to the HIV infection were found in 81% of the AIDS patients and 35% of the asymptomatic HIV infected patients (P<0.05). These included opportunistic infections. non‐Hodgkin's lymphoma. Kaposi's sarcoma, immune disorders. lymphadenopathy and pancreatic pseudocysts. It was noted that AIDS patients had more complications than asymptomatic HIV infected patients with most complications related to chest problems and sepsis (61 vs 7%; P<0.01). Emergency operations carried a higher complication rate than elective operations though this was not significant. The hospital mortality was 12%. On follow up, 13 of the 25 AIDS patients had died with the median survival of 7 months, while three of the 14 asymptomatic HIV infected patients had died with the median survival of 40 months. Of the remaining patients, the 12 AIDS patients had a median postoperative follow up of 7 months and the 11 asymptomatic HIV infected patients had a median postoperative follow up of 29.5 months. Despite impaired immune function, surgical treatment of HIV infected patients with abdominal pathology can be practised with acceptable mortality and morbidity and be of major benefit to these patients.
Diabetic foot ulcers present across the spectrum of nonhealing wounds, be it acute or many months duration. There is developing literature highlighting that despite this group having high caloric intake, they often lack the micronutrients essential for wound healing. This study reports a retrospective cohort of patients’ micro- and macro-nutritional state and its relationship to amputation. A retrospective cohort was observed over a 2-month period at one of Australia’s largest tertiary referral centers for diabetic foot infection and vascular surgery. Patient information, duration of ulcer, various biochemical markers of nutrition and infection, and whether the patient required amputation were collected from scanned medical records. A cohort of 48 patients with a broad-spectrum of biochemical markers was established. Average hemoglobin A1c (HbA1c) was 8.6%. A total of 58.7% had vitamin C deficiency, including 30.4% with severe deficiency, average 22.6 Ł} 5.8 μmol/L; 61.5% had hypoalbuminemia, average albumin 28.7 Ł} 2.5 g/L. Average vitamin B12 was 294.6 Ł} 69.6 pmol/L; 57.9% had low vitamin D, average 46.3 Ł} 8.3 nmol/L. Basic screening scores for caloric intake failed to suggest this biochemical depletion. There was a 52.1% amputation rate; biochemical depletion was associated with risk of amputation with vitamin C ( P < .01), albumin ( P = .03), and hemoglobin ( P = .01), markedly lower in patients managed with amputation than those managed conservatively. There was no relation between duration of ulceration and nutrient depletion. Patients with diabetic foot ulceration rely on multidisciplinary care to optimize their wound healing. An important but often overlooked aspect of this is nutritional state, with micronutrients being very important for the healing of complex wounds. General nutritional screening often fails to identify patients at risk of micronutrient deficiency. There is a high prevalence of vitamin deficiency in patients with diabetic foot ulcers. This presents an excellent avenue for future research to assess if aggressive nutrient replacement can improve outcomes in this cohort of patients.
Significant hypotension, measured by the need for perioperative vasopressor use was associated with EPAT, suggesting that maintenance of higher perfusion pressures may avoid this complication.
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