Project description:BackgroundCarotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke.MethodsWe randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization.ResultsFor 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85).ConclusionsAmong patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)
Project description:With the aging of the general population and the availability of noninvasive imaging studies, carotid artery stenosis is a disease commonly seen in general medical practice. Differentiation between symptomatic and asymptomatic disease is critical to the treatment course because the natural history differs markedly between them. Antiplatelet therapy and aggressive treatment of vascular risk factors are the mainstays of medical therapy. Class I evidence shows that carotid endarterectomy (CEA) is effective in preventing ipsilateral ischemic events in patients with symptomatic moderate- and high-grade stenosis. The procedure is also effective in selected patients with asymptomatic stenosis, but the benefit is marginal. In the past decade, carotid angioplasty and stenting has been proposed as a valid alternative to CEA. Currently, it is unclear whether carotid angioplasty and stenting is as safe as CEA in patients with carotid artery stenosis who need invasive treatment. Large clinical trials are under way to answer this question.
Project description:BackgroundAsymptomatic carotid artery stenosis (ACS) can be treated with carotid endarterectomy (CEA), carotid artery stenting (CAS), or best medical treatment (BMT) only. For all treatment options, optimization of vascular risk factors such as arterial hypertension, hyperlipidemia, smoking, obesity, and insufficient physical activity is essential. Data on adherence to BMT and lifestyle modification in patients with ACS are sparse. The subject of this investigation is the implementation and quality of risk factor adjustment in the context of a randomized controlled trial.MethodsA total of 513 patients in the prematurely terminated, randomized, controlled, multicenter SPACE-2 trial (ISRCTN 78592017) were analyzed within one year after randomization into 3 groups (CEA, CAS, and BMT only) for implementation of prespecified BMT recommendations and lifestyle modifications. Measurement time points were the screening visit and visits after one month (D30), 6 months (M6), and one year (A1). Differences between groups and follow-up visits (FUVs) relative to the screening visit were investigated.FindingsFor all FUVs, a significant increase in statin medication (91% at A1; p < 0.0001) was demonstrated to be associated with a significant decrease (p < 0.01) in cholesterol levels (median 167 mg/dl at A1) and LDL cholesterol levels (median 93 mg/dl at A1). The lowest cholesterol levels were achieved by patients in the BMT group. Seventy-eight percent of all patients reached predefined target cholesterol levels (< 200 mg/dl), with significantly better rates in the BMT group (p = 0.036 at D30). Furthermore, a significant decrease in arterial blood pressure at all FUVs (p < 0.05) was associated with a significant increase in antihypertensive medication (96% at A1, p < 0.0001). However, only 28% of patients achieved the predefined treatment goal of a systolic blood pressure of ≤ 130 mmHg. Forty-two of a total of 100 smokers at the screening visit quit smoking within one year, resulting in a significant increase in nonsmokers at all FUVs (p < 0.0001). Recommended HbA1c levels (< 7%) were achieved in 82% without significant changes after one year. Only 7% of obese (BMI > 25) patients achieved sufficient weight reduction after one year without significant changes at all FUVs (median BMI 27 at A1; p = 0.1201). The BMT group showed significantly (p = 0.024) higher rates of adequate physical activity than the intervention groups. Furthermore, after one year, the BMT group showed a comparatively significantly better implementation of risk factor modification (77%; p = 0.027) according to the treating physician.InterpretationSPACE-2 demonstrated sustained improvement in the noninterventional management of vascular risk factors in patients treated in a clinical trial by general practitioners, internists and neurologists. The best implemented treatment targets were a reduction in cholesterol and HbA1c levels. In this context, a significant increase in statin use was demonstrated. Blood pressure control missed its target but was significantly reduced by intensification of antihypertensive medication. Patients on BMT only had better adjusted lipid parameters and were more physically active. However, all groups failed to achieve sufficient weight reduction. Due to insufficient patient recruitment, the results must be interpreted cautiously.Trial registrationISRCTN Registry, ISRCTN78592017, Registered 16 June 2007, https://www.isrctn.com/search?q=78592017 .
Project description:Tinnitus is the usually unwanted perception of sound, in most cases there is no genuine physical source of sound. Less than 10% of tinnitus patients suffer from pulsatile tinnitus. Objective Pulsatile tinnitus can also be the first indication of dural arteriovenous fistula, so examination for such vascular origin must be performed.
Project description:This study was conducted in order to assess the effects of the compound Mycophenolate mofetil (MMF), an inhibitor of the enzyme inosine monophosphate dehydroxygenase (IMPDH) with a strong cytostatic effect on T-cells, on the phenotype of human carotid artery stenosis in humans in vivo. This was done at the transcriptome level by comparing the gene expression profiles of carotid endarterectomy samples from patients with carotid artery stenosis (>70% diameter stenosis on angiography) that were randomly assigned to treatment with MMF 1000 mg (N=9) or Placebo (N=11), respectively. MMF or placebo was given for at least 2 weeks prior to undergoing carotid endarterectomy (CEA).
Project description:We report the case of a 16-year-old boy with primary sclerosing cholangitis associated with inflammatory bowel disease who was initially treated and controlled pharmacologically. He underwent living donor liver transplantation (LDLT) after he developed progressive biliary tract abnormalities and portal hypertension accompanied by recurrent bile duct infections. Two months following LDLT, the hepaticojejunostomy anastomosis became occluded and it was treated surgically. Few weeks later, an increase in drain production persisted without focus; therefore, further diagnostic tests were conducted which proved the recurrence of biliary cast. Under sonographic guidance, external drainage of bile was carried out by percutaneous transhepatic cholangiography and drainage. In total, our patient underwent 5 interventions under general anesthesia and clinically, our patient's general condition improved, and he gained weight. Minimally invasive procedures such as percutaneous transhepatic cholangiography and drainage and balloon dilation are safe and effective, but may require several attempts before being successful.
Project description:Failure of the blood-brain barrier (BBB) is a critical event in the development and progression of diseases such as acute ischemic stroke, chronic ischemia or small vessels disease that affect the central nervous system. It is not known whether BBB breakdown in subjects with chronic carotid artery stenosis can be restrained with postoperative recovery of cerebral perfusion. The aim of the study was to assess the short-term effect of internal carotid artery stenting on basic perfusion parameters and permeability surface area-product (PS) in such a population. Forty subjects (23 males) with stenosis of >70% within a single internal carotid artery and neurological symptoms who underwent a carotid artery stenting procedure were investigated. Differences in the following computed tomography perfusion (CTP) parameters were compared before and after surgery: global cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), time to peak (TTP) and PS. PS acquired by CTP is used to measure the permeability of the BBB to contrast material. In all baseline cases, the CBF and CBV values were low, while MTT and TTP were high on both the ipsi- and contralateral sides compared to reference values. PS was approximately twice the normal value. CBF was higher (+6.14%), while MTT was lower (-9.34%) on the contralateral than on the ipsilateral side. All perfusion parameters improved after stenting on both the ipsilateral (CBF +22.66%; CBV +18.98%; MTT -16.09%, TTP -7.62%) and contralateral (CBF +22.27%, CBV +19.72%, MTT -14.65%, TTP -7.46%) sides. PS decreased by almost half: ipsilateral -48.11%, contralateral -45.19%. The decline in BBB permeability was symmetrical on the ipsi- and contralateral sides to the stenosis. Augmented BBB permeability can be controlled by surgical intervention in humans.
Project description:Population-based studies have estimated that about 15% of ischemic strokes are caused by large-vessel cerebrovascular disease. We determined the types of large-vessel atherosclerosis responsible for ischemic strokes in a population-based stroke study.Patients with first-ever or recurrent ischemic stroke in the Greater Cincinnati area were identified during 2005 at all local hospitals. Study physicians assigned ischemic stroke subtypes. Overall event rates and incidence rates for first-ever events were calculated, and age-, race- and sex-adjusted to the 2000 US population.There were 2,204 ischemic strokes, including 365 strokes of large-vessel subtype (16.6% of all ischemic strokes). Extracranial internal carotid artery (ICA) stenosis was associated with 8.0% of all ischemic strokes, while extracranial ICA occlusion and intracranial atherosclerosis were each associated with 3.5% of strokes. The annual rate of first-ever and recurrent stroke attributed to extracranial ICA was 13.4 (11.4-15.4) per 100,000 persons. We conservatively estimate that about 41,000 strokes may be attributed to extracranial ICA stenosis annually in the United States.Large-vessel atherosclerosis is an important cause of stroke, with extracranial ICA stenosis being significantly more common than extracranial ICA occlusion or intracranial atherosclerotic disease.
Project description:BackgroundSignificant genetic association has been found in patients with severe carotid artery stenosis (CAS). The present study wished to investigate if metabolites may also act as biomarkers for CAS.MethodsConsecutive patients with at least one carotid artery stenosis > = 60% on cerebral angiography were prospectively recruited from May 2007 to January 2016. Normal controls were recruited from outpatient clinic who had no stroke and coronary artery disease (CAD) history, and the brain magnetic resonance or computed tomographic angiography showed bilateral CAS < 30%. Risk factor profile, clinical characteristics, age, and clinical features were recorded. All subjects were male, and none had diabetes. 1H-NMR spectroscopy-based metabolomics analysis was carried out for plasma samples.ResultsTotally, 130 male subjects were recruited. Age had no significant difference between the controls and CAS group (60.2 ± 5.9 vs. 63.3 ± 6.0, p = 0.050). The CAS group had significantly higher frequency of CAD, hypertension, smoking and alcohol but lower body mass index than the controls (p < 0.05). The laboratory tests showed CAS group had significantly higher level of homocysteine but lower levels of cholesterol, high-density lipoprotein and hemoglobin than the controls (p < 0.05). The 1H-NMR based plasma metabolomics analysis indicated that choline was significantly lower in CAS patients. The VIP values of lipids were greater than 1.0, which were considered significantly different.ConclusionsOur results suggest homocysteine, choline and lipids in association with traditional risk factors may be involved in the pathogenesis of CAS. Diet adjustment to control homocysteine, choline and lipids may be helpful for the prevention of CAS.