Summary Background Clazosentan, an endothelin receptor antagonist, significantly and dose-dependently reduced angiographic vasospasm after aneurysmal subarachnoid haemorrhage (aSAH). We investigated ...whether clazosentan reduced vasospasm-related morbidity and all-cause mortality. Methods In this randomised, double-blind, placebo-controlled, phase 3 study, we randomly assigned patients with aSAH secured by surgical clipping to clazosentan (5 mg/h, n=768) or placebo (n=389) for up to 14 days (27 countries, 102 sites, inpatient and outpatient settings) using an interactive web response system. The primary composite endpoint (week 6) included all-cause mortality, vasospasm-related new cerebral infarcts, delayed ischaemic neurological deficit due to vasospasm, and rescue therapy for vasospasm. The main secondary endpoint was dichotomised extended Glasgow outcome scale (GOSE; week 12). This trial is registered with ClinicalTrials.gov , number NCT00558311. Findings In the all-treated dataset, the primary endpoint was met in 161 (21%) of 764 clazosentan-treated patients and 97 (25%) of 383 placebo-treated patients (relative risk reduction 17%, 95% CI −4 to 33; p=0·10). Poor functional outcome (GOSE score ≤4) occurred in 224 (29%) clazosentan-treated patients and 95 (25%) placebo-treated patients (−18%, −45 to 4; p=0·10). Lung complications, anaemia, and hypotension were more common with clazosentan. Mortality (week 12) was 6% in both groups. Interpretation Clazosentan at 5 mg/h had no significant effect on mortality and vasospasm-related morbidity or functional outcome. Further investigation of patients undergoing endovascular coiling of ruptured aneurysms is needed to fully understand the potential usefulness of clazosentan in patients with aSAH. Funding Actelion Pharmaceuticals.
To compare the clinical safety and efficiency of two optional inferior vena cava (IVC) filters.
Ninety-three consecutive Günther Tulip filters (92 patients) were compared with 83 consecutive OptEase ...filters (80 patients). Filters were placed at the same institution in patients with high-risk multiple trauma or those undergoing neurosurgery with contraindications to primary prophylaxis (70 patients in the Günther Tulip group and 44 in the OptEase group) and in patients with venous thromboembolism and contraindications to anticoagulation (22 patients in the Günther Tulip group and 36 in the OptEase group). The filters were placed in an angiography suite. Catheter vena cavography was performed before filter placement and intended retrieval. Permanent filters were followed-up with duplex ultrasonography and conventional radiography.
All filters were inserted infrarenally without any complications. Fluoroscopy times for placement and retrieval were longer for the Günther Tulip group than the OptEase group. The mean dwelling time was 11 days (range, 3-27 days) for the Günther Tulip filters and 13.8 days (range, 1-34 days) for the OptEase filters. No symptomatic pulmonary emboli (PE) occurred in patients with intended temporary filtration while the devices were in place. Forty-six of the 93 Günther Tulip filters (49%) and 58 of the 83 OptEase filters (70%) were removed. Two Günther Tulip filters could not be retrieved for technical reasons. The mean follow-up for the permanent Günther Tulip (n = 19) and OptEase (n = 8) filters was 41 and 7 months, respectively. One patient from each group had late caval thrombosis. There were no cases of filter migration or disintegration.
Both optional IVC filters are safe and seem to prevent symptomatic PE. On the basis of the fluoroscopy times, the OptEase filters appear to be more operator-friendly. Late filter-associated complications are rare with these filter designs.
We report the case of a 50-year-old man who experienced acute cardiac arrest after transsphenoidal resection of a pituitary adenoma. The cardiopulmonary reanimation was successful, but following ...cranial computed tomography (CT) scans showed an unusual complication of the cardiopulmonary reanimation: the inadvertent intracranial placement of the Wendl tube. Because the endoscopic transsphenoidal approach to the sellar region is a routine neurosurgical procedure, we would like to alert physicians of this unusual complication during cardiopulmonary reanimation.
Objectives The aim of this study was to report the results of an international multicenter experience of cardiac magnetic resonance imaging (MRI) evaluation of cardiac tumors in children, each with ...histology correlation or a diagnosis of tuberous sclerosis, and to determine which characteristics are predictive of tumor type. Background Individual centers have relatively little experience with diagnostic imaging of cardiac tumors in children, because of their low prevalence. The accuracy of cardiac MRI diagnosis on the basis of a pre-defined set of criteria has not been tested. Methods An international group of pediatric cardiac imaging centers was solicited for case contribution. Inclusion criteria comprised: 1) age at diagnosis ≤18 years; 2) cardiac MRI evaluation of cardiac tumor; and 3) histologic diagnosis or diagnosis of tuberous sclerosis. Data from the cardiac MRI images were analyzed for mass characteristics. On the basis of pre-defined cardiac MRI criteria derived from published data, 3 blinded investigators determined tumor type, and their consensus diagnoses were compared with histologic diagnoses. Results Cases (n = 78) submitted from 15 centers in 4 countries had the following diagnoses: fibroma (n = 30), rhabdomyoma (n = 14), malignant tumor (n = 12), hemangioma (n = 9), thrombus (n = 4), myxoma (n = 3), teratoma (n = 2), and paraganglioma, pericardial cyst, Purkinje cell tumor, and papillary fibroelastoma (n = 1, each). Reviewers who were blinded to the histologic diagnoses correctly diagnosed 97% of the cases but included a differential diagnosis in 42%. Better image quality grade and more complete examination were associated with higher diagnostic accuracy. Conclusions Cardiac MRI can predict the likely tumor type in the majority of children with a cardiac mass. A comprehensive imaging protocol is essential for accurate diagnosis. However, histologic diagnosis remains the gold standard, and in some cases malignancy cannot be definitively excluded on the basis of cardiac MRI images alone.
Abstract Background Recent studies suggest that high-dose MgSO4 therapy is safe and reduces the incidence of DIND and subsequent poor outcome after SAH. We intended to assess the safety and efficacy ...of high-dose MgSO4 therapy after SAH as means to prevent DIND and to evaluate the impact on clinical outcome. Methods This was a prospective, randomized, single-blind, placebo-controlled study. The MgSO4 infusion was adjusted every 12 hours until day 12 according to the target serum Mg2+ level. The occurrence of DIND, secondary infarction, side effects, and the outcome after 3 and 12 months were assessed. Results Fifty-eight patients were randomized; 27 received placebo and 31 MgSO4 . The difference in occurrence of DIND and secondary infarction was not significant. The intention-to-treat analysis revealed a trend toward better outcome ( P = .083) after 3 months. On-treatment analysis showed a significantly better outcome after 3 months ( P = .017) and a trend toward better outcome after 1 year ( P = .083). Significantly more often hypotension ( P = .040) and hypocalcemia ( P = .005) occurred as side effects in the treatment group. In 16 patients (52%), the MgSO4 therapy had to be stopped before day 12 because of side effects. No predictive factor leading to termination was found in a postrandomization analysis. Conclusions High-dose MgSO4 therapy might be efficient as a prophylactic adjacent therapy after SAH to reduce the risk for poor outcome. Nevertheless, because of the high frequency of the side effects, patients should be observed in an intensive or intermediate care setting.
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