Browsing by keyword "Catheterization"
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Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolizationBACKGROUND AND PURPOSE: Brain aneurysms and vascular malformations can cause cerebral hemorrhages, with devastating consequences for the patients and their families. Since the development of microcatheters and materials used for endovascular embolization, we have witnessed a rapid advancement in the technology and in the number or patients treated with this approach. The aim of this review is to survey recent data relevant to new technologies and emerging treatment strategies in these areas. SUMMARY OF REVIEW: Clinical trials assessing the safety and efficacy of coil embolization for cerebral aneurysms were based on the use of bare platinum, helical coils. Since then, endovascular operators have been testing and using new materials such as bioactive coils, expandable coils, and complex-shaped coils. Based on the data so far obtained, third and fourth generation coil designs are rapidly emerging and will be ready for clinical application in the near future. Balloon- and stent-assisted coil embolization is enabling the treatment of complex, large-neck aneurysms and the vascular reconstruction of lesions previously considered not treatable. New open- and closed-cell designs allow the navigation and deployment of stents in extremely tortuous vessels. With regards to the embolization of vascular malformations, it is possible to safely navigate microcatheters and microwires through very small arteries previously considered not accessible. In addition, embolization materials such as n-butyl cyanoacrylate and ethylene-vinyl alcohol copolymer are now routinely injected to safely reduce or obliterate large and complex arteriovenous malformations and fistulae. CONCLUSIONS: Advancements in technology are rapidly improving the endovascular approach to the treatment of cerebral aneurysms and arteriovenous malformations.
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Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trialBACKGROUND AND PURPOSE: Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours. METHODS: The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis. RESULTS: Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81-1.67; P=0.407). The primary safety end point did not show a difference in serious adverse events (P=0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control (P=0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31-8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99-3.30), or older than age 70 years (OR, 2.02; CI, 1.02-4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4% = 17/230; 14.4% = 37/257). CONCLUSIONS: The trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00119717.
