ABBREVIATIONS: ASPECTS ϭ Alberta Stroke Program Early Computed Tomography Score; EVT ϭ endovascular therapy; mRS ϭ modified Rankin Scale; mTICI ϭ modified thrombolysis in cerebral infarction; NIHSS ϭ National Institutes of Health Stroke Scale; QI ϭ quality improvement; SAH ϭ subarachnoid hemorrhage; SICH ϭ symptomatic intracranial hemorrhage; SITS-MOST ϭ Safe Implementation of Thrombolysis in Stroke Monitoring Study; TICI ϭ thrombolysis in cerebral infarction; TIMI ϭ thrombolysis in myocardial infarction; TPA ϭ tissue plasminogen activator E ndovascular therapy (EVT) for acute ischemic stroke in selected patients has recently been proved effective in several clinical trials, and the widespread adoption of thrombectomy into routine clinical practice has begun. However, these acute stroke services are resource-intensive, including advanced cerebral im-aging and highly trained multidisciplinary hospital teams rapidly responding to emergency activation. Despite the previous acceptance of intravenous fibrinolysis for acute ischemic stroke and the development of designated stroke centers, 1 ischemic stroke remains a leading cause of adult death and disability. 2 Many patients are not candidates for fibrinolysis, and intravenous therapy is relatively ineffective for severe strokes as a result of large cerebral artery occlusions. Moreover, it is uncertain if the benefits of endovascular stroke treatment in the trial setting can be generalized to clinical care provided by hospitals and teams of varying training, experience, and case volume. In other medical disciplines, rapid technologic advancement required guidelines to utilize these tools effectively and responsibly. 3 Quality-improvement (QI) metrics for the outcomes of endovascular ischemic stroke treatment were published by a multisociety, multispecialty, international consensus group in 2013. 4 These QI metrics have been accepted at a national level in Great Britain and Ireland 5 but have yet to be included into stroke center accreditation requirements in the United States. Subsequent to the publication of the prior QI guidelines, eight randomized trials and several meta-analyses of EVT have been published. 6-20 These randomized trials have established EVT as standard of care when available, 5,21-23 and provide additional data on which to update the metrics and bench-
The purpose of this article is to review and update the current status of carotid artery stent placement in the world. Surveys to major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent information from these 24 centers in addition to 12 new centers has been obtained to update the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 5,210 procedures involving 4,757 patients. There was a technical success of 98.4% with 5,129 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 134 transient ischemic attacks (TIAs) for a rate of 2.82%. Based on the total patient population, there were 129 minor strokes with a rate of occurrence of 2.72%. The total number of major strokes was 71 for a rate of 1.49%. There were 41 deaths within a 30-day postprocedure period resulting in a mortality rate of 0.86%. The combined minor and major strokes and procedure-related death rate was 5.07%. Restenosis rates of carotid stenting have been 1.99 % and 3.46% at 6 and 12 months, respectively. The rate of neurologic events after stent placement has been 1.42% at 6 -12-month follow-up. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients that are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have not changed significantly since the first survey results. Cathet. Cardiovasc. Intervent. 50:160 -167, 2000.
for the FilterWire EX Randomized Evaluation (FIRE) InvestigatorsBackground-The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established. Methods and Results-A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (Pϭ0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, Pϭ0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]ϭϪ1.7% [Ϫ6.4%, 3.1%]; P for superiorityϭ0.53, P for noninferiorityϭ0.0008). Conclusions-Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days. (Circulation. 2003;108:548-553.)
Background:In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the lowprofile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods:Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. conclusions:In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.
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