TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.
Abstract-More than 1.2 million percutaneous coronary interventions are performed annually in the United States, with only an estimated 33% performed in women, despite the established benefits of percutaneous coronary intervention and adjunctive pharmacotherapy in reducing fatal and nonfatal ischemic complications in acute myocardial infarction and high-risk acute coronary syndromes. This statement reviews sex-specific data on the safety and efficacy of contemporary interventional therapies in women. 1 Despite the fact that more women than men die from cardiovascular disease in the United States, and despite the established benefits of PCI in reducing fatal and nonfatal ischemic complications in patients with acute myocardial infarction and high-risk acute coronary syndromes, only an estimated 33% of annual PCIs are performed in women. [1][2][3][4] In addition, women experience greater delays 5 to intervention and are referred for diagnostic catheterization less frequently than are men. 6 -8 Although suggested reasons for referral differences have included women's older age at presentation, greater risk profile, and increased risk for an adverse procedural outcome, as well as differences in symptoms and pain perception between men and women and lower predictive accuracy of noninvasive testing in women, some evidence suggests a potential sex and race bias. 9 In contrast, once women are referred for cardiac catheterization, revascularization rates and practices are similar to those in men. 10 -12 Recent advances in angioplasty equipment and technique have improved options for patients with smaller coronary and peripheral (access) arteries. In addition, the increased use of stents and adjunctive pharmacotherapy has improved outcomes in both women and men. Nevertheless, women continue to represent 15% to 38% of the population in studies of PCI, and still relatively few sex-or race-specific data exist.The purpose of this statement is to review what is known and not known about PCI in women and to put published data in context with contemporary coronary intervention. It is not the intention of the writing group to give specific treatment recommendations but rather to compile and collate the available sex-specific data on the safety and efficacy of interventional therapies in women. Tables 1 and 3 provide summaries of the findings in women drawn from this literature review, as well as recommendations from previously published American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
MethodsThe information in this statement was compiled by systematic literature review. By searching MEDLINE from JanuaryThe American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perc...
Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.
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