OBJECTIVE: This study examined whether extraction of particulate emboli using intra-aortic filtration could decrease neurologic outcomes. METHODS:Patients (N = 582) were enrolled in a prospective, controlled study and alternately assigned to the therapy arm (n = 304; intra-aortic filtration) or control arm (n = 278). Preoperative, procedural, and postoperative data were collected. Neurologic examinations included the National Institutes of Health Stroke Scale, Glasgow Coma Scale, and memory tests. Investigators administering neurologic tests were blinded to the study arm. By the use of logistic regression and propensity matching, composite neurologic outcomes (transient ischemic attack, stroke, delirium, coma, and memory deficit) were evaluated. RESULTS: Patients in the filter group experienced a lower incidence of adverse neurologic outcomes than patients in the control group (4.3% vs 11.9%) (P <.001). There were significantly less transient ischemic attacks (0% vs 1.4%), delirium (3.0% vs 6.5%), and memory deficit (1.3% vs 6.2%). There were fewer strokes in the filter group compared with the control group (0.7% vs 2.2%), although the sample size was too small for a significant finding. Both groups experienced 1 coma outcome. The use of a filter was associated with an adjusted odds ratio of 0.375, implying that a patient who does not receive a filter is 2.7 times more likely to experience an adverse neurologic event. Logistic modeling also demonstrated that there are increasing chances of poor neurologic outcome with increasing age. The model indicates that there may be an increasing protective benefit from the filter with increasing age, although the interaction was not significant. CONCLUSIONS: The extraction of particulate emboli using intra-aortic filtration resulted in decreased neurologic outcomes.
RCT Entities:
OBJECTIVE: This study examined whether extraction of particulate emboli using intra-aortic filtration could decrease neurologic outcomes. METHODS:Patients (N = 582) were enrolled in a prospective, controlled study and alternately assigned to the therapy arm (n = 304; intra-aortic filtration) or control arm (n = 278). Preoperative, procedural, and postoperative data were collected. Neurologic examinations included the National Institutes of Health Stroke Scale, Glasgow Coma Scale, and memory tests. Investigators administering neurologic tests were blinded to the study arm. By the use of logistic regression and propensity matching, composite neurologic outcomes (transient ischemic attack, stroke, delirium, coma, and memory deficit) were evaluated. RESULTS:Patients in the filter group experienced a lower incidence of adverse neurologic outcomes than patients in the control group (4.3% vs 11.9%) (P <.001). There were significantly less transient ischemic attacks (0% vs 1.4%), delirium (3.0% vs 6.5%), and memory deficit (1.3% vs 6.2%). There were fewer strokes in the filter group compared with the control group (0.7% vs 2.2%), although the sample size was too small for a significant finding. Both groups experienced 1 coma outcome. The use of a filter was associated with an adjusted odds ratio of 0.375, implying that a patient who does not receive a filter is 2.7 times more likely to experience an adverse neurologic event. Logistic modeling also demonstrated that there are increasing chances of poor neurologic outcome with increasing age. The model indicates that there may be an increasing protective benefit from the filter with increasing age, although the interaction was not significant. CONCLUSIONS: The extraction of particulate emboli using intra-aortic filtration resulted in decreased neurologic outcomes.
Authors: Caroline Banahan; Zach Rogerson; Clément Rousseau; Kumar V Ramnarine; David H Evans; Emma M L Chung Journal: Ultrasound Med Biol Date: 2014-09-11 Impact factor: 2.998