T ranscatheter aortic valve implantation (TAVI) procedures have been associated with silent ischemic cerebral embolism as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) or high-intensity transient signals as assessed by transcranial Doppler. [1][2][3][4][5][6] Embolic protection devices (EPD) might reduce the risk of cerebral embolic ischemic lesions, either clinically evident cerebrovascular accidents or silent ischemic lesions in patients undergoing TAVI. Nonetheless, the efficacy of EPD in the TAVI setting has only been investigated in studies with relatively small sample sizesBackground and Purpose-Silent ischemic embolic lesions are common after transcatheter aortic valve implantation (TAVI). The use of embolic protection devices (EPD) may reduce the occurrence of these embolic lesions. Thus, a quantitative overview and credibility assessment of the literature was necessary to draw a robust message about EPD. Therefore, the aim of this meta-analysis was to study whether the use of EPD reduces silent ischemic and clinically evident cerebrovascular events associated with TAVI. Methods-We conducted a comprehensive search to identify studies that evaluated patients undergoing TAVI with or without EPD. Random-effects meta-analyses were performed to estimate the effect of EPD compared with no-EPD during TAVI using aggregate data. Results-Sixteen studies involving 1170 patients (865/305 with/without EPD) fulfilled the inclusion criteria. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. Meta-analyses evaluating EPD versus without EPD strategies could not confirm or exclude any differences in terms of clinically evident stroke (relative risk, 0.70; 95% confidence interval [CI], 0.38-1.29; P=0.26) or 30-day mortality (relative risk, 0.58; 95% CI, 0.20-1.64; P=0.30). There were no significant differences in new-single, multiple, or total number of lesions. The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, −0.52; 95% CI, −0.85 to −0.20; P=0.002) and smaller total volume of lesions (standardized mean difference, −0.23; 95% CI, −0.42 to −0.03; P=0.02). Subgroup analysis by type of valve showed an overall trend toward significant reduction in new lesions per patient using EPD (standardized mean difference, −0.41; 95% CI, −0.82 to 0.00; P=0.05), driven by self-expanding devices. Conclusions-The use of EPD during TAVI may be associated with smaller volume of silent ischemic lesions and smaller total volume of silent ischemic lesions. However, EPD may not reduce the number of new-single, multiple, or total number of lesions. There was only very low quality of evidence showing no significant differences between patients undergoing TAVI with or without EPD with respect to clinically evident stroke and mortality. that are underpowered for the end points studied and, thus, subject to selection biases. Hence, a comprehensive systematic review with a rigorous methodology for quality and credibilit...
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