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The use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation (TAVI). Available evidences from single studies are quite inconclusive. The aim of the present meta-analysis was to assess the safety and efficacy profile of current EPD.
EMBASE, PubMed, Web of Science Core Collection, and the Cochrane Library were searched up to May 2017 for studies that evaluated patients undergoing TAVI with or without EPD. Endpoint of interest were: 30-day mortality, 30-day stroke, new-single, new multiple and total number of lesions, ischemic volume per lesion and total volume of lesions.
13 studies involving 1040 patients were included. Overall, the EPD delivery success rate was 94.5%. No differences in terms of clinically evident stroke (OR 0.70 (0.48–1.2; P=0.26), or 30-day mortality (OR 0.64 (0.430–1.54), P=0.30). was observed between patients treated with EPDs versus patient who did not. There were no significant differences in new-single (OR 0.8 (0.55-1.4, p=0.7)), multiple (OR 0.66, (0.44-1.42), p=0.6), or total number of lesions (OR 0.88 (0.42-1.38),p=0.8). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, (−0.52 (−0.85)- (−0.20); P=0.002) and smaller total volume of lesions (standardized mean difference, (−0.23; (−0.42) - (−0.03); P=0.02). A trend towards the reduction in new lesions per patient using EPD (standardized mean difference, −0.41; 95% CI, −0.82 to 0.00; P=0.05), was found for self-expanding devices.
The use of EPD is not associated with a reduced rate of stroke and mortality. Moreover, EPD seem unable to reduce the number of new-single, multiple, or total number of cerebral embolic lesions. The use of EPD during TAVI is associated with smaller volume of silent ischemic lesions and smaller total volume of silent ischemic lesions. Available evidences are of low quality.
STRUCTURAL: Valvular Disease: Aortic