Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation

Abstract

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...

Cerebral Embolic Protection in TAVI: Friend or Foe

“…With current techniques, successful deployment is achieved over 90% of cases, with success rates ranging from 64%–100%. [8] Materials captured by the filters include thrombus, arterial wall tissue, valve tissue, calcification and foreign material. [9–11] In the Cerebral Protection in Transcatheter Aortic Valve Replacement (SENTINEL) trial, histopathologic debris were found within filters in 99% of patients.…”

“…These devices aim to prevent procedural debris reaching the cerebral vasculature. CEPDs have been shown to be effective in the filtration of debris and decreasing the volume of ischaemic embolic lesions,[8] hence, with the potential for decreasing the risk of clinically evident CVA. In this article, we summarise the available data regarding CEPDs and their clinical significance.…”

Cerebrovascular Events After Transcatheter Aortic Valve Implantation

“…The current available evidence in relation to EPD are constituted by a series of observational and 5 randomized studies ( 31 , 58 , 74 – 76 ), which have been also combined in several meta-analysis ( 77 – 80 ). Main limitations of randomized trials have been the relatively low number of patients included and using surrogate events such as the number and volume of cerebral lesions as the primary endpoint, instead of clinical neurological events.…”

“…Several meta-analyses have combined the results of the observational and randomized studies. Surrogate end-point such as the number and volume of new brain lesions seemed to be reduced in favor of the EPD ( 77 , 80 ), although differences in the global rate of stroke or death is more controversial. While, some meta-analyses did not show any an statistical differences, other showed a reduction in the combined event of death or stroke using EPD, performing an analysis by the fixed-effects method ( 79 ).…”

Prediction of Stroke After Cardiac Catheterization: No Reason, No Stroke

“…Indeed, neurological complications due to embolization in transcatheter aortic valve implantation are relatively high 9 ) ; however, its risk factors are yet to be fully elucidated. Furthermore, the use of embolic protection devices still appears to be controversial 10 ) . Thus, the further understanding of possible risk factors and technical advances are also warranted to mitigate the risk of the latest procedure-related complications, including stroke.…”