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Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis.

ABSTRACT: BACKGROUND:The use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta-analysis was to assess the safety and efficacy profile of current EPD. METHODS AND RESULTS:Major medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implantation with or without EPD. End points of interest were 30-day mortality, 30-day stroke, the total number of new lesions, the ischemic volume per lesion, and the total volume of lesions. Eight studies involving 1285 patients were included. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. The use of EPD was not associated with significant differences in terms of 30-day mortality (odds ratio 0.43 [0.18-1.05], P=0.3) but it was associated with a lower rate of 30-day stroke (odds ratio 0.55 [0.31-0.98], P=0.04). No differences were detected with respect to the number of new lesions (standardized mean difference -0.19 [-0.71 to 0.34], P=0.49). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, -0.52 [-0.85 to -0.20], P=0.002) and smaller total volume of lesions (standardized mean difference, -0.23 [-0.42 to -0.03], P=0.02). CONCLUSIONS:The use of EPD is not associated with a reduced rate of mortality and new ischemic cerebral lesions. The use of EPD during transcatheter aortic valve implantation seems to be associated with a lower 30-day stroke rate, although this result is driven by a single nonrandomized study. The use of EPD is associated with a smaller volume of ischemic lesions, and smaller total volume of ischemic lesions.

SUBMITTER: Testa L

PROVIDER: S-EPMC6015324 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis.

Testa Luca L Latib Azeem A Casenghi Matteo M Gorla Riccardo R Colombo Antonio A Bedogni Francesco F

Journal of the American Heart Association 20180504 10

<h4>Background</h4>The use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta-analysis was to assess the safety and efficacy profile of current EPD.<h4>Methods and results</h4>Major medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implant ...[more]

PMID: 29728369

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Project description:BackgroundThe use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data.AimsThis updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System.MethodsA literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period - overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications.ResultsA total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted.ConclusionsIn this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

Dataset Information

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis.

Publications

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis.

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