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Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism.

ABSTRACT: Cerebrovascular events following transcatheter aortic valve implantation (TAVI) is one of the most devastating complications. Several studies with magnetic resonance or cerebral filters have demonstrated the universal brain embolization after TAVI, in the majority of patients clinically silent. Embolic protection devices (EPD) have been developed as a mechanical barrier to prevent these emboli to reach cerebral vasculature and potentially reduce neurological events. We review the current evidence about EPD in relation to histopathological and cerebral imaging findings and neurological events.

SUBMITTER: Nombela-Franco L

PROVIDER: S-EPMC6242920 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism.

Nombela-Franco Luis L Armijo German G Tirado-Conte Gabriela G

Journal of thoracic disease 20181101 Suppl 30

Cerebrovascular events following transcatheter aortic valve implantation (TAVI) is one of the most devastating complications. Several studies with magnetic resonance or cerebral filters have demonstrated the universal brain embolization after TAVI, in the majority of patients clinically silent. Embolic protection devices (EPD) have been developed as a mechanical barrier to prevent these emboli to reach cerebral vasculature and potentially reduce neurological events. We review the current evidenc ...[more]

PMID: 30505542

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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.

Project description:BackgroundStroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited.MethodsWe performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights.ResultsOur analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses.ConclusionsIn this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.

Dataset Information

Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism.

Publications

Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism.

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