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Cerebral Protection Devices during Transcatheter Interventions: Indications, Benefits, and Limitations.

ABSTRACT: PURPOSE OF REVIEW:Stroke remains a devastating complication of cardiovascular interventions. This review is going to discuss stroke rates and outcomes in different cardiovascular procedures with a highlight on the current evidence for the use of cerebral protection devices (CPD). RECENT FINDINGS:Depending on the quality of neurological assessment, stroke occurs in up to 9.1% after TAVI, 3.9% after mitral clipping, 3.1% in LAAO patients, 0.4% after PCIs, and 1.8% after catheter ablation. CPDs are available for routine use. They are easy to use in most anatomies, feasible, and safe. Data on clinical impact and stroke reduction from RCTs are still missing. Most evidence for the routine use of CPDs exists in TAVI patients, who are at the highest risk. The PROTECTED TAVI RCT will shed more light on the clinical impact of CPD-use in TAVI patients. In other cardiovascular procedures like mitral clipping, PCIs, and ablation, the current data do not support the routine use of CPDs in these patients.

SUBMITTER: Haussig S

PROVIDER: S-EPMC7351861 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Cerebral Protection Devices during Transcatheter Interventions: Indications, Benefits, and Limitations.

Haussig Stephan S Linke Axel A Mangner Norman N

Current cardiology reports 20200710 9

<h4>Purpose of review</h4>Stroke remains a devastating complication of cardiovascular interventions. This review is going to discuss stroke rates and outcomes in different cardiovascular procedures with a highlight on the current evidence for the use of cerebral protection devices (CPD).<h4>Recent findings</h4>Depending on the quality of neurological assessment, stroke occurs in up to 9.1% after TAVI, 3.9% after mitral clipping, 3.1% in LAAO patients, 0.4% after PCIs, and 1.8% after catheter abl ...[more]

PMID: 32651654

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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 Protection Devices during Transcatheter Interventions: Indications, Benefits, and Limitations.

Publications

Cerebral Protection Devices during Transcatheter Interventions: Indications, Benefits, and Limitations.

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