Evidence map›Paper›PMID 38837174›Full record

ArticleCirculation. Cardiovascular interventions2024

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Neel M Butala, Samir R Kapadia, Eric A Secemsky, Dianne Gallup, Andrzej S Kosinski, Sreekanth Vemulapalli, John C Messenger, Robert W Yeh, David J Cohen

Abstract readMulticenter Study
In one paragraph

Article in Circulation. Cardiovascular interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Efficacy of Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Cerebrovascular Events in Aortic Stenosis: From Native Valve Disease to TAVR-Specific Risk and Prevention.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Review
  6. Article
  7. Article
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  11. Review
  12. Review
  13. Article
  14. Cerebral Embolic Protection Device Use, Stroke, and Disabling Stroke in TAVR Before and After PROTECTED-TAVR.Journal of the Society for Cardiovascular Angiography & Interventions · 2025
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Neel M ButalaRocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.).ORCID 0000-0001-6937-4041
Samir R KapadiaCleveland Clinic Foundation, OH (S.K.).ORCID 0000-0002-0026-3391
Eric A SecemskyRichard and Susan Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., R.W.Y.).ORCID 0000-0003-3861-3163
Dianne GallupDuke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.).ORCID 0009-0000-1763-6687
Andrzej S KosinskiDuke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.).ORCID 0000-0003-4151-5185
Sreekanth VemulapalliDuke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.).ORCID 0000-0003-1599-2957
John C MessengerUniversity of Colorado School of Medicine, Aurora (N.M.B., J.C.M.).ORCID 0000-0003-0501-1000
Robert W YehRichard and Susan Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., R.W.Y.).ORCID 0000-0002-0564-4468
David J CohenCardiovascular Research Foundation, New York (D.J.C.).ORCID 0000-0001-9163-724X

Funding

Use of Registries, Claims and Health System Data to Enhance the Evaluation of Cardiovascular Therapies in Clinical TrialsR01HL136708 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Issa J. Dahabreh, Robert Yeh · 2017 to 2026
$6.9M
Using Claims-Based Signatures of Frailty to Support Individualized Treatment of Aortic Valve Stenosis and Coronary Artery DiseaseK24HL150321 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Robert Yeh · 2020 to 2026
$862k
Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
NHLBI NIH HHS K23 HL150290NHLBI NIH HHS K24 HL150321NHLBI NIH HHS R01 HL136708
6 · The paper itself

Abstract

backgroundCerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear.

methodsWe used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis.

resultsThe study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (

conclusionsIn the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Indexed as

Aortic Valve StenosisEmbolic Protection DevicesRegistriesTranscatheter Aortic Valve ReplacementAgedAged, 80 and overDisability EvaluationFemaleHospital MortalityHumansIntracranial EmbolismMaleProtective FactorsRetrospective StudiesRisk AssessmentRisk Factorsclinical studiesdeathinstrumental variableoutcomes researchstroketranscatheter aortic valve replacement

Identifiers

PMID38837174
PMCPMC11408089

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.