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Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta-Analysis With Trial Sequential

Nav Warraich1,2, Michel Pompeu Sá3, Xander Jacquemyn4

  • 1Division of Cardiac Surgery, Department of Cardiothoracic Surgery University of Pittsburgh Pittsburgh PA USA.

Journal of the American Heart Association
|March 21, 2025
PubMed
Summary

Cerebral embolic protection devices during transcatheter aortic valve implantation show no significant benefit for stroke or mortality. Current randomized controlled trial data is insufficient to draw definitive conclusions on stroke outcomes.

Keywords:
TAVIcerebral embolic protection devicesmeta‐analysistrial sequential analysis

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Area of Science:

  • Cardiovascular Interventions
  • Neurology
  • Medical Device Technology

Background:

  • Transcatheter aortic valve implantation (TAVI) is a growing procedure.
  • Cerebral embolic protection devices (CEPDs) aim to reduce stroke risk during TAVI.
  • Evidence on CEPD efficacy remains debated.

Purpose of the Study:

  • To reevaluate randomized controlled trial (RCT) data on CEPD use during TAVI.
  • To assess the impact of CEPDs on stroke and mortality outcomes.
  • To evaluate the strength of current evidence using meta-analysis and trial sequential analysis.

Main Methods:

  • Systematic search of RCTs evaluating CEPD use in TAVI.
  • Conventional meta-analysis using random-effects modeling.
  • Trial sequential analysis (TSA) to assess evidence robustness, futility, and required information size.

Main Results:

  • Seven RCTs with 4031 patients (2171 CEPD, 1860 no CEPD) were included.
  • No significant difference in all stroke (RR 0.85) or disabling stroke (RR 0.59) with CEPD use.
  • TSA indicated absence of evidence for all stroke and disabling stroke, and futility for all-cause mortality.

Conclusions:

  • Insufficient RCT data exists to provide conclusive meta-analytic findings on CEPD use for stroke outcomes in TAVI.
  • Further high-quality trials are needed to definitively establish the benefit of CEPDs.