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Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation

Rajesh K Kharbanda1,2,3, James Kennedy2, Zahra Jamal4

  • 1Department of Cardiovascular Medicine, John Radcliffe Hospital, Oxford, United Kingdom.

The New England Journal of Medicine
|March 31, 2025
PubMed

Insights

Routine use of cerebral embolic protection (CEP) devices during transcatheter aortic-valve implantation (TAVI) did not reduce stroke incidence. This randomized trial found no significant difference in stroke rates between TAVI with CEP and TAVI alone.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • Transcatheter aortic-valve implantation (TAVI) is linked to procedure-related strokes.
  • Cerebral embolic protection (CEP) devices are designed to mitigate this risk by reducing cerebral embolization.

Purpose of the Study:

  • To evaluate the efficacy of routine cerebral embolic protection (CEP) devices in reducing stroke incidence following transcatheter aortic-valve implantation (TAVI).

Main Methods:

  • A randomized, controlled trial involving 7635 participants undergoing TAVI across 33 UK centers.
  • Participants were assigned to TAVI with a CEP device or TAVI without a CEP device (control).
  • The primary outcome was stroke occurring within 72 hours post-TAVI or before hospital discharge.

Main Results:

  • The incidence of the primary outcome (stroke within 72 hours) was 2.1% in the CEP group and 2.2% in the control group (P=0.94).
  • Disabling stroke rates were 1.2% with CEP versus 1.4% in the control group.
  • Overall rates of death and access-site complications were similar between the groups.

Conclusions:

  • Routine use of cerebral embolic protection (CEP) devices does not significantly decrease the incidence of stroke within 72 hours after transcatheter aortic-valve implantation (TAVI).
  • Further research may be needed to identify specific patient subgroups who might benefit from CEP during TAVI.
Abstract

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