Valvular & structural heart disease

When absence of evidence equates to evidence of absence: the case of routine use of cerebral embolic protection devices in transcatheter aortic valve implantation

HeartPublished updated hierarchical Bayesian meta-analysis

Pooled result · All strokeResult — go to the resultMedian relative risk 0.94 95% CrI 0.72–1.25

Authors' conclusion

Current-generation CEP devices are ineffective in reducing periprocedural TAVI-stroke risk to a clinically relevant degree, rendering future trials with these devices futile.

Study context

Population
Patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)
Participants
11,590 patients8 randomised controlled trials (RCTs)
Comparison
Transfemoral TAVI with use of cerebral embolic protection (CEP) versus transfemoral TAVI without CEP
  • CEPn = 5,921
  • Controln = 5,669
Outcome
All stroke
Methodological detailssystematic search, randomised controlled trials (RCTs)
  • Systematic search
  • Randomised controlled trials (RCTs)

Pooled result

As reported in the abstract

Median relative risk

0.94

95% CrI 0.72–1.25

By group

Control

2.9%

prevalence

CEPvs control
median RR 0.94 (95% CrI 0.72–1.25)
Mean ARD
−0.17%
NNT
588
Posterior probability of a clinically relevant CEP effect
<1%

Further pooled results

OutcomeControlMedian RR (95% CrI)
Disabling stroke (secondary outcome)prevalence 1.4%0.76 (0.44–1.23)
Disabling stroke (secondary outcome) — mean ARD
−0.36%
Disabling stroke (secondary outcome) — NNT
278
Disabling stroke (secondary outcome) — posterior probability of a clinically relevant CEP effect
<1%

Original publication

When absence of evidence equates to evidence of absence: the case of routine use of cerebral embolic protection devices in transcatheter aortic valve implantation. Heart. Published 10 June 2025. doi:10.1136/heartjnl-2025-326208

Composed by AI from the published abstract and checked against it. How Briefs are made →

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