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Valvular heart disease
Systematic review
Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis
  1. Samuel Heuts1,2,
  2. Andrea Gabrio3,4,
  3. Leo Veenstra5,6,
  4. Bart Maesen1,2,
  5. Suzanne Kats1,
  6. Jos G Maessen1,2,
  7. Antony S Walton7,8,
  8. Shane Nanayakkara7,8,9,
  9. Alexandra J Lansky10,
  10. Arnoud W J van 't Hof2,5,6,
  11. Pieter A Vriesendorp2,5
  1. 1Cardiothoracic Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands
  2. 2Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands
  3. 3Methodology and Statistics, Maastricht University, Maastricht, The Netherlands
  4. 4Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
  5. 5Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands
  6. 6Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands
  7. 7Cardiovascular Medicine, Alfred Hospital, Melbourne, Victoria, Australia
  8. 8Heart Failure Research Group, Baker Heart & Diabetes Institute, Melbourne, Victoria, Australia
  9. 9Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
  10. 10Yale Cardiovascular Research Group, Yale Medical School, New Haven, Connecticut, USA
  1. Correspondence to Dr Pieter A Vriesendorp, Maastricht University, Maastricht, 6229HX, The Netherlands; pvriesendorp{at}gmail.com

Abstract

Objectives The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis of randomised CEP trials, focusing on a clinically relevant reduction in disabling stroke.

Methods A systematic search was applied to three electronic databases, including trials that randomised TAVI patients to CEP versus standard treatment. The primary outcome was the risk of disabling stroke. Outcomes were presented as relative risk (RR), absolute risk differences (ARDs), numbers needed to treat (NNTs) and the 95% credible intervals (CrIs). The minimal clinically important difference was determined at 1.1% ARD, per expert consensus (NNT 91). The principal Bayesian meta-analysis was performed under a vague prior, and secondary analyses were performed under two informed literature-based priors.

Results Seven randomised studies were included for meta-analysis (n=3996: CEP n=2126, control n=1870). Under a vague prior, the estimated median RR of CEP use for disabling stroke was 0.56 (95% CrI 0.28 to 1.19, derived ARD 0.56% and NNT 179, I2=0%). Although the estimated posterior probability of any benefit was 94.4%, the probability of a clinically relevant effect was 0–0.1% under the vague and informed literature-based priors. Results were robust across multiple sensitivity analyses.

Conclusion There is a high probability of a beneficial CEP treatment effect, but this is unlikely to be clinically relevant. These findings suggest that future trials should focus on identifying TAVI patients with an increased baseline risk of stroke, and on the development of new generation devices.

PROSPERO registration number CRD42023407006.

  • Meta-Analysis
  • Biostatistics
  • Heart Valve Diseases

Data availability statement

Data are available upon reasonable request. Requests should be made to the corresponding author.

https://doi.org/10.1136/heartjnl-2023-323359

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    Data availability statement

    Data are available upon reasonable request. Requests should be made to the corresponding author.

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    Footnotes

    • Contributors SH—conceptualisation, data collection, methodology, analyses, writing manuscript, revisions. AG—methodology, analyses, revisions. LV—supervision, validation, revisions. BM—supervision, validation, revisions. SK—supervision, validation, revisions. JM—supervision, validation, revisions. AW—supervision, validation, revisions. SN—supervision, validation, revisions. AJL—data collection, supervision, validation, revisions. AvtH—supervision, validation, revisions. PAV—guarantor, conceptualisation, data collection, methodology, analyses, writing manuscript, revisions.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests AW reports proctoring fees from Medtronic, Edwards and Abbott; serves at the medical advisory board of Medtronic, Edwards and Abbott; and received grant support from Medtronic, Edwards and Abbott. AJL is the principal investigator of the Emboline Study. AvtH received unrestricted grants from Abbott, Roche, Medtronic, Boehringer Ingelheim and AstraZeneca. All other authors report no conflict of interest.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.