Skip to main content

Advertisement

Log in

Safety and efficacy of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: a meta-analysis of in-hospital outcomes

  • Original Article
  • Published:
Cardiovascular Intervention and Therapeutics Aims and scope Submit manuscript

Abstract

The evidence regarding the impact of cerebral embolic protection devices (EPDs) on outcomes following transcatheter aortic valve replacement (TAVR) is limited. The objective of this study was to evaluate in-hospital outcomes with the use of cerebral EPDs in TAVR. We performed a comprehensive EMBASE and PUBMED search to investigate randomized control studies or propensity score-matched retrospective studies which assessed patients undergoing TAVR with or without EPD up to April 2021. Endpoints of interest were in-hospital mortality, stroke, acute kidney injury, pacemaker implantation, major bleeding, vascular complication, length of stay. Ten studies involving 173,002 patients with EPD (n = 16,898, 9.8%) and those without (n = 156,104, 90.2%) fulfilled the inclusion criteria. The use of EPD was associated with significantly lower risk of in-hospital stroke (odds ratio [95% confidential interval]: 0.64 [0.46; 0.89]), but similar rate of in-hospital mortality (odds ratio [95% confidential interval]: 0.75 [0.54; 1.05]). No differences were observed in acute kidney injury, pacemaker implantation, major bleeding, vascular complication, length of stay. EPD during TAVR was associated with lower in-hospital stroke but did not affect procedural complications and length of stay.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Gleason TG, Reardon MJ, Popma JJ, Deeb GM, Yakubov SJ, Lee JS, et al. 5-Year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol. 2018;72(22):2687–96.

    Article  Google Scholar 

  2. Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2485–91.

    Article  Google Scholar 

  3. Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, et al. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J Am Coll Cardiol. 2021;77(9):1149–61.

    Article  Google Scholar 

  4. Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2477–84.

    Article  Google Scholar 

  5. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med. 2020;382(9):799–809.

    Article  Google Scholar 

  6. Ahmad Y, Howard JP. Meta-analysis of usefulness of cerebral embolic protection during transcatheter aortic valve implantation. Am J Cardiol. 2021;146:69–73.

    Article  Google Scholar 

  7. Bagur R, Solo K, Alghofaili S, Nombela-Franco L, Kwok CS, Hayman S, et al. Cerebral embolic protection devices during transcatheter aortic valve implantation: systematic review and meta-analysis. Stroke. 2017;48(5):1306–15.

    Article  Google Scholar 

  8. Testa L, Latib A, Casenghi M, Gorla R, Colombo A, Bedogni F. Cerebral protection during transcatheter aortic valve implantation: an updated systematic review and meta-analysis. J Am Heart Assoc. 2018. https://doi.org/10.1161/JAHA.117.008463).

    Article  PubMed  PubMed Central  Google Scholar 

  9. Butala NM, Makkar R, Secemsky EA, Gallup D, Marquis-Gravel G, Kosinski AS, et al. Cerebral embolic protection and outcomes of transcatheter aortic valve replacement: results from the TVT registry. Circulation. 2021. https://doi.org/10.1161/CIRCULATIONAHA.120.052874.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.

    Article  Google Scholar 

  11. Kim SY, Park JE, Lee YJ, Seo HJ, Sheen SS, Hahn S, et al. Testing a tool for assessing the risk of bias for nonrandomized studies showed moderate reliability and promising validity. J Clin Epidemiol. 2013;66(4):408–14.

    Article  Google Scholar 

  12. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.

    Article  Google Scholar 

  13. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145(1):6–23.

    Article  Google Scholar 

  14. Alkhouli M, Alqahtani F, Harris AH, Hohmann SF, Rihal CS. Early experience with cerebral embolic protection during transcatheter aortic valve replacement in the United States. JAMA Intern Med. 2020;180(5):783–4.

    Article  Google Scholar 

  15. Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lücke C, Woitek F, et al. Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial. JAMA. 2016;316(6):592–601.

    Article  Google Scholar 

  16. Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol. 2017;69(4):367–77.

    Article  Google Scholar 

  17. Kroon HG, van der Werf HW, Hoeks SE, van Gils L, van den Berge FR, El Faquir N, et al. Early clinical impact of cerebral embolic protection in patients undergoing transcatheter aortic valve replacement. Circ Cardiovasc Interv. 2019;12(6):e007605.

    Article  Google Scholar 

  18. Lansky AJ, Makkar R, Nazif T, Messé S, Forrest J, Sharma R, et al. A randomized evaluation of the TriGuardTM HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial. Eur Heart J. 2021. https://doi.org/10.1093/eurheartj/ehab213.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Megaly M, Sorajja P, Cavalcante JL, Pershad A, Gössl M, Abraham B, et al. Ischemic stroke with cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2020;13(18):2149–55.

    Article  Google Scholar 

  20. Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, et al. Randomized evaluation of TriGuard 3 cerebral embolic protection after transcatheter aortic valve replacement: REFLECT II. JACC Cardiovasc Interv. 2021;14(5):515–27.

    Article  Google Scholar 

  21. Seeger J, Gonska B, Otto M, Rottbauer W, Wöhrle J. Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures. JACC Cardiovasc Interv. 2017;10(22):2297–303.

    Article  Google Scholar 

  22. Van Mieghem NM, van Gils L, Ahmad H, van Kesteren F, van der Werf HW, Brueren G, et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention. 2016;12(4):499–507.

    Article  Google Scholar 

  23. Yashima F, Briasoulis A, Kuno T, Noguchi M, Ahmad H, Zaid S, et al. Cerebral embolic protection during transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2021. https://doi.org/10.1016/j.carrev.2021.05.010.

    Article  PubMed  Google Scholar 

  24. Stachon P, Kaier K, Heidt T, Wolf D, Duerschmied D, Staudacher D, et al. The use and outcomes of cerebral protection devices for patients undergoing transfemoral transcatheter aortic valve replacement in clinical practice. JACC Cardiovasc Interv. 2021;14(2):161–8.

    Article  Google Scholar 

Download references

Funding

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Alexandros Briasoulis.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 397 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Shimamura, J., Kuno, T., Malik, A. et al. Safety and efficacy of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: a meta-analysis of in-hospital outcomes. Cardiovasc Interv and Ther 37, 549–557 (2022). https://doi.org/10.1007/s12928-021-00823-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12928-021-00823-1

Keywords

Navigation