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.
Similar content being viewed by others
References
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.
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.
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.
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.
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.
Ahmad Y, Howard JP. Meta-analysis of usefulness of cerebral embolic protection during transcatheter aortic valve implantation. Am J Cardiol. 2021;146:69–73.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Funding
None.
Author information
Authors and Affiliations
Corresponding author
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.
Rights and permissions
About this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12928-021-00823-1