Skip to main content
Top
Published in: Cardiovascular Intervention and Therapeutics 3/2022

13-11-2021 | Aortic Valve Replacement | Original Article

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

Authors: Junichi Shimamura, Toshiki Kuno, Aaqib Malik, Yujiro Yokoyama, Rahul Gupta, Hasan Ahmad, Alexandros Briasoulis

Published in: Cardiovascular Intervention and Therapeutics | Issue 3/2022

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference 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.CrossRef 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.CrossRef
2.
go back to reference 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.CrossRef 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.CrossRef
3.
go back to reference 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.CrossRef 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.CrossRef
4.
go back to reference 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.CrossRef 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.CrossRef
5.
go back to reference 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.CrossRef 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.CrossRef
6.
go back to reference Ahmad Y, Howard JP. Meta-analysis of usefulness of cerebral embolic protection during transcatheter aortic valve implantation. Am J Cardiol. 2021;146:69–73.CrossRef Ahmad Y, Howard JP. Meta-analysis of usefulness of cerebral embolic protection during transcatheter aortic valve implantation. Am J Cardiol. 2021;146:69–73.CrossRef
7.
go back to reference 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.CrossRef 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.CrossRef
10.
go back to reference 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.CrossRef 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.CrossRef
11.
go back to reference 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.CrossRef 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.CrossRef
12.
go back to reference 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.CrossRef 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.CrossRef
13.
go back to reference 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.CrossRef 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.CrossRef
14.
go back to reference 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.CrossRef 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.CrossRef
15.
go back to reference 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.CrossRef 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.CrossRef
16.
go back to reference 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.CrossRef 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.CrossRef
17.
go back to reference 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.CrossRef 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.CrossRef
19.
go back to reference 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.CrossRef 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.CrossRef
20.
go back to reference 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.CrossRef 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.CrossRef
21.
go back to reference 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.CrossRef 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.CrossRef
22.
go back to reference 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.CrossRef 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.CrossRef
24.
go back to reference 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.CrossRef 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.CrossRef
Metadata
Title
Safety and efficacy of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: a meta-analysis of in-hospital outcomes
Authors
Junichi Shimamura
Toshiki Kuno
Aaqib Malik
Yujiro Yokoyama
Rahul Gupta
Hasan Ahmad
Alexandros Briasoulis
Publication date
13-11-2021

Other articles of this Issue 3/2022

Cardiovascular Intervention and Therapeutics 3/2022 Go to the issue