Meta-Analysis of Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has evolved as an important treatment option for patients with severe symptomatic aortic stenosis. Despite advancements with device design, procedural techniques, and improved operator experience, stroke rates after TAVR have not declined (∼2.5%), as per the recent data from the national cardiovascular database registry. 1 Huded CP Tuzcu EM Krishnaswamy A Mick SL Kleiman NS Svensson LG Carroll J Thourani VH Kirtane AJ Manandhar P Kosinski AS Vemulapalli S Kapadia SR Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA. 2019; 321: 2306-2315 Crossref PubMed Scopus (44) Google Scholar Embolic protection devices (EPDs) were introduced to prevent embolization of thrombotic or calcified debris during TAVR. However, randomized controlled trials (RCTs) that investigated the efficacy and safety of these devices have been underpowered for clinical end points. 2 Haussig S Mangner N Dwyer MG Lehmkuhl L Lücke C Woitek F Holzhey DM Mohr FW Gutberlet M Zivadinov R Schuler G Linke A 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: 592-601 Crossref PubMed Scopus (188) Google Scholar , 3 Kapadia SR Kodali S Makkar R Mehran R Lazar RM Zivadinov R Dwyer MG Jilaihawi H Virmani R Anwaruddin S Thourani VH Nazif T Mangner N Woitek F Krishnaswamy A Mick S Chakravarty T Nakamura M McCabe JM Satler L Zajarias A Szeto WY Svensson L Alu MC White RM Kraemer C Parhizgar A Leon MB Linke A SENTINEL Trial InvestigatorsProtection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol. 2017; 69: 367-377 Crossref PubMed Scopus (254) Google Scholar , 4 Van Mieghem NM van Gils L Ahmad H van Kesteren F van der Werf HW Brueren G Storm M Lenzen M Daemen J van den Heuvel AFM Tonino P Baan J Koudstaal PJ Schipper MEI van der Lugt A de Jaegere PPT Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention. 2016; 12: 499-507 Crossref PubMed Scopus (105) Google Scholar , 5 Wendt D Kleinbongard P Knipp S Al-Rashid F Gedik N El Chilali K Schweter S Schlamann M Kahlert P Neuhäuser M Forsting M Erbel R Heusch G Jakob H Thielmann M Intraaortic protection from embolization in patients undergoing transaortic transcatheter aortic valve implantation. Ann Thorac Surg. 2015; 100: 686-691 Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar , 6 Lansky AJ Schofer J Tchetche D Stella P Pietras CG Parise H Abrams K Forrest JK Cleman M Reinöhl J Cuisset T Blackman D Bolotin G Spitzer S Kappert U Gilard M Modine T Hildick-Smith D Haude M Margolis P Brickman AM Voros S Baumbach A A prospective randomized evaluation of the TriGuardTM HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J. 2015; 36: 2070-2078 Crossref PubMed Scopus (192) Google Scholar The Randomized Evaluation of Triguard 3 Cerebral Embolic Protection after Transcatheter Aortic Valve Implantation (REFLECT II) trial was recently presented at the Transcatheter Cardiovascular Therapeutics annual scientific meeting. 7 Keystone HeartA Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation. clinicaltrials.gov, 2019https://clinicaltrials.gov/ct2/show/NCT02536196 Google Scholar Therefore, we performed an updated aggregate data meta-analysis of RCTs that evaluated EPDs during TAVR.