Routine use of cerebral protection devices during transcatheter aortic valve implantation: what does the evidence say?

Abstract

Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic severe aortic stenosis in intermediate and high-risk patients. However, as TAVI indications increase, concerns regarding adverse events and complications rise in the same proportion. Stroke is one of the most feared TAVI complications and a hard endpoint present in all TAVI studies. TAVI-related stroke incidence becomes even more relevant with TAVI indications spreading to younger, low/intermediate-risk patients. Several devices have been developed to prevent this catastrophic event, some of them being broadly used. Nevertheless, the evidence for routine use of cerebral embolic protection devices is still controversial.

Keywords

Transcatheter aortic valve replacement / transcatheter aortic valve implantation / cerebral protection device / cerebral protection system / Sentinel Cerebral Protection System / stroke prevention

References

[1] Velazquez EJ,Jones RH.Coronary-artery bypass surgery in patients with ischemic cardiomyopathy..N Engl J Med2016;374:1511-20 PMCID:PMC4938005

[2] Barker CM.The CoreValve US pivotal trial..Semin Thorac Cardiovasc Surg2014;26:179-86

[3] Kolte D,Palacios IF.Transcatheter versus surgical aortic valve replacement in low-risk patients..J Am Coll Cardiol2019;74:1532-40

[4] Leon MB,Mack MJ.Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients..N Engl J Med2016;374:1609-20

[5] Mack MJ,Thourani VH.Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients..N Engl J Med2019;380:1695-705

[6] Popma JJ,Yakubov SJ.Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients..N Engl J Med2019;380:1706-15

[7] Reardon MJ,Popma JJ.Surgical or transcatheter aortic-valve replacement in intermediate-risk patients..N Engl J Med2017;376:1321-31

[8] Teitelbaum M,Sposato LA.Cerebral embolic protection in TAVI: friend or foe..Interv Cardiol2019;14:22-5 PMCID:PMC6406126

[9] Kroon H,Ziviello F.Heterogeneity of debris captured by cerebral embolic protection filters during TAVI..EuroIntervention2020;EIJ-D-20-00744

[10] Mastoris I,Dangas GD.Stroke after transcatheter aortic valve replacement: incidence, risk factors, prognosis, and preventive strategies..Clin Cardiol2014;37:756-64 PMCID:PMC6647626

[11] Eggebrecht H,Voigtländer T,Erbel R.Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients..EuroIntervention2012;8:129-38

[12] Nombela-Franco L,de Jaegere PP.Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation..Circulation2012;126:3041-53

[13] Muralidharan A,Van Ham R.Meta-analysis of perioperative stroke and mortality in transcatheter aortic valve implantation..Am J Cardiol2016;118:1031-45

[14] Coylewright M,O’Neill ES,Fried TR.Patient-defined goals for the treatment of severe aortic stenosis: a qualitative analysis..Health Expect2016;19:1036-43 PMCID:PMC5054836

[15] Armijo G,Tirado-Conte G.Cerebrovascular events after transcatheter aortic valve implantation..Front Cardiovasc Med2018;5:104 PMCID:PMC6080138

[16] Seeger J,Otto M,Wöhrle J.Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures..JACC Cardiovasc Interv2017;10:2297-303

[17] Giustino G,Veltkamp R,Baber U.Neurological outcomes with embolic protection devices in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis of randomized controlled trials..JACC Cardiovasc Interv2016;9:2124-33

[18] Kroon HG,Hoeks SE.Early clinical impact of cerebral embolic protection in patients undergoing transcatheter aortic valve replacement: a two-center registry in the Netherlands..Circ Cardiovasc Interv2019;12:1-8

[19] Nombela-Franco L,Tirado-Conte G.Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism..J Thorac Dis2018;10:S3604-13 PMCID:PMC6242920

[20] Cubero-Gallego H,Rozado J.Cerebral protection devices for transcatheter aortic valve replacement..Ann Transl Med2019;7:584 PMCID:PMC6861765

[21] Jobanputra Y,Mohananey D,Kandregula K.Cerebral protection devices for transcatheter aortic valve replacement..Expert Rev Med Devices2017;14:529-43

[22] Van Mieghem NM,Ahmad H.Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial..EuroIntervention2016;12:499-507

[23] Ndunda PM,Muutu TM.Clinical outcomes of sentinel cerebral protection system use during transcatheter aortic valve replacement: a systematic review and meta-analysis..Cardiovasc Revasc Med2020;21:717-22

[24] Haussig S,Dwyer MG.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..JAMA2016;316:592-601

[25] Kapadia SR,Makkar R.Protection against cerebral embolism during transcatheter aortic valve replacement..J Am Coll Cardiol2017;69:367-77

[26] Seeger J,Kodali S.Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis..Eur Heart J2019;40:1334-40

[27] Cohen DJ. Cerebral embolic protection and TAVR outcomes: results from the TVT Registry. Presented at: TCT 2020. October 16, 2020. Available from: https://www.tctmd.com/slide/cerebral-embolic-protection-and-tavr-outcomes-results-tvt-registry. [Last accessed on 1 Dec 2020]

[28] Megaly M,Cavalcante JL.Ischemic stroke with cerebral protection system during transcatheter aortic valve replacement..JACC Cardiovasc Interv2020;13:2149-55

[29] Gasior T,Bijoch J.Cerebral embolic protection systems for transcatheter aortic valve replacement..J Interv Cardiol2018;31:891-8

[30] Baumbach A,Brickman AM.Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study..EuroIntervention2015;11:75-84

[31] Lansky AJ,Tchetche D.A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial..Eur Heart J2015;36:2070-8

[32] Simsek C,den Heijer P.The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation..Neth Heart J2020;28:249-52 PMCID:PMC7190763

[33] Moses JW. A randomized evaluation of the TriGUARD3 cerebral embolic protection device to reduce the impact of cerebral embolic lesions after transcatheter aortic valve implantation: the REFLECT II trial. Presented at: TCT 2020. October 15, 2020. Available from: https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2020/10/14/16/42/REFLECT-II. [Last accessed on 1 Dec 2020]

[34] Rodés-Cabau J,Neumann FJ.Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study..JACC Cardiovasc Interv2014;7:1146-55

[35] Samim M,Hendrikse J.Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement..J Thorac Cardiovasc Surg2015;149:799-805.e1-2

[36] Van Mieghem NM.How embolism proof is the Embrella Embolic Deflector system?.JACC Cardiovasc Interv2014;7:1156-8

[37] Latib A,Vezzulli P.First-in-man study evaluating the emblok embolic protection system during transcatheter aortic valve replacement..JACC Cardiovasc Interv2020;13:860-8

[38] Wendt D,Knipp S.Intraaortic protection from embolization in patients undergoing transaortic transcatheter aortic valve implantation..Ann Thorac Surg2015;100:686-91

[39] Shiyovich A.The use of embolic protection devices during transcatheter aortic valve implantation..Isr Med Assoc J2019;21:615-9

[40] Seeger J,Romero M,Rottbauer W.Significant differences in debris captured by the sentinel dual-filter cerebral embolic protection during transcatheter aortic valve replacement among different valve types..JACC Cardiovasc Interv2018;11:1683-93