Filter-based cerebral embolic protection with transcatheter aortic valve implantation: The randomised MISTRAL-C trial

EuroIntervention

Volumn 12, Issue 4, 2016, Pages 499-507

  Van Mieghem, Nicolas M ^a   Van Gils, Lennart ^a   Ahmad, Habib ^a   Van Kesteren, Floortje ^b   Van Der Werf, Hendrik W ^c   Brueren, Guus ^d   Storm, Michiel ^a   Lenzen, Mattie ^a   Daemen, Joost ^a   Van Den Heuvel, Ad F M ^c   Tonino, Pim ^d   Baan, Jan ^b   Koudstaal, Peter J ^a   Schipper, Marguerite E I ^a   Lugt, Aad Van Der ^a   De Jaegere, Peter P T ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d CATHARINA HOSPITAL   (Netherlands)

Author keywords

Aortic stenosis; Cerebral embolic protection; Transcatheter aortic valve implantation (TAVI)

Indexed keywords

AGED; ARTICLE; BRAIN DAMAGE; CARDIOVASCULAR MORTALITY; COGNITION ASSESSMENT; CONTROLLED STUDY; DIFFUSION WEIGHTED IMAGING; DOUBLE BLIND PROCEDURE; EMBOLIC PROTECTION DEVICE; EQUIPMENT DESIGN; FEMALE; FOLLOW UP; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; IMAGE ANALYSIS; IMAGE PROCESSING; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MENTAL DETERIORATION; MINI MENTAL STATE EXAMINATION; MONTREAL COGNITIVE ASSESSMENT; MULTICENTER STUDY; MULTIDETECTOR COMPUTED TOMOGRAPHY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NEUROLOGIC EXAMINATION; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; TRANSCATHETER AORTIC VALVE IMPLANTATION; VERY ELDERLY; AORTIC VALVE STENOSIS; BRAIN ISCHEMIA; HEART CATHETERIZATION; HEART VALVE REPLACEMENT; INTRACRANIAL EMBOLISM; NEUROPSYCHOLOGICAL TEST; PROCEDURES; RISK FACTOR; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; AORTIC VALVE STENOSIS; BRAIN ISCHEMIA; CARDIAC CATHETERIZATION; DIFFUSION MAGNETIC RESONANCE IMAGING; EMBOLIC PROTECTION DEVICES; FEMALE; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INTRACRANIAL EMBOLISM; MALE; NEUROPSYCHOLOGICAL TESTS; RISK FACTORS; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 84983082223     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV12I4A84     Document Type: Article

References (32)

1. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006-8.
2. Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB, Cohen DJ; PARTNER Trial Investigators. Health-related quality of life after transcatheter or surgical aortic valve replacement in highrisk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012;60:548-58.
3. Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015;8:1207-17.
4. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-607.
5. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-98.
6. Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63:1972-81.
7. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U. S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a selfexpanding prosthesis. N Engl J Med. 2014;370:1790-8.
8. Athappan G, Gajulapalli RD, Sengodan P, Bhardwaj A, Ellis SG, Svensson L, Tuzcu EM, Kapadia SR. Influence of transcatheter aortic valve replacement strategy and valve design on stroke after transcatheter aortic valve replacement: a meta-analysis and systematic review of literature. J Am Coll Cardiol. 2014;63: 2101-10.
9. Waksman R, Minha S. Stroke after aortic valve replacement: the known and unknown. Circulation. 2014;129:2245-7.
10. Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010;121:870-8.
11. Ghanem A, Muller A, Nähle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010;55:1427-32.
12. Rodes-Cabau J, Dumont E, Boone RH, Larose E, Bagur R, Gurvitch R, Bedard F, Doyle D, De Larochelliere R, Jayasuria C, Villeneuve J, Marrero A, Cote M, Pibarot P, Webb JG. Cerebral embolism following transcatheter aortic valve implantation: comparison of transfemoral and transapical approaches. J Am Coll Cardiol. 2011;57:18-28.
13. Kahlert P, Al-Rashid F, Döttger P, Mori K, Plicht B, Wendt D, Bergmann L, Kottenberg E, Schlamann M, Mummel P, Holle D, Thielmann M, Jakob HG, Konorza T, Heusch G, Erbel R, Eggebrecht H. Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study. Circulation. 2012;126:1245-55.
14. Nombela-Franco L, Webb JG, de Jaegere PP, Toggweiler S, Nuis RJ, Dager AE, Amat-Santos IJ, Cheung A, Ye J, Binder RK, van der Boon RM, Van Mieghem N, Benitez LM, Perez S, Lopez J, San Roman JA, Doyle D, Delarochelliere R, Urena M, Leipsic J, Dumont E, Rodes-Cabau J. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126:3041-53.
15. Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012;109:1637-43.
16. Tchetche D, Farah B, Misuraca L, Pierri A, Vahdat O, Lereun C, Dumonteil N, Modine T, Laskar M, Eltchaninoff H, Himbert D, Iung B, Teiger E, Chevreul K, Lievre M, Lefevre T, Donzeau-Gouge P, Gilard M, Fajadet J. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. JACC Cardiovasc Interv. 2014;7:1138-45.
17. Van Mieghem NM, Schipper ME, Ladich E, Faqiri E, van der Boon R, Randjgari A, Schultz C, Moelker A, van Geuns RJ, Otsuka F, Serruys PW, Virmani R, de Jaegere PP. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation. 2013;127:2194-201.
18. Van Gils L, Baumbach A, Himbert D, Lansky AJ, Vahanian A, Van Mieghem NM. Tools and Techniques-Clinical: Embolic protection devices in transcatheter aortic valve implantation. EuroIntervention. 2015;11:247-8.
19. Lansky AJ, Schofer J, Tchetche D, Stella P, Pietras CG, Parise H, Abrams K, Forrest JK, Cleman M, Reinohl 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 TriGuard HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J. 2015;36:2070-2078.
20. Naber CK, Ghanem A, Abizaid AA, Wolf A, Sinning JM, Werner N, Nickenig G, Schmitz T, Grube E. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2012;8: 43-50.
21. Van Mieghem NM, El Faquir N, Rahhab Z, Rodriguez-Olivares R, Wilschut J, Ouhlous M, Galema TW, Geleijnse ML, Kappetein AP, Schipper ME, de Jaegere PP. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2015;8:718-24.
22. Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003;348:1215-22.
23. Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV. American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:2064-89.
24. Hensel A, Angermeyer MC, Riedel-Heller SG. Measuring cognitive change in older adults: reliable change indices for the Mini-Mental State Examination. J Neurol Neurosurg Psychiatry. 2007;78:1298-303.
25. Zhao S, Guo C, Wang M, Chen W, Wu Y, Tang W, Zhao Y. A clinical memory battery for screening for amnestic mild cognitive impairment in an elderly chinese population. J Clin Neurosci. 2011;18:774-9.
26. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012;33:2403-18.
27. Flach HZ, Ouhlous M, Hendriks JM, Van Sambeek MR, Veenland JF, Koudstaal PJ, Van Dijk LC, Van Der Lugt A. Cerebral ischemia after carotid intervention. J Endovasc Ther. 2004;11: 251-7.
28. Rodés-Cabau J, Kahlert P, Neumann FJ, Schymik G, Webb JG, Amarenco P, Brott T, Garami Z, Gerosa G, Lefevre T, Plicht B, Pocock SJ, Schlamann M, Thomas M, Diamond B, Merioua I, Beyersdorf F, Vahanian A. 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 Interv. 2014;7:1146-55.
29. Fanning JP, Walters DL, Platts DG, Eeles E, Bellapart J, Fraser JF. Characterization of neurological injury in transcatheter aortic valve implantation: how clear is the picture? Circulation. 2014;129:504-15.
30. Généreux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K, Smith C, Serruys PW, Kappetein AP, Leon MB. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol. 2012;59:2317-26.
31. Ghanem A, Kocurek J, Sinning JM, Wagner M, Becker BV, Vogel M, Schröder T, Wolfsgruber S, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Thomas D, Werner N, Grube E, Nickenig G, Müller A. Cognitive trajectory after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2013;6: 615-24.
32. Hong JM, Chung CS, Bang OY, Yong SW, Joo IS, Huh K. Vertebral artery dominance contributes to basilar artery curvature and peri-vertebrobasilar junctional infarcts. J Neurol Neurosurg Psychiatry. 2009;80:1087-92.