Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement

Catheterization and Cardiovascular Interventions

Volumn 91, Issue 4, 2018, Pages 790-797

  Van Gils, Lennart ^a   Kroon, Herbert ^a   Daemen, Joost ^a   Ren, Claire ^a   Maugenest, Anne Marie ^a   Schipper, Marguerite ^a   De Jaegere, Peter P ^a   Van Mieghem, Nicolas M ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

aortic valve disease; embolic protection devices; percutaneous intervention; transcatheter valve implantation

Indexed keywords

NITINOL;

AGED; AORTIC VALVE STENOSIS; ARTICLE; BLEEDING; BRACHIOCEPHALIC TRUNK; BRAIN EMBOLISM; CLINICAL ARTICLE; CONVERSION TO OPEN SURGERY; FEMALE; FOREIGN BODY; HEART INFARCTION; HEART TAMPONADE; HISTOPATHOLOGY; HUMAN; LEFT COMMON CAROTID ARTERY; MALE; MORTALITY; NEUROPROTECTION; OBSERVATIONAL STUDY; PACEMAKER IMPLANTATION; PARTICLE SIZE; PROSTHETIC VALVE THROMBOSIS; THROMBUS; TRANSCATHETER AORTIC VALVE IMPLANTATION; TREATMENT OUTCOME; VASCULAR DISEASE; VERTEBRAL ARTERY; VERY ELDERLY; AORTIC VALVE; COMMON CAROTID ARTERY; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; DEVICES; DIAGNOSTIC IMAGING; EMBOLIC PROTECTION DEVICE; HEART VALVE PROSTHESIS; PATHOLOGY; PATHOPHYSIOLOGY; PROSPECTIVE STUDY; PROSTHESIS DESIGN; PROTECTION; RISK FACTOR;

AGED; AGED, 80 AND OVER; AORTIC VALVE; AORTIC VALVE STENOSIS; BRACHIOCEPHALIC TRUNK; CAROTID ARTERY, COMMON; COMPUTED TOMOGRAPHY ANGIOGRAPHY; EMBOLIC PROTECTION DEVICES; FEMALE; HEART VALVE PROSTHESIS; HUMANS; INTRACRANIAL EMBOLISM; MALE; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; PROTECTIVE FACTORS; RISK FACTORS; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME; VERTEBRAL ARTERY;

EID: 85029302139     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.27323     Document Type: Article

References (28)

1. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM, 3rd, Thompson A. AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;70:252–289.
2. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, Investigators P. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609–1620.
3. 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, Investigators USCC. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–1798.
4. 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, Investigators PT. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198.
5. 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, Investigators PT. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607.
6. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP, Investigators S. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321–1331.
7. Reinohl J, Kaier K, Reinecke H, Schmoor C, Frankenstein L, Vach W, Cribier A, Beyersdorf F, Bode C, Zehender M. Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med 2015;373:2438–2447.
8. Genereux 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;59:2317–2326.
9. 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;121:870–878.
10. Ghanem A, Muller A, Nahle 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;55:1427–1432.
11. 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;127:2194–2201.
12. Kahlert P, Al-Rashid F, Dottger 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;126:1245–1255.
13. 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;348:1215–1222.
14. 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.
15. 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 Interven 2015;8:718–724.
16. 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, Investigators ST. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 2017;69:367–377.
17. Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lucke 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.
18. 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 AF, Tonino P, Baan J, Koudstaal PJ, Schipper ME, van der Lugt A, de Jaegere PP. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: The randomised MISTRAL-C trial. EuroIntervention 2016;12:499–507.
19. Bogren HG, Buonocore MH, Gu WZ. Carotid and vertebral artery blood flow in left- and right-handed healthy subjects measured with MR velocity mapping. J Mag Reson Imag 1994;4:37–42.
20. Arnold M, Schulz-Heise S, Achenbach S, Ott S, Dorfler A, Ropers D, Feyrer R, Einhaus F, Loders S, Mahmoud F, Roerick O, Daniel WG, Weyand M, Ensminger SM, Ludwig J. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. JACC Cardiovasc Interven 2010;3:1126–1132.
21. 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;11:247–248.
22. Kappetein AP, Head SJ, Genereux 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, Rodes-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. J Am Coll Cardiol 2012;60:1438–1454.
23. 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.
24. Astarci P, Glineur D, Kefer J, D'Hoore W, Renkin J, Vanoverschelde JL, El Khoury G, Grandin C. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: Comparison of transfemoral and trans-apical approaches using Edwards Sapiens valve. Europ J Cardio Thor Surg 2011;40:475–479.
25. Daneault B, Balter S, Kodali SK, Williams MR, Genereux P, Reiss GR, Paradis JM, Green P, Kirtane AJ, Smith C, Moses JW, Leon MB. Patient radiation exposure during transcatheter aortic valve replacement procedures. EuroIntervention 2012;8:679–684.
26. Webb JG, Doshi D, Mack MJ, Makkar R, Smith CR, Pichard AD, Kodali S, Kapadia S, Miller DC, Babaliaros V, Thourani V, Herrmann HC, Bodenhamer M, Whisenant BK, Ramee S, Maniar H, Jr., Kereiakes D, Xu K, Jaber WA, Menon V, Tuzcu EM, Wood D, Svensson LG, Leon MB. A randomized evaluation of the SAPIEN XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. JACC Cardiovasc Interven 2015;8:1797–1806.
27. Fearon WF, Kodali S, Doshi D, Fischbein MP, Yeung AC, Tuzcu EM, Rihal CS, Babaliaros V, Zajarias A, Herrmann HC, Brown DL, Mack M, Teirstein PS, Whisenant BK, Makkar R, Kapadia S, Leon MB, Investigators PT. Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (placement of AoRTic TraNscathetER valves) trial with the NRCA (nonrandomized continued access) registry. JACC Cardiovasc Interven 2014;7:1245–1251.
28. Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed standardized neurological endpoints for cardiovascular clinical trials: An academic research consortium initiative. J Am Coll Cardiol 2017;69:679–691.