First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation

EuroIntervention

Volumn 8, Issue 1, 2012, Pages 43-50

  Naber, Christoph K ^a   Ghanem, Alexander ^b   Abizaid, Alexander A ^c   Wolf, Alexander ^a   Sinning, Jan Malte ^b   Werner, Nikos ^b   Nickenig, Georg ^b   Schmitz, Thomas ^a   Grube, Eberhard ^b  

^a ELISABETH KRANKENHAUS ESSEN   (Germany)

^b UNIVERSITY OF BONN   (Germany)

^c INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA   (Brazil)

Author keywords

Aortic stenosis; Aortic valve disease; Embolic protection device; TAVI

Indexed keywords

AGED; AORTA ARCH; ARTICLE; BLOOD FILTRATION; BRACHIAL ARTERY; BRAIN BLOOD FLOW; BRAIN EMBOLISM; CLINICAL ARTICLE; DEVICE SAFETY; EMBOLIC PROTECTION DEVICE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HUMAN; MALE; MOBILIZATION; PILOT STUDY; POSTOPERATIVE PERIOD; PROSPECTIVE STUDY; RADIAL ARTERY; RISK REDUCTION; STROKE; TRANSCATHETER AORTIC VALVE IMPLANTATION; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; AORTIC VALVE STENOSIS; BRAZIL; CHI-SQUARE DISTRIBUTION; EMBOLIC PROTECTION DEVICES; FEASIBILITY STUDIES; FEMALE; GERMANY; HEART CATHETERIZATION; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INTRACRANIAL EMBOLISM; MALE; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RISK ASSESSMENT; RISK FACTORS; STROKE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84860381197     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV8I1A8     Document Type: Article

References (20)

1. 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.
2. 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.
3. 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.
4. Ghanem A, Müller 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.
5. Rodés-Cabau J, Dumont E, Boone RH, Larose E, Bagur R, Gurvitch R, Bédard F, Doyle D, De Larochellière R, Jayasuria C, Villeneuve J, Marrero A, Côté 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.
6. SPACE Collaborative Group, Ringleb PA, Allenberg J, Brückmann H, Eckstein HH, Fraedrich G, Hartmann M, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Stingele R, Zeumer H, Hacke W. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet. 2006;368:1239-47.
7. Barbato JE, Dillavou E, Horowitz MB, Jovin TG, Kanal E, David S, Makaroun MS. A randomized trial of carotid artery stenting with and without cerebral protection. J Vasc Surg. 2008;47:760-5.
8. Garg N, Karagiorgos N, Pisimisis GT, Sohal DP, Longo GM, Johanning JM, Lynch TG, Pipinos II. Cerebral protection devices reduce periprocedural strokes during carotid angioplasty and stenting: a systematic review of the current literature. J Endovasc Ther. 2009;16:412-27.
9. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011;57:253-69.
10. Lange R, Bleiziffer S, Mazzitelli D, Elhmidi Y, Opitz A, Krane M, Deutsch MA, Ruge H, Brockmann G, Voss B, Schreiber C, Tassani P, Piazza N. Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients a glimpse into the future. J Am Coll Cardiol. 2012;59:280-7.
11. Tay EL, Gurvitch R, Wijesinghe N, Nielispach F, Wood D, Cheung A, Ye J, Lichtenstein SV, Carere R, Thompson C, Webb JG. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2011;4:1290-7.
12. Amat-Santos IJ, Rodés-Cabau J, Urena M, DeLarochellière R, Doyle D, Bagur R, Villeneuve J, Côté M, Nombela-Franco L, Philippon F, Pibarot P, Dumont E. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;59:178-88.
13. Nietlispach F, Wijesinghe N, Gurvitch R, Tay E, Carpenter JP, Burns C, Wood DA, Webb JG. An embolic deflection device for aortic valve interventions. JACC Cardiovasc Interv. 2010;3:1133-8.
14. Grossi EA, Loulmet DF, Schwartz CF, Solomon B, Dellis SL, Culliford AT, Zias E, Galloway AC. Minimally invasive valve surgery with antegrade perfusion strategy is not associated with increased neurologic complications. Ann Thorac Surg. 2011;92:1346-50.
15. Grube E, Buellesfeld L, Mueller R, Sauren B, Zickmann B, Nair D, Beucher H, Felderhoff T, Iversen S, Gerckens U. Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system. CircCardiovascInterv 2008;1:167-75.
16. Webb JG, Vancouver experience. Presented at the 20th Annual Transcatheter Cardiovascular Therapeutics Meeting. Washington, DC; October 12-17, 2008.
17. Kodali S, Edwards experience. Presented at the 20th Annual Transcatheter Cardiovascular Therapeutics Meeting. Washington, DC; October 12-17, 2008.
18. Laborde JC, CoreValve experience. Presented at the 58th Annual Meeting of the American College of Cardiology. Orlando, FL, USA; March 29-31, 2009.
19. Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, Macdonald S, Gaines PA, Waaijer A, Stierli P, Jäger HR, Lyrer PA, Kappelle LJ, Wetzel SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST; ICSS-MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010;9:353-62.
20. Jacobs A, Neveling M, Horst M, Ghaemi M, Kessler J, Eichstaedt H, Rudolf J, Model P, Bönner H, de Vivie ER, Heiss WD. Alterations of neuropsychological function and cerebral glucose metabolism after cardiac surgery are not related only to intraoperative microembolic events. Stroke. 1998;29:660-7.