Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures

JACC: Cardiovascular Interventions

Volumn 10, Issue 22, 2017, Pages 2297-2303

  Seeger, Julia ^a   Gonska, Birgid ^a   Otto, Markus ^a   Rottbauer, Wolfgang ^a   Wöhrle, Jochen ^a  

^a UNIVERSITY OF ULM   (Germany)

Author keywords

cerebral embolic protection; outcome; stroke; TAVR

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; HEPARIN;

ACUTE KIDNEY FAILURE; AGED; ALL CAUSE MORTALITY; ANTICOAGULATION; ARTICLE; BRAIN DAMAGE; BRAIN EMBOLISM; CARDIOVASCULAR MORTALITY; CAROTID ARTERY OBSTRUCTION; CEREBROVASCULAR ACCIDENT; CLINICAL EVALUATION; CONTROLLED STUDY; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PATIENT CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RISK REDUCTION; SOCIETY OF THORACIC SURGEONS SCORE; SURVIVAL; TRANSCATHETER AORTIC VALVE IMPLANTATION; VERY ELDERLY; AORTIC VALVE; AORTIC VALVE STENOSIS; AORTOGRAPHY; CALCINOSIS; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; COMPARATIVE STUDY; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; DEVICES; DIAGNOSTIC IMAGING; DISEASE FREE SURVIVAL; EMBOLIC PROTECTION DEVICE; MORTALITY; MULTIVARIATE ANALYSIS; ODDS RATIO; PATHOLOGY; PROCEDURES; PROPENSITY SCORE; PROSTHESIS DESIGN; RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; AORTIC VALVE; AORTIC VALVE STENOSIS; AORTOGRAPHY; CALCINOSIS; CHI-SQUARE DISTRIBUTION; COMPUTED TOMOGRAPHY ANGIOGRAPHY; DISEASE-FREE SURVIVAL; EMBOLIC PROTECTION DEVICES; FEMALE; HUMANS; INTRACRANIAL EMBOLISM; MALE; MULTIVARIATE ANALYSIS; ODDS RATIO; PROPENSITY SCORE; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RISK FACTORS; STROKE; TIME FACTORS; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 85029156220     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2017.06.037     Document Type: Article

References (34)

1. Thourani, V.H., Kodali, S., Makkar, R.R., et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 387 (2016), 2218–2225.
2. Leon, M.B., Smith, C.R., Mack, M.J., et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374 (2016), 1609–1620.
3. Eggebrecht, H., Schmermund, A., Kahlert, P., Erbel, R., Voigtländer, T., Mehta, R.H., Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention 8 (2012), 129–138.
4. Tchetche, D., Farah, B., Misuraca, L., et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. J Am Coll Cardiol Intv 7 (2014), 1138–1145.
5. Holmes, D.R. Jr., Brennan, J.M., Rumsfeld, J.S., et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA 313 (2015), 1019–1028.
6. Miller, D.C., Blackstone, E.H., Mack, M.J., et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg 143 (2012), 832–843.e13.
7. Erdoes, G., Basciani, R., Huber, C., et al. Transcranial Doppler-detected cerebral embolic load during transcatheter aortic valve implantation. Eur J Cardiothorac Surg 41 (2012), 778–783.
8. Van Belle, E., Hengstenberg, C., Lefevre, T., et al. Cerebral embolism during transcatheter aortic valve replacement: the BRAVO-3 MRI study. J Am Coll Cardiol 68 (2016), 589–599.
9. Kapadia, S., Agarwal, S., Miller, D.C., et al. Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv, 9, 2016, e002981.
10. Lansky, A.J., Schofer, J., Tchetche, D., et al. 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 36 (2015), 2070–2078.
11. Haussig, S., Mangner, N., Dwyer, M.G., et al. 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 316 (2016), 592–601.
12. Van Mieghem, N.M., van Gils, L., Ahmad, H., et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention 12 (2016), 499–507.
13. Rodés-Cabau, J., Kahlert, P., Neumann, F.J., et al. 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. J Am Coll Cardiol Intv 7 (2014), 1146–1155.
14. Baumbach, A., Mullen, M., Brickman, A.M., et al. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention 11 (2015), 75–84.
15. Naber, C.K., Ghanem, A., Abizaid, A.A., et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention 8 (2012), 43–50.
16. Giustino, G., Mehran, R., Veltkamp, R., Faggioni, M., Baber, U., Dangas, G.D., Neurological outcomes with embolic protection devices in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol Intv 9 (2016), 2124–2133.
17. Kapadia, S.R., Kodali, S., Makkar, R., et al., SENTINEL Trial Investigators. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 69 (2017), 367–377.
18. Wöhrle, J., Gonska, B., Rodewald, C., Seeger, J., Scharnbeck, D., Rottbauer, W., Transfemoral aortic valve implantation with the new Edwards Sapien 3 valve for treatment of severe aortic stenosis-impact of valve size in a single center experience. PLoS One, 11, 2016, e0151247.
19. Wöhrle, J., Gonska, B., Rodewald, C., et al. Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve. Int J Cardiol 195 (2015), 171–175.
20. Barbanti, M., Yang, T.H., Rodès Cabau, J., et al. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation 128 (2013), 244–253.
21. Rosenhek, R., Binder, T., Porenta, G., et al. Predictors of outcome in severe, asymptomatic aortic stenosis. N Engl J Med 343 (2000), 611–617.
22. Kappetein, A.P., Head, S.J., Généreux, P., et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 60 (2012), 1438–1454.
23. Markovic, S., Imhof, A., Kunze, M., Rottbauer, W., Wöhrle, J., Standardized radial approach reduces access site complications: a prospective observational registry. Coron Artery Dis 26 (2015), 56–59.
24. Bernick, C., Kuller, L., Dulberg, C., et al. Silent MRI infarcts and the risk of future stroke: the cardiovascular health study. Neurology 57 (2001), 1222–1229.
25. Fairbairn, T.A., Mather, A.N., Bijsterveld, P., et al. Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health status. Heart 98 (2012), 18–23.
26. Vermeer, S.E., Longstreth, W.T. Jr., Koudstaal, P.J., Silent brain infarcts: a systematic review. Lancet Neurol 6 (2007), 611–619.
27. Leon, M.B., Smith, C.R., Mack, M., et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363 (2010), 1597–1607.
28. Lansky, A.J., Brown, D., Pena, C., et al. Neurologic complications of unprotected transcatheter aortic valve implantation (from the Neuro-TAVI Trial). Am J Cardiol 118 (2016), 1519–1526.
29. Goldberg, I., Auriel, E., Russell, D., Korczyn, A.D., Microembolism, silent brain infarcts and dementia. J Neurol Sci 322 (2012), 250–253.
30. van Rooij, F.G., Schaapsmeerders, P., Maaijwee, N.A., et al. Persistent cognitive impairment after transient ischemic attack. Stroke 45 (2014), 2270–2274.
31. Giustino, G., Sorrentino, S., Mehran, R., Faggioni, M., Dangas, G., Cerebral embolic protection during TAVR: a clinical event meta-analysis. J Am Coll Cardiol 69 (2017), 465–466.
32. Wendler, O., Schymik, G., Treede, H., et al. Design and 30-day results of the European postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation 135 (2017), 1123–1132.
33. Meredith Am, I.T., Walters, D.L., Dumonteil, N., et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol 64 (2014), 1339–1348.
34. Popma, J.J., Reardon, M.J., Khabbaz, K., et al. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: results of the Evolut R U.S. study. J Am Coll Cardiol Intv 10 (2017), 268–275.