Current research status of stroke and cerebral embolism protection devices in transcatheter aortic valve replacement_West China Medical Journal

Authors：

ZHU Jiajun , ZHAO Qian , LI Xiaomei ,  YANG Yining

Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830054, P. R. China;

Corresponding author：

YANG Yining, Email: yangyn5126@163.com

Keywords：

Transcatheter aortic valve replacement; Cerebral embolic protection device; Stroke

DOI：

10.7507/1002-0179.202108032

Video：

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Abstract Full text Figures/Tables Video References Cited by

Stroke is one feared complication after transcatheter aortic valve replacement (TAVR). It affects the prognosis of TAVR, leading to a decline in the survival rate and quality of life of patients, while increasing the economic burden of patients. In recent years, a variety of cerebral embolic protection devices have been used to reduce the incidence of stroke during TAVR and improve the prognosis, some of which have been approved for clinical use. However, there are many controversies about their safety and effectiveness. This article reviews the definitions, short-term and long-term incidences, and risk factors of TAVR-related stroke, and elaborates on recent large-scale studies of different cerebral embolic protection devices.

Citation： ZHU Jiajun, ZHAO Qian, LI Xiaomei, YANG Yining. Current research status of stroke and cerebral embolism protection devices in transcatheter aortic valve replacement. West China Medical Journal, 2021, 36(9): 1161-1166. doi: 10.7507/1002-0179.202108032 Copy

1.	Lansky A, Ghare MI, Tchétché D, et al. TAVI and the brain: update on definitions, evidence of neuroprotection and adjunctive pharmacotherapy. EuroIntervention, 2018, 14(AB): AB53-AB63.
2.	Shiyovich A, Kornowski R. Neuroprotective measures throughout the TAVI pathway. Minerva Cardioangiol, 2019, 67(1): 39-56.
3.	中华医学会老年医学分会老年神经病学组, 心源性卒中诊断中国专家共识撰写组. 心源性卒中诊断中国专家共识(2020). 中华老年医学杂志, 2020, 39(12): 1369-1378.
4.	Miller DC, Blackstone EH, Mack MJ, 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, 2012, 143(4): 832-843.e13.
5.	Tay EL, Gurvitch R, Wijesinghe N, et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2011, 4(12): 1290-1297.
6.	Demir OM, Iannopollo G, Mangieri A, et al. The role of cerebral embolic protection devices during transcatheter aortic valve replacement. Front Cardiovasc Med, 2018, 5: 150.
7.	Alkhouli M, Alqahtani F, Harris AH, et al. Early experience with cerebral embolic protection during transcatheter aortic valve replacement in the United States. JAMA Intern Med, 2020, 180(5): 783-784.
8.	Megaly M, Sorajja P, Cavalcante JL, et al. Ischemic stroke with cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2020, 13(18): 2149-2155.
9.	Naber CK, Ghanem A, Abizaid A, et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention, 2012, 8(1): 43-50.
10.	Nietlispach F, Wijesinghe N, Gurvitch R, et al. An embolic deflection device for aortic valve interventions. JACC Cardiovasc Interv, 2010, 3(11): 1133-1138.
11.	Lansky AJ, Messé SR, Brickman AM, et al. Proposed standardized neurological endpoints for cardiovascular clinical trials: an academic research consortium initiative. Eur Heart J, 2018, 39(19): 1687-1697.
12.	Sacco RL, Kasner SE, Broderick JP, et al. 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(7): 2064-2089.
13.	Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg, 2012, 42(5): S45-S60.
14.	Huded CP, Tuzcu EM, Krishnaswamy A, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA, 2019, 321(23): 2306-2315.
15.	Jones BM, Krishnaswamy A, Tuzcu EM, et al. Matching patients with the ever-expanding range of TAVI devices. Nat Rev Cardiol, 2017, 14(10): 615-626.
16.	Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
17.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
18.	Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
19.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
20.	Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
21.	Bjursten H, Norrving B, Ragnarsson S. Late stroke after transcatheter aortic valve replacement: a nationwide study. Sci Rep, 2021, 11(1): 9593.
22.	Van Mieghem NM, Schipper ME, Ladich E, et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation, 2013, 127(22): 2194-2201.
23.	Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation, 2010, 121(7): 870-878.
24.	Caplan LR, Hennerici M. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol, 1998, 55(11): 1475-1482.
25.	Nombela-Franco L, Webb JG, De Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation, 2012, 126(25): 3041-3053.
26.	Udesh R, Mehta A, Gleason T, et al. Carotid artery disease and perioperative stroke risk after surgical aortic valve replacement: a nationwide inpatient sample analysis. J Clin Neurosci, 2017, 42: 91-96.
27.	Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med, 2011, 364(23): 2187-2198.
28.	Seppelt PC, Mas-Peiro S, De Rosa R, et al. Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses. Clin Res Cardiol, 2021, 110(5): 640-648.
29.	Jilaihawi H, Wu YJ, Yang YE, et al. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85(Suppl1): 752-761.
30.	中国医师协会心血管内科医师分会结构性心脏病专业委员会. 经导管主动脉瓣置换术中国专家共识(2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
31.	Forrest JK, Kaple RK, Ramlawi B, et al. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valves from the STS/ACC TVT registry. JACC Cardiovasc Interv, 2020, 13(15): 1749-1759.
32.	Fan J, Fang X, Liu C, et al. Brain injury after transcatheter replacement of bicuspid versus tricuspid aortic valves. J Am Coll Cardiol, 2020, 76(22): 2579-2590.
33.	Macherey S, Meertens M, Mauri V, et al. Meta-analysis of stroke and mortality rates in patients undergoing valve-in-valve transcatheter aortic valve replacement. J Am Heart Assoc, 2021, 10(6): e019512.
34.	Davlouros PA, Mplani VC, Koniari I, et al. Transcatheter aortic valve replacement and stroke: a comprehensive review. J Geriatr Cardiol, 2018, 15(1): 95-104.
35.	Vermeer SE, Hollander M, Van Dijk EJ, et al. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke, 2003, 34(5): 1126-1129.
36.	Seeger J, Gonska B, Otto M, et al. Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures. JACC CardiovascInterv, 2017, 10(22): 2297-2303.
37.	Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol, 2017, 69(4): 367-377.
38.	Schmidt T, Leon MB, Mehran R, et al. Debris heterogeneity across different valve types captured by a cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2018, 11(13): 1262-1273.
39.	Seeger J, Virmani R, Romero M, et al. Significant differences in debris captured by the sentinel dual-filter cerebral embolic protection during transcatheter aortic valve replacement among different valve types. JACC Cardiovasc Interv, 2018, 11(17): 1683-1693.
40.	Rodés-Cabau J, Kahlert P, Neumann FJ, 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. JACC Cardiovasc Interv, 2014, 7(10): 1146-1155.
41.	Samim M, Agostoni P, Hendrikse J, et al. Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2015, 149(3): 799-805.e1.
42.	Latib A, Mangieri A, Vezzulli P, et al. First-in-man study evaluating the Emblok embolic protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2020, 13(7): 860-868.
43.	Baumbach A, Mullen M, Brickman AM, 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, 2015, 11(1): 75-84.
44.	Lansky AJ, 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, 2015, 36(31): 2070-2078.
45.	Lansky AJ, Makkar R, Nazif T, et al. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT Ⅰ trial. Eur Heart J, 2021, 42(27): 2670-2679.
46.	Nazif TM, Moses J, Sharma R, et al. Randomized evaluation of TriGuard 3 cerebral embolic protection after transcatheter aortic valve replacement: REFLECT Ⅱ. JACC Cardiovasc Interv, 2021, 14(5): 515-527.
47.	Yashima F, Briasoulis A, Kuno T, et al. Cerebral embolic protection during transcatheter aortic valve replacement. Cardiovasc Revasc Med, 2021.
48.	Kolte D, Khera S, Nazir S, et al. Trends in cerebral embolic protection device use and association with stroke following transcatheter aortic valve implantation. Am J Cardiol, 2021, 152: 106-112.
49.	Butala NM, Makkar R, Secemsky EA, et al. Cerebral embolic protection and outcomes of transcatheter aortic valve replacement: results from the transcatheter valve therapy registry. Circulation, 2021, 143(23): 2229-2240.
50.	Khan MZ, Zahid S, Khan MU, et al. Use and outcomes of cerebral embolic protection for transcatheter aortic valve replacement: a US nationwide study. Catheter Cardiovasc Interv, 2021.
51.	Abdul-Jawad AO, Puri R, Rodés-Cabau J. Embolic protection devices during TAVI: current evidence and uncertainties. Rev Esp Cardiol (Engl Ed), 2016, 69(10): 962-972.
52.	Case BC, Forrestal BJ, Yerasi C, et al. Real-world experience of the sentinel cerebral protection device: insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Cardiovasc Revasc Med, 2020, 21(2): 235-238.
53.	Stachon P, Kaier K, Heidt T, et al. The use and outcomes of cerebral protection devices for patients undergoing transfemoral transcatheter aortic valve replacement in clinical practice. JACC Cardiovasc Interv, 2021, 14(2): 161-168.

1. Lansky A, Ghare MI, Tchétché D, et al. TAVI and the brain: update on definitions, evidence of neuroprotection and adjunctive pharmacotherapy. EuroIntervention, 2018, 14(AB): AB53-AB63.
2. Shiyovich A, Kornowski R. Neuroprotective measures throughout the TAVI pathway. Minerva Cardioangiol, 2019, 67(1): 39-56.
3. 中华医学会老年医学分会老年神经病学组, 心源性卒中诊断中国专家共识撰写组. 心源性卒中诊断中国专家共识(2020). 中华老年医学杂志, 2020, 39(12): 1369-1378.
4. Miller DC, Blackstone EH, Mack MJ, 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, 2012, 143(4): 832-843.e13.
5. Tay EL, Gurvitch R, Wijesinghe N, et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2011, 4(12): 1290-1297.
6. Demir OM, Iannopollo G, Mangieri A, et al. The role of cerebral embolic protection devices during transcatheter aortic valve replacement. Front Cardiovasc Med, 2018, 5: 150.
7. Alkhouli M, Alqahtani F, Harris AH, et al. Early experience with cerebral embolic protection during transcatheter aortic valve replacement in the United States. JAMA Intern Med, 2020, 180(5): 783-784.
8. Megaly M, Sorajja P, Cavalcante JL, et al. Ischemic stroke with cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2020, 13(18): 2149-2155.
9. Naber CK, Ghanem A, Abizaid A, et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention, 2012, 8(1): 43-50.
10. Nietlispach F, Wijesinghe N, Gurvitch R, et al. An embolic deflection device for aortic valve interventions. JACC Cardiovasc Interv, 2010, 3(11): 1133-1138.
11. Lansky AJ, Messé SR, Brickman AM, et al. Proposed standardized neurological endpoints for cardiovascular clinical trials: an academic research consortium initiative. Eur Heart J, 2018, 39(19): 1687-1697.
12. Sacco RL, Kasner SE, Broderick JP, et al. 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(7): 2064-2089.
13. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg, 2012, 42(5): S45-S60.
14. Huded CP, Tuzcu EM, Krishnaswamy A, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA, 2019, 321(23): 2306-2315.
15. Jones BM, Krishnaswamy A, Tuzcu EM, et al. Matching patients with the ever-expanding range of TAVI devices. Nat Rev Cardiol, 2017, 14(10): 615-626.
16. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med, 2014, 370(19): 1790-1798.
17. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
18. Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
19. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
20. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
21. Bjursten H, Norrving B, Ragnarsson S. Late stroke after transcatheter aortic valve replacement: a nationwide study. Sci Rep, 2021, 11(1): 9593.
22. Van Mieghem NM, Schipper ME, Ladich E, et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation, 2013, 127(22): 2194-2201.
23. Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation, 2010, 121(7): 870-878.
24. Caplan LR, Hennerici M. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol, 1998, 55(11): 1475-1482.
25. Nombela-Franco L, Webb JG, De Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation, 2012, 126(25): 3041-3053.
26. Udesh R, Mehta A, Gleason T, et al. Carotid artery disease and perioperative stroke risk after surgical aortic valve replacement: a nationwide inpatient sample analysis. J Clin Neurosci, 2017, 42: 91-96.
27. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med, 2011, 364(23): 2187-2198.
28. Seppelt PC, Mas-Peiro S, De Rosa R, et al. Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses. Clin Res Cardiol, 2021, 110(5): 640-648.
29. Jilaihawi H, Wu YJ, Yang YE, et al. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85(Suppl1): 752-761.
30. 中国医师协会心血管内科医师分会结构性心脏病专业委员会. 经导管主动脉瓣置换术中国专家共识(2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
31. Forrest JK, Kaple RK, Ramlawi B, et al. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valves from the STS/ACC TVT registry. JACC Cardiovasc Interv, 2020, 13(15): 1749-1759.
32. Fan J, Fang X, Liu C, et al. Brain injury after transcatheter replacement of bicuspid versus tricuspid aortic valves. J Am Coll Cardiol, 2020, 76(22): 2579-2590.
33. Macherey S, Meertens M, Mauri V, et al. Meta-analysis of stroke and mortality rates in patients undergoing valve-in-valve transcatheter aortic valve replacement. J Am Heart Assoc, 2021, 10(6): e019512.
34. Davlouros PA, Mplani VC, Koniari I, et al. Transcatheter aortic valve replacement and stroke: a comprehensive review. J Geriatr Cardiol, 2018, 15(1): 95-104.
35. Vermeer SE, Hollander M, Van Dijk EJ, et al. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke, 2003, 34(5): 1126-1129.
36. Seeger J, Gonska B, Otto M, et al. Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures. JACC CardiovascInterv, 2017, 10(22): 2297-2303.
37. Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol, 2017, 69(4): 367-377.
38. Schmidt T, Leon MB, Mehran R, et al. Debris heterogeneity across different valve types captured by a cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2018, 11(13): 1262-1273.
39. Seeger J, Virmani R, Romero M, et al. Significant differences in debris captured by the sentinel dual-filter cerebral embolic protection during transcatheter aortic valve replacement among different valve types. JACC Cardiovasc Interv, 2018, 11(17): 1683-1693.
40. Rodés-Cabau J, Kahlert P, Neumann FJ, 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. JACC Cardiovasc Interv, 2014, 7(10): 1146-1155.
41. Samim M, Agostoni P, Hendrikse J, et al. Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2015, 149(3): 799-805.e1.
42. Latib A, Mangieri A, Vezzulli P, et al. First-in-man study evaluating the Emblok embolic protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2020, 13(7): 860-868.
43. Baumbach A, Mullen M, Brickman AM, 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, 2015, 11(1): 75-84.
44. Lansky AJ, 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, 2015, 36(31): 2070-2078.
45. Lansky AJ, Makkar R, Nazif T, et al. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT Ⅰ trial. Eur Heart J, 2021, 42(27): 2670-2679.
46. Nazif TM, Moses J, Sharma R, et al. Randomized evaluation of TriGuard 3 cerebral embolic protection after transcatheter aortic valve replacement: REFLECT Ⅱ. JACC Cardiovasc Interv, 2021, 14(5): 515-527.
47. Yashima F, Briasoulis A, Kuno T, et al. Cerebral embolic protection during transcatheter aortic valve replacement. Cardiovasc Revasc Med, 2021.
48. Kolte D, Khera S, Nazir S, et al. Trends in cerebral embolic protection device use and association with stroke following transcatheter aortic valve implantation. Am J Cardiol, 2021, 152: 106-112.
49. Butala NM, Makkar R, Secemsky EA, et al. Cerebral embolic protection and outcomes of transcatheter aortic valve replacement: results from the transcatheter valve therapy registry. Circulation, 2021, 143(23): 2229-2240.
50. Khan MZ, Zahid S, Khan MU, et al. Use and outcomes of cerebral embolic protection for transcatheter aortic valve replacement: a US nationwide study. Catheter Cardiovasc Interv, 2021.
51. Abdul-Jawad AO, Puri R, Rodés-Cabau J. Embolic protection devices during TAVI: current evidence and uncertainties. Rev Esp Cardiol (Engl Ed), 2016, 69(10): 962-972.
52. Case BC, Forrestal BJ, Yerasi C, et al. Real-world experience of the sentinel cerebral protection device: insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Cardiovasc Revasc Med, 2020, 21(2): 235-238.
53. Stachon P, Kaier K, Heidt T, et al. The use and outcomes of cerebral protection devices for patients undergoing transfemoral transcatheter aortic valve replacement in clinical practice. JACC Cardiovasc Interv, 2021, 14(2): 161-168.

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