Transcatheter Aortic Valve Replacement: A Review Article

Document Type: Review Article

Authors

Department of Surgery, University of Arizona Medical Center, University of Arizona, 1501 N Campbell Ave., Tucson, AZ 85719, United States

Abstract

Transcatheter aortic valve replacement (TAVR) is a novel therapeutic intervention for the replacement of severely stenotic aortic valves in high-risk patients for standard surgical procedures. Since the initial PARTNER trial results, use of TAVR has been on the rise each year. New delivery methods and different valves have been developed and modified in order to promote the minimally invasive procedure and reduce common complications, such as stroke. This review article focuses on the current data on the indications, risks, benefits, and future directions of TAVR.
Recently, TAVR has been considered as a standard-of-care procedure. While this technique is used frequently in high-risk surgical candidates, studies have been focusing on the application of this method for younger patients with lower surgical risk. Moreover, several studies have proposed promising results regarding the use of valve-in-valve technique or the procedure in which the valve is placed within a previously implemented bioprosthetic valve. However, ischemic strokes and paravalvular leak remain a matter of debate in these surgeries. New methods and devices have been developed to reduce the incidence of post-procedural stroke. While the third generation of TAVR valves (i.e., Edwards Sapien 3 and Medtronic Evolut R) addresses the issue of paravalvular leak structurally, results on their efficacy in reducing the risk of paravalvular leak are yet to be obtained. Furthermore, TAVR enters the field of hybrid methods in the treatment of cardiac issues via both surgical and catheter-based approaches. Finally, while TAVR is primarily performed on cases with aortic stenosis, new valves and methods have been proposed regarding the application of this technique in aortic regurgitation, as well as other aortic pathologies.
TAVR is a suitable therapeutic approach for the treatment of aortic stenosis in high-risk patients. Considering the promising results in the current patient population, recent studies have been conducted to evaluate the efficacy of this approach as a standard-of-care procedure.  

Keywords


1. Bourantas C, Serruys P. Evolution of transcatheter aortic valve replacement. Circ Res 2014;114:1037-51.

2. Carabello B. The placement of aortic transcatheter valve (PARTNER) trial: the view of a cardiologist. Circulation 2012;125:3240-2.

3. Rosenhek R, Zilberszac R, Schemper M, Czerny M, Mundigler G, Graf S, et al. Natural history of very severe aortic stenosis. Circulation 2010;121:151-6.

4. O’Brien, B, Schoenhagen P, Kapadia S, Svensson LG, Rodriguez L, Griffin BP, et al. Integration of 3D imaging data in the assessment of aortic stenosis: impact on classification of disease severity. Cir Cardiovasc Imaging 2011;4:566-73.

5. Faxon D. Transcatheter Aortic Valve Implantation: Coming of Age. Circulation 2011;124:439-40.

6. Leon MB, Smith CR, Mack M, Miller C, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.

7. Makkar RR, Fontana GP, Jilaihaw H, Kapadia S, Pichard AD, Douglas PS, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696-704.

8. Guyton RA. The placement of aortic transcathter valve (PARTNER) trial: the surgeon’s perspective: celebration and concern. Circulation 2012;125:3237-9.

9. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686-95.

10. Mack M, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, 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;385:2477-84.

11. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-98.

12. Webb JG, Wood DA. Current Status of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2012;60:483-92.

13. Geisbusch S, Bleiziffer S, Mazzitelli D, Ruge H, Bauernschmitt R, Lange R. Incidence and management of CoreValve dislocation during transcatheter aortic valve implantation. Circ Cardiovasc Interv 2010;3:531-6.

14. Webb JG, Cribier A. Percutaneous transarterial aortic valve implantation: what do we know?. Eur Heart J 2011;32:140-7.

15. Eltchaninoff H, Prat A, Gilard M, Lequerrier A, Blanchard D, Fournial G, Iung B, et al. Transcatheter aortic valve implantation: early results of the FRANCE (French Aortic National CoreValve and Edwards) registry. Eur Heart J 2011;32:191-7.

16. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implatnation) registry. J Am Coll Cardiol 2011;58:2130-8.

17. D’Ancona G, Pasic M, Unbehaun A, Hetzer R. Permanent pacemaker implantation after transapical transcatheter aortic valve implantation. Interact CardioVasc Thorac Surg 2011;13:373-6.

18. Mack M. Transcatheter aortic valve implantation: changing patient populations and novel indications. Heart 2012;98:73-9.

19. Wenaweser P, Praz F, Stortecky S. Transcatheter aortic valve implantation today and tomorrow. Swiss Med Wkly 2016;146:w14299.

20. Thomas M, Schymik G, Walther T, Himbert D, Lefebre T, Treede H, et al. Thirty-day results of the SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2010;122:62-9.

21. Ferrar E, Namasivayam J, Marcucci C, Gronchi F, Berdajs D, Niclauss L, et al. Transapical aortic valve replacement in extreme-risk patients: outcomes, risk factors and mid-term results. Eur J Cardiothorac Surg 2013;43:978-85.

22. Petronio AS, De Carlo M, Bedogni G, Marzocchi A, Klugmann S, Maisano F, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 2010;3:359-66.

23. Etienne PY, Papadatos S, El Khoury E, Pieters D, Price J, Glineur D. Transaortic transcatheter aortic valve implantation with the Edwards SAPIEN valve: feasibility, technical considerations, and clinical advantages. Ann Thorac Surg 2011;92:746-8.

24. Clarke A, Wiemers P, Poon KK, Aroney CN, Scalia G, Burstow D, et al. Early experience of transaortic TAVI—the future of surgical TAVI?. Heart, Lung Circ 2013;22:265-9.

25. Pozzi M, Grinberg D, Obadia JF, Saroul C, Green L, Dementhon J, et al. Transcatheter aortic valve implantation using the left transcarotid approach in patients with previous ipsilateral carotid endarterectomy. Catheter Cardiovasc Interv 2015;85:e203-9.

26. Azmoun A, Amabile N, Ramadan R, Ghostine S, Caussin C, Fradi S, et al. Transcatheter aortic valve implantation through carotid artery access under local anaesthesia. Eur J Cardiothorac Surg 2014;46:693-8.

27. Ott I, Greenbaum AB, Schunkert H, Kastrati A, Kasel M. First use of an expandable sheath and transcaval access for transcatheter Edwards SAPIEN 3 aortic valve implantation. EuroIntervention 2015;11.

28. Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 2010;55:1080-90.

29. Thourani VH, Gunter RL, Neravetla S, Block P, Guyton RA, Kilgo P, et al. Use of transaortic, transapical, and transcarotid transcatheter aortic valve replacement in inoperable patients. Ann Thorac Surg 2013;96:1349-57.

30. Thourani VH, Li C, Devireddy C, Jensen HA, Kilgo P, Leshnower BG, et al. High-risk patients with inoperative aortic stenosis: use of transapical, transaortic, and transcarotid techniques. Ann Thorac Surg 2015;99:817-23.

31. Bapat V, Khawaja MZ, Attia R, Narayana A, Wilson K, Macgillivray K, et al. Transaortic transcatheter aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv 2012;79:733-40.

32. Svensson LG, Dewey T, Kapadia S, Roselli EE, Stewart A, Williams M, et al. United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg 2008;86:46-54.

33. Pasic M, Buz S, Dreysse S, Drews T, Unbehaun A, Klein C, et al. Transapical aortic valve implantation in 194 patients: problems, complications, and solutions. Ann Thorac Surg 2010;90:1463-9.

34. Ng A, Delgado V, van der Kley F, Shanks M, van de Veire NR, Bertini M, et al. Comparison of aortic root dimensions and geometries before and after transcatheter aortic valve implantation by 2- and 3- dimensional tranesophageal echocardiography and multislice computed tomography. Circ Cardiovasc Imaging 2010;3:94-102.

35. Messika-Zeitoun D, Serfaty JM, Brochet E, Ducrocq G, Lepage L, Detaint D, et al. Multimodal assessment of the aortic annulus diameter: implications for transcatheter aortic valve implantation. J Am Coll Cardiol 2010;55:186-94.

36. Wang H, Hanna JM, Ganapathi A, Keenan JE, Hurwitz LM, Vavalle JP, et al. Comparison of aortic annulus size by transesophageal echocardiography and computed tomography angiography with direct surgical measurement. Am J Cardiol 2015;115:1568-73.

37. Altiok E, Koos R, Schroder J, Brehmer K, Hamada S, Becker M, et al. Comparison of two-dimensional and three-dimensional imaging techniques for measurement of aortic annulus diameters before transcatheter aortic valve implantation. Heart 2011;97:1578-84.

38. Mollmann H, Kim WK, Kempfert J, Walther T, Hamm C. Complications of transcatheter aortic valve implantation (TAVI): how to avoid and treat them. Heart 2015;101:900-8.

39. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705-15.

40. Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J 2012;33:969-76.

41. Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al. Transcatheter aortic valve implantation: first results from a multi-center real-world registry. Eur Heart J 2011;32:198-204.

42. Elhmidi Y, Bleiziffer S, Deutsch MA, Krane M, Mazzitelli D, Lange R, et al. Acute kidney injury after transcathter aortic valve implantation: incidence, predictors and impact on mortality. Arch Cardiovasc Dis 2014;107:133-9.

43. Strauch JT, Scherner MP, Haldenwang PL, Pfister R, Kuhn EW, Madershahian N, et al. Minimally invasive transapical aortic valve implantation and the risk of acute kidney injury. Ann Thorac Surg 2010;89:465-70.

44. Lo J, Hill C. Intensive care unit management of transcatheter aortic valve recipients. Semin Cardiothorac Vasc Anesth 2015;19:95-105.

45. Elhmidi Y, Bleiziffer S, Piazza N, Hutter A, Opitz A, Hettich I, et al. Incidence and predictors of acute kidney injury in patients undergoing transcatheter aortic valve implantation. Am Heart J 2011;161:735-9.

46. Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, et al. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J 2010;31:865-74.

47. Wang A, Athan E, Pappas PA, Fowler VG Jr, Olaison L, Pare C, et al. Contemporary clinical profile and outcome of prosthetic valve endocarditis. JAMA 2007;297:1354-61.

48. Pericas JM, Llopis J, Cervera C, Sacanella E, Falces C, Andrea R, et al. Infective endocarditis in patients with an implanted transcatheter aortic valve: Clinical characteristics and outcome of a new entity. J Infect 2015;70:565-76.

49. Anguera I, Miro JM, Cabell CH, Abrutyn E, Fowler BG Jr, Hoen B, et al. Clinical characteristics and outcome of aortic endocarditis with periannular abscess in the International Collaboration on Endocarditis Merged Database. Am J Cardiol 2005;96:976-81

50. Latib A, Naim C, De Bonis M, Sinning JM, Maisano F, Barbanti M, et al. TAVR-associated prosthetic valve infective endocarditis: results of a large, multicenter registry. J Am Coll Cardiol 2014;64:2176-8.

51. Egerod I, Nielsen S, Lisby KH, Darmer MR, Pedersen PU. Immediate post-operative responses to transcatheter aortic valve implantation: An observational study. Eur J Cardiovasc Nurs 2015;14:232-9.

52. Unbehaun A, Pasic M, Drews T, Penkalla A, Dreysse S, Klein C, et al. Transapical aortic valve implantation: predictors of survival up to 5 years in 730 patients: an update. Eur J Cardiothorac Surg 2015;47:281-90.

53. Iung B, Laouenan C, Himbert D, Eltchaninoff H, Chevreul K, Donzeau-Gouge P, et al. Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score. Heart 2014;100:1016-23.

54. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2011;123:229-308.

55.Fraccaro C, Al-Lamee R, Tarantini G, Maisano F, Napodano M, Montorfano M, et al. Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study. Circ Cardiovasc Interv 2012;5:253-60.

56. Ewe SH, Marsan NA, Pepi M, Delgado V, Tamborini G, Muratori M, et al. Impact of left ventricular systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation for severe aortic stenosis. Am Heart J 2010;160:1113-20.

57. Goncalves A, Solomon SD. Mitral regurgitation in transcatheter aortic valve replacement: the complexity of multivalvular disease. Circulation 2013;128:2101-3.

58. Bedogni F, Latib A, De Marco F, Agnifili M, Oreglia J, Pizzocri S, et al. Interplay between mitral regurgitation and transcatheter aortic valve replacement with the CoreValve revalving system: a multicenter registry. Circulation 2013;128:2145-53.

59. Pai RG, Varadarajan P. Prognostic implications of mitral regurgitation in patients with severe aortic regurgitation. Circulation 2010;122(11 suppl):s43-7.

60.Rodes-Cabau J, Kahlert P, Neumann FJ, Schymik G, Webb JG, Amarenco P, 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;7:1146-55.

61. Samim M, Agostoni P, Hendrikse J, Budde RP, Nijhoff F, Kluin J, et al. Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg 2015;149:799-805.

62. Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, 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;19:75-84.

63. Van Mieghem NM, van der Lugt A. How embolism proof is the Embrella Embolic Deflector system? JACC Cardiovasc Interv 2014;7:1156-8.

64. Praz F, Nietlispach F. Cerebral protection devices for transcatheter aortic valve implantation: is better the enemy of good? EuroIntervention 2013;9:s124-8.

65. Van Mieghem NM, El Faquir N, Rahhab Z, Rodriguez-Olivares R, Wilschut J, Ouhlous M, et al. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv 2015;8:718-24.

66. Van Mieghem NM, Schipper ME, Ladich E, Fagiri E, van der Boon R, Randijgari A, et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013;127:2194-201.

67. Banbury MK, Kouchoukos NT, Allen KB, Slaughter MS, Weissman NJ, Berry GJ, et al. Emboli capture using the Embol-X intraaortic filter in cardiac surgery: a multicentered randomized trial of 1,289 patients. Ann Thorac Surg 2003;76:508-12.

68. Astarci P, Glineur D, Kefer J, D’Hoore W, Rankin J, Vanoverschelde JL, et al. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfermoral and trans-apical approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg 2011;40:475-9.

69. Etienne PY, Papadatos S, Pieters D, El Khoury E, Alexis F, Price J, et al. Embol-X intraaortic filter and transaortic approach for improved cerebral protection in transcatheter aortic valve implantation. Ann Thorac Surg 2011;92:e95-6.

70. Nijhoff F, Abawi M, Agostoni P, Ramjankhan FZ, Doevendans PA, Stella PR. Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system. Circ Cardiovasc Interv. 2015;8:e002408

71. Ohno Y, Tamburino C, Barbanti M. Transcatheter aortic valve implantation experience with SAPIEN 3. Minerva Cardioangiol. 2015;63:205-16

72. Ye J, Webb JG. Embolic capture with updated intra-aortic filter during coronary artery bypass grafting and transaortic transcatheter aortic valve implantation: first-in-human experience. J Thorac Cardiovasc Surg 2014;148:2905-10.

73. Wenaweser P, Stortecky S, Schwander S, Heg D, Huber C, Pilgrim T, et al. Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation. Eur Heart J 2013;34:1894-905.

74. Kodali S. Early clinical and echocardiographic outcomes with the Sapien 3 transcatheter aortic valve replacement system in inoperable, high-risk, and intermediate-risk aortic stenosis patients. Presented at: American College of Cardiology/i2 Scientific Session; March 15, 2015; San Diego, C, USA.

75. Goel SS, Ige M, Tuzcu EM, Ellis SG, Stewart WJ, Svensson LG, et al. Severe aortic stenosis and coronary artery disease—implications for management in the transcatheter aortic valve replacement era: a comprehensive review. J Am Coll Cardiol 2013;62:1-10.

76. Conradi L, Seiffert M, Farnzen O, Baldus S, Schirmer J, Mainertz T, et al. First experience with transcatheter aortic valve implantation and concomitant percutaneous coronary intervention. Clin Res Cardiol 2011;100:311-6.

77. Khawaja MZ, Wang D, Pocock S, Redwood SR, Thomas MR. The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial. Trials 2014;24:300.

78. Gutsche JT, Patel PA, Walsh EK, Sophocles A, Chern SY, Jones DB, et al. New frontiers in aortic therapy: focus on current trials and devices in transcatheter aortic valve replacement. J Cardiothorac Vasc Anesth 2015;29:536-41.

79. Ferrari E, Sulzer C, Marcucci C, Qanadli SD, Roumy A, Nicaluss L, et al. Successful combined minimally invasive direct coronary artery bypass and transapical aortic valve implantation. Ann Thorac Surg 2011;91:1979-82.

80. ElBardissi AW, Shekar P, Couper GS, Cohn LH. Minimally invasive aortic valve replacement in octogenarian, high-risk, transcatheter aortic valve implantation candidates. J Thorac Cardiovasc Surg 2011;141:328-35.

81. Genereux P, Head S, Van Mieghem N, Kodali S, Kirtane AJ, Xu K, et al. 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.

82. Gotzmann M, Mugge A, Bojara W. Transcatheter aortic valve implantation for treatment of patients with degenerated aortic bioprostheses—valve-in-valve technique. Catheter Cardiovasc Interv 2010;76:1000-6.

83. Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA 2014;312:162-70

84. Faerber G, Schleger S, Diab M, Breuer M, Figulla HR, Eichinger WB, et al. Valve-in-valve transcatheter aortic valve implantation: the new playground for prosthesis-patient mismatch. J Interv Cardiol 2014;27:287-92.

85. Wiegerinck EMA, Piek JJ. Valve implantations on the move. Neth Heart J 2015;23:33-4