A systematic review on the safety of second-generation transcatheter aortic valves

EuroIntervention

Volumn 11, Issue 9, 2016, Pages 1034-1043

  Athappan, Ganesh ^a   Gajulapalli, Rama D ^b   Tuzcu, Murat E ^b   Svensson, Lars G ^b   Kapadia, Samir R ^b  

^a MOUNT SINAI HOSPITAL   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Paravalvular aortic regurgitation; Safety of transcatheter aortic valve implantation (TAVI); Second generation TAVI valves; TAVI and pacemaker

Indexed keywords

ACUTE KIDNEY FAILURE; AORTA VALVE PROSTHESIS; AORTA VALVE REGURGITATION; BLEEDING; CEREBROVASCULAR ACCIDENT; HEART INFARCTION; HUMAN; LIFE THREAT; MORTALITY; OUTCOME ASSESSMENT; PERCUTANEOUS AORTIC VALVE; POSTOPERATIVE COMPLICATION; REVIEW; SURGICAL APPROACH; SURGICAL TECHNIQUE; SYSTEMATIC REVIEW; TRANSCATHETER AORTIC VALVE IMPLANTATION; ADVERSE EFFECTS; AORTIC VALVE; DEVICES; HEART CATHETERIZATION; HEART VALVE DISEASES; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; META ANALYSIS; ODDS RATIO; PATHOPHYSIOLOGY; PATIENT SAFETY; PROSTHESIS DESIGN; RISK ASSESSMENT; RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME;

AORTIC VALVE; CARDIAC CATHETERIZATION; HEART VALVE DISEASES; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; ODDS RATIO; PATIENT SAFETY; PROSTHESIS DESIGN; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84955499206     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV11I9A211     Document Type: Review

References (43)

1. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686-95.
2. Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, Christian A, O'Brien S, Holmes D; STS/ACC TVT Registry. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-77.
3. 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;59:2317-26.
4. Stortecky S, Wenaweser P, Windecker S. Transcatheter aortic valve implantation and cerebrovascular accidents. EuroIntervention. 2012;8:Q60-9.
5. Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: Meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013;61:1585-95.
6. Toggweiler S, Webb JG. Challenges in transcatheter aortic valve implantation. Swiss Med Wkly. 2012;142:w13735.
7. Treede H, Tubler T, Reichenspurner H, Grube E, Pascotto A, Franzen O, Mueller R, Low R, Bolling SF, Meinertz T, Schofer J. Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: The Direct Flow Medical aortic valve. J Thorac Cardiovasc Surg. 2010;140:897-903.
8. Manoharan G, Spence MS, Rodes-Cabau J, Webb JG. St. Jude Medical Portico valve. EuroIntervention. 2012;8:Q97-101.
9. Meredith IT, Hood KL, Haratani N, Allocco DJ, Dawkins KD. Boston Scientific Lotus valve. EuroIntervention. 2012;8:Q70-4.
10. Kempfert J, Mollmann H, Walther T. Symetis ACURATE TA valve. EuroIntervention. 2012;8:Q102-9.
11. Treede H, Mohr FW, Baldus S, Rastan A, Ensminger S, Arnold M, Kempfert J, Figulla HR. Transapical transcatheter aortic valve implantation using the JenaValve system: Acute and 30-day results of the multicentre CE-mark study. Eur J Cardiothorac Surg. 2012;41:e131-8.
12. Sündermann SH, Holzhey D, Bleiziffer S, Treede H, Falk V. Medtronic Engager™ bioprosthesis for transapical transcatheter aortic valve implantation. EuroIntervention. 2013;9:S97-100.
13. Binder RK, Schafer U, Kuck KH, Wood DA, Moss R, Leipsic J, Toggweiler S, Freeman M, Ostry AJ, Frerker C, Willson AB, Webb JG. Transcatheter aortic valve replacement with a new self-expanding transcatheter heart valve and motorized delivery system. JACC Cardiovasc Interv. 2013;6:301-7.
14. Binder RK, Rodes-Cabau J, Wood DA, Mok M, Leipsic J, De Larochellière R, Toggweiler S, Dumont E, Freeman M, Willson AB, Webb JG. Transcatheter aortic valve replacement with the SAPIEN 3: A new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2013;6:293-300.
15. Sinning JM, Werner N, Nickenig G, Grube E. Medtronic CoreValve Evolut valve. EuroIntervention. 2012;8:Q94-6.
16. Moher D, Liberati A. [Reporting systematic reviews and meta-analyses: Asking authors, peer reviewers, editors and funders to do better]. Med Clin (Barc). 2010;135:505-6.
17. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: A proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283:2008-12.
18. Borenstein M, Hedges L, Higgins J, Rothstein H (editors) in Comprehensive Meta-analysis Version 2. Biostat; Englewood, NJ, USA: 2005.
19. Spence MS, Lyons K, McVerry F, Smith B, Manoharan GB, Maguire C, Doherty R, Anderson L, Morton A, Hughes S, Hoeritzauer I, Manoharan G. New St. Jude Medical Portico™ transcatheter aortic valve: Features and early results. Minerva Cardioangiol. 2013;61:263-9.
20. Meredith IT, Worthley SG, Whitbourn RJ, Antonis P, Montarello JK, Newcomb AE, Lockwood S, Haratani N, Allocco DJ, Dawkins KD. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: The REPRISE I study. EuroIntervention. 2014;9: 1264-70.
21. Möllmann H, Diemert P, Grube E, Baldus S, Kempfert J, Abizaid A. Symetis ACURATE TF™ aortic bioprosthesis. EuroIntervention. 2013;9 Suppl:S107-10.
22. Kempfert J, Treede H, Rastan AJ, Schönburg M, Thielmann M, Sorg S, Mohr FW, Walther T. Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA): 6-month outcomes. Eur J Cardiothorac Surg. 2013;43:52-6; discussion 57.
23. Kempfert J. Transapical Aortic Valve Implantation using a new self expandable bioprosthesis: Pilot study mid term outcomes in 50 patients. EuroPCR 2012, Paris, France. http://www.pcronline.com/Lectures/2012/Transapical-aortic-valve-implantation-using-a-new-self-expandable-bioprosthesis-pilot-study-mid-term-outcomes-in-50-patients
24. Trahan R. Wilmington, Del. & Munich: Business Wire, 2010.
25. Falk V, Walther T, Schwammenthal E, Strauch J, Aicher D, Wahlers T, Schäfers J, Linke A, Mohr FW. Transapical aortic valve implantation with a self-expanding anatomically oriented valve. Eur Heart J. 2011;32:878-87.
26. Sündermann SH, Grünenfelder J, Corti R, Rastan AJ, Linke A, Lange R, Falk V, Bleiziffer S. Outcome of patients treated with Engager transapical aortic valve implantation: One-year results of the feasibility study. Innovations (Phila). 2013;8:332-6.
27. Schofer J, Colombo A, Klugmann S, Fajadet J, DeMarco F, Tchétché D, Maisano F, Bruschi G, Latib A, Bijuklic K, Weissman N, Low R, Thomas M, Young C, Redwood S, Mullen M, Yap J, Grube E, Nickenig G, Sinning JM, Hauptmann KE, Friedrich I, Lauterbach M, Schmoeckel M, Davidson C, Lefevre T. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol. 2014;63:763-8.
28. Manoharan G. Portico CE trial: Assessment of the St. Jude Medical portico™ transcatheter aortic valve implant and the transfemoral delivery system. TCT. San Francisco, 2013.
29. Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefèvre T, Lange R, Müller R, Redwood S, Allocco DJ, Dawkins KD. 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. 2014;64:1339-48.
30. Kempfert J, Holzhey D, Hofmann S, Girdauskas E, Treede H, Schröfel H, Thielmann M, Walther T. First registry results from the newly approved ACURATE TA™ TAVI system. Eur J Cardiothorac Surg. 2015;48:137-41.
31. Wendler O, Kappert U, Ensminger S, Franke U, Rüter F, Rastan A, De Kroon T, Eichinger W, Lange R, Beyersdorf F, Feyrer R, Treede H. The JUPITER registry: Thirty-day primary endpoint results of a second generation transapical TAVI system. EuroPCR 2014, Paris, France. http://www.pcronline.com/eurointervention/AbstractsEuroPCR2014/OP289/
32. Sündermann SH, Holzhey D, Bleiziffer S, Treede H, Jacobs S, Falk V. Second-generation transapical valves: The Medtronic Engager system. Multimed Man Cardiothorac Surg. 2014; 2014:mmu001.
33. Dvir D. Preliminary Clinical Experience using the SAPIEN 3 device. J Am Coll Cardiol. 2013;62:B239.
34. Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.
35. Tuzcu EM. SALUS I Trial. TCT. Washington DC, 2014.
36. Davidson C. Direct Flow Medical-Technology Review, Clinical Results, and status of the US clinical Trial. TCT. Washington DC, 2014.
37. Naber C. Real World Multicenter Prospective Registry using the Direct Flow Medical Transcatheter Aortic Valve System for the treatment of Severe Aortic Stenosis: Comparison with DISCOVER Trial. TCT. Washington DC, 2014.
38. Mollmann H. Symetis ACURATE TA and TF. TCT. Washington DC, 2014.
39. 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.
40. Lindman BR, Maniar HS, Jaber WA, Lerakis S, Mack MJ, Suri RM, Thourani VH, Babaliaros V, Kereiakes DJ, Whisenant B, Miller DC, Tuzcu EM, Svensson LG, Xu K, Doshi D, Leon MB, Zajarias A. Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: Insights from the Placement of Aortic Transcatheter Valves II inoperable cohort. Circ Cardiovasc Interv. 2015 Apr;8(4).
41. Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tölg R, Zachow D, Guerra E, Massberg S, Schäfer U, El-Mawardy M, Richardt G; CHOICE investigators. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: The CHOICE randomized clinical trial. JAMA. 2014;311:1503-14.
42. Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Qiao H, Popma JJ. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2015;66:113-21.
43. Seiffert M, Conradi L, Kloth B, Koschyk D, Schirmer J, Schnabel RB, Blankenberg S, Reichenspurner H, Diemert P, Treede H. Single-centre experience with next-generation devices for transapical aortic valve implantation. Eur J Cardiothorac Surg. 2015;47:39-45; discussion 45.