Comparison of multicenter registries and randomized control trials for transcatheter aortic valve replacement (TAVR)

Indian Heart Journal

Volumn 65, Issue 4, 2013, Pages 400-411

  Agarwal, Shikhar ^a   Tuzcu, Murat ^a   Stewart, William ^a   Bajaj, Navkaranbir Singh ^a   Svensson, Lars G ^a   Kapadia, Samir R ^b  

^a LERNER RESEARCH INSTITUTE   (United States)

^b Heart and Vascular Institute   (United States)

Author keywords

Meta analysis; Multicenter registries; Randomized control trials; Transcatheter aortic valve replacement

Indexed keywords

ADVERSE OUTCOME; AORTA VALVE PROSTHESIS; AORTA VALVE REGURGITATION; ARTICLE; BLEEDING; CEREBROVASCULAR ACCIDENT; COMPARATIVE STUDY; HEART INFARCTION; HEART MUSCLE CONDUCTION DISTURBANCE; HUMAN; IMPLANTED HEART PACEMAKER; INCIDENCE; LONG TERM CARE; MAJOR CLINICAL STUDY; MULTICENTER STUDY (TOPIC); PATIENT SELECTION; POSTOPERATIVE COMPLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; SURGICAL APPROACH; TRANSCATHETER AORTIC VALVE IMPLANTATION; TREATMENT OUTCOME; VASCULAR DISEASE;

META-ANALYSIS; MULTICENTER REGISTRIES; RANDOMIZED CONTROL TRIALS; TRANSCATHETER AORTIC VALVE REPLACEMENT;

AORTIC VALVE; AORTIC VALVE STENOSIS; CARDIAC CATHETERIZATION; CAUSE OF DEATH; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; INCIDENCE; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES;

EID: 84888643990     PISSN: 00194832     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ihj.2013.06.007     Document Type: Article

References (40)

1. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis. 2006;15:312-321
2. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro heart survey on valvular heart disease. Eur Heart J. 2003;13:1231-1243
3. Wendt D, Osswald BR, Kayeser K, et al. STS score is superior to the EuroSCORE in determining mortality in high risk patients undergoing isolated aortic valve replacement. Ann Thorac Surg. 2009;2:468-474
4. O?Brien SM, Shahian DM, Filardo G, et al, for the Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models, part 2: Isolated valve surgery. Ann Thorac Surg. 2009;1(suppl):S23eS42
5. Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82:2111-2115
6. Pai RG, Kapoor N, Bansal RC, Varadarajan P. Malignant natural history of asymptomatic severe aortic stenosis: Benefit of aortic valve replacement. Ann Thorac Surg. 2006;82:2116-2122
7. Piazza N, Otten A, Schultz C, et al. Adherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving System. Heart. 2010;96:19-26
8. Leon MB, Smith CR, Mack M, et al, PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607
9. Smith CR, Leon MB, Mack MJ, et al, PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198
10. Makkar RR, Fontana GP, Jilaihawi H, et al, PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696-1704
11. Kodali SK, Williams MR, Smith CR, et al, PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686-1695
12. Rodés-Cabau J, Webb JG, Cheung A, 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;55:1080-1090
13. Thomas M, Schymik G, Walther T, 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;122:62-69
14. Piazza N, Grube E, Gerckens U, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: Results from the multicentre, expanded evaluation registry 1- year following CE mark approval. EuroIntervention. 2008;4:242-249
15. Gilard M, Eltchaninoff H, Iung B, et al, FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in highrisk patients. N Engl J Med. 2012;366:1705-1715
16. Lefèvre T, Kappetein AP, Wolner E, et al, PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011;32:148-157
17. Meredith I. The Australia-New Zealand Multicenter TAVR Registry Experience; 2011 Nov http://www.tctmd.com/show.aspx? id?109728. Accessed 07.06.12
18. Moat NE, Ludman P, de Belder MA, 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 Implantation) Registry. J Am Coll Cardiol. 2011;58:2130-2138
19. Bosmans JM, Kefer J, De Bruyne B, et al, Belgian TAVI Registry Participants. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: Results of the Belgian national registry. Interact Cardiovasc Thorac Surg. 2011;12:762-767
20. Eltchaninoff H, Prat A, Gilard M, et al, FRANCE Registry Investigators. Transcatheter aortic valve implantation: Early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011;32:191-197
21. Zahn R, Gerckens U, Grube E, et al, German Transcatheter Aortic Valve Interventions-Registry Investigators. Transcatheter aortic valve implantation: First results from a multi-centre real-world registry. Eur Heart J. 2011;32:198-204
22. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299-308
23. Sinhal A, Altwegg L, Pasupati S, et al. Atrioventricular block after transcatheter balloon expandable aortic valve implantation. JACC Cardiovasc Interv. 2008;1:305-309
24. Ussia GP, Barbanti M, Petronio AS, et al, CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012;33:969-976
25. Vahanian A, Alfieri O, Al-Attar N, et al, European Association of Cardio-Thoracic Surgery; European Society of Cardiology; European Association of Percutaneous Cardiovascular Interventions. Transcatheter valve implantation for patients with aortic stenosis: A position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2008;29:1463-1470
26. 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;121:870-878
27. Kodali SK, O?Neill WW, Moses JW, et al. Early and late (one year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL trial). Am J Cardiol. 2011;107:1058-1064
28. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: Meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013;61:1585-1595
29. Piazza N, Onuma Y, Jesserun E, et al. Early and persistent intraventricular conduction abnormalities and requirements for pacemaking after percutaneous replacement of the aortic valve. JACC Cardiovasc Interv. 2008;1:310-316
30. El-Khally ZTB, Staniloae C, Theroux P, et al. Prognostic significance of newly acquired bundle branch block after aortic valve replacement. Am J Cardiol. 2004;94:1008-1011
31. Thomas JL, Dickstein RA, Parker Jr FB, et al. Prognostic significance of the development of left bundle conduction defects following aortic valve replacement. J Thorac Cardiovasc Surg. 1982;84:382-386
32. Jilaihawi H, Chin D, Vasa-Nicotera M, et al. Predictors for permanent pacemaker requirement after transcatheter aortic valve implantation with the CoreValve bioprosthesis. Am Heart J. 2009;157:860-866
33. Nuis RJ, Van Mieghem NM, Schultz CJ, et al. Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis. Eur Heart J. 2011;32:2067-2074
34. Baan Jr J, Yong ZY, Koch KT, et al. Factors associated with cardiac conduction disorders and permanent pacemaker implantation after percutaneous aortic valve implantation with the CoreValve prosthesis. Am Heart J. 2010;159:497-503
35. Fraccaro C, Buja G, Tarantini G, et al. Incidence, predictors, and outcome of conduction disorders after transcatheter selfexpandable aortic valve implantation. Am J Cardiol. 2011;107:747-754
36. Rodés-Cabau J. Transcatheter aortic valve implantation: Current and future approaches. Nat Rev Cardiol. 2011;9:15-29
37. Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011;32:205-217
38. Jamieson WR, Rosado LJ, Munro AI, et al. Carpentier-Edwards standard porcine bioprosthesis: Primary tissue failure (structural valve deterioration) by age groups. Ann Thorac Surg. 1988;46:155-162
39. Jamieson WR, Munro AI, Miyagishima RT, Allen P, Burr LH, Tyers GF. Carpentier-Edwards standard porcine bioprosthesis: Clinical performance to seventeen years. Ann Thorac Surg. 1995;60:999-1006
40. Gurvitch R, Wood DA, Tay EL, et al. Transcatheter aortic valve implantation: Durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation. 2010;122:1319-1327