Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions A Consensus Document from the Mitral Valve Academic Research Consortium

Journal of the American College of Cardiology

Volumn 66, Issue 3, 2015, Pages 308-321

  Stone, Gregg W ^a   Adams, David H ^b   Abraham, William T ^c   Kappetein, Arie Pieter ^d   Généreux, Philippe ^a,e   Vranckx, Pascal ^f   Mehran, Roxana ^a,b   Kuck, Karl Heinz ^g   Leon, Martin B ^a   Piazza, Nicolo ^h   Head, Stuart J ^d   Filippatos, Gerasimos ⁱ   Vahanian, Alec S ^j  

^a NewYork Presbyterian Hospital   (United States)

^b MOUNT SINAI HEALTH SYSTEM   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d ERASMUS MEDICAL CENTER   (Netherlands)

^e HÔPITAL DU SACRÉ COEUR DE MONTRÉAL   (Canada)

^f Hartcentrum Hasselt   (Belgium)

^g DEPARTMENT OF CARDIOLOGY   (Germany)

^h MCGILL UNIVERSITY HEALTH CENTRE   (Canada)

ⁱ NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^j BICHAT HOSPITAL   (France)

more..

Author keywords

heart failure; mitral regurgitation; mitral valve; valve intervention; valve surgery (or cardiac surgery)

Indexed keywords

ACUTE KIDNEY FAILURE; ARTICLE; BLEEDING; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); CONVERSION TO OPEN SURGERY; CORONARY ARTERY OBSTRUCTION; DEVICE EMBOLIZATION; DEVICE FAILURE; DEVICE MIGRATION; DEVICE SAFETY; ENDOCARDITIS; HEART ARRHYTHMIA; HEART ATRIUM SEPTUM DEFECT; HEART FAILURE; HEART INFARCTION; HEART MUSCLE CONDUCTION DISTURBANCE; HEMOLYSIS; HOSPITAL READMISSION; HOSPITALIZATION; HUMAN; IATROGENIC DISEASE; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; MEDICAL DEVICE COMPLICATION; MITRAL VALVE REGURGITATION; MITRAL VALVE REPAIR; MITRAL VALVE REPLACEMENT; MORTALITY; PARAVALVULAR LEAK; PERICARDIAL EFFUSION; PRIORITY JOURNAL; PROSTHETIC VALVE THROMBOSIS; STUDY DESIGN; TRANSCATHETER MITRAL VALVE REPAIR; TRANSCATHETER MITRAL VALVE REPLACEMENT; VASCULAR ACCESS; VASCULAR ACCESS SITE RELATED COMPLICATION; VASCULAR DISEASE; ADVERSE EFFECTS; BIOASSAY; CONSENSUS DEVELOPMENT; DEVICES; DISEASE MANAGEMENT; ECHOCARDIOGRAPHY; EUROPE; HEART CATHETERIZATION; HEART VALVE REPLACEMENT; HEART VENTRICLE REMODELING; METHODOLOGY; MITRAL VALVE; MITRAL VALVE INSUFFICIENCY; PATHOPHYSIOLOGY; PATIENT SELECTION; PROCEDURES; PROGNOSIS; RISK ASSESSMENT; UNITED STATES;

CARDIAC CATHETERIZATION; CLINICAL TRIALS AS TOPIC; DISEASE MANAGEMENT; ECHOCARDIOGRAPHY; ENDPOINT DETERMINATION; EUROPE; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; MITRAL VALVE; MITRAL VALVE INSUFFICIENCY; PATIENT SELECTION; PROGNOSIS; RESEARCH DESIGN; RISK ASSESSMENT; UNITED STATES; VENTRICULAR REMODELING;

EID: 84937407690     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2015.05.049     Document Type: Review

References (61)

1. G.W. Stone, A.S. Vahanian, D.H. Adams, and et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: a consensus document from the Mitral Valve Academic Research Consortium J Am Coll Cardiol 66 2015 278 307
2. M.W. Krucoff, R. Mehran, G.A. van Es, A.B. Boam, and D.E. Cutlip The Academic Research Consortium governance charter J Am Coll Cardiol Intv 4 2011 595 596
3. D.E. Cutlip, S. Windecker, R. Mehran, and et al. Clinical end points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351
4. M.B. Leon, N. Piazza, E. Nikolsky, and et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium J Am Coll Cardiol 57 2011 253 269
5. A.P. Kappetein, S.J. Head, P. Genereux, and 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
6. R. Mehran, S.V. Rao, D.L. Bhatt, and et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium Circulation 123 2011 2736 2747
7. P. Généreux, S.J. Head, N.M. Van Mieghem, and 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 59 2012 2317 2326
8. A.S. Go, D. Mozaffarian, V.L. Roger, and et al. Heart disease and stroke statistics - 2013 update: a report from the American Heart Association Circulation 127 2013 e6 e245
9. S. Blecker, M. Paul, G. Taksler, and et al. Heart failure-associated hospitalizations in the United States J Am Coll Cardiol 61 2013 1259 1267
10. G.C. Fonarow, K.F. Adams Jr., W.T. Abraham, and et al. Risk stratification for in-hospital mortality in acutely decompensated heart failure: classification and regression tree analysis JAMA 293 2005 572 580
11. P. Jong, E. Vowinckel, P.P. Liu, and et al. Prognosis and determinants of survival in patients newly hospitalized for heart failure: a population-based study Arch Intern Med 162 2002 1689 1694
12. F. Alla, F. Zannad, and G. Filippatos Epidemiology of acute heart failure syndromes Heart Fail Rev 12 2007 91 95
13. L. Tavazzi, A.P. Maggioni, D. Lucci, and et al. Nationwide survey on acute heart failure in cardiology ward services in Italy Eur Heart J 27 2006 1207 1215
14. J.S. Ross, J. Chen, Z. Lin, and et al. Recent national trends in readmission rates after heart failure hospitalization Circ Heart Fail 3 2010 97 103
15. S.F. Jencks, M.V. Williams, and E.A. Coleman Rehospitalizations among patients in the Medicare fee-for-service program N Engl J Med 360 2009 1418 1428
16. P.J. Hauptman, P.J. Schwartz, M.R. Gold, and et al. Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF Am Heart J 163 2012 954 962.e1
17. R.C. Bourge, W.T. Abraham, P.B. Adamson, and et al. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study J Am Coll Cardiol 51 2008 1073 1079
18. M. Ruel, R.G. Masters, F.D. Rubens, and et al. Late incidence and determinants of stroke after aortic and mitral valve replacement Ann Thorac Surg 78 2004 77 83
19. R.L. Sacco, S.E. Kasner, J.P. Broderick, and 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 44 2013 2064 2089
20. S.R. Messe, M.A. Acker, S.E. Kasner, and et al. Stroke after aortic valve surgery: results from a prospective cohort Circulation 129 2014 2253 2261
21. D.H. Adams, J.J. Popma, M.J. Reardon, and et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis N Engl J Med 370 2014 1790 1798
22. F. Philip, G. Athappan, E.M. Tuzcu, and et al. MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk: a comprehensive systematic review Catheter Cardiovasc Interv 84 2014 581 590
23. T. Feldman, E. Foster, D.D. Glower, and et al. Percutaneous repair or surgery for mitral regurgitation N Engl J Med 364 2011 1395 1406
24. M. Wintermark, G.W. Albers, A.V. Alexandrov, and et al. Acute stroke imaging research roadmap Stroke 39 2008 1621 1628
25. P.D. Lyden, and G.T. Lau A critical appraisal of stroke evaluation and rating scales Stroke 22 1991 1345 1352
26. A. Russo, F. Grigioni, J.F. Avierinos, and et al. Thromboembolic complications after surgical correction of mitral regurgitation incidence, predictors, and clinical implications J Am Coll Cardiol 51 2008 1203 1211
27. K. Lietz, K. Brown, S.S. Ali, and et al. The role of cerebral hyperperfusion in postoperative neurologic dysfunction after left ventricular assist device implantation for end-stage heart failure J Thorac Cardiovasc Surg 137 2009 1012 1019
28. M. Spaziano, D.P. Francese, M.B. Leon, and et al. Imaging and functional testing to assess clinical and subclinical neurological events after transcatheter or surgical aortic valve replacement: a comprehensive review J Am Coll Cardiol 64 2014 1950 1963
29. T.F. Floyd, P.N. Shah, C.C. Price, and et al. Clinically silent cerebral ischemic events after cardiac surgery: their incidence, regional vascular occurrence, and procedural dependence Ann Thorac Surg 81 2006 2160 2166
30. P. Kahlert, S.C. Knipp, M. Schlamann, and et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study Circulation 121 2010 870 878
31. A. Ghanem, A. Muller, C.P. Nahle, and et al. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging J Am Coll Cardiol 55 2010 1427 1432
32. S.C. Knipp, N. Matatko, M. Schlamann, and et al. Small ischemic brain lesions after cardiac valve replacement detected by diffusion-weighted magnetic resonance imaging: relation to neurocognitive function Eur J Cardiothorac Surg 28 2005 88 96
33. D.J. Cook, J. Huston 3rd, M.R. Trenerry, and et al. Postcardiac surgical cognitive impairment in the aged using diffusion-weighted magnetic resonance imaging Ann Thorac Surg 83 2007 1389 1395
34. P.A. Barber, S. Hach, L.J. Tippett, and et al. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery Stroke 39 2008 1427 1433
35. S.C. Knipp, N. Matatko, H. Wilhelm, and et al. Cognitive outcomes three years after coronary artery bypass surgery: relation to diffusion-weighted magnetic resonance imaging Ann Thorac Surg 85 2008 872 879
36. M.A. Acker, M.K. Parides, L.P. Perrault, and et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation N Engl J Med 370 2014 23 32
37. F. Maisano, O. Franzen, S. Baldus, and et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe J Am Coll Cardiol 62 2013 1052 1061
38. W. Schillinger, M. Hunlich, S. Baldus, and et al. Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry EuroIntervention 9 2013 84 90
39. K. Thygesen, J.S. Alpert, A.S. Jaffe, and et al. Third universal definition of myocardial infarction Circulation 126 2012 2020 2035
40. V. Novack, M. Pencina, D.J. Cohen, and et al. Troponin criteria for myocardial infarction after percutaneous coronary intervention Arch Intern Med 172 2012 502 508
41. V. Muthu, H. Kozman, K. Liu, and et al. Cardiac troponins: bench to bedside interpretation in cardiac disease Am J Med Sci 347 2014 331 337
42. P. Venge, N. Johnston, B. Lindahl, and et al. Normal plasma levels of cardiac troponin I measured by the high-sensitivity cardiac troponin I access prototype assay and the impact on the diagnosis of myocardial ischemia J Am Coll Cardiol 54 2009 1165 1172
43. I.D. Moussa, L.W. Klein, B. Shah, and et al. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI) J Am Coll Cardiol 62 2013 1563 1570
44. P. Généreux, J.G. Webb, L.G. Svensson, and et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial J Am Coll Cardiol 60 2012 1043 1052
45. P. Généreux, D.J. Cohen, M.R. Williams, and et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I trial (Placement of Aortic Transcatheter Valve) J Am Coll Cardiol 63 2014 1100 1109
46. G.J. Murphy, B.C. Reeves, C.A. Rogers, and et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery Circulation 116 2007 2544 2552
47. M. Konigstein, E. Ben-Assa, Y. Abramowitz, and et al. Usefulness of updated Valve Academic Research Consortium-2 criteria for acute kidney injury following transcatheter aortic valve implantation Am J Cardiol 112 2013 1807 1811
48. J.R. Brown, R.S. Kramer, S.G. Coca, and et al. Duration of acute kidney injury impacts long-term survival after cardiac surgery Ann Thorac Surg 90 2010 1142 1148
49. C.E. Hobson, S. Yavas, M.S. Segal, and et al. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery Circulation 119 2009 2444 2453
50. R.L. Mehta, J.A. Kellum, S.V. Shah, and et al. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury Crit Care 11 2007 R31
51. C. Hochreiter, N. Niles, R.B. Devereux, and et al. Mitral regurgitation: relationship of noninvasive descriptors of right and left ventricular performance to clinical and hemodynamic findings and to prognosis in medically and surgically treated patients Circulation 73 1986 900 912
52. P. Kligfield, C. Hochreiter, N. Niles, and et al. Relation of sudden death in pure mitral regurgitation, with and without mitral valve prolapse, to repetitive ventricular arrhythmias and right and left ventricular ejection fractions Am J Cardiol 60 1987 397 399
53. R.J. van Bommel, N. Ajmone Marsan, V. Delgado, and et al. Cardiac resynchronization therapy as a therapeutic option in patients with moderate-severe functional mitral regurgitation and high operative risk Circulation 124 2011 912 919
54. A.M. Russo, R.F. Stainback, S.R. Bailey, and et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance J Am Coll Cardiol 61 2013 1318 1368
55. M. Brignole, A. Auricchio, G. Baron-Esquivias, and et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on Cardiac Pacing and Resynchronization Therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA) Eur Heart J 34 2013 2281 2329
56. D. Berdajs, U.P. Schurr, A. Wagner, and et al. Incidence and pathophysiology of atrioventricular block following mitral valve replacement and ring annuloplasty Eur J Cardiothorac Surg 34 2008 55 61
57. P. Meimoun, R. Zeghdi, N. D'Attelis, and et al. Frequency, predictors, and consequences of atrioventricular block after mitral valve repair Am J Cardiol 89 2002 1062 1066
58. P.A. Grayburn, E. Foster, C. Sangli, and et al. Relationship between the magnitude of reduction in mitral regurgitation severity and left ventricular and left atrial reverse remodeling after MitraClip therapy Circulation 128 2013 1667 1674
59. D.S. Lim, M.R. Reynolds, T. Feldman, and et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair J Am Coll Cardiol 64 2014 182 192
60. D. Sürder, G. Pedrazzini, O. Gaemperli, and et al. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry Heart 99 2013 1034 1040
61. D.T. Durack, A.S. Lukes, D.K. Bright, and et al. New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings Am J Med 96 1994 200 209