The evolution of percutaneous mitral valve repair therapy: Lessons learned and implications for patient selection

Journal of the American College of Cardiology

Volumn 64, Issue 24, 2014, Pages 2688-2700

  Beigel, Roy ^a,b,c   Wunderlich, Nina C ^d   Kar, Saibal ^a   Siegel, Robert J ^a  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b SHEBA MEDICAL CENTER   (Israel)

^c TEL AVIV UNIVERSITY   (Israel)

^d Cardiovascular Center Darmstadt   (Germany)

Author keywords

mitral valve; mitral valve annuloplasty; mitral valve insufficiency; outcomes assessment; patient selection

Indexed keywords

ARTICLE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR SURGERY; DISEASE SEVERITY; FOLLOW UP; HIGH RISK PATIENT; HUMAN; IMPLANTABLE CLIP; INTERMETHOD COMPARISON; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; MITRAL VALVE REGURGITATION; MITRAL VALVE REPAIR; NONHUMAN; OBSERVATIONAL STUDY; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT INDICATION; ADVERSE EFFECTS; CLINICAL TRIAL (TOPIC); HEART CATHETERIZATION; HEART SURGERY; MITRAL VALVE; MITRAL VALVE INSUFFICIENCY; MORTALITY; OUTCOME ASSESSMENT; POSTOPERATIVE COMPLICATIONS; PROCEDURES; RISK ASSESSMENT;

CARDIAC CATHETERIZATION; CARDIAC SURGICAL PROCEDURES; CLINICAL TRIALS AS TOPIC; HUMANS; MITRAL VALVE; MITRAL VALVE INSUFFICIENCY; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SELECTION; POSTOPERATIVE COMPLICATIONS; RISK ASSESSMENT;

EID: 84917736056     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.08.049     Document Type: Review

References (63)

1. M. Enriquez-Sarano, C.W. Akins, and A. Vahanian Mitral regurgitation Lancet 373 2009 1382 1394
2. B. Iung, G. Baron, and E.G. Butchart A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease Eur Heart J 24 2003 1231 1243
3. M.J. Mack New techniques for percutaneous repair of the mitral valve Heart Fail Rev 11 2006 259 268
4. Y. Otsuji, M.D. Handschumacher, and E. Schwammenthal Insights from three-dimensional echocardiography into the mechanism of functional mitral regurgitation: direct in vivo demonstration of altered leaflet tethering geometry Circulation 96 1997 1999 2008
5. Y. Otsuji, D. Gilon, and L. Jiang Restricted diastolic opening of the mitral leaflets in patients with left ventricular dysfunction: evidence for increased valve tethering J Am Coll Cardiol 32 1998 398 404
6. R.A. Nishimura, C.M. Otto, and R.O. Bonow 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 63 2014 e57 e185
7. M.W. Connolly, J.S. Gelbfish, and I.J. Jacobowitz Surgical results for mitral regurgitation from coronary artery disease J Thorac Cardiovasc Surg 91 1986 379 388
8. B. Wan, M. Rahnavardi, and D.H. Tian A meta-analysis of MitraClip system versus surgery for treatment of severe mitral regurgitation Ann Cardiothorac Surg 2 2013 683 692
9. M. Mirabel, B. Iung, and G. Baron What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 28 2007 1358 1365
10. F. Maisano, J.J. Schreuder, and M. Oppizzi The double-orifice technique as a standardized approach to treat mitral regurgitation due to severe myxomatous disease: surgical technique Eur J Cardiothorac Surg 17 2000 201 205
11. M. De Bonis, E. Lapenna, and G. La Canna Mitral valve repair for functional mitral regurgitation in end-stage dilated cardiomyopathy: role of the "edge-to-edge" technique Circulation 112 2005 I402 I408
12. S.K. Bhudia, P.M. McCarthy, and N.G. Smedira Edge-to-edge (Alfieri) mitral repair: results in diverse clinical settings Ann Thorac Surg 77 2004 1598 1606
13. F.G. St Goar, J.I. Fann, and J. Komtebedde Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model Circulation 108 2003 1990 1993
14. J.A. Condado, H. Acquatella, and L. Rodriguez Percutaneous edge-to edge mitral valve repair: 2-year follow-up in the first human case Catheter Cardiovasc Interv 67 2006 323 325
15. T. Feldman, E. Foster, D.D. Glower EVEREST II Investigators Percutaneous repair or surgery for mitral regurgitation N Engl J Med 364 2011 1395 1406
16. L. Mauri, P. Garg, and J.M. Massaro The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation Am Heart J 160 2010 23 29
17. E. Lubos, M. Schlüter, and E. Vettorazzi MitraClip therapy in surgical high-risk patients: identification of echocardiographic variables affecting acute procedural outcome J Am Coll Cardiol Intv 7 2014 394 402
18. T. Feldman, S. Kar, M. Rinaldi EVEREST Investigators Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort J Am Coll Cardiol 54 2009 686 694
19. S. Biner, R.J. Siegel, T. Feldman EVEREST Investigators Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation Eur J Heart Fail 14 2012 939 945
20. W. Schillinger, T. Athanasiou, and N. Weicken Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients Eur J Heart Fail 13 2011 1331 1339
21. O. Franzen, S. Baldus, and V. Rudolph Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction Eur Heart J 31 2010 1373 1381
22. L. Mauri, E. Foster, D.D. Glower EVEREST II Investigators 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation J Am Coll Cardiol 62 2013 317 328
23. T. Feldman, L. Mauri, S. Kar on behalf of the EVEREST II Investigators Final results of the EVEREST II randomized controlled trial of percutaneous and surgical reduction of mitral regurgitation (abstr) J Am Coll Cardiol 63 Suppl 12 2014 A1682
24. P.L. Whitlow, T. Feldman, W.R. Pedersen EVEREST II Investigators Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study J Am Coll Cardiol 59 2012 130 139
25. P.A. Grayburn, E. Foster, and C. Sangli 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
26. A. Vahanian, O. Alfieri, F. Andreotti Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS) Guidelines on the management of valvular heart disease (version 2012) Eur Heart J 33 2012 2451 2496
27. F. Maisano, O. Franzen, and S. Baldus 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
28. S. Baldus, W. Schillinger, O. Franzen German Transcatheter Mitral Valve Interventions (TRAMI) Investigators MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry Eur J Heart Fail 14 2012 1050 1055
29. W. Schillinger, M. Hünlich, and S. Baldus Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry EuroIntervention 9 2013 84 90
30. K. Vakil, H. Roukoz, and M. Sarraf Safety and efficacy of the MitraClip® system for severe mitral regurgitation: a systematic review Catheter Cardiovasc Interv 84 2013 129 136
31. S. Munkholm-Larsen, B. Wan, and D.H. Tian A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates Heart 100 2014 473 478
32. W. Flameng, B. Meuris, and P. Herijgers Durability of mitral valve repair in Barlow disease versus fibroelastic deficiency J Thorac Cardiovasc Surg 135 2008 274 282
33. T.E. David, J. Ivanov, and S. Armstrong A comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse J Thorac Cardiovasc Surg 130 2005 1242 1249
34. T.E. David, S. Armstrong, and B.W. McCrindle Late outcomes of mitral valve repair for mitral regurgitation due to degenerative disease Circulation 127 2013 1485 1492
35. D.R. Johnston, A.M. Gillinov, and E.H. Blackstone Surgical repair of posterior mitral valve prolapse: implications for guidelines and percutaneous repair Ann Thorac Surg 89 2010 1385 1394
36. A.M. Gillinov, E.H. Blackstone, and A. Alaulaqi Outcomes after repair of the anterior mitral leaflet for degenerative disease Ann Thorac Surg 86 2008 708 717 discussion 708-17
37. J. Seeburger, M.A. Borger, and N. Doll Comparison of outcomes of minimally invasive mitral valve surgery for posterior, anterior and bileaflet prolapse Eur J Cardiothorac Surg 36 2009 532 538
38. D.J. DiBardino, A.W. ElBardissi, and R.S. McClure Four decades of experience with mitral valve repair: analysis of differential indications, technical evolution, and long-term outcome J Thorac Cardiovasc Surg 139 2010 76 83 discussion 83-4
39. D.S. Lim, M.R. Reynolds, and T. Feldman Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation following transcatheter mitral valve repair J Am Coll Cardiol 64 2014 182 192
40. H. Reichenspurner, W. Schillinger, S. Baldus ACCESS-EU Phase 1 Investigators Clinical outcomes through 12 months in patients with degenerative mitral regurgitation treated with the MitraClip® device in the ACCESS-EUrope Phase I trial Eur J Cardiothorac Surg 44 2013 e280 e288
41. A.H. Wu, K.D. Aaronson, and S.F. Bolling Impact of mitral valve annuloplasty on mortality risk in patients with mitral regurgitation and left ventricular systolic dysfunction J Am Coll Cardiol 45 2005 381 387
42. E.C. McGee, A.M. Gillinov, and E.H. Blackstone Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation J Thorac Cardiovasc Surg 128 2004 916 924
43. D.D. Glower Surgical approaches to mitral regurgitation J Am Coll Cardiol 60 2012 1315 1322
44. M. Enriquez-Sarano, H.V. Schaff, and R.L. Frye Mitral regurgitation: what causes the leakage is fundamental to the outcome of valve repair Circulation 108 2003 253 256
45. M. Enriquez-Sarano, H.V. Schaff, and T.A. Orszulak Valve repair improves the outcome of surgery for mitral regurgitation. A multivariate analysis Circulation 91 1995 1022 1028
46. T. Yamano, A.M. Gillinov, and N. Wada Doppler-derived preoperative mitral regurgitation volume predicts postoperative left ventricular dysfunction after mitral valve repair Am Heart J 157 2009 875 882
47. R.J. Siegel, S. Biner, A.M. Rafique EVEREST Investigators The acute hemodynamic effects of MitraClip therapy J Am Coll Cardiol 57 2011 1658 1665
48. O. Gaemperli, M. Moccetti, and D. Surder Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes Heart 98 2012 126 132
49. W.J.P. van Boven, W.B. Gerritsen, and A.H. Driessen Myocardial oxidative stress, and cell injury comparing three different techniques for coronary artery bypass grafting Eur J Cardiothorac Surg 34 2008 969 975
50. R.D. Weisel, D.A. Mickle, and C.D. Finkle Myocardial free-radical injury after cardioplegia Circulation 80 1989 III14 III18
51. O. Franzen, J. van der Heyden, and S. Baldus MitraClip® therapy in patients with end-stage systolic heart failure Eur J Heart Fail 13 2011 569 576
52. A. Auricchio, W. Schillinger, S. Meyer PERMIT-CARE Investigators Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling J Am Coll Cardiol 58 2011 2183 2189
53. B.J.L. Van den Branden, M.J. Swaans, and M.C. Post Percutaneous edge-to-edge mitral valve repair in high-surgical-risk patients: do we hit the target? J Am Coll Cardiol Intv 5 2012 105 111
54. M. Taramasso, F. Maisano, and A. Latib Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation EuroIntervention 10 2014 746 752
55. S.T. Pleger, M. Schulz-Schönhagen, and N. Geis One year clinical efficacy and reverse cardiac remodelling in patients with severe mitral regurgitation and reduced ejection fraction after MitraClip implantation Eur J Heart Fail 15 2013 919 927
56. ClinicalTrials.gov. Cardiovascular outcomes assessment of the MitraClip therapy percutaneous therapy for high surgical risk patients (COAPT). Available at: http://clinicaltrials.gov/ct2/show/NCT01626079. Accessed October 13, 2014.
57. ClinicalTrials.gov. A randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation (RESHAPE-HF). Available at: http://clinicaltrials.gov/ct2/show/NCT01772108. Accessed October 13, 2014.
58. S. Kar Percutaneous transcatheter mitral valve repair adding life to years J Am Coll Cardiol 62 2013 1062 1064
59. R. Beigel, and R.J. Siegel Should the guidelines for the assessment of the severity of functional mitral regurgitation be redefined? J Am Coll Cardiol Img 7 2014 313 314
60. T. Feldman, and A. Young Percutaneous approaches to valve repair for mitral regurgitation J Am Coll Cardiol 63 2014 2057 2068
61. S. Banai, S. Verheye, and A. Cheung Transapical mitral implantation of the Tiara bioprosthesis: preclinical results J Am Coll Cardiol Intv 7 2014 154 162
62. S. Banai, M. Jolicoeur, and J.F. Tanguay TCT-107 TIARA - a novel catheter-based mitral valve bio-prosthesis short term pre-clinical results (abstr) J Am Coll Cardiol 60 2012 B33
63. S. Biner, G. Perk, and S. Kar Utility of combined two-dimensional and three-dimensional transesophageal imaging for catheter-based mitral valve clip repair of mitral regurgitation J Am Soc Echocardiogr 24 2011 611 617