Subscribe to RSS
DOI: 10.1055/s-0033-1360509
The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines
Publication History
03 May 2013
20 September 2013
Publication Date:
02 December 2013 (online)
![](https://www.thieme-connect.de/media/thoracic/201401/lookinside/thumbnails/10.1055-s-0033-1360509-1.jpg)
Abstract
Background Transcatheter interventions (TIs) are new treatment options for patients with severe mitral valve regurgitation (MR) who cannot undergo open mitral valve surgery (oMVS). Despite the lack of scientific evidence demonstrating the benefit of these procedures, there has been a steady increase in their use. The aim of this study was to evaluate whether there are any indication criteria, process, and structural requirements, or scientific society and institutional guidelines for the use of the MitraClip System (Abbott Vascular-Structural Heart, Menlo Park, California, United States).
Method A systematic literature search was conducted using the common medical and scientific databases. Of a total of 1,395 publications, 42 publications met the inclusion criteria and were included for the evaluation.
Results Despite a general lack of high-quality evidence and of consensus recommendations from scientific societies or institutions, an assessment of indication criteria and process and structural requirements for the use of the MitraClip System, including noncontrolled studies, was possible. The majority of studies agree that an interdisciplinary heart team including a cardiothoracic surgeon, an interventional cardiologist, and an echocardiographic specialist should actively participate in clinical decision making, and in the procedure itself. Participation in a scientific-based registry is strongly recommended.
Conclusions The MitraClip System is a promising procedure, but evidence-based indication criteria, structural, and process requirements for its use are lacking. Further results from prospective, randomized controlled trials are needed to determine patients, potential adverse events, device durability, and long-term follow-up. MitraClip should be used in only a small number of centers with procedure-specific, high-quality surgical and interventional experience, and training.
-
Reference
- 1 Enriquez-Sarano M, Schaff HV, Orszulak TA, Tajik AJ, Bailey KR, Frye RL. Valve repair improves the outcome of surgery for mitral regurgitation. A multivariate analysis. Circulation 1995; 91 (4) 1022-1028
- 2 Bonow RO, Carabello BA, Kanu C , et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. ACC/AHA 2006 guidelines 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 (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation 2006; 114 (5) e84-e231
- 3 Vahanian A, Alfieri O, Andreotti F , et al; ESC Committee for Practice Guidelines (CPG); 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): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2012; 42 (4) S1-S44
- 4 Carabello BA. The current therapy for mitral regurgitation. J Am Coll Cardiol 2008; 52 (5) 319-326
- 5 Vassileva CM, Boley T, Markwell S, Hazelrigg S. Meta-analysis of short-term and long-term survival following repair versus replacement for ischemic mitral regurgitation. Eur J Cardiothorac Surg 2011; 39 (3) 295-303
- 6 ACCESS. ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe. Available at: http://clinicaltrialfeedsorg/clinical-trials/show/NCT01288976 . Accessed on June 19th, 2012.
- 7 Mirabel M, Iung B, Baron G , et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery?. Eur Heart J 2007; 28 (11) 1358-1365
- 8 Boekstegers P, Hausleiter J, Baldus S , et al. Interventionelle Behandlung der Mitralklappeninsuffizienz mit dem MitraClip-Verfahren. Kardiologe 2013; 7: 91-104
- 9 Nickenig G, Mohr FW, Kelm M , et al. Konsensus der Deutschen Gesellschaft für Kardiologie - Herz-und Kreislaufforschung und der Deutschen Gesellschaft für Thorax-, Herz- und Gefäßchirurgie zur Behandlung der Mitralinsuffizienz. Kardiologe 2013; 7: 76-90
- 10 Feldman T, Foster E, Glower DD , et al; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011; 364 (15) 1395-1406
- 11 NHC. Transcatheter mitral valve repair for severe mitral valve regurgitation. New Zealand: National Health Commitee; 2011: 1-8
- 12 Maisano F, Godino C, Giacomini A , et al. Patient selection for MitraClip therapy impaired left ventricular systolic function. Minerva Cardioangiol 2011; 59 (5) 455-471
- 13 Auricchio A, Schillinger W, Meyer S , et al; 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 2011; 58 (21) 2183-2189
- 14 Baldus S, Schillinger W, Franzen O , et al; 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 2012; 14 (9) 1050-1055
- 15 Bohnenblust H, Hitz P, Stettbacher D , et al. Perkutane, Katheter-basierte Behandlung der schweren Mitralklappeninsuffizienz (Percutaneous Mitral Valve Repair). Medical Board; 2010
- 16 Doebler K, Boukamp K, Mayer ED. Indication and structures and management of transcatheter aortic valve implantation: a review of the literature. Thorac Cardiovasc Surg 2012; 60 (5) 309-318
- 17 Rosenhek R, Iung B, Tornos P , et al. ESC Working Group on Valvular Heart Disease Position Paper: assessing the risk of interventions in patients with valvular heart disease. Eur Heart J 2012; 33 (7) 822-828 , 828a, 828b
- 18 Alegria-Barrero E, Chan PH, Paulo M , et al. Edge-to-edge percutaneous repair of severe mitral regurgitation—state-of-the-art for Mitraclip® implantation. Circ J 2012; 76 (4) 801-808
- 19 Medical Service Advisory Committee. Final Decision Analytic Protocol (DAP) to guide the assessment of reduction of mitral regurgitation through tissue approximation using transvenous/transseptal techniques; Australian Goverment - Departement of Health and Ageing. Available at: http://www msac gov au/internet/msac/publishing nsf/Content/1192 . Accessed May 2012
- 20 Conradi L, Treede H, Franzen O , et al. Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg 2011; 40 (6) 1521-1526
- 21 Divchev D, Kische S, Paranskaya L , et al. In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip® device. J Interv Cardiol 2012; 25 (2) 180-189
- 22 Feldman T, Cilingiroglu M. Percutaneous leaflet repair and annuloplasty for mitral regurgitation. J Am Coll Cardiol 2011; 57 (5) 529-537
- 23 Franzen O, Seiffert M, Baldus S , et al. Percutaneous mitral valve repair as a bail-out strategy for patients with severe mitral regurgitation after cardiac surgery. J Thorac Cardiovasc Surg 2011; 142 (1) 227-230
- 24 Franzen O, van der Heyden J, Baldus S , et al. MitraClip® therapy in patients with end-stage systolic heart failure. Eur J Heart Fail 2011; 13 (5) 569-576
- 25 Glower D, Ailawadi G, Argenziano M , et al; EVEREST II Investigators. EVEREST II randomized clinical trial: predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. J Thorac Cardiovasc Surg 2012; 143 (4, Suppl): S60-S63
- 26 Holmes Jr DR, Mack MJ, Kaul S , et al; American Heart Association; American Society of Echocardiography; European Association for Cardio-Thoracic Surgery; Heart Failure Society of America; Mended Hearts; Society of Cardiovascular Anesthesiologists; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement: developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Catheter Cardiovasc Interv 2012; 79 (7) 1023-1082
- 27 Jilaihawi H, Hussaini A, Kar S. MitraClip: a novel percutaneous approach to mitral valve repair. J Zhejiang Univ Sci B 2011; 12 (8) 633-637
- 28 Maisano F, Franzen O, Baldus S , 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 2013; 62 (12) 1052-1061
- 29 Neuss M, Schau T, Schoepp M , et al. Patient selection criteria and midterm clinical outcome for MitraClip therapy in patients with severe mitral regurgitation and severe congestive heart failure. Eur J Heart Fail 2013; 15 (7) 786-795
- 30 NICE Percutaneous mitral valve annuloplasty. Available at: http://www.nice.org.uk/nicemedia/live/12351/49902/49902.pdf . Accessed: July 2010
- 31 Obadia JF. MitraClip: Actual data and perspectives. Congrès EBR 2012, Marseille, France, May 3–4 2012
- 32 Siegel RJ, Luo H, Biner S. Transcatheter valve repair/implantation. Int J Cardiovasc Imaging 2011; 27 (8) 1165-1177
- 33 Siegel RJ, Luo H. Echocardiography in transcatheter aortic valve implantation and mitral valve clip. Korean J Intern Med 2012; 27 (3) 245-261
- 34 Smith T, McGinty P, Bommer W , et al. Prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the MitraClip system. Catheter Cardiovasc Interv 2012; 80 (4) 678-685
- 35 Sürder D, Pedrazzini G, Gaemperli O , et al. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart 2013; 99 (14) 1034-1040
- 36 Krumsdorf U, Chorianopoulos E, Rottbauer W, Katus H, Bekeredjian R. Percutaneous aortic valve implantation improves quality of life in a geriatric patient population. EuroIntervention 2011; 7 (May Suppl). http://www.pcronline.com/eurointervention/search/?keyword_string=krumsdorf
- 37 Swaans MJ, Van den Branden BJ, Van der Heyden JA , et al. Three-dimensional transoesophageal echocardiography in a patient undergoing percutaneous mitral valve repair using the edge-to-edge clip technique. Eur J Echocardiogr 2009; 10 (8) 982-983
- 38 Tamburino C, Immè S, Barbanti M , et al. Reduction of mitral valve regurgitation with Mitraclip® percutaneous system. Minerva Cardioangiol 2010; 58 (5) 589-598
- 39 Taramasso M, Denti P, Buzzatti N , et al. Mitraclip therapy and surgical mitral repair in patients with moderate to severe left ventricular failure causing functional mitral regurgitation: a single-centre experience. Eur J Cardiothorac Surg 2012; 42 (6) 920-926
- 40 Treede H, Schirmer J, Rudolph V , et al. A heart team's perspective on interventional mitral valve repair: percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients. J Thorac Cardiovasc Surg 2012; 143 (1) 78-84
- 41 Turi ZG, Rosenbloom M. An option for the high-comorbidity patient with mitral regurgitation. J Am Coll Cardiol 2012; 59 (2) 140-142
- 42 Van den Branden BJ, Swaans MJ, Post MC , et al. Percutaneous edge-to-edge mitral valve repair in high-surgical-risk patients: do we hit the target?. JACC Cardiovasc Interv 2012; 5 (1) 105-111
- 43 Whitlow PL, Feldman T, Pedersen WR , et al; 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 2012; 59 (2) 130-139
- 44 Yuksel UC, Kapadia SR, Tuzcu EM. Percutaneous mitral repair: patient selection, results, and future directions. Curr Cardiol Rep 2011; 13 (2) 100-106
- 45 Zamorano JL, Badano LP, Bruce C , et al. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. J Am Soc Echocardiogr 2011; 24 (9) 937-965
- 46 Vahanian A, Iung B. 'Edge to edge' percutaneous mitral valve repair in mitral regurgitation: it can be done but should it be done?. Eur Heart J 2010; 31 (11) 1301-1304
- 47 Maisano F, Alfieri O, La Canna G. Percutaneous mitral repair with the MitraClip. Ann Fr Anesth Reanim 2011; 30 (Suppl. 01) S33-S37
- 48 Tamburino C, Ussia GP, Maisano F , et al. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J 2010; 31 (11) 1382-1389
- 49 NICE. National Institute for Health and Clinical Excellence: Percutaneous mitral valve leaflet repair for mitral regurgitation. Available at: http://guidance.nice.org.uk/ipg309 . Accessed on June 19, 2012
- 50 Feldman T, Glower D. Patient selection for percutaneous mitral valve repair: insight from early clinical trial applications. Nat Clin Pract Cardiovasc Med 2008; 5 (2) 84-90
- 51 Kappetein AP, Head SJ, Généreux P , et al; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 2013; 145 (1) 6-23
- 52 AHRQ-ECRI Institute. AHRQ Healthcare Horizon Scanning System Potential High Impact Interventions: Priority Area 03: Cardiovascular Disease. (Prepared by ECRI Institute under Contract No. HHSA290201000006C.) Rockville, MD: Agency for Healthcare Research and Quality. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm . Accessed July 24, 2012
- 53 Conradi L, Treede H, Baldus S, Seiffert M, Blankenberg S, Reichenspurner H. Treating mitral regurgitation: a surgical and interventional update. Herz 2011; 36 (8) 677-685