Advertisement

Transcatheter Mitral Valve Repair With MitraClip for Symptomatic Functional Mitral Valve Regurgitation

      Transcatheter edge-to-edge mitral valve repair (TMVr) with MitraClip has proved to be safe and effective for high-risk surgical patients with severe symptomatic degenerative mitral regurgitation. There is paucity of data regarding its use in functional mitral regurgitation (FMR). The objective of this study was to evaluate the use of MitraClip in patients with symptomatic moderate or severe FMR and a high surgical risk. Medical libraries were systematically searched for studies assessing the use of MitraClip for patients with symptomatic moderate or severe FMR and a high surgical risk. Studies reporting safety and efficacy outcomes at 12 months were included in the analysis. A total of 12 studies including 1,695 patients (age 73 [interquartile range [IQR] 70.5 to 74], 69.8% men, left ventricular ejection fraction 32.5% [IQR 29.5 to 36], New York Heart Association class II to IV) who underwent TMVr with MitraClip were included in the analysis. Acute procedural success was 89% (IQR 85.5 to 92). Ischemic cardiomyopathy was the most common cause of left ventricular dysfunction. Over 2/3 of patients had known coronary artery disease, 35% a previous myocardial infarction, and 38.5% had a previous cardiac surgery. Survival to hospital discharge was 98% (IQR 97 to 100) and 30-day survival 97% (IQR 96 to 98). Overall survival at 12 months was 82% (IQR 77 to 87). Mitral valve re-intervention at 12 months was infrequent (3%; IQR 2 to 6.5). In conclusion, our pooled analysis suggests that TMVr with MitraClip is feasible, safe, and carries a low rate of mitral valve re-intervention at 12 months in patients with symptomatic moderate or severe FMR and a high surgical risk.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Nishimura R.A.
        • Otto C.M.
        • Bonow R.O.
        • Carabello B.A.
        • Erwin III, J.P.
        • Guyton R.A.
        • O'Gara P.T.
        • Ruiz C.E.
        • Skubas N.J.
        • Sorajja P.
        • Sundt III, T.M.
        • Thomas J.D.
        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. 2014; 63: e57-e185
        • Trichon B.H.
        • Felker G.M.
        • Shaw L.K.
        • Cabell C.H.
        • O'Connor C.M.
        Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure.
        Am J Cardiol. 2003; 91: 538-543
        • Kaneko H.
        • Suzuki S.
        • Uejima T.
        • Kano H.
        • Matsuno S.
        • Takai H.
        • Oikawa Y.
        • Yajima J.
        • Aizawa T.
        • Yamashita T.
        Functional mitral regurgitation and left ventricular systolic dysfunction in the recent era of cardiovascular clinical practice, an observational cohort study.
        Hypertens Res. 2014; 37: 1082-1087
        • Grigioni F.
        • Enriquez-Sarano M.
        • Zehr K.J.
        • Bailey K.R.
        • Tajik A.J.
        Ischemic mitral regurgitation: long-term outcome and prognostic implications with quantitative Doppler assessment.
        Circulation. 2001; 103: 1759-1764
        • Cioffi G.
        • Tarantini L.
        • De Feo S.
        • Pulignano G.
        • Del Sindaco D.
        • Stefenelli C.
        • Di Lenarda A.
        • Opasich C.
        Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure.
        Eur J Heart Fail. 2005; 7: 1112-1117
        • Wu A.H.
        • Aaronson K.D.
        • Bolling S.F.
        • Pagani F.D.
        • Welch K.
        • Koelling T.M.
        Impact of mitral valve annuloplasty on mortality risk in patients with mitral regurgitation and left ventricular systolic dysfunction.
        J Am Coll Cardiol. 2005; 45: 381-387
        • Herrmann H.C.
        • Rohatgi S.
        • Wasserman H.S.
        • Block P.
        • Gray W.
        • Hamilton A.
        • Zunamon A.
        • Homma S.
        • Di Tullio M.R.
        • Kraybill K.
        • Merlino J.
        • Martin R.
        • Rodriguez L.
        • Stewart W.J.
        • Whitlow P.
        • Wiegers S.E.
        • Silvestry F.E.
        • Foster E.
        • Feldman T.
        Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation.
        Catheter Cardiovasc Interv. 2006; 68: 821-828
        • Giannini C.
        • Petronio A.S.
        • De Carlo M.
        • Guarracino F.
        • Conte L.
        • Fiorelli F.
        • Pieroni A.
        • Di Bello V.
        Integrated reverse left and right ventricular remodelling after MitraClip implantation in functional mitral regurgitation: an echocardiographic study.
        Eur Heart J Cardiovasc Imaging. 2014; 15: 95-103
        • Vahanian A.
        • Alfieri O.
        • Andreotti F.
        • Antunes M.J.
        • Baron-Esquivias G.
        • Baumgartner H.
        • Borger M.A.
        • Carrel T.P.
        • De Bonis M.
        • Evangelista A.
        • Falk V.
        • Lung B.
        • Lancellotti P.
        • Pierard L.
        • Price S.
        • Schafers H.J.
        • Schuler G.
        • Stepinska J.
        • Swedberg K.
        • Takkenberg J.
        • Von Oppell U.O.
        • Windecker S.
        • Zamorano J.L.
        • Zembala M.
        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: S1-S44
        • Moher D.
        • Liberati A.
        • Tetzlaff J.
        • Altman D.G.
        Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
        BMJ. 2009; 339: b2535
        • Koelling T.M.
        • Aaronson K.D.
        • Cody R.J.
        • Bach D.S.
        • Armstrong W.F.
        Prognostic significance of mitral regurgitation and tricuspid regurgitation in patients with left ventricular systolic dysfunction.
        Am Heart J. 2002; 144: 524-529
        • Yancy C.W.
        • Jessup M.
        • Bozkurt B.
        • Butler J.
        • Casey Jr., D.E.
        • Drazner M.H.
        • Fonarow G.C.
        • Geraci S.A.
        • Horwich T.
        • Januzzi J.L.
        • Johnson M.R.
        • Kasper E.K.
        • Levy W.C.
        • Masoudi F.A.
        • McBride P.E.
        • McMurray J.J.
        • Mitchell J.E.
        • Peterson P.N.
        • Riegel B.
        • Sam F.
        • Stevenson L.W.
        • Tang W.H.
        • Tsai E.J.
        • Wilkoff B.L.
        2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines.
        J Am Coll Cardiol. 2013; 62: e147-e239
        • Yancy C.W.
        • Jessup M.
        • Bozkurt B.
        • Butler J.
        • Casey Jr., D.E.
        • Colvin M.M.
        • Drazner M.H.
        • Filippatos G.
        • Fonarow G.C.
        • Givertz M.M.
        • Hollenberg S.M.
        • Lindenfeld J.
        • Masoudi F.A.
        • McBride P.E.
        • Peterson P.N.
        • Stevenson L.W.
        • Westlake C.
        2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the Heart Failure Society of America.
        J Am Coll Cardiol. 2016; 68: 1476-1488
        • Brignole M.
        • Auricchio A.
        • Baron-Esquivias G.
        • Bordachar P.
        • Boriani G.
        • Breithardt O.A.
        • Cleland J.
        • Deharo J.C.
        • Delgado V.
        • Elliott P.M.
        • Gorenek B.
        • Israel C.W.
        • Leclercq C.
        • Linde C.
        • Mont L.
        • Padeletti L.
        • Sutton R.
        • Vardas P.E.
        • Zamorano J.L.
        • Achenbach S.
        • Baumgartner H.
        • Bax J.J.
        • Bueno H.
        • Dean V.
        • Deaton C.
        • Erol C.
        • Fagard R.
        • Ferrari R.
        • Hasdai D.
        • Hoes A.W.
        • Kirchhof P.
        • Knuuti J.
        • Kolh P.
        • Lancellotti P.
        • Linhart A.
        • Nihoyannopoulos P.
        • Piepoli M.F.
        • Ponikowski P.
        • Sirnes P.A.
        • Tamargo J.L.
        • Tendera M.
        • Torbicki A.
        • Wijns W.
        • Windecker S.
        • Kirchhof P.
        • Blomstrom-Lundqvist C.
        • Badano L.P.
        • Aliyev F.
        • Bansch D.
        • Baumgartner H.
        • Bsata W.
        • Buser P.
        • Charron P.
        • Daubert J.C.
        • Dobreanu D.
        • Faerestrand S.
        • Hasdai D.
        • Hoes A.W.
        • Le Heuzey J.Y.
        • Mavrakis H.
        • McDonagh T.
        • Merino J.L.
        • Nawar M.M.
        • Nielsen J.C.
        • Pieske B.
        • Poposka L.
        • Ruschitzka F.
        • Tendera M.
        • Van Gelder I.C.
        • Wilson C.M.
        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. 2013; 34: 2281-2329
        • Russo A.M.
        • Stainback R.F.
        • Bailey S.R.
        • Epstein A.E.
        • Heidenreich P.A.
        • Jessup M.
        • Kapa S.
        • Kremers M.S.
        • Lindsay B.D.
        • Stevenson L.W.
        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.
        Heart Rhythm. 2013; 10: e11-e58
        • Spartera M.
        • Galderisi M.
        • Mele D.
        • Cameli M.
        • D'Andrea A.
        • Rossi A.
        • Mondillo S.
        • Novo G.
        • Esposito R.
        • D'Ascenzi F.
        • Montisci R.
        • Gallina S.
        • Margonato A.
        • Agricola E.
        Role of cardiac dyssynchrony and resynchronization therapy in functional mitral regurgitation.
        Eur Heart J Cardiovasc Imaging. 2016; 17: 471-480
        • Conradi L.
        • Treede H.
        • Rudolph V.
        • Graumuller P.
        • Lubos E.
        • Baldus S.
        • Blankenberg S.
        • Reichenspurner H.
        Surgical or percutaneous mitral valve repair for secondary mitral regurgitation: comparison of patient characteristics and clinical outcomes.
        Eur J Cardiothorac Surg. 2013; 44 (discussion 496): 490-496
        • Ondrus T.
        • Bartunek J.
        • Vanderheyden M.
        • Stockman B.
        • Kotrc M.
        • Van Praet F.
        • Van Camp G.
        • Lecomte P.
        • Mo Y.
        • Penicka M.
        Minimally invasive mitral valve repair for functional mitral regurgitation in severe heart failure: MitraClip versus minimally invasive surgical approach.
        Interact Cardiovasc Thorac Surg. 2016; 23: 784-789
        • De Bonis M.
        • Taramasso M.
        • Lapenna E.
        • Denti P.
        • La Canna G.
        • Buzzatti N.
        • Pappalardo F.
        • Di Giannuario G.
        • Cioni M.
        • Giacomini A.
        • Alfieri O.
        MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience dagger.
        Eur J Cardiothorac Surg. 2016; 49: 255-262
        • Pleger S.T.
        • Schulz-Schonhagen M.
        • Geis N.
        • Mereles D.
        • Chorianopoulos E.
        • Antaredja M.
        • Lewening M.
        • Katus H.A.
        • Bekeredjian R.
        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. 2013; 15: 919-927
        • Rudolph V.
        • Lubos E.
        • Schluter M.
        • Lubs D.
        • Goldmann B.
        • Knap M.
        • de Vries T.
        • Treede H.
        • Schirmer J.
        • Conradi L.
        • Wegscheider K.
        • Reichenspurner H.
        • Blankenberg S.
        • Baldus S.
        Aetiology of mitral regurgitation differentially affects 2-year adverse outcomes after MitraClip therapy in high-risk patients.
        Eur J Heart Fail. 2013; 15: 796-807
        • Maisano F.
        • Franzen O.
        • Baldus S.
        • Schafer U.
        • Hausleiter J.
        • Butter C.
        • Ussia G.P.
        • Sievert H.
        • Richardt G.
        • Widder J.D.
        • Moccetti T.
        • Schillinger W.
        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: 1052-1061
        • Auricchio A.
        • Schillinger W.
        • Meyer S.
        • Maisano F.
        • Hoffmann R.
        • Ussia G.P.
        • Pedrazzini G.B.
        • van der Heyden J.
        • Fratini S.
        • Klersy C.
        • Komtebedde J.
        • Franzen O.
        Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling.
        J Am Coll Cardiol. 2011; 58: 2183-2189
        • Braun D.
        • Lesevic H.
        • Orban M.
        • Michalk F.
        • Barthel P.
        • Hoppe K.
        • Sonne C.
        • Pache J.
        • Mehilli J.
        • Kastrati A.
        • Hausleiter J.
        • Massberg S.
        Percutaneous edge-to-edge repair of the mitral valve in patients with degenerative versus functional mitral regurgitation.
        Catheter Cardiovasc Interv. 2014; 84: 137-146
        • Capodanno D.
        • Adamo M.
        • Barbanti M.
        • Giannini C.
        • Laudisa M.L.
        • Cannata S.
        • Curello S.
        • Imme S.
        • Maffeo D.
        • Bedogni F.
        • Petronio A.S.
        • Ettori F.
        • Tamburino C.
        • Grasso C.
        Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair.
        Am Heart J. 2015; 170: 187-195
        • Giannini C.
        • Fiorelli F.
        • De Carlo M.
        • Guarracino F.
        • Faggioni M.
        • Giordano P.
        • Spontoni P.
        • Pieroni A.
        • Petronio A.S.
        Comparison of percutaneous mitral valve repair versus conservative treatment in severe functional mitral regurgitation.
        Am J Cardiol. 2016; 117: 271-277
        • Matsumoto T.
        • Nakamura M.
        • Yeow W.L.
        • Hussaini A.
        • Ram V.
        • Makar M.
        • Gurudevan S.V.
        • Trento A.
        • Siegel R.J.
        • Kar S.
        Impact of pulmonary hypertension on outcomes in patients with functional mitral regurgitation undergoing percutaneous edge-to-edge repair.
        Am J Cardiol. 2014; 114: 1735-1739
        • Nickenig G.
        • Estevez-Loureiro R.
        • Franzen O.
        • Tamburino C.
        • Vanderheyden M.
        • Luscher T.F.
        • Moat N.
        • Price S.
        • Dall'Ara G.
        • Winter R.
        • Corti R.
        • Grasso C.
        • Snow T.M.
        • Jeger R.
        • Blankenberg S.
        • Settergren M.
        • Tiroch K.
        • Balzer J.
        • Petronio A.S.
        • Buttner H.J.
        • Ettori F.
        • Sievert H.
        • Fiorino M.G.
        • Claeys M.
        • Ussia G.P.
        • Baumgartner H.
        • Scandura S.
        • Alamgir F.
        • Keshavarzi F.
        • Colombo A.
        • Maisano F.
        • Ebelt H.
        • Aruta P.
        • Lubos E.
        • Plicht B.
        • Schueler R.
        • Pighi M.
        • Di Mario C.
        Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry.
        J Am Coll Cardiol. 2014; 64: 875-884
        • Orban M.
        • Braun D.
        • Orban M.
        • Grebmer C.
        • Sibbing D.
        • Thaler R.
        • Tittus J.
        • Wimbauer F.
        • Lesevic H.
        • Sonne C.
        • Mehilli J.
        • Ott I.
        • Nabauer M.
        • Massberg S.
        • Boekstegers P.
        • Hausleiter J.
        Long-term outcome of patients with severe biventricular heart failure and severe mitral regurgitation after percutaneous edge-to-edge mitral valve repair.
        J Interv Cardiol. 2015; 28: 164-171
        • Schau T.
        • Isotani A.
        • Neuss M.
        • Schopp M.
        • Seifert M.
        • Hopfner C.
        • Burkhoff D.
        • Butter C.
        Long-term survival after MitraClip((R)) therapy in patients with severe mitral regurgitation and severe congestive heart failure: a comparison among survivals predicted by heart failure models.
        J Cardiol. 2016; 67: 287-294
        • Swaans M.J.
        • Bakker A.L.
        • Alipour A.
        • Post M.C.
        • Kelder J.C.
        • de Kroon T.L.
        • Eefting F.D.
        • Rensing B.J.
        • Van der Heyden J.A.
        Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients.
        JACC Cardiovasc Interv. 2014; 7: 875-881
        • Taramasso M.
        • Maisano F.
        • Latib A.
        • Denti P.
        • Buzzatti N.
        • Cioni M.
        • La Canna G.
        • Colombo A.
        • Alfieri O.
        Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation.
        EuroIntervention. 2014; 10: 746-752
        • Triantafyllis A.S.
        • Kortlandt F.
        • Bakker A.L.
        • Swaans M.J.
        • Eefting F.D.
        • van der Heyden J.A.
        • Post M.C.
        • Rensing B.W.
        Long-term survival and preprocedural predictors of mortality in high surgical risk patients undergoing percutaneous mitral valve repair.
        Catheter Cardiovasc Interv. 2016; 87: 467-475
        • Vandendriessche T.
        • Kotrc M.
        • Tijskens M.
        • Bartunek J.
        • Delesie M.
        • Paelinck B.P.
        • De Bock D.
        • Penicka M.
        • Stockman B.
        • De Maeyer C.
        • Vrints C.
        • Vanderheyden M.
        • Claeys M.J.
        Percutaneous mitral valve repair in high-risk patients: initial experience with the Mitraclip system in Belgium.
        Acta Cardiol. 2014; 69: 265-270
      1. Mack M, Stone G, Abraham WT, Lindenfeld J. A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects. ClinicalTrials.gov: U.S. National Institutes of Health, 2012:NCT01626079.

      2. Ponikowski PA. Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation (RESHAPE-hf). ClinicalTrials.gov: U.S. National Institutes of Health, 2013:NCT01772108.

        • Obadia J.F.
        • Armoiry X.
        • Iung B.
        • Lefevre T.
        • Mewton N.
        • Messika-Zeitoun D.
        • Cormier B.
        • Berthiller J.
        • Maucort-Boulch D.
        • Boutitie F.
        • Vaz B.
        • Trochu J.N.
        • Vahanian A.
        The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation.
        EuroIntervention. 2015; 10: 1354-1360
      3. Freixa X, Hernandez M. MitraClip in Non-responders to Cardiac Resynchronization Therapy (MITRA-CRT). ClinicalTrials.gov: U.S. National Institutes of Health, 2015:NCT02592889.

      4. Anker S, Schillinger W, Hunlich M, Bekeredjan R, Frankenstein L, von Bardeleben RS, Gori T. A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation. ClinicalTrials.gov: U.S. National Institutes of Health, 2015:NCT02444338.