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Meta-Analysis of the Usefulness of Mitraclip in Patients With Functional Mitral Regurgitation

      Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.
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      References

        • 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
        • Schillinger W.
        • Hunlich M.
        • Baldus S.
        • Ouarrak T.
        • Boekstegers P.
        • Hink U.
        • Butter C.
        • Bekeredjian R.
        • Plicht B.
        • Sievert H.
        • Schofer J.
        • Senges J.
        • Meinertz T.
        • Hasenfuss G.
        Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral Valve Interventions (TRAMI) Registry.
        EuroIntervention. 2013; 9: 84-90
      1. Giannini C, Petronio AS, De CM, Guarracino F, Conte L, Fiorelli F, Pieroni A, Di B 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.

        • Higgins J.P.T.
        • Green S.
        Cochrane Handbook for Systematic Reviews of Interventions, version 5.0.2 [updated September 2009].
        The Cochrane Collaboration, 2009 (Available at:) (Accessed on 2009)
        • Moher D.
        • Cook D.J.
        • Eastwood S.
        • Olkin I.
        • Rennie D.
        • Stroup D.F.
        Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of Meta-analyses.
        Lancet. 1999; 354: 1896-1900
        • Stroup D.F.
        • Berlin J.A.
        • Morton S.C.
        • Olkin I.
        • Williamson G.D.
        • Rennie D.
        • Moher D.
        • Becker B.J.
        • Sipe T.A.
        • Thacker S.B.
        Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group.
        JAMA. 2000; 283: 2008-2012
        • Bozdag-Turan I.
        • Paranskaya L.
        • Birkemeyer R.
        • Turan R.G.
        • Kische S.
        • Akin I.
        • Ortak J.
        • Stoeckicht Y.
        • Schubert J.
        • Westphal B.
        • Nienaber C.A.
        • Ince H.
        Percutaneous mitral repair with the MitraClip system in patients with mild-to-moderate and severe heart failure: a single-centre experience.
        Cardiovasc Ther. 2014; 32: 66-73
        • Edelman J.J.
        • Dias P.
        • Passage J.
        • Yamen E.
        Percutaneous mitral valve repair in a high-risk Australian series.
        Heart Lung Circ. 2014; 23: 520-526
        • Grayburn P.A.
        • Foster E.
        • Sangli C.
        • Weissman N.J.
        • Massaro J.
        • Glower D.G.
        • Feldman T.
        • Mauri L.
        Relationship between the magnitude of reduction in mitral regurgitation severity and left ventricular and left atrial reverse remodeling after MitraClip therapy.
        Circulation. 2013; 128: 1667-1674
        • Yeo K.K.
        • Yap J.
        • Yamen E.
        • Muda N.
        • Tay E.
        • Walters D.L.
        • Santoso T.
        • Liu X.
        • Jansz P.
        • Yip J.
        • Zambahari R.
        • Passage J.
        • Koh T.H.
        • Wang J.
        • Scalia G.
        • Kuntjoro I.
        • Soesanto A.M.
        • Muller D.
        Percutaneous mitral valve repair with the MitraClip: early results from the MitraClip Asia-Pacific Registry (MARS).
        EuroIntervention. 2014; 10: 620-625
        • Mauri L.
        • Foster E.
        • Glower D.D.
        • Apruzzese P.
        • Massaro J.M.
        • Herrmann H.C.
        • Hermiller J.
        • Gray W.
        • Wang A.
        • Pedersen W.R.
        • Bajwa T.
        • Lasala J.
        • Low R.
        • Grayburn P.
        • Feldman T.
        4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation.
        J Am Coll Cardiol. 2013; 62: 317-328
        • Schillinger W.
        • Athanasiou T.
        • Weicken N.
        • Berg L.
        • Tichelbacker T.
        • Puls M.
        • Hunlich M.
        • Wachter R.
        • Helms H.J.
        • Seipelt R.
        • Schondube F.A.
        • Hasenfuss G.
        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. 2011; 13: 1331-1339
        • MacHaalany J.
        • Bilodeau L.
        • Hoffmann R.
        • Sack S.
        • Sievert H.
        • Kautzner J.
        • Hehrlein C.
        • Serruys P.
        • Senechal M.
        • Douglas P.
        • Bertrand O.F.
        Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial.
        Am Heart J. 2013; 165: 761-769
        • 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
        • Chan P.H.
        • She H.L.
        • egria-Barrero E.
        • Moat N.
        • Di M.C.
        • Franzen O.
        Real-world experience of MitraClip for treatment of severe mitral regurgitation.
        Circ J. 2012; 76: 2488-2493
        • Franzen O.
        • van der H.J.
        • Baldus S.
        • Schluter M.
        • Schillinger W.
        • Butter C.
        • Hoffmann R.
        • Corti R.
        • Pedrazzini G.
        • Swaans M.J.
        • Neuss M.
        • Rudolph V.
        • Surder D.
        • Grunenfelder J.
        • Eulenburg C.
        • Reichenspurner H.
        • Meinertz T.
        • Auricchio A.
        MitraClip(R) therapy in patients with end-stage systolic heart failure.
        Eur J Heart Fail. 2011; 13: 569-576
        • Gaita F.
        • Moretti C.
        • Castagno D.
        • Colombo F.
        • D'Amico M.
        Initial experience of mitraclip: a single center experience.
        Gise, 2014 (Ref Type: Abstract)
        • Perl L.
        • Vaturi M.
        • Assali A.
        • Shapira Y.
        • Bruckheimer E.
        • Ben-Gal T.
        • Vaknin-Assa H.
        • Sagie A.
        • Kornowski R.
        Preliminary experience using the transcatheter mitral valve leaflet repair procedure.
        Isr Med Assoc J. 2013; 15: 608-612
        • Rudolph V.
        • Lubos E.
        • Schluter M.
        • Lubs D.
        • Goldmann B.
        • Knap M.
        • de V.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
        • Taramasso M.
        • Denti P.
        • Buzzatti N.
        • De B.M.
        • La C.G.
        • Colombo A.
        • Alfieri O.
        • Maisano F.
        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: 920-926
        • Castel M.A.
        • Mendez F.
        • Tamborero D.
        • Mont L.
        • Magnani S.
        • Tolosana J.M.
        • Berruezo A.
        • Godoy M.
        • Sitges M.
        • Vidal B.
        • Roig E.
        • Brugada J.
        Six-minute walking test predicts long-term cardiac death in patients who received cardiac resynchronization therapy.
        Europace. 2009; 11: 338-342
        • Mehra M.R.
        • Lavie C.J.
        • Milani R.V.
        Predicting prognosis in advanced heart failure. Use of exercise indices.
        Chest. 1996; 110: 310-312
        • Olsson L.G.
        • Swedberg K.
        • Clark A.L.
        • Witte K.K.
        • Cleland J.G.
        Six minute corridor walk test as an outcome measure for the assessment of treatment in randomized, blinded intervention trials of chronic heart failure: a systematic review.
        Eur Heart J. 2005; 26: 778-793
        • Chua Y.L.
        • Schaff H.V.
        • Orszulak T.A.
        • Morris J.J.
        Outcome of mitral valve repair in patients with preoperative atrial fibrillation. Should the maze procedure be combined with mitral valvuloplasty?.
        J Thorac Cardiovasc Surg. 1994; 107: 408-415
        • De B.M.
        • Taramasso M.
        • Verzini A.
        • Ferrara D.
        • Lapenna E.
        • Calabrese M.C.
        • Grimaldi A.
        • Alfieri O.
        Long-term results of mitral repair for functional mitral regurgitation in idiopathic dilated cardiomyopathy.
        Eur J Cardiothorac Surg. 2012; 42: 640-646
        • Anselmino M.
        • Grossi S.
        • Scaglione M.
        • Castagno D.
        • Bianchi F.
        • Senatore G.
        • Matta M.
        • Casolati D.
        • Ferraris F.
        • Cristoforetti Y.
        • Negro A.
        • Gaita F.
        Long-term results of transcatheter atrial fibrillation ablation in patients with impaired left ventricular systolic function.
        J Cardiovasc Electrophysiol. 2013; 24: 24-32
        • Ousdigian K.T.
        • Borek P.P.
        • Koehler J.L.
        • Heywood J.T.
        • Ziegler P.D.
        • Wilkoff B.L.
        The epidemic of inadequate biventricular pacing in patients with persistent or permanent atrial fibrillation and its association with mortality.
        Circ Arrhythm Electrophysiol. 2014; 7: 370-376
        • Herrmann H.C.
        • Gertz Z.M.
        • Silvestry F.E.
        • Wiegers S.E.
        • Woo Y.J.
        • Hermiller J.
        • Segar D.
        • Heimansohn D.
        • Gray W.
        • Homma S.
        • Argenziano M.
        • Wang A.
        • Jollis J.
        • Lampert M.B.
        • Alexander J.
        • Mauri L.
        • Foster E.
        • Glower D.
        • Feldman T.
        Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial.
        J Am Coll Cardiol. 2012; 59: 1312-1319
        • Gaemperli O.
        • Biaggi P.
        • Gugelmann R.
        • Osranek M.
        • Schreuder J.J.
        • Buhler I.
        • Surder D.
        • Luscher T.F.
        • Felix C.
        • Bettex D.
        • Grunenfelder J.
        • Corti R.
        Real-time left ventricular pressure-volume loops during percutaneous mitral valve repair with the MitraClip system.
        Circulation. 2013; 127: 1018-1027
        • Starling M.R.
        Effects of valve surgery on left ventricular contractile function in patients with long-term mitral regurgitation.
        Circulation. 1995; 92: 811-818
        • Suri R.M.
        • Schaff H.V.
        • Dearani J.A.
        • Sundt III, T.M.
        • Daly R.C.
        • Mullany C.J.
        • Sarano M.E.
        • Orszulak T.A.
        Determinants of early decline in ejection fraction after surgical correction of mitral regurgitation.
        J Thorac Cardiovasc Surg. 2008; 136: 442-447
        • D'Ascenzo F.
        • Cavallero E.
        • Moretti C.
        • Omede P.
        • Sciuto F.
        • Rahman I.A.
        • Bonser R.S.
        • Yunseok J.
        • Wagner R.
        • Freiberger T.
        • Kunst G.
        • Marber M.S.
        • Thielmann M.
        • Ji B.
        • Amr Y.M.
        • Modena M.G.
        • Zoccai G.B.
        • Sheiban I.
        • Gaita F.
        Remote ischaemic preconditioning in coronary artery bypass surgery: a meta-analysis.
        Heart. 2012; 98: 1267-1271
        • Chan V.
        • Ahrari A.
        • Ruel M.
        • Elmistekawy E.
        • Hynes M.
        • Mesana T.G.
        Perioperative deaths after mitral valve operations may be overestimated by contemporary risk models.
        Ann Thorac Surg. 2014; 98: 605-610
        • Siregar S.
        • de H.F.
        • Groenwold R.H.
        • Versteegh M.I.
        • Bekkers J.A.
        • Brinkman E.S.
        • Bots M.L.
        • van der G.Y.
        • van Herwerden L.A.
        Trends and outcomes of valve surgery: 16-year results of Netherlands Cardiac Surgery National Database.
        Eur J Cardiothorac Surg. 2014; 46: 386-397
        • D'Ascenzo F.
        • Biondi-Zoccai G.
        Network meta-analyses: the “white whale” for cardiovascular specialists.
        J Cardiothorac Vasc Anesth. 2014; 28: 169-173