Acute reverse annular remodeling during MitraClip® therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study

Theresa Herbrand, Silke Eschenhagen, Tobias Zeus, Eva Kehmeier, Katharina Hellhammer, Verena Veulemans, Malte Kelm, Jan Balzer, Theresa Herbrand, Silke Eschenhagen, Tobias Zeus, Eva Kehmeier, Katharina Hellhammer, Verena Veulemans, Malte Kelm, Jan Balzer

Abstract

Background: Transcatheter mitral valve repair (TMVR) has been shown to have acute effects on mitral valve geometry in patients with functional mitral regurgitation (FMR). This study investigates the impact of MitraClip® therapy-induced annular remodeling on clinical outcome and mitral regurgitation in heart failure patients.

Methods: TMVR was performed successfully in 45 patients with FMR. In this study, mitral valve datasets were obtained before and directly after MitraClip® implantation using three-dimensional (3D) transesophageal echocardiography, and were analyzed offline retrospectively using dedicated 3D reconstruction software. Patients underwent clinical and echocardiographic evaluation at baseline and after 6 months. At follow-up, the patients were allocated into two groups according to their improvement in New York Heart Association (NYHA) functional class: a Low Responder group with ΔNYHA <1.5 (n = 25); and a High Responder group with ΔNYHA ≥1.5 (n = 20).

Results: At 6-month follow-up, data analysis revealed that while mitral regurgitation was reduced significantly in both groups, only the High Responder group had experienced significant downsizing of the 3D circumference (137 ± 14 mm to 126 ± 13 mm; p < 0.01) and the anterior-to-posterior diameter (33 ± 5 mm to 29 ± 4 mm; p < 0.01) of the mitral annulus during the intervention. Furthermore, only the High Responder group with reverse annular remodeling as shown had substantial advances in quality of life (Minnesota living with heart failure questionnaire: 55 ± 10 to 34 ± 14 points; p < 0.01) and functional status (6-min walk distance: 290 ± 104 m to 462 ± 111 m; p = 0.07).

Conclusion: Our study demonstrates that instantaneous left ventricular annular remodeling during MitraClip® implantation is associated with improved clinical outcome of heart failure patients with functional mitral regurgitation. Trial registration The study was approved by the local ethics committee (Study Number 4497R, Registration ID: 2013121585).

Trial registration: NCT02033811 Retrospectively registered January 9, 2014.

Keywords: Echocardiography; MitraClip®; Mitral valve insufficiency; Remodeling; TMVR; Three-dimensional.

Figures

Fig. 1
Fig. 1
Flowchart of patients who underwent TMVR. Unsuccessful procedures were attributed to difficult anatomy in two cases and a thrombus in the left atrium in one case. One patient was previously excluded from the study despite successful TMVR due to participation in another trial. MR mitral regurgitation, MLHFQ Minnesota living with heart failure questionnaire, MVQ mitral valve quantification, NYHA New York Heart Association, 6MWD 6-min walk distance
Fig. 2
Fig. 2
Severity of mitral regurgitation in High and Low Responders. MR mitral regurgitation, TMVR transcatheter mitral valve repair
Fig. 3
Fig. 3
Statistical analysis. Clinical parameters are shown on the y-axis, pre- and postprocedural measurements on the x-axis, respectively. Each diagram contains the p value of measurements before and after TMVR. MLHFQ Minnesota Living With Heart Failure Questionnaire, NT pro-BNP N-terminal pro b-type natriuretic peptide, NYHA New York Heart Association, 6MWT 6-min walk distance
Fig. 4
Fig. 4
Exemplary 3D models of the acute effects of TMVR on the mitral valve of Low Responder (left) and High Responder (right). Upper picture: Overview of three-dimensional transesophageal echocardiography images comparing Low and High Responder before and after TMVR. Mitral regurgitation jet is visible (right arrow) as well as the MitraClip® device (asterisk) itself. a 3D TEE image of Low Responder before TMVR showing severe MR. b 3D TEE image of Low Responder after TMVR showing mild MR. c 3D TEE image of High Responder before TMVR showing severe MR. d 3D TEE image of High Responder after TMVR showing mild MR. Lower picture: Left: 3D model of mitral valves (MV) before and after TMVR of Low Responders with corresponding colored models placed on top of each other to demonstrate change in annular size. Model of MV before and after clip with little change in annular size. Right: Model of Qlab MV before and after TMVR. Change in annular size is more prominent here. AML anterior mitral leaflet, AV aortic valve, C circumference, LA left atrium, LV left ventricle, MV mitral valve, MVA mitral valve annulus, PML posterior mitral leaflet, target indicates mitral regurgitation jet, asterisk indicates clip

References

    1. Asgar AW, Mack MJ. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015;65:1231–1248. doi: 10.1016/j.jacc.2015.02.009.
    1. Nickenig G, Estevez-Loureiro R, et al. 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. doi: 10.1016/j.jacc.2014.06.1166.
    1. Maisano F, Franzen O, 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;62:1052–1061. doi: 10.1016/j.jacc.2013.02.094.
    1. Rassaf T, Balzer J, et al. Influence of percutaneous mitral valve repair using the MitraClip® system on renal function in mitral regurgitation. Catheter Cardiovasc Interven. 2015;85(5):899–903. doi: 10.1002/ccd.25705.
    1. Hellhammer K, Balzer J, et al. Percutaneous mitral valve repair using the MitraClip system in patients with anemia. Int J Cardiol. 2015;184:399–404. doi: 10.1016/j.ijcard.2015.02.081.
    1. Hellhammer K, Zeus T, et al. Safety and efficacy of percutaneous mitral valve repair using the MitraClip® system in patients with diabetes mellitus. PLoS ONE. 2014;9(11):e111178. doi: 10.1371/journal.pone.0111178.
    1. Pleger ST, Schulz-Schonhagen M, et al. 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. doi: 10.1093/eurjhf/hft046.
    1. Grayburn PA, Foster E, et al. 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. doi: 10.1161/CIRCULATIONAHA.112.001039.
    1. Schmidt FP, Von Bardeleben RS, et al. Immediate effect of the MitraClip®(R) procedure on mitral ring geometry in primary and secondary mitral regurgitation. Eur Heart J Cardiovasc Imag. 2013;14:851–857. doi: 10.1093/ehjci/jes293.
    1. Schueler R, Momcilovic D, et al. Acute changes of mitral valve geometry during interventional edge-to-edge repair With the MitraClip® system are associated with midterm outcomes in patients with functional valve disease: preliminary results from a prospective single-center study. Circ Cardiovasc Interven. 2014;7:390–399. doi: 10.1161/CIRCINTERVENTIONS.113.001098.
    1. Lipiecki Janusz, Siminiak Tomasz, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016;3(2):e00411. doi: 10.1136/openhrt-2016-000411.
    1. Vahanian A, Alfieri O, et al. 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 Heart J. 2012;33:2451–2496. doi: 10.1093/eurheartj/ehs109.
    1. Feldman T, Wasserman HS, et al. Percutaneous mitral valve repair using the edge-to-edge technique: 6-month results of the EVEREST phase I clinical trial. J Am Coll Cardiol. 2005;46:2134–2140. doi: 10.1016/j.jacc.2005.07.065.
    1. Lang RM, Badano LP. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imag. 2015;28(1):1–39.
    1. Lancellotti P, Tribouilloy C, et al. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imag. 2013;14:611–644. doi: 10.1093/ehjci/jet105.
    1. Flachskampf FA, Wouters PF, et al. Recommendations for transesophageal echocardiography: EACVI update 2014. European heart journal cardiovascular Imaging. 2014;15:353–365. doi: 10.1093/ehjci/jeu015.
    1. Zamorano JL, Badano LP, et al. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. Eur Heart J. 2011;32:2189–2214. doi: 10.1093/eurheartj/ehr259.
    1. Debonnaire P, Delgado V, et al. Tools & techniques—clinical: 3D transesophageal echocardiography for selecting and guiding in percutaneous mitral valve repair using MitraClip®. EuroInterven J EuroPCR Collab Work Group Interven Cardiol Eur Soc Cardiol. 2014;10:884–886.
    1. Van Mieghem NM, Piazza N, et al. Anatomy of the mitral valvular complex and its implications for transcatheter interventions for mitral regurgitation. J Am Coll Cardiol. 2010;56:617–626. doi: 10.1016/j.jacc.2010.04.030.
    1. Zamorano JL, Gonzalez-Gomez A, et al. Mitral valve anatomy: implications for transcatheter mitral valve interventions. EuroIntervention. J Europcr Collab Work Group Interven Cardiol Eur Soc Cardiol. 2014;10(Suppl U):U106–111.
    1. Glower DD, Kar S, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014;64:172–181. doi: 10.1016/j.jacc.2013.12.062.
    1. Franzen O, Baldus S, et al. 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. 2010;31:1373–1381. doi: 10.1093/eurheartj/ehq050.
    1. Al Amri I, Debonnaire P. Acute effect of MitraClip implantation on mitral valve geometry in patients with functional mitral regurgitation: insights from three-dimensional transesophageal echocardiography. Euro Interven. 2016;11(13):1554–1561.
    1. Lang RM, Badano LP, et al. EAE/ASE recommendations for image acquisition and display using three-dimensional echocardiography. Eur Heart J Cardiovasc Imag. 2012;13:1–46. doi: 10.1093/ehjci/jer316.
    1. Lancellotti P, Zamorano JL, et al. Imaging challenges in secondary mitral regurgitation: unsolved issues and perspectives. Circ Cardiovasc Imag. 2014;7:735–746. doi: 10.1161/CIRCIMAGING.114.000992.
    1. Faletra FF, Pedrazzini G, et al. 3D TEE during catheter-based interventions. JACC Cardiovasc Imag. 2014;7:292–308. doi: 10.1016/j.jcmg.2013.10.012.
    1. Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, et al. Left atrial and left ventricular function and remodeling following percutaneous mitral valve repair. J Heart Valve Dis. 2016;25(3):309–319.
    1. Giannini C, Petronio AS, et al. Integrated reverse left and right ventricular remodelling after MitraClip® implantation in functional mitral regurgitation: an echocardiographic study. Eur Heart J Cardiovasc Imag. 2014;15:95–103. doi: 10.1093/ehjci/jet141.
    1. Grasso C, Attizzani G, et al. Catheter-based edge-to-edge mitral valve repair after percutaneous mitral valve annuloplasty failure. JACC Cardiovasc Interv. 2014;7(7):e85–e86. doi: 10.1016/j.jcin.2013.11.027.

Source: PubMed

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