https://doi.org/10.4081/monaldi.2025.3264
Transcatheter edge-to-edge mitral valve repair versus medical therapy for secondary mitral regurgitation: a meta-analysis of randomized controlled trials
Submitted: November 16, 2024
Accepted: December 19, 2024
Published: February 6, 2025
Accepted: December 19, 2024
Abstract Views: 262
PDF_EARLY VIEW: 98
SUPPLEMENTARY MATERIAL: 11
SUPPLEMENTARY MATERIAL: 11
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Secondary mitral regurgitation (SMR) is associated with increased hospitalizations and mortality. Clinical trials comparing mitral valve transcatheter edge-to-edge repair (M-TEER) with guideline-directed medical therapy (GDMT) show conflicting results, but the RESHAPE-HF2 trial offers new insights. This study aims to assess the M-TEER effect in addition to GDMT in reducing all-cause mortality, cardiovascular death, and heart failure hospitalizations (HHF) in patients with SMR when compared to GDMT alone. On September 2, 2024, PubMed, Cochrane CENTRAL, Scopus, and Web of Science were searched for randomized controlled trials comparing M-TEER in addition to GDMT with GDMT in SMR patients with heart failure. A study-level random-effects meta-analysis was conducted using trial-reported point estimates. Seven records from three trials (COAPT, MITRA-FR, RESHAPE-HF2) involving 1426 participants were included. At 24 months, M-TEER (using MitraClip®) significantly reduced the first HHF [hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.45-0.96] and all HHF (HR 0.63, 95% CI 0.49-0.81). However, no significant reduction was observed in all-cause mortality (HR 0.76, 95% CI 0.57-1.01) or cardiovascular death (HR 0.77, 95% CI 0.56-1.06). The intervention group had more patients in the New York Heart Association class I/II at 12 and 24 months but no significant improvement in 6-minute walk test performance at 12 months. High trial heterogeneity requires careful interpretation of pooled estimates. Differences in medical therapy and patient characteristics likely affected outcomes across trials. While M-TEER demonstrates benefits in reducing HHF, its effectiveness in reducing mortality remains inconclusive. The degree of left ventricular enlargement may have influenced outcomes, underscoring the importance of careful patient selection.
Goliasch G, Bartko PE, Pavo N, et al. Refining the prognostic impact of functional mitral regurgitation in chronic heart failure. Eur Heart J 2018;39:39-46.
DOI: https://doi.org/10.1093/eurheartj/ehx402
Wu AH, Aaronson KD, Bolling SF, et al. Impact of mitral valve annuloplasty on mortality risk in patients with mitral regurgitation and left ventricular systolic dysfunction. J Am Coll Cardiol 2005;45:381-7.
DOI: https://doi.org/10.1016/j.jacc.2004.09.073
Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter MITRAL-VALVE REPAIR IN PATIENTS WITH HEART FAILURE. N Engl J Med 2018;379:2307-18.
DOI: https://doi.org/10.1056/NEJMoa1806640
Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 2018;379:2297-306.
DOI: https://doi.org/10.1056/NEJMoa1805374
McDonagh TA, Metra M, Adamo M, et al. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2021;42:3599-726.
DOI: https://doi.org/10.1093/eurheartj/ehab670
Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2022;145:e895-e1032.
DOI: https://doi.org/10.1161/CIR.0000000000001073
Anker SD, Friede T, von Bardeleben RS, et al. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation. N Engl J Med 2024;391:1799-809.
DOI: https://doi.org/10.1056/NEJMe2410896
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg 2010;8:336-41.
DOI: https://doi.org/10.1016/j.ijsu.2010.02.007
Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res 2018;27:1785-805.
DOI: https://doi.org/10.1177/0962280216669183
Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol 2014;14:135.
DOI: https://doi.org/10.1186/1471-2288-14-135
Shi J, Luo D, Wan X, et al. Detecting the skewness of data from the five-number summary and its application in meta-analysis. Stat Methods Med Res 2023;32:1338-60.
DOI: https://doi.org/10.1177/09622802231172043
Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539-58.
DOI: https://doi.org/10.1002/sim.1186
Iung B, Armoiry X, Vahanian A, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail 2019;21:1619-27.
DOI: https://doi.org/10.1002/ejhf.1616
Mack MJ, Lindenfeld J, Abraham WT, et al. 3-year outcomes of transcatheter mitral valve repair in patients with heart failure. J Am Coll Cardiol 2021;77:1029-40.
DOI: https://doi.org/10.1016/j.jacc.2020.12.047
Ponikowski P, Friede T, von Bardeleben RS, et al. Hospitalization of symptomatic patients with heart failure and moderate to severe functional mitral regurgitation treated with mitraclip: insights from RESHAPE-HF2. J Am Coll Cardiol 2024;84:2347-63.
DOI: https://doi.org/10.1016/j.jacc.2024.08.027
Stone GW, Abraham WT, Lindenfeld J, et al. Five-year follow-up after transcatheter repair of secondary mitral regurgitation. N Engl J Med 2023;388:2037-48.
DOI: https://doi.org/10.1056/NEJMoa2300213
Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003;16:777-802.
DOI: https://doi.org/10.1016/S0894-7317(03)00335-3
Lancellotti P, Moura L, Pierard LA, et al. European Association of Echocardiography recommendations for the assessment of valvular regurgitation. Part 2: mitral and tricuspid regurgitation (native valve disease). Eur J Echocardiogr 2010;11:307-32.
DOI: https://doi.org/10.1093/ejechocard/jeq031
Grayburn PA, Sannino A, Packer M. Proportionate and disproportionate functional mitral regurgitation: a new conceptual framework that reconciles the results of the MITRA-FR and COAPT trials. JACC Cardiovasc Imaging 2019;12:353-62.
DOI: https://doi.org/10.1016/j.jcmg.2018.11.006
Gupta A, Packer M, Makkar R, Grayburn P. A volume-based framework reconciling COAPT, MITRA-FR and RESHAPE-HF2. J Am Coll Cardiol 2024;84:2376-9.
DOI: https://doi.org/10.1016/j.jacc.2024.08.029
Michler RE, Smith PK, Parides MK, et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med 2016;374:1932-41.
DOI: https://doi.org/10.1056/NEJMoa1602003
Milwidsky A, Mathai SV, Topilsky Y, Jorde UP. Medical therapy for functional mitral regurgitation. Circ Heart Fail 2022;15:e009689.
DOI: https://doi.org/10.1161/CIRCHEARTFAILURE.122.009689
Stone Gregg W, Bhavanadhar P. M-TEER for functional MR: erasing all doubt. J Am Coll Cardiol 2024;84:2372-5.
DOI: https://doi.org/10.1016/j.jacc.2024.08.037
Kang DH, Park SJ, Shin SH, et al. Angiotensin receptor neprilysin inhibitor for functional mitral regurgitation. Circulation 2019;139:1354-65.
DOI: https://doi.org/10.1161/CIRCULATIONAHA.118.037077
Huang ZS, Fan R, Xie PH, et al. Dapagliflozin effect on functional mitral regurgitation and myocardial remodeling (DEFORM trial). Eur Heart J 2023;44:ehad655.1751.
DOI: https://doi.org/10.1093/eurheartj/ehad655.1751
Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med 2020;382:1883-93.
DOI: https://doi.org/10.1056/NEJMoa1915928
Stolz L, Doldi PM, Sannino A, et al. The evolving concept of secondary mitral regurgitation phenotypes: lessons from the M-TEER trials. JACC Cardiovasc Imaging 2024;17:659-68.
DOI: https://doi.org/10.1016/j.jcmg.2024.01.012
Gavazzoni M, Taramasso M, Zuber M, et al. Functional mitral regurgitation and cardiac resynchronization therapy in the “era” of trans-catheter interventions: is it time to move from a staged strategy to a tailored therapy? Int J Cardiol 2020;315:15-21.
DOI: https://doi.org/10.1016/j.ijcard.2020.03.071
Cleland J, Freemantle N, Ghio S, et al. Predicting the long-term effects of cardiac resynchronization therapy on mortality from baseline variables and the early response a report from the CARE-HF (Cardiac Resynchronization in Heart Failure) trial. J Am Coll Cardiol 2008;52:438-45.
DOI: https://doi.org/10.1016/j.jacc.2008.04.036
St John Sutton MG, Plappert T, Abraham WT, et al. Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation 2003;107:1985-90.
DOI: https://doi.org/10.1161/01.CIR.0000065226.24159.E9
Cazeau S, Leclercq C, Lavergne T, et al. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med 2001;344:873-80.
DOI: https://doi.org/10.1056/NEJM200103223441202
Baldus S, Doenst T, Pfister R, et al. Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. N Engl J Med 2024;391:1787-98.
DOI: https://doi.org/10.1056/NEJMoa2408739
How to Cite
Mata, Emídio, Bárbara Lage Garcia, Mariana Tinoco, Margarida Castro, Luísa Pinheiro, João Português, Francisco Ferreira, Silvia Ribeiro, Bruno Melica, and António Lourenço. 2025. “Transcatheter Edge-to-Edge Mitral Valve Repair <i>versus< i> Medical Therapy for Secondary Mitral Regurgitation: A Meta-Analysis of Randomized Controlled Trials”. Monaldi Archives for Chest Disease, February. https://doi.org/10.4081/monaldi.2025.3264.
Copyright (c) 2025 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Similar Articles
- Enrico Vizzardi, Edoardo Sciatti, Ivano Bonadei, Natalia L. Pezzali, Carlo M. Lombardi, Marco Metra, Red cell distribution width and chronic heart failure: prognostic role beyond echocardiographic parameters , Monaldi Archives for Chest Disease: Vol. 84 No. 1-2 (2015): Cardiac series
- Alberto Genovesi Ebert, Furio Colivicchi, Marco Malvezzi Caracciolo, Carmine Riccio, Additive beneficial effects of beta blockers in the prevention of symptomatic heart failure , Monaldi Archives for Chest Disease: Vol. 72 No. 1 (2009): Cardiac series
- Donatella Del Sindaco, Giovanni Pulignano, Andrea Di Lenarda, Luigi Tarantini, Giovanni Cioffi, Stefano Tolone, Maria Denitza Tinti, Luca Monzo, Giulia Barbati, Giovanni Minardi, Role of a multidisciplinary program in improving outcomes in cognitively impaired heart failure older patients , Monaldi Archives for Chest Disease: Vol. 78 No. 1 (2012): Cardiac series
- Vittorio Palmieri, Antonio Palermo, Patients’ self-evaluation of symptoms, signs and compliance to therapy for heart failure surveillance: A pilot study on identification of worsening heart failure , Monaldi Archives for Chest Disease: Vol. 88 No. 2 (2018)
- Rodolfo Citro, Angelo Silverio, Roberto Ascoli, Antonio Longobardi, Eduardo Bossone, Giuseppe Di Benedetto, Federico Piscione, Anterior mitral valve aneurysm perforation in a patient with preexisting aortic regurgitation , Monaldi Archives for Chest Disease: Vol. 78 No. 4 (2012): Cardiac series
- Francesco Giallauria, Lucrezia Piccioli, Giuseppe Vitale, Filippo M. Sarullo, Exercise training in patients with chronic heart failure: A new challenge for Cardiac Rehabilitation Community , Monaldi Archives for Chest Disease: Vol. 88 No. 3 (2018)
- Elio Gorga, Marta Scodro, Francesca Valentini, Renzo D'Ortona, Mariachiara Arisi, Edoardo Sciatti, Ivano Bonadei, Valentina Regazzoni, Enrico Vizzardi, Marco Metra, Piergiacomo Calzavara Pinton, Echocardiographic evaluation of diastolic dysfunction in young and healthy patients with psoriasis: A case-control study , Monaldi Archives for Chest Disease: Vol. 88 No. 3 (2018)
- Gabriella Malfatto, Paola Cuoccio, Caterina Bizzi, Giovanna Branzi, Alessandra Villani, Francesco Della Rosa, Gianfranco Parati, Mario Facchini, What underlies NYHA class in elderly patients with heart failure? role of diastolic dysfunction, functional mitral regurgitation and abnormal ventilation during exercise , Monaldi Archives for Chest Disease: Vol. 72 No. 2 (2009): Cardiac series
- Shi-Min Yuan, Amihay Shinfeld, Ehud Raanani, Mitral valve cleft associated with secundum atrial septal defect: case report and review of the literature , Monaldi Archives for Chest Disease: Vol. 68 No. 1 (2007): Cardiac series
- Giovanni Pulignano, Maria Denitza Tinti, Donatella Del Sindaco, Stefano Tolone, Giovanni Minardi, Antonio Lax, Massimo Uguccioni, Barriers to cardiac rehabilitation access of older heart failure patients and strategies for better implementation , Monaldi Archives for Chest Disease: Vol. 84 No. 1-2 (2015): Cardiac series
You may also start an advanced similarity search for this article.
