Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry

Evaldas Girdauskas, Jonas Pausch, Hermann Reichenspurner, Jörg Kempfert, Thomas Kuntze, Tamer Owais, Tomas Holubec, Markus Krane, Keti Vitanova, Michael Borger, Matthias Eden, Violetta Hachaturyan, Peter Bramlage, Volkmar Falk, Evaldas Girdauskas, Jonas Pausch, Hermann Reichenspurner, Jörg Kempfert, Thomas Kuntze, Tamer Owais, Tomas Holubec, Markus Krane, Keti Vitanova, Michael Borger, Matthias Eden, Violetta Hachaturyan, Peter Bramlage, Volkmar Falk

Abstract

Background: Functional mitral regurgitation (FMR) is one of the most common heart valve diseases that is a sequel of left ventricular remodelling. Although mitral valve annuloplasty is a standard treatment of FMR, the recurrence of FMR is a major drawback and occurs in 10-50% of patients. The REFORM-MR registry aims to investigate the effectiveness of standardized papillary muscle relocation and ring annuloplasty and to identify the risk factors associated with recurrent FMR.

Methods: REFORM-MR is a prospective, multicenter registry that enrols consecutive FMR patients across five sites in Germany. All patients with FMR and restricted movement of leaflets during systole (i.e., type IIIb mitral regurgitation) undergoing standardized subannular repair in combination with mitral valve annuloplasty are included in the study. The primary objective is to examine the effect of combined papillary muscle relocation and ring annuloplasty on the recurrence of FMR at 2 years postoperatively. The secondary objectives are MACCE rate, reinterventions on the mitral valve and cardiac-related mortality in the study cohort. Echocardiography core-lab and MRI core-lab will provide anonymized analysis of the imaging data in the REFORM-MR registry. Student's t-test or Mann-Whitney U test for continuous variables and the Chi-Square or Fisher exact test for categorical variables are used for group comparisons. Kaplan-Meier analyses is performed for survival and safety outcomes.

Results: As of May 2021, a total of 97 patients were enrolled across five sites in Germany.

Conclusions: The results of this study will help define the outcomes of combined papillary muscle relocation and ring annuloplasty in the FMR treatment in a multicentre setting and to improve the understanding of the limitations of subannular repair procedures while treating patients with type III FMR. Trial registration clinicaltrials.gov Identifier: NCT03470155.

Keywords: Functional mitral regurgitation; Mitral annuloplasty; Mitral regurgitation; Mitral valve repair; Subannular repair.

Conflict of interest statement

EG: Received research funding for this registry and compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). JP: received compensation for patient documentation. HR: received compensation for patient documentation. JK: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). TK: received compensation for patient documentation. TO: received compensation for patient documentation. TH: received compensation for patient documentation. MK: received compensation for patient documentation. KV: received compensation for patient documentation. MB: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). ME: has no conflict to declare. VH: has no conflict to declare. PB: received research funding for this registry and compensation for talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). VF: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland).

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Standardized relocation of both papillary muscles using 2 pledgeted Polytetrafluoroethylene sutures

References

    1. Douedi S, Douedi H. Mitral regurgitation. Treasure Island: StatPearls Publishing; 2021.
    1. Pausch J, Harmel E, Sinning C, Reichenspurner H, Girdauskas E. Standardized subannular repair for type IIIb functional mitral regurgitation in a minimally invasive mitral valve surgery setting†. Eur J Cardiothorac Surg. 2019;56(5):968–975. doi: 10.1093/ejcts/ezz114.
    1. Petrus AHJ, Dekkers OM, Tops LF, Timmer E, Klautz RJM, Braun J. Impact of recurrent mitral regurgitation after mitral valve repair for functional mitral regurgitation: long-term analysis of competing outcomes. Eur Heart J. 2019;40(27):2206–2214. doi: 10.1093/eurheartj/ehz306.
    1. Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015;65(12):1231–1248. doi: 10.1016/j.jacc.2015.02.009.
    1. Echarte-Morales J, Minguito-Carazo C, Benito-González T, Estévez-Loureiro R, Garrote-Coloma C, Prado APd, et al. Percutaneous treatment of mitral regurgitation recurrence after mitral valve surgery. Vessel Plus. 2021;5:54.
    1. Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, et al. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021;42(13):1254–1269. doi: 10.1093/eurheartj/ehab086.
    1. Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370(1):23–32. doi: 10.1056/NEJMoa1312808.
    1. Ciarka A, Braun J, Delgado V, Versteegh M, Boersma E, Klautz R, et al. Predictors of mitral regurgitation recurrence in patients with heart failure undergoing mitral valve annuloplasty. Am J Cardiol. 2010;106(3):395–401. doi: 10.1016/j.amjcard.2010.03.042.
    1. Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MIM, et al. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation. 2004;110(11 Suppl 1):II103–II108.
    1. Hung J, Papakostas L, Tahta SA, Hardy BG, Bollen BA, Duran CM, et al. Mechanism of recurrent ischemic mitral regurgitation after annuloplasty: continued LV remodeling as a moving target. Circulation. 2004;110(11 Suppl 1):II85–90.
    1. Borger MA, Murphy PM, Alam A, Fazel S, Maganti M, Armstrong S, et al. Initial results of the chordal-cutting operation for ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2007;133(6):1483–92.e1. doi: 10.1016/j.jtcvs.2007.01.064.
    1. Fattouch K, Castrovinci S, Murana G, Dioguardi P, Guccione F, Nasso G, et al. Papillary muscle relocation and mitral annuloplasty in ischemic mitral valve regurgitation: midterm results. J Thorac Cardiovasc Surg. 2014;148(5):1947–1950. doi: 10.1016/j.jtcvs.2014.02.047.
    1. Rabbah J-PM, Siefert AW, Bolling SF, Yoganathan AP. Mitral valve annuloplasty and anterior leaflet augmentation for functional ischemic mitral regurgitation: quantitative comparison of coaptation and subvalvular tethering. J Thorac Cardiovasc Surg. 2014;148(4):1688–1693. doi: 10.1016/j.jtcvs.2014.04.008.
    1. Robb JD, Minakawa M, Koomalsingh KJ, Shuto T, Jassar AS, Ratcliffe SJ, et al. Posterior leaflet augmentation improves leaflet tethering in repair of ischemic mitral regurgitation☆,☆☆. Eur J Cardiothorac Surg. 2011;40(6):1501–1507.
    1. Harmel EK, Reichenspurner H, Girdauskas E. Subannular reconstruction in secondary mitral regurgitation: a meta-analysis. Heart. 2018;104(21):1783–1790. doi: 10.1136/heartjnl-2017-312277.
    1. Pausch J, Girdauskas E, Conradi L, Reichenspurner H. Secondary mitral regurgitation repair techniques and outcomes: subannular repair techniques in secondary mitral regurgitation type IIIb. JTCVS Tech. 2021;10:92–97. doi: 10.1016/j.xjtc.2021.09.019.
    1. Liel-Cohen N, Guerrero JL, Otsuji Y, Handschumacher MD, Rudski LG, Hunziker PR, et al. Design of a new surgical approach for ventricular remodeling to relieve ischemic mitral regurgitation: insights from 3-dimensional echocardiography. Circulation. 2000;101(23):2756–2763. doi: 10.1161/01.CIR.101.23.2756.
    1. Mihos CG, Larrauri-Reyes M, Santana O. A meta-analysis of ring annuloplasty versus combined ring annuloplasty and subvalvular repair for moderate-to-severe functional mitral regurgitation. J Card Surg. 2016;31(1):31–37. doi: 10.1111/jocs.12662.
    1. Nappi F, Lusini M, Spadaccio C, Nenna A, Covino E, Acar C, et al. Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation. J Am Coll Cardiol. 2016;67(20):2334–2346. doi: 10.1016/j.jacc.2016.03.478.
    1. Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014;147(1):496–499. doi: 10.1016/j.jtcvs.2013.03.006.
    1. Micali LR, Qadrouh MN, Parise O, Parise G, Matteucci F, de Jong M, et al. Papillary muscle intervention vs mitral ring annuloplasty in ischemic mitral regurgitation. J Card Surg. 2020;35(3):645–653. doi: 10.1111/jocs.14407.
    1. Fattouch K, Lancellotti P, Castrovinci S, Murana G, Sampognaro R, Corrado E, et al. Papillary muscle relocation in conjunction with valve annuloplasty improve repair results in severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2012;143(6):1352–1355. doi: 10.1016/j.jtcvs.2011.09.062.
    1. Harmel E, Pausch J, Gross T, Petersen J, Sinning C, Kubitz J, et al. Standardized subannular repair improves outcomes in Type IIIb functional mitral regurgitation. Ann Thorac Surg. 2019;108(6):1783–1792. doi: 10.1016/j.athoracsur.2019.04.120.
    1. Li B, Sun H. Subannular repair for moderate to severe ischemic mitral regurgitation: Still a long way to go: Authors’ reply. Cardiol J. 2020;27(2):223–224. doi: 10.5603/CJ.2020.0052.

Source: PubMed

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