Key result
The REFORM-MR registry enrolled 97 patients to evaluate the 2-year outcomes of combined papillary muscle relocation and ring annuloplasty for type IIIb functional mitral regurgitation.
Why the study?
Mitral valve annuloplasty is a standard treatment for functional mitral regurgitation, but recurrent regurgitation occurs in 10-50% of patients.
Does standardized subannular repair by papillary muscle relocation combined with ring annuloplasty prevent recurrent FMR in patients with type IIIb functional mitral regurgitation and reduced LVEF?
Observational (n=97)
Yes
Does standardized subannular repair by papillary muscle relocation combined with ring annuloplasty prevent recurrent FMR in patients with type IIIb functional mitral regurgitation and reduced LVEF?
The REFORM-MR registry is designed to evaluate the efficacy of standardized papillary muscle relocation combined with ring annuloplasty in preventing recurrent functional mitral regurgitation in patients with reduced left ventricular function.
Prospective multicenter registry data on papillary muscle relocation plus annuloplasty are needed; leaves open long-term efficacy versus annuloplasty alone in type IIIb FMR.
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.
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Girdauskas et al. (2022) conducted an observational in Functional mitral regurgitation with reduced systolic ventricle function (n=97). Standardized subannular repair by papillary muscle relocation and ring annuloplasty was evaluated on Freedom from recurrent FMR (> Grade 2) at 2-years follow-up. The REFORM-MR registry enrolled 97 patients to evaluate the 2-year outcomes of combined papillary muscle relocation and ring annuloplasty for type IIIb functional mitral regurgitation.
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