Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry
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Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. / Girdauskas, Evaldas; Pausch, Jonas; Reichenspurner, Hermann; Kempfert, Jörg; Kuntze, Thomas; Owais, Tamer; Holubec, Tomas; Krane, Markus; Vitanova, Keti; Borger, Michael; Eden, Matthias; Hachaturyan, Violetta; Bramlage, Peter; Falk, Volkmar.
In: J CARDIOTHORAC SURG, Vol. 17, No. 1, 343, 30.12.2022.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry
AU - Girdauskas, Evaldas
AU - Pausch, Jonas
AU - Reichenspurner, Hermann
AU - Kempfert, Jörg
AU - Kuntze, Thomas
AU - Owais, Tamer
AU - Holubec, Tomas
AU - Krane, Markus
AU - Vitanova, Keti
AU - Borger, Michael
AU - Eden, Matthias
AU - Hachaturyan, Violetta
AU - Bramlage, Peter
AU - Falk, Volkmar
N1 - © 2022. The Author(s).
PY - 2022/12/30
Y1 - 2022/12/30
N2 - 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.
AB - 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.
KW - Humans
KW - Mitral Valve Insufficiency/etiology
KW - Prospective Studies
KW - Neoplasm Recurrence, Local
KW - Mitral Valve Annuloplasty/methods
KW - Registries
KW - Magnetic Resonance Imaging
KW - Treatment Outcome
U2 - 10.1186/s13019-022-02045-9
DO - 10.1186/s13019-022-02045-9
M3 - SCORING: Journal article
C2 - 36581901
VL - 17
JO - J CARDIOTHORAC SURG
JF - J CARDIOTHORAC SURG
SN - 1749-8090
IS - 1
M1 - 343
ER -
