Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry
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. Th...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Journal of Cardiothoracic Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13019-022-02045-9 |
| _version_ | 1797973474123186176 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Evaldas Girdauskas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T04:05:05Z |
| format | Article |
| id | doaj.art-4e8238a0acd84b01aa59827fae842305 |
| institution | Directory Open Access Journal |
| issn | 1749-8090 |
| language | English |
| last_indexed | 2024-04-11T04:05:05Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Cardiothoracic Surgery |
| spelling | doaj.art-4e8238a0acd84b01aa59827fae8423052023-01-01T12:27:16ZengBMCJournal of Cardiothoracic Surgery1749-80902022-12-011711710.1186/s13019-022-02045-9Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registryEvaldas Girdauskas0Jonas Pausch1Hermann Reichenspurner2Jörg Kempfert3Thomas Kuntze4Tamer Owais5Tomas Holubec6Markus Krane7Keti Vitanova8Michael Borger9Matthias Eden10Violetta Hachaturyan11Peter Bramlage12Volkmar Falk13Department of Cardiovascular Surgery, University Heart and Vascular Center HamburgDepartment of Cardiovascular Surgery, University Heart and Vascular Center HamburgDepartment of Cardiovascular Surgery, University Heart and Vascular Center HamburgDepartment of Cardiothoracic and Vascular Surgery, German Heart Center BerlinDepartment of Cardiology, Central Hospital Bad BerkaDepartment of Cardiovascular and Thoracic Surgery, University Hospital AugsburgDepartment of Cardiovascular Surgery, University Hospital Frankfurt, Johann Wolfgang Goethe University FrankfurtGerman Heart Center MunichGerman Heart Center MunichDepartment Cardiac Surgery, Leipzig Heart Center, University Clinic LeipzigDepartment for Internal Medicine III, Molecular Cardiology and Angiology, University Hospital Schleswig-HolsteinInstitute for Pharmacology and Preventive MedicineInstitute for Pharmacology and Preventive MedicineDepartment of Cardiothoracic and Vascular Surgery, German Heart Center BerlinAbstract 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.https://doi.org/10.1186/s13019-022-02045-9Functional mitral regurgitationMitral regurgitationMitral valve repairMitral annuloplastySubannular repair |
| spellingShingle | 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 Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry Journal of Cardiothoracic Surgery Functional mitral regurgitation Mitral regurgitation Mitral valve repair Mitral annuloplasty Subannular repair |
| title | Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry |
| title_full | Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry |
| title_fullStr | Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry |
| title_full_unstemmed | Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry |
| title_short | Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry |
| title_sort | subannular repair for functional mitral regurgitation with reduced systolic ventricle function rationale and design of reform mr registry |
| topic | Functional mitral regurgitation Mitral regurgitation Mitral valve repair Mitral annuloplasty Subannular repair |
| url | https://doi.org/10.1186/s13019-022-02045-9 |
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