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Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.
Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| functional mitral insufficiency op | Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitral valve repair | Procedure | operative reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrent mitral valve insufficiency > grade 2 | see above | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | major adverse cardiovascular and cerebrovascular events | 1 year |
| re-intervention at mitral valve | see above | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry
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| Name | Affiliation | Role |
|---|---|---|
| Evaldas Girdauskas, MD | Universitäres Herzzentrum Hamburg am UKE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Leipzig | Leipzig | Saxony | 04289 | Germany | ||
| Zentralklinik Bad Berka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37376817 | Derived | Pausch J, Harmel E, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Walther T, Krane M, Vitanova K, Borger MA, Eden M, Hachaturyan V, Bramlage P, Falk V, Girdauskas E. Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole. Heart. 2023 Aug 24;109(18):1394-1400. doi: 10.1136/heartjnl-2022-322239. | |
| 36581901 |
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no IPD will be made available
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| device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure | see above | 2 years |
| cardiovascular mortality | see above | 2 years |
| re-hospitalisation due to heart failure | see above | 2 years |
| Bad Berka |
| 99437 |
| Germany |
| Charité - Klinik für kardiovaskuläre Chirurgie | Berlin | 10117 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE | Hamburg | 20246 | Germany |
| Deutsches Herzzentrum München | München | 80636 | Germany |
| Girdauskas E, Pausch J, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Krane M, Vitanova K, Borger M, Eden M, Hachaturyan V, Bramlage P, Falk V. Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. J Cardiothorac Surg. 2022 Dec 30;17(1):343. doi: 10.1186/s13019-022-02045-9. |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D018487 | Ventricular Dysfunction, Left |
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D016127 | Heart Valve Prolapse |
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| ID | Term |
|---|---|
| D058386 | Mitral Valve Annuloplasty |
| ID | Term |
|---|---|
| D058385 | Cardiac Valve Annuloplasty |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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