Rheumatic mitral valve disease in the elderly
Conditions
Interventions
Mitral valve repair group (MVr group):Mitral valve repair according to the "four-step method" : removing the borderline fiber plaque
Probe and determine the natural movement of the interface
Borderline incision
Release and fuse subvalvular devices (papillary muscle separation, etc.). In addition, if there is severe mitral valve device structure contracture, such as mitral valve leaf contracture, autopericard
Mitral biologic valve replacement group (MVR group):The replacement method of discontinuous pad suture of the posterior mitral valve was used to select the corresponding size of the biological valve a
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age =60 years old, regardless of gender. 2) The presence of mitral rheumatic disease confirmed by clinical diagnosis and ultrasound, and the presence of invasive intervention indications: i. Mitral stenosis: The clinical symptoms were obvious (NYHA grade =3) and the mitral opening area was =1.5cm2. The anatomic and morphological characteristics required surgical management (Wilkins score =8 or mitral regurgitation was more than moderate). ii. Mitral regurgitation: severe mitral regurgitation with obvious clinical symptoms; Severe mitral regurgitation with no obvious clinical symptoms but LVEF=60% or left ventricular end-systolic diameter =40mm. iii. Failure of mitral balloon dilation (PBMC). iv. Voluntary signing of informed
Exclusion criteria
Exclusion criteria: 1) Previous history of heart surgery. 2) Infective endocarditis and pericarditis. 3) Aortic valve or aortic root surgery should be performed at the same time. 4) There is anticoagulant contraindication of warfarin. 5) Indications of PBMC intervention: Wilkins score < 8 or mitral regurgitation at or below moderate. 6) Life expectancy < 6 months. 7) Untreated or difficult to control hypertension (antihypertensive drug triple therapy is still not effective in reducing blood pressure). 8) Elevated aminotransferase, exceeding the upper limit by 3 times, elevated bilirubin exceeding the upper limit, severe liver function impairment (Child C grade), cirrhosis. 9) History of gastrointestinal bleeding, gastrointestinal diverticulosis, or gastrointestinal tumors. 10) A history of alcoholism (drinking 5 or more bottles of beer at one time or having a blood alcohol level of 0.08g/dl or higher). 11) Patients with dementia, mental illness and other conditions. 12) Diseases of the blood system (hemophilia, Willebrand disease, thrombocytopenia and thrombocytopelopathy). 13) Participated in other clinical trials within 6 months. 14) Those who have been confirmed by preoperative ultrasound evaluation combined with the opinion of the surgeon to be unsuitable for surgical repair (such as severe calcification, severe thickening of the valve leaflet, and significant thrombus formation in the subvalvular fibrosis) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 24 months, the non-resting mitral annular plane displacement of the interventricular septum; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mitral annular systolic velocity;A composite of major adverse cardiac or cerebrovascular events (mortality, stroke, repeat mitral-valve surgery, hospitalization for heart failure, or an increase in New York Heart Association [NYHA] class of =1);Recurrent mitral stenosis and/or regurgitation;Quality of life score;Pulmonary arterial systolic pressure;Left atrial volume index ; | — |
Countries
China
Contacts
Public ContactWang Jiangang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed