Aortic stenosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for emergency TAVR treatment (1) New York Heart Function (NYHA) grade IV; (2) Meet one of the following conditions: acute decompensated heart failure or cardiogenic shock that is difficult to control with drugs; Uncontrolled recurrent unstable angina with elevated markers of myocardial injury; Recurrent syncope; (3) Patients with indications for transcranial aortic valve implantation were evaluated by the cardiac valvular disease team; (4) Patients signed informed consent before surgery; 2. inclusion Criteria for admission and discharge for TAVR treatment via carotid artery (1) Marked tortuosity (hyperacute curvature) of the thoracic or abdominal aorta; (2) Severe calcification of proximal lower extremity vessels, severe distortion or vascular diameter insufficient to accommodate the delivery sheath; (3) History of aortic dissection with abdominal or thoracic aortic occlusion or severe aortic stenosis; (4) Aortic arch or descending aorta unstable arteriosclerosis plaque or severe arteriosclerosis descending aortic thrombosis; (5) Abnormal chest anatomy leads to difficulty in coaxial operation of the instrument (such as funnel chest); (6) The aortic root anatomical structure is complex (for example, patients with severe calcification of aortic valve). After discussion by the heart team, TAVR via carotid artery approach is judged to be better; 3. inclusion criteria for Study on optimal treatment strategy: (1)Patients aged 75 years with severe aortic valve disease confirmed by ECHO cardiography.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for emergency TAVR treatment: (1) The patient and relatives refused to accept surgical treatment; (2) Mechanical valve has been implanted in the aortic valve position; (3) Congenital aortic stenosis or no calcification; (4) Abnormal coronary arteries that interfere with the placement of the valve; (5) Echocardiography showing evidence of intracardiac mass, thrombus or vegetations; (6) Uncontrolled severe infection; (7) Active gastrointestinal bleeding; (8) Acute stroke, including ischemic stroke and hemorrhagic stroke; (9) Severe bleeding and coagulation dysfunction, known contraindications or allergic reactions to anticoagulant drugs; (10) Life expectancy less than 1 year due to cancer, chronic liver disease or chronic end-stage lung disease; (11) Severe aortic disease, including significant tortuosity (hyperacute curvature), coarctation of the abdominal or thoracic aorta (especially with calcification and uneven surface), severe "extension" of the thoracic aorta, and tortuosity; 2. Exclusion criteria for TAVR treatment via carotid artery: (1) Evidence of acute myocardial infarction (MI) within 1 month (30 days) prior to expected treatment [WHO definition]. (2) Abnormal coronary arteries that interfere with proper valve placement. (3) Leukopenia (WBC < 3000 cells/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cells/mL). (4) Emergency intervention/surgery was performed within 1 month (30 days) before TAVR. (5) Hypertrophic cardiomyopathy (HCM) with or without obstruction (myocardium thickness exceeding 1.5 cm without a clear cause) (HOCM); (6) Severe ventricular dysfunction, LVEF < 20%; (7) Echocardiography showing evidence of lumen mass, thrombus or vegetations; (8) Active upper gastrointestinal bleeding occurred within 3 months (90 days) before surgery; (9) Known contraindications or allergic reactions to all anticoagulant regimens, or the inability to perform anticoagulant therapy prescribed by the study surgery; (10) A stroke/TIA occurred within 3 months (90 days) before surgery; (11) Life expectancy less than 12 months (365 days) due to cancer, chronic liver disease, chronic kidney disease or chronic end-stage lung disease; (12) Active bacterial endocarditis occurred 6 months (180 days) prior to surgery, with or without treatment; 3. Exclusion criteria for research on optimal treatment strategies: (1) Patients who cannot participate in follow-up for various reasons; (2) Patients who died during hospitalization from non-cardiogenic causes or were in extremely critical condition and were estimated to have died recently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE event;death; | — |
Secondary
| Measure | Time frame |
|---|---|
| valvular function; | — |
Countries
China
Contacts
Fuwai Hospital