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This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI). AS patients undergoing emergent TAVI always have complicated clinical situations. Therefore, the aims of the study are to collect the incidence and outcomes of emergent TAVI in patients with severe symptomatic AS, to assess the safety and effectiveness of emergency TAVI system for severe AS, and to describe a more practical evidence of emergency TAVI system in severe AS patients.
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | including cardiac and non-cardiac deaths. | 12 months post-TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) during the trial | Incidence of MACCEs (including mortality, disabling stroke, myocardial infarction, reoperation, arrhythmias and conduction blocks) during the trial. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive patients with severe aortic valve stenosis undergoing emergency transcatheter aortic valve implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanbao Li, Dr | Contact | +86-18560083097 | bao2460@126.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Acute kidney injury |
Incidence of acute kidney injury (kidney function was accessed by AKIN kidney function classification, including AKIN class II, AKIN class III and renal replacement therapy (RRT: hemodialysis, peritoneal dialysis, hemofiltration) ). |
| immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| Permanent pacemaker implantation | Rate of patients implanted with permanent pacemaker. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| Vascular complications (life-threatening or disabling) | including dissection, occlusion, rupture and bleeding of access vessels. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| The incidence of other TAVI complications | including conversion to surgery, unexpected cardiopulmonary mechanical assistance, coronary artery occlusion, ventricular septal perforation, mitral valve injury or loss of function, pericardial tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), valve-in-valve, reoperation due to valve dysfunction, and so on. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| Valve function | Doppler echocardiography was used to evaluate the valve performance at each follow-up point, including valve orifice area, mean aortic gradient, degree of valve regurgitation, moderate or above perivalvular leakage (PVL), and degree of aortic stenosis. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| Cardiac function improvement | Doppler echocardiography was used to evaluate the heart function at each follow-up point, and cardiac function improvement is accessed by NYHA cardiac function classification, including NYHA class I, II, III and IV. | immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI |
| Device success rate | Incidence of device success | immediate post-TAVI |
| D014694 |
| Ventricular Outflow Obstruction |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |