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Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency. The investigators aim to discuss the clinical efficacy of extracorporeal life support system(ECLS) during TAVR procedure in severe aortic lesion under very low ejection fraction (EF).
Transcatheter aortic valve replacement (TAVR), characterized by minimal invasion, no need for thoracotomy and extracorporeal circulation and definite mid- and long-term efficacy, has been recognized as an effective alternative replacing valve replacement through conventional thoracotomy for senile aortic valve stenosis. However, there are still a large number of patients whose left ventricular ejection fraction (LVEF) significantly declines due to the long history of disease and long-term heart injury, entering the decompensation stage. TAVR will still lead to such severe complications as intraoperative hemodynamic collapse and malignant arrhythmia in these patients, greatly increasing the mortality rate. It is pointed out in the American Heart Association Guideline (2017) that TAVR is not recommended as a treatment means for patients with very poor cardiac function under EF <20%. After conservative medication, the prognosis of patients with aortic valve stenosis under very low EF is poor with a 3-year mortality rate above 85%, and the prognosis after heart transplantation remains controversial. According to the pathological basis of patients and preoperative results of dobutamine test, the cardiac systolic function of some patients is expected to be significantly improved after removal of aortic valve stenosis. Therefore, applying extracorporeal life support system, such as extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass (CPB) in the guarantee of cardiopulmonary function during perioperative period of TAVR is considered as the optimal surgical strategy for such patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-ECLS GROUP | Active Comparator | For AS/R patients with normal EF, only TAVR was performed |
|
| ECLS GROUP | Experimental | For AS/R patients with low EF, TAVR under ECLS-assisted was performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve replacement | Procedure | Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS |
|
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiac event | Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| minor adverse event | Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications | 1 year |
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Inclusion Criteria:
4. The subject was informed of the clinical application nature of the technology and agreed to participate in all requirements of the clinical application of the new technology, signed the informed consent and agreed to complete.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Yang, M.D PH.D | Contact | +8613892828016 | yangjian@fmmu.edu.cn | |
| Jiayou Tang, M.D PH.D | Contact | +8615353618121 | tjy-heart@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiqiang Yu, M.D. PH.D. | The First Affiliated Hospital of Air Force Medicial University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| D015199 | Extracorporeal Membrane Oxygenation |
| D002315 | Cardiopulmonary Bypass |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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ECLS-assisted TAVR for patients with very low EF(<20%). Only TAVR for patients with fair EF(>20%)
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|
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |