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This study intends to conduct a prospective observation to investigate the prevalence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS), compare the clinical characteristics between patients with isolated AS and those with AS complicated by CA (CA-AS), and simultaneously explore the impact of transcatheter aortic valve replacement (TAVR) on serum transthyretin (TTR) levels in patients with AS complicated by transthyretin amyloidosis (ATTR-AS), as well as its influence on the treatment outcomes of patients with isolated AS and ATTR-AS.
Amyloid infiltration involving the aortic valve may cause endothelial damage, which in turn accelerates calcification and leads to the development or exacerbation of aortic stenosis (AS). Previous studies have shown that the comorbidity rate of transthyretin amyloid cardiomyopathy (ATTR-CA) and AS ranges from 4.9% to 16%, and this rate is particularly notable in patients who have undergone transcatheter aortic valve replacement (TAVR).
Currently, although small-scale studies have explored the prognosis of patients with AS complicated by CA, some conclusions are contradictory and have limitations. The present study intends to conduct a prospective observational study: on one hand, to investigate the prevalence of CA in patients with AS and compare the clinical characteristics between patients with isolated AS and those with CA-complicated AS (CA-AS); on the other hand, to explore the impact of TAVR on serum transthyretin (TTR) levels in patients with ATTR-complicated AS (ATTR-AS), as well as its influence on the treatment outcomes of patients with isolated AS and ATTR-AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTR-AS group | Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group. |
| |
| AS group | Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve replacement (TAVR) | Procedure | TAVR is a minimally invasive cardiac interventional procedure that delivers a compressed artificial aortic valve to the diseased aortic valve site via peripheral blood vessels (e.g., the femoral artery) or the apex of the heart through a catheter, releases and deploys the valve to replace the original diseased valve leaflets, thereby restoring normal valve function and treating severe aortic stenosis (AS). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with | All-cause mortality is a statistical measure that counts all deaths in a specific population over a given time period, regardless of the cause of death. | baseline, 1 month, 3 months, 6 months, and 12 months |
| Composite endpoint of death and first hospitalization for heart failure | In accordance with the Valve Academic Research Consortium-2 (VARC-2) criteria, the composite endpoints for early safety and clinical efficacy after transcatheter aortic valve replacement (TAVR) were evaluated. | 12 months |
| Change in serum transthyretin (TTR) level from baseline | At baseline, 1 month, 3 months, 6 months, 12 months, the serum TTR levels were measured to assess the changes compared to the baseline. | baseline, 1 month, 3 months, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline | NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated. | baseline, 1 month, 3 months, 6 months, and 12 months |
| Change in New York Heart Association (NYHA) functional classification from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular remodeling indices | Cardiac Magnetic Resonance (CMR) was used to assess patients' ventricular function and structure at baseline and 12 months. | at baseline and 12 months |
| Echocardiographic indices |
Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the Cardiology Ward who undergo transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) from May 2025 to May 2028.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Li | Contact | 13564254007 | li.mingfei@zs-hospital.sh.cn | |
| Dan Tian | Contact | 13916157135 | tian.dan@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Daxin Zhou | Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| 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 |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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On the morning of the day after admission, 4 mL of elbow venous blood was routinely collected. The supernatant was separated and aliquoted into 3 EP tubes (500 μL per tube), then stored in a -80°C refrigerator. Repeated freezing and thawing was avoided, and the samples were kept for subsequent analysis. Serum samples were thawed at room temperature for more than 30 minutes, and subsequent procedures were performed after complete thawing.
|
NYHA functional classification was assessed at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated. The assessment was based on the New York Heart Association Functional Classification Scale, which is a 4-level ordinal scale with a minimum value of Class Ⅰ and a maximum value of Class Ⅳ. For this scale, higher scores represent worse clinical outcomes: Class Ⅰ: No limitation of physical activity Class Ⅱ: Slight limitation of physical activity Class Ⅲ: Marked limitation of physical activity Class Ⅳ: Unable to carry on any physical activity without symptoms |
| baseline, 1 month, 3 months, 6 months, and 12 months |
| Change in quality of life from baseline | In this study, the Minnesota Living With Heart Failure Questionnaire (MLHFQ) was used to assess patients' quality of life at baseline, 6 months, and 12 months. The MLHFQ corresponds to the full name Minnesota Living With Heart Failure Questionnaire, a disease-specific tool for evaluating heart failure-related quality of life. This scale has a total score range of 0 (minimum) to 105 (maximum). A higher total score reflects more severe quality of life impairment (i.e., worse outcome), while a lower score indicates better physical and psychological well-being in patients with heart failure. | baseline, 6 months, and 12 months |
| Change in Left Ventricular Ejection Fraction (LVEF) from baseline | LVEF changes were evaluated at baseline, 1 month, 3 months, 6 months, and 12 months. | baseline, 1 month, 3 months, 6 months, and 12 months |
Echocardiography was used to assess ventricular systolic function at baseline, 1 month, 3 months, 6 months, and 12 months.
| baseline, 1 month, 3 months, 6 months, and 12 months |
| Change in cardiac troponin T (cTnT) level from baseline | The change in cTnT level from baseline was evaluated at baseline, 1 month, 3 months, 6 months, and 12 months. | baseline, 1 month, 3 months, 6 months, and 12 months |
| 99Tcm-phosphonate (99Tcm-PYP) bone scan indices | Patients underwent 99Tcm-PYP bone scans at baseline and 12 months, and the visual scoring grades and heart/contralateral lung (H/CL) ratios were recorded. | baseline, 12 months |
| Incidence of postprocedural complications | Incidence of postprocedural complications, such as acute kidney injury, major bleeding, vascular complications, stroke, and new pacemaker implantation. | 1 month |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) within 12 months | Number of participants with one or more AEs and SAEs within 12 months | 12 months |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |