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| Name | Class |
|---|---|
| Sarawak Heart Centre | OTHER |
| King Chulalongkorn Memorial Hospital | OTHER |
| Ramathibodi Hospital | OTHER |
| University Malaysia Sarawak |
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Transcatheter aortic valve implantation (TAVI) presents unique challenges for Asian patients compared to Caucasians, largely due to the prevalence of small aortic annulus (SAA) defined based on Caucasians' data (430 mm²), bicuspid aortic valve (BAV), and substantial calcium deposits. No universally accepted cutoff value for defining SAA exists among Asian patients, who tend to have smaller body-built, resulting in inconsistencies across various studies. For the new-generation 20-/23-mm balloon expandable valve, a SAA is categorized as <330 mm². Additionally, Asian Japanese patients have been identified to have extremely SAA (<314 mm²), associated with unexpectedly larger residual transvalvular gradients following TAVI.
Previous research on patient prosthesis mismatch (PPM) impact within the Asian population has also shown inconsistency. The OCEAN-TAVI registry with 1,546 Japanese patients found no significant differences in one-year all-cause and cardiovascular mortality between PPM and non-PPM groups. A study on the Sapien 3 balloon expandable valve in patients with SAA (<430 mm²) found comparable clinical outcomes to non-SAA patients up to five years post-procedure, consistent with findings from a South Korean study. However, a Taiwan study involving 201 patients with PPM indicated higher rates of adverse outcomes at mid-term follow-up. Moreover, TAVI with self-expanding valves (SEV) has shown improved hemodynamic outcomes and reduced PPM incidence compared to balloon expandable valves (BEV) in patients with extreme SAA.
To date, research on inter-racial differences in TAVI among Asian populations is lacking. This multicenter registry aims to evaluate SEV versus BEV outcomes in diverse Asian patients, particularly those with extreme SAA, and to address ethnic-specific challenges in TAVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS TAVI patient in Prince of Wales Hospital | |||
| AS TAVI patient in Sarawak Heart Centre/University Malaysia Sarawak | |||
| AS TAVI patient in National Heart Centre Malaysia | |||
| AS TAVI patient in King Chulalongkorn Memorial Hospital | |||
| AS TAVI patient in Ramathibodi Hospital | |||
| AS TAVI patient in St. Luke's Medical Cente | |||
| AS TAVI patient in Sapporo Cardiovascular Clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months | 12 months Post-Operation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Mortality of patients 12 months post-operation | |
| Disabling stroke rate | Rate of disabling stroke 12 months post-operation | |
| Heart failure re-hospitalization rate |
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Inclusion Criteria:
Exclusion Criteria:
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Retrospective data collection will be carried out at multiple TAVI sites in Asia. Patients with severe AS who underwent TAVI (SEV/ BEV) will be identified from retrospective records (Physical/ Electronic). Consecutive patients who underwent pre-procedural computed tomography (CT) scans for aortic valve evaluation from 2018-1-1 to 2024-12-31 were included.
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| Name | Affiliation | Role |
|---|---|---|
| Chak Yu Kent So, Clinicnal Assistant Professor | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Shatin | 0000 | Hong Kong |
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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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| OTHER |
| St. Luke's Medical Center, Philippines | OTHER |
| Sapporo Heart Center | UNKNOWN |
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| Heart failure re-hospitalization rate at 12 month post-operation |
| Rate of moderate prosthesis-patient mismatch (PPM) | In patients with a body mass index <30 kg/m2, PPM was defined as none or mild if the indexed EOA (iEOA) was>0.85 cm2/m2, moderate if the iEOA was 0.85-0.66 cm2/m2 and severe if the iEOA was ≤0.65 cm2/m2. In patients with a body mass index ≥30 kg/m2, PPM was defined as none or mild if the iEOA was>0.70 cm2/m2, moderate if the iEOA was 0.56-0.70 cm2/m2 and severe if the iEOA was ≤0.55 cm2/m2 | Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation |
| Rate of severe prosthesis-patient mismatch (PPM) | Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation |
| Device success rate | Device success rate at 30-days post-operation |
| Device safety rate | Device safety rate at 30-days post-operation |
| Rate of Bioprosthetic Structural Valve Dysfunction | Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up |
| Rate of endocarditis | Rate of endocarditis at 12 month |
| Rate of Non-structural valve dysfunction (NSVD) | ≥Moderate aortic regurgitation rate of moderate or severe PPM (PPM: In patients with a body mass index <30 kg/m2, PPM was defined as none or mild if the indexed EOA (iEOA) was>0.85 cm2/m2, moderate if the iEOA was 0.85-0.66 cm2/m2 and severe if the iEOA was ≤0.65 cm2/m2. In patients with a body mass index ≥30 kg/m2, PPM was defined as none or mild if the iEOA was>0.70 cm2/m2, moderate if the iEOA was 0.56-0.70 cm2/m2 and severe if the iEOA was ≤0.55 cm2/m2, PVL, and DVI (severe <0.25, moderate 0.25-0.5, mild >0.5) | Rate of Non-structural valve dysfunction (NSVD) at 12 month |
| D014694 |
| Ventricular Outflow Obstruction |