Aortic Stenosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Sarawak Heart Centre
King Chulalongkorn Memorial Hospital
Ramathibodi Hospital
University Malaysia Sarawak
St. Luke's Medical Center, Philippines
Sapporo Heart Center
Prince of Wales Hospital, Shatin, Hong Kong
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention
Exclusion criteria
* Transcatherter Aortic Valve Intervention for pure Aortic Regurgitation * Emergent procedure for any reason; * Previous aortic valve replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months | 12 months Post-Operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Heart failure re-hospitalization rate at 12 month post-operation | — |
| Rate of moderate prosthesis-patient mismatch (PPM) | Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation | 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 Non-structural valve dysfunction (NSVD) | Rate of Non-structural valve dysfunction (NSVD) at 12 month | ≥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) |
| 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 severe prosthesis-patient mismatch (PPM) | Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation | — |
Countries
Hong Kong
Outcome results
None listed