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.
Study Type
OBSERVATIONAL
Enrollment
31
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months
Time frame: 12 months Post-Operation
Mortality rate
Time frame: Mortality of patients 12 months post-operation
Disabling stroke rate
Time frame: Rate of disabling stroke 12 months post-operation
Heart failure re-hospitalization rate
Time frame: 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
Time frame: Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation
Rate of severe prosthesis-patient mismatch (PPM)
Time frame: Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation
Device success rate
Time frame: Device success rate at 30-days post-operation
Device safety rate
Time frame: Device safety rate at 30-days post-operation
Rate of Bioprosthetic Structural Valve Dysfunction
Time frame: Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up
Rate of endocarditis
Time frame: 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)
Time frame: Rate of Non-structural valve dysfunction (NSVD) at 12 month
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