Abstract
Objectives: The aim of this study was to compare the incidence and prognostic significance of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) according to racial groups. Background: PPM after TAVR may be of more concern in Asian populations considering their relatively small annular and valve sizes compared with Western populations. Methods: TP-TAVR (Transpacific TAVR Registry) was an international multicenter cohort study of patients with severe aortic stenosis who underwent TAVR in the United States and South Korea from January 2015 to November 2019. PPM was defined as moderate (0.65-0.85 cm2/m2) or severe (<0.65 cm2/m2) at the indexed effective orifice area. The primary outcome was a composite of death, stroke, or rehospitalization at 1 year. Results: Among 1,101 eligible patients (533 Asian and 569 non-Asian), the incidence of PPM was significantly lower in the Asian population (33.6%; moderate, 26.5%; severe, 7.1%) than in the non-Asian population (54.5%; moderate, 29.8%; severe, 24.7%). The 1-year rate of the primary outcome was similar between the PPM and non-PPM groups (27.5% vs 28.1%; P = 0.69); this pattern was consistent between Asian (25.4% vs 25.2%; P = 0.31) and non-Asian (28.7% vs 32.1%; P = 0.97) patients. After multivariable adjustment, the risk for the primary outcome did not significantly differ between the PPM and non-PPM groups in the overall population (HR: 0.95; 95% CI: 0.74-1.21), in Asian patients (HR: 1.07; 95% CI: 0.74-1.55), and in non-Asian patients (HR: 0.86; 95% CI: 0.63-1.19). Conclusions: In this study of patients with severe aortic stenosis who underwent TAVR, the incidence of PPM was significantly lower in Asian patients than in non-Asian patients. The 1-year risk for the primary composite outcome was similar between the PPM and non-PPM groups regardless of racial group.
Original language | English (US) |
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Pages (from-to) | 2670-2681 |
Number of pages | 12 |
Journal | JACC: Cardiovascular Interventions |
Volume | 14 |
Issue number | 24 |
DOIs | |
State | Published - Dec 27 2021 |
Funding
All 3 databases were standardized according to the common database model and merged in accordance with the policy of data use agreed upon among the participating centers; patient demographics, surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality score), functional status, clinical risk factors or comorbidities, anatomical or hemodynamic parameters by cardiac computed tomography or echocardiography, procedural details, and in-hospital and follow-up outcomes were collected in the common database. Each center’s Institutional Review Board or ethics committee approved the protocol for the registry. TP-TAVR was partly funded by the CardioVascular Research Foundation and was supported by a grant (2020IF0016) from Asan Institute for Life Sciences and Corporate Relations of Asan Medical Center. The sponsor had no role in the study design or in the collection, analysis, or interpretation of data. This study was supported by grant 2020IF0016 from the Asan Institute for Life Sciences and Corporate Relations of Asan Medical Center with NAVER. This study was also funded in part by the CardioVascular Research Foundation and Edwards Lifesciences. The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Dr Yeung has received institutional research support from Edwards Lifesciences. Dr Fearon has received institutional research support from Edwards Lifesciences. Dr Malaisrie has received consulting fees from Edwards Lifesciences, Medtronic, CryoLife, and Terumo Aortc. Dr D.-W. Park received research grants, consulting, and speaker fees from Edwards Lifesciences, Medtronic, Abbott, and Daiichi-Sankyo during the conduct of this study. Dr S.-J. Park received grants from Edwards Lifesciences, Medtronic, and Abbott during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Keywords
- TAVR
- aortic valve stenosis
- mortality
- outcomes
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine