Hirofumi Hioki, Masanori Yamamoto, Tetsuro Shimura, Shinichi Shirai, Yohei Ohno, Fumiaki Yashima, Toru Naganuma, Yusuke Watanabe, Futoshi Yamanaka, Gaku Nakazawa, Masahiko Noguchi, Masaki Izumo, Masahiko Asami, Hidetaka Nishina, Yasushi Fuku, Daisuke Hachinohe, Kenji Nishioka, Toshiaki Otsuka, Kentaro Hayashida, OCEAN-TAVI Investigators
Early mortality after TAVR in the Asian cohort has remained consistently low over the past decade. Although device-related complications such as PMI and PVL improved substantially, periprocedural stroke remained as a key unmet clinical challenge.
BACKGROUND: As transcatheter aortic valve replacement (TAVR) has expanded across a broad range of surgical risk profiles, evaluating temporal changes in outcomes has become increasingly important, particularly in the Asian population where patient characteristics differ from those of the Western population. The aim of the study was to evaluate the temporal trends in short-term outcomes after TAVR over the past decade in a large Asian multicenter registry.
METHODS: This retrospective multicenter registry included 13,245 patients who underwent TAVR at 18 centers from 2013 to 2023. Temporal trends in 30-day mortality, 30-day stroke, and 30-day pacemaker implantation (PMI), and paravalvular leakage (PVL) ≥ mild at discharge were assessed using multiple imputation and center-clustered generalized estimating equations. The effect modification by age and surgical risk was prespecified.
RESULTS: The median age was 85 years, and the median Society of Thoracic Surgeons (STS) score was 5.6%. Over time, patient profiles shifted toward lower risk, and procedures became less invasive. Consistent across age and Society of Thoracic Surgeons risk strata, the overall risk-adjusted 30-day mortality remained low and did not change significantly over time. In contrast, the risk-adjusted PMI and PVL ≥ mild declined significantly over time, particularly in TAVR using balloon-expandable valves (BEVs). The risk-adjusted incidence of 30-day stroke did not change significantly.
CONCLUSIONS: Early mortality after TAVR in the Asian cohort has remained consistently low over the past decade. Although device-related complications such as PMI and PVL improved substantially, periprocedural stroke remained as a key unmet clinical challenge.