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. 2025 Nov 14;21(22):1350-1363.
doi: 10.4244/EIJ-D-25-00682.

Long-term outcomes and durability of balloon-expandable TAVI in small and large annuli

Masanori Yamamoto  1   2   3 , Hirofumi Hioki  4 , Ai Kagase  2 , Hiroshi Tsunamoto  2 , Takahiro Tokuda  2 , Atsuhi Sugiura  2 , Tetsuro Shimura  3 , Azusa Murata  3 , Ryo Yamaguchi  1 , Shinichi Shirai  5 , Kenichi Ishizu  5 , Yohei Ohno  6 , Fumiaki Yashima  7 , Toru Naganuma  8 , Yusuke Watanabe  9 , Futoshi Yamanaka  10 , Gaku Nakazawa  11 , Masahiko Noguchi  12 , Masaki Izumo  13 , Masahiko Asami  14 , Hidetaka Nishina  15 , Yasushi Fuku  16 , Toshiaki Otsuka  17 , Kentaro Hayashida  18 , On Behalf The Ocean-Tavi Investigators
Affiliations

Long-term outcomes and durability of balloon-expandable TAVI in small and large annuli

Masanori Yamamoto et al. EuroIntervention. .

Abstract

Background: Evidence regarding the long-term outcomes and durability of balloon-expandable transcatheter heart valves (BE-THVs) after transcatheter aortic valve implantation (TAVI) is still scarce.

Aims: This study evaluates these outcomes and further examines their association with the annular size in patients.

Methods: A total of 2,699 patients who had undergone TAVI with a BE-THV at least 5 years prior to our study were analysed. A small aortic annulus (SAA) was defined as an area ≤430 mm2; any larger annuli were labelled large aortic annuli (LAA). The primary endpoints were the incidence of all-cause mortality and bioprosthetic valve failure (BVF) between the SAA and LAA groups. As a subanalysis, the primary endpoints were examined in relation to postprocedural mean pressure gradient (mPG) ≥20 mmHg, severe prosthesis-patient mismatch (PPM), and sex differences, comparing SAA and LAA each time.

Results: Overall, 66.4% (n=1,793) of patients were categorised into the SAA group. At 7 years after TAVI, the cumulative all-cause mortality showed differences between the SAA and LAA groups (55.2% vs 58.6%), while BVF assessed by Gray's test was similar between the groups (3.3% vs 2.7%). The Cox multivariable analysis revealed no association between SAA and worse prognosis (hazard ratio 1.07, 95% confidence interval: 0.85-1.36; p=0.56). There were no significant differences in mortality or BVF regarding an mPG ≥20 mmHg, severe PPM, or sex between the SAA and LAA groups (allp>0.05).

Conclusions: Annular size differences were not found to influence long-term outcomes or valve durability following TAVI with a BE-THV, suggesting that other factors warrant further investigation.

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Conflict of interest statement

M. Yamamoto, S. Shirai, Y. Watanabe, G. Nakazawa, M. Asami, Y. Fuku, and K. Hayashida served as clinical proctors for Edwards Lifesciences, Abbott, and Medtronic. K. Ishizu is a proctor of intracardiac echocardiography for Johnson & Johnson. M. Izumo is a screening proctor for Edwards Lifesciences. F. Yashima and H. Nishina are clinical proctors for Medtronic. T. Naganuma is a clinical proctor for Edwards Lifesciences and Medtronic. Y. Ohno is a clinical proctor for Medtronic and Abbott. T. Shimura is a clinical proctor for Medtronic and Abbott. The other authors have no conflicts of interest relevant to the content of this manuscript to declare.

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