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

Masanori Yamamoto¹^,²^,³, MD; Hirofumi Hioki⁴, MD; Ai Kagase², MD; Hiroshi Tsunamoto², MD; Takahiro Tokuda², MD; Atsuhi Sugiura², MD; Tetsuro Shimura³, MD; Azusa Murata³, MD; Ryo Yamaguchi¹, MD; Shinichi Shirai⁵, MD; Kenichi Ishizu⁵, MD; Yohei Ohno⁶, MD; Fumiaki Yashima⁷, MD; Toru Naganuma⁸, MD; Yusuke Watanabe⁹, MD; Futoshi Yamanaka¹⁰, MD; Gaku Nakazawa¹¹, MD; Masahiko Noguchi¹², MD; Masaki Izumo¹³, MD; Masahiko Asami¹⁴, MD; Hidetaka Nishina¹⁵, MD; Yasushi Fuku¹⁶, MD; Toshiaki Otsuka¹⁷, MD; Kentaro Hayashida¹⁸, MD; on behalf the OCEAN-TAVI investigators

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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