Durability of balloon-expandable and self-expandable transcatheter aortic valves in patients with a large aortic annulus

IF 2.3 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiovascular Revascularization Medicine Pub Date : 2026-08-01 Epub Date: 2025-12-11 DOI:10.1016/j.carrev.2025.12.006

Kenichi Ishizu, Shinichi Shirai, Masaomi Hayashi, Toru Morofuji, Akihiro Isotani, Nobuhisa Ohno, Shinichi Kakumoto, Kenji Ando, Masanori Yamamoto, Hirofumi Hioki, Tetsuro Shimura, Fumiaki Yashima, Toru Naganuma, Masahiko Asami, Yohei Ohno, Yusuke Watanabe, Futoshi Yamanaka, Gaku Nakazawa, Masahiko Noguchi, Masaki Izumo, Kentaro Hayashida

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引用次数: 0

Abstract

Background

Limited evidence has been available on the long-term prognosis and valve durability of balloon-expandable transcatheter heart valve (BE-THV) and self-expandable transcatheter heart valve (SE-THV) in patients with large aortic annulus (LAA).

Objectives

To compare the long-term outcomes between the BE-THV and SE-THV.

Methods

We retrospectively analyzed 1054 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) for tricuspid aortic valve stenosis with LAA, defined as an annulus area > 430 mm², using either a BE-THV (SAPIEN 3, Edwards Life Sciences) or SE-THV (Evolut R/PRO, Medtronic). The 7-year cumulative incidences of all-cause mortality and bioprosthetic valve failure (BVF) were evaluated in the overall cohort and the propensity score (PS)-matched cohort.

Results

Among the 1054 patients with LAA, 829 (78.7 %) received a BE-THV. The PS-matched population resulted in 218 pairs. The cumulative incidence of all-cause mortality 7 years after TAVI was comparable between the BE-THV and SE-THV groups in the overall cohort (58.6 % vs. 67.6 %, log-rank P = 0.848) and the PS-matched cohort (53.2 % vs. 69.9 %, log-rank P = 0.173). In the overall cohort, the BE-THV group demonstrated a lower exposure-adjusted BVF rate as compared with the SE-THV, although the difference was not significant (6.1 vs. 9.6 events per 1000 patient-years, P = 0.258). This trend became pronounced after PS matching (3.3 vs. 9.9 events per 1000 patient-years, P = 0.017), which was also confirmed by Gray's test (P = 0.032).

Conclusions

In the current analysis focusing on patients with LAA, the BE-THV and SE-THV groups had a comparable long-term prognosis, but the BE-THV group had a lower BVF rate than did the SE-THV group.

Clinical trial registration

UMIN000020423

查看原文本刊更多论文

大主动脉环患者经导管主动脉瓣的球囊膨胀性和自膨胀性耐久性。

背景：关于大主动脉环（LAA）患者使用球囊可膨胀经导管心脏瓣膜（BE-THV）和自膨胀经导管心脏瓣膜（SE-THV）的长期预后和瓣膜耐久性的证据有限。目的：比较BE-THV与SE-THV的远期疗效。方法：采用BE-THV （SAPIEN 3, Edwards Life Sciences）或SE-THV (Evolut R/PRO, Medtronic)，回顾性分析1054例接受经股经导管主动脉瓣植入术（TAVI）治疗伴有LAA的三尖瓣狭窄的患者。在整个队列和倾向评分（PS）匹配的队列中评估了7年全因死亡率和生物假体瓣膜衰竭（BVF）的累积发生率。结果：1054例LAA患者中，829例（78.7%）接受了BE-THV治疗。ps匹配的群体共有218对。TAVI后7年的全因死亡率累积发生率在整个队列中BE-THV组和SE-THV组（58.6%比67.6%,log-rank P = 0.848）和ps匹配组（53.2%比69.9%,log-rank P = 0.173）具有可比性。在整个队列中，与SE-THV组相比，BE-THV组显示出较低的暴露调整BVF率，尽管差异不显著（6.1 vs 9.6事件/ 1000患者年，P = 0.258）。这种趋势在PS匹配后变得明显（3.3 vs 9.9事件/ 1000患者年，P = 0.017），这也被Gray检验证实（P = 0.032）。结论：在目前针对LAA患者的分析中，BE-THV组和SE-THV组的长期预后相当，但BE-THV组的BVF率低于SE-THV组。临床试验注册号：UMIN000020423。

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来源期刊

Cardiovascular Revascularization Medicine CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

3.30

自引率

5.90%

发文量

687

审稿时长

36 days

期刊介绍： Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.