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当代经导管主动脉瓣在小主动脉瓣环中的植入:国际多中心 TAVI-SMALL 2 注册研究。

Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry.

机构信息

Montefiore Medical Center, New York, NY, USA.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.

出版信息

EuroIntervention. 2023 Jun 19;19(3):256-266. doi: 10.4244/EIJ-D-22-00843.

Abstract

BACKGROUND

Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM).

AIMS

We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli.

METHODS

The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL).

RESULTS

The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001).

CONCLUSIONS

In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.

摘要

背景

对于小瓣环的主动脉瓣狭窄患者的治疗具有挑战性,并且可能导致假体-患者不匹配(PPM)。

目的

我们旨在比较小瓣环患者使用经导管瓣膜的前向血流动力学和临床结果。

方法

TAVI-SMALL 2 国际回顾性登记研究纳入了 2011 年至 2020 年期间在 16 个大容量中心接受经股动脉自膨式(SEV;n=1092)和球囊扩张式瓣膜(BEV;n=286)治疗的 1378 例严重主动脉瓣狭窄合并小瓣环(瓣环周长<72mm 或面积<400mm)患者。比较 SEV 与 BEV 以及 supra-annular(SAV;n=920)与 intra-annular 瓣膜(IAV;n=458)的分析包括逆概率治疗加权(IPTW)。主要终点是出院前平均主动脉梯度和严重 PPM 的发生率。次要终点是瓣周漏(PVL)大于轻度的发生率。

结果

与 IAV 相比,SAV (7.8±3.9 对 12.0±5.1;p<0.001)和 SEV (8.0±4.1 对 13.6±4.7;p<0.001)的出院前平均主动脉梯度更低。与 SAV 和 SEV 植入相比,IAV 和 BEV 时更常见严重 PPM(分别为 8.8%对 3.6%;p=0.007 和 8.7%对 4.6%;p=0.041)。在 IPTW 加权的多变量逻辑回归中,无论其定义如何,SAV 都能预防严重 PPM。与 BEV 相比,SEV 时发生的瓣周漏大于轻度的情况更多(11.6%对 2.6%;p<0.001)。

结论

在小主动脉瓣环中,与 IAV 和 BEV 植入相比,SAV 和 SEV 的植入与更有利的前向血流动力学特征相关。SEV 比 BEV 植入时更常见瓣周漏大于轻度。

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