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经导管主动脉瓣置换术后瓣环上和瓣环内假体的假体-患者不匹配。

Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement With Supra-Annular and Intra-Annular Prostheses.

机构信息

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.

Clinical Trials Unit, University of Bern, Bern, Switzerland.

出版信息

JACC Cardiovasc Interv. 2019 Nov 11;12(21):2173-2182. doi: 10.1016/j.jcin.2019.07.027. Epub 2019 Sep 26.

Abstract

OBJECTIVES

This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV).

BACKGROUND

PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient.

METHODS

A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe (<0.65 cm/m) or moderate (0.65 to 0.85 cm/m) in the general population, and as severe (<0.60 cm/m) or moderate (0.60 to 0.90 cm/m) in the obese population (body mass index ≥30 kg/m).

RESULTS

Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%; p = 0.004; severe PPM, 6.7% vs. 15.6%; p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year.

CONCLUSIONS

SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m.

摘要

目的

本研究旨在比较自膨式瓣膜(SEV)与球囊扩张式瓣膜(BEV)的假体-患者不匹配(PPM)发生率。

背景

PPM 与经导管主动脉瓣置换术后死亡率增加相关。关于 PPM 与经导管心脏瓣膜的瓣上或瓣内位置之间关系的数据不足。

方法

本研究共纳入 2007 年 8 月至 2017 年 6 月期间接受 SEV(CoreValve、Evolut R)和 BEV(SAPIEN THV/XT/3)治疗的 757 例患者。根据出院时根据体表面积(BSA)索引的假体有效瓣口面积将 PPM 分为严重(<0.65cm/m)或中度(0.65 至 0.85cm/m)在普通人群中,以及肥胖人群(BMI≥30kg/m)中严重(<0.60cm/m)或中度(0.60 至 0.90cm/m)。

结果

倾向评分匹配后得到 224 对匹配。出院时,SEV 与 BEV 相比,PPM 的发生率较低(PPM,33.5% vs. 46.9%;p=0.004;严重 PPM,6.7% vs. 15.6%;p=0.003)。即使在瓣环较大的患者中,SEV 也观察到严重 PPM 的发生率较低。尽管 BSA>1.83m 的患者接受 SEV 治疗的 PPM 发生率明显低于 BEV,但 BSA≤1.83m 的患者无显著差异。我们发现 1 年内 PPM 对心血管死亡率或纽约心脏协会功能分级没有影响。

结论

SEV 与 BEV 相比,PPM 的发生率较低,与瓣环面积无关。这种差异主要是由 BSA>1.83m 的较大患者驱动的。

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