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三种球囊扩张式经导管主动脉瓣置换术后主动脉瓣反流的定量血管造影评估。

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves.

机构信息

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland and CORRIB Corelab and Center for Research and Imaging, IE.

Amsterdam UMC, University of Amsterdam, Amsterdam, NL.

出版信息

Glob Heart. 2021 Mar 19;16(1):20. doi: 10.5334/gh.959.

Abstract

OBJECTIVES

The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves.

BACKGROUND

Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI.

METHODS

This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database.

RESULTS

The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246).

CONCLUSION

The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

摘要

目的

本分析旨在比较三种球囊扩张瓣膜经导管主动脉瓣置换术(TAVI)后的定量血管造影主动脉瓣反流(AR)。

背景

定量视频密度法主动脉造影是一种客观、准确和可重复的工具,用于裁决 TAVI 后的 AR。

方法

这是一项回顾性核心实验室分析,独立于行业,对接受球囊扩张型 Myval 经导管心脏瓣膜(THV)(印度 Meril Life Sciences Pvt. Ltd.)、Sapien 3 和 XT THV(爱德华兹生命科学公司,加利福尼亚州欧文)治疗的患者的主动脉造影进行分析。该研究纳入了多中心欧洲注册中心连续接受 Myval THV 植入的 108 例可分析主动脉造影患者。从已发表的合并数据库中检索到 Sapien 3 THV(n=397)和 Sapien XT THV(n=239)定量评估 AR 的结果。

结果

与 Sapien 3 THV(8.3%;p=0.049)和 Sapien XT THV(10.9%;p=0.012)相比,Myval THV 患者中度或重度血管造影定量 AR 的比例最低(2.8%)。此外,Myval THV 的血管造影定量 AR 平均值最低(6.3±6.3%),其次是 Sapien 3 THV(7.6±7.1%)和 Sapien XT THV(8.8±7.5%),与 Sapien XT THV 相比差异有统计学意义(p=0.006),但与 Sapien 3 THV 相比差异无统计学意义(p=0.246)。

结论

与我们数据库中分析的其他 BEV 相比,Myval THV 在 TAVI 后发生中度或重度 AR 的几率较低。这些结果应在随机患者的前瞻性队列中与头对头 THV 比较进行确认。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f809/7977026/4a59283ebb0b/gh-16-1-959-g1.jpg

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