评估 TAVR 与 SAVR 在低至中度手术风险的主动脉瓣狭窄患者中的安全性和疗效:系统评价概述。

Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

机构信息

European Commission, Joint Research Centre (JRC), Ispra, Italy.

European Commission, Joint Research Centre (JRC), Ispra, Italy.

出版信息

Int J Cardiol. 2020 Sep 1;314:43-53. doi: 10.1016/j.ijcard.2020.04.022. Epub 2020 Apr 11.

Abstract

BACKGROUND

Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties.

METHODS

To obtain information on TAVR versus SAVR in low-to intermediate risk groups, we conducted an overview of systematic reviews following PRISMA guidelines and based on a systematic search of EMBASE, MEDLINE, Cochrane and CRD databases. We focused on systematic reviews assessing mortality and VARC 2 as clinical outcomes.

RESULTS

The majority of the 11 systematic reviews included in our study reported no differences in mortality between TAVR and SAVR at short and long-term follow-up times. Two reviews that included the most recent RCTs on low-risk patients reported a decreased mortality risk with TAVR at one-year follow-up. Regarding the secondary endpoints of stroke and MI, the majority of studies presented similar results for TAVR and SAVR. Acute Kidney Injury, Bleeding Complications, Atrial Fibrillation were less frequent with TAVR, with lower risk of Permanent Pacemaker Implantation and Aortic Regurgitation with SAVR.

CONCLUSIONS

Our overview indicated that TAVR is a promising intervention for low-to-intermediate surgical risk patients; however additional evidence from longer term follow-up is needed to confirm these findings. This overview highlights inconsistencies about reporting and presentation of data, most notably limited clarity on effects of risk of bias on trial results.

摘要

背景

经导管主动脉瓣置换术(TAVR)最初被引入用于治疗外科主动脉瓣置换术(SAVR)高危患者的主动脉瓣狭窄(AS)。如今,有大量证据支持高危人群进行 TAVR。然而,近年来 TAVR 已扩展到低至中危人群,相关临床证据仍在不断涌现,存在一些不确定性。

方法

为了获取关于低至中危人群中 TAVR 与 SAVR 的信息,我们按照 PRISMA 指南进行了系统评价概述,并对 EMBASE、MEDLINE、Cochrane 和 CRD 数据库进行了系统搜索。我们重点关注评估死亡率和 VARC 2 的系统评价作为临床结局。

结果

我们研究中纳入的 11 项系统评价中的大多数报告在短期和长期随访时间内,TAVR 与 SAVR 之间的死亡率没有差异。两项纳入了最新 RCT 中低危患者的综述报告称,TAVR 可降低一年随访时的死亡率风险。关于卒中和 MI 的次要终点,大多数研究报告 TAVR 和 SAVR 的结果相似。TAVR 发生急性肾损伤、出血并发症、心房颤动的频率较低,SAVR 发生永久性心脏起搏器植入和主动脉瓣反流的风险较低。

结论

我们的综述表明,TAVR 是低至中危手术风险患者的一种有前途的干预措施;然而,需要更长时间的随访来证实这些发现。本综述突出了报告和呈现数据方面的不一致性,尤其是对偏倚风险对试验结果的影响的不明确性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6de4/7322533/e4e3bee3978e/gr1.jpg

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