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经导管二尖瓣修复术后的功能状态和生活质量:一项前瞻性队列研究和系统评价。

Functional status and quality of life after transcatheter mitral valve repair: a prospective cohort study and systematic review.

机构信息

Department III of Internal Medicine, Heart Center, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.

出版信息

Clin Res Cardiol. 2017 Dec;106(12):1005-1017. doi: 10.1007/s00392-017-1150-x. Epub 2017 Aug 7.

Abstract

BACKGROUND

Estimating the quantitative effect of transcatheter mitral valve repair on functional parameters and quality of life is important for individual treatment decision-making.

METHODS

We combined data from a prospective monocentric cohort study (N = 215) with data from a systematic literature review (PubMed search term "mitraclip", till 30.04.2016) on patients undergoing MitraClip with at least mortality after discharge reported as an outcome. Effects on functional parameters were reported as range of mean change.

RESULTS

36 observational studies and 1 randomized controlled trial were identified. Due to substantial heterogeneity of effect estimates (I -heterogeneity >75%) and inadequate quality of studies with a lack of comparison group in 97.4% and lack of an independent assessment of outcomes in 86.8%, no pooled estimates were calculated. All studies reported improvements of mean New York Heart Association (NYHA) class (0.5-1.9 classes), Short-Form (SF)-12/36 scores (4.4-9.2 for physical component score, 2.6-8.9 for mental component score), 6-min walk distance [(6MWD) 2-336 m] and Minnesota Living with Heart failure questionnaire (MLWHFQ) score (-7 to -18 points), with improvements regarded as clinically relevant in 20 of 29 studies for NYHA class, in all of 7 studies for SF12/36, in 9 of 15 studies for 6MWD and in all of 8 studies for MLWHFQ.

CONCLUSION

MitraClip therapy provides improvements in physical capacity, physical and mental functioning and disease-specific quality of life in the majority of patients. However, more comparative and high-quality studies are required for understanding the heterogeneity of results, which is crucial for optimal patient selection.

摘要

背景

评估经导管二尖瓣修复术对功能参数和生活质量的定量影响对于个体治疗决策非常重要。

方法

我们将前瞻性单中心队列研究(N=215)的数据与系统文献综述(PubMed 搜索词“mitraclip”,截止至 2016 年 4 月 30 日)的数据相结合,该综述纳入了至少在出院后报告了死亡率的接受 MitraClip 治疗的患者,以作为结果。功能参数的影响以均值变化范围报告。

结果

共确定了 36 项观察性研究和 1 项随机对照试验。由于效应估计值存在显著的异质性(I -异质性>75%),且 97.4%的研究缺乏对照组,86.8%的研究缺乏对结局的独立评估,因此未进行汇总估计。所有研究均报告了纽约心功能协会(NYHA)分级(0.5-1.9 级)、SF-12/36 评分(生理成分评分 4.4-9.2,心理成分评分 2.6-8.9)、6 分钟步行距离[(6MWD) 2-336m]和明尼苏达州心力衰竭生活质量问卷(MLWHFQ)评分(-7 至-18 分)的改善,其中 29 项研究中有 20 项研究、7 项研究、15 项研究中的 9 项研究和 8 项研究中的所有研究均报告 NYHA 分级、SF12/36、6MWD 和 MLWHFQ 的改善具有临床意义。

结论

MitraClip 治疗可改善大多数患者的身体活动能力、身体和心理功能以及特定疾病的生活质量。然而,需要更多的比较性和高质量研究来理解结果的异质性,这对于优化患者选择至关重要。

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