Functional status and quality of life after transcatheter aortic valve replacement: a systematic review.

Functional status and quality of life after transcatheter aortic valve replacement: a systematic review.
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DOI:
10.7326/m13-1316
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发表时间:
2014-02-18
影响因子:
39.2
通讯作者:
Kim DH
Kim DH
中科院分区:
医学1区
文献类型:
--
作者:
Kim CA;Rasania SP;Afilalo J;Popma JJ;Lipsitz LA;Kim DH

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经导管主动脉瓣置换术(TAVR)可延长患有严重主动脉瓣狭窄的高危患者的生存期。然而,其功能和生活质量益处尚未确定。评估TAVR术后功能状态和生活质量的变化。 MEDLINE、Embase 和 Cochrane 对照试验中央注册库,从 2002 年 1 月 1 日到 2013 年 9 月 30 日。TAVR 研究报告了纽约心脏协会 (NYHA) 等级、简式 (SF)-12/36 身体和精神成分摘要(分)或其他功能状态测量指标。两名评价者独立提取主要结局的平均变化(随访-基线)。由于存在很大的异质性,未汇总数据;总结了平均变化的范围(最小、最大)。我们确定了 60 项观察性研究(56 项前后比较和 4 项头对头比较研究)和 2 项随机对照试验(11,205 名患者)。大多数研究显示,NYHA 分级在 6-11 个月(范围:-0.8,-2.1)、12-23 个月(-0.8,-2.1)、24-35 个月(-1.2,-2.6)和≥36 个月(-1.2,-1.6)时出现临床重要下降。 SF-12/36 身体成分评分的改善在 12 个月内具有临床重要意义(4.9,26.9),而心理成分评分的变化较小(1.0,8.9)。在其他特定疾病的测量和 6 分钟步行测试中观察到临床上重要的改善,但在一般健康测量中观察到的效果不太一致。比较证据受到功能结果的头对头研究的限制。幸存者偏差可能高估了收益。 TAVR 在身体功能和特定疾病的生活质量测量方面提供了临床上重要的益处,但在心理和一般健康测量方面的益处有限。需要对功能状态和生活质量进行更多比较研究,以做出明智的治疗决策。
Transcatheter aortic valve replacement (TAVR) prolongs survival in high-risk patients with severe aortic stenosis. However, its functional and quality-of-life benefits have not been established. To evaluate the changes in functional status and quality of life after TAVR. MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from January 1, 2002, to September 30, 2013. Studies of TAVR that reported the New York Heart Association (NYHA) class, Short-Form (SF)-12/36 physical and mental component summary (points), or other measures of functional status. Two reviewers independently extracted the mean change (follow-up – baseline) in primary outcomes. Due to substantial heterogeneity, data were not pooled; the range (minimum, maximum) of mean change was summarized. We identified 60 observational studies (56 pre-post comparison and 4 head-to-head comparative studies) and 2 randomized controlled trials (11,205 patients). Most studies showed a clinically important decrease in NYHA class at 6–11 months (range: −0.8, −2.1), 12–23 months (−0.8, −2.1), 24–35 months (−1.2, −2.6), and ≥36 months (−1.2, −1.6). The improvement in SF-12/36 physical component score was clinically important over 12 months (4.9, 26.9), while the change in mental component score was smaller (1.0, 8.9). Clinically important improvements were observed in other disease-specific measures and 6-minute walk test, but less consistently seen in general health measures. Comparative evidence is limited by few head-to-head studies of functional outcomes. Survivor bias may have overestimated the benefits. TAVR provides clinically important benefits in physical function and disease-specific measures of quality of life, but modest benefits in psychological and general health measures. More comparative studies on functional status and quality of life are needed for informed treatment decision-making.