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重度症状性主动脉瓣狭窄患者生物人工主动脉瓣置换术后的预后:观察性研究的系统评价

Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies.

作者信息

Foroutan Farid, Guyatt Gordon H, O'Brien Kathleen, Bain Eva, Stein Madeleine, Bhagra Sai, Sit Daegan, Kamran Rakhshan, Chang Yaping, Devji Tahira, Mir Hassan, Manja Veena, Schofield Toni, Siemieniuk Reed A, Agoritsas Thomas, Bagur Rodrigo, Otto Catherine M, Vandvik Per O

机构信息

Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, Ontario, Canada L8S 4L8 Heart Failure/Transplant Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada

Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, Ontario, Canada L8S 4L8.

出版信息

BMJ. 2016 Sep 28;354:i5065. doi: 10.1136/bmj.i5065.

Abstract

OBJECTIVE

To determine the frequency of survival, stroke, atrial fibrillation, structural valve deterioration, and length of hospital stay after surgical replacement of an aortic valve (SAVR) with a bioprosthetic valve in patients with severe symptomatic aortic stenosis.

DESIGN

Systematic review and meta-analysis of observational studies.

DATA SOURCES

Medline, Embase, PubMed (non-Medline records only), Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to June 2016.

STUDY SELECTION

Eligible observational studies followed patients after SAVR with a bioprosthetic valve for at least two years.

METHODS

Reviewers, independently and in duplicate, evaluated study eligibility, extracted data, and assessed risk of bias for patient important outcomes. We used the GRADE system to quantify absolute effects and quality of evidence. Published survival curves provided data for survival and freedom from structural valve deterioration, and random effect models provided the framework for estimates of pooled incidence rates of stroke, atrial fibrillation, and length of hospital stay.

RESULTS

In patients undergoing SAVR with a bioprosthetic valve, median survival was 16 years in those aged 65 or less, 12 years in those aged 65 to 75, seven years in those aged 75 to 85, and six years in those aged more than 85. The incidence rate of stroke was 0.25 per 100 patient years (95% confidence interval 0.06 to 0.54) and atrial fibrillation 2.90 per 100 patient years (1.78 to 4.79). Post-SAVR, freedom from structural valve deterioration was 94.0% at 10 years, 81.7% at 15 years, and 52% at 20 years, and mean length of hospital stay was 12 days (95% confidence interval 9 to 15).

CONCLUSION

Patients with severe symptomatic aortic stenosis undergoing SAVR with a bioprosthetic valve can expect only slightly lower survival than those without aortic stenosis, and a low incidence of stroke and, up to 10 years, of structural valve deterioration. The rate of deterioration increases rapidly after 10 years, and particularly after 15 years.

摘要

目的

确定严重症状性主动脉瓣狭窄患者接受生物瓣主动脉瓣置换术(SAVR)后的生存率、中风、心房颤动、人工瓣膜结构退化频率及住院时间。

设计

对观察性研究进行系统评价和荟萃分析。

数据来源

2002年至2016年6月期间的Medline、Embase、PubMed(仅非Medline记录)、Cochrane系统评价数据库和Cochrane CENTRAL。

研究选择

符合条件的观察性研究对接受生物瓣SAVR的患者进行至少两年的随访。

方法

评审人员独立且重复地评估研究的合格性,提取数据,并评估患者重要结局的偏倚风险。我们使用GRADE系统来量化绝对效应和证据质量。已发表的生存曲线提供了生存及无人工瓣膜结构退化的数据,随机效应模型为中风、心房颤动和住院时间合并发病率估计提供了框架。

结果

接受生物瓣SAVR的患者中,65岁及以下患者的中位生存期为16年,65至75岁患者为12年,75至85岁患者为7年,85岁以上患者为6年。中风发病率为每100患者年0.25例(95%置信区间0.06至0.54),心房颤动为每100患者年2.90例(1.78至4.79)。SAVR后,10年时无人工瓣膜结构退化的比例为94.0%,15年时为81.7%,20年时为52%,平均住院时间为12天(95%置信区间9至15天)。

结论

接受生物瓣SAVR的严重症状性主动脉瓣狭窄患者的生存率仅略低于无主动脉瓣狭窄者,中风发生率低,且人工瓣膜结构退化在10年内发生率低。10年后退化率迅速增加,尤其是15年后。

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