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经导管主动脉瓣置换术后的生活质量:来自 GARY(德国主动脉瓣登记处)的前瞻性数据。

Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

机构信息

Department of Cardiovascular Surgery, German Heart Center, Technische Universität München (TUM), Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.

Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie [DGTHG], Berlin, Germany.

出版信息

JACC Cardiovasc Interv. 2016 Dec 26;9(24):2541-2554. doi: 10.1016/j.jcin.2016.09.050.

Abstract

OBJECTIVES

This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry).

BACKGROUND

Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population.

METHODS

In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year.

RESULTS

Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits.

CONCLUSIONS

TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.

摘要

目的

本研究旨在基于 GARY(德国主动脉瓣注册研究)的数据,分析行经导管主动脉瓣置换术(TAVR)患者的健康相关生活质量(HrQoL)结局。

背景

通常情况下,目前接受 TAVR 治疗的患者年龄较大,同时伴有多种合并症、残疾和有限的预期寿命。除了死亡率和发病率之外,评估 HrQoL 至关重要,不仅可以指导以患者为中心的临床决策,还可以判断这种新的治疗方法在高危患者人群中的效果。

方法

2011 年,3875 例接受 TAVR 的患者纳入 GARY 注册研究。使用纸质版欧洲生命质量 5 维量表问卷(EuroQol 5 dimensions questionnaire self-complete version)在基线和 1 年时前瞻性测量 HrQoL。

结果

2288 例患者(经血管 TAVR[TAVR-TV]:n=1626;经心尖 TAVR[TAVR-TA]:n=662)完成了完整的随访 EuroQol 5 维量表问卷评估。院内死亡率为 5.9%(n=229),1 年死亡率为 23%(n=893)。TAVR-TV 的基线总体健康状况视觉模拟量表评分为 52.6%,TAVR-TA 的评分为 55.8%,随着纽约心脏协会功能分级的改善,分别在 1 年时改善至 59.6%和 58.5%(p<0.001)。在基线至 1 年期间,报告无任何不适的患者数量增加了 7.8%(TAVR-TV),在活动能力维度增加了 3.5%,在日常活动维度增加了 14.1%(TAVR-TV)和 9.2%,而自我护理、疼痛或不适以及焦虑或抑郁维度的变化则较为适度。在多元线性回归分析中,几个术前和术后因素对 HrQoL 获益的程度有预测作用。

结论

TAVR 治疗可改善 HrQoL,特别是在活动能力和日常活动方面。与 TAVR-TA 组相比,TAVR-TV 组的改善幅度更大。然而,仍有相当一部分患者没有从 TAVR 治疗中获益。有几个独立的术前和术后因素被确定为对 HrQoL 获益程度有预测作用。

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