Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months.

IF 2.9 Q2 HEALTH CARE SCIENCES & SERVICES
Marte Sævik, Marit Helen Andersen, Jan Otto Beitnes, Lars Aaberge, Per Steinar Halvorsen
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引用次数: 0

Abstract

Aim: The study aimed to determine the proportion of patients with significant improvements in Health-Related Quality of Life (HRQoL) 12 months after Transcatheter Aortic Valve Implantation (TAVI), using a threshold for physical function (PF) and physical role (RP) domains of the SF-36 questionnaire. Additionally, we explored shared baseline characteristics of patients reporting these improvements.

Methodology: In this prospective observational study, 88 patients with symptomatic, severe aortic stenosis (AS) and preserved ejection fraction were enrolled between April 2017 and February 2020. Exclusion criteria were clinical instability, pacemaker, chronic AF, comorbidities with life expectancy < 1 year. HRQoL was evaluated before and 12 months after transfemoral TAVI using the Norwegian version 2.0 of SF-36, and presented as mean (95% confidence interval). Other outcome measures were 6-minute walking test and NYHA- classification. Independent samples t-test or Mann-Whitney U test was used for between-group comparisons as appropriate. Logistic regression or Chi2-test were used to explore associations between changes in PF and RP and clinical parameters. Statistical significance was set at p ≤ 0.05, and clinically significant changes in HRQoL were defined as increase of ≥ 15 points in the PF and RP categories.

Results: Mean age of the cohort was 80 ± 6 years. 44 (50%) patients reported clinically significant improvement in PF, and 46 (52%) in the RP domain. Baseline scores were significantly lower in patients reporting clinical improvement after TAVI, with PF scores pre intervention 43.07 (37.37-48.78) vs. 65.34 (59.01-71.68), p < 0.001, and RP 36.01 (29.56-42.46) vs. 59.92 (50.91-68.92), p < 0.001. No significant associations were found between improvement in domain scores and parameters from the routine baseline examination, but having ≥ 15-point improvement correlated to baseline PF and RP scores.

Conclusion: Our study highlights the importance of defining a uniform threshold for clinically significant improvement in the SF-36 HRQoL questionnaire for patients undergoing TAVI. Half of the patients reported favorable long-term outcome for PF and RP aspects of SF-36. This emphasizes the importance of HRQoL assessment in the preoperative work up for patients undergoing TAVI.

Trial registration: https://www.

Clinicaltrials: gov/ 05.04.2017 with ID NCT03107923.

主动脉瓣狭窄患者经导管主动脉瓣置入术后健康相关生活质量(HRQoL):探索12个月后临床显著改善的新阈值
目的:本研究旨在确定经导管主动脉瓣植入术(TAVI)后12个月健康相关生活质量(HRQoL)显著改善的患者比例,采用SF-36问卷的生理功能(PF)和生理作用(RP)域的阈值。此外,我们探讨了报告这些改善的患者的共同基线特征。方法:在这项前瞻性观察研究中,在2017年4月至2020年2月期间,88例有症状的严重主动脉瓣狭窄(AS)和保留射血分数的患者入组。排除标准为临床不稳定、起搏器、慢性房颤、合并症与预期寿命。结果:队列平均年龄为80±6岁。44例(50%)患者报告了PF的临床显著改善,46例(52%)患者报告了RP域的临床显著改善。TAVI后报告临床改善的患者的基线评分明显较低,干预前的PF评分为43.07(37.37-48.78)比65.34(59.01-71.68)。p结论:我们的研究强调了在TAVI患者的SF-36 HRQoL问卷中定义临床显著改善的统一阈值的重要性。一半的患者报告SF-36的PF和RP方面的长期预后良好。这强调了HRQoL评估在TAVI患者术前工作中的重要性。试验注册:https://www.Clinicaltrials: gov/ 05.04.2017, ID NCT03107923。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Patient-Reported Outcomes
Journal of Patient-Reported Outcomes Health Professions-Health Information Management
CiteScore
3.80
自引率
7.40%
发文量
120
审稿时长
20 weeks
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