Multidisciplinary Cardiovascular Research Centre, Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, Leeds, UK.
J Am Coll Cardiol. 2012 May 8;59(19):1672-80. doi: 10.1016/j.jacc.2012.01.035.
The goal of this study was to assess serial changes in patient health-related quality of life (HRQOL) over time and identify predictors of patient benefit.
Severe aortic stenosis reduces the length and quality of a patient's life. Transcatheter aortic valve implantation (TAVI) is superior to standard medical therapy and noninferior to surgical aortic valve replacement for 1-year mortality. HRQOL is an important outcome measure for which there is limited evidence in TAVI populations.
A total of 102 patients (mean age 80 ± 0.6 years; 49% male) undergoing TAVI consented to participate. Two HRQOL questionnaires-the social functioning (SF)-12v2 with physical component summaries (PCS) and mental component summaries (MCS) and the EQ-5D (with a visual analog scale [VAS])-were completed at baseline, 30 days, 6 months, and 1 year according to the recommendations of the Valve Academic Research Consortium. A SF-6D utility measure was calculated from the SF-12 survey.
HRQOL significantly improved over 1 year (PCS p = 0.02; EQ-5D p = 0.02; VAS p = 0.01; SF-6D p = 0.03), becoming similar to age-adjusted U.S. population norms. The greatest change occurred from baseline to 30 days (p < 0.001), with further significant improvements to 6 months (p < 0.01). An insignificant decline occurred between 6 months and 1 year (p > 0.05), but a linear pattern of change remained for PCS, EQ-5D, and VAS (p < 0.05). Male sex (SF-6D p = 0.01) and increased operator experience (PCS, EQ-5D, and VAS p < 0.05) were independent predictors of a greater improvement in HRQOL.
HRQOL significantly improved early after TAVI and was maintained out to 1 year. Patient factors, procedural complications, and operator experience are predictors of health benefit at 1 year.
本研究旨在评估患者健康相关生活质量（HRQOL）随时间的变化，并确定患者获益的预测因素。
严重的主动脉瓣狭窄会降低患者的生活质量和预期寿命。与标准药物治疗相比，经导管主动脉瓣植入术（TAVI）可降低 1 年死亡率，且不劣于外科主动脉瓣置换术。HRQOL 是一个重要的结果衡量标准，但 TAVI 人群中的证据有限。
共纳入 102 名（平均年龄 80 ± 0.6 岁，49%为男性）接受 TAVI 的患者。根据 Valve Academic Research Consortium 的建议，所有患者在基线、30 天、6 个月和 1 年时分别完成 2 份 HRQOL 问卷，即社会功能（SF）-12v2 与身体成分综合评分（PCS）和精神成分综合评分（MCS）和 EQ-5D（含视觉模拟量表[VAS]）。SF-12 调查计算 SF-6D 效用评分。
1 年内 HRQOL 显著改善（PCS p = 0.02；EQ-5D p = 0.02；VAS p = 0.01；SF-6D p = 0.03），与年龄校正的美国人群正常值相似。最大的变化发生在基线至 30 天（p < 0.001），6 个月时进一步显著改善（p < 0.01）。6 个月至 1 年之间的变化不显著（p > 0.05），但 PCS、EQ-5D 和 VAS 的变化呈线性模式（p < 0.05）。男性（SF-6D p = 0.01）和术者经验增加（PCS、EQ-5D 和 VAS p < 0.05）是 HRQOL 改善更大的独立预测因素。
TAVI 后早期 HRQOL 显著改善，并持续到 1 年。患者因素、手术并发症和术者经验是 1 年时健康获益的预测因素。
