Kala Petr, Tretina Martin, Poloczek Martin, Ondrasek Jiri, Malik Petr, Pokorny Petr, Parenica Jiri, Spinar Jindrich, Jarkovsky Jiri, Littnerova Simona, Nemec Petr
Department of Internal Cardiology Medicine LF MU and FN Brno, Czech Republic.
Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2013 Mar;157(1):75-80. doi: 10.5507/bp.2012.062. Epub 2012 Sep 5.
The aim of this study was to compare the quality of life after transcatheter aortic valve implantation (TAVI) and surgical replacement (SAVR) at one year.
The study included 45 consecutive high-risk patients (average age 82.0 years; logistic Euroscore 22.3%) with symptomatic severe aortic stenosis allocated to TAVI transfemoral, TAVI transapical using the Edwards-Sapien valve or SAVR with the Edwards Perimount bioprosthesis (n=15 in each). The pre-operative characteristics were similar except for more myocardial infarctions in TAVI. The quality of life was assessed using the standardized EQ-5D questionnaire at baseline and on days 30, 90 and 360. The protocol was approved by the local ethics committee and an informed consent was signed. A total of 7 patients (15.5%) died during follow-up.
At baseline no significant differences in any of the quality-of-life parameters were found except for usual activities described as "best" (46.7% in SAVR vs. 10.0% in TAVI; P=0.002). At 30 and 90 days surviving patients were similar and at 360 days only the anxiety/depression score was "best" in 83.3% SAVR vs. 59.1% (P=0.046). Functional status improved in all patients (NYHA class I-II in 13.3% at baseline vs. 78.9% at 360-days) and the general health median significantly improved in TAVI patients (from 50 to 67; P=0.001) with a positive trend in SAVR patients (P=0.060).
At one year, the general quality of life of high-risk patients had significantly improved after transcatheter aortic valve implantation with a positive trend in surgically treated patients.
本研究旨在比较经导管主动脉瓣植入术（TAVI）和外科主动脉瓣置换术（SAVR）术后一年的生活质量。
本研究纳入了45例连续性高危患者（平均年龄82.0岁；逻辑欧洲心脏手术风险评估系统评分为22.3%），这些患者均有症状性严重主动脉瓣狭窄，被分配接受经股动脉TAVI、使用爱德华兹-赛沛瓣膜的经心尖TAVI或使用爱德华兹Perimount生物瓣膜的SAVR（每组15例）。术前特征相似，只是TAVI组心肌梗死更多。在基线、第30天、第90天和第360天使用标准化的EQ-5D问卷评估生活质量。该方案已获当地伦理委员会批准，并签署了知情同意书。共有7例患者（15.5%）在随访期间死亡。
在基线时，除了将日常活动描述为“最佳”的情况外，未发现任何生活质量参数存在显著差异（SAVR组为46.7%，TAVI组为10.0%；P = 0.002）。在第30天和第90天，存活患者情况相似，在第360天，只有焦虑/抑郁评分在SAVR组为“最佳”的比例为83.3%，而TAVI组为59.1%（P = 0.046）。所有患者的功能状态均有所改善（纽约心脏协会心功能分级在基线时I-II级的患者占13.3%，在第360天时占78.9%），TAVI患者的总体健康中位数显著改善（从50提高到67；P = 0.001），SAVR患者有改善趋势（P = 0.060）。
一年时，高危患者经导管主动脉瓣植入术后总体生活质量显著改善，手术治疗患者有改善趋势。
