HTA Unit, Estav Centro Toscana, Regional Health Service, Firenze and Prato, Italy.
BMJ Open. 2013 Jan 11;3(1):e001770. doi: 10.1136/bmjopen-2012-001770.
Transcatheter aortic valve implants (TAVIs) is indicated as an alternative to surgical valve replacement for patients unfit for surgery. No systematic review has studied survival after 2 years and limited information is available on between-study heterogeneity.
A systematic review and meta-analysis on intermediate survival after TAVI.
PubMed, EMBASE, Scopus and references of selected articles.
Clinical studies evaluating TAVI, published between 2010 and 2012, reporting survival at 2 or more years.
About 3500 patients from 14 studies.
Proportion meta-analysis with 95% CI and heterogeneity assessment (I(2) and Cochran's Q). Meta-regression analysis was performed as well.
Pooled immediate postoperative death rate was 7.8% (95% CI 6.2% to 9.8%, I(2)=40.8%; Cochran's Q=97.7 with 92.9 df, p<0.0001) and stroke rate was 3.8% (95% CI 2.8% to 5.0%, I(2)=34.3%; Cochran's Q=96.5 with 92.9 df, p<0.0001). Pooled death rates at 1, 2 and 3 years were 23.2%, 31.0% and 38.6%, respectively. Among studies reporting on concomitant percutaneous coronary intervention, pooled death rates at 30 days, 1 year and 2 years were 6.3%, 17.8% and 25.8%, respectively.
Although our analysis examined a total of about 3500 patients, only a minority of these were actually followed up after 2 years.
Pooled survival rates after TAVI (at 2 years: 69.0%; at 3 years: 61.4%) can be considered excellent, particularly in the light of the high-risk profile of this patient population. IMPLICATIONS OF KEY FINDINGS: The favourable intermediate outcome in patients subjected to TAVI seems to justify its use in patients unfit for surgery. Such pooled results indicate that TAVI is a valid alternative to surgical valve replacement, but lack of data on late durability after TAVI prevents its use in low-risk patients with long expectancy of life.
经导管主动脉瓣植入术（TAVI）适用于不适合手术的患者作为手术瓣膜置换的替代方法。没有系统评价研究过 TAVI 后 2 年的生存率，并且关于研究间异质性的信息有限。
对 TAVI 后中期生存率进行系统评价和荟萃分析。
PubMed、EMBASE、Scopus 和选定文章的参考文献。
评估 TAVI 的临床研究，发表于 2010 年至 2012 年之间，报告 2 年以上的生存率。
来自 14 项研究的约 3500 名患者。
采用 95%CI 和异质性评估（I²和 Cochran's Q）的比例荟萃分析。还进行了荟萃回归分析。
汇总的术后即刻死亡率为 7.8%（95%CI 6.2%至 9.8%，I²=40.8%；Cochran's Q=97.7，92.9 自由度，p<0.0001），卒中发生率为 3.8%（95%CI 2.8%至 5.0%，I²=34.3%；Cochran's Q=96.5，92.9 自由度，p<0.0001）。1、2 和 3 年的死亡率分别为 23.2%、31.0%和 38.6%。在报告同时进行经皮冠状动脉介入治疗的研究中，30 天、1 年和 2 年的死亡率分别为 6.3%、17.8%和 25.8%。
尽管我们的分析共纳入了约 3500 名患者，但只有少数患者在 2 年后实际接受了随访。
TAVI 后的汇总生存率（2 年：69.0%；3 年：61.4%）可以被认为是优异的，特别是考虑到该患者人群的高风险特征。
接受 TAVI 的患者的中期结果良好，似乎证明了 TAVI 在不适合手术的患者中的应用是合理的。这些汇总结果表明 TAVI 是手术瓣膜置换的有效替代方法，但缺乏 TAVI 后晚期耐久性的数据，限制了其在预期寿命长的低风险患者中的应用。
