Department of Cardiothoracic Surgery, King's Health Partners, London, UK.
Eur J Cardiothorac Surg. 2011 Jun;39(6):853-9; discussion 859-60. doi: 10.1016/j.ejcts.2010.11.018. Epub 2010 Dec 22.
Trans-apical aortic valve implantation (TA-AVI) has been shown to be a reproducible technique. Early results from the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry identified major access complications associated with high 30-day mortality. Using the SOURCE Registry, we analyze the learning curve for TA-AVI over the first 2 years after commercialization.
The SOURCE Registry gathered data for 2 consecutive years at European centers following commercialization of the Edwards SAPIEN bioprosthesis, totaling 2339 patients (1038 in COHORT 1 and 1301 in COHORT 2). Only data from centers that provided all of their consecutively treated patients were included in this study. We compared the 30-day results of TA-AVI from COHORT 1 (C-1: January/2008-January/2009) with the 30-day results of COHORT 2 (C-2: February/2009-January/2010).
This analysis is based on a total number of 575 TA-AVIs in C-1 and 819 TA-AVIs in C-2. Mean age (C-1: 80.7 years, C-2: 80.5 years) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (C-1: 29.1%, C-2 27.3%) were not significantly different. Valve malposition (C-1: 1.6%, C-2: 1.2%), valve migration/embolization (C-1: 0.5%, C-2: 1.0%), and major access complications (C-1: 2.1%, C-2: 1.8%) were in total less frequent, but not statistically significant lower in C-2. However, the reduction of aortic regurgitation >2+ immediately following the procedure (C-1: 4.52%, C-2: 2.1%, p=0.011) and conversion rate to open surgery (C-1: 3.7%, C-2: 1.5%, p=0.0315) reached statistical significance. Postoperative complications included dialysis (C-1: 7.0%, C-2: 5.7%, p=ns), pacemaker implantation (C-2: 7.7%, C-2: 6.7%, p=ns), stroke (C-1: 2.4%, C-2: 2.6%, p=ns), and myocardial infarct (C-1: 0.7%, C-2: 0.4%, p=ns). The total 30-day mortality was 10.8% and not significantly different between the two groups (C-1: 10.8%, C-2: 10.7%, p=ns).
Although the incidence of technical intra procedural complications has trended downward, reflecting the learning curve for TA-AVI, 30-day mortality was unchanged, likely due to patient co-morbidities not captured by preoperative risk variables.
经心尖主动脉瓣置换术（TA-AVI）已被证明是一种可重复的技术。来自 SAPIEN 主动脉生物瓣欧洲结局（SOURCE）注册的早期结果确定了与高 30 天死亡率相关的主要入路并发症。利用 SOURCE 注册表，我们分析了商业化后 TA-AVI 在最初 2 年内的学习曲线。
SOURCE 注册表在商业化后连续 2 年在欧洲中心收集数据，共纳入 2339 例患者（COHORT 1 为 1038 例，COHORT 2 为 1301 例）。本研究仅纳入了提供所有连续治疗患者数据的中心。我们比较了 COHORT 1（C-1：2008 年 1 月/2009 年 1 月）和 COHORT 2（C-2：2009 年 2 月/2010 年 1 月）的 30 天 TA-AVI 结果。
本分析基于 C-1 中总共 575 例 TA-AVI 和 C-2 中 819 例 TA-AVI。平均年龄（C-1：80.7 岁，C-2：80.5 岁）和 logistic 欧洲心脏手术风险评估系统（EuroSCORE）（C-1：29.1%，C-2：27.3%）无显著差异。瓣膜位置不良（C-1：1.6%，C-2：1.2%）、瓣膜迁移/栓塞（C-1：0.5%，C-2：1.0%）和主要入路并发症（C-1：2.1%，C-2：1.8%）的总发生率较低，但 C-2 无统计学意义。然而，术后即刻主动脉瓣反流>2+的减少（C-1：4.52%，C-2：2.1%，p=0.011）和转为开放手术的比率（C-1：3.7%，C-2：1.5%，p=0.0315）具有统计学意义。术后并发症包括透析（C-1：7.0%，C-2：5.7%，p=ns）、起搏器植入（C-2：7.7%，C-2：6.7%，p=ns）、中风（C-1：2.4%，C-2：2.6%，p=ns）和心肌梗死（C-1：0.7%，C-2：0.4%，p=ns）。30 天总死亡率为 10.8%，两组间无显著差异（C-1：10.8%，C-2：10.7%，p=ns）。
尽管技术相关的术中并发症发生率呈下降趋势，反映了 TA-AVI 的学习曲线，但 30 天死亡率没有变化，可能是由于术前风险因素未捕获的患者合并症所致。
