Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.
Ann Cardiothorac Surg. 2012 Jul;1(2):129-37. doi: 10.3978/j.issn.2225-319X.2012.06.09.
Transcatheter aortic valve implantation (TAVI) represents a significant development in the treatment of high risk patients with aortic stenosis. As one of the first centers to perform transapical TAVI (taTAVI), we herein review our five-year experience with this technique.
All patients undergoing taTAVI with an Edwards Sapien valve at the Leipzig Heart Center between 2006 and 2011 (n=439) were analysed. Data was drawn from a prospective database and retrospectively analysed. The learning curve was reviewed by means of descriptive statistics as well as cumulative sum failure analysis (CUSUM). All results are presented in compliance with Valve Academic Research Consortium (VARC) criteria.
The mean patient age was 81.5±6.4 years and 64.0% were female. The mean logistic EuroSCORE and STS risk of mortality were 29.7%±15.7% and 11.4%±7.6%, respectively. Procedural success was 90.2%. Stroke occurred in 2.1% of patients intra-operatively and a further 2.1% suffered stroke during their hospital stay. Mean transvalvular gradient was 9.0±3.9 mmHg and effective valve orifice area 1.3±0.6 cm(2). Moderate or greater aortic insufficiency was present in 5.7% of patients and remained stable during follow up. Overall survival was 90% at 30 days, 73% at 1 year, 68% at 2 years, 58% at 3 years, 53% at 4 years, and 44% at 5 years. CUSUM analysis revealed a definitive learning curve regarding the occurrence of major complications, with a progressive improvement after the initial 150 cases.
TaTAVI has become a routine approach for high risk patients with symptomatic severe aortic stenosis. Although taTAVI is a safe procedure with reproducible results, future research should focus on methods of reducing known complications and the associated learning curve for this procedure.
经导管主动脉瓣植入术（TAVI）代表了治疗高危主动脉瓣狭窄患者的重大进展。作为最早开展经心尖主动脉瓣植入术（taTAVI）的中心之一，我们在此回顾了我们在该技术方面的五年经验。
在 2006 年至 2011 年间，莱比锡心脏中心对接受 Edwards Sapien 瓣膜 taTAVI 的所有患者（n=439）进行了分析。数据取自一个前瞻性数据库，并进行了回顾性分析。通过描述性统计和累积和失败分析（CUSUM）来审查学习曲线。所有结果均符合瓣膜学术研究联盟（VARC）标准。
患者的平均年龄为 81.5±6.4 岁，64.0%为女性。平均逻辑欧洲心脏手术风险评分（EuroSCORE）和 STS 死亡率风险分别为 29.7%±15.7%和 11.4%±7.6%。手术成功率为 90.2%。术中发生卒中的患者占 2.1%，住院期间发生卒中的患者占 2.1%。平均跨瓣梯度为 9.0±3.9mmHg，有效瓣口面积为 1.3±0.6cm²。5.7%的患者存在中度或重度主动脉瓣关闭不全，且在随访期间保持稳定。术后 30 天、1 年、2 年、3 年、4 年和 5 年的总生存率分别为 90%、73%、68%、58%、53%和 44%。CUSUM 分析显示，在主要并发症的发生方面，存在明确的学习曲线，在最初的 150 例之后，该曲线呈渐进式改善。
taTAVI 已成为治疗有症状的高危严重主动脉瓣狭窄患者的常规方法。虽然 taTAVI 是一种安全的手术，具有可重复的结果，但未来的研究应集中于降低已知并发症的方法和该手术的相关学习曲线。
