Department of Cardiothoracic Surgery, King's Health Partners, London, UK.
Eur J Cardiothorac Surg. 2010 Aug;38(2):119-27. doi: 10.1016/j.ejcts.2009.12.048. Epub 2010 Mar 4.
Trans-catheter aortic valve implantation is an alternative treatment option for patients facing high risk for aortic valve replacement. Currently, the results of trans-apical trans-catheter procedures performed outside controlled trials are unknown.
The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry collects data of patients treated at European centres during the first year following commercialisation of the Edwards SAPIEN bioprosthesis. Only data from centres that could provide 100% of their consecutively treated patients (n=32) were included in the study population. This article provides the 30-day outcome data involving the trans-apical patients, including univariate and multivariate risk analyses for postoperative 30-day mortality.
The interim results are based on a total number of 575 procedures performed between January 2008 and 31 January 2009. Mean age at implant was 80.7 years, and patients had a mean logistic EuroSCORE of 29.1%. Baseline characteristics included coronary artery disease 56%, prior coronary intervention 27.1%, prior coronary bypass grafting 26.9%, concomitant mitral valve disease 32.8%, porcelain aorta 11.5%, peripheral vascular disease 27.5%, prior stroke 6.3% and pulmonary disease 29.4%. Successful valve deployment was observed in 92.7% with a 3.5% conversion rate to open surgery, incidence of coronary obstruction of 0.7% and valve embolisation of 0.5%. The incidence of aortic regurgitation in excess of 2+ was 2.3% immediately following the procedure. The incidence of major postoperative complications included bleeding requiring re-operation 2.1%, dialysis 7.1%, pacemaker implantation 7.3%, stroke 2.6%, major vascular complications 2.4% and myocardial infarction 0.7%. The total 30-day mortality was 10.3%. Logistic EuroSCORE > or =30% and missing ejection fraction were found to be the only independent predictors for 30-day mortality.
These results demonstrate that although trans-apical trans-catheter aortic valve implantation is a complex surgical technique, the learning curve can be minimised by appropriate training programmes. Very high logistic EuroSCOREs predict inferior survival and make it likely that in this subgroup of patients there may be some who, despite having had a successful trans-catheter aortic valve implantation procedure, do not benefit in the midterm.
经导管主动脉瓣植入术是主动脉瓣置换术高危患者的另一种治疗选择。目前，经心尖经导管治疗的结果在临床试验之外尚不清楚。
爱德华兹 SAPIEN 主动脉生物瓣欧洲结果（SOURCE）登记处收集了在爱德华兹 SAPIEN 生物瓣商业化后第一年在欧洲中心接受治疗的患者的数据。只有能够提供 100%连续治疗患者数据的中心（n=32）被纳入研究人群。本文提供了涉及经心尖患者的 30 天结果数据，包括术后 30 天死亡率的单变量和多变量风险分析。
中期结果基于 2008 年 1 月至 2009 年 1 月 31 日期间进行的 575 例手术。植入时的平均年龄为 80.7 岁，患者的平均逻辑欧洲心脏手术风险评分（EuroSCORE）为 29.1%。基线特征包括冠状动脉疾病 56%，既往冠状动脉介入治疗 27.1%，既往冠状动脉旁路移植术 26.9%，合并二尖瓣疾病 32.8%，瓷主动脉 11.5%，周围血管疾病 27.5%，既往中风 6.3%和肺部疾病 29.4%。成功进行瓣膜植入的比例为 92.7%，转换为开放手术的比例为 3.5%，冠状动脉阻塞发生率为 0.7%，瓣膜栓塞发生率为 0.5%。术后即刻主动脉瓣反流超过 2+的发生率为 2.3%。主要术后并发症包括需要再次手术的出血 2.1%，透析 7.1%，起搏器植入 7.3%，中风 2.6%，大血管并发症 2.4%和心肌梗死 0.7%。总的 30 天死亡率为 10.3%。逻辑 EuroSCORE >或=30%和射血分数缺失被发现是 30 天死亡率的唯一独立预测因素。
这些结果表明，尽管经心尖经导管主动脉瓣植入术是一种复杂的手术技术，但通过适当的培训计划可以将学习曲线最小化。非常高的逻辑 EuroSCORE 预测生存率较差，这表明在这个亚组患者中，尽管已经成功进行了经导管主动脉瓣植入术，但在中期可能有些患者并未从中受益。
