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单中心经导管主动脉瓣植入术(Edwards-SAPIEN 和 CoreValve 两种装置)的结果:米兰经验。

Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

机构信息

Interventional Cardiology Unit, San Raffaele Institute, Milan, Italy.

出版信息

JACC Cardiovasc Interv. 2010 Nov;3(11):1110-21. doi: 10.1016/j.jcin.2010.09.012.

Abstract

OBJECTIVES

Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion.

BACKGROUND

Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis.

METHODS

We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach.

RESULTS

A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events.

CONCLUSIONS

Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.

摘要

目的

我们旨在评估经皮主动脉瓣置换术(TAVI)中使用 2 种商业上可获得的瓣膜,以及以递进方式选择的 3 种输送途径的临床结果。

背景

对于使用经股、经心尖和经腋动脉途径治疗严重主动脉瓣狭窄的不同瓣膜的综合 TAVI 方案的结果,目前仅有有限的数据。

方法

我们报告了在一家中心连续治疗的高危患者的 30 天和 6 个月的结果,这些患者分别使用经股或经腋途径输送的美敦力-CoreValve(MCV)(美敦力,明尼苏达州明尼阿波利斯)或爱德华兹-SAPIEN 瓣膜(ESV)(爱德华兹生命科学公司,加利福尼亚州欧文),以及经心尖途径输送的 ESV。

结果

共 137 例患者接受了 TAVI:107 例经股(46 例 MCV 和 61 例 ESV),15 例经腋(12 例 MCV 和 3 例 ESV),15 例经心尖。经股途径后,手术成功率为 93.5%,大血管并发症发生率为 20.6%。无术中死亡。经心尖和经腋途径的手术成功率分别为 86.6%和 93.3%。股部组 30 天死亡率为 0.9%,心尖组为 13.3%,腋部无死亡。6 个月时累积死亡率分别为股部组 12.2%、心尖组 26.6%和腋部组 18.2%。多变量分析显示,逻辑欧洲心脏手术风险评估系统、体表面积和脑血管病史与主要不良心脑血管事件风险增加显著相关。

结论

常规使用 MCV 和 ESV 并选择不同的途径进行 TAVI 是可行的,可以治疗广泛的患者,总体手术成功率高,30 天和 6 个月的结果良好。

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