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多中心倾向性匹配研究:比较使用 ACURATE TA/neo 自膨式和 SAPIEN 3 球囊扩张式经导管主动脉瓣置换术。

Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis.

机构信息

Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt a. d. Saale, Germany.

出版信息

EuroIntervention. 2019 Nov 20;15(10):884-891. doi: 10.4244/EIJ-D-18-01120.

Abstract

AIMS

In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching.

METHODS AND RESULTS

From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2).

CONCLUSIONS

In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

摘要

目的

由于缺乏随机数据,我们旨在使用倾向评分匹配比较经心尖的 ACURATE 和经股动脉的 ACURATE neo 与 SAPIEN 3 假体。

方法和结果

2012 年至 2016 年,在德国的三个中心,共有 1306 名患者接受了 ACURATE/ACURATE neo 假体(n=591)或 SAPIEN 3 假体(n=715)。通过对于入路和中心的精确分配的最近邻匹配,每组确定了 329 名患者(250 名经股动脉,79 名经心尖)的配对。患者平均年龄为 81 岁,logistic EuroSCORE I 为 19%。预扩张和后扩张在 ACURATE 组更为常见(97.6%对 52.1%,p<0.001 用于预扩张,40.4%对 11.6%,p<0.001 用于后扩张),但植入时快速起搏使用较少(37.1%对 98.2%,p<0.001)。术后超声心动图检查显示,ACURATE 组中超过轻度主动脉瓣反流的比例为 12.0%,SAPIEN 组为 3.1%,p≤0.001。ACURATE 组中的超过轻度主动脉瓣反流在中心之间存在差异,中心 A 为 6.0%(3/50),中心 B 为 34.1%(29/85),中心 C 为 3.4%(6/181)。与 SAPIEN 3 组相比,ACURATE 组中接受起搏器植入的患者较少(11.9%对 18.5%,p=0.020),30 天死亡率分别为 4.6%和 2.1%,p=0.134,一年生存率分别为 83.1%(95%CI:77.6-87.4)和 88.8%(95%CI:84.0-92.2)。

结论

在这项倾向评分分析中,经心尖的 ACURATE 或经股动脉的 ACURATE neo 假体治疗的患者在 30 天时更少有起搏器,但有更多的主动脉瓣反流和较低的一年生存率。

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