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经导管主动脉瓣植入术(TAVI)使用 ACURATE neo 在二叶式和三叶式主动脉瓣狭窄中的应用:一项来自欧洲经验的倾向评分匹配分析。

Transcatheter aortic valve implantation using the ACURATE neo in bicuspid and tricuspid aortic valve stenosis: a propensity-matched analysis of a European experience.

机构信息

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

出版信息

EuroIntervention. 2018 Dec 20;14(12):e1269-e1275. doi: 10.4244/EIJ-D-18-00281.

Abstract

AIMS

The aim of this study was to assess the performance of a self-expanding valve in bicuspid aortic valve (BAV) stenosis.

METHODS AND RESULTS

An international registry included a total of 712 patients with aortic stenosis treated with the ACURATE neo in bicuspid (n=54; 7.5%) or tricuspid (n=658; 92.4%) anatomy. The overall mean age was 81±5.6 years. At baseline, no significant differences were found between the two groups. BAV more frequently required both predilatation (94.4% vs. 78.1%, p=0.004) and post-dilation (57.4% vs. 38.7%, p=0.007). Moderate perivalvular regurgitation was more frequently found in patients with BAV (7.4% vs. 3.18%, p=0.0001). After propensity score matching (PSM), the rate of predilation and post-dilation was confirmed to be higher in the BAV group (94.4% vs. 66.6%, p=0.001, and 57.4% vs. 37.1%, p=0.034, respectively), while the incidence of moderate perivalvular regurgitation was similar between the two groups (BAV 3.1% vs. 5.5% in tricuspid anatomy, p=0.734). In unmatched cohorts, the 30-day outcome showed a higher rate of stroke in the BAV group (7.4% vs. 1.8%, p=0.001). After adjustment for PSM quintiles, the rate of stroke resulted in being similar (odds ratioadj 1.20, 95% confidence interval [CI]: 0.81-1.76, p=0.819). The other 30-day clinical endpoints were similar between the two populations.

CONCLUSIONS

This preliminary analysis shows that the use of the ACURATE neo in bicuspid aortic valves is feasible and has acceptable 30-day outcomes. Larger studies are needed to confirm our preliminary findings.

摘要

目的

本研究旨在评估自膨式瓣膜在二叶式主动脉瓣(BAV)狭窄中的性能。

方法和结果

一项国际注册研究共纳入 712 例接受 ACURATE neo 治疗的主动脉瓣狭窄患者,其中二叶式(n=54;7.5%)或三叶式(n=658;92.4%)解剖结构。总体平均年龄为 81±5.6 岁。在基线时,两组之间没有发现显著差异。BAV 更常需要预扩张(94.4%比 78.1%,p=0.004)和后扩张(57.4%比 38.7%,p=0.007)。BAV 患者更常出现中度瓣周反流(7.4%比 3.18%,p=0.0001)。在进行倾向评分匹配(PSM)后,BAV 组的预扩张和后扩张率仍较高(94.4%比 66.6%,p=0.001,57.4%比 37.1%,p=0.034),而两组中度瓣周反流发生率相似(BAV 3.1%比三叶式解剖结构的 5.5%,p=0.734)。在未匹配队列中,BAV 组 30 天的卒中发生率更高(7.4%比 1.8%,p=0.001)。调整 PSM 五分位数后,卒中发生率相似(调整比值比 1.20,95%置信区间[CI]:0.81-1.76,p=0.819)。两组的其他 30 天临床终点相似。

结论

本初步分析表明,在二叶式主动脉瓣中使用 ACURATE neo 是可行的,且 30 天结果可接受。需要更大规模的研究来证实我们的初步发现。

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