Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
EuroIntervention. 2018 Dec 20;14(12):e1269-e1275. doi: 10.4244/EIJ-D-18-00281.
The aim of this study was to assess the performance of a self-expanding valve in bicuspid aortic valve (BAV) stenosis.
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.
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.
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。
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。
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。