Nakashima Makoto, Watanabe Yusuke, Hioki Hirofumi, Nara Yugo, Nagura Fukuko, Hosogoe Naoyoshi, Kawashima Hideyuki, Kataoka Akihisa, Otsuki Shuji, Konno Kumiko, Kyono Hiroyuki, Yokoyama Naoyuki, Kozuma Ken
Department of Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-0003, Japan.
Cardiovasc Interv Ther. 2018 Oct;33(4):384-390. doi: 10.1007/s12928-017-0502-9. Epub 2017 Nov 28.
We aimed to compare the efficacy and safety of transcatheter aortic valve implantation (TAVI) using Edwards SAPIEN 3 (S3) valve and SAPIEN XT) in smaller anatomy. The new generation S3 TAVI device has been used worldwide; however, its efficacy and safety in smaller Asian anatomy remain unknown. Between February 2014 and March 2017, 166 consecutive patients (S3, 54; XT, 112) were treated with balloon-expandable TAVI in a single center and their outcomes were analyzed. Median patient age was 85 (range: 81-88) years and mean body surface area was 1.41 ± 0.15 m. A 23-mm size valve was used in S3 and XT groups (70 vs. 62%, p = 0.224). The transfemoral approach was more frequently used in the S3 than in the XT group (96 vs. 72%, p < 0.001). Although, the minimal luminal diameter of the femoral artery was smaller in the S3 group (5.9 vs. 6.4 mm, p = 0.001), the rates of major (2 vs. 11%, p = 0.226) and minor (11 vs. 5%, p = 0.107) vascular complications did not increase. The frequency of paravalvular leaks (PVL) ≥ 2 was significantly reduced in the S3 group (11 vs. 61%, p < 0.001); however, pre- (24 vs. 91%, p < 0.001) and post- (4 vs. 19%, p < 0.001) dilatations were less frequently performed. Pacemaker implantation incidence did not increase (4 vs. 5%, p = 1.0) and peak velocity of the transcatheter heart valve was significantly higher in the S3 group (2.3 vs. 2.2 m/s, p = 0.046). Device success was high (89 vs. 93%, p = 0.387) while the 30-day all-cause mortality was low (2 vs. 1%, p = 0.583) in both groups. TAVI with the S3 device was safe and effective, with low incidence of vascular complications and reduced PVL, in smaller body-sized Asians.
我们旨在比较使用爱德华兹SAPIEN 3（S3）瓣膜和SAPIEN XT瓣膜进行经导管主动脉瓣植入术（TAVI）在较小解剖结构中的疗效和安全性。新一代S3 TAVI装置已在全球范围内使用；然而，其在较小亚洲人解剖结构中的疗效和安全性仍不清楚。在2014年2月至2017年3月期间，166例连续患者（S3组54例；XT组112例）在单一中心接受了球囊扩张式TAVI治疗，并对其结果进行了分析。患者中位年龄为85岁（范围：81 - 88岁），平均体表面积为1.41±0.15平方米。S3组和XT组均使用23毫米尺寸的瓣膜（70%对62%，p = 0.224）。S3组经股动脉途径的使用频率高于XT组（96%对72%，p < 0.001）。尽管S3组股动脉的最小管腔直径较小（5.9毫米对6.4毫米，p = 0.001），但严重（2%对11%，p = 0.226）和轻微（11%对5%，p = 0.107）血管并发症的发生率并未增加。S3组中≥2级瓣周漏（PVL）的频率显著降低（11%对61%，p < 0.001）；然而，预扩张（24%对91%，p < 0.001）和后扩张（4%对19%，p < 0.001）的操作频率较低。起搏器植入发生率没有增加（4%对5%，p = 1.0），且S3组经导管心脏瓣膜的峰值速度显著更高（2.3米/秒对2.2米/秒，p = 0.046）。两组的器械成功率都很高（89%对93%，p = 0.387），而30天全因死亡率都很低（2%对1%，p = 0.583）。对于体型较小的亚洲人，使用S3装置进行TAVI是安全有效的，血管并发症发生率低且PVL减少。
