SAPIEN 3与SAPIEN XT经导管心脏瓣膜支架框架扩张的比较：使用多层计算机断层扫描进行评估

Comparison of SAPIEN 3 and SAPIEN XT transcatheter heart valve stent-frame expansion: evaluation using multi-slice computed tomography.

作者信息

Kazuno Yoshio, Maeno Yoshio, Kawamori Hiroyuki, Takahashi Nobuyuki, Abramowitz Yigal, Babak Hariri, Kashif Mohammad, Chakravarty Tarun, Nakamura Mamoo, Cheng Wen, Friedman John, Berman Daniel, Makkar Raj R, Jilaihawi Hasan

机构信息

Cedars-Sinai Medical Center, Heart Institute, Advanced Health Sciences Pavilion, 127 S. San Vicente Blvd, Third Floor, Suite A3414, Los Angeles, CA 90048, USA.

Cedars-Sinai Medical Center, Heart Institute, Advanced Health Sciences Pavilion, 127 S. San Vicente Blvd, Third Floor, Suite A3414, Los Angeles, CA 90048, USA

出版信息

Eur Heart J Cardiovasc Imaging. 2016 Sep;17(9):1054-62. doi: 10.1093/ehjci/jew032. Epub 2016 Mar 21.

AIMS

Stent-frame morphology of the newer-generation, balloon-expandable transcatheter heart valve (THV), the SAPIEN 3 (S3), after transcatheter aortic valve implantation (TAVI) is unknown. We evaluated the THV stent-frame morphology post TAVI of the S3 using multi-slice computed tomography (MSCT) compared with the prior-generation THV, SAPIEN XT (S-XT).

METHODS AND RESULTS

A total of 94 consecutive participants of RESOLVE registry (NCT02318342) had MSCT after balloon-expandable TAVI (S3 = 39 and S-XT = 55). The morphology of the THV stent-frame was evaluated for expansion area and eccentricity at the THV-inflow, native annulus, mid-THV and THV-outflow levels. Mean %-expansion area for the S3 and the S-XT was 100.9 ± 5.7 and 96.1 ± 5.5%, respectively (P < 0.001). In the S3 group, the THV-inflow level had the largest value of %-expansion area, which decreased from THV-inflow to mid-THV level (105.2 ± 6.4 to 96.5 ± 5.9%, P < 0.001). However, in the S-XT group, %-expansion area increased from THV-inflow level to mid-THV level (93.2 ± 6.2 to 95.1 ± 6.1%, P = 0.0058). On nominal delivery balloon volume, the S3 in 88.5% of cases had overexpansion at the THV-inflow level. The observed degree of THV oversizing of the S3 was significantly lower than the S-XT (6.3 ± 8.6 vs. 11.8 ± 8.5%, P = 0.0027). Nonetheless, the incidence of post-procedural paravalvular aortic regurgitation (PVR) ≥ mild following the S3 TAVI was also significantly lower than the S-XT TAVI (17.9 vs. 43.6%, P = 0.014).

CONCLUSION

The newer-generation, balloon-expandable device, the S3, has a flared inflow morphology, whereas the prior-generation device, the S-XT, has relatively constrained inflow morphology post TAVI. This may contribute to a lesser degree of PVR with the S3.

目的

新一代球囊扩张式经导管心脏瓣膜（THV）SAPIEN 3（S3）在经导管主动脉瓣植入术（TAVI）后的支架框架形态尚不清楚。我们使用多层计算机断层扫描（MSCT）评估了S3在TAVI后的THV支架框架形态，并与前代THV SAPIEN XT（S-XT）进行了比较。

方法和结果

RESOLVE注册研究（NCT02318342）的94名连续参与者在接受球囊扩张式TAVI后进行了MSCT检查（S3组 = 39例，S-XT组 = 55例）。在THV流入、天然瓣环、THV中部和THV流出水平评估THV支架框架的形态，包括扩张面积和偏心度。S3和S-XT的平均扩张面积百分比分别为100.9±5.7%和96.1±5.5%（P<0.001）。在S3组中，THV流入水平的扩张面积百分比最大，从THV流入到THV中部水平逐渐降低（105.2±6.4%至96.5±5.9%，P<0.001）。然而，在S-XT组中，扩张面积百分比从THV流入水平到THV中部水平增加（93.2±6.2%至95.1±6.1%，P = 0.0058）。在标称输送球囊体积下，88.5%的S3病例在THV流入水平出现过扩张。观察到的S3的THV过大尺寸程度明显低于S-XT（6.3±8.6%对11.8±8.5%，P = 0.0027）。尽管如此，S3 TAVI后≥轻度的术后瓣周主动脉反流（PVR）发生率也明显低于S-XT TAVI（17.9%对43.6%，P = 0.014）。