Unit of Interventional Cardiology, Department of Cardiothoracic Surgery, IRCCS-ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), UPMC, Palermo, Italy.
Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.
EuroIntervention. 2023 Apr 24;18(17):1418-1427. doi: 10.4244/EIJ-D-22-01022.
Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce.
We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3).
The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year.
The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups.
Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.
新一代 SAPIEN 3 Ultra（S3U）瓣膜的初步数据非常有前景。然而，关于 S3U 的长期性能和安全性的数据很少。
我们旨在研究经股动脉主动脉瓣置换术（TAVI）中使用 S3U 与前代 SAPIEN 3 瓣膜（S3）相比的 1 年临床和超声心动图结果。
SAPIEN 3 Ultra 注册研究纳入了 2016 年 10 月至 2020 年 12 月期间在 12 个欧洲中心接受经股动脉 TAVI 治疗的连续患者，使用 S3U 或 S3。采用 1:1 倾向评分（PS）匹配来考虑基线特征的差异。主要研究终点为 1 年时全因死亡和全因死亡、致残性中风和心力衰竭住院的复合终点。
总研究队列包括 1692 例患者，其中 S3U 组 519 例，S3 组 1173 例。PS 匹配后共有 992 例患者（每组 496 例）。1 年时，S3U 组的全因死亡率为 4.9%，S3 组为 6.3%（p=0.743）。同样，S3 组和 S3U 组的主要复合终点发生率也无显著差异（S3 组为 9.5%，S3U 组为 6.6%；p=0.162）。与 S3 相比，S3U 与较低的轻度瓣周漏（PVL）发生率相关（比值比 0.63，95%置信区间：0.44 至 0.88；p<0.01）。两组之间的跨瓣梯度无显著差异。
与 S3 相比，S3U 经导管心脏瓣膜的 1 年临床结果相似，但轻度 PVL 发生率较低。
