Tarantini Giuseppe, Mojoli Marco, Purita Paola, Napodano Massimo, D'Onofrio Augusto, Frigo Annachiara, Covolo Elisa, Facchin Michela, Isabella Giambattista, Gerosa Gino, Iliceto Sabino
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy.
EuroIntervention. 2015 Jul;11(3):343-50. doi: 10.4244/EIJY14M11_06.
Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate.
Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group.
The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.
关于爱德华 Sapien 3 瓣膜（S3-THV）的早期数据显示瓣周漏和血管并发症发生率较低，但 30 天永久起搏器植入（PPMI）率相对较高。目前尚无 S3-THV 与爱德华 Sapien XT（XT-THV）在包括 PPMI 率在内的临床结局方面的直接比较。我们旨在比较接受这两种假体治疗患者的 30 天 PPMI 率，并评估瓣膜类型、植入深度与 PPMI 率之间的相互作用。
纳入 209 例接受经导管主动脉瓣置换术（TAVI）治疗的患者。总体而言以及在根据 PPMI 的多个预测因素匹配的亚组中，S3-THV 的 PPMI 率均高于 XT-THV。然而，在 S3-THV 组中，30 天 PPMI 与瓣膜深度植入密切相关，高植入深度 S3-THV 的 PPMI 风险与总体 XT-THV 匹配组相似。S3-THV 组未观察到明显瓣周漏病例。
与 XT-THV 相比，S3-THV 的 PPMI 发生率更高。在 S3-THV 组中，起搏器植入与瓣膜深度植入密切相关。一种涉及将中心标记初始放置位置更高（在主动脉瓣叶基部上方 0 至 3 毫米）从而使最终瓣膜深度更高的植入技术，可能有助于预防 TAVI 术后 S3-THV 相关的 PPMI，同时不影响瓣周漏风险。
