Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany.
Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany.
JACC Cardiovasc Interv. 2016 Apr 25;9(8):805-813. doi: 10.1016/j.jcin.2015.12.023. Epub 2016 Mar 23.
The aim of this study was to analyze the pacemaker implantation rate (PMIR) with the new balloon-expandable Edwards SAPIEN 3 valve (S3) and the factors associated with it.
The introduction of the S3 for transcatheter aortic valve replacement (TAVR) has led to a reduction in paravalvular regurgitation. There are, however, concerns that the new design may increase the PMIR.
The first 206 patients treated with the S3 were compared with 371 preceding patients treated with SAPIEN XT valves. Patients who previously underwent pacemaker or implantable cardioverter defibrillator implantation or transapical and valve-in-valve procedures were excluded from the analysis. All patients were monitored for at least 7 days. Previous and new conduction abnormalities were documented, and prosthesis implantation height was assessed for the S3.
There were no significant differences in baseline characteristics between groups. The PMIR was, however, significantly higher for the S3 (19.1% vs. 12.2%; p = 0.046). The mean implantation height was significantly lower in patients requiring PMI (67%/33% vs. 72%/28% aortic/ventricular stent extension, p = 0.032). On multivariate regression analysis, implantation height was the only independent predictor of PMI (odds ratio: 0.94 [95% confidence interval: 0.90 to 0.99]; p = 0.009). It increased from 68%/32% to 75%/25% when comparing the first with the second half of S3 implantations (p < 0.0001). This change was associated with a significant decrease in PMIR from 25.9% to 12.3% (p = 0.028), no longer different from the XT valve (12.2%).
The PMIR after TAVR is higher with the S3 than with the XT and is independently associated with the implantation height. This increase in the PMIR may be avoided by intending an aortic stent extension >70%.
本研究旨在分析新型球囊扩张式 Edwards SAPIEN 3 瓣膜（S3）的起搏器植入率（PMIR）及其相关因素。
S3 被引入经导管主动脉瓣置换术（TAVR）后，瓣周漏的发生率有所降低。然而，人们担心新设计可能会增加 PMIR。
对 206 例接受 S3 治疗的患者与 371 例接受 SAPIEN XT 瓣膜治疗的患者进行比较。排除先前接受起搏器或植入式心律转复除颤器植入、经心尖和瓣中瓣手术的患者。所有患者均至少监测 7 天。记录先前和新出现的传导异常，并评估 S3 的假体植入高度。
两组患者的基线特征无显著差异。然而，S3 的 PMIR 明显更高（19.1%比 12.2%；p = 0.046）。需要 PMI 的患者的平均植入高度明显较低（67%/33%比 72%/28%主动脉/心室支架延伸，p = 0.032）。多元回归分析显示，植入高度是 PMI 的唯一独立预测因素（优势比：0.94[95%置信区间：0.90 至 0.99]；p = 0.009）。将 S3 的第一次和第二次植入进行比较时，植入高度从 68%/32%增加到 75%/25%（p < 0.0001）。这一变化与 PMIR 从 25.9%显著下降至 12.3%（p = 0.028）相关，与 XT 瓣膜（12.2%）无差异。
与 XT 瓣膜相比，S3 行 TAVR 后的 PMIR 更高，且与植入高度独立相关。通过植入主动脉支架延伸>70%，可避免 PMIR 增加。
