Cedars-Sinai Heart Institute, Los Angeles, California.
Cedars-Sinai Heart Institute, Los Angeles, California.
JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.
This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards Lifesciences, Irvine, California) transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calcification in the aortic-valvular complex (AVC).
The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon expandable valve TAVR.
At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC was characterized precisely by leaflet sector and region.
The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length, and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities were generated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the model for PPMI was area under the curve of 0.88, sensitivity of 77.1%, and specificity of 87.1%; this risk model had high negative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with the parameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92, sensitivity to 94.3%, specificity to 83.8%, and negative predictive value to 98.8% CONCLUSIONS: By using a precise characterization of distribution of calcification in the AVC in a single-center, retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon expandable valve TAVR. The findings also reinforce the importance of short MS length, pre-existing RBBB, and ventricular implantation depth as important synergistic PPMI risk factors. This risk model will need validation by future prospective multicenter studies.
本研究旨在开发一种稳健且明确的新永久起搏器植入（PPMI）风险模型，用于经第三代球囊扩张瓣膜（爱德华生命科学公司，加利福尼亚州欧文市）经导管主动脉瓣置换术（第三代球囊扩张瓣膜 TAVR）后发生的 SAPIEN 3（第三代球囊扩张瓣膜）（爱德华生命科学公司，加利福尼亚州欧文市），包括主动脉瓣复合体（AVC）中的钙化。
第三代球囊扩张瓣膜 TAVR 后，AVC 中的钙与 PPMI 之间的关系尚未明确。
在加利福尼亚州洛杉矶的雪松西奈心脏研究所，共有 240 名严重主动脉瓣狭窄患者接受了第三代球囊扩张瓣膜 TAVR 并进行了对比计算机断层扫描。通过叶瓣扇区和区域精确地描述了 AVC。
总新发 PPMI 率为 14.6%。在 PPMI 的预测因素的多变量分析中，包括术前第三代球囊扩张瓣膜 TAVR、右束支传导阻滞（RBBB）、较短的膜间隔（MS）长度和非冠状动脉瓣装置着陆区钙体积（NCC-DLZ CA）。使用此逻辑回归模型生成预测概率。如果存在 3 个术前危险因素，则该模型对 PPMI 的 C 统计量为 0.88，敏感性为 77.1%，特异性为 87.1%；该风险模型具有较高的阴性预测值（95.7%）。将手术因素设备深度添加到模型中，同时添加植入深度与 MS 长度之间的差值参数，再加上 RBBB 和 NCC-DLZ CA，可将 C 统计量提高到 0.92，敏感性提高到 94.3%，特异性提高到 83.8%，阴性预测值提高到 98.8%。
通过使用单中心回顾性研究中对 AVC 中钙化分布的精确描述，发现 NCC-DLZ CA 是第三代球囊扩张瓣膜 TAVR 后新发 PPMI 的独立预测因子。研究结果还强调了短 MS 长度、预先存在的 RBBB 和心室植入深度作为重要的协同 PPMI 风险因素的重要性。该风险模型需要通过未来的前瞻性多中心研究进行验证。
