Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA.
Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
J Cardiovasc Electrophysiol. 2023 Nov;34(11):2225-2232. doi: 10.1111/jce.16061. Epub 2023 Sep 13.
The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score.
We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis.
A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001).
The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.
在经导管主动脉瓣置换术（TAVR）后，需要植入起搏器是常见的并发症。我们之前描述了埃默里风险评分（ERS），以预测 TAVR 后是否需要植入新的起搏器（PPM）。评分中包含的指标包括晕厥史、预先存在的右束支阻滞、QRS 持续时间≥140ms 和假体过大≥16%。本研究旨在前瞻性验证之前描述的风险评分。
我们前瞻性评估了 2019 年 3 月至 2020 年 12 月在我院接受爱德华兹 SAPIEN 3 假体 TAVR 治疗且无先前起搏器、ICD 或起搏指征的所有患者（n=661）。患者进行前瞻性评分；然而，评分结果对临床决策是盲态的。主要终点是 TAVR 后 30 天 PPM。使用逻辑回归、与先前性能的校准曲线和接受者操作特征（ROC）分析来评估 ERS 的性能。
共有 48 名患者（7.3%）在 TAVR 后植入了 PPM。更高的 ERS 预测 PPM 的可能性增加（OR 2.61，95%CI：每点 2.05-3.25，p<0.001）。校准曲线的观察值和预期值之间存在良好的相关性（斜率=1.04，校准度大=0.001）。ROC 曲线下面积为 0.81（95%CI [0.74-0.88]，p<0.001）。
ERS 前瞻性地预测了一系列接受球囊扩张型假体 TAVR 的患者中 PPM 的需求，证实了先前在回顾性队列中描述的发现。值得注意的是，评分的前瞻性性能与最初队列的性能相当。风险评分可作为 TAVR 后 PPM 术前风险分层的框架。
