St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.
CHU Bordeaux, Bordeaux, France.
Catheter Cardiovasc Interv. 2023 Aug;102(2):318-327. doi: 10.1002/ccd.30752. Epub 2023 Jun 24.
Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models.
This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI.
Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process.
Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%.
MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device.
经导管二尖瓣置换术（TMVI）是一种治疗有症状的二尖瓣疾病的新疗法。评估患者的解剖学适用性是 TMVI 筛选过程中的关键步骤，但目前需要专门的软件和计算机设备模型。
本分析旨在评估简单且标准化的多层 CT（MSCT）解剖测量在区分通过 Tendyne™TMVI 解剖筛选的患者方面的有效性。
从 2016 年 1 月至 2019 年 9 月，筛选参加 Tendyne 扩大临床研究的患者。核心实验室筛选测量包括收缩末期和舒张末期的二尖瓣环（MA）尺寸、模拟设备植入和新左心室流出道（LVOT）面积。此外，还评估了患者解剖结构的 9 项标准测量值，以评估其对患者通过解剖筛选过程的预测价值。
在筛选出的 496 名符合条件的患者中，257 名患者的 MA 尺寸符合制造商建议的范围，符合临床入选标准：153 名（59.5%）接受 TMVI，而 104 名（40.5%）因其他解剖原因被排除在研究之外（76%因 LVOT 阻塞风险）。CT 衍生的左心室收缩末期直径（LVESD）对预测 TMVI 解剖学适宜性具有最高的区分能力（曲线下面积为 0.908，p<0.0001）。二尖瓣间室（IC）尺寸对 MA 尺寸在范围内的预测最佳，尺寸<30 或>50mm 导致阴性预测值为 94.4%。
MSCT 衍生的二尖瓣 IC 尺寸和 LVESD 是一种简单且易于操作的方法，可有效预测基于系绳的 TMVI 设备的解剖学适宜性或筛选失败。
