Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Cardiology, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.
Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E243-E253. doi: 10.1002/ccd.29678. Epub 2021 May 5.
This multicenter, prospective clinical study investigates whether the microelectromechanical-systems-(MEMS)-sensor pressure microcatheter (MEMS-PMC) is comparable to a conventional pressure wire in fractional flow reserve (FFR) measurement.
As a conventional tool for FFR measurement, pressure wires (PWs) still have some limitations such as suboptimal handling characteristics and unable to maintain the wire position during pullback assessment. Recently, a MEMS-PMC compatible with any 0.014″ guidewire is developed. Compared with the existing optical-sensor PMC, this MEMS-PMC has smaller profiles at both the lesion crossing and sensor packaging areas.
Two hundred and forty-two patients with visually 30-70% coronary stenosis were enrolled at four centers. FFR was measured first with the MEMS-PMC, and then with the PW. The primary endpoint was the Bland-Altman mean bias between the MEMS-PMC and PW FFR.
From the 224-patient per-protocol data, quantitative coronary angiography showed 17.9% and 55.9% vessels had diameter < 2.5 mm and stenosis >50%, respectively. The two systems' mean bias was -0.01 with [-0.08, 0.06] 95% limits-of-agreement. Using PW FFR≤0.80 as cutoff, the MEMS-PMC per-vessel diagnostic accuracy was 93.4% [95% confidence interval: 89.4-96.3%]. The MEMS-PMC's success rate was similar to that of PW (97.5 vs. 96.3%, p = .43) with no serious adverse event, and its clinically-significant (>0.03) drift rate was 43% less (9.5 vs. 16.7%, p = .014).
Our study showed the MEMS-PMC is safe to use and has a minimal bias equal to the resolution of current FFR systems. Given the MEMS-PMC's high measurement accuracy and rapid-exchange nature, it may become an attractive new tool facilitating routine coronary physiology assessment.
本多中心前瞻性临床研究旨在探讨微机电系统（MEMS）-传感器压力微导管（MEMS-PMC）在血流储备分数（FFR）测量方面是否可与传统压力导丝相媲美。
压力导丝（PW）作为FFR 的传统测量工具仍存在一些局限性，例如操作性能不理想，在回撤评估过程中无法保持导丝位置。最近，开发了一种与任何 0.014"导丝兼容的 MEMS-PMC。与现有的光学传感器 PMC 相比，这种 MEMS-PMC 在病变交叉和传感器封装区域的尺寸都更小。
在四个中心共纳入 242 例可视 30-70%冠状动脉狭窄的患者。首先使用 MEMS-PMC 测量 FFR，然后使用 PW 测量。主要终点是 MEMS-PMC 和 PW FFR 之间的 Bland-Altman 平均偏差。
根据 224 例符合方案患者的数据，定量冠状动脉造影显示 17.9%和 55.9%的血管直径<2.5mm 和狭窄>50%。两种系统的平均偏差为-0.01，95%一致性界限为[-0.08，0.06]。以 PW FFR≤0.80 为截断值，MEMS-PMC 每支血管的诊断准确性为 93.4%[95%置信区间：89.4-96.3%]。MEMS-PMC 的成功率与 PW 相似（97.5%比 96.3%，p=0.43），无严重不良事件，临床显著（>0.03）漂移率降低 43%（9.5%比 16.7%，p=0.014）。
我们的研究表明 MEMS-PMC 使用安全，偏差极小，与当前 FFR 系统的分辨率相当。鉴于 MEMS-PMC 具有较高的测量准确性和快速交换的特性，它可能成为一种有吸引力的新工具，有助于常规冠状动脉生理学评估。
