压力微导管对血流储备分数测定准确性的随机对照研究  

A Randomized Controlled Study of the Accuracy of Pressure Microcatheters for Fractional Blood Flow Reserve Measurement

作　　者：蒋盛林 陈雯雯 李晨[1] 贺勇[1] 王华[1] Jiang Shenlin;Chen Wenwen;Li Cheng(Department of Cardiology,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China)

机构地区：[1]四川大学华西医院心脏内科,四川成都610041

出　　处：《四川医学》2024年第1期23-27,共5页Sichuan Medical Journal

摘　　要：目的探究压力微导管(PMC)在血流储备分数(FFR)测量方面的准确性及明确其是否比压力导丝(PW)的测量操作更方便快捷。方法前瞻性纳入38例慢性冠脉综合征的患者,将其1∶1随机分为甲、乙两组。乙组使用PMC为试验器械,甲组使用PW为对照器械。甲组先行PW的FFR测量,后在同一位置行PMC的FFR测量;乙组行相反测量顺序(先PMC后PW);主要终点指标为压力微导管在FFR测量方面的准确性,通过分析压力微导管测量的FFR(FFRpmc)与压力导丝测量的FFR(FFPpw)的平均偏差获得。次要终点指标包括通过测量操作时间、通过率和测量成功率验证的器械操作便捷性。结果乙组的测量均值为(0.77±0.11),甲组的测量均值为(0.76±0.11),两组检测结果间的平均偏差为0.005,95%一致性界限为[-0.068,0.078];两组成功率和通过率的差异无统计学意义(P=0.31和P=0.32);而乙组的测量耗时均值为(290±40)s,显著低于甲组(441±41)s,差异具有统计学意义(P<0.001)。结论压力微导管对FFR的测定与压力导丝有非常好的测量一致性,具且有测量耗时短,操控和使用更便捷的优点。Objective To explore the accuracy of pressure microcatheter(PMC)in the measurement of fractional flow reserve(FFR)by using pressure wire(PW)as a standard reference and find the difference on measurement convenient between two devices.Methods 38 patients with chronic coronary syndrome were included prospectively and randomly divided 1∶1 into group A and B.Test device was pressure microcatheter(PMC),while control device was pressure wire(PW).FFR was measured first with PMC,and then with PW at the same position in group A and with the reverse measurement order in group B(PW before PMC).Primary endpoint was the accuracy of the pressure microcatheter in FFR measurement,obtained by the Bland–Altman mean bias between FFR measured by the pressure microcatheter(FFRpmc)and the FFR measured by the pressure wire(FFPpw).Secondary endpoints included the operate time,cross rate,and measurement success rate,which indicated the measurement convenient.Results Mean values of group B and group A were(0.77±0.11)and(0.76±0.11),respectively,with a mean bias of 0.005 and a 95%limits-of-agreement of[-0.068,0.078].There was no significant difference in the device success rate and cross rate between the two groups(P=0.31 and P=0.32,respectively).However,the mean operate time of test device was(290±40)s,which was significantly lower than that of control device(441±41)s(P<0.001).Conclusion There would be a high consistency between the FFR measurement of the pressure microcatheter and pressure wire,and it has superiority on measurement with the shorter operate time than pressure wires.

关 键 词：血流储备分数(FFR) 压力微导管 头对头研究 

分 类 号：R541.4[医药卫生—心血管疾病]