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基于手动血流储备分数回撤得出的回撤压力梯度(PPG)的开发、验证及可重复性研究

Development, validation, and reproducibility of the pullback pressure gradient (PPG) derived from manual fractional flow reserve pullbacks.

作者信息

Sonck Jeroen, Mizukami Takuya, Johnson Nils P, Nagumo Sakura, Gallinoro Emanuele, Candreva Alessandro, Mileva Niya, Munhoz Daniel, Shinke Toshiro, Svanerud Johan, Barbato Emanuele, De Bruyne Bernard, Collet Carlos

机构信息

Department of Cardiology, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium.

Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy.

出版信息

Catheter Cardiovasc Interv. 2022 Apr;99(5):1518-1525. doi: 10.1002/ccd.30064. Epub 2022 Mar 2.

Abstract

Fractional flow reserve (FFR) pullbacks assess the location and magnitude of pressure drops along the coronary artery. The pullback pressure gradient (PPG) quantifies the FFR pullback curve and provides a numeric expression of focal versus diffuse coronary artery disease. This study aims (1) to validate the PPG using manual FFR pullbacks compared with motorized FFR pullbacks as a reference; and (2) to determine the intra- and interoperator reproducibility of the PPG derived from manual FFR pullbacks. Patients with stable coronary artery disease and an FFR ≤ 0.80 were included. All patients underwent FFR pullback evaluation either with a motorized device or manually, depending on the study cohort. The agreement of the PPG between repeated pullbacks was assessed using the Bland-Altman method. Overall, 116 FFR pullback maneuvers (96 manual and 20 motorized) were analyzed. There was excellent agreement between the PPG derived from manual and motorized pullbacks (mean difference -0.01 ± 0.07, 95% limits of agreement [LOA] -0.14 to 0.12). The intra- and interoperator reproducibility of PPG derived from manual pullbacks were excellent (mean difference <0.01, 95% LOA -0.11 to 0.12, and mean difference <0.01, 95% LOA -0.12 to 0.11, respectively). The duration of the pullback maneuver did not impact the reproducibility of the PPG (r = 0.12, 95% CI: -0.29 to 0.49, p = 0.567). Manual pullbacks allow for an accurate PPG calculation. The inter- and intraoperator reproducibility of PPG derived from manual pullbacks were excellent.

摘要

血流储备分数(FFR)回撤评估冠状动脉沿线压力降的位置和大小。回撤压力梯度(PPG)对FFR回撤曲线进行量化,并提供局灶性与弥漫性冠状动脉疾病的数值表达。本研究旨在:(1)以电动FFR回撤作为参考,验证手动FFR回撤时PPG的情况;(2)确定手动FFR回撤得出的PPG在操作者内和操作者间的可重复性。纳入稳定型冠状动脉疾病且FFR≤0.80的患者。根据研究队列,所有患者均使用电动设备或手动进行FFR回撤评估。使用Bland-Altman方法评估重复回撤时PPG的一致性。总体而言,分析了116次FFR回撤操作(96次手动和20次电动)。手动和电动回撤得出的PPG之间具有极好的一致性(平均差异-0.01±0.07,95%一致性界限[LOA]-0.14至0.12)。手动回撤得出的PPG在操作者内和操作者间的可重复性均极佳(平均差异<0.01,95%LOA-0.11至0.12,以及平均差异<0.01,95%LOA-0.12至0.11)。回撤操作的持续时间不影响PPG的可重复性(r=0.12,95%CI:-0.29至0.49,p=0.567)。手动回撤可实现准确的PPG计算。手动回撤得出的PPG在操作者间和操作者内的可重复性均极佳。

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