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使用单轨压力导管评估冠状动脉血流储备分数:首例人体ACCESS-NZ试验

Assessment of coronary fractional flow reserve using a monorail pressure catheter: the first-in-human ACCESS-NZ trial.

作者信息

Menon Madhav, Jaffe Warwick, Watson Tim, Webster Mark

机构信息

Cardiology Department, Waikato Hospital, Hamilton, New Zealand.

出版信息

EuroIntervention. 2015 Jul;11(3):257-63. doi: 10.4244/EIJV11I3A51.

DOI:10.4244/EIJV11I3A51
PMID:26196752
Abstract

AIMS

FFR measurements have been limited by the handling characteristics of pressure wire (PW) systems, and by signal drift. This first-in-human study evaluated the safety and efficacy of a new monorail catheter (Navvus) to assess coronary FFR, compared to a PW system.

METHODS AND RESULTS

Resting measurements were acquired with both systems. After initiating IV adenosine, FFR was measured with the PW alone, simultaneously using both systems, and again with PW alone. Any zero offset of PW or Navvus was then recorded. Navvus measured FFR in all patients in whom a PW recording was obtained (50 of 58 patients); there were no complications related to Navvus. Navvus FFR correlated well with PW FFR (r=0.87, slope 1.0, intercept -0.02). Within PW measurement accuracy, in no cases did Navvus FFR classify lesion significance differently from PW FFR. PW signal drift was significantly greater than Navvus (0.06±0.12 vs. 0.02±0.02, p=0.014).

CONCLUSIONS

Navvus and PW FFR correlated well. Navvus had less sensor drift. This new catheter-based system offers an alternative method for measuring FFR, with some potential advantages over PW.

摘要

目的

血流储备分数(FFR)测量受压力导丝(PW)系统的操作特性及信号漂移的限制。本首次人体研究评估了一种新型单轨导管(Navvus)与PW系统相比,用于评估冠状动脉FFR的安全性和有效性。

方法与结果

两个系统均进行静息测量。静脉注射腺苷后,先单独使用PW测量FFR,然后同时使用两个系统测量,之后再单独使用PW测量。随后记录PW或Navvus的任何零偏移。Navvus在所有获得PW记录的患者中均测量了FFR(58例患者中的50例);未发生与Navvus相关的并发症。Navvus测量的FFR与PW测量的FFR相关性良好(r = 0.87,斜率1.0,截距 -0.02)。在PW测量精度范围内,Navvus测量的FFR对病变严重程度的分类与PW测量的FFR在任何情况下均无差异。PW的信号漂移显著大于Navvus(0.06±0.12对0.02±0.02,p = 0.014)。

结论

Navvus与PW测量的FFR相关性良好。Navvus的传感器漂移较小。这种基于导管的新系统为测量FFR提供了一种替代方法,相对于PW具有一些潜在优势。

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