PDF(Pubmed)
Abstract：
BACKGROUND: Indocyanine green fluorescence angiography (ICG-FA) may reduce perfusion-related complications of gastrointestinal anastomosis. Software implementations for quantifying ICG-FA are emerging to overcome a subjective interpretation of the technology. Comparison between quantification algorithms is needed to judge its external validity. This study aimed to measure the agreement for visceral perfusion assessment between two independently developed quantification software implementations.
METHODS: This retrospective cohort analysis included standardized ICG-FA video recordings of patients who underwent esophagectomy with gastric conduit reconstruction between August 2020 until February 2022. Recordings were analyzed by two quantification software implementations: AMS and CPH. The quantitative parameter used to measure visceral perfusion was the normalized maximum slope derived from fluorescence time curves. The agreement between AMS and CPH was evaluated in a Bland-Altman analysis. The relation between the intraoperative measurement of perfusion and the incidence of anastomotic leakage was determined for both software implementations.
RESULTS: Seventy pre-anastomosis ICG-FA recordings were included in the study. The Bland-Altman analysis indicated a mean relative difference of + 58.2% in the measurement of the normalized maximum slope when comparing the AMS software to CPH. The agreement between AMS and CPH deteriorated as the magnitude of the measured values increased, revealing a proportional (linear) bias (R2 = 0.512, p < 0.001). Neither the AMS nor the CPH measurements of the normalized maximum slope held a significant relationship with the occurrence of anastomotic leakage (median of 0.081 versus 0.074, p = 0.32 and 0.041 vs 0.042, p = 0.51, respectively).
CONCLUSIONS: This is the first study to demonstrate technical differences in software implementations that can lead to discrepancies in ICG-FA quantification in human clinical cases. The possible variation among software-based quantification methods should be considered when interpreting studies that report quantitative ICG-FA parameters and derived thresholds, as there may be a limited external validity.
METHODS: This retrospective cohort analysis included standardized ICG-FA video recordings of patients who underwent esophagectomy with gastric conduit reconstruction between August 2020 until February 2022. Recordings were analyzed by two quantification software implementations: AMS and CPH. The quantitative parameter used to measure visceral perfusion was the normalized maximum slope derived from fluorescence time curves. The agreement between AMS and CPH was evaluated in a Bland-Altman analysis. The relation between the intraoperative measurement of perfusion and the incidence of anastomotic leakage was determined for both software implementations.
RESULTS: Seventy pre-anastomosis ICG-FA recordings were included in the study. The Bland-Altman analysis indicated a mean relative difference of + 58.2% in the measurement of the normalized maximum slope when comparing the AMS software to CPH. The agreement between AMS and CPH deteriorated as the magnitude of the measured values increased, revealing a proportional (linear) bias (R2 = 0.512, p < 0.001). Neither the AMS nor the CPH measurements of the normalized maximum slope held a significant relationship with the occurrence of anastomotic leakage (median of 0.081 versus 0.074, p = 0.32 and 0.041 vs 0.042, p = 0.51, respectively).
CONCLUSIONS: This is the first study to demonstrate technical differences in software implementations that can lead to discrepancies in ICG-FA quantification in human clinical cases. The possible variation among software-based quantification methods should be considered when interpreting studies that report quantitative ICG-FA parameters and derived thresholds, as there may be a limited external validity.
摘要：
背景：吲哚菁绿荧光血管造影术（ICG-FA）可以减少胃肠道吻合的灌注相关并发症。用于量化ICG-FA的软件实现正在出现，以克服对技术的主观解释。需要对量化算法进行比较以判断其外部有效性。本研究旨在衡量两个独立开发的量化软件实现之间内脏灌注评估的一致性。
方法：这项回顾性队列分析包括2020年8月至2022年2月期间接受食道切除术和胃导管重建的患者的标准化ICG-FA视频记录。通过两个定量软件实现:AMS和CPH来分析记录。用于测量内脏灌注的定量参数是从荧光时间曲线得出的归一化最大斜率。在Bland-Altman分析中评估了AMS和CPH之间的一致性。对于两种软件实现，均确定了术中灌注测量与吻合口漏发生率之间的关系。
结果：本研究包括70个吻合前ICG-FA记录。Bland-Altman分析表明,当将AMS软件与CPH进行比较时,归一化最大斜率的测量值的平均相对差异为+58.2%。AMS和CPH之间的一致性随着测量值的大小增加而恶化，揭示比例(线性)偏差(R2=0.512，p<0.001)。归一化最大斜率的AMS和CPH测量值与吻合口漏的发生都没有显着关系（中位数分别为0.081对0.074，p=0.32和0.041对0.042，p=0.51）。
结论：这是第一项证明软件实现技术差异的研究，这些差异可能导致人类临床病例中ICG-FA定量的差异。在解释报告定量ICG-FA参数和导出阈值的研究时，应考虑基于软件的量化方法之间的可能差异，因为外部有效性可能有限。
方法：这项回顾性队列分析包括2020年8月至2022年2月期间接受食道切除术和胃导管重建的患者的标准化ICG-FA视频记录。通过两个定量软件实现:AMS和CPH来分析记录。用于测量内脏灌注的定量参数是从荧光时间曲线得出的归一化最大斜率。在Bland-Altman分析中评估了AMS和CPH之间的一致性。对于两种软件实现，均确定了术中灌注测量与吻合口漏发生率之间的关系。
结果：本研究包括70个吻合前ICG-FA记录。Bland-Altman分析表明,当将AMS软件与CPH进行比较时,归一化最大斜率的测量值的平均相对差异为+58.2%。AMS和CPH之间的一致性随着测量值的大小增加而恶化，揭示比例(线性)偏差(R2=0.512，p<0.001)。归一化最大斜率的AMS和CPH测量值与吻合口漏的发生都没有显着关系（中位数分别为0.081对0.074，p=0.32和0.041对0.042，p=0.51）。
结论：这是第一项证明软件实现技术差异的研究，这些差异可能导致人类临床病例中ICG-FA定量的差异。在解释报告定量ICG-FA参数和导出阈值的研究时，应考虑基于软件的量化方法之间的可能差异，因为外部有效性可能有限。
