Assessment of Retinopathy of Prematurity Regression and Reactivation Using an Artificial Intelligence-Based Vascular Severity Score.

Assessment of Retinopathy of Prematurity Regression and Reactivation Using an Artificial Intelligence-Based Vascular Severity Score.
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DOI:
10.1001/jamanetworkopen.2022.51512
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发表时间:
2023-01-03
期刊:
影响因子:
13.8
通讯作者:
Stahl, Andreas
Stahl, Andreas
中科院分区:
医学1区
文献类型:
--
作者:
Eilts, Sonja K.;Pfeil, Johanna M.;Poschkamp, Broder;Krohne, Tim U.;Eter, Nicole;Barth, Teresa;Guthoff, Rainer;Lagreze, Wolf;Grundel, Milena;Bruender, Marie-Christine;Busch, Martin;Kalpathy-Cramer, Jayashree;Chiang, Michael F.;Chan, R. V. Paul;Coyner, Aaron S.;Ostmo, Susan;Campbell, J. Peter;Stahl, Andreas

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基于人工智能的血管严重程度评分(VSS)能否用于分析抗血管内皮生长因子(VEGF)治疗后早产儿视网膜病变的消退和再激活?在这项对19名早产儿视网膜病变婴儿进行的预后研究中,这些婴儿参加了比较替代雷珠单抗剂量在早产儿视网膜病变中的安全性和有效性的随机临床试验,抗VEGF治疗后VSS迅速下降。在需要重新开始治疗的眼睛中,VSS在重新开始治疗时再次增加;这些眼睛在重新开始治疗的需要变得临床明显之前,在基线和第1周之间也显示出VSS的更大变化。这些结果表明,抗VEGF治疗后的VSS与临床疾病严重程度相关,VSS对抗VEGF治疗的初始应答(从基线至第1周)可能有助于识别随后需要再次治疗的眼睛。使用抗血管内皮生长因子(VEGF)药物治疗早产儿视网膜病变(ROP)的最大挑战之一是需要进行长期随访检查,以确定需要再次治疗的ROP再激活风险眼睛。评价基于人工智能(AI)的血管严重程度评分(VSS)是否可用于分析抗VEGF治疗后的ROP消退和再激活,并可能识别需要再治疗的ROP再激活风险眼。这项预后研究是对多中心、双盲、研究者发起的比较雷珠单抗替代剂量在早产儿视网膜病变中的安全性和有效性(CARE-ROP)随机临床试验期间收集的后极眼底图像的二次分析,该试验比较了2种不同剂量的雷珠单抗(0.12 mg vs 0.20 mg)治疗视网膜病变。CARE-ROP试验在2014年9月5日至2016年7月14日期间筛选并招募了婴儿。共1046广角眼底图像从19个婴儿在预定的研究时间点进行了分析。VSS分析在2021年1月20日至2022年11月18日期间进行。基于AI的算法将1(正常)和9(最严重)之间的VSS分配给眼底图像。ROP婴儿随时间推移的VSS分析和2个治疗组(0.12 mg vs 0.20 mg雷珠单抗)之间以及接受和未接受ROP再激活再治疗的婴儿之间的VSS比较。在CARE-ROP随机临床试验的19名ROP婴儿中,首次治疗时的中位(范围)经后年龄为36.4(34.7-39.7)周; 10名婴儿(52.6%)为男性,18名(94.7%)为白色。基线时平均(SD)VSS为6.7(1.9),第1周显著降低至2.7(1.9)(P < .001),第4周显著降低至2.9(1.3)(P < .001)。ROP再激活需要再治疗的婴儿在再治疗时的平均(SD)VSS为6.5(1.9),显著高于第4周的VSS(P <0.001)。未发现两个治疗组之间的VSS存在显著差异,但基线和第1周之间的VSS变化在以后需要重新治疗的婴儿中更高(基线时平均值[SD]为7.8 [1.3],第1周时为1.7 [0.7]),而在以后不需要重新治疗的婴儿中更高(基线时平均值[SD]为6.4 [1.9],第1周时为3.0 [2.0])。在需要再治疗的眼睛中,较高的基线VSS与较早的再治疗时间相关(Pearson r =-0.9997; P < .001)。在这项研究中,雷珠单抗治疗后VSS下降,与临床疾病消退一致。在需要再治疗的ROP再激活病例中,VSS再次升高至与基线值相当的值。此外,初步治疗后第一周内VSS的较大变化与后期ROP再激活的风险较高相关,高基线VSS与早期再治疗相关。这些发现可能对监测抗VEGF治疗后ROP的消退和再激活具有意义。这项预后研究评估了基于人工智能的血管严重程度评分是否可用于分析抗血管内皮生长因子治疗早产儿视网膜病变后早产儿视网膜病变的消退和再激活。
Can an artificial intelligence–based vascular severity score (VSS) be used for analyzing regression and reactivation of retinopathy of prematurity after anti–vascular endothelial growth factor (VEGF) treatment? In this prognostic study of 19 infants with retinopathy of prematurity who participated in the Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity randomized clinical trial, VSS decreased rapidly after anti-VEGF treatment. In eyes requiring retreatment, VSS increased again at the time of retreatment; these eyes also displayed a greater change in VSS between baseline and week 1, before the need for retreatment became clinically apparent. These findings suggest that VSS after anti-VEGF treatment correlates with clinical disease severity and that the initial response in VSS to anti-VEGF therapy (from baseline to week 1) may help identify eyes that will later require retreatment. One of the biggest challenges when using anti–vascular endothelial growth factor (VEGF) agents to treat retinopathy of prematurity (ROP) is the need to perform long-term follow-up examinations to identify eyes at risk of ROP reactivation requiring retreatment. To evaluate whether an artificial intelligence (AI)–based vascular severity score (VSS) can be used to analyze ROP regression and reactivation after anti-VEGF treatment and potentially identify eyes at risk of ROP reactivation requiring retreatment. This prognostic study was a secondary analysis of posterior pole fundus images collected during the multicenter, double-blind, investigator-initiated Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP) randomized clinical trial, which compared 2 different doses of ranibizumab (0.12 mg vs 0.20 mg) for the treatment of ROP. The CARE-ROP trial screened and enrolled infants between September 5, 2014, and July 14, 2016. A total of 1046 wide-angle fundus images obtained from 19 infants at predefined study time points were analyzed. The analyses of VSS were performed between January 20, 2021, and November 18, 2022. An AI-based algorithm assigned a VSS between 1 (normal) and 9 (most severe) to fundus images. Analysis of VSS in infants with ROP over time and VSS comparisons between the 2 treatment groups (0.12 mg vs 0.20 mg of ranibizumab) and between infants who did and did not receive retreatment for ROP reactivation. Among 19 infants with ROP in the CARE-ROP randomized clinical trial, the median (range) postmenstrual age at first treatment was 36.4 (34.7-39.7) weeks; 10 infants (52.6%) were male, and 18 (94.7%) were White. The mean (SD) VSS was 6.7 (1.9) at baseline and significantly decreased to 2.7 (1.9) at week 1 (P < .001) and 2.9 (1.3) at week 4 (P < .001). The mean (SD) VSS of infants with ROP reactivation requiring retreatment was 6.5 (1.9) at the time of retreatment, which was significantly higher than the VSS at week 4 (P < .001). No significant difference was found in VSS between the 2 treatment groups, but the change in VSS between baseline and week 1 was higher for infants who later required retreatment (mean [SD], 7.8 [1.3] at baseline vs 1.7 [0.7] at week 1) vs infants who did not (mean [SD], 6.4 [1.9] at baseline vs 3.0 [2.0] at week 1). In eyes requiring retreatment, higher baseline VSS was correlated with earlier time of retreatment (Pearson r = −0.9997; P < .001). In this study, VSS decreased after ranibizumab treatment, consistent with clinical disease regression. In cases of ROP reactivation requiring retreatment, VSS increased again to values comparable with baseline values. In addition, a greater change in VSS during the first week after initial treatment was found to be associated with a higher risk of later ROP reactivation, and high baseline VSS was correlated with earlier retreatment. These findings may have implications for monitoring ROP regression and reactivation after anti-VEGF treatment. This prognostic study evaluates whether an artificial intelligence–based vascular severity score can be used to analyze regression and reactivation of retinopathy of prematurity after anti-vascular endothelial growth factor treatment among infants with retinopathy of prematurity.
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