The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction.
The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction.
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DOI：
10.1097/prs.0b013e3181f059c7
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发表时间：
2010-11
影响因子：
3.6
通讯作者：
Frangioni JV
中科院分区：
文献类型：
--
作者：
Lee BT;Hutteman M;Gioux S;Stockdale A;Lin SJ;Ngo LH;Frangioni JV
在重建手术中确定皮瓣灌注的能力仍然主要基于临床检查。在这项研究中，我们证明了使用术中，近红外（NIR）荧光成像系统的交通支的位置和皮瓣灌注的评价。对6例乳腺癌术后行腹壁下动脉穿支（DIEP）皮瓣乳房再造的患者静脉注射吲哚菁绿色（ICG）。使用放射性辅助切除和探查（FLARE™）成像系统评估三种剂量水平的ICG。该系统使用发光二极管（LED）进行荧光激发;与当前市售系统不同。在这项初步研究中，手术医生对成像结果不知情。在所有6名研究受试者中成功使用FLARE™系统，无并发症或后遗症。在三个剂量水平中，4 mg/次注射导致观察到的最高对比度-背景比（CBR）、信噪比和信噪比。然而，由于样本量较小，我们没有足够的把握度在多重比较校正的I类误差为0.017时检测这些成对比较的统计学显著性。6 mg/进样提供了相似的CBR，但残留背景信号也较高。基于该初步研究，我们得出结论，使用基于LED的系统对穿支皮瓣乳房重建进行NIR评估是可行的，并且与用于评估皮瓣灌注的2或6 mg剂量相比，每次注射4 mg ICG的剂量产生了最佳观察到的CBR。
The ability to determine flap perfusion in reconstructive surgery is still primarily based on clinical examination. In this study, we demonstrate the use of an intraoperative, near infrared (NIR) fluorescence imaging system for evaluation of perforator location and flap perfusion. Indocyanine green (ICG) was injected intravenously in six breast cancer patients undergoing a deep inferior epigastric perforator (DIEP) flap breast reconstruction after mastectomy. Three dose levels of ICG were assessed using the Fluorescence-Assisted Resection and Exploration (FLARE™) imaging system. This system uses light emitting diodes (LED) for fluorescence excitation; different from current commercially available systems. In this pilot study, the operating surgeons were blinded to the imaging results. Use of the FLARE™ system was successful in all six study subjects with no complications or sequelae. Among the three dose levels, 4 mg per injection resulted in the highest observed contrast-to-background ratio (CBR), signal-to-background ratio, and signal-to-noise ratio. However, due to small sample size, we did not have sufficient power to detect statistical significance for these pairwise comparisons at the multiple-comparison adjusted type-I error of 0.017. Six mg per injection provided a similar CBR, but also a higher residual background signal. Based on this pilot study, we conclude that NIR assessment of perforator flap breast reconstruction is feasible with an LED based system, and that a dose of 4 mg of ICG per injection yields the best observed CBR compared to a dose of 2 or 6 mg for assessment of flap perfusion.