抢先看！中国心血管医疗器械产业创新白皮书诊断篇节选内容发布

创新引领，研究先行。

系统的行业研究对于实现更有效创新，洞悉创新趋势，找准创新突破点至关重要。

为了更好地呈现心血管领域行业发展脉络，引领心血管医疗器械创新动向，由CCI牵头，来自医疗机构、工程院校、器械企业、投资机构等50多家单位的专家共同编撰完成了《2021中国心血管医疗器械产业创新白皮书》，白皮书将于11月18日重磅发布。

内容抢先看！以下为白皮书第三章诊断篇节选内容“影像学检查器械综述”。

3.1.1 影像学检查器械综述

随着新器械的研发和新技术的应用，医学影像学在临床诊断和治疗中日益发挥着不可替代的作用。以冠状动脉CTA（CCTA）、心脏磁共振成像（CMR）和核素心肌显像为代表的心血管成像技术，已成为诊断冠心病、心肌病等不可替代的手段，并在鉴别诊断中发挥着重要作用。此外，近年来以血管内超声（IVUS）、光学相干断层成像（OCT）和血流储备分数（FFR）为代表的冠状动脉腔内影像和 功能生理学得到了长足的发展和广泛的应用。这些影像技术和冠状动脉造影一起，已成为心血管疾病介入治疗的基石。

CCTA作为无创性心血管影像技术的代表，在评估冠状动脉狭窄、识别易损斑 块、指导慢性闭塞（CTO）病变介入治疗以及评估支架植入术后疗效等方面具有一定的优势。由CCTA和FFR结合而来的FFR-CT技术，能够提供可靠的冠状动脉功能学评价[1,2]。基于能量频谱技术，CCTA可对易损斑块进行较为精确的定性和定量分析，在显示斑块组织学特征和功能学特点方面具有相当的潜力[3,4]。在指导CTO 病变介入治疗方面，CCTA可提供闭塞段血管走行的图像信息，帮助介入医师制定具 体的血运重建策略[5]。而基于CCTA 的CT-RECTOR 评分，则比传统的J-CTO 评分具有更好的预测手术成功率的能力[6]。生物可吸收支架（BRS）克服了金属伪影的影 响，CCTA 和FFR-CT 能精准评估BRS 植入后的管腔结构和血流动力学情况[7]。近年来，基于CCTA的管腔内密度衰减梯度（TAG）作为一种反映冠脉血流情况的新指  标得到了较多的关注。联合应用CCTA 和TAG，可显著提高功能性狭窄的诊断效力，可能成为评估冠脉功能性狭窄的可靠指标之一[8,9]。此外，新一代的“Revolution CT” 成像系统，具有更高的空间分辨率（230μm）和时间分辨率（29ms），可在单次心动周期内完成心脏成像，不受患者心率和心律条件的影响，同时放射剂量与对比剂使用量能减至以往的18% 和50%。我们有理由相信，无创CCTA 将在冠心病介入诊疗领域中发挥越来越重要的作用，带动介入心脏病学的快速发展。

CMR以其高时间和空间分辨率、最佳软组织对比度、大视野、无辐射、成像参数多、获得信息量大等优势，在心血管疾病早期诊断、评估病情严重程度、风险和预后等方面具有独特的价值，为心脏、大血管结构测量和功能评估的“金标准”。定量血流灌注技术能精确评价冠心病冠状动脉微血管障碍[10]。磁共振心肌灌注、钆对比剂延迟强化（LGE）及二维血流成像等技术是目前临床广泛使用的无创性评价心肌梗死或纤维瘢痕灶的技术，能够区分心肌病的病因（缺血性、非缺血性心肌病）[11]。LGE能够评价缺血性心肌病梗死或瘢痕组织范围、病变的透壁程度，已成为评价心肌梗死后心肌瘢痕形成的参照标准[12]。此外，一些新技术，如心脏T1、T2 mapping 及DTI 技术实现了对心肌组织T1、T2 值以及水分子扩散运动的定量，在细胞及分子水平反应了心肌微观结构的改变[13]。4D Flow 技术是一种无创的可对心腔及大血管血流进行定性和定量分析的新技术，可同时对3 个相互垂直的维度进行速度编码并获得三位相位对比电影，经1 次扫描即可获得扫面范围内任意位置的血流方向、速度、剪切力等血流动力学参数[14]。CMR具有结构、功能和组织学的“一站式”成像能力，是目前其他影像技术难以比拟的，具有广阔的发展前景。

大量循证医学证据表明，核素心肌显像在冠心病的诊断、危险分层、存活心肌检测、治疗决策制定、疗效评价、预后评估以及其他多种心脏疾病的诊治中具有重要的临床价值。其中，核素心肌灌注显像是诊断冠心病患者心肌缺血准确且循证医学证据最充分的无创性方法；核素心肌葡萄糖代谢显像是目前评价存活心肌的“金标准”。心肌灌注显像分为心肌灌注单光子发射计算机断层显像（SPECT）和心肌灌注正电子发射计算机断层显像（PET）。SPECT 心肌灌注显像是目前最常用的心肌灌注显像方法。PET心肌灌注显像国内开展较少，与SPECT心肌灌注显像相比，后者有更优异的分辨率和完善的图像衰减校正技术，还可进行心肌血流绝对定量，并通过基础和最大充血状态下心肌血流获得心肌血流储备（MFR）和冠状动脉血流储备（CFR）。PET 是目前公认的无创检测CFR的“金标准”。而随着技术的发展，部分SPECT（如D-SPECT）也可实现无创心肌血流定量。

腔内影像技术（IVUS 和OCT）已越来越多地被用于指导冠状动脉介入治疗（PCI）。来自于美国心脏介入的数据显示，自2004 年至2014 年，由腔内影像学指导的PCI 术例数和比例均显著上升，由此带来了患者全因死亡和住院死亡的下降[15]。腔内影像通过帮助术者更高效地识别病变性质、更精确地选择支架尺寸、更及时地发现支架相关并发症（如边缘夹层、扩张不全、贴壁不良或组织脱垂等）、更有效地寻找支架晚期失败的原因（如支架血栓、新生粥样硬化病变、支架断裂、内膜增生等）而改善PCI 预后[16-27]。在一些特殊器械（如BRS）和复杂病变（CTO 病变、左主干病变、分叉病变等）的介入治疗中，腔内影像技术仍将发挥越来越重要的作用。此外，尚有将IVUS 和OCT 整合到一根成像导管上的融合成像技术。2018 年底， 来自加拿大安大略省Hamilton 总医院的几位医生首次报道了IVUS-OCT 融合成像导管在人体的应用[28]。国内也有类似的器械已经开展临床研究。此外，基于IVUS/ OCT的近红外光谱成像（NIRS）也已开始用于临床，指导易损斑块的治疗[29,30]。最近报道称新的OCT系统具有更高的分辨率，可对冠状动脉的单个细胞，甚至是亚细胞结构进行成像，这种OCT 系统被称为显微OCT（Micro OCT）[31]。但这种显微OCT能否用于临床目前还无法确定。

FFR是评估冠状动脉血流的功能学和生理学指标，已成为判断冠脉缺血的“金标准”。目前FFR 的适应证已从稳定性心绞痛扩展至不稳定性心绞痛、非ST 段抬高心梗和ST 段抬高心梗的非罪犯血管，从临界病变扩展至多支病变、弥漫病变、分叉病变和左主干病变[32-37]。在冠脉最大充血状态下通过压力导丝测量Pd/Pa 比值，是经典的获得FFR 的方法。此外，国内尚有通过压力微导管来获得FFR 的方法，其准确性与压力导丝相似[38]。一些非充血的冠状动脉功能生理学评估方法（如iFR、RFR）[39-41] 和基于造影的冠脉功能生理学评估方法（如QFR、caFFR）[42-45] 也在临床上获得了一定的应用。

受价格因素、缺少收费立项和医保覆盖、操作时间长的因素的影响，国内无论腔内影像还是功能生理学的使用比例均偏低。随着医保覆盖逐渐完善、术者对腔内影像和功能生理学逐渐重视，未来介入治疗术中使用腔内影像和功能生理学的比例将明显增加。腔内影像和功能生理学的融合成像也将是未来的发展热点。已有研究者将IVUS/OCT 与FFR结合，通过一次导管回撤，同时获得管腔的形态学信息和功能生理学信息[46-48]。此类融合成像导管可能将成为未来冠脉影像学和功能学检查的主流。展望未来，心血管影像将进入一个快速发展的通道。随着人工智能（AI）的加入，心血管影像已具备了自动识别、自动报告、提供治疗建议等特点，在辅助临床医生决策方面具有了初步优势，使心血管疾病的精准介入治疗成为可能。

参考文献

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本期策划：沈雳

本文作者：吴轶喆

后期制作：凌武娟