Department of Medicine, Division of Cardiology, McGill University, Montreal, Canada.
Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.
Catheter Cardiovasc Interv. 2022 Feb;99(3):686-698. doi: 10.1002/ccd.30001. Epub 2021 Nov 18.
We evaluated the first in-human performance of a novel hybrid imaging catheter that permits simultaneous and co-registered acquisition of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) images.
A total of 17 patients undergoing planned percutaneous coronary intervention (PCI) were imaged between August 2018 and August 2019. Eleven patients with both pre- and post-PCI IVUS and OCT images were included in the offline image analysis. IVUS and OCT images were analyzed separately then together with co-registered images for pre-stent findings, and only separately for post-stent findings. A total of 926 frames were analyzed (218 pre-PCI, 708 post-PCI). There was substantial agreement to detect calcific plaque between co-registered IVUS-OCT and standalone IVUS (Kappa 0.72 [0.65-0.79]) and standalone OCT (Kappa 0.75 [0.68-0.81]) while standalone imaging modalities showed lower agreement to detect lipidic and fibrotic plaques compared with co-registered IVUS-OCT. There were more frames with stent underexpansion on IVUS than OCT [72 (28.7%) vs. 58 (23.1%), respectively, p = 0.039]. Detection rates of incomplete stent apposition (present on 20 OCT frames vs. 2 IVUS frames, p < 0.001) and tissue protrusion (40 vs. 27 frames, p < 0.001) were higher on OCT than IVUS. One stent edge dissection was detected in the image analysis and was seen on OCT but not IVUS. All 177 frames with image artifacts contained at least one co-registered imaging modality with interpretable diagnostic content. There were no study device-related adverse events.
Hybrid image acquisition was safe. The availability of both IVUS and OCT changed image interpretation compared to either modality alone, suggesting a complementary role of these two techniques.
我们评估了一种新型混合成像导管的首次人体性能，该导管允许同时和共注册采集血管内超声（IVUS）和光相干断层扫描（OCT）图像。
2018 年 8 月至 2019 年 8 月期间，共对 17 例计划行经皮冠状动脉介入治疗（PCI）的患者进行了成像。对 11 例患者进行了 PCI 前后 IVUS 和 OCT 图像的离线图像分析。分别分析 IVUS 和 OCT 图像，然后与共注册图像一起分析支架前发现，仅分别分析支架后发现。共分析了 926 帧（218 个 PCI 前，708 个 PCI 后）。与单独的 IVUS 和 OCT 相比，共注册的 IVUS-OCT 在检测钙化斑块方面具有显著一致性（Kappa 0.72 [0.65-0.79]）和单独的 OCT（Kappa 0.75 [0.68-0.81]），而单独的成像方式与共注册的 IVUS-OCT 相比，对脂质斑块和纤维斑块的检测一致性较低。IVUS 上显示支架扩张不足的帧数多于 OCT [分别为 72 帧（28.7%）和 58 帧（23.1%），p=0.039]。OCT 上检测到不完全支架贴壁（20 个 OCT 帧和 2 个 IVUS 帧，p<0.001）和组织突出（40 个和 27 个帧，p<0.001）的检出率高于 IVUS。图像分析中检测到 1 例支架边缘夹层，OCT 上可见，但 IVUS 上未见。所有 177 帧图像伪影均至少包含一种可解释诊断内容的共注册成像方式。无研究器械相关不良事件。
混合图像采集是安全的。与单独使用任何一种模态相比，同时使用 IVUS 和 OCT 改变了图像解释，这表明这两种技术具有互补作用。
