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Table of Contents
RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 3  |  Page : 90-96

Safety and efficiency of a novel argus optical coherence tomography: A preclinical experiment


Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital Fudan University, Shanghai, China

Date of Web Publication24-Sep-2018

Correspondence Address:
Junbo Ge
Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/cp.cp_20_18

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  Abstract 


Aims: This study investigated the application of the domestic Argus Insight-100 optical coherence tomography (OCT) system in porcine arteries and to evaluate the efficiency and safety of Insight-100°CT immediately after implantation and at 4-week follow-up. Subjects and Methods: Eight porcine arteries were implanted with HELIOS drug-eluting stents. Scans were performed with Insight-100 and C7-XR OCT immediately after implantation and at 4-week follow-up, respectively, to obtain lumen images and measured data. Statistical Analysis Used: SPSS v22 software was used for statistical analysis. Results: Both the Insight-100 and C7-XR scans were successfully performed during the implantation and follow-up. Parameters at 4-week postoperatively showed no significant difference between these two groups. No differences were observed in the reference vessel minimal lumen diameters between Insight-100 and C7-XR in the same frame (2.59 ± 0.18 mm vs. 2.60 ± 0.23 mm, respectively, P = 0.91 and 2.83 ± 0.27 mm vs. 2.98 ± 0.27 mm, respectively, P = 0.19). Moreover, the values of mean lumen diameter in the stent segment are comparable between Insight-100 and C7-XR (2.91 ± 0.11 mm vs. 2.97 ± 0.16 mm, P = 0.50). At 4-week follow-up, the mean lumen diameter of Insight-100 was 2.54 ± 0.28 mm, while that of C7-XR was 2.55 ± 0.32 mm, without difference between two groups (P = 0.92). Conclusions: The Argus OCT system appears to be safe during implantation and follow-up. The efficacy and measurement accuracy of Argus OCT is equivalent to that of the C7-XR.

Keywords: Coronary artery disease, optical coherence tomography, restenosis


How to cite this article:
Chen J, Wu Y, Shen L, Yin J, Wang R, Lv X, Chen H, Ji M, Wang Q, Qian J, Ge J. Safety and efficiency of a novel argus optical coherence tomography: A preclinical experiment. Cardiol Plus 2018;3:90-6

How to cite this URL:
Chen J, Wu Y, Shen L, Yin J, Wang R, Lv X, Chen H, Ji M, Wang Q, Qian J, Ge J. Safety and efficiency of a novel argus optical coherence tomography: A preclinical experiment. Cardiol Plus [serial online] 2018 [cited 2018 Oct 19];3:90-6. Available from: http://www.cardiologyplus.org/text.asp?2018/3/3/90/242078




  Introduction Top


Coronary angiography (CAG) is a traditional imaging method of visual evaluation of coronary arteries, which play an important role in the diagnosis of coronary artery disease (CAD) and guidance of percutaneous coronary interventions (PCIs). However, the images obtained by CAG are two-dimensional, so there are many disadvantages, such as only looking at the lumen, not observing the vessel wall so we cannot accurately assess the size of the vessel or the characteristics of the plaque and vessel dissection.[1] The evaluations of CAG for intramural hematoma and stent implantation were relatively low. With the continuous development of imaging techniques, intracoronary imaging emerged as one alternative.[1],[2] Observational studies,[3] randomized controlled trials,[4] and meta-analyses [1],[5] show that coronary artery therapy guided by intravascular ultrasound (IVUS) improves the efficiency of interventions and further improves the clinical results.[3],[6],[7],[8] However, IVUS also has some limitations, such as grayscale image and low resolution.[9] Optical coherence tomography (OCT) is a safe alternative to both of these limited approaches.[10] The images are not grayscale, and the resolution is improved.[11],[12],[13],[14] The application of OCT in coronary artery imaging provides valuable information for judging the characters of coronary artery plaque,[15],[16],[17],[18] selecting suitable stent size,[19],[20] optimizing stent implantation,[4],[21],[22] reducing stent-related problems,[23] and follow-up intervention efficacy.[24],[25],[26],[27] Three-dimensional (3D) OCT is helpful for side-branch intervention [28],[29] and observing the bioresorption process of bioresorbable vascular scaffold (BRS).[30] Moreover, OCT plays an important role in the implantation and follow-up of bioresorbable scaffolds.[31],[32],[33],[34],[35],[36] This has enabled its use as a clinical tool.[37],[38] OCT systems routinely used in clinical settings are mostly from Boston Technologies and Terumo Corporation and are relatively expensive. In this study, we evaluate the safety and effectiveness of a domestic, less inexpensive Argus Insight-100°CT (Argus Scientific Corporation, Suzhou, China) instrument compared with a representative OCT system C7-XR (St. Jude Medical Inc., Boston, USA).


  Subjects And Methods Top


Materials and Methods

The OCT system contained Insight-100 image system and eight Insight-100-1350 imaging catheters which were produced and provided by Suzhou Argus scientific corporation (Suzhou, China). The control group used C7-XR imaging system and eight C7 Dragonfly imaging catheters (St. Jude Medical Inc., Boston, USA).

Animal procedure

Eight white pigs weighing 35–40 kg and aged 6–8 months were used for the current study. All animal protocols complied with the Declaration of Helsinki and were approved by the Ethics Committee of Zhongshan Hospital (Shanghai, China). Pigs utilized in the study were cared for according to the policies and principles established by the Animal Welfare Act and the NIH Guide for the Care and Use of Laboratory Animals. Before the procedure started, the animals were pretreated with aspirin 100 mg and clopidogrel 75 mg daily for 3 days. Animals were injected with 0.3 mg/kg ketamine and 3–4 mg/kg diazepam subcutaneously as basal anesthesia and then 30–40 mg/kg pentobarbital intravenously for continuous sedation. Limb lead electrocardiography and invasive blood pressure were monitored throughout the procedure. After the placement of a sheath in the right femoral artery surgically, an unfractured heparin bolus of 200 U/kg was given intravenously.

Under fluoroscopic guidance (GE Medical, Innova 2000), a guiding catheter (6F EBU3.5 for the left coronary artery and 6F JR3.5 for the right coronary artery) was positioned in left or right coronary ostium successively. After infusing 200 μg of nitroglycerin into vessel, CAG was performed in at least two orthogonal views and recorded on cine film. Tortuous arteries were excluded. Arteries whose diameters were larger than 3.5 mm and smaller than 2.5 mm were excluded from the study. Eight HELIOS stents (Kinhely Biotechnology Co., Ltd., Shenzhen, China) were implanted in the porcine coronary arteries. Each artery accommodated only one stent.

Before implantation, the target artery was scanner 3D using C7-XR (Boston Scientific, USA) and Insight-100 (Argus Scientific, China). Angiography was repeated after stent implantation. Then, OCT was performed immediately after implantation, and two kinds of OCT instruments were used to detect the lumen and whether there was acute thrombosis or collapse. After infusing 200 μg of nitroglycerin into the stented vessel through a guiding catheter, imaging catheter was advanced approximately 10 mm beyond the stent into the distal vessel through a guidewire. The Argus transducer was automatically withdrawn at a speed of 15 mm/s back to the guiding catheter, while the C7-XR retreated at a speed of 10 mm/s. All cines were recorded for further analysis. The cross-sectional area (CSA) and diameter at external distal segment of stent, distal of stent, 10 mm from the distal of stent, proximal parts of stent, and external proximal segment of stent were calculated and analyzed using two OCT instruments. After the intervention, all animals were recovered and observed for complications. Aspirin 100 mg and clopidogrel 75 mg daily were given for 4 weeks. Penicillin 4 million units were injected for 3 days after intervention. No animals died during observation. At 4-week follow-up, angiography and OCT were performed again following the previous protocol.

Optical coherence tomography analysis

All OCT data were analyzed by an independent observer. Measurements were made based on calibration of a contrast-filled catheter and automatic contour detection of treated segment using Argus software package (Argus Scientific Corp, Suzhou, China). The exclusion criteria of image for analysis are the bifurcated vessel on the frame accounts for more than 50% of the vessel area and the distribution of struts is <270° of the lumen. In this case, the adjacent image is used to instead.

Endpoint event

Main evaluation criteria were as follows: (1) the OCT system was successfully used to scan and image the blood vessels and the stent, (2) the images were clear and stable, and (3) the imaging catheter was successfully withdrawn. Secondary evaluation criteria were as follows: (1) the equipment was operated successfully, including automatic loading, unloading, and automatic withdraw catheter, (2) whether the software achieved the desired goal, (3) the imaging catheter successfully cooperated with the equipment and the guidewire, (4) the catheter reached the desired position, and (5) the catheter imaged successfully. Safety endpoint events were as follows: (1) catheter fracture or bend, (2) artery perforation caused by imaging catheter, and (3) animals died during the procedure.

Statistical analysis

All quantitative measurements and histological parameters were obtained by blinded observations. SPSS v22 software (IBM, New York, USA) was used for statistical analysis. The data are expressed as mean ± standard deviation. The partial correlation coefficient between the two variables was calculated and tested. Independent two-sample t-tests were performed to detect the difference between groups. Significant was established by P < 0.05.


  Results Top


Eight mini pigs were enrolled in this study. A total of eight stents were implanted into porcine coronary arteries. The CSA and lumen diameter of the images recorded by Insight-100 and C7-XR were calculated and analyzed using Argus OCT analysis software. OCT analysis parameters after implantation immediately and at 4-week follow-up were listed in [Table 1] and [Table 2] separately.
Table 1: Optical coherence tomography analysis parameters after implantation

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Table 2: Optical coherence tomography analysis parameters at 4-week follow-up

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Immediately after implantation

Minimal lumen diameters (MLD) [Figure 1] and minimal lumen area (MLA) [Figure 2] were measured with C7 and Insight-100. [Table 1] shows the immediate implanted lumen measurement data. The lumen area and diameter of the two OCT detectors are similar (P > 0.05). [Figure 3] shows the image scanned using Insight-100 and C7-XR immediately after stent implantation. The vessel lumen, neointima, medial membrane, and struts could be clearly displayed by Insight-100. No acute thrombosis, dissection, or stent malapposition were found by two OCT systems.
Figure 1: Using C7 and Insight to measure the minimum lumen diameter of different segments immediately after implantation

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Figure 2: Using C7 and Insight to measure the minimum lumen area of different segments immediately after implantation (minimal lumen area)

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Figure 3: (a-f) are images of the external distal end of the stent, the minimal in-stent lumen and the external proximal end of the stent, respectively, after implantation. (a-c) recorded by using Argus optical coherence tomography. (d-f) recorded using C7-XR optical coherence tomography

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No significant difference was detected about the distal and proximal reference vessel MLA between the Insight-100 and C7-XR in the same frame (5.79 ± 0.69 mm2 vs. 5.69 ± 0.94 mm2, respectively, P = 0.71 and 7.23 ± 1.36 mm2 vs. 7.69 ± 1.60 mm2, respectively, P = 0.25), as well as MLD (2.59 ± 0.18 mm vs. 2.60 ± 0.23 mm, respectively, P = 0.91; 2.83 ± 0.27 mm vs. 2.98 ± 0.27 mm, respectively, P = 0.19). No difference existed between the Insight-100 and C7-XR in mean lumen diameter (2.91 ± 0.11 mm vs. 2.97 ± 0.16 mm, P = 0.50) and MLA (6.66 ± 0.50 mm2 vs. 6.82 ± 0.58 mm2, P = 0.66) of the frame 10 mm to the distal end of the stent. Moreover, mean lumen diameter (2.87 ± 0.16 mm vs. 2.86 ± 0.11 mm, respectively, P = 0.85 and 3.01 ± 0.07 mm vs. 3.06 ± 0.07 mm, respectively, P = 0.07) and MLA (6.50 ± 0.70 mm2 vs. 6.38 ± 0.43 mm2, respectively, P = 0.7; 7.11 ± 0.32 mm2 vs. 7.36 ± 0.34 mm2, respectively, P = 0.08) in the distal and proximal of stent are comparable with Argus Insight-100 and C7-XR.

Four-week Follow-up

To further improve the image resolution and the clinical diagnostic accuracy, the imaging characteristics of the Insight-100 were improved at 28-day follow-up [Figure 4], which greatly improved the resolution of the image. OCT images of distal, middle, and proximal parts of the stent at 4-week follow-up were illustrated in [Figure 4]. No acute thrombosis, dissection, or stent malapposition were found by two OCT systems.
Figure 4: (a-f) are images of the external distal end of the stent, the minimal in-stent lumen and the external proximal end of the stent, respectively, at 4-week follow-up. (a-c) recorded by using Argus optical coherence tomography. (d-f) recorded using C7-XR optical coherence tomography. The vessel and stent structure could be clearly displayed by Argus Insight and C7-XR machine scanning

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The MLD [Figure 5] and MLA [Figure 6] parameters of the two groups were similar. There was no significant statistical difference (P > 0.05) [Table 2]. At 4-week follow-up, the mean lumen diameter of Insight-100 was 2.54 ± 0.28 mm, while that of C7-XR was 2.55 ± 0.32 mm, without difference between two groups (P = 0.92). Meanwhile, no difference existed between Insight-100 and C7-XR in mean stent diameter (2.78 ± 0.15 mm vs. 2.86 ± 0.26 mm, P = 0.49) of the frame 10 mm to the distal end of the stent. MLD (2.22 ± 0.37 mm vs. 2.37 ± 0.35 mm, respectively, P = 0.22; 2.36 ± 0.38 mm vs. 2.38 ± 0.33 mm, respectively, P = 0.75) and MLA (4.62 ± 1.40 mm2 vs. 4.87 ± 1.22 mm2, respectively, P = 0.55; 5.04 ± 1.46 mm2 vs. 5.08 ± 1.39 mm2, respectively, P = 0.90) are comparable with Argus Insight-100 and C7-XR in the distal and proximal of stent. Within the group of the Insight-100, mean stent area of distal, middle, and proximal part of stent was 5.90 ± 0.91 mm2, 6.10 ± 0.63 mm2, and 6.30 ± 0.54 mm2, respectively. There was no significant statistical difference between the two groups.
Figure 5: Using C7 and Insight-100 to measure the minimum lumen diameter of different segments immediately at 4-week follow-up

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Figure 6: Using C7 and Insight-100 to measure the lumen area (minimal lumen area) of different segments at 4-week follow-up

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  Discussion Top


Coronary atherosclerosis can lead to plaque rupture and may lead to occlusive thrombosis.[31] IVUS has been widely used to analyze the risk of plaque characteristics, plaque rupture,[39] restenosis, and thrombosis and evaluate the effect of intervention therapy. As the microstructural tissue components are out of the resolution,[40] they may not be detected in the IVUS images. However, OCT can be used to accurately identify plaque components.[15] Besides characterization and classification, the measurement of plaque components along with risk assessment was also presented in the above section. Atherosclerotic plaque characterization,[14] neointima,[27],[41] in-stent/scaffold restenosis,[41] detection of vulnerable plaque and thrombosis,[24],[42] malapposition of the stent,[40],[43] quantification of macrophages, and calcification of coronary arteries [16] using the OCT are the potential future challenges.

BRS is the current direction of stent development. However, there are still many problems to be solved before they are widely used in the clinic. For example, the incidence of stent thrombosis in BRS is relatively high, which may be closely related to the prognosis of BRS implantation. The causes of in-scaffold thrombosis may be related to patients' basic conditions, surgical procedures, scaffold types, antiproliferative drugs, and the use of antiplatelet drugs after implantation. Using OCT to guide the implantation of BRS, we can observe the microscopic circulation of BRS in the atherosclerotic vessels to better guiding scaffold implantation and evaluate the changes of the scaffold and vessels after implantation accurately. The combination of OCT and BRS will be an important research field of coronary intervention.

The domestic Argus OCT system was flexible and showed excellent maneuverability in animal experiments. There were no adverse events during the operation and follow-up. The Argus has good comparability with C7-XR in measuring lumen area and diameter. Moreover, the Argus has an immediate 3D imaging technique, which can be used to observe the whole vessel, side branch, and stent structure. The safety and effectiveness of Argus OCT in the human body needs to be verified by further clinical trials. The Argus OCT system will be a powerful challenge to the imported OCT systems currently used.


  Conclusions Top


The Argus OCT system appears to be safe during implantation and follow-up of BRS stents. The efficacy and measurement accuracy of the Argus OCT system is equivalent to that of the C7-XR. Therefore, these two kinds of OCT system are comparable in judging the character of the lesion and guiding stent implantation. This preclinical study was designed to provide preliminary data for future studies of the efficacy and safety of the Argus OCT system. We will further apply for clinical trials to evaluate the performance of the Argus OCT system in humans.

Limitations

The limitations of this study are as follows: (1) The number of animals in this study was small. Moreover, better-designed studies in the future are likely to have a longer follow-up. (2) All arteries were normal when implanting stents in this study. Endothelium hyperplasia was not serious at 4-week follow-up. Further studies are needed to evaluate the flexibility of the Argus OCT system in complicated CAD. (3) No serious restenosis, severe inflammation (macrophage), thrombosis, malapposition, or dissection was found in this study. It was impossible to assess the efficacy and safety of the Argus OCT system in these situations.

Financial support and sponsorship

This work was supported by National Natural Science Fund of China (81521001 and 81670319) and ZhongshanHospital Science Foundation(2018ZSQN037).

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
    Tables

  [Table 1], [Table 2]



 

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