Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study

• Published in: The Journal of invasive cardiology Vol. 24; no. 5; p. 206
• Main Authors: Yoon, Joo Heung, Di Vito, Luca, Moses, Jeffrey W, Fearon, William F, Yeung, Alan C, Zhang, Shaosong, Bezerra, Hiram G, Costa, Marco A, Jang, Ik-Kyung
• Format: Journal Article
• Language: English
• Published: United States 01.05.2012
• Subjects: Acute Coronary Syndrome - diagnostic imaging; Acute Coronary Syndrome - therapy; Aged; Angina Pectoris - diagnostic imaging; Angina Pectoris - therapy; Angioplasty, Balloon, Coronary; Coronary Angiography - methods; Coronary Angiography - trends; Device Approval; Equipment Design; Feasibility Studies; Female; Humans; Image Processing, Computer-Assisted; Male; Middle Aged; Reproducibility of Results; Stents; Tomography, Optical Coherence - instrumentation; Tomography, Optical Coherence - methods; Tomography, Optical Coherence - trends
• ISSN: 1557-2501; 1557-2501

This study sought to assess the effectiveness and safety of the second-generation frequency-domain optical coherence tomography (FD-OCT) system. The second-generation FD-OCT was recently developed, with simplified imaging technique and faster acquisition time compared to the first-generation time-domain OCT. However, the safety and effectiveness of the FD-OCT has not been evaluated, and this study was conceived as a preapproval study for Food and Drug Administration clearance for clinical use in the United States. A total of 50 patients were enrolled from 3 institutions. Following stent implantation, the FD-OCT was performed with contrast injection through the guiding catheter to acquire pullback images with the pressure-triggered automatic pullback device. The primary endpoint was to achieve a median clear image length of more than 24 mm. Serious procedure-related or postprocedural adverse events (death, myocardial infarction, or ventricular arrhythmia) were recorded to assess safety of the device. The primary endpoint of obtaining >24 mm of median clear image length (CIL) was achieved in 94% of the subjects (47 out of 50), with measured CIL of 43.2 mm. In 5 patients (10.6%), a second attempt was necessary due to suboptimal image quality of the first pullback. In 36 patients (76.6%), a full stent length was obtained during the first attempt. There were no serious procedure-related or postprocedural adverse events. The new second-generation FD-OCT system provides fast and reliable resolution images of the coronary artery. The pullback can be safely performed over long segments of the artery without serious adverse events.