DIAMondback Atherectomy With OCT Visualization for Calcified PAD Lesions (DIAMOCT-PAD Study)

Abstract

Objective. In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely calcified lesions. Background. Debulking the calcified atherosclerotic plaque with the orbital atherectomy system (OAS) can potentially enhance vessel compliance and increase the chance of reaching a desirable angioplasty result. Methods. A total of 7 patients were evaluated both at baseline and at 6-month follow-up. Following a diagnostic peripheral angiogram, patients with significant SFA disease had a baseline intravascular optical coherence tomography (IV-OCT) and the lesion was treated with OAS. Repeat IV-OCT was performed after atherectomy and after drug-coated balloon, if used. Patients were also evaluated with angiography and IV-OCT imaging at their 6-month follow-up. Results. The majority of tissue removed was fibrous tissue. During follow-up, luminal volume increased for 4 of the 7 patients from baseline to 6-month follow-up and decreased in 3 patients. On average there was a 6% increase of luminal volume (P<.01 compared with baseline). A recent virtual histology algorithm was used for automatic classification of IV-OCT images unaided by any reader. The algorithm used convolutional neural networks to identify regions as either calcium, fibrous, or lipid plaque, and it agreed with an expert reader 82% of the time. Conclusion. To the best of our knowledge, the current report is the first to describe vascular effects of OAS in medial calcified lesions immediately after and at follow-up using IV-OCT in patients with severe PAD.