Intravascular Ultrasound Assessment of Arterial Dissections Following Rotarex Atherectomy: Results of the iDissection Rotarex Study.

Background: There are limited data on the mechanism of the Rotarex Rotational Excisional Atherectomy System in treating femoropopliteal arterial disease. The Rotarex iDissection study is a prospective, single center study evaluating the extent of excision and dissection in de novo and restenotic (not in-stent) lesions of the femoropopliteal arteries in symptomatic peripheral arterial disease patients. Methods: Consecutive patients with symptomatic peripheral arterial disease were prospectively enrolled in the Rotarex iDissection study at a single US center after obtaining informed consent. The study was approved by a central ethics committee. Quantitative vascular angiography and intravascular ultrasound images were analyzed by an independent core laboratory. The Eagle Eye Platinum ST intravascular ultrasound (Phillips) was used to identify the depth (A, B, C for intima, media, and adventitia, respectively) and arc of dissections (1 and 2 for <180° and ≥180°, respectively) using the iDissection classification. Statistical significance was determined by a Results: A total of 19 patients (20 procedures) were enrolled by 1 endovascular specialist. There were 57.9% men with mean age of 71.1 ± 9.6 years. Of the patients, 31.6% had diabetes mellitus, and 84.2% were current or past smokers. Thirty percent of treated vessels were chronic total occlusions. A total of 10 patients received stents (2 covered stents due to perforation, 6 due to National Heart, Lung, and Blood Institute Type C dissections, and 2 were primary stenting). Two distal embolizations occurred; one was attributed to the Rotarex, and both were treated with no adverse consequences. Angiographic baseline stenosis was 74.7% ± 25.6%; after Rotarex, 48.7% ± 14.8%; and after percutaneous transluminal angioplasty (PTA), 16.0% ± 6.2%. Baseline minimal lumen diameter was 1.0 ± 1.0 mm; after Rotarex, 2.4 ± 1.1 mm; and after PTA, 4.4 ± 1.0 mm. Angiographically, there was 1 type A dissection at baseline; 1 A, 1 B, and 2 C after Rotarex, and 3 A and 5 C after final adjunctive PTA. Intravascular ultrasound revealed a reference diameter of 6.2 ± 1.0 mm; 70% of patients had adventitial dissections. The mean arc of calcium was 221° ± 39.4° (moderate to severe calcium). Conclusions: The Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of adventitial dissections is seen with the Rotarex. The long-term outcomes of this finding need to be further studied.