Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial

Abstract

Objective: The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease. Background: Infrapopliteal occlusive disease is a common cause of critical limb ischemia and claudication. There are no American College of Cardiology/American Heart Association guidelines for infrapopliteal revascularization for chronic limb ischemia. Methods: One hundred twenty four patients (201 stenoses) were enrolled in a prospective non-randomized multicenter registry of orbital atherectomy for severe infrapopliteal disease. Data were collected as part of an investigational device exemption from the Food and Drug Administration. Results: The primary safety endpoint of major adverse events (MAE) at 30-days (death, myocardial infarction, amputation, or repeat revascularization) was observed in four patients (3.2%). The primary efficacy endpoint (final diameter stenosis) was 17.8 6 13.5%. The secondary endpoints of procedural success (final diameter stenosis 30%) and 6 month MAE (death, amputation, or target vessel revascularization) were observed in 90.1 and 10.4% of patients, respectively. Stand-alone atherectomy was performed in 116 lesions (57.4%). At 6-months, no patients required surgical bypass or unplanned amputation, and improvement in Rutherford ordinal scale was observed in 78.2% of patients. Conclusions: Orbital atherectomy is a unique approach to infrapopliteal disease, and provides predictable and safe lumen enlargement. Short-term data demonstrate substantial symptomatic improvement and infrequent need for further revascularization or amputation. '

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty ― Propensity Score-Matched Registry ―

“…17 In the OASIS trial orbital AT had satisfactory results in infrapopliteal lesions, nevertheless adjunctive balloon angioplasty was performed after plaque modification only in 42.6%. 18 In the CALCIUM 360 trial, the infra-popliteal arteries in 50 patients with CLI were qualified to plaque modification with subsequent balloon angioplasty vs. balloon angioplasty alone. 19 In that study the AT group had a lower rate of target vessel revascularization and all-cause mortality in comparison with balloon angioplasty alone.…”

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach

“…This percutaneous, minimally invasive endovascular device system is composed of a single-use, low-profile catheter with a diamond-coated crown that orbits at high speeds while removing a thin layer of calcific plaque with each pass of the crown [8]. Randomized clinical trial (RCT) evidence indicated that CLI patients receiving BA plus atherectomy involving OAS had a lower rate of complications [9][10][11][12], and medial damage [8], and reduced need for bailout stenting [12], thus preserving future treatment options.…”

Removing vascular obstructions: a challenge, yet an opportunity for interventional microdevices

“…It is a grinding-type device with rotational speed in the range 80,000-200,000 rpm that is controlled by a pressure valve. An eccentric diamondcoated crown is responsible for grinding: by increasing the rotational speed, lumen diameter can be increased by 1.75 times the device diameter (Safian et al 2009). Tool diameter ranges from 1.25 to 2.5 mm and the unprotected shaft portion, driven by a compressed gas turbine, is limited to 6 cm.…”