Overview
Dr. Sadeem Mahmood used orbital atherectomy in the treatment of multi-stage vessel disease.
Dr. Sadeem Mahmood used orbital atherectomy in the treatment of multi-stage vessel disease.
An 88-year-old female complained of bilateral lower extremity pain with exercise and right lower extremity pain at rest. After multiple antegrade access attempts, retrograde access was achieved under ultrasound guidance and successful Orbital Atherectomy System (OAS) treatment of multi-stage vessel disease was performed.
Patient presented with bilateral lower extremity pain with exercise and right lower extremity pain at rest. She was diagnosed with Peripheral Arterial Disease (PAD) and classified as Rutherford category 4 with past medical history of diabetes mellitus, renal insufficiency, hypertension and coronary artery disease. An angiogram revealed 80% stenosis in the right superficial femoral artery, 75% stenosis in the proximal popliteal artery and 100% stenosis [chronic total occlusion (CTO)] of the right anterior tibial artery.*
4 Fr. 60cm Diamondback 360® Peripheral Orbital Atherectomy System (OAS) facilitated retrograde treatment of multi-vessel disease.
Retrograde access of the right anterior artery was successfully achieved using ultrasound guidance after multiple failed attempts to cross the lesion through the antegrade approach. A 60cm Diamondback 360® Peripheral 1.25mm Solid Crown was used for retrograde orbital atherectomy treatment of lesions in the right anterior tibial, popliteal, and superficial femoral arteries. Lesions were treated with low, medium, and high speed OAS passes. This was followed by low-pressure percutaneous transluminal angioplasty (PTA) at 6 ATM in each of the lesions treated. PTA was also used to treat the tibial peroneal trunk and peroneal artery through an antegrade approach.
Final results showed less than 5% residual stenosis in all target lesions. Excellent blood flow to the foot was present. No complications occurred and the patient was discharged on the same day.
Indications Statement: The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.
Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
*WARNING: When treating chronic total occlusion (CTO), create a channel at low or medium speed before traversing the lesion at high speed. Crossing the CTO on high speed may cause the shaft and/or guide wire to fracture as a result of excessive force.
Results may vary.
Suggestions on case studies offered by the physician are based on their experience using the Diamondback® Orbital Atherectomy System and are their opinion. Medical decisions for your patients are to be based upon their condition and your medical judgment. CSI does not recommend or endorse any particular course of treatment or medical choice. Before using any medical device, including those demonstrated or referenced in this case study, review all relevant Instructions for Use, with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device.