Overview
Dr. William Hull used orbital atherectomy via radial artery access in the treatment of severe claudication and stenosis in the left common femoral artery.
Dr. William Hull used orbital atherectomy via radial artery access in the treatment of severe claudication and stenosis in the left common femoral artery.
A 69-year-old male patient presented with severe claudication in his left lower leg. The patient had multiple previous coronary interventions, including coronary bypass surgery. Because of the left radial harvest for the previously performed CABG, this procedure was done via the patient’s right radial artery.
The primary care doctor for the patient noticed a loss of pulse in the left upper extremity. Since the patient had a left internal mammary graft to the left anterior descending artery, this was concerning. Additional symptoms included numbness in the patient’s upper left leg if he walked further than 50 feet, accompanied by discomfort in the left calf.
Pre-procedure the patient was classified as Rutherford Class 3, indicating severe claudication. The angiogram revealed 70% calcified stenosis in the left common femoral artery (CFA).
The right radial artery was accessed using a 5 fr access kit. A .035 guide wire was advanced to the abdominal aorta. The radial sheath was then exchanged for a 149 cm sheath. This was positioned in the left common iliac to access the left common femoral artery and used to perform the left lower extremity angiography. The angiography revealed 70% calcified stenosis in the proximal CFA with reduced blood flow to the lower leg.
A 475 cm ViperWire® Advance Guide wire was advanced across the CFA lesion. A Diamondback 360 Orbital Atherectomy System 1.50 Solid crown, 200 cm length was used to prep the vessel before ballooning. The Diamondback 360® was advanced to the proximal left CFA and into the proximal superficial femoral artery (SFA) to perform orbital atherectomy of the left SFA lesion, using low, medium, and high speeds for a total of 180 seconds. The orbital atherectomy resulted in brisk blood flow to the lower extremity. A 6 mm balloon catheter, 135 cm length, was then advanced across the SFA lesion with full balloon expansion noted at 2.5 atm and inflated to 8 atm for 90 seconds.
The final angiography revealed 0% stenosis with complete filling of all vessels to the foot with brisk blood flow. The patient was symptom-free post-procedure, with no angina or angina equivalent and no claudication.
Indications Statement: The Diamondback 360® and Stealth 360® Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems 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.
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.
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.