Overview
Dr. Mahir D. Elder used orbital atherectomy in the treatment of a superficial femoral artery (SFA) chronic total occlusion (CTO).
Dr. Mahir D. Elder used orbital atherectomy in the treatment of a superficial femoral artery (SFA) chronic total occlusion (CTO).
A 58-year-old African American male presented with a CTO of the SFA and a non-healing ulcer of the great toe. Multiple attempts to cross the lesion from an antegrade approach were unsuccessful despite the use of a variety of catheters, wires, and other devices. Finally, retrograde access through a collateral artery was achieved and the Diamondback 360® 1.25 mm Micro Peripheral Orbital Atherectomy System was used to successfully treat the calcified lesion.
This patient presented with complaints of severe claudication. He was unable to walk more than 50 feet significantly limiting his ability to perform activities of daily living.
The patient was also forced to resign from his job as a tow truck driver due to severe lower extremity pain.
The patient’s major contributing risk factor for peripheral artery disease (PAD) was diabetes. He was Rutherford category 4 to 5. The patient had not received prior surgical treatment for PAD.
Angiographic assessment prior to atherectomy showed a right SFA CTO greater than 250 mm in length, which was heavily calcified and visible under fluoroscopy.
After multiple failed antegrade crossing attempts, retrograde crossing of the superficial femoral artery (SFA) chronic total occlusion (CTO) via the medial collateral artery was achieved; the lesion was successfully treated with a 145 cm Diamondback 360® 1.25 mm Micro Crown without the need for post-atherectomy stent placement.*
Flush ostial CTO prevented an antegrade approach despite several attempts and the use of multiple devices. Retrograde crossing via the medial collateral artery was attempted and achieved. A right SFA stick was performed and a 5 Fr introducer sheath was placed. The medial collateral artery was successfully crossed and the SFA was re-entered below the lesion. The CTO was then crossed via a retrograde approach and successful atherectomy of the heavily calcified lesion was achieved with a 145 cm Diamondback 360® 1.25 mm Micro Crown. The crown was passed two times on low speed.
After atherectomy, balloon dilatation was performed using a 4.0 mm X 120 mm Chocolate® Balloon [TriReme Medical] at 8 ATM for 2 minutes and a 3.5 mm balloon catheter at 6 ATM for 3 minutes. No waist was observed in either balloon.
After atherectomy and adjunctive PTA, residual stenosis in the SFA was 10%. Stent placement was not required. The patient later stated that his leg and foot pain had subsided substantially and the ulcer on his great toe had begun to heal. The patient was optimistic about returning to work.
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.