Overview
Dr. Howard J. Feldman used orbital atherectomy to improve distal flow in a Peripheral Artery Disease (PAD) patient with diffuse and densely calcified disease.
Dr. Howard J. Feldman used orbital atherectomy to improve distal flow in a Peripheral Artery Disease (PAD) patient with diffuse and densely calcified disease.
A 73-year-old male with critical limb ischemia (the most severe form of PAD) and chronic total occlusion (CTO) presented with non-healing ulcers on his right toes and associated osteomyelitis of the right second toe. After a failed antegrade approach, successful retrograde access was achieved through the right anterior tibial artery allowing for treatment of diffuse and densely calcified disease in three vessels.
This Rutherford category 5 patient had multiple risk factors for peripheral artery disease. He was a poorly controlled Type 2 diabetic who continued to use tobacco. Medical history also included hypertension, hyperlipidemia, ischemic heart disease with prior coronary artery bypass grafting (CABG), peripheral neuropathy, and chronic obstructive pulmonary disease (COPD). Previously, he underwent a right common femoral endarterectomy with bilateral femoral popliteal bypasses. A second left femoral popliteal bypass was performed two months after the initial procedure.
Pre-atherectomy assessment showed the right dorsalis pedis pulse to be detectable by Doppler while the right posterior tibial pulse was absent. Angiography revealed CTO of the right femoral popliteal bypass graft, a patent right profunda femoris artery, and a diffuse and densely calcified CTO of the right superficial femoral artery (SFA) extending below the knee into the popliteal artery.*
Through retrograde access, a 4 Fr. 60 cm Diamondback 360® Peripheral Orbital Atherectomy System improved distal flow in a Peripheral Artery Disease (PAD) patient with diffuse and densely calcified disease.
Initially, antegrade crossing of the right SFA CTO was attempted but was unsuccessful. Retrograde crossing was then attempted under ultrasound guidance. Retrograde angiography via an anterior tibial access revealed a diffusely diseased anterior tibial (AT) artery and densely calcified subtotal occlusion to CTO of the tibial-peroneal trunk (TPT) and peroneal arteries.
Retrograde anterior tibial access was achieved and a .012″ ViperWire guide wire was advanced across the lesion to the distal right popliteal artery. Orbital atherectomy treatment was completed in three different vessels with a 4 Fr. 60 cm Diamondback 360® 1.25 mm Micro Crown. Since the patient had diffuse disease, multiple lesions were treated within each vessel. The anterior tibial artery was treated followed by the tibial-peroneal trunk and peroneal arteries. Low pressure percutaneous transluminal angioplasty (PTA) was then performed at 6 ATM and 4 ATM in the right peroneal and right anterior tibial arteries, respectively.
Orbital atherectomy facilitated reduction in the ostial right anterior tibial artery stenosis from >80% to 0% and reduction in the proximal right peroneal artery stenosis from 95% to <30%. Post-procedural flow was sufficiently enhanced to render retrograde luminal opacification suboptimal. Additionally, the dorsalis pedis Doppler signal changed from monophasic and severely damped prior to treatment to strong and biphasic post-intervention. With improved distal flow to the right foot, the patient was referred for a femoral tibial bypass graft surgery.
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.