Overview
Dr. Mehiar El-Hamdani used orbital atherectomy in the treatment of a severely calcified below the knee TPT stenosis.
Dr. Mehiar El-Hamdani used orbital atherectomy in the treatment of a severely calcified below the knee TPT stenosis.
This 67-year-old caucasian male is a self-employed bar owner who spends long hours on his feet. He presented with severe leg pain while walking and severe rest pain.
The patient had a history of peripheral artery disease (PAD), neuropathy, diabetes, coronary artery disease, hypertension, and hyperlipidemia. He has smoked 3 to 4 packs per day for the past 47 years. Rutherford classification was category 4 due to rest pain.
Prior treatments for PAD (including a non-healing right leg ulcer of 2 to 3 months duration) included above the knee balloon angioplasty and stent placement in the left superficial femoral artery (SFA) in August 2013 and the left and right common iliac arteries in July 2013. The right leg ulcer healed completely but the patient continued to complain of claudication mainly in the left leg. Walking was limited to less than 100 yards.
Assessment prior to atherectomy showed a severely calcified lesion in the TPT, which was 80 mm long and 80% stenosed. Severe disease was also noted in the popliteal artery and the superficial femoral artery (SFA) with in-stent restenosis (ISR).
Retrograde anterior tibial artery access with a 60 cm Diamondback 360® 1.25 mm Solid Crown resulted in reduction of a tibial peroneal trunk (TPT) stenosis from 85% to 0%. The orbital atherectomy procedure was completed quickly in 11 minutes.
Prior to treating below-the-knee lesions with orbital atherectomy, the patient underwent endovascular treatment for inflow disease. After accessing the anterior tibial artery via ultrasound guidance and treating inflow disease through a 6 Fr sheath, a guidewire was used to cross the TPT lesion and advanced down into the posterior tibial artery from the sheath placed in the distal anterior tibial artery. After exchange of the Asahi Regalia for a 0.012″ CSI ViperWire®, orbital atherectomy was carried out using a 60 cm Diamondback 360® Peripheral Device 1.25 mm Solid Crown. The initial pass of the crown was at low speed for 30 seconds. This was followed by two additional passes, one at medium speed for 15 seconds and a final pass at high speed for 20 seconds.
After orbital atherectomy of the TPT, balloon dilatation was performed using a 4.0 mm x 80 mm Chocolate® Balloon [TriReme Medical] at 6 ATM for 3 minutes. No waist was observed in the balloon.
Total procedure time for the retrograde anterior tibial artery approach and treatment of the TPT was approximately 11 minutes, which included passing and exchange of the guide wires, access of the TPT lesion, atherectomy, and post-atherectomy balloon angioplasty.
After Diamondback Peripheral Orbital Atherectomy and adjunctive PTA, residual stenosis in the TPT was 0%. The patient was discharged to home 8 hours after the procedure. Rest pain resolved, and the patient was able to walk further without experiencing claudication.
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.