Overview
Dr. Wail Asfour used orbital atherectomy via radial artery access to revascularize chronic calcified occlusions of the right and the left superficial femoral artery.
Dr. Wail Asfour used orbital atherectomy via radial artery access to revascularize chronic calcified occlusions of the right and the left superficial femoral artery.
A 70-year-old female patient presented with claudication in both legs after limited ambulation and reported dissatisfaction in quality of life. The patient’s podiatrist performed an ankle-brachial index examination of both lower extremities and referred the patient for treatment.
The patient previously had bilateral external iliac stents implanted. The patient also suffers from, heart disease, Type 2 diabetes mellitus, hypertension and obesity. Because of the patient’s obesity and chronic conditions, a trans-radial approach was decided.
Ultrasound-guided access of the left radial artery was obtained, and a pigtail catheter and long guide wire were introduced and negotiated into the abdominal aorta. After interrogating the abdominal aortogram, the bilateral external iliac stents were identified.
A 200 cm, .035″ ViperCath™ XC Peripheral Exchange Catheter with a 30° angled tip was introduced to image the right lower extremity and the tibial arteries selectively. Following the angiogram, the sheath was positioned in the right external iliac and the guide wire was exchanged for a 475 cm ViperWire® Guide Wire, and the 1.75 Solid crown 180 cm Diamondback 360® Peripheral Orbital Atherectomy System was advanced through the right common iliac artery. Orbital atherectomy was performed followed by angioplasty a 6.0 x 200 mm balloon. These interventions successfully treated the calcified disease of the right lower extremity.
It was then decided to retract the angled tipped ViperCath and sub-select the left lower extremity to identify infrainguinal disease and develop a treatment plan. Multi-level peripheral artery disease was noted in the left superficial femoral artery (SFA) with severe 99% high-grade stenosis. The ViperCath was used to direct and position the ViperWire into the popliteal artery, and an angiogram of the crural arteries was performed. Successful orbital atherectomy of the SFA was performed using the Diamondback 360. After which, angioplasty using a 6.0 x 200 mm balloon was performed to dilate the left SFA to the common femoral artery.
Using a left radial approach, the successful atherectomy and angioplasty of the right and left SFA were performed. Post-procedure angiogram showed good blood flow and the patient had no complications.
Bilateral peripheral orbital atherectomy utilizing radial access is a useful alternative option for compromised obese or hypersthenic patients, even with severely stenosed vasculature.
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 ViperCath™ XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.
Contraindications: Use of the ViperCath™ XC Peripheral Exchange Catheter is contraindicated in coronary or cerebral arteries, pregnant women, and patients with a contraindication to antiplatelet and/or anticoagulant therapy.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indication: The Diamondback 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 stenotic material from artificial arteriovenous dialysis fistulae.
Important Safety Information: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. 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.