Overview
Dr. Siddhartha Rao used the Diamondback 360® Peripheral Orbital Atherectomy System in the treatment of the left common iliac artery.
Dr. Siddhartha Rao used the Diamondback 360® Peripheral Orbital Atherectomy System in the treatment of the left common iliac artery.
The patient is a 73-year-old male with a history of diabetes, hyperlipidemia, hypertension, end-stage renal disease, and prior history of tobacco use. After a previous left distal common iliac artery stent placement, the patient presented with life-limiting left lower extremity claudication. Diagnostic angiography revealed an under-expanded left distal common iliac artery stent and a new 90% calcified proximal common iliac artery stenosis.
Using ultrasound guidance, access was obtained into bilateral common femoral arteries and 7 Fr 23 cm sheaths were placed. On the left side, a guidewire was advanced and the distal under-expanded stent was treated with a 7 x 20 mm balloon, and subsequently, a 8 x 20 mm balloon at rated burst pressures. The stented segment showed no appreciable luminal gain. The balloon catheter was then removed.
Due to the concern for a similar suboptimal angiographic result for the newer more proximal lesion using the same balloon and stent strategy, the decision was made to modify the calcified plaque using orbital atherectomy prior to stent placement.
The guidewire was exchanged for a ViperWire Advance® guide wire in the left iliac artery. A peripheral Diamondback® 2.00 mm Solid Crown was used to perform atherectomy with one pass on medium and four passes on high speed. This was followed by post-dilation with an 8 x 20 mm balloon with full expansion. Kissing balloon angioplasty of bilateral proximal common iliac arteries was performed with two 8 x 20 mm balloons.
A stent catheter was inserted into the left iliac artery and the 10 x 40 mm self-expanding stent deployed across the proximal left common iliac artery lesion. The stent was then post-dilated using a 9 x 40 mm balloon at nominal pressures. A final kissing balloon angioplasty of bilateral proximal common iliac arteries was performed with two 9 x 40 mm balloons.
Bilateral groin hemostasis was obtained with closure devices. The total procedure time from access to hemostasis was 84 minutes.
Angiography revealed excellent stent expansion and apposition with no complications. The patient experienced a complete resolution of claudication symptoms on the left side after the procedure.
The use of the Diamondback 360 Orbital Atherectomy device for calcified plaque modification in this patient facilitated stent expansion and led to complete symptom relief.
Previously, in the more distal segment, suboptimal vessel preparation of calcified plaque led to inadequate stent expansion (and accompanying clinical hazards).
The use of the Diamondback illustrated the clinical benefits of the Orbital Atherectomy device to modify calcified plaque as a means of vessel preparation.
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.
Use of the OAS is contraindicated when the target lesion is within a bypass graft or stent.
Case and images courtesy of Dr. Siddhartha Rao, WakeMed Hospital, Raleigh, North Carolina. Dr. Rao is a consultant of CSI. The opinions and clinical experience presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Results and procedure times 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.