Overview
Dr. Tarpan R. Patel used the Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series with GlideAssist® in the treatment of multi-level disease to avoid amputation.
Dr. Tarpan R. Patel used the Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series with GlideAssist® in the treatment of multi-level disease to avoid amputation.
The patient is a 70-year-old African American female with a history of diabetes, hypercholesteremia, and is in end stage renal disease that requires frequent dialysis. The patient had already undergone a below the knee amputation on the right side and has had multiple percutaneous transluminal angioplasties (PTAs) of her left superficial femoral artery (SFA) and posterior tibial artery.
The patient presented with PAD with CLI of her left foot. Additionally, the patient presented with worsening disease above and below the knee, putting the limb at risk for an above the knee amputation
The right femoral artery was accessed using a micro puncture kit. A sheath was inserted, along with a rim catheter and 0.035 guide wire was used to advance the rim catheter into the abdominal aorta to perform a pelvic angiogram. The rim catheter was advanced to perform a left lower extremity angiogram. The sheath was exchanged for a 6 Fr 65 cm guiding sheath. Then a 0.014 support catheter was used with a 0.014 guide wire to cross the superficial femoral artery into the distal posterior tibial artery of the left foot. The guide wire was then exchanged for a ViperWire Advance® Guide Wire. A Diamondback 360® Orbital Atherectomy System Exchangeable Series – with GlideAssist® device was used with a 1.25 micro crown to perform orbital atherectomy of the left distal posterior tibial artery. Afterward, a 2.0-2.5 x 210 mm balloon was inflated at 10 atm x 3 for one minute.
This resulted in a brisk blood flow from the popliteal artery down to the foot via the posterior tibial artery.
The secondary lesion in the left SFA was addressed next. The 1.25 micro crown cartridge was exchanged for a 2.00 solid crown to allow for an appropriate sized crown to be used for treatment of the larger sized vessel in the SFA. Afterward, a 6.0 x 60 cm balloon was inserted and inflated within the lesion at 8 atm. Due to the multiple previous interventions, a 5.5 x 87 cm stent was deployed and was post-dilated with a 6.0 x 60 cm balloon at 10 atm for 30 seconds.
An angiogram performed after the stent insertion showed that blood flow was restored from the superficial femoral artery, down the popliteal artery, and down the left popliteal artery to the left posterior tibial artery and into the left foot.
The use of the Diamondback 360 Orbital Atherectomy device for calcified plaque modification led to procedure success and helped avoid a second amputation for this patient.
The Exchangeable Series device allowed for multiple crowns to be used for treatment of different sized vessels that needed to be addressed in a single procedure.
GlideAssist allowed smooth passage through tortuous anatomy to enable the physician to perform orbital atherectomy of the left distal posterior tibial artery.
Indications Statement: The Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series 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.