Dr. Nathan Aranson is a vascular surgeon at Maine Medical Center in Portland, Maine. He shares with us his experience using IVL for aortoiliac occlusive disease (AIOD).
Background on AIOD
Dense calcification in AIOD has long been a challenge for endovascular tools. The TransAtlantic Inter-Society Consensus (TASC) II guidelines recommend endovascular treatment for TASC A and B lesions and surgical therapy for more complicated TASC C and D lesions. However, several studies have demonstrated success with endovascular tools for these more complicated lesions as well. Intravascular lithotripsy (IVL) is a new tool in our armamentarium and has the potential to allow us to treat more of these challenging lesions with an endovascular approach. This is undoubtedly better for patients in terms of morbidity and recovery and also likely more cost effective from the hospital perspective than using an open surgical approach, which tends to require long recovery and hospital length of stay.
Medical History & Physical Assessment (H&P)
As an example of the use of this technology, we recently performed “kissing” bilateral IVL in 54 y.o. female. The patient was unable to participate in cardiac rehab due to her aortoiliac occlusive disease with short distance claudication and left lower extremity rest pain. Axial imaging suggested distal aorta and proximal common iliac occlusive disease and she was recommended to undergo bilateral pelvic angiography with iliac intervention. The angiogram revealed aortic ectasia with severe stenosis at the aortic bifurcation extending into the bilateral common iliac arteries all greater than 70%. The Right external iliac artery had a prior stent with greater than 50% stenosis proximal to the stent and greater than 70% stenosis distal to stent. Diffuse left external iliac artery stenosis less than 50% was also visualized.
We performed ultrasound-guided bilateral femoral access. The lesions were crossed retrograde with catheters and wires and the sheaths were appropriately upsized. Two Sparta core 0.014 wires were advanced bilaterally. We advanced our 7 x 60 mm IVL catheters into the infrarenal aorta centered around the aortic bifurcation where the disease was heaviest. We delivered 90 pulses with each catheter before moving the catheters distally into the common iliac arteries and repeating. We then removed the IVL balloons and performed angiography which revealed an excellent result with the IVL balloons alone. We then placed our 8 x 59 mm iCAST stents bilaterally into the common iliac arteries in “kissing” fashion raising the aortic bifurcation proximally a few cm. We then performed right pelvic angiography and treated the endpoint stent stenosis with 6x60mm POBA.
Overall, the patient did well and there were no access site complications at the end of the procedure. She had palpable pulses in bilateral femoral arteries and profunda only outflow raising her ABI from 0.4 to 0.6. Her rest pain disappeared and her walking was greatly improved allowing her to participate in cardiac rehab and a formal walking program.
We believe that the case provides a nice example of the potential for IVL to provide a safe and effective endovascular option for patients who would, without this technology, almost certainly have required surgical intervention.
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Important Safety Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indication for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Contraindications – Do not use if unable to pass 0.014 guidewire across the lesion • Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.
Warnings – Only to be used by physicians who are familiar with interventional vascular procedures • Physicians must be trained prior to use of the device • Use the Generator in accordance with recommended settings as stated in the Operator’s Manual
Precautions – Use only the recommended balloon inflation medium • Appropriate anticoagulant therapy should be administered by the physician • Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology
Adverse Effects – Possible adverse effects consistent with standard angioplasty include: • Access site complications • Allergy to contrast or blood thinners • Arterial bypass surgery • Bleeding complications • Death • Fracture of guidewire or device • Hypertension/Hypotension • Infection/sepsis • Placement of a stent • Renal failure • Shock/pulmonary edema • Target vessel stenosis or occlusion • Vascular complications. Risks unique to the device and its use: • Allergy to catheter material(s) • Device malfunction or failure • Excess heat at target site
Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com