ARTERIAL DILATIVE

• A proximal aortic landing zone for the sealing ring 7 mm below the inferior renal artery.

• Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7 mm below the inferior renal artery,
• Lack of significant calcification at the level of 7 mm below the inferior renal artery,
• Conicity < 10% as measured from the inferior renal artery to the aorta 7 mm below the inferior renal artery,
• An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and
• An aortic angle of ≤ 60 degrees

• With a length of at least 10 mm, and
• With an inner wall diameter of no less than 8 mm and no greater than 25 mm.

• Patients with abdominal aortic or aortoiliac aneurysms having morphology not suitable for endovascular repair
• Patients with known sensitivities or allergies polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, contrast agents, fluorinated ethylene propylene [FEP], titanium, nickel, platinum, or iridium.
• Patients with a systemic infection who may be at increased risk of endovascular graft infection

• 2000 mg Kefzol
• Check anticoagulation
• Check allergies
• Imaging and EVAR measurement on wall/monitor
• Check ordered grafts tents
• Intravenous line

• Chlorhexidine
• Standard angiography set
• Lidocaine 10 ml x 2
• Bupivacaine 10 ml x 2
• Contrast
• Heparinized saline and flushing syringes
• 6F Introducer x 2
• 0.035" Terumo Stiff guidewire (260 cm)
• 0.035" Compatible radiopaque tip 5 F angiographic pigtail catheter
• 0.035" Lunderquist guidewire (260 cm) x 2
• 0.014" or 0.018", 300 cm Non-hydrophillic, snare compatible guidewires
• Endovascular snare
• 20 ml syringe for integrated balloon inflation
• Exchange catheters and shaped catheters for contralateral gate cannulation
• ALTO Abdominal Stent Graft Aortic Body preloaded in delivery system
• Ovation iX Iliac Limbs preloaded in delivery systems— size one for each: ipsilateral and contralateral limbs (may require additional limbs if extending to external iliac or if long distance from IR to the internal iliac) Ovation iX Iliac Extension (as required)
• CustomSeal Polymer Fill Kit (14-minute cure time) Autoinjector 2
• Non-compliant balloons (for leg/limb overlap) Compliant aortic balloon
• Manta 14F (up to 14F)
• Manta 18F (15-20F)

• Balloon expandable stent with appropriately sized balloon
• 14 F sheath (e.g. 45 cm)
• Embolization devices (coils)

• Head first
• Supine

Access

• Infiltration with Lidocaine and Bupivacaine
• Access both sides under ultrasound
• Measure Manta, and record (in format x +1)
• Place 6F sheaths
• On the side of the main body: pigtail angiography catheter over floppy guidewire (Terumo) to the aortic arch
• Replace floppy guidewire with stiff guidewire (Lunderqvist), mark length with sticker on the table
• Remove angiography catheter
• On the left side of the leg: pigtail angiography catheter over floppy guidewire just above the level of renal artery origin
• Remove floppy guidewire, flush with heparin-saline, connect to the pump
• 5000 IU heparin i.v.

• Set the C-arm at the level of the renal artery origin with the correct inclination and rotation
• Insert the main body proximally above the renal arteries, position the marker of the contralateral leg (line on the ipsilateral side)
• Position the endograft and de-sheath
• Turn and remove the mid-crown deployment knob (yellow)
• Remove the white cap from the integral balloon injection port
• With 5 or 10 ml (see table) contrast/NaCl partially deploy the proximal markers
• Deflate the balloon
• Adjust C-Arm for parallax, make sure to project the 8 markers on line
• Pump angiography (20cc, 10cc/sec, 3 images/sec)
• Mark the most distal renal artery on the monitor (both upper and lower border)
• Position the markers at the mid-level of the renal artery
• Retract the pigtail angiography catheter (over the wire)
• Turn and pull the proximal crown deployment knob (yellow) to fully deploy the proximal stent, which fixates the stent

• Open the stop cock and mix polymer by 20 strokes in the two syringes
• Start a timer for 14 minutes
• Transfer contents to syringe with green band, then expel to the minimum fill syringe volume appropriate to the aortic diameter (according to the table on the mixing system
• Close stopcocks. Remove green tear tab and disconnect fill syringe (there is a plastic cover over the syringe connection with the green marker).
• Remove green fill cap from the polymer injection port and attach fill syringe.
• Push Autoinjector over the syringe plunger and lock into place by rotating 90 degrees, until you hear an audible click. Filling will begin aortic body in aproximately one minute
• Retract aortic body guidewire until the stiff to floppy transition is in the ipsilateral leg

• Cannulate the contralateral leg (if unsuccessful see tips and tricks
• Place stiff guidewire (Lunderquist) to the level of the aortic arch
• Measurement catheter on the wire
• Angulate for AII image
• Blowback angiography on the leg side
• Mark upper limit of AII on the screen
• Fluoroscopy
• Measure the leg (upper half ring leg to AII)
• Remove sheath
• Position iliac limb radiopaque markers between the third and fourth half ring of the aortic body leg to ensure appropriate overlap.
• Deploy the leg
• Maintain position of sheath and retract catheter handle to position nosecone in end of delivery system outer sheath.
• Continue to retract the blue handle until entire inner catheter is removed

• Remove the green autoinjector from fill syringe
• Readvance aortic body guidewire
• Position balloon radiopaque markers proximal to the primary sealing ring and distal to secondary ring
• Manually inflate balloon with 4:1 saline and contrast mixture to recommended volume (see table).
• Completely deflate balloon by pulling vacuum and confirm seal angiographically

• Rotate the third deployment knob ¼ turn counterclockwise and pull knob and wire from handle.
• Advance the delivery system sheath to the first ring of the aortic body.
• Stabilize the delivery system and retract inner catheter until the nosecone is within the aortic body,
• Slightly retract the sheath 2-4 cm, then continue to retract the inner catheter handle to reseat the nosecone into the outer sheath
• To use the integrated sheath, while maintaining guidewire position, move entire delivery system to desired position
• Retract handle to remove the inner catheter from the outer sheath

• Exchange to 14F sheath
• Measurement catheter on the wire
• Angulate for AII image
• Blowback angiography
• Mark upper limit of AII on the screen
• Fluoroscopy
• Measure the leg (upper half ring leg to AII)
• Place limb delivery system over guidewire
• Position iliac limb radiopaque markers between the third and fourth half ring of the aortic body leg to ensure appropriate overlap
• Retract sheath to deploy iliac limb
• Retract catheter handle to position nosecone in end of delivery system outer sheath
• If maintaining the sheath, reposition sheath tip to desired location and continue to retract the blue handle until entire inner catheter is removed.

• Balloon the first covered stent body and both legs entirely over stiff guidewires
• Angiography with syringe pump (20cc, 10cc/sec, 3 images/sec) and aspiration sheaths with two empty 20 cc syringes. Long series to exclude endoleaks

• Hemostasis with Manta devices

Cannulation of the contralateral leg

• The integrated crossover lumen may be used to facilitate the process using a maximum 0.018” guidewire through the crossover lumen port on the handle, which then can be snared from the contralateral side. Insert a 5 F sheath over the contralateral crossover guidewire. Insert a buddy guidewire into the aortic body leg and advance proximally. Then remove the cross-over wire

• 0 to 14 minutes - No ballooning allowed
• ≥14 minutes - Integrated balloon (or compliant if integrated balloon has been removed or damaged)
• >30 minutes - Ballooning much less effective

• 4 hours bedrest
• 2000 mg Kefzol 8 and 16 h after the procedure

Pre-Discharge and Follow-Up Plan

• Pre-discharge CTA (CT angiography)
• 6-week follow-up with the operating surgeon, including a CTA, to be discussed in the vascular meeting
• Annual follow-up CTA

• Type 1 or 3 endoleak on first postoperative CTA → Refer to vascular meeting and plan reintervention
• Type 2 endoleak without aneurysm growth → Conservative management
• Type 2 endoleak with aneurysm growth (≥5 mm in 1 year) → Refer to vascular meeting and plan reintervention
• Target vessel occlusion or stenosis → Refer to vascular meeting

• Verify if the patient is on antiplatelet therapy or anticoagulation and a statin
• If not prescribed, initiate:
• Clopidogrel 75 mg once daily
• Atorvastatin 40 mg once daily