Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing General Steps for Planning and Sizing the Zenith® Fenestrated AAA Endovascular Graft 1. Plan the seal/fenestration Zone • Choose the lowest aortic segment that will provide an adequate seal – both designing and deploying a graft increase in difficulty with the number of fenestrations • Go higher only as needed to find the straightest segment of aorta (at least 50% of segment should be straight) • Avoid being too aggressive with first cases Choose one or two internal stents • In general two internal stents is preferred because it: – Maximizes the available sealing potential – Allows greater range of fenestration placement • Note that choosing two internal stents does: – Increase the proximal graft length by 8 or 10mm, depending on diameter – Reduce parallel overlap with the distal graft piece (Note the minimum overlap is 2 stents/ 36mm long) The number of internal stents chosen should be reviewed and confirmed later when selecting graft lengths. 2. Select Side for Graft Body Introduction • Assess potential access vessels with reference to: Tortuosity Diameter Stenosis Calcification Length, etc. • Generally choose the side that has the best access vessels, as this facilitates advancement and manipulation of the graft (e.g., rotation) to position the fenestrations where they will be easier to cannulate. • EXCEPTION: Unusual anatomy may dictate that the body be placed through the less desirable access vessels (e.g., because the graft delivery system will straighten access vessels more than wires and catheters will — anticipated difficulty in graft cannulation may justify graft delivery through more tortuous side. Revised March 2007 1 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing • The diameter of the access vessel to be used should be checked throughout its full length to ensure that it is large enough. Graft Diameters Minimum Access Vessel Diameter 22-36mm Proximal Body (20Fr) 7.5 mm Distal Body (20Fr) 7.5 mm 8-16mm TFLE Leg extension (14Fr) 5 mm 18-24mm TFLE Leg extension (16Fr) 6 mm 3. Choose fenestration Configuration Determine the Clock Position of Vessel(s): • This is established from the AP MIP CT angiography – The 2mm images at right angles to the centre line axis of the neck must NOT be used; these images will falsely represent the vessel clock positions and will likely cause misalignment of the fenestrations. • Clock positions are determined by first noting the middle of the aorta, then: 12 o’clock is on the anterior margin 6 o’clock is on the posterior margin 3 o’clock is 90 degrees away from 12 o’clock on the anatomical left 12:00 3:00 9:00 6:00 NOTE: a vessel falling between two clock positions is recorded to the quarter hour (e.g., 2:15, 2:30, 2:45 etc.) Revised March 2007 2 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing • A sagittal plane drawing can be used to record the clock positions of the vessels – accurate clock and distance information is needed to determine where the fenestrations should be placed during graft construction. NOTE: any aortic angulation should also be taken into account Coeliac CT Table position _______ Clock position_________ SMA CT Table position _______ Clock position_________ Left Renal CT Table position _______ Clock position_________ Right Renal CT Table position _______ Clock position_________ Accessory Vessel CT Table position _______ Clock position_________ Revised March 2007 3 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing • Complete form with fenestration dimensions and heights (heights are difference between table position targeted for top of graft material, and table position of corresponding vessel) Revised March 2007 4 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing EXAMPLES OF FENESTRATION CONFIGURATIONS: Example 1 – Single scallop When one renal is lower than the other, distance from lower limit of upper renal and mid line of lower renal is 3-9 mm, and distance from lower edge of upper renal and lower limit of infra-renal neck is 20 mm or more Steps Choose depth of scallop: 6, 8, 10, or 12 mm Choose angle (clock position) of scallop Limitations None (other than general principles) Example 2 – Two scallops When infra-renal neck is 8-15 mm, renal arteries are within 3 mm of same level and distance from mid-line of lower renal and lower limit of SMA is greater than 9mm Steps Choose depth of 1st scallop (6, 8, 10, or 12 mm) Choose clock position of 1st scallop Choose depth of 2nd scallop (6, 8, 10, or 12 mm) Choose clock position of 2nd scallop Limitations Angles of scallops must be two hours or more apart Example 3 – One scallop and one small fenestration When one renal artery is lower than the other, the infra-renal neck is < 10 mm, and distance from mid line of lower renal and lower limit of SMA is > 12mm Steps Choose size of small fenestration (6 mm or 6x8 mm) Choose distance of small fenestration from top edge (>15mm) Choose angle of small fenestration Choose depth of scallop Choose angle of scallop Limitations Fenestration and scallop must be more than 1hr 30min apart in angle if they are at the same stent level Revised March 2007 5 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Example 4 – Two small fenestrations When infra-renal neck < 10 mm, and distance from mid line of upper renal and lower limit of SMA is > 12 mm Steps Choose size of 1st small fenestration (6 or 6x8 mm) Choose distance of 1st small fenestration from top (>15mm) Choose angle of 1st small fenestration Choose size of 2nd small fenestration Choose distance of 2nd small fenestration from top Choose angle of 2nd small fenestration Limitations Small fenestrations must be > 2 hrs apart in angle Example 5 – Two small fenestrations and a scallop When infrarenal neck < 10 mm, and distance from mid line of upper renal and lower limit of SMA is > 5mm (distance of the celiac artery above the SMA should be checked to ensure that it is clear of the upper edge of the graft) Steps Choose depth and angle of scallop Choose size, distance, and angle of 1st small fenestration Repeat steps for 2nd small fenestration Limitations Small fenestrations must be > 1hr 30min apart in angle from scallop, and > 2 hr apart from each other Revised March 2007 6 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Example 6 – Two small fenestrations and one large fenestration When infra-renal neck < 10 mm, and distance from mid line of upper renal and lower limit of SMA is less than 5 mm (distance of celiac above SMA should be checked to ensure that it is clear of the upper edge of the graft) Steps Choose diameter of large fenestration (8, 10, or 12 mm) Choose distance of large fenestration below top edge of graft (>10 mm) Choose angle of large fenestration Choose size. distance below the top, and angle of 1st small fenestration Repeat for 2nd small fenestration Limitations Small fenestrations must be > 1hr 30min apart from large fenestration, and > 2 hr apart from each other if they are at the same stent level. 4. Choose Proximal Body Diameter (D1) • • • • • Measure aortic diameter over a length of approximately 20-30 mm, or the length of the sealing stent(s). Measure at the external diameter of the vessel, including the vessel wall thickness when it can be seen. Add an appropriate amount of over-sizing to ensure that the graft has an ‘interference fit’ within the vessel. When the landing zone has varying diameters throughout its length, the graft should be oversized to ensure good contact with the largest diameter of the landing zone. Over-sizing can vary from 15-25%, depending upon anatomy and physician preference. Aortic Diameter Proximal Body Diameter (D1) % Oversize 19-21 mm 24 mm 26.3% - 14.3% Introducer Sheath 20Fr 21-22 mm 26 mm 23.8% - 18.2% 20Fr 23-24 mm 28 mm 21.7% - 16.7% 20Fr 24-26 mm 30 mm 25.0% - 15.4% 20Fr 26-28 mm 32 mm 23.1% - 14.3% 20Fr 28-29 mm 34 mm 21.4% - 17.2% 20Fr 29-31 mm 36 mm 24.1% - 16.1% 20Fr Revised March 2007 7 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Considerations • With an oblique axial CT slice, the true diameter is usually the longest distance measured across the short axis of the vessel seen on the axial slice • Consider that the ellipse or elongated shape may be due to vessel irregularities rather than imaging angle • Calibrated angiography may be helpful in confirming the vessel size and nature, but be mindful that angiography generally shows only lumen size without atheroma, thrombus or vessel wall thickness NOTE: Angiography should not be used exclusively to determine vessel diameters, as it can be misleading. 5. Determine Inner Aortic Vessel Diameter • The inner aortic vessel diameter is taken at the level of the fenestrations — this measurement will determine the lateral placement of the fenestrations in graft construction • If there is any thrombus present, do not measure the lumen size — measure the inner vessel size. 6. Choose proximal graft length (L1) • • • In general, choose a proximal graft length that will place the distal end of the graft between 20-35 mm above the aortic bifurcation Review of CT angiography can be used to check that the choice of graft length would be suitable Angiography using a vessel-sizing catheter is helpful in considering suitable graft length 7. Choose Distal Body Length (L2) When choosing the distal body length: • The minimum overlap that must be planned is two stents (36mm) • It is usual to plan more overlap, e.g., 3-4 stents • The length chosen should place the contralateral limb position 5-10 mm above the aortic bifurcation • You must ensure that the proximal edge of the distal body is well below the lowest renal artery/lowest fenestration • The use of calibrated angiography, CT angiography, the anatomy sketch or a combination of these tools, are useful to confirm that aspects of the selected distal body are suitable Considerations • The graft component lengths should be chosen so that adequate overlap will be maintained if the completed graft takes a curved path out into the aneurysm sac Revised March 2007 8 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing 8. Choose Distal Body Ipsilateral Leg Diameter (D3) • • The integral ipsilateral leg distal diameter is determined by the sealing zone iliac vessel diameter from axial CT images: – Measure the vessel diameter at the landing zone of the sealing stent – Note the diameters over the length of the vessel – Measure at the external diameter of the vessel, including the vessel wall thickness when it can be seen Oversize from 15-25% to ensure an interference fit within the vessel, depending upon anatomy and personal choice Vessel Diameter 9-11 mm Graft Diameter (D3) 12 mm 12-15 mm 16 mm 15-18 mm 20 mm 18-21 mm 24 mm Considerations • • • In the presence of thrombus or atheroma, diameter should be determined from the outer vessel wall diameter and not from the lumen diameter Care should be taken with the amount of oversizing in small vessels – with larger vessels, a greater degree of oversizing can be applied, without the risk of compromising an adequate lumen The incidence of complications and secondary procedures is increased in iliac vessels that have: – Length less than 17mm – Diameters greater than 20mm – Tapering – Irregularities – Tortuosity Revised March 2007 9 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing 9. Choose Distal Body Ipsilateral Leg Length (L3) • • Plan the integral ipsilateral leg length to land just above the common iliac bifurcation – this increases stability and lowers risk of endoleak Choose a limb length that will span the distance from the contralateral limb (5-10 mm above the aortic bifurcation) to the desired landing zone NOTE: Because tortuous iliac arteries are angled posterior to the pelvis, the measured distance from the aortic bifurcation to the landing zone around the greater curvature will be greater than that measured using a 2D frontal image. During deployment, the stiff wireguide and introducing systems will straighten and foreshorten the vessel – a leg extension chosen from true length of a vessel (as determined by calibrated angiography or mid-lumen CT) may be too long In general if the ipsilateral limb length is chosen from the length measured on a twodimensional frontal image using CT reconstruction, the undersizing that arises will be compensated by the vessel shortening during graft introduction Considerations • • When the ipsilateral internal iliac is to be sacrificed, a standard TFLE leg graft may be required to reach the desired landing zone in the external iliac – this can be achieved by planning a 12 mm diameter ipsilateral leg on the distal body, long enough to maximise overlap with a standard TFLE leg graft (at least two stents should land in the external iliac artery) If endoluminal treatment might require sacrificing one or both of the internal iliac arteries, possible consequences of this approach should be considered and discussed with the patient Revised March 2007 10 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing 10. Choose Controlateral Leg Diameter NOTE: The contralateral leg graft is a standard Zenith TFLE-XX-XX • • • From axial CT images, measure the vessel diameter over the length of the landing zone of the sealing stent Measure at the external diameter of the vessel, including the vessel wall thickness when it can be seen Oversize from 15-25%, depending on anatomy and personal choice to ensure an interference fit within the vessel Vessel Diameter 7 mm 8-9 mm 10-11 mm 12-13 mm 13-15 mm 15-17 mm 16-18 mm 18-19 mm 20-21 mm Graft Diameter (D4) 8 mm 10 mm 12 mm 14 mm 16 mm 18 mm 20 mm 22 mm 24 mm Considerations (same as for ipsilateral leg) • • • In the presence of thrombus or atheroma, diameter should be determined from the outer vessel wall diameter and not from the lumen diameter Care should be taken with the amount of oversizing in small vessels – with larger vessels, a greater degree of oversizing can be applied, without the risk of compromising an adequate lumen The incidence of complications and secondary procedures is increased in iliac vessels that have: – Length less than 17mm – Diameters greater than 20mm – Tapering – Irregularities – Tortuosity Revised March 2007 11 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing 11.Choose Contralateral Leg Length (L4) • • • Estimate the position that the contralateral limb of the distal graft body is expected to take after deployment Determine the length from the distal edge of the limb (of the distal body) to the chosen landing zone in the iliac artery Choose a limb length that would satisfactorily span this distance Note the following: • The contralateral leg graft is a standard Zenith TFLE-XX-XX • TFLE leg grafts are 22mm longer than the nominal length to allow a 1 to 1¾ stent overlap into the contralateral limb • The overlap must never be less than one stent Considerations • It is usually desirable to plan the contralateral leg to land just above the common iliac bifurcation for greater stability and reduced likelihood of endoleak • When an internal iliac is to be sacrificed, it is suggested that at least two stents (34mm) land in the external iliac artery • If endoluminal treatment might require sacrificing one or both of the internal iliac arteries, possible consequences of this approach should be considered and discussed with the patient Revised March 2007 12 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Revised March 2007 13 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Revised March 2007 14 of 15 Zenith® Fenestrated AAA Endovascular Graft – General Steps for Planning and Sizing Revised March 2007 15 of 15