E-liac stent graft: Sustaining hypogastric flow—preserving pelvic functionality

September2018

E D U C AT I O N A L S U P P L E M E N T

Section Name Aortoiliac aneurysms

Application of iliac branch device for preserving the internal iliac artery in patients with aortoiliac aneurysmatic disease

By Professor Jan Sigge Brunkwall and Dr Spyridon Mylonas, from the Vascular Surgery Department of University Hospital Cologne in Germany

T

Jan Sigge Brunkwall

he presence of common iliac artery aneurysm might pose considerable challenges in achieving an effective seal and distal fixation for conventional endovascular aneurysm repair. They exacerbate the complexity of endovascular aneurysm repair and increase the incidence of type Ib endoleak, iliac limb occlusion, and aneurysm rupture.1 Abdominal aortic aneurysms are associated with unilateral common iliac artery aneurysms in 43% and bilateral common iliac artery aneurysms are found in 11% of patients with non-ruptured abdominal aortic aneurysms.2 Moreover, isolated iliac artery aneurysms are rare, representing <1% of the aortoiliac aneurysm repairs and their prevalence in the general population is estimated at 0.03%.3,4 The natural history of iliac artery aneurysms, particularly those occurring in isolation, is less well understood but deserves special mention. The Mayo Clinic group reported a median expansion rate in common iliac artery aneurysms of 0.29cm per year and reported no ruptures at less than 3.8cm.5 The most frequently applied approach in those cases involving the iliac bifurcation is to sacrifice the internal iliac artery and to extend the stent graft into the external iliac

Spyridon Mylonas

artery. 1,6 Although usually well tolerated, occlusion of the internal iliac artery can cause ischaemic manifestations after endovascular aneurysm repair such as buttock claudication, sexual dysfunction and colonic ischaemia. 7-9 The incidence of postoperative sexual dysfunction and buttock claudication varies widely in the literature, ranging from 16% to 50% for unilateral and 16% to 80% for bilateral internal iliac artery embolisation. 10 Additionally, rare serious complications, such as spinal cord ischaemia or and gluteal necrosis may occur in up to 1â&#x20AC;&#x201C;3% of bilateral internal iliac artery occlusion cases. 11,12 Therefore, the European Society for Vascular Surgery established the Clinical Practical Guidelines for the management of abdominal aortic aneurysms, wherein it is recommended that bilateral interruption of the internal iliac artery, at least in standard-risk patients, should be avoided. 13 On the same concept, the recently revised Guidelines of the Society for Vascular Surgery recommend preservation of flow to at least one internal iliac artery. 14 Several endovascular techniques have been described to preserve internal iliac artery flow, including the

development of commercially available aortoiliac endografts that incorporate an iliac branch. Currently, there are several designs of iliac branch devices commercially available in Europe for the treatment of aneurysms involving the iliac bifurcation.

The E-liac stent graft system is a novel iliac branch device initiated by JOTEC, and consists of electropolished self-expanding nitinol stents covered with woven polyester.

In the middle segment of the implant, the stents are sutured to the fabric using a flat, highdensity polyethylene suture material, whereas increased friction to the landing areas is provided by a braided polyester suture line at the distal and proximal segments.

The asymmetric spring configuration provides good conformability to the vessel shape, which minimises the risk of kinking in angulated anatomies, while maintaining appropriate longitudinal stiffness. Smooth bridging to Continued on next page

Figure 1: Preoperative CT angiogram depicting the infrarenal aortic aneurysm and the right common iliac artery aneurysm involving the iliac bifurcation

Figure 2: The E-liac device is partially deployed with the markers facing the iliac stump

All rights reserved. Published by BIBA Publishing, London T:+44 (0)207736 8788, publishing@bibamedical.com. The opinions expressed in this supplement are solely those of JOTEC/CryoLife and the physicians and may not reflect the views of Vascular News.

References 1. Hobo R, Sybrandy JE, Harris PL, Buth J. Endovascular repair of abdominal aortic aneurysms with concomitant common iliac artery aneurysm: outcome analysis of the EUROSTAR Experience. J Endovasc Ther. 2008;15(1):12–22.

2. Hinchliffe RJ, Alric P, Rose D, et al. Comparison of morphologic features of intact and ruptured aneurysms of infrarenal abdominal aorta. J Vasc Surg. 2003;38(1):88–92.

3. Brunkwall J, Hauksson H, Bengtsson H, et al. Solitary aneurysms of the iliac arterial system: an estimate of their frequency of occurrence. J Vasc Surg. 1989;10(4):381–4.

4. Sandhu RS, Pipinos, II. Isolated iliac artery aneurysms.

Semin Vasc Surg. 2005;18(4):209–15.

5. Huang Y, Gloviczki P, Duncan AA, et al. Common iliac artery aneurysm: expansion rate and results of open surgical and endovascular repair. J Vasc Surg. 2008;47(6):1203–10; discussion 10–1.

6. Papazoglou KO, Sfyroeras GS, Zambas N, et al. Outcomes of endovascular aneurysm repair with selective internal iliac artery coverage without coil embolization. J Vasc Surg.

2012;56(2):298–303.

7. Karch LA, Hodgson KJ, Mattos MA, et al. Adverse consequences of internal iliac artery occlusion during endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2000;32(4):676–83.

8. Lin PH, Chen AY, Vij A. Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important?

Semin Vasc Surg. 2009;22(3):193–200.

9. Pavlidis D, Hormann M, Libicher M, et al. Buttock claudication after interventional occlusion of the hypogastric artery--a mid-term follow-up. Vasc Endovascular Surg.

2012;46(3):236–41.

10. Rayt HS, Bown MJ, Lambert KV, et al. Buttock claudication and erectile dysfunction after internal iliac artery embolization in patients prior to endovascular aortic aneurysm repair.

Cardiovasc Intervent Radiol. 2008;31(4):728–34.

11. Duvnjak S. Endovascular treatment of aortoiliac aneurysms: From intentional occlusion of the internal iliac artery to branch iliac stent graft. World J Radiol.

2016;8(3):275–80.

12. Kouvelos GN, Katsargyris A, Antoniou GA, et al. Outcome after Interruption or Preservation of Internal Iliac Artery Flow During Endovascular Repair of Abdominal Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2016;52(5):621–34.

13. Moll FL, Powell JT, Fraedrich G, et al. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011;41 Suppl 1:S1–S58.

14. Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg.

2018;67(1):2–77 e2.

15. Mylonas SN, Rumenapf G, Schelzig H, et al. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg.

2016;64(6):1652–9 e1.

16. Wong S, Greenberg RK, Brown CR, et al. Endovascular repair of aortoiliac aneurysmal disease with the helical iliac bifurcation device and the bifurcated-bifurcated iliac bifurcation device. J Vasc Surg. 2013;58(4):861–9.

17. Loth AG, Rouhani G, Gafoor SA, et al. Treatment of iliac artery bifurcation aneurysms with the second-generation straight iliac bifurcated device. J Vasc Surg. 2015;62(5):1168– 75.

18. Brunkwall J, Vaquero Puerta C, Heckenkamp J, et al.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular.

2018:1708538118789510.

Section Name

claudication provoked by stent graft limb stenosis. At 30 days, a 100% survival rate and complete absence of pelvic or buttock ischaemia/claudication were reported.

Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% for the latter. These findings are in alignment with the results of other iliac branch devices. 16,17 In summary, the preservation of flow to at least one internal iliac artery is imperative when dealing with aneurysms involving the iliac bifurcation. A total endovascular approach is offered by the aortoiliac endografts that incorporate an iliac branch. The initial experience with the E-liac stent graft reveals that it can be safely and effectively applied for the treatment of aortoiliac aneurysmatic disease while maintaining pelvic circulation. The low reintervention rates and high patency rates observed within 30-day follow-up are promising. Long-term data are, however, awaited to confirm the efficacy of the device.

Aortoiliac aneurysms

system allows stepwise deployment of the stent graft in the target position. The device is available in several configurations, with a proximal diameter of 14, 16, and 18mm whereas the distal diameter of the implant to be placed in the external iliac artery is available between 10 and 14mm in 2mm steps.

In a multicentre retrospective study from Germany on 70 patients, the E-liac stent graft showed promising midterm results. 15 Moreover, an observational, prospective, single arm study, which aims at evaluating the safety and the efficacy of the E-liac stent graft at 30 days, at 12 months, and at 36 months was designed. The PLIANT Figure 3: After cannulation of the stump and the internal iliac artery, study (Patients with Iliac the bridging stent is placed in the right internal iliac artery Aneurysm undergoing endovascular stenting Continued from next page with a New generation of low profile E-liac Stent Graft System) the internal iliac artery is supported by includes a total of 45 patients at 11 sites the unique reinforced 8mm side branch in four European countries. Eighty seven of the device with the 6mm compression per cent of them were treated with an spring at the distal end, which secures iliac branch graft in combination with an efficient anchoring of the peripheral abdominal aortic aneurysm stent graft, covered stent. The squeeze-to-release whereas three patients received a bilateral deployment mechanism of the delivery E-liac stent graft. Thus, a total of 48 E-liac stent grafts were implanted.

Recently, the perioperative and 30-day results were published. 18 The peri-procedural primary patency rate of the internal iliac artery and external iliac artery on E-liac implantation side was 100%. Four patients had clinically relevant endoleaks type Ia; three located in the infrarenal aorta and one in the common iliac artery. The 30-day clinical success was achieved in 43 (96%) out of the 45 patients. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic Figure 4: At 12-month follow up, CT scan shows successful stent graft, and one due occlusion of the aneurysms to bilateral lower limb

Section Name Case report

Treatment of aortoiliac aneurysms: Case report from Watford General Hospital

By Mr Tahir Bhatti, consultant general surgeon at West Herts Hospital NHS Trust in West Hertfordshie, UK

PATIENT

76-year-old male Bilateral calf claudication Moderate exertional dyspnea Previous coronary artery bypass and percutaneous coronary intervention Glomerular filtration rate: 56

ANGIOGRAPHIC BASELINE Aortic aneurysm 5.5cm Right iliac aneurysm 3.2cm Left iliac aneurysm 2cm

PROCEDURAL CHARACTERISTICS

E-liac IBD Stent Up-and-over 0.18”x300cm wire 8F destination sheath Hydrophilic 0.35”x260cm wire E-ventus BX balloon-expanding stent Contra limb 16mm diameter

Technique

The planning of the case was carried out on Osirix software. To use the E-liac IBD stent graft, the common iliac artery length should be 53mm or more, with at least a 15mm landing zone necessary in the internal iliac artery and an angle of 50 degrees or less between the internal and external iliac arteries.

We passed an up-and-over 0.18”x300cm wire from the contralateral side and snared from the ipsilateral groin. A stiff wire

Figure 1: Preprocedural Angio 3D reconstruction

was passed into the thoracic aorta from the ipsilateral side. The E-liac IBD stent graft was passed from the ipsilateral side over both these wires, through respective lumens. Alignment was achieved by adjusting the C-arm position in accordance with preoperative planning, to ensure the side branch is positioned just proximal to the internal iliac artery. An 8F destination sheath was passed up and over, through the up-and-over wire, and fed into the side branch of E-liac IBD stent graft. A further 0.35”x260cm hydrophilic wire was then fed through a destination sheath and the side branch into the internal iliac artery, then replaced by a stiff wire after successful cannulation of the artery. An appropriately sized E-ventus BX balloon-expanding stent was deployed through this stiff wire and dilated. The E-liac IBD stent graft was then deployed fully into the external iliac artery.

The main body was deployed through the contralateral side and then bridged with the E-liac device using a 16mm diameter contra limb—available in five different sizes for this purpose.

CASE

A 76-year-old male presented with complaints of bilateral calf claudication. He had past medical history of coronary artery bypass graft and percutaneous coronary intervention, and suffered from moderate exertional dyspnea. He had a full cardiology assessment and optimisation before the operation. His estimated glomerular filtration rate was 56.

A CT angiogram confirmed a 5.5cm aortic aneurysm, 3.2cm right iliac aneurysm and 2cm left iliac artery. The aortic bifurcation

Figure 2: Cross-over manoeuvre to advance the bridging stent

Tahir Bhatti

and right common iliac artery were narrow, posing technical challenges.

The case was discussed with our vascular multidisciplinary team, and the patient was subsequently offered an endovascular aneurysm repair with right E-liac IDB. The procedure was carried out under continuous spinal epidural with sedation. He had antibiotic cover and 5000 units of heparin administered intravenously. The common femoral arteries were used as access vessels through cut down.

Completion angiogram showed good position of graft and good flow in the limbs with the internal iliac branch on the right side with no endoleak.

The patient was kept in recovery for six hours and then transferred to the vascular ward as per the unit’s protocols.

Postoperative course was uneventful, and he was discharged 48 hours after the operation.

We followed up the patient six weeks after Continued on next page

Figure 3: Partially deployed stent graft

Tahir Bhatti is a consultant general surgeon at the West Herts Hospital NHS Trust in

Figure 4: Deployed stent grafts

The E-liac Stent Graft System is indicated for the endovascular treatment of patients with the following characteristics: Unilateral or bilateral aorto-iliac or iliac aneurysm Suitable for endovascular repair Patient must be compliant with lifelong follow-up investigations >18 years old Iliac/femoral access vessel morphology compatible with the implantation procedure and the 18F (6mm OD) delivery system Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥20mm Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm Non-aneurysmal external iliac artery segment distal to the aneurysm ≥15mm Diameter of the external iliac artery in the distal landing area: 8mm to 13mm Non-aneurysmal internal iliac artery segment distal to the aneurysm ≥15mm Angle between external iliac artery and internal iliac artery ≤50° (measured 10mm above iliac bifurcation) Thrombus free iliac lumen in the area of iliac bifurcation to open side branch and to implant covered stent ≥18mm Sufficiently open internal iliac artery ostium

Section Name

West Hertfordshire, UK as well as a pioneer of endovenous treatment and ultrasoundguided foam sclerotherapy for varicose veins in the NHS. Watford General Hospital is a busy district general hospital, serving a population of 600,000 people. The team in Watford carry out 60–70 endovascular aneurysm repairs a year, and consists of four vascular surgeons and three interventional radiologists.

Figure 5: Final angiogram

E-liac Stent Graft System Indication

Indications for use

the procedure with a CT scan, at which point he had recovered well from the procedure: wounds were healed completely, CT scan showed good graft position with no endoleak and the right iliac branch device was wellpositioned with good profusion of the right internal iliac artery.

Figure 6: Control Angio CT 3D reconstruction

Section Name Experience

Do the old open repair rules no longer apply?

By Dr Lee H Bouwman and Dr Cornelis JJM Sikkink, Vascular Surgery of Zuyderland Medisch Centrum in Heerlen, the Netherlands

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he introduction of endovascular aortic aneurysm repair (EVAR) by Parodi some 28 years ago revolutionised aortic surgery. Within less than three decades, the vast majority of aneurysms of the abdominal aorta were being treated

by EVAR. EVAR devices have undergone tremendous technical improvements when comparing first generation to the current third generation devices. These will continue to improve, as medical technology companies in collaboration with various physicians are still in the process of developing more sophisticated devices and techniques.

The current focus of research and development appears to be aimed at attacking the “hostile neck”. Instructions for use are being questioned and challenged, new techniques are being introduced and off-the-shelf fenestrated EVAR devices are being developed.

The expectation is that an even greater part of abdominal aortic aneurysms will be treated with EVAR as opposed to open repair. Subsequently, younger patients with less comorbidity are being treated endovascularly. With the diminishing number of open repairs being done, the question arises: “do the old open repair rules no longer apply?”

Glancing through our vascular inventory room in the operation theatre, there is one thing that stands out. The largest aorta bifurcation prosthesis for open repair is 20-10-10mm. The largest EVAR distal graft diameter yet is 28mm. In case of a ruptured aortic aneurysm, we understand that “all is fair in love and war”. However, it is questionable if using large diameter grafts for distal landing in the common iliac artery is such a good option in elective cases. In elective open surgery, a vascular surgeon would never accept anastomosing a 10mm graft on a 25mm common iliac artery.

Instead, the graft would be anastomosed on

the iliac bifurcation or more distally.

For an endovascular approach it should be appreciated that once a large diameter graft has been placed in the common iliac artery, the option of endovascular repair in case of a progressing iliac aneurysm preserving the internal iliac artery is impeded. Furthermore, landing in an enlarged and thus diseased part of a vessel is intuitively less optimal.

A large diameter distal graft maintains the aneurysmatic shape of the vessel, making it prone to further dilation, thrombotic clot formation in the graft and distal embolisation or even occlusion.

For the above stated reasons we increasingly treat patients with an abdominal aortic aneurysm and enlarged iliac arteries with EVAR combined with endovascular iliac branched devices. We consider the use of iliac branched devices in patients receiving an EVAR with common iliac arteries greater than 20mm. The use of large distal diameter EVAR grafts is reserved for patients with significant comorbidity, where procedural time should be minimalised.

Recently we implanted the 2000th E-liac stent graft system worldwide from JOTEC.

Figure 1: Preoperative image

Figure 2: Intraoperative angiogram

Lee H Bouwman and Cornelis JJM Sikkink awarded centre of excellence after the 2000th E-liac procedure

Figure 3: Preoperative image

Figure 4: Postoperative angiogram

The device was implanted in a 67-yearold patient with an aneurysm of the left common iliac artery of 37mm. The patient received an open repair of an aneurysm of the right common iliac artery in 2014.

An isolated iliac branched device could not be implanted as the aneurysm started at the aortic bifurcation. The distal aorta had a diameter of 37mm. Using the E-liac graft system and E-tegra stent graft system, an endovascular repair was performed successfully. The patient recovery was uneventful and the CT scan six-weeks postoperative showed a good position of the stent grafts and patent iliac arteries.

To date, we have implanted 37 E-liac grafts for isolated iliac aneurysms and combined aorto-iliac aneurysms. The E-liac stent graft system is compatible with our current EVAR system, allowing us to perform the EVAR and iliac branch device procedures with minimal change in our regular operation procedures.

As announced by JOTEC GmbH, a fully owned subsidiary of CryoLife, Inc., USA, the 2000th E-liac stent graft was implanted successfully on the 20th of June. The endovascular implantation was performed at Zuyderland Hospital in Heerlen, the Netherlands, by the vascular surgeons Dr Lee H Bouwman and Dr Cornelis JJM Sikkink.

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he procedure performed was an aorto-iliac aneurysm on a 67-yearold male patient. The E-liac stent graft was implanted on the left side and an E-tegra stent graft was used to seal proximally.

This stent graft system is intended for the endovascular treatment of patients with aorto-iliac or stand-alone iliac aneurysms. The E-liac stent graft consists of a bifurcated graft including a main

iliac limb with an additional reinforced branch for the IIA vessel. The tip to tip design with asymmetric stents provides flexibility, stability and the compression spring ensures connection of the bridging stent at the side branch.

The Zuyderland Hospital in Heerlen, Netherlands, was awarded as JOTEC Center of Excellence due to their large Experience with E-liac Stent Graft implantations.

Use of the E-liac device for aortoiliac aneurysms Procedural steps

1. Percutaneous retrograde access is established for both femoral arteries. In cases of previous EVAR, transbrachial access is required.

2. Introduction of an ipsilateral stiff guidewire.

3. Snaring manoeuvre of the crossover wire from contralateral groin.

4. Angiographic overview in an oblique projection. It is important to assess optimal angles for visualisation of the internal iliac artery in a preinterventional CT scan.

5. Introduction of both wire ends into the delivery system.

6. Introduction of the device over the two wires with the crown of the

E-Marker pointing to the internal iliac artery ostium.

7. Positioning of the distal side branch marker approximately 1cm above the internal iliac artery ostium.

8. Partial release of the stent graft until the side branch is open.

9. Introduction of a crossover sheath over the crossover wire with placement of its tip close to the sidebranch.

10. Catheterisation of the internal iliac artery through the sheath using a diagnostic catheter over a soft wire.

11. Exchange for a stiff guidewire.

12. Placement of the balloonexpandable covered stent over the stiff guidewire in the internal iliac artery.

13. Positioning of the stent using the markers of the side branch and the covered stent. If needed, correction of E-liac position is still possible at this point.

14. Retraction of the sheath out of the side branch and removal of the crossover wire. The side branch will now fully open.

15. Deployment of the internal iliac artery covered stent 16. Release of the distal part of the E-liac stent graft und removal of the trigger wire for distal fixation.

17. If a combined abdominal aorto-iliac aneurysm is present, a bifurcated E-tegra stent graft is introduced through the contralateral iliac artery and deployed as usual. A bridging stent graft (E-tegra leg) is implanted between the short limb of the bifurcated E-tegra and the E-liac to complete exclusion.

18. The stent graft is ballooned with an E-xpand stent graft balloon catheter under protection of the E-liac bifurcation. In case of stenosis of the stent graft at the E-liac bifurcation it is possible to use kissing balloon technique with two 8mm balloons. In angulated vessels, it can be difficult to introduce a balloon into the side branch in an antegrade fashion.

19. Completion angiography is performed to exclude endoleaks and to verify that the internal iliac artery is open.

Section Name

Procedural steps

2000th JOTEC E-liacÂŽ Stent Graft System successfully implanted in the Netherlands