Case Report Iliac FenestrationdAn Alternative Endovascular Option for Common Iliac Aneurysms Sebastian Mafeld,1 Raghuram Lakshminarayan,2 Cha-ney Kim,2 Mike Clarke,3 and Rob Williams,1 Newcastle upon Tyne and Hull; and Newcastle upon Tyne, United Kingdom
We report the use of manufacturer-customized fenestrated iliac stent grafts to treat common iliac artery aneurysms (CIAAs) in patients with challenging iliac anatomy, unsuitable for iliac branched devices (IBDs). A 71-year-old woman presented with bilateral CIAAs measuring 44 mm and 29 mm and a perivisceral abdominal aortic aneurysm (AAA). The second patient, a 72-year-old male, had a 42-mm CIAA and an AAA, which expanded to 50 mm during the short-term follow-up. The contralateral internal iliac was occluded. Both patients were deemed high risk for open repair, and endovascular repair was recommended. The aneurysm anatomies were unsuitable for isolated CIAA repair. Suitable sealing zones for endovascular repair were the visceral segment proximally and the external iliac arteries. Preservation of both internal iliac arteries (IIAs) was important to reduce the risk of spinal cord ischemia, but due to distal CIA narrowing, neither patient had sufficient ‘‘space’’ for the branches used in conventional IBD deployment. Three fenestrated Vascutek AnacondaÔ iliac limbs were successfully deployed. All three IIAs were preserved with no endoleak, and the patients were discharged after an uneventful postprocedural course. To our knowledge, this is the first successful report of iliac aneurysm repair with manufacturer-customized fenestrated iliac limbs.
INTRODUCTION Common iliac artery aneurysms (CIAAs) are primarily due to atherosclerosis and rarely develop in isolationdthey most frequently occur in association with abdominal aortic aneurysms (AAA).1 The common iliac artery is classified as aneurysmal with a diameter of 1.5 cm in women and 1.7 cm in
Conflict of Interest: Robin Williams is a proctor for Terumo Aortic (formerly Vascutek). Raghuram Lakshminarayan work as a consultant for Cook & WL Gore. The remaining authors declare that they have no conflict of interest. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. 1 Department of Interventional Radiology, Freeman Hospital, Newcastle upon Tyne, UK.
men.2 The literature has varying size thresholds for treatment, but both open surgical and endovascular treatment options exist. Iliac branched devices (IBDs) are an endovascular solution to iliac artery aneurysm repair, and there is a growing body of evidence to support their effectiveness.3,4 However, there are specific anatomical limits for IBDs. We present a novel endovascular paradigm for the
2 Department of Interventional Radiology, Hull and East Yorkshire Hospitals NHS Trust Hull Royal Infirmary, Hull, UK. 3 Department of Vascular Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
Correspondence to: Sebastian Mafeld, Department of Interventional Radiology, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, UK; E-mail:
[email protected] Ann Vasc Surg 2019; -: 1.e1–1.e6 https://doi.org/10.1016/j.avsg.2019.02.044 Ó 2019 Elsevier Inc. All rights reserved. Manuscript received: October 12, 2018; manuscript accepted: February 14, 2019; published online: - - -
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Fig. 1. Preprocedural anatomyd3D reconstruction demonstrating abdominal aortic and bilateral common iliac artery aneurysms.
successful treatment of CIAAs using manufacturercustomized fenestrated iliac stent grafts in cases where an IBD was not anatomically suitable.
PATIENT 1 A 71-year-old female was referred to the vascular surgical team with an AAA measuring 46 mm and bilateral CIAAs with the left measuring 44 mm and the right measuring 29 mm (Fig. 1). The patient was an active smoker and had a significant past medical history including chronic obstructive pulmonary disease, emphysema, hypertension, ischemic heart disease, type 2 diabetes mellitus, diverticulosis, cervical spondylosis, small vessel cerebrovascular disease, fatty liver, and depression. The normal threshold for iliac aneurysm treatment for this unit was 35 mm (although this has since been revised to 40 mm). The iliac aneurysm could not be treated in isolation and required simultaneous repair of the AAA. Anesthetic assessment revealed a good anaerobic threshold despite a significant respiratory limitation with a reduced forced expiratory volume in 1 second. On this basis, the patient was considered to be at high risk for major respiratory complications if an open repair was to be performed. Conservative management was considered, but the patient was eager to proceed with
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repair. Open repair was deemed high risk, and the mutlidisciplinary team recommended an endovascular solution. The neck of the AAA was not suitable for conventional infrarenal endovascular aneurysm repair; therefore, a customized four fenestrated repair of the visceral renal segment was required. Preservation of both internal iliac arteries (IIAs) was felt to be desirable to reduce the risk of spinal cord ischemia (SCI) secondary to the four fenestrated visceral renal segment repair. The common iliac aneurysms extended to the iliac bifurcations but had thrombus lining and narrowing of the lumens to 11 mm 10 mm on the right and 12 mm on the left. This is suboptimal for an IBD which has a graft IFU that mandates a lumen diameter of >16 mm. Other options including offlabel use of IBDs, bilateral IIA embolization, and extension to the external iliac arteries (EIAs) were considered, but all felt to be suboptimal. The authors had some experience with physician-modified fenestrated grafts (including iliac limbs) for emergency cases.5 Vascutek-Terumo was approached and asked whether fenestrated iliac limbs were technically possible to manufacture, and subsequently, bilateral customized fenestrated iliac grafts were planned.
METHODS A four fenestrated customized Vascutek-Terumo (Glasgow, United Kingdom) AnacondaÔ was designed for the AAA. Factory customized AnacondaÔ limbs were planned with a fenestration for each IIA (Fig. 2). The fenestrated limbs were based on standard AnacondaTM iliac limbs with a single nitinol ring removed to create space on the polyester fabric for the fenestration. The fenestration was reinforced with a nitinol wire ring identical to those used in the fenestrated aortic grafts. A prototype of the fenestrated iliac limb grafts was manufactured and tested to ensure compatibility with both the main body and the intended covered stents for the IIAs. Further benchtop testing of the grafts took place in 3-dimensional (3D) printed models to ensure anatomic accuracy and suitability of the graft designs. The 3D printed models are manufactured from the patient computed tomography (CT) data for all Vascutek custom-made grafts. They are a faithful, life-sized recreation of the arterial anatomy. In combination with the prototypes of the aortic and iliac grafts, the models are used for rehearsal of the
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Fig. 2. Preprocedural device planning of the fenestrated iliac graft.
case and allow confirmation of the design. After successful testing and physician approval, the grafts were fabricated. Potential failure of the technique was considered and a back-up plan was in place. In the event of device failure or unsuitability for the first side at the time of the procedure, the internal iliac artery would be embolized and the fenestration covered with a further tube graft. A Cook (Indiana, USA) Zenith Iliac Branch Device was available to be used on the contralateral side (acknowledging that its use would be outside manufacturer IFU). The procedure was performed under general anesthesia with percutaneous bilateral common femoral arterial (CFA) access and ProStar XL (Abbott Laboratories, Lake Bluff, Illinois) closure devices predeployed. Open right infraclavicular axillary artery access was also obtained (standard unit practice when antegrade access to visceral vessels is required). A Vascutek AnacondaÔ four fenestrated graft was inserted via the right CFA. Fenestrations to all four visceral arteries were stented from the right subclavian artery due to marked caudal angulation of the visceral vessels. A fenestrated iliac limb was introduced via the right CFA. The IIA fenestration was catheterized over the aortic bifurcation from the left with a Cook Ansel 7F 55-cm sheath. The IIA fenestration was stented using a 8 mm 26 mm Bard (Covington, GA, USA) Lifestream covered stent and flared to 10 mm to seal the fenestration. To avoid minimal protrusion into the iliac fenestrated limb, the IIA covered stent were placed with minimal overlap. After successful deployment on the right, the process was repeated for the left. However, as a result of the short overlap, a type III endoleak was seen at the fenestration. A second Bard Lifestream covered
stent was used to improve the overlap zone which immediately abolished the endoleak. The fenestrated limbs were then connected to the main aortic body with straight 12-mm iliac limbs. Completion angiogram revealed exclusion of the AAAs and CIAAs with no endoleak and patent visceral and iliac arteries. No immediate or postoperative complication was seen, and the patient was discharged at 5 days on clopidogrel 75 mg once daily. Follow-up imaging at 24 months has confirmed all fenestrations remain patent with reduction in size of the CIAAs and AAA (Fig. 3).
PATIENT 2 A 72-year-old male was found to have incidental aortic and iliac aneurysms while undergoing staging CT of the thorax, abdomen, and pelvis for a rectosigmoid colon carcinoma. Over a six-year period, the patient underwent a thoracoscopic resection of a metastatic lung nodule several years after initial anterior resection for the colonic tumor. At the end of this period, a further surveillance CT showed that the iliac aneurysm had increased in size to 50 mm with an AAA of 42 mm (Fig. 4). Both open and endovascular repair were discussed with the patient; however, the patient was concerned about the risks of major open surgery, and given the history of previous anterior resection, a multidisciplinary decision was made that endovascular repair of the aortic and iliac aneurysms would be the safest option. The CT angiogram demonstrated an occluded right IIA. The infrarenal neck of the aortic aneurysm had considerable posterior mural thrombus and was unsuitable for a conventional endovascular
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Fig. 4. Preprocedural CT demonstrating a 5-cm left common iliac artery aneurysm and 4.2-cm abdominal aortic aneurysm. Note the right internal iliac occlusion.
Fig. 3. Postprocedural 3D reconstruction of the successful 4 fenestrated abdominal stent graft and bilateral fenestrated iliac limbs.
aneurysm repair (EVAR). The left iliac artery aneurysm narrowed to 12 mm proximal to the iliac bifurcation with insufficient space for an IBD. As the right IIA was occluded, it was considered important to preserve the left IIA to reduce risk of SCI. After discussion with the manufacturer, a custom-made 3-vessel fenestrated AnacondaÔ graft with a separate fenestrated left iliac graft limb was deemed to be technically feasible.
METHODS A three-vessel custom-made fenestrated AnacondaÔ graft (Vascutek-Terumo, Glasgow, UK) was designed for the AAA, with a separate custom-made fenestrated AnacondaÔ limb for the left IIA. The procedure was performed under general anesthesia with bilateral open CFA and open left
axillary artery access. The custom-made fenestrated AnacondaÔ graft was inserted via the right CFA. Fenestrations to the renal arteries were stented from the left CFA, and the superior mesenteric artery fenestration was stented via the left axillary artery access. On the left side, two overlapping 12/ 15 80 mm extensions were placed into the common iliac artery, followed by the custom-made internal iliac fenestrated limb. The IIA fenestration was accessed from above and stented with an Atrium V12 (Maquet, Rastatt, Germany) stent and flared to 10 mm. The right limb of the graft was then deployed into the EIA. Completion angiogram demonstrated a type 2 endoleak arising from a lumbar artery with successful exclusion of the aortic and left iliac aneurysm. There were no immediate complications, and after an episode of postoperative hypotension was managed pharmacologically, the patient was discharged at five days postprocedure on 75 mg of aspirin and 75 mg of clopidogrel once daily. Predischarge CT angiogram confirmed successful exclusion of the aortic and iliac aneurysm. Follow-up CT at six months demonstrated exclusion
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Fig. 5. Postprocedural contrast-enhanced arterial phase CT demonstrating a patent left iliac fenestrated stent graft.
of the aneurysms, decreased in size of the AAA sac to 32 mm, and no significant change in the left CIAA (Fig. 5). The left IIA remained patent.
DISCUSSION Iliac branched stent grafts typically require a landing zone of "normal" caliber artery of 1.5 cm or more. With aneurysms that extend to the iliac bifurcation, more complex strategies are required. Embolizing and covering the IIA to create a distal landing zone is common, but coverage of a unilateral IIA is associated with morbidity including a 50% chance of gluteal claudication and occasionally complications such as pelvic ischemia/necrosis, spinal cord ischemia, and erectile dysfunction.6 Therefore, the IIAs should be preserved where possible, particularly where the proximal lumbar arteries may be occluded. Several different IBDs are available to treat iliac artery aneurysms which involve the iliac bifurcation, and there is evidence to support their effectiveness.3,4 Although IBDs can prevent unwanted complications of coverage of the IIAs, some patients have anatomies which are unsuitable for IBD selection criteria.7 Attempts have been made to create physician-modified stent grafts that suit various anatomies, but to our knowledge, this is the first reported technique using a manufacturer-customized fenestrated iliac limb to treat an iliac aneurysm.8-11 Unlike physician-modified stent grafts, a manufacturer-customized stent graft has benefits such as precise fenestration size and ability to choose graft length and allow for varying diameters. Both patients presented had a common iliac bifurcation diameter of 10e12 mm, mainly due to circumferential mural thrombus. This diameter is
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too small to accommodate both branches of available IBDs; therefore, an alternative solution was required. Before the first case, the unit had the experience of successfully bench modifying a Medtronic (Dublin, Ireland) EndurantÒ iliac limb with a fenestration for a transplant pancreatic artery pseudoaneurysm, and it was felt that the proposed solution of a manufacturer-customized iliac graft would be technically achievable.5 Anatomical model testing before the procedure further supported the feasibility of the case. Importantly, an endovascular back-up plan was in place before starting the case, and the procedure was performed by an experienced endovascular operator who had experience in performing over 200 branched and fenestrated aneurysm repairs and experience with IBDs.
CONCLUSION To our knowledge, these are the first reported cases demonstrating the feasibility of manufacturercustomized fenestrated iliac stent grafts for the treatment of CIAAs. This technique could be considered as an alternative to iliac branch grafts or open repair where appropriate.
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8. Oderich GS, Ricotta JJ. Novel surgeon-modified hypogastric branch stent graft to preserve pelvic perfusion. Ann Vasc Surg 2010;24:278e86. 9. Zhang T, Guo W, Ma X, et al. Novel-designed iliac branch stent graft for internal iliac artery reconstruction during aneurysm repair. Ann Vasc Surg 2015;29: 189e96.
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10. Park YE, Lee JH, Yun W-S, et al. Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair. J Korean Med Sci 2014;29:1678e83. 11. Zha B, Zhu H, Liu B, et al. Preservation of internal iliac artery after endovascular repair of common iliac artery dissection using modified fenestrated stent graft. Korean Circ J 2016;46:412e6.