EVAR of Aortoiliac Aneurysms with Branched Stent-grafts

Eur J Vasc Endovasc Surg 35, 677e684 (2008) doi:10.1016/j.ejvs.2007.10.022, available online at http://www.sciencedirect.com on

EVAR of Aortoiliac Aneurysms with Branched Stent-grafts N.V. Dias,* T.A. Resch, B. Sonesson, K. Ivancev and M. Malina Vascular Centre Malmo¨-Lund, Malmo¨ University Hospital, Malmo¨, Sweden Introduction. Branched iliac stent-grafts (bSG) have recently been developed in order to preserve internal iliac artery (IIA) flow in patients with aneurysmal or short common iliac arteries. The aim of this study is to evaluate a single-center experience with bSG for the IIA. Methods. Twenty-two male patients (70 (IQR 65e79) years old) underwent EVAR with 23 bSG (1 bilateral repair) between September 2002 and August 2007. Median AAA diameter was 52 (37e60) mm while common iliac diameter on the side of the bSG was 34 (27e41) mm. Two in-house modified Zenith SG and subsequently 21 commercially available bSG (18 Zenith Iliac Side and 3 Helical Branches) were used. Follow-up (FU) included CT at one month and yearly thereafter. Data was prospectively entered in a database. Results. Primary technical success was 91% (21 bSG). Median FU duration was 20 (8e31) months. One patient (5 %) died after discharge from acute myocardial infarction on day 13. Another patient died 30 months after EVAR of an unrelated cause. The overall bSG patency was 74% due to 6 branch occlusions (2 intraoperative and 4 late). All patients with patent bSG were asymptomatic. Three occlusions were asymptomatic findings on CT, while the other three developed claudication (two patients with contralateral IIA occlusion and one with simultaneous occlusion of the external iliac). One patient (5%) developed an asymptomatic type III endoleak at 1 month and was successfully treated with a bridging SG. Overall, four patients (18%) required reinterventions (1 bilateral stenting of the external iliac arteries, 1 external and 1 internal SG extensions and 1 femoro-femoral cross-over bypass). Nine out of 16 patients (56%) with CT-FU  1 year had shrinking aneurysms. There were no postoperative aneurysm expansions. Conclusions. EVAR of aortoiliac aneurysms with IIA bSG is a good alternative to occlusion of the IIA in patients with challenging distal anatomy. Ó 2007 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. Keywords: Endovascular Aneurysm Repair (EVAR); Branched Stent-graft; Iliac Aneurysm; Aortoiliac aneurysm; Hypogastric aneurysm; Stentgraft; Endograft; Claudication; Aortic aneurysm.

Introduction The presence of short or aneurysmal common iliac arteries in patients with abdominal aortic aneurysm (AAA) may jeopardize the applicability of endovascular aneurysm repair (EVAR).1e3 This has been typically dealt with by embolizing the internal iliac artery (IIA) with stent-graft extension to the external iliac artery. However the sacrifice of the IIA, especially when bilateral, may cause buttock claudication, erectile dysfunction and, less frequently, gluteal necrosis, colonic and spinal ischemia.4,5 Occlusive disease of the ipsilateral deep femoral6 or contralateral IIA4 and distal embolization of the IIA have been associated with higher risk of developing symptoms.7 Symptoms can improve over *Corresponding author. N. V. Dias, Vascular Centre Malmo¨-Lund, Malmo¨ University Hospital, Entrance 59 e 7th floor, 205 02 Malmo¨, Sweden. E-mail address: [email protected]

time, but up to 15% of the patients remain symptomatic.4,8 Preserving the flow to at least one of the internal iliac arteries increases bilateral pelvic perfusion9,10 by taking advantage of the extensive collateral network in the pelvis. This reduces the frequency of the complications11,12 and the disability level.13 A multitude of flow-preserving techniques have been used to address this problem. These include transposition/bypass of the IIA,14 external-to-internal endografting,15 EVAR with a bifurcated stent-graft where the contralateral limb is extended into the contralateral IIA while a femoro-femoral cross-over bypass maintains the perfusion of the lower limb,16 bell-bottom stent-grafts,17 surgical suturing of the distal implantation site18 and branched stent-grafts (bSG) for the IIA.19,20 The first series of bSG, including our initial experience, showed promising results.21e24 The aim of this study is to evaluate our extended experience with bSG for the IIA.

1078–5884/000677 + 08 $34.00/0 Ó 2007 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

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Methods

Table 2. Aneurysm morphology Median (IQR)

Patients Twenty-two male patients (70 (65e79) years-old) underwent EVAR with 23 bSG (12 on the right side and 11 on the left) between September 2002 and August 2007. Ten of these patients were included in our initial report.21 Preoperative co-morbidity and aneurysm morphology are described in Tables 1 and 2, respectively. In eight patients with small AAAs the main indication for treatment was a large common iliac aneurysm. Twenty-one patients received simultaneous aortic stent-grafts. One patient received bilateral bSG due to bilateral distal type I endoleak caused by cranial migration of the stent-graft limbs from short aneurysmal iliac arteries (3 years and 2 months after EVAR). For unilateral implantation, the branched stent-graft was placed in the side with the most favorable anatomy for the procedure. Dilatation of the proximal internal iliac artery was accepted as long as a distal implantation site was identified (up to 11 mm in diameter and at least 10 mm long). Contralateral iliac artery aneurysms were treated by either bell-bottom stent-grafts or stent-graft extension into the external iliac after embolization of the IIA (8 preoperatively and 3 at the time of EVAR). A percutaneous approach was our standard technique applying either suturing devices25 or fascia sutures.26 General anesthesia was used in all patients. The study was approved by the local ethics committee and all patients gave informed consent before the procedure.

AAA diameter (mm) Ipsilateral common iliac diameter (mm) Contralateral common iliac diameter (mm) Preoperative Embolization of Contralateral IIA Preoperative Inferior Mesenteric Artery Embolization

n

52 (37e60) 34 (27e41) 28 (20e33) 8 (36%) 4 (18%)

Branched stent-graft description and deployment technique Three different devices have been used. Two patients received an in-house modified bifurcated Zenith stent-graft (William Cook Europe, Bjaeverskov, Denmark) where the proximal uncovered stent was removed. The remaining patients received Zenith bifurcated iliac side (n ¼ 18) or helical (n ¼ 3) branch devices (William Cook Inc, Brisbane, Australia). The helical branch stent-grafts were used in order to test the only alternative system available. No specific indication for any of systems was used. The stent-grafts used are listed in Table 3. A detailed description of the bSG and of the implantation technique can be found elsewhere.20,21,27 In summary, the bSG was inserted from the ipsilateral groin and orientated (Fig. 1A) in the most optimal view for the internal iliac origin seen in the 3-D preoperative imaging (Fig. 2A). The bSG was partially deployed until the side branch was released from the Table 3. Stent-grafts used

Table 1. Patients’ characteristics Median (IQR) Age Cardiac disease* Stroke COPDy Renal insufficiencyz Diabetes BMI Smoker Current Ex-smoker

n

70 (65e79) 13 4 11 1 2

(59%) (18%) (50%) (4%) (9%)

28 (26e30) 4 (18%) 12 (54%)

COPD e Chronic Obstructive Pulmonary Disease; BMI e Body Mass Index. * Defined as current angina pectoris, previous myocardial infarction, CABG operation or PCI, current or previous arrhythmia or heart failure. y Defined as a forced expiratory volume in the 1st second of < 80% of the expected value and less than 70% of the forced vital capacity, and/or severe dyspnea on exertion due to pulmonary disease. z Defined as a serum creatinine level > 130 mmol/L.

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Location and Type of Stent-graft or Stent

n

Aortic Stent-graft Zenith Tri-fab Zenith Fenestrated*

19 (86%) 3 (14%)

bSG Zenith Iliac Side Branch Zenith Iliac Helical Branch In-house Modified Zenith Tri-fab

18 (78%) 3 (13%) 2 (9%)

IIA Bridging Stent-graft Advanta V12 Jomed Stent-graft Fluency Plus Vascular Stent-graft

10 (43%) 6 (26%) 7 (30%)

Additional Stents or Stent-grafts in the IIA Advanta V12 Jomed Stent-graft AVE stenty Luminexxz

3 2 1 1

* One patient had undergone EVAR with a fenestrated stent-graft 3 years and 2 months before the insertion of bilateral iliac bSG to treat bilateral distal type I endoleaks. y AVE stent, Medtronic Vascular, Medtronic Vascular, Santa Rosa, CA, USA. z Luminexx stent, C.R. Bard, Inc., Tempe, AZ, USA.

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the branch and from there the IIA was selectively catheterized (Fig. 1B). A stent-graft was advanced to bridge the gap between the bSG-branch and the IIA. After releasing the through-and-through wire the bridging stent-graft was deployed (Fig. 3). The choice between self- (Fluency Plus Vascular Stent-graft, C.R. Bard, Inc., Tempe, AZ, USA) or balloon-expandable (Advanta V12, Atrium Medical, Hudson NH, USA or Jomed Stent-graft, Abbot Vascular Devices, Rangendingen, Germany) stent-grafts was left to the discretion of the operator. Additional balloon-expandable stents or stent-grafts were used selectively for reinforcement when self-expandable stents had been deployed initially. The procedure was then completed by deployment of the proximal part of the aortic stent-graft from the contralateral side with subsequent bridging into the bSG. An exception to this sequence was done when a Zenith Fenestrated stent-graft was used (William Cook Inc, Brisbane, Australia). In those cases the deployment of the proximal tubular fenestrated component and target vessel stenting was done before the insertion of the bSG.

Imaging

Fig. 1. A) Intraoperative angiography showing the orientation of a Zenith Iliac Side Branch Stent-graft. Note the radioopaque markers on the medial side facing the origin of the internal iliac artery which is stenotic. B) Selective catheterization of the internal iliac artery from the contralateral side.

The imaging protocols included contrast-enhanced spiral-computer tomography (CT) scans preoperatively and at one month after EVAR and yearly thereafter. CT scans were reconstructed with 0.75e3 mm axial slices. Until 2004 preoperative work-up included calibrated digital subtraction angiography. Since then a vascular dedicated digital workstation has been used for CT-scan image analysis (TeraRecon Aquarius Workstation, TeraRecon, CA, USA). Arterial diameters were measured as the shortest transverse diameter of the artery on axial CT-scans by the same observer (NVD). AAA and iliac diameter changes were considered significant when exceeding 5 and 3 mm, respectively. Arterial length was measured either with preoperative calibrated angiography or on centerline of flow from the CT-scan (Fig. 2B).

Data collection and presentation sheath. Through-and-through wire was established with the contralateral side by taking advantage of the pre-loaded coaxial catheter going in the internal iliac side branch. Brachial artery access was used in the bilateral bSG for establishing through-and-through wire. An introducer was advanced antegrade into

All patients were prospectively registered in a computer based register. Retrospective data analysis was performed. All values are presented as medians and interquartile range (IQR). Technical success was defined according to the reporting standards.28 Eur J Vasc Endovasc Surg Vol 35, June 2008

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Fig. 2. A and B) 3-D reconstruction (A) and maximum intensity projection (B) of a preoperative CT-scan showing a good view for the origin of the internal iliac artery. C) Centerline of flow used for the length measurement of the different stent-graft components.

Results Intraoperative results Primary technical success was achieved in 21 bSG (91%). One internal side branch occluded due to a dissection of the internal iliac artery after excessive dilatation of a balloon-expandable stent-graft. One helical side branch occluded intraoperatively after a long Eur J Vasc Endovasc Surg Vol 35, June 2008

procedure where difficulties were experienced in advancing the contralateral sheath into the branch. A self-expandable stent-graft was ultimately successfully deployed into the IIA. However by the end of the procedure the branch had occluded. The operations took 279 (234e327) minutes with fluoroscopy being used for 80 (67e108) minutes. The iodine dose given was 58 (48e78) grams and the intraoperative bleeding was 700 (475e1550) ml.

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No in-hospital mortalities occurred, however one patient died at home on the 13th postoperative day. The autopsy identified an acute myocardial infarction as the cause of death and revealed a well excluded aneurysm with a patent stent-graft. Two patients (9%) developed postoperative complications. One patient suffered a transitory ischemic attack on the 6th postoperative day and developed a significant increase in the serum creatine (from 116 to 197 mmol/L). No patients required hemodialysis postoperatively. Another patient suffered a postoperative gastrointestinal paralysis during the first 4 days. This patient had received a proximal fenestrated stent-graft with bilateral fenestrations for the renal arteries and a scallop for the superior mesenteric artery. The patency of all target vessels was verified with a diagnostic angiography on the 2nd postoperative day. Mid-term follow-up

Fig. 3. Intra-operative angiography showing a completely deployed internal iliac bSG.

Thirty-seven intraoperative adjunctive procedures were needed in 18 patients (82%) with a median of 2 (1e3) procedures in each patient (Table 4). Perioperative results The median hospital stay was 4 (3e6) days. The intensive care unit was required in a single patient for 2 days after a long operation where a large common femoral artery aneurysm was concomitantly repaired. Table 4. Intraoperative adjunctive procedures

The duration of the follow-up was 20 (8e31) months. During this period only one patient died 30 months after EVAR and the autopsy identified a large myocardial infarction with ventricular wall rupture as the cause of death. The stent-graft was patent and the aneurysm well excluded. AAA and iliac aneurysm diameter No AAAs or iliac aneurysms expanded in diameter. Nine of the 16 patients (56%) followed-up for 1 year or more after the operation (23 (IQR 12e24) months) showed aneurysm shrinkage (6 AAA and iliac aneurysm shrinkage, 2 isolated iliac aneurysm shrinkage and 1 isolated AAA). Table 5. Occluded branched stent-grafts Patient Type of bSG

Embolized Time of contralateral occlusion IIA

1

No

Intraoperative No*

Yes No

Intraoperative Buttock claudication 1 month No

No

4 months

No

24 months

Yes

30 months

n Stent in external iliac artery segment Stent/stent-graft in junction of aortic stent-graft and bSG Stent in aortic stent-graft limbs Balloon-expandable stent for proximal type I endoleak Distal stent-graft extension Primary embolization of internal iliac artery Completing embolization of internal iliac artery* Coil embolization of large lumbar artery Arterioraphy of the common femoral arteryy Femoral endarterectomy with patch angioplasty Common femoral aneurysm resection Embolectomy of aortic stent-graft limb

10 3 5 2 1 3 2 1 6 2 1 1

* 1 with persistent slow flow in the internal iliac artery due to a small ileolumbal artery and 1 occluding plug that did not completely seal the flow in the previously embolized internal iliac artery. y After failed percutaneous closure.

2 3 4 5 6

Zenith Side Branch Zenith Helical Branch Zenith Side Branch Zenith Side Branch In-house Modified Zenith Tri-fab Zenith Side Branch

Symptoms

Leg claudicationy No Buttock claudication

* Progressed to an occlusion of the common and external iliac artery segments, but continued asymptomatic. y Developed also occlusion of the external iliac artery and underwent a femoro-femoral cross-over bypass.

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bSG patency Seventeen out of the 23 bSG (74%) were patent during the follow-up. No patients developed colonic or spinal cord ischemia during the study period. A total of six IIA branches occluded (Table 5). Two occlusions were noted intra-operatively as mentioned above. One of these patients was asymptomatic but, at 1 year, CT scan revealed progression of the occlusion into the common and external iliac segments. This was caused most likely by a double kink at the transition between the short limb of the aortic stent-graft and the bSG, and in external iliac artery. Two of the other four occluded internal iliac artery branches were diagnosed shortly after EVAR (1 and 4 months). The first had a dissection in the IIA with slow flow on the completion angiography. The second patient (bilateral bSG) had a kink in the transition between the abdominal stent-graft and the bSG. This last patient occluded both the internal and external iliac arteries on the right side but had a patent bSG on the other side. The two other internal iliac branches occluded at 2 and 2.5 years postoperatively of unknown causes. One patient treated with an in-house modified Zenith Tri-fab stent-graft developed an asymptomatic external iliac artery occlusion ipsilateral to the bSG. This was first noticed on the 6 month CT-scan and was caused by a kink in the external iliac segment of the stent-graft. The contralateral external and ipsilateral internal iliac arteries were patent at the latest follow-up (60 months after EVAR) and the patient was asymptomatic. This patient together with the other two mentioned above with external iliac occlusions following the internal iliac branch occlusion, represent the 3 failures of this segment. Endoleaks Two patients had type II endoleaks, one of which sealed spontaneously on the one-month CT-scan. One type III endoleak was identified on the 1month CT-scan at the connection of the bSG and the extension to the aortic bifurcated stent-graft. Reinterventions Four patients (18%) required reinterventions during the follow-up. One patient underwent bilateral stenting of the external iliac arteries on the 8th postoperative day due to asymptomatic kinks. One patient with an intraoperatively occluded internal iliac branch, already described above, received an extension from the limb of the aortic stent-graft into the external iliac artery due to a type III endoleak (1.5 months after EVAR). Another patient also described above with Eur J Vasc Endovasc Surg Vol 35, June 2008

bilateral bSG developed a unilateral occlusion of the internal and external iliac arteries and underwent a femoral-femoral cross-over bypass due to life-style limiting claudication 4 months after EVAR. One patient received an extension of the IIA stent-graft 9 months after EVAR through an axillary approach due to inadequate overlap into the artery (Advanta V12 stent-graft 9 mm diameter and 38 mm long). Discussion Primary technical success for the implantation of bSG was high in this series (91%). However these are demanding procedures. For example in a local series of 305 consecutive conventional EVAR with the Zenith stent-graft the operation time was 185 (147e246) minutes as opposed to the 279 (234e327) of the current study. Furthermore, the use of bSG also required long fluoroscopy times and frequent intra-operative adjunctive procedures. Our mid-term results confirm the good initial results. No patients experienced serious ischemic complications or claudication if the bSG was patent. Occlusion of the IIA branch lead to buttock claudication in 50% of cases and was worse in patients with contralateral IIA occlusion. We believe that these results justify the additional efforts required by the use of bSG, especially when considering the aforementioned risks of IIA occlusion. This view is supported by other published series.22e24 Furthermore, the occlusion of a bSG leaves the patient in a similar condition as if primary embolization of the internal iliac artery had been performed. Additionally, bSG for the internal iliac artery can be considered a gateway for the skills and technology development of branched stent-grafts for other more hazardous territories, such as thoracoabdominal aortic aneurysms. The ultimate value of bSG in the treatment of aortoiliac aneurysms will, nevertheless, only be determined by randomized control trials, which will need to take into account the cost-effectiveness of the procedure. Preoperative planning is an essential tool for the future success of the procedure. The use of 3-D imaging avoids the invasiveness of a calibrated digital subtraction angiography and helps in the identification of the optimal angiographic view of the IIA origin. Another important issue for planning a bSG is the length of the common iliac artery. The bSG should reach to, but not extend beyond, the origin of the common iliac artery, in order to avoid difficulties in the placement of the cross-over sheath. The placement of the bSG exclusively in the common iliac artery has the advantage of decreasing the risk of destabilizing the aortic stent-graft. The use of balloon- or self-expandable stent-grafts in the internal iliac artery is still an unsolved issue.

EVAR of Aortoiliac Aneurysms

When tortuosity or severely angled IIA takeoff is an issue, self-expandable stent-grafts are usually chosen. Additional balloon-expandable stents were used selectively to increase the radial force when selfexpandable stent-grafts appeared unable to maintain the lumen without stenosis. Balloon-expandable stent-grafts are chosen when there is a need to primarily have a good radial force such as in cases of proximal stenotic IIA. The dilatation of the IIA should be done with minimal oversizing since this artery seems prone to dissection. The tortuosity often seen in patients with aortoiliac aneurysms increases the difficulty in the orientation of the bSG. Furthermore, our results suggest that stentgrafts are prone to kinking with the potential for occlusion. This is mostly seen in the external iliac artery and in the transition between the aortic stent-graft and the bSG. We are, therefore, currently advocating the liberal use of long self-expanding stents in the external iliac artery and stenting of the modular joints. A similar policy to minimize this complication has also been adapted by others when using conventional devices,24 especially when the risk is increased by the extension of the stent-graft in to the external iliac artery.25 The current bSG design allows the combination of different components for the treatment of the aortic segment of the aneurysm. This provides flexibility in the range of patients suitable for this technique, but it also creates additional modular junctions with short overlap in-between. The possible risk of endoleak from these junctions is considered small, but can be further reduced by the insertion of additional balloon-expandable stents or stent-grafts, for instance in the overlap between the bSG and the bridging stent-graft to the IIA. In conclusion, the use of bSG maintaining the flow to at least one of the IIA provides good results, avoiding pelvic ischemic complications while the bSG is patent. Further technical developments are required especially concerning its modular design and ability to avoid kinking in tortuous arteries.

3

4

5

6

7

8 9

10

11

12

13

14 15

16

Acknowledgments We are very grateful to Associate Professor Bengt Lindblad, Kristina Lindholm, PhD, and Christel Ekberg-Jo¨nsson for their assistance.

17

18

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25 BO¨RNER G, IVANCEV K, SONESSON B, LINDBLAD B, GRIFFIN D, MALINA M. Percutaneous AAA repair: is it safe? J Endovasc Ther 2004;11(6):621e626. 26 LARZON T, GEIJER H, GRUBER G, POPEK R, NORGREN L. Fascia suturing of large access sites after endovascular treatment of aortic aneurysms and dissections. J Endovasc Ther 2006;13(2):152e157. 27 GREENBERG RK, WEST K, PFAFF K, FOSTER J, SKENDER D, HAULON S et al. Beyond the aortic bifurcation: branched endovascular grafts for thoracoabdominal and aortoiliac aneurysms. J Vasc Surg 2006;43(5):879e886 [discussion 886e7]. 28 CHAIKOF EL, BLANKENSTEIJN JD, HARRIS PL, WHITE GH, ZARINS CK, BERNHARD VM et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002;35(5):1048e1060. Accepted 24 October 2007 Available online 18 April 2008