Volume 39, Issue 3 , Pages 285-294, March 2010
Endovascular Aneurysm Repair with Preservation of the Internal Iliac Artery Using the Iliac Branch Graft Device
Article Outline
- Abstract
- 1. Introduction
- 2. Sequelae of Sacrificing the Internal Iliac Artery: Supply and Demand
- 3. Alternatives to IIA Sacrifice
- 4. Iliac Branch Devices
- 5. Methods
- 6. Results and Discussion
- 7. Conclusion
- Conflict of Interest
- References
- Copyright
Abstract
Objectives
Aortoiliac aneurysms comprise up to 43% of the specialist endovascular caseload. In such cases endovascular aneurysm repair (EVAR) requires distal extension of the aortoiliac endograft beyond the ostium of the internal iliac artery (IIA) and into the external iliac artery, conventionally necessitating the embolisation of one or both IIA. This has been associated with a wide range of complications, and the use of an Iliac Branch-graft Device (IBD) offers an appealing endovascular solution.
Design
Medline, trial registries, conference proceedings and article reference lists were searched to identify case series reporting IBD use. Data were extracted for review.
Results
Nine series have reported the use of IBD in a total of 196 patients. Technical success was 85–100%. Median operating times were 101–290
min and median contrast dose was 58–208g, with no aneurysm-related mortality. Claudication developed in 12/24 patients after IBD occlusion. One type I endoleak and two type III endoleaks occurred and were managed endovascularly. Re-occlusion occurred in 24/196 patients.
Conclusion
IBD was performed with high technical success rates and encouraging mid-term patency. Formalised risk stratification and morphological data are required to identify the group of patients who will benefit most. Cost-effectiveness appraisals are needed for this technique.
Keywords: Internal iliac artery, Iliac branch graft device, Endovascular aneurysm repair, Aortoiliac aneurysm
1. Introduction
The evolution of endovascular techniques has increased the proportion of patients with abdominal aortic aneurysm (AAA) suitable for treatment by endovascular aneurysm repair (EVAR) in addition to open repair. However, the proximal or distal extension of aneurysmal disease to visceral or iliac branches of the aorta increases the complexity of EVAR and its consequent morbidity and mortality.1
Although isolated iliac aneurysms are rare,2 aortoiliac aneurysms comprise a significant proportion of the specialist vascular caseload. Unilateral common iliac artery (CIA) aneurysms are present in 43%, and bilateral CIA aneurysms in 11% of patients with intact AAA;3 In such cases EVAR requires distal extension of the aortoiliac endograft beyond the ostium of the internal iliac artery (IIA) and into the external iliac artery (EIA), conventionally necessitating the embolisation of one or both internal iliac arteries (IIA). Sacrifice of the IIA in this manner has been associated with a wide range of complications. These predominantly comprise buttock claudication4, 5 and erectile dysfunction6 but may even include bowel or spinal ischaemia,7 sloughing of the scrotal skin8 or ischaemic injury to the lumbosacral plexus.9
2. Sequelae of Sacrificing the Internal Iliac Artery: Supply and Demand
The severity of symptoms following the sacrifice of one or both IIA is affected by the demand of end organs in the vascular territory of the IIA, as well as their collateral supply. Younger, more active patients have a greater demand for blood supply and a significantly higher risk of buttock claudication after IIA occlusion, and those with poor supply due to reduced cardiac output are also at high risk.10 Collateral blood supply is derived from the contralateral IIA and bilaterally from profunda femoris and external iliac branches.11 Although it is logical to presume that bilateral IIA occlusion would be associated with a greater risk of complications due to pelvic ischaemia, the published evidence suggests that there is no increase in risk compared to unilateral IIA occlusion.12 A systematic literature review identified the development of buttock claudication in 31% of patients who underwent unilateral IIA embolisation prior to EVAR and in 35% of patients with bilateral IIA embolisation prior to EVAR.12 New onset erectile dysfunction was reported in 17% of patients undergoing unilateral IIA embolisation prior to EVAR and in 24% of patients undergoing bilateral IIA embolisation prior to EVAR.12 Publication bias is likely to exert a significant effect and such findings must be interpreted with caution. Furthermore, the rate of major complications occurring as a result of bilateral IIA occlusion is probably under-reported. However, there is no evidence for benefit from the sequential rather than simultaneous sacrifice of bilateral IIA.13 Interruption of the IIA as proximally as possible reduces ischaemic complications and it is likely that this is due to greater preservation of collateral blood supply.4, 13 However, the importance of significant publication bias in the reporting of pelvic complications following IIA occlusion must be emphasised.
3. Alternatives to IIA Sacrifice
The group of patients at greatest risk from sacrifice of the IIA remains largely unidentified. Although complications from bilateral IIA sacrifice are relatively innocuous in some series,4 persistent and debilitating buttock claudication is seen in other series after unilateral IIA occlusion.12 There are many confounding factors in the literature to explain such heterogeneity, including differences in the prevalence of diabetes, variations in population age, the length of follow-up and the small sample size of existing studies. Nevertheless, some (as yet undefined) groups of patients at high risk of developing complications might benefit from preservation of IIA flow. Techniques described for preservation of the IIA include relocation of the IIA origin,14 IIA bypass,15 bell-bottom grafts,16 and external-to-internal iliac stent-grafts with femoro-femoral cross-over.17, 18, 19 In comparison to these more invasive techniques, the use of Internal Iliac Branch-Graft Devices (IBDs) offers an appealing endovascular solution.
4. Iliac Branch Devices
IBDs extend from a conventional EVAR stent-graft in to the EIA whilst preserving flow in to the ipsilateral IIA using a side branch. The IIA is cannulated from the contralateral femoral artery using a pre-loaded wire from the side branch (Fig. 1).
Figure 1
Angiogram to illustrate cannulation of right IIA from the left femoral artery, using a pre-loaded wire from the IIA side branch of the Zenith Bifurcated Iliac Side (ZBIS) device (Cook Inc., Bloomington, IN).
Two systems have been reported in current use: the Zenith Bifurcated Iliac Side (ZBIS) device (Cook Inc., Bloomington, IN, USA) (Fig. 2) and the Helical Branch Endograft (HBE) device described by Greenberg et al20 (Fig. 3) available for commercial use (Cook Inc., Bloomington, IN).
Figure 2
Photograph of the Zenith Bifurcated Iliac Side (ZBIS) device (Cook Inc., Bloomington, IN) illustrating the straight side branch for preservation of the internal iliac artery (IIA).
Figure 3
Photograph of the Helical Branch Endograft (HBE) developed by Greenberg et al incorporating a directional side-branch for preservation of the IIA.
5. Methods
An electronic search was performed using the Embase and Medline databases from 1966 until 1 September, 2009. The search terms “EVAR”, “Hypogastric artery”, “Internal Iliac Artery” and “Branch Graft” were used in combination with the Boolean operators AND or OR. The electronic search was supplemented by a hand search of published abstracts from meetings of the Veith Symposium, the International Symposium on Endovascular Therapy (ISET), Euro-PCR, the European Society of Vascular Surgery (ESVS), the British Society of Endovascular Therapy (BSET), the Society for Vascular Surgery (SVS) and the Vascular Society of Great Britain and Ireland. The reference lists of articles obtained were also searched to identify further relevant citations. Finally, the search included the Current Controlled Trials Register (www.controlled-trials.com) and the Cochrane Database of Controlled Trials. IBD reports containing fewer than 5 patients were excluded unless supplementary data from a greater number of patients were available following personal communication. Data were extracted for review, using consensus definitions for reporting outcomes after EVAR.21
6. Results and Discussion
There have been 8 published series20, 22, 23, 24, 25, 26, 27, 28 reporting the use of IBD. Following personal communication (authors A.K. and J.B.), data from one unpublished series were obtained, which incorporated previously published data29 (Cambridge Vascular Unit, Cambridge University Hospitals NHS Foundation Trust, UK). In total, 9 series of patients undergoing IBD were therefore included for review. An earlier article has previously reviewed 5 of these 9 series.30 One of the series not previously reviewed incorporated the first comparative study of IBD with IIA occlusion.27 Two pairs of reports by Dias/Malina22, 24 and Greenberg/Haulon20, 23 included the same patients; therefore only the most recent data were reviewed. This resulted in the review of 7 unique case series reporting the use of IBD in a total of 196 patients.
6.1. Indications for use and patient selection
A wide range of morphological and clinical indications for use was found across the included series (Table 2). In patients with two patent IIA prior to IBD, Tielliu et al adopted minimum exercise tolerance criteria for IBD selection to exclude those who had a limited level of activity.26 In patients with only one patent IIA prior to consideration for an IBD, Tielliu et al did not employ exercise tolerance as a selection criterion. In all series, at least 19 of 196 patients undergoing IBD underwent occlusion of the contralateral IIA (Table 1).
Table 1. Characteristics of patients treated in IBD series.
| Author, year | No. of patients treated with IBD | Median follow-up (months) | Age (years) | Device used | Median AAA diameter (mm) | Median CIA aneurysm diameter (mm) | No. of patients in whom contralateral IIA was occluded | No. of patients in whom bilateral IBD was attempted |
|---|---|---|---|---|---|---|---|---|
| Dias/Malina et al, 2008/200623, 25 | 22 | 20 (8–31) | 70 (65–79) | 2 Custom-Made 18 ZBIS 3HBE | 52 (37–60) | 34 (27–41) | 8/23 | 1/23 |
| Haulon/Greenberg et al, 2007/200621, 24 | 52 | 14 | 72 (56–86) | All HBE | 56 (32–89) | 38 (23–78) | Not stated | 1/52 |
| Ziegler et al, 200729 | 46 | 24 (3–60) | 69 (52–86) | 26 1st Generation Unibody device 20 ZBIS | 57.1 (45–90) | 32.3 (15–60) | Not stated | 5/46 |
| Serracino-Inglott et al, 200726 | 8 | 6 (1–14) | 72 (64–80) | All ZBIS | 48 (20–60) | 31.5 (1.5–6.3) | 3/8 | 0/8 |
| Tielliu et al, 200927 | 27 | 16 (1–38) | 70 (58–79) | All ZBIS | – | – | 2/27 | 3/27 |
| Cambridge Vascular Unit (unpublished), 2009 | 8 | 11.3 (2.6–24) | 73 (68–79) | All ZBIS | (46–58) | 39 (26–50) | ||
| Verzini et al, 200928 | 32 | 9.8 (1–24) | 73.6±8.3 | All ZBIS | – | 40.2±7.9 | 4/32 | 0/32 |
Table 2. Inclusion criteria for IBD series.
| Author, year | Morphological inclusion criteria | Clinical inclusion criteria |
|---|---|---|
| Dias/Malina et al 2008/200623, 25 | IIA diameter <11mm IIA length >10 mm | None specified |
| Haulon/Greenberg et al, 2007/200621, 24 | None specified | None specified |
| Ziegler et al, 200729 | CIA diameter >24mm Difficulty with: intraluminal CIA thrombus, severe EIA kinking, stenosis of IIA ostium, >500 IIA offspring | None specified |
| Serracino-Inglott et al, 200726 | IIA calibre “normal” IIA length > 10 mmEIA>20 mm lengthEIA diameter 8–11 mm | None specified |
| Tielliu et al, 200927 | Patent CIA lumen >18mm (free of intraluminal thrombus) Relative contra-indications: sharp aortic bifurcation, iliac tortuosity Non-aneurysmal IIA IIA not heavily stenotic | Level of activity: If contralateral IIA patent, patient had to walk one block to get IBD If contralateral IIA occluded, activity level not considered |
| Verzini et al, 200928 | CIA diameter >24mm Patent CIA lumen >20 mmCIA length >40 mmIIA length >10 mmEIA length >15 mm | None specified |
| Cambridge Vascular Unit (unpublished), 2009 | None specified | None specified |
Standardised morphological criteria for the use of IBD have not been defined or validated. Objective criteria required for patients to receive an IBD included the presence of an aneurysmal CIA of diameter >24mm,27, 28 the presence of a patent CIA lumen greater than 18mm26 or 20mm,27 an adequate length of EIA for distal landing of >20mm25 or >15mm,27 and sufficient length of IIA of >10mm22, 25, 27 to secure the branch device. It has been stated that the IIA must ideally be of “normal diameter”25 or up to 11mm in diameter22 to receive the IBD device. Although patients with aneurysmal IIA were excluded from some series,26 this challenging anatomy was tackled in other series using IBD25, 27, 29 (Table 3). Increasing experience with the IBD will permit the derivation and stratification of morphological risk factors for device failure, to improve patient selection for this new technique.
Table 3. Extension of aneurysm disease (%, *not exclusive).
| Author, year | IBD as Secondary Procedure | AAA+ CIA aneurysm | Solitary CIA aneurysm | *IIA aneurysm |
|---|---|---|---|---|
| Dias/Malina et al, 2008/200623, 25 | 4.3 | 60.7 | 35 | – |
| Haulon/Greenberg et al, 2007/200621, 24 | – | 80 | 20 | – |
| Ziegler et al, 200729 | 8.7 | 73.9 | 17.4 | – |
| Serracino-Inglott et al, 200726 | 12.5 | 75 | – | 12.5 |
| Tielliu et al, 200927 | – | 74 | 26 | – |
| Verzini et al, 200928 | – | 78 | 12 | 19 |
| Cambridge Vascular Unit, 2009 | – | 88 | 12 | 25 |
Excluding patients who were rejected for non-anatomical reasons on clinical grounds alone, 52% (27/52) of patients with aortoiliac or solitary iliac aneurysms assessed by Tielliu et al,26 were deemed anatomically suitable to receive IBD. The external validity of this anatomical application rate requires further investigation, as there is a paucity of literature to assess the proportion of patients with CIA aneurysms who are morphologically suitable for IBD.
6.2. Technical success
There was no significant difference in technical success rate between IBD deployment and IIA embolisation in the single comparative study of these techniques.27 The rate of technical success varied between 85% and 100% for modern IBDs in current use (Table 4). This demonstrates the feasibility of IBD use in a selected group of patients. The technical success rate has been shown to improve with time, secondary to the learning curve associated with IBD deployment and the development of second-generation modular IBDs following withdrawal of the first-generation unibody IBD.28 A range of bridging stents was used across different series (Table 4) and there has been no comparative analysis to determine if this affects outcome. As expected for a novel technique, there was a wide range of median operating times (101–290min) and median contrast dose (58–208g) across all series. This partly reflected heterogeneity in the operations reported, which ranged from bilateral IBD with simultaneous fenestrated EVAR to solitary CIA aneurysm repair.
Table 4. Outcomes in patients with IBD.
| Author, year | Mortality % (n) | Technical success % (n) | Initial clinical success (<30 days) % (n) | Short-term clinical success (30 days–6months) % (n) | Mid-term clinical success (6months–5 years) % (n) | Operating time (min) | Iodine dose | IIA bridging stent-grafta | Additional adjuncts deployed in IIAa | Brachial or axillary access required |
|---|---|---|---|---|---|---|---|---|---|---|
| Dias/Malina et al, 2008/200623, 25 | 9.1% (2/22) 0 aneurysm-related | 91.3% (21/23) 2 IBD occlusions | 87% (20/23) 1 IBD occlusion | 83% (19/23) 1 IBD occlusion | 74% (17/23) 2 IBD occlusions | 279 (234–327) | 58 (48–78) | Advanta V12 (10) Jomed (6) Fluency Plus (7) | Advanta V12 (3) Jomed stent-graft (2) AVE stent (1) Luminexx (1) | 1/22 |
| Haulon/Greenberg et al, 2007/200621, 24 | 13% (7/52) 0 aneurysm-related | 94% (49/52) 2 unable to visualise IIA1 unable to cross aortic bifurcation | 79% (41/52) 6 IBD occlusions (2 EIA thrombosis) | 79% (41/52) 0 further complications | 79% (41/52) 0 further complications | – | 208 | Fluency Plus Advanta V12 (2) | Genesis expandable | Common (exact no. not stated) |
| Ziegler et al, 200729 | ||||||||||
| 1st Generation Unibody IBD: | 0 | 62% (16/26) | 72% (33/46) 0 further complications | 63% (29/46) 4 IBD occlusions | 63% (29/46) 0 further complications | 183 (100–330) | 88 (35–180) | Not described | Not described | Exact no. not stated |
| 2nd Generation IBD: | 0 | 85% (17/20) | Not described | Not described | ||||||
| Serracino-Inglott et al, 200726 | 0 | 100% (8/8) | 88% (7/8) 1 IBD occlusion | 88% (7/8) 0 further complications | 88% (7/8) 0 further complications | 101 (84–130) | 103 (84–130) | Advanta V12 (8) | – | 1/8 |
| Tielliu et al, 200927 | 11.1% (3/27) 0 aneurysm-related | 96% (26/27) | 86% (18/21) 3 IBD occlusions | 185±31 | – | Advanta V12 (23) Jomed (3) | – | 2/27 | ||
| Verzini et al, 200928 | 3% (1/32) 0 aneurysm-related | 94% (30/32) 2 IBD occlusions | 153 (no range or s.d.) | – | Advanta V12 (19) Fluency (13) | “Self-expanding stent” (5) 2nd Fluency stent (1) | Not stated | |||
| Cambridge Vascular Unit (unpublished), 2009 | 0 | 75% (6/8) 2 IBD occlusions | 290 (230–390) | – | Advanta V12 (6) | – | 1/8 | |||
aThe following bridging stent-grafts or adjuncts were deployed: AVE Stent, Medtronic Vascular, Santa Rosa, CA, USA; Luminexx Stent, CR Bard, Inc. Tempe, AZ, USA; Fluency Plus Vascular Stent-Graft, CR Bard, Tempe, AZ, USA; Advanta V12, Atrium Medical, Hudson NH, USA; Jomed Stent-graft, Abbot Vascular Devices, Rangendingen, Germany; Genesis Balloon Expandable Stent Graft, Cordis, Great Lakes, NJ, USA. |
Intraoperative IIA dissection occurred in two patients. The first of these dissections was caused by technical difficulty in a female patient with a small IIA23 and the second occurred due to operator error after excessive dilatation of the balloon-expandable IIA stent-graft.22
It has been reported that difficulty in negotiating the cross-over of the aortic bifurcation can lead to technical failure. Difficulty in negotiation of the aortic cross-over is a particular concern in patients undergoing IBD as a secondary procedure after initial aorto-bi-iliac EVAR.26, 28 In this setting, a brachial or axillary approach may be used for IIA cannulation.28 Where necessary, a brachial approach was employed in all the studied series (Table 4), despite exposing patients to a potential risk of stroke. However, this was not reported in any of the patients requiring brachial or axillary access. Overall, IBD deployment was associated with a low rate of post-operative medical complications and there was only 1 TIA and 1 subarachnoid haemorrhage in the series reported, with 0% aneurysm-related mortality (Table 5).
Table 5. Complications and secondary interventions.
| Author, year | Morbidity | IIA Dissection | Type I endoleak | Type II endoleak | Type III endoleak | Post-operative re-interventions | Patients with buttock claudication or sexual dysfunction following IBD occlusion, as proportion of the total number of patients with post-operative IBD occlusion |
|---|---|---|---|---|---|---|---|
| Dias/Malina et al, 2008/200623, 25 | 1/22 TIA | 1/22 | 0 | 2/23 at discharge 1/23 at 1 month | 1/22 | 4/221 stenting of EIA for asymptomatic kinking1 extension from AAA graft into EIA for type III endoleak1 femoro-femoral cross-over after IBD occlusion 1 IIA stent-graft extension | 3/6 (buttock claudication) |
| Haulon/Greenberg et al, 2007/200621, 24 | 0 | 1/52 | 0 | 6/52 at discharge 5/46 at 1 month5/31 at 6 months1/21 at 12 months0/2 at 24 months | 0 | 3/52 2 thrombolysis for occlusion of tortuous EIA contralateral to IBD 1 thrombolysis for occlusion of EIA ipsilateral to occluded IBD | 6/6 (buttock claudication) |
| Ziegler et al, 200729 | 1/46 Subarachnoid bleeding | 0 | 0 | 0 | 0 | 0 1 intraoperative thrombolysis and angioplasty to occluded IBD, which recanalised 1 occluded IBD recanalised spontaneously | 1/4 (buttock claudication) |
| Serracino-Inglott et al, 200726 | 2/8 groin lymphocoeles | 0 | 0 | 1/8 | 0 | 0 | 0/1 |
| Tielliu et al, 200927 | 1/27 pneumonia 1/27 EIA rupture | 0 | 0 | 0 | 0 | 0 | 1/3 (buttock claudication) |
| Verzini et al, 200928 | 1/32 atrial fibrillation 1/32 pulmonary embolism 1/32 renal failure requiring dialysis | 0 | 1/32 | 0 | 1/32 | 5/322 thrombectomy for EIA occlusion 1 femoral artery repair for pseudoaneurysm at access site 1 secondary IIA stent for type I endoleak at distal IBD sealing zone 1 interposition endograft for type III endoleak at IIA branch/IIA stent interface | 0/2 |
| Cambridge Vascular Unit (unpublished), 2009 | 0 | 0 | 0 | 1/8 | 0 | 0 | 1/2 (buttock claudication) |
6.3. Clinical success
Only one patient who underwent successful implantation of an IBD experienced buttock claudication.27 By intention-to-treat analysis, clinical success rates varied from 63% to 88% within the follow-up range of the 7 studies included in review. There were 24 IBD occlusions across 196 patients in all series. Occluded IBDs did not cause aneurysm rupture or sac expansion. However, there remains a significant rate of device failure, and therefore a degree of caution should be exercised in patient selection for IBD.
Amongst 24 patients in whom post-operative IBD occlusion followed the attainment of initial technical success, 50% (12/24) manifested symptomatic buttock claudication (Table 5). The low rate of symptoms following IBD occlusion adds weight to the importance of case selection for IBD. Across all the studies, factors associated with technical difficulty predisposing to IBD occlusion included a sharp aortic bifurcation, iliac tortuosity or calcification, the presence of intraluminal CIA thrombus, severe EIA kinking, stenosis of the IIA ostium, IIA atherosclerosis or IIA aneurysm. Cases of post-operative IBD occlusion were managed with a range of techniques. Most IBD occlusions were managed conservatively, one of which recanalised spontaneously.28 One case of IBD occlusion was managed successfully with thrombolysis28, one case was managed with femoro-femoral cross-over.22 In two cases of IBD occlusion, EVAR was converted to open repair, IBD explantation and open aorto-bi-iliac reconstruction without IIA revascularisation.28
There was a low endoleak rate, with only 1 type I endoleak and 2 type III endoleaks across all series (Table 5). All type II endoleaks were managed conservatively, as none were associated with sac expansion. The type I endoleak occurred at the distal sealing zone of the IBD and was managed endovascularly with an additional stent-graft.27 Both cases of type III endoleak occurred at the junction of the IIA limb of the IBD with its main body,22, 27 and these were also managed with an interposition endovascular stent-graft.
There was a low rate of post-operative re-intervention, with 12 patients requiring re-intervention across all series (Table 5). There were 5 EIA occlusions (Table 5). Three of these cases were managed with thrombolysis23 and two were managed with thrombectomy.27 Extension of the endograft into the EIA has been shown to increase the risk of iliac limb occlusion after EVAR31, 32, 33 and this is therefore a particular hazard with IBD deployment, although two of the five EIA occlusions occurred contralateral to the IBD in a tortuous native EIA.23
6.4. Implications for further research
Further research is required to identify the subset of patients at greatest risk of complications following IBD use, including EIA occlusion, IBD branch occlusion, IBD endoleak and the need for re-intervention. This is likely to require multi-centre or registry data, incorporating morphological assessment, to enable the development of a risk stratification model to inform patient selection for IBD. Patients with aortoiliac or solitary CIA aneurysms require morphological study to further identify the proportion that is anatomically suitable for IBD, using risk-stratified indications for use. The existing literature suggests that up to 52% of these patients may not be suitable for IBD use,26 although no validated objective criteria for IBD use have yet been derived and studied.
The development of endoleak following IIA embolisation is included in the standardised reporting criteria after EVAR, though no consensus criteria have been outlined for the reporting of complications following IBD use.21 Agreed definitions should be produced for the standardised reporting of complications following the deployment of IBD. For example, the post-operative penile-brachial pressure index has been suggested as an objective marker of impotence following IBD occlusion27. Only one study has been conducted to directly compare EVAR in patients undergoing IIA embolisation with those undergoing IIA revascularisation with IBD.27 There has been no comparative assessment of quality of life, cost-effectiveness or long-term outcomes; and a randomised trial might therefore be useful. There are no data to compare the outcomes of the HBE device compared to the ZBIS device. Surgeons’ preference appears to be the main distinguishing factor at present. The helical device may allow more physiological flow, though no clinical data are available to confirm this suggestion. The Fluency stent-graft (Bard, Phoenix, AZ, USA) may be more suitable for use with the HBE device as it is self-expanding and conformable whereas the Atrium stent (Atrium Medical, Hudson NH, USA) has been used with the ZBIS straight side-branch IBD as it is balloon-expandable and less flexible; there are no data regarding these combinations and these are issues to be addressed in future studies.
6.5. Cost-effectiveness
It has been shown that hypogastric artery embolisation is achievable at a cost of approximately $470.34 Undoubtedly, IBD is a costly technique. The use of Zenith Bifurcated Iliac Side (ZBIS) device (Cook Inc., Bloomington, IN) adds $6000 to the cost of standard EVAR with the Zenith endograft, excluding the additional cost of the bridging stent. Furthermore, EVAR is already associated with greater costs compared to open AAA repair.35 The cost-effectiveness of IBD devices is open to question, and this confirms the need for cautious patient selection. Young patients with high activity levels at high risk of manifesting symptomatic pelvic ischaemia may gain most from IBD use. A formal cost-effectiveness appraisal is needed.
7. Conclusion
IBD procedures may be performed with high technical success rates and are associated with encouraging mid-term patency of IIA in selected patients. However, a significant re-occlusion rate has occurred in existing series, with requirement for re-intervention in these cases. Formalised risk stratification and morphological data are required to identify the group of patients who will benefit most from EVAR featuring IBD. Cost-effectiveness appraisals are needed for this technique.
Conflict of Interest
None declared.
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PII: S1078-5884(09)00587-5
doi:10.1016/j.ejvs.2009.11.018
© 2009 European Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
Volume 39, Issue 3 , Pages 285-294, March 2010
