679132
research-article2016
JETXXX10.1177/1526602816679132Journal of Endovascular TherapyJongsma et al
A SAGE Publication
Clinical Investigation
Endovascular Treatment of Common Iliac Artery Aneurysms With an Iliac Branch Device: Multicenter Experience of 140 Patients
Journal of Endovascular Therapy 2017, Vol. 24(2) 239–245 © The Author(s) 2016 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1526602816679132 www.jevt.org
Hidde Jongsma, MD1, Joost A. Bekken, MD1, Wouter J. J. Bekkers, MSc1, Clark J. Zeebregts, MD, PhD2, Joost van Herwaarden, MD, PhD3, Arjan Hoksbergen, MD, PhD4, Philip Cuypers, MD, PhD5, Jean Paul P. M. de Vries, MD, PhD6, Hence J. Verhagen, MD, PhD7, and Bram Fioole, MD, PhD1 Abstract Purpose: To evaluate the efficacy, feasibility, and long-term outcomes of the Zenith ZBIS iliac branch device (IBD) to preserve internal iliac artery (IIA) perfusion in a large Dutch multicenter cohort. Methods: Between September 2004 and August 2015, 140 patients (mean age 70.9±7.4 years; 130 men) with 162 IBD implantations were identified in 7 vascular centers. The indication for IBD implantation was an abdominal aortic aneurysm >55 mm with a concomitant common iliac artery (CIA) aneurysm >20 mm (n=40), a CIA aneurysm with a diameter >30 mm (n=89), or revision of a type Ib endoleak after endovascular aneurysm repair (n=11). Results: Technical success (aneurysm exclusion, no type I or III endoleak, and a patent IIA) was obtained in 157 (96.9%) of 162 IBD implantations. Six (4.3%) patients developed major complications; 2 (1.4%) died. Mean follow-up was 26.6±24.1 months, during which 17 (12.1%) IBD-associated secondary interventions were performed. Including technical failures and intentional IIA embolizations, 15 (9.3%) IIA branch occlusions were identified; buttock claudication developed in 6 of these patients. The freedom from secondary intervention estimate was 75.9% (95% confidence interval 59.7 to 86.3) at 5 years. Conclusion: CIA aneurysms can be treated safely and effectively by IBDs with preservation of antegrade flow to the IIA. Secondary interventions are indicated in >10% of patients during follow-up but can be performed endovascularly in most. Keywords abdominal aortic aneurysm, branch occlusion, branched stent-graft, common iliac artery aneurysm, complications, endoleak, endovascular aneurysm repair, hypogastric artery, iliac artery, internal iliac artery, mortality, reintervention
Introduction Isolated iliac artery aneurysms are uncommon. However, an iliac artery aneurysm coexists in up to 40% of patients with an abdominal aortic aneurysm (AAA).1 The presence of a common iliac artery (CIA) aneurysm during endovascular aneurysm repair (EVAR) makes it challenging to obtain durable distal fixation and sealing. EVAR in patients without a suitable CIA landing zone is associated with an increased incidence of type Ib endoleak and AAA sac increase.2,3 Extending the graft into the external iliac artery (EIA), with or without embolization of the internal iliac artery (IIA), may result in buttock claudication, erectile dysfunction, or even intestinal ischemia.4 To prevent these complications, several endovascular and hybrid techniques can preserve flow to the IIA. One of
1
Department of Vascular Surgery, Maasstad Hospital, Rotterdam, the Netherlands 2 Department of Vascular Surgery, University Medical Center, Groningen, the Netherlands 3 Department of Vascular Surgery, University Medical Center, Utrecht, the Netherlands 4 Department of Vascular Surgery, Vrije Universiteit Medical Center, Amsterdam, the Netherlands 5 Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands 6 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands 7 Department of Vascular Surgery, Erasmus Medical Center, Rotterdam, the Netherlands Corresponding Author: Hidde Jongsma, Department of Vascular Surgery, Maasstad Hospital, Maasstadweg 29, 3079 DZ Rotterdam, the Netherlands. Email:
[email protected]
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Table 1. Distribution of Patients and Outcomes per Participating Centers. Center
A (n=13) a
Operation time, min Technical success, % 30-Day major complication, % Mortality, % Reintervention, %
B (n=13)
C (n=18)
D (n=19)
E (n=22)
F (n=23)
G (n=32)
135 (90–190) 220 (120–340) 201 (150–370) 228 (122–350) 188 (90–260) 150 (100–240) 200 (120–329) 100 77 100 100 95 100 97 7.7 23 0 5.3 4.5 0 0 0 15
7.7 23
0 5.5
5.3 5.3
0 14
0 17
0 9.4
a
Data are presented as the median (range).
the newer methods involves an iliac branch device (IBD), but chimney grafts, double bifurcations, the sandwich technique, and retrograde endovascular IIA preservation are commonly used.5,6 This study evaluated the efficacy and long-term outcomes of the ZBIS IBD (Cook Medical, Bloomington, IN, USA) in a large multicenter cohort in the Netherlands.
Methods Study Design and Patient Sample The study included 140 consecutive patients (mean age 70.9±7.4 years; 130 men) who were treated with 162 ZBIS IBDs between September 2004 and August 2015 at 7 vascular centers in the Netherlands. Patients treated with the Iliac Branch Endoprosthesis (W. L. Gore & Associates, Flagstaff, AZ, USA) were excluded from this study. The indication for use of a ZBIS IBD was a CIA aneurysm with a diameter >30 mm or an AAA (diameter >55 mm in men and >50 mm in women) with a concomitant CIA aneurysm >20 mm in diameter. Patients requiring endovascular revision of a type Ib endoleak using an IBD were also included, as well as patients with distal paraanastomotic aneurysms after open aortic surgery. Data were collected retrospectively from electronic medical records and stored in online case report forms (Castor edc; Ciwit BV, Amsterdam, the Netherlands). The ethics committees of each participating hospital approved this retrospective cohort study and issued a waiver for patient informed consent. The number of patients per center ranged from 13 to 32 (Table 1). Patient characteristics are presented in Table 2. The majority of patients (n=89) had CIA aneurysms >30 mm (Table 3); 40 patients had AAAs with a CIA aneurysm, and 11 patients were treated for type Ib endoleak. No isolated IIA aneurysms were treated. In 22 patients, bilateral IBD implantation was performed simultaneously. In 118 (84.3%) patients, the IBD was combined with an aortic stent-graft. An IBD was the sole device implanted in the 11 endoleaks cases, in 9 CIA aneurysms after previous open aortic surgery, and in 2 isolated CIA aneurysms. All patients
Table 2. Patient Characteristics.a Age, y Men Diabetes mellitus Hypertension Hyperlipidemia Cardiac disease Neurologic disease Renal failureb Smoking No Past Current Missing Previous aortic surgery EVAR Open procedure
70.9±7.4 130 (92.9) 20 (14.3) 94 (67.1) 71 (50.7) 54 (38.6) 21 (15.0) 19 (13.6) 27 (19.3) 39 (27.9) 39 (27.9) 35 (25) 11 (7.9) 22 (15.7)
Abbreviation: EVAR, endovascular aneurysm repair. a Continuous data are presented as the means ± standard deviation; categorical data are given as the counts (percentage). b Glomerular filtration rate 20 mm CIA aneurysm (diameter >30 mm) Isolated
40 (28.6)
Combined with AAA 55 mm for men and >50 mm for women.
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Jongsma et al Table 4. Details of the 5 Technical Failures. Technical Failure Covered stent dislodged into the EIA Intraoperative IIA branch occlusion due to severe covered stent angulation Intraoperative IIA branch occlusion due to severe covered stent angulation Failure to enter IIA with 7-F sheath due to extreme iliac artery tortuosity Type Ib endoleak at the IIA branch
Intervention Extension of stent-graft to EIA, overstenting IIA branch Watchful waiting Watchful waiting IIA coil embolization Watchful waiting, patient died after 6 weeks
Abbreviations: EIA, external iliac artery; IIA, internal iliac artery.
were prescribed aspirin lifelong unless they were taking coumarin derivatives.
IBD Procedure Patients were treated under regional or general anesthesia. Access was obtained through both common femoral arteries; 18 patients had a concomitant upper extremity access. After orientation of the orifice of the target IIA, the IBD graft was advanced. A femorofemoral crossover or brachiofemoral body floss technique was used to advance a 12-F sheath into the branched graft. A second wire was used to cannulate the IIA through the 12-F sheath, and a 7-F sheath was advanced through the 12-F sheath into the IIA. A covered stent was used to bridge from the IBD to the IIA, either the balloonexpandable Atrium Advanta V12 (Atrium Maquet Getinge Group, Mijdrecht, the Netherlands) or the self-expanding Fluency (Bard, Tempe, AZ, USA). The overlap and landing zones were routinely balloon dilated. The follow-up protocol was not standardized among the participating centers. Some centers performed computed tomography angiography (CTA) while others used duplex ultrasound in combination with plain radiography. Imaging was typically done at 6 weeks after the operation and yearly thereafter.
Definitions Comorbidities were defined in accord with the proposed standards of the DEFINE group.7 Technical success referred to exclusion of the aneurysm, freedom from type I and III endoleaks, and a patent IIA after implantation of the device.8 Endoleaks were classified according to standards reported by Cao et al.9 Morbidity was defined as any adverse event within 30 days after the operation. Major complications were events requiring surgical intervention or causing prolonged hospitalization, irreversible disability, or death.8 IIA patency was defined as uninterrupted contrast enhancement on CTA or antegrade arterial flow on duplex ultrasound imaging. Aneurysm sac regression and enlargement referred
to diameter changes >5 mm as measured on CTA. Preoperative and postoperative CTAs were assessed by at least 2 of 3 observers (H.J., W.J.J.B., J.A.B.). Arterial diameters were measured as the outer-to-outer wall diameter perpendicular to the largest diameter on axial CT scans.
Statistical Analysis All results were analyzed on an as-treated basis. Continuous data were presented as means ± standard deviation, and categorical data are given as the counts (percentage). KaplanMeier analysis was used to estimate freedom from secondary intervention; the estimate is given with the 95% confidence interval (CI). Bland-Altman plots were used to assess interobserver variability in diameter measurements on CTA. Analyses were performed using SPSS software (version 22; IBM Corporation, Somers, NY, USA).
Results Technical success was obtained in 157 IBDs (96.9%). A total of 102 (63%) IBDs were implanted in the right CIA and 60 in the left CIA. Causes of technical failure are listed in Table 4. Mean total operation time was 189±57 minutes. The mean contrast volume was 153±91 mL. All but 1 patient received the balloon-expandable Atrium Advanta V12 covered bridging stent. A total of 64 (39.6%) iliac arteries were treated outside the instructions for use (IFU). In 56 (34.9%), the EIA diameter exceeded 11 mm, but an extension was required in only 13 (8.0%). In 8 (4.7%), the IIA landing zone was 32 patients, the results are similar to highvolume centers (Table 6)10–19 that have also reported excellent technical success, low mortality and major morbidity, and reintervention rates ranging from 3% to 18%. Aneurysmal CIAs used for landing zones during EVAR are associated with an increased incidence of graft limb complications.20 Schanzer et al2 analyzed a study population of 10,228 patients who underwent EVAR. They
identified 1215 (11.9%) AAA patients with at least 1 CIA aneurysm (>20-mm diameter), which was an independent predictor of sac enlargement.2 Extending the graft into the EIA, with or without IIA embolization, may result in buttock claudication and erectile dysfunction. The incidence of these complications is similar in unilateral and bilateral embolizations.21,22 Verzini et al13 compared IBD treatment with embolization of the IIA in 74 patients. They found treatment with an IBD was feasible and safe in midterm follow-up and showed similar technical success and secondary intervention rates compared with IIA embolization. However, endoleak and buttock claudication were more common in patients with IIA exclusion than in patients treated with an IBD.13 In patients with Amplatzer plug embolization of the IIA, buttock claudication rates up to 24.3% have been described.23 These rates seem to be even higher in patients treated with coil embolization.24–26 In contrast, only 4.3% of patients with IBD failure demonstrated buttock claudication in the current series. The applicability of the ZBIS IBD seems limited. In a retrospective analysis of 88 iliac artery aneurysms,27 only 40.9% of procedures were compliant with the ZBIS IBD IFU. Using their more liberal in-house protocol, the authors could have treated 58% of the analyzed iliac arteries with the ZBIS IBD. The most important limiting factor for the use of the IBD was an aneurysmal IIA.27 Tielliu and coworkers12 and Karthikesalingam et al28 described similar application rates in smaller series. In the current series, >60% of the iliac arteries were treated according to the ZBIS IBD IFU. In contrast with previous studies, the most important limiting factor in the current series was an EIA diameter >11 mm. However, when indicated, most large-diameter EIAs can be treated with an extension. Moreover, even an IIA aneurysm may not be an exclusion criterion as shown by Noel-Lamy
244 et al.29 They published a series of 15 patients with an IIA aneurysm who underwent successful placement of a ZBIS IBD with extension of the IIA component into the superior gluteal artery. Right-sided CIA aneurysms were more common in our series than left-sided CIA aneurysms (63% vs 37%), an observation that has been reported previously.30
Limitations Owing to the retrospective data collection in this study, selection bias may have occurred. Although all consecutive patients were included, no data were available on the patients with a CIA aneurysm who were not treated with an IBD. Missing data were another limitation as a result of the retrospective data collection. However, missing data were minimized by an extensive search in all electronic patient files and radiologic images. Furthermore, the follow-up protocol after IBD implantation was not standardized throughout the hospitals in the Netherlands. Postoperative CTAs were not obtained in all patients because some centers chose a combination of duplex ultrasound imaging with radiography as the follow-up regimen.
Conclusion CIA aneurysms can be treated safely and effectively using IBDs to preserve antegrade flow to the IIA. Secondary interventions are indicated in >10% of patients during follow-up but can be performed using endovascular techniques in most patients. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Ghosh J, Murray D, Paravastu S, et al. Contemporary management of aorto-iliac aneurysms in the endovascular era. Eur J Vasc Endovasc Surg. 2009;37:182–188. 2. Schanzer A, Greenberg RK, Hevelone N, et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011;123:2848–2855. 3. Hobo R, Sybrandy JE, Harris PL, et al. Endovascular repair of abdominal aortic aneurysms with concomitant common iliac artery aneurysm: outcome analysis of the EUROSTAR experience. J Endovasc Ther. 2008;15:12–22.
Journal of Endovascular Therapy 24(2) 4. Engelke C, Elford J, Morgan RA, et al. Internal iliac artery embolization with bilateral occlusion before endovascular aortoiliac aneurysm repair—clinical outcome of simultaneous and sequential intervention. J Vasc Interv Radiol. 2002;13:667–676. 5. Massiere B, von Ristow A, Vescovi A, et al. Ten-year experience with management of aortoiliac aneurysms using retrograde endovascular internal iliac artery preservation. Ann Vasc Surg. 2016;35:163–167. 6. Reyes A, Donas KP, Pitoulias G, et al. Complementary role of fenestrated/branched endografting and the chimney technique in the treatment of pararenal aneurysms after open abdominal aortic repair. J Endovasc Ther. 2016;23:599–605. 7. Diehm N, Baumgartner I, Jaff M, et al. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J. 2007;28:798–805. 8. Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35:1048–1060. 9. Cao P, De Rango P, Verzini F, et al. Endoleak after endovascular aortic repair: classification, diagnosis and management following endovascular thoracic and abdominal aortic repair. J Cardiovasc Surg (Torino). 2010;51:53–69. 10. Ziegler P, Avgerinos ED, Umscheid T, et al. Branched iliac bifurcation: 6 years experience with endovascular preservation of internal iliac artery flow. J Vasc Surg. 2007;46: 204–210. 11. Dias NV, Resch TA, Sonesson B, et al. EVAR of aortoiliac aneurysms with branched stent-grafts. Eur J Vasc Endovasc Surg. 2008;35:677–684. 12. Tielliu IF, Bos WT, Zeebregts CJ, et al. The role of branched endografts in preserving internal iliac arteries. J Cardiovasc Surg (Torino). 2009;50:213–218. 13. Verzini F, Parlani G, Romano L, et al. Endovascular treatment of iliac aneurysm: concurrent comparison of side branch endograft versus hypogastric exclusion. J Vasc Surg. 2009;49:1154–1161. 14. Donas KP, Torsello G, Pitoulias GA, et al. Surgical versus endovascular repair by iliac branch device of aneurysms involving the iliac bifurcation. J Vasc Surg. 2011;53: 1223–1229. 15. Parlani G, Verzini F, De Rango P, et al. Long-term results of iliac aneurysm repair with iliac branched endograft: a 5-year experience on 100 consecutive cases. Eur J Vasc Endovasc Surg. 2012;43:287–292. 16. Maurel B, Bartoli MA, Jean-Baptiste E, et al. Perioperative evaluation of iliac ZBIS branch devices: a French multicenter study. Ann Vasc Surg. 2013;27:131–138. 17. 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;58:861–869. 18. 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: 1168–1175. 19. Lebas B, Galley J, Legall M, et al. Preservation of the internal iliac arteries with branched iliac stent grafts (Zenith
Jongsma et al bifurcated iliac side): 5 years of experience. Ann Vasc Surg. 2016;33:18–22. 20. Griffin CL, Scali ST, Feezor RJ, et al. Fate of aneurysmal common iliac artery landing zones used for endovascular aneurysm repair. J Endovasc Ther. 2015;22:748–759. 21. 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;31:728–734. 22. Kouvelos GN, Koutsoumpelis A, Peroulis M, et al. In endovascular aneurysm repair cases, when should you consider internal iliac artery embolization when extending a stent into the external iliac artery? Interact Cardiovasc Thorac Surg. 2014;18:821–824. 23. Warein E, Feugier P, Chaufour X, et al. Amplatzer plug to occlude the internal iliac artery during endovascular aortic aneurysm repair: a large multicenter study. Eur J Vasc Endovasc Surg. 2016;51:641–646. 24. Chun JY, Mailli L, Abbasi MA, et al. Embolization of the internal iliac artery before EVAR: is it effective? Is it safe? Which technique should be used? Cardiovasc Intervent Radiol. 2014;37:329–336.
245 25. Jean-Baptiste E, Brizzi S, Bartoli MA, et al. Pelvic ischemia and quality of life scores after interventional occlusion of the hypogastric artery in patients undergoing endovascular aortic aneurysm repair. J Vasc Surg. 2014;60:40–49.e1. 26. Libicher M, Pavlidis D, Bangard C, et al. Occlusion of the internal iliac artery prior EVAR: comparison of coils and plugs. Vasc Endovascular Surg. 2012;46:34–39. 27. Gray D, Shahverdyan R, Jakobs C, et al. Endovascular aneurysm repair of aortoiliac aneurysms with an iliac side-branched stent graft: studying the morphological applicability of the Cook device. Eur J Vasc Endovasc Surg. 2015;49:283–288. 28. Karthikesalingam A, Hinchliffe RJ, Malkawi AH, et al. Morphological suitability of patients with aortoiliac aneurysms for endovascular preservation of the internal iliac artery using commercially available iliac branch graft devices. J Endovasc Ther. 2010;17:163–171. 29. Noel-Lamy M, Jaskolka J, Lindsay TF, et al. Internal iliac aneurysm repair outcomes using a modification of the iliac branch graft. Eur J Vasc Endovasc Surg. 2015;50:474–479. 30. Armon MP, Wenham PW, Whitaker SC, et al. Common iliac artery aneurysms in patients with abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 1998;15:255–257.
