Endovascular Treatment of Common Iliac Artery Aneurysms With an Iliac Branch Device

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 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 para-anastomotic 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 were prescribed aspirin lifelong unless they were taking coumarin derivatives.

Table 1.

Distribution of Patients and Outcomes per Participating Centers.

Center	A (n=13)	B (n=13)	C (n=18)	D (n=19)	E (n=22)	F (n=23)	G (n=32)
Operation time, min^a	135 (90–190)	220 (120–340)	201 (150–370)	228 (122–350)	188 (90–260)	150 (100–240)	200 (120–329)
Technical success, %	100	77	100	100	95	100	97
30-Day major complication, %	7.7	23	0	5.3	4.5	0	0
Mortality, %	0	7.7	0	5.3	0	0	0
Reintervention, %	15	23	5.5	5.3	14	17	9.4

Data are presented as the median (range).

Table 2.

Patient Characteristics.^a

Age, y	70.9±7.4
Men	130 (92.9)
Diabetes mellitus	20 (14.3)
Hypertension	94 (67.1)
Hyperlipidemia	71 (50.7)
Cardiac disease	54 (38.6)
Neurologic disease	21 (15.0)
Renal failure^b	19 (13.6)
Smoking
No	27 (19.3)
Past	39 (27.9)
Current	39 (27.9)
Missing	35 (25)
Previous aortic surgery
EVAR	11 (7.9)
Open procedure	22 (15.7)

Abbreviation: EVAR, endovascular aneurysm repair.

Continuous data are presented as the means ± standard deviation; categorical data are given as the counts (percentage).

Glomerular filtration rate <60 mL/min/1.72 m².

Table 3.

Indication for Intervention in 140 IBD Cases.^a

	N	CIA Diameter, mm
AAA^b with CIA aneurysm >20 mm	40 (28.6)	34.9±9.2 (21.8–62.0)
CIA aneurysm (diameter >30 mm)	89 (63.6)	39.7±10.7 (28.6–69.7)
Isolated	17 (12.1)	41.4±12.3 (29.0–67.0)
Combined with AAA <55 mm	50 (35.7)	37.8±10.0 (29.3–69.7)
After previous open aortic surgery	22 (15.7)	39.0±10.9 (28.6–66.0)
Revision of type Ib endoleak	11 (7.9)	37.0±8.4 (28.3–52.7)

Abbreviations: AAA, abdominal aortic aneurysm; IBD, iliac branch device; CIA, common iliac artery.

Continuous data are presented as the means ± standard deviation (range); categorical data are given as the counts (percentage).

Diameter >55 mm for men and >50 mm for women.

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 balloon-expandable 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). Kaplan-Meier 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 <10 mm long, resulting in extension of the IIA component and coverage of one or more side branches. No additional stents were placed to straighten the EIA.

Table 4.

Details of the 5 Technical Failures.

Technical Failure	Intervention
Covered stent dislodged into the EIA	Extension of stent-graft to EIA, overstenting IIA branch
Intraoperative IIA branch occlusion due to severe covered stent angulation	Watchful waiting
Intraoperative IIA branch occlusion due to severe covered stent angulation	Watchful waiting
Failure to enter IIA with 7-F sheath due to extreme iliac artery tortuosity	IIA coil embolization
Type Ib endoleak at the IIA branch	Watchful waiting, patient died after 6 weeks

Abbreviations: EIA, external iliac artery; IIA, internal iliac artery.

Complications

Complications developed in 10 (7.1%) patients during the first 30 days after surgery (Table 5); 6 (4.3%) were classified as major. Two (1.4%) patients died of postoperative complications. A secondary infection of a right groin hematoma following open femoral access presented 4 weeks postoperatively in a 79-year-old patient. The wound was surgically drained and debrided; septic bleeding occurred 1 week later. Antibiotics were administered and reexploration of the right groin identified a large ruptured aneurysm of the common femoral artery. The common femoral artery was ligated, and limb ischemia ensued. After further deterioration, palliative treatment was started, and the patient died 7 weeks postoperatively.

Table 5.

Details of the Postoperative Complications in 10 Patients.

Complication	Intervention	Outcome
Major
SFA occlusion	Surgical thrombectomy	Successful
Stroke	Watchful waiting	Full recovery
Cardiac arrest	Resuscitation	Full recovery
Groin hematoma	Debridement	Full recovery
Large gluteal hematoma after perforation of the gluteal artery	Watchful waiting	Died 6 weeks
Infected groin hematoma and septic CFA bleeding	Multiple debridements and CFA ligation	Died 7 weeks
Minor
Transient stridor due to intubation	Watchful waiting	Full recovery
Acute kidney injury	Watchful waiting	Full recovery
Urinary tract infection	Antibiotics	Full recovery
Urinary tract infection	Antibiotics	Full recovery

Abbreviations: CFA, common femoral artery; SFA, superficial femoral artery.

The second patient was readmitted 2 weeks postoperatively with buttock pain. CTA revealed a large gluteal hematoma and a type Ib endoleak at the IIA branch of the IBD. The hematoma resulted from a gluteal artery perforation and was treated conservatively because no active bleeding was identified on CTA. During admission, the patient deteriorated due to delirium and poor nutritional status; multiorgan failure developed after infection of the hematoma. The patient died 6 weeks postoperatively.

Secondary Interventions

Mean follow-up was 26.6±24.1 months. Postoperative CTA or duplex ultrasound examination was available in 134 (95.7%) patients. Preoperative and postoperative CTAs were compared in 107 (76.4%) patients; Bland-Altman plots demonstrated no interobserver variability in diameter measurements. Sac regression of the AAA or CIA aneurysm was observed in 55 (51.3%) patients. Sac enlargement was recorded in 14 (13.1%) patients; in 6, it was due to a type I endoleak and in 1 to a type III endoleak. There was no apparent cause in the other 7 patients.

No type Ia endoleaks in isolated CIA aneurysms were observed. Seven IIA type Ib endoleaks were identified during follow-up. In 4 patients, the IIA branch was successfully extended with a covered stent. In 2 patients, the branch and the IIA were excluded with Amplatzer plugs or coils after persistent growth of the CIA aneurysm despite extension with a covered stent and repeated balloon dilation. A perforation of the IIA occurred in 1 patient during endovascular treatment of a type Ib endoleak; emergency laparotomy was performed, and the IIA was ligated.

Three type III endoleaks resulting from disconnection of the covered IIA stent from the IBD branch were encountered; no kinking or angulation was observed in these branches. Two patients were treated with additional covered stent placement. One patient was managed successfully by watchful waiting due to the small size of the endoleak and the absence of sac enlargement.

In 7 patients, the EIA occluded during follow-up. Four patients were successfully treated with thrombolysis; 3 required additional stent placement. Surgical thrombectomy was performed in 2 patients. One patient was treated conservatively, and intermittent claudication developed.

Including 4 of the technical failures, 2 intentional IIA embolizations, 1 emergent ligation, and 8 branch occlusion during follow-up, a total of 15 (9.3%) IIA branch occlusions were identified. Buttock claudication developed in 6 of these patients. During follow-up, a proximal stenosis in 1 IBD was treated with a Palmaz stent, resulting in 17 (12.1%) IBD-associated secondary interventions. Figure 1 depicts a survival curve estimating a 75.9% (95% CI 59.7 to 86.3) freedom from secondary interventions over 60 months of follow-up.

Twenty-one (15%) patients died during the first 5 years of follow-up. Causes of death were procedure-related in 2 as noted above, cardiac in 3, malignancies in 3, pulmonary in 6, and undetermined in 7.

Discussion

The current series is one of the largest published reports regarding endovascular treatment of CIA aneurysms with an IBD. Moreover, this multicenter series represents daily practice in the Netherlands. Although the individual centers did not include >32 patients, the results are similar to high-volume 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%.

Table 6.

Review of Published Series With at Least 20 Patients.

Author, Year, Country	Centers	Study Period	Follow-up, mo^a	N	Technical Success, %	Morbidity, %	30-Day Mortality, %	Reintervention, %
Ziegler, 2007,⁸ Germany	1	2/2001–9/2006	26±17	46	72.0	NR	0	3.0
Dias, 2008,⁹ Sweden	1	9/2002–8/2007	20 (8–31)	22	91.0	9.0	5	18.0
Tielliu, 2009,¹⁰ Netherlands	1	9/2004–2009	16±14	27	96.3	NR	0	NR
Verzini, 2009,¹¹ Italy	1	1/2000–5/2008	9.8 (1–24)	32	94.0	NR	0	16
Donas, 2011,¹² Germany, Greece	2	1/2004–3/2010	NR	64	NR	4.6	0	3.1
Parlani, 2011,¹³ Italy	2	1/2006–3/2011	21 (1–60)	100	95.0	5.8	0	7.5
Maurel, 2013,¹⁴ France	10	1/2009–4/2010	NR	39	90.0	NR	0	10.5
Wong 2013,¹⁵ USA	1	10/2003–2/2012	20.3 (1–72)	130	94.0	NR	1.0	9.0
Loth, 2015,¹⁶ Germany	2	1/2004–12/2012	32±27	41	87.0	2.4	0	17.0
Lebas, 2016,¹⁷ France	1	1/2010–1/2015	29 (1–60)	25	96.1	4.0	0	4.0
Current study, 2016, Netherlands	7	9/2004–8/2015	26.6±24.1	140	96.9	4.3	1.4	12.1

Abbreviations: NR, not reported. ^aData are presented as the means ± standard deviation (range).

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 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.

Footnotes

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.

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