The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair

The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair Alexandros Giosdekos, MD, MSc,a Constantine N. Antonopoulos, MD, MSc, PhD, FEBVS,a George S. Sfyroeras, MD, MSc, PhD, FEBVS,a Konstantinos G. Moulakakis, MD, MSc, PhD, FEBVS,a Nikolaos Tsilimparis, MD, MSc, PhD, FEBVS,b John D. Kakisis, MD, MSc, PhD, FEBVS,a Andreas Lazaris, MD, MSc, PhD, FEBVS,a Achilleas Chatziioannou, MD, MSc, PhD,c and George Geroulakos, MD, MSc, PhD, FEBVS,a Athens, Greece; and Munich, Germany

ABSTRACT Objective: Common iliac artery aneurysms are present in more than a third of patients with abdominal aortic aneurysm and may pose a challenge during open and endovascular repair. Although embolization of the internal iliac artery is an established method, it may be complicated with buttock claudication, erectile dysfunction, colon ischemia, and pelvic necrosis. Iliac branch devices (IBDs), which permit preservation of the hypogastric artery, have been used to prevent these complications. We conducted a meta-analysis to assess the safety and outcomes of IBDs and to explore potential differences between the commercially available types of IBDs. Methods: The meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and MetaAnalyses guidelines. After review of the literature, 36 eligible studies with a total of 1502 patients were included in our study. A meta-analysis was performed with investigation of the following outcomes: technical success rate, 30-day mortality, 30-day patency, follow-up patency, endoleak, buttock claudication, and IBD-associated reintervention. Furthermore, we conducted a subgroup meta-analysis by commercial type of endograft among the outcomes of interest. Results: Among all eligible studies, technical success of the method was 97.35% (95% confidence interval [CI], 96.2798.29). The endoleak rate postoperatively and during the follow-up period was 12.68% (95% CI, 8.80-17.07). The 30-day patency of IBDs was estimated at 97.59% (95% CI, 96.49-98.54), whereas follow-up patency was 94.32% (95% CI, 91.7096.54). Furthermore, reintervention rate associated with IBDs was 6.96% (95% CI, 5.10-9.03), and buttock claudication during the follow-up period was 2.15% (95% CI, 1.25-3.22). Conclusions: IBD seems to be a safe, feasible, and effective technique for the treatment of aortoiliac aneurysms in select patients with suitable anatomy. Further results are awaited to explore the long-term efficacy and durability of these devices. (J Vasc Surg 2019;-:1-13.) Keywords: Iliac branch device; Internal iliac artery; Endovascular aortic aneurysm repair; Meta-analysis

Abdominal aortic aneurysm (AAA) is the most common true arterial aneurysm. Up to 40% of patients with AAA have concomitant unilateral or bilateral iliac artery aneurysms.1,2 Endovascular aneurysm repair (EVAR) of an aortic aneurysm extending to the iliac artery still remains a challenge, despite the significant improvement of endovascular techniques during the last 20 years. Open From the Department of Vascular Surgery, “Attikon” General Hospital,a and First Department of Radiology,b Medical School, National and Kapodistrian University of Athens, Athens; and the Department of Vascular Surgery, University Hospital of Ludwig-Maximilian University Munich, Munich.c Author conflict of interest: none. Correspondence: Constantine N. Antonopoulos, MD, MSc, PhD, FEBVS, Department of Vascular Surgery, “Attikon” General Hospital, Medical School, National and Kapodistrian University of Athens, 1 Rimini St, Chaidari, 12462 Athens, Greece (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.10.087

repair of aortoiliac aneurysms is an effective treatment, but it is technically challenging because of the deep pelvic location, with increased risk of ureteric or iliac vein injury, and it is associated with increased blood loss, longer hospital stay, and higher morbidity and mortality.3 Endovascular repair of iliac aneurysms is a widely accepted technique. Among the available types of intervention is the occlusion of either one or both internal iliac arteries (IIAs) using coils, Amplatzer vascular plugs (Abbott, St. Paul, Minn), or similar occlusion devices. However, this technique may be related to buttock claudication, ranging from 1.6% to 56%.4 Other complications include erectile dysfunction in 17% of patients,5 spinal cord ischemia, bowel ischemia, and pelvic necrosis, affecting about 1% of the patients.6,7 To compensate for these potential complications, preservation of hypogastric blood flow is strongly recommended. Several endovascular techniques have been described to preserve perfusion through unilateral or bilateral hypogastric arteries in aortoiliac aneurysms, including iliac branch devices (IBDs), flared limbs,8 and 1

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parallel graft techniques (sandwich graft, crossover chimney technique).9,10 Hybrid techniques have also been reported; these include external iliac artery (EIA) to IIA bypass with proximal ligation of the IIA to effectively “move” the iliac bifurcation more distally11 and aortouniiliac endograft with a femoral-femoral artery bypass with a covered stent deployment from the contralateral EIA to the IIA in a reverse U fashion.12 Of these techniques, in the endovascular era, many surgeons consider IBDs the first option for the treatment of complex aortoiliac aneurysms. Five commercial IBD configurations by three manufacturers, namely, Cook Medical (Bloomington, Ind), W. L. Gore & Associates (Flagstaff, Ariz), and Jotec (Hechingen, Germany), have been developed so far in Western countries for the preservation of hypogastric flow. Among these, only the Gore Excluder Iliac Branch Endoprosthesis (IBE) is commercially available in the United States. Furthermore, a novel IBD designed by Lifetech, the iliac branch stent graft (IBSG; Lifetech Science, Shenzhen, China), was used for preservation of the IIA in Asian patients with a shorter common iliac artery (CIA). The aim of our meta-analysis was to investigate the safety and outcomes of these types of IBDs for the treatment of aortoiliac aneurysms and to explore potential differences in outcomes per commercial type of IBD.

METHODS Data collection. The meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We performed a comprehensive search of the relevant literature using MEDLINE, Embase, Scopus, Google Scholar, and Ovid, and thereafter, all reference lists were manually searched for potentially relevant articles. Search methodology, inclusion and exclusion criteria, and data extraction. The literature search was performed using the following Medical Subject Headings terms alone and in combination: “iliac artery aneurysm,” “common iliac aneurysm,” “aortoiliac aneurysm,” “iliac branch device,” “iliac branch endoprosthesis,” “iliac branch stent graft,” “endovascular repair,” and “hypogastric.” We searched for all scientific papers until January 2019 without applying any language, sex, or other restriction. Any unpublished studies, studies with a sample size of fewer than five patients, case reports, meta-analyses, studies that did not provide numerical data, and surgeon-modified stent grafts were excluded. Moreover, we excluded studies that were unrelated to the use of IBDs, technical reports, studies focusing on other endovascular or hybrid techniques, and studies focusing exclusively on proximal sealing during EVAR. Two investigators independently extracted and analyzed the data using the same terms, and final decision was reached by consensus. Data extracted from eligible studies included the first author’s name, study year and type, number of centers that

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participated in the study, total number of patients, number of male and female patients, mean age, indications for IBD, mean diameter of CIA aneurysm (CIAA), number of bilateral CIAAs, types of IBDs, bridge stent grafts for the IIA, follow-up in months, and use of IBDs outside instructions for use (IFU). We also extracted the number of patients with the following outcomes of interest: technical success rate, 30-day mortality, 30-day patency, follow-up patency, endoleak, buttock claudication, and IBD-associated reintervention. Technical success was defined as the successful implantation of the IBD in the intended iliac vessels with preservation of antegrade flow to the IIA tributaries and exclusion of the aneurysm. A 30-day patency and follow-up patency were defined as the patency of the CIA, EIA, and IIA branches. Endoleak included any endoleak associated with IBD and endoleaks originating from the AAA sac. Reinterventions were defined as all types of IBD-associated interventions, endovascular, open, or hybrid procedures, performed after the initial IBD implantation, that were necessary to maintain IBD patency or to treat any IBDrelated complication. Statistical analyses. We extracted the number of patients with events and the total number of patients for each studied outcome from all eligible studies. Thereafter, the outcome rates were estimated for each study and reported as the proportion of patients with the corresponding outcome among all patients treated with IBDs. Values of the concomitant outcomes were subsequently appropriately calculated, expressed as proportions and 95% confidence intervals (CIs), and thereafter transformed into quantities according to the FreemanTukey variant of the arcsine square root transformed proportion. The pooled effect estimates were calculated as the back-transformation of the weighted mean of the transformed proportions, using Der Simonian-Laird weights of random effects model and expressed as percentage proportions. A subgroup analysis per type of IBD was also performed. Using all available data from the eligible studies, we calculated separate outcome rates of technical success rate, 30-day patency, follow-up patency, endoleak rate, and IBD-associated reintervention for every commercial type of endograft. Heterogeneity and publication bias. A formal statistical test for heterogeneity using the I2 test was performed. Publication bias was assessed using the Egger test for small-study effects as well as visual inspection of funnel plots. We used Stata statistical software version 14 (StataCorp LP, College Station, Tex) for the analyses.

RESULTS Study characteristics. After an initial search of the literature, we identified 1278 potentially eligible studies. After removing duplications, we selected 924 studies for further evaluation. Review of the titles and abstracts

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Fig 1. Flow chart. EVAR, Endovascular aneurysm repair.

evidenced that 601 articles were irrelevant. After examination of the full text and application of exclusion criteria, 287 studies were excluded and finally 36 articles participated in the meta-analysis13-48 (Fig 1). The demographic characteristics of the 36 eligible studies included in our study are presented in Table I. The eligible studies were published from 2006 to 2018, and a total of 1502 patients were included in our metaanalysis. Among the studies with available relevant information, 14 were prospective studies with 808 patients (54.6%) and 19 studies were retrospective with 671 patients (45.4%); 22 articles including 743 patients (50.5%) were single-center studies, and 11 articles including 728 patients (49.5%) were multicenter studies. A total of 94.9% of the patients were male. The mean age of the patients was 72 years; the mean CIA diameter was 36 mm, and the mean follow-up was 16 months. Indication for implantation of IBDs was provided by 34 studies. Among studies reporting detailed data of 1271

patients, 24.6% (n ¼ 313) presented with isolated CIAA; 1.7% (n ¼ 22) presented with isolated IIA aneurysm (IIAA); 67.1% (n ¼ 853) presented with both AAA and CIAA; 0.9% (n ¼ 12) presented with CIAA and IIAA; and 0.9% (n ¼ 12) presented with AAA, CIAA, and IIAA. In 4.6% (n ¼ 59) of the patients, IBDs were implanted for other pathologic processes, which is a small group of patients and did not affect the outcome of the metaanalysis. Other characteristics of the eligible studies, such as the type of IBDs and bridging stent grafts for the IIA, number of bilateral CIAAs and IBDs, and use of IBDs outside IFU, are also presented in Table I. Six types of IBDs were used for preservation of the IIA among the eligible studies: Zenith bifurcated iliac side branch device (Cook), Zenith helical iliac side branch device (ZHIS; Cook), bifurcated-bifurcated configuration (BB-IBD; Cook), Gore Excluder IBE, Lifetech IBSG, and E-liac IBD (Jotec). More specifically, 1024 Zenith bifurcated iliac side branch devices (60.6%), 241 IBEs (14.3%),

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Table I. Demographic characteristics of the eligible studies included in the meta-analysis Study

No. of participating centers

Study Total No. of type patients Male Age, years

Indications for IBD

CIA diameter, mm

Follow-up, months

1

R

21

21

73.3 6 6.7

4 AAA þ CIAA 6 AAA þ CIAA þ IIAA 10 AAA þ BCIAA 1 CIA þ

33.2 6 7.7 (19-57)

11 (0-36)

Brunkwall,16 2018

11

P

45

42

72 (53-90)

37 AAA þ CIAA 3 AAA þ BCIAA 5 CIAA

38 (26-79)

30 6 15 days 12 6 2 months 36 6 2 months

Marques de Marino,31 2018

1

R

29

29

64.1 6 10

29 AAAþ BCIAA

35.2 6 8

11 (1-79)

24

R

47

45

68 (41-84)

32 AAA þ BCIAA þ BCIAA 11 BCIAA 4 AAA þ BCIAA þ IIAA

40.3

6.5 (1-36)

Delay,18 2017

2

R

30

29

77

16 AAA þ CIAA 5 UCIAA 3 BCIAA 3 AAA þ BCIAA 2 CIAA þ IIAA 1 BCIAA þ BIIAA

36 6 11

15

Jongsma,27 2017

7

R

140

130

70.9 6 7.4

112 AAA þ CIAA 17 CIAA 11 type I endoleak

39.7 6 10.7 34.9 6 9.2

26.6 6 24.1

Naji,35 2017

1

R

41

41

71.7 (55-87)

21 AAA þ CIAA 20 BCIAA

Right CIAA: 32.73 6 10.73 Left CIAA: 32.77 6 12.45

12

28

P

63

62

69.6 6 8.4 (51-88)

39 UCIAA 25 BCIAA

41.0 6 11 (25.2-76.3)

6

Simonte,41 2017

1

P

149

NA

74.0 6 7.3

54 CIAA 43 AAA associated 3 IIAA 7 BCIAA þ IIAA 8 AAA þ BCIAA 2 AAA þ IIAA 17 BCIAA 15 recurrence of aortic iliac aneurysm

37.0 6 8.1

44.2 6 35.1 34 (1-121)

Lebas,29 2016

1

R

25

24

76 (64-89)

24 AAA þ CIAA 1 CIAA

NA

24/29 (1-60)

Maus,33 2016

1

R

17

17

72.5 (64-85)

13 AAA þ CIAA 3 CIAA 1 BCIAA

30 6 8

8.2 6 5.4 (1-20)

Millon,34 2016

1

R

10

10

75 (65-82)

5 AAA þ CIAA 5 BCIAA

43.2 (32-49)

10/9 6 3 (6-12)

Mylonas,47 2016

6

P

70

69

74 (51-87)

53 CIAA 13 BCIAA 2 AAA associated 2 endoleaks

34.4 (17-56)

12 (6-16)

van Sterkenburg,44 2016

13

R

46

45

70.2 6 8.5

34 AAA þ CIAA 12 CIAA

40.5 (25-90)

5.6 (1.8-12.2)

Loth,48 2015

1

P

41

36

70.4 6 9.2 (48-86)

30 AAA þ CIAA 4 BCIAA 7 UCIAA

37 6 9.8 (25-66) 32 6 27.3 (0109)

Noel-Lamy,36 2015

2

R

15

15

76.8 6 6.1 (69.8-85.7)

13 AAA þ CIAA 2 CIAA

35 6 11.1 (18-58)

Anton,13 2018

Maldonado,30 2018

Schneider,40 2017

18.3 6 15.1

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Table I. Continued. Study

No. of participating centers

Study Total No. of type patients Male Age, years

Indications for IBD

CIA diameter, mm

Follow-up, months

Zhang,46 2015

1

P

11

11

70 (65-80)

4 AAA þ BCIAA 3 AAA þ left CIAA 1 AD þ AAA þ left CIAA 3 AAA þ right CIAA

38 (31-60)

12 (8-21)

Bisdas,15 2014

1

R

18

17

70 6 10

14 AAA 6 UCIAA 4 AAA 6 BCIAA

36 6 6

15 (4-25)

Chowdhury,17 2014

1

P

27

26

73.9 6 8.2

25 AAA þ CIAA 2 IIAA

37.1 6 10

11.3 6 5.3

Unno,43 2014

1

NA

6

5

77.5 (67-93)

6 AAA þ BCIAA

Right CIAA: 42.3 (35-58) Left CIAA: 37.7 (30-54)

14.2 (5-28)

Austermann,14 2013

1

R

16

NA

69.2 6 4.4

10 AAA þ CIAA 6 UIIAA

NA

24

Fernandez-Alonso,21 2013

1

NA

9

9

71.1 (62-80)

7 AAA þ CIAA 1 BCIAA 1 AAA þ BCIAA þ IIAA

34.8 (29-50)

14.7 (9-29)

Maurel,32 2013

11

P

39

38

73 6 10

24 AAA þ CIAA 15 CIAA

32.3 6 9.1

1

Pratesi,38 2013

2

P

81

NA

NA

48 AAA þ UCIAA 30 AAA þ BCIAA 3 CIAA

NA

20.4 6 15.4

Wong,45 2013

1

P

130

122

71.3 6 7.8/ 71.4 6 8.8

NA

34.6 6 12.1/ 31.2 6 9.9

20.3 (1-72)

Parlani,37 2012

2

P

100

96

74.1 (54-89)

57 AAA þ CIAA 11 AAA þ CIAA þ IIAA 32 CIAA

40 (35-44)

17 (1-60)

Donas,20 2011

1

R

64

60

70.3 6 7.6

25 AAA þ BCIAA 30 AAA þ UCIAA 9 IIAA

27 6 10.3 30 6 10.6

30.5 6 20.9

NA

P

6

5

73 (62-85)

4 AAA þ BCIAA 2 BCIAA

Right CIA: 35 (23-47) Left CIA: 28 (24-34)

15 (7-34)

Pua,39 2011

1

R

14

13 70.1 (59.3-80)

6 AAA þ CIAA 6 AAA þ BCIAA 1 BCIAA 1 BCIAA þ IIAA

39 (34-57)

18.7 (6-35)

Ferreira,22 2010

1

R

37

30

27 AAA þ BCIAA 8 AAA þ UCIAA 2 CIAA

NA

11.6 6 7.5 (2-31)

Karthikesalingam,28 2010

1

NA

8

1 AAA þ CIAA 4 AAA þ BCIAA 1 BCIAA 1 AAA þ CIAA þ IIAA 1 BCIAA þ IIAA

NA

13 (3-24)

NA

P

25

23

75 (60-85)

22 AAA þ CIAA 3 CIAA

37 (24-71)

12 (1- 38)

1

R

27

NA

70.4 6 5.5 (58-79)

5 AAA þ BCIAA 15 AAA þ UCIAA 2 CIAA

NA

16 6 14 (1-38)

Huilgol,26 2011

Huilgol,25 2009 Tielliu,42 2009

71.2 (54-88)

NA 72.8 (68- 79)

(Continued on next page)

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Table I. Continued. Study

No. of participating centers

Study Total No. of type patients Male Age, years

Indications for IBD

CIA diameter, mm

Follow-up, months

Dias,19 2008

1

R

22

22

70 (65-79)

21 AAA þ CIAA 1 endoleak

34 (27-41)

20 (8-31)

Haulon,24 2007

5

P

52

47

72 (56-86)

50 AAA þ CIAA 2 IIAA

38 (23-78)

14.2

Greenberg,23 2006

1

P

21

NA

NA

18 AAA þ BCIAA 3 AAAþ UCIAA

38

11

AAA, Abdominal aortic aneurysm; AD, aortic dissection; BCIAA, bilateral common iliac artery aneurysm; BIIAA, bilateral internal iliac artery aneurysm; CIA, common iliac artery; CIAA, common iliac artery aneurysm; IBD, iliac branch device; IIAA, internal iliac artery aneurysm; NA, not available; P, prospective; R, retrospective; UCIAA, unilateral common iliac artery aneurysm; UIIAA, unilateral internal iliac artery aneurysm. Continuous variables are presented as mean (range) or mean 6 standard deviation.

213 ZHIS devices (12.6%), 153 E-liac IBDs (9.1%), 43 BB-IBDs (2.5%), and 15 IBSGs (0.9%) were used among the 36 studies. A total of 10 deaths (0.67% raw mortality rate) were recorded among the eligible studies; 4 deaths were associated with cardiac events, 2 deaths were attributed to multiorgan failure, 1 death was due to acute renal failure, 1 death was associated with bowel ischemia, 1 death was attributed to an infected groin hematoma, and 1 death was associated with an extensive gluteal hematoma related to perforation of the gluteal artery. No aneurysm rupture, open conversion, or paraplegia was reported by the eligible studies. Type II was the most common endoleak recorded with a rate of 8.5% (129/1511). Among them, 112 (87%) were under surveillance, 10 endoleaks (8%) sealed spontaneously, and 7 required reintervention (5%). A total of 41 patients (2.7%) developed type I endoleak, and 31 of them (75%) required additional treatment; 8 patients (20%) were under surveillance, and the endoleak resolved spontaneously in 2 patients (5%). Finally, a total of 17 patients (1.1%) developed type III endoleak; 13 of them (76%) had stent implantation and 4 (24%) were under surveillance. During the perioperative period after IBD implantation, IIA branch occlusion occurred in 26 patients, but only 5 (19%) developed buttock claudication. The rest of the patients were treated with thrombolysis and deployment of an additional stent, and only a small proportion was treated conservatively. EIA occlusion occurred in 10 patients; 6 patients were treated by thrombectomy and stenting, 3 patients with femoral-femoral bypass, and 1 patient with thrombectomy and iliofemoral artery bypass. During the follow-up period, 37 patients developed IIA occlusion or compression, and 20 of them required an additional intervention. EIA occlusion occurred in 29 patients, and 27 of them required an additional intervention. In total, reintervention associated with IBDs was 6.96%. Only 21 of 36 studies provided information about the commercial type of bridging stent grafts for the IIA. The Gore IBE comes with its own dedicated bridging stent.

The Advanta covered stent (Atrium Medical, Hudson, NH) was the most popular bridging stent among the eligible studies (69.7%), followed by Fluency stent graft (Bard Peripheral Vascular, Tempe, Ariz) in 10%. Moreover, 29.9% (232/776) of the IBDs were placed outside IFU according to the information provided by 17 studies. According to the available data, the most common reason seems to be the inadequacy of the distal zone because of coexisting IIAA and short length of the CIA or insufficient distance from lower renal artery to iliac bifurcation. Four of the investigators, Maldonado et al,30 Marques de Marino et al,31 Huilgol et al,26 and Unno et al,43 focused on the deployment of bilateral IBDs in a total of 88 patients. From the remaining studies, bilateral IBDs were deployed in 103 patients (7.2%). Meta-analysis. Technical success of the method was reported by 35 studies, and the pooled estimate was 97.35% (95% CI, 96.27-98.29). Endoleak rate was 12.68% (95% CI, 8.80-17.07; Fig 2), with 8.5% attributed to type II endoleak. Patency of IBDs was reported by 32 studies. The pooled estimate for 30-day patency of IBDs was 97.59% (95% CI, 96.49-98.54) as reported by 32 studies (Fig 3); follow-up IBD patency was estimated at 94.32% (95% CI, 91.70-96.54; Fig 4). The pooled estimate for reintervention associated with IBDs was 6.96% (95% CI, 5.10-9.03); buttock claudication rate during the follow-up period was 2.15% (95% CI, 1.25-3.22). The subgroup meta-analysis by commercial type of endograft is presented in Table II. A total of 29 studies used a specific type of IBD for treatment of aortoiliac aneurysms; in the remaining, two or more different types of IBDs were implanted. All commercial types of IBDs presented with high technical success rates and 30-day patency of >85%. Cook ZHIS IBD had the lowest endoleak rate at 0.09% (95% CI, 0-4.38). The highest reintervention rate at 36.36% (95% CI, 10.93-69.21) was recorded after implantation of Lifetech IBSG IBD. However, further statistical comparison of pooled rates by commercial type of IBD was not applicable in our subgroup analysis.

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study

ES (95% CI)

% Weight

Anton, 2018 Brunkwall, 2018 Maldonado, 2018 de Marino, 2018 Delay, 2017 Jongsma, 2017 Naji, 2017 Schneider, 2017 Simonte, 2017 Lebas, 2016 Maus, 2016 Millon, 2016 Mylonas, 2016 van Sterkenburg, 2016 Loth, 2015 Noel- Lamy, 2015 Zhang, 2015 Bisdas, 2014 Chowdhury, 2014 Unno, 2014 Austermann, 2013 Fernandez-Alonso, 2013 Maurel, 2013 Pratesi, 2013 Wong, 2013 Parlani, 2012 Donas, 2011 Huilgol, 2011 Pua, 2011 Ferreira, 2010 Karthikesalingam, 2010 Huilgol, 2009 Tielliu, 2009 Dias, 2008 Haulon, 2007 Greenberg, 2006 Overall (I^2 = 77.8%, p = 0.000)

43.48 (23.19, 65.51) 8.89 (2.48, 21.22) 30.00 (16.56, 46.53) 6.90 (0.85, 22.77) 10.00 (2.11, 26.53) 7.14 (3.48, 12.74) 41.46 (26.32, 57.89) 54.72 (40.45, 68.44) 8.05 (4.23, 13.65) 12.00 (2.55, 31.22) 23.53 (6.81, 49.90) 10.00 (0.25, 44.50) 13.41 (6.89, 22.74) 12.50 (4.19, 26.80) 9.76 (2.72, 23.13) 5.00 (0.13, 24.87) 18.18 (2.28, 51.78) 11.11 (1.38, 34.71) 3.70 (0.09, 18.97) 16.67 (0.42, 64.12) 12.50 (1.55, 38.35) 33.33 (7.49, 70.07) 25.64 (13.04, 42.13) 3.70 (0.77, 10.44) 3.85 (1.26, 8.75) 3.00 (0.62, 8.52) 12.50 (5.55, 23.15) 8.33 (0.21, 38.48) 25.00 (5.49, 57.19) 0.00 (0.00, 9.49) 12.50 (0.32, 52.65) 20.00 (6.83, 40.70) 4.76 (0.12, 23.82) 18.18 (5.19, 40.28) 11.54 (4.35, 23.44) 4.76 (0.12, 23.82) 12.68 (8.80, 17.07)

2.66 3.17 3.09 2.85 2.88 3.68 3.10 3.27 3.69 2.73 2.38 1.88 3.49 3.09 3.10 2.53 1.97 2.44 2.79 1.42 2.33 1.78 3.07 3.48 3.65 3.57 3.37 2.05 2.05 3.03 1.67 2.73 2.58 2.62 3.25 2.58 100.00

0

70.1

Fig 2. Forest plot presenting the meta-analysis of endoleak based on event rates for the use of iliac branch devices (IBDs) during endovascular aneurysm repair (EVAR). Event rates in the individual studies are presented as squares, with 95% confidence intervals (CIs) presented as extending lines. The pooled event rate with its 95% CI is depicted as a diamond. ES, Effect size.

DISCUSSION This meta-analysis was derived from a comprehensive review of 36 studies and provided pooled outcome rates for patients who had endovascular repair of aortoiliac aneurysms with preservation of one or both IIAs. We recorded a high technical success rate of 97%, with an almost 0% 30-day mortality and a low reintervention rate of 7%. Although the overall endoleak rate was 13%, this was mainly attributed to type II endoleak (8.5%). In our meta-analysis, buttock claudication during the follow-up period was significantly low (2%) because of

the preservation of antegrade flow to the IIA through the IBD. The main causes of buttock claudication were the embolization of the contralateral IIA (26/51) and IIA branch occlusion (25/51). Buttock claudication is the most frequent ischemic complication, and symptoms can even improve with time; at least half of the patients are left with chronic symptoms that can affect quality of life.49 Verzini et al50 compared IBD treatment with embolization of the IIA in 74 patients and found that buttock claudication was more common in patients with IIA exclusion than in patients treated with an IBD.

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study

ES (95% CI)

% Weight

Anton, 2018 Maldonado, 2018 de Marino, 2018 Delay, 2017 Naji, 2017 Simonte, 2017 Lebas, 2016 Maus, 2016 Millon, 2016 Mylonas, 2016 van Sterkenburg, 2016 Noel- Lamy, 2015 Zhang, 2015 Bisdas, 2014 Chowdhury, 2014 Unno, 2014 Austermann, 2013 Fernandez-Alonso, 2013 Maurel, 2013 Pratesi, 2013 Wong, 2013 Parlani, 2012 Donas, 2011 Huilgol, 2011 Pua, 2011 Ferreira, 2010 Karthikesalingam, 2010 Huilgol, 2009 Tielliu, 2009 Dias, 2008 Haulon, 2007 Greenberg, 2006 Overall (I^2 = 0.0%, p = .)

100.00 (85.18, 100.00) 96.25 (89.43, 99.22) 94.83 (85.62, 98.92) 93.33 (77.93, 99.18) 100.00 (91.59, 100.00) 96.82 (92.72, 98.96) 96.15 (80.36, 99.90) 100.00 (81.47, 100.00) 100.00 (69.15, 100.00) 98.78 (93.39, 99.97) 98.44 (91.60, 99.96) 100.00 (78.20, 100.00) 86.67 (59.54, 98.34) 100.00 (81.47, 100.00) 100.00 (87.23, 100.00) 100.00 (73.54, 100.00) 95.24 (76.18, 99.88) 100.00 (66.37, 100.00) 94.87 (82.68, 99.37) 98.77 (93.31, 99.97) 94.62 (89.22, 97.81) 95.00 (88.72, 98.36) 98.44 (91.60, 99.96) 100.00 (73.54, 100.00) 100.00 (76.84, 100.00) 85.11 (71.69, 93.80) 75.00 (34.91, 96.81) 100.00 (86.28, 100.00) 96.67 (82.78, 99.92) 100.00 (85.18, 100.00) 88.46 (76.56, 95.65) 85.71 (63.66, 96.95) 97.59 (96.49, 98.54)

1.72 5.88 4.27 2.23 3.10 11.50 1 1.94 1.35 0.77 6.03 4.71 1.13 1.13 1.35 2.01 0.91 1.57 0.69 2.89 5.95 9.53 7.34 4.71 0.91 1.06 3.47 0.62 1.86 2.23 1.72 3.83 1.57 100.00

0

34.9

2019

100

Fig 3. Forest plot presenting the meta-analysis of 30-day patency based on event rates for the use of iliac branch devices (IBDs) during endovascular aneurysm repair (EVAR). Event rates in the individual studies are presented as squares, with 95% confidence intervals (CIs) presented as extending lines. The pooled event rate with its 95% CI is depicted as a diamond. ES, Effect size.

Patients who had embolization of IIA with Amplatzer plug developed buttock claudication at rates up to 24%,7 and these rates were even higher for patients treated with coil embolization according to studies of Jean-Baptiste et al51 and Libicher et al.52 In case of contralateral iliac coil embolization, that should be performed as proximal as possible to prevent interference with pelvic collateral circulation.53 IBDs can be used for the treatment of large CIAs, but the major limitation is still the anatomic requirements. Although we had data from only 17 studies, 29.9% (232/ 776) of the IBDs were placed outside IFU. Certain anatomic restrictions must be considered before their implantation:

length and diameter of EIA, excessive iliac tortuosity, calcification, angulation between the CIA and the IIA, intraluminal CIA thrombus, and IIA stenosis. The most common limitation is inadequacy of the distal landing zone because of coexisting IIAA and short length of CIA or insufficient distance from lower renal artery to iliac bifurcation. Nonetheless, it may not always be an exclusion factor. Noel-Lamy et al,36 in a series of 15 patients, reported treatment of IIAAs with IBDs extending to the superior gluteal artery with satisfactory results. D’Oria et al54 also reported that repair can still be done by extending the distal landing zone into healthy main division branches. Where it is necessary, the posterior divisional branch of the IIA should be

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study

ES (95% CI)

% Weight

Anton, 2018 Maldonado, 2018 de Marino, 2018 Delay, 2017 Jongsma, 2017 Naji, 2017 Schneider, 2017 Simonte, 2017 Lebas, 2016 Maus, 2016 Millon, 2016 Mylonas, 2016 van Sterkenburg, 2016 Loth, 2015 Noel- Lamy, 2015 Zhang, 2015 Bisdas, 2014 Chowdhury, 2014 Unno, 2014 Austermann, 2013 Fernandez-Alonso, 2013 Pratesi, 2013 Wong, 2013 Parlani, 2012 Donas, 2011 Huilgol, 2011 Pua, 2011 Ferreira, 2010 Karthikesalingam, 2010 Huilgol, 2009 Ti elliu, 2009 Dias, 2008 Haulon, 2007 Greenberg, 2006 Overall (I^2 = 64.7%, p = 0.000)

100.00 (85.18, 100.00) 95.00 (87.69, 98.62) 93.10 (83.27, 98.09) 76.67 (57.72, 90.07) 89.29 (82.94, 93.88) 100.00 (91.59, 100.00) 95.08 (86.29, 98.97) 90.45 (84.73, 94.55) 94.74 (73.97, 99.87) 94.44 (72.71, 99.86) 90.00 (55.50, 99.75) 92.59 (84.57, 97.23) 93.75 (84.76, 98.27) 80.49 (65.13, 91.18) 100.00 (76.84, 100.00) 100.00 (78.20, 100.00) 88.89 (65.29, 98.62) 96.30 (81.03, 99.91) 100.00 (73.54, 100.00) 100.00 (83.89, 100.00) 100.00 (66.37, 100.00) 98.65 (92.70, 99.97) 80.77 (72.93, 87.15) 91.00 (83.60, 95.80) 100.00 (94.40, 100.00) 91.67 (61.52, 99.79) 100.00 (76.84, 100.00) 87.23 (74.26, 95.17) 75.00 (34.91, 96.81) 96.00 (79.65, 99.90) 87.50 (67.64, 97.34) 73.91 (51.59, 89.77) 100.00 (93.15, 100.00) 85.71 (63.66, 96.95) 94.32 (91.70, 96.54)

2.57 4.01 3.69 2.91 4.45 3.32 3.75 4.53 2.33 2.26 1.58 4.02 3.80 3.30 1.95 2.03 2.26 2.77 1.77 2.45 1.47 3.94 4.40 4.21 3.80 1.77 1.95 3.46 1.35 2.68 2.62 2.57 3.57 2.45 100.00

0

34.9

100

Fig 4. Forest plot presenting the meta-analysis of patency during follow-up based on event rates for the use of iliac branch devices (IBDs) during endovascular aneurysm repair (EVAR). Event rates in the individual studies are presented as squares, with 95% confidence intervals (CIs) presented as extending lines. The pooled event rate with its 95% CI is depicted as a diamond. ES, Effect size.

preserved as this maintains flow in the iliolumbar, lateral sacral, and superior gluteal arteries. However, there are risks to leaving side branches intact as these tend to persist over time, leading to aneurysm sac enlargement through retrograde flow. Thus, it is important to maintain pelvic collaterals but at the same time not to compromise the efficacy of the repair. Interestingly, the helical IBD was developed to address issues concerning insufficient overlap in the straight branch configuration to accommodate a self-expanding stent. The theoretical advantage was that a self-expanding stent would be better suited to the tortuous angles. However, the helical IBD was used as an alternative device only in some earlier studies.

Concerning the type of bridging stent grafts, Donas et al55 studied the performance of self-expanding vs balloonexpandable bridging stent grafts in 185 patients and recommended the use of Viabahn (W. L. Gore & Associates) because of its better conformability in the tortuous IIA. In addition, Bisdas et al15 and Simonte and Parlani56 recommended use of the Gore IBE in tortuous iliac anatomy because the continuous metallic stent support was deemed to be more kink resistant in cases of large IIAs and because of the availability of hypogastric graft diameters up to 14.5 mm. On the other hand, the Cook device was chosen for shorter renal to iliac bifurcation lengths owing to wider graft length options when a bifurcated aortoiliac

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Table II. Subgroup meta-analysis by commercial type of endograft IBD by commercial type Cook ZBIS (n ¼ 1024)

Cook ZHIS (n ¼ 213)

Cook BB-IBD (n ¼ 43)

Gore IBE (n ¼ 241)

Jotec IBD (n ¼ 153)

Lifetech IBSG (n ¼ 15)

Technical success

96.69 (94.38-98.52)

98.34 (94.28-100)

97.5 (86.84-99.94)

96.65 (92.81-99.28)

99.43 (95.25-100)

100 (71.51-100)

30-day patency

98.53 94.23 (87.06-99.05) 97.50 (86.84- 99.94) 98.43 (95.12-100.00) 99.47 (96.34-100) 86.67 (59.54-98.34) (96.85-99.67)

Follow-up patency

94.52 (90.18-97.86)

99.54 (84.09-100)

NA

Endoleak

10.73 (6.46-15.73)

0.09 (0-4.38)

IBD-associated reintervention

7.78 (5.06-10.91)

4.09 (0-13.75)

Pooled rates of studied outcomes

95.19 (91.51-98.02) 95.30 (89.93-98.93)

100 (78.20-100)

5 (0.61-16.92)

22.32 (5.11-46.02)

18.86 (5.48-37.19)

18.18 (2.28-51.78)

NA

2.73 (0.54-5.98)

4.63 (1.41-9.17)

36.36 (10.93-69.21)

BB-IBD, Bifurcated-bifurcated iliac branch device; IBD, iliac branch device; IBE, iliac branch endoprosthesis; IBSG, iliac branch stent graft; NA, not available; ZBIS, Zenith bifurcated iliac side branch device; ZHIS, Zenith helical iliac side branch device. Values are reported as percentage (95% confidence interval).

graft was already in place, for easier access from brachial or axillary artery for the hypogastric component delivery, for smaller proximal CIA diameters, and for smaller diameter of the IBD. Also, a few cases have highlighted the necessity of using both a self-expanding and a balloon-expandable stent in the same artery to provide less kinking and more conformability. In our meta-analysis, Viabahn was used in only 6% of the IBDs, and the most common bridging stent was the Advanta stent graft (69.7%), followed by the Fluency stent graft (10%). However, in some studies, the Viabahn stents became the stents of choice recently and are more versatile than balloon-expandable stents to bridge into the hypogastric artery. Maldonado et al30 and Marques de Marino et al31 used bilateral IBDs for repair of bilateral CIAAs with excellent results and similar technical success and midterm outcomes to unilateral iliac branch grafting. Our findings are in line with the results of a previous review indicating that treating aortoiliac aneurysm with IBDs produces satisfactory outcomes in midterm follow-up.57 Therefore, implantation of bilateral IBDs is safe. It should be considered in young, physically and sexually active patients; in those with a previous or concomitant operation for thoracoabdominal aortic aneurysm; and in patients with impaired collateral circulation from the inferior mesenteric artery, ipsilateral femoral artery system, or contralateral IIA with suitable anatomy. Concerning the role of potential modifiers that might complicate IBD implantation, peripheral vascular disease has been proposed as a risk factor complicating IBD implantation and should be investigated in future studies. Interestingly, Cheng et al58 investigated the morphologic features of AAAs in an Asian cohort and found that both CIAs are significantly shorter in Asians, particularly on the right side. These

differences in iliac morphology might also make endovascular repair in the Asian population challenging. Regarding the subgroup meta-analysis by commercial type of endograft, we recorded a high technical success rate in all groups. Whereas commercial type of endograftspecific outcomes are of interest as presented in Table II, a direct comparison should be addressed with caution, given the different IFUs, indications, and technical characteristics of different IBDs. The 30-day patency was significantly lower for the novel IBSG at 86.67% compared with the other IBDs. Zhang et al46 used this novel device to preserve the IIA during EVAR in Chinese patients, who have shorter CIAs and EIAs compared with whites. As expected, IBD-associated reintervention was also high at 36.36%, but the secondary patency rate at the end was 100%. Although it was a small study with 11 patients, Zhang et al46 showed that this novel IBSG is safe and effective for the anatomic characteristics of Asian-Pacific patients, but more studies in the future should focus on this specific category of patients. Furthermore, although five commercial IBD configurations have been developed so far, the Gore Excluder IBD is the only commercially available IBD in the United States. As a result, availability might be a reason for choosing one type of endograft vs another; the cost may be another important factor, although the eligible studies did not include economic criteria for choice of the graft. With respect to the endoleak rate, Gore IBE presented with a rate of 22%, which is slightly higher than with the other IBDs. This outcome is clearly exhibited in the study of Schneider et al,40 who observed a high incidence of type II endoleaks in >50% of patients at 6 months. However, this increased number did not have any impact on the clinical outcomes of the patients who had IBD, such as aneurysm enlargement or reintervention rates, and the

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authors believe that it may be related to improved new imaging modalities. Indication for treatment of endoleak after IBD implantation according to endoleak type was similar to EVAR procedures. A slightly higher endoleak rate reported by more recent studies may be attributed to improvements in imaging modalities or stricter selection of patients in earlier studies. Although our meta-analysis included 36 studies, several limitations need to be acknowledged. We were not able to extract specific data from all the studies. Only 21 studies provided information about the commercial type of bridging stent grafts for the IIA; only 17 studies reported whether IBDs were deployed according to IFU; and endoleak type was not provided by all studies. The eligible studies did not report separate results for the patients treated with isolated iliac aneurysms or in case of patients treated outside IFU. In 4.6% of the patients included in the meta-analysis, the IBD was implanted for reasons other than aneurysmal disease, such as type IB endoleak or recurrence of aortoiliac aneurysm. Furthermore, the original articles did not report the number of side branches of the IIA. Therefore, their impact on endoleak rate could not be directly assessed. More than one endograft model was used as an IBD, and selection bias may have occurred in the selection of patients, aiming for a high technical success rate. Furthermore, the mean follow-up was 16 months, and additional data are required to establish the long-term durability of IBDs. Another potential limitation is that statistical comparison of pooled rates by commercial type of IBD is not applicable in our subgroup analysis.

CONCLUSIONS Unilateral or bilateral hypogastric preservation with an IBD during repair of aortoiliac aneurysms seems to be safe, feasible, and effective in select patients with suitable anatomy, preventing the potential risks of pelvic ischemia. The technical success was high, whereas the mortality rate and the incidence of buttock claudication were low. Although the reintervention rate was 7%, most of the secondary interventions can be successfully done with endovascular techniques. Although long-term results are pending to state the efficacy and durability, IBDs may be considered a first option for the treatment of patients with aortoiliac aneurysms who do not meet the criteria for a standard EVAR.

AUTHOR CONTRIBUTIONS Conception and design: AG, CA, GS, KM, NT, JK, AL, AC, GG Analysis and interpretation: AG, CA Data collection: AG, CA Writing the article: AG, CA, GS, NT Critical revision of the article: AG, CA, GS, KM, NT, JK, AL, AC, GG

Final approval of the article: AG, CA, GS, KM, NT, JK, AL, AC, GG Statistical analysis: CA Obtained funding: Not applicable Overall responsibility: GG AG and CA contributed equally to this article and share co-first authorship.

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Submitted Aug 5, 2019; accepted Oct 19, 2019.