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Outcomes for concomitant common iliac artery aneurysms after endovascular abdominal aortic aneurysm repair
From the Society for Clinical Vascular Surgery
Outcomes for concomitant common iliac artery aneurysms after endovascular abdominal aortic aneurysm repair Mohsen Bannazadeh, MD,a Christina Jenkins, MD,a Andrew Forsyth, MD,b Jason Kramer, MD,b Ankur Aggarwal, MD,a Amy E. Somerset, MD,a Paul G. Bove, MD,c and Graham W. Long, MD,c Royal Oak, Mich
ABSTRACT Objective: This study evaluated the morbidity of endovascular abdominal aortic aneurysm repair (EVAR) in patients with concomitant common iliac artery aneurysm (CCIAA). Methods: This was a retrospective review of all patients who underwent elective EVAR from June 2006 through June 2012 at a single institution. Demographics, comorbidities, preoperative presentation, intraoperative details, and postoperative complications were tabulated. Patients with CCIAA were categorized into three groups according to the distal extent of their iliac limb: iliac limb extension into the external iliac artery with internal iliac artery coil embolization (EE); flared iliac limb $20 mm in diameter to the iliac bifurcation (FL); and iliac limb #20 mm ending proximal to the CCIAA (no-FL). Results: During this period, 627 consecutive patients underwent elective EVAR and preoperative computed tomographic angiograms were available for 523 patients to evaluate the presence of CCIAA. Of these, 211 patients (40.2%) had a CCIAA in at least one common iliac artery, with a total of 307 aneurysmal arteries. Of these 307 aneurysmal arteries, 62 (20.2%) were treated with EE, 132 (43.0%) were treated with FL, and 113 (36.8%) had a sufficient landing zone in the proximal common iliac artery to use an iliac limb #20 mm in diameter (no-FL). The overall reintervention rate was 12.4% of patients, with a higher reintervention rate between patients with CCIAA compared with those without (15.2% vs 10.9%; P ¼ .039). There were no significant differences in reintervention rates between the EE, FL, and no-FL techniques (4.5% vs 4.8% vs 6.2%; P ¼ .802) over a mean 59.8 months follow-up. The FL and EE techniques had a lower risk of distal endoleak than the no-FL technique, but the difference was not statistically significant (3.2% vs 2.3% vs 5.3% compared with 4.23% in the entire cohort). Conclusions: Patients with CCIAA had a higher reintervention rate after EVAR for abdominal aortic aneurysm compared with non-CCIAA patients. Of the techniques studied (EE, FL, and no-FL), there was no significant difference in reintervention rates between the three. All three techniques remain viable options for the endovascular repair of CCIAA. (J Vasc Surg 2017;-:1-8.)
Endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is widely accepted as a less invasive alternative to open repair.1,2 However, EVAR durability has been questioned secondary to graft-related complications and need for reintervention.3 EVAR is associated with a 1% to 4% per year risk of reintervention, incurring additional costs and necessitating vigorous surveillance.4 Complicated proximal seal and aneurysm neck anatomy
From the Department of Surgery,a Department of Radiologyb and Section of Vascular Surgery,c Beaumont Health. Author conflict of interest: none. Presented at the Forty-second Annual Symposium of Society for Clinical Vascular Surgery, Carlsbad, Calif, March 18-22, 2014. Correspondence: Graham W. Long, MD, Department of Surgery, Section of Vascular Surgery, William Beaumont Hospital, 3601 W 13 Mile Rd, Royal Oak, MI 48073 (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 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2017.02.058
have been shown to increase the rate of reintervention after EVAR.5,6 Few studies, however, have investigated the effect of concomitant common iliac artery aneurysm (CCIAA), and these studies have conflicting results. The report from the European Collaborators on Stent-Graft Techniques for Abdominal Aortic Aneurysm Repair (EUROSTAR) registry found an increased incidence of reintervention in patients with CCIAA extending to the distal one-third of the common iliac artery caused by distal type 1 endoleak and limb thrombosis.7 Conversely, Parlani et al8 reported that CCIAA did not affect feasibility and long-term outcomes of EVAR. Various techniques have been used to treat CCIAA during EVAR. The two most common techniques include the flared iliac limb technique (FL) and the combined internal iliac artery coil embolization with iliac limb extension into the external iliac artery (EE). Less commonly, a nonflared limb (no-FL) is placed proximal to a CCIAA if there is a sufficient landing zone to obtain a seal. Although the EE technique is technically more demanding and associated with pelvic ischemia, using the FL technique can lead to an increased rate of distal endoleak.7,9 1
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Recently, iliac branch devices have been used to treat selected patients with CCIAA to prevent complications associated with internal iliac coil embolization.10,11 These devices potentially offer an anatomic alternative, but there are anatomic restrictions to their use and their long-term durability is unknown.12 The purpose of this study was to evaluate the morbidity of EVAR in patients with CCIAA and to compare reintervention rates among patients with CCIAA treated with these three techniques.
METHODS This study was a retrospective review of all consecutive patients who underwent elective EVAR at our institution from June 2006 to June 2012. Patients were identified from medical records by diagnosis codes. The study had the approval of our Institutional Review Board, and consenting was not required. Patients who underwent EVAR for ruptured AAA, focal abdominal dissection, and aortoiliac occlusive disease were excluded, as were patients without a preoperative computed tomography angiogram (CTA). Demographics, comorbidities, preoperative presentation, intraoperative details, and postoperative complications were tabulated. Preoperative and follow-up CTAs were analyzed. Aneurysm morphology and maximum diameter were measured using the centerline technique (TeraRecon, Foster City, Calif). CCIAA was defined as maximum outer wall-to-outer wall common iliac artery diameter $20 mm. Patients with AAA were divided into two groups. Group A included patients without CCIAA, and group B consisted of patients with at least one CCIAA. Endovascular procedures were performed under local or general anesthesia in a hybrid operating suite equipped with a fixed, ceiling-mounted C-arm (Philips, Andover, Mass). The stent grafts used were AneuRx (Medtronic, Santa Rosa, Calif), Talent (Medtronic), Excluder (W. L. Gore & Associates, Flagstaff, Ariz), Endologix (Endologix, Irvine, Calif), and Zenith (Cook Medical, Inc, Bloomington, Ind). Endograft selection was at the discretion of the operating surgeon based on anatomic limitations and personal preference. Device sizing was determined from the preoperative CTA and intraoperative angiograms. Flared limb was defined as an iliac limb $20 mm in distal diameter. Aneurysmal iliac arteries (group B) were categorized into three groups according to the distal treatment of the aneurysmal iliac limb: iliac limb extension into the external iliac artery with internal iliac artery embolization (EE); flared iliac limb $20 mm in diameter to the iliac bifurcation (FL); and iliac limb #20 mm ending proximal to the CCIAA (no-FL). Treatment strategy was selected and performed according to surgeon preference and patient anatomy. FL extensions were selected from commercially available large-diameter iliac extension
2017
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Retrospective analysis of prospectively collected single-center registry data Take Home Message: The 213 patients undergoing endovascular abdominal aortic aneurysm repair who were also treated for concomitant common iliac artery aneurysms using flared limbs or internal iliac artery embolization had acceptable and similar reintervention rates (8.7% vs 16.1%; P ¼ .17). Iliac branched devices were not studied. Recommendation: The authors recommend using a flared iliac limb or embolization of the internal iliac artery in patients who need endovascular abdominal aortic aneurysm repair but also have concomitant common iliac artery aneurysms. Iliac branch devices were not used in this study.
limbs ranging from 20 to 28 mm. In aneurysmal arteries treated with EE, internal iliac coil embolization was performed from a contralateral approach before EVAR in a one- or two-stage fashion. The Amplatzer vascular plug (AGA Medical, Golden Valley, Minn) or embolization coils (MR Eye or Nestor Coils, Cook Medical) were used to achieve internal iliac arterial occlusion. Postoperative complications are reported according to previously established guidelines.13 Renal insufficiency was defined as any postoperative creatinine level >1.8 mg/dL or a 50% increase above the preoperative baseline creatinine in patients with preoperative renal insufficiency. Major pulmonary complications were defined as prolonged postoperative intubation >48 hours, need for reintubation, or positive sputum culture and radiographic evidence of pneumonia. Major cardiac complications included myocardial infarction, defined as an elevation of creatine phosphokinase or troponin levels and concomitant electrocardiographic changes, or other major cardiac dysrhythmia. Late graft-related complications included aneurysm rupture, endoleak, iliac limb thrombosis, and endograft infection or migration. Outcomes measured included reintervention rate, 30-day postoperative mortality, overall survival, intervention-free device survival, and complication rates. Patients with one or more occluded internal iliac arteries were reviewed for new-onset buttock claudication, intestinal ischemia, and erectile dysfunction. Electronic medical records and the Social Security Death Index were used to collect survival dates. After discharge, patients were monitored with physical examination and abdominopelvic CTA at 1, 6, and 12 months in the first year and annually thereafter. Duplex ultrasound imaging was also used in selected patients after the first 12 months. Statistical analyses were performed using SAS 9.3 software (SAS Institute Inc, Cary, NC), SPSS 21.0 software
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Table I. Baseline demographics and comorbidities Baseline characteristicsa Male Age, years
All (N ¼ 523) 81 (422)
Group A (n ¼ 312)
Group B (n ¼ 211)
Pb
75 (233)
90 (189)
<.001 .306
73.9 (8.7)
74.2 (8.7)
73.4 (8.8)
CAD
33 (172)
29 (90)
39 (82)
.018
Diabetes
14 (71)
12 (39)
15 (32)
.435
Renal insufficiency
5 (27)
4 (14)
6 (13)
.425
COPD
22 (113)
17 (54)
28 (59)
.005
Hypertension
55 (289)
53 (164)
59 (125)
.152
Hyperlipidemia
37 (193)
35 (110)
39 (83)
.357
PVD
11 (57)
11 (33)
11 (24)
.777
CVA
7 (37)
6 (19)
8.5 (18)
.301
33 (172)
31 (98)
35 (74)
.394
Tobacco
CAD, Coronary artery disease; COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; Group A, no concomitant common iliac artery aneurysm (CCIAA); Group B, at least one CCIAA; PVD, peripheral vascular disease. a Continuous variables are presented as mean (standard deviation) and categoric data as percentage (number). b P values in bold are statistically significant (P < .05).
(IBM Corp, Armonk, NY), and GraphPad 5.04 software (GraphPad Software, La Jolla, Calif). The significance level for all tests was 0.05. Fisher exact tests or c2 tests were used for categoric variables. Two-sample t-tests or Wilcoxon rank sum tests were used for continuous variables as indicated. Survival and its association with measured factors were evaluated using Kaplan-Meier models. Cox proportional hazard models were used to estimate hazard ratios.
RESULTS Demographic and preoperative measurements. Preoperative CTAs were available in our database for 523 of the 627 consecutive patients who underwent elective EVAR during this period. Of these, 312 (59.7%) had no CCIAA in either common iliac artery (group A), and 211 (40.3%) had CCIAA in at least one common iliac artery (group B), with 307 aneurysmal arteries in total. The overall mean age was 73.9 6 8.7 years, and 80.7% were men. Demographics and comorbidities are summarized in Table I. Patients with CCIAA (group B) were more likely to be male (90% vs 75%; P < .001), have coronary artery disease (39% vs 29%; P ¼ .018), and have chronic obstructive pulmonary disease (28% vs 17%; P ¼ .005). The iliac artery measurements are summarized in Table II. In the entire cohort, the common iliac artery diameter was larger on the right than on the left side (18.6 vs 17.1 mm; P < .01). The mean maximum aortic aneurysm diameter was larger in group B than in group A (57.3 vs 54.5 mm; P ¼ .008). Aneurysmal arteries treated with EE had significantly larger diameter than those treated with the FL and no-FL techniques (Table III). Procedural details. EVAR was performed using commercially available stent graft devices in the following proportions: Zenith, 57%; Excluder, 19%; Talent, Endurant, or AneuRx, 11%; and Endologix, 11%. Of 307 aneurysmal common iliac arteries, 62 (20.2%) were
treated with EE, 132 (43.0%) were treated with FL, and 113 (36.8%) arteries had sufficient landing zone in the proximal common iliac artery to use a iliac limb #20 mm in diameter (no-FL). Reintervention. The overall reintervention rate was 12.4% of patients. More overall reinterventions were required in patients in group B than in group A (15.2% [32 of 211] vs 10.9% [34 of 312]; P ¼ .039). However, when only reinterventions involving the distal limbs of the grafts were investigated, there was also a significant difference in reintervention rates between iliac arteries in group A and aneurysmal iliac arteries in group B (3.8% [24 of 624] vs 6.8% [21 of 307]; P ¼ .035). Complications. Major postoperative complications were similar between group A and group B (Table IV). However, the late complication of distal (Ib) endoleak was more common in group B (6.2% vs 0.3%; P < .001). In subgroup analysis of aneurysmal arteries in group B patients, a comparison of the three techniques with regard to distal endoleak showed no significant difference between EE, FL, and no-FL (3.2% vs 2.3% vs 5.3%) compared with the entire cohort (4.23%; P ¼ .44). The indications for reintervention are summarized in Table V, with no statistically significant difference between the groups. Arteries treated with FL had the lowest distal reintervention rates compared with the EE and no-FL arteries; however, this difference was not significant (4.5% vs 4.8% vs 6.2%; P ¼ .80). In aneurysmal arteries treated with the EE technique, four reinterventions of the distal limb were required in three patients. All patients originally received coil embolization of the internal iliac arteries. This embolization was unsuccessful in one patient, and subsequent additional coils were placed into the internal iliac artery through a communicating iliolumbar artery, followed by cyanoacrylate glue embolization of the lumbar artery
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Table II. Aortic aneurysm and common iliac artery measurements Variable Maximum aortic aneurysm
Right common iliac artery
Left common iliac artery
Group
No.
Mean (mm)
95% Confidence interval (mm)
Pa
A
311
54.5
53.5-55.5
.008
B
204
57.3
55.7-58.9
Total
515
55.6
54.7-56.5
A
312
14.7
14.4-15.0
B
204
24.5
23.3-25.7
Total
516
18.6
17.9-19.2
A
312
14.3
14.1-14.6
B
204
21.3
20.4-22.2
Total
516
17.1
16.6-17.6
<.001
<.001
Group A, Patients without concomitant common iliac artery aneurysm (CCIAA); Group B, patients with at least one CCIAA. a P values in bold are statistically significant (P < .05).
Table III. Comparison of aortic and aneurysmal common iliac artery measurements by treatment technique Variable Aortic aneurysm
Aneurysmal right common iliac arteries
Aneurysmal left common iliac arteries
Mean (mm)
95% Confidence interval (mm)
Pa
52
55.7
52.2-59.3
.68
111
58.2
56.1-60.3
NoeFL
99
58.4
56.1-60.8
EE
35
36.3
22.9-40.4 22.4-24.0
Group
No.
EE FL
FL
83
23.2
No-FL
68
23.1
21.8-24.4
EE
20
33.1
28.8-37.4
FL
45
23.4
20.5-26.3
No-FL
46
22.3
21.1-23.6
<.001
<.001
EE, Iliac limb extension into the external iliac artery with internal iliac artery embolization; FL, flared iliac limb $20 mm in diameter to the iliac bifurcation; No-FL, iliac limb #20 mm ending proximal to the concomitant common iliac artery aneurysm (CCIAA). a P values in bold are statistically significant (P < .05).
to resolve type II and Ib endoleaks. A decrease in aneurysm size was noted after the reintervention. In a second patient, iliac aneurysm enlargement with a new type Ib endoleak was treated with extension limbs further into the external iliac artery, and was likely due to proximal migration of the iliac limb. The other two reinterventions were for iliac limb occlusion, both of which were treated with placement of a femorofemoral artery bypass graft. In aneurysmal arteries treated with the FL technique, six reinterventions were required in six patients. Type Ib endoleaks developed in three patients and were treated with EE. Occlusion of the FL-treated iliac limb developed in two patients. In the first of these, the contralateral iliac artery had developed an aneurysm, and this was treated with EE, followed by femorofemoral bypass of the occluded FL limb. In the second, the occluded FL-treated limb was treated with a femorofemoral arterial bypass graft. The last patient suffered graft failure at the iliac gate with aneurysm rupture and cardiac arrest. This patient underwent successful open repair with interposition graft placement from the gate to the external iliac artery and hypogastric artery ligation with excellent results.
Six patients with seven aneurysms treated with the no-FL technique required reintervention. Six arteries developed type Ib endoleaks: three were treated with EE, and one artery was treated with angioplasty and limb extensions to the distal common iliac artery. One patient with bilateral type Ib endoleaks was treated by relining the endograft with another bifurcated endograft with extensions into the distal common iliac arteries. Despite expansion of the iliac artery aneurysms, there was a sufficient landing zone above each iliac artery bifurcation to use the no-FL technique on both sides. The last patient had a type III endoleak caused by separation of the iliac limb from the gate. This was successfully treated with a bridging limb and EE performed on that side. Buttock claudication occurred postoperatively in seven of the 58 patients (12.1%) who received plug or coil embolization in one or more iliac arteries. Only one of the seven patients with buttock claudication received coils bilaterally. Six patients were lost to follow-up, and their complication status could not be determined. Three patients underwent bilateral internal iliac artery exclusion, one of whom developed bowel ischemia.
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Table IV. Complication rates in patients with and without concomitant common iliac artery aneurysm (CCIAA) undergoing endovascular abdominal aortic aneurysm (AAA) repair (EVAR) Complication
All (N ¼ 627), % (No.)
Group A (n ¼ 312), % (No.)
Group B (n ¼ 211), % (No.)
Pa
Post-op major complications Renal
4.0 (25)
3.2 (10)
4.3 (9)
.34
Pulmonary
2.7 (17)
1.3 (4)
2.8 (6)
.17
Cardiac
3.0 (19)
2.4 (5)
.15
4 (14)
Stroke
0.5 (3)
0.6 (2)
0.5 (1)
.64
Bowel ischemia
0.8 (5)
0.6 (2)
0.9 (2)
.53
1.1 (7)
1 (3)
2 (4)
.30
1.0 (5)
1.0 (3)
0.9 (2)
.67
Bleeding Late complications Rupture Endoleak Anyb
19.9 (104)
19.6 (61)
20.4 (43)
.45
Type Ia
3.6 (19)
3.5 (11)
3.8 (8)
.53
Type Ib
2.7 (14)
0.3 (1)
6.2 (13)
<.001
Type II
16.1 (84)
17.9 (56)
13.3 (28)
.10
Type III
0.8 (4)
0.3 (1)
1.4 (3)
.16
4.0 (21)
3.5 (11)
4.7 (10)
.17
Migration
1.3 (8)
1.6 (5)
1.4 (3)
.59
Graft infection
1.0 (5)
1.0 (3)
0.9 (2)
.67
Graft failurec
1.0 (5)
0.3 (1)
1.9 (4)
.08
Limb thrombosis
Group A, No concomitant common iliac artery aneurysm (CCIAA); Group B, at least one CCIAA. a P values in bold are statistically significant (P < .05). b Patients may have more than one endoleak. c Includes limb separation.
Table V. Distal indications for reintervention by technique type EE (n ¼ 62), % (No.)a
FL (n ¼ 132), % (No.)
No-FL (n ¼ 113), % (No.)
P
Total distal reinterventions
4.8 (4)
4.5 (6)
6.2 (7)
.80
Distal endoleak
3.2 (2)
2.3 (3)
5.3 (6)
.44
Limb thrombosis
3.2 (2)
1.5 (2)
0 (0)
.19
0 (0)
0.8 (1)
1 (1)
.77
Variable
Graft failure (limb separation)
EE, Iliac limb extension into the external iliac artery with internal iliac artery embolization; FL, flared iliac limb $20 mm in diameter to the iliac bifurcation; no-FL, iliac limb #20 mm ending proximal to the concomitant common iliac artery aneurysm (CCIAA). a No. refers to the number of arteries.
Survival. Overall perioperative mortality was 1.45%. Overall median reintervention-free device survival was 52.5 months (range, 0-141.4 months), with no significant difference between the non-CCIAA group A (51.7 months; range, 0-141.4 months) and CCIAA group B (49.5 months; range, 0-120.5 months; P ¼ .73) (Fig). Median time to reintervention for the entire cohort was 19.2 months (range, 0-141.4 months), with no significant differences between the non-CCIAA group A (19.6 months, range, 0.46-141.44 months) and the CCIAA group B (15.49 months, range, 0-120.5 months; P ¼ .80). Within group B, there were no significant differences in reintervention-free device survival between the EE, FL, and no-FL groups during most of the recorded follow-up (95% for EE vs 91% for FL vs 93% for no-FL at 100 months;
P ¼ .54). After 120 months of follow-up, the EE and FL techniques proved more durable (Fig, A). The mean (standard deviation) follow-up was 57.75 (34.97) months in non-CCIAA patients and 58.9 (34.8) months in CCIAA patients.
DISCUSSION The extension of AAAs into the common iliac arteries increases the complexity of EVAR. Although multiple studies examined aneurysm neck anatomy and its effect on long-term outcomes, few investigations focused on outcomes for CCIAA. We found 40% of patients who underwent EVAR at our institution had CCIAA. This prevalence is higher than the 16% reported in the EUROSTAR registry.7 Similar to the EUROSTAR report, the current
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Percent reintervention free survival
A 100
80
60
40
20
0
Months:0 No. at risk:
25 192
50 106
75 38
100 9
125 3
150
175
200
Percent reinternvention-free survival
Percent reintervention free survival
B 100 100
EE FL
80 80
60 60
40 40 0 Months: No. at risk: EE No. at risk: FL No. at risk: no-FL
non-FL
25 50 104 82
50 39 76 58
75 20 43 27
100 9 14 14
125 2 1 2
150
Fig. Reintervention-free device survival. The error bars represent the standard error. A, Group A (nonconcomitant common iliac artery aneurysm [CCIAA]) arteries. Reintervention-free device survival remained >50% until 125 months. B, Group B aneurysmal arteries, separated by treatment technique. There were no significant differences between combined iliac limb extension into the external iliac artery with internal iliac artery embolization (EE), flared iliac limb $20 mm in diameter to the iliac bifurcation (FL), and iliac limb #20 mm ending proximal to the CCIAA (no-FL) techniques before 120 months. At 120.5 months, the survival proportion was 94.8% in the EE group, 90.4% in the FL group, and 46.4% in the no-FL group (P < .001).
study found that coronary artery disease, chronic obstructive pulmonary disease, and male gender were more common in patients with CCIAA. Our study found more overall reinterventions in patients with CCIAA compared with those without CCIAA (15.2% vs 10.9%), similar to the report from the EUROSTAR registry (17.6% vs 8.9%).7 The EUROSTAR registry also showed that patients with CCIAA had more distal type I endoleaks (9.1% vs 4.3%; P < .01) than those without, similar to our findings. However, in contrast to EUROSTAR, we found no difference in limb occlusion,
aneurysm rupture, and migration rate between patients with and without CCIAA. Naughton et al9 compared the outcomes of FL vs EE techniques and found that the reintervention and perioperative complication rates were similar between groups. Similarly, the current study demonstrated that reintervention rates were similar between the FL and EE techniques. The specific indications for reintervention varied between these groups, with no statistical difference. However, the two techniques were not evenly applied across the cohort, because the
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maximum commercially available iliac limb diameter is 28 mm, making the EE technique more frequent in larger aneurysms. We found no significant differences in early to midterm reintervention-free device survival between the three groups. More distal endoleaks and a sharp drop-off in reintervention-free device survival after 10 years were observed in aneurysms treated by the no-FL technique, where the distal seal was achieved by deploying an iliac limb in a common iliac arterial segment <20 mm in diameter proximal to the CCIAA. The higher rate of late no-FL seal failure may be explained by the natural history of iliac aneurysm progression. Surprisingly, this subsequent degeneration in these patients occurred over a much longer period than might be anticipated, making this a stable and useful strategy in certain patients, acknowledging the average aneurysm diameters were small (22-23 mm) at the time of initial treatment. Specifically, it may be useful in patients with a relatively limited life expectancy, chronic contralateral hypogastric artery occlusion, or those requiring contralateral hypogastric artery coil embolization. Patients in this latter situation could undergo close surveillance and subsequent staged EE on the no-FL side to decrease the risk of pelvic ischemic symptoms. Other than in these subsets of patients, our data seem to indicate that CCIAAs >20 mm should be treated with the FL or EE technique. The importance of a staggered strategy for bilateral internal iliac artery exclusion is underscored by our limited experience in the current series in which postoperative bowel ischemia developed in one of three patients who underwent simultaneous internal iliac artery exclusion. Our postembolization buttock claudication rate of 12% is at the lower end of the published range, which varies from 12% to 58%.14-19 We do not have any anatomic explanation for this lower rate, but six patients were lost to follow-up, which may have affected the reported incidence of claudication. Iliac limb occlusion is one of the potential complications of the EE technique. However, these results showed iliac limb occlusion developed in only one aneurysm (1.6%) that underwent EE. The rate of limb occlusion was not different between EE and FL techniques (1.6% vs 1.5%; P ¼ .68). Similarly, Naughton et al9 reported no difference in the limb patency between EE and FL in their experience (2% vs 3%; P ¼ .5). EE failure associated with distal endoleak may be related to proximal migration of iliac limbs, which was likely the cause in one of our patients. Some centers have used iliac branched endografts to treat CCIAA.20 However, their use is not applicable for all anatomic configurations, and their long-term results are still unknown. The Excluder Iliac Branch Endoprosthesis is commercially available; the Zenith Branch Endovascular
Graft is currently in clinical trials in the United States but is commercially available outside the United States. This study has several important limitations. First, it represents a retrospective review of a single-institution experience. Second, aneurysms treated with the EE technique were significantly larger than those the other groups, likely from selection bias, limiting the comparison with aneurysms treated with the other two techniques. Third, mean follow-up was only 58.9 months and was limited in patients living substantial distances from our institution. Last, the number of aneurysms treated with the EE technique was small compared with the entire cohort, which could introduce a type II error.
CONCLUSIONS The presence of CCIAA leads to a higher rate of reintervention after EVAR for AAA compared with patients without CCIAA. Of the techniques studied, there was no significant difference in reintervention rates between the EE, FL, and no-FL techniques. The EE technique is most applicable in patients with a large CCIAA when the other two strategies are not feasible. The no-FL technique can be useful in certain patient subsets, but close surveillance for CCIAA expansion is required. Despite the increasing availability of iliac branched devices, these techniques will continue to be applicable in patients with CCIAA for the foreseeable future.
AUTHOR CONTRIBUTIONS Conception and design: MB, PB, GL Analysis and interpretation: MB, CJ, PB, GL Data collection: MB, CJ, AF, AA, JK, AS Writing the article: MB, CJ, PB, GL Critical revision of the article: MB, CJ, AF, AA, JK, PB, GL, AS Final approval of the article: MB, CJ, AF, AA, JK, PB, GL, AS Statistical analysis: MB Obtained funding: Not applicable Overall responsibility: GL
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5. AbuRahma AF, Campbell J, Stone PA, Nanjundappa A, Jain A, Dean LS, et al. The correlation of aortic neck length to early and late outcomes in endovascular aneurysm repair patients. J Vasc Surg 2009;50:738-48. 6. Leurs LJ, Kievit J, Dagnelie PC, Nelemans PJ, Buth J; EUROSTAR Collaborators. Influence of infrarenal neck length on outcome of endovascular abdominal aortic aneurysm repair. J Endovasc Ther 2006;13:640-8. 7. Hobo R, Sybrandy JE, Harris PL, Buth J; EUROSTAR Collaborators. 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. 8. Parlani G, Zannetti S, Verzini F, De Rango P, Carlini G, Lenti M, et al. Does the presence of an iliac aneurysm affect outcome of endoluminal AAA repair? An analysis of 336 cases. Eur J Vasc Endovasc Surg 2002;24:134-8. 9. Naughton PA, Park MS, Kheirelseid EA, O’Neill SM, Rodriguez HE, Morasch MD, et al. A comparative study of the bell-bottom technique vs hypogastric exclusion for the treatment of aneurysmal extension to the iliac bifurcation. J Vasc Surg 2012;55:956-62. 10. Verzini F, Parlani G, Romano L, De Rango P, Panuccio G, Cao P. Endovascular treatment of iliac aneurysm: concurrent comparison of side branch endograft versus hypogastric exclusion. J Vasc Surg 2009;49:1154-61. 11. Wong S, Greenberg RK, Brown CR, Mastracci TM, Bena J, Eagleton MJ. Endovascular repair of aortoiliac aneurysmal disease with the helical iliac bifurcation device and the bifurcated-bifurcated iliac bifurcation device. J Vasc Surg 2013;58:861-9. 12. Ziegler P, Avgerinos ED, Umscheid T, Perdikides T, Erz K, Stelter WJ. Branched iliac bifurcation: 6 years experience with endovascular preservation of internal iliac artery flow. J Vasc Surg 2007;46:204-10. 13. Johnston KW, Rutherford RB, Tilson MD, Shah DM, Hollier L, Stanley JC. Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for
14.
15.
16.
17.
18.
19.
20.
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Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg 1991;13:452-8. Jean-Baptiste E, Brizzi S, Bartoli MA, Sadaghianloo N, Baque J, Magnan PE, 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;60:40-9. 49.e1. Lyden SP, Sternbach Y, Waldman DL, Green RM. Clinical implications of internal iliac artery embolization in endovascular repair of aortoiliac aneurysms. Ann Vasc Surg 2001;15:539-43. Park KM, Yang SS, Kim YW, Park KB, Park HS, Do YS, et al. Clinical outcomes after internal iliac artery embolization prior to endovascular aortic aneurysm repair. Surg Today 2014;44:472-7. Rayt HS, Bown MJ, Lambert KV, Fishwick NG, McCarthy MJ, London NJ, et al. Buttock claudication and erectile dysfunction after internal iliac artery embolization in patients prior to endovascular aortic aneurysm repair. Cardiovasc Intervent Radiol 2008;31:728-34. Razavi MK, DeGroot M, Olcott C 3rd, Sze D, Kee S, Semba CP, et al. Internal iliac artery embolization in the stent-graft treatment of aortoiliac aneurysms: analysis of outcomes and complications. J Vasc Interv Radiol 2000;11:561-6. Yano OJ, Morrissey N, Eisen L, Faries PL, Soundararajan K, Wan S, et al. Intentional internal iliac artery occlusion to facilitate endovascular repair of aortoiliac aneurysms. J Vasc Surg 2001;34:204-11. Parlani G, Verzini F, De Rango P, Brambilla D, Coscarella C, Ferrer C, 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: 287-92.
Submitted Jan 19, 2016; accepted Feb 23, 2017.
Outcomes for concomitant common iliac artery aneurysms after endovascular abdominal aortic aneurysm repair Mohsen Bannazadeh, MD,a Christina Jenkins, MD,a Andrew Forsyth, MD,b Jason Kramer, MD,b Ankur Aggarwal, MD,a Amy E. Somerset, MD,a Paul G. Bove, MD,c and Graham W. Long, MD,c Royal Oak, Mich
ABSTRACT Objective: This study evaluated the morbidity of endovascular abdominal aortic aneurysm repair (EVAR) in patients with concomitant common iliac artery aneurysm (CCIAA). Methods: This was a retrospective review of all patients who underwent elective EVAR from June 2006 through June 2012 at a single institution. Demographics, comorbidities, preoperative presentation, intraoperative details, and postoperative complications were tabulated. Patients with CCIAA were categorized into three groups according to the distal extent of their iliac limb: iliac limb extension into the external iliac artery with internal iliac artery coil embolization (EE); flared iliac limb $20 mm in diameter to the iliac bifurcation (FL); and iliac limb #20 mm ending proximal to the CCIAA (no-FL). Results: During this period, 627 consecutive patients underwent elective EVAR and preoperative computed tomographic angiograms were available for 523 patients to evaluate the presence of CCIAA. Of these, 211 patients (40.2%) had a CCIAA in at least one common iliac artery, with a total of 307 aneurysmal arteries. Of these 307 aneurysmal arteries, 62 (20.2%) were treated with EE, 132 (43.0%) were treated with FL, and 113 (36.8%) had a sufficient landing zone in the proximal common iliac artery to use an iliac limb #20 mm in diameter (no-FL). The overall reintervention rate was 12.4% of patients, with a higher reintervention rate between patients with CCIAA compared with those without (15.2% vs 10.9%; P ¼ .039). There were no significant differences in reintervention rates between the EE, FL, and no-FL techniques (4.5% vs 4.8% vs 6.2%; P ¼ .802) over a mean 59.8 months follow-up. The FL and EE techniques had a lower risk of distal endoleak than the no-FL technique, but the difference was not statistically significant (3.2% vs 2.3% vs 5.3% compared with 4.23% in the entire cohort). Conclusions: Patients with CCIAA had a higher reintervention rate after EVAR for abdominal aortic aneurysm compared with non-CCIAA patients. Of the techniques studied (EE, FL, and no-FL), there was no significant difference in reintervention rates between the three. All three techniques remain viable options for the endovascular repair of CCIAA. (J Vasc Surg 2017;-:1-8.)
Endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is widely accepted as a less invasive alternative to open repair.1,2 However, EVAR durability has been questioned secondary to graft-related complications and need for reintervention.3 EVAR is associated with a 1% to 4% per year risk of reintervention, incurring additional costs and necessitating vigorous surveillance.4 Complicated proximal seal and aneurysm neck anatomy
From the Department of Surgery,a Department of Radiologyb and Section of Vascular Surgery,c Beaumont Health. Author conflict of interest: none. Presented at the Forty-second Annual Symposium of Society for Clinical Vascular Surgery, Carlsbad, Calif, March 18-22, 2014. Correspondence: Graham W. Long, MD, Department of Surgery, Section of Vascular Surgery, William Beaumont Hospital, 3601 W 13 Mile Rd, Royal Oak, MI 48073 (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 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2017.02.058
have been shown to increase the rate of reintervention after EVAR.5,6 Few studies, however, have investigated the effect of concomitant common iliac artery aneurysm (CCIAA), and these studies have conflicting results. The report from the European Collaborators on Stent-Graft Techniques for Abdominal Aortic Aneurysm Repair (EUROSTAR) registry found an increased incidence of reintervention in patients with CCIAA extending to the distal one-third of the common iliac artery caused by distal type 1 endoleak and limb thrombosis.7 Conversely, Parlani et al8 reported that CCIAA did not affect feasibility and long-term outcomes of EVAR. Various techniques have been used to treat CCIAA during EVAR. The two most common techniques include the flared iliac limb technique (FL) and the combined internal iliac artery coil embolization with iliac limb extension into the external iliac artery (EE). Less commonly, a nonflared limb (no-FL) is placed proximal to a CCIAA if there is a sufficient landing zone to obtain a seal. Although the EE technique is technically more demanding and associated with pelvic ischemia, using the FL technique can lead to an increased rate of distal endoleak.7,9 1
2
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Recently, iliac branch devices have been used to treat selected patients with CCIAA to prevent complications associated with internal iliac coil embolization.10,11 These devices potentially offer an anatomic alternative, but there are anatomic restrictions to their use and their long-term durability is unknown.12 The purpose of this study was to evaluate the morbidity of EVAR in patients with CCIAA and to compare reintervention rates among patients with CCIAA treated with these three techniques.
METHODS This study was a retrospective review of all consecutive patients who underwent elective EVAR at our institution from June 2006 to June 2012. Patients were identified from medical records by diagnosis codes. The study had the approval of our Institutional Review Board, and consenting was not required. Patients who underwent EVAR for ruptured AAA, focal abdominal dissection, and aortoiliac occlusive disease were excluded, as were patients without a preoperative computed tomography angiogram (CTA). Demographics, comorbidities, preoperative presentation, intraoperative details, and postoperative complications were tabulated. Preoperative and follow-up CTAs were analyzed. Aneurysm morphology and maximum diameter were measured using the centerline technique (TeraRecon, Foster City, Calif). CCIAA was defined as maximum outer wall-to-outer wall common iliac artery diameter $20 mm. Patients with AAA were divided into two groups. Group A included patients without CCIAA, and group B consisted of patients with at least one CCIAA. Endovascular procedures were performed under local or general anesthesia in a hybrid operating suite equipped with a fixed, ceiling-mounted C-arm (Philips, Andover, Mass). The stent grafts used were AneuRx (Medtronic, Santa Rosa, Calif), Talent (Medtronic), Excluder (W. L. Gore & Associates, Flagstaff, Ariz), Endologix (Endologix, Irvine, Calif), and Zenith (Cook Medical, Inc, Bloomington, Ind). Endograft selection was at the discretion of the operating surgeon based on anatomic limitations and personal preference. Device sizing was determined from the preoperative CTA and intraoperative angiograms. Flared limb was defined as an iliac limb $20 mm in distal diameter. Aneurysmal iliac arteries (group B) were categorized into three groups according to the distal treatment of the aneurysmal iliac limb: iliac limb extension into the external iliac artery with internal iliac artery embolization (EE); flared iliac limb $20 mm in diameter to the iliac bifurcation (FL); and iliac limb #20 mm ending proximal to the CCIAA (no-FL). Treatment strategy was selected and performed according to surgeon preference and patient anatomy. FL extensions were selected from commercially available large-diameter iliac extension
2017
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Retrospective analysis of prospectively collected single-center registry data Take Home Message: The 213 patients undergoing endovascular abdominal aortic aneurysm repair who were also treated for concomitant common iliac artery aneurysms using flared limbs or internal iliac artery embolization had acceptable and similar reintervention rates (8.7% vs 16.1%; P ¼ .17). Iliac branched devices were not studied. Recommendation: The authors recommend using a flared iliac limb or embolization of the internal iliac artery in patients who need endovascular abdominal aortic aneurysm repair but also have concomitant common iliac artery aneurysms. Iliac branch devices were not used in this study.
limbs ranging from 20 to 28 mm. In aneurysmal arteries treated with EE, internal iliac coil embolization was performed from a contralateral approach before EVAR in a one- or two-stage fashion. The Amplatzer vascular plug (AGA Medical, Golden Valley, Minn) or embolization coils (MR Eye or Nestor Coils, Cook Medical) were used to achieve internal iliac arterial occlusion. Postoperative complications are reported according to previously established guidelines.13 Renal insufficiency was defined as any postoperative creatinine level >1.8 mg/dL or a 50% increase above the preoperative baseline creatinine in patients with preoperative renal insufficiency. Major pulmonary complications were defined as prolonged postoperative intubation >48 hours, need for reintubation, or positive sputum culture and radiographic evidence of pneumonia. Major cardiac complications included myocardial infarction, defined as an elevation of creatine phosphokinase or troponin levels and concomitant electrocardiographic changes, or other major cardiac dysrhythmia. Late graft-related complications included aneurysm rupture, endoleak, iliac limb thrombosis, and endograft infection or migration. Outcomes measured included reintervention rate, 30-day postoperative mortality, overall survival, intervention-free device survival, and complication rates. Patients with one or more occluded internal iliac arteries were reviewed for new-onset buttock claudication, intestinal ischemia, and erectile dysfunction. Electronic medical records and the Social Security Death Index were used to collect survival dates. After discharge, patients were monitored with physical examination and abdominopelvic CTA at 1, 6, and 12 months in the first year and annually thereafter. Duplex ultrasound imaging was also used in selected patients after the first 12 months. Statistical analyses were performed using SAS 9.3 software (SAS Institute Inc, Cary, NC), SPSS 21.0 software
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Table I. Baseline demographics and comorbidities Baseline characteristicsa Male Age, years
All (N ¼ 523) 81 (422)
Group A (n ¼ 312)
Group B (n ¼ 211)
Pb
75 (233)
90 (189)
<.001 .306
73.9 (8.7)
74.2 (8.7)
73.4 (8.8)
CAD
33 (172)
29 (90)
39 (82)
.018
Diabetes
14 (71)
12 (39)
15 (32)
.435
Renal insufficiency
5 (27)
4 (14)
6 (13)
.425
COPD
22 (113)
17 (54)
28 (59)
.005
Hypertension
55 (289)
53 (164)
59 (125)
.152
Hyperlipidemia
37 (193)
35 (110)
39 (83)
.357
PVD
11 (57)
11 (33)
11 (24)
.777
CVA
7 (37)
6 (19)
8.5 (18)
.301
33 (172)
31 (98)
35 (74)
.394
Tobacco
CAD, Coronary artery disease; COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; Group A, no concomitant common iliac artery aneurysm (CCIAA); Group B, at least one CCIAA; PVD, peripheral vascular disease. a Continuous variables are presented as mean (standard deviation) and categoric data as percentage (number). b P values in bold are statistically significant (P < .05).
(IBM Corp, Armonk, NY), and GraphPad 5.04 software (GraphPad Software, La Jolla, Calif). The significance level for all tests was 0.05. Fisher exact tests or c2 tests were used for categoric variables. Two-sample t-tests or Wilcoxon rank sum tests were used for continuous variables as indicated. Survival and its association with measured factors were evaluated using Kaplan-Meier models. Cox proportional hazard models were used to estimate hazard ratios.
RESULTS Demographic and preoperative measurements. Preoperative CTAs were available in our database for 523 of the 627 consecutive patients who underwent elective EVAR during this period. Of these, 312 (59.7%) had no CCIAA in either common iliac artery (group A), and 211 (40.3%) had CCIAA in at least one common iliac artery (group B), with 307 aneurysmal arteries in total. The overall mean age was 73.9 6 8.7 years, and 80.7% were men. Demographics and comorbidities are summarized in Table I. Patients with CCIAA (group B) were more likely to be male (90% vs 75%; P < .001), have coronary artery disease (39% vs 29%; P ¼ .018), and have chronic obstructive pulmonary disease (28% vs 17%; P ¼ .005). The iliac artery measurements are summarized in Table II. In the entire cohort, the common iliac artery diameter was larger on the right than on the left side (18.6 vs 17.1 mm; P < .01). The mean maximum aortic aneurysm diameter was larger in group B than in group A (57.3 vs 54.5 mm; P ¼ .008). Aneurysmal arteries treated with EE had significantly larger diameter than those treated with the FL and no-FL techniques (Table III). Procedural details. EVAR was performed using commercially available stent graft devices in the following proportions: Zenith, 57%; Excluder, 19%; Talent, Endurant, or AneuRx, 11%; and Endologix, 11%. Of 307 aneurysmal common iliac arteries, 62 (20.2%) were
treated with EE, 132 (43.0%) were treated with FL, and 113 (36.8%) arteries had sufficient landing zone in the proximal common iliac artery to use a iliac limb #20 mm in diameter (no-FL). Reintervention. The overall reintervention rate was 12.4% of patients. More overall reinterventions were required in patients in group B than in group A (15.2% [32 of 211] vs 10.9% [34 of 312]; P ¼ .039). However, when only reinterventions involving the distal limbs of the grafts were investigated, there was also a significant difference in reintervention rates between iliac arteries in group A and aneurysmal iliac arteries in group B (3.8% [24 of 624] vs 6.8% [21 of 307]; P ¼ .035). Complications. Major postoperative complications were similar between group A and group B (Table IV). However, the late complication of distal (Ib) endoleak was more common in group B (6.2% vs 0.3%; P < .001). In subgroup analysis of aneurysmal arteries in group B patients, a comparison of the three techniques with regard to distal endoleak showed no significant difference between EE, FL, and no-FL (3.2% vs 2.3% vs 5.3%) compared with the entire cohort (4.23%; P ¼ .44). The indications for reintervention are summarized in Table V, with no statistically significant difference between the groups. Arteries treated with FL had the lowest distal reintervention rates compared with the EE and no-FL arteries; however, this difference was not significant (4.5% vs 4.8% vs 6.2%; P ¼ .80). In aneurysmal arteries treated with the EE technique, four reinterventions of the distal limb were required in three patients. All patients originally received coil embolization of the internal iliac arteries. This embolization was unsuccessful in one patient, and subsequent additional coils were placed into the internal iliac artery through a communicating iliolumbar artery, followed by cyanoacrylate glue embolization of the lumbar artery
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Table II. Aortic aneurysm and common iliac artery measurements Variable Maximum aortic aneurysm
Right common iliac artery
Left common iliac artery
Group
No.
Mean (mm)
95% Confidence interval (mm)
Pa
A
311
54.5
53.5-55.5
.008
B
204
57.3
55.7-58.9
Total
515
55.6
54.7-56.5
A
312
14.7
14.4-15.0
B
204
24.5
23.3-25.7
Total
516
18.6
17.9-19.2
A
312
14.3
14.1-14.6
B
204
21.3
20.4-22.2
Total
516
17.1
16.6-17.6
<.001
<.001
Group A, Patients without concomitant common iliac artery aneurysm (CCIAA); Group B, patients with at least one CCIAA. a P values in bold are statistically significant (P < .05).
Table III. Comparison of aortic and aneurysmal common iliac artery measurements by treatment technique Variable Aortic aneurysm
Aneurysmal right common iliac arteries
Aneurysmal left common iliac arteries
Mean (mm)
95% Confidence interval (mm)
Pa
52
55.7
52.2-59.3
.68
111
58.2
56.1-60.3
NoeFL
99
58.4
56.1-60.8
EE
35
36.3
22.9-40.4 22.4-24.0
Group
No.
EE FL
FL
83
23.2
No-FL
68
23.1
21.8-24.4
EE
20
33.1
28.8-37.4
FL
45
23.4
20.5-26.3
No-FL
46
22.3
21.1-23.6
<.001
<.001
EE, Iliac limb extension into the external iliac artery with internal iliac artery embolization; FL, flared iliac limb $20 mm in diameter to the iliac bifurcation; No-FL, iliac limb #20 mm ending proximal to the concomitant common iliac artery aneurysm (CCIAA). a P values in bold are statistically significant (P < .05).
to resolve type II and Ib endoleaks. A decrease in aneurysm size was noted after the reintervention. In a second patient, iliac aneurysm enlargement with a new type Ib endoleak was treated with extension limbs further into the external iliac artery, and was likely due to proximal migration of the iliac limb. The other two reinterventions were for iliac limb occlusion, both of which were treated with placement of a femorofemoral artery bypass graft. In aneurysmal arteries treated with the FL technique, six reinterventions were required in six patients. Type Ib endoleaks developed in three patients and were treated with EE. Occlusion of the FL-treated iliac limb developed in two patients. In the first of these, the contralateral iliac artery had developed an aneurysm, and this was treated with EE, followed by femorofemoral bypass of the occluded FL limb. In the second, the occluded FL-treated limb was treated with a femorofemoral arterial bypass graft. The last patient suffered graft failure at the iliac gate with aneurysm rupture and cardiac arrest. This patient underwent successful open repair with interposition graft placement from the gate to the external iliac artery and hypogastric artery ligation with excellent results.
Six patients with seven aneurysms treated with the no-FL technique required reintervention. Six arteries developed type Ib endoleaks: three were treated with EE, and one artery was treated with angioplasty and limb extensions to the distal common iliac artery. One patient with bilateral type Ib endoleaks was treated by relining the endograft with another bifurcated endograft with extensions into the distal common iliac arteries. Despite expansion of the iliac artery aneurysms, there was a sufficient landing zone above each iliac artery bifurcation to use the no-FL technique on both sides. The last patient had a type III endoleak caused by separation of the iliac limb from the gate. This was successfully treated with a bridging limb and EE performed on that side. Buttock claudication occurred postoperatively in seven of the 58 patients (12.1%) who received plug or coil embolization in one or more iliac arteries. Only one of the seven patients with buttock claudication received coils bilaterally. Six patients were lost to follow-up, and their complication status could not be determined. Three patients underwent bilateral internal iliac artery exclusion, one of whom developed bowel ischemia.
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Table IV. Complication rates in patients with and without concomitant common iliac artery aneurysm (CCIAA) undergoing endovascular abdominal aortic aneurysm (AAA) repair (EVAR) Complication
All (N ¼ 627), % (No.)
Group A (n ¼ 312), % (No.)
Group B (n ¼ 211), % (No.)
Pa
Post-op major complications Renal
4.0 (25)
3.2 (10)
4.3 (9)
.34
Pulmonary
2.7 (17)
1.3 (4)
2.8 (6)
.17
Cardiac
3.0 (19)
2.4 (5)
.15
4 (14)
Stroke
0.5 (3)
0.6 (2)
0.5 (1)
.64
Bowel ischemia
0.8 (5)
0.6 (2)
0.9 (2)
.53
1.1 (7)
1 (3)
2 (4)
.30
1.0 (5)
1.0 (3)
0.9 (2)
.67
Bleeding Late complications Rupture Endoleak Anyb
19.9 (104)
19.6 (61)
20.4 (43)
.45
Type Ia
3.6 (19)
3.5 (11)
3.8 (8)
.53
Type Ib
2.7 (14)
0.3 (1)
6.2 (13)
<.001
Type II
16.1 (84)
17.9 (56)
13.3 (28)
.10
Type III
0.8 (4)
0.3 (1)
1.4 (3)
.16
4.0 (21)
3.5 (11)
4.7 (10)
.17
Migration
1.3 (8)
1.6 (5)
1.4 (3)
.59
Graft infection
1.0 (5)
1.0 (3)
0.9 (2)
.67
Graft failurec
1.0 (5)
0.3 (1)
1.9 (4)
.08
Limb thrombosis
Group A, No concomitant common iliac artery aneurysm (CCIAA); Group B, at least one CCIAA. a P values in bold are statistically significant (P < .05). b Patients may have more than one endoleak. c Includes limb separation.
Table V. Distal indications for reintervention by technique type EE (n ¼ 62), % (No.)a
FL (n ¼ 132), % (No.)
No-FL (n ¼ 113), % (No.)
P
Total distal reinterventions
4.8 (4)
4.5 (6)
6.2 (7)
.80
Distal endoleak
3.2 (2)
2.3 (3)
5.3 (6)
.44
Limb thrombosis
3.2 (2)
1.5 (2)
0 (0)
.19
0 (0)
0.8 (1)
1 (1)
.77
Variable
Graft failure (limb separation)
EE, Iliac limb extension into the external iliac artery with internal iliac artery embolization; FL, flared iliac limb $20 mm in diameter to the iliac bifurcation; no-FL, iliac limb #20 mm ending proximal to the concomitant common iliac artery aneurysm (CCIAA). a No. refers to the number of arteries.
Survival. Overall perioperative mortality was 1.45%. Overall median reintervention-free device survival was 52.5 months (range, 0-141.4 months), with no significant difference between the non-CCIAA group A (51.7 months; range, 0-141.4 months) and CCIAA group B (49.5 months; range, 0-120.5 months; P ¼ .73) (Fig). Median time to reintervention for the entire cohort was 19.2 months (range, 0-141.4 months), with no significant differences between the non-CCIAA group A (19.6 months, range, 0.46-141.44 months) and the CCIAA group B (15.49 months, range, 0-120.5 months; P ¼ .80). Within group B, there were no significant differences in reintervention-free device survival between the EE, FL, and no-FL groups during most of the recorded follow-up (95% for EE vs 91% for FL vs 93% for no-FL at 100 months;
P ¼ .54). After 120 months of follow-up, the EE and FL techniques proved more durable (Fig, A). The mean (standard deviation) follow-up was 57.75 (34.97) months in non-CCIAA patients and 58.9 (34.8) months in CCIAA patients.
DISCUSSION The extension of AAAs into the common iliac arteries increases the complexity of EVAR. Although multiple studies examined aneurysm neck anatomy and its effect on long-term outcomes, few investigations focused on outcomes for CCIAA. We found 40% of patients who underwent EVAR at our institution had CCIAA. This prevalence is higher than the 16% reported in the EUROSTAR registry.7 Similar to the EUROSTAR report, the current
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Percent reintervention free survival
A 100
80
60
40
20
0
Months:0 No. at risk:
25 192
50 106
75 38
100 9
125 3
150
175
200
Percent reinternvention-free survival
Percent reintervention free survival
B 100 100
EE FL
80 80
60 60
40 40 0 Months: No. at risk: EE No. at risk: FL No. at risk: no-FL
non-FL
25 50 104 82
50 39 76 58
75 20 43 27
100 9 14 14
125 2 1 2
150
Fig. Reintervention-free device survival. The error bars represent the standard error. A, Group A (nonconcomitant common iliac artery aneurysm [CCIAA]) arteries. Reintervention-free device survival remained >50% until 125 months. B, Group B aneurysmal arteries, separated by treatment technique. There were no significant differences between combined iliac limb extension into the external iliac artery with internal iliac artery embolization (EE), flared iliac limb $20 mm in diameter to the iliac bifurcation (FL), and iliac limb #20 mm ending proximal to the CCIAA (no-FL) techniques before 120 months. At 120.5 months, the survival proportion was 94.8% in the EE group, 90.4% in the FL group, and 46.4% in the no-FL group (P < .001).
study found that coronary artery disease, chronic obstructive pulmonary disease, and male gender were more common in patients with CCIAA. Our study found more overall reinterventions in patients with CCIAA compared with those without CCIAA (15.2% vs 10.9%), similar to the report from the EUROSTAR registry (17.6% vs 8.9%).7 The EUROSTAR registry also showed that patients with CCIAA had more distal type I endoleaks (9.1% vs 4.3%; P < .01) than those without, similar to our findings. However, in contrast to EUROSTAR, we found no difference in limb occlusion,
aneurysm rupture, and migration rate between patients with and without CCIAA. Naughton et al9 compared the outcomes of FL vs EE techniques and found that the reintervention and perioperative complication rates were similar between groups. Similarly, the current study demonstrated that reintervention rates were similar between the FL and EE techniques. The specific indications for reintervention varied between these groups, with no statistical difference. However, the two techniques were not evenly applied across the cohort, because the
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maximum commercially available iliac limb diameter is 28 mm, making the EE technique more frequent in larger aneurysms. We found no significant differences in early to midterm reintervention-free device survival between the three groups. More distal endoleaks and a sharp drop-off in reintervention-free device survival after 10 years were observed in aneurysms treated by the no-FL technique, where the distal seal was achieved by deploying an iliac limb in a common iliac arterial segment <20 mm in diameter proximal to the CCIAA. The higher rate of late no-FL seal failure may be explained by the natural history of iliac aneurysm progression. Surprisingly, this subsequent degeneration in these patients occurred over a much longer period than might be anticipated, making this a stable and useful strategy in certain patients, acknowledging the average aneurysm diameters were small (22-23 mm) at the time of initial treatment. Specifically, it may be useful in patients with a relatively limited life expectancy, chronic contralateral hypogastric artery occlusion, or those requiring contralateral hypogastric artery coil embolization. Patients in this latter situation could undergo close surveillance and subsequent staged EE on the no-FL side to decrease the risk of pelvic ischemic symptoms. Other than in these subsets of patients, our data seem to indicate that CCIAAs >20 mm should be treated with the FL or EE technique. The importance of a staggered strategy for bilateral internal iliac artery exclusion is underscored by our limited experience in the current series in which postoperative bowel ischemia developed in one of three patients who underwent simultaneous internal iliac artery exclusion. Our postembolization buttock claudication rate of 12% is at the lower end of the published range, which varies from 12% to 58%.14-19 We do not have any anatomic explanation for this lower rate, but six patients were lost to follow-up, which may have affected the reported incidence of claudication. Iliac limb occlusion is one of the potential complications of the EE technique. However, these results showed iliac limb occlusion developed in only one aneurysm (1.6%) that underwent EE. The rate of limb occlusion was not different between EE and FL techniques (1.6% vs 1.5%; P ¼ .68). Similarly, Naughton et al9 reported no difference in the limb patency between EE and FL in their experience (2% vs 3%; P ¼ .5). EE failure associated with distal endoleak may be related to proximal migration of iliac limbs, which was likely the cause in one of our patients. Some centers have used iliac branched endografts to treat CCIAA.20 However, their use is not applicable for all anatomic configurations, and their long-term results are still unknown. The Excluder Iliac Branch Endoprosthesis is commercially available; the Zenith Branch Endovascular
Graft is currently in clinical trials in the United States but is commercially available outside the United States. This study has several important limitations. First, it represents a retrospective review of a single-institution experience. Second, aneurysms treated with the EE technique were significantly larger than those the other groups, likely from selection bias, limiting the comparison with aneurysms treated with the other two techniques. Third, mean follow-up was only 58.9 months and was limited in patients living substantial distances from our institution. Last, the number of aneurysms treated with the EE technique was small compared with the entire cohort, which could introduce a type II error.
CONCLUSIONS The presence of CCIAA leads to a higher rate of reintervention after EVAR for AAA compared with patients without CCIAA. Of the techniques studied, there was no significant difference in reintervention rates between the EE, FL, and no-FL techniques. The EE technique is most applicable in patients with a large CCIAA when the other two strategies are not feasible. The no-FL technique can be useful in certain patient subsets, but close surveillance for CCIAA expansion is required. Despite the increasing availability of iliac branched devices, these techniques will continue to be applicable in patients with CCIAA for the foreseeable future.
AUTHOR CONTRIBUTIONS Conception and design: MB, PB, GL Analysis and interpretation: MB, CJ, PB, GL Data collection: MB, CJ, AF, AA, JK, AS Writing the article: MB, CJ, PB, GL Critical revision of the article: MB, CJ, AF, AA, JK, PB, GL, AS Final approval of the article: MB, CJ, AF, AA, JK, PB, GL, AS Statistical analysis: MB Obtained funding: Not applicable Overall responsibility: GL
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Submitted Jan 19, 2016; accepted Feb 23, 2017.