J ENDOVASC THER 2014;21:223–229

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INVESTIGATION ——————————————————————————

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Endovascular Treatment of External Iliac Artery Occlusive Disease: Midterm Results ´ Sergio Revuelta Suero, MD; Isaac Mart´ınez Lopez, MD; Manuel Hernando Rydings, MD; ´ de Marino, MD; Ana Saiz Jerez, MD; Manuela Maria Herna´ndez Mateo, MD; Pablo Marques and Francisco Javier Serrano Hernando, MD, PhD Servicio de Angiolog´ıa y Cirug´ıa Vascular, Hospital Cl´ınico San Carlos, Universidad Complutense, Madrid, Spain. ^

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Purpose: To report midterm outcomes for endovascular treatment of external iliac artery (EIA) occlusive disease and assess possible factors affecting patency. Methods: A retrospective analysis was conducted of 99 consecutive patients (91 men; mean age 67.3 years) with claudication (n¼70) or critical limb ischemia (n¼29) owing to occlusive EIA disease treated at our center from January 2005 to June 2012. The majority of lesions (79/108) were TASC A/B. Lesions were a mean 42.2 mm long (range 10–125); 43/108 affected the distal third of the EIA. Balloon angioplasty alone was performed in 7 limbs, while the remaining 101 lesions were stented (65 self-expanding, 24 balloon-expandable, and 12 covered). Clinical and hemodynamic follow-up was performed at 1, 3, 6, and 12 months after therapy and yearly thereafter. The factors examined were procedure characteristics and patency rates. Results: Over a median follow-up of 27.5 months (range 1–89), there were 2 (1.9%) early occlusions followed by a successful reintervention, 4 late occlusions, and 5 hemodynamic failures followed by 7 reinterventions. These events led to primary and secondary patency rates at 30 months of 89.7% and 94.1%, respectively. No differences in patency rates were detected according to age, clinical state, or comorbidity. Use of covered stents (p¼0.006) was the only variable associated with lower primary patency rates. Conclusion: Endovascular therapy to treat TASC A/B lesions of the EIA yielded good short and midterm patency and low early morbidity and mortality. Lesions involving the distal third of the EIA treated by simple angioplasty 6 stenting fared worse. No clinical factors could be correlated with patency. J Endovasc Ther. 2014;21:223–229 Key words: endovascular repair, external iliac artery, claudication, critical limb ischemia, stenosis, chronic total occlusion, balloon angioplasty, stent, covered stent, patency ^ ^

The open surgical treatment of aortoiliac occlusive disease has provided excellent long-term outcomes, though perioperative morbidity has been far from negligible.1 The introduction of endovascular therapy (EVT) has meant a substantial improvement in this morbidity, given its minimally invasive nature

along with published patency and mortality rates that compare favorably with the open surgery procedure. The EVT approach is thus, in most cases, the aortoiliac revascularization technique of choice.2 Several factors possibly leading to a lower patency rate in aortoiliac EVT have been

The authors declare no association with any individual, company, or organization having a vested interest in the subject matter/products mentioned in this article. Corresponding author: Sergio Revuelta Suero, MD, Department of Vascular Surgery, Hospital Cl´ınico San Carlos, C/Mart´ın Lagos, 28040 Madrid, Spain. E-mail: [email protected] Q 2014 by the INTERNATIONAL SOCIETY

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ENDOVASCULAR SPECIALISTS

Available at www.jevt.org

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examined. Among these variables, the anatomical location of the stenotic lesion to be treated has been one of the most investigated. In addition, lower patency rates in response to EVT have been reported for the external iliac artery (EIA) compared to the common iliac artery (CIA).3 However, there are few published studies that have addressed the issue of endovascular treatment of the EIA alone. The present study was designed to examine outcomes of EVT used to treat EIA occlusive disease at our center in a cohort of patients with claudication or critical limb ischemia (CLI) and to identify possible factors associated with a lower patency rate.

METHODS Study Design A retrospective cohort study was designed to include consecutive patients treated for EIA occlusive disease at our hospital over the period January 2005 to June 2012. Patients undergoing concurrent treatment for stenotic lesions affecting other vessels were also included. In all patients, the preoperative examination involved a hemodynamic study, in which segmental pressure measurements were made, and digital subtraction angiography or computed tomographic angiography. Clinical severity was assessed according to the Rutherford classification.4 Lesions were staged and defined in terms of the degree and length of stenoses as well as TASC (TransAtlantic Inter-Society Consensus) II criteria.2 Data were collected related to demographics, cardiovascular risk factors, concomitant disease, type of procedure (balloon dilation vs. stenting), and device characteristics, such as diameter, length, number, and type of stent (self-expanding, balloon-expandable, or covered). Selective stenting was reserved for short lesions close to the inguinal ligament. Self-expanding stents were used preferentially; balloon-expandable stents were used for short, intensely-calcified lesions (the anatomy of the artery permitting), and covered stents were used for long stenoses. Ultimately, the device used depended on the surgeon’s choice. For chronic total occlusions (CTO), intraluminal recanalization was the first

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choice, but subintimal recanalization was attempted when this failed. Concurrent procedures included EVT of the CIA, femoral artery reconstruction, infrainguinal revascularization, or femorofemoral bypass. Intraoperative and 30-day complications were recorded. Up to December 2008, postoperative treatment was simple antiplatelet therapy and statins. Starting in 2009, patients were discharged under statin treatment and double antiplatelet therapy (aspirin 100 mg/d plus clopidogrel 75 mg/d), which was continued for 6 weeks; thereafter, only clopidogrel was maintained indefinitely at the same dose. Patients requiring anticoagulation were discharged under treatment with an anticoagulant plus simple antiplatelet therapy with clopidogrel. Early outcomes (,30 days) were recorded in terms of primary and secondary patency rates, technical success (defined as ,30% residual stenosis), and the need for conversion to open surgery.

Patient Cohort During the observation period, endovascular procedures were performed on 108 EIAs in 99 consecutive patients (91 men; mean age 67.3 years, range 41–88). Risk factors and associated comorbidities are provided in Table 1. At the time of EVT, 76 (70.4%) patients had ischemic symptoms in the affected limbs classified as Rutherford category 3, 11 (10.2%) patients were category 4, and 21 (19.4%) were category 5. The mean preoperative thigh-brachial index ( TBI) was 0.7360.14. Mean lesion length was 42.2 mm (range 10– 125). The treated lesions were classified as TASC A (35, 32.4%), TASC B (44, 40.8%), TASC C (28, 25.9%), and TASC D (1, 0.9%). With a mean length of 50.4 mm (range 12–125), most TASC C lesions (Table 2) in this patient series involved the iliac bifurcation or were associated with significant stenosis of the common femoral artery (CFA). About half of the lesions (57, 52.8%) involved the proximal third of the EIA, while 59 (54.6%) were in the middle third and 43 (39.8%) the distal third. Only 9 (8.3%) lesions involved the entire artery; 66 (61.1%)

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^ TABLE 1 Demographics and Comorbidities for the 99 Study Patients Age, y Men Arterial hypertension Smoking Hypercholesterolemia Diabetes mellitus Coronary artery disease Chronic renal failure Cerebrovascular disease COPD

67.3 91 61 85 33 36 28 12 21 9

(41–88) (91.9%) (61.6%) (85.9%) (33.3%) (36.4%) (28.3%) (12.1%) (21.2%) (9.1%)

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^ Continuous data are presented as the means (range); categorical data are given as the counts (percentage). COPD: chronic obstructive pulmonary disease.

involved only one third and 33 (30.6%) two thirds.

Follow-up Follow-up consisted of clinical and hemodynamic surveillance at 1, 3, 6, and 12 months after EVT and yearly thereafter. Patients showing clinical worsening or a TBI reduction .0.15 had a duplex scan to assess stent patency. The indication for reintervention was .50% restenosis associated with claudication or CLI.

Statistical Analysis Continuous data are presented as the mean (range); categorical data are given as the counts (percentage). Qualitative variables were compared using the chi-square test

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and the Fisher exact test; the Student t test was used for quantitative variables. Follow-up data were subjected to survival analysis by the Kaplan-Meier procedure and the Breslow test; estimates are given with the standard error in parentheses. A receiver operating curve (ROC) was constructed to assess the effects of lesion or stent length on the primary patency; outcomes are presented as the area under the curve (AUC). Lesion length was also tested using a 60-mm cutoff and stent length using an 80-mm cutoff to determine the sensitivity and specificity of these variables with regard to patency. Significance was set at p,0.05. All statistical tests were performed using the SPSS software package (version 20.0; IBM Corporation, Armonk, NY, USA).

RESULTS Technical success was 99.1%; recanalization of one EIA was not possible and was subsequently treated by open surgery. Of the 17 (15.7%) CTOs, 16 were recanalized using the intraluminal technique. In 65 (60.2%) procedures, a self-expanding stent was used, while a balloon-expandable stent was deployed in 24 (22.2%) and a covered stent in 12 (11.1%); 7 (6.5%) lesions were treated with simple balloon dilation. In 90 (83.3%) procedures, a single stent was used; 2 stents were required in 11 (10.2%) limbs. Implanted devices had a mean length of 59.7 mm (range 29–150) and an average diameter of 7.7 mm (range 6–10). Forty-one associated procedures were done: EVT of the CIA in 10, femoral endarterectomy or profundaplasty in 16, femorofemoral bypass in 9, infrainguinal bypass in 3, and femoropopliteal EVT in 3. Most patients (65,

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^ TABLE 2 Breakdown of Lesion Morphology According to TASC II Classification TASC II Class Total A B C D

N 108 35 44 28 1

(100%) (32.4%) (40.8%) (25.9%) (0.9%)

Lesion Length, mm 42.2 23.4 52.1 50.4

(10–125) (10–30) (27–100) (12–125) 40

Occlusions 17 0 11 6 0

(15.7%) (0.0%) (25%) (21.4%) (0.0%)

Associated CFA Procedure 16 0 0 16 0

(14.8%) (0.0%) (0%) (57.1%) (0.0%)

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^ Continuous data are presented as the means (range); categorical data are given as the counts (percentage). TASC: TransAtlantic Inter-Society Consensus, CFA: common femoral artery.

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60.2%) were prescribed double antiplatelet therapy for 6 weeks followed by a single drug. Nineteen (17.6%) patients took only aspirin and 24 (22.2%) only clopidogrel. No intraoperative complications were recorded, but 2 (1.9%) occlusions occurred in the first 30 postoperative days. In one, a 50mm-long covered stent had been implanted, and thrombectomy was required. In the second patient with a 150-mm-long selfexpanding stent, open surgery was required. In both cases, the stent was placed across the inguinal ligament. One early death was due to chronic obstructive pulmonary disease complications.

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Primary Patency at 30 Months

p*

Gender Male Female

90.0% 100%

1

91.0% 90.2%

1

91.4% 86.7%

0.627

94.6% 88.7%

0.489

97.4% 87.1%

0.095

93.9% 89.3%

0.720

Yes No

83.3% 91.7%

0.307

COPD Yes No

100% 89.8%

0.594

87.0% 91.8%

0.441

Arterial hypertension Yes No Smoking Yes No Hypercholesterolemia

Late Outcomes Mean follow-up was 27.5 months (range 1– 89). Nine (8.3%) deaths were recorded, and 16 (14.8%) patients were lost to follow-up after at least a year. There were 5 cases of restenosis, all of which were repaired by EVT; 4 were patent at the last follow-up. In addition, 4 late occlusions occurred, one of which was treated using an endovascular procedure in a patient who presented acute limiting claudication. In the 3 remaining cases, occlusion of the device was well tolerated, and there was no need for revascularization up to the last follow-up. Two below-knee amputations were required in diabetic patients with infrainguinal disease and a patent procedure. At the end of followup, 68 (63.0%) patients were asymptomatic (Rutherford stage 0), while 18 (16.7%), 16 (14.8%), 4 (3.7%), and 2 (1.9%) had stages 1, 2, 3, and 5 disease, respectively. Cumulative survival at 12 and 30 months was 95.0% (2.4%) and 89.8% (3.3%), respectively. Primary patency, assisted primary patency, and secondary patency rates were 93.4% (2.4%), 96.0% (2.0%), and 97.9% (1.5%), respectively, at 12 months and 89.7% (3.3%), 93.1% (2.8%), and 94.1% (3.0%) at 30 months. Finally, the reintervention-free rates for the entire sample were 96.1% (2.0%) and 91.8% (3.0%) at 12 and 30 months, respectively. No differences in primary patency rates were observed relative to the antiplatelet agent used (acetylsalicylic acid, clopidogrel, or both, p¼0.56), sex, cardiovascular risk factors, or concomitant disease (Table 3).

^ TABLE 3 Cardiovascular Risk Factors and Comorbidities Examined as Possible Primary Patency Predictors

Yes No Diabetes Yes No Coronary artery disease Yes No Chronic renal failure

Cerebrovascular disease Yes No

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^ COPD: chronic obstructive pulmonary disease. * Breslow.

CLI and greater lesion severity according to TASC II classification were not associated with lower patency. Primary patency rates for the treatment of CTOs were 88.2% (7.8%) at 12 and 18 months, vs. 95.1% (2.4%) and 93.7% (2.8%) for the treatment of stenotic lesions for the same time period, though this difference lacked significance (p¼0.10). The need for an associated procedure on the CIA or the infrainguinal segment had no effect on the patency rates, with a primary patency at 30 months of 92.5% (3.7%) when required vs. 83.6% (7.5%) when not (p¼0.20).

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Lesion or stent length did not have any effect on primary patency according to the ROC analysis (Fig. 1), with AUCs of 0.61 for lesion length and 0.65 for stent length. Lesion length around a 60-mm cutpoint resulted in a sensitivity of 44.4% and a specificity of 88.4% for lesion length. Stent length around an 80mm cutpoint produced a sensitivity of 44.4% and a specificity of 71.1%. Primary patency rates for lesions ,60 mm at 12 and 30 months were 96.3% (2.1%) and 91.3% (3.5%), respectively, while rates for lesions .60 mm were both 81.1% (9.8%) (Fig. 2A), though this difference was not significant (p¼0.07). Stent length showed a similar effect (Fig. 2B), with primary patency rates at 12 and 30 months of 96.9% (2.2%) and 92.5% (3.7%), respectively, for stents ,80 mm vs. 88.0% (6.5%) and 83.6% (7.5%), respectively, for the longer stents (p¼0.07). Patency rates recorded at 12 and 30 months for lesions involving the distal third of the EIA as opposed to an unaffected distal third were 87.0% (3.2%) and 83.3% (4.0%) vs. 96.4% (3.9%) and 94.1% (7.3%) (p¼0.08). The only factor found to affect the outcome of EVT was stent type (Fig. 3) in that a significantly lower primary patency was observed for the use of a covered stent compared with bare stent types [83.3% (9.9%) vs. 96.5% (1.5%) at 8 months, p¼0.006].

Figure 2 ^ Primary patency rates according to (A) lesion or (B) stent length.

DISCUSSION

Figure 1 ^ ROC curves for lesion length (sensitivity 44.4%, specificity 88.4%, AUC 0.61) and stent length (sensitivity 44.4%, specificity 71.1%, AUC 0.65).

Endovascular therapy is today the first line treatment for aortoiliac occlusive disease, mainly because of substantial improvements in both the technique and endovascular devices but also because of the higher morbidity of open surgery performed on this vascular segment.5,6 The anatomical location of lesions in the aortoiliac segment has been one of the most investigated topics in recent studies. Ballard et al.7 and Lee and colleagues8 detected no difference in patency

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Figure 3 ^ Primary patency rates recorded for covered and bare stents. The standard error for covered stents was valid to only 8 months due to the small numbers.

according to the location of the treated lesion (CIA vs. EIA), while others observed effects of lesion location as well as other factors. For instance, Laborde et al.9 reported worse midterm outcomes for EIA stenting, especially when associated factors were infrainguinal disease, female sex, and perioperative complications. Thus, treatment of the EIA seems to be related to a worse outcome, although this effect could be influenced by numerous associated factors. Although we did not compare outcomes of EVT in the EIA and CIA, we obtained high patency rates in line with those described by Lee et al.8 Morbidity and mortality rates for our cohort were low, with early complications resolved mostly by endovascular treatment. No technical defect could be identified in the 2 early occlusions, though we propose the proximity of the device to the inguinal ligament as the most likely cause of these occlusions. Calligaro et al.10 recently reported high primary patency rates at 2 years for EVT across the inguinal ligament using covered stents. Our data revealed a lower patency rate for lesions involving the distal third of the EIA, though the difference was not significant, perhaps because of an insufficient number

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of cases. The lack of information in the literature and contradictory results indicate a need for further work in this area. Today, there is still much controversy over two aspects of EVT applied in the EIA: the treatment of occlusions vs. stenoses and primary vs. selective stenting at this location. Tsetis et al.11 reported worse patency rates for the treatment of EIA occlusions compared to stenoses, yet recent studies have detected no differences in the short and long term.12 In the present study, occlusions fared worse, though our sample was perhaps statistically underpowered for a significant effect to emerge. Several studies have compared the outcomes of simple balloon angioplasty or selective stenting vs. primary stenting. For short lesions, no differences in terms of patency and reoperations have been observed.13 However, AbuRahma et al.14 reported higher patency rates for primary stenting, especially when used to treat complex lesions. The STAG trial15 (stents vs. angioplasty for the treatment of iliac artery occlusions) compared primary stenting with simple balloon dilation in the iliac segment. The investigators noted no differences in primary or secondary patency rates, though primary stenting improved technical success and reduced procedural complications. Our approach favors the systematic deployment of a stent in the EIA. Maurel et al.16 has cited good outcomes of primary stenting of the EIA in patients with claudication. To the best of our knowledge, no study has specifically addressed the use of EVT for the EIA in a sample of patients with claudication or CLI. We were unable to detect any difference in outcomes between these two patient groups. In clinical practice, the current trend seems to be the use of a self-expanding stent, and covered stents are reserved for longer, more complex lesions.17 However, the worse prognosis of these complex lesions could explain the poorer patency rates recorded for these devices in the present study. In our sample, though, the covered stents that occluded during follow-up were used in favorable lesions. Finally, no differences in patency were detected between isolated EIA procedures and those associated with another procedure.

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This finding is consistent with the comparable outcomes recently cited by Piazza and colleagues18 of hybrid aortoiliac EVT plus open surgery of the CFA vs. open aortoiliac surgery with femoral artery reconstruction.

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8.

9.

Conclusion In this retrospective analysis, the use of endovascular therapy to treat TASC A/B lesions of the EIA yielded good short and midterm patency and low early morbidity and mortality. Our results reveal worse outcome for lesions involving the distal third of the EIA treated by simple angioplasty 6 stenting. No clinical factors could be correlated with patency. Covered stents achieved worse results in terms of patency, although a larger sample size is needed to confirm this observation.

10.

11.

12.

REFERENCES 1. Chiu KW, Davies RS, Nightinagale PG, et al. Review of direct anatomical open surgical management of atherosclerotic aorto-iliac occlusive disease. Eur J Vasc Endovasc Surg. 2010;39:460–471. 2. Norgren L, Hiatt WR, Dormandy JA, et al. InterSociety Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1–75. 3. Powell RJ, Fillinger M, Bettmann M, et al. The durability of endovascular treatment of multisegment iliac occlusive disease. J Vasc Surg. 2000;31:S1–296. 4. Ahn SS, Rutherford RB, Becker GJ, et al. Reporting standards for lower extremity arterial endovascular procedures. Society for Vascular Surgery/International Society for Cardiovascular Surgery. J Vasc Surg. 1993;17: 1103–1107. 5. Timaran CH, Prault TL, Stevens SL, et al. Iliac artery stenting versus surgical reconstruction for TASC (TransAtlantic Inter-Society Consensus) type B and type C iliac lesions. J Vasc Surg. 2003;38:272–278. 6. Schurmann K, Mahnken A, Meyer J, et al. Longterm results 10 years after iliac arterial stent placement. Radiology. 2002;224:731–738. 7. Ballard JL, Bergan JJ, Singh P, et al. Aortoiliac stent deployment versus surgical reconstruc-

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tion: analysis of outcome and cost. J Vasc Surg. 1998;28:94–101. Lee E, Coleman C, Trimble K, et al. Comparing patency rates between external iliac and common iliac artery stents. J Vasc Surg. 2000;31: 889–894. Laborde JC, Palmaz JC, Rivera FJ, et al. Influence of anatomic distribution of atherosclerosis on the outcome of revascularization with iliac stent placement. J Vasc Interv Radiol. 1995;6:513–521. Calligaro KD, Balraj P, Moudgill N, et al. Results of polytetrafluoroethylene-covered nitinol stents crossing the inguinal ligament. J Vasc Surg. 2013;57:421–426. Tsetis D, Uberoi R. Quality improvement guidelines for endovascular treatment of iliac artery occlusive disease. Cardiovasc Intervent Radiol. 2008;31:238–245. Pulli R, Dorigo W, Fargion A, et al. Early and long-term comparison of endovascular treatment of iliac artery occlusions and stenosis. J Vasc Surg. 2011;53:92–98. Klein WM, van der Graaf Y, Seegers J, et al. Long-term cardiovascular morbidity, mortality, and reintervention after endovascular treatment in patients with iliac artery disease: The Dutch Iliac Stent Trial study. Radiology. 2004; 232:491–498. AbuRahma AF, Hayes JD, Flaherty SK, et al. Primary iliac stenting versus transluminal angioplasty with selective stenting. J Vasc Surg. 2007;46:965–970. Goode SD, Cleveland TJ, Gaines PA, et al. Randomized clinical trial of stents versus angioplasty for the treatment of iliac artery occlusions (STAG trial). Br J Surg. 2013;100: 1148–1153. Maurel B, Lancelevee J, Jacobi D, et al. Endovascular Treatment of External Iliac Artery Stenoses for Claudication with Systematic Stenting. Ann Vasc Surg. 2009;23:722–728. Mwipatayi BP, Thomas S, Wong J, et al. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2011;54:1561–1570. Piazza M, Ricotta JJ, Bower TC, et al. Iliac artery stenting combined with open femoral endarterectomy is as effective as open surgical reconstruction for severe iliac and common femoral occlusive disease. J Vasc Surg. 2011; 54:402–411.

Endovascular treatment of external iliac artery occlusive disease: midterm results.

To report midterm outcomes for endovascular treatment of external iliac artery (EIA) occlusive disease and assess possible factors affecting patency...
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