754862
research-article2018
JETXXX10.1177/1526602818754862Journal of Endovascular TherapyGiaquinta et al
A SAGE Publication
Clinical Investigation
Isolated Common Iliac Artery Aneurysms Treated Solely With Iliac Branch Stent-Grafts: Midterm Results of a Multicenter Registry
Journal of Endovascular Therapy 2018, Vol. 25(2) 169–177 © The Author(s) 2018 Reprints and permissions: sagepub.com/journalsPermissions.nav https://doi.org/10.1177/1526602818754862 DOI: 10.1177/1526602818754862 www.jevt.org
Alessia Giaquinta, MD, PhD1, Vincenzo Ardita, MD1 , Ciro Ferrer, MD2, Clive B. Beggs, PhD3, Massimiliano Veroux, MD, PhD1 , Matteo Barbante, MD4, Matteo Orrico, MD5, Piergiorgio Cao, MD6, and Piefrancesco Veroux, MD1, on behalf of the Iliac Branch Stent-Graft Italian Trial Collaborators
Abstract Purpose: To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA). Methods: From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Mean CIAA diameter was 39.1±10.5 mm (range 25–65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed. Results: Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2±33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage ≥5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up. Conclusion: The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results. Keywords aneurysm, common iliac artery, endovascular repair, iliac artery aneurysm, iliac branch device, iliac branched stent-graft, internal iliac artery
Introduction The common iliac artery (CIA) is considered aneurysmal when the transverse diameter is >18.5 mm for men and >15 mm for women.1 Abdominal aortic aneurysms (AAA) are associated with CIA aneurysm (CIAA) in 20% to 30% of cases; of these, bilateral disease may be present in up to 50%.2 However, isolated CIAAs are somewhat rare, with a reported prevalence as low as 0.03% in autopsy studies.1 Usually, patients with isolated CIAA are asymptomatic and diagnosis is incidental during imaging studies. However, isolated CIAAs that rupture have high mortality (50%– 100%).2 Even if the risk of rupture is not clearly defined, Huang et al3 demonstrated that the expansion rate of CIAAs was 0.29 cm/y in a series of 715 CIAAs treated in a 20-year
1
Vascular Surgery and Organ Transplant Unit, University Hospital of Catania, Italy 2 Department of Surgery “Pietro Valdoni,” “Sapienza” University, Rome, Italy 3 Research Institute for Sport, Physical Activity and Leisure, Carnegie Faculty, Leeds Beckett University, Leeds, UK 4 Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome “Tor Vergata,” Rome, Italy 5 Department of Vascular Surgery, San Filippo Neri Hospital, Rome, Italy 6 Division of Vascular Surgery, Azienda Ospedaliera S. Camillo Forlanini, Rome, Italy Corresponding Author: Massimiliano Veroux, Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Via Santa Sofia 84, 95123 Catania, Italy. Email:
[email protected]
170 period; the incidence was higher in patients with hypertension. Since rupture is unlikely when the CIAA is 3 cm.3–5 Isolated CIAAs can be treated using either a surgical or endovascular approach. The main goal of the treatment is to exclude the aneurysm sac while maintaining internal iliac artery (IIA) perfusion to prevent complications, such as buttock claudication (1.6%–56%), erectile dysfunction (33%), gluteal region necrosis, and colon or spinal cord ischemia (6%–9%).6–10 Surgical treatment is associated with a not negligible mortality (10%) and may be burdened by some dangerous complications, such as damage to adjacent organs during exposure of the vessels and bowel or ureteral ischemia.4 The endovascular approach has been proposed to reduce surgical risk, thereby making it available to elderly patients with significant comorbidities deemed unfit for open repair. Initially, endovascular treatment included IIA sacrifice; however, new techniques, such as bell-bottom or parallel grafting, have been developed to maintain antegrade flow in at least one IIA.11–16 Nevertheless, these options are not always applicable, and long-term results are scarce and frequently questioned. Over the last few years, a dedicated iliac branch device (IBD) for the exclusion of aortoiliac and isolated CIA aneurysms has been developed to preserve pelvic circulation. Several studies have demonstrated excellent early and midterm safety and efficacy, with low complication rates and mortality.6–24 Although the IBD should always be used in conjunction with an aortic stent-graft, according to the instructions for use (IFU) there are some anatomical constraints, such as reduced aortic or iliac length, that may limit its on-label use. In addition, coverage of a nonaneurysmal aorta remains a controversial issue. The use of an IBD without an aortic stent-graft for isolated unilateral or bilateral CIAAs or in cases of healthy or minimally dilated aorta with an accessory renal artery arising distally has been recently described in case reports or small case series.20,21 The aim of this multicenter retrospective analysis was to assess early and midterm results of IBD use without concomitant bifurcated aortic stent-grafts in patients with isolated CIAAs.
Methods Patient Cohort and IBD Implantation From December 2006 to June 2016, 46 patients with 49 isolated CIAAs treated solely with an IBD were enrolled in a multicenter registry. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Demographics, comorbidities, and morphological
Journal of Endovascular Therapy 25(2) characteristics at baseline are listed in Table 1 according to type of IBD implanted. All patients were considered at high risk for open surgery (American Society of Anesthesiologists class III or IV). All preoperative (Figure 1) and postoperative computed tomography angiography (CTA) scans were reviewed by a single core laboratory using a dedicated workstation (TeraRecon Aquarius, Foster City, CA, USA). Five patients presented with bilateral CIAAs (Figure 2) and another 5 had an associated IIA aneurysm. Three patients had abdominal aorta ectasia (mean 30.1±2.1 mm). Two patients had a previously implanted thoracic endograft. The preoperative mean CIAA diameter was 39.5±10.1 mm (range 25.0–65.0). Other baseline measurements (Figure 1) were a proximal iliac neck length of 25.2±12.1 mm (range 10–84) and diameter of 13.2±3.1 mm (range 9–20). The IIA distal neck measured 27.5±11.2 mm in length (range 8–30) and 8.1±1.5 mm in diameter (range 7.6–11), and the EIA distal neck was always >20 mm long and a mean 9.4±1.3 mm in diameter (range 7–12). Two commercially available devices were used based on the CIA dimensions and operator preference: the Zenith bifurcated iliac side branch device (ZBIS; Cook, Inc., Bloomington, IN, USA) and the Gore Excluder Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ, USA). Bilateral femoral accesses, either percutaneous or surgical cutdown, were performed in all cases. A dedicated IIA stent-graft (HGB; W.L. Gore & Associates) was used in conjunction with the Gore IBE. Balloon-expandable stent-grafts (Advanta V-12; Atrium Maquet Getinge Group, Mijdrecht, the Netherlands) or self-expanding covered stents [Fluency (Bard Peripheral Vascular Inc., Tempe, AZ, USA) or Viabahn (W.L. Gore & Associates)] were used with the Cook ZBIS as bridges between the IBD and the IIA. Kissing balloon angioplasty of the iliac bifurcation was performed when needed. Contralateral CIA stenting with a kissing stent technique was used in cases of IBD protrusion above the aortic bifurcation. If the proximal or distal sealing zone was not covered, a stent-graft extension was deployed. Completion angiography was performed to assess patency of the IBD and aneurysm exclusion (Figure 2). Postoperative follow-up consisted of clinical examination, specifically assessing buttock claudication, erectile dysfunction, and any other symptoms that could be related to visceral ischemia or to IIA occlusion. Imaging follow-up included duplex ultrasound before discharge and at 1 and every 6 months; a CTA was acquired within the first month after intervention and yearly thereafter (Figure 3).
Definitions, Outcomes, and Statistical Analysis The primary outcomes were technical success, patient survival, aneurysm exclusion, device patency, and freedom from reintervention. Technical success was defined as IBD
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Giaquinta et al Table 1. Characteristics of 41 Patients With Common Iliac Artery Aneurysm Undergoing Endovascular Repair With Iliac Branch Devices Without Aortobi-iliac Components.a Clinical Data Age, y Men Interventions Right side Left side Body mass index, kg/m2 COPD Smoking Hypertension Coronary artery disease Diabetes Dyslipidemia Chronic renal failure Stroke/TIA Carotid disease PAD CIAA diameter, mm Baseline 1 Month 12 Months Internal iliac artery component patency 1 Month 12 Months Device patency 1 Month 12 Months Deaths Reinterventions
Zenith IBD (n=32)
Excluder IBE (n=9)
p
72.2±8.4 32 34 19 15 26.5±2.9 11 16 20 9
73.7±5.3 9 10 6 4 26.4±2.7 5 5 8 5
0.620 — — 0.817 0.817 0.889 0.250 0.768 0.133 0.125
4 9 6 1 1 2
3 4 1 0 0 0
0.142 0.353 0.591 0.591 0.591 0.442
39.6±10.6 38.7±10.5 33.5±9.4
39.3±8.8 39.0±8.9 30.9±5.0
0.937 0.937 0.483
31/34 31/34
8/10 7/10
0.328 0.086
31/34 30/34 3 1
8/10 7/10 1 0
0.328 0.166 0.877 0.583
Abbreviations: CIAA, common iliac artery aneurysm; COPD, chronic obstructive pulmonary disease; IBD, iliac branch device; IBE, iliac branch endoprosthesis; PAD, peripheral artery disease; TIA, transient ischemic attack. a Continuous data are presented as the means ± standard deviation; categorical data are given as the counts.
deployment as intended, exclusion of the CIAA, and patency of the IIA and external iliac artery (EIA). Data regarding procedure and fluoroscopy time, contrast volume administration, and admission time were collected as well. Major adverse events and mortality were evaluated at 30 days from intervention and at latest follow-up. The presence of endoleaks, IBD patency, migration, component disconnection, and aneurysm diameter changes were evaluated by CTA when available or alternatively with ultrasound. Aneurysm diameter changes ≥5 mm were considered significant. Continuous data were expressed as means ± standard deviation and were compared using a 2-tailed t test or Pearson chi-square test. Change in aneurysm diameter over time was assessed using repeated-measures analysis of variance with post hoc pairwise comparisons. The threshold of statistical significance was p
