Multicenter CT Image-Based Anatomic Assessment of Patients with Aortoiliac Aneurysm Undergoing Endovascular Repair with Iliac Branch Devices.

BACKGROUND: The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIEs) in aortoiliac aneurysms treated with iliac branch devices (IBDs). METHODS: Patients with pre-IBD and post-IBD computed tomography imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pretreatment and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pretreatment to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD. RESULTS: We analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -0.20 [-0.22 to -0.18] vs. -0.09 [-0.12 to -0.06], P < 0.0001 and -19.6° [-22.4° to -16.9°] vs. -11.2° [-15.3° to -7.0°], P = 0.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and 5 device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (nAIE, nitinol = 8). CONCLUSIONS: Purpose-built IBDs effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at 4 years. Anatomic predictors of AIE are limited.

Conformability of the GORE EXCLUDER iliac branch endoprosthesis is associated with freedom from adverse iliac events.

OBJECTIVE: The GORE EXCLUDER iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz) is designed to preserve internal iliac artery (IIA) patency during endovascular treatment of aneurysms involving the common iliac artery. The device is intended to conform to iliac tortuosity, which may decrease adverse iliac events (AIE). The objective of this study was to evaluate risk factors for AIE after IBE implantation. METHODS: This was a post hoc analysis of the prospective, multicenter GORE 12-04 IBE pivotal trial. Patients with preoperative and postoperative axial imaging were included, with analysis based on each treated iliac system. An independent core laboratory performed all scan measurements, including iliac diameters, lengths, and tortuosity. Conformability was analyzed by the changes in tortuosity after IBE deployment, with less change indicating greater conformation. The end point was AIE, defined as ipsilateral radiographic or clinical complications. Critical nonconformation was defined as a threshold change in tortuosity associated with a significant increase in AIE. RESULTS: We included 98 patients with 101 treated iliac systems. There were eight AIE (8%; six IIA component occlusions, one iliac branch component occlusion, and one EIA dissection requiring reintervention). Patients with AIE had smaller IIA diameters and less IBE conformability. After multivariable logistic regression analysis, an IIA diameter of less than 10 mm and a change in total iliac tortuosity beyond -15% were independently associated with AIE (odds ratio, 12 [interquartile range, 1.4-110] and odds ratio, 8.2 [interquartile range, 1.5-46], respectively), and the latter was used to define critical nonconformation. Critical nonconformation occurred in 11% of treated systems, and was associated with a high rate of AIE (36% vs 4%; P = .004). CONCLUSIONS: Endograft conformation is a novel device property and technical outcome that, along with a larger IIA diameter, is associated with freedom from AIE after IBE deployment. An evaluation of these risk factors may better inform the management of patients with iliac aneurysmal disease. Further research on endograft conformation and patient outcomes is warranted, particularly for those with challenging anatomy undergoing complex procedures.

Fate of excluded popliteal artery aneurysms.

OBJECTIVE: Popliteal artery aneurysms (PAA) are frequently treated with ligation and exclusion bypass grafting. It is assumed that these aneurysms will shrink and remain asymptomatic. This may not always be true. We sought to elucidate the fate of excluded PAA over time. METHODS: Data for all PAAs treated with ligation and exclusion bypass grafting between 1986 and 1999 were retrospectively reviewed. Computed tomography (CT) scans and duplex ultrasound scans provided aneurysm patency data and maximal transverse diameter measurements of the popliteal artery during late postoperative follow-up. This information was compared with that from similar preoperative studies. RESULTS: Forty-one patients (39 men, 2 women) underwent 57 ligation and exclusion bypass grafting procedures. Both preoperative and late postoperative (mean, 4.0 years; range, 0.43-13.5 years) CT scans or duplex ultrasound scans were available for review of 25 PAAs in 18 patients (ages 42-80 years; mean, 63 years). Preoperative PAA size ranged from 14 to 45 mm (mean, 28.7 mm). In late follow-up, 12 (48%) PAA had decreased in size (mean, 7.3 mm), 5 (20%) remained unchanged, and 8 (32%) increased in mean transverse diameter (mean, 5.9 mm). One large aneurysm increased by 50%. Contrast material enhancement was identified in the excluded sac in 11 aneurysms. CONCLUSIONS: PAA treated with ligation and exclusion bypass grafting often expand and can become symptomatic. This may be analogous to type II endoleak or endotension noted after aortic endovascular repair. We recommend PAA excision or endoaneurysmorrhaphy when feasible.

Percutaneous repair of abdominal aortic aneurysm.

OBJECTIVE: Percutaneous treatment of an abdominal aortic aneurysm (AAA) is feasible, but is associated with a unique set of risks. A comparison of Excluder endograft deployment with femoral artery cutdown (FAC) versus percutaneous femoral access (PFA) for treatment of infrarenal AAA was undertaken. METHODS: A single-institution, controlled, retrospective review was carried out in patients who underwent either bilateral FAC or bilateral PFA for endovascular repair of infrarenal AAA with the Gore bifurcated Excluder endograft between March 1999 and November 2003. To November 2000, 35 patients underwent bilateral FAC; since then, 47 patients have undergone bilateral PFA. All have been followed up for at least 30 days. RESULTS: Mean AAA size was 5.7 cm in the FAC group and 6.0 cm in the PFA group. During hospitalization there were six access-related complications in the FAC group; three required early surgical intervention. In the PFA group nine perioperative access-related complications occurred, all consisting of either hemorrhage or arterial occlusion; seven required additional intervention, and were recognized and ameliorated while the patient was still in the operating room. At 30-day follow-up there were no additional access-related complications in the PFA group. There were eight other access-related complications in eight additional patients who underwent FAC. In patients undergoing bilateral PFA total operative time was shorter (PFA 139 minutes vs FAC 169 minutes; P =.002), total in-room anesthesia time was less (PFA 201 minutes vs FAC 225 minutes; P <.008), and use of general anesthesia was reduced (P <.001). No significant differences were observed between groups with respect to estimated blood loss (PFA 459 mL vs FAC 389 mL; P =.851). CONCLUSION: Complete percutaneous treatment of AAA may have some advantages over open femoral artery access, but it is not free from risk. Percutaneous treatment of AAA can be completed successfully in most patients, but should be performed at an institution where conversion to an open procedure can be completed expeditiously if necessary.