Aortoiliac Aneurysm Repair Research Articles

A Canadian Post-Market Study of the Zenith Alpha Abdominal Endovascular Graft.

To evaluate the performance of the low-profile Zenith Alpha Abdominal Endovascular Graft in a Canadian post-market setting. A prospective, multicenter, non-randomized, post-market study was conducted at 5 sites in Canada between May 2017 and June 2018. Patients were treated for abdominal aortic or aorto-iliac aneurysms using the Zenith Alpha Abdominal Endovascular Graft and followed for 2 years after the initial procedure in accordance with each institution's standard of care. A total of 100 patients (mean age 75.2 ± 7.4 years, 88% male; 16% with aortoiliac aneurysms) were treated. Technical success was achieved in 99% (98/99) of patients. One patient was excluded from the technical success endpoint due to missing data. The single technical failure was due to partial coverage of the left renal artery by the main body graft. Mean follow-up duration was 635.9 ± 213.6 days. Device success through two-year follow-up was achieved in 86.9% (86/99) of patients. Overall, 9 deaths occurred; none were related to the study device nor to the procedure. No patient required conversion to open surgery. Through follow-up, 4 patients experienced a Type I endoleak. There were no instances of Type III or IV endoleaks. One case of aneurysm rupture (related to Type Ib endoleak and retrograde migration of an iliac leg graft) was successfully treated with angioplasty, coil embolization, and iliac graft extension. Eight patients experienced aneurysm growth >5mm throughout follow-up. Iliac leg graft occlusions occurred in 5 patients. In total, 14 patients required 15 secondary interventions. Iliac leg-graft-related secondary interventions were performed in 7 patients, for device occlusion (n=3), kink/compression (n=2), stenosis(n=2), or non-occlusive thrombus (n=3). Other reasons for secondary interventions included Type II endoleak (n=8), Type Ib endoleak (n=2), iliac artery dissection (n=1), abdominal aortic aneurysm rupture (n=1), and partial coverage of the left renal artery (n=1). The Zenith Alpha Abdominal Endovascular Graft demonstrates high rates of technical success, no open conversions, and no aneurysm -related mortality after abdominal aortic or aorto-iliac aneurysm repair. Type I endoleak rates were low. These outcomes support the safety and performance of the Zenith Alpha Abdominal Endovascular Graft.

Transatlantic Delphi Consensus on the Common Iliac Artery Sealing Zone in Endovascular Aorto-Iliac Aneurysm Repair (the DECIDE Study).

Knowledge of hostile factors and their influence on long-term seal in the iliac landing zone is limited. Currently endorsed clinical practice guidelines lack structural evidence on how the iliac landing zone should be assessed in the pre-, intra-, and postoperative phases. The goal of this study was to obtain an international, expert-based consensus on the definition of a hostile iliac landing zone, on how to size and plan stent-grafts to optimize sustainable distal seal, and on the postprocedural follow-up protocol. Delphi consensus methodology was used, involving a panel of international vascular surgeons experienced in endovascular aneurysm repair (EVAR). The first round consisted of open-ended and multiple-choice questions to explore current practices, with subsequent rounds refining statements through a 4-point Likert scale. Consensus was defined as >75% agreement or disagreement, and the analysis included stability testing and strength of consensus. The study engaged 77 international vascular surgeons, reflecting diverse geographic locations and hospital affiliations. Consensus was achieved on critical preoperative planning elements for EVAR, including a clear definition for a hostile iliac landing zone. The importance of computed tomography angiography for postoperative follow-up imaging was emphasized, including evaluating distal seal length and recommending specific timing for follow-up computed tomography scans and intervention strategies for diminishing iliac seal. This international expert-based Delphi consensus establishes a comprehensive set of consensus-driven recommendations focused on the definition and management of hostile iliac landing zones in EVAR. The key recommendation of this study is the definition of a hostile iliac landing zone as short (<15 mm), wide (>24 mm), or conical (>10% diameter difference along the landing zone). Although consensus was achieved on several critical aspects, the study also reveals ongoing debates and considerations that warrant further exploration, including how to tackle diminishing seal without a type IB endoleak. This Delphi consensus introduces a standardized definition of a hostile iliac landing zone as short (<15 mm), wide (>24 mm), or conical (>10% diameter difference), clinicians now have a clearer framework for assessing complex anatomies. This study provides a comprehensive set of consensus-driven recommendations focused on the definition and management of hostile iliac landing zones in EVAR which gives guidance where current guidelines lack specificity, particularly for distal iliac sealing. The study also reveals ongoing debates and considerations that warrant further exploration, including how to tackle diminishing seal without a type IB endoleak.

Percutaneous Retrograde Trans-Gluteal Embolization of Type 2 Endoleak Causing Iliac Aneurysm Enlargement after Endovascular Repair: Case Report and Literature Review.

Late type II endoleaks (T2ELs) arising from the internal iliac artery (IIA) may present during follow-up after endovascular aortic repair (EVAR) of aortoiliac aneurysm and may warrant embolization if enlargement of the aneurysmal sac is demonstrated. When coverage of the IIA ostium has been made due to extensive iliac disease, access options can be challenging. Different treatment options have been reported over recent years, and a careful selection of the best one must be made based on the characteristics of each case. The present study reports a simple and reproducible sheathless percutaneous superior gluteal artery (SGA) access and provides a discussion based on a review of the existing literature on this topic.

Early results of transcatheter electrosurgical aortic septotomy for endovascular repair of chronic dissecting aortoiliac aneurysms

ObjectiveEndovascular repair of chronic dissecting aortoiliac aneurysms is challenging given the rigid septum, compressed true lumen (TL), and target vessels frequently originating in the false lumen. We have used transcatheter electrosurgical aortic septotomy (TEAS) before stent graft implantation under intravascular ultrasound (IVUS) and fusion guidance. The purpose of this study is to assess the outcomes of TEAS during complex endovascular repair of dissecting aneurysms. MethodsFrom 2021 to 2023, 17 patients underwent TEAS. The primary end point was technical success, with secondary end points of proximal and distal seals, target vessel instability, aortic and iliac TL and cross-sectional area (CSA) expansion, and aortic-related death. During the procedure, the aortic septum is crossed through a pre-existing entry or via electrocautery-activated 0.018-in. Astato XS20 wire (Asahi-Intecc) under IVUS and fusion guidance. The penetrated wire is then snared in the false lumen and pulled through the ipsilateral femoral access. A 1-cm length of the middle of the Astato wire coating is kinked in a three-sided polygonal configuration, denuded the inner surface of the wire using a no. 15 blade, and positioned at the apex of the septum. Both ends of the Astato wire are insulated with 0.018-in. microcatheters, and the back end of the wire is denuded and connected to cautery. Gentle traction is applied to the wire, and short bursts of electrocautery cutting are applied at 60 to 80 W. ResultsThe technical success of the septotomy was 100%. No incidence of visceral or lower extremity malperfusion, vascular injury, or distal embolization occurred. Of the 17 patients, 4 underwent thoracic endovascular aneurysm repair, 2 underwent endovascular aortic repair, and 11 underwent fenestrated/branched endovascular aneurysm repair after septotomy. All target vessels were successfully stented. A distal landing zone seal with exclusion of the false lumen was achieved in 16 of the 17 patients (94.1%). One patient required embolization of the false lumen of the celiac artery after septotomy. The TL mean diameter and CSA of the descending thoracic aorta after septotomy was expanded by 7.01 ± 1.9 mm (relative mean diameter expansion, 42.3%; P < .0001) and 2.71 ± 0.4 cm2 (relative mean CSA expansion, 57.3%, P<.0001). For patients who required septotomy through the common iliac arteries, the mean TL was expanded by 8.1 ± 3.7 mm (relative mean diameter expansion, 76%; P < .0001) and 1.76 ± 0.91 cm2 (relative mean CSA expansion, 209%; P < .0001). The 1-year freedom from target vessel instability was 91%. ConclusionsThe use of IVUS and fusion-guided TEAS offers a promising technique to facilitate TL expansion and false lumen exclusion in chronic dissecting aortic aneurysms before repair. The durability and long-term outcomes of this technique in a larger cohort remain to be elucidated.

Influence of aortic bifurcation in iliac limbs patency in endovascular repair of aortoiliac aneurysms

Influence of aortic bifurcation in iliac limbs patency in endovascular repair of aortoiliac aneurysms

Incidence and Long-Term Implications of Type 2 Endoleak after Endovascular Repair of Abdominal Aortic and Aortoiliac Aneurysms.

Type 2 endoleak has been proved not to significantly increase the risk of aneurysm rupture. However, it is associated with aneurysm enlargement and may require secondary interventions. Its role has been widely investigated, but a definitive consensus about its management has still not been obtained. We performed a retrospective, single-center observational study that investigates the incidence of type 2 endoleak and its implications in the long-term follow-up in all the patients who underwent endovascular aortic repair (EVAR) for abdominal aortic aneurysm from 2011 to 2016 at our institution. A total of 216 patients who underwent EVAR during the specified time period were enrolled, and 85 of them (39%) developed type 2 endoleak in their follow-up. Thirty-one of the patients who developed type 2 endoleak faced an aneurysm sac growth > 10 mm and required secondary intervention. Only nine of them showed resolution of the leak. In the long-term follow-up, patients who developed type 2 endoleak after EVAR did not show a significantly increased mortality compared with those who did not, but some of them required late open conversion due to aneurysm sac enlargement and some other developed a secondary type 1 endoleak which required correction. The management of type 2 endoleak remains debated, despite consensus exist regarding the need for intervention when a > 10-mm aneurysm sac growth is observed. Further studies are necessary to better define which are the "high-risk" type 2 endoleaks and identify the patients who would benefit more from correction.

Global Iliac Branch Study: Image-based Detailed Anatomic Assessment and Device Performance

Iliac branch devices are designed to preserve patency of the internal iliac artery for endovascular repair of aortoiliac aneurysms. The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective study of over 300 iliac branch devices with diverse use. The objective of this project was to evaluate potential anatomic determinants of adverse iliac events. Patients were included if they had both pre- and post-treatment computed tomography imaging available after implantation of a bifurcated device. Morphologic measurements included arterial diameters, stenosis, calcification, aortic and iliac bifurcation angles, and tortuosity indices (Fig), performed by a core laboratory with a standardized and validated protocol. Adverse iliac events were defined as type I or III endoleak, occlusion, device constriction (due to either narrow anatomy or another component), or clinical events requiring reintervention of the ipsilateral iliac branch system. This abstract is based on univariate analysis. Paired t test was used to compare tortuosity indices and splay angles pre- and post-treatment. Logistic regression was used to assess associations between anatomic measurements and adverse iliac events. Analysis was performed by iliac system (ie, bilaterally treated patients’ right and left sides were analyzed independently). We analyzed 297 subjects (286 males, 11 females) with 331 iliac branch devices (104 nitinol, 227 stainless steel). Mean clinical follow-up was 3.8 years. Mean baseline total iliac artery index was 1.47 (range, 1.44 to 1.50), mean baseline common iliac artery index was 1.10 (range, 1.09 to 1.12). Changes in iliac artery tortuosity indices and aortic and iliac splay angles are reported in Table. Anatomy is significantly straightened with treatment in all devices. There were 54 adverse iliac events in 44 systems, requiring 35 reinterventions (median time to reintervention, 41 days; range, 0 days to 6.2 years). There were 18 endoleaks (17 type I, 1 type III), 29 occlusions, and five device constrictions. In nitinol devices, diameter of the internal iliac landing zone <10 mm and non-conformability (reduction in total iliac index beyond 15%) were associated with adverse iliac events (odds ratio [OR], 14; P = .016 and OR, 7.8; P = .021, respectively.) In the stainless steel devices, no significant univariate associations were found with anatomic measurements. These results suggest that purpose-built iliac branch devices are highly efficacious in treating tortuous iliac anatomy, with a high patency rate and low reintervention rate. Some anatomic factors are strongly predictive of adverse iliac events in nitinol devices.TableChanges in iliac artery tortuosity indices and splay anglesPre-treatment [95% CI]Post-treatment [95% CI]P-valueAll iliac branch systems (n = 331) Total iliac artery index1.47 [1.44-1.50]1.31 [1.28-1.33]<.0001 Common iliac artery index1.10 [1.09-1.12]1.04 [1.03-1.04]<.0001 Aortic splay angle58.3 [56.2-60.5]41.4 [39.6-43.1]<.0001 Iliac branch splay angle52.3 [49.7-54.8]47.4 [45.3-49.6]<.0001Nitinol iliac branch systems (n = 104) Total iliac artery index1.53 [1.47-1.60]1.44 [1.38-1.50]<.0001 Common iliac artery index1.13 [1.10-1.16]1.06 [1.05-1.08]<.0001 Aortic splay angle56.4 [52.1-60.8]45.3 [42.3-48.3]<.0001 Iliac branch splay angle48.0 [43.5-52.5]44.5 [40.7-48.3].0633Stainless steel iliac branch systems (n = 227) Total iliac artery index1.44 [1.42-1.47]1.25 [1.23-1.26]<.0001 Common iliac artery index1.09 [1.07-1.10]1.03 [1.02-1.03]<.0001 Aortic splay angle59.2 [56.8-61.7]39.6 [37.5-41.7]<.0001 Iliac branch splay angle54.2 [51.1-57.3]48.8 [46.2-51.4]<.0001CI, Confidence interval. Open table in a new tab

Shape memory polymer technology in peripheral vascular embolization.

Porous, radiolucent, shape memory polymer is a new technology available in discrete peripheral vascular embolization devices. Shape memory polymers can exist in two stable shapes; crimped for catheter delivery and expanded for vessel embolization. The expanded shape memory polymer in these new devices is hemostatic, and the porous polymeric scaffold has been shown to support tissue ingrowth and eventually bioabsorbs in preclinical animal studies. This report describes clinical experience with this novel material in vascular plug devices. a prospective, single-arm, safety study at a single center in New Zealand with longer term follow-up via retrospective imaging review. The study device was a pushable shape memory polymer vascular plug with a distal nitinol anchor coil and a proximal radiopaque marker. Ten male patients were each implanted with a single shape memory polymer vascular plug. Three inferior mesenteric arteries and an accessory renal artery were embolized during endovascular aneurysm repair. An internal iliac artery was treated prior to the open surgical repair of aorto-iliac aneurysms. An internal iliac artery and a subclavian artery were embolized to treat/prophylactically address potential endoleaks. A profunda branch was embolized prior to tumor resection, and two testicular veins were embolized to treat varicoceles. Acute technical success of target vessel embolization was achieved in all implantation cases. Patients were followed for 30days as part of the study, and no serious adverse events with a relationship to the study device occurred. No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented. There was no evidence of recanalization on retrospective review of follow-up imaging through a mean of 22.2months (range, <1-44months) post-procedure. Shape memory polymer vascular embolization devices were safe and effective over the follow-up period of this small safety study. Further experience and longer term follow-up will assess further applicability.

Comparative performance of three comorbidity scores in predicting survival after the elective repair of abdominal aortic aneurysms.

We aimed to study the discriminative power of 3 comorbidity scores for predicting 5-year survival after the elective repair of aorto-iliac aneurysms (AAA). 444 patients with AAA undergoing elective repair (33% open and 67% endovascular) between 2000 and 2020 were reviewed. The Charlson Comorbidity Index (CCI) and subsequent adjustments by Schneeweiss, Quan and Armitage, the Modified Frailty Index (MFI) and the American Society of Anesthesiologists Score (ASA) were calculated from preoperative data. Their association with 5-year survival was analyzed using Cox regression models and their discriminative power and its changes with C statistics and Net Reclassification Index (NRI). All comorbidity scores were associated with survival after adjusting by age, sex and type of surgical repair: original CCI HR=1.24, P<0.001; Schneeweiss CCI HR=1.23, P<0.001; Quan CCI HR=1.27, P<0.001, Armitage CCI HR=1.46, P<0.001, MFI HR=1.39, P<0.001 and ASA HR=1.68 (P=0.04) and 2.86 (P=0.01) for classes III and IV, respectively. Associated C statistics were of 0.64, 0.65, 0.65, 0.64, 0.61 and 0.59, respectively. Compared with the original CCI, models based on Schneeweiss CCI and Armitage CCI provided minor improvements in NRI (0.32 and 0.23), and the model based on ASA showed lower C statistics (P=0.014) and NRI (-0.30). Established comorbidity scores, such as CCI, MFI or ASA, are all associated with 5-year survival after the elective repair of AAAs, being ASA the worst of them. However, their predictive power is in no case sufficient to identify, by themselves, those patients who may not be eligible for intervention on the basis of life expectancy.

Incidence of endograft limb thrombosis in different types of endovascular aortoiliac aneurysm repair

Incidence of endograft limb thrombosis in different types of endovascular aortoiliac aneurysm repair

Effect of preservation of antegrade hypogastric flow on development of claudication following aortoiliac aneurysm repair

ObjectiveThe objective of this study was to compare the rate of development of buttock claudication in patients undergoing aortoiliac aneurysm repair with and without exclusion of antegrade hypogastric arterial flow. In the absence of convincing data, questions remain regarding the best management of hypogastric arterial flow to prevent the theoretical risk of buttock claudication. MethodsThe Veterans’ Affairs Open Versus Endovascular Repair (OVER) Cooperative Study prospectively collected information on buttock claudication. Trial participants were specifically prompted both pre- and postoperatively to report the development of claudication symptoms at several anatomic levels. Of note, trial investigators were specifically trained to occlude the trunk hypogastric arterial, preserving the anterior and posterior divisions. Bayesian survival models were created to evaluate time to development of left, right, or bilateral buttock claudication according to the presence/absence of antegrade hypogastric perfusion. ResultsA total of 881 patients from the OVER trial with information regarding status of hypogastric flow were included in the analysis. Of these, 788 patients maintained bilateral antegrade hypogastric arterial perfusion, 63 had right hypogastric coverage/occlusion, and 27 had left hypogastric coverage/occlusion, whereas 3 patients had bilateral hypogastric coverage/occlusion. Just under 5% of all patients (n = 41) developed buttock claudication. After adjustment for smoking, chronic obstructive pulmonary disease, medications, study arm, preoperative activity level, body mass index, age, and diabetes, intervention-related changes to hypogastric perfusion had no effect on time to development of buttock claudication. A Maximum A Posteriori Kullback- Leibler misfit χ2 was 14.45 with 24 degrees of freedom, resulting in a goodness of fit P-value of P = .94, indicative of a good fit. ConclusionsOVER is the largest aneurysm treatment study to prospectively collect data related to the development of claudication as well as hypogastric preservation status. Despite this, we were unable to find evidence to support the assertion that preservation of antegrade hypogastric flow decreases the rate of development of buttock claudication symptoms. The low rate of development of buttock claudication overall and in the subgroups is striking.

Abstract 12986: Internal Iliac Artery Occlusion With the Amplatzer Vascular Plug During Endovascular Repair of Large Abdominal Aortic Aneurysm

Background: Retrograde blood flow from the internal iliac artery resulting in a type II endoleak is a challenging complication of endovascular aorto-iliac aneurysm repair. Several methods have been developed to address this concern. We present a case where the Amplatzer vascular plug was used to embolize the internal iliac artery in a patient undergoing aorto-iliac stent-grafting with extension of the graft into the external iliac artery. Case: A 67-year-old male presented with abdominal pain. Abdominal contrast computed tomography confirmed a large infrarenal abdominal aortic aneurysm (AAA) measuring 100 mm across, extending into the common iliac artery on the right and the external iliac artery on the left, with perianeurysmal fat stranding indicating impending rupture. The patient was taken emergently to the operating room. Vascular access was obtained through bilateral common femoral arteries. The left internal iliac was occluded with an Amplatzer 16 mm by 12 mm vascular plug, with excellent angiographic apposition. A bifurcated aorto-iliac graft was then sequentially deployed to repair the aneurysm. Final angiography showed patent renal arteries with no endoleak. The patient was discharged home the following day. Discussion: Embolization of the internal iliac artery is indicated in endovascular aorto-iliac aneurysm repair to prevent endoleak formation. Traditionally performed with coils, the Amplatzer vascular plug has emerged as a safe and effective alternative, with the added advantage of recoverability prior to definitive release. Conclusion: Endovascular repair of an AAA must consider the complication of endoleak formation. In this case, the use of an Amplatzer vascular plug was successful in preventing a type II endoleak from the internal iliac artery. Panel A. 3D reconstruction of aneurysm anatomy; Panel B. Angiogram showing final result of endovascular repair with successful occlusion of the left internal iliac artery

Effect Of Preservation Of Antegrade Hypogastric Flow On Development Of Claudication Following Aortoiliac Aneurysm Repair

The objective of this study was to compare the rate of development of buttock claudication (BC) in patients undergoing aortoiliac aneurysm repair with and without exclusion of antegrade hypogastric arterial flow. In the absence of convincing data, questions remain regarding the best management of hypogastric arterial (HA) flow to prevent the theoretical risk of BC.

Outcomes of “Anterior Versus Posterior Divisional Branches of the Hypogastric Artery as Distal Landing Zone for Iliac Branch Devices”: The International Multicentric R3OYAL Registry

Objective: The aim of this multicentric registry was to assess the outcomes of “anteRior versus posteRior divisional bRanches Of the hYpogastric artery as distAl landing zone for iLiac branch devices (R3OYAL).” Methods: The main exposure of interest for the purpose of this study was the internal iliac artery (IIA) divisional branch (anterior vs posterior) that was used as distal landing zone. Early endpoints included technical success and adverse events. Late endpoints included survival, primary/secondary IIA patency, and IIA branch instability. Results: A total of 171 patients were included in the study, of which 50 received bilateral implantation of iliac branch devices (IBDs). This resulted in a total of 221 incorporated IIAs included in the final analysis, of which 40 were anterior divisional branches and 181 were posterior divisional branches. Technical success was high in both groups (anterior division: 98% vs posterior division: 100%, P = .18). Occurrence of any adverse event was noted in 14% of patients in both groups (P = 1.0). The overall rate of freedom from the composite IBD branch instability did not show significant differences between patients receiving distal landing in the anterior or posterior division of the IIA at 3 years (79% vs 87%, log-rank test = .215). The 3-year estimates of IBD patency were significantly lower in patients who received distal landing in the anterior divisional branch than those who received distal landing in the posterior divisional branch (primary patency: 81% vs 96%, log-rank test = .009; secondary patency: 81% vs 97%, log-rank test < .001). Conclusions: The use of the anterior or posterior divisional branches of the IIA as distal landing zone for IBD implantation shows comparable profiles in terms of immediate technical success, perioperative safety, and side-branch instability up to 3 years. However, IBD patency at 3 years was higher when the distal landing zone was achieved within the posterior divisional branch of the IIA. Clinical Impact The results from this large multicentric registry confirm that use of the anterior or posterior divisional branches of the internal iliac artery (IIA) as distal landing zone for implantation of iliac branch devices (IBD) shows comparable profiles of safety and feasibility, thereby allowing to extend the indications for endovascular repair of aorto-iliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Although mid-term rates of device durability and branch instability seem to be similar, the rates of primary and secondary IBD patency at three years was favored when the distal landing zone was achieved in the posterior divisional branch of the IIA.

Outcomes of the Gore Excluder Iliac Branch Endoprosthesis for Japanese Patients With Aortoiliac Aneurysms: A Study Based on J-Preserve Registry

Purpose: To evaluate the clinical utility of the Gore Excluder iliac branch endoprosthesis (IBE) for Japanese patients with aortoiliac aneurysms. Materials and Methods: This was a multicenter retrospective cohort study (J-Preserve Registry). Patients undergoing endovascular aortic repair using the Gore Excluder IBE for aortoiliac aneurysms between August 2017 and June 2020 were enrolled. Data pertaining to the baseline and anatomical characteristics, technical details, and clinical outcomes were collected from each institution. The primary endpoints were technical success, IBE-related complications, and reinterventions. Secondary endpoints were mortality, aneurysm size change, and reintervention during follow-up. Technical success was defined as accurate deployment of the IBE without type Ib, Ic, or III endoleaks on the IBE sides on completion angiography. A change in aneurysm size of 5 mm or more was taken to be a significant change. Results: We included 141 patients with 151 IBE implantations. Sixty-five IBE implantations (43.0%) had at least one instruction for use violation. Twenty-two patients (15.6%) required internal iliac artery (IIA) embolization for external iliac artery extension on the contralateral side. Of 151 IBE implantations, 19 exhibited IIA branch landing zones due to IIA aneurysms. Mean maximum and proximal common iliac artery (CIA) diameters were 32.9±9.9 mm and 20.5±6.9 mm, respectively. The mean CIA length was 59.1±17.1 mm. The IIA landing diameter and length were 9.0±2.3 mm and 33.8±14.6 mm. The overall technical success rate was 96.7%. There were no significant differences in IBE-related complications (2.3% vs 5.3%, p=0.86) or IBE-related reinterventions (1.5% vs 5.3%, p=0.33) between the IIA trunk and IIA branch landing groups. The mean follow-up period was 635±341 days. The all-cause mortality rate was 5.0%. There were no aneurysm-related deaths or ruptures during the follow-up. Most patients (95.7%) had sac stability or shrinkage. Conclusion: The Gore Excluder IBE was safe and effective for Japanese patients in the midterm. Extending the IIA device into the distal branches of the IIA was acceptable, which may permit extending indications for endovascular aortic aneurysm repair of aortoiliac aneurysms to more complex lesions. Clinical Impact This study suggests clinical benefits of the Gore Excluder IBE for Japanese patients, despite 43% of the IBE implantations having at least one IFU violation.

Abstract No. 82 Bridging stent graft selection for iliac bifurcated grafts: balloon vs. self-expanding stent graft outcomes in a 14-year cohort

To compare long-term outcomes of balloon-expandable stent grafts (BESG), self-expandable stent grafts (SESG) and a combination of SESG and BESG for bridge stenting with iliac bifurcated grafts (IBG) during endovascular aortoiliac aneurysm repair

Outcomes of balloon-expandable versus self-expandable stent graft for endovascular repair of iliac aneurysms using iliac branch endoprosthesis: Presented at the 2021 Vascular Annual Meeting of the Society of Vascular Surgery, San Diego, Calif, August 18-21, 2021.

Purpose The purpose of this study was to compare outcomes of internal iliac artery (IIA) stenting using balloon-expandable (BESG) or self-expandable stent grafts (SESG) during endovascular repair of aortoiliac aneurysms with iliac branch endoprosthesis (IBE; W. L. Gore, Flagstaff, Ariz).

Outcomes of Gore iliac branch endoprosthesis with internal iliac component versus Gore Viabahn VBX

ObjectiveThe Gore Excluder iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) is the only iliac branch device approved in the United States to preserve blood flow to the external and internal iliac arteries (IIAs). Some surgeons have used the Gore Viabahn VBX balloon expandable endoprosthesis (VBX; W.L. Gore & Associates) in the IIA rather than the self-expanding endograft designed for the IBE, the internal iliac component (IIC). The objective of the present study was to examine the outcomes for patients treated for aortoiliac artery aneurysms using the IBE with either the IIC or VBX stent. MethodsWe performed a retrospective, single-center review of patients treated for aortoiliac artery aneurysms using the Gore IBE device, with either the IIC or VBX stent into the IIA, from February 2016 to March 2021. The patient demographics, procedure details, 30-day morbidity and mortality, and 6-month and 1-year outcomes and mortality were analyzed. The categorical factors are summarized using frequencies and proportions. Continuous measures are summarized as the mean ± standard deviation. A significance level of P = .05 was assumed for all test results. The analyses were performed using SAS software, version 9.4 (SAS Institute, Cary, NC). ResultsA total of 62 patients (64 arteries) had undergone elective aortoiliac artery aneurysm repair with the IBE. The IIC was used exclusively in 35 cases (55%) and the VBX in 29 (45%). The patients who had received the VBX had had a higher American Society of Anesthesiologists class (P = .006). Upper extremity access was used for VBX delivery in 24.1% of the procedures. No return to the operating room was required in either group. No differences were found in technical success (IIC, 97.1%; VBX, 93.1%; P = .59), the presence of endoleak on completion (20.0% vs 6.9%; P = .17), readmission (97.1% vs 93.1%; P = .59), or mortality (1.6% vs 0%; P = .45) at 30 days. No differences were found in the requirement for any IBE reintervention after 30 days. No type Ia, Ib, or III endoleaks had occurred in either group at any follow-up point. No significant difference was found in internal iliac limb primary patency (IIC, 100%; VBX, 96.3%) between groups. A nonstatistically significant trend was found toward fewer trunk–ipsilateral leg type II endoleaks in the VBX group during follow-up. ConclusionsThese data suggest that the VBX is a reasonable substitute for the IIC, with a comparable safety and efficacy profile. Given its inherent conformability, greater range of diameters, and longer working length, the VBX stent offers expanded IIA branch options with the IBE.

Outcomes of balloon-expandable versus self-expandable stent graft for endovascular repair of iliac aneurysms using iliac branch endoprosthesis

PurposeThe purpose of this study was to compare outcomes of internal iliac artery (IIA) stenting using balloon-expandable (BESG) or self-expandable stent grafts (SESG) during endovascular repair of aortoiliac aneurysms with iliac branch endoprosthesis (IBE; W. L. Gore, Flagstaff, Ariz). MethodsWe retrospectively reviewed all consecutive patients treated for aortoiliac aneurysms using IBE between 2014 and 2020. IIA stenting was performed using either the IIA side branch SESG or a Gore VBX BESG (W. L. Gore). Indications for use of BESGs were “up-and-over” IBE technique for type IB endoleak after prior endovascular aortic aneurysm repair (EVAR), short IIA length, and need for IIA extension into divisional branches (outside instructions for use). End points included technical success, freedom from buttock claudication, primary IIA patency, and freedom from IIA branch instability (eg, branch-related death or rupture, occlusion, disconnection, or reintervention for stenosis, kink, or endoleak), freedom from type IC/IIIC endoleak, and freedom from secondary interventions. ResultsThere were 90 patients (86 males and 4 females) with a mean age of 74 ± 7 years treated by EVAR with 108 IBEs. Choice of stent was BESG in 43 and SESG in 65 targeted IIAs. BESGs were used more frequently in patients with prior EVAR (22% vs 2%; P = .003,), isolated IBEs (31% vs 2%; P < .001), and in patients with IIA aneurysms requiring stenting into divisional branches (36% vs 5%; P < .001). Technical success was similar for BESGs and SESGs (97% vs 100%; P = .40), respectively. The mean follow-up was 25 ± 16 months (range, 11-34 months). At 2 years, freedom from buttock claudication was 100% for BESG and 95 ± 3% for SESG (Log-rank 0.26), with no difference in primary patency (BESG, 100% vs SESG, 94 ± 4%; Log-rank 0.94). There were four (9%) IIA-related endoleaks in the BESG group and one (2%) in the SESG group (P = .08). Freedom from IIA branch instability was 87 ± 6% for BESG and 96 ± 3% for SESG at 2 years (Log-rank 0.043). Freedom from type IC/IIIC endoleak was 87 ± 7% for BESG and 98 ± 2% for SESG at the same interval (Log-rank 0.06). There was no difference in freedom from reinterventions for BESG and SESG (92 ± 6% vs 98 ± 2%; Log-rank 0.34), respectively. ConclusionsBESGs were used more frequently during IBE procedures indicated for failed EVAR, isolated common iliac aneurysms, and IIA aneurysms requiring extension into divisional branches. Despite these differences and BESG being used outside instructions for use, both stent types had similar primary patency, freedom from buttock claudication, and freedom from reinterventions. However, BESGs were associated with higher rates of IIA-related branch instability.

Long-term outcome results after endovascular aortoiliac aneurysm repair with the bifurcated EXCLUDER Endoprosthesis

ObjectiveTo report the long-term outcome of patients presenting with an aortic, aortoiliac, or isolated common iliac aneurysm treated with the bifurcated EXCLUDER Endoprosthesis. Furthermore, potential differences in late outcome results between the original- and low-permeability endoprosthesis were analyzed. MethodsA retrospective analysis of prospectively collected data of 182 patients who underwent endovascular aneurysm repair with the EXCLUDER Endoprosthesis between June 1998 and October 2015 in an academic, tertiary care center for aortic disease was performed. Patient follow-up was from 3 to 20 years (mean follow-up of 6.9 years). Primary end points were overall survival and reintervention-free survival. Secondary end points were device-related complications, endoleaks, and reinterventions. ResultsOverall survival at 5, 10, and 15 years was 72.8%, 42.1%, and 12.2%, respectively, with no aneurysm-related mortality and no difference in overall survival between the original- vs low-permeability endoprosthesis group (P = .617). Freedom from type I endoleak at 5 years was 94.8%. No new type I endoleak was detected beyond the 5-year follow-up mark. No type III endoleak was identified. Reintervention-free survival was 83.6%, 66.7%, and 66.7% at 5-, 10-, and 15-year follow-up, respectively. There was a significant difference in intervention-free survival between the original- vs low-permeability endoprosthesis group (P = .029) and after the 5-year follow-up mark. In addition, patients with the low-permeability endoprosthesis showed significantly fewer device-related complications (P = .002) and endoleaks (P = .005). ConclusionsEndovascular aneurysm repair using the EXCLUDER Endoprosthesis is effective and durable on long-term follow-up, with acceptably low device-related complications and reinterventions. The low-permeability endoprosthesis was associated with significantly fewer new device-related complications and endoleaks after 5 years of follow-up.