Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks.

OBJECTIVE OR BACKGROUND: To report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). METHODS: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. RESULTS: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. CONCLUSIONS: The IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U.S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥ 10mm and proximal neck angulation of ≤ 60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (>=10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Risk Factors for Development of Incisional Hernia after Aortic Aneurysm Repair: Secondary Analysis of the OVER Randomized Controlled Trial.

BACKGROUND: Since the risk of mortality from rupture is elevated, elective repair of abdominal aortic aneurysms (AAAs) is often recommended. Currently, over 80% of elective repairs are carried out using an endovascular approach. While open repair has similar late survival and fewer reintervention outcomes when compared to endovascular repair, incisional hernia is a frequent complication with morbidity and cost implications. The Open versus Endovascular Repair (OVER) trial was the largest randomized trial of endovascular versus open repair of AAA in the United States. The purpose of this study was to determine risk factors associated with incisional hernia development following AAA repair via secondary analysis of the OVER data. METHODS: This was a multisite trial conducted within the Veterans Affairs health-care system. Study participants (N = 881) were enrolled from 2002 to 2008 and followed until 2011 with additional administrative data collection until 2016. Eligible patients had AAA for which elective repair was planned and randomized 1:1 to either open or endovascular repair. Incisional hernia was a prespecified end point in the OVER protocol, specifically assessed at each protocol follow-up visit. Technical details were extracted from each operative report, repair case report form(s), and adverse event form(s). Patient demographics, comorbid conditions, reported preoperative activity level, and operative details including initial approach, blood loss, and closure methods were analyzed using Bayesian hierarchical Weibull survival regression modeling. RESULTS: Incisional hernias were recorded among 46 participants (5.2%). The average time to hernia diagnosis was 3.5 years. Of the 437 participants randomized to open treatment, 427 received an open repair including crossovers from endovascular treatment assignment. Transperitoneal repair was performed in 81%, running suture in 96%, and absorbable suture in 71% of cases. Randomization to endovascular repair was associated with reduced risk of hernia (hazard ratio [HR] 0.70, 95% credible interval [CI] 0.49-0.94). Higher activity level was associated with increased hernia risk (HR 1.39, 95% CI 1.06-1.84). Approach, suture closure techniques, body mass index, diabetes, and smoking status were not associated with increased risk of hernia development. CONCLUSIONS: Incisional hernia is a frequent complication associated with open repair of abdominal aortic aneurysm and commonly required reintervention. Endovascular repair was associated with reduced risk of hernia. Patients with increased activity experienced a higher incidence of hernia. However, no other modifiable patient, operative, or technical factors were found to be associated with hernia development.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

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.

Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

Sex and outcomes after stenting and endarterectomy in asymptomatic severe carotid stenosis patients.

OBJECTIVES: To determine if sex was an effect modifier in a pooled analysis of asymptomatic patients from CREST and ACT I. MATERIALS AND METHODS: We analyzed data from 2544 patients aged <80 with ≥70 % asymptomatic carotid stenosis randomized to CAS or CEA (nCREST = 1091; nACT-1 = 1453). The pre-specified primary endpoint in both trials was any stroke, myocardial infarction or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. The secondary endpoint was any stroke or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. RESULTS: There was no significant difference in the frequency of events for men or women between CAS and CEA for the primary or secondary endpoints. When assessing for an interaction of sex and risks between procedures, the treatment-by-sex interaction was not significant for either primary or secondary endpoints in the four-year period or the peri-procedural period. However, women had significantly fewer post-procedural events (ipsilateral stroke) with CAS than CEA (HR = 0.33, 95 % CI: 0.09-1.18) compared to men (HR = 2.09, 95 % CI: 0.78-5.61), p = 0.02 for interaction. CONCLUSIONS: In this large, pooled analysis of asymptomatic patients comparing CAS to CEA, sex did not act as an effect modifier of treatment differences in the four-year primary stroke-MI-or-death endpoint or the secondary stroke-or-death endpoint. However, during the post-procedural period men treated with CAS were at higher risk than their female counterparts.

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

OBJECTIVE: The 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. METHODS: The 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. RESULTS: A 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. CONCLUSIONS: OVER 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.