Sac Regression Research Articles

Open aneurysmorraphy following branched and fenestrated endovascular repair of complex thoracic aneurysms

ObjectiveWe present a review of our hybrid management (endovascular + open surgery) of large thoracic aortic aneurysms (>80 mm). The strategy comprises a primary endovascular repair using thoracic endovascular aortic repair (TEVAR), and/or fenestrated and branched endografts (FBEVAR), followed by open thoracotomy and aneurysmorraphy, specifically without the need for aortic cross-clamping. MethodsWe performed a retrospective review of all patients who had undergone aneurysmorraphy via thoracotomy following TEVAR and FBEVAR in two high-volume aortic centers between December 2017 and March 2024. We performed aneurysmorraphy in two clinical situations: (1) in the setting of a planned staged treatment, shortly after TEVAR or FBEVAR in young patients with aneurysm diameter >100 mm; and (2) as a secondary intervention during follow-up for patients with persistent sac enlargement and aneurysm diameters >80 mm. The primary end points were 30-day survival and aneurysm-related mortality during follow-up. Secondary endpoints were sac size evolution, perioperative and postoperative complications, freedom from further reintervention, and late aortic complications. ResultsTwelve patients underwent aneurysmorraphy following TEVAR and/or FBEVAR during the study period. Mean patient age was 60 ± 12 years, and the mean sac diameter before thoracotomy was 101 ± 25 mm. Endovascular embolization of intercostal arteries prior to aneurysmorraphy was performed in four patients. The 30-day survival rate was 100%. During the mean follow up period of 21 months, two patients died—one of COVID and another of intra-cerebral hemorrhage. No aneurysm-related mortality occurred, and sac regression was achieved in all patients except one experiencing aortic growth below the aneurysmorraphy. ConclusionsThis study demonstrates that thoracic aneurysmorraphy performed after TEVAR and FBEVAR for complex thoracic aneurysms is a safe and effective technique. This procedure allows the eradication of endoleaks and an immediate sac volume reduction, which prevents aorta-bronchial or esophageal fistulation and secures the endovascular repair; the reduction of the aneurysm mass effect restores normal lung parenchyma expansion. This hybrid management strategy drastically reduces the morbidity associated with standard open surgery performed for thoracic endograft explantation.

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

To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). This is a prospective, multicenter, investigational device exemption clinical trial at 31 US. 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. There were 80 patients enrolled (88.8% male, mean 73.5± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0mm (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 (≥10mm), or aneurysm ruptures. At 36months, 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 36months underwent reintervention. 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.

TREO Aortic Endograft Demonstrates Superior Aneurysmal Sac Regression Over Mid-Term Follow-Up

IntroductionAneurysmal sac regression is a predictor of long-term outcomes after endovascular aneurysm repair (EVAR). This study aimed to compare a large cohort of TREO and non-TREO endografts over a mid-term follow-up and compare abdominal aortic aneurysm sac regression. The hypothesis was that TREO endografts have an increased sac regression by 24 mo. MethodsThis is a retrospective analysis of all EVARs completed at a single institution between 2015 and 2024. Clinical and imaging data were collected from an institutional database and patients’ records. The analysis included all TREO and age, sex, anticoagulation use and current smoking-matched non-TREO endografts that satisfied anatomic indications for use of the TREO graft. The primary outcomes were sac regression at 12 and 24 mo, and secondary outcomes were rates of mortality, endoleak, and reintervention. ResultsTwenty-one TREO grafts were matched to 68 non-TREO grafts. The groups were similar in demographics, comorbidities, and preoperative anatomy. Preoperative abdominal aortic aneurysm sac size was larger in the TREO cohort. The mean reduction in sac size in mm was greater in the TREO cohort compared to the non-TREO cohort (−12.6 ± 8.95 versus −7.83 ± 7.74 mm, P = 0.039) over the study period. Cox regression analysis identified the TREO stent graft to be associated with 1-y sac regression (hazard ratio = 2.42, P = 0.019). The incidence of all-cause endoleaks, reintervention, and mortality were similar between cohorts. ConclusionsThese findings suggest that the TREO endograft offers better mid-term outcomes with respect to sac regression with no differences in the incidence of endoleak, mortality, or reintervention.

Beta Blockers are Associated with Increased Mortality Without a Decrease in Reinterventions After Endovascular Abdominal Aortic Repair (EVAR)

ObjectivePredictors of sac behavior after EVAR and the impact of sac behavior on long-term survival are not well known. There are limited multicenter trials studying the impact of beta-blockers (BB) on sac behavior. Beta-blockers have consistently failed to show a benefit on AAA sac regression in patients with connective tissue disorders and the general population. This study aims to assess the association between BBs and sac behavior after endovascular aortic aneurysm repair (EVAR). MethodsPatients undergoing EVAR registered in Vascular Quality Initiative (VQI) (2003-2021) stratified by BB and no BB on discharged after an index procedure were assessed at follow-up of 30-days and 1-year. The primary outcomes included mortality and reintervention at 30-days and 1-year. The causes of reintervention were also studied at the defined time endpoints. Categorical and continuous variables were analyzed separately for association between the two groups. A p-value of <0.05 was considered statistically significant. ResultsA total of 50,411 patients, stratified by BB (28,866; 57.3%), and No BB (21,545; 42.7%) were studied. Patients with hypertension, diabetes, COPD, coronary artery disease, prior history of coronary artery bypass graft or percutaneous coronary intervention, prior angioplasty or stent, lower extremity bypass, carotid surgery, major amputation, and smokers were more likely to be on a BB at the time of discharge (p<0.05). There was no significant difference in reinterventions when comparing patients with and without BB (p=0.061). At 30-day follow up, there was no significant difference between the two groups for any cause of reintervention. At 1-year follow up, patients on BB were less likely to need reintervention for graft occlusion (no BB 18.70%, BB 11.77%, p=0.002). There was no significant difference in reintervention for all other causes at 1-year follow up. There was an increase in 30-day (no BB 0.20%, BB 0.33%, p=0.007) and 1-year mortality (no BB 2.35%, BB 3.19%, p<0.001) in patients on beta-blockers. A time to event adjusted analysis based on Cox proportional hazard model revealed a 26% higher risk of 1-year mortality for patients on BB (HR:1.26 [1.10-1.41] p<0.001) ConclusionDespite theoretical benefits of beta-blockers on aneurysm behavior, review of the largest national vascular surgery database shows that patients on beta-blockers do not have lower incidence of endovascular reinterventions after EVAR while additionally showing a higher mortality in this patient population.

Association between diabetes status and long-term outcomes following open and endovascular repair of infrarenal abdominal aortic aneurysms

ObjectiveCurrent literature reports conflicting findings regarding the effect of diabetes mellitus (DM) on outcomes of abdominal aortic aneurysm (AAA) repair. In this study we examined the effect of DM and its management on outcomes after open AAA repair (OAR) and endovascular AAA repair (EVAR). MethodsWe identified all patients undergoing OAR or EVAR for infrarenal AAA between 2003 and 2018 in the Vascular Quality Initiative registry data linked with Medicare claims. We excluded patients with missing DM status. Patients were stratified by their preoperative DM status, and then further stratified by DM management: dietary, noninsulin antidiabetic medications (NIMs), or insulin. Outcomes of interest included 1-year aneurysm sac dynamics, 8-year aneurysm rupture, reintervention, and all-cause mortality. These outcomes were analyzed with the χ2 test, Kaplan-Meier methods, and multivariable Cox regression analyses. ResultsWe identified 34,021 EVAR patients and 4127 OAR patients, of whom 20% and 16% had DM, respectively. Of all DM patients, 22% were managed by dietary management, 59% by NIM, and 19% by insulin. After EVAR, DM patients were more likely to have stable sacs, whereas non-DM patients were more likely to have sac regression at 1 year. Compared with non-DM, DM was associated with a significantly lower risk for 8-year rupture in EVAR (EVAR hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.51-0.92). Compared with non-DM, NIM was associated with lower risk of rupture within 8-years for both EVAR and OAR (EVAR HR, 0.64; 95% CI, 0.44-0.94; OAR HR, 0.29; 95% CI, 0.41-0.80), whereas dietary control and insulin had a similar rupture risk compared with non-DM. However, compared with non-DM, DM was associated with a higher risk of 8-year all-cause mortality after EVAR and OAR (DM vs non-DM: EVAR HR, 1.17; 95% CI, 1.11-1.23; OAR HR, 1.16; 95% CI, 1.00-1.36). After further DM management substratification, compared with non-DM, management with NIM and insulin were associated with a higher 8-year mortality in EVAR and OAR (EVAR: NIM HR, 1.12; 95% CI, 1.05-1.20; insulin: HR, 1.40; 95% CI, 1.26-1.55; OAR: NIM HR, 1.27; 95% CI, 1.06-1.54; and insulin: HR, 1.57; 95% CI, 1.15-2.13). Finally, there was a similar risk of reintervention across the DM and non-DM populations for EVAR and OAR. ConclusionsDM was associated with a lower adjusted risk of rupture after EVAR as well as OAR in patients managed with NIM. Nevertheless, just as in patients without AAA, preoperative DM was associated with a higher adjusted risk of all-cause mortality. Further study is needed to evaluate for differences in aneurysm-related mortality between DM and non-DM patients, and studies are planned to evaluate the independent effect of NIM on aneurysm-related outcomes.

Early Experience With the Iliac Branch Endoprosthesis (IBE) in Managing Iliac Aneurysms.

Aim The objective of this study is to evaluate the feasibility of using iliac branch endoprosthesis (IBE) devices and to examine their short-term outcomes. Materials and methods This was a descriptive, retrospective observational study involving 15 patients diagnosed with either aortoiliac or isolated iliac artery aneurysms and treated with an IBE device. Data were collected for patients who received IBE devices at Glan Clwyd Hospital in Rhyl, United Kingdom, from February 2020 to May 2023. Results Most patients presented with asymptomatic aneurysms; 86.7% (n = 13) had bilateral common iliac artery (CIA) aneurysms. The mean diameter of the CIA was 38.7 ± 8.8 mm, and the mean diameter of the abdominal aortic aneurysm (AAA) was 39.8 ± 23 mm. For the indications of IBE use, 60% (n = 9) of the patients had iliac aneurysms reaching the intervention threshold, 20% (n = 3) had AAA reaching the threshold, and 20% (n = 3) had aortoiliac aneurysms reaching the threshold. The majority of patients underwent bilateral femoral access (86.7%; n = 13), while 13.3% (n = 2) required both femoral and brachial access. Technical success was achieved in all cases. Aside from 20% (n = 3) of cases where the sac size remained static, the majority of patients (80%; n = 12) experienced sac regression. All patients were free from buttock claudication. A type II endoleak was observed in 33.3% (n = 5) of patients. No reinterventions were reported. The mean primary patency was 30.9 ± 0.7 months, and the follow-up period ranged from 12 to 36 months. Conclusions IBEs are an effective medical device, demonstrating a high rate of technical success, minimal need for additional procedures, and a low incidence of complications while maintaining a satisfactory rate of primary patency.

358 Driving Endovascular Solutions for Abdominal Aortic Aneurysms: A 9-Year International Experience with the Fenestrated Anaconda Endograft

Abstract Aim Endovascular aortic repair (EVAR) has become the mainstay treatment for abdominal aortic aneurysms and is associated with optimal outcomes. However, there remains a risk of complications requiring reintervention. Several EVAR devices exist commercially, yet, the Fenestrated Anaconda™ (FA) has demonstrated outstanding results. This study aims to presents a 9-year cross-sectional international analysis of custom-made FA outcomes. Method Patient data was collected prospectively in 27 countries over 9 years and stored in an international registry. This was later retrieved and analysed retrospectively. Results A total of 5058 patients received the FA endograft. This was indicated either due to complex anatomy for competitor devices (n = 3891, 76.9%) or based on surgeon preference (n = 1167, 23.1%). Overall, the FA was utilised to rescue 2987 (59%) failed previous EVARs. The predominant device category and proximal ring stent configuration were bifurcate (83.6%) and standard (64.5%). Most devices were delivered within 6-8 weeks (55.4%) of diagnosis and 95% came with a prototype. As for clinical outcomes, both survival and TVP were 100% during the first 6 postoperative years but dropped to 77.1% and 81% thereafter. A sac regression of 0-30% was observed in 4772 (94.3%) patients over the first 4 years, whilst all patients had 20-45% sac regression in years 5-9 of follow-up. No cases of endograft migration or reintervention were recorded. All clinical outcomes were further stratified by indication group. Conclusions The custom-made FA endograft features a highly unique and innovative design which enables it to treat highly complex aortic anatomy while achieving favourable results.

Sex Related Differences in Perioperative Outcomes after Complex Endovascular Aortic Aneurysm Repair

Prior studies suggest female sex is associated with worse outcomes after complex endovascular aortic aneurysm repair (EVAR) due to anatomic differences. Therefore, we aimed to compare 30-day perioperative and long-term outcomes after complex EVAR by sex. A single-center retrospective review of consecutive elective and emergent complex EVAR with company-manufactured devices, laser fenestration, snorkel/periscope, or octopus technique was performed from 2012-2023. The primary outcome was a composite endpoint of any major adverse event (MAE), new-onset dialysis, or death within 30days. Secondary 30-day technical and long-term outcomes were also assessed. 293 patients (57 females, 19%), mean age 74years, underwent complex EVAR with commercially available Zenith fenestrated endovascular graft (71%), p-Branch (2%), laser fenestration (8%), snorkel/periscope (16%), or octopus (2%) techniques. Females had significantly different aneurysm-related anatomic characteristics compared to males, including smaller aneurysm diameters (58±7.2 vs. 64±13.2mm, P<0.001), more involved aneurysm extent (21.7% vs. 9.8% thoracoabdominal, P=0.04), increased renal artery calcification (43.9% vs. 27.1%, P=0.01), and smaller iliac (7.6±1.3 vs. 8.9±1.8mm, P<0.01). Operative outcomes were similar; however, females had a greater need for adjunctive access conduits (21.1% vs. 10.6%, P=0.04), lower technical success (91.2% vs. 98.3%, P=0.02), and longer median [interquartile range] length of stay (3.0 [4.0] vs. 2.0 [2.5] days, P<0.001). The composite 30-day outcome of any MAE, new dialysis, or death was not significantly different (15.8% females vs. 11.4% males, P=0.37). Technical endpoints including 30-day rates of target artery occlusion and type 1 or 3 endoleak were also similar between groups. At mean follow-up of nearly 3years, females had significantly lower rate of renal function decline (16.0% vs. 41.9%, P<0.001), but no differences were found in long-term all-cause mortality, aneurysm sac regression, reintervention, or total follow-up imaging studies between groups. Females undergoing complex EVAR had challenging anatomy with higher intraoperative target artery occlusion, conduit use, and longer length of stay. However, 30-day and long-term outcomes were similar, suggesting females can undergo complex EVAR with high technical success and comparable perioperative outcomes to males. Females appeared to have protection from long-term renal function decline, which will be important for future study.

Urgent Candy-Plug technique for distal false lumen occlusion in chronic aortic dissection

ObjectiveThis study aimed to assess the impact of urgency on early and midterm outcomes of the Candy-Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection. MethodsThe CP registry was reviewed, and patients were categorized into elective and urgent/emergent groups for analysis. End points included technical success, clinical success, early (30-day) computed tomography angiography findings, early (30-day) mortality, adverse events, and aortic remodeling in patients with available computed tomography angiography follow-up and reintervention. ResultsA total of 155 patients received a custom-made CP, of whom 32 patients (44% male, mean age 61 ± 9 years) were treated urgently and 123 patients (63% male, mean age 62 ± 11 years) electively. The primary CP rate was higher in the urgent group (28/32, 88%, in the urgent group vs 96/123, 78%, in the elective group, P = .051). The mean contrast volume was higher in the urgent group (157 ± 56 mL in the urgent group vs 130 ± 71 mL in the elective group, P = .017). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25 of 32 (78%) patients in the urgent group vs 113 and 123 (92%) in the elective group (P = .159). The early mortality rate was 13% (4 of 32 patients) in the urgent group vs 1% (1 of 123 patients) in the elective group (P = .120). There was no statistically significant difference regarding the early adverse events between the urgent and elective CP groups. Early aortic-related reinterventions were required in 6 of 32 (19%) patients in the urgent group vs 6 of 123 (5%) in the elective group (P = .094). Thoracic aortic aneurysm sac regression was lower in the urgent group (5/28, 18%, in the urgent group vs 63/114, 55%, in the elective group, P = .001). Stable thoracic aortic aneurysm sac was higher in the urgent group (22/28, 79%, in the urgent group vs 47/114, 41%, in the elective group, P = .000). An increase in thoracic aortic aneurysm sac occurred in 1 of 28 (4%) patients in the urgent group vs 4 of 114 (4%) patients in the elective group (P = .096). ConclusionsThe urgent use of the CP technique for distal FL occlusion in aortic dissection was feasible and effective. The decrease in aortic FL sac diameter may be affected by the urgent use of CP due to limited sizing availability. However, it achieved a high rate of aortic remodeling.

Postdissection aortic aneurysm sac enlargement after fenestrated and branched endovascular aortic aneurysm repair

ObjectivesAneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement. MethodsFBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes. ResultsAmong 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival. ConclusionsAneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement.

Endovascular Treatment of Abdominal Aortic Aneurysm: Impact of Diabetes on Endoleaks and Reintervention.

Background: Diabetes has a protective effect on abdominal aortic aneurysms (AAAs); however, there are contrasting reports on the impact of diabetes on endovascular aortic repair (EVAR) outcomes, endoleaks (ELs) being the major negative outcome. The present study characterizes ELs and their outcomes in AAA patients, diabetic or not. Methods: This single-center, retrospective, comparative study was carried out on 324 AAA patients who underwent elective EVARs between 2007 and 2016 at the University Hospital of Liège (Belgium). The primary endpoint was the incidence and effect of ELs on the evolution of the aneurysmal sac; the secondary endpoints were surgical reintervention and mortality rate. Diabetic and non-diabetic patients were compared with respect to various risk factors by logistic regression, while a Cox regression was used to analyze survival. Results: In AAA patients meeting the inclusion criteria (n = 248), 23% were diabetic. EL incidence was comparable (p = 0.74) in diabetic (38.7%) vs. non-diabetic (43.9%) patients. EL risk factors were age (HR = 1.04, p = 0.014) and fibrate intake (HR = 3.12, p = 0.043). A significant association was observed between ELs and aneurysm sac enlargement (p < 0.001), regardless of group (p = 0.46). Aneurysm sac regression per month for non-diabetic patients was -0.24 ± 0.013, while for diabetics it was -0.18 ± 0.027 (p = 0.059). Dyslipidemia (HR = 3.01, p = 0.0060) and sulfonylureas (HR = 8.43, p = 0.043) were associated with shorter EL duration, while diabetes (HR = 0.080, p = 0.038) and beta blockers (HR = 0.46, p = 0.036) were associated with longer EL duration. The likelihood of reoperation decreased with more recent surgery (OR = 0.90, p = 0.040), regardless of diabetic status. All-cause mortality was higher for the non-diabetic group (45.5% vs. 26.3%, p = 0.0096). Conclusions: Endoleak occurrence is a known risk factor for sac expansion. In diabetic patients, endoleaks lasted longer, and regression of the aneurysm sac tended to be slower. The number and type of reintervention was not related to the diabetic status of AAA patients, but overall survival was higher in patients with diabetes.

The Effect of One Year Aneurysm Sac Dynamics on Five Year Mortality and Continued Aneurysm Sac Evolution

One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with a greater all cause mortality risk in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated between the one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was the five year all cause mortality rate. Kaplan-Meier estimates for freedom from all cause death were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all cause death. At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, the five year all cause mortality rate was 20%, compared with 28% for stable sac (p= .007) and 37% for the sac expansion (p= .010) cohorts. After adjustment, the sac expansion and stable sac cohorts were associated with a greater all cause mortality rate (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p= .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p= .019). In the ENGAGE Global Registry, the one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings using data from vascular registries. Sac regression could become the new standard for success after EVAR.

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

ObjectivesThe early postoperative benefits of EVAR have been well established but questions remain regarding its durability at mid and long-term timepoints. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study utilized the GREAT Registry to explore the 5-year outcomes with the GORE® EXCLUDER® device in real-world clinical circumstances. MethodsAll patients within the GREAT registry that underwent an infrarenal AAA repair with the GORE® EXCLUDER® device were included in this study. Baseline characteristics and demographic information of the cohort were collected. Endpoints included mortality (all-cause and aneurysm related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events (MACE). ResultsA total of 3216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson comorbidity index score of ≥ 5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Post-operative MACE occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. ConclusionsThis study supports the durability of the GORE® EXCLUDER® device though 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter though 5 years.

Predictive Factors for Iliac Limb Occlusions After Endovascular Abdominal Aneurysm Repair: Determined from Aortoiliac Anatomy, Endovascular Procedures, and Aneurysmal Remodeling.

Iliac limb occlusion (ILO) is a serious complication of endovascular abdominal aneurysm repair (EVAR). This study aimed to identify predictive factors for ILO derived from aortoiliac morphology, endovascular procedure-related parameters, and aneurysmal remodeling characteristics. Patient demographics, pre-EVAR anatomical characteristics of the aneurysm, endovascular procedure details, and post-EVAR aneurysmal remodeling outcomes were analyzed and compared using univariate analysis. Statistically significant factors were subsequently subjected to Cox regression and Kaplan-Meier analyses. Between January 2013 and April 2022, 66 patients were included in this study. Fourteen patients presented with ILO and were compared with 52 control patients with patent endograft limb over at least 1-year of follow-up. The tortuosity indices of the common iliac artery (CIA) and endograft iliac limb to vessel oversizing were significantly larger in the ILO group than in the patent endograft limb group. The CIA index of tortuosity ≥1.08, and endograft iliac limb to vessel oversizing ≥18.8% were independent predictors for ILO. During the follow-up of all patients, the proximal aortic neck and CIA diameters increased, aneurysm sac diameter decreased, and aortic neck and aortic length increased. The aortoiliac length increased over time in patients with patent endograft limb but not in patients with ILO. A change in the lowest renal artery-left iliac bifurcation distance ≦0.07 mm increased the risk of ILO. ILO is predisposed to occur when the CIA index of tortuosity ≥1.08 and endograft iliac limb to vessel oversizing ≥18.8% are present. Significant aortoiliac remodeling, including proximal aortic neck dilatation, neck straightening, aneurysmal sac regression, iliac artery enlargement, and aortic lengthening, occurs after EVAR. Aortoiliac elongation was observed in patients with patent endograft limb, but not in patients with ILO. ILO was associated with a change in the lowest renal artery-left iliac bifurcation from the postoperative measurements ≦ 0.07 mm.

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience.

Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013-1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836-0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.

Early Clinical Results From the Japanese Prospective Multicenter Study to Evaluate Zenith Alpha Abdominal Stent Graft for Abdominal Aortic Aneurysm (JUSTICE) Registry Demonstrate Acceptable Limb Patency at 12 Months.

Recent reports of the Zenith Alpha abdominal endovascular graft (Zenith Alpha AAA, Cook, Inc., Bloomington, Indiana) have demonstrated an unexpectedly high incidence of limb graft occlusion (LGO). The purpose of this study was to prospectively evaluate the performance of the Zenith AAA in Japan, with a specific focus on LGO. All endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms performed using the Zenith Alpha AAA from July 2020 to October 2021 in 23 Japanese hospitals were prospectively evaluated. All computed tomographic images were analyzed in the core laboratory. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reintervention were excluded as late complications. During the study period, 147 EVARs were performed using the Zenith Alpha AAA. The mean patient age was 76.5±7.7 years, 84.4% of patients were male, and the mean aneurysm diameter was 52.4±9.2 mm. Instruction-for-use violations were observed in 76 patients (51.7%), primarily associated with a severely angulated proximal neck (>60°). There were six intraoperative complications and 62 additional intraoperative treatments reported, most of which involved preemptive coil embolization of the inferior mesenteric artery (37 cases). Technical success, defined as the absence of type 1 or 3 endoleaks on final angiography, was achieved in 99.3% of patients. At 12 months, there was only one case of type 1/3 endoleak (0.8%) and one aneurysm sac enlargement exceeding 5 mm (0.8%); however, a high incidence of type 2 endoleaks was observed in 35.2% of patients, and aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients. Nine late complications were observed, and the rate of freedom from late complications at 12 months was 93.5%, encompassing four LGOs and one limb graft stenosis (3.4%). In contrast to recent reports, our Japanese multicenter prospective study demonstrated satisfactory early clinical results, including an acceptable LGO rate, for the low-profile Zenith Alpha AAA. Long-term follow-ups will be performed to confirm the persistence of these outcomes. This study prospectively evaluated the performance of 147 Zenith Alpha AAAs used for endovascular aneurysm repair with core-lab adjudication focusing especially on limb graft occlusion (LGO). At 12 months, aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients, and there was only one type 1/3 endoleak, one aneurysm sac enlargement (>5 mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg." 5mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg.

Effectiveness and Safety of Endoanchors in Abdominal and Thoracic Endovascular Aneurysm Repair: A Systematic Review and Meta-analysis

Purpose: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Materials and methods: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. Results: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). Conclusions: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. Clinical Impact Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

Midterm outcomes of endovascular repair for abdominal aortic aneurysm using the cuff-first technique to prevent type II endoleaks

ObjectiveThe aim of this study was to evaluate the initial and midterm outcomes of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) using the cuff-first technique (CFT) to prevent type II endoleak (T2EL). MethodsCFT involves deploying an aortic cuff inside the AAA to cover the ostium of the aortic side branch vessels before deploying the main body. We performed a retrospective review of all patients undergoing EVAR with CFT or side branch embolization (SBE) for AAAs at The Jikei University Hospital between 2016 and 2022. Primary endpoint was the rate of aneurysm sac shrinkage. Secondary endpoints were procedure time, radiation exposure, technical and clinical success rates, occurrence of T2EL, and freedom from reintervention or aneurysm-related death. ResultsOf 406 patients who underwent EVAR for AAAs, CFT was utilized in 56 (CFT group) and SBE in 35 (SBE group); all 91 patients were included in this study. There were no differences in patient demographics between groups, but there were differences in patency rate of the inferior mesenteric artery and absent intraluminal thrombus. The technical success rate per target vessel in the CFT and SBE group was 97.8% and 91.8%, and the clinical success rate was 91.0% and 100%, respectively. The median procedure time was shorter for CFT than for SBE: CFT, 10 (interquartile range [IQR], 6-14) minutes vs SBE, 25 (IQR, 18.5-45) minutes; P < .05), and median radiation exposure was lower for CFT than for SBE (CFT, 1455 (IQR, 840-2634) mGy vs SBE, 2353 (IQR, 1552-3586) mGy; P < .05). During the median follow-up of 25 months (IQR, 12.5-47 months), sac shrinkage occurred at similar rates in both groups (CFT, 37.5% vs SBE, 40.0%; P = .812), and there were no differences in freedom from reintervention (CFT, 96.2% and 91.4% at 12 and 36 months vs SBE, 100% and 89.5% at 12 and 36 months; log-rank P = .761) and freedom from aneurysm-related death (100% at 36 months in both groups; log-rank P = .440). The odds ratio of CFT vs SBE for sac regression was calculated by adjusting for inferior mesenteric artery patency and absent intraluminal thrombus, resulting in no statistical significance (odds ratio, 1.231; 95% confidence interval, 0.486-3.122). ConclusionsCFT is feasible with a shorter procedure time and lower radiation exposure than SBE and comparable mid-term outcomes, including sac shrinkage rate, compared with SBE. We believe that CFT, if anatomically suitable, is an alternative to SBE for the prevention of T2EL during EVAR.

Endosutured Aneurysm Repair of Abdominal Aortic Aneurysms with Short Necks Achieves Acceptable Midterm Outcomes—Results from the Peru Registry

IntroductionThe study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair (ESAR) using the Heli-FX EndoAnchor system. MethodsThis is a retrospective study of prospectively collected data from nine vascular surgery departments between June 2010 - December 2019, including treated AAAs with neck lengths ≤ 10mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each centre’s practice. There were two subgroups further assessed according to neck length, A (≥4 and < 7mm) and B (≥7 and ≤10mm). The main outcomes analysed were technical success, freedom from type Ia endoleaks (TIaEL), sac size increase, all-cause (ACM) and aneurysm related mortality (ARM). Results76 patients were included in the study, 17 fell into Subgroup A and 59 into subgroup B. Median follow-up for the cohort was 40.5 (IQR 12-61) months. A median of 6 (IQR 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (p=0.534) for subgroups A and B respectively. Six out of ten (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for subgroup A and 88% at both intervals in subgroup B (p=0.545). In total, there were 7 (9.2%) patients presenting with type Ia endoleaks over the entire study period. Two (11.8%) in subgroup A and 5 (8.5%) in subgroup B (p=0.679). There were more patients with sac regression in subgroup B (subgroup A=6 - 35.3% versus subgroup B=34 - 57.6%, p=0.230) with no statistical significance. ACM was 19 (25%) patients, with no difference (4 – 23.5% versus 15 – 25.4%, p=0.874) between subgroups; whereas ARM occurred in one patient from subgroup A and 3 from subgroup B. ConclusionsThis study demonstrates reasonable outcomes for patients with short-necked AAAs treated by ESAR in terms of type Ia endoleaks up to 5 year follow up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

Incidence of endoleak type IA in patients undergoing chimney endovascular aortic repair (ChEVAR) vs. standard endovascular repair.

Almost half of endovascular aortic aneurysm repair (EVAR) procedures are performed in hostile anatomy, increasing the risk of procedure related complications such as type IA endoleaks, which may be prevented with the chimney technique in EVAR (ChEVAR). Our aim is to describe the differential characteristics between EVAR in favorable anatomy and ChEVAR in hostile necks. A cohort of patients with infrarenal abdominal aortic aneurysms (AAA) that were treated with EVAR or ChEVAR were included. The primary outcome was the incidence of type IA endoleak. Secondary outcomes were the rate of chimney occlusion, reintervention, migration, rupture, acute limb ischemia, sac growth, and aneurysm-related mortality during the follow-up period. . With a median follow-up of 11.5 months, 79 patients were treated with EVAR and 21 with ChEVAR. The overall age was 76.49 ± 7.32 years old, and 82% were male. The ChEVAR cohort had a higher prevalence of tobacco use than the EVAR cohort (38.1% vs. 17.7%, p = 0.041), and a shorter neck (7.88 mm ± 5.73 vs 36.28 mm ± 13.73, p<0.001). There were no differences in type IA endoleak incidence between the groups (a single endoleak type IA in the EVAR group, p = 0.309). One patient experienced an asymptomatic chimney occlusion in the ChEVAR group, and another patient required a reintervention due to chimney occlusion. Sac regression and reinterventions were not different between groups. There were no migration, rupture, acute limb ischemia, or aneurysm-related mortality events. . In patients with abdominal aortic aneurysms, ChEVAR in hostile necks had similar event rates to EVAR in favorable necks.