Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). METHODS: From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. RESULTS: We identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. CONCLUSIONS: Results at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

A three-year experience with the balloon expandable GORE® VIABAHN® VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND Trial.

OBJECTIVE: The EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the three-year outcomes of the VBX stent as a bridging stent-graft (BSG) for visceral vessels during branched endovascular aortic repair (BEVAR). METHODS: This prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included three-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events (SAE). RESULTS: Seventy-three patients of whom 57 (78.1%) were male with a mean age of 73 years (± 8.1) were included. At three years, 42 (57.5%) patients returned for follow-up. Overall, 223 target vessels (TV) were treated. The estimated freedom from loss of TV primary patency was 93.6%. Per target vessel primary patency rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery (SMA), 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of secondary patency was 96.8%, and freedom from target vessel instability was 94.5%. CONCLUSIONS: The VBX stent demonstrated excellent sustained results at three years with almost 94% primary patency, 97% secondary patency, and 94.5% freedom from target vessel instability. Patency in the renal arteries was lower than in the celiac trunk and SMA. The VBX stent appears to be a reliable bridging stent for target vessels in BEVAR.

Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

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

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Role of Antiplatelet Therapy in Patients Managed for Complex Aortic Aneurysms using Fenestrated or Branched Endovascular Repair.

OBJECTIVE: Despite the increasing number of fenestrated/branched endovascular aortic repair (f/bEVAR) procedures, evidence on post-operative antiplatelet therapy is lacking. This study aimed to investigate the role of single antiplatelet therapy (SAPT) vs. double antiplatelet therapy (DAPT) after f/bEVAR on 30 day and follow up outcomes. METHODS: A multicentre retrospective analysis was conducted, including f/bEVAR patients managed from 1 January 2018 to 31 December 2022. Comparative outcomes were assessed according to post-operative antiplatelet therapy. The cohort was divided into the SAPT group (acetylsalicylic acid [ASA] or clopidogrel) and DAPT group (ASA and clopidogrel). The duration of SAPT or DAPT was one to six months. Primary outcomes were 30 day death, and cardiovascular ischaemic and major haemorrhagic events. Secondary outcomes were survival and target vessel (TV) patency during follow up. RESULTS: A total of 1 430 patients were included: 955 under SAPT and 475 under DAPT. The 30 day mortality was similar (SAPT 2.1% vs. DAPT 1.5%; p = .42). Cardiovascular ischaemic events were lower in the DAPT group (SAPT 11.9% vs. DAPT 8.2%; p = .040), with DAPT being an independent protector for acute mesenteric (p = .009) and lower limb ischaemia (p = .020). No difference was found in 30 day major haemorrhagic events (SAPT 7.5% vs. DAPT 6.3%; p = .40). The mean follow up was 21.8 ± 2.9 months. Cox regression showed no cofounders on survival, with similar rates between groups (log rank p = .71). DAPT patients presented higher TV patency (SAPT 93.4%, standard error [SE] 0.7% vs. DAPT 96.6%, SE 0.7%; log rank p = .007) at thirty six months. Cox regression revealed bEVAR as a predictor of worse TV patency (hazard ratio 2.03, 95% confidence interval 1.36 - 3.03; p < .001). DAPT was related to higher patency within bEVAR patients (SAPT 87.2%, SE 2.1% vs. DAPT 94.9%, SE 1.9%; p < .001). CONCLUSIONS: DAPT after f/bEVAR was associated with lower risk of cardiovascular ischaemic events and higher TV patency, especially in bEVAR cases. No difference in major haemorrhagic events was observed at 30 days.

Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

Long-Term Outcome of Lower Extremity Bypass Surgery in Patients with Chronic Kidney Disease and Critical Limb Ischemia in Germany.

BACKGROUND: The aim of this study is to present short- and long-term outcomes after lower extremity bypass (LEB) surgery in patients with chronic limb-threatening ischemia and chronic kidney disease (CKD), differentiated by peripheral artery disease (PAD) Fontaine stage III and IV. METHODS: Retrospective analysis of anonymized data from a nationwide German health insurance company (AOK). Data from 22,633 patients (14,523 men) who underwent LEB from 2010 to 2015 were analyzed, presenting 18,271 with CKD stage 1/2, 2,483 patients with CKD stage 3, and 1,879 with CKD stage 4/5. RESULTS: Perioperative mortality (60-day mortality) was 7.2% for CKD stage 1/2, 12.4% for CKD stage 3, and 19.8% for CKD stage 4/5. Patients with PAD stage IV had significantly higher perioperative mortality (10.3%) than patients with PAD stage III (4.5%). The perioperative major amputation rate depended significantly on PAD stage IV (odds ratio [OR]: 2.57 confidence interval [CI]: 2.16-3.05, P < 0.001), the LEB level below the knee and crural/pedal (OR: 2.49 CI: 2.14-2.90, P < 0.001), CKD stage 4/5 (OR: 1.28, CI: 1.06-1.54, P = 0.009), and the presence of diabetes mellitus type 2 (OR: 1.19, CI: 1.05-1.36, P = 0.007). Kaplan-Meier estimated long-term survival of up to 9 years after surgery was 31.7% for patients with CKD stage 1 and 2, 14.3% for CKD stage 3, and only 10.1% for CKD stage 4 and 5 (P < 0.001). PAD Fontaine stage IV versus III (hazard ratio: 1.64, CI: 1.56-1.71, P < 0.001), but not bypass level, had an independent adverse influence on long-term survival. CONCLUSION: CKD and PAD stage were equally significant independent predictors of patient survival and major adverse cardiovascular events with higher PAD and CKD stages associated with less favorable long-term outcomes.

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.

Perspective or Spectacle? Teaching thoracic aortic anatomy in a mixed reality assisted educational approach- a two-armed randomized pilot study.

PURPOSE: Anatomical understanding is an important basis for medical teaching, especially in a surgical context. The interpretation of complex vascular structures via two-dimensional visualization can yet be difficult, particularly for students. The objective of this study was to investigate the feasibility of an MxR-assisted educational approach in vascular surgery undergraduate education, comparing an MxR-based teaching-intervention with CT-based material for learning and understanding the vascular morphology of the thoracic aorta. METHODS: In a prospective randomized controlled trial learning success and diagnostic skills following an MxR- vs. a CT-based intervention was investigated in 120 thoracic aortic visualizations. Secondary outcomes were motivation, system-usability as well as workload/satisfaction. Motivational factors and training-experience were also assessed. Twelve students (7 females; mean age: 23 years) were randomized into two groups undergoing educational intervention with MxR or CT. RESULTS: Evaluation of learning success showed a mean improvement of 1.17 points (max.score: 10; 95%CI: 0.36-1.97). The MxR-group has improved by a mean of 1.33 [95% CI: 0.16-2.51], against 1.0 points [95% CI: -0.71- 2.71] in the CT-group. Regarding diagnostic skills, both groups performed equally (CT-group: 58.25 ± 7.86 vs. MxR-group:58.5 ± 6.60; max. score 92.0). 11/12 participants were convinced that MxR facilitated learning of vascular morphologies. The usability of the MxR-system was rated positively, and the perceived workload was low. CONCLUSION: MxR-systems can be a valuable addition to vascular surgery education. Further evaluation of the technology in larger teaching situations are required. Especially regarding the acquisition of practical skills, the use of MxR-systems offers interesting application possibilities in surgical education.

Prevalence of relevant early complications during the first 24 h on a normal ward in patients following PACU care after medium and major surgery: a monocentric retrospective observational study.

PURPOSE: Even today, it remains a challenge for healthcare professionals to decide whether a clinically stable patient who is recovering from uncomplicated medium or major surgery would benefit from a postoperative intensive care unit (ICU) admission, or whether they would be at least as adequately cared for by a few hours of monitoring in the post-operative care unit (PACU). METHODS: In this monocentric retrospective observational study, all adult patients who (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin (DGAI) in Anästh Intensivmed (50):S486-S489, 2009) underwent medium or major surgery between 1 January 1 2014 and 31 December 2018 at the Heidelberg University Surgical Center, and (Vimlati et al. in Eur J Anaesthesiol September 26(9):715-721, 2009) were monitored for 1-12 h in the PACU, and then (De Pietri et al. in World J Gastroenterol 20(9):2304-23207, 2014) transferred to a normal ward (NW) immediately thereafter were included. At the end of the PACU stay, each patient was cleared by both a surgeon and an anesthesiologist to be transferred to a NW. The first objective of this study was to determine the prevalence of relevant early complications (RECs) within the first 24 h on a normal ward. The secondary objective was to determine the prevalence of RECs in the subgroup of included patients who underwent partial pancreaticoduodenectomy. RESULTS: A total of 10,273 patients were included in this study. The prevalence of RECs was 0.50% (confidence interval [CI] 0.40-0.60%), with the median length of stay in the PACU before the patient's first transfer to a NW being 285 min (interquartile range 210-360 min). In the subgroup of patients who underwent partial pancreaticoduodenectomy (n = 740), REC prevalence was 1.1% (CI = 0.55-2.12%). CONCLUSION: Based on a medical case-by-case assessment, it is possible to select patients who after a PACU stay of only up to 12 h have a low risk of emergency readmission to an ICU within the 24 h following the transfer to the NW. Continued research will be needed to further improve transfer decisions in such low-risk subgroups.

Genetic variants in patients with multiple arterial aneurysms.

PURPOSE: The aim of this study was to identify causal genetic variants in patients with multiple arterial aneurysms. METHODS: From a total cohort of 3107 patients diagnosed with an arterial aneurysm from 2006 to 2016, patients with known hereditary connective tissue diseases, vasculitis, or other arterial pathologies (n = 918) were excluded. Of the remaining cohort (n = 2189), patients with at least 4 aneurysms at different arterial locations (n = 143) were included. Nine blood samples of respective patients were available and derived from the institutional vascular biomaterial bank, and analyzed by whole exome sequencing (WES). Possible candidate variants were selected based on in silico predictions: (I) Truncating variants or (II) Variants that were classified as likely pathogenic (SIFT score < 0.05 or PolyPhen score > 0.9) and with low (< 0.001) or unknown gnomAD allele frequency. The human genome databases GeneCards and MalaCards were used to correlate the variants with regard to possible associations with vascular diseases. RESULTS: A total of 24 variants in 23 different genes associated with vascular diseases were detected in the cohort. One patient with eight aneurysms was heterozygous for a variant in SMAD3, for which pathogenic variants are phenotypically associated with Loeys-Dietz syndrome 3. A heterozygous variant in TNXB was found in a patient with five aneurysms. Homozygous or compound heterozygous pathogenic variants in this gene are associated with Ehlers-Danlos syndrome (classical-like). Another patient with six aneurysms carried two heterozygous TET2 variants together with a heterozygous PPM1D variant. Pathogenic variants in these genes are associated with clonal hematopoiesis of indeterminate potential (CHIP), a known risk factor for cardiovascular disease. CONCLUSION: All nine patients in this study carried variants in genes associated with vascular diseases. Current knowledge of the specific variants is insufficient to classify them as pathogenic at the present time, underlining the need for a better understanding of the consequences of genetic variants. WES should be considered for patients with multiple arterial aneurysms to detect germline variants and to improve clinical management for the individual and family members.

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.

Co-prevalence of arterial aneurysm location - a correlation analysis based on a retrospective cross-sectional observational study.

Background: The aim of this retrospective single-centre cross-sectional observational study was to investigate co-prevalence of arterial aneurysm location systematically. Patients and methods: Patients with the diagnosis of any arterial aneurysm from January 2006 to January 2016 were investigated in a single centre. Patients with hereditary disorders of connective tissue, systemic inflammatory disease, or arterial pathologies other than true aneurysms were excluded. Aneurysm locations were assessed for every patient included. For patients with at least two co-existing aneurysms, co-prevalence of aneurysm location was investigated by calculating correlation coefficients and applying Fisher's exact test. This study report is prepared according to the STROBE statement. Results: Of 3107 identified patients with arterial aneurysms, 918 were excluded. Of the remaining 2189 patients, 951 patients with at least two aneurysms were included in the study. Bilateral aneurysm combinations of paired iliac, femoral and popliteal arteries showed the highest correlation (ϕ=0.35 to 0.67), followed by bilateral combinations of subclavian (ϕ=0.36) and internal carotid (ϕ=0.38) arteries. Abdominal aortic aneurysms in combination with visceral artery aneurysms (ϕ=-0.24 to -0.12), popliteal arteries (ϕ=-0.22) and the ascending aorta (ϕ=-0.19) showed the lowest correlation, followed by the descending aorta in combination with the common iliac arteries (ϕ=-0.12 to -0.13). Conclusions: In our study sample, aneurysm co-prevalence was highly non-random. This should be considered in the context of aneurysm screening programs.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

A New Method for Common Femoral Arterial Access Using a Mixed Reality-Assisted Technique on a Phantom Model.

PURPOSE: The purpose of this study was to investigate the technical feasibility and usability of a mixed reality (MiR)-assisted common femoral arterial (CFA) access technique using a sonography-assisted registration method. MATERIALS AND METHODS: A total of 60 CFA punctures were performed on a phantom model by 2 observers. Thirty punctures were performed using MiR (MiR group) and 30 punctures were performed using a conventional sonography-guided access procedure (control group). In the MiR group, a virtual object was created based on a computed tomography (CT) angiography scan of the model and registered to the physical patient in an MiR environment utilizing a software prototype that allowed registration based on a sonography scan. Positional error assessment encompassed 4 measurements using cone beam CT scans: (1) distance of the needle tip to the centerline, (2) distance of the needle entry site from the mid-level of the ostium of the profound femoral artery, (3) angle of entry of the needle in coronal, and (4) sagittal planes. Technical success rates as well as positional errors were compared between both groups. In addition, the usability of the system was assessed according to the system usability scale (SUS). RESULTS: Technical success was 96.7% and 100% in the MiR and control groups, respectively. The median distance between the needle tip and the centerline was 3.0 (interquartile range [IQR]: 2.0-4.6) in the MiR group and 3.2 mm (IQR: 2.3-3.9) (p=0.63) in the control group. Similarly, the median distance from the needle entry site to the mid-level of the ostium of the profound femoral artery was 3.0 mm (IQR: 2.0-5.0) in the MiR group and 4.5 mm (IQR: 2.0-7.8) (p=0.18) in the control group. The median coronal angles of needle entry were 7.5° (IQR: 6-11) and 6° (IQR: 2-12) (p=0.13), and the median sagittal angles were 50° (IQR: 47-51) and 51° (IQR: 50-55) (p<0.01) in the MiR and control groups, respectively. The mean SUS score provided by both observers was 51.3. CONCLUSION: The feasibility of an MiR-assisted CFA access technique could be demonstrated on a phantom model. Further studies are needed to investigate the technique beyond phantom model experiments and in different anatomical settings. CLINICAL IMPACT: This study demonstrates the technical feasibility of a Mixed-Reality-assisted common femoral arterial access procedure on a phantom model. The positional accuracy was comparable to a conventional sonography-guided technique. However, there are several limitations that need to be resolved prior to potential implementation into clinical practice. Further studies are needed to investigate its performance beyond phantom model experiments and the prototypical application requires further technical refinement to increase its usability.

Systematic Review on Abdominal Penetrating Atherosclerotic Aortic Ulcers: Outcomes of Endovascular Repair.

PURPOSE: To systematically review existing evidence on outcomes of endovascular repair of abdominal atherosclerotic penetrating aortic ulcers (PAUs). MATERIAL AND METHODS: Cochrane Central Registry of Registered Trials (CENTRAL), MEDLINE (via PubMed), and Web of Science databases were systematically searched. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P 2020). The protocol was registered in the international registry of systematic reviews (PROSPERO CRD42022313404). Studies reporting on technical and clinical outcomes of endovascular PAU repair in 3 or more patients were included. Random effects modeling was used to estimate pooled technical success, survival, reinterventions, and type 1 and type 3 endoleaks. Statistical heterogeneity was assessed using the I2 statistic. Pooled results are reported with 95% confidence intervals (CIs). Study quality was assessed using an adapted version of the Modified Coleman Methodology Score. RESULTS: Sixteen studies including 165 patients with a mean/median age ranging from 64 to 78 years receiving endovascular therapy for PAU between 1997 and 2020 were identified. Pooled technical success was 99.0% (CI: 96.0%-100%). In all, 30-day mortality was 1.0% (CI: 0%-6.0%) with an in-hospital mortality of 1.0% (CI: 0.0%-13.0%). There were no reinterventions, type 1, or type 3 endoleaks at 30 days. Median/mean follow-up ranged from 1 to 33 months. Overall, there were 16 deaths (9.7%), 5 reinterventions (3.3%), 3 type 1 (1.8%), and 1 type 3 endoleak (0.6%) during follow-up. The quality of studies was rated low according to the Modified Coleman score at 43.4 (+/- 8.5) of 85 points. CONCLUSION: There is low-level evidence on outcomes of endovascular PAU repair. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. Recommendations with regard to treatment indications and techniques in asymptomatic PAU should be made cautiously. CLINICAL IMPACT: This systematic review demonstrated that evidence on outcomes of endovascular abdominal PAU repair is limited. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. In the context of a benign prognosis of asymptomatic PAU and lacking standardization in current reporting, recommendations with regard to treatment indications and techniques in asymptomatic PAUs should be made cautiously.

Persisting Type 2 Endoleaks Following EVAR for AAA Are Associated With AAA Expansion.

PURPOSE: To determine the evolution of abdominal aortic aneurysm (AAA) diameter in the presence of persisting type 2 endoleaks (pEL2) following endovascular abdominal aortic aneurysm repair (EVAR). MATERIALS AND METHODS: This is a retrospective, single-center, case-control study. All patients with pEL2 (pEL2 group, persisting for > 12 months) between 2004 and 2018 were identified and compared with a 1:1 age- and gender-matched control with no endoleak (control group). Primary outcome measures were freedom from AAA expansion and freedom from AAA shrinkage over time. AAA diameter measurements were performed on computed tomography angiography (CTA). Secondary outcome measures were survival, AAA-related mortality, reinterventions for pEL2, incidence of secondary type 1 endoleaks (EL1), and infrarenal aortic branch vessel anatomy. RESULTS: A total of 773 patients were treated with EVAR for AAA between 2004 and 2018. Of them, 286 patients demonstrated type 2 endoleaks (EL2) in postoperative CTA or intraoperative angiography (37%). Forty-five of 286 EL2 (15.7%) were pEL2 (pEL2 group). Freedom from AAA expansion in the pEL2 group was 100%, 96.7%, 85.2%, and 54.3% after 1, 2, 3, and 4 years, respectively, compared with 100% after 1, 2, 3, and 4 years in the control group (p<0.01). Freedom from AAA shrinkage in the pEL2 group after 1, 2, 3, and 4 years was 95.5%, 90.4%, 90.4%, and 79.1%, respectively, compared with 86.7%, 34.8%, 19.3%, and 19.3% in the control group (p<0.01). Overall survival at 1, 2, 3, and 4 years was 100%, 97.6%, 95.0% and 95.0% in the pEL2 group and 100% at 1, 2, 3, and 4 years in the control group (p=0.17). There were no AAA-related deaths in either group. Patients with pEL2 had a significantly increased number of infrarenal aortic branches (p<0.05, respectively). Eighteen patients (40.0%) in the pEL2 group underwent 34 reinterventions for pEL2, with a median follow-up (FU) of 925 days (0-4173). Clinical success was achieved in 9 patients (50.0%). Four patients (8.9%) with pEL2 developed secondary EL1 after a median FU of 1278 days (662-2121). CONCLUSION: pEL2 are associated with AAA expansion during midterm FU. Further studies are warranted to evaluate the association of AAA expansion due to pEL2 with clinical outcomes to allow recommendations with regard to treatment indications.

Long-term outcome and cancer incidence after lower extremity bypass surgery in patients with critical limb threatening ischemia.

PURPOSE: The influence of cancer development on long-term outcome after lower extremity bypass surgery in patients with critical limb threatening ischemia was investigated. METHODS: Patient survival and cancer incidence were recorded for 21,082 patients with peripheral artery disease (PAD) stage III (n = 5631; 26.7%) and stage IV (n = 15,451; 73.3%) registered with the AOK health insurance company in Germany who underwent infrainguinal bypass surgery. All patients were preoperative and in their history cancer-free. RESULTS: After a median follow-up of 44 months, 25.6% of all patients developed cancer (Kaplan-Meier estimated), with no significant differences between patients with PAD stage III and IV (cancer incidence stage III 25.7%, stage IV 25.5%; p = 0.421). In the Cox regression analysis, male gender (HR 1.885; 95% CI 1.714-2.073, p < 0.001) and age over 70 years (HR 1.399; 95% CI 1.285-1.522, p < 0.001) were significant risk factors for the development of cancer. Survival was significantly lower in stage IV (23.4%) compared to stage III (44.5%) (HR 1.720; 95% CI 1.645-1.799, p < 0.001). Cancer was a significant risk factor for overall survival in PAD stage III patients (HR: 1.326; 95% CI 1.195-1.471, p < 0.001) but not in PAD stage IV (HR 0.976; 95% CI 0.919-1.037, p = 0.434). CONCLUSION: Patients with PAD stage III have significantly better survival after infrainguinal bypass surgery compared to patients with stage IV. While cancer incidence was essential for survival in stage III, it was of no importance in stage IV.

Mixed reality for the assessment of aortoiliac anatomy in patients with abdominal aortic aneurysm prior to open and endovascular repair: Feasibility and interobserver agreement.

OBJECTIVES: The objective is to evaluate the feasibility and interobserver agreement of a Mixed Reality Viewer (MRV) in the assessment of aortoiliac vascular anatomy of abdominal aortic aneurysm (AAA) patients. METHODS: Fifty preoperative computed tomography angiographies (CTAs) of AAA patients were included. CTAs were assessed in a mixed reality (MR) environment with respect to aortoiliac anatomy according to a standardized protocol by two experienced observers (Mixed Reality Viewer, MRV, Brainlab AG, Germany). Additionally, all CTAs were independently assessed applying the same protocol by the same observers using a conventional DICOM viewer on a two-dimensional screen with multi-planar reconstructions (Conventional viewer, CV, GE Centricity PACS RA1000 Workstation, GE, United States). The protocol included four sets of items: calcification, dilatation, patency, and tortuosity as well as the number of lumbar and renal arteries. Interobserver agreement (IA, Cohen's Kappa, κ) was calculated for every item set. RESULTS: All CTAs could successfully be displayed in the MRV (100%). The MRV demonstrated equal or better IA in the assessment of anterior and posterior calcification (κMRV: 0.68 and 0.61, κCV: 0.33 and 0.45, respectively) as well as tortuosity (κMRV: 0.60, κCV: 0.48) and dilatation (κMRV: 0.68, κCV: 0.67). The CV demonstrated better IA in the assessment of patency (κMRV: 0.74, κCV: 0.93). The CV also identified significantly more lumbar arteries (CV: 379, MRV: 239, p < 0.01). CONCLUSIONS: The MRV is a feasible imaging viewing technology in clinical routine. Future efforts should aim at improving hologram quality and enabling accurate registration of the hologram with the physical patient.