Use of Artificial Intelligence With Deep Learning Approaches for the Follow-up of Infrarenal Endovascular Aortic Repair.

INTRODUCTION: Endoleaks represent one of the main complications after endovascular aortic repair (EVAR) and can lead to increased re-intervention rates and secondary rupture. Serial lifelong surveillance is required and traditionally involves cross-sectional imaging with manual axial measurements. Artificial intelligence (AI)-based imaging analysis has been developed and may provide a more precise and faster assessment. This study aims to evaluate the ability of an AI-based software to assess post-EVAR morphological changes over time, detect endoleaks, and associate them with EVAR-related adverse events. METHODS: Patients who underwent EVAR at a tertiary hospital from January 2017 to March 2020 with at least 2 follow-up computed tomography angiography (CTA) were analyzed using PRAEVAorta 2 (Nurea). The software was compared to the ground truth provided by human experts using Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), and Positive Predictive Value (PPV). Endovascular aortic repair-related adverse events were defined as aneurysm-related death, rupture, endoleak, limb occlusion, and EVAR-related re-interventions. RESULTS: Fifty-six patients were included with a median imaging follow-up of 27 months (interquartile range [IQR]: 20-40). There were no significant differences overtime in the evolution of maximum aneurysm diameters (55.62 mm [IQR: 52.33-59.25] vs 54.34 mm [IQR: 46.13-59.47]; p=0.2162) or volumes (130.4 cm3 [IQR: 113.8-171.7] vs 125.4 cm3 [IQR: 96.3-169.1]; p=0.1131) despite a -13.47% decrease in the volume of thrombus (p=0.0216). PRAEVAorta achieved a Se of 89.47% (95% confidence interval [CI]: 80.58 to 94.57), a Sp of 91.25% (95% CI: 83.02 to 95.70), a PPV of 90.67% (95% CI: 81.97 to 95.41), and an NPV of 90.12% (95% CI: 81.70 to 94.91) in detecting endoleaks. Endovascular aortic repair-related adverse events were associated with global volume modifications with an area under the curve (AUC) of 0.7806 vs 0.7277 for maximum diameter. The same trend was observed for endoleaks (AUC of 0.7086 vs 0.6711). CONCLUSIONS: The AI-based software PRAEVAorta enabled a detailed anatomic characterization of aortic remodeling post-EVAR and showed its potential interest for automatic detection of endoleaks during follow-up. The association of aortic aneurysmal volume with EVAR-related adverse events and endoleaks was more robust compared with maximum diameter. CLINICAL IMPACT: The integration of PRAEVAorta AI software into clinical practice promises a transformative shift in post-EVAR surveillance. By offering precise and rapid detection of endoleaks and comprehensive anatomic assessments, clinicians can expect enhanced diagnostic accuracy and streamlined patient management. This innovation reduces reliance on manual measurements, potentially reducing interpretation errors and shortening evaluation times. Ultimately, PRAEVAorta's capabilities hold the potential to optimize patient care, leading to more timely interventions and improved outcomes in endovascular aortic repair.

Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

BACKGROUND: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. METHODS: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). RESULTS: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). CONCLUSION: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. CLINICAL IMPACT: This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

Creation of a Shared Medical Decision Support Tool for the Management of Abdominal Aortic Aneurysms.

BACKGROUND: Patients with unruptured abdominal aortic aneurysm (AAA) at the surgical threshold may benefit from aneurysmal exclusion either by open surgery or endovascular repair. A patient decision aid (PtDA) could be useful to help patients and their surgeons choose between the 2 techniques. The aim of this study was to develop a shared medical decision support tool, in french language, for the surgical treatment of AAA. METHODS: Following the steps recommended by the International Patient Decision Aids Standards, we carried out a qualitative study using semi-structured interviews with patients and vascular surgeons and focus group with patients to identify their main points of interest. After analyzing the interviews using grounded theory with independent double coding, the verbatims were discussed at a steering committee, at the end of which a prototype of the tool was created. RESULTS: Four surgeons and 14 patients were interviewed. No new codes emerged from the last 2 interviews. At the end of the steering committee meeting, the information selected for inclusion in the PtDA tool were the definition of an AAA, a description of the 2 surgical techniques (approach, duration of operation), the main complications, the peri-operative mortality rate, and postoperative follow-up (length of hospital stay, monitoring frequency, and risk of re-intervention). It had to be produced on a synthetic paper format, with 6 illustrations and a simple vocabulary. CONCLUSIONS: We developed a PtDA tool for use in a sharing decision making process with the patient during consultation with the vascular surgeon and the general practitioner. Further studies are needed to validate the tool and to test it in clinical practice.

Reconstruction of primary and secondary aortic infections with an antimicrobial graft.

INTRODUCTION: In situ reconstruction (ISR) with autologous veins is the preferred method in infectious native aortic aneurysms (INAAs) or vascular (endo)graft infection (VGEI). However, access to biological substitutes can prove difficult and lacks versatility. This study evaluates survival and freedom from reinfection after ISR of INAA/VGEI using the antimicrobial Intergard Synergy graft combining silver and triclosan. METHODS: From February 2014 to April 2020, 86 antimicrobial grafts were implanted for aortic infection. The diagnosis of INAA/VGEI and reinfection was established based on the Management of Aortic Graft Infection Collaboration criteria. Survival was analyzed using the Kaplan-Meier method and log-rank P values. RESULTS: The antimicrobial graft was implanted in 32 cases of INAA, 28 of VGI, and 26 of VEI. The median age was 69.0 (interquartile range: 62.0; 74.0), with a history of coronary artery disease (n = 21; 24.4%), chronic kidney disease (n = 11; 12.8%), cancer (n = 21; 24.4%), and immunosuppression (n = 27; 31.4%). Imaging showed infiltration (n = 14; 16.3%), air (n = 10; 11.6%), and rupture (n = 16; 18.6% including 22 aortoenteric fistulae [AEnF]). Symptoms included fever (n = 37; 43.0%), shock (n = 11; 12.8%), and pain (n = 47; 54.7%). Repair was undertaken through a midline laparotomy in 75 cases (87.2%) and coeliac cross-clamping in 19 (22.1%), suprarenal in 26 (30.2%), plus celiac trunk (n = 3), mesenteric (n = 5), renal (n = 13), or hypogastric (n = 4) artery reconstruction, and omental flap coverage (n = 41; 48.8%). For AEnF, the gastrointestinal tract was repaired using direct suture (n = 14; 16.3%) or resection anastomosis (n = 8; 9.3%). Causative organisms were identified in 74 patients (86.0%), with polymicrobial infection in 32 (37.2%) and fungal coinfection in 7 (8.1%). Thirty-day and in-hospital mortality were 14.0% and 22.1% (n = 12 and 19, respectively, 3 INAA [9.4%], 7 VGI [25.0%], and 9 VEI [34.6%]). Seventy patients (81.4%) had a postoperative complication, 44 (51.2%) of whom returned to the operative room. The 1- and 2-year survival rates were 74.0% (95% confidence interval [CI]: 63.3-82.1) and 69.8% (95% CI: 58.5-78.5), respectively. Survival was significantly better for INAA vs VGEI (P = .01) and worse for AEnF (P = .001). Freedom from reinfection was 97.2% (95% CI: 89.2-99.3) and 95.0% (95% CI: 84.8-98.4) with six reinfections (7.0%) requiring two radiological/six surgical drainage and two graft removals. Primary patency was 88.0% (95% CI: 78.1-93.6) and 79.9% (95% CI: 67.3-88.1) with no significant difference between INAA and VGEI (P = .16). CONCLUSIONS: ISR of INAA or VGEI with the antimicrobial graft showed encouraging early mortality, comparable to the rates found in femoral vein (9%-16%) and arterial allograft (8%-28%) studies, as well as mid-term reinfection. The highest in-hospital mortality was noted for VEI including nearly 50% of AEnF.

Diabetic retinopathy relates to the incidence of foot ulcers and amputations in type 2 diabetes.

AIMS: We investigated whether Diabetic Retinopathy (DR) is related to Diabetic Foot Ulcer (DFU) development, adjusted for the stratification of the International Work Group on Diabetic Foot (IWGDF) guidance. MATERIALS AND METHODS: DR and IWGDF stratification was registered retrospectively in patients hospitalised from 2009 to 2017 for uncontrolled and/or complicated type 2 diabetes. New DFUs were registered until 2020. Survival analyses categorised the subjects for DR, and multivariate Cox regression adjusted for confounders. RESULTS: The 522 patients (57.9% male) were 62 ± 9 years old with a diabetes duration of 14 ± 10 years, HbA1c of 8.7 ± 1.8%, 33.9% macroangiopathies and 44.8% diabetic kidney diseases. Their grades of DFU risk were 0 for 43.3%, 1 for 23.9%, 2 for 7.1%, and 3 for 25.6%. During the 52 months follow-up (Inter Quartile Range: 32-71), 58 new DFUs and 18 lower-limb amputations occurred, mostly in patients with DR present in 140 (26.8%) patients. Adjusted for age, sex and conventional risk factors (duration and control of diabetes, arterial hypertension, and dyslipidemia), and other complications (macroangiopathy and diabetic kidney disease), DR was associated with a greater incidence of DFUs. Adjusted for the IWGDF classification, DR was related to new DFUs (HR: 2.51, 95%Confidence Interval [CI]: 1.48-4.26) and amputations (HR: 3.56, 95%CI: 1.26-10.07). This relationship persisted in ascending IWGDF grades with incidences of DFUs from 2/1000 (grade 0, no DR) to 121/1000 patient-years (grade 3 and DR) and amputations from 0 (grade 0, no DR) to 38/1000 patient-years (grade 3 and DR). CONCLUSIONS: Diabetic retinopathy independently relates to the incidence of foot ulcers and amputations in patients hospitalised for type 2 diabetes.

Referral Centre Experience with Infected Abdominal Aortic Endograft Explantation.

OBJECTIVE: The increasing use of endovascular aneurysm repair (EVAR) appears to be associated with the burden of vascular endograft infections. Complete stent graft explantation is recommended but leads to significant mortality. This study aimed to assess the technical challenges, complications, and mortality rate following infected endograft explantation. METHODS: Patients who underwent abdominal aortic endograft explantation for infection at the Bordeaux University Hospital from July 2008 to December 2020 were included retrospectively in this single centre observational study. The diagnosis was established based on the MAGIC criteria. The primary endpoint was 30 day mortality. Secondary endpoints were 90 day and in hospital mortality, survival, and re-infection. RESULTS: Thirty-four patients were included, median age 69 years (interquartile range [IQR] 65, 76), with four (12%) treated as an emergency. The median time from EVAR to explantation was 17.5 months (4.5 - 36.3). In situ reconstruction was carried out with prosthetic grafts in 24 patients (71%, including 23 antimicrobial grafts combining silver and triclosan), and biological grafts in 10 (five femoral veins, four arterial allografts, three bovine patches, one biosynthetic graft). Seventeen aorto-enteric fistulae (AEnF) were addressed with direct repair of the intestinal tract (n = 10/17; 59%) or resection and anastomosis (n = 7/17; 41%). The culture was polymicrobial in 12 patients (35%) and remained sterile in four (12%). The 30 day and in hospital mortality rates were 21% (n = 7) and 27% (n = 9). Twenty-five patients (73%) presented with early post-operative complications, requiring 16 revision procedures (47%). Over a median follow up of 16.2 months (IQR 8.3, 33.6), the mortality rate was 35% (n = 12; 11 aortic related; 32%), with two re-infections (6%), both after biological reconstruction (one for an AEnF). CONCLUSION: Early morbidity and mortality remain high after complete infected endograft explantation, even in a high volume centre. Comparison with other treatment modalities in large multicentre cohorts might be of interest.

Management of Inflammatory Aortic Aneurysms - A Scoping Review.

OBJECTIVE: Inflammatory abdominal aortic aneurysms (InflAAAs) account for 5 - 10% of aortic aneurysms and are characterised by retroperitoneal fibrosis. Diagnosis is often delayed, and doubts remain about the optimal management strategy. This scoping review describes the current state of knowledge on InflAAAs. METHODS: Medline, PubMed, EMBASE, and Scopus were searched for relevant studies that evaluated the diagnosis and treatment of InflAAAs. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was followed. RESULTS: Fifty-seven papers were selected (low level of evidence), which included 1 554 patients, who were mostly male and heavy smokers. A triad of chronic abdominal or back pain, weight loss, and elevated inflammatory markers was highly suggestive of the diagnosis but rarely present, and fever was noted only randomly. A mantle sign was seen on computed tomography angiography (CTA) in 73 - 100% of patients. Open surgical repair (OSR) and endovascular aortic aneurysm repair (EVAR) was reported in 1 376 and 178 patients, respectively. OSR was associated with significant iatrogenic bowel (n = 22), urinary tract system (n = 7), venous (n = 30), pancreatic (n = 6), and splenic (n = 5) injuries, while EVAR was associated with lower 30 day mortality (0 - 5% vs. 0 - 32%). One and two year mortality rates were similar between the two treatment modalities (0 - 20% and 0 - 36%, respectively). EVAR was more often associated with post-operative progression of inflammation (17% vs. 0.4%), and a higher frequency of persistent hydronephrosis (> 50%) and limb occlusion (20%). Used in < 10% of patients, corticosteroids led to complete pain relief and a reduction in peri-aortic inflammation within 6 - 18 months. CONCLUSION: InflAAAs are characterised by non-specific symptoms, with the mantle sign on CTA being pathognomonic. Corticosteroids may be considered a basic treatment that all patients should receive initially. Low quality data indicate that EVAR (vs. OSR) is associated with fewer intra-operative complications and lower peri-operative mortality but more late fibrosis related adverse events. International multicentre registries are required to gather more insights into this challenging pathology.

Fully automatic volume segmentation using deep learning approaches to assess aneurysmal sac evolution after infrarenal endovascular aortic repair.

OBJECTIVE: Endovascular aortic repair (EVAR) surveillance relies on serial measurements of the maximal diameter despite significant inter- and intraobserver variability. Volumetric measurements are more sensitive; however, their general use has been hampered by the time required for their implementation. An innovative, fully automated software (PRAEVAorta; Nurea, Bordeaux, France), using artificial intelligence, had previously demonstrated fast and robust detection of the characteristics of infrarenal abdominal aortic aneurysms on preoperative imaging studies. In the present study, we assessed the robustness of these data on post-EVAR computed tomography (CT) scans. METHODS: We compared fully automatic and semiautomatic segmentation manually corrected by a senior surgeon (E.D.) using a dataset of 48 patients (48 early post-EVAR CT scans with 6466 slices and 101 follow-up CT scans with 13,708 slices). RESULTS: The analyses confirmed the excellent correlation of the post-EVAR volumes and surfaces and the proximal neck and maximum aneurysm diameters measured using the fully automatic and manually corrected segmentation methods (Pearson's coefficient correlation, >0.99; P < .0001). A comparison between the fully automatic and manually corrected segmentation methods revealed a mean Dice similarity coefficient of 0.950 ± 0.015, Jaccard index of 0.906 ± 0.028, sensitivity of 0.929 ± 0.028, specificity of 0.965 ± 0.016, volumetric similarity of 0.973 ± 0.018, and mean Hausdorff distance/slice of 8.7 ± 10.8 mm. The mean volumetric similarity reached 0.873 ± 0.100 for the lumen and 0.903 ± 0.091 for the thrombus. The segmentation time was nine times faster with the fully automatic method (2.5 minutes vs 22 minutes per patient with the manually corrected method; P < .0001). A preliminary analysis also demonstrated that a diameter increase of 2 mm can actually represent a >5% volume increase. CONCLUSIONS: PRAEVAorta enabled a fast, reproducible, and fully automated analysis of post-EVAR abdominal aortic aneurysm sac and neck characteristics, with a comparison between different time points. It could become a crucial adjunct for EVAR follow-up through the early detection of sac evolution, which might reduce the risk of secondary rupture.

Outcomes of patients with aortic vascular graft and endograft infections initially contra-indicated for complete graft explantation.

OBJECTIVE: Complete excision in patients with aortic vascular graft and endograft infections (VGEIs) is a significant undertaking, and many patients never undergo definitive treatment. Knowing their fate is important to be able to assess the risks of graft excision vs alternative strategies. This study analyzed their life expectancy and sepsis-free survival. METHODS: VGEIs were diagnosed according to the Aortic Graft Infection (MAGIC) criteria, and patients turned down for graft removal from November 2006 to December 2020 were included. Primary endpoints were aortic-related and sepsis-free survival estimated using the Kaplan-Meier method. A Cox proportional hazards regression analysis was used to compute the hazard ratio (HR) and 95% confidence interval (CI) as estimates of survival without sepsis. RESULTS: Seventy-four patients were included, with a median age of 71 years (range, 63-79 years). The index aortic repair was either open (n = 33; 44.6%), endovascular (n = 19; 25.7%), or hybrid (n = 22; 29.7%). Causative organisms were identified in 56 patients (75.7%). At presentation, 26 patients (35.1%) required salvage surgery, open (n = 22; 29.7%) or endovascular (n = 8; 10.8%), and 17 radiological drainage (23.0%). During follow-up, eight required drainage and 11 (14.9%) graft removal (five complete). Infectious complications included pseudoaneurysms (n = 14; 18.9%), rupture (n = 9; 12.2%), gastro-intestinal bleeding (n = 13; 17.6%), septic embolisms (n = 4; 5.4%), and thrombosis (n = 12; 16.2%). In-hospital mortality was 20.3% (n = 15), freedom from aortic-related death and overall survival was 77.1% (95% CI, 65.2%-85.3%) and 70.4% (95% CI, 58.3%-79.7%) at 1 year, and 61.7% (95% CI, 46.1%-74.0%) and 43.1% (95% CI, 29.2%-56.3%) at 5 years. Sepsis recurrence occurred in 37 patients (50.0%). Seven (16.3%) developed acquired antimicrobial resistance. Malnutrition (HR, 3.3; 95% CI, 1.4-7.6; P = .005), hemorrhagic shock at presentation (HR, 2.9; 95% CI, 1.0-8.2; P = .048), aorto-enteric fistulae (HR, 3.3; 95% CI, 1.3-8.4; P = .011), fungal coinfection (HR, 3.5; 95% CI, 1.2-11.5; P = .030), and infection with resistant micro-organisms (HR, 3.1; 95% CI, 1.1-8.3; P = .023) were significantly associated with worse survival without sepsis. CONCLUSIONS: In-hospital and aortic-related mortality were significant, but with salvage surgery and antibiotic therapy, the median survival was 3 years. Sepsis recurrence remained frequent, and further procedures were needed. These outcomes should be considered when graft excision is proposed. Known predictors of adverse outcomes should become important points for discussion in multidisciplinary team meetings.

EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease.

BACKGROUND: Endovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD. METHODS: Our consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded. RESULTS: Between March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters. CONCLUSIONS: The results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Fifteen-year, single-center experience with in situ reconstruction for infected native aortic aneurysms.

OBJECTIVE: The purpose of the present study was to evaluate the survival and freedom from reinfection for patients with infected native aortic aneurysms (INAAs) treated with in situ revascularization (ISR), using either open surgical repair (OSR) or endovascular aneurysm repair (EVAR), and to identify the predictors of outcome. METHODS: Patients with INAAs who had undergone ISR from January 2005 to December 2020 were included in the present retrospective single-center study. The diagnosis of INAAs required a combination of two or more of the following criteria: (1) clinical presentation, (2) laboratory results, (3) imaging findings, and (4) intraoperative findings. The primary endpoint was 30-day mortality. The secondary endpoints were in-hospital mortality, estimated survival, patency, and freedom from reinfection using the Kaplan-Meier method. The predictive factors for adverse outcomes were evaluated using the Mann-Whitney U test or the Fisher exact test and multivariate regression analysis. RESULTS: A total of 65 patients (53 men [81.5%]; median age, 69.0 years; interquartile range, 61.5-75.0 years) were included, 31 (47.7%) were immunocompromised, 60 were symptomatic (92.3%), and 32 (49.2%) had presented with rupture, including 3 aortocaval fistulas (4.6%) and 12 aortoenteric fistulas (18.5%). The most common location was infrarenal (n = 39; 60.0%). Of the 65 patients, 55 (84.6%) had undergone primary OSR with ISR, 3 (4.6%) had required EVAR as a bridge to OSR, and 8 (12.3%) had undergone EVAR as definitive treatment. The approach was a midline laparotomy for 44 patients (67.7%), mostly followed by reconstruction and aortic-aortic bypass (n = 28; 40.6%) and the use of a silver and triclosan Dacron graft (n = 30; 43.5%). Causative organisms were identified in 55 patients (84.6%). The 30-day and in-hospital mortality rates were 6.2% (n = 4) and 10.8% (n = 7). The median follow-up was 33.5 months (interquartile range, 13.6-62.3 months). The estimated 1- and 5-year survival rates were 79.7% (95% confidence interval [CI], 67.6%-87.7%) and 67.4% (95% CI, 51.2%-79.3%). The corresponding freedom from reinfection rates were 92.5% (95% CI, 81.1%-97.1%) and 79.4% (95% CI, 59.1%-90.3%). On multivariate analysis, in-hospital mortality increased with uncontrolled sepsis (P < .0001), rapidly expanding aneurysms (P = .008), and fusiform aneurysms (P = .03). The incidence of reinfection increased with longer operating times (P = .009). CONCLUSIONS: The selective use of ISR and OSR combined with targeted antimicrobial therapy functioned reasonably well in the treatment of INAAs, although larger, prospective, multicenter studies with appropriately powered comparative cohorts are necessary to confirm our findings and to determine the best vascular substitute and precise role of EVAR as a bridge to OSR or definitive treatment.

Contemporary Results with the Biosynthetic Glutaraldehyde Denatured Ovine Collagen Graft (Omniflow II) in Lower Extremity Arterial Revascularization in a Septic Context.

BACKGROUND: Peripheral vascular graft infections are poorly-evaluated, despite high mortality and amputation rates. The vascular substitute of choice remains controversial when veins are unavailable. This study aims to evaluate the results of a biosynthetic collagen graft (Omniflow II®) in an infected field when autologous veins are unavailable. METHODS: This retrospective, multicentric study included all consecutive patients in whom an Omniflow II graft was used for infra-inguinal revascularization in a septic context from January 2015 to January 2020. The primary end-point was freedom from major amputation; secondary end-points were 30-day mortality, survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method. RESULTS: Twenty-nine patients (27 men, median age of 69 years interquartile range IQR:60; 76) were included. Fever was present in 58.6%, a septic rupture in 17.9%, a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4%. Median follow-up reached 49 months. At 1 and 3 years, estimated freedom from major amputation was 88.4% and 83.9%, survival: 96%, primary patency: 74.6% and 65.8%, and reinfection free-survival: 85.6%. There were 7 occlusions (1 iliofemoral, 1 below-knee, and 5 above-knee bypasses), 3 explantations for persistent sepsis, 4 reinfections (all within 6 months which led to 1 death and 3 out of 4 major amputations). The risk of major amputation increased with bypass reinfection (P = 0.004), occlusion (P = 0.005), and polymicrobial infection (P = 0.05). CONCLUSIONS: In a septic context, the Omniflow II graft shows acceptable freedom from major amputation and reinfection. This usage remains outside the instructions of use, it is, therefore, is essential to pursue longer-term studies in larger cohorts.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment.

BACKGROUND: For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath. METHODS: FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month. RESULTS: Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline. CONCLUSION: FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.

Fully automatic volume segmentation of infrarenal abdominal aortic aneurysm computed tomography images with deep learning approaches versus physician controlled manual segmentation.

OBJECTIVE: Imaging software has become critical tools in the diagnosis and decision making for the treatment of abdominal aortic aneurysms (AAA). However, the interobserver reproducibility of the maximum cross-section diameter is poor. This study aimed to present and assess the quality of a new fully automated software (PRAEVAorta) that enables fast and robust detection of the aortic lumen and the infrarenal AAA characteristics including the presence of thrombus. METHODS: To evaluate the segmentation obtained with this new software, we performed a quantitative comparison with the results obtained from a semiautomatic segmentation manually corrected by a senior and a junior surgeon on a dataset of 100 preoperative computed tomography angiographies from patients with infrarenal AAAs (13,465 slices). The Dice similarity coefficient (DSC), Jaccard index, sensitivity, specificity, volumetric similarity (VS), Hausdorff distance, maximum aortic transverse diameter, and the duration of segmentation were calculated between the two methods and, for the semiautomatic software, also between the two observers. RESULTS: The analyses demonstrated an excellent correlation of the volumes, surfaces, and diameters measured with the fully automatic and manually corrected segmentation methods, with a Pearson's coefficient correlation of greater than 0.90 (P < .0001). Overall, a comparison between the fully automatic and manually corrected segmentation method by the senior surgeon revealed a mean Dice similarity coefficient of 0.95 ± 0.01, a Jaccard index of 0.91 ± 0.02, sensitivity of 0.94 ± 0.02, specificity of 0.97 ± 0.01, VS of 0.98 ± 0.01, and mean Hausdorff distance per slice of 4.61 ± 7.26 mm. The mean VS reached 0.95 ± 0.04 for the lumen and 0.91 ± 0.07 for the thrombus. For the fully automatic method, the segmentation time varied from 27 seconds to 4 minutes per patient vs 5 minutes to 80 minutes for the manually corrected methods (P < .0001). CONCLUSIONS: By enabling a fast and fully automated detailed analysis of the anatomic characteristics of infrarenal AAAs, this software could have strong applications in daily clinical practice and clinical research.

Adjuncts to the Management of Graft Aorto-Enteric Erosion and Fistula with in situ Reconstruction.

OBJECTIVE: The objective of this retrospective single centre study was to determine whether different enteric reconstruction methods and adjuncts confer a benefit after in situ reconstructions (ISRs) of graft aorto-enteric erosion (AEnE) and fistula (AEnF). METHODS: Primary endpoints were in hospital mortality and AEnE/F recurrence. Survival was estimated using the Kaplan-Meier method and explanatory factors were searched for using uni- ± multivariable Cox regression analysis. In 2013, a multidisciplinary team meeting was convened and since then the primary operator has always been a senior surgeon. RESULTS: Sixty-six patients were treated for AEnE (n = 38) and AEnF (n = 28, 42%) from 2004 to 2020. All patients with AEnF presented with gastrointestinal bleeding (vs. 0 for AEnE; p < .001). Signs of infection were seen in 50 patients (76% [37 for AEnE vs. 13 for AEnF]; p < .001). Referrals for endograft infection increased over time (n = 15, 23%; one before 2013 vs. 14 after; p = .002). Most patients underwent complete graft excision (n = 52, 79%) with increasing suprarenal cross clamping (n = 21, 32%; four before 2013 vs. 17 after; p = .015). Complex visceral reconstructions decreased over time (n = 31, 47%; 17 before 2013 vs. 14 after; p = .055), while "open abdomens" (OAs) increased (one before 2013 vs. 22 after; p < .001), reducing operating time (p = .012). In hospital mortality reached 42% (n = 28). Estimated survival reached 47.6% (95% confidence interval [CI] 35.0 - 59.1) at one year and 45.6% (95% CI 33.0 - 57.3) at three years and was higher for AEnE than for AEnF (log rank p = .029). AEnE/F recurrence was noted in 12 patients (18%). Older age predicted in hospital mortality in multivariable analysis (p = .034). AEnE/F recurrence decreased with the presence of a primary senior surgeon (vs. junior; p = .003) and OA (1 [4.4%] vs. 11 [26%] for primary fascial closure; p = .045) in univariable analysis. CONCLUSION: Mortality and recurrence rates remain high after ISR of AEnE/F. Older age predicted in hospital mortality. Primary closure of enteric defects ≤ 2 cm in diameter reduced operating time without increasing the recurrence of AEnF.

Rigorous focus on paclitaxel-related mortality in femoropopliteal artery disease.

Paclitaxel-coated balloons and stents have emerged as the most promising strategy for the inhibition of neointimal hyperplasia after endovascular treatment of the femoropopliteal artery. However, a few months ago, cause for concern was raised in a systematic review and meta-analysis of randomized controlled trials investigating paclitaxel-coated balloon angioplasty or paclitaxel-coated metal stents in the femoral and popliteal arteries. This editorial reviews the data available to date relative to the potential increased risk of mortality after the use of drug-eluting technologies in the femoropopliteal segment.

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease.

OBJECTIVE: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. METHODS: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. RESULTS: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. CONCLUSIONS: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.

Restoring Endothelial Function by Targeting Desert Hedgehog Downstream of Klf2 Improves Critical Limb Ischemia in Adults.

RATIONALE: Klf (kruppel-like factor) 2 is critical to establish and maintain endothelial integrity. OBJECTIVE: Therefore, determining upstream and downstream mediators of Klf2 would lead to alternative therapeutic targets in cardiovascular disease management. METHODS AND RESULTS: Here we identify Dhh (desert hedgehog) as a downstream effector of Klf2, whose expression in endothelial cells (ECs) is upregulated by shear stress and decreased by inflammatory cytokines. Consequently, we show that Dhh knockdown in ECs promotes endothelial permeability and EC activation and that Dhh agonist prevents TNF-α (tumor necrosis factor alpha) or glucose-induced EC dysfunction. Moreover, we demonstrate that human critical limb ischemia, a pathological condition linked to diabetes mellitus and inflammation, is associated to major EC dysfunction. By recreating a complex model of critical limb ischemia in diabetic mice, we found that Dhh-signaling agonist significantly improved EC function without promoting angiogenesis, which subsequently improved muscle perfusion. CONCLUSION: Restoring EC function leads to significant critical limb ischemia recovery. Dhh appears to be a promising target, downstream of Klf2, to prevent the endothelial dysfunction involved in ischemic vascular diseases.

The Common Femoral Artery Bifurcation Lesions: Clinical Outcome of Simple Versus Complex Stenting Techniques - An Analysis Based on the TECCO Trial.

BACKGROUND: Common femoral artery (CFA) stenting appears as a promising alternative treatment to the open surgery for de novo CFA stenosis. The stenting of lesions just located at the CFA is simple, whereas stenting of CFA bifurcation lesions is more complex, and outcomes are still matter of debate. The aim of this study was to describe and to compare clinical outcomes of techniques used to treat simple over complex lesions for the stenting of CFA lesions. MATERIALS/METHODS: From the French randomized controlled trial, TECCO, a total of 54 patients underwent stenting intervention and were enrolled in this study. Patients were excluded if they had CFA thrombosis, restenosis, and nonatheromatous lesions. Patients were classified by simple and complex lesions based on the type of lesion. The primary end point was the primary sustained clinical improvement. RESULTS: Eighteen patients were included in the simple lesion group, and 36 patients, in the complex lesion group. Baseline characteristics of patients were comparable between the 2 groups. The technical success was 100% in the simple lesion group and 91.7% in the complex lesion group. There was no significant difference between the 2 groups, regarding the primary sustained clinical improvement. The primary patency rates at 24 months for simple and complex lesion groups were 86.3% and 79%, respectively (P = 0.66). Freedom from target lesion revascularization was of 93.3% and 82% in the simple and complex lesion group, respectively (P = 0.34). CONCLUSIONS: The stenting technique for CFA bifurcation lesions is a safe and effective technique. More trials with a large number of patients are needed to define the optimal stenting technique.

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

BACKGROUND: Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA. METHODS: The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and pneumonia/prolonged ventilation-time during the first 8 postoperative days. The secondary objectives are to compare both arms with respect to cardiac complications within 48 h, renal and pulmonary complications within 21 days and mortality at 60 days. To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used. Assuming that the event occurs among 36% of the patients when no IPC is performed, the allocation of 55 patients to each arm should allow detecting a hazard ratio of at least 2.75 with a power of 80% when admitting 5% for an error of first kind. This means that 110 patients, enrolled in this multicenter study, may be randomised within 36 months of the first randomization. Randomization will be performed to allocate patients either to surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping (Arm 2). Randomization takes place during the intervention after intravenous injection of heparin, or after the start of femoral assistance. The procedure for IPC will be a supra-visceral thoracic aortic cross clamping for 5 min followed by an unclamping period of 5 min. This procedure will be repeated twice before starting thoracic aortic cross clamping needed to perform surgery. CONCLUSIONS: Our hypothesis is that ischemic preconditioning could reduce clinical morbidity and the incidence of lung damage associated with supra-visceral aortic clamping. TRIAL REGISTRATION: EPICATAStudy registered in ClinicalTrial.gov / number: NCT03718312 on Oct.24.2018 URL number.