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.

Predictors of major adverse lower limb events in patients with tissue loss secondary to critical limb-threatening ischemia.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is the end-stage of peripheral arterial disease (PAD) posing a high risk for limb loss and mortality. This study aims to evaluate and list possible predictors of major adverse limb events (MALEs) in CLTI patients with tissue loss. METHODS: This retrospective study included all Rutherford-Becker stage 5 or 6 patients who required foot debridement and revascularization in our department from January 2016 to December 2018. The limbs were classified according to the TASC II, GLASS and WiFI grading systems. The primary composite outcome was MALEs at 2 years. The secondary outcomes included all-cause mortality, primary patency, freedom from reintervention, and major amputation. Kaplan-Meier estimates were used to determine the event rates, and Cox proportional hazards model with the index MALE as a time-dependent covariate was used to search for MALEs predictors. RESULTS: Of 241 included patients, 19 underwent open surgeries (7.9 %) 207 had endovascular interventions (85.9 %) and 15 required a hybrid approach (6.2 %). On univariate analysis, patients who experienced MALEs (n = 111) more often required hemodialysis (25 vs 15; p = .02), presented with more complex lesions (TASC D on femoropopliteal (p = .05) or below the knee (BTK) arteries (p = .006) with increasing infra-inguinal GLASS Stage (p < .0001)), a history of index limb open (p = .009) or endovascular (p = .049) revascularization, an occluded tibial artery (p = .002 for the posterior tibial and p = .052 for the anterior tibial), or a "desert foot" (p = .02). The CRP level was also higher at admission (p = .001). Technical success of BTK revascularization significantly reduced MALEs (p < .0001) along with the number of patent BTK vessels (p = .0007). Independent predictors of MALEs included hemodialysis (HR = 2.00; 95%CI: 1.14 to 3.39), pulsatile arterial pressure (HR = 1.01; 95%CI: 1.00 to 1.03) and the infra-inguinal GLASS Stage (HR = 2.50; 95%CI: 1.17 to 5.82). We could not correlate our results with the WiFI scores for amputation risk and revascularization benefit. CONCLUSION: For patients with CLTI at the stage of trophic disorders, with or without a history of index limb revascularization, the GLASS successfully predicted MALEs. Hemodialysis and high pulsatile arterial pressure increased the risk of MALEs. The WiFI score did not demonstrate its interest in this subgroup of patients.

Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.

The skin autofluorescence of advanced glycation end-products relates to the development of foot ulcers in type 2 diabetes: A longitudinal observational study.

OBJECTIVES: The long-term glycemic memory contributes to vascular complications in type 2 diabetes, including those patients with Diabetic Foot Ulcers (DFU). We investigated whether the skin autofluorescence (SAF) of Advanced Glycation End-products related to later DFUs. RESEARCH DESIGN & METHODS: SAF was measured with an AGE-Reader in a retrospective cohort of patients hospitalized from 2009 to 2017 for Type 2 Diabetes. New DFUs were registered until the year 2020 and survival analyses were performed. RESULTS: The 517 patients (men: 58.0 %), were 62 ± 9 years old at baseline, with a duration of diabetes of 14 ± 10 years, HbA1c: 8.7 ± 1.8 %, complications included 33.8 % macroangiopathies, 44.9 % diabetic kidney diseases and 26.7 % retinopathies. According to the IWGDF classification, the grades of risk for DFU were 0 for 43.2 %, 1 for 23.9 %, 2 for 7.2 %, and 3 for 25.7 %. During the 53 months of follow-up, 58 new DFUs occurred, mostly in patients with SAF higher than its median value (2.65 AU). Adjusted for age and sex, conventional risk factors (duration and control of diabetes, arterial hypertension, dyslipidemia, smoking), and other complications (macroangiopathy, diabetic kidney disease, retinopathy), SAF related to later DFUs. Adjusted for the IWGDF classification, SAF related to new DFUs (HR: 1.81, 95%CI:1.25-2.62). This relationship was significant for the 403 subjects without previous history of DFU (HR: 2.32, 95%CI: 1.36-3.95). SAF did not predict recurrence for patients with a previous history of DFUs. CONCLUSION: SAF, a simple non-invasive marker of glycemic memory, independently predicts the occurrence of a first foot ulcer in patients with Type 2 Diabetes.

Lower-limb peripheral arterial disease and amputations in people with diabetes: Risk factors, prognostic value and management.

Lower-limb peripheral arterial disease (PAD), is a common manifestation of systemic atherosclerosis, resulting from a partial or complete obstruction of at least one lower-limb arteries. PAD is a major endemic disease with an excess risk of major cardiovascular events and death. It also leads to disability, high rates of lower-limb adverse events and non-traumatic amputation. In patients with diabetes, PAD is particularly frequent and has a worse prognosis than in patients without diabetes. The risk factors of PAD are comparable to those for cardiovascular disease. The ankle-brachial index is usually recommended to screen PAD despite its limited performance in patients with diabetes, affected by the presence of peripheral neuropathy, medial arterial calcification, incompressible arteries and infection. Toe brachial index and toe pressure emerge as alternative screening tools. The management of PAD requires strict control of cardiovascular risk factors including diabetes, hypertension and dyslipidaemia, the use of antiplatelet agents and lifestyle management, to reduce cardiovascular adverse events, but few randomized controlled trials have evaluated the benefits of these treatments in PAD. Several advances have been achieved in endovascular and surgical revascularization procedures, with obvious improvement in PAD prognosis. Further studies are required to increase our understanding of the pathophysiology of PAD and to evaluate the interest of different therapeutic strategies in the occurrence and progression of PAD in patients with diabetes. Here, we present a narrative and contemporary review to synthesize the key epidemiology findings, screening and diagnosis methods, and major therapeutic advances regarding PAD in patients with diabetes.

BCG Aortitis, a Rare Complication of BCG Therapy.

Introduction: Intravesical Bacillus Calmette-Guerin (BCG) is an effective treatment for in situ bladder carcinomas; however, extravesical BCG infection may occur in remote organs in patients with underlying primary immunodeficiency and is a potentially serious complication in 3-5% of cases. It includes granulomatous pneumonia, hepatitis as well as specific dermatological, ophthalmic, and haematopoietic manifestations. Diagnosis is difficult and often based on high clinical suspicion as in many cases Mycobacterium bovis is not isolated. This report presents a rare case of BCGaortitis treated in a tertiary care centre. Report: A 74 year old man, with a history of bladder cancer treated with BCG therapy over a year ago, presented with malaise, abdominal pain, anorexia, and significant weight loss for several months associated with acute on chronic renal failure and a tender aneurysm. He was diagnosed with hepatic BCGitis and pararenal BCGaortitis. He was considered too high risk for open surgery after a multidisciplinary team meeting and was treated with a four vessel physician modified endograft (PMEG) and antituberculous therapy. At seven month follow up, he was clinically well and control computed tomography showed a patent endograft with complete exclusion of the aortic aneurysm. Discussion: Infectious BCG complications after intravesical BCG administration for in situ bladder carcinomas can lead to severe early and late complications. In the present case, the patient presented with both liver and aortic BCG infection. The lack of positive microbiological data should not discourage clinicians from considering BCG infection even if several months have passed since the last BCG instillation.

Albuminuric diabetic kidney disease predicts foot ulcers in type 2 diabetes.

Diabetic Foot Ulcers (DFU) are feared among individuals with diabetic kidney disease (DKD), but it is unclear whether they are more frequent, especially in normoalbuminuric DKD. Five hundred and twenty patients admitted in our diabetology ward from 2007 to 2017 were followed up during 54 ±â€¯26 months. New DFUs were registered, and their relationship with the initial renal status was analyzed by LogRank and multivariate Cox regression analysis. The 520 subjects were mainly men (57.9 %), 62 ±â€¯9 years old, with a duration of diabetes of 14 ±â€¯10 years, HbA1c: 8.7 ±â€¯1.8 % (72 ±â€¯19 mmol/mol), and complications: 33.7 % macroangiopathies, 22.1 % previous foot ulcers, 44.8 % DKD, 26.9 % retinopathies. Fifty-seven new DFU occurred, mainly in subjects with DKD. DKD was related to later DFU (HR: 1.79; 95%CI: 1.05-3.07), this relationship stayed significant adjusted for age, gender, and a history of previous DFU (HR: 3.61; 95%CI: 2.11-6.18), and further adjusted for the duration of diabetes, HbA1c, BMI, arterial hypertension, and dyslipidemia. Among the 233 subjects with DKD, 129 (55.3 %) had an isolated AER > 30 mg/24H, 41 (17.6 %) had an isolated eGFR<60 mL/min/1.73 m2, and 63 (27.0 %) cumulated both abnormalities. By Cox regression analysis adjusted for age and gender, albuminuric DKDs were related to later DFU: with eGFR≥60: HR: 1.91; 95%CI: 1.02-3.59, with eGFR<60: HR: 2.53; 95%CI: 1.25-5.10, whereas normoalbuminuric DKD was not: HR: 1.04; 95%CI: 0.35-3.07, despite similar rates of neuropathies, peripheral arterial diseases, and retinopathies. In people with type 2 diabetes, albuminuric DKD was associated with two to three folds increased risk of DFUs, whereas normoalbuminuric DKD was not.

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.

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.

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.

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.

Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.

PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.

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.

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.