French Multicentric Registry on LUMINOR Drug-Eluting Balloon for Superficial Femoral and Popliteal Arteries.

BACKGROUND: Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal revascularizations. Luminor, nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in the Effpac trial. The LUMIFOLLOW registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in femoropopliteal lesions. METHODS: LUMIFOLLOW enrolled 542 patients with 580 lesions across 15 French centers. It included both de novo and restenotic lesions, with calcified and/or long occlusions. Primary endpoints were medical safety (defined as freedom from peri-procedural death, index limb amputation, and/or all-cause mortality) and efficacy (primary patency defined as freedom from target lesion revascularization (f-TLR) and/or binary restenosis); secondary endpoints included acute device success, procedural and clinical success, major adverse events, and functional assessments. RESULTS: The mean age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (42.6% n=231/542), hypertension (72.1%, n=391/542), hyperlipidemia (56.3%, n=305/542) and current smoking (27.2%, n=147/540); 23.8% were classified as Rutherford classification (RC) 2 (n=129/542), 43.2% as RC 3 (n=234/542), 16.8% as RC 4 (n=91/542) and 16.2% as RC 5 (n=88/542). Lesions were located in the superficial femoral artery (57.5%, n=329/572) and could extend to the popliteal artery (42.5%, n=243/572), with 43.6% classified TASC II C-D; 24.2% were restenosis (n=139/575) with a 44.3% rate of total occlusions (n=255/576). Mean lesion length was 140.55±99.42mm. Provisional stenting was required in 43.1% (n=249/580) with a mean stent length shorter than the initial lesion length at 87.21±42.30mm. The acute procedural success rate was 99.4% (n=536/539), with 2 in-hospital deaths and one thrombosis of target lesion. Acute clinical success was achieved in 93.5% (n=504/539). The 12-month composite safety endpoint was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and estimated primary patency was 87.4% (95%CI: 84.1;90.1%), with f-TLR at 96.2% (95%CI: 93.9;97.6%) and from target vessel revascularization at 94.9% (95%CI: 92.5;96.6%). The EQ-5D-5L questionnaire indicated significant improvements in quality of life at 12 months, with 67.4% improved mobility, 63.5% reduced pain and discomfort, and 47.8% enhanced usual activities. Walking Impairment Questionnaire scores increased significantly in walking distance, speed, and stair-climbing ability (from 31.4±24.7 to 62.5±31.0, p<.001). CONCLUSION: The LUMIFOLLOW registry demonstrates that Luminor DCBs are effective and safe for femoropopliteal interventions. The significant improvement in quality of life and walking ability, along with high primary patency and low complication rates, underscore the benefits of Luminor DCBs in real-world settings. However, the high rate of provisional stenting underscores the need for these devices to be used alongside other endovascular techniques in challenging lesions.

Fenestrated Endovascular Aortic Repair of Complex Aneurysm Using the Anaconda Fenestrated Device: 1-Year Results From the French Multicenter Registry.

PURPOSE: This study aims to assess the safety and efficacy of the fenestrated Anaconda device for the treatment of complex aortic aneurysms over 1 year in daily clinical practice. MATERIALS AND METHODS: All patients who received the graft between October 2019 and October 2020 were prospectively enrolled in an observational, multicenter national registry. The primary endpoint was the aneurysm-related 1-year mortality rate. Secondary endpoints included all-cause mortality, technical success, device-related adverse events (AEs) and major complications, secondary reinterventions, endoleaks, target vessel (TV) outcomes, and a center-volume analysis comparing mortality and secondary reintervention rate between expert centers (>15 F/BEVAR per year) and nonexpert centers (≤15 F/BEVAR per year). RESULTS: Ninety-seven patients from 28 centers were treated. Aneurysms types included juxta-renal and short neck (84.6%), pararenal (5.2%), paravisceral (3.1%), and type IV thoracoabdominal (2.5%). Configurations with 1, 2, 3, and 4 fenestrations were used in 2, 12, 18, and 65 cases, respectively, totaling 350 TVs. Technical success was 98.0%, with 1 type Ic and 1 type IIIc endoleak. Mean follow-up was 468 days. Ten patients died, with 8 deaths (8.2%) due to non-aortic causes and 2 deaths (2.1%) from unknown causes. The estimated 1-year survival rate was 92.7% (95% CI: 87.8-98.1%). The reintervention rate at 30 days was 11.3% and the estimated reintervention rate at 1 year was 21.6% (95% CI: 12.7-29.6%). No type Ia endoleak occurred during follow-up. Three type III endoleaks occurred and required reintervention. Three TV occlusion occurred, yielding a 1-year TVI-free rate of 92.4% (95% CI: 89.4-99.3). No device-related major complication was recorded, and 3 device-related AEs occurred: 1 limb migration, 1 limb kinking and 1 limb thrombosis. There was no statistically significant difference in mortality and survival without reintervention between expert and nonexpert centers (Log rank p=0.52 and p=0.16, respectively). CONCLUSION: The fenestrated Anaconda device demonstrated acceptable early and at 1-year safety and efficacy for treating primarily juxta-renal and short-neck aortic aneurysms, in centers with varying levels of experience. CLINICAL IMPACT: The Anaconda Fenestrated, as the second commercially available custom-made device for complex endovascular aortic surgery, might adress some anatomical challenges. Following market authorization, this registry presents the 1-year outcomes of real-world device usage in a large number of centers, including small clinics. The results indicate that the device provided adequate efficacy and safety for treating mostly juxta-renal and short neck aneurysms, with notable improvement in technical success rate compared to older reports.

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.

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.

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.

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.

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.

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.