A prospective observational study to evaluate a possible relationship between vitamin K antagonist therapy and risk of peripheral arterial disease in patients with type 2 diabetes.

AIM: The use of vitamin K antagonists (VKAs) may increase the risk of peripheral arterial disease (PAD) because vitamin K is a strong inhibitor of medial arterial calcification. Type 2 diabetes (T2D) exposes patients to an increased risk of PAD. We examined how the use of VKAs modulates the risk of incident PAD in people with T2D. MATERIALS AND METHODS: SURDIAGENE is a French cohort including 1468 patients with T2D with a prospective follow-up from 2002 to 2015. The primary outcome of the current analysis was the first occurrence of PAD, a composite of lower-limb amputation (LLA) or lower-limb revascularization. LLA and lower-limb revascularization were considered individually as secondary outcomes. RESULTS: During a 7-year median follow-up, PAD occurred in 147 (10%) of the 1468 participants. The use of VKAs was not significantly associated with the risk of PAD [multivariable adjusted hazard ratio (HR) 1.42, 95% confidence interval (CI), 0.88-2.31]. During the study period, LLA and lower-limb revascularization occurred in 82 (6%) and 105 (7%) participants, respectively. The use of VKAs was significantly associated with increased risk of LLA [multivariable adjusted HR 1.90 (95% CI, 1.04-3.47)], but not lower-limb revascularization [multivariable adjusted HR 1.08 (95% CI, 0.59-1.97)]. CONCLUSIONS: In this prospective study, we did not observe any excess risk of PAD requiring lower-limb revascularization in people with type 2 diabetes using VKAs. However, our data suggest a high risk of LLA in VKA users. Further studies are required to confirm this observation.

Editor's Choice - Infra-inguinal Endovascular Revascularisation and Bypass Surgery for Chronic Limb Threatening Ischaemia: a Retrospective European Multicentre Cohort Study with Propensity Score Matching.

OBJECTIVE: The aim of this study was to compare the long term efficacy of lower limb bypass with that of endovascular treatment (EVT) in patients with chronic limb threatening ischaemia (CLTI). METHODS: This retrospective, multicentre study evaluated the outcomes of patients with CLTI who underwent first time infra-inguinal bypass or EVT. The primary outcome was to compare amputation free survival (AFS) rates between the two propensity score matched groups. The secondary outcome was to compare wound healing within the first six months. Major adverse events were compared according to the type of revascularisation. RESULTS: Overall, 793 patients fulfilled the eligibility criteria, from whom 236 propensity score matched pairs were analysed. The mean follow up was 52 months. The 236 bypass procedures included 190 autogenous bypass grafts (80.5%), 151 (64.0%) of which were infrapopliteal. Among the 236 EVT procedures, the target lesion was the femoropopliteal segment in 81 patients (34.3%), the femoropopliteal and infrapopliteal segments in 101 patients (42.8%), and the infrapopliteal segment in 54 patients (22.9%). AFS was significantly better in the bypass group at five years (60.5 ± 3.6%) compared with the EVT group (35.3 ± 3.6%) (p < .001). Major amputation occurred in 61 patients (25.8%) in the bypass group and 85 patients (36.0%) in the EVT group (HR 0.66, 95% CI 0.47 - 0.92; p = .014). The probability of healing was significantly better in the bypass group at six months compared with the EVT group (p = .003). The median length of stay was shorter for the EVT group (4 days) than for the bypass group (8 days) (p = .001). Urgent re-intervention and re-admission rates were high and did not differ significantly between the groups. CONCLUSION: This study has shown that lower limb bypass surgery offered a significantly higher probability of AFS and wound healing compared with EVT in patients with CLTI.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.

PURPOSES: The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. MATERIALS AND METHODS: STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin. RESULTS: Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95% CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5 h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95% CI: 1.93 to 6.15; p = 0.0016). CONCLUSIONS: In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. CLINICAL TRIAL REGISTRATION: Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

Plasma concentrations of lipoproteins and risk of lower-limb peripheral artery disease in people with type 2 diabetes: the SURDIAGENE study.

AIMS/HYPOTHESIS: The lipid profile has not been fully investigated in individuals with peripheral artery disease (PAD). We aimed to evaluate the relationship between plasma concentrations of lipoproteins and the prevalence of lower-limb PAD at baseline and its incidence during follow-up in people with type 2 diabetes. METHODS: Plasma concentrations of total cholesterol, HDL-cholesterol, triacylglycerol and apolipoprotein (Apo) A-I, ApoA-II, ApoB-100 and Apo(a) were measured at baseline using colorimetric or MS methods in the SURDIAGENE cohort. Total cholesterol/HDL-cholesterol ratio, non-HDL-cholesterol and LDL-cholesterol were estimated using computation formulas. Logistic and Cox proportional hazard regression models were fitted to estimate OR or HR, with related 95% CI, for baseline prevalence or incidence of major PAD (lower-limb amputation or requirement of revascularisation) during follow-up by increasing lipoprotein tertiles, after adjustment for key confounders. RESULTS: Among 1468 participants (women 42%, mean ± SD age 65 ± 11 years, duration of diabetes 14 ± 10 years at baseline), 129 (8.8%) had a baseline history of major PAD. Major PAD was less prevalent at baseline in the highest (vs lowest) tertile of HDL-cholesterol (OR 0.42 [95% CI 0.26, 0.71], p = 0.001) and ApoA-I (OR 0.39 [95% CI 0.23, 0.67], p = 0.0007), and more frequent in the highest tertile of total cholesterol/HDL-cholesterol ratio (OR 1.95 [95% CI 1.18, 3.24], p = 0.01). Among 1339 participants without a history of PAD at baseline, incident PAD occurred in 97 (7.2%) during a median (25th-75th percentile) duration of follow-up of 7.1 (4.4-10.7) years, corresponding to 9685 person-years and an incidence rate of 9.8 (95% CI 8.0, 12.0) per 1000 person-years. The risk of incident PAD was lower in the top (vs bottom) tertile of HDL-cholesterol (HR 0.54 [95% CI 0.30, 0.95], p = 0.03) or ApoA-I (HR 0.50 [95% CI 0.28, 0.86], p = 0.01) and higher in the top tertile of total cholesterol/HDL-cholesterol ratio (HR 2.81 [95% CI 1.61, 5.04], p = 0.0002) and non-HDL-cholesterol (HR 1.80 [95% CI 1.06, 3.12], p = 0.03). CONCLUSIONS/INTERPRETATION: We reported independent associations between HDL-cholesterol, ApoA-I, total cholesterol/HDL-cholesterol ratio or non-HDL-cholesterol and the prevalence or the incidence of major PAD in people with type 2 diabetes. Our findings provide a picture of lipoprotein profile in people with type 2 diabetes. Graphical abstract.

Relationship Between Diabetic Retinopathy Stages and Risk of Major Lower-Extremity Arterial Disease in Patients With Type 2 Diabetes.

OBJECTIVE: We evaluated the association between diabetic retinopathy stages and lower-extremity arterial disease (LEAD), its prognostic value, and the influence of potential contributors to this relationship in a prospective cohort of patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Diabetic retinopathy was staged at baseline as absent, nonproliferative, or proliferative. A Cox regression model was fitted in order to compute the hazard ratio (HR) (95% CI) for major LEAD (lower-limb amputation or revascularization) during follow-up by baseline retinopathy stages. The retinopathy-LEAD association was assessed in subgroups by age, sex, diabetes duration, HbA1c, systolic blood pressure, diabetic kidney disease, smoking, and macrovascular disease at baseline. The performance of retinopathy in stratifying LEAD risk was assessed by using the C statistic, integrated discrimination improvement (IDI), and net reclassification improvement (NRI). RESULTS: Among 1,320 participants without a history of LEAD at baseline, 94 (7.1%) developed a major LEAD during a 7.1-year median follow-up (incidence rate 9.6 per 1,000 person-years [95% CI 7.8-11.7]). The LEAD incidence rate (per 1,000 person-years) increased as retinopathy worsened: it was 5.5 (95% CI 3.9-7.8) in participants in whom retinopathy was absent, 14.6 (11.1-19.3) in those with nonproliferative retinopathy, and 20.1 (11.1-36.3) in those with proliferative retinopathy. Nonproliferative retinopathy (adjusted HR 2.31 [95% CI 1.43-3.81], P = 0.0006) and proliferative retinopathy (3.14 [1.40-6.15], P = 0.007) remained associated with major LEAD. No heterogeneity was observed across subgroups. Retinopathy enhanced the C statistic (+0.023 [95% CI 0.003-0.044], P = 0.02), IDI (0.209 [0.130-0.321], P < 0.001), and NRI (0.562 [0.382-0.799], P < 0.001) values for risk of LEAD, beyond traditional risk factors. CONCLUSIONS: An independent dose-response relationship was identified between diabetic retinopathy stages and major LEAD. Retinopathy yielded incremental prognostic information for stratifying risk of LEAD, suggesting its usefulness as a predictor of LEAD.

Delayed severe median nerve palsy due to undiagnosed brachial pseudoaneurysm.

Post-catheterization pseudoaneurysms are a well-known complication of many endovascular procedures at the site of arterial puncture. However, long-term neurological complications due to undiagnosed compression are rare. A 60-year-old man presented to our unit for round, non-pulsatile, painless swelling in the inner side of his upper arm. Clinical examination showed finger paralysis, associated with amyotrophy of the forearm. Large brachial pseudoaneurysm with median nerve compression was diagnosed. The patient underwent autologous vein bypass, with poor 6-month neurological recovery. Early diagnosis of pseudoaneurysms is paramount because, when associated with nerve compression, the longer the diagnostic delay, the poorer the neurological prognosis.

Multicentre Experience with the Chimney Technique for Abdominal Aortic Aneurysms in French University Hospitals.

OBJECTIVE: The chimney technique (ChEVAR) allows for proximal landing zone extension for endovascular repair of complex aortic aneurysms. The aim of the present study was to assess ChEVAR national outcomes in French university hospital centres. METHODS: All centres were contacted and entered data into a computerised online database on a voluntary basis. Clinical and radiological data were collected on all consecutive ChEVAR patients operated on in 14 centres between 2008 and 2016. Patients were deemed unfit for open repair. Factors associated with early (30 day or in hospital) mortality and type 1 endoleak (Type I EL) were calculated using multivariable analysis. RESULTS: In total, 201 patients with 343 target vessels were treated. There were 94 juxtarenal (46.8%), 67 pararenal (33.3%), 10 Crawford type IV thoraco-abdominal (5%) aneurysms, and 30 (15.1%) proximal failures of prior repairs. The pre-operative diameter was 66.8 ± 16.7 mm and 28 (13.9%) ChEVAR were performed as an emergency, including six (2.9%) ruptures. There were 23 (11.7%) unplanned intra-operative procedures, mainly related to access issues. The rate of early deaths was 11.4% (n = 23). The elective mortality rate was 9.8% (n = 17). Nine patients (4.5%) presented with a stroke. The rate of early proximal Type I EL was 11.9%. Survival was 84.6%, 79.4%, 73.9%, 71.1% at 6, 12, 18, and 24 months, respectively. The primary patency of chimney stents was 97.4%, 96.7%, 95.2%, and 93.3% at 6, 12, 18, and 24 months, respectively. Performing unplanned intra-operative procedures (OR 3.7, 95% CI 1.3-10.9) was identified as the only independent predictor of post-operative death. A ChEVAR for juxtarenal aneurysm was independently associated with fewer post-operative Type I ELs (OR 0.17, 95% CI 0.05-0.58). CONCLUSION: In this large national ChEVAR series, early results were concerning. The reasons may lie in heterogeneous practices between centres and ChEVAR use outside of current recommendations regarding oversizing rates, endograft types, and sealing zones. Future research should focus on improvements in pre-operative planning and intra-operative technical aspects.

Lower limb events in individuals with type 2 diabetes: evidence for an increased risk associated with diuretic use.

AIMS/HYPOTHESIS: Recently, safety data signalled an increased risk of amputations in people taking canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. If this side effect is due to drug-induced hypovolaemia, diuretics should also increase that risk. The aim of this study was to analyse the association between diuretic use and the risk of lower limb events (LLEs) in people with type 2 diabetes. METHODS: SURDIAGENE (SUivi Rénal, DIAbète de type 2 et GENEtique) is a prospective observational cohort that includes people with type 2 diabetes enrolled from 2002 to 2012 and followed-up until onset of LLE, death or 31 December 2015, whichever came first. Primary outcome was the first occurrence of LLE, a composite of lower limb amputation (LLA) and lower limb revascularisation (LLR). The rates of primary outcome were compared between participants taking and not taking diuretics at baseline in a Cox-adjusted model. RESULTS: At baseline, of the 1459 participants included, 670 were taking diuretics. In participants with and without diuretics, the mean ages were 67.1 and 62.9 years and 55.8% and 59.8% were men, respectively. During a median follow-up of 7.1 years, the incidence of LLE was 1.80 per 100 patient-years in diuretic users vs 1.00 in non-users (p < 0.001). The HR for LLE in users vs non-users was 2.08 (95% CI 1.49, 2.93), p < 0.001. This association remained significant in a multivariable-adjusted model (1.49 [1.01, 2.19]; p = 0.04) and similar after considering death as a competing risk (subhazard ratio 1.89 [1.35, 2.64]; p < 0.001). When separated, LLA but not LLR, was associated with the use of diuretics: 2.01 (1.14, 3.54), p = 0.02 and 1.05 (0.67, 1.64), p = 0.84, respectively, in the multivariable-adjusted model. CONCLUSIONS/INTERPRETATION: Among people with type 2 diabetes treated with diuretics, there was a significant increase in the risk of LLE, predominantly in the risk of LLA.

Prognostic Values of Inflammatory and Redox Status Biomarkers on the Risk of Major Lower-Extremity Artery Disease in Individuals With Type 2 Diabetes.

OBJECTIVE: Inflammation and oxidative stress play an important role in the pathogenesis of lower-extremity artery disease (LEAD). We assessed the prognostic values of inflammatory and redox status biomarkers on the risk of LEAD in individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: Plasma concentrations of tumor necrosis factor-α receptor 1 (TNFR1), angiopoietin-like 2, ischemia-modified albumin (IMA), fluorescent advanced glycation end products, protein carbonyls, and total reductive capacity of plasma were measured at baseline in the SURDIAGENE (Survie, Diabete de type 2 et Genetique) cohort. Major LEAD was defined as the occurrence during follow-up of peripheral revascularization or lower-limb amputation. RESULTS: Among 1,412 participants at baseline (men 58.2%, mean [SD] age 64.7 [10.6] years), 112 (7.9%) developed major LEAD during 5.6 years of follow-up. High plasma concentrations of TNFR1 (hazard ratio [95% CI] for second vs. first tertile 1.12 [0.62-2.03; P = 0.71] and third vs. first tertile 2.16 [1.19-3.92; P = 0.01]) and of IMA (2.42 [1.38-4.23; P = 0.002] and 2.04 [1.17-3.57; P = 0.01], respectively) were independently associated with an increased risk of major LEAD. Plasma concentrations of TNFR1 but not IMA yielded incremental information, over traditional risk factors, for the risk of major LEAD as follows: C-statistic change (0.036 [95% CI 0.013-0.059]; P = 0.002), integrated discrimination improvement (0.012 [0.005-0.022]; P < 0.001), continuous net reclassification improvement (NRI) (0.583 [0.294-0.847]; P < 0.001), and categorical NRI (0.171 [0.027-0.317]; P = 0.02). CONCLUSIONS: Independent associations exist between high plasma TNFR1 or IMA concentrations and increased 5.6-year risk of major LEAD in people with type 2 diabetes. TNFR1 allows incremental prognostic information, suggesting its use as a biomarker for LEAD.

Use of VIABAHN Open Revascularisation TEChnique (VORTEC) for Iliofemoral Bypass.

INTRODUCTION: The VIABAHN Open Revascularisation TEChnique (VORTEC) was initially described for visceral revascularisation and supra-aortic reconstruction for complex aortic hybrid surgery. Herein is reported the use of this innovative technique for revascularisation of the iliofemoral arteries. REPORT: The use of the VORTEC to perform proximal anastomosis of a prosthetic iliofemoral bypass in two symptomatic patients with heavily calcified iliac artery lesions and redo surgery, respectively, is reported. DISCUSSION: In case of loco-regional hostile conditions, a sutureless telescoping iliac anastomosis should be considered as a valuable adjunct in iliofemoral revascularisation.

Influence of micro- and macro-vascular disease and Tumor Necrosis Factor Receptor 1 on the level of lower-extremity amputation in patients with type 2 diabetes.

BACKGROUND: Patients with type 2 diabetes (T2D) face a high amputation rate. We investigated the relationship between the level of amputation and the presence of micro or macro-vascular disease and related circulating biomarkers, Tumor Necrosis Factor Receptor 1 (TNFR1) and Angiopoietin like-2 protein (ANGPTL2). METHODS: We have analyzed data from 1468 T2D participants in a single center prospective cohort (the SURDIAGENE cohort). Our outcome was the occurrence of lower limb amputation categorized in minor (below-ankle) or major (above ankle) amputation. Microvascular disease was defined as a history of albuminuria [microalbuminuria: uACR (urinary albumine-to-creatinine ratio) 30-299 mg/g or macroalbuminuria: uACR ≥ 300 mg/g] and/or severe diabetic retinopathy or macular edema. Macrovascular disease at baseline was divided into peripheral arterial disease (PAD): peripheral artery revascularization and/or major amputation and in non-peripheral macrovascular disease: coronary artery revascularization, myocardial infarction, carotid artery revascularization, stroke. We used a proportional hazard model considering survival without minor or major amputation. RESULTS: During a median follow-up period of 7 (0.5) years, 79 patients (5.5%) underwent amputation including 29 minor and 50 major amputations. History of PAD (HR 4.37 95% CI [2.11-9.07]; p < 0.001), severe diabetic retinopathy (2.69 [1.31-5.57]; p = 0.0073), male gender (10.12 [2.41-42.56]; p = 0.0016) and serum ANGPTL2 concentrations (1.25 [1.08-1.45]; p = 0.0025) were associated with minor amputation outcome. History of PAD (6.91 [3.75-12.72]; p < 0.0001), systolic blood pressure (1.02 [1.00-1.03]; p = 0.004), male gender (3.81 [1.67-8.71]; p = 0.002), and serum TNFR1 concentrations (HR 13.68 [5.57-33.59]; p < 0.0001) were associated with major amputation outcome. Urinary albumin excretion was not significantly associated with the risk of minor and major amputation. CONCLUSIONS: This study suggests that the risk factors associated with the minor vs. major amputation including biomarkers such as TNFR1 should be considered differently in patients with T2D.

Impact of angiosome- and nonangiosome-targeted peroneal bypass on limb salvage and healing in patients with chronic limb-threatening ischemia.

BACKGROUND: Direct (DIR) or indirect (IND) revascularization of pedal angiosomes in patients with chronic limb-threatening ischemia (CLTI) has an unclear impact on limb salvage and healing. The aim of this study was to evaluate the outcomes of DIR and IND revascularization in patients with a peroneal bypass and tissue loss. METHODS: We conducted a retrospective study of a prospectively maintained database in two European university centers from 2004 to 2015. We extracted from this database all patients with CLTI and tissue loss who had received a bypass to the peroneal artery. All patients underwent angiography before bypass. Revascularization was considered DIR if the wound was in a peroneal angiosome. Wounds, ischemia, and infection were categorized according to the Wound, Ischemia, and foot Infection (WIfI) classification. Limb salvage and amputation-free survival were calculated using the Kaplan-Meier method. Cox regression was used to compare the role of patient characteristics, including diabetes, peroneal runoff, pedal arch angiosome, WIfI grade, chronic kidney disease, and diabetes, in amputation-free-survival. RESULTS: From January 2004 through October 2015, there were 120 peroneal bypasses performed in 120 patients with CLTI and foot tissue loss. Only 55 wounds (46%) could be ascribed to a peroneal angiosome. At 3 years, amputation-free survival in patients with DIR revascularization was 54.9% ± 7.3% compared with 56.5% ± 6.3% in patients with IND revascularization (P = .44), with no significant difference in wound healing. Amputation-free survival at 3 years in patients with two patent peroneal branches was 74.8% ± 6.9% compared with 45.0% ± 6.0% in patients with one patent peroneal branch (P = .003). Amputation-free survival at 3 years in patients with a patent pedal arch (Rutherford 0-1) was 73.0% ± 7.0% vs 45.7% ± 6.0% in patients with incomplete pedal arch (Rutherford 2-3; P = .0002). Amputation-free survival at 3 years in patients with grade 1 or grade 2 WIfI was 87.4% ± 8.3% compared with 48.4% ± 5.3% in patients with grade 3 or grade 4 WIfI (P = .001). Amputation-free survival at 3 years in patients with diabetes was 43.7% ± 6.2% compared with 73.1% ± 6.7% in patients without diabetes (P = .002). Wound healing at 6 months was not significantly improved by its location within or outside a peroneal angiosome. Cox regression analysis demonstrated that diabetes, patency of both peroneal branches, patency of pedal arch, and WIfI stage but not DIR angiosome revascularization were significant predictors of amputation-free survival. CONCLUSIONS: Our results suggest that in patients with CLTI and tissue loss receiving a peroneal bypass, patency of both peroneal branches and pedal arch was associated with a better healing rate and a better amputation-free survival rate irrespective of wound angiosome location.

Prosthetic bypass for restenosis after endarterectomy or stenting of the carotid artery.

OBJECTIVE: The objective of this study was to evaluate the results of prosthetic carotid bypass (PCB) with polytetrafluoroethylene (PTFE) grafts as an alternative to carotid endarterectomy (CEA) in treatment of restenosis after CEA or carotid artery stenting (CAS). METHODS: From January 2000 to December 2014, 66 patients (57 men and 9 women; mean age, 71 years) presenting with recurrent carotid artery stenosis ≥70% (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) were enrolled in a prospective study in three centers. The study was approved by an Institutional Review Board. Informed consent was obtained from all patients. During the same period, a total of 4321 CEAs were completed in the three centers. In these 66 patients, the primary treatment of the initial carotid artery stenosis was CEA in 57 patients (86%) and CAS in nine patients (14%). The median delay between primary and redo revascularization was 32 months. Carotid restenosis was symptomatic in 38 patients (58%) with transient ischemic attack (n = 20) or stroke (n = 18). In this series, all patients received statins; 28 patients (42%) received dual antiplatelet therapy, and 38 patients (58%) received single antiplatelet therapy. All PCBs were performed under general anesthesia. No shunt was used in this series. Nasal intubation to improve distal control of the internal carotid artery was performed in 33 patients (50%), including those with intrastent restenosis. A PTFE graft of 6 or 7 mm in diameter was used in 6 and 60 patients, respectively. Distal anastomosis was end to end in 22 patients and end to side with a clip distal to the atherosclerotic lesions in 44 patients. Completion angiography was performed in all cases. The patients were discharged under statin and antiplatelet treatment. After discharge, all of the patients underwent clinical and Doppler ultrasound follow-up every 6 months. Median length of follow-up was 5 years. RESULTS: No patient died, sustained a stroke, or presented with a cervical hematoma during the postoperative period. One transient facial nerve palsy and two transient recurrent nerve palsies occurred. Two late strokes in relation to two PCB occlusions occurred at 2 years and 4 years; no other graft stenosis or infection was observed. At 5 years, overall actuarial survival was 81% ± 7%, and the actuarial stroke-free rate was 93% ± 2%. There were no fatal strokes. CONCLUSIONS: PCB with PTFE grafts is a safe and durable alternative to CEA in patients with carotid restenosis after CEA or CAS in situations in which CEA is deemed either hazardous or inadvisable.

Dual Antiplatelet Therapy Does Not Increase the Risk of Bleeding After Carotid Endarterectomy: Results of a Prospective Study.

BACKGROUND: The purpose of this study was to evaluate the risk of bleeding and other postoperative complications of carotid endarterectomy (CEA) in patients receiving dual antiplatelet therapy (DAPT). METHODS: From January 2005 to December 2015, 188 consecutive patients undergoing CEA and receiving DAPT (aspirin 100 mg + clopidogrel 75 mg) were enrolled in a prospective study. All of them underwent coronary artery stenting with drug-eluting stents during the 6 months preceding CEA. In the entire series, DAPT was continued until the evening before CEA and resumed on the evening of the operation. All patients received intraoperative heparinization (5,000 IU before carotid clamping), which was reversed in 5 patients. In addition, all of them were given 2,000 units of enoxaparin every 12 hr after the operation, beginning 6 hr after completion of the operation, and until discharge. All the patients presented with carotid artery stenosis >70% (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria), which was symptomatic in 42 patients (transient ischemic attack, n = 32; minor stroke, n = 10) and asymptomatic in 146. The CEA technique was standard, with prosthetic patch closure in 109 cases (58%) and eversion in 79 (42%). The primary endpoints of the study were occurrence of a postoperative cervical hematoma requiring surgical hemostasis and occurrence of cranial nerve injuries. The secondary endpoint was the combined rate of postoperative mortality, stroke, and myocardial ischemia. RESULTS: No postoperative cervical hematoma requiring surgical evacuation occurred in this series. One hypoglossal nerve palsy, regressive within 2 weeks, was observed. Postoperative mortality and neurologic and cardiac morbidity were nil. CONCLUSIONS: CEA under DAPT yields results comparable with those obtained in patients receiving a single antiplatelet treatment. No hemorrhagic complications were observed in this prospective series.

How to manage hypertension with atherosclerotic renal artery stenosis?

The management of atherosclerotic renal artery stenosis (ARAS) in patients with hypertension has been the topic of great controversy. Major contemporary clinical trials such as the Cardiovascular Outcomes for Renal Artery lesions (CORAL) and Angioplasty and Stenting for Renal Atherosclerotic lesions (ASTRAL) have failed to show significant benefit of revascularization over medical management in controlling blood pressure and preserving renal function. We present here the implications and limitations of these trials and formulate recommendations for management of ARAS.

Resection of recurrent neck cancer with carotid artery replacement.

OBJECTIVE: The management of patients with recurrent neck cancer invading the carotid artery is controversial. The purpose of this study was to evaluate overall survival rate, primary patency of vascular reconstructions, and quality-adjusted life-years (QALYs) after en bloc resection of the carotid artery and tumor with in-line polytetrafluoroethylene (PTFE) carotid grafting, followed by radiotherapy. METHODS: From 2000 to 2014, 31 consecutive patients with recurrent neck cancer invading the carotid artery underwent en bloc resection and simultaneous carotid artery reconstruction with a PTFE graft, which was associated in 18 cases with a myocutaneous flap. The primary tumor was a squamous cell carcinoma of the larynx in 17 patients and of the hypopharynx in 7, an undifferentiated carcinoma of unknown origin in 4, and an anaplastic carcinoma of the thyroid in 3. All of the patients underwent postoperative radiotherapy (50-70 Gy), and 10 of them also underwent chemotherapy (doxorubicin and cisplatin). RESULTS: None of the patients died or sustained a stroke during the first 30 days after the index procedure. Postoperative morbidity consisted of 6 transitory dysphagias, 3 vocal cord palsies, 2 wound dehiscences, 1 transitory mandibular claudication, and 1 partial myocutaneous flap necrosis. No graft infection occurred during follow-up. Fifteen patients (48%) died from metastatic cancer during a mean follow-up of 45.4 months (range, 8-175 months). None of the patients showed evidence of local recurrence, stroke, or thrombosis of the carotid reconstruction. The 5-year survival rate was 49 ± 10%. The overall number of QALYs was 3.12 (95% confidence interval, 1.87-4.37) with a significant difference between patients without metastasis at the time of redo surgery (n = 26; QALYs, 3.74) and those with metastasis (n = 5; QALYs, 0.56; P = .005). QALYs were also significantly improved in patients with cancer of the larynx (n = 17; QALYs, 4.69) compared to patients presenting with other types of tumors (n = 14; QALYs, 1.29; P = .032). CONCLUSIONS: Aggressive en bloc resection of recurrent neck cancer with PTFE grafting can be curative in patients without metastases at the time of redo surgery. In this subset of patients, extensive neck surgery with carotid artery replacement can lead to excellent local control of the disease with improved quality of survival.

Chirurgie aortique totalement laparoscopique ou par laparotomie: comparaison des résultats après appariement par un score de propension.

STUDY OBJECTIVE: To compare the postoperative and medium-term outcomes of laparoscopic aortic surgery with those of conventional aortic surgery performed by a surgical team trained in laparoscopic aortic surgery. METHODS: A prospective study was conducted between January 2006 and December 2011 with 228 consecutive patients having undergone aortic bypass surgery for either an abdominal aortic aneurysm (n = 139) or an occlusive aortoiliac disease (n = 89). Conventional open aortic surgery was carried out in 145 patients, and total laparoscopic repair in 83 patients. The composite primary endpoint measure grouped together the following adverse events (AE): (1) any details < 30 days or later deaths related to the operation, (2) postoperative hemorrhage necessitating reoperation, (3) myocardial infarction I 30 days. (4) stroke I 30 days, (5) postoperative respiratory failure necessitating reintubation or assisted ventilation J 4 days, (6) aortic prosthesis infection, (7) aortic prosthesis occlusion, (8) any reoperation related to aortic surgery. In order to diminish biases attributable to the absence of randomization, the two surgical groups were matched by a propensity score enabling analysis of 50 pairs of patients having presented with identical preoperative characteristics. Univariate analysis of the AE occurring during the first 30 postoperative days was followed by multivariate analysis through logistic regression. The incidence rate of AE during follow-up was calculated using the Kaplan-Meier method and the roles of the different covariables were analyzed using the Cox model. RESULTS: Univariate analysis of the groups adjusted for propensity score showed that laparoscopic repair was associated with significantly higher risk of AE over the first 30 postoperative days (p = 0.03). Logistic regression analysis showed that laparoscopic aortic technique (Odds Ratio (OR) ; 4.50) and coronary artery disease (OR ; 4.67) were independently related to occurrence of an AE during the postoperative period. Occurrence of AE during follow-up was analyzed using the Cox model. Only two variables, laparoscopic aortic surgery [Hazard Ratio (HR) ; 4,40 ; CI 95 % 1.70-11.38 ; p. = 0.002] and coronary artery occurrence of an AE during follow-up. The small number of patients prevented a separate analysis with regard to aneurysmal and occlusive aortic disease. CONCLUSIONS: This study suggests that even with a well-trained surgical team, the laparoscopic approach increases risk for AE observed in the course of aortic surgery. ClinicalTrials. gov Identifier: NCT02325700.

Amniotic fluid-derived mesenchymal stem cells prevent fibrosis and preserve renal function in a preclinical porcine model of kidney transplantation.

It is well known that ischemia/reperfusion injuries strongly affect the success of human organ transplantation. Development of interstitial fibrosis and tubular atrophy is the main deleterious phenomenon involved. Stem cells are a promising therapeutic tool already validated in various ischemic diseases. Amniotic fluid-derived mesenchymal stem cells (af-MSCs), a subpopulation of multipotent cells identified in amniotic fluid, are known to secrete growth factors and anti-inflammatory cytokines. In addition, these cells are easy to collect, present higher proliferation and self-renewal rates compared with other adult stem cells (ASCs), and are suitable for banking. Consequently, af-MSCs represent a promising source of stem cells for regenerative therapies in humans. To determine the efficiency and the safety of af-MSC infusion in a preclinical porcine model of renal autotransplantation, we injected autologous af-MSCs in the renal artery 6 days after transplantation. The af-MSC injection improved glomerular and tubular functions, leading to full renal function recovery and abrogated fibrosis development at 3 months. The strong proof of concept generated by this translational porcine model is a first step toward evaluation of af-MSC-based therapies in human kidney transplantation.

Cholesterol crystal embolism and delayed-onset paraplegia after thoracoabdominal aneurysm repair.

Postoperative paraplegia caused by ischemic injury of the spinal cord is the most disabling complication of thoracoabdominal surgery. We described the case of a 75-year-old patient who underwent a thoracoabdominal aneurysm repair (type IV aneurysm according to Crawford classification). The aorta clamping was done at the T11 level without specific medullary protection. The first postoperative week was uneventful. On the postoperative day 8, renal failure and livedo of the left lower limb occurred together with complete hypotonic paraplegia and severe sepsis. Exploratory laparotomy revealed a gangrenous cholecystitis, and skin biopsies showed cholesterol crystals embolisms in the hypodermis small arteries. The patient died on the postoperative day 28 from a multiorgan failure. In this case, paraplegia was due to cholesterol crystal embolism, which migrated secondarily after aortic clamping.