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.

Outcomes in the treatment of aberrant subclavian arteries using the hybrid approach.

OBJECTIVES: Aberrant subclavian artery (ASCA) occurs rarely but is one of the most frequent anatomical variations of the supra-aortic trunks. No consensus has been established on its best treatment. The goal of this study was to report the outcomes of ASCA treated by the hybrid approach. METHODS: This non-interventional retrospective multicentre analysis included patients treated for ASCA by the hybrid approach in 12 French university hospitals between 2007 and 2019. The hybrid approach was defined as an endovascular procedure combined with open surgery or a hybrid stent graft. Patients were divided in 4 groups (from less to more complex treatment). The primary end point was 30-day mortality. The secondary end points were 30-day complications and late mortality. RESULTS: This study included 43 patients. The mean age was 65 (SD, standard deviation: 16) years. Symptoms were found in 33 patients. Subclavian revascularization combined with aberrant subclavian artery occlusion was undertaken in 13 patients. Unilateral and bilateral subclavian revascularization combined with a thoracic aortic stent graft was undertaken in 11 and 6 patients, respectively. Total aortic arch repair combined with a thoracic aortic stent graft was undertaken in 13 patients. Thirty-day mortality was 2.3% with a technical success rate of 95.3%. The 30-day major postoperative complication rate was 16.3%: 4 strokes, 2 tamponades, 1 acute respiratory distress syndrome. Mean follow-up was 56.3 (SD: 44.7) months. The late mortality was 18.6%. CONCLUSIONS: The ASCA hybrid approach is feasible, safe and effective with low early mortality. Morbidity is rather high. However, it increases with the complexity of the hybrid approach, which should be kept as simple as possible if the anatomical morphology allows.

Late Outcomes of Carotid Artery Stenting for Radiation Therapy-Induced Carotid Stenosis.

PURPOSE: Carotid artery stenting (CAS) appears as a promising alternative treatment to carotid endarterectomy for radiation therapy (RT)-induced carotid stenosis. However, this is based on a poor level of evidence studies (small sample size, primarily single institution reports, few long-term data). The purpose of this study was to report the long-term outcomes of a multicentric series of CAS for RT-induced stenosis. METHODS: All CAS for RT-induced stenosis performed in 11 French academic institutions from 2005 to 2017 were collected in this retrospective study. Patient demographics, clinical risk factors, elapsed time from RT, clinical presentation and imaging parameters of carotid stenosis were preoperatively gathered. Long-term outcomes were determined by clinical follow-up and duplex ultrasound. The primary endpoint was the occurrence of cerebrovascular events during follow-up. Secondary endpoints included perioperative morbidity and mortality rate, long-term mortality rate, primary patency, and target lesion revascularization. RESULTS: One hundred and twenty-one CAS procedures were performed in 112 patients. The mean interval between irradiation and CAS was 15 ± 12 years. In 31.4% of cases, the lesion was symptomatic. Mean follow-up was 42.5 ± 32.6 months (range 1-141 months). The mortality rate at 5 years was 23%. The neurologic event-free survival and the in-stent restenosis rates at 5 years were 87.8% and 38.9%, respectively. Diabetes mellitus (p=0.02) and single postoperative antiplatelet therapy (p=0.001) were found to be significant predictors of in-stent restenosis. Freedom from target lesion revascularization was 91.9% at 5 years. CONCLUSION: This study showed that CAS is an effective option for RT-induced stenosis in patients not favorable to carotid endarterectomy. The CAS was associated with a low rate of neurological events and reinterventions at long-term follow-up.

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

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

Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial).

Background Color-duplex ultrasonography (DUS) could be an alternative to computed tomography-aortography (CTA) in the lifelong surveillance of patients after endovascular aneurysm repair (EVAR), but there is currently no level 1 evidence. The aim of this study was to assess the diagnostic accuracy of DUS as an alternative to CTA for the follow-up of post-EVAR patients. Methods Between December 16, 2010, and June 12, 2015, we conducted a prospective, blinded, diagnostic-accuracy study, in 15 French university hospitals where EVAR was commonly performed. Participants were followed up using both DUS and CTA in a mutually blinded setup until the end of the study or until any major aneurysm-related morphological abnormality requiring reintervention or an amendment to the follow-up policy was revealed by CTA. Database was locked on October 2, 2017. Our main outcome measures were sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios of DUS against reference standard CTA. CIs are binomial 95% CI. Results This study recruited prospectively 659 post-EVAR patients of whom 539 (82%) were eligible for further analysis. Following the baseline inclusion visit, 940 additional follow-up visits were performed in the 539 patients. Major aneurysm-related morphological abnormalities were revealed by CTA in 103 patients (17.2/100 person-years [95% CI, 13.9-20.5]). DUS accurately identified 40 patients where a major aneurysm-related morphological abnormality was present (sensitivity, 39% [95% CI, 29-48]) and 403 of 436 patients with negative CTA (specificity, 92% [95% CI, 90-95]). The negative predictive value and positive predictive value of DUS were 92% (95% CI, 90-95) and 39% (95% CI, 27-50), respectively. The positive likelihood ratio was 4.87 (95% CI, 2.9-9.6). DUS sensitivity reached 73% (95% CI, 51-96) in patients requiring an effective reintervention. Conclusions DUS had an overall low sensitivity in the follow-up of patients after EVAR, but its performance improved meaningfully when the subset of patients requiring effective reinterventions was considered. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01230203.

A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial.

OBJECTIVES: The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions. BACKGROUND: No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions. METHODS: BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period. RESULTS: Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization. CONCLUSIONS: In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.

Editor's Choice - Durability of Open Repair of Juxtarenal Abdominal Aortic Aneurysms: A Multicentre Retrospective Study in Five French Academic Centres.

OBJECTIVES: With a focus on renal function, the goal of this multicentre study was to assess peri-operative complications and late mortality of open surgical repair (OSR) of juxtarenal abdominal aortic aneurysms (JRAAA). METHODS: From February 2005 to December 2015, 315 consecutive patients undergoing elective OSR of a JRAAA in five French academic centres were evaluated retrospectively. The definition of JRAAA was an aortic aneurysm extending up to but not involving the renal arteries, i.e., a short neck <10 mm. End points included post-operative death; acute kidney injury (AKI) defined by the RIFLE (Risk, Injury, Failure, Loss of function, End stage renal disease) criteria; and long term follow-up with freedom from chronic renal decline (CRD) and any graft related complications. Factors predictive of renal insufficiency were determined by multivariable analysis. RESULTS: Of 315 patients, 292 (92.6%) were men (mean age 68 ± 8 years), and 73 (23.2%) had baseline chronic kidney disease (CKD) with an estimated glomerular filtration rate of <60 mL/min/1.73 m2. The level of aortic clamping was supracoeliac (n = 11), suprarenal (n = 235), or inter-renal above one renal artery (n = 69). The mean duration of renal artery clamping was 24 ± 7 min (range 10-55 min). Eleven patients (3.5%) presented with a renal artery stenosis that was treated conservatively. Perfusion of the renal arteries with a chilled Ringer's solution was used selectively in seven patients (2.2%). The overall 30 day mortality was 0.9% (three patients). AKI occurred in 53 patients (16.8%). Nine patients (2.9%) required temporary dialysis and one patient required chronic dialysis. Predictors of AKI were pre-existing CKD (odds ratio [OR] 2.25, 95% confidence interval [CI] 1.13-4.48; p = .021], diabetes (OR 3.15, 95% CI 1.48-6.71; p = .003), hypertension (OR 3.38, 95% CI 1.33-8.57; p = .01), and age (OR 1.05, 95% CI 1.01-1.10; p = .014). The level of aortic clamping and duration of renal artery clamping were not associated with an increased risk of AKI. The Kaplan-Meier survival estimate was 71% ± 5% at five years. Predictors of CRD during follow up were AKI (hazard ratio [HR] 15.81, 95% CI 5.26-47.54; p = .001), diabetes (HR 4.56, 95% CI 1.57-13.17; p = .005), and pre-existing CKD (HR 2.93, 95% CI 1.19-7.20; p = .019), with freedom from CRD of 89% ± 3% at five years. Surveillance imaging was obtained by computed tomography angiography in 290 patients (92.6%) at a mean follow up of 4.3 ± 2.4 years. Renal artery occlusion occurred in two patients (0.7% of imaged renal arteries). One patient (1.9%) had an aneurysm of the visceral aorta and eight patients had a descending thoracic aneurysm. CONCLUSIONS: This multicentre study suggests that in fit patients, open JRAAA repair can be performed with acceptable operative risk with durable results in terms of both graft integrity and preservation of renal function.

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

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

Lower Rate of Restenosis and Reinterventions With Covered vs Bare Metal Stents Following Innominate Artery Stenting.

PURPOSE: To determine any difference between bare metal stents (BMS) and balloon-expandable covered stents in the treatment of innominate artery atheromatous lesions. MATERIALS AND METHODS: A multicenter retrospective study involving 13 university hospitals in France collected 93 patients (mean age 63.2±11.1 years; 57 men) treated over a 10-year period. All patients had systolic blood pressure asymmetry >15 mm Hg and were either asymptomatic (39, 42%) or had carotid (20, 22%), vertebrobasilar (24, 26%), and/or brachial (20, 22%) symptoms. Innominate artery stenosis ranged from 50% to 70% in 4 (4%) symptomatic cases and between 70% and 90% in 52 (56%) cases; 28 (30%) lesions were preocclusive and 8 (9%) were occluded. One (1%) severely symptomatic patient had a <50% stenosis. Demographic characteristics, operative indications, and procedure details were compared between the covered (36, 39%) and BMS (57, 61%) groups. Multivariate analysis was performed to determine relative risks of restenosis and reinterventions [reported with 95% confidence intervals (CI)]. RESULTS: The endovascular procedures were performed mainly via retrograde carotid access (75, 81%). Perioperative strokes occurred in 4 (4.3%) patients. During the mean 34.5±31.2-month follow-up, 30 (32%) restenoses were detected and 13 (20%) reinterventions were performed. Relative risks were 6.9 (95% CI 2.2 to 22.2, p=0.001) for restenosis and 14.6 (95% CI 1.8 to 120.8, p=0.004) for reinterventions between BMS and covered stents. The severity of the treated lesions had no influence on the results. CONCLUSION: Patients treated with BMS for innominate artery stenosis have more frequent restenoses and reinterventions than patients treated with covered stents.

A Randomized Controlled Trial Comparing Crude Versus Heparin-Bonded PTFE Graft in Below the Knee Bypass Surgery for Critical Limb Ischemia (REPLACE Trial): Design and Protocol.

BACKGROUND: Although autogenous venous grafts are preferable for below-the-knee bypass surgery in patients with critical limb ischemia, some 20% of patients will have no suitable vein for grafting, compelling a resort to artificial graft materials. Retrospective subgroup analyses within published studies comparing heparin-bonded polytetrafluoroethylene (PTFE) with crude PFTE graft in below-the-knee bypass suggest that heparin-bonded graft offers superior long-term patency rates, but this has not been prospectively verified in patients with critical limb ischemia. METHODS: A single-blind randomized controlled trial in 20 French centers has been designed. Patients assessed as having no suitable autologous vein for bypass grafting for critical lower limb ischemia will be randomized to receive either a heparin-bonded PTFE graft or a crude PTFE graft. A literature review suggested expected 1-year patency rates of 53% for the crude ePTFE arm and 74% for the heparin-bonded PTFE arm. On analyzing 1-year patency rate as a binary variable, for a significance level α = 0.05 and a randomization ratio of 1:1, a total of 176 patients (88 in each arm) will be required to obtain approximately 80% power to reject the null hypothesis. Assuming 10% dropout at 1 year and 20% mortality, 228 patients will be randomized (114 patients in each arm). RESULTS: The primary outcome variable will be patency at 1 year assessed by duplex ultrasound color-flow scan. Any intervention to open up or prevent a graft occlusion before 1 year will be classified as loss of patency. Technical success, deaths, complications, major adverse cardiovascular and limb events, length of hospitalization, and quality of life will also be recorded and analyzed as secondary outcome variables. Cost-utility and cost-effectiveness analyses based on standard tariffs in the French health insurance system will be performed. CONCLUSIONS: The REPLACE trial is the first randomized controlled trial designed to determine if heparin-bonded PTFE graft is superior to crude PTFE graft in below-the-knee bypass surgery for critical limb ischemia.

Muscle wasting in patients with end-stage renal disease or early-stage lung cancer: common mechanisms at work.

BACKGROUND: Loss of muscle mass worsens many diseases such as cancer and renal failure, contributes to the frailty syndrome, and is associated with an increased risk of death. Studies conducted on animal models have revealed the preponderant role of muscle proteolysis and in particular the activation of the ubiquitin proteasome system (UPS). Studies conducted in humans remain scarce, especially within renal deficiency. Whether a shared atrophying programme exists independently of the nature of the disease remains to be established. The aim of this work was to identify common modifications at the transcriptomic level or the proteomic level in atrophying skeletal muscles from cancer and renal failure patients. METHODS: Muscle biopsies were performed during scheduled interventions in early-stage (no treatment and no detectable muscle loss) lung cancer (LC), chronic haemodialysis (HD), or healthy (CT) patients (n = 7 per group; 86% male; 69.6 ± 11.4, 67.9 ± 8.6, and 70.2 ± 7.9 years P > 0.9 for the CT, LC, and HD groups, respectively). Gene expression of members of the UPS, autophagy, and apoptotic systems was measured by quantitative real-time PCR. A global analysis of the soluble muscle proteome was conducted by shotgun proteomics for investigating the processes altered. RESULTS: We found an increased expression of several UPS and autophagy-related enzymes in both LC and HD patients. The E3 ligases MuRF1 (+56 to 78%, P < 0.01), MAFbx (+68 to 84%, P = 0.02), Hdm2 (+37 to 59%, P = 0.02), and MUSA1/Fbxo30 (+47 to 106%, P = 0.01) and the autophagy-related genes CTPL (+33 to 47%, P = 0.03) and SQSTM1 (+47 to 137%, P < 0.01) were overexpressed. Mass spectrometry identified >1700 proteins, and principal component analysis revealed three differential proteomes that matched to the three groups of patients. Orthogonal partial least square discriminant analysis created a model, which distinguished the muscles of diseased patients (LC or HD) from those of CT subjects. Proteins that most contributed to the model were selected. Functional analysis revealed up to 238 proteins belonging to nine metabolic processes (inflammatory response, proteolysis, cytoskeleton organization, glucose metabolism, muscle contraction, oxidant detoxification, energy metabolism, fatty acid metabolism, and extracellular matrix) involved in and/or altered by the atrophying programme in both LC and HD patients. This was confirmed by a co-expression network analysis. CONCLUSIONS: We were able to identify highly similar modifications of several metabolic pathways in patients exhibiting diseases with different aetiologies (early-stage LC vs. long-term renal failure). This strongly suggests that a common atrophying programme exists independently of the disease in human.

Prospective evaluation of a dynamic insulin infusion algorithm for non critically-ill diabetic patients: A before-after study.

INTRODUCTION: Insulin infusion is recommended during management of diabetic patients in critical care units to rapidly achieve glycaemic stability and reduce the mortality. The application of an easy-to-use standardized protocol, compatible with the workload is preferred. Glycaemic target must quickly be reached, therefore static algorithms should be replaced by dynamic ones. The dynamic algorithm seems closer to the physiological situation and appreciates insulin sensitivity. However, the protocol must meet both safety and efficiency requirements. Indeed, apprehension from hypoglycaemia is the main deadlock with the dynamic algorithms, thus their application remains limited. In contrary to the critical care units, to date, no prospective study evaluated a dynamic algorithm of insulin infusion in non-critically ill patients. AIM: This study primarily aimed to evaluate the efficacy of a dynamic algorithm of intravenous insulin therapy in non-critically-ill patients, and addressed its safety and feasibility in different departments of our university hospital. METHODS: A "before-after" study was conducted in five hospital departments (endocrinology and four "non-expert" units) comparing a dynamic algorithm (during the "after" period-P2) to the static protocol (the "before" period-P1). Static protocol is based on determining insulin infusion according to an instant blood glycaemia (BG) level at a given time. In the dynamic algorithm, insulin infusion rate is determined according to the rate of change of the BG (the previous and actual BG under a specific insulin infusion rate). Additionally, two distinct glycaemic targets were defined according to the patients' profile: 100-180 mg/dl (5.5-10 mmol/l) for vigorous patients and 140-220 mg/dl (7.8-12.2 mmol/l) for frail ones. Different BG measurements for each patient were collected and recorded in a specific database (e-CRF) in order to analyse the rates of hypo- and hyperglycaemia. A satisfaction survey was also performed. A study approval was obtained from the institutional revision board before starting the study. RESULTS: Over 8 months, 72 and 66 patients during P1 and P2 were respectively included. The dynamic algorithm was more efficient, with reduced time to control hyperglycaemia (P1 vs P2:8.3 vs 5.3 hours; HR: 2.02 [1.27; 3.21]; p<0.01), increased the number of in-target BG measurements (P1 vs P2: 37.0% vs 41.8%; p<0.05), and reduced the glycaemic variability related to each patient (P1 vs P2, %CV: 40.9 vs 38.2;p<0.05, Index Correlation Class:0.30 vs 0.14; p<0.05). In patients after the first event of hypoglycemia after having started the infusion, new events were lower (P1 vs P2: 19.4 vs 11.4; p<0.001) thanks to an earlier reaction to hypoglycaemia (8.3% during P1 vs 44.3% during P2; p = 0.004). With the dynamic algorithm, the percentage of recurrence of mild hypoglycaemia was significantly lower in frail patients (20.5% vs 10.2%; p<0.001), and in patients managed in the non-expert units (18 vs 7.1%, p<0.001). The %CV was significantly improved in frail patients (36.9%). Mean BG measurements for each patient/day were 5.5±1.1 during P1 and 6.0±1.6 during P2 (p = 0.6). The threat from hypoglycaemia and the difficulty in using dynamic algorithm are barriers for nurses' adherence. CONCLUSIONS: This dynamic algorithm for non-critically-ill patients is more efficient and safe than the static protocol, and adapted for frail patients and non-expert units.

Treatment of Complex Aortic Aneurysms Using Combination of Renal and Visceral Bypass and Fenestrated/Branched Stent Grafts.

BACKGROUND: The purpose of this study was to report our experience of treatment of aortic aneurysms using combination of renal and visceral arteries bypasses and fenestrated/branched stent graft in various complex anatomical situations. METHODS: Between November 2005 and March 2017, 10 patients underwent a hybrid strategy combining bypasses for renal and/or visceral arteries and custom-made fenestrated/branched stent grafts. Two patients had abdominal aortic aneurysm (1 juxtarenal and 1 suprarenal), and 8 patients had thoracoabdominal aortic aneurysm (1 type I, 2 type II including one dissection, 2 type III, 1 type IV, and 2 type V). In total, 37 renal and visceral arteries were targeted, of which 23 were treated using fenestrated or branched stent graft and 14 were treated by bypass (11 to renal artery and 3 to celiac trunk). RESULTS: Technical success was 100%, and no patient died during a mean follow-up of 24.3 ± 21 months. Six patients had 7 postoperative complications after bypass surgery, and 3 patients had 3 complications after fenestrated or branched endovascular aneurysm repair (FEVAR/BEVAR) procedure. Seven reinterventions were performed in 3 patients. No occlusion of target vessels occurred. Renal function was stable during follow-up in all patients except one who developed end-stage renal failure requiring permanent dialysis. On the last follow-up computed tomography scan, aneurysm diameter decreased for 6 patients, was stable for 3 patients, and increased for one patient, in which persistent type II endoleak was observed. Aneurysm exclusion was complete in the remaining 9 patients. CONCLUSIONS: Combination of FEVAR/BEVAR procedures with renal and/or visceral artery bypass in patients with complex aortic aneurysms is feasible with acceptable results. Morbidity associated with bypass surgery has to be carefully balanced with the risk of catheterization difficulties in the setting of adverse anatomical features of the visceral/renal arteries or the aorta.

Cryopreserved arterial allografts for in situ reconstruction of abdominal aortic native or secondary graft infection.

OBJECTIVE: The objective of this study was to evaluate the early and long-term outcome of cryopreserved arterial allografts (CAAs) used for in situ reconstruction of abdominal aortic native or secondary graft infection and to identify predictors of mortality. METHODS: We retrospectively included 71 patients (mean age, 65.2 years [range, 41-84 years]; men, 91.5%) treated for abdominal aortic native or secondary graft infection (65 prosthetic graft infections; 16 of them had secondary aortoenteric fistula, 2 venous graft infections, and 4 mycotic aneurysms) by in situ reconstruction with CAA in the university hospitals of Clermont-Ferrand and Saint-Etienne from 2000 to 2016. The cryopreservation protocol was identical in both centers (-140°C). Early (<30 days) and late (>30 days) mortality and morbidity, reinfection, and CAA patency were assessed. Computed tomography was performed in all survivors. Survival was analyzed with the Kaplan-Meier method. Univariate analyses were performed with the log-rank test and multivariate analysis with the Cox regression model. RESULTS: Mean follow-up was 45 months (0-196 months). Early postoperative mortality rate was 16.9% (11/71). Early postoperative CAA-related mortality rate was 2.8% (2/71); both patients died of proximal anastomotic rupture on postoperative days 4 and 15. Early CAA-related reintervention rate was 5.6% (4/71); all had an anastomotic rupture, and two were lethal. Early postoperative reintervention rate was 15.5% (11/71). Intraoperative bacteriologic samples were positive in 56.3%, and 31% had a sole microorganism. Escherichia coli was more frequently identified in the secondary aortoenteric fistula and Staphylococcus epidermidis in the infected prosthesis. Late CAA-related mortality rate was 2.8%: septic shock at 2 months in one patient and proximal anastomosis rupture at 1 year in one patient. Survival at 1 year, 3 years, and 5 years was 75%, 64%, and 54%, respectively. Multivariate analysis identified type 1 diabetes (hazard ratio, 2.49; 95% confidence interval, 1.05-5.88; P = .04) and American Society of Anesthesiologists class 4 (hazard ratio, 2.65; 95% confidence interval, 1.07-6.53; P = .035) as predictors of mortality after in situ CAA reconstruction. Reinfection rate was 4% (3/71). Late CAA-related reintervention rate was 12.7% (9/71): proximal anastomotic rupture in one, CAA branch stenosis/thrombosis in five, ureteral-CAA branch fistula in one, and distal anastomosis false aneurysm in two. Primary patency at 1 year, 3 years, and 5 years was 100%, 93%, and 93%, respectively. Assisted primary patency at 1 year, 3 years, and 5 years was 100%, 96%, and 96%, respectively. No aneurysm or dilation was observed. CONCLUSIONS: The prognosis of native or secondary aortic graft infections is poor. Aortic in situ reconstruction with CAA offers acceptable early and late results. Patients with type 1 diabetes and American Society of Anesthesiologists class 4 are at higher risk of mortality.

Stenting or Surgery for De Novo Common Femoral Artery Stenosis.

OBJECTIVES: The TECCO (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND: Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS: From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS: Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2 ± 2.9 days vs. 6.3 ± 3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS: In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term. (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery] [TECCO]; NCT01353651).

Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy.

While both ephedrine and phenylephrine are currently used to treat hypotension occurring during carotid endarterectomy (CEA) under general anaesthesia, phenylephrine may have deleterious effects on the cerebral watershed, due to its exclusively vasoconstrictive action. In this controlled, double-blind randomised trial, we compared the effects of ephedrine and phenylephrine administered in a standardised algorithm to treat the first hypotensive event occurring since induction of anaesthesia until carotid cross-clamping. The algorithm consisted of 1-to-3 boluses of 6 mg of ephedrine or 50 µg of phenylephrine, after a goal-directed fluid therapy. In case of failure, the treatment switched to the other study drug. Cerebral tissue oxygen saturation (SctO2 ) was monitored by near infrared spectroscopy (NIRS), and the primary outcome was the restoring effect of SctO2 (ipsilateral to surgery) to baseline values. Secondary postoperative outcomes were: contralateral SctO2 , neurological outcomes, and plasma S100B protein measured at discharge from post-anaesthesia care unit. Ephedrine treatment provided a higher rate of restoration of ipsilateral SctO2 than phenylephrine (93.2% vs 85.1%, P=.034); this was also noted for contralateral SctO2 (93.5% vs 90.7%, P=.026). The gain in SctO2 on the lowest value during hypotension was also higher under ephedrine than phenylephrine (6.4% vs 4.3% ipsilateral, 5.1% vs 4% contralateral), but not significantly so. Clinical outcomes were unaffected by the treatment, but S100B protein plasma concentration was higher in the phenylephrine group. To conclude, this pilot trial, focusing on intermediate outcomes, suggests that ephedrine should be preferred to phenylephrine to treat hypotension during CEA.

Predictors of Autogenous Arteriovenous Hemodialysis Access Thrombosis after Renal Transplantation.

BACKGROUND: The fate of autogenous arteriovenous fistula (aAVF) after renal transplantation (RT) remains variable. The aim of this study was to determine the predictors for their thrombosis after RT. METHODS: We conducted a monocentric retrospective review of prospective clinical records of 145 patients with a functional aAVF who had an RT between January 2004 and December 2009 in the University Hospital of Clermont-Ferrand. Our primary end point was the thrombosis of the aAVF. Univariate and multiple logistic regression analyses were used to identify risk factors associated to aAVF thrombosis after RT. RESULTS: There were 105 men (72%) and 40 women (28%), mean age 52 years (range: 18.4-74.7 years). The aAVF was created on average 40 months (range: 2-169) before the RT. The aAVF was distal in 96 cases (66%) and proximal in 49 cases (34%). Nineteen aAVF (13.1%) were complicated and required an endovascular or surgical repair before RT. Forty-nine patients (34%) required multiple aAVF (>2). Mean follow-up from RT was 58 months (range: 1 day-123 months) and from aAVF creation 97 months (range: 5-262 months). At the end of the follow-up, 81 aAVFs (59%) were patent, 42 (29%) were thrombosed, and 22 (15%) were surgically closed. Patients that had multiple fistulas before RT and active smokers were significantly at risk to thrombose their aAVF after the RT in univariate (P = 0.03 and P = 0.02, respectively) and multiple logistic regression analyses (P = 0.03 and P = 0.047, respectively). CONCLUSIONS: Thrombosis is a part of the natural history of the aAVF after RT. A history of multiple aAVF creations before RT and active smoking were associated to significant increased risk for fistula thrombosis. Because hemodialysis may be needed after RT, the aAVF patency should be preserved, excepted when the aAVF resulted in complications. Follow-up of the aAVF after RT is important to detect and treat complications before thrombosis occurs.

Eversion carotid endarterectomy without shunt: concerning 1385 consecutive cases.

BACKGROUND: The aim of this study was to evaluate the perioperative results of eversion carotid endarterectomy (e-CEA) without shunt at 30 days. METHODS: From January 2004 to December 2013, 1385 e-CEAs were performed in 981 men and 404 women, for 268 hemispheric, 55 ocular and 12 oculopyramidal symptoms of carotid stenosis. The average age was 71.1 years. The contralateral internal carotid artery (ICA) was occluded in 77 cases. All e-CEAs were performed using Vanmaele technique, with blood pressure monitoring and under general anesthesia except in two cases (locoregional anesthesia alone). The need for application of an intra-arterial shunt was evaluated using visual quantification of adequate retrograde ICA pressure based on the quality of back-bleeding from the ICA. If well pulsatile, a shunt was not required. Otherwise, the systolic blood pressure was increased until a good quality ICA back-flow was obtained. RESULTS: Freedom from intra-arterial shunt placement was 100% as a result of estimation and augmentation of arterial perfusion to demonstrate pulsatile perfusion by retrograde ICA filling. A peroperative angiography was performed in 910 cases. All surgical sites were evaluated postoperatively by Duplex imaging. The overall stroke and death rate was 1.3%. Nine (0.7%) patients died perioperatively. The 24 (1.7%) non-fatal neurologic events were ipsilateral: 6 (0.4%) disabling and 9 (0.6%) regressive stroke, 3 (0.2%) permanent and 1 (0.1%) transient ocular ischemia, and 5 (0.4%) transient ischemic attacks. Three (0.2%) patients had a perioperative myocardial infarction. Eleven compressive neck hematomas (0.8%) were reoperated in emergency. CONCLUSIONS: E-CEA can be performed safely, as a routine technique, based on the surgeon's evaluation of arterial back-bleeding and an increase in ipsilateral arterial perfusion with standard anesthetic procedures. Also e-CEA may be considered a cost effective method of reducing the frequency of intra-arterial shunt placement and adjuncts used to assess adequate cerebral perfusion of the ipsilateral carotid artery during e-CEA.

Renal Function after Fenestrated or Branched Endovascular Aortic Repair: The Early Impairment Predictive Factors.

BACKGROUND: The purpose of this study was to define predictive factors of early renal impairment after fenestrated or branched endovascular aortic repair (FEVAR or BEVAR) for aortic aneurysm. METHODS: Eighty-two patients underwent FEVAR or BEVAR for aortic aneurysm from January 2008 to December 2014. The primary end point was postoperative renal impairment on day 15 (D15). Renal impairment was defined as a 25% decrease in the glomerular filtration rate (GFR) and a GFR < 60 mL/min/1.73 m2 according to the Risk Injury Failure Loss and End-Stage criteria. Univariate and multivariate analyses were used to determine variables associated with early postoperative renal impairment. RESULTS: Seventy-seven of the 82 patients had a creatinine level on D15 and were included in this study, including a total of 145 target renal arteries. A preoperative GFR < 60 mL/min/1.73 m2 was present in 16 (20.8%) patients. On D15, 8 (10.4%) patients had an early postoperative renal impairment and 21 (27.3%) patients had a GFR < 60 mL/min/1.73 m2. A single patient had immediate postoperative dialysis for 10 days. "Perirenal hematoma" and "preoperative renal length under 100 mm" were significantly associated with the occurrence of the renal impairment after mutual adjustment in multivariate analysis (P < 0.001 and P = 0.01). No significant association was found between preoperative renal insufficiency combining all stages or with a GFR < 60 mL/min/1.73 m2 and early renal impairment after surgery (P = 0.096 and P = 0.263). CONCLUSION: The presence of a reduced preoperative renal length and the postoperative occurrence of a perirenal hematoma are predictive factors of renal impairment on D15 for patients treated with FEVAR or BEVAR.