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.

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm.

OBJECTIVE: The aim of this study was to compare midterm results of EndoAnchors in EndoSuture aneurysm repair (ESAR) versus fenestrated endovascular aneurysm repair (FEVAR) in short neck abdominal aortic aneurysm (AAA). METHODS: All patients who underwent an ESAR procedure for a short neck AAA at our center between September 2017 and May 2020 were considered for analysis. To form the control group, preoperative computed tomography angiography of patients who underwent FEVAR for juxtarenal AAA between April 2012 and May 2020 were reviewed and patients who met short neck criteria selected. A propensity-matched score on neck length and neck diameter was calculated, resulting in 18 matched pairs. AAA shrinkage, type Ia endoleaks (EL), AAA-related reinterventions, and AAA-related deaths were compared. RESULTS: The median AAA diameter was 54 mm (interquartile range [IQR], 52-61 mm) versus 58 mm (IQR, 53-63 mm) with a median neck length of 8 mm (IQR, 6-12 mm) vs 10 mm (IQR, 6-13 mm) in ESAR and FEVAR patients, respectively. Technical success was 100% in both groups. Procedural success was 94% in the ESAR group versus 100% in the FEVAR group. The median procedure duration was 138 mm (IQR, 113-182 mm) vs 240 mm (IQR, 199-293 mm) ( P < .001) and the median length of stay was 2 days (IQR, 2-3 days) vs 7 days (IQR, 6-7 days) (P < .001) in ESAR and FEVAR patients, respectively. No major hospital complications were observed in ESAR patients compared with two in FEVAR patients (11%) with one transient acute kidney injury and one transient paraplegia. The median follow-up was 23 months (IQR, 19-33 months) vs 36 months (IQR, 22-57 months) with 67% versus 61% AAA shrinkage in the ESAR and FEVAR groups, respectively (P = .73). No type Ia EL, proximal neck-related reinterventions, or AAA-related deaths were observed in either group. No AAA-related reintervention was observed in the ESAR group versus three reinterventions in the FEVAR group (P = .23). CONCLUSIONS: ESAR seems to be a safe technique with no major postoperative complications or reinterventions observed during follow-up. It seems to offer similar midterm results as FEVAR in terms of type Ia EL, aneurysm shrinkage, and aneurysm-related mortality. ESAR seems to be a good off-the-shelf alternative to FEVAR in case of technical constraints.

An angiosome-centred approach for TcpO2 electrode positioning.

Background: The latest guidelines propose a TcpO2 value of 30 mmHg to help to confirm the diagnosis of chronic limb threatening ischemia. However, placement of electrodes is not standardised. The relevance of an "angiosome-centred" approach for TcpO2 electrode positioning has never been evaluated. We therefore retrospectively analysed our TcpO2 results to study the impact of electrode placement on the different angiosomes of the foot. Patients and methods: Patients consulting the vascular medicine department laboratory for suspicion of CLTI using TcpO2 electrodes placement on the different angiosome arteries of the foot (first inter metatarsal space, lateral edge of the foot and plantar side of the foot) were included. As the mean intra-individual variation is reported to be 8 mmHg, a variation of mean TcpO2 for the 3 locations ≤8 mmHg was considered to be not clinically significant. Results: Thirty-four patients (34 ischemic legs) were analysed. The mean TcpO2 was higher at the lateral edge of the foot (55 mmHg) and plantar side of the foot (65 mmHg) than at the first intermetatarsal space (48 mmHg). There was no clinically significant variation of mean TcpO2 according to anterior/posterior tibial artery patency and fibular artery patency. This was present when stratifying on the number of patent arteries. Conclusions: The present study suggests that multi-electrode TcpO2 is not useful to assess tissue oxygenation in the different angiosomes of the foot to guide surgical decision; first intermetatarsal electrode alone would be preferred. TcpO2 seems rather to evaluate overall tissue oxygenation of the foot. Electrode location on the plantar side of the foot may overestimate results and lead to misinterpretation.

Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Coeliac and Inferior Mesenteric Artery Status.

OBJECTIVE: The benefit of preventive treatment for superior mesenteric artery (SMA) stenosis remains uncertain. The latest European Society for Vascular Surgery (ESVS) guidelines remain unclear given the lack of data in the literature. The aim of this study was to evaluate asymptomatic SMA stenosis prognosis according to the presence of associated coeliac artery (CA) and/or inferior mesenteric artery (IMA) stenosis. METHODS: This was a single academic centre retrospective study. The entire computed tomography (CT) database of a single tertiary hospital was reviewed from 2009 to 2016. Two groups were defined: patients with isolated > 70% SMA stenosis (group A) and patients with both SMA and CA and/or IMA > 70% stenosis (group B). Patient medical histories were reviewed to determine the occurrence of mesenteric disease (MD) defined as development of acute mesenteric ischaemia (AMI) or chronic mesenteric ischaemia (CMI). RESULTS: Seventy-seven patients were included. Median follow up was 39 months. There were 24 patients in group A and 53 patients in group B. In group B, eight (10.4%) patients developed MD with a median onset of 50 months. AMI occurred in five patients with a median of 33 months and CMI in three patients with a median of 88 months. Patients of group B developed more MD (0% vs. 15.1%; p = .052). The five year survival rate was 45% without significant difference between groups. CONCLUSION: Patients with SMA stenosis associated with CA and/or IMA seem to have a higher risk of developing mesenteric ischaemia than patients with isolated SMA stenosis. Considering the low life expectancy of these patients, cardiovascular risk factor assessment and optimisation of medical treatment is essential. Preventive endovascular revascularisation could be discussed for patients with non-isolated > 70% SMA stenosis, taking into account life expectancy.

Analysis of Preoperative CT Scan Can Help Predict Technical Failure of Endovascular Treatment of TASC C-D Aortoiliac Chronic Total Occlusions.

BACKGROUND AND AIMS: To evaluate if features of occlusion analyzable on preoperative computed tomography scan could predict risks of technical failure or iliac rupture of endovascular treatment of TransAtlantic InterSociety Consensus C-D aortoiliac chronic total occlusion. METHODS AND RESULTS: All patients treated by endovascular techniques for a TransAtlantic InterSociety Consensus C-D aortoiliac chronic total occlusion between 2009 and 2016 were included (107 patients, 148 iliac arteries). We evaluated the location of the occlusion and the importance of the arterial calcifications. For this factor, patients were divided into 3 groups: the Black occlusion group with mild or no calcifications, the white occlusion group with moderate no protrusive calcifications, and the white protrusive occlusion group with heavy endoluminal calcifications. Technical failure occurred in 11 iliac arteries and peroperative iliac rupture in 6. The location in the external iliac artery is the most significate risk factor of technical failure in univariate (OR = 9.93; P = 0.0012) and multivariate analysis (OR = 15.26; P = 0.0006). The presence of heavy endoluminal calcifications is a further significate risk factor (OR = 13.88; P = 0.0365). Rupture rate was comparable between the 3 groups. CONCLUSIONS: Preoperative computed tomography scan can predict risk of technical failure but not of iliac rupture.

Anatomical Considerations of Infrageniculate Popliteal Artery Puncture: Alternative Pathway for Retrograde Access After Failed Re-entry.

BACKGROUND: A distal approach in endovascular procedures for revascularization of lowers limbs can be considered in case of no re-entry in subintimal recanalization. The aim of this study is to evaluate the feasibility of a medial approach to the infrageniculate popliteal artery (IPA) using existing computed tomography (CT) scan simulation and punctures performed on cadavers. METHODS AND RESULTS: CT angiographies of lower extremities were used to simulate IPA puncture and puncture trajectory. Tissues damaged during the trajectory between the puncture site and the access-related injuries were analyzed. Anatomical punctures on cadaverous model were also performed. Corpses were placed in supine position, the hip in slight flexion (40°) and abduction (external rotation of 60°). A 16 G needle was used for the IPA puncture. Twelve CT angiography simulations were made. Of these 12 simulations, 9 revealed an isolated lesion of the popliteal vein and 2 isolated lesions of the tibial nerve. A lesion of the tibial nerve and the popliteal vein on the same simulation was once observed. Damage to the medial gastrocnemius muscle could not be avoided in each case. Ten punctures were performed on cadavers with technical success. There were 6 popliteal vein lesions, 3 tibial nerve lesions, and 1 case without lesion. In all cases, damage to the medial gastrocnemius muscle was seen. CONCLUSIONS: This medial approach was feasible and is accompanied by trauma of elements of the popliteal pedicle. Preoperative CT angiography could anticipate best site of puncture and potential access-related injury.

Association between physical activity and sedentary behaviour on carotid atherosclerotic plaques: an epidemiological and histological study in 90 asymptomatic patients.

OBJECTIVE: Carotid atherosclerotic plaques are a source of emboli for stroke. 'Unstable' carotid atherosclerotic plaques may have intraplaque haemorrhages, neovessels, prevalent macrophages, excessive calcium deposits, a large lipid core and a thin fibrous cap. Regular physical activity (PA) may lower the risk of plaques becoming unstable. We evaluated the association of both PA and sedentary behaviour (SB) with carotid plaque histopathology. METHODS: 90 asymptomatic patients who were undergoing carotid endarterectomy for carotid artery narrowing identified on ultrasound reported their PA and SB by questionnaires. We calculated PA intensity in MET (metabolic equivalent of task)-min/week. For analysis, the population was divided into tertiles according to PA (T1PA: the less PA patients; T2PA: the intermediate PA patients; T3PA: the most physically active patients) (T1PA900 and <900 MET-min/week, respectively). All the other features that associate with plaque instability (eg, neovessels, macrophages, etc) did not differ by level of PA or SB. CONCLUSION: In this cross-sectional study of asymptomatic patients who underwent endarterectomy (i) higher reported PA, (ii) intensity of PA and (iii) lower reported SB were associated with lower prevalence of intraplaque haemorrhage. This could be a mechanism whereby PA protects against cerebrovascular disease (stroke) and death.

Results of retrograde open mesenteric stenting for acute thrombotic mesenteric ischemia.

OBJECTIVE: Acute mesenteric ischemia (AMI) is an emergent event with a high mortality rate; survivors have high rates of intestinal failure. Restoration of blood flow using endovascular or surgical revascularization is associated with better outcome in terms of survival rate and intestinal resection. Retrograde open mesenteric stenting (ROMS), which is a hybrid technique, combines two benefits: prompt blood flow restoration with an endovascular approach and inspection and resection of the small bowel. The aim of the study was to assess the results of ROMS in thrombotic AMI in a retrospective multicenter study. METHODS: We retrospectively enrolled all consecutive patients who underwent ROMS revascularization for occlusive thrombotic AMI in three participating tertiary care centers between November 2012 and March 2017. RESULTS: Twenty-five patients (14 men and 11 women; mean age, 64.9 ± 11.6 years) were included. In two patients, ROMS was not possible because of failure of re-entry in the aortic lumen (technical success, 92%). One patient required revascularization of two visceral arteries and underwent an aortohepatic bypass. Five patients (20%) underwent endarterectomy and patch angioplasty of the superior mesenteric artery before retrograde stenting. Thirteen patients (52%) required bowel or colon resection (11 patients required both resections) during the initial procedure with a mean length of small bowel resection of 52 ± 87 cm. The 30-day operative mortality rate was 25%, and the overall 1-year survival rate was 65%. The 1-year primary patency rate was 92%. In one patient, postoperative imaging at 1 month showed stent migration in the aortic bifurcation. CONCLUSIONS: ROMS for thrombotic AMI has a high technical success rate and a high midterm primary patency rate. It could be an alternative procedure to retrograde superior mesenteric artery bypass for patients when percutaneous endovascular revascularization is not indicated or has failed.

Correction to: Comments on Chavent et al.: Renovascular hypertension: results in adulthood of renal autotransplantation performed in children.

In the name of the first author, the element "Della" was misinterpreted as a second given name. In fact, it is part of her surname.

Effects on Mortality and Cardiovascular Events of Adherence to Guideline-Recommended Therapy 4 Years after Lower Extremity Arterial Revascularization.

BACKGROUND: All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and HMG-CoA-reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the current risk of cardiovascular (CV) events and mortality and also to evaluate the effect of pharmacologic treatment on patient's survival, CV events, and additional vascular surgery in vascularized LE-PAD patients. This observational, cohort study analyzed prospectively collected data of 140 consecutive patients after hospitalization for LE-PAD revascularization in the vascular surgery department of our university hospital, between January 1 and June 30, 2013. METHODS: Data from guideline-recommended classes of medications (ACE, ARB, statins, and antiplatelet agents or anticoagulation) were collected at the time of discharge to hospitalization and at the end of the follow-up. Information about mortality, CV events, and additional vascular surgery was collected during follow-up. RESULTS: The mean follow-up of patients was 41 months. Mortality and CV events concerned 24% and 12% of the patients, respectively, and additional vascular surgery was performed in 33% of the patients. There was no difference in mortality and CV event rates according to pharmacologic treatment. Additional vascular surgery rate of LE-PAD patients with best medical treatment tended to be lower than without (incidence rate ratio = 0.5777; 95% confidence interval, 0.3101-1.06; P = 0.08). Best medical treatment was prescribed in 54% of patients at discharge of hospitalization. This proportion (54%) was statistically unchanged at the end of follow-up. CONCLUSIONS: In this small cohort, we failed to show that best medical treatment decreased mortality or CV event rates, but it tended to be associated with decreased additional vascular surgery rate. Further studies taking into consideration the control of CV risk factors could be interesting to demonstrate better outcome from LE-PAD patients with best medical treatment compared with LE-PAD patients without. There is an urgent need for a more effective implementation of currently recommended medication and a continued search after more effective pharmacologic treatment options in LE-PAD.

How Admission to a Vascular Surgery Department Improves Medical Treatment in Patients with Lower Extremity Peripheral Arterial Disease.

BACKGROUND: All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs), and hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the number of patients who received best medical treatment at admission and at discharge from a vascular surgery department. We also examined the number of patients who received adapted medical treatment and every pharmacologic class separately. Finally, we investigated whether there were differences in prescribing rates according to patient characteristics and cardiovascular history, clinical grade of LE-PAD, and the type of surgery practiced. MATERIALS AND METHODS: This study is a retrospective chart analysis of 140 consecutive patients admitted to the vascular surgery department of our university hospital, between January 1, 2013, and June 30, 2013. To be included, patients required a vascular surgery for peripheral arterial disease with atherosclerosis. Data from guideline-recommended classes of medications (antiplatelet agents, ACE, ARBs, and statins) at the time of admission and discharge were collected and compared. RESULTS: Best medical treatment was prescribed in 44% patients before hospital admission and in 50% at discharge (P = 0.10). Before hospital admission, 84% of patients had antiplatelet therapy compared with 96% at discharge (P = 0.0004); 73% had a statin, compared with 83% at discharge (P = 0.001); 64% had an ACE inhibitor or ARB, compared with 63% at the time of discharge (P = 1).The proportion of patients receiving best medical treatment at admission and discharge increased in case of coronary artery disease (P = 0.004). There was no difference in prescriptions of best medical treatment and best or adapted treatments at admission and discharge according to the severity of LE-PAD or type of revascularization. CONCLUSIONS: Admission to a vascular department significantly increased the rate of prescription of antiplatelet and statin therapy, but no significant improvement was achieved for the prescription of best medical treatment and best or adapted treatments.

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.

Factors associated with Clostridium difficile infection: A nested case-control study in a three year prospective cohort.

BACKGROUND: Clostridium difficile infection (CDI) is a serious medical condition that is associated with substantial morbidity and mortality. Identification of risk factors associated with CDI and prompt recognition of patients at risk is key to successfully preventing CDI. METHODS: A 3-year prospective, observational, cohort study was conducted in a French university hospital and a nested case-control study was performed to identify risk factors for CDI. Inpatients aged 18 years or older, suffering from diarrhea suspected to be related to CDI, were asked to participate. RESULTS: A total of 945 patients were included, of which 233 cases had a confirmed CDI. CDI infection was more common in men (58.4%) (P = 0.04) compared with patients with diarrhea not related to C. difficile. Previous hospitalization (P < 0.001), prior treatment with antibiotics (P = 0.001) or antiperistaltics (P = 0.002), liver disease (P = 0.003), malnutrition (P < 0.001), and previous CDI (P < 0.001) were significantly more common in patients with CDI. Multivariate logistic regression analysis showed that exposure to antibiotics in the last 60 days (especially third generation cephalosporins and penicillins with ß-lactamase inhibitor), chronic renal or liver disease, malnutrition or previous CDI, were associated with an independent high risk of CDI. Age was not related with CDI. CONCLUSIONS: This study showed that antibiotics and some comorbid conditions were predictors of CDI. Patients at high risk of acquiring CDI at the time of admission may benefit from careful monitoring of antibiotic prescriptions and early attention to infection control issues. In future, these "high-risk" patients may benefit from novel agents being developed to prevent CDI.