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.

Surgical Management of Carotid Body Tumors: Experience of Two Centers.

BACKGROUND: Carotid body tumors (CBTs) are rare but require surgical resection given their potential for growth and malignancy. For some surgical teams, tumor hypervascularity justifies preoperative embolization to facilitate resection and limit complications. The objective of our study was to evaluate 2 different practices of surgical resection with or without preoperative embolization in a 2-center cohort. METHODS: A consecutive series of patients who underwent CBT surgery, from January 2011 to June 2019, were divided into 2 groups, as to whether they were (embolized CBT [ECBT]) or not (nonembolized CBT [NECBT]) preoperatively embolized. Both groups were compared specifically according to the duration of operation, postoperative complications, and length of stay. RESULTS: Twenty-two patients with a mean age of 48.5 ± 14.3 years were included. In the series, 23 CBTs were resected: 13 were embolized preoperatively; the mean time between embolization and surgery was 2.62 ± 1.50 days. Both groups were comparable based on characteristics of population and tumor, with a mean size of 33.2 ± 11.9 mm. We noted a significant increase in operation duration in the ECBT group: 151 min (±40.9) vs. 87.0 min (±21); P < 0.01. There was no difference between the 2 groups regarding cranial nerve (50% vs. 46%; P = 1), sympathetic nervous system (20% vs. 23%; P = 1), or vascular nerve (20% vs. 23%; P = 0.18) complications. No cerebrovascular accident was identified. The length of stay was 3.60 days (±1.78) vs. 3.73 days (±1.19; P = 0.44). CONCLUSIONS: This study reflects the experience of 2 centers in the management of CBT which is a rare pathology with no standardized treatment. Our series showed no significant difference between the ECBT and NECBT groups regarding postoperative complications and length of hospital stay. The reduction in operating time in the NECBT group remains to be demonstrated.

Preoperative Sizing to Lower In-Stent Restenosis in Peripheral Arterial Occlusive Disease.

BACKGROUND: The primary treatment for lower-extremity peripheral arterial occlusive disease (PAOD) is angioplasty stenting. Its main complication is in-stent restenosis. Poor selection of stent dimensions has been identified as a factor contributing to early in-stent restenosis. The aim of this study is to determine whether the implantation of stents, selected based on arterial morphological reconstruction using a sizing software program, reduces the occurrence of in-stent restenosis. The study also aims to evaluate the potential benefits of routine preoperative sizing. METHODS: Between January 2016 and December 2020, all patients treated for PAOD through scheduled angioplasty stenting in our department were included in the study. Using systematic preoperative computed tomography angiography, precise reconstruction and sizing were performed to select the ideal length and diameter of stents, resulting in the selection of a so-called IDEAL stent. During the procedure, the surgeon implanted either the IDEAL stent or a different one, named the ACTUAL stent, based on intraoperative data and/or availability. We compared the in-stent restenosis rate between IDEAL and ACTUAL stents. RESULTS: There were no significant differences in the overall characteristics between the IDEAL and ACTUAL stent groups. The in-stent restenosis rate at 1 year was 13% (N = 28/212, P = 0.994) in the IDEAL group and 17% (N = 25/149, P = 0.994) in the ACTUAL group. Among the ACTUAL stents, a total of 19.6% of stents with a diameter mismatch when chosen based on arteriography showed a significantly higher restenosis rate during the first year of follow-up (P = 0.02). CONCLUSIONS: Our study did not demonstrate a significant difference in 1-year restenosis rate between the IDEAL and the ACTUAL stent groups. It specifically revealed the significant impact of diameter selection on the intrastent restenosis rate during the first year of follow-up. Stents chosen based on arteriographic criteria, which exhibited diameter discordance, compared to the IDEAL stents group selected using sizing reconstructions, could be either oversized or undersized. This led to a significantly higher restenosis rate at 1 year postoperatively.

Inflammation and oxidative stress markers in type 2 diabetes patients with Advanced Carotid atherosclerosis.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major global health issue and a significant risk factor for atherosclerosis. Atherosclerosis in T2DM patients has been associated with inflammation, insulin resistance, hyperglycemia, dyslipidemia, and oxidative stress. Identifying molecular features of atherosclerotic plaques in T2DM patients could provide valuable insights into the pathogenesis of the disease. METHODS: The MASCADI (Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients) study aimed to investigate the increase of 2-arachidonoyl-lysophatidylcholine (2-AA-LPC) in carotid plaques from T2DM and control patients and to explore its association with plaque vulnerability as well as with blood and intra-plaque biomarkers altered during diabetes. RESULTS: In a population of elderly, polymedicated patients with advanced stage of atherosclerosis, we found that T2DM patients had higher systemic inflammation markers, such as high-sensitivity C-reactive protein (hsCRP) and IL-1ß, higher levels of oxysterols, increased triglyceride levels, and decreased HDL levels as compared to control patients. Furthermore, 2-AA-LPC was significantly enriched in plaques from diabetic patients, suggesting its potential role in diabetic atherosclerosis. Interestingly, 2-AA-LPC was not associated with systemic markers related to diabetes, such as hsCRP, triglycerides, or HDL cholesterol. However, it was significantly correlated with the levels of inflammatory markers within the plaques such as lysophospholipids and 25-hydroxycholesterol, strengthening the link between local inflammation, arachidonic acid metabolism and diabetes. CONCLUSION: Our study is in line with a key role for inflammation in the pathogenesis of diabetic atherosclerosis and highlights the involvement of 2-AA-LPC. Further research is needed to better understand the local processes involved in the alteration of plaque composition in T2DM and to identify potential therapeutic targets. TRIAL REGISTRATION: The MASCADI was registered on ClinicalTrials.gov (clinical registration number: NCT03202823).

Comparative Evaluation of Two Paclitaxel-Coated Stents in an Experimental Setting.

INTRODUCTION: Unlike paclitaxel-coated balloons, pre-clinical data comparing different paclitaxel-coated stents (PCSs) are weak. The study objective was to compare the features of the 2 main PCSs: Eluvia® (Boston Scientific, Marlborough, MA) versus ZilverPTX® (Cook Medical, Bloomington, IN). METHOD: Analysis was carried out on 12 pigs divided into 2 groups: Eluvia® (n=6) and ZilverPTX® (n=6). The pigs received the PCS corresponding to their group in each external iliac artery and were paired one by one, to examine 6 different post-implantation timepoints: after 30 minutes, 6 hours, 24 hours, 3 days, 7 days, and 14 days. The paclitaxel concentration measurements and the histological analysis were carried out under blind testing on the plasma, arterial, lymph node, and muscle samples. A linear regression model and Wilcoxon Mann-Whitney test were used to study the variables. RESULTS: The plasma paclitaxel rate decrease over 24 hours after PCS implantation was significantly different between the two groups, expressed by the correlation coefficient 0.19 (0.14-0.23; p<0.001) with an undetectable concentration at the 10th hour for Eluvia® versus 3 days for ZilverPTX®. Significantly higher paclitaxel concentrations with ZilverPTX® PCS were observed in muscle samples at each timepoint: extensor digitorum brevis 3.2 (1.17-5.23; p=0.005), biceps femoris 4.27 (2.27-6.26; p<0.001), semi-tendinosus 3.79 (1.85-5.73; p=0.001), tibialis anterior 3.0 (1.37-4.64; p=0.001), and in the femoral nodes 2.27±1.74 ng/g versus 0.14±0.13 ng/g (p<0.001). Histological analysis revealed a trend for more marked intimal inflammation in the arteries stented with ZilverPTX® (p=0.063), especially after the 7th and 14th days. CONCLUSION: Such a difference in the concentration of paclitaxel in the plasma, muscles, and lymph nodes between the two stents was higher than expected based on differences in device design. The clinical consequences of these results remain to be elucidated, particularly regarding the concerning presence of paclitaxel in muscles and adjacent lymph nodes. CLINICAL IMPACT: This experimental study compares 2 paclitaxel-coated stents. It demonstrates that differences in stent designs and drug features (coatings and concentrations) translate into differences in terms of concentrations of paclitaxel in the plasma, muscles, and lymph nodes. Our results favor the Eluvia® stent over the ZilverPTX® stent, although more studies are required to confirm this conclusion.

Two-Year Results on Real-World Fenestrated or Branched Endovascular Repair for Complex Aortic Abdominal Aneurysm in France.

PURPOSE: To describe and compare mid-term outcomes from 2 real-world data collection efforts on fenestrated and branched endovascular aortic repair (fbEVAR) for complex abdominal aortic aneurysms (AAAs) in France and to evaluate the potential of health care databases for long-term post-market surveillance (PMS) and continued reimbursement approval. METHODS: Two real-world studies were conducted in France: a retrospective health care database study (SNDS) and a prospective clinical study. In the SNDS study, data from implantation and/or hospital stays occurring during follow-up were extracted for all patients treated with the study devices from April 2012 to December 2018. In the clinical study, high-risk patients undergoing fbEVAR with the study devices were enrolled consecutively at 15 sites in France from December 2016 to November 2018. RESULTS: Data from 1073 patients were extracted from SNDS and compared with analogous variables from 186 patients in the clinical study. Most demographic details were similar between studies (SNDS vs clinical: mean age, 71.9 vs 71.8 years; men, 91.0% vs 89.8%), as was 30-day mortality (SNDS: 5.5%, clinical: 4.3%). Patients received custom-made fenestrated or branched devices (SNDS: 80.7%, clinical: 96.2%) or CE-marked Zenith Fenestrated devices (SNDS: 19.3%, clinical: 3.8%). Initial or technical success was above 94% for both studies. Two-year freedom from all-cause mortality was 80.0% (SNDS) and 85.1% (clinical study). Two-year freedom from aneurysm-related mortality was 93.8% (SNDS) and 94.6% (clinical study). Detailed imaging outcomes were not captured within SNDS; however, information on secondary procedures to restore patency was available and used as a surrogate measure for secondary interventions. Two-year freedom from secondary interventions was 73% for the SNDS study. In the clinical study, at 2 years, aneurysm stability or shrinkage was observed in 92.3% of patients, freedom from target vessel primary patency loss was above 95% for all visceral target vessels, and freedom from secondary interventions was 79.1%. CONCLUSION: Real-world outcomes from the SNDS and clinical study suggest positive mid-term outcomes in high-risk populations following fbEVAR for complex AAAs. The similarities between these studies suggest that the use of health care databases may be an alternative to prospective clinical studies for long-term follow-up and PMS. CLINICAL IMPACT: Positive results following endovascular repair of complex abdominal aortic aneurysms are observed from data extracted from both the French health care database and a post-market clinical study despite initial high-risk patient status and diverse center experience. These outcomes parallel more rigorously designed studies and suggest that with careful study design, real-world data collections have high translatable value to add to the clinical understanding of fenestrated and branched endovascular aortic repair (fbEVAR).

Evaluation of the Effectiveness of Endovascular Treatment of Type 2 Endoleaks.

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) is a safe and minimally invasive alternative to open surgical repair for infra renal aortic aneuvrysm. EVAR requires lifelong post-procedural surveillance. Endoleaks represent the main complication. Type II endoleaks (EL2) are the most frequent and tend to be indolent. Most practitioners do not treat in EL2 as long as they are associated with stable aneurysm diameter. European guidelines recommend treatment in case of aneurysm growth. Several techniques can be offered, such as transarterial embolization and translumbar embolization. This study reports the experience and results of a single center for EL2 endovascular treatment. The aim of this study was to determine more precisely the efficacity of embolization for type 2 endoleaks treatment. METHODS: A single center cohort of patients treated for EL2 with endovascular technique between 1998 and 2018 was formed to perform a descriptive analysis. Preoperative sizing, risk factors of endoleaks and intraoperative data were collected. Computed topography (CT) scans were regularly performed after EVAR to detect endoleak recurrence. Clinical recurrence was defined as the persistence of aneurysm sac growth and radiological recurrence was defined as the occurrence of EL2 on a post-embolization CT scan. Data related to reintervention, overall mortality and aneurysm related mortality were also collected. Kaplan-Meier survival analyses were used to determine the rates of reoperation-free survival and recurrence-free survival. RESULTS: Six hundred seven patients underwent an endovascular treatment for abdominal aorta aneurysm between 1998 and 2018. One hundred forty-five type 2 endoleaks occurred during this period. Nineteen patients (median age 76 years), underwent endovascular treatment for EL2, with immediate success on 15 patients (8 transarterial embolization, 8 direct sac puncture and 3 combined procedures). During follow-up, 5 patients required a new translumbar embolization and 6 required an open surgery for recurrence of the EL2. Six patients died, 2 of them of causes related to the aneurysm. At 59,6 months median follow-up, 53% of the patients presented a radiologic recurrence, with a sac growth of more than 5 mm since last procedure in 4 patients (24%). CONCLUSIONS: Long term clinical recurrence of type 2 endoleaks treated by endovascular procedures appear to be frequent in our experience, leading to several deaths and requiring open surgical treatment.

Impact of the first COVID-19 pandemic peak and lockdown on the interventional management of carotid artery stenosis in France.

OBJECTIVE: The aim of this study was to evaluate the impact of the COVID-19 pandemic on the trends of carotid revascularization (endarterectomy [CEA], transfemoral carotid artery stenting [TFCAS]) for symptomatic and asymptomatic carotid stenosis before, during, and after the end of the first lockdown in 2020 in France. METHODS: Nationwide data were provided by the French National Hospital Discharge database (Programme de Médicalisation des Systèmes d'Information). We retrospectively analyzed patients admitted for CEA or TFCAS in all French public and private hospitals during a 9-month period (January-September) in 2017, 2018, 2019, and 2020. Procedures were identified using the French Common Classification of Medical Procedures. Stenoses were considered symptomatic in the presence of stroke and/or transient ischemic attack codes (according to the International Classification of Diseases-Tenth Revision) during the stay, and asymptomatic in the absence of these codes. Hospitalization rates in 2020 were compared with the rates in the same period in the 3 previous years. RESULTS: Between January and September 2020, 12,546 patients were hospitalized for carotid artery surgery (CEA and TFCAS) in France. Compared with the 3 previous years, there was a decrease in hospitalization rates for asymptomatic (-68.9%) and symptomatic (-12.6%) CEA procedures in April, starting at the pandemic peak concomitant with the first national lockdown. This decrease was significant for asymptomatic CEA (P < .001). After the lockdown, while CEA for asymptomatic stenosis returned to usual activity, CEA for symptomatic stenosis presented a significant rebound, up 18.52% in August compared with previous years. Lockdown also had consequences on TFCAS procedures, with fewer interventions for both asymptomatic (-60.53%) and symptomatic stenosis (-16.67%) in April. CONCLUSIONS: This study demonstrates a severe decrease for all interventions during the first peak of the COVID-19 pandemic in France. However, the trends in the postlockdown period were different for the various procedures. These data can be used to anticipate future decisions and organization for cardiovascular care.

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.

A Prospective Survey of the Incidence of Cranial and Cervical Nerve Injuries After Carotid Surgery.

BACKGROUND: To prospectively evaluate the involvement of the cranial nerves and cervical plexus branches during carotid surgery and to look for risk factors. METHODS: All patients (n = 50) undergoing carotid endarterectomy between June 1st and October 31st, 2016 in our center were evaluated prospectively. A complete neurological examination was done before the intervention then daily until hospital discharge, and then at 2 months, 6 months and 1 year. A nasal endoscopy was systematically performed postoperatively before discharge by an ear, nose, and throat specialist. RESULTS: Twenty-six patients (52%) had at least one damaged nerve immediately after surgery. There were 15 cases involving the VII nerve (30%), 12 the C2-C3 branches (24%), 7 the XII nerve (14%), and 2 the X nerve (4%). At 2 months, 6 months, and 1 year, 22%, 16%, and 8% of lesions remained, respectively. We found no independent factor for nerve damage at 6 months or 1 year. In the case of dysphonia and/or dysphagia without recurrent nerve paralysis, 6 hematomas and 7 laryngeal edemas were identified under nasal endoscopy and all healed without sequelae. CONCLUSIONS: This prospective study showed cranial and cervical nerve injury to be much more frequent than expected in the short-term, when assessed by independent ear, nose, and throat and nasal endoscopy exam. Though mainly transient, these lesions can cause post-operative functional discomfort and must be disclosed preoperatively to the patient, in view of the judicialization of health care.

Continuous Transversus Abdominis Plane Infusion via Surgically Inserted Catheter for Postoperative Analgesia After Abdominal Aortic Surgery by Retroperitoneal Approach: TAPCACAO Study.

BACKGROUND: The purpose of our study was to evaluate the analgesic properties of continuous transversus abdominis plane (TAP) infusion with ropivacaine compared to placebo for postoperative analgesia in elective surgery of the abdominal aorta by retroperitoneal exposure. METHODS: We conducted a prospective, single-center, randomized, double-blind study comparing a group of patients with a TAP catheter undoing ropivacaine infusion with a placebo group. Patients received a left retroperitoneal pararectal exposure for abdominal aortic surgery. A continuous infusion catheter was placed under visual control by the surgeon before closure and removed after 48 hr. All patients had postoperative patient-controlled analgesia with morphine. The primary endpoint was morphine consumption during the first 24 hr. RESULTS: The analysis included 25 patients in the placebo group and 24 in the ropivacaine group. The average morphine consumption during the first 24 hr was significantly different, with 31 ± 16 mg in the ropivacaine group and 41 ± 17 mg in the placebo group (P = 0.019). At 48 hr, morphine consumption was still lower in the ropivacaine group (42 ± 26 mg) than in the placebo group (64 ± 25 mg) (P = 0.003). The opioid narcotic-related side effects of opioid infusion (postoperative nausea and vomiting, constipation) and length of hospital stay were similar in both populations. CONCLUSIONS: Our study showed that continuous TAP block with ropivacaine via surgically inserted catheter significantly decreased morphine consumption at 24 and 48 hr after elective abdominal aortic surgery by retroperitoneal exposure.

Stress Analysis in AAA does not Predict Rupture Location Correctly in Patients with Intraluminal Thrombus.

BACKGROUND: A biomechanical approach to the rupture risk of an abdominal aortic aneurysm could be a solution to ensure a personalized estimate of this risk. It is still difficult to know in what conditions, the assumptions made by biomechanics, are valid. The objective of this work was to determine the individual biomechanical rupture threshold and to assess the correlation between their rupture sites and the locations of their maximum stress comparing two computed tomography scan (CT) before and at time of rupture. METHODS: We included 5 patients who had undergone two CT; one within the last 6 months period before rupture and a second CT scan just before the surgical procedure for the rupture. All DICOM data, both pre- and rupture, were processed following the same following steps: generation of a 3D geometry of the abdominal aortic aneurysm, meshing and computational stress analysis using the finite element method. We used two different modelling scenarios to study the distribution of the stresses, a "wall" model without intraluminal thrombus (ILT) and a "thrombus" model with ILT. RESULTS: The average time between the pre-rupture and rupture CT scans was 44 days (22-97). The median of the maximum stresses applied to the wall between the pre-rupture and rupture states were 0.817 MPa (0.555-1.295) and 1.160 MPa (0.633-1.625) for the "wall" model; and 0.365 MPa (0.291-0.753) and 0.390 MPa (0.343-0.819) for the "thrombus" model. There was an agreement between the site of rupture and the location of maximum stress for only 1 patient, who was the only patient without ILT. CONCLUSIONS: We observed a large variability of stress values at rupture sites between patients. The rupture threshold strongly varied between individuals depending on the intraluminal thrombus. The site of rupture did not correlate with the maximum stress except for 1 patient.

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.

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.

OBJECTIVE: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). METHODS: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. RESULTS: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. CONCLUSION: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold.

Cross-over Deployment of a Tapered Stent Graft to Repair a Ruptured Isolated Internal Iliac Aneurysm.

We report the case of a 72-year-old man who presented with a left ruptured internal iliac aneurysm (IIA). A percutaneous cross-over approach was used to coil-embolize the 3 distal branches of the IIA. A tapered endograft limb was then delivered via the right common femoral artery using a femorofemoral through-and-through cross-over approach. The widest part of the graft was deployed in the common iliac artery and the smallest in the external iliac artery. This percutaneous endovascular technique opens up new perspectives in emergency care for ruptured internal iliac artery aneurysms.

Combined Pull through and Balloon Anchoring Bailout Technique to Repair a Failed Bifurcated Endovascular Aortic Repair.

BACKGROUND: To describe a bailout technique used to manage the left stump of a bifurcated endograft that was stuck above a narrowed distal aortic neck. METHODS: An 80-year-old man with a suprarenal aneurysm was treated with a custom-made 4-vessel fenestration endograft. During the procedure, the left stump of the distal bifurcated graft module was chased out of a narrow distal aortic neck and became stuck horizontally at the bottom of the aortic aneurysmal sac. Through a femoral to left subclavian artery through-and-through percutaneous access, a balloon-anchoring technique was successfully used to return the endograft stump into the narrowed aortic neck and exclude the aneurysm. CONCLUSIONS: The combined technique of a through-and-through and anchoring balloon was found to be suitable for introducing an endograft limb into a narrow distal aortic neck.

Scannographic Study of Risk Factors of Abdominal Aortic Aneurysm Rupture.

BACKGROUND: Current decision about when to operate abdominal aortic aneurysms (AAAs) is based only on the maximum aneurysm diameter (MAD). However, small aneurysms still rupture and we can observe very large AAA without any symptom. A simple morphologic analysis could be a tool to assess the risk of rupture. The main objective of this study was to assess the relevance of ratios between MAD and healthy aorta on computed tomography (CT) as a risk factor of AAA rupture. The secondary objective was to evaluate CT signs as risk factors of AAA rupture. METHODS: Retrospective observational bicentric study comparing CT scans of a ruptured AAA group and a control group treated electively was conducted. Appariement 1:1 based on MAD was applied. Ratios between healthy aorta diameters at several levels, celiac trunk (CTR), superior mesenteric artery (SMA), highest renal artery (RA), and the MAD were calculated. The presence of blebs, crescent signs, ruptures of calcifications of the aneurysm sack, and draped aorta were notified. RESULTS: From 2010 to 2016, 38 ruptured AAA and 38 controls were included. Ratios were superior in the rupture group, respectively: MAD/CTR [2.77 (±0.5) versus 2.58 (±0.4) P < 0.095], MAD/SMA [2.92 (±0.7) versus 2.74 (±0.5) P < 0.194], and MAD/RA [3.02 (±0.70) versus 2.76 (±0.5) P < 0.054] but not significatively. Receiver operating characteristic curve analysis demonstrated optimal threshold to detect rupture at 2.8 for the ratio MAD/CTR (area under the curve (AUC) 0.593, sensitivity 47.4%, specificity 78.9%), at 3.3 for the ratio MAD/SMA (AUC 0.564, sensitivity 31.6%, specificity 92.1%), and at 3.3 for the ratio MAD/RA (AUC 0.591, sensitivity 31.6%, specificity 94.7%). Bivariate analysis for rupture risk factor showed significance for the three ratios (MAD/CTR > 2.8 [OR = 11 (1.42; 85.20) P < 0.0217], MAD/SMA > 3.3 [OR = 10 (1.28; 78.12) P < 0.0281], and MAD/RA >3.3 [OR = 11.00 (1.42; 85.20) P < 0.0217]). One scannographic sign was more present in the rupture group: crescent sign 36.8% versus 5.3%, P = 0.0007, as well in bivariate analysis [OR = 7 (1.59; 30.80) P < 0.0326]. CONCLUSIONS: In our experience, specific ratios when they exceed calculated threshold, seem to be more prone to rupture. We could consider that these measures, easy to apply in clinical practice, would be complementary keys for rupture risk individual assessment.

Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).

BACKGROUND: Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA. METHODS: The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and pneumonia/prolonged ventilation-time during the first 8 postoperative days. The secondary objectives are to compare both arms with respect to cardiac complications within 48 h, renal and pulmonary complications within 21 days and mortality at 60 days. To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used. Assuming that the event occurs among 36% of the patients when no IPC is performed, the allocation of 55 patients to each arm should allow detecting a hazard ratio of at least 2.75 with a power of 80% when admitting 5% for an error of first kind. This means that 110 patients, enrolled in this multicenter study, may be randomised within 36 months of the first randomization. Randomization will be performed to allocate patients either to surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping (Arm 2). Randomization takes place during the intervention after intravenous injection of heparin, or after the start of femoral assistance. The procedure for IPC will be a supra-visceral thoracic aortic cross clamping for 5 min followed by an unclamping period of 5 min. This procedure will be repeated twice before starting thoracic aortic cross clamping needed to perform surgery. CONCLUSIONS: Our hypothesis is that ischemic preconditioning could reduce clinical morbidity and the incidence of lung damage associated with supra-visceral aortic clamping. TRIAL REGISTRATION: EPICATAStudy registered in ClinicalTrial.gov / number: NCT03718312 on Oct.24.2018 URL number.