Monte Carlo Dosimetry Validation for X-Ray Guided Endovascular Procedures.

BACKGROUND: Endovascular treatment is continuously gaining ground in vascular surgery procedures. However, current patient radiation dose estimation does not take into account the exact patient morphology and organs' composition. Monte Carlo (MC) simulation can accurately estimate the dose by recreating the irradiation process generated during X-ray-guided interventions. This study aimed to validate the MC simulation models by comparing simulated and measured dose distributions in endovascular aortic aneurysm repair (EVAR) procedures. METHODS: We conducted a clinical study in patients treated for EVAR. Patient dose measurements were taken with passive dosimeters using Optically Stimulated Luminescence technology in 4 specific anatomical points on the skin: xiphoid process, pubic symphysis, right and left iliac crest. Dose measurements were compared to the corresponding simulated doses with the Geant4 Application for Emission Tomography (GATE) and GPU Geant4-based Monte Carlo Simulations (GGEMS) MC simulations softwares. The MC simulation took as input the computed tomography scan of the patient and the parameters of the imaging system (orientation angles, tube voltage, and aluminum filtration) and gives as output the three-dimensional (3D) dose map for each patient and angulation. RESULTS: A good agreement with real doses was found for doses simulated by the MC GATE method (P < 0.0001; r = 0.97; 95% confidence interval [CI] [0.96-0.98]), as well as for doses simulated by the GGEMS method (P < 0.0001; r = 0.96; 95% CI [0.94-0.97]). The mean relative error for all measurements was 5 ± 5% in the MC GATE group and 6 ± 5% in the GGEMS group. Process execution on GGEMS (6 sec) was faster than the GATE MC simulation (5 hr). CONCLUSION: Considering the current imaging settings, this study shows the potential of using the GATE and GGEMS MC simulations platforms to model the 3D dose distributions during EVAR procedures.

Outcomes of Using Balloon-Expandable Covered Stent for Percutaneous Treatment of Access-Site Vascular Injury after Transfemoral Aortic Valve Implantation: A Single Center Experience.

BACKGROUND: Access-site vascular injury (ASVI) remains a challenge for transfemoral transcatheter aortic valve implantation (TAVI). Although surgery is the gold standard, endovascular therapy gains growing acceptance as primary treatment option for ASVI. The aim of this study was to analyze the safety and efficacy of covered balloon-expandable stents (BXSs) placement for ASVI after transfemoral TAVI. METHODS: All patients treated with a covered BXS between January 2018 and December 2020 for access-site related bleeding complications following femoral TAVI were included in this single center retrospective study. Primary measure outcome of this study was the primary patency at 12 months. Technical success, limb clinical worsening and device related complications were additionally analyzed. RESULTS: During the study period, 576 percutaneous femoral TAVIs were performed. Of these, 36 patients (6%) underwent covered stent deployment for a femoral access-site complication (19 men, median age 83 years old). Procedural success was 97%. The median follow-up was 12 months (interquartile range [IQR] = 9.7, range 0-36 months). One patient was lost to follow-up. The primary patency rates at 6 and 12 months were 100% and 95% respectively. No clinical deterioration or stent fracture was described during this period. CONCLUSIONS: Our results suggest that covered BXS deployment is a safe and effective alternative to surgery and may be a promising option for treating ASVI after femoral TAVI.

Predictors of Recurrent Venous Thromboembolism or Arterial Thrombotic Events during and after Anticoagulation for a First Venous Thromboembolism.

After first episodes of venous thromboembolism (VTE), patients are at increased risk of recurrent VTE and arterial thrombotic events (ATE) compared with the general population, two disorders that are influenced by anticoagulation. However, risk factors of these conditions occurring during and after anticoagulation are little described. Using cause-specific hazard regression models, we aimed to determine risk factors of the composite outcome recurrent VTE/ATE, and separately recurrent VTE or ATE, during and after anticoagulation in patients with first episodes of VTE from a prospective cohort. Hazard ratios (HRs) are given with 95% confidence intervals (CIs). A total of 2,011 patients treated for at least 3 months were included. A total of 647 patients had recurrent VTE/ATE (incidence: 4.69% per patient-years) during overall follow-up (median: 92 months). Of these events, 173 occurred during anticoagulation (incidence: 3.67% per patient-years). Among patients free of events at the end of anticoagulation, 801 had a post-anticoagulation follow-up ≥3 months; and 95 had recurrent VTE/ATE (incidence: 1.27% per patient-years). After adjustment for confounders, cancer-associated VTE (HR: 2.64, 95% CI: 1.70-4.11) and unprovoked VTE (HR: 1.95, 95% CI: 1.35-2.81) were the identified risk factors of recurrent VTE/ATE during anticoagulation (vs. transient risk factor-related VTE). Risk factors of recurrent VTE/ATE after anticoagulation included 50 to 65 years of age (vs. < 50, HR: 1.99, 95% CI: 1.04-3.81), older than 65 years (vs. < 50, HR: 5.28, 95% CI: 3.03-9.21), and unprovoked VTE (vs. transient risk factor-related VTE, HR: 2.06, 95% CI: 1.27-3.34). Cancer-associated VTE and unprovoked VTE are the main risk factors of recurrent VTE/ATE during anticoagulation, while older age and unprovoked VTE mainly predict the risk of these events after anticoagulation.

Perioperative adverse events in percutaneous versus open brachial access.

OBJECTIVE: The objective of the present study was to compare the incidence of complications at the access site after percutaneous brachial access (PBA) and open brachial access (OBA) in the treatment of peripheral arterial disease. METHODS: From November 2016 to November 2021, all patients who had undergone peripheral artery revascularization with brachial access were included. The primary outcome was the 30-day rate of postoperative complications at the access site. The complications included hematoma, arteriovenous fistula, and pseudoaneurysms that had resulted in prolonged hospitalization and/or reintervention. RESULTS: Overall, 259 procedures with brachial access had been performed (PBA, n = 101; OBA, n = 158). The baseline clinical and demographic characteristics were well-balanced between the two groups. The sheath size was larger for the OBA procedures. Complications had occurred in 11 of 101 patients (11.1%) in the PBA group and 5 of 158 patients (3.2%) in the OBA group (P = .01). The mean duration of the procedure was significantly shorter for the PBA group (73.5 ± 46.5 minutes vs 101.2 ± 60.8 minutes; P = .0001). CONCLUSIONS: For patients who had undergone brachial access for peripheral vascular disease, the rate of access site-related complications was significantly lower for the patients who had undergone open access compared with that for the patients who had undergone percutaneous access.

A comparison of suprarenal and infrarenal fixation and renal volumetric analysis after endovascular aneurysm repair.

OBJECTIVE: Clinical and experimental studies of the stent-graft fixation impact on the renal volume after endovascular abdominal aortic aneurysm repair have focused on glomerular filtration rate, and the results were controversial. The aim of this study was to analyze and compare the impact of the suprarenal (SRF group) and infrarenal (IRF group) stent-graft fixation on the renal volume. METHODS: Between December 2016 and December 2019, all patients treated with endovascular aneurysm repair were retrospectively analyzed. Patients with atrophic or multicystic kidney, renal transplantation, ultrasound examination, or incomplete follow-up were excluded. The renal volume in both groups was extracted with a semiautomatic segmentation from contrast-enhanced computed tomography scan performed before the procedure, at 1 month, and at 12 months of follow-up. A subgroup analysis of the SRF group was performed in order to study the impact of the stent strut position relative to the renal arteries. RESULTS: A total of 63 patients were analyzed (SRF: 32 and IRF: 31). Demographic and anatomic characteristics were similar between the groups. The procedure contrast volume was higher in the IRF group (P = .01). At 12 months, we observed a decrease in the renal volume of 1.4% in the SRF group and 2.3% in the IRF group (P = .86). The SRF subgroup analysis showed only two patients with no stent struts crossing the renal arteries. In the remaining cases, struts crossed one renal artery in 60% of cases (19 patients) and two renal arteries in 34% of cases (11 patients). The renal volume decrease was not correlated with the presence of stent wire struts, crossing a renal artery. CONCLUSIONS: Stent graft with suprarenal fixation seems not to be correlated with renal volume deterioration. A randomized clinical trial with a higher effective and longer follow-up is needed to assess the impact of SRF on renal function.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial.

PURPOSE: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). METHODS: The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. RESULTS: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. CONCLUSION: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.

Risk Factors for Major Adverse Cardiovascular Events and Major Adverse Limb Events after Venous Thromboembolism: A Large Prospective Cohort Study.

BACKGROUND: There is an increased risk of arterial events including major adverse cardiovascular events (MACE) and major adverse limb events (MALE) after venous thromboembolism (VTE). However, their risk factors remain little explored. METHODS: We aimed to determine the risk factors for MACE (acute coronary syndrome/stroke/cardiovascular death) and MALE (limb ischemia/critical limb ischemia/non-traumatic amputation/any limb revascularization) after VTE. Competing risk models (Fine-Gray) were used in a multicenter prospective cohort of 4,940 patients (mean age: 64.6 years and median follow-up: 64 months). RESULTS: MACE occurred in 17.3% of participants (2.35% per patient-years) and MALE in 1.7% (0.27% per patient-years). In multivariable analysis, the identified risk factors for MACE were the age of 50 to 65 years (vs. <50 years, hazard ratio [HR]: 2.00, 95% confidence interval [CI]: 1.38-2.91), age >65 years (vs. <50 years, HR 4.85, 95% CI: 3.35-7.02), pulmonary embolism + deep vein thrombosis (DVT) (vs. isolated-DVT, HR: 1.25, 95% CI: 1.02-1.55), unprovoked-VTE (vs. transient risk factor associated-VTE, HR: 1.29, 95% CI: 1.04-1.59), current tobacco use (vs. never, HR: 1.45, 95% CI: 1.07-1.98), hypertension (HR: 1.61, 95% CI: 1.30-1.98), past history of symptomatic atherosclerosis (HR: 1.52, 95% CI: 1.17-1.98), heart failure (HR: 1.71, 95% CI: 1.21-2.42), atrial fibrillation (HR: 1.55, 95% CI: 1.15-2.08), and vena cava filter insertion (HR: 1.46, 95% CI: 1.03-2.08). The identified risk factors for MALE were the age of 50-65 years (vs. <50 years, HR: 3.49, 95% CI: 1.26-9.65) and atrial fibrillation (HR: 2.37, 95% CI: 1.15-4.89). CONCLUSIONS: Risk factors for MACE and MALE after VTE included some traditional cardiovascular risk factors, patient's comorbidities, and some characteristics of VTE.

Fusion Imaging Guidance Does Not Affect Radiation Exposure During Endovascular Procedures for Lower Extremity Arterial Disease: A Randomized Controlled Trial.

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

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.

Antegrade Superficial Femoral Artery Approach Using Manual Compression and 4-F Delivery System for Infrainguinal Occlusive Disease.

BACKGROUND: This study sought to assess the feasibility and safety of antegrade superficial femoral artery (SFA) duplex-guided puncture using a 4-F catheter sheath and manual compression for the treatment of infrainguinal occlusive lesions. METHODS: From March 2017 to March 2019, all patients who underwent endovascular treatment employing an antegrade SFA approach for femoropopliteal or below-the-knee lesions were included in this study. Follow-up included clinical and duplex ultrasound examinations at 1 month. The primary endpoint was the frequency of major complications at the puncture site. RESULTS: In all, 71 procedures were performed in 70 patients (46 men; mean age: 79.1 ± 11.5 years), most of whom presented with critical limb-threatening ischemia (n = 59; 83%). Of these 71 procedures, 35 (49.3%) were performed for isolated femoropopliteal lesions and 24 (33.8%) for multilevel lesions. The primary endpoint was observed in 4 patients (5.6%). There were 3 observed hematomas (4.2%): 2 required surgical treatment, and 1 necessitated transfusion without intervention. At 30 days, we reported 1 pseudoaneurysm (1.4%). CONCLUSIONS: Our results showed that antegrade SFA puncture is feasible and safe with duplex ultrasound guidance and use of a 4-F catheter sheath.

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.

Algorithm of Femoropopliteal Endovascular Treatment.

Background and Objectives: Indications for the endovascular treatment of femoropopliteal lesions have steadily increased over the past decade. Accordingly, the number of devices has also increased, but the choice of the best endovascular treatment remains to be defined. Many devices are now available for physicians. However, in order to obtain a high success rate, it is necessary to respect an algorithm whose choice of device is only one step in the treatment. Materials and Methods: The first step is, therefore, to define the approach according to the lesion to be treated. Anterograde approaches (femoral, radial, or humeral) are distinguished from retrograde approaches depending on the patient's anatomy and surgical history. Secondarily, the lesion will be crossed intraluminally or subintimally using a catheter or an angioplasty balloon. The third step corresponds to the preparation of the artery, which is essential before the implantation of the device. It has a crucial role in reducing the rate of restenosis. Several tools are available and are chosen according to the lesion requiring treatment (stenosis, occlusion). Among them, we find the angioplasty balloon, the atherectomy probes, or intravascular lithotripsy. Finally, the last step corresponds to the choice of the device to be implanted. This is also based on the nature of the lesion, which is considered short, up to 15 cm and complex beyond that. The choice of device will be between bare stents, covered stents, drug-coated balloons, and drug-eluting stents. Currently, drug-eluting stents appear to be the treatment of choice for short lesions, and active devices seem to be the preferred treatment for more complex lesions, although there is a lack of data. Results: In case of failure to cross the lesion, the retrograde approach is a safe and effective alternative. Balloon angioplasty currently remains the reference method for the preparation of the artery, the aim of which is to ensure the intraoperative technical success of the treatment (residual stenosis < 30%), to limit the risk of dissection and, finally, to limit the occurrence of restenosis. Concerning the treatment, the drug-eluting devices seem to present the best results, whether for simple or complex lesions. Conclusions: Endovascular treatment for femoropopliteal lesions needs to be considered upstream of the intervention in order to anticipate the treatment and the choice of devices for each stage.

Epithelioid Hemangioendothelioma of the Lower Limb, Discovered by a Claudication.

Epithelioid hemangioendothelioma (EHE) is a rare case of a tumor with different clinical behaviors and a difficult anatomopathological diagnosis. The diagnosis of EHE is usually confirmed by postoperative histopathologic examination. Actually, it is a challenge to put a correct diagnosis and to propose aggressive treatment. We report a case of an EHE of the left lower limb discovered in a 53-year-old claudicant woman. Surgical resection, arterial, and venous bypass were performed. The histology demonstrated EHE with a low mitotic index, emerging for the femoral vein.

The Common Femoral Artery Is a Fixed Arterial Segment.

BACKGROUND: The risk of stent fracture caused by the movements of the hip joint is one of the limitations of the endovascular treatment of the common femoral artery (CFA). The aim of this study was to describe and analyze the deformations of the iliofemoral axis during flexion and extension of the hip, and to evaluate the impact of stents implanted in the CFA on the deformations observed. MATERIALS AND METHODS: This monocentric descriptive study was carried out on the pelvis obtained from three fresh cadavers (two men aged 72 and 71 years, respectively, and one 94-year-old woman). Arteriography was carried out to appreciate the deformations of the external iliac and common femoral arteries, and to analyze the femoral junctions. A first arteriography was carried out on native arteries, and a second one was carried out after the implantation of a stent in the CFA (Zilver PTX, Cook Medical, Bloomington, IN, USA). In all the cases, anterior and lateral images were obtained, with the hip maintained in extension (0°) or flexion (45°, 90°). RESULTS: In a neutral position (extension), four points of deformation of the iliofemoral axis were identified in the frontal (A, B, C, and D) and sagittal (A', B', C', D') planes. These points were the vertices of the angles formed by the arterial deformation in the frontal and sagittal planes. These four points of deformation observed in the two planes appeared overlapping (A/A', B/B', C/C', and D/D') and were located on the external iliac artery, the origin of the CFA, the femoral bifurcation and the superficial femoral artery, respectively. In the frontal plane, all the angles closed during flexion, and the closure of the angle increased with the degree of flexion. In the sagittal plane, we observed that the angles with the A', C', and D' vertices closed during the flexion of the hip, and that the angle with the B' vertex opened during flexion. The higher was the degree of flexion, the more the angles were accentuated. The implantation of one stent in the CFA modified neither the localization of the points of deformation nor the modifications of angles previously observed on the frontal and the sagittal sections. CONCLUSIONS: As seen from the front and side, the CFA is a fixed segment during the movements of extension and flexion of the hip. The implantation of a stent does not modify this observation.

Stent Size Optimization in the Femoral Bifurcation Using a Fractal Model: A Morphological Analysis.

OBJECTIVES: Stenting of common femoral artery (CFA) bifurcation lesions is complex due to harmonious asymmetric geometry between the CFA and deep or superficial femoral artery. In order to ensure an optimal flow, the stents must be implanted according to the diameter of the CFA and the diameter of the daughter vessels. The aim of this study was to validate a mathematical formula for the CFA bifurcation in order to optimize the implantation of stents in this bifurcation with a fast and efficient method. MATERIALS/METHODS: We retrospectively included all patients who underwent transcatheter aortic valve implantation and who had a healthy CFA bifurcation on the CT-scan. Diameters of the mother vessel (Dm), daughter vessels (Dl: larger vessel; Ds: smaller vessel), and the ratio between the two were calculated. According to the latter, the following linear model was proposed: [Dm = (Dm/Dl + Ds) × (Dl + Ds)] and was compared to the four existing models (Murray, HK, Flow, Finet). Finally, we calculated the relative error between the prediction of the four models and the measurements. RESULTS: Overall, 110 CFA bifurcations were included. Mean CFA diameter was 7.75 ± 1.67 mm. Mean Dl diameter was 5.79 ± 1.21 mm and mean Ds diameter was 5.23 ± 1.09 mm. A reduction of 25 % was seen between the CFA and the larger daughter-vessel. The mean ratio between the CFA and the daughter vessels was 0.71. Our model [Dm = 0.71× (Dl + Ds)] and the flow law were the most accurate (relative difference of 1.59 ± 11.97% and 1.01 ± 11.94%, respectively). However, Murray's law had a statistically significant deviation from the real mother-vessel diameter (P < 0.001). CONCLUSIONS: We developed a simple fractal ratio between CFA and daughter vessels, which could be easily used in daily practice during CFA percutaneous reconstruction to identify the optimal diameters of the diseased vessels.

Bare Stents for Iliac Chronic Total Occlusions ("TELIS"): A Prospective Cohort Study with a Midterm Follow-up.

BACKGROUND: This study aims to assess primary bare stenting for iliac chronic total occlusions (CTOs) with midterm follow-up. METHODS: From April 2013 to May 2016, all patients presenting with symptomatic iliac CTO were treated endovascularly and included in a prospective single-center cohort. Common iliac CTOs were treated with balloon-expandable bare-metal stents. External iliac lesions were treated with bare self-expandable nitinol stents. Primary end point was primary sustained clinical improvement. A total of 49 iliac CTOs were treated in 46 patients. RESULTS: A total of 22 lesions were located at the level of the common iliac artery (45%), 20 at the external iliac artery (41%), and 7 extending to both (14%). Mean stenting length was 114.4 ± 49.8 mm. Technical success was 98%. Primary sustained clinical improvement was achieved for 93.4 ± 3.7% of patients at 12 months and 87.7 ± 5.2% at 24 months. Three in-stent thrombosis were observed with no restenosis in the remaining patients at 24 months. Freedom from target lesion revascularization was 93.3% ± 3.7% at 24 months. Three stent fractures were noted, none were symptomatic. Mean quality of life (EQ5D-3L) was significantly improved at 24 months (71.2 ± 20.3 vs. 52.4 ± 22.6, P = 0.001). CONCLUSIONS: Our results showed that primary bare-metal stenting for iliac CTO is safe and efficient at 24 months and could be considered as a first-line strategy.

Automated Image Fusion Guidance during Endovascular Aorto-Iliac Procedures: A Randomized Controlled Pilot Study.

BACKGROUND: The benefits of imaging guidance using a new fully automated fusion process (CYDAR) have been demonstrated during endovascular aortic aneurysm repair, but little is known about its use during aorto-iliac occlusive disease endovascular revascularization. The aim of this study was to evaluate the influence of CYDAR image fusion guidance during endovascular treatment of symptomatic aorto-iliac occlusive lesions, compared with control patients treated using standard 2D fluoroscopy alone. METHODS: This is a single-center randomized controlled pilot study that recruited patients undergoing aorto-iliac endovascular revascularization. RESULTS: Between January 2019 and February 2020, 37 patients with symptomatic aorto-iliac lesions were enrolled: 18 were assigned to the fusion group and 19 to the control group. Patients and lesions characteristics were well balanced between both study groups. The technical success of the procedure was 100% in the Fusion group and 94% in the control group. All radiation-related parameters were lower in the fusion compared to the control group, including: median DAP 18.5 Gy.cm2 vs. 21.8 Gy.cm2; Air Kerma 0.10 Gy vs. 0.12 Gy; fluoroscopy dose 4.2 Gy.cm2 vs. 5.1 Gy.cm2; and number of DSA 7.5 vs. 8. The volume of iodinated contrast used was higher in the fusion group: 41 mL vs. 30 mL. The total procedure time was the same in both groups:60 min vs. 60 min. CONCLUSIONS: The results of this pilot study suggest the use of fusion imaging in endovascular treatment of aorto-iliac disease results in reduction in radiation-related measured parameters with no change in procedure time and higher doses of iodinated contrast used. These results need to be further investigated in a larger, adequately powered study.

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.

In vivo validation of Dosemap software use in interventional cardiology with dosimetrics indicators and peak skin dose evaluation.

OBJECTIVES: The aim of this study was to determine the accuracy of DoseMap™ software as compared to gafchromic film in real clinical practices. BACKGROUND: The radiation exposure from cardiovascular procedures could expose patients to potential risk of cancer and/or skin injury. New tools like Dosemap software were developed to estimate the patient skin dose in the cardiac catheterization laboratory. However, little data are available to validate this estimation of patient radiation skin dose. METHODS: This is a prospective cross-sectional study comparing the peak skin dose (PSD) measured by gafchromic film used as reference with an estimated PSD given by Dosemap software, in patients with BMI > 30 kg/m2 undergoing elective diagnostic and/or therapeutic interventional cardiology procedures, from April 2016 to December 2016, at the Brest University Hospital Centre, France. RESULTS: After four exclusions of patients for poor quality of gafchromic films, 90 patients were included, with 58 angiography (67.4%), 14 percutaneous interventions (16.3%), and 14 both (16.3%). The median PSDDosemap and PSDFilm were similar with 157 mGy [IQR: 99; 273] versus 158 mGy [IQR: 101; 295] (P = 0.65), respectively, with an excellent correlation (r = 0.95). The comparison between cumulative air kerma and PSDFilm was different 366 mGy [IQR: 246; 575] versus 158 mGy [IQR: 101; 295] (P < 0.01) with moderate correlation (r = 0.79). No correlation was found between the dose area product and PSDFilm (r = 0.51). CONCLUSION: DoseMap is an effective and valid method as compared to gafchromic films to estimate PSDs during interventional cardiologic procedures.