Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak.

OBJECTIVE: Failed endovascular infrarenal aortic aneurysm repair (EVAR) due to development of late type Ia endoleak exposes patients to the risk of rupture and should be treated. The purpose of this study was to evaluate the results of fenestrated/branched EVAR (F/BEVAR) for treatment of failed EVAR with type Ia endoleak. METHODS: From January 2010 to December 2019, a prospective multicentre study was conducted (ClinicalTrials.gov identifier: NCT04532450) that included 85 consecutive patients who had undergone F/BEVAR to treat a type Ia endoleak following EVAR. The primary outcome was overall freedom from any re-intervention or death related to the F/BEVAR procedure. RESULTS: In 30 cases (35%) EVAR was associated with a short < 10 mm or angulated (> 60°) infrarenal aortic neck, poor placement of the initial stent graft (n = 3, 4%), sizing error (n = 2, 2%), and/or stent graft migration (n = 7, 8%). Type Ia endoleak was observed after a period of 59 ± 25 months following EVAR. The authors performed 82 FEVAR (96%) and three BEVAR (4%) procedures with revascularisation of 305 target arteries. Overall technical success was 94%, with three failures including one persistent Type Ia endoleak and two unsuccessful stent graft implantations. Intra-operative target artery revascularisation was successful in 303 of 305 attempts. The in hospital mortality rate was 5%. Cardiac, renal and pulmonary complications occurred in 6%, 14%, and 7% of patients, respectively. Post-operative spinal cord ischaemia occurred in four patients (4.7%). At three years, the survival rate was 64% with overall freedom from any re-intervention or aneurysm related death of 40%, and freedom from specific F/BEVAR re-intervention of 73%. At three years, the secondary patency rate of the target visceral arteries was 96%. During follow up, 27 patients (33%) required a revision procedure of the fenestrated (n = 11) or index EVAR stent graft (n = 16), including six open conversions. CONCLUSION: While manufactured F/BEVAR was effective in treating type Ia endoleak in patients with failed EVAR, it was at the cost of a number of secondary endovascular and open surgical procedures.

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.

Use of rifampicin and graft removal are associated with better outcomes in prosthetic vascular graft infection.

OBJECTIVES: Prosthetic vascular graft infection (PVGI) is a very severe disease. We aimed to determine the factors associated with treatment failure. METHODS: Patients admitted to two University Hospitals with PVGI were included in this retrospective study. PVGI was classified as possible, probable or proven according to an original set of diagnostic criteria. We defined treatment failure if one of the following events occurred within the first year after PVGI diagnosis: death and infection recurrence due to the same or another pathogen. RESULTS: One hundred and twelve patients were diagnosed with possible (n = 26), probable (n = 22) and proven (n = 64) PVGI. Bacterial documentation was obtained for 81% of patients. The most frequently identified pathogen was Staphylococcus aureus (n = 39). Surgery was performed in 96 patients (86%). Antibiotics were administered for more than 6 weeks in 41% of patients. Treatment failure occurred in 30 patients (27.5%). The factors associated with a lower probability of treatment failure were total removal of the infected graft (OR = 0.2, 95% CI [0.1-0.6]), rifampicin administration (OR = 0.3 [0.1-0.9]) and possible PVGI according to the GRIP criteria (OR = 0.3 [0.1-0.9]). CONCLUSIONS: Treatment failure occurred in 27.5% of patients with PVGI. Total removal of the infected graft and rifampicin administration were associated with better outcomes.

Fusion Imaging with a Mobile C-Arm for Peripheral Arterial Disease.

BACKGROUND: Fusion imaging makes it possible to improve endovascular procedures and is mainly used in hybrid rooms for aortic procedures. The objective of this study was to evaluate the feasibility of fusion imaging for femoropopliteal endovascular procedures with a mobile flat plane sensor and dedicated software to assist endovascular navigation. MATERIALS AND METHODS: Between May and December 2017, 41 patients requiring femoropopliteal endovascular revascularization were included. Interventions were carried out in a conventional surgical room equipped with a mobile plane sensor (Cios Alpha, Siemens). The numerical video stream was transmitted to an angionavigation station (EndoNaut (EN), Therenva). The software created an osseous and arterial panorama of the treated limb from the angiographies carried out at the beginning of procedure. After each displacement of the table, the software relocated the current image on the osseous panorama, with 2D-2D resetting, and amalgamated the mask of the arterial panorama. The success rates of creation of osseous and arterial panorama and the success of relocation were evaluated. The data concerning irradiation, the volume of contrast (VC) injected, and operative times were recorded. RESULTS: Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%). About 35 relocations based on a 2D-2D resetting could be obtained in the 41 procedures, with a success rate of 85%. The causes of failure were a change in table height or arch angulation. The average duration of intervention was 74.5 min. The irradiation parameters were duration of fluoroscopy 17.8 ± 13.1 min, air kerma 80.5 ± 68.4 mGy, and dose area product 2140 ± 1599 µGy m2. The average VC was 24.5 ± 14 mL. CONCLUSIONS: This preliminary study showed that fusion imaging is possible in a nonhybrid room for peripheral procedures. Imagery of mobile C-arms can be improved for femoropopliteal endovascular procedures without heavy equipment. These imagery tools bring an operative comfort and could probably reduce irradiation and the injected VC. The clinical benefit must be evaluated in more patients in a randomized comparative study with a rigorous methodology.

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

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

Identification of Parameters Influencing the Vascular Structure Displacement in Fusion Imaging during Endovascular Aneurysm Repair.

PURPOSE: To quantify the displacement of the vascular structures after insertion of stiff devices during endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm and to identify potential parameters influencing this displacement. MATERIALS AND METHODS: A total of 50 patients from a single center undergoing EVAR were prospectively enrolled between January 2016 and December 2017. Fusion imaging was employed using the EndoNaut (Therenva, Rennnes, France) station through a 3-dimensional (3D)/2-dimensional (2D) technology synchronizing the 3D computed tomography scan to the live intraoperative fluoroscopy. The accuracy of the fusion roadmap was evaluated before deployment by conventional digital subtraction angiogram on a single plane (with different C-arm incidences). RESULTS: The mean displacement error of the ostium of the lowest renal artery was 4.1 ± 2.4 mm (range, 0-11.7 mm), with a left/right displacement of 1.6 ± 1.7 mm (range, 0-6.9 mm) and a craniocaudal displacement of 3.5 ± 2.4 mm (range, 0-11.3 mm). The correction required for the ostium of the lower renal artery was mostly cranial and to the left. Multiple linear regression analysis revealed only the sharpest angle between the aneurysm neck and sac as the factor influencing the accuracy of fusion imaging. All other parameters did not show any correlation. CONCLUSIONS: This study identified the sources of fusion error after insertion of rigid material during EVAR. As the sharpest angulation between aneurysm neck and sac increases, the overall accuracy of the fusion might be affected.

Fusion Imaging for EVAR with Mobile C-arm.

BACKGROUND: Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study was to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angionavigation station. METHODS: From May 2016 to June 2017, the study included all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angionavigation station (EndoNaut, Therenva). The intention was to perform preoperative 3D computerized tomography/perioperative 2D fluoroscopy fusion imaging using an automatic registration process. Registration was considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation time, and fluoroscopy time (FT) were compared with those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier. RESULTS: The study included 54 patients, and the procedures performed were 49 EVAR, 2 TEVAR, 2 IBD, and 1 FEVAR. Of the 178 registrations that were initialized, it was possible to use the fusion imaging in 170 cases, that is, a 95.5% success rate. In the EVAR comparison, there were no difference with the control group (n = 103) for FT (21.9 ± 12 vs. 19.5 ± 13 min; P = 0.27), but less contrast agent was used in the group undergoing a procedure with the angionavigation station (42.3 ± 22 mL vs. 81.2 ± 48 mL; P < 0.001), and operation time was shorter (114 ± 44 vs. 140.8 ± 38 min; P < 0.0001). CONCLUSIONS: Fusion imaging is feasible with a mobile C-arm in a conventional operating room and thus represents an alternative to hybrid rooms. Its clinical benefits should be evaluated in a randomized series, but our study already suggests that EVAR procedures might be facilitated with an angionavigation system.

Use of Numerical Simulation to Predict Iliac Complications During Placement of An Aortic Stent Graft.

BACKGROUND: During endovascular aneurysm repair (EVAR), complex iliac anatomy is a source of complications such as unintentional coverage of the hypogastric artery. The aim of our study was to evaluate ability to predict coverage of the hypogastric artery using a biomechanical model simulating arterial deformations caused by the delivery system. METHODS: The biomechanical model of deformation has been validated by many publications. The simulations were performed on 38 patients included retrospectively, for a total of 75 iliac arteries used for the study. On the basis of objective measurements, two groups were formed: one with "complex" iliac anatomy (n = 38 iliac arteries) and the other with "simple" iliac anatomy (n = 37 iliac arteries). The simulation enabled measurement of the lengths of the aorta and the iliac arteries once deformed by the device. Coverage of the hypogastric artery was predicted if the deformed renal/iliac bifurcation length (Lpre) was less than the length of the implanted device (Lstent-measured on the postoperative computed tomography [CT]) and nondeformed Lpre was greater than Lstent. RESULTS: Nine (12%) internal iliac arteries were covered unintentionally. Of the coverage attributed to perioperative deformations, 1 case (1.3%) occurred with simple anatomy and 6 (8.0%) with complex anatomy (P = 0.25). All cases of unintentional coverage were predicted by the simulation. The simulation predicted hypogastric coverage in 35 cases (46.7%). There were therefore 26 (34.6%) false positives. The simulation had a sensitivity of 100% and a specificity of 60.6%. On multivariate analysis, the factors significantly predictive of coverage were the iliac tortuosity index (P = 0.02) and the predicted margin between the termination of the graft limb and the origin of the hypogastric artery in nondeformed (P = 0.009) and deformed (P = 0.001) anatomy. CONCLUSIONS: Numerical simulation is a sensitive tool for predicting the risk of hypogastric coverage during EVAR and allows more precise preoperative sizing. Its specificity is liable to be improved by using a larger cohort.

The FREEDOM Study: A Pilot Study Examining the Feasibility and Safety of Early Walking following Femoral Manual Compression after Endovascular Interventions Using 5F Sheath-Compatible Devices.

BACKGROUND: Increasing prevalence of peripheral arterial disease (PAD) burning and pressure to reduce costs and promote patient empowerment make outpatient endovascular procedures an attractive alternative to conventional hospitalization. For outpatient peripheral endovascular procedures, femoral manual compression could replace the use of arterial closure devices for small-bore punctures. Presently, safety and feasibility evidence for femoral manual compression is still lacking. FREEDOM is a pilot study designed to demonstrate the feasibility and safety of early walking after femoral manual puncture point compression following a therapeutic endovascular procedure for PAD. METHODS: From May to August 2015, all patients requiring endovascular treatment for PAD were prospectively screened. Those patients that received therapeutic endovascular procedures involving retrograde femoral punctures with a 5F sheath were included. Manual compression and pressure dressing of the femoral puncture points was applied. The primary end point was defined as the walking ability 5 hr after index procedure (H5), which was assessed by a walk test. RESULTS: In total, 129 consecutive patients were screened, and 30 patients met the study criteria. The mean age was 66 ± 11 years. The mean duration of the procedure and of the manual compression was 63 ± 24 min and 12.8 ± 4 min, respectively. At 5 hr following the procedure, 97% of the patients were able to walk 100 m. Two patients failed to walk due to cardiac arrhythmia and to a false aneurysm at the femoral puncture site. No further complications were observed at 1 month, and quality of life assessed by EQ-5D test was significantly increased compare to baseline (72.3 vs. 60.4; P = 0.001). CONCLUSIONS: This pilot study demonstrated the benefits of manual compression to close arterial punctures over procedures using 5F shealth-compatible endovascular devices. A sufficiently powered randomized controlled trial is needed to further characterize the potential benefits of manual compression following use of low-profile devices.

Predictive Factors of Silent Brain Infarcts after Asymptomatic Carotid Endarterectomy.

BACKGROUND: The optimization of medical treatment regularly challenges the role of carotid surgery for asymptomatic patients. Current research seeks to determine which of these patients will benefit most from surgery. The goal of this study was to identify in a multicenter study, using magnetic resonance imaging (MRI), the risk factors for postoperative silent cerebral ischemic lesions after carotid surgery for asymptomatic stenosis. METHODS: The multicenter, retrospective study included patients with asymptomatic severe carotid stenosis suitable for surgical treatment and who did not have a history of cerebral ischemia. A diffusion MRI scan was performed the day before and in the 3 days after the procedure. An analysis by an independent neuroradiologist determined the presence of preoperative silent ischemia and the appearance of new lesions postoperatively. The analysis also took into account the plaque type, lesions of supra-aortic trunks, the circle of Willis, the type of surgery, and anesthesia, shunt use, and clamp time. RESULTS: Between April 2011 and November 2015, 141 patients were included. The mean degree of carotid stenosis in the patients who underwent surgery was 78.2% ± 6.5, with 9 (6.4%) cases of contralateral stenosis ≥70% and 6 (4.3%) of which were thrombosis. The circle of Willis was incomplete in 23 (16.3%) patients. Twenty-one (14.9%) plaques were of high embolic risk. The preoperative MRI found 34 (24.1%) patients with embolic ischemic lesions. The majority of procedures were eversions performed under general anesthesia, 7 (5%) required a shunt, and the mean clamp time was 39 ± 16 min. The postoperative MRI revealed that 10 (7%) patients had a new ischemic lesion on the operated side. None of these lesions were symptomatic. On multivariate analysis, the risk factors for appearance of a new ischemic lesion on the operated side were significant severe stenosis of the vertebral artery ipsilateral to the lesion (odds ratio [OR] = 9.2, 95% confidence interval [CI] [2.1-39.8], P = 0.003) and insertion of a shunt (OR = 9.1, 95% CI [1.1-73.1], P = 0.039). The 30-day follow-up showed one death at D4 due to hemorrhagic stroke on the operated side and one contralateral stroke. None of the study patients had a myocardial infarction. CONCLUSIONS: In this multicenter study, the rate of silent ischemic lesions in asymptomatic carotid surgery showed 43.3% of preoperative silent ischemic lesions and 9.2% of new silent lesions after surgery. The use of a shunt and presence of ipsilateral vertebral stenosis are risk factors for perioperative embolism.

Comparison of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease with Flat-Panel Detectors on Mobile C-arm versus Fixed Systems.

BACKGROUND: Flat-panel detectors on mobile C-arm (MC-arm) systems are currently challenging fixed C-arm (FC-arm) systems used in hybrid operating rooms. MC-arm systems offer an alternative to FC-arm systems in the endovascular treatment of peripheral arterial disease (PAD) but their efficiency has not been evaluated comparatively. METHODS: Two series of patients undergoing arteriography with intention to treat were included. Each series consisted of 2 nonrandomized groups: an MC-arm group and an FC-arm group. Series 1 evaluated exposure to the patient (MC-arm, n = 113; FC-arm, n = 206) while series 2 evaluated exposure to patients and also health care personnel (MC-arm, n = 24; FC-arm, n = 76). The primary end points for evaluating exposure were air kerma (AK, in mGy) for patients and effective dose for health care personnel (in µSv). RESULTS: After adjustment for the effect of body mass index (analysis of covariance test), AK was found to be lower in the MC-arm group than in the FC-arm group (124.1 ± 142 vs. 173.3 ± 248.7, P = 0.025). There was no difference between the groups with regard to effective dose recorded for senior surgeons or for operating room nurses. However, a higher effective dose was recorded by the MC-arm group external dosimeter for the trainee resident and for nurse anesthetists. CONCLUSIONS: In endovascular treatment of lower limb PAD, use of an FC-arm system is associated with more radiation exposure to the patient than an MC-arm system. However, this type of imaging system does not appear to affect exposure to health care personnel.

Impact of Vascular Calcifications on Long Femoropopliteal Stenting Outcomes.

BACKGROUND: Vascular calcifications (VCs) may be a prognostic factor for outcome after endovascular treatment of peripheral arterial disease (PAD). Semiquantitative analysis with X-ray imaging is the main limiting factor for assessing VCs. The aim of the present study was to find a correlation between the amount of VC with computed tomography (CT) scan quantification and midterm results of endovascular treatment of Trans-Atlantic Inter-Society Consensus C/D femoropopliteal (FP) lesions. METHODS: Patients belonging to 2 previously published registries (STELLA and STELLA PTX) and who underwent a preoperative CT scan were retrospectively included in the study. VC quantification was performed with a dedicated workstation (EndoSize, Therenva) on the basis of Hounsfield units (HU). The VC percentage was calculated as the ratio between VC volume and the volume of the region of interest. For the analysis, patients were divided into 3 groups according to VC percentage, from lowest to highest: group 1 (G1) included the first quartile of VCs, group 2 (G2) included the second and third quartiles, and group 3 (G3) included the fourth quartile. Risk of in-stent thrombosis was analysed using a multivariate model. RESULTS: Thirty-nine patients were included (10 in G1, 19 in G2, and 10 in G3), and mean follow-up duration was 24 ± 14.6 months. Patients in G1 and G3 had, respectively, a VC rate of <1% (no VC) and >20% (severe VC). In G2, VC was considered to be intermediate. There was no statistical difference in the cardiovascular risk factors and preoperative medication. A significant difference was found for the healthy FP diameter between G1 (4.6 ± 0.8 mm) and G3 (6.8 ± 0.8 mm, P < 0.0001) and between G2 (5.2 ± 1 mm) and G3 (P < 0.0001). The rate of drug-eluting stents was similar in all groups. There was no difference between groups concerning the rate of in-stent restenosis, target lesion revascularization, and target extremity revascularization. There was a higher rate of in-stent thrombosis for G1 versus G2 (P = 0.037), and no difference was noted between G1 versus G3 (P = 0.86) or G2 versus G3 (P = 0.12). G3 was associated with early stent thrombosis (<1 month), while G1 was associated with late stent thrombosis (6-24 months). On multivariate analysis, only one predictive factor for stent thrombosis was found: patients with intermediate VC seemed to be protected against in-stent thrombosis (odds ratio = 0.27, 95% confidence interval: 0.1-0.77; P = 0.014). CONCLUSIONS: The study showed that VC quantification with CT imaging is feasible and useful for comparing outcomes following PAD endovascular revascularization. Below a certain threshold, the presence of VC might be necessary for plaque stability and may protect against in-stent thrombosis.

An improved nonlinear diffusion in Laplacian pyramid domain for cone beam CT denoising during image-guided vascular intervention.

BACKGROUND: Cone-beam computed tomography (CBCT) acquisition during endovascular aneurysm repair is an emergent technology with more and more applications. It may provide 3-D information to achieve guidance of intervention. However, there is growing concern on the overall radiation doses delivered to patients, thus a low dose protocol is called when scanning. But CBCT images with a low dose protocol are degraded, resulting in streak artifacts and decreased contrast-to-noise ratio (CNR). In this paper, a Laplacian pyramid-based nonlinear diffusion is proposed to improve the quality of CBCT images. METHOD: We first transform the CBCT image into its pyramid domain, then a modified nonlinear diffusion is performed in each level to remove noise across edges while keeping edges as far as possible. The improved diffusion coefficient is a function of the gradient magnitude image; the threshold in the modified diffusion function is estimated using the median absolute deviation (MAD) estimator; the time step is automatically determined by iterative image changes and the iteration is stopped according to mean absolute error between two adjacent diffusions. Finally, we reconstruct the Laplacian pyramid using the processed pyramid images in each level. RESULT: Results from simulation show that the filtered image from the proposed method has the highest peak signal-noise ratio (81.92), the highest correlation coefficient (99.77%) and the lowest mean square error (27.61), compared with the other four methods. In addition, it has highest contrast-to-noise ratio and sharpness in ROIs. Results from real CBCT images show that the proposed method shows better smoothness in homogeneous regions meanwhile keeps bony structures clear. CONCLUSION: Simulation and patient studies show that the proposed method has a good tradeoff between noise/artifacts suppression and edge preservation.

Influencing factors of sac shrinkage after endovascular aneurysm repair.

OBJECTIVE: Sac shrinkage is considered a reliable surrogate marker of success after endovascular aneurysm repair (EVAR). Whereas sac shrinkage is the best expected outcome, predictive factors of sac shrinkage remain unclear. The aim of this study was to identify the role of preoperative and postoperative influencing factors of sac reduction after EVAR. METHODS: Online searches across MEDLINE, Embase, and Cochrane Library medical databases were simultaneously performed. Study effects were pooled using a random-effects model, and forest plots were generated for every potential influencing factor. RESULTS: A total of 24 studies with 14,754 patients were included (mean age, 73.4 years; 76% male). At a mean follow-up of 24 months, the pooled shrinkage proportion was 47%. Random-effects meta-analysis revealed that renal impairment (odds ratio [OR], 0.74; 95% confidence interval [CI], 0.57-0.96), type I endoleaks (OR, 0.17; 95% CI, 0.08-0.39), type II endoleaks (OR, 0.21; 95% CI, 0.14-0.33), and combined type I and type II endoleaks (OR, 0.32; 95% CI, 0.22-0.47) were found to prevent sac shrinkage, whereas hypercholesterolemia (OR, 1.24; 95% CI, 1.02-1.51) and smoking (OR, 1.32; 95% CI, 1.17-1.49) have a significant positive impact on sac shrinkage. In addition, there was a trend toward the association between shrinkage and statin therapy (OR, 4.07; 95% CI, 1.02-16.32) and nearly significant negative impacts of coronary artery disease (OR, 0.84; 95% CI, 0.70-1.01), diabetes (OR, 0.79; 95% CI, 0.60-1.04), and sac thrombus (OR, 0.88; 95% CI, 0.77-1.01) on sac shrinkage. CONCLUSIONS: In this large meta-analysis of patients undergoing EVAR, we found that several comorbidity and postoperative factors were associated with postoperative sac shrinkage. These findings may contribute to a better understanding of the shrinkage process of patients undergoing EVAR.

French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries.

BACKGROUND: Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease. METHODS: This retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis. RESULTS: The GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months. CONCLUSIONS: Our multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.

Long-Term Outcomes of Common Femoral Artery Stenting.

BACKGROUND: The purpose of this study was to report the 5-year outcome relative to endovascular repair of the common femoral artery (CFA) for occlusive disease. METHODS: Thirty-six consecutive patients (40 limbs) underwent stenting for CFA lesions. Patients were followed up systematically within a prospectively maintained database over 5 years. Follow-up included clinical examination, duplex scan, and biplane X-ray at 1, 6, 12 months and yearly thereafter. RESULTS: Indications for endovascular repair of the CFA included 25 patients (70%) for claudication and 11 patients (30%) for critical limb ischemia. Mean follow-up was 64 months. Two patients were lost to follow-up. The mortality rate at 5 years was 38%. At 3 and 5 years, primary sustained clinical improvements were 77% and 73%, respectively. In-stent restenosis rate was 28%. The significant predictors of in-stent restenosis were deep femoral artery stenting (P = 0.0007) and type III lesions (P = 0.014). Freedom from target lesion revascularization and target extremity revascularization were 79% and 73%, respectively. One stent fracture was noted at the first year follow-up without clinical consequence, and no other stent fracture was noted during the remainder of the study. CONCLUSIONS: Endovascular repair of the CFA and its bifurcation seems to provide sustained clinical and morphological long-term results. Fear of stent fracture and local complications due to hip mobility are no longer relevant.

Systematic Review and Meta-Analysis of Preoperative Risk Factors of Type II Endoleaks after Endovascular Aneurysm Repair.

BACKGROUND: Type II endoleaks (T2Es) remain the Achilles heel of endovascular aneurysm repair (EVAR), involving a close follow-up and sometimes leading to reintervention. Identifying risk factors impacting T2Es is of concern to improve decision making and optimize follow-up. However, it has led to contradictory results, with supporting evidence for the majority of factors being weak. METHODS: A systematic review and meta-analysis was conducted to study risk factors of T2Es following EVAR to identify risk factors and measure their dedicated strength of association. Using a literature search of MEDLINE, EMBASE, and the Cochrane Library, 31 retrospective studies including a total of 15,793 patients were identified and fulfilled the strict specified inclusion criteria. Random-effects meta-analysis was conducted for each factor to combine effect estimate across studies. A total of 21 factors related to demography, preoperative treatment, comorbidity, and morphology were statistically pooled. RESULTS: On the basis of the pooled odds ratios and their 95% confidence intervals, patency of aortic side branches, represented by the patency of the inferior mesenteric artery, lumbar arteries, or total number of aortic side branches, were found to be significant harmful risk factors of T2Es. Women were also found to have nearly significant higher risk of developing T2Es than men. On the contrary, the following were found to have a significant protective role: smoking, peripheral artery disease, and thrombus load, represented by the maximum thickness at the maximum aneurysm diameter, the presence of circumferential thrombus, or the presence of thrombus at the level of inferior mesenteric artery. CONCLUSION: Identifying significant risk factors of development of T2Es is mandatory to improve decision making and optimize surveillance planning in EVAR.

Predictive Models of Complications after Endovascular Aortic Aneurysm Repair.

BACKGROUND: The risk of long-term complications after endovascular aneurysm repair (EVAR) is still higher than open surgery and is a critical issue. This study aims to make available reliable statistical predictive models of complications after EVAR. METHODS: Two hundred and thirteen patients who underwent EVAR between 2002 and 2012 were included in this study. The preoperative computed tomography scans were analyzed with a dedicated workstation to provide spatially correct 3-dimensional data. Age, gender, operation-related factors, and 21 morphologic variables were measured and included in the analyses. Five postoperative outcomes were studied. After an initial selection of predictors based on univariate analysis, binomial logistic regression models were proposed for each outcome. The ability to predict each outcome was assessed with receiver operating characteristic curves considering that an area under the curve (AUC) > 0.70 is generally considered sufficiently accurate. RESULTS: The mean age was 74.8 ± 8.6 years with a mean follow-up of 43.8 ± 22.1 months. Respectively, rates and risk factors of each outcome were 25.3% (n = 51) for abdominal aortic aneurysm (AAA) enlargement (age, number of patent sac branches, iliac calcifications and tortuosity, aneurysmal thrombus), 7% (n = 15) for type IA endoleak (neck calcification and AAA diameter), 3.7% (n = 8) for type IB endoleak (iliac tortuosity, AAA diameter, neck thrombus), 19.8% (n = 40) for type II endoleak (female, number of patent sac branches), and 25.9% (n = 55) for reintervention from any cause (neck calcification). The risk associated to each outcome can be calculated with a combination of these different preoperative variables. AUC for each outcome were 79.6% for AAA enlargement, 70.4% for reintervention, 81.3% for type IA endoleak, 92.3% for type IB endoleak, 70.6% for type II endoleak. CONCLUSIONS: This study shows that an exhaustive description of the preoperative anatomy before EVAR is a powerful and reliable tool to predict the risk of developing the most common complications after EVAR.

Bare Metal Versus Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a Propensity Score-Matched Analysis.

BACKGROUND: The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES). METHODS: In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18 months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias. RESULTS: In total, 110 limbs were treated (STELLA: n = 62; STELLA PTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLA PTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency. CONCLUSIONS: Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.