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.

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.

Single Centre Experience in Open and Endovascular Treatment of Renal Artery Aneurysms.

BACKGROUND: The true incidence and natural history of renal artery aneurysm (RAA) remain unclear and still exists controversy over indication for treatment. Several techniques of conventional surgical reconstructions are described in literature, and more recently endovascular therapies have been reported with satisfying results and lower complication rate. This paper aims to investigate the outcomes of both endovascular and open repair of RAA achieved in a single institution involving 3 medical teams (urology, vascular surgery and neuroradiology). MATERIAL AND METHODS: We conducted a single-centre retrospective observational study about all patients surgically or endovascularly treated for RAA over a 15-year period. Pre-operative, procedural and post-operative data at the early, mid- and long-term follow-up were collected and analysed, focusing on operative technique used for repair and related outcomes. RESULTS: A total of 27 patients (n = 17 (63%) women, mean age 58 ± 13.2, n = 26 saccular RAA) were included. Mean aneurysm was size was 18.8 ± 6.3 mm. Most diagnosis were accidental. Symptomatic RAA showed with macroscopic haematuria (n = 3, 25.9%), unstable hypertension (n = 2; 7%), chronic lumbar pain (n = 1, 3.7%) and renal infarct (n = 1, 3.7%). Conventional surgery (ex-vivo repair, aneurysmorraphy, aneurysm resection and end-to-end anastomosis) was performed in 14 (51.8%) cases and endovascular coiling embolization in 13 (48.2%). Mean hospital length of stay was 5.4 ± 3.6 days. Intensive Care Unit stay was needed only in the surgically treated patients (mean 1.1 ± 1.2 days). During the early follow-up, morbidity rate was 7/14 in surgically treated patients vs. 1/13 in endovascular group; it included bleeding, retroperitoneal hematoma, arterial thrombosis and bowel obstruction. The discharge imaging showed complete aneurysm exclusion and renal artery patency in all cases. At a mean follow-up of 39 ± 42 months, 3 patients (11%) were lost to follow up and 2 (7.4 %) died from unrelated cause. None of these patients required dialysis but a statistically significant (P = 0.09) decrease in GFR was noted between the preoperative period and last follow-up control. RAA repair neither showed blood pressure control improvement nor reduced the need for anti-hypertensive drug use. CONCLUSION: Open or endovascular techniques are both safe and efficient to treat RAA. Even though, surgical management is burdened with higher morbidity rate, the operative technique should be selected according to anatomical features, diameters and location of RRA; and the number of renal branches involved. Further larger studies are needed to define the feasibility and safety for a wider application of the endovascular approach.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.

PURPOSES: The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. MATERIALS AND METHODS: STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin. RESULTS: Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95% CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5 h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95% CI: 1.93 to 6.15; p = 0.0016). CONCLUSIONS: In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. CLINICAL TRIAL REGISTRATION: Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

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.

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.

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.

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.

Endovascular Treatment of Asymptomatic Abdominal Aortic Aneurysms in Octogenarians: Factors Influencing Long-term Survival.

BACKGROUND: Beyond the age of 80 years, the preventive treatment of an asymptomatic abdominal aortic aneurysm (AAA) has to be decided in light of the life expectancy which it is difficult to evaluate, but it is important to determine who in this population will benefit from it. The objective of our study was to determine the factors influencing short-term mortality and long-term survival in patients aged 80 years and older after the endovascular treatment of AAAs (EVAR). MATERIAL AND METHODS: We present a retrospective analysis of the prospective databases of 4 French academic departments of vascular surgery, bringing together the data of all the patients presenting an AAA who were treated by EVAR between 1998 and 2011. Logistic regression and multivariate analysis with a Cox survival model were used to determine the factors influencing perioperative and long-term mortality. The cumulative rate of events for the measurement of survival was calculated with the technique of Kaplan-Meier. RESULTS: We treated 345 octogenarians and 339 younger patients. The average follow-up was 40 months. Average survival was 75% at 36 months and 49% at 60 months. There was no evidence of any risk factor influencing mortality at 30 days in the octogenarians. However, chronic kidney disease (odds ratio [OR] = 3.95, P <0.001) and chronic respiratory failure (OR = 2.62, P <0.001) proved to be independent factors of a poor long-term prognosis. CONCLUSIONS: The treatment by stent graft in octogenarians is effective in the long term. The presence of an impaired renal function or respiratory failure in this population could put into question the operative indication.

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.

Management of ambulatory (day case) endovascular procedures for peripheral arterial disease.

INTRODUCTION: Thanks to exceptional improvements in technological developments and vascular teams' expertise, endovascular repair of peripheral arterial disease (PAD) has drastically increased these past decades. Incidence of PAD rising, pressure to reduce costs and patient's empowerment make outpatient endovascular procedures for PAD an attractive alternative to conventional hospitalization. This review describes outpatient endovascular procedures for PAD in the literature. EVIDENCE ACQUISITION: We used PRISMA guidelines and Medline to conduct this systematic review. 448 relevant articles were found. Twelve articles, all published after year 2000 were included and reviewed by two independent investigators. EVIDENCE SYNTHESIS: Among 12 selected articles, 10762 outpatient endovascular procedures were performed and 3883 procedures were realized for arterial lower limb revascularization. Average age was 65.2. Major exclusion criteria were social isolation (no available accompanying adult for the first 24 hours, no available communication system) and high-risk patients (ASA 4 and above). During the perioperative period, no death was noted. Major hematoma rate was 0% to 3%, minor hematoma rate went from 1.6% to 20%. Conversion to in-patient status for overnight observation occurred in 0% to 16% in ten real life studies and was mostly due to complications at puncture site. Reintervention over the first month occurred in 0% to 4%. Readmission in the first month after being discharged occurred in 0% to 3.2%. Diabetes and critical limb ischemia were not related to higher complication rate. CONCLUSIONS: This review indicates that outpatient endovascular procedures for PAD are safe and efficient. Guidelines are necessary to enforce patients' selection and insure high quality perioperative care.

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.

The role for DCBs in the treatment of ISR.

INTRODUCTION: Currently, endovascular therapy is the standard of care for peripheral artery disease. The main issue of these techniques is restenosis which is a complex mechanism associating elastic recoil, constrictive remodelling and intimal hyperplasia. More and more evidence show that drug-coating balloon (DCB) is a promising device to prevent and to treat restenosis. Herein we have reviewed the role for DCB's in the treatment of in-stent restenosis (ISR). EVIDENCE ACQUISITION: Currently, few studies are available regarding DCB use for femoropopliteal (FP) ISR treatment. In different studies evaluating DCB for treatment of FP ISR the freedom from target lesion revascularization rate at one year are range from 87% to 92.1%. In comparison to other devices used for treatment of FP ISR such as atherectomy, cutting balloon, standard angioplasty, DCB seems to show better results in terms of freedom from TLR and primary patency. Other devices such as drug-eluting stent, brachytherapy, covered stent show also good results for FP ISR. EVIDENCE SYNTHESIS: Majority of assessed data on FP ISR treated with DCB derived from uncontrolled study or historical comparisons. Only one randomized, controlled study compared DCB versus standard angioplasty. The FAIR trial showed better results in favour of DCB in terms of freedom from TLR at 12 months (90.8%). CONCLUSIONS: Drug coating balloon could be the first choice of devices for the treatment of FP ISR, because of its efficacy, its ease of use in comparison with more complex and less efficient devices.

Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.

BACKGROUND: Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). METHODS/DESIGN: A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. DISCUSSION: This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Primary stenting of TASC C and D femoropopliteal lesions: results of the STELLA register at 30 months.

BACKGROUND: The 1-year results of the prospective register STELLA suggested that primary stenting of long femoropopliteal (FP) lesions (≥15-cm) was a sure and effective treatment. However, the long-term results of this technique remain unknown. METHODS: STELLA is a prospective monocentric register of patients treated for FP lesions ≥15-cm (Trans-Atlantic Inter-Society Consensus [TASC] C and D) by direct stenting (Flexstar(®), Bard). The patients with de novo atheromatous lesions were included between November 2008 and October 2009 when the guidewire had crossed the lesion. Restenoses were excluded. The follow-up was coordinated by a clinical research assistant. Clinical and ultrasound evaluation were carried out every 3 months for 12 months, then every 6 months up to 30 months. Restenosis was defined by an index of peak systolic velocity >2.4. RESULTS: Among the 58 patients (62 limbs) included, 40.3% presented an effort ischemia and 59.7% a critical ischemia (CI). The mean age was 71 ± 12 years. The lesions were classified as TASC D in 37.1% of the cases. The median length of the stenting was 26 ± 18 cm. The average follow-up was 26.1 months (1-30). At 30 months, a complete follow-up was obtained in 55 patients (58 limbs). The rate of survival was 79.6%. Nine of the 11 patients deceased presented initially with CI. Death was in connection with CI in 2 cases. At the date of latest news, 98.3% of the patients were under antiaggregating treatment, 20% received antivitamin K treatment, 75% received statins, and 75% received angiotensin-converting-enzyme inhibitors. The rates of maintenance of the primary and secondary clinical improvement were 68.6 ± 6.0% and 82.6 ± 5.1% at 12 months and 65.1 ± 6.2% and 78.4 ± 5.6% at 30 months, respectively. The mean Rutherford index was 4.1 ± 1.0 in preoperative, 0.7 ± 1.2 at 12 months, and 0.6 ± 1.1 at 30 months (P < 0.001). Two major amputations were carried out at 9 and 28 months for patients initially with CI. The mean systolic pressure index was 0.6 ± 0.1 in preoperative and 1.0 ± 0.2 at 1-year and 0.9 ± 0.3 at 30 months (P < 0.001). The rates of primary and secondary patency were 66 ± 6.3% and 80.9 ± 9.5% at 12 months and 62.2 ± 6.6% and 77.2 ± 5.9% at 30 months, respectively. Between 0 and 12 months, 12 (19.3%) intrastent restenosis (ISR) were noted. One ISR was observed after 12 months. At the same period, we observed 11 and 1 target lesion revascularization, respectively. CONCLUSIONS: In the long run, the primary stenting of long FP lesions (≥15-cm) is a safe and durable treatment. A strong clinical and ultrasound monitoring is indicated during the first year to maintain the clinical improvement.

Clinical and economic evaluation of ambulatory endovascular treatment of peripheral arterial occlusive lesions.

BACKGROUND: Ambulatory management of patients is an alternative to conventional hospitalization. In this study we evaluate the results of a prospective cohort study of patients receiving ambulatory endovascular treatment for peripheral arterial lesions. METHODS: From June 2008 to October 2010, ambulatory management was proposed for endovascular treatment of peripheral arterial lesions. An arterial closure device (Angio-Seal(®); St. Jude Medical) was used. For ambulatory treatment, patients were prohibited from driving a vehicle at discharge, had to be accompanied the first night after the procedure, had to live <1 hour from a medical facility, had to be reachable by telephone the day after the intervention, and had to remain hospitalized in the event of a complication. The principal criterion was morbimortality at 1 month. Secondary criteria were clinical improvement, patency, complications related to the arterial closure, and costs evaluation at 1 month. RESULTS: Forty-five patients were included and 50 ambulatory procedures were carried out. The patients presented with claudication (92%) or a critical ischemia (8%) of the lower extremities. All procedures were carried out by femoral puncture (retrograde in 94% and anterograde in 6% of the cases). The patients presented with iliac (68%) and femoropopliteal (64%) lesions. Lesions included stenoses (70%), thromboses (16%), and intrastent restenoses (14%). The rate of failure of ambulatory hospitalization was 16% (n = 8) without a serious undesirable event: 2 patients were hospitalized after a surgical conversion for iliac rupture and disinsertion of stent; 3 patients developed a hematoma during the intervention at the point of puncture; and in 3 cases the system of percutaneous closure failed. The mean duration of hospitalization was 1.36 ± 1.33 days. At 1 month, clinical improvement was observed in 97.5% of cases, with a primary patency of 100%. No perioperative rehospitalization or puncture site complications were observed. Ambulatory management made it possible to save 42 days of hospitalization, with associated costs of 10,971€, compared with conventional hospitalization. The additional costs related to use of the Angio-Seal amounted to 7427€. CONCLUSION: Ambulatory endovascular treatment of patients presenting with peripheral arterial lesions is reliable and effective and may contribute to savings in healthcare spending.

Acute compartment syndrome of the thigh secondary to isolated common femoral vessel injury: an unusual etiology.

We report a case of acute compartment syndrome of the thigh secondary to common femoral vessel injury. The lesion was associated with common femoral artery dissection and common femoral vein rupture. Emergency surgical treatment consisted of resection-anastomosis of the arterial dissection, vein ligature, and fasciotomies. The patient is symptom-free after 15 months of follow-up. Isolated vascular injury is an unusual cause of acute compartment syndrome of the thigh. This case serves to increase awareness that isolated vascular injury, without femoral fracture or multiple injury, can result in thigh compartment syndrome. Early recognition and treatment of vascular involvement contributes to better functional outcome of this rare condition, but treatment modalities remain subject to discussion.

Long-term influence of suprarenal or infrarenal fixation on proximal neck dilatation and stentgraft migration after EVAR.

BACKGROUND: We evaluated the influence of the proximal fixation systems of stentgrafts on proximal inter-renal or infrarenal aneurysm neck dilatation after endovascular repair of abdominal aortic aneurysms. Anatomic and clinical predictive factors of neck dilatation and stentgraft proximal migration were searched for. MATERIAL AND METHODS: Taking account of a prospective and monocenter register, 58 patients' files, with a complete minimum 3-year follow-up, were analyzed after treatment with stentgrafts with a suprarenal fixation (SRF: 33 Talent) or an infrarenal fixation (IRF: 25 AneuRx). Both groups were compared in terms of inter-renal neck dilatation (D1: diameter between the two renal arteries), infrarenal neck dilatation (D2: 7-mm diameter under the lowest renal artery), and specific complication (proximal migration, endoleak). The diameter measured on the last control computed tomography scan was compared with the postoperative diameter. Neck dilatation was defined by a diameter increase exceeding 3 mm and by the proximal migration due to a caudal displacement of the stentgraft ≥10 mm. Predictive factors of proximal migration or neck dilatation were searched for (anatomy of the neck, aneurysm anatomy, stent graft oversize percentage, demographic factors). RESULTS: Preoperatively, both groups were comparable in terms of anatomic and demographic characteristics of the aneurysm. Mean follow-up was longer in the AneuRx group (62 ± 17 months vs. 53 ± 13 months, p = 0.045) and the percentage of stent graft oversize was greater in the Talent group (18 ± 6% vs. 13 ± 5%, p < 10(-4)). Freedom from a dilatation exceeding 3 mm in D1 and D2 did not bring any significant difference between the two groups. In each group, the remodeling of the aneurysmal sac (AneuRx median = -4 mm, Talent median = -5 mm, p > 0.05) was only moderately related to proximal neck remodeling. A small angulation of the neck and a smaller neck were the only predictive factors of neck dilatation found respectively in D1 (p = 0.007) and in D2 (p = 0.022). Stent graft proximal migration was more frequent in the AneuRx group (p = 0.031) and was more frequent with large aneurysms (p = 0.029). CONCLUSION: In the long term, the absence of proximal stent graft fixation system on the dilatation of the aneurysm proximal neck enhances proximal migration. Conversely, the inter-renal or infrarenal proximal neck dilatation does not depend on the type of proximal fixation but on anatomic factors and on the natural evolution of the aneurysmal disease.

Association of aneurysmal and occlusive lesions in Behçet's disease.

Arterial involvement in Behçet's disease is rare, occurring in various locations with multiple clinical expressions. When Behçet's disease is associated with large arteries, lesions are usually in the form of aneurysms or occlusions. The simultaneous occurrence of these two lesions is even more unusual. We present a case of Behçet's disease in which arterial involvement included an iliac artery thrombosis and an asymptomatic aneurysm of the infrarenal abdominal aorta. Behçet's disease must be considered in the diagnosis of any unexplained inflammatory arteriopathy. Surgery is indicated for the majority of aneurysms and severe symptoms. The postoperative follow-up is based on noninvasive radiologic examinations.