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.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment.

BACKGROUND: For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath. METHODS: FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month. RESULTS: Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline. CONCLUSION: FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.

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

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

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.

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.

The psychological impact of implantable cardioverter defibrillator implantation on Brugada syndrome patients.

AIMS: Brugada syndrome (BrS) is a hereditary arrhythmic disease, responsible for sudden death in patients without known heart disease. An implantable cardioverter defibrillator (ICD) is recommended in patients at high risk of sudden death, but the resulting psychological impact has never been studied. The aim of our study was to assess the impact on quality of life of BrS and ICD implantation. METHODS AND RESULTS: Patients were selected from the reference centre for hereditary arrhythmic disease database in Nantes. This population was divided into three groups: Group 1 (G1), symptomatic implanted patients; Group 2 (G2), asymptomatic implanted patients; and Group 3 (G3), asymptomatic patients without ICD. One hundred and ninety questionnaires [36-item short-form health survey (SF-36) and subsidiary questions] were analysed (60 in G1, 78 in G2, and 52 in G3). We failed to identify any difference in the evaluation of the SF-36 between the three groups and the SF-36 score was similar to the French population score. However, specific questions regarding tolerance of the ICD showed that ICD implantation resulted in significant negative impact, especially for professional careers and purchasing insurance, even though the patient considered ICD implantation as reassuring. CONCLUSION: Whatever the group, BrS patients have a good quality of life with no difference between implanted and non-implanted patients. However, ICD implantation is accompanied by difficulties in their social and professional life. This work emphasizes the need to propose specific recommendations applicable to insurance to reduce the complications experienced by these patients.

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).

A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial.

OBJECTIVES: The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions. BACKGROUND: No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions. METHODS: BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period. RESULTS: Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization. CONCLUSIONS: In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.

Noninvasive Ventilation in Obese Subjects After Acute Respiratory Failure.

INTRODUCTION: Noninvasive ventilation (NIV) has been widely used to treat acute respiratory failure in obese patients. Criteria that could help clinicians to decide whether they should continue to use NIV after such an initial episode remain unclear. Our retrospective study aims to analyze characteristics of subjects receiving long-term NIV after an initial hospitalization for acute respiratory failure. METHODS: From January 2011 to December 2012, 77 obese adults were admitted in the ICU of the respiratory disease department in Nantes University Hospital in France. After discharge, adherence, body mass index (BMI), and arterial blood gases were assessed or measured at 6 months and 12 months. RESULTS: In all, 53 subjects were analyzed, including 62% who were admitted for idiopathic acute hypercapnic respiratory failure. Mean BMI was 42 ± 11 kg/m2. Failure of NIV occurred in 10% cases in the ICU. At the end of the hospital stay, 34 subjects were discharged with NIV at home. They had higher BMI and higher initial inspiratory positive airway pressure than those who were not ventilated at home. During follow-up, BMI, PaCO2 , and bicarbonate rate significantly decreased. At 12 months, 4 subjects were not ventilated anymore after a mean duration of 6 ± 4.2 months of ventilation. Adherence was correct in 86%, with a mean use of 7 ± 3.1 h/d. Adherent subjects had better adherence at 1 month, a lower forced vital capacity, a higher bicarbonate rate, and a higher NIV breathing frequency when compared to subjects with poor adherence. CONCLUSIONS: Subjects with the most severe obesity or who experienced the most difficult initial ventilation were more likely to receive long-term NIV after initial management of acute respiratory failure in the ICU. In those subjects, long-term NIV at home was effective and well tolerated.

Stenting or Surgery for De Novo Common Femoral Artery Stenosis.

OBJECTIVES: The TECCO (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND: Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS: From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS: Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2 ± 2.9 days vs. 6.3 ± 3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS: In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term. (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery] [TECCO]; NCT01353651).