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.

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).

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.

Self-assessment of voice outcomes after total thyroidectomy using the Voice Handicap Index questionnaire: Results of a prospective multicenter study.

BACKGROUND: Voice disorders are frequent after thyroidectomy. We report the long-term voice quality outcomes after thyroidectomy using the voice handicap index self-questionnaire. METHODS: Eight hundred patients who underwent total thyroidectomy between 2014 and 2017 in 7 French hospitals were prospectively included. All patients filled in voice handicap index questionnaires, preoperatively and 2 and 6 months after surgery. RESULTS: Median (range) voice handicap index scores were significantly increased at month 2 (4 [0; 108]) compared to preoperative values (2 [0; 76]) and were unchanged at month 6 (2 [2; 92]). Clinically significant voice impairment (voice handicap index score difference ≥18 points) was reported in 19.7% at month 2 and 13% at month 6. Thirty-seven (4.6%) had postoperative vocal cord palsy. In patients with vocal cord palsy compared to those without, median voice handicap index scores were increased at month 2 (14 [0; 107] vs 4 [0; 108]; P = .0039), but not at month 6 (5 [0; 92] vs 2 [0; 87]; P = .0702). Clinically significant impairment was reported in 38% vs 19% at month 2 (P = .010), and in 19% vs 13% at month 6 (P = .310). Thyroid weight, postoperative hypocalcemia, vocal cord palsy, and absence of intraoperative neuromonitoring utilization were associated with an increased risk of clinically significant self-perceived voice impairment at month 2. CONCLUSION: Thyroidectomy impairs patients' voice quality perception in patients with and without vocal cord palsy.

Long-term voice quality outcomes after total thyroidectomy: a prospective multicenter study.

BACKGROUND: Postthyroidectomy voice disorders can occur without any recurrent laryngeal nerve injury, and probably are the most frequent complication after thyroidectomy. We report the long-term voice quality outcomes after total thyroidectomy without vocal cord palsy using a simple self-assessment tool: the voice handicap index self-questionnaire. METHODS: This observational prospective multicenter study included 203 patients from the "ThyrQoL" study (ClinicalTrial NCT02167529), who underwent total thyroidectomy between October 2014 and August 2015 in 3 French Hospitals (Nantes, La Roche-sur-Yon, and Limoges). Exclusion criteria included confirmed malignant disease, age <18 years, and preoperative voice troubles with confirmed vocal cord palsy. Direct flexible laryngoscopy was performed after surgery. Nineteen patients with a postoperative vocal cord palsy were excluded from analysis. RESULTS: One hundred and seventy-six patients with no vocal cord palsy were analyzed. Voice handicap index scores were significantly altered on postoperative month 2 compared with preoperative values (7.02 ± 11.56 vs 14.41 ± 19.44; P<.0001). Voice handicap index scores were not significantly different on postoperative month 6 compared with preoperative values (7.02 ± 11.56 vs 7.61 ± 14.02; P=.381). Thirty-six patients (20.5%) described significant voice impairment 2 months after total thyroidectomy. Nine patients (5.7%) still experienced significant discomfort at 6 months. CONCLUSION: Twenty percent of patients had initial voice impairment at 2 months postthyroidectomy, with a progressive recovery to preoperative levels at 6 months with <6% with persistent voice complaints.