Coralie Barbe

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial

IMPORTANCE Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil. OBJECTIVE To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. DESIGN, SETTING, AND PARTICIPANTS Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). INTERVENTIONS Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures. MAIN OUTCOMES AND MEASURES The primary outcome was improvement of at least 54 m in the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St Georges Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness. RESULTS Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18% (1-sided 95% CI, 4% to ∞; P = .03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95% CI, 0.05 L to ∞) (P = .001) and +0.08 L (95% CI, 0.03 L to ∞) (P = .002) for forced expiratory volume in the first second, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (P = .12) for 6-minute walk distance, and -13.4 points (95% CI, -8 points to ∞) and -10.6 points (95% CI, -5.8 points to ∞) for St Georges Respiratory Questionnaire (1-sided P < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was

High Frequency and Clinical Prognostic Value of MYD88 L265P Mutation in Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg-Type

47,908 (95% CI,

Prevalence of abdominal aortic aneurysm and large infrarenal aorta in patients with acute coronary syndrome and proven coronary stenosis: a prospective monocenter study.

47,879-

Clinical and Immunologic Factors Associated With Bullous Pemphigoid Relapse During the First Year of Treatment: A Multicenter, Prospective Study

48,073) (P < .001); the incremental cost-effectiveness ratio was

Endovascular Treatment of Very Small Unruptured Aneurysms Rate of Procedural Complications, Clinical Outcome, and Anatomical Results

782,598 per additional quality-adjusted life-year. CONCLUSIONS AND RELEVANCE In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01822795.

Factors Associated with Caregivers’ Underestimation of Quality of Life in Patients with Alzheimer’s Disease

IMPORTANCE The activating mutation of MYD88 L265P is a frequent feature of primary cutaneous diffuse large B-cell lymphoma, leg-type (PCLBCL-LT), reported in up to 69% of the cases. Whether patients with MYD88 mutation display specific clinical and evolutive features has not been evaluated. OBJECTIVE To identify the clinical characteristics associated with MYD88 mutation, confirm its high prevalence, and evaluate its effect on prognosis in patients with PCLBCL-LT. DESIGN, SETTING, AND PARTICIPANTS A retrospective multicenter study was conducted using the medical records of patients from dermatology departments belonging to the French Study Group for Cutaneous Lymphomas. Sixty-one patients with a diagnosis of PCLBCL-LT made between 1988 and 2010 who were available for molecular study were included. Of these, 58 patients displaying interpretable results constituted the study group. Median follow-up was 33 months, and 39 patients (67%) were monitored until death. MAIN OUTCOMES AND MEASURES Clinical features (age, sex, number of skin lesions, tumor stage, and location as leg vs elsewhere), MYD88 mutation (allele-specific TaqMan polymerase chain reaction assay), treatment regimen, and outcome were recorded. Baseline characteristics and outcome were compared according to the status of MYD88. RESULTS The median age of the patients was 79 years, and 59% were female. Skin lesions were located on the leg in 76% of the cases. Thirty-four of 58 patients (59%) harbored the MYD88 L265P mutation. Patients had similar clinical characteristics at presentation regardless of their MYD88 status, except that those harboring the MYD88 mutation were older (P = .006) and had more frequent involvement of the leg (P = .008). Patients harboring the MYD88 mutation had 3- and 5-year-specific survival rates of 65.7% and 60.2% vs 85.4% and 71.7% in patients with the wild-type allele. The MYD88 mutation was significantly associated with shorter disease-specific survival in univariate (P = .03) and multivariate (odds ratio, 3.01; 95% CI, 1.03-8.78; P = .04) analysis. There was no significant difference between the groups in their treatment regimens. Considering overall survival, in univariate (P = .002) and multivariate (odds ratio, 2.94; 95% CI, 1.18-7.30; P = .02) analysis, MYD88 L265P mutation was an independent adverse prognostic factor. CONCLUSIONS AND RELEVANCE This study confirms the high prevalence of MYD88 L265P mutation in PCLBCL-LT and shows its association with shorter survival. The clinical effect of MYD88 mutation activating the nuclear factor-κB pathway supports the use of targeted therapies at the time of relapse after conventional therapies.

The modified Medical Research Council scale for the assessment of dyspnea in daily living in obesity: a pilot study

BACKGROUND Little is known about the prevalence of abdominal aortic aneurysm (AAA) in patients with coronary heart disease. The aims of this prospective study were to evaluate the prevalence of AAA and of large abdominal aorta in patients hospitalized for acute coronary syndrome and coronary stenosis of 50% or greater. METHODS AAA ultrasound screening was prospectively performed in 306 patients after they gave informed consent. AAA and large abdominal aorta were defined by maximum anteroposterior diameter of 30 mm or greater and of 20 to 29 mm, respectively. Patient characteristics were prospectively collected. Univariate and multivariate analyses were used to identify risk factors for AAA and large abdominal aorta. A p value <0.05 was considered statistically significant. RESULTS AAAs were diagnosed in 20 patients (6.6%). Mean diameter was 33 +/- 3.7 mm, and median diameter [min--max] was 31 mm [30 - 45 mm]. All except one AAA were between 30 and 40 mm. No AAAs were detected in patients younger than 50 years. Prevalence reached 7.7% in patients older than 50 years. Using stepwise logistic regression analysis, age (odds ratio [OR] 1.04. 95% confidence [CI] 1.00-1.09 per year of age, p = 0.06) and previous coronary events (OR 2.44, 95% CI 0.96-6.25, p = 0.06) showed a borderline significant association with AAA. Large infrarenal aortic diameter was observed in 32% of patients. Age (OR 1.03, 95% CI 1.02-1.05 per year of age, p < 0.0001), male gender (OR 16.7, 95% CI 6.25-50.0, p < 0.0001), and overweight (OR 2.0, 95% CI 1.2-3.4, p = 0.01) showed a significant independent association with large aorta. CONCLUSION AAA and large infrarenal aorta prevalence seems high in patients with acute coronary syndrome and proven coronary stenosis of 50% or greater. Previous coronary events and older age might be associated with higher risk of AAA, and age, male gender, and obesity are significantly associated with large infrarenal aorta. If these results are confirmed in larger studies, further guidelines concerning AAA screening in this well-defined population should be considered.

Outcome after mechanical thrombectomy using a stent retriever under conscious sedation: Comparison between tandem and single occlusion of the anterior circulation

IMPORTANCE Although predisposing factors for bullous pemphigoid (BP) have been recently established, no clinical or immunologic factors have yet been identified to predict disease outcome. OBJECTIVE To identify risk factors for BP relapse during the first year of treatment. DESIGN, SETTING, AND PARTICIPANTS Multicenter prospective study of 120 consecutive patients with newly diagnosed BP in 8 French dermatology departments. Baseline and 6 follow-up visits were planned to record disease activity and collect blood samples for measurement of serum anti-BP180 and anti-BP230 levels by means of enzyme-linked immunosorbent assay (ELISA). MAIN OUTCOMES AND MEASURES The end point was clinical relapse within the first year of therapy. Associations of clinical and immunologic (including serum levels of anti-BP180 and anti-BP230 autoantibodies) parameters with clinical relapse were assessed using univariate and multivariate analyses. RESULTS During the 1-year follow-up, 35 patients (29.2%) experienced relapse, whereas anti-BP180 and anti-BP230 ELISA results were similar at baseline between patients who did and did not experience relapse. Factors at baseline independently associated with relapse were extensive disease at inclusion (hazard ratio [HR], 2.37 [95% CI, 1.2-4.8]) and an associated dementia (HR, 2.09 [95% CI, 1.0-4.2]). Use of superpotent topical corticosteroids alone (by 100 patients [83.3%]) induced a dramatic, early decrease in serum levels of anti-BP180 and anti-BP230 autoantibodies. Mean early decreases in autoantibody levels between baseline and day 60 were lower in patients with relapse compared with patients with ongoing remission (-10.0% and -45.2%, respectively, for anti-BP180 levels [P < .001] and -11.8% and -35.4%, respectively, for anti-BP230 levels [P = .046]). A higher serum level of anti-BP180 at day 150, with a cutoff of 23 U/mL, provided 84.2% sensitivity, 44.8% specificity, 33.3% positive predictive value, and 89.7% negative predictive value for the occurrence of relapses between days 150 and 360. CONCLUSIONS AND RELEVANCE The pronounced decrease in the level of anti-BP180 autoantibodies and, to a lesser extent, those directed against BP230 confirmed the use of superpotent topical corticosteroids alone as a reference BP treatment. Furthermore, our study suggests that neurological diseases play a major role in BP, not only as a predisposing but also as a prognostic factor.

Distinctive features of melanoma and its management in elderly patients: a population-based study in France.

Background and Purpose— The strategy of treatment of small unruptured intracranial aneurysms is complex because of their presumably low risk of rupture. A precise knowledge of the perioperative complications in this specific subgroup is mandatory. The purpose of this study was to compare the results of the endovascular treatment of aneurysms ≤3 mm and aneurysms >3 mm included in the Analysis of Treatment by Endovascular Approach of Nonruptured Aneurysms study. Methods— The study included 626 patients harboring 682 unruptured aneurysms. Perioperative adverse events and clinical outcome were analyzed in patients treated for aneurysms ≤3 mm (51 patients, 51 aneurysms) and in patients treated for aneurysms >3 mm (575 patients, 631 aneurysms). Results— Endovascular treatment failed more often in aneurysms ≤3 mm (13.7%) compared to aneurysms >3 mm (3.3%; P=0.003). The rate of intraoperative rupture for aneurysms ≤3 mm (3.9%; 95% CI, 0.5–13.5) did not significantly differ compared to aneurysms >3 mm (2.4%; 95% CI, 1.2–3.6; P=0.37). Thromboembolic events were not significantly different in both groups (3.9%; 95% CI, 0.5–13.5 in very small aneurysms and 7.1%; 95% CI, 5.1–9.1 in larger aneurysms; P=0.57). One month morbidity/mortality was not significantly different for patients with very small aneurysms (2.0%; 95% CI, 0.05–10.45) and for patients with larger aneurysms (3.3%; 95% CI, 1.8–4.8; P=0.60). Conclusions— The risks of endovascular treatment are similar in patients with very small or with larger aneurysms. Because the risk of spontaneous rupture is lower in very small aneurysms, their management will include follow-up MRI and active treatment in case of morphological modification.

Clinical and pathological characteristics of melanoma: a population-based study in a French regional population.

Objective: The aim of this study was to identify the factors associated with differences between how Alzheimer’s disease (AD) patients and their caregivers rate the patient’s health-related quality of life (QoL). Methods: Cross-sectional, multicentre study. Patients were 65 years or more, suffering from mild to moderate AD, native French speakers, with a main caregiver. Interrater agreement of the QoL-AD was assessed using the intraclass coefficient. A generalised linear model was used to identify factors related to the difference in health-related QoL scores between patients and their caregivers. Results: The 122 patients of the study were 82 ± 6 years old and mainly women (69%). Independent factors related to the difference between patients and caregivers were: Mini Mental State Exam score (β = 0.32; 95% CI = 0.05–0.59); instrumental activities of daily living score (β = –0.61; 95% CI = –1.14 to –0.07); total Neuropsychiatric Inventory score (β = 0.10; 95% CI = 0.05–0.59), and Zarit’s burden score (β = 0.09; 95% CI = 0.01–0.17). Conclusion: Practitioners must take into account the trend towards underestimation when health-related QoL is rated by caregivers or proxies.