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Purpose: The aim of this study was to compare the long-term clinical and radiological results between fixed (FB) and mobile bearing (MB) implants with identical design from the same manufacturer., Methods: From March 2007 to May 2009, we recruited 160 patients in a prospective, single centered, randomized controlled trial. The authors compared 81 FB total knee arthroplasty (TKA) versus 79 MB with medial compartment osteoarthritis. The same posterior stabilized HLS Noetos knee prosthesis (CORIN) was used in all patients. The two groups only differed by the tibial insert (fixed or mobile). The authors compared the postoperative Knee Society Score (KSS), the passive clinical and active radiological knee flexion, the implant survivorship, the complications, and the presence of radiolucent lines., Results: At mean 10.5 years' follow-up (range 8-12.1 years) no significant differences were found in clinical scores (KSS (p = 0.54), pain score (p = 0.77), stair climbing (p = 0.44), passive maximum flexion (p = 0.5)) or for radiological analyses (maximum active radiological flexion (p = 0.06), presence of progressive radiolucent lines (5 (MB group) versus 6 (FB group); p = 0.75)) between groups. No significant difference was found in overall implant survivorship (82% (MB group) versus 78% (FB group) p = 0.58) or complication rate (p = 0.32) at the last follow-up., Conclusion: No significant clinical and radiological differences were found between fixed and mobile bearing TKA using the same semi-constrained implant type with comparable overall survivorship. The choice between a fixed or mobile bearing implant should be based on surgeon preference and experience with the selected implant., Level of Evidence: Prospective randomized controlled trial, Level II., (© 2020. European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA).)

Competing Interests: RS has received consulting fees from GSK, BMS, Fresenius Kabi, Boerhinger, Jansen, Amgen, Pfizer, and Roche. AB has received honoraria from AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Biogen, and UCB. M-ET has received honoraria or participated on advisory boards for Galapagos, Eli Lilly, SOBI, Boehringer Ingelheim, Fresenius Kabi, MSD, and AbbVie and had received research support from Gilead. AR has received honoraria from AbbVie and Pfizer. J-EG has received honoraria or participated on advisory boards for AbbVie, BMS, Eli Lilly, Galapagos, Gilead, Pfizer, Roche, Sanofi, Novartis, MSD, CSL-Behrin,g and Genzyme and received research support from BMS. RF has received honoraria or participated on advisory boards for AbbVie, Eli Lilly, and Pfizer. AC has received honoraria from Chugai and Pfizer. JA has received consultancy fees from AbbVie, Sanofi, and Nordic Pharma; honoraria from Galapagos, AbbVie, BMS, Sanofi, Roche-Chugai, Nordic Pharma, Biogen, Fresenius Kabi, and MSD; and research support from Pfizer, BMS, and Novartis. XM has received consulting fees from BMS, Galapagos, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, Sanofi, and UCB and research support from Ose Pharmaceutical and Pfizer. CP has received honoraria from UCB, Eli Lilly, AbbVie, Sandoz, Pfizer, and Novartis; support for attending meetings from Chugai, AbbVie, Sandoz, and Amgen; and a research grant from Pfizer. J-HS has received consulting fees or honoraria from Eli Lilly, Pfizer, AbbVie, and Galapagos. ED has received honoraria from AbbVie, Amgen, Celgene, BMS, UCB, Eli Lilly, Janssen, MSD, and Novartis. All other authors declare no competing interests. We thank the French Society of Rheumatology, the sponsor of this study. We also thank the MAJIK scientific committee and the group of MAJIK Registry investigators and Pascale Thevenot for her great help. Funding of the MAJIK Registry is supported by the French Rheumatology Society. The French Rheumatology Society received unrestricted institutional grants for conducting the MAJIK Registry from AbbVie, Galapagos, Eli Lilly, and Pfizer. The French Rheumatology Society, AbbVie, Galapagos, Eli Lilly, and Pfizer were not involved in the study design, data collection, data analysis, data interpretation, or writing of the manuscript. RS and MC contributed to study conception, study design, data collection, statistical analysis, interpretation of data and writing - original draft. RS and MC had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. J-HS, CR, ED, AB, VG, CL, SB, M-ET, AR, J-EG, RF, FC, AC, CP, XM, and JA contributed to interpretation of data and writing - critical review for intellectual concept and editing.

Oxaliplatin, a pivotal drug in the management of colorectal cancer, causes chemotherapy-induced peripheral neuropathy (CIPN) in a third of cancer survivors. Based on a previous cross-sectional study assessing oxaliplatin-related sensory CIPN in colorectal cancer survivors, a secondary analysis was designed to explore the possibility that different clusters of patients may co-exist among a cohort of patients with oxaliplatin-related CIPN. Other objectives were to characterize these clusters considering CIPN severity, anxiety, depression, health-related quality of life (HRQOL), patients' characteristics and oxaliplatin treatments. Among the 96 patients analyzed, three clusters were identified (cluster 1: 52, cluster 2: 34, and cluster 3: 10 patients). Clusters were significantly different according to CIPN severity and the proportion of neuropathic pain (cluster 1: low, cluster 2: intermediate, and cluster 3: high). Anxiety, depressive disorders and HRQOL alteration were lower in cluster 1 in comparison to clusters 2 and 3, but not different between clusters 2 and 3. This study underlines that patients with CIPN are not a homogenous group, and that CIPN severity is associated with psychological distress and a decline of HRQOL. Further studies are needed to explore the relation between clusters and CIPN management., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Kerckhove, Selvy, Lambert, Gonneau, Feydel, Pétorin, Vimal-Baguet, Melnikov, Kullab, Hebbar, Bouché, Slimano, Bourgeois, Lebrun-Ly, Thuillier, Mazard, Tavan, Benmammar, Monange, Ramdani, Péré-Vergé, Huet-Penz, Bedjaoui, Genty, Leyronnas, Busserolles, Trévis, Pinon, Pezet and Balayssac.)

Objectives: COVID-19 vaccines have become the new hope for stemming the pandemic. We aimed to assess pre-launch vaccine acceptance among hospital workers in the Auvergne-Rhône-Alpes Administrative Region of France., Methods: We performed a cross sectional study involving all hospital workers in 11 Auvergne-Rhône-Alpes hospitals in December 2020. Univariate and multivariate analyses were performed to identify factors associated with vaccine hesitancy., Results: We analyzed completed questionnaires from 1,964 respondents (78% women, mean age 42 years, 21.5% physicians, 41% private care centers). A total of 1,048 (53%) hospital workers were in favor of COVID-19 vaccination. Vaccine hesitancy was associated with: female gender; young age; paramedical, technical, and administrative professions (i.e., all non-medical professions); no prior flu vaccination; and employment in the private medical care sector (p<0.05). Distrust of health authorities and pharmaceutical lobbying were the main obstacles to vaccination. Inversely, creating herd immunity and protecting patients and household members were the most frequently cited reasons in favor of vaccination. More than two-thirds of participants feared that the clinical and biological research was too rapid and worried about serious adverse effects. Most participants were interested in written information on the available vaccines, but the most vaccine-hesitant categories preferred oral information. Only 35% supported mandatory vaccination., Conclusions: Targeted written and oral information campaigns will be necessary to improve vaccination coverage among hospital workers who show a surprisingly high hesitancy rate. Imposing mandatory vaccination could be counterproductive., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Meningiomas are the most common intracranial tumours in adults and they are infrequently associated with a metastasis clinical course. Pleural metastases are extremely rare and no guidelines on a specific treatment have been established. When localized, surgical resection is the mainstay of treatment, but there is a high risk of pleural recurrence. We aimed to describe a novel surgical approach in pleural metastasis of meningiomas. We report the case of a 41-year-old man with the medical history of surgically resected intracranial atypical meningioma. Nine years after diagnosis of atypical meningioma, a CT scan of the chest disclosed 10 pleural implants gathered in the fissure, in the paramediastinal pleura and at the base of the left hemithorax. Surgical resection was decided. Parietal and mediastinal pleura resection with visceral pleural lesions removal were performed. Cytoreductive surgery was associated with intrathoracic hyperthermic chemotherapy. Postoperative course was uneventful and no adjuvant therapy was undertaken. The patient is free of pleural recurrence 12 months post operatively. The present case report suggests that cytoreductive surgery with intrathoracic hyperthermic chemotherapy is feasible and safe in pleural metastasis from meningioma. Prolonged follow-up and prospective studies are mandatory to assess its oncological benefit., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs)., Background: The choice of optimal drug for anticoagulation after TAVR remains debated., Methods: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety)., Results: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups., Conclusions: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR., Competing Interests: Funding Support and Author Disclosures This work is supported by the French Government, managed by the National Research Agency under the program “Investissements d’avenir” with the reference ANR-16-RHUS-0003. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Purpose: Iodine-125 ( 125 I) brachytherapy (BT) alone for intermediate-risk (IR) prostate adenocarcinoma (PCA) is controversial. The purpose of the study was to investigate potential predictive factors in selected IR-PCA patients treated with BT., Material and Methods: Among 547 patients treated with 125 I BT between 2003 and 2013, 149 IR-PCA cases were selected according to NCCN classification after an additional exclusion of patients with prostate specific antigen (PSA) > 15 ng/ml and ISUP group 3. A relapse was defined as a biochemical failure, using ASTRO Phoenix definition, or a relapse identified on imaging. Survival curves were estimated with Kaplan-Meier method. Potential prognostic variables including EAU/ESTRO/SIOG guidelines eligibility criteria were analyzed using univariate and Cox's proportional hazards regression analysis., Results: Of the 149 IR patients, 112 were classified as favorable, with 69 cases eligible to BT according to EAU/ESTRO/SIOG guidelines, and 37 patients were identified as unfavorable as per NCCN. Androgen deprivation therapy (ADT) was applied in 6 patients only. Percentage of positive biopsy cores were ≤ 33% and ≥ 50% for 119 and 11 patients, respectively. With a median follow-up of 8.5 years, 30 patients experienced a relapse. 10-year overall survival, progression-free survival (PFS), and relapse-free survival (RFS) were 84% (95% CI: 75-90%), 66% (95% CI: 56-75%), and 77% (95% CI: 67-84%), respectively. Failure to meet EAU/ESTRO/SIOG criteria was significantly associated with a lower RFS ( p = 0.0267, HR = 2.37 [95% CI: 1.10-5.08%])., Conclusions: Brachytherapy is an effective treatment for selected IR-PCA cases. Patients who were not eligible according to EAU/ESTRO/SIOG guidelines demonstrated a lower RFS., Competing Interests: The authors report no conflict of interest., (Copyright © 2021 Termedia.)

Aim: Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial., Method: PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The primary endpoint was the tumour regression grade. Secondary endpoints were 3-year overall survival (OS), disease-free survival (DFS), recurrence-free survival (RFS) and time to recurrence (TTR)., Results: Overall, 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped for futility. The remaining 104 patients represented our intention-to-treat population. In the perioperative group, 96% received the scheduled four neoadjuvant cycles and all but one had adjuvant FOLFOX for eight cycles. In the control arm, 38 (73%) patients received adjuvant FOLFOX. The median follow-up was 54.3 months. Three-year OS was 90.4% in both arms [hazard ratio (HR) = 0.85], 3-year DFS, RFS and TTR were, respectively, 76.8% and 69.2% (HR=0.94), 73% and 69.2% (HR = 0.86) and 82% and 72% (HR = 0.67) in the perioperative and control arms, respectively. Forest plots did not show any subgroup with significant difference for survival outcomes. No benefit from adding cetuximab was observed., Conclusion: Perioperative FOLFOX has no detrimental effect on long-term oncological outcomes and may be an option for some patients with locally advanced CC., (© 2021 The Association of Coloproctology of Great Britain and Ireland.)

Prolonged and unexplained fevers in young adults are uncommon, especially when access to diagnostic tests is simplified. Therefore, the definition of unexplained fever depends on the volume of tests performed. However, low-grade fever has not been a priority in research. Management of low-grade fever [eg, an oral temperature of ≥37.8°C (100°F) and <38.3°C (101°F) at any time of the day] is not codified. The presented case of a 37-year-old nurse with an intermittent fever for three months, with no clear diagnostic evidence and no elevated markers of inflammation, illustrates "habitual hyperthermia" (HH)-retained after ordering tests sequentially in town and at the hospital. HH was made known by Prof. H.A. Reimann (1897-1986) an American virologist, although the diagnostic criteria are fallible. The article reviews the criteria and then discusses how to select diagnostic tests in family practice for prolonged fever in young adults without clinical signs of orientation. Given the polymorphism of febrile illnesses, the principle of parsimony must be transgressed, and in the event of an early suspicion of HH, surveillance is a rule to be further amended., Competing Interests: The authors report no conflicts of interest in this work., (© 2021 Ginier-Gillet and Esparcieux.)

Background: The benefit of arterial revascularization in coronary surgery remains controversial. The incremental value of additional grafts to the left internal thoracic artery (ITA) has been mainly assessed according to the number of arterial grafts, possibly limiting the detection of its actual impact. We analyzed the influence of the number of distal arterial anastomoses (DAA) performed on late mortality in patients having received from one to three arterial grafts., Methods: Retrospective review of 3685 primary isolated coronary artery bypass grafting (CABG) performed from 1989 to 2014 was conducted with a 13-year mean follow-up. One arterial graft (SITA) was used in 969 patients, two arterial grafts, ITA or gastroepiploic artery (GEA), in 1883 patients (BITA: 1644; SITA+GEA: 239), and three arterial grafts in 833 patients (BITA+GEA). Totally, 795 patients (22%) received one DAA, 1142 patients (31%) two, 1337 patients (36%) three, and 411 patients (11%) four or more. A sub-group analysis was done in the 2104 patients with 3-vessel disease who received at least 2 arterial grafts., Results: In this series the early mortality was 1.6% and it was not influenced by the surgical technique. Late mortality was significantly influenced by age, gender, heart failure, LV ejection fraction, diabetes status, complete revascularization, number of arterial grafts, number of DAA, both ITA, sequential ITA graft, GEA graft. In multivariable analysis with Cox regression model, the number of DAA was the only technical significant independent prognosis factor of late survival (p < 0.0001), predominant over both ITA, complete revascularization and number of arterial grafts. The impact of the number of DAA on survival was found discriminant from 1 to 3; after 3 there was no more additional effect. In 3-vessel disease patients who received at least 2 arterial grafts, the number of DAA remained a significant independent prognosis factor of late survival (p < 0.0001)., Conclusions: The number of distal arterial anastomoses is an independent predictor of long-term survival, predominant over the number of arterial grafts and the completeness of the revascularization; higher the number, better the late survival. It is a strong support of the extensive use of arterial grafting in CABG.

Purpose: To assess the feasibility and tumor outcome of re-irradiation with low-dose-rate brachytherapy for macroscopic local recurrences after radical prostatectomy (RP) followed by adjuvant or salvage external beam radiation therapy (EBRT)., Methods and Materials: Between 2011 and 2018, five men with histologically proven local failure within the prostate (4) or seminal vesicle bed (1) after RP and adjuvant or salvage EBRT (median dose: 67.5 Gy) underwent a salvage brachytherapy (S-BT). The median delay after EBRT was 86 months (range 75-234). Two patients were castration-resistant at the time of S-BT. The gross tumor volume was defined on a multiparametric MRI and transrectal US imaging. Echo-guided transperineal implants of Iodine-125 seeds were optimized with a per-operative dosimetry and delivered with the seed-selectron., Results: A high conformity was achieved with a high dose to the CTV (D 95%  > 145 Gy in all but one) and very low dose to the rectum, urethra, and bladder. With a median followup of 21 months, all but one patient experienced nodes and/or bone metastases. Local control was achieved in 3/4 of evaluable patients (local failure distant to the treated volume in one). To date, no Grade 2 or more late toxicities were observed., Conclusion: For selected patients, focal local recurrence brachytherapy after PR and EBRT appears technically feasible and safe, but the efficacy remains uncertain as the majority of patients quickly relapsed at other sites. Large prospective studies are still required to better select patients who will benefit from this strategy., (Copyright © 2021 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population., Materials and Methods: Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications., Results: Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m 2 . Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically)., Conclusion: The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.

Purpose: In the general context of medical judicialization, spine surgeons are impacted by the part that medical responsibility and the risk of malpractice play in their actions and decisions. Our aim was to evaluate possible shifts in practices among private neurosurgeons who are highly exposed to this judicial risk and detect alterations in their pleasure in exercising their profession. We present the first national survey on French physicians' perception of surgical judicialization and consequences on their practice., Methods: An online survey was submitted to the 121 members of the French Society of Private Neurosurgery, who represent 29.1% of the total number of spine surgeons and perform 36.0% of the national total spine surgery activity. The French law (no-fault out-of-court scheme) significantly impacts these surgeons in the event of litigation., Results: A total of 78 surveys were completed (64.5% response rate): 89.7% of respondents experienced alteration of doctor-patient relationship related to judicialization and 60.2% had already refused to perform risky surgeries. Fear of being sued added negative pressure during surgery for 55.1% of respondents and 37.2% of them had already considered stopping their practice because of this litigation context., Conclusion: The increasing impact of medical liability is prompting practitioners to change their practice and perceptions. The doctor-patient relationship appears to be altered, negative pressure is placed on physicians and defensively, some neurosurgeons may refuse high-risk patients and procedures. This situation causes professional disenchantment and can ultimately prove disadvantageous for both doctors and patients., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

(1) Background: Oxaliplatin is among the most neurotoxic anticancer drugs. Little data are available on the long-term prevalence and consequences of chemotherapy-induced peripheral neuropathy (CIPN), even though the third largest population of cancer survivors is made up of survivors of colorectal cancer. (2) Methods: A multicenter, cross-sectional study was conducted in 16 French centers to assess the prevalence of CIPN, as well as its consequences (neuropathic pain, anxiety, depression, and quality of life) in cancer survivors during the 5 years after the end of adjuvant oxaliplatin chemotherapy. (3) Results: Out of 406 patients, the prevalence of CIPN was 31.3% (95% confidence interval: 26.8-36.0). Little improvement in CIPN was found over the 5 years, and 36.5% of patients with CIPN also had neuropathic pain. CIPN was associated with anxiety, depression, and deterioration of quality of life. None of the patients with CIPN were treated with duloxetine (recommendation from American Society of Clinical Oncology), and only 3.2%, 1.6%, and 1.6% were treated with pregabalin, gabapentin, and amitriptyline, respectively. (4) Conclusions: Five years after the end of chemotherapy, a quarter of patients suffered from CIPN. The present study showed marked psychological distress and uncovered a failure in management in these patients.

Background: Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB) is a reliable surgical option for the control of anterior knee laxity after ACL injury. The addition of a lateral extra-articular tenodesis (LET) may improve control of rotation knee laxity and improve short-term graft survival in high-risk patients., Purpose: The aims of this study were to compare long-term patient-reported outcomes, graft survival, and risk of osteoarthritis between ACLR with and without LET., Study Design: Randomized controlled trial; Level of evidence, 2., Methods: This study included 121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999. In total, 61 knees were randomized to an isolated BTB ACLR, and 60 knees were randomized to a BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire)., Results: Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2). Of those patients, 43 had a clinical examination and completed patient-reported outcome questionnaires, and the other 37 patients were evaluated through the questionnaires alone. Standard radiographs were available for 45 patients and laximetry (TELOS) for 42 patients. Mean subjective International Knee Documentation Committee score at last follow-up was 81.8, and no differences were noted between the BTB and BTB-LET groups ( P = .7). Two-thirds of patients were still participating in pivoting sports. A total of 17 knees (21%) experienced a graft failure, 5 of which (6%) underwent revision ACLR. There was no significant difference in graft failure risk between the BTB group (29%) and the BTB-LET group (13%; P = .1). Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02). Lateral compartment osteoarthritis was correlated with partial lateral meniscectomy., Conclusion: There were no significant differences in long-term patient-reported outcomes after ACLR with or without an LET. LET may increase the risk of lateral compartment osteoarthritis at long-term follow-up. There was a trend toward decreased graft failure risk with the addition of LET but this study was underpowered to assess this outcome.

Background: Perioperative chemotherapy has proven valuable in several tumors, but not in colon cancer (CC)., Objective: The aim of this study was to evaluate the efficacy and safety of perioperative chemotherapy in patients with locally advanced nonmetastatic CC., Methods: This is a French multicenter randomized phase II trial in patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type patients, a third arm testing perioperative FOLFOX-cetuximab was added. Tumor Regression Grade (TRG1) of Ryan et al was the primary endpoint. Secondary endpoints were toxicity, perioperative morbidity, and quality of surgery., Results: A total of 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped (lack of efficacy). The remaining 104 patients (control, n = 52; FOLFOX preop n = 52) represented our intention-to-treat population. In the FOLFOX perioperative group, 96% received the scheduled 4 cycles before surgery. R0 resection and complete mesocolic excision rate were 94% and 93%, respectively. Overall mortality and morbidity rates were similar in both groups. Perioperative FOLFOX chemotherapy did not improve major pathological response rate (TRG1 = 8%) but was associated with a significant pathological regression (TRG1-2 = 44% vs 8%, P < 0.001) and a trend to tumor downstaging as compared to the control group. CT scan criteria were associated with a 33% rate of overstaging in control group., Conclusions: Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected. However, perioperative FOLFOX induces pathological regression and downstaging. Better preoperative staging tools are needed to decrease the risk of overtreating patients.

Background: Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction., Methods: The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction. Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater. All patients were treated with a self-expanding nitinol stent developed for dedicated use in the venous system (Vici Venous Stent System, Veniti, Inc/Boston Scientific, Marlborough, MA). Patients returned for clinical and imaging follow-up visits at 1 month, 6 months, and 1 year. The primary safety outcome was freedom from major adverse events at 30 days. The primary effectiveness outcome was venographic primary patency at 1-year. Adverse events were adjudicated by a Clinical Events Committee, and all imaging including venograms, intravascular ultrasound, and Doppler examinations were assessed by respective core laboratories., Results: Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent endovenous stent placement. Mean diameter stenosis was 78%, with 31.2% total occlusions. Mean lesion length was 111.3 mm, range 10 to 260 mm (mean 125.3 mm for post-thrombotic patients and 70.2 mm for nonthrombotic patients). Freedom from a major adverse event through 30 days was 98.8%. The 1-year primary patency rate for the entire group was 84.0%. Venographic patency rates for the nonthrombotic and chronic post-thrombotic groups were 96.2% and 79.8%, respectively. At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score., Conclusions: Twelve-month safety and effectiveness were demonstrated with the use of a dedicated venous stent to treat symptomatic iliofemoral venous obstructions, with reductions in clinical symptoms and improvements in quality of life, through 1-year follow-up., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02112877.

Purpose: To evaluate outcomes of patients treated with intensive intravitreal therapy and to describe the evolution of quantitative real-time polymerase chain reaction (qPCR) in patients treated for acute retinal necrosis (ARN) syndrome., Design: Retrospective observational case series., Methods: This study included 25 eyes of 24 patients with ARN who were treated and followed up in 2 departments of ophthalmology in Lyon, France. Assessed outcomes included qPCR viral load profile during treatment, number of antiviral intravitreal injections (IVT), retinal detachment rate, and best-corrected visual acuity., Results: Final visual acuity was 20/200 or less in 20% of cases; the rate of retinal detachment was 16%. Viral load kinetics changed in 3 phases: a first plateau period that was not consistent, a logarithmic decrease phase, and a negativation phase. Mean decay of the logarithm of the viral load was estimated at 0.076 per day; mean time of negativation was 56.1 days. Median IVT number was 9 (range, 0-28). Ten patients were treated with injections until the viral load was undetectable. Resistance to acyclovir was observed in a patient with a prolonged initial plateau of the viral load., Conclusions: Numerous and prolonged IVTs, used as adjunctive therapy, could improve the prognosis of treated patients by decreasing the risk of retinal detachment and improving visual acuity. QPCR enables monitoring of the response to treatment and can provide evidence for resistance to antiviral treatment by enabling the detection of cases with a prolonged initial plateau of viral load., (Copyright © 2019 Elsevier Inc. All rights reserved.)

We report two patients presenting with delayed complicationsafter Vibrant SounBridge® middle ear implant surgery: in both cases, a revision surgery was performed and lysis of the long process of the incus was highlighted. A re-assembly of the clip around the remaining long process of the incus was performed, associated with hydroxyapatite bone cement application, on the clip and the incudo-stapedial joint. Both patients had a satisfying result, with a mean follow up of 12 months., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: The separate design concepts of dual-mobility cups and triple-taper femoral stems were developed to improve survivorship following total hip replacement (THR) by reducing instability/dislocation and enabling enhanced fixation. Successful outcomes at over two decades have been reported with earlier-generation devices based on these concepts. The current study aimed to provide the first long-term results with a unique pairing of later-generation dual-mobility cup and triple-taper cementless femoral stem after a decade of use in patients undergoing THR., Methods: In this retrospective analysis, records were reviewed for all subjects implanted with this dual-mobility cup/cementless femoral stem combination at three centers between 2002 and 2005. Any subject who had not already had follow-up visit beyond 10 years, was not previously revised, and still living were invited for a single follow-up visit consisting of Merle d'Aubgine Scores, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, and standard radiographs., Results: There were 244 THRs available for analysis. At a mean follow-up of 11.9 years, the Kaplan-Meier survivorship (endpoint: revision for any reason) was 99.1% (95% CI, 97.6-99.7) for the stem and 95.9% (95% CI, 93.1-97.6) for the cup. Merle d'Aubigne Scores were significantly improved from baseline and WOMAC scores were in the satisfactory range at the final follow-up. Radiographic analysis revealed no cases of stem subsidence, no cases of bone hypertrophy, 1 (0.4%) case of bone atrophy, and 3 (1.2%) cases of osteolysis around the stem. No subjects had radiolucent lines greater than 1 mm in any femoral Gruen zone. Evidence of cup migration was seen in 1 (0.4%) subject and 1 (0.4%) subject had evidence of osteolysis that was seen in Gruen zones I, II, IV, and V., Conclusions: This combination of a later-generation dual-mobility cup and cementless triple-taper stem was associated with excellent survivorship and satisfactory functional outcomes at over 10 years follow-up., Trial Registration: ClinicalTrials.gov, NCT02648152. Date of registration: January 6, 2016. Retrospectively registered.

Background: The long-term evolution of premature coronary artery disease (CAD) is unknown., Objectives: The objective of this study was to describe the evolution of coronary atherosclerosis in young patients and identify the risk factors of poor outcomes., Methods: Participants age ≤45 years with acute or stable obstructive CAD were prospectively enrolled and followed. The primary endpoint was all-cause death, myocardial infarction (MI), refractory angina requiring coronary revascularization, and ischemic stroke., Results: Eight hundred-eighty patients with premature CAD were included. They were age 40.1 ± 5.7 years, mainly men, smokers, with a family history of CAD or hypercholesterolemia. At baseline presentation, 91.2% underwent coronary revascularization, predominantly for acute MI (78.8%). Over a follow-up of 20 years, one-third (n = 264) of patients presented with a total of 399 ischemic events, and 36% had at least a second recurrent event. MI was the most frequent first recurrent event (n = 131 of 264), mostly related to new coronary lesions (17.3% vs. 7.8%; p = 0.01; hazard ratio [HR]:1.45; 95% confidence interval [CI]: 1.09 to 1.93 for new vs. initial culprit lesion). All-cause death (n = 55; 6.3%) occurred at 8.4 years (median time). Ethnic origin (sub-Saharan African vs. Caucasian, adjusted hazard ratio [adjHR]: 1.95; 95% CI: 1.13 to 3.35; p = 0.02), inflammatory disease (adjHR: 1.58; 95% CI: 1.05 to 2.36; p = 0.03), and persistent smoking (adjHR: 2.32; 95% CI: 1.63 to 3.28; p < 0.01) were the strongest correlates of a first recurrent event. When considering all recurrent events, the same factors and Asian ethnicity predicted poor outcome, but persistent smoking had the greatest impact on prognosis., Conclusions: Premature CAD is an aggressive disease despite the currently recommended prevention measures, with high rates of recurrent events and mortality. Ethnicity and concomitant inflammatory disease are associated with poor prognoses, along with insufficient control of risk factors., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Although proposed to facilitate pulmonary vein isolation (PVI), high-power ablation may favor extracardiac damage. Negative component abolition of the unipolar signal reflects lesion transmurality. The present study sought to evaluate the safety and efficacy of high-power ablation using unipolar signal modification as a local end point. Methods High power and standard power were compared in 4 swine and 100 consecutive patients referred for PVI. The first 50 patients were included in the control group (25-30 W) and the last 50 patients in the study group (40-50 W). Atrial radiofrequency applications were stopped 2 s (study group and swine) or 5 s (control group) after unipolar signal modification. Ventricular radiofrequency applications of 500 J (25 W·20 s versus 50 W·10 s) were performed at the swine epicardium. Results Swine gross necropsy did not show any extracardiac damage related to atrial lesions. At equal energy of 500 J, 50 W lesions were deeper (3±0.9 versus 2.6±1.1 mm; P=0.03) and wider (6.2±2 versus 5±2.3 mm; P=0.006) than 25 W lesions. No complications occurred during the clinical study, whatever the power output used for PVI. For a similar sinus rhythm maintenance at 12 months (90% versus 88%; P=0.75), the study group displayed higher first-pass PVI (92% versus 73%; P<0.001), lower acute pulmonary vein reconnection (2% versus 17%; P<0.001), reduced procedure time (73.1±18.2 versus 107.4±21.2 min; P<0.001), and ablation time (13±2.9 versus 30.3±8.8 min; P<0.001). Conclusions High-power PVI guided by unipolar signal modification safely decreases procedural burden while ensuring robust 12-month outcomes.

Objectives: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device., Background: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device., Methods: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2)., Results: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%., Conclusions: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort., (Copyright © 2019. Published by Elsevier Inc.)

Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry., Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions., Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%)., Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Acute or subacute interstitial lung diseases from autoimmune origins are especially hard to diagnose but have to be detected promptly. We illustrate this necessity with three case reports. One case of paraneoplasic polymyositis, one case of interstitial lung disease caused by a connectivite and one case of interstitial lung disease related to an anti-synthetase syndrome. The subject is to alert the practitioners to the early search of extra pulmonary signs, autoantibodies analysis in the objective to set up quickly the right treatment., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Sialolithiasis is rare in children, there are no guidelines for its treatment, and there are few, if any, long term follow-up studies. We report a retrospective review of medical records of children who were treated for sialolithiasis by sialendoscopy between 1 January 2007 and 31 December 2011, and who have been followed up for 4-8 years. Personal and clinical details, including age, sex, symptoms, whether the lithiasis was parotid or submandibular, the technique of sialendoscopy and complications, were recorded. Twenty-six children (30 sides) were successfully treated by sialendoscopy between 2007 and 2011 (mean (range) age 12 (3-17) years). Stones were removed from the parotid gland in four patients and the submandibular gland in 22. The main indication for sialendoscopy was swelling of the salivary gland during meals. Twenty-six procedures were done endoscopically. Twelve were treated with a wire basket alone, 10 by the combined approach, and laser was used in eight. Four patients developed complications, but without long-term effects. During follow-up of 4-8 years there were no recurrent swellings. We conclude that endoscopic treatment of stones in childhood is an efficient and conservative option for salivary glands, has few complications and no clinical recurrence at medium to long-term follow-up., (Copyright © 2017 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.)

Enhanced recovery after surgery (ERAS) aims at reducing the length of hospital stays and complications. Everyone has a role to play - healthcare professionals, medical secretaries, administrative staff and patients. A coordinated treatment pathway must be ensured and changes in practices must be accepted., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Introduction: For patients with a first unprovoked venous thromboembolism (VTE), the optimal duration of anticoagulation is a crucial clinical dilemma which has yet to be resolved. The decision to stop anticoagulant therapy (AT) after the initial 3-6 months or to continue AT indefinitely, is primarily governed by the long-term risk of recurrence when treatment is discontinued. This risk however, is not well established, hindering decision making., Methods and Analysis: We will conduct a systematic review and a meta-analysis of studies involving patients diagnosed with a first, symptomatic unprovoked VTE or VTE provoked by minor transient risk factors, who have completed at least 3 months of initial AT; and who were followed-up for standardised time intervals of 1, 2, 5, 10 and 20 years (±3 months) after stopping AT. We will search (from inception to January 2017) MEDLINE, Embase and the Cochrane library for randomised controlled trials and prospective observational studies. Two reviewers will conduct all screening and data collection independently. The primary outcome of the rate of recurrent VTE at the standardised time intervals will be calculated for each study from the total number of recurrent events and the corresponding number of patient-years of follow-up. We will use a random-effects model to pool study results and report a weighted estimate of the absolute rate of recurrent VTE (events per 100 patient-years) over standardised time intervals of 1, 2, 5, 10 and 20 years after discontinuing anticoagulants., Ethics and Dissemination: Ethical approval is not applicable for this study. Findings from this study will be disseminated through peer-reviewed journal publication as well as relevant national and international conference presentations., Prospero Registration Number: CRD42017056309., Competing Interests: Competing interests: MC reports receiving research support form Leo Pharma and BMS, and honoraria from Pfizer, Bayer, BMS, and Sanofi, outside the submitted work. SS reports receiving honoraria from Boehringer Ingelheim, Bayer HealthCare, Daiichi Sankyo and Sanofi, and research support from Boehringer Ingelheim, Baxter and Octapharma, outside the submitted work. FC reports having received research grant support from Pfizer, honoraria for board memberships or symposia from Bayer and AstraZeneca, and travel support from Bayer, Daiichi Sankyo, Leo Pharma, Intermune, and Actelion, outside the submitted work. PP reports receiving consultancy and lectures fees from Bayer Pharma, Sanofi, Daiichi-Sankyo and Pfizer, outside the submitted work. CB reports receiving lectures fees from Bayer HealthCare, Bristol Meyer Squibb and Boehringer Ingelheim, outside the submitted work. GA reports personal fees from Bristol-Myers-Squibb, Pfizer, Bayer Healthcare, Boehringer Ingelheim, and Daiichi Sankyo, outside the submitted work. HRB reports receiving research support and consultancy fees from Sanofi-aventis, Bayer HealthCare, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Pfizer, Roche, Isis, Thrombogenics, and Boehringer Ingelheim, outside the submitted work. TAB reports receiving personal fees from Bayer, Bayer Australia, Novo Nordisk, and Glaxo Smith Klein, outside the submitted work. GP reports Advisory Board for Alfa-Wassermann, Daiichi-Sankyo, Pfizer and Roche, and speaker fees from Werfen, outside the submitted work. BH reports receiving honoraria from Cornerstone Research Group for provision of methodologic advice related to systematic reviews and meta-analysis. MAR reports receiving research support from Biomerieux, outside of the submitted work. All other authors (FK, AR, CK, SE, LP, ES and GAW) declare that they have no relevant competing interests., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Purpose: Elimination of the negative component of the unipolar atrial electrogram is a reliable indicator of the creation of a transmural lesion. Contact-force (CF) sensing technology has the potential to increase the durability of pulmonary vein isolation (PVI). In the present multicenter study, we assessed the 2-year sinus rhythm (SR) maintenance rate in patients with paroxysmal atrial fibrillation (PAF) after PVI guided by these two approaches., Methods: Two hundred fifteen consecutive PAF patients (62.1 ± 10.1 years, 65 women) were prospectively enrolled. All patients underwent PVI under CARTO guidance according to a systematic contiguous "point-by-point" approach, using radiofrequency energy, and a CF externally irrigated ablation catheter with the goal of at least 10g (ideally 20g) of force. The ablation endpoint of each individual lesion was elimination of the negative component of the unipolar atrial signal. The procedural endpoint was PVI with bidirectional block., Results: All PVs were successfully isolated. After 30 min of waiting time, 35 patients (16%) had PV reconnection and in all of them, the PVs were re-isolated. Two years after a single ablation procedure, 187 patients (87%) remained arrhythmia free, without anti-arrhythmic drugs. Of the 28 patients presenting with AF recurrence, 25 had PV reconnection and underwent repeat PVI while in the remaining 3 patients, all four PVs were isolated and extra-PV triggers were identified. There were six groin hematomas and one transient ischemic attack., Conclusions: Unipolar atrial signal analysis combined with CF sensing ensures a robust 2-year SR maintenance rate in the treatment of PAF. Clinical trial registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT02520960.

Introduction: Enhanced recovery after surgery program (ERP) has now surpassed the stage of clinical research in certain specialties and currently poses the problematic of large-scale implementation. The goal of this study was to report the experience during the first year of implementation in three French-speaking countries., Material and Methods: This is a prospective study in which 67 healthcare centers, all registered in the Grace-Audit databank, participated. Included were patients undergoing colorectal (CRS), bariatric (BS) and orthopedic hip and knee surgery (OS), performed within an ERP. The main endpoints were duration of hospital stay, postoperative morbidity, the degree of compliance with the elements of the ERP, the relation between the extent of application of the elements and postoperative hospital stay, and finally the completeness of data inclusions in the databank., Results: A total of 1904 patients were included in the Grace-Audit databank between January 1, 2015 and January 31, 2016, undergoing CRS (n=490), BS (n=431), and OS (n=983). The mean implementation rate was 83.7±10.0% for CRS, 75.0±23.7% for BS, and 83.5±14.9% for OS. The duration of hospital stay was 6.5 days for CRS, 2.6 days for BS and 3.4 days for OS. Overall postoperative morbidity (onset of postoperative undesirable event), surgical morbidity (superficial or deep organ space surgical site complications such as bleeding, infection or defective healing) and readmission rates were 20.6%, 7.5%, and 5.7% for CRS; 2.5%, 1.4%, and 1.6% for BS and 2.9%, 0.2%, and 2% for OS, respectively. A statistically significant relationship was found between the degree of compliance of the elements of ERP and the duration of hospital stay for CRS and BS; hospital stay was reduced when at least 15 of the 22 elements of the program were applied (P<0.001). The patients included in the Grace-Audit databank represented less than 20% of the patients undergoing operation in the same establishments during the study period for all three specialties., Conclusions: This study shows that large-scale ERPs are feasible and safe in French-speaking countries. Nonetheless, although encouraging, these preliminary results highlight that implementation must be improved in specialties such as bariatric surgery and that more complete data collection is needed., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up., Objectives: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry., Methods: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used., Results: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up., Conclusions: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: In August 2015, the US Food and Drug Administration (FDA) has approved Addyi ® (flibanserin) for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in pre-menopausal women. We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in women with HSDD., Patients and Methods: A systematic literature review from the PubMed database search was carried out until April 2016 using the following keywords: "HSDD", "flibanserin", "sexual desire" and "ransomised controlled trial"., Results: We found four randomized double-blind control studies and two meta-analyzes and literature reviews. For the comparison of flibanserin with placebo, the results were reported in standardized mean difference (SMD). Regarding the main criterion "Satisfactory Sexual Event" (SSE), SMD was ranged from 0.49 to 1 (P<0.05); "Desire Sexual Score" SMD was ranged from 1.63 to 2.20 (P<0.05). For the Female Sexual Function Index (FSFI) desire domain score SMD was ranged from 0.03 to 0.4 (P<0.05). Adverse effects were mostly minor: dizziness and drowsiness., Conclusion: Flibanserin showed a moderate benefit in terms of frequency of sex and patient satisfaction. The long-term safety of flibanserin is still poorly defined and scientific data concerning this drug are still few., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Background.  Atypical mycobacteria, or nontuberculous mycobacteria (NTM), have been barely reported as infective endocarditis (IE) agents. Methods.  From January 2010 to December 2013, cardiac valve samples sent to our laboratory as cases of blood culture-negative suspected IE were analyzed by 16S rDNA polymerase chain reaction (PCR). When positive for NTM, hsp PCR allowed species identification. Demographic, clinical, echocardiographic, histopathological, and Ziehl-Neelsen staining data were then collected. Results.  Over the study period, 6 of 370 cardiac valves (belonging to 5 patients in 3 hospitals) were positive for Mycobacterium chelonae (n = 5) and Mycobacterium lentiflavum (n = 1) exclusively on bioprosthetic material. The 5 patients presented to the hospital for heart failure without fever 7.1-18.9 months (median 13.1 months) after biological prosthetic valve implantation. Echocardiography revealed paravalvular regurgitation due to prosthesis dehiscence in all patients. Histopathological examination of the explanted material revealed inflammatory infiltrates in all specimens, 3 of which were associated with giant cells. Gram staining and conventional cultures remained negative, whereas Ziehl-Neelsen staining showed acid-fast bacilli in all patients. Allergic etiology was ruled out by antiporcine immunoglobulin E dosages. These 5 cases occurred exclusively on porcine bioprosthetic material, revealing a statistically significant association between bioprosthetic valves and NTM IE (P < .001). Conclusions.  The body of evidence confirmed the diagnosis of prosthetic IE. The statistically significant association between bioprosthetic valves and NTM IE encourages systematic Ziehl-Neelsen staining of explanted bioprosthetic valves in case of early bioprosthesis dysfunction, even without an obvious sign of IE. In addition, we strongly question the cardiac bioprosthesis conditioning process after animal sacrifice.

Background: Dual antiplatelet therapy, comprising aspirin and clopidogrel, is recommended in patients undergoing coronary stenting to avoid the occurrence of stent thrombosis and others ischaemic events. Interindividual response to clopidogrel varies, however, with poor response associated with an increased risk of ischaemic events. New assays are available for testing aspirin and clopidogrel response routinely at the bedside., Aim: To evaluate the prognostic value of testing antiplatelet response in an intermediate-risk population undergoing stent implantation., Methods: We prospectively assessed clopidogrel and aspirin response using the VerifyNow assay at the time of coronary stenting in 1001 patients who presented with stable coronary disease or non-ST-segment elevation acute coronary syndrome. The main ischaemic endpoint was the composite of definite and probable stent thrombosis, cardiovascular death or spontaneous myocardial infarction at one year. The safety endpoint was major bleeding., Results: Overall, 36.0% of patients had high on-clopidogrel platelet reactivity (OCR) and 8.6% had high on-aspirin platelet reactivity (OAR). The main ischaemic composite endpoint occurred in 3.9% of patients with high vs. 2.3% of patients with normal OCR (hazard ratio 1.66, 95% confidence interval 0.78-3.54; P=0.18). Definite or probable stent thrombosis occurred in 1.1% of patients with high vs. 0.3% of patients with normal OCR (P=0.86). There was no significant difference in ischaemic endpoints according to OAR and there was no difference in rates of major bleeding between patients with high versus normal on-treatment platelet reactivity., Conclusions: On-treatment platelet reactivity was not associated with 1-year ischaemic or bleeding events in an intermediate-risk population undergoing stent implantation., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Cardiac surgery and cardiopulmonary bypass (CPB) have made significant progress in recent years. Despite these efforts, adverse events continue to occur during surgery. From recent studies of incidents and accidents during CPB, this article focuses on critical recommendations to respect when in charge of a CPB. Some facts are based only on data unsupported by scientific research. Others have not proven their benefit in terms of postoperative morbidity or mortality. The management of anticoagulation, hematocrit, pump flow, and the temperature is discussed. Finally, the importance of teamwork especially in terms of cohesion and communication is highlighted., (Copyright © 2014 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)