Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up.

Background: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS).

Methods: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed.

Comparison of predictive models for cumulative live birth rate after treatment with ART.

Research Question: Can a machine learning model better predict the cumulative live birth rate for a couple after intrauterine insemination or embryo transfer than Cox regression based on their personal characteristics?

Study Design: Retrospective cohort study conducted in two French infertility centres (Créteil and Tenon Hospitals) between 2012 and 2019, including 1819 and 1226 couples at Créteil and Tenon, respectively. Two models were applied: a Cox regression, which is almost exclusively used in assisted reproductive technology (ART) predictive modelling, and a tree ensemble-based model using XGBoost implementation. Internal validations were performed on each hospital dataset separately; an external validation was then carried out on the Tenon Hospital's population.

Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial.

Objectives: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts.

Methods: PERSIST-AVR is a prospective, randomized, open-label trial.

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

Objective: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.

Methods: Perceval Sutureless Implant vs.

Detection of DNA damage by alkaline comet assay in mouse colonic mucosa.

We recently characterized the association between DNA damage and immunoresponse in colonic mucosa of mice infected with a Typhimurium strain expressing a genotoxin, known as typhoid toxin. In this protocol, we describe the specific steps for assessing DNA damage by the alkaline comet assay of colonic mucosal samples. The description of the comet assay protocol follows the international guidelines (Minimum Information for Reporting on the Comet Assay [Moller et al.

Efficacy of emergency medical center use of a protocol during telephone calls to give medical advice related to fever or gastroenteritis: a cluster randomized controlled trial.

Objectives: To determine the efficacy of emergency medical center physicians' use of a protocol to guide their management of telephone consultations for fever and gastroenteritis.

Material And Methods: Cluster randomized controlled trial. Participating centers were randomized to use the telephone protocol or provide usual telephone assistance.

Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial.

Objectives: Platelet count reduction is a common but not fully understood phenomenon after aortic valve replacement (AVR) with bioprosthesis implantation. The aim of the present study was to investigate the occurrence and the clinical impact of platelet count reduction in patients receiving the Perceval bioprosthesis compared to those receiving standard sutured stented bioprosthetic aortic valve in a randomized, controlled AVR study.

Methods: PERceval Sutureless Implant versus STandard Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial.

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis.

Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis.

Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial.

Effect of hydroxyurea exposure before puberty on sperm parameters in males with sickle cell disease.

Sperm parameters are known to be impaired in men with sickle cell disease (SCD). Although treatment with hydroxyurea (HU) has an impact on sperm quality, sperm preservation is impossible before puberty. This study's primary objective was to analyze and compare sperm parameters in male patients with SCD exposed (or not) to HU before puberty.

Comparison of F-sodium fluoride PET/CT, F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France.

Background: The diagnostic performance of F-sodium fluoride positron emission tomography/computed tomography (PET/CT) (NaF), F-fluorocholine PET/CT (FCH) and diffusion-weighted whole-body magnetic resonance imaging (DW-MRI) in detecting bone metastases in prostate cancer (PCa) patients with first biochemical recurrence (BCR) has already been published, but their cost-effectiveness in this indication have never been compared.

Methods: We performed trial-based and model-based economic evaluations. In the trial, PCa patients with first BCR after previous definitive treatment were prospectively included.

Factors associated with tuberculosis-associated haemophagocytic syndrome: a multicentre case-control study.

Tuberculosis (TB) is a potential trigger of haemophagocytic syndrome (HS) but little is known about the features of TB-associated HS. To assess the risk factors associated with HS in patients with TB. We performed a multicentre case-control study assessing the medical records of adult patients diagnosed with proven TB with (TB/HS+) or without (TB/HS-) associated HS.

Cost-effectiveness of a cardiac contractility modulation device in heart failure with normal QRS duration.

Aims: The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service.

Methods And Results: We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life.

[Vagus nerve stimulation and depression].

Vagus nerve stimulation (VNS) is an old, yet new, option for treatment-resistant depression. Despite several clinical trials over the last 15 years showing a consistent benefit-risk balance of the technic, VNS still struggles to find its place in our therapeutic algorithms. This is especially true in France, where only a few surgeries have been performed nationwide, all in the last year.

Gene Therapy for Parkinson's Disease: Preclinical Evaluation of Optimally Configured TH:CH1 Fusion for Maximal Dopamine Synthesis.

A recent phase I-II, open-label trial of ProSavin, a lentiviral vector delivering the key enzymes in the dopamine biosynthetic pathway to non-dopaminergic striatal neurons, demonstrated safety and improved motor function in parkinsonian patients. However, the magnitude of the effect suggested that optimal levels of dopamine replacement may not have been achieved. OXB-102, a lentiviral vector with an optimized expression cassette for dopamine biosynthesis, has been shown to achieve a significantly higher dopamine yield than ProSavin.

A variant erythroferrone disrupts iron homeostasis in -mutated myelodysplastic syndrome.

Myelodysplastic syndromes (MDS) with ring sideroblasts are hematopoietic stem cell disorders with erythroid dysplasia and mutations in the splicing factor gene. Patients with MDS with mutations often accumulate excessive tissue iron, even in the absence of transfusions, but the mechanisms that are responsible for their parenchymal iron overload are unknown. Body iron content, tissue distribution, and the supply of iron for erythropoiesis are controlled by the hormone hepcidin, which is regulated by erythroblasts through secretion of the erythroid hormone erythroferrone (ERFE).

Adventitious Virus Detection in Cells by High-Throughput Sequencing of Newly Synthesized RNAs: Unambiguous Differentiation of Cell Infection from Carryover of Viral Nucleic Acids.

The use of high-throughput sequencing (HTS) to identify viruses in biologicals differs from current molecular approaches, since its use enables an unbiased approach to detection without the need to design specific primers to preamplify target sequences. Its broad range of detection and analytical sensitivity make it an important tool to ensure that biologicals are free from adventitious viruses. Similar to other molecular methods, however, identification of viral sequences in cells by HTS does not prove viral infection, since this could reflect carryover of inert viral sequences from reagents or other sources or the presence of transcriptionally inactive cellular sequences.

Hereditary angioedema, emergency management of attacks by a call center.

Objective: Hereditary angiœdema (HAE) is a rare autosomal dominant disease characterized by recurrent, unpredictable, potentially life-threatening swelling. Objective is to assess the management of the acute HAE attacks in the real life setting through a call center in France.

Methods: A pre-specified ancillary study of SOS-HAE, a cluster-randomized prospective multicenter trial, was conducted.

Postimplant biological aortic prosthesis degeneration: challenges in transcatheter valve implants.

Surgical aortic valve replacement (SAVR) is highly effective and can be achieved with relatively low risk in patients with severe aortic stenosis. Bioprostheses have been used most frequently during the past 60 years. However, the function of biological valves usually declines after 10-15 years from implant when structural valve degeneration occurs often mandating a reoperation once valve dysfunction becomes haemodynamically significant.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.

Introduction: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance.

Materials And Methods: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697).

Adverse Event with the Use of Carmustine Wafers and Postoperative Radiochemotherapy for the Treatment of High-grade Glioma.

Randomized, controlled trials have shown significant improvement of survival after implantation of 1,3-bis(2-Chloroethyl)-1-nitrosourea (BCNU) wafers for patients suffering from high-grade glioma. A combination of local chemotherapy with BCNU and concomitant radiochemotherapy with temozolomide (TMZ) appears to be attractive to enhance the overall survival, even though these treatments may potentially cumulate their toxicity. We report a clinical case of a patient submitted to this combined treatment protocol.

Impact of sodium F-fluoride PET/CT, F-fluorocholine PET/CT and whole-body diffusion-weighted MRI on the management of patients with prostate cancer suspicious for metastasis: a prospective multicentre study.

Purpose: To compare the impact of 18F-sodium-fluoride (NaF) PET/CT, 18F-fluorocholine (FCH) PET/CT and diffusion-weighted whole-body MRI (DW-MRI) on the management of patients with prostate cancer (PCa) suspicious for distant metastasis.

Methods: Prostate cancer patients were prospectively included between December 2011 and August 2014 and benefited from these three whole-body imaging (WBI) modalities within 1 month in addition to the standard PCa workup. Management was prospectively decided by clinicians during two multidisciplinary meetings, before and after the whole-body imaging workup.