Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial

International audienceBackgroundAortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the 'gold standard' treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses.Methods and designFirst, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery.DiscussionThis prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient's morphological characteristics.Trial registrationClinicalTrials.gov Identifier: NCT0152235

Assessing brain function in stressed healthy individuals following the use of a combination of green tea, Rhodiola, magnesium, and B vitamins: an fMRI study

IntroductionThis randomized, controlled, single-blinded trial assessed the effect of magnesium (Mg)-Teadiola (Mg, vitamins B6, B9, B12, Rhodiola, and green tea/L-theanine) versus placebo on the brain response to stressful thermal stimulus in chronically stressed, but otherwise healthy subjects. Impacts on stress-related quality-of-life parameters (depression, anxiety, sleep, and perception of pain) were also explored.MethodsThe study recruited a total of 40 adults (20 per group), suffering from stress for more than 1 month and scaling ≥14 points on the Depression Anxiety Stress Scale (DASS)-42 questionnaire at the time of inclusion. Individuals received oral Mg-Teadiola or placebo for 28 days (D). fMRI analysis was used to visualize the interplay between stress and pain cerebral matrices, using thermal stress model, at baseline (D0) and after D28.ResultsBased on blood-oxygen-level-dependent (BOLD) signal variations during the stress stimulation (before pain perception), a significantly increased activation between D0 and D28 was observed for left and right frontal area (p = 0.001 and p = 0.002, respectively), left and right anterior cingulate cortex (ACC) (p = 0.035 and p = 0.04, respectively), and left and right insula (p = 0.034 and p = 0.0402, respectively) in Mg-Teadiola versus placebo group. During thermal pain stimulation, a significantly diminished activation of the pain matrix was observed between D0 and D28, for left and right prefrontal area (both p = 0.001), left and right insula (p = 0.008 and p = 0.019, respectively), and left and right ventral striatum (both p = 0.001) was observed in Mg-Teadiola versus placebo group. These results reinforce the clinical observations, showing a perceived benefit of Mg-Teadiola on several parameters. After 1 month of treatment, DASS-42 stress score significantly decreased in Mg-Teadiola group [effect size (ES) −0.46 (−0.91; −0.01), p = 0.048]. Similar reductions were observed on D14 (p = 0.011) and D56 (p = 0.008). Sensitivity to cold also improved from D0 to D28 for Mg-Teadiola versus placebo [ES 0.47 (0.02; 0.92) p = 0.042].ConclusionSupplementation with Mg-Teadiola reduced stress on D28 in chronically stressed but otherwise healthy individuals and modulated the stress and pain cerebral matrices during stressful thermal stimulus

Impact of Vitamin D Supplementation on Influenza Vaccine Response and Immune Functions in Deficient Elderly Persons: A Randomized Placebo-Controlled Trial

Background: Immunosenescence contributes to reduced vaccine response in elderly persons, and is worsened by deficiencies in nutrients such as Vitamin (Vit-D). The immune system is a well-known target of Vit-D, which can both potentiate the innate immune response and inhibit the adaptive system, and so modulate vaccination response.Objective: This randomized placebo-controlled double-blind trial investigated whether Vit-D supplementation in deficient elderly persons could improve influenza seroprotection and immune response.Design: Deficient volunteers (Vit-D serum <30 ng/mL) were assigned (V1) to receive either 100,000 IU/15 days of cholecalciferol (D, n = 19), or a placebo (P, n = 19), over a 3 month period. Influenza vaccination was performed at the end of this period (V2), and the vaccine response was evaluated 28 days later (V3). At each visit, serum cathelicidin, immune response to vaccination, plasma cytokines, lymphocyte phenotyping, and phagocyte ROS production were assessed.Results: Levels of serum 25-(OH)D increased after supplementation (D group, V1 vs. V2: 20.7 ± 5.7 vs. 44.3 ± 8.6 ng/mL, p < 0.001). No difference was observed for serum cathelicidin levels, antibody titers, and ROS production in D vs. P groups at V3. Lower plasma levels of TNFα (p = 0.040) and IL-6 (p = 0.046), and higher ones for TFGβ (p = 0.0028) were observed at V3. The Th1/Th2 ratio was lower in the D group at V2 (D: 0.12 ± 0.05 vs. P: 0.18 ± 0.05, p = 0.039).Conclusions: Vit-D supplementation promotes a higher TGFβ plasma level in response to influenza vaccination without improving antibody production. This supplementation seems to direct the lymphocyte polarization toward a tolerogenic immune response. A deeper characterization of metabolic and molecular pathways of these observations will aid in the understanding of Vit-D's effects on cell-mediated immunity in aging. This clinical trial was registered at clinicaltrials.gov as NCT01893385

The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery

International audienceL'objectif de cette étude était d'évaluer les effets d'une administration continue post-opératoire d'un anesthésique local au travers de deux cathéters placés par le chirurgien en regard des bords latéraux du sternum, à proximité de l'émergence du nerf intercostal. Nous nous sommes concentrés sur la douleur lors de la mobilisation, car cet aspect est susceptible d'interagir avec la morbidité postopératoire. Quarante patients adultes devant subir une chirurgie à coeur ouvert avec sternotomie ont été inclus dans cette étude randomisée, contrôlée contre placebo, en double insu. Soit une perfusion continue à un taux fixe de 4 ml / h de ropivacaïne à 0,2%, soit du sérum physiologique, ont été infusés au cours des 48 premières heures postopératoires. Tous les patients recevaient du paracétamol et de la morphine auto-administrée. Les critères d'efficacité étaient les suivants: score de douleur lors de la mobilisation normalisée et au repos; consommation de morphine; gaz du sang artériel et spirométrie ; critères de réhabilitation post-opératoires ; satisfaction du patient. Les taux plasmatiques de ropivacaïne totale ont été mesurés tout au long de l'étude. Les scores de douleur étaient plus faibles dans le groupe ropivacaïne lors de la mobilisation (P = 0,0004) et au repos (P = 0,0006), mais les effets analgésiques étaient pour la plupart apparents au cours de la 2ème journée postopératoire, avec une réduction globale de 41% des scores de douleur au mouvement. Le bloc bi-latérosternal a également réduit la consommation de morphine. Il a amélioré la satisfaction du patient et de sa capacité à la réadaptation, tandis qu'aucun effet n'a été noté sur les paramètres respiratoires. Aucun effet secondaire majeur lié au traitement n'a eu lieu, mais la concentration plasmatique de la ropivacaïne a été supérieure à 4 mg / litre chez un patient. Conclusions: Cette technique peut trouver une place dans le cadre d'une analgésie multimodale après sternotomie, même si d'autres études de confirmation sont nécessaires

A Systematic Review of Labour Pain Used as an Outcome Criterion in Clinical Research

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FAAH inhibitors in the limelight, but regrettably

International audienceThis short review focuses on the recent drug development of FAAH inhibitors, as recent serious adverse events have been reported in a phase I study with a compound of this class. The authors overview the potential interest in targeting FAAH inhibition, the current programs, and the available information on the recent dramatic events. 3 See refs. on Clinicaltrials.gov: NCT02134080

FAAH inhibitors in the limelight, but regrettably

Abstract. This short review focuses on the recent drug development of FAAH inhibitors, as recent serious adverse events have been reported in a phase I study with a compound of this class. The authors overview the potential interest in targeting FAAH inhibition, the current programs, and the available information on the recent dramatic events

Impact of sympathetic activation on pain threshold in human subjects

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