13 research outputs found

    Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: Study protocol for a multicentre randomized controlled trial

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    Background: Clavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures. Management of this group of fractures is often challenging and the outcome can be unsatisfactory. In particular it is not clear whether surgery produces better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform our decision.Methods/Design: We aim to undertake a multicentre randomised controlled trial evaluating the effectiveness and safety of conservative management versus open reduction and internal fixation for displaced mid-shaft clavicle fractures in adults. Surgical treatment will be performed using the Acumed clavicle fixation system. Conservative management will consist of immobilisation in a sling at the side in internal rotation for 6 weeks or until clinical or radiological union. We aim to recruit 300 patients. These patients will be followed-up for at least 9 months. The primary endpoint will be the rate of non-union at 3 months following treatment. Secondary endpoints will be limb function measured using the Constant-Murley Score and the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 9 months post-operatively.Discussion: This article presents the protocol for a multicentre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.Trial Registration: United Kingdom Clinical Research Network ID: 8665. The date of registration of the trial is 07/09/2006. The date the first patient was recruited is 18/12/2007. © 2011 Longo et al; licensee BioMed Central Ltd

    Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018

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    Background: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. Methods: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. Results: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson’s comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. Conclusions: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients

    1:4.000.000

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    Fil: Zappettini, E.O. Servicio Geológico Minero Argentino; Argentina.Fil: Prieto Rincón, G.; ColombiaFil: Amezcua, Natalia; México.Fil: Muñoz Tapia, Santiago; República Dominicana.Fil: Sepúlveda Ospina, Janeth; Colombia.Fil: Celada Arango, Marlos Mario; Colombia.Fil: Jara, David; Costa Rica.Fil: Cazañas Díaz, Xiomara; Cuba.Fil: Torres Zafra, Jorge Luis; Cuba.Fil: Cobiella Reguera, Jorge Luis; Cuba.Fil: Zurcher, Lukas; Estados Unidos de América.Fil: Orris, Greta; Estados Unidos de América.Fil: Gray, Floyd; Estados Unidos de América.Fil: Maldonado Díaz, Carolina; Guatemala.Fil: Rodriguez, Noé; Honduras.Fil: Mérida Montiel, Ramón; México.Fil: Zarruk, Carlos; Nicaragua.La Asociación de Servicios Geológicos y Mineros de Iberoamérica (ASGMI), bajo los auspicios de la Comisión de la Carta Geológica del Mundo (CCGM) preparó la primera versión del Mapa Metalogénico de América Central y el Caribe. La coordinación general estuvo a cargo del Servicio Geológico Minero Argentino (SEGEMAR), con tres coordinaciones regionales: América Central a cargo del Servicio Geológico Mexicano (SGM), las islas del Caribe a cargo del Servicio Geológico Nacional de la República Dominicana y el norte de América del Sur a cargo del Servicio Geológico Colombiano. Participaron además los Servicios Geológicos, Direcciones de Minería u organismos equivalentes de los países involucrados, que designaron Coordinadores Nacionales. El proyecto fue presentado y aprobado en ocasión de la Asamblea de ASGMI realizada en La Habana (Cuba) en 2017. Posteriormente fue presentado ante la Comisión de la Carta Geológica del Mundo (CCGM) en París en 2018. Los objetivos, criterios metodológicos y cronograma de trabajo fueron así establecidos. En los años 2018 y 2019 se realizaron dos reuniones de los participantes, una en Santo Domingo, República Dominicana, y otra en Tegucigalpa, Honduras. Los avances del mapa fueron presentados durante la Reunión Santo Domingo de 2018 y en ocasión del XV Simposio IAGOD, celebrado en Salta (Argentina) ese mismo año. El mapa fue generado digitalmente a partir del Mapa Estructural del Caribe (Bouysse et al., 2020), provisto por la Comisión de la Carta Geológica del Mundo, realizándose una actualización de la información geológica, a partir de la bibliografía citada en el texto. Los polígonos fueron reclasifi cados y reagrupados en orden a defi nir unidades tectonoestratigráfi cas y mejor refl ejar la metalogénesis de la región. El proyecto en SIG creado es también mostrado en la página WEB de ASGMI (www.asgmi.org.es) con el fi n de facilitar la difusión de los datos del mapa creado. Su formato digital y su disponibilidad en la WEB aseguran un fácil acceso para actualizar la información y hacerlo accesible a los usuarios

    One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial

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    Background: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna EaseTM, Crown PRTTM, and TrifectaTM). Methods: The sample used in this study comes from the “BEST-VALVE” clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. Results: 154 patients were included. Carpentier Perimount Magna EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3–26) and 227.1 (IQR 202.0–268.8) for Carpentier Perimount Magna EaseTM, 21.4 (IQR 14.5–26.7) and 237.8 (IQR 195.9–261.9) for Crown PRTTM, and 13 (IQR 9.6–17.8) and 209.7 (IQR 176.5–241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. Conclusions: One year after surgery, the three prostheses presented a different hemodynamic performance, being TrifectaTM superior to Crown PRTTM

    Translational large animal model of hibernating myocardium: characterization by serial multimodal imaging

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    Nonrevascularizable coronary artery disease is a frequent cause of hibernating myocardium leading to heart failure (HF). Currently, there is a paucity of therapeutic options for patients with this condition. There is a lack of animal models resembling clinical features of hibernating myocardium. Here we present a large animal model of hibernating myocardium characterized by serial multimodality imaging. Yucatan minipigs underwent a surgical casein ameroid implant around the proximal left anterior descending coronary artery (LAD), resulting in a progressive obstruction of the vessel. Pigs underwent serial multimodality imaging including invasive coronary angiography, cardiac magnetic resonance (CMR), and hybrid 18F-Fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT). A total of 43 pigs were operated on and were followed for 120 ± 37 days with monthly multimodality imaging. 24 pigs (56%) died during the follow-up. Severe LAD luminal stenosis was documented in all survivors. In the group of 19 long-term survivors, 17 (90%) developed left ventricular systolic dysfunction [median LVEF of 35% (IQR 32.5-40.5%)]. In 17/17, at-risk territory was viable on CMR and 14 showed an increased glucose uptake in the at-risk myocardium on 18FDG-PET/CT. The present pig model resembles most of the human hibernated myocardium characteristics and associated heart failure (systolic dysfunction, viable myocardium, and metabolic switch to glucose). This human-like model might be used to test novel interventions for nonrevascularizable coronary artery disease and ischemia heart failure as a previous stage to clinical trials.his study has been partially funded by the Horizon 2020 European Research Area Network on Cardiovascular Diseases (ERA-CVD) Joint Transnational Call “AC16/00021: FAT-4HEART,” by the Spanish Society of Cardiology through a “Translational Research grant 2019,” and by the Instituto de Salud Carlos III (ISCIII) and the European Regional Development Fund (ERDF) through a FIS grant (Ref # PI16/02110). Imaging phenotyping was partially supported by the Comunidad de Madrid (S2017/BMD-3867 RENIM-CM) and cofunded with European structural and investment funds. The CNIC is supported by the ISCIII, the Ministerio de Ciencia e Innovación and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (SEV-2015-0505).S

    Metastatic adenocarcinoma of the colon presenting as a monarthritis of the hip in a young patient

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    <p>Abstract</p> <p>Background</p> <p>Malignant arthritis is a rare manifestation of metastatic disease. We describe the case of a previously well 28 year old man in whom hip pain was the presenting symptom of disease. We describe the case and discuss the aetiology of colorectal cancer in young patients. We then review the literature and discuss the investigation and management of malignant joint arthritis.</p> <p>Case presentation</p> <p>We present the case of a 28 year old man who presented to the emergency department with an acute monoarthritis of the hip. He had an unremarkable past medical history and was systemically well. A diagnosis of malignant joint effusion was reached after a heightened index of clinical suspicion, magnetic resonance imaging and cytological evaluation of the synovial fluid. Computed tomography and bone scan confirmed widespread metastatic disease from a primary colonic adenocarcinoma. The patient tolerated three cycles of oxaliplatin and capecitabine but died 4 months after presentation.</p> <p>Conclusion</p> <p>The metastatic spread of cancer to the joint and the synovium is one of the rarest manifestations of malignant disease and has not been previously reported as the presenting symptom of disease. The diagnosis is a difficult one to reach and is associated with a poor prognosis. This case illustrates the importance of thorough investigation in reaching this diagnosis and entertaining the possibility in individuals who do not respond to conventional management of acute monoarthritis, even in young patients and individuals who do not display any other symptoms of disease.</p

    Risk score for cardiac surgery in active left-sided infective endocarditis

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    International audienceObjective To develop and validate a calculator to predict the risk of in-hospital mortality in patients with active infective endocarditis (IE) undergoing cardiac surgery. Methods Thousand two hundred and ninety-nine consecutive patients with IE were prospectively recruited (1996-2014) and retrospectively analysed. Left-sided patients who underwent cardiac surgery (n=671) form our study population and were randomised into development (n=424) and validation (n=247) samples. Variables statistically significant to predict in-mortality were integrated in a multivariable prediction model, the Risk-Endocarditis Score (RISK-E). The predictive performance of the score and four existing surgical scores (European System for Cardiac Operative Risk Evaluation (EuroSCORE) I and II), Prosthesis, Age >= 70, Large Intracardiac Destruction, Staphylococcus, Urgent Surgery, Sex (Female) (PALSUSE), EuroSCORE >= 10) and Society of Thoracic Surgeons's Infective endocarditis score (STS-IE)) were assessed and compared in our cohort. Finally, an external validation of the RISK-E in a separate population was done. Results Variables included in the final model were age, prosthetic infection, periannular complications, Staphylococcus aureus or fungi infection, acute renal failure, septic shock, cardiogenic shock and thrombocytopaenia. Area under the receiver operating characteristic curve in the validation sample was 0.82 (95% CI 0.75 to 0.88). The accuracy of the other surgical scores when compared with the RISK-E was inferior (p=0.010). Our score also obtained a good predictive performance, area under the curve 0.76 (95% CI 0.64 to 0.88), in the external validation. Conclusions IE-specific factors (microorganisms, periannular complications and sepsis) beside classical variables in heart surgery (age, haemodynamic condition and renal failure) independently predicted perioperative mortality in IE. The RISK-E had better ability to predict surgical mortality in patients with IE when compared with other surgical scores
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