Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 18 de 18
Filtrar
1.
Anaesth Crit Care Pain Med ; 41(4): 101107, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35643391

RESUMO

OBJECTIVES: To assess the effect of preoperative levosimendan on mortality at day 90 in patients with left ventricular ejection fraction (LVEF) ≤ 40%, and to investigate a possible differential effect between patients undergoing isolated coronary artery bypass grafting (CABG) versus CABG combined with valve replacement surgery. DESIGN: Pooled analysis of two multicentre randomised controlled trials (RCT) investigating prophylactic levosimendan versus placebo prior to CABG surgery on mortality at day 90 in patients with LVEF ≤ 40%. A meta-analysis of all RCT investigating the same issue was also conducted. RESULTS: A cohort of 1084 patients (809 isolated CABG, and 275 combined surgery) resulted from the merging of LEVO-CTS and LICORN databases. Seventy-two patients were dead at day 90. The mortality at day 90 was not different between levosimendan and placebo (Hazard Ratio (HR): 0.73, 95% CI: 0.41-1.28, p = 0.27). However, there was a significant interaction between the type of surgery and the study drug (p = 0.004). We observed a decrease in mortality at day 90 in the isolated CABG subgroup (HR: 0.39, 95% CI: 0.19-0.82, p = 0.013), but not in the combined surgery subgroup (HR: 1.73, 95% CI: 0.77-3.92, p = 0.19). The meta-analysis of 6 RCT involving 1441 patients confirmed the differential effect on mortality at day 30 between the 2 subgroups. CONCLUSIONS: Preoperative levosimendan did not reduce mortality in a mixed surgical population with LV dysfunction. However, the subgroup of patients undergoing isolated CABG had a reduction in mortality at day 90, whereas there was no significant effect in combined surgery patients. This finding requires confirmation with a specific prospective trial.


Assuntos
Complicações Pós-Operatórias , Disfunção Ventricular Esquerda , Ponte de Artéria Coronária/métodos , Humanos , Estudos Multicêntricos como Assunto , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Simendana/uso terapêutico , Volume Sistólico , Disfunção Ventricular Esquerda/etiologia , Função Ventricular Esquerda
2.
J Geriatr Oncol ; 13(7): 978-986, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35717533

RESUMO

INTRODUCTION: Bladder cancer occurs mainly in older adults and surgery is not always possible when there are geriatric conditions and comorbidities. Trimodal treatment (TMT) combining trans-urethral resection of bladder tumour (TURBT) followed by concurrent chemoradiation (CRT) would be a curative alternative in such patients. MATERIALS AND METHODS: All consecutive patients 75 years of age and older with non-metastatic muscle-invasive bladder cancer (MIBC) treated with TMT by Georges Pompidou European Hospital team were retrospectively analysed. Induction CRT combined hypofractionated twice-daily radiotherapy targeting bladder and pelvis to a total dose of 24 Gy (Gy) with concurrent platinum salt and 5-fluorouracil. Consolidation CRT to a total dose of 44 Gy was proposed to patients with biopsy-proven complete response after induction phase and those with persistent tumour underwent salvage cystectomy. We assessed using Kaplan-Meier method overall survival (OS), cancer specific survival (CSS), invasive recurrence-free survival (IRFS), metastasis-free survival (MFS), survival with bladder preserved (SBP), and toxicities. With a Cox model for OS and the Fine Gray method of competing risk for secondary endpoints, we analysed in univariate (u) and multivariate (m) analysis the impact of tumour characteristics and patient profiles: gender, age, age-adjusted Charlson comorbidity index, polypharmacy, and malnutrition. RESULTS: From 1988 to 2017, 85 patients were included. After induction, complete response rate was 83.5%. With a median follow-up of 63 months, 5 year-OS, CSS, IRFS, MFS and SBP were 61.0%, 77.6%, 71%, 82.9%, and 70.2% respectively. A persistent tumour after induction impacted SBP (SHRm 3.61; p = 0.004), CSS (SHRm 3.27; p = 0.023), and MFS (SHRm 3.68; p = 0.018). Late grade 3 urinary and gastrointestinal toxicities were 3.5% and 1.2%. DISCUSSION: We report here the largest series of bladder preservation over 75 years in a curative intent. Outcomes and tolerance in selected older adults compared favourably with surgical series and with CRT studies using classical fractionation.


Assuntos
Neoplasias da Bexiga Urinária , Idoso , Terapia Combinada , Cistectomia/métodos , Fluoruracila , Humanos , Músculos/patologia , Invasividade Neoplásica , Tratamentos com Preservação do Órgão/métodos , Platina , Estudos Retrospectivos , Resultado do Tratamento , Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/terapia
3.
Cancers (Basel) ; 14(5)2022 Feb 22.
Artigo em Inglês | MEDLINE | ID: mdl-35267412

RESUMO

Pre-therapeutic factors associated with overall survival (OS) among older patients ≥70 years with metastatic pancreatic cancer (mPC) are not known. This was a retrospective single-centre cohort study in Paris including 159 consecutive older patients with mPC between 2000 and 2018. Alongside geriatric parameters, specific comorbidities, cancer-related data and chemotherapy regimens were retrieved. Cox multivariate models were run to assess predictors for OS. The median age was 80 years, 52% were women, 21.5% had diabetes, and 48% had pancreatic head cancer and 72% liver metastases. 62% of the patients (n = 99) received chemotherapy, among which the gemcitabine + nab-paclitaxel (GnP) regimen was the most frequent (72%). Median OS [95%CI] was 7.40 [5.60-10.0] and 1.40 [0.90-2.20] months respectively for patients with and without chemotherapy. The GnP regimen (aHR [95%CI] = 0.47 [0.25-0.89], p = 0.02) and diabetes (aHR = 0.44 [0.24-0.77], p = 0.004) (or anti-diabetic therapy) were multivariate protective factors for death, while ECOG-PS, liver metastases, and the neutrophil cell count were multivariate risk factors for death. In the chemotherapy group, ECOG-PS, number of metastatic sites and the GnP remained significantly associated with OS. Our study confirms the feasibility and efficacy of chemotherapy and the protective effects of diabetes among older patients with mPC.

4.
Chest ; 161(3): 781-790, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34627853

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE. RESEARCH QUESTION: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE? STUDY DESIGN AND METHODS: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months. RESULTS: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97). INTERPRETATION: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02746185; URL: www. CLINICALTRIALS: gov.


Assuntos
Dalteparina , Neoplasias , Rivaroxabana , Tromboembolia Venosa , Idoso , Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Hemorragia/induzido quimicamente , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Neoplasias/complicações , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/etiologia , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia
5.
J Vasc Interv Radiol ; 32(8): 1136-1143, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34098072

RESUMO

PURPOSE: To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization. MATERIALS AND METHODS: This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months). RESULTS: The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items. CONCLUSIONS: EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.


Assuntos
Embolização Terapêutica , Neoplasias Hepáticas , Embolização Terapêutica/efeitos adversos , Hepatectomia , Humanos , Neoplasias Hepáticas/terapia , Masculino , Veia Porta , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento
6.
Cancer Med ; 10(11): 3635-3645, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33988316

RESUMO

BACKGROUND: Tyrosine kinase inhibitors (TKI) can be safely discontinued in chronic phase chronic myeloid leukemia (CP-CML) patients who had achieved a sustained deep molecular response. Based on the results of discontinuation trials, recommendations regarding patient selection for a treatment-free remission (TFR) attempt had been proposed. The aims of this study were to evaluate the rate of patients eligible for TKI discontinuation and molecular recurrence-free survival (MRFS) after stop according to recommendations. METHODS: Over a 10-year period, newly diagnosed CP-CML patients and treated with first-line TKI in the nine French participating centers were included. Eligibility to treatment discontinuation and MRFS were analyzed and compared according to selection criteria defined by recommendations and first-line treatments. RESULTS: From January 2006 to December 2015, 398 patients were considered. Among them, 73% and 27% of patients received imatinib or either second or third generation tyrosine kinase inhibitors as frontline treatment, respectively. Considering the selection criteria defined by recommendations, up to 55% of the patients were selected as optimal candidates for treatment discontinuation. Overall 95/398 (24%) discontinued treatment. MRFS was 51.8% [95% CI 41.41-62.19] at 2 years and 43.8% [31.45-56.15] at 5 years. Patients receiving frontline second-generation TKI and fulfilling the eligibility criteria suggested by recommendations had the lowest probability of molecular relapse after TKI stop when compare to others. CONCLUSION: One third of CP-CML patients treated with TKI frontline fulfilled the selection criteria suggested by European LeukemiaNet TFR recommendations. Meeting selection criteria and second-generation TKI frontline were associated with the highest MRFS.


Assuntos
Mesilato de Imatinib/uso terapêutico , Leucemia Mieloide de Fase Crônica/tratamento farmacológico , Seleção de Pacientes , Inibidores de Proteínas Quinases/uso terapêutico , Suspensão de Tratamento , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , França , Proteínas de Fusão bcr-abl/análise , Guias como Assunto , Humanos , Leucemia Mieloide de Fase Crônica/genética , Masculino , Pessoa de Meia-Idade , Intervalo Livre de Progressão , Recidiva , Indução de Remissão , Suspensão de Tratamento/estatística & dados numéricos , Adulto Jovem
7.
Obes Surg ; 30(6): 2206-2216, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32030617

RESUMO

CONTEXT: The 30-day readmission rate after bariatric surgery is considered an important metric of the quality of hospital care. However, readmission rate beyond 30 days is rarely reported and does not provide any information about trajectories of care which would be of great interest for healthcare planning. The aim of this study was to analyze trajectories of care during the first year after bariatric surgery on a nationwide basis using data mining methods. METHOD: This was a retrospective descriptive study on the trajectories of care within the first year after bariatric surgery. Data were extracted from a national administrative claims database (the PMSI database) and trajectories were defined as principal diagnosis of successive readmissions. Formal Concept Analysis was performed to find common concepts of trajectories of care. RESULTS: We included for analysis 198,389 bariatric procedures performed on 196,323 patients. Twelve main concepts were selected. About one third of patients (32.4%) were readmitted in the first year after surgery. Most common trajectories were as follows: regular follow-up (14.9%), cholelithiasis (2.2%), abdominal pain (1.9%), and abdominal sepsis (1.3%). Important differences were found in trajectories among different bariatric procedures: 1.8% of gastric banding patients had pregnancy-related events (delivery or medical abortion), while we observed a readmission rate for abdominal sepsis in 2.7% and 5.1% of patients operated of gastric bypass and sleeve gastrectomy respectively. CONCLUSION: Administrative claim data can be analyzed through Formal Concept Analysis in order to classify trajectories of care. This approach permits to quantify expected postoperative complications and to identify unexpected events.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Obesidade Mórbida , Mineração de Dados , Humanos , Obesidade Mórbida/cirurgia , Readmissão do Paciente , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos
8.
Stat Med ; 38(18): 3476-3502, 2019 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-31016792

RESUMO

Recurrent events arise when an event occurs many times for a subject. Many models have been developed to analyze these kind of data: the Andersen-Gill's model is one of them as well as the Prentice-William and the Peterson's model, the Wei Lee and Weissfeld's model, or even frailty models, all assuming an independent and noninformative censoring. However, in practice, these assumptions may be violated by the existence of a terminal event that permanently stops the recurrent process (eg, death). Indeed, a patient who experiences an early terminal event is more likely to have a lower number of recurrent events than a patient who experiences a terminal event later. Thus, ignoring terminal events in the analysis may lead to biased results. Many methods have been developed to handle terminal events. In this paper, we describe the existing methods classifying into conditional or marginal methods and compare them in a simulation study to highlight bias in results if an inappropriate method is used, when recurrent events and terminal event are correlated. In addition, we apply the different models on a real dataset to show how results should be interpreted. Finally, we provide recommendations for choosing the appropriate method for analyzing recurrent events in the presence of a terminal event.


Assuntos
Neoplasias Colorretais/cirurgia , Interpretação Estatística de Dados , Modelos Estatísticos , Readmissão do Paciente/estatística & dados numéricos , Viés , Bioestatística , Simulação por Computador , Bases de Dados Factuais , Humanos , Funções Verossimilhança , Recidiva
9.
Eur Respir J ; 52(4)2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30262574

RESUMO

The anti-tumour and anti-metastatic properties of heparins have not been tested in patients with early stage cancer. Whether adjuvant low molecular weight heparin (LMWH) tinzaparin impacts the survival of patients with resected non-small cell lung cancer (NSCLC) was investigated.Patients with completely resected stage I, II or IIIA NSCLC were randomly allocated to receive subcutaneous tinzaparin 100 IU·kg-1 once a day for 12 weeks or no treatment in addition to standard of care. The trial was open-label with blinded central adjudication of study outcomes. The primary outcome was overall survival.In 549 patients randomised to tinzaparin (n=269) or control (n=280), mean±sd age was 61.6±8.9 years, 190 (34.6%) patients had stage II-III disease, and 220 (40.1%) patients received adjuvant chemotherapy. Median follow-up was 5.7 years. There was no significant difference in overall survival between groups (hazard ratio (HR) 1.24, 95% CI 0.92-1.68; p=0.17). There was no difference in the cumulative incidence of recurrence between groups (subdistribution HR 0.94, 95% CI 0.68-1.30; p=0.70).Adjuvant tinzaparin had no detectable impact on overall and recurrence-free survival of patients with completely resected stage I-IIIA NSCLC. These results do not support further clinical evaluation of LMWHs as anti-tumour agents.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Heparina de Baixo Peso Molecular/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Idoso , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Quimioterapia Adjuvante , Feminino , França/epidemiologia , Humanos , Injeções Subcutâneas , Neoplasias Pulmonares/cirurgia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Análise de Sobrevida , Tinzaparina/uso terapêutico
10.
Abdom Radiol (NY) ; 43(7): 1670-1681, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29110059

RESUMO

PURPOSE: To assess the value of Hepatobiliary phase MRI (HPB-MRI) to differentiate FNH and HCA, and evaluate its impact on diagnostic accuracy, diagnostic confidence, inter-observer variability, and patient clinical management. METHODS: Forty-nine patients referred for Gd-BOPTA-enhanced MRI were retrospectively included in this IRB-approved study, with a total of 119 lesions-90 FNH and 29 HCA. Two observers separately assessed in 2 distinct randomized reading sessions the performance of MRI with (HBP-MRI) or without (conventional MRI) the use of HBP images. Each lesion was ranked with a 5-point scale (from 1 Typical FNH to 5 Certainly not a FNH). Sensitivity, specificity, overall accuracy, and inter-observer agreement for the differentiation of FNH from HCA were calculated and compared between conventional and HBP-MRI. RESULTS: Both sensitivity (respective values of 38.9% and 97.8%), overall accuracy (respective values of 53.8% and 98.3%), and inter-observer agreement (respective values of Kappa 0.56 and 0.88) were significantly higher using HBP-MRI than with conventional MRI, with unchanged specificity (100%). The sensitivity of conventional MRI for the diagnosis of FNH was significantly lower in lesions ≤ 3 cm (20% vs. 88%). Overall, HBP could have changed lesion management in 59/119 cases (49.5%), including 53 FNH and 6 HCA with no impact in 60/119 lesions (50.5%) including all 35 lesions classified as scores 1 and 2 for the diagnosis of FNH. CONCLUSIONS: The clinical impact of HBP-MRI is mostly important for smaller than 3-cm FNH, and more limited in larger FNH lesions as well as for HCA diagnosis for which conventional MRI is already accurate. The use of extracellular contrast agents upfront could limit the required use of linear HBP contrast agents for benign hepatocellular lesion characterization. On HBP, all FNH appeared hypointense compared to adjacent liver while close to 97% of HCA appeared hypointense.


Assuntos
Adenoma de Células Hepáticas/diagnóstico por imagem , Hiperplasia Nodular Focal do Fígado/diagnóstico por imagem , Aumento da Imagem/métodos , Neoplasias Hepáticas/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Meglumina/análogos & derivados , Compostos Organometálicos , Adulto , Idoso , Meios de Contraste , Diagnóstico Diferencial , Feminino , Humanos , Fígado/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Adulto Jovem
11.
Abdom Radiol (NY) ; 43(8): 2212, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29230554

RESUMO

The original version of this article unfortunately contained a mistake. There was an error in the last sentence of the summary and the last sentence of the discussion. It should read as "On HBP, all FNH appeared hyper- or iso-intense compared to adjacent liver while close to 97% of HCA appeared hypointense".

12.
J Inorg Biochem ; 181: 132-138, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29079320

RESUMO

Patients with macrophagic myofasciitis (MMF) present with diffuse arthromyalgias, chronic fatigue, and cognitive disorder. Representative features of MMF-associated cognitive dysfunction include attentional dysfunction, dysexecutive syndrome, visual memory deficit and left ear extinction. Our study aims to reevaluate the neuropsychological profile of MMF. 105 unselected consecutive MMF patients were subjected to a neuropsychological battery of screen short term and long-term memory, executive functions, attentional abilities, instrumental functions and dichotic listening. From these results, patients were classified in four different groups: Subsymptomatic patients (n=41) with performance above pathological threshold (-1.65 SD) in all tests; Fronto-subcortical patients (n=31) who showed pathological results at executive functions and selective attention tests; Papezian patients (n=24) who showed pathological results in storage, recognition and consolidation functions for episodic verbal memory, in addition to fronto-subcortical dysfunction; and Extinction patients (n=9) who had a left ear extinction at dichotic listening test in association to fronto-subcortical and papezian dysfunction. In addition, inter-test analysis showed that patients with apparently normal cognitive functions (Subsymptomatic group) performed significantly worse to attention tests compared to others. In conclusion, our study shows that (i) most patients have specific cognitive deficits; (ii) all patients with cognitive deficit have impairment of executive functions and selective attention; (iii) patients without measurable cognitive deficits display significant weakness in attention; (iv) episodic memory impairment affects verbal, but not visual, memory; (v) none of the patients show an instrumental dysfunction.


Assuntos
Adjuvantes Imunológicos/efeitos adversos , Hidróxido de Alumínio/efeitos adversos , Disfunção Cognitiva/etiologia , Fasciite/fisiopatologia , Miosite/fisiopatologia , Síndromes Neurotóxicas/fisiopatologia , Doenças Assintomáticas , Atenção/efeitos dos fármacos , Estudos de Coortes , Diagnóstico Diferencial , Testes com Listas de Dissílabos , Função Executiva/efeitos dos fármacos , Fasciite/induzido quimicamente , Fasciite/diagnóstico , Fasciite/diagnóstico por imagem , Feminino , França , Hospitais Especializados , Hospitais Universitários , Humanos , Imageamento por Ressonância Magnética , Masculino , Memória Episódica , Miosite/induzido quimicamente , Miosite/diagnóstico , Miosite/diagnóstico por imagem , Neuroimagem , Testes Neuropsicológicos , Síndromes Neurotóxicas/diagnóstico , Síndromes Neurotóxicas/diagnóstico por imagem , Estudos Retrospectivos , Comportamento Verbal/efeitos dos fármacos
13.
JAMA ; 318(6): 548-556, 2017 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-28787507

RESUMO

Importance: Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function. Objective: To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled trial conducted in 13 French cardiac surgical centers. Patients with a left ventricular ejection fraction less than or equal to 40% and scheduled for isolated or combined coronary artery bypass grafting with cardiopulmonary bypass were enrolled from June 2013 until May 2015 and followed during 6 months (last follow-up, November 30, 2015). Interventions: Patients were assigned to a 24-hour infusion of levosimendan 0.1 µg/kg/min (n = 167) or placebo (n = 168) initiated after anesthetic induction. Main Outcomes and Measures: Composite end point reflecting low cardiac output syndrome with need for a catecholamine infusion 48 hours after study drug initiation, need for a left ventricular mechanical assist device or failure to wean from it at 96 hours after study drug initiation when the device was inserted preoperatively, or need for renal replacement therapy at any time postoperatively. It was hypothesized that levosimendan would reduce the incidence of this composite end point by 15% in comparison with placebo. Results: Among 336 randomized patients (mean age, 68 years; 16% women), 333 completed the trial. The primary end point occurred in 87 patients (52%) in the levosimendan group and 101 patients (61%) in the placebo group (absolute risk difference taking into account center effect, -7% [95% CI, -17% to 3%]; P = .15). Predefined subgroup analyses found no interaction with ejection fraction less than 30%, type of surgery, and preoperative use of ß-blockers, intra-aortic balloon pump, or catecholamines. The prevalence of hypotension (57% vs 48%), atrial fibrillation (50% vs 40%), and other adverse events did not significantly differ between levosimendan and placebo. Conclusions and Relevance: Among patients with low ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite end point of prolonged catecholamine infusion, use of left ventricular mechanical assist device, or renal replacement therapy. These findings do not support the use of levosimendan for this indication. Trial Registration: EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.


Assuntos
Baixo Débito Cardíaco/prevenção & controle , Cardiotônicos/uso terapêutico , Ponte de Artéria Coronária/efeitos adversos , Hidrazonas/uso terapêutico , Pré-Medicação , Piridazinas/uso terapêutico , Idoso , Ponte Cardiopulmonar , Cardiotônicos/efeitos adversos , Catecolaminas/administração & dosagem , Método Duplo-Cego , Feminino , Coração Auxiliar , Humanos , Hidrazonas/efeitos adversos , Infusões Intravenosas , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/prevenção & controle , Piridazinas/efeitos adversos , Terapia de Substituição Renal , Simendana , Volume Sistólico/efeitos dos fármacos , Falha de Tratamento
14.
Ann Intensive Care ; 7(1): 26, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28265980

RESUMO

BACKGROUND: As the population ages and cancer therapies improve, there is an increased call for elderly cancer patients to be admitted to the intensive care unit (ICU). This study aimed to assess short-term survival and prognostic factors in critically ill patients with solid tumors aged ≥65 years. METHODS: We conducted a retrospective study. The primary endpoint was ICU mortality. Resumption of anticancer therapy in patients who survived the ICU stay and 90-day mortality were secondary endpoints. All patients aged ≥65 years admitted to the ICU of Georges Pompidou Hospital (Paris, France) between 2009 and 2014 were eligible. RESULTS: Of 2327 eligible elderly patients (EP), 262 (75.0 ± 6.7 years) with solid tumors were analyzed. These patients were extremely critically ill (SAPS 2 61.9 ± 22.5), and 60.3% had metastatic disease. Gastrointestinal, lung and genitourinary cancers were the most common types of tumors. Mechanical ventilation was required in 51.5% of patients, inotropes in 48.1% and dialysis in 12.6%. Most patients (66.7%) were admitted for reasons unrelated to cancer, including sepsis (30.5%), acute respiratory failure (28.2%) and neurological problems (8.0%). ICU mortality in patients with cancer was 33.6 versus 32.6% among patients without cancer (p = 0.75). Among the cancer EP, the 90-day mortality was 51.9% (n = 136). In multivariate analysis, increased SAPS 2 score and primary tumor site were associated with 90-day death, whereas previous anticancer therapies and poor performance status were not. Among survivor patients from ICU with anti-tumoral treatment indication, 77 (52.7%) had resumption of anticancer treatment. CONCLUSIONS: Elderly solid tumor patients admitted to the ICU had a mortality rate similar to EP without cancer. Prognostic factors for 90-day mortality were more related to severity of clinical status at admission than the presence or stage of cancer, suggesting that early admission of EP with cancer to the ICU is appropriate.

15.
J Arthroplasty ; 32(2): 413-418.e1, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27430181

RESUMO

BACKGROUND: In a large prospective cohort, we recently showed that only 66.1% of total knee arthroplasty (TKA) with a perfect outcome according to Knee Society Knee Score was completely forgotten in all everyday activities. The main objective of this study was to identify clinical and orthopedic factors associated with the acquisition of "forgotten knee" (FK). METHODS: Patients undergoing TKA were enrolled between January 2001 and January 2008. Preoperative medical history, anthropometric data, and clinical data were recorded, and composite scores (Knee Society Score, Lequesne) were assessed. Radiography was performed before and after surgery. At each follow-up, FK acquisition was assessed by a closed question "Does the operated knee feel always normal in all everyday activities?" RESULTS: We included 510 TKAs performed in 423 patients followed up for a mean of 76.6 ± 28.5 months. On multivariate analysis, depression at baseline and presence of patellar subluxation after surgery were negatively associated with FK acquisition (odds ratio [OR] = 0.28 [95% confidence interval {CI}, 0.13-0.61], P = .001; and OR = 0.31 [0.12-0.79], P = .01, respectively), whereas increased active flexion at last follow-up was positively associated (OR = 1.07 [1.03-1.10], P < .0001). In patients with a perfect outcome (Knee Society Knee Score = 100), preoperative patellar pain, and postoperative patellar subluxation were negatively associated with FK acquisition (OR = 0.41 [0.18-0.93], P = .03 and OR = 0.21 [0.05-0.90], P = .04, respectively). Gender, age, body mass index, preoperative pain and functional limitation, and patellar resurfacing were not significantly related to FK. CONCLUSION: Depression and patella maltracking may be associated with lack of FK acquisition after TKA, while postoperative increase in flexion may have a positive impact.


Assuntos
Artroplastia do Joelho/efeitos adversos , Articulação do Joelho/cirurgia , Idoso , Antropometria , Índice de Massa Corporal , Feminino , Seguimentos , Humanos , Luxações Articulares/etiologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Ortopedia , Dor/cirurgia , Patela/cirurgia , Período Pós-Operatório , Estudos Prospectivos , Amplitude de Movimento Articular , Fatores de Tempo , Resultado do Tratamento
16.
Knee Surg Sports Traumatol Arthrosc ; 23(6): 1734-40, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25533698

RESUMO

PURPOSE: The range of motion achieved after a total knee arthroplasty (TKA) affects many daily activities and overall patients' satisfaction. This study aims to define the determinants affecting post-operative midterm active flexion according to a specific cruciate-sacrificing prosthesis, the rotating concave-convex (ROCC(®)) TKA. METHOD: Four hundred and eighty-four consecutive patients (584 TKAs) were prospectively followed. After baseline patient demographics and anatomical characteristics, clinical and radiological post-operative assessments were periodically recorded. The rotational alignment of the femoral component was additionally reported for 120 patients. Eligibility for final inclusion was a minimum of 5-year follow-up. Univariate analyses followed by a multivariate model were fitted to determine the independent predictors of midterm active knee flexion. RESULTS: Thirty-four TKA (5.8%) were excluded for a secondary surgery before their 50 years, 69 patients died (11.8%), and 21 (3.6%) were lost to follow-up. Overall, 460 TKAs were included. The post-operative mean knee flexion angle was measured at 127.7° ± 9.3°. Significant factors affecting final flexion under univariate analyses were the patient height and body mass index, the absence of previous surgery, a depressive state, the preoperative flexion angle, a preoperative flexion contracture, a patellar residual subluxation, the reconstructed patellar height, and the rotation of the femoral component. The multivariate model confirmed the patient's height, a depression, the preoperative flexion angle, a patellar residual subluxation, and the patellar height as statistically significant determinants. CONCLUSION: Aside from the preoperative flexion angle, numerous predictors of flexion, both patient- and procedure-related were identified. Surgeons should take these into account both when adequately informing their patient before surgery and when performing the arthroplasty itself. LEVEL OF EVIDENCE: Prognostic, Level II.


Assuntos
Artroplastia do Joelho , Avaliação de Resultados da Assistência ao Paciente , Amplitude de Movimento Articular , Idoso , Estatura , Depressão/epidemiologia , Feminino , Seguimentos , Humanos , Prótese do Joelho , Masculino , Análise Multivariada , Osteoartrite do Joelho/cirurgia , Sobrepeso/epidemiologia , Patela/anatomia & histologia , Estudos Prospectivos
17.
PLoS One ; 9(6): e98371, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24896266

RESUMO

INTRODUCTION AND OBJECTIVES: Numerous studies have assessed cost-effectiveness of different treatment modalities for stable angina. Direct comparisons, however, are uncommon. We therefore set out to compare the efficacy and mean cost per patient after 1 and 3 years of follow-up, of the following treatments as assessed in randomized controlled trials (RCT): medical therapy (MT), percutaneous coronary intervention (PCI) without stent (PTCA), with bare-metal stent (BMS), with drug-eluting stent (DES), and elective coronary artery bypass graft (CABG). METHODS: RCT comparing at least two of the five treatments and reporting clinical and cost data were identified by a systematic search. Clinical end-points were mortality and myocardial infarction (MI). The costs described in the different trials were standardized and expressed in US $ 2008, based on purchasing power parity. A network meta-analysis was used to compare costs. RESULTS: Fifteen RCT were selected. Mortality and MI rates were similar in the five treatment groups both for 1-year and 3-year follow-up. Weighted cost per patient however differed markedly for the five treatment modalities, at both one year and three years (P<0.0001). MT was the least expensive treatment modality: US $3069 and 13 864 after one and three years of follow-up, while CABG was the most costly: US $27 003 and 28 670 after one and three years. PCI, whether with plain balloon, BMS or DES came in between, but was closer to the costs of CABG. CONCLUSIONS: Appreciable savings in health expenditures can be achieved by using MT in the management of patients with stable angina.


Assuntos
Ponte de Artéria Coronária/economia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/economia , Intervenção Coronária Percutânea/economia , Doença da Artéria Coronariana/economia , Análise Custo-Benefício , Humanos
18.
J Magn Reson Imaging ; 39(2): 317-25, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23723012

RESUMO

PURPOSE: To determine if intra-voxel incoherent motion diffusion-weighted imaging (IVIM-DWI) parameters, including free molecular-based (D) and perfusion-related (D*, f) diffusion parameters, correlate with the degree of tumor necrosis and viable tumor in colo-rectal cancer (CRC) metastasis. MATERIALS AND METHODS: Fifteen patients referred for resection of liver metastases from CRC were retrospectively included in this Institutional Review Board approved study. An IVIM-DWI sequence was performed on a 1.5 Tesla MR imaging system, with 10 b factors (0, 10, 20, 30, 50, 80, 100, 200, 400 and 800 s/mm(2) ). Mean D, D*, f and apparent diffusion coefficient (ADC) values were determined in metastases with a longest diameter above 10 mm. Correlations between the diffusion parameters and the degree of liver tumor necrosis and viable tissue were determined (Spearman). RESULTS: Correlation between diffusion parameters and histopathological findings was performed in 35 hepatic metastases with a diameter of more than 10 mm (mean size of 17.9 mm; range, 1-68 mm). Both D (r = 0.36; P = 0.035) and ADC (r = 0.4; P = 0.02) correlated with the degree of tumor necrosis but not with viable tumor. CONCLUSION: ADC variation observed in CRC metastases following systemic chemotherapy reflects a specific increase in free-molecular diffusion (D), in itself correlated to the degree of metastasis necrosis.


Assuntos
Colo/patologia , Neoplasias Colorretais/patologia , Imageamento Tridimensional/métodos , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/secundário , Fígado/patologia , Imageamento por Ressonância Magnética/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Diagnóstico Diferencial , Humanos , Aumento da Imagem/métodos , Pessoa de Meia-Idade , Movimento (Física) , Necrose , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA