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OBJECTIVES: To analyze the incidence, clinical impact on survival, and risk factors of lower limb ischemia (LLI) of surgical peripheral femoral venoarterial extracorporeal membrane oxygenation (VA ECMO) in the current era. DESIGN: A retrospective analysis of the authors' institutional database of VA ECMO was performed. Patients were divided into 2 groups according to the occurrence of LLI. The primary endpoint was survival to hospital discharge. Risk factors of LLI were searched with multivariate analyses. SETTING: University hospital. PARTICIPANTS: Adult patients receiving peripheral VA ECMO for refractory cardiogenic shock and cardiac arrest. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From January 2018 to December 2021, 188 patients (mean age: 52.0 ± 14.1 years; 63.8% male, 36.2% female) received peripheral VA ECMO. Male sex was more prevalent in the group without LLI (65.9% v 33.3%; p = 0.031). Twelve (6.4%) patients developed LLI during VA ECMO support (n = 6) or after VA ECMO removal (n = 6). Survival to hospital discharge was not statistically different between patients with and without LLI (50.0% v 48.3%; p = 0.571). Female sex patients were at increased risk for LLI (odds ratio 4.38, 95% CI 1.21-15.81; p = 0.024). CONCLUSIONS: Peripheral femoral VA ECMO through a surgical approach is associated with a low LLI rate, which does not increase the risk of in-hospital mortality. The female sex is an independent risk factor for LLI.
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Oxigenação por Membrana Extracorpórea , Doenças Vasculares Periféricas , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Oxigenação por Membrana Extracorpórea/efeitos adversos , Estudos Retrospectivos , Choque Cardiogênico/cirurgia , Fatores de Risco , Isquemia/etiologia , Isquemia/cirurgiaRESUMO
OBJECTIVE: To analyze the impact of the modification of the authors' institutional protocol on outcomes after extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA). DESIGN: An observational analysis. The protocol complied with national recommendations. A further eligibility criterion was added since January 2015: the presence of sustained shockable rhythm at extracorporeal life support (ECLS) implantation. To assess the impact of this change, patients were divided into two groups: (1) from January 2010 to December 2014 (group A) and (2) from January 2015 to December 2019 (group B). The primary endpoint was survival to hospital discharge with good neurologic outcome. Predictors of survival were searched with multivariate analyses. SETTING: University hospital. PARTICIPANTS: Adult patients supported with ECPR for refractory OHCA. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From January 2010 to December 2019, 85 patients had ECLS for OHCA (group A, n = 68, 80%; group B, n = 17, 20%). The mean age was 42.4 years, 78.8% were male. The rate of implantation of ECLS was significantly lower in group B (p = 0.01). Mortality during ECLS support was significantly lower (58.8 v 86.8%; p = 0.008), and the weaning rate was significantly higher (41.2 v 13.2%; p = 0.008) in group B. Survival to discharge with good neurologic outcome was significantly improved (23.5 v 4.4%; p = 0.027) in group B. A sustained shockable rhythm was the only independent predictor of survival to hospital discharge with good neurologic outcome. CONCLUSIONS: The modification of the authors' institutional protocol throughout the further criterion of sustained shockable rhythm yielded a favorable impact on outcomes after ECPR for OHCA.
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Reanimação Cardiopulmonar , Oxigenação por Membrana Extracorpórea , Parada Cardíaca Extra-Hospitalar , Adulto , Reanimação Cardiopulmonar/métodos , Oxigenação por Membrana Extracorpórea/métodos , Feminino , Humanos , Masculino , Estudos Observacionais como Assunto , Parada Cardíaca Extra-Hospitalar/terapia , Alta do Paciente , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: Whether the effects of therapies may wane over time is a matter of debate, especially when considering their long-term cost-effectiveness. Here, we examined how the assumption of the waning of treatment effect was applied across the National Institute for Health and Care Excellence (NICE) appraisals for disease-modifying therapies (DMTs) used in multiple sclerosis. METHODS: We undertook a document analysis following a search of the NICE website. The inclusion criteria of the study were as follows: all publicly available documents related to completed appraisals for DMTs (period: January 2000 to July 2021). The exclusion criteria of the study were as follows: all documents that did not meet the inclusion criteria, especially pertaining to drugs used in other disease areas. We extracted information about the waning of treatment effect assumption as considered by companies, assessment groups, and appraisal committees, and we analyzed trends over time. RESULTS: We reviewed fifteen appraisals that reported guidance on sixteen DMTs. Irrespective of the drugs' mechanism of action or their pharmaceutical nature, there was substantial variation in the modalities when the assumption of waning was implemented. We noted the recent preference to use all-cause discontinuation as a proxy. This heterogeneity did not appear to affect acceptance of the DMTs (all but one were recommended for use across the National Health System (NHS)). CONCLUSIONS: Modeling the long-term effect of therapies is challenging, especially given the limited follow-up duration of related trials. This generates recurrent debates on the presence of waning of treatment efficacy and heterogeneity across appraisals. More refined recommendations obtained by consensus among stakeholders could help to achieve greater consistency in decision making.
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Esclerose Múltipla , Avaliação da Tecnologia Biomédica , Humanos , Análise Custo-Benefício , Esclerose Múltipla/tratamento farmacológico , Tecnologia Biomédica , Resultado do TratamentoRESUMO
BACKGROUND AND AIM OF THE STUDY: Acute cardiovascular failure remains a leading cause of death in severe poisonings. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used as a rescue therapeutic option for those cases refractory to optimal conventional treatment. We sought to evaluate the outcomes after VA-ECMO used for drug intoxications in a single-center experience. METHODS: We performed an observational analysis of our prospective institutional database. The primary endpoint was survival to hospital discharge. RESULTS: Between January 2007 and December 2020, 32 patients (mean age: 45.4 ± 15.8 years; 62.5% female) received VA-ECMO for drug intoxication-induced refractory cardiogenic shock (n = 25) or cardiac arrest (n = 7). Seven (21.8%) patients developed lower limb ischemia during VA-ECMO support. Twenty-six (81.2%) patients were successfully weaned after a mean VA-ECMO support of 2.9 ± 1.3 days. One (3.1%) patient died after VA-ECMO weaning for multiorgan failure and survival to hospital discharge was 78.1% (n = 25). In-hospital survivors were discharged from hospital with a good neurological status. Survival to hospital discharge was not statistically different according to sex (male = 75.0% vs. female = 80.0%; p = .535), type of intoxication (single drug = 81.8% vs. multiple drugs = 76.1%; p = .544) and location of VA-ECMO implantation (within our center = 75% vs. peripheral hospital using our Mobile Unit of Mechanical Circulatory Support = 100%; p = .352). Survival to hospital discharge was significantly lower in patients receiving VA-ECMO during on-going cardiopulmonary resuscitation (42.8% vs. 88.0%; p = .026). CONCLUSIONS: VA-ECMO appears to be a feasible therapeutic option with a satisfactory survival rate and acceptable complications rate in poisonings complicated by refractory cardiogenic shock or cardiac arrest.
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Oxigenação por Membrana Extracorpórea , Parada Cardíaca , Adulto , Oxigenação por Membrana Extracorpórea/efeitos adversos , Feminino , Parada Cardíaca/induzido quimicamente , Parada Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Choque Cardiogênico/etiologiaRESUMO
BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia , Intervenção Coronária Percutânea , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hospitalização/estatística & dados numéricos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/mortalidade , Falha de Prótese , Volume Sistólico , Resultado do Tratamento , Disfunção Ventricular Esquerda/etiologiaRESUMO
Several low-impact laparoscopic strategies have been developed to improve the safety of pneumoperitoneum. We conducted a systematic review to establish the current evidence base for the use of the AIRSEAL® insufflation device for low-pressure pneumoperitoneum in laparoscopic surgery. We searched the literature using several electronic databases, for studies with comparative design published in the English language from January 2010 to April 2020. The population of interest included patients with any type of health condition who underwent laparoscopic surgery using the AIRSEAL® insufflation system or a standard CO2 insufflator. Ten studies (four randomized clinical trials/six non-randomized clinical trials), that enrolled 1394 participants in total who underwent urology, gynaecology or abdominal surgeries, were included. Total complication rates were similar between groups. Only three studies evaluated the impact of the insufflation system on post-operative pain, and showed inconsistent benefit of AIRSEAL® (significant decrease in pain in two studies, no difference in one). The same was observed in the two sole studies in which pain killers consumption was measured (significant decrease in morphine consumption 24 h after surgery in one study, no difference in the other). Operative duration was significantly shorter with AIRSEAL® in three studies. For both post-operative room and total length of stay, there was no difference between groups. No studies reported economic outcomes. Current literature supports the feasibility of the AIRSEAL® system during laparoscopic surgery but more studies are required to establish the added clinical benefit and to explore the preferences of physicians and patients.
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Insuflação , Laparoscopia , Dióxido de Carbono , Humanos , Dor Pós-Operatória/prevenção & controle , Pneumoperitônio ArtificialRESUMO
BACKGROUND AND AIM OF THE STUDY: Data about the beating heart (BH) technique for isolated tricuspid valve (TV) surgery compared to the arrested heart (AH) technique are sparse. We compared the outcomes of isolated TV surgery between BH and AH technique. METHODS: We performed an observational analysis of our database of isolated TV surgery. Patients were divided into two groups according to whether surgery was performed without (BH group) or with (AH group) aortic cross-clamping and cardioplegic arrest. The primary endpoint was survival to hospital discharge. Risk factors for in-hospital mortality were searched with multivariate analyses. We undertook further comparisons after propensity-score matching. RESULTS: From January 2007 to December 2017, we performed 82 isolated TV surgery (BH group, n = 47, 57.3%; AH group, n = 35, 42.7%). The mean age was 59.1 years, 56.1% were female. BH group patients were older (61.8 vs. 55.4 years; p = .035), had greater impaired renal function (glomerular filtration rate, 61.1 vs. 74.6 ml/min; p = .012), were more frequently operated for secondary TR (61.7 vs. 31.4%; p = .008), underwent more frequently a reoperation (53.2 vs. 28.6%; p = .042) and exhibited a higher surgical risk (EuroSCORE II, 3.92 vs. 2.50%; p = .013). In-hospital mortality was not different between both groups, either considering unmatched (BH = 10.6 vs. AH = 5.7%; OR = 1.96, 95% confidence interval [CI] = 0.36-10.77) or matched populations (BH = 10.6 vs. AH = 6.4%; OR = 1.89, 95% CI = 0.36-9.97). Age was the only predictor of in-hospital mortality. CONCLUSIONS: The BH technique showed comparable outcomes to the AH technique for isolated TV surgery despite a higher risk profile.
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Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/cirurgiaRESUMO
OBJECTIVES: To analyze the results of extracorporeal life support (ECLS) for cardiogenic shock complicating acute myocardial infarction (AMI) in a single-center experience. BACKGROUND: Cardiogenic shock is still a leading cause of death for AMI. Conventional management carries mortality rates exceeding 50%. ECLS may be considered as a bridge to decision in the setting of AMI complicated by cardiogenic shock not responsive to standard management. METHODS: We performed an observational analysis of our local database. The primary end-point was survival to hospital discharge. All variables were compared between survivors and nonsurvivors. RESULTS: Between January 2007 and December 2017, 56 patients were supported for cardiogenic shock complicating AMI. The mean age was 56.7 years and 89.3% were males. Baseline characteristics were comparable between both groups. Of the 50 primary percutaneous coronary interventions that were attempted, 44 (88.0%) were successful. Twenty-three (41.1%) patients died during ECLS support. The complications' rate during ECLS support was comparable between both groups. Twenty-eight (50%) patients were successfully weaned from ECLS after a mean support of 8.7 days. Eight (14.3%) patients eventually died after weaning before hospital discharge. Five (8.9%) patients could not be weaned from ECLS and were switched to a long-term mechanical circulatory support. Overall survival to hospital discharge was 41.1% (n = 23). Eighteen (32.1%) patients were alive after a mean follow-up of 38.0 ± 29.9 (range, 4.2-95.4) months. CONCLUSIONS: ECLS should be considered as a therapeutic solution in the management of AMI-related cardiogenic shock with a satisfactory short- and long-term survival.
Assuntos
Oxigenação por Membrana Extracorpórea , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Choque Cardiogênico/terapia , Adulto , Idoso , Bases de Dados Factuais , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Alta do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Recuperação de Função Fisiológica , Fatores de Risco , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Choque Cardiogênico/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
High-risk pulmonary embolism (PE) requires hemodynamic and respiratory support along with reperfusion strategies. Recently updated European guidelines assign a low class of recommendation to extracorporeal membrane oxygenation (ECMO) for high-risk PE. This systematic review assessed clinical outcomes after ECMO in high-risk PE. We searched electronic databases including PubMed, Embase and Web of Science from January 2000 to April 2020. Efficacy outcomes included in-hospital survival with good neurological outcome and survival at follow-up. Safety outcomes included lower limb ischemia and hemorrhagic and ischemic stroke. Where possible (absence of high heterogeneity), meta-analyses of outcomes were undertaken using a random-effects model. We included 16 uncontrolled case-series (533 participants). In-hospital survival with good neurological outcome ranged between 50% and 95% while overall survival at follow-up ranged from 35% to 95%, both with a major degree of heterogeneity (I2 > 70%). The prevalence of lower limb ischemia was 8% (95% CI 3% to 15%). The prevalence of stroke (either hemorrhagic or ischemic) was 11% (95% CI 3% to 23%), with notable heterogeneity (I² = 63.35%). Based on currently available literature, it is not possible to draw definite conclusions on the usefulness of ECMO for high-risk PE. Prospective, multicenter, large-scale studies or nationwide registries are needed to best define the role of ECMO for high-risk PE. PROSPERO registration ID: CRD42019136282.
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Oxigenação por Membrana Extracorpórea , Embolia Pulmonar/terapia , Adulto , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
An amendment to this paper has been published and can be accessed via the original article.
RESUMO
BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used over the last decade in patients with refractory cardiogenic shock. ECMO weaning can, however, be challenging and lead to circulatory failure and death. Recent data suggest a potential benefit of levosimendan for ECMO weaning. We sought to further investigate whether the use of levosimendan could decrease the rate of ECMO weaning failure in adult patients with refractory cardiogenic shock. METHODS: We performed an observational single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan). The primary endpoint was VA-ECMO weaning failure defined as death during VA-ECMO treatment or within 24 h after VA-ECMO removal. Secondary outcomes were mortality at day 28 and at 6 months. The two groups were compared after propensity score matching. P < 0.05 was considered statistically significant. RESULTS: Two hundred patients were analyzed (levosimendan group: n = 53 and control group: n = 147). No significant difference was found between groups on baseline characteristics except for ECMO duration, which was longer in the levosimendan group (10.6 ± 4.8 vs. 6.5 ± 4.7 days, p < 0.001). Levosimendan administration started 6.6 ± 5.4 days on average following ECMO implantation. After matching of 48 levosimendan patients to 78 control patients, the duration of ECMO was similar in both groups. The rate of weaning failure was 29.1% and 35.4% in levosimendan and control groups, respectively (OR: 0.69, 95%CI: 0.25-1.88). No significant difference was found between groups for all secondary outcomes. CONCLUSION: Levosimendan did not improve the rate of successful VA-ECMO weaning in patients with refractory cardiogenic shock. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04323709 .
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Choque Cardiogênico/tratamento farmacológico , Simendana/farmacologia , Desmame do Respirador/normas , Adulto , Idoso , Cardiotônicos/farmacologia , Cardiotônicos/uso terapêutico , Estudos de Coortes , Oxigenação por Membrana Extracorpórea/métodos , Oxigenação por Membrana Extracorpórea/normas , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Simendana/uso terapêutico , Desmame do Respirador/métodos , Desmame do Respirador/estatística & dados numéricosRESUMO
BACKGROUND: A review of therapies for advanced cancers licenced by the EMA between 2009 and 2013 concluded that for more than half of these drugs there was little evidence of overall survival or quality of life benefit. Recent years have witnessed a growing number of licensed second-line pharmacotherapies for advanced/metastatic non-small cell lung cancer (NSCLC). With the aim of gauging patient survival benefit, we conducted a systematic review of randomised controlled trials (RCT) and compared survival outcomes from available licensed treatments for patients with advanced/metastatic NSCLC. METHODS: RCTs of second/third line treatments in participants with advanced/metastatic NSCLC and negative/low expression of Anaplastic Lymphoma Kinase (ALK) and of Epidermal Growth Factor Receptor (EGFR) were included. We searched electronic databases (MEDLINE; EMBASE; Web of Science) from January, 2000 up to July, 2017. Two or more independent reviewers screened bibliographic records, extracted data, and assessed risk of bias of studies. Published Kaplan Meier plots for OS and PFS along with restricted-mean-survival methods and parametric modelling were used to estimate the survival outcomes as mean number of months of survival. Network meta-analysis was undertaken to rank interventions and to make indirect comparisons. RESULTS: We included 11 RCTs with data for 7581 participants that compared nine different drugs. In studies of patients regardless of histology groups, targeted drugs (ramucirumab and nintedanib) yielded small overall survival gains of < 2.5 months over docetaxel, erlotinib provided no benefit, while immunotherapies (atezolizumab and pembrolizumab) delivered 5 to 6 months gain. Studies with patients stratified by histology confirmed the apparent superiority of immunotherapy (nivolumab and atezolizumab) over targeted treatments (ramucirumab, nintedanib, afatinib) providing between about 4 to 8 months OS gain over docetaxel. In network analysis immunotherapies consistently ranked higher than alternatives irrespective of population histology and outcome measure. CONCLUSION: Our review indicates that nivolumab, pembrolizumab and atezolizumab provide superior survival benefits compared to other licensed drugs for late stage NSCLC. Patient gains from these immunotherapies are substantial compared to the expected average survival with chemotherapy (docetaxel) of < 1 year for people with squamous histology and about 1.25 year for those with non-squamous histology.
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Quinase do Linfoma Anaplásico/genética , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/patologia , Receptores ErbB/genética , Cloridrato de Erlotinib/uso terapêutico , Humanos , Imunoterapia , Metástase Neoplásica , Segunda Neoplasia Primária/tratamento farmacológico , Segunda Neoplasia Primária/genética , Segunda Neoplasia Primária/patologia , Intervalo Livre de Progressão , Inibidores de Proteínas Quinases/uso terapêutico , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , RamucirumabRESUMO
PURPOSE: A first cost-effectiveness analysis has raised a strong concern regarding the cost of tumor treatment fields (TTF) added to maintenance temozolomide for patients with glioblastoma. This evaluation was based on effectiveness outcomes from an interim analysis of the pivotal trial, moreover it used a "standard" Markov model. Our objective was to update the cost-effectiveness evaluation using the more flexible potential of the "partitioned survival" model design and using the latest effectiveness data. METHODS: We developed the model with three mutually exclusive health states: stable disease, progressive disease, and dead. Good fit parametric models were developed for overall survival and progression free survival and these generated clinically plausible extrapolations beyond the observed data. We adopted the perspective of the French national health insurance and used a 20-year time horizon. Results were expressed as cost/life-years (LY) gained (LYG). RESULTS: The base case model generated incremental benefit of 0.604 LY at a cost of 453,848 which, after 4% annual discounting of benefits and costs, yielded an incremental cost effectiveness ratio (ICER) of 510,273/LYG. Using sensitivity analyses and bootstrapping methods results were found to be relatively robust and were only sensitive to TTF device costs and the modelling of overall survival. To achieve an ICER below 100,000/LYG would require a reduction in TTF device cost of approximately 85%. CONCLUSIONS: Using a different type of model and updated survival outcomes, our results show TTF remains an intervention that is not cost-effective, which greatly restrains its diffusion to potentially eligible patients.
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Antineoplásicos Alquilantes/economia , Teorema de Bayes , Análise Custo-Benefício , Glioblastoma/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Temozolomida/economia , Antineoplásicos Alquilantes/uso terapêutico , Glioblastoma/tratamento farmacológico , Humanos , Prognóstico , Taxa de Sobrevida , Temozolomida/uso terapêuticoRESUMO
BACKGROUND AND AIM OF THE STUDY: Extracorporeal life support (ECLS) may be necessary in refractory postcardiotomy cardiogenic shock (PCS) unresponsive to optimal medical treatment. We sought to analyze the results and temporal outcomes of ECLS for PCS. METHODS: We performed an observational analysis of our prospective database. In order to analyze the temporal trends of ECLS for PCS, patients were divided into two groups according to the period of ECLS implantation: Group I from January 2007-June 2012, Group II from July 2012-December 2017. The primary endpoint was survival to hospital discharge. RESULTS: During the study period, 90 patients required ECLS for PCS (Group I n = 29, 32%; Group II n = 61, 68%). Mean age was 57.5 ± 15.0 years with 62% of males. Preoperative characteristics were comparable over the two periods. A high proportion of patients were in NYHA class III/IV (61%) or cardiogenic shock (22%). Group II showed a significantly higher proportion of miscellaneous cardiac surgery operations (23 vs 3%, P = 0.031). Crossclamp and cardiopulmonary bypass times were significantly shorter in Group II (85.4 vs 114.2 min, P = 0.023 and 135.2 vs 184.2 min, P = 0.022, respectively). The complication rate during ECLS support was comparable between both groups. Successful weaning from ECLS could be accomplished in 45 (50%) patients (Group I = 52% vs Group II = 49%, P = 0.822) after a mean support of 6.4 days. Thirty-five (39%) patients survived to hospital discharge (Group I = 41% vs Group II = 38%, P = 0.738). CONCLUSIONS: Outcomes following ECLS remained stable over an 11-year period. ECLS may be limited in patients with severe preoperative cardiac dysfunction. Our data suggest that these patients may be better served with less invasive, percutaneous procedures.
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Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Choque Cardiogênico/terapia , Feminino , Seguimentos , França/epidemiologia , Cardiopatias/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: We systematically reviewed the comparative effectiveness of injectable beta-interferons (IFN-ß) and glatiramer acetate (GA) on annualised relapse rate (ARR), progression and discontinuation due to adverse events (AEs) in RRMS, using evidence from within the drugs' recommended dosages. METHODS: We updated prior comprehensive reviews, checked references of included studies, contacted experts in the field, and screened websites for relevant publications to locate randomised trials of IFN-ß and GA with recommended dosages in RRMS populations, compared against placebo or other recommended dosages. Abstracts were screened and assessed for inclusion in duplicate and independently. Studies were appraised using the Cochrane risk of bias tool. Rate ratios for ARR, hazard ratios for time to progression, and risk ratios for discontinuation due to AEs were synthesised in separate models using random effects network meta-analysis. RESULTS: We identified 24 studies reported in 42 publications. Most studies were at high risk of bias in at least one domain. All drugs had a beneficial effect on ARR as compared to placebo, but not compared to each other, and findings were robust to sensitivity analysis. We considered time to progression confirmed at 3 months and confirmed at 6 months in separate models; while both models suggested that the included drugs were effective, findings were not consistent between models. Discontinuation due to AEs did not appear to be different between drugs. CONCLUSIONS: Meta-analyses confirmed that IFN-ß and GA reduce ARR and generally delay progression as defined in these trials, though there was no clear 'winner' across outcomes. Findings are additionally tempered by the high risk of bias across studies, and the use of an impairment/mobility scale to measure disease progression. Future research should consider more relevant measures of disability and, given that most trials have been short-term, consider a longitudinal approach to comparative effectiveness. REVIEW REGISTRATION: PROSPERO CRD42016043278 .
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Acetato de Glatiramer/uso terapêutico , Imunossupressores/uso terapêutico , Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Progressão da Doença , Humanos , Metanálise em RedeRESUMO
BACKGROUND: The communication relationship between parents of children or young people with health conditions and health professionals is an important part of treatment, but it is unclear how far the use of digital clinical communication tools may affect this relationship. OBJECTIVE: The objective of our study was to describe, assess the feasibility of, and explore the impact of digital clinical communication between families or caregivers and health professionals. METHODS: We searched the literature using 5 electronic databases. We considered all types of study design published in the English language from January 2009 to August 2015. The population of interest included families and caregivers of children and young people aged less than 26 years with any type of health condition. The intervention was any technology permitting 2-way communication. RESULTS: We included 31 articles. The main designs were randomized controlled trials (RCTs; n=10), cross-sectional studies (n=9), pre- and postintervention uncontrolled (pre/post) studies (n=7), and qualitative interview studies (n=2); 6 had mixed-methods designs. In the majority of cases, we considered the quality rating to be fair. Many different types of health condition were represented. A breadth of digital communication tools were included: videoconferencing or videoconsultation (n=14), and Web messaging or emails (n=12). Health care professionals were mainly therapists or cognitive behavioral therapists (n=10), physicians (n=8), and nurses (n=6). Studies were very heterogeneous in terms of outcomes. Interventions were mainly evaluated using satisfaction or acceptance, or outcomes relating to feasibility. Clinical outcomes were rarely used. The RCTs showed that digital clinical communication had no impact in comparison with standard care. Uncontrolled pre/post studies showed good rates of satisfaction or acceptance. Some economic studies suggested that digital clinical communication may save costs. CONCLUSIONS: This rapid review showed an emerging body of literature on the use of digital clinical communication to improve families' and caregivers' involvement in the health management of children or young people. Further research with appropriate study designs and longer-term outcome measures should be encouraged. TRIAL REGISTRATION: PROSPERO CRD42016035467; http://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD 42016 035467(Archived by WebCite at http://www.webcitation.org/6vpgZU1FU).
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Cuidadores/normas , Comunicação , Adolescente , Adulto , Criança , Estudos Transversais , Família , Feminino , Humanos , Masculino , Pesquisa Qualitativa , Adulto JovemRESUMO
OBJECTIVES: To assess the efficacy and safety profile of stent-retriever thrombectomy (SRT) in acute anterior ischemic stroke patients with tandem occlusion. MATERIALS AND METHODS: Using the MEDLINE database, we conducted a systematic review and meta-analysis of all studies that included patients with acute ischemic stroke attributable to tandem occlusion who received treatment with SRT between November 2010 and May 2015. RESULTS: The literature search identified 11 previous studies involving a total of 237 subjects out of whom 193 (81.4 %) were treated with acute stent placement for the extracranial internal carotid artery occlusion. Mean initial NIHSS score was 17, and median time from onset to recanalization was 283.5 min. Mean intravenous thrombolysis rate was 63.8 %. In the meta-analysis, the recanalization rate reached 81 % (95 % CI, 73-89). Meta-analysis of clinical outcomes showed a pooled estimate of 44 % (95 % CI, 33-55; 10 studies) for favourable outcome, 13 % (95 % CI, 8-20; 10 studies) for mortality, and 7 % (95 % CI, 2-13; eight studies) for symptomatic intracranial haemorrhage. CONCLUSION: SRT with emergency carotid stenting is associated with acceptable safety and efficacy in acute anterior stroke patients with tandem occlusion compared to natural history. However, the best modality to treat proximal stenosis is based on an individual case basis. KEY POINTS: ⢠Stent retriever thrombectomy of tandem occlusion is efficient and safe. ⢠Emergent carotid stenting during thrombectomy increase symptomatic intracranial haemorrhage without impact mortality. ⢠Thrombectomy of tandem anterior circulation occlusion may be the first therapeutic option.
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Arteriopatias Oclusivas/cirurgia , Stents , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Arteriopatias Oclusivas/complicações , Artéria Carótida Interna/cirurgia , Estenose das Carótidas/complicações , Estenose das Carótidas/cirurgia , Remoção de Dispositivo , Humanos , Artéria Cerebral Média , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoAssuntos
Cateterismo Cardíaco , Ensaios Clínicos como Assunto , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Seleção de Pacientes , Idoso , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Tomada de Decisão Clínica , Progressão da Doença , Definição da Elegibilidade , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Desenho de Prótese , Recuperação de Função Fisiológica , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
The current first-line treatment of malignant gliomas consists in surgical resection (if possible) as large as possible. The existing tools don't permit to identify the limits of tumor infiltration, which goes beyond the zone of contrast enhancement on MRI. The fluorescence-guided malignant gliomas surgery was started 15 years ago and had become a standard of care in many countries. The technique is based on fluorescent molecule revelation using the filters, positioned within the surgical microscope. The fluorophore, protoporphyrin IX (PpIX), is converted in tumoral cells from 5-aminolevulinic acid (5-ALA), given orally before surgery. Many studies have shown that the ratio of gross total resections was higher if the fluorescence technique was used. The fluorescence signal intensity is correlated to the cell density and the PpIX concentration. The current method has a very high specificity but still lower sensibility, particularly regarding the zones with poor tumoral infiltration. This book reviews the principles of the technique and the results (extent of resection and survival).
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Ácido Aminolevulínico , Neoplasias Encefálicas/patologia , Neoplasias Encefálicas/cirurgia , Glioblastoma/patologia , Glioblastoma/cirurgia , Microscopia de Fluorescência/métodos , Microcirurgia/métodos , Neuronavegação/métodos , Protoporfirinas/metabolismo , Cirurgia Assistida por Computador/métodos , Encéfalo/patologia , Encéfalo/cirurgia , Fluorescência , Humanos , Gradação de Tumores , Neoplasia Residual/patologia , Neoplasia Residual/cirurgia , Sensibilidade e Especificidade , Estatística como AssuntoRESUMO
BACKGROUND: Mechanical thrombectomy with stent retrievers is now the reference therapy for acute ischemic stroke (AIS) in the anterior circulation in association with thrombolysis. We conducted an extensive systematic review and meta-analysis to evaluate the clinical and angiographic outcomes of stent-retriever thrombectomy in patients with acute anterior circulation stroke. Available literature published to date on observational studies and three randomized trials (MR CLEAN, ESCAPE, and EXTEND-IA) involving the stent-retriever device were reviewed. Successful recanalization and favorable clinical outcome were defined by a TICI ≥ 2b and modified Rankin Scale score of ≤ 2 at 90 days following AIS, respectively. A total of 2067 patients harboring an anterior circulation stroke were treated with a stent retriever: 433 patients from 3 randomized trials involving the device and 1634 patients from observational studies. Mean NIH Stroke Scale score on admission was 16.6, and mean time from onset to recanalization was 300 minutes. Successful recanalization was achieved in 82% (95%CI 77-86, 31 studies). The 90 day favorable outcome was achieved in 47% (95%CI 42-5.2, 34 studies) with an overall mortality rate of 17% (95%CI 13-20, 31 studies). Symptomatic intracerebral hemorrhage was identified in 6% (95%CI 4-8, 32 studies). In patients with AIS caused by a proximal intracranial occlusion of the anterior circulation, stent-retriever thrombectomy is safe and restores brain reperfusion in four of five treated patients, allowing favorable clinical outcome in one of two AIS patients with large vessel occlusion.