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1.
Artigo em Inglês | MEDLINE | ID: mdl-31837963

RESUMO

OBJECTIVES: Landiolol is an ultrashort-acting beta-blocker with high beta-1 receptor affinity and less blood pressure-lowering properties than other beta-blockers available for intravenous use in Germany. The present analysis aimed to determine whether perioperative treatment with landiolol in cardiac surgical patients is cost-effective under the conditions of the German Diagnosis-Related Groups health cost reimbursement system. DESIGN: On the basis of clinical outcome data from a meta-analysis that included 622 patients from 7 randomized controlled trials, a decision-model was developed to determine the cost-effectiveness of landiolol versus standard-of-care (SoC). SETTING: Hospital setting. PARTICIPANTS: Hospital patients undergoing a representative mix of cardiac surgical procedures (MIX-CS) and isolated coronary artery bypass grafting (CABG). INTERVENTIONS: Landiolol versus SoC in prevention of atrial fibrillation immediately after cardiac surgery. MEASUREMENTS AND MAIN RESULTS: The model benefit was expressed in a reduction of postoperative atrial fibrillation (POAF) episodes and reduced complications. The model calculated total inpatient costs over the hospital length of stay. Costs from published sources were used for the German hospital perspective. SoC was associated with POAF rates of 36.0% to 39.2% and 24.4% to 30.1% in the MIX-CS and CABG populations, respectively. Patients with POAF had a higher morbidity and mortality. Estimated total costs for SoC patients in the MIX-CS and CABG groups were 28.792 € and 25.630 €, respectively. Landiolol reduced the incidence of POAF to 12.6% in the MIX-CS and 12.1% in the CABG groups. This was associated with a cost reduction of 2.209 € and 1.470 €. CONCLUSIONS: This analysis suggests that preventing POAF with landiolol is highly cost-effective. Additional studies are needed to assess whether a comparable reduction in POAF and associated cost savings may be achieved using conventional intravenous beta-blockers or amiodarone.

2.
J Clin Med ; 8(11)2019 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-31683969

RESUMO

Both acute and advanced heart failure are an increasing threat in term of survival, quality of life and socio-economical burdens. Paradoxically, the use of successful treatments for chronic heart failure can prolong life but-per definition-causes the rise in age of patients experiencing acute decompensations, since nothing at the moment helps avoiding an acute or final stage in the elderly population. To complicate the picture, acute heart failure syndromes are a collection of symptoms, signs and markers, with different aetiologies and different courses, also due to overlapping morbidities and to the plethora of chronic medications. The palette of cardio- and vasoactive drugs used in the hospitalization phase to stabilize the patient's hemodynamic is scarce and even scarcer is the evidence for the agents commonly used in the practice (e.g. catecholamines). The pipeline in this field is poor and the clinical development chronically unsuccessful. Recent set backs in expected clinical trials for new agents in acute heart failure (AHF) (omecamtiv, serelaxine, ularitide) left a field desolately empty, where only few drugs have been approved for clinical use, for example, levosimendan and nesiritide. In this consensus opinion paper, experts from 26 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, The Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, U.K. and Ukraine) analyse the situation in details also by help of artificial intelligence applied to bibliographic searches, try to distil some lesson-learned to avoid that future projects would make the same mistakes as in the past and recommend how to lead a successful development project in this field in dire need of new agents.

3.
Best Pract Res Clin Anaesthesiol ; 33(2): 155-163, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31582095

RESUMO

The clinical usefulness of the so-called "static" cardiac filling pressures - central (CVP) and pulmonary-artery-occlusion-pressure (PAOP) - has come into question for guiding hemodynamic therapy due to their poor ability to predict fluid responsiveness in comparison with other monitoring modalities such as transpulmonary thermodilution-derived volumetric measurements, dynamic variables for assessing fluid responsiveness, and the potential risks associated with pulmonary artery catheterization. This contrasts with observations in multiple patient populations showing a clear association between increased CVP and PAOP levels and poor outcomes, probably due to a reduction in effective perfusion pressure (mean arterial pressure minus CVP) and their role as effectiveness parameters of the cardiovascular system. Furthermore, clinical studies have revealed beneficial effects when interpreting CVP and PAOP dynamically and combining them with flow-related hemodynamic variables. Taking into account the additional information derived from bedside CVP and PAOP pulse curve interpretation, cardiac filling pressures remain an important hemodynamic monitoring tool.

4.
Artigo em Inglês | MEDLINE | ID: mdl-31358329

RESUMO

OBJECTIVE: In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS: Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS: The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS: Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.

5.
BMC Cardiovasc Disord ; 19(1): 26, 2019 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-30678657

RESUMO

BACKGROUND: The aim of our study was the identification of genetic variants associated with postoperative complications after cardiac surgery. METHODS: We conducted a prospective, double-blind, multicenter, randomized trial (RIPHeart). We performed a genome-wide association study (GWAS) in 1170 patients of both genders (871 males, 299 females) from the RIPHeart-Study cohort. Patients undergoing non-emergent cardiac surgery were included. Primary endpoint comprises a binary composite complication rate covering atrial fibrillation, delirium, non-fatal myocardial infarction, acute renal failure and/or any new stroke until hospital discharge with a maximum of fourteen days after surgery. RESULTS: A total of 547,644 genotyped markers were available for analysis. Following quality control and adjustment for clinical covariate, one SNP reached genome-wide significance (PHLPP2, rs78064607, p = 3.77 × 10- 8) and 139 (adjusted for all other outcomes) SNPs showed promising association with p < 1 × 10- 5 from the GWAS. CONCLUSIONS: We identified several potential loci, in particular PHLPP2, BBS9, RyR2, DUSP4 and HSPA8, associated with new-onset of atrial fibrillation, delirium, myocardial infarction, acute kidney injury and stroke after cardiac surgery. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov NCT01067703, prospectively registered on 11 Feb 2010.


Assuntos
Lesão Renal Aguda/genética , Fibrilação Atrial/genética , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Delírio/genética , Infarto do Miocárdio/genética , Polimorfismo de Nucleotídeo Único , Acidente Vascular Cerebral/genética , Lesão Renal Aguda/diagnóstico , Idoso , Fibrilação Atrial/diagnóstico , Proteínas do Citoesqueleto/genética , Delírio/diagnóstico , Fosfatases de Especificidade Dupla/genética , Feminino , Predisposição Genética para Doença , Estudo de Associação Genômica Ampla , Proteínas de Choque Térmico HSC70/genética , Humanos , Masculino , Pessoa de Meia-Idade , Fosfatases da Proteína Quinase Ativada por Mitógeno/genética , Estudos Multicêntricos como Assunto , Infarto do Miocárdio/diagnóstico , Fosfoproteínas Fosfatases/genética , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Canal de Liberação de Cálcio do Receptor de Rianodina/genética , Acidente Vascular Cerebral/diagnóstico , Resultado do Tratamento
7.
Minerva Anestesiol ; 85(3): 263-270, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-29945434

RESUMO

BACKGROUND: In patients with hemodynamic instability echocardiography has been recommended as the preferred modality to evaluate the underlying pathophysiology. However, due to the fact that recent scientific data on the utilization of echocardiography in German Intensive Care Units (ICU) are scarce, we sought to investigate current practice. METHODS: A structured, web-based, anonymized survey was performed from May until July 2015 among members of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) consisting of 14 questions. Descriptive data analysis was performed. RESULTS: One hundred four intensivists participated in the survey. Two-thirds of participants (66%) used echocardiography regularly for hemodynamic monitoring and stated that it changed the therapy in 26-50% of the cases irrespective of the time performed after ordering the examination. Transthoracic (TTE) were more frequently used than transesophageal (TEE) examinations. Twenty-six percent of the participants held an echocardiography certificate with a formal examination, 27% completed a structured training without an examination and almost half of the questioned ICU personnel (47%) did not complete a comprehensive training. CONCLUSIONS: The results of this survey demonstrate a widespread utilization of echocardiography as part of routine diagnostic on frequent number of operative ICUs. However, there might be a lack of structured echocardiographic training especially for anesthesiologists.

8.
Anesth Analg ; 128(2): 265-277, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-29369096

RESUMO

Maintaining brain function and integrity is a pivotal part of anesthesiological practice. The present overview aims to describe the current role of the 2 most frequently used monitoring methods for evaluation brain function in the perioperative period, ie, electroencephalography (EEG) and brain oxygenation monitoring. Available evidence suggests that EEG-derived parameters give additional information about depth of anesthesia for optimizing anesthetic titration. The effects on reduction of drug consumption or recovery time are heterogeneous, but most studies show a reduction of recovery times if anesthesia is titrated along processed EEG. It has been hypothesized that future EEG-derived indices will allow a better understanding of the neurophysiological principles of anesthetic-induced alteration of consciousness instead of the probabilistic approach most often used nowadays.Brain oxygenation can be either measured directly in brain parenchyma via a surgical burr hole, estimated from the venous outflow of the brain via a catheter in the jugular bulb, or assessed noninvasively by near-infrared spectroscopy. The latter method has increasingly been accepted clinically due to its ease of use and increasing evidence that near-infrared spectroscopy-derived cerebral oxygen saturation levels are associated with neurological and/or general perioperative complications and increased mortality. Furthermore, a goal-directed strategy aiming to avoid cerebral desaturations might help to reduce these complications. Recent evidence points out that this technology may additionally be used to assess autoregulation of cerebral blood flow and thereby help to titrate arterial blood pressure to the individual needs and for bedside diagnosis of disturbed autoregulation.


Assuntos
Encéfalo/metabolismo , Circulação Cerebrovascular/fisiologia , Eletroencefalografia/métodos , Monitorização Intraoperatória/métodos , Consumo de Oxigênio/fisiologia , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Encéfalo/irrigação sanguínea , Homeostase/fisiologia , Humanos , Monitorização Fisiológica/métodos , Oximetria/métodos
10.
Eur Heart J Suppl ; 20(Suppl A): A4-A9, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30188961

RESUMO

Landiolol is an intravenous ultra-short acting beta-blocker which has been used in Japan for many years to prevent and/or to treat post-operative atrial fibrillation following cardiac surgery. The drug is now available in Europe. This article is a systematic review of literature regarding the use of landiolol in that specific surgical setting.

12.
Artigo em Alemão | MEDLINE | ID: mdl-29772591

RESUMO

Patients undergoing cardiac surgery are growing older, present with more comorbidities, and are frequently scheduled for more complex and prolonged surgical procedures. Routine application of neurological as well as extended hemodynamic monitoring combined with goal-directed perioperative hemodynamic optimization, targeting optimization of systemic and cerebral oxygen balance, show promise to reduce postoperative complications and to improve mortality in this high risk population. Expert recommendations suggest to avoid synthetic colloids for fluid optimization. Additionally, pathophysiological reasoning and results from recent trials suggest to start inotropic and vasoactive therapy primarily with non-adrenergic drugs like levosimendan and vasopressin and to add classical catecholamines like dobutamine and noradrenalin only if necessary to accomplish hemodynamic goals.


Assuntos
Anestesia/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Hemodinâmica , Monitorização Intraoperatória/métodos , Ecocardiografia Transesofagiana , Humanos , Masculino , Pessoa de Meia-Idade , Medicação Pré-Anestésica
13.
J Am Heart Assoc ; 7(7)2018 03 26.
Artigo em Inglês | MEDLINE | ID: mdl-29581218

RESUMO

BACKGROUND: Remote ischemic preconditioning (RIPC) has been suggested to protect against certain forms of organ injury after cardiac surgery. Previously, we reported the main results of RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study, a multicenter trial randomizing 1403 cardiac surgery patients receiving either RIPC or sham-RIPC. METHODS AND RESULTS: In this follow-up paper, we present 1-year follow-up of the composite primary end point and its individual components (all-cause mortality, myocardial infarction, stroke and acute renal failure), in a sub-group of patients, intraoperative myocardial dysfunction assessed by transesophageal echocardiography and the incidence of postoperative neurocognitive dysfunction 5 to 7 days and 3 months after surgery. RIPC neither showed any beneficial effect on the 1-year composite primary end point (RIPC versus sham-RIPC 16.4% versus 16.9%) and its individual components (all-cause mortality [3.4% versus 2.5%], myocardial infarction [7.0% versus 9.4%], stroke [2.2% versus 3.1%], acute renal failure [7.0% versus 5.7%]) nor improved intraoperative myocardial dysfunction or incidence of postoperative neurocognitive dysfunction 5 to 7 days (67 [47.5%] versus 71 [53.8%] patients) and 3 months after surgery (17 [27.9%] versus 18 [27.7%] patients), respectively. CONCLUSIONS: Similar to our main study, RIPC had no effect on intraoperative myocardial dysfunction, neurocognitive function and long-term outcome in cardiac surgery patients undergoing propofol anesthesia. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01067703.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Cognição , Precondicionamento Isquêmico Miocárdico/métodos , Infarto do Miocárdio/epidemiologia , Traumatismo por Reperfusão Miocárdica/epidemiologia , Transtornos Neurocognitivos/epidemiologia , Anestésicos Intravenosos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/mortalidade , Método Duplo-Cego , Ecocardiografia Transesofagiana , Alemanha/epidemiologia , Humanos , Incidência , Precondicionamento Isquêmico Miocárdico/efeitos adversos , Precondicionamento Isquêmico Miocárdico/mortalidade , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/prevenção & controle , Traumatismo por Reperfusão Miocárdica/diagnóstico por imagem , Traumatismo por Reperfusão Miocárdica/prevenção & controle , Transtornos Neurocognitivos/diagnóstico , Transtornos Neurocognitivos/prevenção & controle , Transtornos Neurocognitivos/psicologia , Testes Neuropsicológicos , Propofol/efeitos adversos , Estudos Prospectivos , Fatores de Proteção , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Can J Anaesth ; 65(7): 766-775, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29484605

RESUMO

PURPOSE: The present study aimed to test the hypothesis that cerebral oxygen saturation (ScO2) measurements with the INVOS-5100-C and the ForeSight-Elite cerebral oximeters vary in their correlation with mixed venous oxygen saturation (SvO2) upon changes in systemic oxygenation in extubated cardiac surgical patients. Additionally, we aimed to elucidate whether the ScO2 measurements of both devices can be used interchangeably to detect reduced SvO2. METHODS: Forty-eight spontaneously breathing patients extubated after cardiac surgery were included in this prospective observational study. The patients were exposed to both high (10 oxygen L·min-1 via face mask) and low (room air) inspiratory oxygen concentrations. Bi-hemispherical ScO2 was determined with the INVOS and ForeSight Elite cerebral oximeters. The SvO2 was measured with a pulmonary artery catheter. RESULTS: Significant changes in oxygen delivery, ScO2 (by both cerebral oximeters), and SvO2 were observed upon variation of oxygenation. The minimum mean (standard deviation) ScO2 (ScO2min) using the INVOS and ForeSight did not differ significantly during high oxygen delivery [63.1 (8.6) % vs 65.8 (4.7) %, respectively; P = 0.07], but during low oxygen delivery, the INVOS value was significantly lower than that of the ForeSight oximeter [56.7 (8.9) % vs 61.3 (4.4) %, respectively; P = 0.003]. Both devices differed in the correlation between ScO2min and SvO2 for the combined oxygenation data (0.59, INVOS vs 0.28, ForeSight; correlation difference, 0.31; Bonferroni-adjusted 95% confidence interval [CI], 0.08 to 0.54; P = 0.008). The receiver-operating curve analysis revealed an area under the curve of 0.83 (95% CI, 0.74 to 0.9; P = 0.005) for detecting an SvO2 below 50% by ScO2min with the INVOS and 0.51 (95% CI, 0.41 to 0.62; P = 0.92), respectively, with the ForeSight. CONCLUSIONS: These findings suggest that the cerebral oximeters tested react differently to variations in systemic oxygenation and in their relationship with SvO2 and thus give different information on cardiopulmonary function. These findings raise doubt about whether these devices should be used interchangeably.


Assuntos
Encéfalo/metabolismo , Oxigênio/metabolismo , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oximetria , Estudos Prospectivos
15.
J Cardiovasc Pharmacol ; 71(1): 1-9, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29076887

RESUMO

Levosimendan is a calcium sensitizer and adenosine triphosphate-dependent potassium channel opener, which exerts sustained hemodynamic, symptomatic, and organ-protective effects. It is registered for the treatment of acute heart failure, and when inotropic support is considered appropriate. In the past 15 years, levosimendan has been widely used in clinical practice and has also been tested in clinical trials to stabilize at-risk patients undergoing cardiac surgery. Recently, 3 randomized, placebo-controlled, multicenter studies (LICORN, CHEETAH, and LEVO-CTS) have been published reporting on the perioperative use of levosimendan in patients with compromised cardiac ventricular function. Taken together, many smaller trials conducted in the past suggested beneficial outcomes with levosimendan in perioperative settings. By contrast, the latest 3 studies were neutral or inconclusive. To understand the reasons for such dissimilarity, a group of experts from Austria, Belgium, Finland, France, Germany, Italy, Switzerland, and Russia, including investigators from the 3 most recent studies, met to discuss the study results in the light of both the previous literature and current clinical practice. Despite the fact that the null hypothesis could not be ruled out in the recent multicenter trials, we conclude that levosimendan can still be viewed as a safe and effective inodilator in cardiac surgery.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Cardiopatias/cirurgia , Assistência Perioperatória/métodos , Simendana/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Tomada de Decisão Clínica , Congressos como Assunto , Consenso , Medicina Baseada em Evidências/métodos , Cardiopatias/diagnóstico , Cardiopatias/fisiopatologia , Humanos , Seleção de Pacientes , Assistência Perioperatória/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Simendana/efeitos adversos , Resultado do Tratamento
16.
Anesthesiology ; 127(6): 918-933, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28872484

RESUMO

BACKGROUND: Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. METHODS: In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24 h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15 ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. RESULTS: The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09 ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. CONCLUSIONS: In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible.


Assuntos
Anestesia Intravenosa , Ponte de Artéria Coronária/tendências , Internacionalidade , Éteres Metílicos/administração & dosagem , Troponina I/sangue , Xenônio/administração & dosagem , Idoso , Anestésicos Inalatórios/administração & dosagem , Biomarcadores/sangue , Ponte de Artéria Coronária/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Sevoflurano , Método Simples-Cego , Resultado do Tratamento
18.
N Engl J Med ; 376(21): 2032-2042, 2017 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-28316276

RESUMO

BACKGROUND: Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. METHODS: In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 µg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 µg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5. RESULTS: A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval [CI], 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups. CONCLUSIONS: Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).


Assuntos
Baixo Débito Cardíaco/tratamento farmacológico , Procedimentos Cirúrgicos Cardíacos , Cardiotônicos/uso terapêutico , Hidrazonas/uso terapêutico , Mortalidade , Piridazinas/uso terapêutico , Disfunção Ventricular Esquerda/tratamento farmacológico , Idoso , Cardiotônicos/efeitos adversos , Método Duplo-Cego , Feminino , Coração Auxiliar/estatística & dados numéricos , Humanos , Hidrazonas/efeitos adversos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Período Perioperatório , Complicações Pós-Operatórias/tratamento farmacológico , Piridazinas/efeitos adversos , Terapia de Substituição Renal/estatística & dados numéricos , Simendana , Volume Sistólico/efeitos dos fármacos , Falha de Tratamento
20.
J Cardiothorac Vasc Anesth ; 31(6): 2042-2048, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28073619

RESUMO

OBJECTIVE: To clarify whether reactivated cytomegalovirus (CMV) infections in critically ill patients lead to worse outcome or just identify more severely ill patients. If CMV has a pathogenic role, latently infected (CMV-seropositive) patients should have worse outcome than seronegative patients because only seropositive patients can experience a CMV reactivation. DESIGN: Post-hoc analysis of a prospective observational study. SETTING: Single university hospital. PARTICIPANTS: The study comprised 983 consecutive patients scheduled for on-pump surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: CMV antibodies were analyzed in preoperative plasma samples. Postoperative adverse events (reintubation, low cardiac output or reinfarction, dialysis, stroke) and 30-day and 1-year mortality were evaluated prospectively. The plasma of reintubated patients and matched control patients was tested for CMV deoxyribonucleic acid, and 618 patients were found to be seropositive for CMV (63%). Among these, the risk for reintubation was increased (10% v 4%, p = 0.001). This increase remained significant after correction for confounding factors (odds ratio 2.70, p = 0.003) and was detectable from the third postoperative day throughout the whole postoperative period. Other outcome parameters were not different. Reintubated seropositive patients were more frequently CMV deoxyribonucleic acid-positive than were matched control patients (40% v 8%, p<0.001). CONCLUSIONS: CMV-seropositive patients had an increased risk of reintubation after cardiac surgery, which was associated with reactivations of their CMV infections. Additional studies should determine whether this complication may be prevented by monitoring of latently infected patients and administering antiviral treatment for reactivated CMV infections.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Infecções por Citomegalovirus/sangue , Infecções por Citomegalovirus/epidemiologia , Citomegalovirus/isolamento & purificação , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/epidemiologia , Idoso , Procedimentos Cirúrgicos Cardíacos/tendências , Infecções por Citomegalovirus/diagnóstico , Feminino , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Valor Preditivo dos Testes , Estudos Prospectivos
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