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3.
J Am Heart Assoc ; 8(22): e012655, 2019 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-31711387

RESUMO

Background Dosing of renin-angiotensin-aldosterone system inhibitors (RAASi) may be modified to manage associated hyperkalemia risk; however, this approach could adversely affect cardiorenal outcomes. This study investigated real-world associations of RAASi dose, hyperkalemia, and adverse clinical outcomes in a large cohort of UK cardiorenal patients. Methods and Results This observational study included RAASi-prescribed patients with new-onset chronic kidney disease (n=100 572) or heart failure (n=13 113) first recorded between January 2006 and December 2015 in Clinical Practice Research Datalink and linked Hospital Episode Statistics databases. Odds ratios associating hyperkalemia and RAASi dose modification were estimated using logistic generalized estimating equations with normal (<5.0 mmol/L) serum potassium level as the reference category. Patients with serum potassium ≥5.0 mmol/L had higher risk of RAASi down-titration (adjusted odds ratios, chronic kidney disease: 1.79 [95% CI, 1.64-1.96]; heart failure: 1.33 [95% CI, 1.08-1.62]). Poisson models were used to estimate adjusted incident rate ratios of adverse outcomes based on total RAASi exposure (<50% and ≥50% of the guideline-recommended RAASi dose). Incidence of major adverse cardiac events and mortality was consistently higher in the lower dose group (adjusted incident rate ratios: chronic kidney disease: 5.60 [95% CI, 5.29-5.93] for mortality and 1.60 [95% CI, 1.55-1.66] for nonfatal major adverse cardiac events; heart failure: 7.34 [95% CI, 6.35-8.48] for mortality and 1.85 [95% CI, 1.71-1.99] for major adverse cardiac events). Conclusions The results of this real-world analysis highlight the potential negative impact of suboptimal RAASi dosing and the need for strategies that allow patients to be maintained on appropriate therapy, avoiding RAASi dose modification or discontinuation.

4.
PLoS One ; 14(11): e0224582, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31675367

RESUMO

BACKGROUND: Atrial fibrillation (AF) is the most common sustained heart arrhythmia. However, as many cases are asymptomatic, a large proportion of patients remain undiagnosed until serious complications arise. Efficient, cost-effective detection of the undiagnosed may be supported by risk-prediction models relating patient factors to AF risk. However, there exists a need for an implementable risk model that is contemporaneous and informed by routinely collected patient data, reflecting the real-world pathology of AF. METHODS: This study sought to develop and evaluate novel and conventional statistical and machine learning models for risk-predication of AF. This was a retrospective, cohort study of adults (aged ≥30 years) without a history of AF, listed on the Clinical Practice Research Datalink, from January 2006 to December 2016. Models evaluated included published risk models (Framingham, ARIC, CHARGE-AF), machine learning models, which evaluated baseline and time-updated information (neural network, LASSO, random forests, support vector machines), and Cox regression. RESULTS: Analysis of 2,994,837 individuals (3.2% AF) identified time-varying neural networks as the optimal model achieving an AUROC of 0.827 vs. 0.725, with number needed to screen of 9 vs. 13 patients at 75% sensitivity, when compared with the best existing model CHARGE-AF. The optimal model confirmed known baseline risk factors (age, previous cardiovascular disease, antihypertensive medication usage) and identified additional time-varying predictors (proximity of cardiovascular events, body mass index (both levels and changes), pulse pressure, and the frequency of blood pressure measurements). CONCLUSION: The optimal time-varying machine learning model exhibited greater predictive performance than existing AF risk models and reflected known and new patient risk factors for AF.

5.
BMC Cardiovasc Disord ; 19(1): 165, 2019 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-31299906

RESUMO

BACKGROUND: Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018. METHODS: ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years. RESULTS: Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA2DS2-VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label. CONCLUSION: Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label. TRIAL REGISTRATION: NCT02944019; Date of registration: October 24, 2016.

6.
Cochrane Database Syst Rev ; 4: CD005351, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30950507

RESUMO

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been used to treat respiratory distress due to acute cardiogenic pulmonary oedema (ACPE). We performed a systematic review and meta-analysis update on NPPV for adults presenting with ACPE. OBJECTIVES: To evaluate the safety and effectiveness of NPPV compared to standard medical care (SMC) for adults with ACPE. The primary outcome was hospital mortality. Important secondary outcomes were endotracheal intubation, treatment intolerance, hospital and intensive care unit length of stay, rates of acute myocardial infarction, and adverse event rates. SEARCH METHODS: We searched CENTRAL (CRS Web, 20 September 2018), MEDLINE (Ovid, 1946 to 19 September 2018), Embase (Ovid, 1974 to 19 September 2018), CINAHL Plus (EBSCO, 1937 to 19 September 2018), LILACS, WHO ICTRP, and clinicaltrials.gov. We also reviewed reference lists of included studies. We applied no language restrictions. SELECTION CRITERIA: We included blinded or unblinded randomised controlled trials in adults with ACPE. Participants had to be randomised to NPPV (continuous positive airway pressure (CPAP) or bilevel NPPV) plus standard medical care (SMC) compared with SMC alone. DATA COLLECTION AND ANALYSIS: Two review authors independently screened and selected articles for inclusion. We extracted data with a standardised data collection form. We evaluated the risks of bias of each study using the Cochrane 'Risk of bias' tool. We assessed evidence quality for each outcome using the GRADE recommendations. MAIN RESULTS: We included 24 studies (2664 participants) of adult participants (older than 18 years of age) with respiratory distress due to ACPE, not requiring immediate mechanical ventilation. People with ACPE presented either to an Emergency Department or were inpatients. ACPE treatment was provided in an intensive care or Emergency Department setting. There was a median follow-up of 13 days for hospital mortality, one day for endotracheal intubation, and three days for acute myocardial infarction. Compared with SMC, NPPV may reduce hospital mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.51 to 0.82; participants = 2484; studies = 21; I2 = 6%; low quality of evidence) with a number needed to treat for an additional beneficial outcome (NNTB) of 17 (NNTB 12 to 32). NPPV probably reduces endotracheal intubation rates (RR 0.49, 95% CI 0.38 to 0.62; participants = 2449; studies = 20; I2 = 0%; moderate quality of evidence) with a NNTB of 13 (NNTB 11 to 18). There is probably little or no difference in acute myocardial infarction (AMI) incidence with NPPV compared to SMC for ACPE (RR 1.03, 95% CI 0.91 to 1.16; participants = 1313; studies = 5; I2 = 0%; moderate quality of evidence). We are uncertain as to whether NPPV increases hospital length of stay (mean difference (MD) -0.31 days, 95% CI -1.23 to 0.61; participants = 1714; studies = 11; I2 = 55%; very low quality of evidence). Adverse events were generally similar between NPPV and SMC groups, but evidence was of low quality. AUTHORS' CONCLUSIONS: Our review provides support for continued clinical application of NPPV for ACPE, to improve outcomes such as hospital mortality and intubation rates. NPPV is a safe intervention with similar adverse event rates to SMC alone. Additional research is needed to determine if specific subgroups of people with ACPE have greater benefit of NPPV compared to SMC. Future research should explore the benefit of NPPV for ACPE patients with hypercapnia.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Mortalidade Hospitalar , Edema Pulmonar/terapia , Adulto , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Humanos , Unidades de Terapia Intensiva , Intubação Intratraqueal/estatística & dados numéricos , Tempo de Internação , Ventilação não Invasiva , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
BMC Nephrol ; 20(1): 31, 2019 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-30704421

RESUMO

BACKGROUND: People with chronic kidney disease (CKD) are at an increased risk of developing hyperkalaemia due to their declining kidney function. In addition, these patients are often required to reduce or discontinue guideline-recommended renin-angiotensin-aldosterone system inhibitor (RAASi) therapy due to increased risk of hyperkalaemia. This original research developed a model to quantify the health and economic benefits of maintaining normokalaemia and enabling optimal RAASi therapy in patients with CKD. METHODS: A patient-level simulation model was designed to fully characterise the natural history of CKD over a lifetime horizon, and predict the associations between serum potassium levels, RAASi use and long-term outcomes based on published literature. The clinical and economic benefits of maintaining sustained potassium levels and therefore avoiding RAASi discontinuation in CKD patients were demonstrated using illustrative, sensitivity and scenario analyses. RESULTS: Internal and external validation exercises confirmed the predictive capability of the model. Sustained potassium management and ongoing RAASi therapy were associated with longer life expectancy (+ 2.36 years), delayed onset of end stage renal disease (+ 5.4 years), quality-adjusted life-year gains (+ 1.02 QALYs), cost savings (£3135) and associated net monetary benefit (£23,446 at £20,000 per QALY gained) compared to an absence of RAASi to prevent hyperkalaemia. CONCLUSION: This model represents a novel approach to predicting the long-term benefits of maintaining normokalaemia and enabling optimal RAASi therapy in patients with CKD, irrespective of the strategy used to achieve this target, which may support decision making in healthcare.

8.
ESC Heart Fail ; 6(2): 280-290, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30629342

RESUMO

AIMS: At present, the clinical burden of hypokalaemia and hyperkalaemia among European heart failure patients, and relationships between serum potassium and adverse clinical outcomes in this population, is not well characterized. The aim of this study was to investigate associations between mortality, major adverse cardiac events, and renin-angiotensin-aldosterone system inhibitor (RAASi) discontinuation across serum potassium levels, in a UK cohort of incident heart failure patients. METHODS AND RESULTS: This was a retrospective observational cohort study of newly diagnosed heart failure patients listed in the Clinical Practice Research Datalink, with a first record of heart failure (index date) between 2006 and 2015. Hypokalaemia and hyperkalaemia episodes were defined as the number of serum potassium measurements exceeding each threshold (<3.5, ≥5.0, ≥5.5, and ≥6.0 mmol/L), without such a measurement in the preceding 7 days. Risk equations developed using Poisson generalized estimating equations were utilized to estimate adjusted incident rate ratios (IRRs) relating serum potassium and clinical outcomes (death, major adverse cardiac event, and RAASi discontinuation). Among 21,334 eligible heart failure patients, 1969 (9.2%), 7648 (35.9%), 2725 (12.8%), and 763 (3.6%) experienced episodes of serum potassium <3.5, ≥5.0, ≥5.5, and ≥6.0 mmol/L, respectively. The adjusted IRRs for mortality exhibited a U-shaped association pattern with serum potassium. Relative to the reference category (4.5 to <5.0 mmol/L), adjusted IRRs for mortality were estimated as 1.98 (95% confidence interval: 1.69-2.33), 1.23 (1.12-1.36), 1.35 (1.14-1.60), and 3.02 (2.28-4.02), for patients with serum potassium <3.5, ≥5.0 to <5.5, ≥5.5 to <6.0, and ≥6.0 mmol/L, respectively. The adjusted IRRs for major adverse cardiac events demonstrated a non-statistically significant relationship with serum potassium. Discontinuation of RAASi therapy exhibited a J-shaped trend in association with serum potassium. Compared with the reference category (4.5 to <5.0 mmol/L), adjusted IRRs were estimated as 1.07 (0.89-1.28) in patients with serum potassium <3.5 mmol/L, increasing to 1.32 (1.14-1.53) and 2.19 (1.63-2.95) among those with serum potassium ≥5.5 to <6.0 and ≥6.0 mmol/L, respectively. CONCLUSIONS: In UK patients with new onset heart failure, both hypokalaemia and hyperkalaemia were associated with increased mortality risk, and hyperkalaemia was associated with increased likelihood of RAASi discontinuation. Our results demonstrate the potential importance of serum potassium monitoring for heart failure outcomes and management.


Assuntos
Insuficiência Cardíaca/sangue , Hiperpotassemia/sangue , Hipopotassemia/sangue , Potássio/sangue , Medição de Risco , Idoso , Antagonistas de Receptores de Angiotensina/uso terapêutico , Biomarcadores/sangue , Feminino , Seguimentos , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Hiperpotassemia/epidemiologia , Hiperpotassemia/etiologia , Hipopotassemia/epidemiologia , Hipopotassemia/etiologia , Incidência , Masculino , Prognóstico , Sistema Renina-Angiotensina/fisiologia , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Reino Unido/epidemiologia
9.
J Cardiovasc Med (Hagerstown) ; 20(2): 97-104, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30540648

RESUMO

AIM: Edoxaban, a nonvitamin K antagonist oral anticoagulant, is an oral factor Xa inhibitor approved for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation and for the treatment and secondary prevention in adult patients with venous thromboembolism (VTE). This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study - a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. METHODS: The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). Patients treated with edoxaban were prospectively enrolled and will be followed up for 4 years with yearly follow-up visits. ASSESSMENTS: The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality. In addition, efficacy will be assessed by recording major adverse cardiovascular events including stroke, systemic embolic events, transient ischemic attacks, and also VTE episodes, acute coronary syndromes, and hospitalizations related to cardiovascular condition. Event rates will be compared with event rates reported in the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation in atrial fibrillation (PREFER in AF) and PREFER in AF Prolongation registries, and in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation - Thrombolysis in Myocardial Infarction 48 study datasets.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Piridinas/administração & dosagem , Projetos de Pesquisa , Acidente Vascular Cerebral/prevenção & controle , Tiazóis/administração & dosagem , Administração Oral , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Europa (Continente)/epidemiologia , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Estudos Prospectivos , Piridinas/efeitos adversos , Sistema de Registros , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
10.
J Med Econ ; 21(12): 1172-1182, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30160541

RESUMO

AIMS: Patients with heart failure are at increased risk of hyperkalemia, particularly when treated with renin-angiotensin-aldosterone system inhibitor (RAASi) agents. This study developed a model to quantify the potential health and economic value associated with sustained potassium management and optimal RAASi therapy in heart failure patients. MATERIALS AND METHODS: A patient-level, fixed-time increment stochastic simulation model was designed to characterize the progression of heart failure through New York Heart Association functional classes, and predict associations between serum potassium levels, RAASi use, and consequent long-term outcomes. Following internal and external validation exercises, model analyses sought to quantify the health and economic benefits of optimizing both serum potassium levels and RAASi therapy in heart failure patients. Analyses were conducted using a UK payer perspective, independent of costs and utilities related to pharmacological potassium management. RESULTS: Validation against multiple datasets demonstrated the predictive capability of the model. Compared to those who discontinued RAASi to manage serum potassium, patients with normokalemia and ongoing RAASi therapy benefited from longer life expectancy (+1.38 years), per-patient quality-adjusted life year gains (+0.53 QALYs), cost savings (£110), and associated net monetary benefit (£10,679 at £20,000 per QALY gained) over a lifetime horizon. The predicted value of sustained potassium management and ongoing RAASi treatment was largely driven by reduced mortality and hospitalization risks associated with optimal RAASi therapy. LIMITATIONS: Several modeling assumptions were made to account for a current paucity of published literature; however, ongoing refinement and validation of the model will ensure its continued accuracy as the clinical landscape of hyperkalemia evolves. CONCLUSIONS: Predictions generated by this novel modeling approach highlight the value of sustained potassium management to avoid hyperkalemia, enable RAASi therapy, and improve long-term health economic outcomes in patients with heart failure.


Assuntos
Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Insuficiência Cardíaca/tratamento farmacológico , Hiperpotassemia/induzido quimicamente , Hiperpotassemia/economia , Potássio/sangue , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Análise Custo-Benefício , Progressão da Doença , Gastos em Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Hiperpotassemia/mortalidade , Hiperpotassemia/prevenção & controle , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Tempo
11.
BMC Nephrol ; 19(1): 211, 2018 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-30134846

RESUMO

BACKGROUND: To address a current paucity of European data, this study developed equations to predict risks of mortality, major adverse cardiac events (MACE) and renin angiotensin-aldosterone system inhibitor (RAASi) discontinuation using time-varying serum potassium and other covariates, in a UK cohort of chronic kidney disease (CKD) patients. METHODS: This was a retrospective observational study of adult CKD patients listed on the Clinical Practice Research Datalink, with a first record of CKD (stage 3a-5, pre-dialysis) between 2006 and 2015. Patients with heart failure at index were excluded. Risk equations developed using Poisson Generalized Estimating Equations were utilised to estimate adjusted incident rate ratios (IRRs) between serum potassium and adverse outcomes, and identify other predictive clinical factors. RESULTS: Among 191,964 eligible CKD patients, 86,691 (45.16%), 30,629 (15.96%) and 9440 (4.92%) experienced at least one hyperkalaemia episode, when defined using serum potassium concentrations 5.0-< 5.5 mmol/L, 5.5-< 6.0 mmol/L and ≥ 6.0 mmol/L, respectively. Relative to the reference category (4.5 to < 5.0 mmol/L), adjusted IRRs for mortality and MACE exhibited U-shaped associations with serum potassium, with age being the most important predictor of both outcomes (P < 0.0001). A J-shaped association between serum potassium and RAASi discontinuation was observed; estimated glomerular filtration rate was most predictive of RAASi discontinuation (P < 0.0001). CONCLUSIONS: Hyperkalaemia was associated with increased mortality and RAASi discontinuation risk. These risk equations represent a valuable tool to predict clinical outcomes among CKD patients; and identify those likely to benefit from strategies that treat hyperkalaemia, prevent RAASi discontinuation, and effectively manage serum potassium levels.


Assuntos
Pesquisa Biomédica , Bases de Dados Factuais , Hiperpotassemia/sangue , Potássio/sangue , Insuficiência Renal Crônica/sangue , Idoso , Idoso de 80 Anos ou mais , Pesquisa Biomédica/tendências , Bases de Dados Factuais/tendências , Feminino , Seguimentos , Humanos , Hiperpotassemia/diagnóstico , Hiperpotassemia/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologia , Estudos Retrospectivos , Reino Unido/epidemiologia
12.
J Med Econ ; 21(6): 616-621, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29557218

RESUMO

OBJECTIVES: The effects of acute coronary syndrome (ACS) events on health-related quality-of-life (HRQoL) and the time dependency of these effects are unknown. This study aimed to characterize health utilities in ACS patients to aid development of future economic models estimating the cost per quality-adjusted life-year impact of ACS events and potential treatments. METHODS: Multi-center, non-interventional, longitudinal evaluation of health utility in patients experiencing ACS or stroke events. EuroQol-5 dimension 3 level (EQ-5D-3L) surveys were sent to patients (≥18 years) from three UK centers, 1 month after hospital discharge for myocardial infarction (MI), unstable angina (UA), or stroke. Patient demographics, lifestyle, and baseline utility score were collected in the first survey. Follow-up surveys were sent at 6, 12, 18, and 24 months to prospectively capture utility and subsequent health events. Two methods of patient identification were adopted-prospective, where the patient's qualifying events occurred after the study index date, and retrospective, where the patient's qualifying event occurred prior to the study index date. General healthy population utility values were assumed for pre-event HRQoL. RESULTS: Between January 2011 and March 2014, 2,103 prospectively (n = 1,350)/retrospectively (n = 753) identified patients (mean age = 68.3 years; 67.9% male) responded: MI = 55.9% (n = 1,176), UA = 42.7% (n = 898), stroke = 1.4% (n = 29); 24% had type 2 diabetes. Post-event utility values were lower than general healthy population values, although significant differences in utility between subsequent 6 (n = 1,031, change = -0.002), 12 (n = 1,096, change = -0.008), 18 (n = 1,246, change = -0.007), and 24 (n = 1,277, change = -0.004) month timepoints were not detected. Through multivariate regression analyses, wheelchair use, current smoking, and secondary mental and joint health events were associated with the greatest statistically significant utility decrements. CONCLUSIONS: This study indicates that health utility decreases following a cardiovascular event and, although some improvement occurs over the subsequent 24 months, general healthy population utility is not necessarily attained.


Assuntos
Síndrome Coronariana Aguda/complicações , Acidente Vascular Cerebral/complicações , Síndrome Coronariana Aguda/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Nível de Saúde , Humanos , Estudos Longitudinais , Masculino , Saúde Mental , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Análise de Regressão , Estudos Retrospectivos , Fumar/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Reino Unido
13.
Open Heart ; 4(1): e000357, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28674615

RESUMO

INTRODUCTION: Evidence suggests that the rate of cardiovascular implantable electronic device (CIED) infections is increasing more rapidly than the rates of CIED implantation and is associated with considerable mortality, morbidity and health economic impact. Antimicrobial surface treatments are being developed for CIEDs to reduce the risk of postimplantation infection within the subcutaneous implant pocket. METHODS AND ANALYSIS: The feasibility of processing cardiac pacemakers with the Agluna antimicrobial silver ion surface technology and in vivo biocompatibility were evaluated. Antimicrobially processed (n=6) and control pacemakers (n=6) were implanted into subcutaneous pockets and connected to a part of the sacrospinalis muscle using an ovine model for 12 weeks. Pacemaker function was monitored preimplantation and postimplantation. RESULTS: Neither local infection nor systemic toxicity were detected in antimicrobial or control devices, and surrounding tissues showed no abnormal pathology or over-reactivity. Semiquantitative scores of membrane formation, cellular orientation and vascularity were applied over five regions of the pacemaker capsule and average scores compared. Results showed no significant difference between antimicrobially processed and control pacemakers. Silver analysis of whole blood at 7 days found that levels were a maximum of 10 parts per billion (ppb) for one sample, more typically ≤2 ppb, compared with <<2 ppb for preimplantation levels, well below reported toxic levels. CONCLUSIONS: There was no evidence of adverse or abnormal pathology in tissue surrounding antimicrobially processed pacemakers, or deleterious effect on basic pacing capabilities and parameters at 12 weeks. This proof of concept study provides evidence of basic biocompatibility and feasibility of applying this silver ion-based antimicrobial surface to a titanium pacemaker surface.

14.
Ann Noninvasive Electrocardiol ; 21(6): 588-594, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27778457

RESUMO

BACKGROUND: Electrocardiogram (ECG) variability is greatly affected by the ECG recording method. This study aims to compare Holter and standard ECG recording methods in terms of central locations and variations of ECG data. METHODS: We used the ECG data from a double-blinded, placebo-controlled, randomized clinical trial and used a mixed model approach to assess the agreement between two methods in central locations and variations of eight ECG parameters (Heart Rate, PR, QRS, QT, RR, QTcB, QTcF, and QTcI intervals). RESULTS: A total of 34 heathy male subjects with mean age of 25.7 ± 4.78 years were randomized to receive either active drug or placebo. Digital 12-lead ECG and digital 12-lead Holter ECG recordings were performed to assess ECG variability. There are no significant differences in least square mean between the Holter and the standard method for all ECG parameters. The total variance is consistently higher for the Holter method than the standard method for all ECG parameters except for QRS. The intraclass correlation coefficient (ICC) values for the Holter method are consistently lower than those for the standard method for all ECG parameters except for QRS, in particular, the ICC for QTcF is reduced from 0.86 for the standard method to 0.67 for the Holter method. CONCLUSIONS: This study suggests that Holter ECGs recorded in a controlled environment are not significantly different but more variable than those from the standard method.


Assuntos
Benzimidazóis/farmacologia , Compostos Bicíclicos com Pontes/farmacologia , Eletrocardiografia/métodos , Adulto , Método Duplo-Cego , Eletrocardiografia Ambulatorial , Voluntários Saudáveis , Humanos , Masculino
15.
Eur Heart J Qual Care Clin Outcomes ; 2(4): 299-305, 2016 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-29474715

RESUMO

Aims: Atrial fibrillation (AF) is a common condition that is a major cause of stroke. A significant proportion of patients with AF are not classically symptomatic at diagnosis or soon after diagnosis. There is little information comparing their characteristics, treatment, and outcomes of patients with symptoms, which predominate in clinical trials to those without. Methods and results: We analysed data from the Prevention of Thromboembolic Events-European Registry in Atrial Fibrillation. This was a prospective, real-world registry with a 12-month follow-up that included AF patients aged 18 years and over. Patients were divided into those with and without AF symptoms using the European Heart Rhythm Association (EHRA) score (Category I vs. Categories II-IV). Of the 6196 patients (mean age 72 years) with EHRA scores available, 501 (8.1%) were asymptomatic. A lower proportion of asymptomatic patients was female (22.8 vs. 41.2%), with less noted to have heart failure and coronary artery disease (P < 0.01 for all). There were no differences in terms of the prevalence of diabetes, obesity, or prior stroke. Asymptomatic patients had a lower CHA2DS2-VASc score (2.9 ± 1.7 vs. 3.4 ± 1.8; P < 0.01) and HAS-BLED score (1.8 ± 1.1 vs. 2.1 ± 1.2; P < 0.01). During the 1-year follow-up, adverse events occurred at similar frequencies in asymptomatic and symptomatic patients (1.6 vs. 0.8% for ischaemic stroke; P = 0.061; 1.4 vs. 1.3% for transient ischaemic attack; P = 0.840). Patients with higher CHA2DS2-VASc and HAS-BLED scores experienced more events, independent of symptoms. Antithrombotic therapy was comparable for both groups at baseline and at follow-up. Conclusions: The similar clinical characteristics and frequency of adverse events between asymptomatic and symptomatic AF patients revives the question of whether screening programmes to detect people with asymptomatic AF are worthwhile, particularly in those aged 65 and over potentially likely to have clinical and economic benefits from anticoagulants. This evidence may be informative if clinicians may not be comfortable participating in future clinical trials, leaving asymptomatic patients with AF and high stroke risk without anticoagulation.


Assuntos
Doenças Assintomáticas/epidemiologia , Fibrilação Atrial/diagnóstico , Hemorragia/induzido quimicamente , Ataque Isquêmico Transitório/complicações , Acidente Vascular Cerebral/complicações , Tromboembolia/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/epidemiologia , Eletrocardiografia , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Hemorragia/epidemiologia , Humanos , Ataque Isquêmico Transitório/tratamento farmacológico , Ataque Isquêmico Transitório/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia/complicações , Tromboembolia/etiologia , Resultado do Tratamento
17.
Expert Rev Neurother ; 14(9): 1019-28, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25091395

RESUMO

Patients with atrial fibrillation have an increased risk of ischemic stroke that can be dramatically lowered by treatment with anticoagulants. The annual rate of major bleeds with warfarin averages about 2%. The rates of intracerebral and intracranial bleeds are significantly reduced with the use of the novel direct oral anticoagulants (DOACs) compared with warfarin. Treatment of anticoagulation-related intracerebral hemorrhage is based on the results of case series and small trials. Resumption of anticoagulation in patients with atrial fibrillation who had an intracerebral bleed depends on the etiology and location of the bleeding and the absolute rate of stroke in the absence of anticoagulation.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Hemorragias Intracranianas/tratamento farmacológico , Animais , Humanos
18.
BMC Cardiovasc Disord ; 13: 108, 2013 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-24289181

RESUMO

BACKGROUND: Long-term management of chronic conditions, such as atrial fibrillation (AF), require frequent interactions with the healthcare systems. The multinational EUropean Patient Survey in Atrial Fibrillation (EUPS-AF) was conducted to investigate patient satisfaction with AF management in different of five European healthcare systems at a time of changing treatment paradigms for stroke prophylaxis, prior to the advent of newer oral anticoagulants. METHODS: Adults (>18 years) were recruited at random from the total populations of France, Germany, Italy, Spain and the UK using a randomized telephone dialling system. At least 300 respondents per country reporting to have a diagnosis of AF or receiving oral anticoagulation therapy for suspected AF or to have a heart rhythm disturbance completed a structured telephone interview. RESULTS: Most respondents were satisfied with their treatment for AF over the previous 12 months, with 85.5% (n = 1289) rating their care as good or better. Suboptimal clinical practices, however, were identified in several key areas. Coordination of primary and secondary care and a lack of patient engagement and support were particular issues, especially for those patients likely to have extensive contact with their healthcare system. CONCLUSIONS: In the context of Europe-wide guidelines for management of AF, most patients with AF were satisfied with their care, but for a greater proportion of patients, some aspects are unsatisfactory. Patient-centred surveys, such as the EUPS-AF, are crucial for understanding the factors that contribute to patient satisfaction and compliance with long-term treatment for chronic conditions.


Assuntos
Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Assistência à Saúde/métodos , Participação do Paciente , Satisfação do Paciente , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Coleta de Dados/métodos , Gerenciamento Clínico , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Participação do Paciente/psicologia
19.
Muscles Ligaments Tendons J ; 3(3): 116-7, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24367769

RESUMO

Calculating the sample size is a most important determinant of statistical power of a study. A study with inadequate power, unless being conducted as a safety and feasibility study, is unethical. However, sample size calculation is not an exact science, and therefore it is important to make realistic and well researched assumptions before choosing an appropriate sample size accounting for dropouts and also including a plan for interim analyses during the study to amend the final sample size.

20.
Int J Cardiol ; 170(2): 239-45, 2013 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-24225199

RESUMO

BACKGROUND: We sought to evaluate outcomes, costs of care, quality of life and predictors at 12 months in patients with an acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and evaluated use of optimal secondary prevention therapy, defined as use of aspirin and clopidogrel along with ≥ 3 of the following 4 therapies at both hospital discharge and at one-year post-PCI: statins, beta-blockers, ARB/ACE-inhibitors, and exercise or diet. METHODS: Data were from the prospective, observational APTOR study of 14 European countries from 2007 to 2009 (n=4184 patients). RESULTS: Optimal therapy was received in 43% of patients. Use of optimal therapy varied significantly by country. Diet or exercise at 1 year was more likely prescribed to the optimal cohort (34% vs 16%) as was dual antiplatelet therapy (99% vs 49%). Rates of CV event (3.1% vs 3.5%), bleeding (2.9% vs 2.8%) and mortality (0.9% vs 1.3%) at 1 year were similar between the optimal and non-optimal cohorts, respectively. Total costs were similar for both cohorts, but differences in post-discharge costs were observed (optimal: £1760 [£1682-£1844]; non-optimal: £1492 [£1434-£1554]), primarily due to post-discharge medication and resource use. CONCLUSIONS: In conclusion, in this contemporary, European ACS-PCI registry, optimal therapy was low (<50%) overall, particularly for diet or exercise and dual antiplatelet therapy, highlighting a considerable gap between evidence-based guidelines and implementation of such treatments. Whether this gap reflects a missed opportunity to improve patient outcomes or whether it reflects appropriate deviation from guidelines by front-line clinicians requires further investigation.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/economia , Custos de Cuidados de Saúde , Inibidores da Agregação de Plaquetas/economia , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária/economia , Síndrome Coronariana Aguda/prevenção & controle , Antagonistas Adrenérgicos beta/economia , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Aspirina/economia , Aspirina/uso terapêutico , Clopidogrel , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/economia , Valor Preditivo dos Testes , Estudos Prospectivos , Qualidade de Vida , Sistema de Registros , Stents/economia , Ticlopidina/análogos & derivados , Ticlopidina/economia , Ticlopidina/uso terapêutico , Resultado do Tratamento
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