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BACKGROUND: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of 'watchful waiting'. METHODS: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. RESULTS: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. CONCLUSIONS: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Calidad de Vida , Humanos , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Enfermedades Asintomáticas , Índice de Severidad de la Enfermedad , Análisis Costo-Beneficio , Válvula Aórtica/cirugía , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , FemeninoRESUMEN
BACKGROUND: In previous analyses, myocardial injury after noncardiac surgery, major bleeding, and sepsis were independently associated with most deaths in the 30 days after noncardiac surgery, but most of these deaths occurred during the index hospitalization for surgery. The authors set out to describe outcomes after discharge from hospital up to 1 yr after inpatient noncardiac surgery and associations between predischarge complications and postdischarge death up to 1 yr after surgery. METHODS: This study was an analysis of patients discharged after inpatient noncardiac surgery in a large international prospective cohort study across 28 centers from 2007 to 2013 of patients aged 45 yr or older followed to 1 yr after surgery. The study estimated (1) the cumulative postdischarge incidence of death and other outcomes up to a year after surgery and (2) the adjusted time-varying associations between postdischarge death and predischarge complications including myocardial injury after noncardiac surgery, major bleeding, sepsis, infection without sepsis, stroke, congestive heart failure, clinically important atrial fibrillation or flutter, amputation, venous thromboembolism, and acute kidney injury managed with dialysis. RESULTS: Among 38,898 patients discharged after surgery, the cumulative 1-yr incidence was 5.8% (95% CI, 5.5 to 6.0%) for all-cause death and 24.7% (95% CI, 24.2 to 25.1%) for all-cause hospital readmission. Predischarge complications were associated with 33.7% (95% CI, 27.2 to 40.2%) of deaths up to 30 days after discharge and 15.0% (95% CI, 12.0 to 17.9%) up to 1 yr. Most of the association with death was due to myocardial injury after noncardiac surgery (15.6% [95% CI, 9.3 to 21.9%] of deaths within 30 days, 6.4% [95% CI, 4.1 to 8.7%] within 1 yr), major bleeding (15.0% [95% CI, 8.3 to 21.7%] within 30 days, 4.7% [95% CI, 2.2 to 7.2%] within 1 yr), and sepsis (5.4% [95% CI, 2.2 to 8.6%] within 30 days, 2.1% [95% CI, 1.0 to 3.1%] within 1 yr). CONCLUSIONS: One in 18 patients 45 yr old or older discharged after inpatient noncardiac surgery died within 1 yr, and one quarter were readmitted to the hospital. The risk of death associated with predischarge perioperative complications persists for weeks to months after discharge.
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Alta del Paciente , Sepsis , Humanos , Estudios Prospectivos , Cuidados Posteriores , Hemorragia , Complicaciones Posoperatorias/epidemiología , Factores de RiesgoRESUMEN
OBJECTIVES: To assess the frequency of clinical cardiovascular outcomes for people hospitalised with coronavirus disease 2019 (COVID-19), and the impact of vaccination. STUDY DESIGN: Observational cohort study. SETTING, PARTICIPANTS: All index admissions of adults with laboratory-confirmed COVID-19 to 21 hospitals participating in the Australian Cardiovascular COVID-19 Registry (AUS-COVID), 4 September 2020 - 11 July 2022. MAIN OUTCOME MEASURES: Frequency of elevated troponin levels, new arrhythmia, new or deteriorating heart failure or cardiomyopathy, new pericarditis or myocarditis, new permanent pacemaker or implantable cardioverter-defibrillator, and pulmonary embolism. SECONDARY OUTCOMES: impact of COVID-19 vaccination on likelihood of in-hospital death, intubation, troponin elevation, and clinical cardiovascular events. RESULTS: The mean age of the 1714 people admitted to hospital with COVID-19 was 60.1 years (standard deviation, 20.6 years); 926 were men (54.0%), 181 patients died during their index admissions (10.6%), 299 required intensive care (17.4%). Thirty-eight patients (2.6%) developed new atrial fibrillation or flutter, 27 (2.6%) had pulmonary embolisms, new heart failure or cardiomyopathy was identified in 13 (0.9%), and pre-existing cardiomyopathy or heart failure was exacerbated in 21 of 110 patients (19%). Troponin was elevated in 369 of the 986 patients for whom it was assessed (37.4%); in-hospital mortality was higher for people with elevated troponin levels (86, 23% v 23, 3.7%; P < 0.001). The COVID-19 vaccination status of 580 patients was known (no doses, 232; at least one dose, 348). The likelihood of in-hospital death (adjusted odds ratio [aOR], 0.38; 95% confidence interval [CI], 0.18-0.79) and intubation (aOR, 0.30; 95% CI, 0.15-0.61) were lower for people who had received at least one vaccine dose, but not the likelihood of troponin elevation (aOR, 1.44; 95% CI, 0.80-2.58) or clinical cardiovascular events (aOR, 1.56; 95% CI, 0.59-4.16). CONCLUSIONS: Although troponin levels were elevated in a considerable proportion of people hospitalised with COVID-19, clinical cardiovascular events were infrequent, and their likelihood was not influenced by vaccination. COVID-19 vaccination, however, was associated with reduced likelihood of in-hospital death and intubation. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12620000486921 (prospective).
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Vacunas contra la COVID-19 , COVID-19 , Enfermedades Cardiovasculares , Hospitalización , Humanos , COVID-19/mortalidad , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/complicaciones , Masculino , Femenino , Persona de Mediana Edad , Anciano , Hospitalización/estadística & datos numéricos , Australia/epidemiología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/epidemiología , Mortalidad Hospitalaria , Adulto , Estudios de Cohortes , Vacunación/estadística & datos numéricos , SARS-CoV-2 , Troponina/sangre , Sistema de RegistrosRESUMEN
PURPOSE: Ultra-processed food (UPF) intake has increased in recent decades, yet limited knowledge of long-term effects on cardiovascular health persists and sex-specific data is scant. We determined the association of UPF intake with incident cardiovascular disease (CVD) and/or hypertension in a population-based cohort of women. METHODS: In the Australian Longitudinal Study on Women's Health, women aged 50-55 years were prospectively followed (2001-2016). UPFs were identified using NOVA classification and contribution of these foods to total dietary intake by weight was estimated. Primary endpoint was incident CVD (self-reported heart disease/stroke). Secondary endpoints were self-reported hypertension, all-cause mortality, type 2 diabetes mellitus, and/or obesity. Logistic regression models assessed associations between UPF intake and incident CVD, adjusting for socio-demographic, medical comorbidities, and dietary variables. RESULTS: We included 10,006 women (mean age 52.5 ± 1.5; mean UPF intake 26.6 ± 10.2% of total dietary intake), with 1038 (10.8%) incident CVD, 471 (4.7%) deaths, and 4204 (43.8%) hypertension cases over 15 years of follow-up. In multivariable-adjusted models, the highest [mean 42.0% total dietary intake] versus the lowest [mean 14.2% total dietary intake] quintile of UPF intake was associated with higher incident hypertension [odds ratio (OR) 1.39, 95% confidence interval (CI) 1.10-1.74; p = 0.005] with a linear trend (ptrend = 0.02), but not incident CVD [OR 1.22, 95% CI 0.92-1.61; p = 0.16] or all-cause mortality (OR 0.80, 95% CI 0.54-1.20; p = 0.28). Similar results were found after multiple imputations for missing values. CONCLUSION: In women, higher UPF intake was associated with increased hypertension, but not incident CVD. These findings may support minimising UPFs within a healthy diet for women.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Hipertensión , Persona de Mediana Edad , Masculino , Humanos , Femenino , Enfermedades Cardiovasculares/epidemiología , Estudios Longitudinales , Alimentos Procesados , Australia/epidemiología , Dieta , Hipertensión/epidemiología , Manipulación de Alimentos , Comida Rápida/efectos adversosRESUMEN
INTRODUCTION: The 2023 Australian guideline for assessing and managing cardiovascular disease risk provides updated evidence-based recommendations for the clinical assessment and management of cardiovascular disease (CVD) risk for primary prevention. It includes the new Australian CVD risk calculator (Aus CVD Risk Calculator), based on an equation developed from a large New Zealand cohort study, customised and recalibrated for the Australian population. The new guideline replaces the 2012 guideline that recommended CVD risk assessment using the Framingham risk equation. MAIN RECOMMENDATIONS: The new guideline recommends CVD risk assessment in people without known CVD: all people aged 45-79 years, people with diabetes from 35 years, and First Nations people from 30 years. The new Aus CVD Risk Calculator should be used to estimate and categorise CVD risk into low (< 5% risk over five years), intermediate (5% to < 10% risk over five years) or high risk (≥ 10% over five years). The following reclassification factors may be applied to recategorise calculated risk to improve accuracy of risk prediction, particularly in individuals close to a risk threshold: Indigenous status/ethnicity, estimated glomerular filtration rate, urine albumin to creatinine ratio measurements, severe mental illness, coronary artery calcium score and family history of premature CVD. A variety of communication formats is available to communicate CVD risk to help enable shared decision making. Healthy lifestyle modification, including smoking cessation, nutrition, physical activity and limiting alcohol, is encouraged for all individuals. Blood pressure-lowering and lipid-modifying pharmacotherapies should be prescribed for high risk and considered for intermediate risk individuals, unless contraindicated or clinically inappropriate. Reassessment of CVD risk should be considered within five years for individuals at low risk and within two years for those with intermediate risk. Reassessment of CVD risk is not recommended for individuals at high risk. CHANGES IN ASSESSMENT AND MANAGEMENT AS A RESULT OF THE GUIDELINE: The updated guideline recommends assessment over a broader age range and uses the Aus CVD Risk Calculator, which replaces the previous Framingham-based equation. It incorporates new variables: social disadvantage, diabetes-specific risk markers, diagnosis of atrial fibrillation and use of blood pressure-lowering and lipid-modifying therapies. Reclassification factors are also a new addition. Updated risk categories and thresholds are based on the new Aus CVD Risk Calculator. The proportion of the population in the high risk category (≥ 10% over five years) is likely to be broadly comparable to more than 15% risk from the Framingham-based equation. The full guideline and Aus CVD Risk Calculator can be accessed at www.cvdcheck.org.au.
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Enfermedades Cardiovasculares , Humanos , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/terapia , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Australia , Medición de Riesgo/métodos , Persona de Mediana Edad , Anciano , Femenino , Masculino , Factores de Riesgo de Enfermedad Cardiaca , Guías de Práctica Clínica como Asunto , Prevención Primaria , AdultoRESUMEN
BACKGROUND: Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater chance of suffering a recurrent cardiovascular event than people without known CVDs. Although drug interventions have been shown to be cost-effective in reducing the risk of recurrent cardiovascular events, adherence to medication remains suboptimal. As a scalable and cost-effective approach, mobile phone text messaging presents an opportunity to convey health information, deliver electronic reminders, and encourage behaviour change. However, it is uncertain whether text messaging can improve medication adherence and clinical outcomes. This is an update of a Cochrane review published in 2017. OBJECTIVES: To evaluate the benefits and harms of mobile phone text messaging for improving medication adherence in people with CVDs compared to usual care. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We also checked the reference lists of all primary included studies and relevant systematic reviews and meta-analyses. The date of the latest search was 30 August 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim of improving adherence to medication for the secondary prevention of cardiovascular events. The comparator was usual care. We excluded cluster-RCTs and quasi-RCTs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were medication adherence, fatal cardiovascular events, non-fatal cardiovascular events, and combined CVD event. Secondary outcomes were low-density lipoprotein cholesterol for the effect of statins, blood pressure for antihypertensive drugs, heart rate for the effect of beta-blockers, urinary 11-dehydrothromboxane B2 for the antiplatelet effects of aspirin, adverse effects, and patient-reported experience. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 18 RCTs involving a total of 8136 participants with CVDs. We identified 11 new studies in the review update and seven studies in the previous version of the review. Participants had various CVDs including acute coronary syndrome, coronary heart disease, stroke, myocardial infarction, and angina. All studies were conducted in middle- and high-income countries, with no studies conducted in low-income countries. The mean age of participants was 53 to 64 years. Participants were recruited from hospitals or cardiac rehabilitation facilities. Follow-up ranged from one to 12 months. There was variation in the characteristics of text messages amongst studies (e.g. delivery method, frequency, theoretical grounding, content used, personalisation, and directionality). The content of text messages varied across studies, but generally included medication reminders and healthy lifestyle information such as diet, physical activity, and weight loss. Text messages offered advice, motivation, social support, and health education to promote behaviour changes and regular medication-taking. We assessed risk of bias for all studies as high, as all studies had at least one domain at unclear or high risk of bias. Medication adherence Due to different evaluation score systems and inconsistent definitions applied for the measurement of medication adherence, we did not conduct meta-analysis for medication adherence. Ten out of 18 studies showed a beneficial effect of mobile phone text messaging for medication adherence compared to usual care, whereas the other eight studies showed either a reduction or no difference in medication adherence with text messaging compared to usual care. Overall, the evidence is very uncertain about the effects of mobile phone text messaging for medication adherence when compared to usual care. Fatal cardiovascular events Text messaging may have little to no effect on fatal cardiovascular events compared to usual care (odds ratio 0.83, 95% confidence interval (CI) 0.47 to 1.45; 4 studies, 1654 participants; low-certainty evidence). Non-fatal cardiovascular events We found very low-certainty evidence that text messaging may have little to no effect on non-fatal cardiovascular events. Two studies reported non-fatal cardiovascular events, neither of which found evidence of a difference between groups. Combined CVD events We found very low-certainty evidence that text messaging may have little to no effect on combined CVD events. Only one study reported combined CVD events, and did not find evidence of a difference between groups. Low-density lipoprotein cholesterol Text messaging may have little to no effect on low-density lipoprotein cholesterol compared to usual care (mean difference (MD) -1.79 mg/dL, 95% CI -4.71 to 1.12; 8 studies, 4983 participants; very low-certainty evidence). Blood pressure Text messaging may have little to no effect on systolic blood pressure (MD -0.93 mmHg, 95% CI -3.55 to 1.69; 8 studies, 5173 participants; very low-certainty evidence) and diastolic blood pressure (MD -1.00 mmHg, 95% CI -2.49 to 0.50; 5 studies, 3137 participants; very low-certainty evidence) when compared to usual care. Heart rate Text messaging may have little to no effect on heart rate compared to usual care (MD -0.46 beats per minute, 95% CI -1.74 to 0.82; 4 studies, 2946 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Due to limited evidence, we are uncertain if text messaging reduces medication adherence, fatal and non-fatal cardiovascular events, and combined cardiovascular events in people with cardiovascular diseases when compared to usual care. Furthermore, text messaging may result in little or no effect on low-density lipoprotein cholesterol, blood pressure, and heart rate compared to usual care. The included studies were of low methodological quality, and no studies assessed the effects of text messaging in low-income countries or beyond the 12-month follow-up. Long-term and high-quality randomised trials are needed, particularly in low-income countries.
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Enfermedades Cardiovasculares , Teléfono Celular , Cumplimiento de la Medicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Prevención Secundaria , Envío de Mensajes de Texto , Humanos , Prevención Secundaria/métodos , Enfermedades Cardiovasculares/prevención & control , Sistemas Recordatorios , Sesgo , Persona de Mediana Edad , Accidente Cerebrovascular/prevención & control , Infarto del Miocardio/prevención & controlRESUMEN
BACKGROUND: Women with a history of gestational diabetes (GD) have a high risk of developing diabetes and subsequent cardiovascular disease (CVD). AIM: To assess whether diabetes screening and CVD risk screening occurred in general practice (GP) among postpartum women with GD. METHODS: This is a retrospective study of clinical record data of women with GD, under active GP management, from the MedicineInsight programme, run by Australia's National Prescribing Service MedicineWise, with GP sites located in Australia from January 2015 to March 2021. Documentation of screening for diabetes, assessment of lipids and measurement of blood pressure (BP) was assessed using proportions and mixed-effects logistic regression with a log follow-up time offset. RESULTS: There were 10 413 women, with a mean age of 37.9 years (standard deviation, 7.6), from 406 clinics with a mean follow-up of 4.6 years (interquartile range, 1.8-6.2 years) A total of 29.41% (3062/10 413; 95% confidence interval [CI], 28.53-30.28) had not been assessed for diabetes, 37.40% (3894/10 413; 95% CI, 36.47-38.32) were not assessed for lipids and 2.19% (228/10 413; 95% CI, 1.91-2.47) had no BP documented. In total, 51.82% (5396/10 413; 95% CI, 50.86-52.78) were screened for all three (diabetes + lipids + BP) at least once. Obesity, comorbidities and dyslipidaemia were associated with increased likelihood of screening. New diabetes diagnosis was documented in 5.73% (597/10 413; 95% CI, 5.29-6.18) of the cohort. CONCLUSION: Screening for diabetes and hyperlipidaemia was suboptimal in this high-risk cohort of women with prior GD. Improved messaging that women with a GD diagnosis are at high cardiovascular risk may improve subsequent screening.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Embarazo , Humanos , Femenino , Adulto , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/epidemiología , Diabetes Gestacional/terapia , Estudios Retrospectivos , Diabetes Mellitus Tipo 2/diagnóstico , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Australia/epidemiología , Atención Primaria de Salud , LípidosRESUMEN
BACKGROUND: Single-lead electrocardiogram (ECG) devices may allow detection and diagnosis of cardiac rhythms. However, data on their accuracy for detecting cardiac arrhythmias beyond atrial fibrillation are limited. We aimed to determine the accuracy of the AliveCor KardiaMobile (AC) (AliveCor Inc, Mountain View, CA, USA) for the diagnosis of arrhythmias against gold standard cardiac electrophysiology study (EPS). METHOD: Patients undergoing clinically indicated EPS underwent simultaneous rhythm recording with an AC, standard 12-lead ECG, and EP catheters for intracardiac electrograms. Rhythms recorded during EPS were classified based on electrogram, 12-lead ECG, and clinical findings. Blinded reviewers provided differential diagnoses for the single-lead AC tracings; a separate reviewer compared diagnoses made between the AC tracings and EPS findings. RESULTS: In 49 patients, 843 cardiac rhythms were captured during 502 AC recordings. Analysis of tracings containing sinus rhythm (n=273) returned an overall accuracy of 92%, with sensitivity and specificity values of 93% and 92%, respectively. Accuracy for tracings per rhythm was atrial fibrillation 91% (n=51); supraventricular tachycardia accuracy was 89% (n=191), ventricular tachycardia 91% (n=198), ventricular fibrillation 98% (n=11), and asystole 100% (n=5). Accuracy for supraventricular ectopy was 93% (n=28) and for premature ventricular complexes was 91% (n=86). Overall accuracy was 94% for solitary rhythms and 93% in tracings from patients with baseline bundle branch block. CONCLUSIONS: When compared against the gold standard EPS diagnosis, the interpretation of arrhythmias recorded by an AliveCor single-lead ECG device had reasonable diagnostic accuracy.
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BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among cancer survivors. Mental health is considered an important risk factor affecting the treatment of cardiovascular disease. However, little is known about the use of secondary prevention strategies for CVD in patients with both cancer and CVD. This study aimed to compare the utilisation of primary care chronic disease management plans, mental health care and guideline-indicated cardioprotective medications among CVD patients with and without cancer. METHODS: Retrospective cross-sectional study utilising clinical data of patients with CVD from 50 Australian primary care practices. Outcomes included the use of chronic disease management plans, mental health care, guideline-indicated cardioprotective medications and influenza vaccination. Logistic regression, accounting for demographic and clinical covariates and clustering effects by practices, was used to compare the two groups. RESULTS: Of the 15,040 patients with CVD, 1,486 patients (9.9%) concurrently had cancer. Patients with cancer, compared to those without, were older (77.6 vs 71.8 years, p<0.001), more likely to drink alcohol (62.6% vs 55.7%, p<0.001), have lower systolic (130.3±17.8 vs 132.5±21.1 mmHg, p<0.001) and diastolic (72.2±11 vs 75.3±34 mmHg, p<0.001) blood pressure. Although suboptimal for both groups, patients with cancer were significantly more likely to have general practice management plans (GPMPs) (51.4% vs 43.2%, p<0.001), coordination of team care arrangements (TCAs) (46.2% vs 37.0%, p<0.001), have a review of either GPMP or TCA (42.8% vs 34.7%, p<0.001), have a mental health treatment consultation (15.4% vs 10.5%, p=0.004) and be prescribed blood pressure-lowering medications (70.1% vs 66.0%, p=0.002). However, there were no statistical differences in the prescription of lipid-lowering or antiplatelet medications. After adjustments for covariates and multiple testing, patients with cancer did not show a difference in GPMPs, TCAs, and a review of either, but were more likely to receive mental health treatment consultations than those without cancer (odds ratio 1.76; 95% confidence interval 1.42-2.19). CONCLUSIONS: Less than half of patients with CVD had a GPMP, TCA or review of either. Although those patients with cancer were more likely to receive these interventions, still around half the patients did not. Medicare-funded GPMPs, TCAs and a review of either GPMP or TCA were underutilised, and future studies should seek to identify ways of improving access to these services.
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Enfermedades Cardiovasculares , Neoplasias , Atención Primaria de Salud , Humanos , Estudios Transversales , Masculino , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Femenino , Estudios Retrospectivos , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/epidemiología , Anciano , Enfermedad Crónica , Australia/epidemiología , Servicios de Salud Mental/estadística & datos numéricos , Cardiotónicos/uso terapéutico , Persona de Mediana Edad , Manejo de la EnfermedadRESUMEN
BACKGROUND: TEXTMEDS (Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome) examined the effects of text message-delivered cardiac education and support on medication adherence after an acute coronary syndrome. METHODS: TEXTMEDS was a single-blind, multicenter, randomized controlled trial of patients after acute coronary syndrome. The control group received usual care (secondary prevention as determined by the treating clinician); the intervention group also received multiple motivational and supportive weekly text messages on medications and healthy lifestyle with the opportunity for 2-way communication (text or telephone). The primary end point of self-reported medication adherence was the percentage of patients who were adherent, defined as >80% adherence to each of up to 5 indicated cardioprotective medications, at both 6 and 12 months. RESULTS: A total of 1424 patients (mean age, 58 years [SD, 11]; 79% male) were randomized from 18 Australian public teaching hospitals. There was no significant difference in the primary end point of self-reported medication adherence between the intervention and control groups (relative risk, 0.93 [95% CI, 0.84-1.03]; P=0.15). There was no difference between intervention and control groups at 12 months in adherence to individual medications (aspirin, 96% vs 96%; ß-blocker, 84% vs 84%; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, 77% vs 80%; statin, 95% vs 95%; second antiplatelet, 84% vs 84% [all P>0.05]), systolic blood pressure (130 vs 129 mmâ Hg; P=0.26), low-density lipoprotein cholesterol (2.0 vs 1.9 mmol/L; P=0.34), smoking (P=0.59), or exercising regularly (71% vs 68%; P=0.52). There were small differences in lifestyle risk factors in favor of intervention on body mass index <25 kg/m2 (21% vs 18%; P=0.01), eating ≥5 servings per day of vegetables (9% vs 5%; P=0.03), and eating ≥2 servings per day of fruit (44% vs 39%; P=0.01). CONCLUSIONS: A text message-based program had no effect on medical adherence but small effects on lifestyle risk factors. REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364448; Unique identifier: ANZCTR ACTRN12613000793718.
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Síndrome Coronario Agudo , Envío de Mensajes de Texto , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/prevención & control , Australia , Femenino , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Prevención Secundaria , Método Simple CiegoRESUMEN
Coronary artery disease (CAD) remains the leading cause of adult mortality globally. Targeting known modifiable risk factors has had substantial benefit, but there remains a need for new approaches. Improvements in invasive and noninvasive imaging techniques have enabled an increasing recognition of distinct quantitative phenotypes of coronary atherosclerosis that are prognostically relevant. There are marked differences in plaque phenotype, from the high-risk, lipid-rich, thin-capped atheroma to the low-risk, quiescent, eccentric, nonobstructive calcified plaque. Such distinct phenotypes reflect different pathophysiologic pathways and are associated with different risks for acute ischemic events. Noninvasive coronary imaging techniques, such as computed tomography, positron emission tomography, and coronary magnetic resonance imaging, have major potential to accelerate cardiovascular drug development, which has been affected by the high costs and protracted timelines of cardiovascular outcome trials. This may be achieved through enrichment of high-risk phenotypes with higher event rates or as primary end points of drug efficacy, at least in phase 2 trials, in a manner historically performed through intravascular coronary imaging studies. Herein, we provide a comprehensive review of the current technology available and its application in clinical trials, including implications for sample size requirements, as well as potential limitations. In its effort to accelerate drug development, the US Food and Drug Administration has approved surrogate end points for 120 conditions, but not for CAD. There are robust data showing the beneficial effects of drugs, including statins, on CAD progression and plaque stabilization in a manner that correlates with established clinical end points of mortality and major adverse cardiovascular events. This, together with a clear mechanistic rationale for using imaging as a surrogate CAD end point, makes it timely for CAD imaging end points to be considered. We discuss the importance of global consensus on these imaging end points and protocols and partnership with regulatory bodies to build a more informed, sustainable staged pathway for novel therapies.
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Fármacos Cardiovasculares , Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Estados Unidos , Humanos , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Corazón , Desarrollo de MedicamentosRESUMEN
The technological evolution and widespread availability of wearables and handheld ECG devices capable of screening for atrial fibrillation (AF), and their promotion directly to consumers, has focused attention of health care professionals and patient organizations on consumer-led AF screening. In this Frontiers review, members of the AF-SCREEN International Collaboration provide a critical appraisal of this rapidly evolving field to increase awareness of the complexities and uncertainties surrounding consumer-led AF screening. Although there are numerous commercially available devices directly marketed to consumers for AF monitoring and identification of unrecognized AF, health care professional-led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AF have failed to demonstrate a significant reduction in stroke. Although it remains uncertain if consumer-led AF screening reduces stroke, it could increase early diagnosis of AF and facilitate an integrated approach, including appropriate anticoagulation, rate or rhythm management, and risk factor modification to reduce complications. Companies marketing AF screening devices should report the accuracy and performance of their products in high- and low-risk populations and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials. Generally, the diagnostic yield of AF screening increases with the number, duration, and temporal dispersion of screening sessions, but the prognostic importance may be less than for AF detected by single-time point screening, which is largely permanent, persistent, or high-burden paroxysmal AF. Consumer-initiated ECG recordings suggesting possible AF always require confirmation by a health care professional experienced in ECG reading, whereas suspicion of AF on the basis of photoplethysmography must be confirmed with an ECG. Consumer-led AF screening is unlikely to be cost-effective for stroke prevention in the predominantly young, early adopters of this technology. Studies in older people at higher stroke risk are required to demonstrate both effectiveness and cost-effectiveness. The direct interaction between companies and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices. Although several barriers for optimal use of consumer-led screening exist, results of large, ongoing trials, powered to detect clinical outcomes, are required before health care professionals should support widespread adoption of consumer-led AF screening.
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Fibrilación Atrial , Accidente Cerebrovascular , Humanos , Anciano , Electrocardiografía/métodos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/complicaciones , Tamizaje Masivo/métodos , Factores de RiesgoRESUMEN
BACKGROUND: Despite high blood pressure being the leading preventable risk factor for death, only 1 in 3 patients achieve target blood pressure control. Key contributors to this problem are clinical inertia and uncertainties in relying on clinic blood pressure measurements to make treatment decisions. METHODS: The NEXTGEN-BP open-label, multicenter, randomized controlled trial will investigate the efficacy, safety, acceptability and cost-effectiveness of a wearable blood pressure monitor-based care strategy for the treatment of hypertension, compared to usual care, in lowering clinic blood pressure over 12 months. NEXTGEN-BP will enroll 600 adults with high blood pressure, treated with 0 to 2 antihypertensive medications. Participants attending primary care practices in Australia will be randomized 1:1 to the intervention of a wearable-based remote care strategy or to usual care. Participants in the intervention arm will undergo continuous blood pressure monitoring using a wrist-wearable cuffless device (Aktiia, Switzerland) and participate in 2 telehealth consultations with their primary care practitioner (general practitioner [GP]) at months 1 and 2. Antihypertensive medication will be up-titrated by the primary care practitioner at the time of telehealth consults should the percentage of daytime blood pressure at target over the past week be <90%, if clinically tolerated. Participants in the usual care arm will have primary care consultations according to usual practice. The primary outcome is the difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. Secondary outcomes will be assessed at month 3 and month 12, and include acceptability to patients and practitioners, cost-effectiveness, safety, medication adherence and patient engagement. CONCLUSIONS: NEXTGEN-BP will provide evidence for the effectiveness and safety of a new paradigm of wearable cuffless monitoring in the management of high blood pressure in primary care. TRIAL REGISTRATION: ACTRN12622001583730.
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Hipertensión , Dispositivos Electrónicos Vestibles , Adulto , Humanos , Presión Sanguínea/fisiología , Antihipertensivos/uso terapéutico , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Atención Primaria de Salud/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
AIMS: This study assessed associations of minimum final extrastimulus coupling interval utilized within electrophysiology study (EPS) after myocardial infarction (MI) and possible site of origin of induced ventricular tachycardia (VT) with long-term occurrence of spontaneous ventricular tachyarrhythmia and long-term survival. METHODS AND RESULTS: This prospective study recruited consecutive patients with left ventricular ejection fraction (LVEF) ≤ 40% who underwent EPS days 3-5 after MI between 2004 and 2017. Positive EPS was defined as sustained monomorphic VT cycle length ≥200â ms for ≥10â s or shorter duration if haemodynamic compromise occurred. Each of the four extrastimuli was shortened by 10â ms at a time, until it failed to capture the ventricle (ventricular refractoriness) or induced ventricular tachyarrhythmia. Outcomes included spontaneous ventricular tachyarrhythmia occurrence and all-cause mortality. Shorter coupling interval length of final extrastimulus that induced VT was associated with higher risk of spontaneous ventricular tachyarrhythmia (P < 0.001). Significantly higher rates of spontaneous ventricular tachyarrhythmia (65.2% vs. 23.2%; P < 0.001) were observed for final coupling interval at EPS <200â ms vs. >200â ms. Right bundle branch block (RBBB) morphology of induced VT, with possible site of origin from the left ventricle, was associated with all-cause mortality [hazard ratio (HR) 3.2, P = 0.044] and a composite of spontaneous ventricular tachyarrhythmia recurrence or mortality (HR 1.8, P = 0.043). CONCLUSION: Ventricular tachycardia induced with shorter coupling intervals was associated with higher risk of spontaneous ventricular tachyarrhythymia on follow-up, indicating that the final extrastimulus coupling interval at EPS early after MI should be determined by ventricular refractoriness. Induced VT with possible origin from left ventricle was associated with increased risk of spontaneous ventricular tachyarrhythmia recurrence or death.
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Desfibriladores Implantables , Infarto del Miocardio , Taquicardia Ventricular , Humanos , Volumen Sistólico/fisiología , Función Ventricular Izquierda , Estudios Prospectivos , Desfibriladores Implantables/efectos adversos , Infarto del Miocardio/complicaciones , Infarto del Miocardio/diagnóstico , Electrofisiología Cardíaca , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/etiología , Taquicardia Ventricular/prevención & control , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Muerte Súbita Cardíaca/epidemiología , Estudios de SeguimientoRESUMEN
Chest pain is the second most common reason for adult emergency department presentations. Most patients have low or intermediate risk chest pain, which historically has led to inpatient admission for further evaluation. Rapid access chest pain clinics represent an innovative outpatient pathway for these low and intermediate risk patients, and have been shown to be safe and reduce hospital costs. Despite variations in rapid access chest pain clinic models, there are limited data to determine the most effective approach. Developing a national framework could be beneficial to provide sites with evidence, possible models, and business cases. Multicentre data analysis could enhance understanding and monitoring of the service.
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Dolor en el Pecho , Clínicas de Dolor , Adulto , Humanos , Nueva Zelanda , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/etiología , Dolor en el Pecho/terapia , Australia , Servicio de Urgencia en HospitalRESUMEN
Peri-operative cardiovascular events occur in up to 3% of patients undergoing non-cardiac surgery. Accurate cardiovascular risk assessment is important in the peri-operative setting, as it allows informed and shared decisions regarding the appropriateness of proceeding with surgery, guides surgical and anaesthetic approaches, and may influence the use of preventive medications and post-operative cardiac monitoring. Quantitative risk assessment may also inform a reconsideration of choosing a more limited lower risk type of surgery, or conservative management. Pre-operative cardiovascular risk assessment starts with clinical assessment and should include an estimate of functional capacity. Specialised cardiac investigations are rarely indicated specifically to assess pre-operative cardiovascular risk. The decision regarding cardiac investigations is influenced by the nature, extent and urgency of surgery. The strategy of performing pre-operative revascularisation to improve post-operative outcomes is not evidence-based and recent international guidelines recommend against this.
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Enfermedades Cardiovasculares , Humanos , Enfermedades Cardiovasculares/prevención & control , Factores de Riesgo , Medición de Riesgo , Factores de Riesgo de Enfermedad Cardiaca , Monitoreo FisiológicoRESUMEN
We examined behavioural risk factors and quality of life (QoL) in women and men, younger and older adults 12 months after a Rapid Access Cardiology Clinic (RACC) visit. Routine clinical care data were collected in person from three Sydney hospitals between 2017 and 2018 and followed up by questionnaire at 365 days. 1491 completed the baseline survey, at 1 year, 1092 provided follow-up data on lifestyle changes, and 811 completed the EQ-5D-5L (QoL) survey. 666 (44.7%) were women, and 416 (27.9%) were older than 60 years of age. Almost 50% of participants reported improving physical activity and diet a year after their RACC visit. These changes were less likely in women and older participants.
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Instituciones de Atención Ambulatoria , Cardiopatías , Calidad de Vida , Anciano , Femenino , Humanos , Masculino , Estilo de Vida , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
BACKGROUND: The association of smoking with new-onset cardiovascular disease, chronic lung disease, malignancy and mortality in dialysis is well-known. The smoking prevalence and its association with clinical outcome was assessed. METHODS: Multicentre cohort study using 'ANZDATA' Registry, 57 838 adults who commenced dialysis (>3 months) between 1990 and 2016 were included. Patients' demographics, initial dialysis modality, presence of comorbidities and smoking history are predictors. The primary outcome was all-cause mortality. Secondary outcomes were smoking prevalence, cause-specific mortality, non-skin cancers, cardiovascular and chronic lung diseases. RESULTS: Of the 57 838 patients, 56 512 (mean age of 58.9 ± 15.1 years, 40.1% female, 43% diabetic), had data on smoking history with 13.6% current, 40.7% former and 45.6% never smokers. Former and current smokers had 10% (HR 1.10; 95% CI: 1.08, 1.13) and 22%(HR 1.22; 95% CI: 1.18, 1.26) higher risk of all-cause mortality. They were 13% (HR 1.13; 95% CI: 1.09, 1.18) and 23% (HR 1.23; 95% CI: 1.17, 1.29) for CVD mortality. Smoking was associated with higher mortality from respiratory failure (HR 1.59; 95% CI: 1.13, 2.23, p = .073 and HR 1.33; 95% CI: 1.01, 1.74, p = .042) for current and former smokers. Current and former smokers had higher risk for non-skin cancer (HR 1.30; 95% CI: 1.19, 1.42 and HR 1.24; 95% CI: 1.17, 1.32). Smoking was associated with a higher rate of death from cancer (HR 1.26; 95% CI 1.19-1.33) and chronic lung disease (HR 1.48; 95% CI 1.15-1.92). Former and current smokers had a higher adjusted risk for de novo vascular disease (PVD, CVD), CAD (adjusted RR 1.1; 95% Cl: 1.09-1.12). CONCLUSIONS: In dialysis patients, smoking was associated with higher rates of all-cause mortality, cardiovascular mortality, respiratory failure, chronic lung disease and malignancy along with higher risks of non-skin cancers, de novo vascular disease and chronic lung disease.
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Enfermedades Cardiovasculares , Fumar Cigarrillos , Enfermedades Pulmonares , Neoplasias , Insuficiencia Respiratoria , Enfermedades Vasculares , Adulto , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Diálisis Renal/efectos adversos , Estudios de Cohortes , Enfermedades Cardiovasculares/epidemiología , Neoplasias/epidemiología , Evaluación de Resultado en la Atención de Salud , Factores de RiesgoRESUMEN
OBJECTIVES: Health service providers are currently making decisions on the public funding of digital health technologies (DHTs) for managing chronic diseases with limited understanding of stakeholder preferences for DHT attributes. This study aims to understand the community, patient/carer, and health professionals' preferences to help inform a prioritized list of evaluation criteria. METHODS: An online best-worst scaling survey was conducted in Australia, New Zealand, Canada, and the United Kingdom to ascertain the relative importance of twenty-four DHT attributes among stakeholder groups using an efficient incomplete block design. The attributes were identified from a systematic review of DHT evaluation frameworks for consideration in a health technology assessment. Results were analyzed with multinomial models by stakeholder group and latent class. RESULTS: A total of 1,251 participants completed the survey (576 general community members, 543 patients/carers, and 132 health professionals). Twelve attributes achieved a preference score above 50 percent in the stakeholder group model, predominantly related to safety but also covering technical features, effectiveness, ethics, and economics. Results from the latent class model supported this prioritization. Overall, connectedness with the patient's healthcare team seemed the most important; with "Helps health professionals respond quickly when changes in patient care are needed" as the most highly prioritized of all attributes. CONCLUSIONS: It is proposed that these prioritized twelve attributes be considered in all evaluations of DHTs that manage chronic disease, supplemented with a limited number of attributes that reflect the specific perspective of funders, such as equity of access, cost, and system-level implementation considerations.
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Toma de Decisiones , Personal de Salud , Humanos , Australia , Cuidadores , Servicios de SaludRESUMEN
BACKGROUND: Maintaining engagement and support for patients with chronic diseases is challenging. SMS text messaging programs have complemented patient care in a variety of situations. However, such programs have not been widely translated into routine care. OBJECTIVE: We aimed to examine the implementation and utility of a customized SMS text message-based support program for patients with type 2 diabetes (T2D), coronary heart disease, or both within a chronic disease integrated care program. METHODS: We conducted a 6-month pragmatic parallel-group, single-blind randomized controlled trial that recruited people with T2D or coronary heart disease. Intervention participants received 4 semipersonalized SMS text messages per week providing self-management support to supplement standard care. Preprogrammed algorithms customized content based on participant characteristics, and the messages were sent at random times of the day and in random order by a fully automated SMS text messaging engine. Control participants received standard care and only administrative SMS text messages. The primary outcome was systolic blood pressure. Evaluations were conducted face to face whenever possible by researchers blinded to randomization. Participants with T2D were evaluated for glycated hemoglobin level. Participant-reported experience measures were evaluated using questionnaires and focus groups and summarized using proportions and thematic analysis. RESULTS: A total of 902 participants were randomized (n=448, 49.7% to the intervention group and n=454, 50.3% to the control group). Primary outcome data were available for 89.5% (807/902) of the participants. At 6 months, there was no difference in systolic blood pressure between the intervention and control arms (adjusted mean difference=0.9 mm Hg, 95% CI -1.1 to 2.1; P=.38). Of 642 participants with T2D, there was no difference in glycated hemoglobin (adjusted mean difference=0.1%, 95% CI -0.1% to 0.3%; P=.35). Self-reported medication adherence was better in the intervention group (relative risk=0.82, 95% CI 0.68-1.00; P=.045). Participants reported that the SMS text messages were useful (298/344, 86.6%) and easily understood (336/344, 97.7%) and motivated change (217/344, 63.1%). The lack of bidirectional messaging was identified as a barrier. CONCLUSIONS: The intervention did not improve blood pressure in this cohort, possibly because of high clinician commitment to improved routine patient care as part of the chronic disease management program as well as favorable baseline metrics. There was high program engagement, acceptability, and perceived value. Feasibility as part of an integrated care program was demonstrated. SMS text messaging programs may supplement chronic disease management and support self-care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001689460; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371769&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-025923.