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AIMS: To describe the baseline characteristics of participants in the FINEARTS-HF trial, contextualized with prior trials including patients with heart failure (HF) with mildly reduced and preserved ejection fraction (HFmrEF/HFpEF). The FINEARTS-HF trial is comparing the effects of the non-steroidal mineralocorticoid receptor antagonist finerenone with placebo in reducing cardiovascular death and total worsening HF events in patients with HFmrEF/HFpEF. METHODS AND RESULTS: Patients with symptomatic HF, left ventricular ejection fraction (LVEF) ≥40%, estimated glomerular filtration rate ≥ 25 ml/min/1.73 m2, elevated natriuretic peptide levels and evidence of structural heart disease were enrolled and randomized to finerenone titrated to a maximum of 40 mg once daily or matching placebo. We validly randomized 6001 patients to finerenone or placebo (mean age 72 ± 10 years, 46% women). The majority were New York Heart Association functional class II (69%). The baseline mean LVEF was 53 ± 8% (range 34-84%); 36% of participants had a LVEF <50% and 64% had a LVEF ≥50%. The median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1041 (interquartile range 449-1946) pg/ml. A total of 1219 (20%) patients were enrolled during or within 7 days of a worsening HF event, and 3247 (54%) patients were enrolled within 3 months of a worsening HF event. Compared with prior large-scale HFmrEF/HFpEF trials, FINEARTS-HF participants were more likely to have recent (within 6 months) HF hospitalization and greater symptoms and functional limitations. Further, concomitant medications included a larger percentage of sodium-glucose cotransporter 2 inhibitors and angiotensin receptor-neprilysin inhibitors than previous trials. CONCLUSIONS: FINEARTS-HF has enrolled a broad range of high-risk patients with HFmrEF and HFpEF. The trial will determine the safety and efficacy of finerenone in this population.
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Insuficiência Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Naftiridinas , Volume Sistólico , Humanos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/tratamento farmacológico , Volume Sistólico/fisiologia , Feminino , Masculino , Idoso , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Naftiridinas/uso terapêutico , Método Duplo-Cego , Função Ventricular Esquerda/fisiologia , Função Ventricular Esquerda/efeitos dos fármacos , Pessoa de Meia-Idade , Resultado do Tratamento , Taxa de Filtração Glomerular/fisiologia , Peptídeo Natriurético Encefálico/sangueRESUMO
OBJECTIVES: When dental practitioners encounter a defective restoration, they are faced with a crucial decision whether to repair or replace it. This study aims to explore international preferences for repair procedures and the clinical steps taken during the repair process. METHOD: An 11-question survey was distributed to dentists across 21 countries via different platforms. The survey comprised two sections: the first included five questions aimed at gathering demographic information, while the second consisted of six questions focusing on participants' practices related to the repair of composite or amalgam restorations A meta-analysis was employed to ascertain the pooled odds ratio of repairing versus replacement. The statistical analysis was carried out using the RevMan 5.3 program and forest plots were generated using the same program to visualize the results. RESULTS: The survey was completed by 3680 dental practitioners. The results indicated a strong tendency to repair defective composite restorations (OR: 14.23; 95 % CI: 7.40, 27.35, p < 0.001). In terms of amalgam, there was a significant tendency to replace the restorations (OR: 0.19; 95 % CI: 0.12, 0.30, p < 0.001). When repairing restorations, the most common protocols were etching with orthophosphoric acid and creating an enamel bevel, regardless of the restorative material used. CONCLUSION: The findings of this study indicate that there exists a knowledge gap among dental practitioners regarding restoration repair. It is imperative that dental practitioners receive proper education and training on restoration repair, to ensure the usage of adequate protocols and restoration survival. CLINICAL SIGNIFICANCE: A significant portion of dental practitioners lack the necessary knowledge and education required for the repair of restorations. Therefore, it is imperative to establish guidelines aimed at enhancing the management of defective restorations, along with protocols for clinical interventions. This includes the incorporation of proper courses in undergraduate, graduate, and continuing education programs.
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Resinas Compostas , Amálgama Dentário , Reparação de Restauração Dentária , Restauração Dentária Permanente , Humanos , Restauração Dentária Permanente/métodos , Estudos Transversais , Resinas Compostas/química , Inquéritos e Questionários , Padrões de Prática Odontológica/estatística & dados numéricos , Falha de Restauração Dentária , Odontólogos , Masculino , Feminino , AdultoRESUMO
AIM: The aim of this study was two-folded: i) to assess the prevalence of Distolingual Canal (DLC) and Radix Entomolaris (RE) in Mandibular First Molars (M1Ms), using Cone Beam Computed Tomography (CBCT) images and ii) to assess the impact of sociodemographic factors on the prevalence of these conditions worldwide. METHODS: CBCT images were scanned retrospectively and the ones including bilateral M1Ms were included in the study. The evaluation was performed by 1 researcher in each country, trained with CBCT technology. A written and video instruction program explaining the protocol to be followed step-by-step was provided to all observers to calibrate them. The CBCT imaging screening procedure consisted of evaluating axial sections from coronal to apical. The presence of DLC and RE in M1Ms (yes/no) was identified and recorded. RESULTS: Six thousand three hundred four CBCTs, representing 12,608 M1Ms, were evaluated. A significant difference was found between countries regarding the prevalence of both RE and DLC (P < .05). The prevalence of DLC ranged from 3% to 50%, and the overall prevalence was 22% (95% CI: 15%-29%). RE prevalence ranged from 0% to 12%, and the overall prevalence was 3% (95% CI: 2%-5%). There were no significant differences between left and right M1Ms or between genders for either DLC or RE (P > .05). CONCLUSION: The overall prevalence of RE and DLC in M1Ms was 3% and 22%. Additionally, both RE and DLC showed substantial bilaterally. These variations should be considered by endodontic clinicians during endodontic procedures in order to avoid potential complications.
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Mandíbula , Raiz Dentária , Humanos , Masculino , Feminino , Estudos Transversais , Prevalência , Estudos Retrospectivos , Raiz Dentária/diagnóstico por imagem , Mandíbula/diagnóstico por imagem , Cavidade Pulpar/diagnóstico por imagem , Dente Molar/diagnóstico por imagem , Tomografia Computadorizada de Feixe Cônico/métodosRESUMO
INTRODUCTION: Direct pulp capping (DPC) procedures require the placement of a bioactive material over an exposure site without selective pulp tissue removal. This web-based multicentered survey had 3 purposes: (1) to investigate the factors that affect clinicians' decisions in DPC cases, (2) to determine which method of caries removal is preferred, and (3) to evaluate the preferred capping material for DPC. METHODS: The questionnaire comprised 3 sections. The first part comprised questions regarding demographic features. The second part comprised questions on how treatment plans change according to factors such as nature, location, number and size of the pulp exposure, and patients' age. The third part composed of questions on the common materials and techniques used in DPC. To estimate the effect size, the risk ratio (RR) and 95% confidence interval (CI) were calculated using a meta-analysis software. RESULTS: A tendency toward more invasive treatment was observed for the clinical scenario with carious-exposed pulp (RR = 2.86, 95% CI: 2.46, 2.32; P < .001) as opposed to the clinical scenario with 2 pulp exposures (RR = 1.38, 95% CI: 1.24, 1.53; P < .001). Complete caries removal was significantly preferred to selective caries removal (RR = 4.59, 95% CI: 3.70, 5.69; P < .001). Among the capping materials, calcium silicate-based materials were preferred over calcium hydroxide-based materials (RR = 0.58, 95% CI: 0.44, 0.76; P < .05). CONCLUSIONS: While carious-exposed pulp is the most important factor in clinical decisions regarding DPC, the number of exposures has the least impact. Overall, complete caries removal was preferred over selective caries removal. In addition, the use of calcium silicate-based materials appears to have replaced calcium hydroxide-based materials.
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Cárie Dentária , Agentes de Capeamento da Polpa Dentária e Pulpectomia , Humanos , Hidróxido de Cálcio/uso terapêutico , Capeamento da Polpa Dentária/métodos , Odontólogos , Papel Profissional , Compostos de Cálcio/uso terapêutico , Silicatos/uso terapêutico , Polpa Dentária , Cárie Dentária/terapia , Inquéritos e Questionários , Agentes de Capeamento da Polpa Dentária e Pulpectomia/uso terapêuticoRESUMO
BACKGROUND: An additional canal found in the mandibular first molar (M1M) is the middle mesial canal (MMC), which is often missed during root canal treatment. In this study, the prevalence of MMC in M1M on cone-beam computed tomography (CBCT) images was evaluated in 15 countries, along with the effect of some demographic factors on its prevalence. METHODS: Deidentified CBCT images were scanned retrospectively, and the ones including bilateral M1Ms were included in the study. A written and video instruction program explaining the protocol to be followed step-by-step was provided to all observers to calibrate them. The CBCT imaging screening procedure consisted of evaluating three planes (coronal, sagittal, and axial) after a 3-dimensional alignment of the long axis of the root(s). The presence of an MMC in M1Ms (yes/no) was identified and recorded. RESULTS: In total, 6304 CBCTs, representing 12,608 M1Ms, were evaluated. A significant difference was found between countries (P < .05). MMC prevalence ranged from 1% to 23%, and the overall prevalence was 7% (95% confidence interval [CI]: 5%-9%). No significant differences were found between the left and right M1M (odds ratio = 1.09, 95% CI: 0.93, 1.27; P > .05) or between genders (odds ratio= 1.07, 95% CI: 0.91, 1.27; P > .05). As for the age groups, no significant differences were found (P > .05). CONCLUSIONS: The prevalence of MMC varies by ethnicity, but it is generally estimated at 7% worldwide. Physicians must pay close attention to the presence of MMC in M1M, especially for opposite M1Ms, due to the prevalence of MMC being significantly bilateral.
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Cavidade Pulpar , Raiz Dentária , Humanos , Masculino , Feminino , Cavidade Pulpar/diagnóstico por imagem , Estudos Transversais , Prevalência , Estudos Retrospectivos , Mandíbula/diagnóstico por imagem , Dente Molar/diagnóstico por imagem , Tomografia Computadorizada de Feixe Cônico/métodosRESUMO
Little is known about the changes in perception of illness among patients with the acute coronary syndrome (ACS) during cardiac rehabilitation programme (CRP). The purpose of this study is to determine changes in perception of illness with ACS patients during CRP to evaluate the association of patients' characteristics with the perception of illness at the end of Phase II of CRP. A descriptive longitudinal study was conducted among 450 patients who attended 8-weeks of Phase II CRP at 2 public hospitals in Malaysia and perception of illness was assessed using Brief Illness Perception Questionnaire (BIPQ). The assessment was conducted before Phase II (T0), during the 4th session (T1), and at the end of right after the 8th session (T2). One-way repeated measures of ANOVA analysed the changes of perception at T1 and T2 while logistic regression analysis evaluated the association of patients' characteristics with the perception of illness at T2. Perception of illness changed during and after CRP from T0 to T1, and T1 to T2 (p < 0.001). The patient viewed ACS as an illness that changed from being more acute to a chronic condition as the sessions progressed. Previous history of acute myocardial infarction (OR = 2.380, 95% CI 1.46, 5.49) and angioplasty intervention were both found to be associated with the perception of illness (OR = 3.857, 95% CI 1.55, 9.61). Perception of illness changed during CRP and these changes are associated with patients' previous history of cardiac events. Phase II can be viewed as the second window of opportunity for healthcare professionals to intervene early in modifying the perception of illness.
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BACKGROUND: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. METHODS: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 µg/mm²) with the clinically proven PCB (SeQuent Please, 3 µg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. CONCLUSIONS: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996318, NCT03242096.
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Angioplastia Coronária com Balão , Reestenose Coronária , Stents Farmacológicos , Bifenilos Policlorados , Angioplastia Coronária com Balão/efeitos adversos , Constrição Patológica/induzido quimicamente , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Humanos , Paclitaxel/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/efeitos adversos , Stents , Resultado do TratamentoRESUMO
OBJECTIVE: Female sex is a major barrier to completing a programme of cardiac rehabilitation (CR) after acute coronary syndrome (ACS). Women require significant social support to promote compliance and the ability to cope with CR programme attendance. The aim of this systematic review of qualitative studies was to explore social support among women coping with CR programme attendance at phase II CRP is 3 months after their cardiac event. METHODS: Articles were searched through CINAHL (Cumulative Index and Allied Health Literature), Science Direct and PubMed databases using the following terms: "women", "acute coronary syndrome", "coping", "social support" and "cardiac rehabilitation". RESULTS: A total of 6 articles were selected based on eligibility criteria. Thematic analysis was used to analyse the data using line to line coding into descriptive themes, interpreting further to generate new insights. The 3 most common themes regarding social support for women attending the CR programme were: family support, female as the primary caregiver in the family, and peer support. For most women who perceived themselves as the primary caregiver in the family there was a negative impact on their ability to cope fully with CR programme attendance. On the other hand, encouraging support from family and peers positively improved their coping mechanism for attending the CR programme, leading to improved compliance. CONCLUSION: Women with ACS consider that support from their family plays a vital role as a coping mechanism in their attendance at a CR programme. Healthcare providers should teach the importance of social support among women after discharge to help them cope with CR programme attendance.
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Síndrome Coronariana Aguda , Reabilitação Cardíaca , Feminino , Pessoal de Saúde , Humanos , Pesquisa Qualitativa , Apoio SocialRESUMO
AIMS: Coronary artery disease (CAD) portends worse outcomes in heart failure (HF). We aimed to characterize patients with CAD and worsening HF with reduced ejection fraction (HFrEF) and evaluate post hoc whether vericiguat treatment effect varied according to CAD. METHODS AND RESULTS: Cox proportional hazards were generated for the primary endpoint of cardiovascular death or HF hospitalization (CVD/HFH). CAD was defined as previous myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting. Of 5048 patients in VICTORIA with available data on CAD status, 2704 had CAD and were older, were more frequently male, diabetic, and had a lower glomerular filtration rate than those without CAD (all p <0.0001). Use of implantable cardioverter defibrillators and cardiac resynchronization therapy (CRT) was higher in patients with versus without CAD (33.5% vs. 21.1%; p <0.0001 and 16.3% vs. 12.8%; p = 0.0006). The primary endpoint of CVD/HFH was higher in those with versus without CAD (40.6 vs. 30.1/100 patient-years; adjusted hazard ratio [HR] 1.23; p <0.001) as was all-cause mortality (17.9% vs. 12.7%; adjusted HR 1.32; p <0.001). The primary outcome of CVD/HFH associated with vericiguat in patients with or without CAD was 38.8 versus 27.6 per 100 patient-years and for placebo was 42.6 versus 32.7 per 100 patient-years (interaction p = 0.78). CONCLUSION: In this post hoc study, CAD was associated with more CVD and HFH in patients with HFrEF and worsening HF. Vericiguat was beneficial and safe regardless of concomitant CAD.
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Doença da Artéria Coronariana , Insuficiência Cardíaca , Compostos Heterocíclicos com 2 Anéis , Disfunção Ventricular Esquerda , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/tratamento farmacológico , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Compostos Heterocíclicos com 2 Anéis/uso terapêutico , Humanos , Masculino , Pirimidinas , Volume Sistólico , Disfunção Ventricular Esquerda/tratamento farmacológicoRESUMO
Background QRS duration (QRSd) is a marker of electrical remodeling in heart failure. Anthropometrics and left ventricular size may influence QRSd and, in turn, may influence the association between QRSd and heart failure outcomes. Methods and Results Using the prospective, multicenter, multinational ASIAN-HF (Asian Sudden Cardiac Death in Heart Failure) registry, this study evaluated whether electroanatomic ratios (QRSd indexed for height or left ventricular end-diastole volume) are associated with 1-year mortality in individuals with heart failure with reduced ejection fraction. The study included 4899 individuals (aged 60±19 years, 78% male, mean left ventricular ejection fraction: 27.3±7.1%). In the overall cohort, QRSd was not associated with all-cause mortality (hazard ratio [HR], 1.003; 95% CI, 0.999-1.006, P=0.142) or sudden cardiac death (HR, 1.006; 95% CI, 1.000-1.013, P=0.059). QRS/height was associated with all-cause mortality (HR, 1.165; 95% CI, 1.046-1.296, P=0.005 with interaction by sex pinteraction=0.020) and sudden cardiac death (HR, 1.270; 95% CI, 1.021-1.580, P=0.032). QRS/left ventricular end-diastole volume was associated with all-cause mortality (HR, 1.22; 95% CI, 1.05-1.43, P=0.011) and sudden cardiac death (HR, 1.461; 95% CI, 1.090-1.957, P=0.011) in patients with nonischemic cardiomyopathy but not in patients with ischemic cardiomyopathy (all-cause mortality: HR, 0.94; 95% CI, 0.79-1.11, P=0.467; sudden cardiac death: HR, 0.734; 95% CI, 0.477-1.132, P=0.162). Conclusions Electroanatomic ratios of QRSd indexed for body size or left ventricular size are associated with mortality in individuals with heart failure with reduced ejection fraction. In particular, increased QRS/height may be a marker of high risk in individuals with heart failure with reduced ejection fraction, and QRS/left ventricular end-diastole volume may further risk stratify individuals with nonischemic heart failure with reduced ejection fraction. Registration URL: https://Clinicaltrials.gov. Unique identifier: NCT01633398.
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Terapia de Ressincronização Cardíaca/métodos , Insuficiência Cardíaca/fisiopatologia , Sistema de Registros , Medição de Risco/métodos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Ecocardiografia , Eletrocardiografia , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Singapura/epidemiologia , Taxa de Sobrevida/tendênciasRESUMO
INTRODUCTION: The objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design. METHODS: The Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES. The PF-SES's used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints. RESULTS: A total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age (p = 0.744), male gender (0.987), diabetes mellitus (p = 0.293), hypertension (p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p < 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%, p = 0.891). The accumulated MACE rates were not significantly different (p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively. CONCLUSIONS: Modifications in coronary stent architecture which enhance the radial strength and radiopacity without gross changes in strut thickness and design do not seem to impact clinical outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214.
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Takotsubo syndrome is a rare disease and remained ambiguous with its etiology. The disease manifests in various clinical characteristics and even mimicking acute coronary syndrome. We are reporting a case of an elderly lady who manifested by unsteady gaits and recurrent falls. Subacute infarct of the right corona radiata was observed on the brain CT. In addition, coronary angiography and ventriculogram were performed because of dynamic ECG changes and elevated troponin I levels. The angiogram was normal while ventriculogram showed apical ballooning. She was diagnosed and treated as Takotsubo syndrome.
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Ventricular wall rupture possesses a high mortality rate in patients with acute myocardial infarction. We presented a case of a ninety-year-old gentleman who presented with acute inferolateral myocardial infarction in cardiogenic shock and right ventricular free wall rupture. He was treated conservatively and survived.
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PURPOSE: To determine the lifetime cumulative incidence of syncope, potential ethnic differences and factors associated with syncope using the Malaysian elders longitudinal research (MELoR) study first wave dataset. METHODS: The MELoR study recruited community-dwelling adults aged 55 years and over, selected through stratified random sampling from three parliamentary constituencies. The baseline data collected during the first wave was obtained through face-to-face interviews in participants' homes using computer-assisted questionnaires. During their baseline assessments, participants were asked whether they had ever experienced a blackout in their lifetime and if they had experienced a blackout in the preceding 12 months. RESULTS: Information on blackouts and ethnicity were available for 1530 participants. The weight-adjusted lifetime cumulative incidence of syncope for the overall population aged 55 years and above was 27.7%. The estimated lifetime cumulative incidence according to ethnic groups was 34.6% for Malays, 27.8% for Indians and 23.7% for Chinese. The estimated 12-month incidence of syncope was 6.1% overall, equating to 11.7% for Malays, 8.7 % for Indians and 2.3% for Chinese. Both Malay [odds ratio (OR) 1.46; 95% confidence interval (CI) 1.10-1.95 and OR 3.62, 95% CI 1.96-6.68] and Indian (OR 1.34; 95% CI 1.01-1.80 and OR 3.31, 1.78-6.15) ethnicities were independently associated with lifetime and 12-month cumulative incidence of syncope, respectively, together with falls, dizziness and myocardial infarction. CONCLUSION: Ethnic differences exist for lifetime cumulative incidence of syncope in community-dwelling individuals aged 55 years and over in an urban area in Southeast Asia. Future studies should now seek to determine potential genetic, cultural and lifestyle differences which may predispose to syncope.
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Pesquisa Biomédica/tendências , Etnicidade , Síncope/diagnóstico , Síncope/etnologia , Idoso , Pesquisa Biomédica/métodos , Estudos Transversais , Etnicidade/genética , Feminino , Humanos , Incidência , Estilo de Vida/etnologia , Estudos Longitudinais , Malásia/etnologia , Masculino , Pessoa de Meia-Idade , Síncope/genéticaRESUMO
BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin. METHODS: This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor®) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups. RESULTS: 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p < 0.05) between proprietary and generic atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups. CONCLUSIONS: Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.
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Atorvastatina/farmacologia , LDL-Colesterol/efeitos dos fármacos , Medicamentos Genéricos , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Hipercolesterolemia/tratamento farmacológico , Triglicerídeos/sangue , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND: Percutaneous coronary interventions (PCI) in coronary artery disease (CAD) with very small vessel diameters remains controversial and challenging. These lesions are usually more diffuse, calcified and tortuous. The usage of thin strut bare metal stents (BMS) with excellent crossing profiles in a very small caliber coronary lesions has increased the likelihood of procedural success. OBJECTIVES: This observational study assessed the 9-month clinical outcomes in an 'all-comers' population with very small caliber CAD after implantation of thin strut cobalt chromium BMS. METHODS: Thin strut cobalt chromium BMS implantation in a priori pre-defined subgroups was investigated in a non-randomized, international, multi-center 'all-comers' observational study. Primary end-point was the 9-month clinically driven target lesion revascularization (TLR) rate. Secondary end-points included the 9-month major adverse cardiac event (MACE) and procedural success rates. Data collection was done using an established electronic data acquisition form with built-in plausibility checks. RESULTS: A total of 783 patients with a mean age of 70.4 ± 12.8 years were enrolled, 205 (26.2 %) of them had vessel diameters of 2.5 mm and smaller which was defined as CAD with very small reference vessel calibers. Older age and diabetics were associated with higher incidences of very small caliber vessels. The mean reference vessel diameter in the very small vessel group was 2.05 ± 0.27 mm and mean diameter for vessels >2.5 mm was 3.41 ± 0.55 mm. Pre-dilatation was performed more often in the very small vessel patients (52.2 vs. 42.2 %; p value 0.007). There was no difference in the overall technical success rates in very small vessel disease group (97.9 vs. 97.7 %). The 9-month TLR rate was 6.3 % for the very small vessels and 3.7 % for vessels >2.5 mm (p = 0.129). The 9-month and in-hospital MACE rates in the very small vessel group and patient with vessel diameters >2.5 mm were not significantly different (13.1 vs. 9.2 %; p = 0.1265 and 5.2 vs. 3.7 %; p = 0.349) respectively. CONCLUSION: This study has demonstrated that the use of thin strut cobalt chromium BMS in very small vessel CAD was reasonably safe and efficacious in the context of 'real-world' practice.
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OBJECTIVES: Heart Quality of Life (HeartQoL) is a new "hybrid" developed from the MacNew and two condition-specific questionnaires measuring health-related quality of life (HRQoL) in patients with ischemic heart disease (IHD). This study investigates test-retest reliability of HeartQoL (English version) according to international criteria (e.g., COSMIN, GRRAS). Findings on HeartQoL are compared to the published data on MacNew in view that both serve as the core IHD-specific HRQoL instrument. METHODS: Out of 105 patients with IHD, 76 completed self-administration of HeartQoL at the clinic followed by at home within a 2-week interval. In retest, patients responded using non-interview methods (phone messaging, email, fax, and post). Phone interviewing was reserved for non-respondents to reminder. RESULTS: Reliability of HeartQoL was good (intraclass correlation coefficients = 0.78-0.82), was supported in the Bland-Altman plot, and was comparable to five studies on MacNew of similar retest interval (MacNew-English = 0.70-0.75; translated MacNew = 0.72-0.91). Applicability of its standard error of measurement (0.20-0.25) and smallest detectable change (0.55-0.70) will depend on availability of normative data in future. CONCLUSION: The reliability of HeartQoL is comparable to its parent instrument, the MacNew. The HeartQoL is a potentially reliable core IHD-specific HRQoL instrument in measuring group change.
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Doença da Artéria Coronariana/psicologia , Nível de Saúde , Psicometria/instrumentação , Qualidade de Vida/psicologia , Inquéritos e Questionários , Adulto , Idoso , Angina Instável/psicologia , Doença da Artéria Coronariana/terapia , Feminino , Insuficiência Cardíaca/psicologia , Humanos , Idioma , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/psicologia , Pais , Reprodutibilidade dos Testes , TraduçãoRESUMO
Unruptured right sinus of Valsalva aneurysm that causes severe obstruction of the right ventricular outflow tract is extremely rare. We describe the case of a 47-year-old woman who presented with exertional dyspnea. Upon investigation, we discovered an unruptured right sinus of Valsalva aneurysm with associated right ventricular outflow tract obstruction and a supracristal ventricular septal defect. To our knowledge, only 2 such cases have previously been reported in the medical literature. Although treatment of unruptured sinus of Valsalva aneurysm remains debatable, surgery should be considered for extremely large aneurysms or for progressive enlargement of the aneurysm on serial evaluation. Surgery was undertaken in our patient because there was clear evidence of right ventricular outflow tract obstruction, right-sided heart dilation, and associated exertional dyspnea.
Assuntos
Aneurisma Aórtico/complicações , Comunicação Interventricular/complicações , Seio Aórtico , Obstrução do Fluxo Ventricular Externo/etiologia , Aneurisma Aórtico/diagnóstico , Aneurisma Aórtico/fisiopatologia , Aneurisma Aórtico/cirurgia , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Dispneia/etiologia , Ecocardiografia Doppler em Cores , Ecocardiografia Transesofagiana , Feminino , Comunicação Interventricular/diagnóstico , Comunicação Interventricular/fisiopatologia , Comunicação Interventricular/cirurgia , Implante de Prótese de Valva Cardíaca , Humanos , Hipertrofia Ventricular Direita/etiologia , Pessoa de Meia-Idade , Seio Aórtico/diagnóstico por imagem , Seio Aórtico/fisiopatologia , Seio Aórtico/cirurgia , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/diagnóstico , Obstrução do Fluxo Ventricular Externo/fisiopatologia , Obstrução do Fluxo Ventricular Externo/cirurgiaRESUMO
Transient cortical blindness after coronary angiography and bypass graft is a very rare complication. In this report we present the case of a 63-year-old man who developed transient cortical blindness within 30 minutes of coronary angioplasty and graft study, but subsequently recovered within 72 hours without any neurological deficit. A plain computed tomography brain scan showed bilateral symmetrical subarachnoid hyperdensities in the posterior cerebral circulation area suspicious of subarachnoid bleed. However, magnetic resonance imaging and magnetic resonance angiography scans were normal. Excess contrast volume causing direct neurotoxicity seems to be the most probable cause, but the exact mechanism is unclear.
Assuntos
Cegueira Cortical/etiologia , Angiografia Coronária/efeitos adversos , Oclusão Coronária/diagnóstico por imagem , Angioplastia , Meios de Contraste/efeitos adversos , Ponte de Artéria Coronária , Oclusão Coronária/etiologia , Oclusão Coronária/terapia , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
INTRODUCTION: Achieving target door-needle times for ST elevation myocardial infarction remains challenging. Data on emergency department (ED) doctor-led thrombolysis in developing countries and factors causing delay are limited. OBJECTIVES: To assess the effect on door-needle times by transferring responsibility for thrombolysis to the ED doctors and to identify predictors of prolonged door-needle times. METHODOLOGY: Data on medical on-call team-led thrombolysis at a tertiary Asian hospital were prospectively collected from May 2007 to Aug 2008 (1st study period). In September 2008, ED doctors were empowered to perform thrombolysis. The practice change was accompanied by new guidelines, tick chart implementation, and training sessions. Data were then consecutively collected from September 2008 to May 2009 (2nd study period). Door-to-needle times for the 1st and 2nd study periods were compared. All cases were analysed for factors of delay by multiple logistic regression. RESULTS: 297 patients were thrombolysed, 169 by the medical on-call team during the 1st study period and 128 by the ED doctors during the 2nd study period. Median door-needle times were 54 and 48 min, respectively (p=0.76). Significant delays were predicted by 'incorrect initial ECG interpretation' (adjusted OR (aOR) 14.3), 'inappropriate triage' (aOR 10.4) and 'multiple referrals' (aOR 5.9). No cases of inappropriate thrombolysis were recorded. CONCLUSIONS: Transfer of responsibility for thrombolysis to the ED doctors did not improve door-needle times despite measures introduced to facilitate this change. Key causative factors for this failure were identified.