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2.
Gastroenterology ; 157(3): 682-691, ago., 30 2019. ilus, tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1015771

RESUMO

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 x 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. (AU)


Assuntos
Bactérias , Doenças Cardiovasculares , Aspirina
3.
Gastroenterology ; 157(2): 403-412, Aug., 2019. tabela, grafico
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1022748

RESUMO

BACKGROUND & AIMS: Antiplatelets and anticoagulants are associated with increased upper gastrointestinal bleeding. We evaluated whether proton pump inhibitor therapy could reduce this risk. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Participants were randomly assigned to groups given pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone. The primary outcome was time to first upper gastrointestinal event, defined as a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper gastrointestinal obstruction, or perforation. RESULTS: There was no significant difference in upper gastrointestinal events between the pantoprazole group (102 of 8791 events) and the placebo group (116 of 8807 events) (hazard ratio, 0.88; 95% confidence interval [CI], 0.67-1.15). Pantoprazole significantly reduced bleeding of gastroduodenal lesions (hazard ratio, 0.52; 95% confidence interval, 0.28-0.94; P = .03); this reduction was greater when we used a post-hoc definition of bleeding gastroduodenal lesion (hazard ratio, 0.45; 95% confidence interval, 0.27-0.74), although the number needed to treat still was high (n = 982; 95% confidence interval, 609-2528).CONCLUSIONS: In a randomized placebo-controlled trial, we found that routine use of proton pump inhibitors in patients receiving low-dose anticoagulation and/or aspirin for stable cardiovascular disease does not reduce upper gastrointestinal events, but may reduce bleeding from gastroduodenal lesions. ClinicalTrials. (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Doenças Cardiovasculares/prevenção & controle , Aspirina/administração & dosagem , Método Duplo-Cego , Relação Dose-Resposta a Droga , Hemorragia Gastrointestinal/prevenção & controle , Anticoagulantes/administração & dosagem
5.
Gastroenterology ; 157(3): 682-691.e2, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31152740

RESUMO

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. ClinicalTrials.gov Number: NCT01776424.


Assuntos
Aspirina/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Hemorragia Gastrointestinal/prevenção & controle , Pantoprazol/administração & dosagem , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Bomba de Prótons/administração & dosagem , Rivaroxabana/administração & dosagem , Idoso , Aspirina/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Método Duplo-Cego , Esquema de Medicação , Enterocolite Pseudomembranosa/induzido quimicamente , Enterocolite Pseudomembranosa/microbiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Pantoprazol/efeitos adversos , Doença Arterial Periférica/diagnóstico , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Prospectivos , Inibidores da Bomba de Prótons/efeitos adversos , Medição de Risco , Fatores de Risco , Rivaroxabana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
6.
Gastroenterology ; 157(2): 403-412.e5, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31054846

RESUMO

BACKGROUND & AIMS: Antiplatelets and anticoagulants are associated with increased upper gastrointestinal bleeding. We evaluated whether proton pump inhibitor therapy could reduce this risk. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Participants were randomly assigned to groups given pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone. The primary outcome was time to first upper gastrointestinal event, defined as a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper gastrointestinal obstruction, or perforation. RESULTS: There was no significant difference in upper gastrointestinal events between the pantoprazole group (102 of 8791 events) and the placebo group (116 of 8807 events) (hazard ratio, 0.88; 95% confidence interval [CI], 0.67-1.15). Pantoprazole significantly reduced bleeding of gastroduodenal lesions (hazard ratio, 0.52; 95% confidence interval, 0.28-0.94; P = .03); this reduction was greater when we used a post-hoc definition of bleeding gastroduodenal lesion (hazard ratio, 0.45; 95% confidence interval, 0.27-0.74), although the number needed to treat still was high (n = 982; 95% confidence interval, 609-2528). CONCLUSIONS: In a randomized placebo-controlled trial, we found that routine use of proton pump inhibitors in patients receiving low-dose anticoagulation and/or aspirin for stable cardiovascular disease does not reduce upper gastrointestinal events, but may reduce bleeding from gastroduodenal lesions. ClinicalTrials.gov ID: NCT01776424.


Assuntos
Anticoagulantes/efeitos adversos , Doenças Cardiovasculares/prevenção & controle , Hemorragia Gastrointestinal/prevenção & controle , Pantoprazol/administração & dosagem , Úlcera Péptica/prevenção & controle , Inibidores da Bomba de Prótons/administração & dosagem , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Úlcera Péptica/induzido quimicamente , Úlcera Péptica/epidemiologia , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Resultado do Tratamento
7.
ESC Heart Fail ; 6(4): 863-866, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31095902

RESUMO

AIMS: From the various mechanical cardiac assist devices and indications available, the use of the percutaneous intraventricular Impella CP pump is usually restricted to acute ischaemic shock or prophylactic indications in high-risk interventions. In the present study, we investigated clinical usefulness of the Impella CP device in patients with non-ischaemic cardiogenic shock as compared with acute ischaemia. METHODS AND RESULTS: In this retrospective single-centre analysis, patients who received an Impella CP at the University Hospital Würzburg between 2013 and 2017 due to non-ischaemic cardiogenic shock were age-matched 2:1 with patients receiving the device due to ischaemic cardiogenic shock. Inclusion criteria were therapy refractory haemodynamic instability with severe left ventricular systolic dysfunction and serum lactate >2.0 mmol/L at implantation. Basic clinical data, indications for mechanical ventricular support, and outcome were obtained in all patients with non-ischaemic as well as ischaemic shock and compared between both groups. Continuous variables are expressed as mean ± standard deviation or median (quartiles). Categorical variables are presented as count and per cent. Twenty-five patients had cardiogenic shock due to non-ischaemic reasons and were compared with 50 patients with cardiogenic shock due to acute myocardial infarction. Resuscitation rates before implantation of Impella CP were high (32 vs. 42%; P = 0.402). At implantation, patients with non-ischaemic cardiogenic shock had lower levels of high-sensitive troponin T (110.65 [57.87-322.1] vs. 1610 [450.8-3861.5] pg/mL; P = 0.001) and lactate dehydrogenase (377 [279-608] vs. 616 [371.3-1109] U/L; P = 0.007), while age (59 ± 16 vs. 61.7 ± 11; P = 0.401), glomerular filtration rate (43.5 [33.2-59.7] vs. 48 [35.75-69] mL/min; P = 0.290), C-reactive protein (5.17 [3.27-10.26] vs. 10.97 [3.23-17.2] mg/dL; P = 0.195), catecholamine index (30.6 [10.6-116.9] vs. 47.6 [11.7-90] µg/kg/min; P = 0.663), and serum lactate (2.6 [2.2-5.8] vs. 2.9 [1.3-6.6] mmol/L; P = 0.424) were comparable between both groups. There was a trend for longer duration of Impella support in the non-ischaemic groups (5 [2-7.5] vs. 3 [2-5.25] days, P = 0.211). Rates of haemodialysis (52 vs. 47%; P = 0.680) and transition to extracorporeal membrane oxygenation (13.6 vs. 22.2%; P = 0.521) were comparable. No significant difference was found regarding both 30 day survival (48 vs. 30%; P = 0.126) and in-hospital mortality (66.7 vs. 74%; P = 0.512), although there was a trend for better survival in the non-ischaemic group. CONCLUSIONS: These data suggest that temporary use of the Impella CP device might be a useful therapeutic option for bridge to recovery not only in ischaemic but also in non-ischaemic cardiogenic shock.

9.
Eur Heart J ; 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30957867

RESUMO

AIMS: Anxiety, depression, and reduced quality of life (QoL) are common in patients with implantable cardioverter-defibrillators (ICDs). Treatment options are limited and insufficiently defined. We evaluated the efficacy of a web-based intervention (WBI) vs. usual care (UC) for improving psychosocial well-being in ICD patients with elevated psychosocial distress. METHODS AND RESULTS: This multicentre, randomized controlled trial (RCT) enrolled 118 ICD patients with increased anxiety or depression [≥6 points on either subscale of the Hospital Anxiety and Depression Scale (HADS)] or reduced QoL [≤16 points on the Satisfaction with Life Scale (SWLS)] from seven German sites (mean age 58.8 ± 11.3 years, 22% women). The primary outcome was a composite assessing change in heart-focused fear, depression, and mental QoL 6 weeks after randomization to WBI or UC, stratified for age, gender, and indication for ICD placement. Web-based intervention consisted of 6 weeks' access to a structured interactive web-based programme (group format) including self-help interventions based on cognitive behaviour therapy, a virtual self-help group, and on-demand support from a trained psychologist. Linear mixed-effects models analyses showed that the primary outcome was similar between groups (ηp2 = 0.001). Web-based intervention was superior to UC in change from pre-intervention to 6 weeks (overprotective support; P = 0.004, ηp2 = 0.036), pre-intervention to 1 year (depression, P = 0.004, ηp2 = 0.032; self-management, P = 0.03, ηp2 = 0.015; overprotective support; P = 0.02, ηp2 = 0.031), and 6 weeks to 1 year (depression, P = 0.02, ηp2 = 0.026; anxiety, P = 0.03, ηp2 = 0.022; mobilization of social support, P = 0.047, ηp2 = 0.018). CONCLUSION: Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.

10.
Eur J Prev Cardiol ; : 2047487319838218, 2019 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-30889979

RESUMO

BACKGROUND: We assessed prevalence and determinants in appropriate physician-led lifestyle advice (PLA) in a population-based sample of individuals without cardiovascular disease (CVD) compared with a sample of CVD patients. METHODS: PLA was assessed via questionnaire in a subsample of the population-based Characteristics and Course of Heart Failure Stages A-B and Determinants of Progression (STAAB) cohort free of CVD (primary prevention sample) and the German subset of the fourth EUROASPIRE survey (EUROASPIRE-IV) comprising CVD patients (secondary prevention sample). PLA was fulfilled if the participant reported having ever been told by a physician to: stop smoking (current/former smokers), reduce weight (overweight/obese participants), increase physical activity (physically inactive participants) or keep to a healthy diet (all participants). Factors associated with receiving at least 50% of the PLA were identified using logistic regression. RESULTS: Information on PLA was available in 665 STAAB participants (55 ± 11; 55% females) and in 536 EUROASPIRE-IV patients (67 ± 9; 18% females). Except for smoking, appropriate PLA was more frequently given in the secondary compared with the primary prevention sample. Determinants associated with appropriate PLA in primary prevention were: diabetes mellitus (odds ratio (OR) 4.54; 95% confidence interval (CI) 1.88-10.95), hyperlipidaemia (OR 3.12; 95% CI 2.06-4.73) and hypertension (OR 1.74; 95% CI 1.15-2.62); in secondary prevention: age (OR per year 0.96; 95% CI 0.93-0.98) and diabetes mellitus (OR 2.33; 95% CI 1.20-4.54). CONCLUSIONS: In primary prevention, PLA was mainly determined by the presence of vascular risk factors, whereas in secondary prevention the level of PLA was higher in general, but the association between CVD risk factors and PLA was less pronounced.

11.
Eur J Heart Fail ; 21(3): 322-333, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30604559

RESUMO

AIM: Serelaxin is a recombinant human relaxin-2 hormone, which confers receptor-mediated vasodilatation in a tissue-specific fashion. The RELAX-AHF-EU study assessed the effect of serelaxin when added to standard-of-care (SoC) therapy on worsening heart failure (WHF)/all-cause death through Day 5 in patients hospitalised for acute heart failure (AHF) in Europe. METHODS AND RESULTS: This multicentre, prospective, randomised, open-label, blinded-endpoint validation study enrolled hospitalised AHF patients and randomised (2:1) eligible patients (mild-to-moderate renal impairment and systolic blood pressure ≥ 125 mmHg) within 16 h of presentation with signs/symptoms of AHF, to receive 48 h intravenous infusion of 30 µg/kg/day serelaxin + SoC or SoC alone. The primary endpoint was adjudicated WHF/all-cause death through Day 5. Of 3183 patients targeted, 2666 were randomised when the study was terminated early by the sponsor due to the neutral results of the pivotal RELAX-AHF-2 study. Adjudicated WHF/all-cause death through Day 5 was significantly reduced in the serelaxin + SoC vs. SoC group (5.0% vs. 6.9%; hazard ratio 0.71; 95% confidence interval 0.51-0.98; P = 0.0172) (absolute risk reduction 1.9%, number needed to treat 53). The difference between treatment groups was not significant for WHF/all-cause death/heart failure rehospitalisation through Day 14 and length of hospital stay. A significantly smaller proportion of patients in the serelaxin + SoC vs. SoC group experienced persistent heart failure signs/symptoms at each visit until Day 4, or renal deterioration through Day 5 (all P ≤ 0.01). Overall incidence of treatment-emergent adverse events was comparable between treatment groups. Hypotension and decrease in haemoglobin/haematocrit were more frequent in the serelaxin + SoC group. CONCLUSION: When added to SoC, serelaxin reduced adjudicated WHF or all-cause death through Day 5 in AHF patients. The results from this open-label study should be considered in the context of the totality of the double-blind, randomised evidence on serelaxin in AHF.

12.
Artigo em Inglês | MEDLINE | ID: mdl-30553401

RESUMO

BACKGROUND: Epidemiologic studies on the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in heart failure are scarce, while one large intervention trial demonstrated a modest benefit. METHODS: This is a secondary analysis from the Interdisciplinary Network Heart Failure (INH) program. Patients hospitalized for systolic heart failure were enrolled and followed for 36 months. At baseline, whole blood samples from 899 patients were analyzed for fatty acid composition using a standardized analytical procedure (HS-Omega-3 Index®, O3-I). Associations of the O3-I with markers of heart failure severity, clinical characteristics, biomarkers, and mortality were analyzed. RESULTS: The mean O3-I was 3.7 ±â€¯1.0%. Patient mean age was 68 ±â€¯12 years (72% male, 43% in New York Heart Association (NYHA) class III or IV, mean LVEF 30 ±â€¯8%). During follow-up 258 patients (28.7%) died. After adjustment for potential confounders, the O3-I showed weak associations with uncured malignancy, end-systolic diameter of the left atrium, left ventricular end-diastolic and end-systolic diameters, and blood lipids and other laboratory parameters (all p < 0.05), but not with NYHA class, left ventricular ejection fraction, and the underlying cause of heart failure. The O3-I did not predict the 3-year mortality risk. CONCLUSIONS: Our results show a marked depletion of omega-3 fatty acids in patients hospitalized for decompensated heart failure (suggested target range 8-11%). Although the O3-I was associated with a panel of established risk indicators in heart failure, it did not predict mortality risk. CLINICAL TRIAL REGISTRATION: www.controlled-trials.com; ISRCTN23325295.

13.
Curr Heart Fail Rep ; 15(6): 398-410, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30402659

RESUMO

PURPOSE OF REVIEW: Depression, anxiety, and cognitive impairment constitute established risk markers for incident cardiovascular disease (CVD) and are associated with impaired life expectancy and quality of life and high hospitalization rates and healthcare expenditure. This review summarizes current knowledge about mental health disorders in patients with CVD and heart failure (HF). RECENT FINDINGS: Emerging evidence suggests various shared pathophysiological mechanisms between psychological comorbidities and CVD (e.g., systemic inflammation and autonomic dysfunction). Bi-directional interactions involving the central nervous and cardiovascular systems may help explain the rising prevalence of comorbid mood disorders with increasing CVD severity and support the concept of alternative pathophysiological mechanisms in the presence of severe somatic illness, making symptoms less responsive or unresponsive to psychotropic pharmacotherapy. Considering high prevalence and negative impact of psychological comorbidities in CVD and HF, routine care should integrate screening for these conditions. Multidisciplinary treatment approaches with active patient participation in disease management were shown to improve outcomes. However, better understanding of factors mediating the adverse prognostic effects of mood disorders is needed. This might enable more targeted treatment and possibly also facilitate better understanding of the pathophysiological mechanisms driving CVD.

14.
Magn Reson Med ; 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30417940

RESUMO

PURPOSE: Cardiac T1 mapping has become an increasingly important imaging technique, contributing novel diagnostic options. However, currently utilized methods are often associated with accuracy problems because of heart rate variations and cardiac arrhythmia, limiting their value in clinical routine. This study aimed to introduce an improved arrhythmia-related robust T1 mapping sequence called RT-TRASSI (real-time Triggered RAdial Single-Shot Inversion recovery). METHODS: All measurements were performed on a 3.0T whole-body imaging system. A real-time feedback algorithm for arrhythmia detection was implemented into the previously described pulse sequence. A programmable motion phantom was constructed and measurements with different simulated arrhythmias arranged. T1 mapping accuracy and susceptibility to artifacts were analyzed. In addition, in vivo measurements and comparisons with 3 prevailing T1 mapping sequences (MOLLI, ShMOLLI, and SASHA) were carried out to investigate the occurrence of artifacts. RESULTS: In the motion phantom measurements, RT-TRASSI showed excellent agreement with predetermined reference T1 values. Percentage scattering of the T1 values ranged from -0.6% to +1.9% in sinus rhythm and -1.0% to +3.1% for high-grade arrhythmias. In vivo, RT-TRASSI showed diagnostic image quality with only 6% of the acquired T1 maps including image artifacts. In contrast, more than 40% of the T1 maps acquired with MOLLI, ShMOLLI, or SASHA included motion artifacts. CONCLUSION: Accuracy issues because of heart rate variability and arrhythmia are a prevailing problem in current cardiac T1 mapping techniques. With RT-TRASSI, artifacts can be minimized because of the short acquisition time and effective real-time feedback, avoiding potential data acquisition during systolic heart phase.

15.
Circ Cardiovasc Imaging ; 11(8): e007131, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30354492

RESUMO

Background Long-term data on evolution and clinical impact of myocardial fibrosis in valvular heart disease are scarce. Methods and Results In this 10 years' extension of a prospective study in patients undergoing conventional aortic valve replacement because of symptomatic severe aortic valve stenosis, the impact of myocardial replacement fibrosis (MRF) on long-term outcome was assessed. Endomyocardial biopsies were acquired during aortic valve replacement in 58 consecutive patients. MRF was graded using the calculated percentage area of fibrosis and patients categorized as severe (n=21), mild (n=15), and no fibrosis (n=22). Echocardiography including strain imaging, as well as cardiovascular magnetic resonance, to assess late gadolinium enhancement was performed at baseline, 1, and 10 years after aortic valve replacement. Death of any cause occurred in 21 patients (38.9%): 3 (14.3%) in the group without MRF, 6 (42.9%) in the mild MRF group, and 12 (63.2%) in the severe MRF group ( P=0.006), resulting in the lowest cumulative survival for patients with severe MRF (log-rank P=0.003). In the group without MRF, none died of cardiovascular cause. MRF was found to be an independent predictor of survival (hazard ratio, 1.271; 95% CI, 1.032-1.564; P=0.024). Conclusions This 10-year follow-up study underlines the profound impact of replacement fibrosis with regard to cardiac and all-cause mortality in patients undergoing aortic valve replacement for severe aortic valve stenosis. Integrating cardiovascular magnetic resonance and echocardiographic functional imaging beyond ejection fraction quantification could help in clinical decision making to stratify patient prognosis with regard to myocardial longitudinal function and prevalence of replacement fibrosis.

17.
J Thorac Dis ; 10(8): 4966-4975, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30233871

RESUMO

Background: This study aimed to explore the value of cardiac biomarker [serum high sensitive troponin T (hs-TNT) and N-terminal pro-brain natriuretic peptide (NT-proBNP)] measurement in the differential diagnosis of infiltrative cardiomyopathy patients [Friedreich's ataxia (FA), Fabry disease (FD) and light-chain (AL) cardiac amyloidosis (CA)] with preserved left ventricular (LV) systolic function. Methods: Between 2012 and 2014, all consecutive patients presenting at our center with infiltrative cardiomyopathy and concomitant symmetrical LV hypertrophy as well as preserved LV systolic function were included in this study. Serum hs-TNT and NT-proBNP, morphologic and functional features derived from echocardiography and cardiac magnetic resonance imaging (cMRI) examinations were compared among these patients. Results: A total of 57 patients (FA 20, FD 23 and CA 14) were included. Hs-TNT and NT-proBNP levels were significantly higher in the CA group [median: hs-TNT 98 pg/mL, NT-proBNP 4,110 pg/mL] than in the FA group [hs-TNT 14 pg/mL, NT-proBNP 40 pg/mL] and FD group [hs-TNT 18 pg/mL, NT-proBNP 131 pg/mL, both P<0.001]. There was a negative correlation between NT-proBNP and estimated glomerular filtration rate (eGFR) in CA patients (r=-0.72, P=0.012). Both hs-TNT >60 pg/mL (sensitivity 0.79, specificity 0.93) and NT-proBNP >1,000 pg/mL (sensitivity 0.91, specificity 0.93) excellently differentiated CA from FA and FD. Conclusions: Increased hs-TNT and NT-proBNP levels are suggestive of CA diagnosis among patients with infiltrative cardiomyopathy and preserved LV ejection fraction.

18.
Clin Res Cardiol ; 2018 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-30097684

RESUMO

BACKGROUND: Depression is more common in females than in males and is 3-5 times more prevalent in patients with heart failure (HF) than in the general population. The 9-item Patient Health Questionnaire (PHQ-9) is a validated depression screening instrument; higher sum-scores predict adverse clinical outcomes. Sex- and gender differences in PHQ-9 symptom profile, diagnostic and prognostic properties, and impact on health-related quality of life (HRQOL) have not been comprehensively studied in HF patients. METHODS AND RESULTS: This post hoc analysis from the Interdisciplinary Network Heart Failure program enrolled 852/1022 participants (67 ± 13 years, 28% female) who completed the PHQ-9 at hospital discharge after cardiac decompensation. All had a left ventricular ejection fraction ≤ 40%. Women had a higher mean PHQ-9 sum-score than men (8.4 ± 5.6 vs. 7.4 ± 5.5; p = 0.027), and higher proportions rated the following items ≥ 2 (i.e., present on ≥ 50% of days): 'feeling down, hopeless' (25.8 vs. 18.0%; p = 0.011); 'fatigue' (51.9 vs. 37.2%; p < 0.001); and 'trouble concentrating' (21.6 vs. 15.4%; p = 0.032). A PHQ-9 sum-score ≥ 10 predicted increased mortality in women [hazard ratio 1.91 (95% confidence interval 1.06-3.43); p = 0.030] and men [2.10 (1.43-3.09); p < 0.001] and was associated with worse HRQOL (p < 0.001 for all comparisons). Sum-scores ≥ 10 predicted higher re-hospitalization rates in men only [1.35 (1.08-1.69); p = 0.008]. CONCLUSIONS: Differences in several PHQ-9 items indicated sex- or gender-specific depression symptomatology in HF. For both sexes, HRQOL and survival were worse when PHQ-9 sum-score was ≥ 10, but higher sum-scores predicted higher re-hospitalization rates in men only. Considering these specific aspects might help optimize care strategies in HF.

19.
Int J Cardiovasc Imaging ; 34(12): 1877-1887, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30039338

RESUMO

Low-dose dobutamine stress echocardiography (DSE) is a valuable tool to distinguish true-severe (TS) from pseudo-severe (PS) low gradient aortic valve stenosis (LGAS) in patients with reduced left ventricular ejection fraction (LVEF). However, only scanty studies reported the clinical utility of DSE in differentiating TS-LGAS patients with preserved LVEF. We investigated the clinical utility of DSE in LGAS patients with preserved LVEF and the echocardiographic determinants suggestive of TS-LGAS. 130 consecutive LGAS patients [indexed aortic valve area (AVA) ≤ 0.6cm2/m2 and mean trans-aortic pressure gradient (PGmean) < 40mmHg] with preserved (≥ 50%, n = 63) and reduced (< 50%, n = 67) LVEF were included. DSE defined TS-LGAS (projected AVA ≤ 1 cm2) in 61.2% patients with reduced LVEF and in 68.3% patients with preserved LVEF. Multivariate logistic regression analysis showed that baseline AVA was an independent determinant of TS-LGAS both in LVEF ≥ 50% (OR 0.45, P = 0.004) and LVEF < 50% groups (OR 0.55, P = 0.005). Reduced septal and lateral mitral annular plane systolic excursion (MAPSE, OR 0.72 and 0.75, P = 0.013 and 0.016) and septal TDI-s´ were significantly associated with TS-LGAS in patients with LVEF ≥ 50%. Higher systolic pulmonary artery pressure (SPAP, OR 1.43, P = 0.045) was associated with TS-LGAS in patients with LVEF < 50%. DSE is useful to define TS-LGAS also in patients with preserved LVEF. Lower baseline AVA values are linked with TS-LGAS in both patients with reduced and preserved LVEF. Reduced MAPSE and septal TDI-s´ are suggestive of TS-LGAS in patients with preserved LVEF, while higher SPAP is associated with TS-LGAS in patients with reduced LVEF.

20.
Int J Stroke ; : 1747493018784478, 2018 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-30058959

RESUMO

Background Covert vascular disease of the brain manifests as infarcts, white matter hyperintensities, and microbleeds on MRI. Their cumulative effect is often a decline in cognition, motor impairment, and psychiatric disorders. Preventive therapies for covert brain ischemia have not been established but represent a huge unmet clinical need. Aims The MRI substudy examines the effects of the antithrombotic regimens in COMPASS on incident covert brain infarcts (the primary outcome), white matter hyperintensities, and cognitive and functional status in a sample of consenting COMPASS participants without contraindications to MRI. Methods COMPASS is a randomized superiority trial testing rivaroxaban 2.5 mg bid plus acetylsalicylic acid 100 mg and rivaroxaban 5 mg bid against acetylsalicylic acid 100 mg per day for the combined endpoint of MI, stroke, and cardiovascular death in individuals with stable coronary artery disease or peripheral artery disease. T1-weighted, T2-weighted, T2*-weighted, and FLAIR images were obtained close to randomization and near the termination of assigned antithrombotic therapy; biomarker and genetic samples at randomization and one month, and cognitive and functional assessment at randomization, after two years and at the end of study. Results Between March 2013 and May 2016, 1905 participants were recruited from 86 centers in 16 countries. Of these participants, 1760 underwent baseline MRI scans that were deemed technically adequate for interpretation. The mean age at entry of participants with interpretable MRI was 71 years and 23.5% were women. Coronary artery disease was present in 90.4% and 28.1% had peripheral artery disease. Brain infarcts were present in 34.8%, 29.3% had cerebral microbleeds, and 93.0% had white matter hyperintensities. The median Montreal Cognitive Assessment score was 26 (interquartile range 23-28). Conclusions The COMPASS MRI substudy will examine the effect of the antithrombotic interventions on MRI-determined covert brain infarcts and cognition. Demonstration of a therapeutic effect of the antithrombotic regimens on brain infarcts would have implications for prevention of cognitive decline and provide insight into the pathogenesis of vascular cognitive decline.

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