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1.
Laryngoscope ; 2019 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-31471971

RESUMO

OBJECTIVES: The human sense of smell constitutes the main part of flavor perception. Typically, patients with loss of olfactory function complain of diminished perception during eating and drinking. However, some patients with smell loss still report normal enjoyment of foods. The aim of the present study was to compare orthonasal and retronasal olfactory function in patients with non-sinonasal smell loss and subjectively normal flavor perception. METHODS: Nineteen patients (mean age [range] 52.0 [8-83 years]) with self-reported olfactory impairment but subjective normal flavor perception were included. Olfactory performance was assessed using the Sniffin' Sticks (TDI) for orthonasal and the Candy Smell Test (CST) for retronasal function. Visual analogue scales were used for self-assessment of odor (SOP), taste (STP), and flavor perception (SFP), ranging from 0 (no perception) to 10 (excellent perception). RESULTS: Mean (SD) SFP was 8.0 (1.8). Mean (SD) orthonasal TDI-score of all patients was 14.4 (5.3, range 6-25.3) with 11 patients classified as anosmic and eight as hyposmic. Mean/SD retronasal CST-score was 8.8 (2.7, range 3-13) within the range of anosmia/hyposmia. No correlation was found between SFP and the CST (P = .62). CONCLUSION: The present results showed that despite claiming normal flavor perception, our patients were ortho- and retronasally dysosmic using standard tests for olfactory function. Although other explanations could be possible, we suggest that this subjective flavor perception might be due to unconscious memory recall from previously experienced cross-modal sensory interactions. LEVEL OF EVIDENCE: 4 Laryngoscope, 2019.

2.
J Am Coll Cardiol ; 2019 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-31479722

RESUMO

BACKGROUND: While guidelines recommend in-hospital initiation of high-intensity statin therapy in patients with acute coronary syndromes (ACS), low-density lipoprotein cholesterol (LDL-C) target levels are frequently not attained. Evolocumab, a rapidly acting, potent LDL-C-lowering drug, has not been studied in the acute phase of ACS. OBJECTIVES: To assess the feasibility, safety, and LDL-C lowering efficacy of evolocumab initiated during the in-hospital phase of ACS. METHODS: We conducted an investigator-initiated, randomized, double-blind, placebo-controlled trial involving 308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/L on high-intensity statin for at least 4 weeks; ≥2.3 mmol/L on low- or moderate-intensity statin; or ≥3.2 mmol/L on no stable dose of statin). Patients were randomly assigned 1:1 to receive subcutaneous evolocumab 420mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40mg. The primary endpoint was percentage change in calculated LDL-C from baseline to 8 weeks. RESULTS: Most patients (78.2%) had not been on previous statin treatment. Mean LDL-C levels decreased from 3.61 mmol/L to 0.79 mmol/L at week 8 in the evolocumab group, and from 3.42 mmol/L to 2.06 mmol/L in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% CI: -45.2 to -36.2; p<0.001). LDL-C levels <1.8 mmol/L were achieved at week 8 by 95.7% of patients in the evolocumab group vs. 37.6% in the placebo group. Adverse events and centrally adjudicated cardiovascular events were similar in both groups. CONCLUSIONS: In this first randomized trial assessing a PCSK9 antibody in the very high-risk setting of ACS, evolocumab added to high-intensity statin therapy was well tolerated and resulted in substantial reduction in LDL-C levels, rendering >95% of patients within currently recommended target levels.

3.
Acta Otolaryngol ; 139(10): 876-880, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31460819

RESUMO

Background: Rhinosinusitis may cause serious complications, such as secondary orbital infections, resulting in expansion and erosion of process through the orbital wall. Aims: The aim is to evaluate long-term outcome of ESS in patients suffered from endocrine ophthalmopathy and orbital complications of rhinosinusitis. Material and methods: Thirteen patients with loss of vision, endocrine ophthalmopathy and orbital complication of rhinosinusitis were treated by ESS. Preoperative and postoperative vision was rated by best-corrected visual acuity (BCVA) testing. Nine (69%) have been reinvestigated after 6 years by ophthalmology examination and 10-point scale for assessment of clinical symptoms. Results: The mean BCVA significantly increased after surgery comparing to results before surgery (0.84, 0.62; respectively) (p = .007). The mean values of 10-point scale for subjective assessment of symptoms 6 years after surgery were: headache 2.11, sinonasal pressure 1.72, subjective estimation of vision quality on the affected eye was 7.33 and olfaction 7.66. None of the patients developed impairment of vision loss in postoperative period. Conclusions: Long-term outcome of ESS showed decreased symptoms in patients who had endocrine ophthalmopathy and orbital complication of rhinosinusitis. Significance: ESS has numerous advantages for patients with orbital complication and vision loss comparing to conservative treatment and should be considered even in abscess absence.

4.
Nat Biotechnol ; 37(8): 884-894, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31375812

RESUMO

Sustained silencing of gene expression throughout the brain using small interfering RNAs (siRNAs) has not been achieved. Here we describe an siRNA architecture, divalent siRNA (di-siRNA), that supports potent, sustained gene silencing in the central nervous system (CNS) of mice and nonhuman primates following a single injection into the cerebrospinal fluid. Di-siRNAs are composed of two fully chemically modified, phosphorothioate-containing siRNAs connected by a linker. In mice, di-siRNAs induced the potent silencing of huntingtin, the causative gene in Huntington's disease, reducing messenger RNA and protein throughout the brain. Silencing persisted for at least 6 months, with the degree of gene silencing correlating to levels of guide strand tissue accumulation. In cynomolgus macaques, a bolus injection of di-siRNA showed substantial distribution and robust silencing throughout the brain and spinal cord without detectable toxicity and with minimal off-target effects. This siRNA design may enable RNA interference-based gene silencing in the CNS for the treatment of neurological disorders.

5.
Circulation ; 2019 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-31416346

RESUMO

BACKGROUND: Variations in cardiac troponin concentrations by age, sex and time between samples in patients with suspected myocardial infarction are not currently accounted for in diagnostic approaches. We aimed to combine these variables through machine learning to improve the assessment of risk for individual patients. METHODS: A machine learning algorithm (myocardial-ischemic-injury-index [MI3]) incorporating age, sex, and paired high-sensitivity cardiac troponin I concentrations, was trained on 3,013 patients and tested on 7,998 patients with suspected myocardial infarction. MI3 uses gradient boosting to compute a value (0-100) reflecting an individual's likelihood of a diagnosis of type 1 myocardial infarction and estimates the sensitivity, negative predictive value (NPV), specificity and positive predictive value (PPV) for that individual. Assessment was by calibration and area under the receiver-operating-characteristic curve (AUC). Secondary analysis evaluated example MI3 thresholds from the training set that identified patients as low-risk (99% sensitivity) and high-risk (75% PPV), and performance at these thresholds was compared in the test set to the 99th percentile and European Society of Cardiology (ESC) rule-out pathways. RESULTS: Myocardial infarction occurred in 404 (13.4%) patients in the training set and 849 (10.6%) patients in the test set. MI3 was well calibrated with a very high AUC of 0.963 [0.956-0.971] in the test set and similar performance in early and late presenters. Example MI3 thresholds identifying low-risk and high-risk patients in the training set were 1.6 and 49.7 respectively. In the test set, MI3 values were <1.6 in 69.5% with a NPV of 99.7% (99.5%-99.8%) and sensitivity of 97.8% (96.7-98.7%), and were ≥49.7 in 10.6% with a PPV of 71.8% (68.9-75.0%) and specificity of 96.7% (96.3-97.1%). Using these thresholds, MI3 performed better than the ESC 0/3-hour pathway (sensitivity 82.5% [74.5-88.8%], specificity 92.2% [90.7-93.5%]) and the 99th percentile at any time-point (sensitivity 89.6% [87.4-91.6%]), specificity 89.3% [88.6-90.0%]). CONCLUSIONS: Using machine learning, MI3 provides an individualized and objective assessment of the likelihood of myocardial infarction, which can be used to identify low-risk and high-risk patients who may benefit from earlier clinical decisions. CLINICAL TRIAL REGISTRATION: Unique Identifier: Australian New Zealand Clinical Trials Registry: ACTRN12616001441404. URL: https://www.anzctr.org.au.

6.
J Am Coll Cardiol ; 74(7): 842-854, 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31416527

RESUMO

BACKGROUND: Early and accurate detection of short-term major adverse cardiac events (MACE) in patients with suspected acute myocardial infarction (AMI) is an unmet clinical need. OBJECTIVES: The goal of this study was to test the hypothesis that adding clinical judgment and electrocardiogram findings to the European Society of Cardiology (ESC) high-sensitivity cardiac troponin (hs-cTn) measurement at presentation and after 1 h (ESC hs-cTn 0/1 h algorithm) would further improve its performance to predict MACE. METHODS: Patients presenting to an emergency department with suspected AMI were enrolled in a prospective, multicenter diagnostic study. The primary endpoint was MACE, including all-cause death, cardiac arrest, AMI, cardiogenic shock, sustained ventricular arrhythmia, and high-grade atrioventricular block within 30 days including index events. The secondary endpoint was MACE + unstable angina (UA) receiving early (≤24 h) revascularization. RESULTS: Among 3,123 patients, the ESC hs-cTnT 0/1 h algorithm triaged significantly more patients toward rule-out compared with the extended algorithm (60%; 95% CI: 59% to 62% vs. 45%; 95% CI: 43% to 46%; p < 0.001), while maintaining similar 30-day MACE rates (0.6%; 95% CI: 0.3% to 1.1% vs. 0.4%; 95% CI: 0.1% to 0.9%; p = 0.429), resulting in a similar negative predictive value (99.4%; 95% CI: 98.9% to 99.6% vs. 99.6%; 95% CI: 99.2% to 99.8%; p = 0.097). The ESC hs-cTnT 0/1 h algorithm ruled-in fewer patients (16%; 95% CI: 14.9% to 17.5% vs. 26%; 95% CI: 24.2% to 27.2%; p < 0.001) compared with the extended algorithm, albeit with a higher positive predictive value (76.6%; 95% CI: 72.8% to 80.1% vs. 59%; 95% CI: 55.5% to 62.3%; p < 0.001). For 30-day MACE + UA, the ESC hs-cTnT 0/1 h algorithm had a higher positive predictive value for rule-in, whereas the extended algorithm had a higher negative predictive value for the rule-out. Similar findings emerged when using hs-cTnI. CONCLUSIONS: The ESC hs-cTn 0/1 h algorithm better balanced efficacy and safety in the prediction of MACE, whereas the extended algorithm is the preferred option for the rule-out of 30-day MACE + UA. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE]; NCT00470587).

9.
J Am Coll Cardiol ; 74(6): 744-754, 2019 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-31395124

RESUMO

BACKGROUND: The prevalence of pulmonary embolism (PE) in patients presenting with syncope to the emergency department (ED) is largely unknown. This information, however, is necessary to balance the potential medical benefit or harm of systematic PE screening in patients presenting with syncope to the ED. OBJECTIVES: This study sought to determine the prevalence of PE in patients with syncope. METHODS: Unselected patients presenting with syncope to the ED were prospectively enrolled in a diagnostic multicenter study. Pre-test clinical probability for PE was assessed using the 2-level Wells score and the results of D-dimer testing using age-adapted cutoffs. Presence of PE was evaluated by imaging modalities, when ordered as part of the clinical assessment by the treating ED physician or by long-term follow-up data. RESULTS: Long-term follow-up was complete in 1,380 patients (99%) at 360 days and 1,156 patients (83%) at 720 days. Among 1,397 patients presenting with syncope to the ED, PE was detected at presentation in 19 patients (1.4%; 95% confidence interval [CI]: 0.87% to 2.11%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.5% to 1.5%). In the subgroup of patients hospitalized (47%), PE was detected at presentation in 15 patients (2.3%; 95% CI: 1.4% to 3.7%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.4% to 2.0%). CONCLUSIONS: PE seems to be a rather uncommon cause of syncope among patients presenting to the ED. Therefore, systematic PE-screening in all patients with syncope does not seem warranted. (BAsel Syncope EvaLuation Study [BASEL IX]; NCT01548352).

10.
N Engl J Med ; 381(8): 716-726, 2019 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-31433919

RESUMO

BACKGROUND: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 µg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).


Assuntos
Doenças Cardiovasculares/mortalidade , Insuficiência Cardíaca/tratamento farmacológico , Relaxina/uso terapêutico , Vasodilatadores/uso terapêutico , Doença Aguda , Idoso , Pressão Sanguínea/efeitos dos fármacos , Progressão da Doença , Método Duplo-Cego , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Hospitalização , Humanos , Incidência , Infusões Intravenosas , Masculino , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacologia , Proteínas Recombinantes/uso terapêutico , Relaxina/efeitos adversos , Relaxina/farmacologia , Falha de Tratamento , Vasodilatadores/efeitos adversos
11.
J Am Coll Cardiol ; 74(4): 483-494, 2019 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-31345421

RESUMO

BACKGROUND: The European Society of Cardiology (ESC) recommends the 0/1-h algorithm for rapid triage of patients with suspected non-ST-segment elevation myocardial infarction (MI). However, its impact on patient management and safety when routinely applied is unknown. OBJECTIVES: This study sought to determine these important real-world outcome data. METHODS: In a prospective international study enrolling patients presenting with acute chest discomfort to the emergency department (ED), the authors assessed the real-world performance of the ESC 0/1-h algorithm using high-sensitivity cardiac troponin T embedded in routine clinical care and its associated 30-day rates of major adverse cardiac events (MACE) (the composite of cardiovascular death and MI). RESULTS: Among 2,296 patients, non-ST-segment elevation MI prevalence was 9.8%. In median, 1-h blood samples were collected 65 min after the 0-h blood draw. Overall, 94% of patients were managed without protocol violations, and 98% of patients triaged toward rule-out did not require additional cardiac investigations including high-sensitivity cardiac troponin T measurements at later time points or coronary computed tomography angiography in the ED. Median ED stay was 2 h and 30 min. The ESC 0/1-h algorithm triaged 62% of patients toward rule-out, and 71% of all patients underwent outpatient management. Proportion of patients with 30-day MACE were 0.2% (95% confidence interval: 03% to 0.5%) in the rule-out group and 0.1% (95% confidence interval: 0% to 0.2%) in outpatients. Very low MACE rates were confirmed in multiple subgroups, including early presenters. CONCLUSIONS: These real-world data document the excellent applicability, short time to ED discharge, and low rate of 30-day MACE associated with the routine clinical use of the ESC 0/1-h algorithm for the management of patients presenting with acute chest discomfort to the ED.

13.
Diagnosis (Berl) ; 6(3): 189-201, 2019 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-31271552

RESUMO

Skeletal myopathies have been suggested as a non-cardiac cause of elevations of cardiac troponin (cTn), particularly cardiac troponin T (cTnT). This is of major clinical relevance and concern as cTn plays a major role in the early diagnosis of myocardial infarction (MI). While both the incidence as well as the true pathophysiology (cardiac versus non-cardiac) underlying elevations in cTn in skeletal myopathies remain largely unknown, re-expression of cTnT in regenerating adult skeletal muscle has been suggested as a possible contributor. However, unequivocal protein characterization in skeletal muscle and quantification of the relative amounts of this possible signal versus the cTn signal derived from true cardiomyocyte injury remains elusive. Alternatively, minor cross-reactivity of the cTnT (and possibly at times also cTnI) detection and capture antibodies used in current monoclonal immunoassays with the skeletal troponin T or I isoform may be considered. Both would represent "false positive" elevations from a clinical perspective and would need to be reliably differentiated from "true positive elevations" from subclinical cardiomyocyte injury not detectable by currently available imaging techniques such as echocardiography and contrast enhanced magnetic resonance imaging (MRI), which have at least a 5 times lower sensitivity for cardiomyocyte injury. This review aims to explore the currently available data, its methodological limitations and provide guidance to clinicians to avoid misinterpretation of cTn concentrations.

14.
Eur J Heart Fail ; 21(6): 715-731, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31222929

RESUMO

Natriuretic peptide [NP; B-type NP (BNP), N-terminal proBNP (NT-proBNP), and midregional proANP (MR-proANP)] concentrations are quantitative plasma biomarkers for the presence and severity of haemodynamic cardiac stress and heart failure (HF). End-diastolic wall stress, intracardiac filling pressures, and intracardiac volumes seem to be the dominant triggers. This paper details the most important indications for NPs and highlights 11 key principles underlying their clinical use shown below. NPs should always be used in conjunction with all other clinical information. NPs are reasonable surrogates for intracardiac volumes and filling pressures. NPs should be measured in all patients presenting with symptoms suggestive of HF such as dyspnoea and/or fatigue, as their use facilitates the early diagnosis and risk stratification of HF. NPs have very high diagnostic accuracy in discriminating HF from other causes of dyspnoea: the higher the NP, the higher the likelihood that dyspnoea is caused by HF. Optimal NP cut-off concentrations for the diagnosis of acute HF (very high filling pressures) in patients presenting to the emergency department with acute dyspnoea are higher compared with those used in the diagnosis of chronic HF in patients with dyspnoea on exertion (mild increase in filling pressures at rest). Obese patients have lower NP concentrations, mandating the use of lower cut-off concentrations (about 50% lower). In stable HF patients, but also in patients with other cardiac disorders such as myocardial infarction, valvular heart disease, atrial fibrillation or pulmonary embolism, NP concentrations have high prognostic accuracy for death and HF hospitalization. Screening with NPs for the early detection of relevant cardiac disease including left ventricular systolic dysfunction in patients with cardiovascular risk factors may help to identify patients at increased risk, therefore allowing targeted preventive measures to prevent HF. BNP, NT-proBNP and MR-proANP have comparable diagnostic and prognostic accuracy. In patients with shock, NPs cannot be used to identify cause (e.g. cardiogenic vs. septic shock), but remain prognostic. NPs cannot identify the underlying cause of HF and, therefore, if elevated, must always be used in conjunction with cardiac imaging.

15.
Eur Heart J ; 40(24): 1952-1960, 2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-31226214

RESUMO

AIMS: The diagnosis of acute aortic syndromes (AASs) is challenging and requires integrated strategies. Transthoracic focused cardiac ultrasound (FoCUS) is endorsed by guidelines as a first-line/triage tool allowing rapid bedside assessment of the aorta. However, the performance of FoCUS in the European Society of Cardiology-recommended workup of AASs awaits validation. METHODS AND RESULTS: This was a prespecified subanalysis of the ADvISED multicentre prospective study. Patients with suspected AAS underwent FoCUS for detection of direct/indirect signs of AAS. Clinical probability assessment was performed with the aortic dissection detection risk score (ADD-RS). Case adjudication was based on advanced imaging, surgery, autopsy, or 14-day follow-up. An AAS was diagnosed in 146 (17.4%) of 839 patients. Presence of direct FoCUS signs had a sensitivity and specificity of 45.2% [95% confidence interval (CI) 37-53.6%] and 97.4% (95% CI 95.9-98.4%), while presence of any FoCUS sign had a sensitivity and specificity of 89% (95% CI 82.8-93.6%) and 74.5% (95% CI 71-77.7%) for AAS. The additive value of FoCUS was most evident within low clinical probability (ADD-RS ≤1). Herein, direct FoCUS signs were identified in 40 (4.8%) patients (P < 0.001), including 29 with AAS. ADD-RS ≤1 plus negative FoCUS for AAS rule-out had a sensitivity of 93.8% (95% CI 88.6-97.1%) and a failure rate of 1.9% (95% CI 0.9-3.6%). Addition of negative D-dimer led to a failure rate of 0% (95% CI 0-1.2%). CONCLUSION: FoCUS has additive value in the workup of AASs. Direct FoCUS signs can rapidly identify patients requiring advanced imaging despite low clinical probability. In integrated bundles, negative FoCUS is useful for rule-out of AASs.

16.
Acad Emerg Med ; 2019 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-31220387

RESUMO

OBJECTIVES: Guidelines recommend chest radiography (CR) in the workup of suspected acute aortic syndromes (AASs) if the pretest clinical probability is low. However, the diagnostic impact of CR integration for the rule-in and rule-out of AASs is unknown. METHODS: We performed a secondary analysis of the ADvISED multicenter study. Emergency department outpatients were eligible if an AAS was clinically suspected. Clinical probability was defined with the aortic dissection detection risk score (ADD-RS). CR was evaluated blindly by a radiologist, who judged on mediastinum enlargement (ME) and other signs. RESULTS: In 2014 through 2016, a total of 1,129 patients were enrolled and 1,030 were analyzed, including 48 (4.7%) with AASs. ADD-RS/ME and ADD-RS/any CR sign (aCRs) integration were more accurate than ADD-RS alone (area under the curve = 0.8 and 0.78 vs. 0.66, p < 0.001). The sensitivity and specificity of the integrated strategies were 66.7% (95% confidence interval [CI] = 51.5% to 79.9%) and 82.5% (95% CI = 79.9% to 84.8%) for ADD-RS/ME and 68.8% (95% CI = 53.6% to 80.9%) and 76.5% (95% CI = 73.7% to 79.1%) for ADD-RS/aCRs, respectively. The sensitivity and specificity of CR per se were 54.2% (95% CI = 39.2% to 68.6%) and 92.4% (95% CI = 90.5% to 93.9%) for ME and 60.4% (95% CI = 45.3% to 74.2%) and 85.2% (95% CI = 82.9% to 87.4%) for aCRs. The agreement (κ) between attending physicians and radiologists for ME was 0.44 (95% CI = 0.35 to 0.54). ADD-RS/ME rule-in (ADD-RS ≤ 1 and ME-present, or ADD-RS > 1) applied to 204 versus 130 patients with ADD-RS > 1, including 14 with AAS and 60 false-positives (FP). ADD-RS/aCRs rule-in (ADD-RS ≤ 1 and aCRs-present, or ADD-RS > 1) applied to 264 patients, including 15 with AAS and 119 FP. ADD-RS/ME rule-out (ADD-RS ≤ 1 and ME-absent) applied to 826 (80.2%) patients, including 16 with AAS (33.3% of cases). ADD-RS/aCRs rule-out (ADD-RS ≤ 1 and aCRs-absent) applied to 766 patients (74.4%), including 15 with AAS (31.3% of cases). CONCLUSIONS: CR integration with clinical probability assessment showed modest rule-in efficiency and insufficient sensitivity for conclusive rule-out.

17.
Int J Cardiol ; 292: 241-245, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31174919

RESUMO

BACKGROUND: To assess the prognostic performance of Growth differentiation factor-15 (GDF-15) concentrations in unselected patients presenting with suspected acute myocardial infarction (AMI) and adjudication based on high-sensitivity cardiac troponin (hs-cTn). METHODS AND RESULTS: In an ongoing prospective multicenter diagnostic study, consecutive patients presenting with suspected AMI to the emergency department and available GDF-15 and hs-cTnT concentrations were included. Adjudication of AMI was performed central by two independent cardiologists using all available clinical information including cardiac imaging and serial hs-cTn concentrations. Overall, 718 patients were included, with 23% (162/718) having an adjudicated diagnosis of AMI. The cumulative incidence of death within 2 years was 19% in patients with AMI (30 deaths in 162 patients) versus 5% in patients without AMI (25 deaths in 556 patients; P < 0.001). In AMI patients, GDF-15 provided an AUC of 0.89 (95% confidence interval [CI] 0.83-0.94) for 2-year death versus 0.55 (95% CI 0.44-0.66) for hs-cTnT (P < 0.001). A GDF-15 cutoff of ≤1560 ng/L predicted 2-year survival in 47% (76/162) of AMI patients and had 100% sensitivity (95% CI 88-100%) for 2-year death. In patients without AMI, GDF-15 provided an AUC of 0.83 (95% CI 0.76-0.89) versus 0.76 (95% CI 0.67-0.85) for hs-cTnT (P = 0.096). A GDF-15 cutoff of ≤886 ng/L predicted 2-year survival in 37% (203/556) of non-AMI patients and had 100% sensitivity (95% CI 86-100%) for 2-year death. CONCLUSIONS: GDF-15 concentrations at emergency department presentation have a high predictive accuracy for all-cause death in patients with suspected AMI and allow the identification of a large proportion of AMI patients with very low mortality risk.

18.
Eur J Heart Fail ; 21(7): 827-843, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31243866

RESUMO

Peripartum cardiomyopathy (PPCM) is a potentially life-threatening condition typically presenting as heart failure with reduced ejection fraction (HFrEF) in the last month of pregnancy or in the months following delivery in women without another known cause of heart failure. This updated position statement summarizes the knowledge about pathophysiological mechanisms, risk factors, clinical presentation, diagnosis and management of PPCM. As shortness of breath, fatigue and leg oedema are common in the peripartum period, a high index of suspicion is required to not miss the diagnosis. Measurement of natriuretic peptides, electrocardiography and echocardiography are recommended to promptly diagnose or exclude heart failure/PPCM. Important differential diagnoses include pulmonary embolism, myocardial infarction, hypertensive heart disease during pregnancy, and pre-existing heart disease. A genetic contribution is present in up to 20% of PPCM, in particular titin truncating variant. PPCM is associated with high morbidity and mortality, but also with a high probability of partial and often full recovery. Use of guideline-directed pharmacological therapy for HFrEF is recommended in all patients respecting contraindications during pregnancy/lactation. The oxidative stress-mediated cleavage of the hormone prolactin into a cardiotoxic fragment has been identified as a driver of PPCM pathophysiology. Pharmacological blockade of prolactin release using bromocriptine as a disease-specific therapy in addition to standard therapy for heart failure treatment has shown promising results in two clinical trials. Thresholds for devices (implantable cardioverter-defibrillators, cardiac resynchronization therapy and implanted long-term ventricular assist devices) are higher in PPCM than in other conditions because of the high rate of recovery. The important role of education and counselling around contraception and future pregnancies is emphasised.

19.
Eur J Heart Fail ; 21(7): 844-851, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31218825

RESUMO

Lung ultrasound is a useful tool for the assessment of patients with both acute and chronic heart failure, but the use of different image acquisition methods, inconsistent reporting of the technique employed and variable quantification of 'B-lines,' have all made it difficult to compare published reports. We therefore need to ensure that future studies utilizing lung ultrasound in the assessment of heart failure adopt a standardized approach to reporting the quantification of pulmonary congestion. Strategies to improve patient care by use of lung ultrasound in the assessment of heart failure have been difficult to develop. In the present document, key aspects of standardization are discussed, including equipment used, number of chest zones assessed, the method of quantifying B-lines, the presence and timing of additional investigations (e.g. natriuretic peptides and echocardiography) and the impact of therapy. This consensus report includes a checklist to provide standardization in the preparation, review and analysis of manuscripts. This will serve as a guide for investigators and clinicians and enhance the quality and transparency of lung ultrasound research.

20.
Ophthalmol Retina ; 3(9): 753-759, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31153850

RESUMO

PURPOSE: A recent increase in sterile intraocular inflammation after aflibercept (EYLEA; Regeneron Pharmaceuticals, Inc, Tarrytown, NY) injection was reported to the American Society of Retina Specialists' Research and Safety in Therapeutics Committee. This study describes their clinical characteristics and outcomes. DESIGN: Case series. PARTICIPANTS: Sixty-eight eyes of 66 patients (97% reported from May 2017 through February 2018). METHODS: Exclusion criteria were intravitreal antibiotic injection and follow-up of less than 7 days. Diagnosis was at each physician's discretion. MAIN OUTCOME MEASURES: Presenting signs and symptoms, injection characteristics, management details, and visual outcomes. RESULTS: Mean time to presentation was 2.6 days (median, 2.0 days; range, 0-15 days). Symptoms included blurry vision (93%), floaters (60%), pain (44%), severe pain (6%), and photophobia (19%). Mean visual acuities before and after injection were 20/50 and 20/178, respectively. All patients showed intraocular inflammation: 24% with only vitritis, 16% with only anterior chamber reaction, and 60% with both. Less common findings included keratic precipitates (22%), corneal edema (13%), conjunctival injection (10%), chemosis (4%), hypopyon (4%), and fibrin (3%). Two patients were affected bilaterally. Treatment included topical steroids (93%), with 1% supplemented by oral steroids. Inflammation resolved in 79% at study completion (mean, 34 days; range, 7-105 days; 51% resolved by 1 month). This group's mean final visual acuity (VA) was 20/55, and 15% lost 2 lines or more. This vision loss was associated with shorter time to presentation (P < 0.0001), magnitude of decrease in presenting VA (P = 0.0004), presence of fibrin (P = 0.02), and trended toward receiving only observation (P = 0.10). There were no other presenting factors that significantly affected visual outcome. In patients with unresolved inflammation at the final visit, mean follow-up was 29 days, and mean final VA was 20/118. Overall, 26 aflibercept lots were involved. CONCLUSIONS: This is the largest study of aflibercept-related sterile intraocular inflammation, and is the only large report to exclude eyes injected with intraocular antibiotics. Most patients presented early with decreased VA and intraocular inflammation, but without injection, hypopyon, fibrin, or severe pain. Final VA remained decreased in a significant minority of patients.

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