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1.
CVIR Endovasc ; 7(1): 18, 2024 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-38353904

RESUMO

BACKGROUND: In radiologically guided interventions, medical practitioners are subjected to radiation exposure, which may lead to radiation-induced diseases. In this study, novel radiation shields for the head and neck were evaluated for their potential to reduce radiation exposure. METHOD: An anthropomorphic phantom was exposed on its left side to scattered radiation from beneath to simulate the exposure of an operator in a x-ray operating room. Thermoluminescent dosimeters (TLDs) were positioned at different depths in five slices in the phantom, measuring personal dose equivalent. Two different set up situations were evaluated: a head protector designed to reduce radiation in the upper section of the head; and a novel thyroid protector prototype extended in the front and on both sides, designed to reduce radiation in the lower and middle sections of the head. A standard thyroid collar prototype and a ceiling mounted lead glass shield were used as comparisons. Furthermore, the head protector was evaluated in a clinical study in which TLDs were positioned to measure scattered radiation exposure to the heads of operators during endovascular interventions. RESULTS: The extended thyroid protector reduced the scattered radiation in the throat, chin, and ear slices. Some shielding effect was seen in the brain and skull slices. The head protector showed a shielding effect in the skull slice up to two cm depth where it covered the phantom head. As expected, the ceiling mounted lead glass shield reduced the scattered radiation in all measuring points. CONCLUSIONS: A ceiling mounted lead glass shield is an effective radiation protection for the head, but in clinical practice, optimal positioning of a ceiling mounted lead shield may not always be possible, particularly during complex cases when radiation protection may be most relevant. Added protection using these novel guards may compliment the shielding effect of the ceiling mounted lead shield. The head protector stand-alone did not provide sufficient protection of the head. The extended thyroid protector stand-alone provided sufficient protection in the lower and middle sections of the head and neck.

2.
Eur Heart J Case Rep ; 7(6): ytad259, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37323528

RESUMO

Background: A case of stent thrombosis as a complication of coronary bifurcation stenting is described. We review potential complications of bifurcation stenting and established guidelines. Case summary: A 64-year-old man presented with a non-ST segment elevation myocardial infarction. High-sensitivity troponin I peaked at 99 000 ng/L (normal <5). He previously had coronary stenting for stable angina when residing in another country 2 years previously. Coronary angiography revealed no significant stenosis with TIMI 3 flow in all vessels. Cardiac magnetic resonance imaging demonstrated a left anterior descending artery (LAD) territory regional motion abnormality, late gadolinium enhancement consistent with recent infarction, and a left ventricular apical thrombus. Repeat angiography and intravascular ultrasound (IVUS) confirmed bifurcation stenting at the junction of the LAD and second diagonal (D2) with protrusion of several millimetres of the uncrushed proximal segment of the D2 stent in the LAD vessel lumen. There was under-expansion of the LAD stent in the mid-vessel and stent malapposition in the proximal LAD, extending into the distal left main stem coronary artery and involving the ostium of the left circumflex coronary artery. Percutaneous balloon angioplasty was performed along the length of the stent, including an internal crush of the D2 stent. Coronary angiography confirmed a uniform expansion of the stented segments and TIMI 3 flow. Final IVUS confirmed full stent expansion and apposition. Discussion: This case highlights the importance of provisional stenting as a default strategy and familiarity with procedural steps in bifurcation stenting. Furthermore, it emphasizes the benefit of intravascular imaging for lesion characterization and stent optimization.

3.
Risk Anal ; 43(2): 391-404, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35212002

RESUMO

The nature of the current rotating roster, providing 24-h air traffic services over five irregular shifts, leads to accumulated fatigue which impairs air traffic controllers' cognitive function and task performance. It is imperative to develop an effective fatigue risk management system to improve aviation safety based upon scientific approaches. Two empirical studies were conducted to address this issue. Study 1 investigated the mixed effect of circadian rhythm disorders and resource depletion on controllers' accumulated fatigue. Then, study 2 proposed a potential biofeedback solution of quick coherence technique which can mitigate air traffic controllers' (ATCOs') fatigue while on controller working position and improve ATCOs' mental/physical health. The current two-studies demonstrated a scientific approach to fatigue analysis and fatigue risk mitigation in the air traffic services domain. This research offers insights into the fluctuation of ATCO fatigue levels and the influence of a numbers of factors related to circadian rhythm and resource depletion impact on fatigue levels on study 1; and provides psychophysiological coherence training to increase ATCOs' fatigue resilience to mitigate negative impacts of fatigue on study 2. Based on these two studies, the authors recommended that an extra short break for air traffic controllers to permit practicing the quick coherence breathing technique for 5 min at the sixth working hour could substantially recharge cognitive resources and increase fatigue resilience. Application: Present studies highlight an effective fatigue intervention based on objective biofeedback to moderate controllers' accumulated fatigue as a result of rotating shift work. Accordingly, air navigation services providers and regulators can develop fatigue risk management systems based on scientific approaches to improve aviation safety and air traffic controller's wellbeing.


Assuntos
Aviação , Humanos , Análise e Desempenho de Tarefas , Cognição , Fadiga
4.
Ergonomics ; 66(8): 1176-1189, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36305276

RESUMO

This study investigates the effect of quick coherence technique (QCT) on commercial pilots' resilience to the unprecedented impact of a pandemic. Eighteen commercial pilots voluntarily participated in a 2-day training course on QCT followed by 2 months of self-regulated QCT practicing during controlled rest in the flight deck and day-to day life. There are subjective and objective assessments to evaluate the effects of QCT on commercial pilots' psychophysiological resilience. Results demonstrated that QCT training can significantly increase pilots' psychophysiological resilience thereby improving their mental/physical health, cognitive functions, emotional stability and wellness on both subjective (PSS & AWSA) and objective measures (coherence scores). Moreover, pilots who continued practicing self-regulated QCT gained the maximum benefits. Current research has identified great potential to enhance pilots' mental/physical health via QCT training. Operators can develop peer support programs for pilots to increase resilience and maintain mental and physical health using the QCT technique. Practitioner summary: QCT breathing has been proven to increase commercial pilots' resilience by moderating psychophysiological coherence, strengthening mental/physical capacity and sustaining positive emotions to deal with the challenges both on the flight deck and in everyday life.HIGHLIGHTSPilots have suffered from the impact of the Covid-19 pandemic across many factors including social, economic, mental, physical, emotional, and operational issuesBiofeedback training can increase commercial pilots' resilience by moderating psychophysiological coherence, strengthening mental and physical capacitySelf-regulated practicing QCT to form a habitual behaviour is required to sustain the maximum benefits either in the flight or day-to-day lifeQCT is an effective intervention for aviation authorities and airline operators to develop peer support programs to increase pilots' fatigue resilience.


Assuntos
Biorretroalimentação Psicológica , COVID-19 , Saúde Mental , Pilotos , Psicofisiologia , Resiliência Psicológica , Adulto , Humanos , Pessoa de Meia-Idade , Aviação , Biorretroalimentação Psicológica/métodos , Cognição , COVID-19/epidemiologia , Autoavaliação Diagnóstica , Regulação Emocional , Fadiga Mental/prevenção & controle , Fadiga Mental/psicologia , Motivação , Pilotos/psicologia , Respiração , Segurança , Estresse Psicológico
5.
J Neurol ; 269(9): 4802-4807, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35428899

RESUMO

INTRODUCTION: Hereditary amyloidogenic transthyretin (ATTR) amyloidosis is an autosomal dominant, multi-systemic and progressive disorder characterised by polyneuropathy, cardiomyopathy and dysautonomia to varying degrees. In Ireland, the p.Thr80Ala mutation has been well documented, but little has been reported about a second variant, the p.His110Asp mutation first discovered in a family native to county Cork. Here we elaborate on the phenotype of this recently identified mutation using an extended pedigree of the original kindred and include for the first time a second affected family. MATERIALS AND METHODS: Patients attending our centre with confirmed or suspected ATTR amyloidosis as a result of a p.His110Asp mutation were identified. Detailed chart reviews and patient interviews were completed. Data on symptoms, examination findings, neurophysiology, histology, biochemistry, and cardiac investigations were gathered. A large extended pedigree was plotted. RESULTS: A total of 17 members across four generations of one kindred, and 2 members of a previously unreported family were identified. A phenotype of progressive late-onset polyneuropathy with cardiac involvement was common to both families. An early manifestation was carpal tunnel syndrome, preceededing neuropathy by many years. Gastrointestinal and urinary symptoms were common. DISCUSSION: We describe a wider phenotype of the p.His110Asp mutation of transthyretin in two Irish families. Importantly, we describe cardiac involvement which was not previously emphasised. The discovery of a new unrelated family highlights the importance of clinical suspicion even in those without known family history. We suggest that this second important transthyretin mutation should be considered in patients of Irish origin.


Assuntos
Neuropatias Amiloides Familiares , Polineuropatias , Neuropatias Amiloides Familiares/diagnóstico , Neuropatias Amiloides Familiares/genética , Humanos , Mutação/genética , Fenótipo , Pré-Albumina/genética
6.
BMJ Case Rep ; 14(7)2021 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-34301692

RESUMO

Kawasaki-like hyperinflammatory syndrome has been widely described as a manifestation of SARS-CoV-2 infection in paediatric patients. We report a compatible presentation and suggest that physicians consider the potential for this multisystem inflammatory syndrome to occur in adults. A 23-year-old man presented to hospital with a 4-day history of vomiting, diarrhoea, dry cough, fever and a blanching erythematous rash on hands, feet and buttocks. He was otherwise fit and healthy. On day 3 of admission, marked bilateral conjunctivitis developed and high sensitivity troponin I increased significantly, followed by acute respiratory compromise requiring high-flow nasal oxygen therapy. Transthoracic echocardiogram on day 5 showed severe global hypokinesis of the left ventricle with an ejection fraction of 22%. SARS-CoV-2 was not detected by reverse transcription PCR on nasopharyngeal swabs, sputum or stool samples, however, SARS-CoV-2 antibody was positive. The patient's syndrome resolved and cardiomyopathy reversed completely with supportive measures. He has since made a good recovery.


Assuntos
COVID-19 , SARS-CoV-2 , Adulto , Criança , Diarreia , Febre , Humanos , Masculino , Síndrome de Resposta Inflamatória Sistêmica , Adulto Jovem
7.
Open Heart ; 8(1)2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34172561

RESUMO

BACKGROUND: Studying variability in the care provided to secondary prevention coronary heart disease (CHD) outpatients can identify interventions to improve their outcomes. METHODS: We studied outpatients who had an index CHD event in the preceding 6-24 months. Eligible CHD events included acute coronary syndrome (ACS) and coronary revascularisation for stable chronic coronary syndrome (CCS). Site training was provided by a core team and data were collected using standardised methods. RESULTS: Between 2017 and 2019, we enrolled 721 outpatients at nine Irish study sites; 81% were men and mean age was 63.9 (SD ±8.9) years. The study examination occurred a median of 1.16 years after the index CHD event, which was ACS in 399 participants (55%) and stable-CCS in 322. On examination, 42.5% had blood pressure (BP) >140/90 mm Hg, 63.7% had low-density lipoprotein cholesterol (LDL-C) >1.8 mmol/L and 44.1% of known diabetics had an HbA1c >7%. There was marked variability in risk factor control, both by study site and, in particular, by index presentation type. For example, 82% of outpatients with prior-ACS had attended cardiac rehabilitation versus 59% outpatients with prior-CCS (p<0.001) and there were also large differences in control of traditional risk factors like LDL-C (p=0.002) and systolic BP (p<0.001) among outpatients with prior-ACS versus prior-CCS as the index presentation. CONCLUSIONS: Despite international secondary prevention guidelines broadly recommending the same risk factor targets for all adults with CHD, we found marked differences in outpatient risk factor control and management on the basis of hospital location and index CHD presentation type (acute vs chronic). These findings highlight the need to reduce hospital-level and patient-level variability in preventive care to improve outcomes; a lesson that should inform CHD prevention programmes in Ireland and around the world.


Assuntos
Síndrome Coronariana Aguda/prevenção & controle , Reabilitação Cardíaca/métodos , Pacientes Ambulatoriais , Prevenção Secundária/métodos , Síndrome Coronariana Aguda/reabilitação , Idoso , Doença Crônica , Estudos Transversais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo
8.
Risk Anal ; 41(6): 1004-1018, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-32920882

RESUMO

Fatigue is an inevitable hazard in the provision of air traffic services and it has the potential to degrade human performance leading to occurrences. The International Civil Aviation Organization (ICAO) requires air navigation services which providers establish fatigue risk management systems (FRMS) based on scientific principles for the purpose of managing fatigue. To develop effective FRMSs, it is important to investigate the relationship between traffic volume, air traffic management occurrences, and fatigue. Fifty-seven qualified ATCOs from a European Air Navigation Services provider participated in this research by providing data indicating their alertness levels over the course of a 24-hour period. ATCOs' fatigue data were compared against the total of 153 occurrences and 962,328 air traffic volumes from the Eurocontrol TOKAI incident database in 2019. The result demonstrated that ATCO fatigue levels are not the main contributory factor associated with air traffic management occurrences, although fatigue did impact ATCOs' performance. High traffic volume increases ATCO cognitive task load that can surpass available attention resources leading to occurrences. Furthermore, human resilience drives ATCOs to maintain operational safety though they suffer from circadian fatigue. Consequently, FRMS appropriately implemented can be used to mitigate the effects of fatigue. First-line countermeasure strategies should focus on enough rest breaks and roster schedule optimization; secondary strategies should focus on monitoring ATCOs' task loads that may induce fatigue. It is vital to consider traffic volume and ATCOs' alertness levels when implementing effective fatigue risk management protocols.


Assuntos
Atenção , Aviação , Fadiga , Gestão de Riscos , Adulto , Europa (Continente) , Fadiga/diagnóstico , Fadiga/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sonolência , Adulto Jovem
10.
Am J Med ; 132(8): 921-925, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30853472

RESUMO

Provision and participation in formal external continuing medical education (CME) is costly. Employer or state support of CME is the exception rather than the rule. The medical industry has supported both providers and consumers of educational activities, leading to concerns of commercial bias. Recent medical industry initiatives in Europe to improve the transparency of the relationship between industry and the profession, including the field of medical education, have had the paradoxical effect of the industry playing an increasingly direct role in the provision of physician education. Funding of medical professional society annual congresses has been directly and indirectly jeopardized. Acknowledging that there are areas of cooperation in the field of education between the medical profession and the medical industry from which both can benefit, we argue that medical education requires an objective approach that the primary fiduciary duty of medical industry companies precludes. Medical professional societies, as not-for-profit organizations whose core mission is the development and promotion of best practice, are best placed to guide and deliver medical education to their members.


Assuntos
Educação Médica Continuada/métodos , Educação Médica Continuada/normas , Médicos/normas , Educação Médica Continuada/tendências , Previsões/métodos , Humanos , Médicos/estatística & dados numéricos , Sociedades Médicas/organização & administração , Sociedades Médicas/tendências
11.
Int J Comput Assist Radiol Surg ; 14(4): 645-657, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30730031

RESUMO

INTRODUCTION: Unobtrusive metrics that can auto-assess performance during clinical procedures are of value. Three approaches to deriving wearable technology-based metrics are explored: (1) eye tracking, (2) psychophysiological measurements [e.g. electrodermal activity (EDA)] and (3) arm and hand movement via accelerometry. We also measure attentional capacity by tasking the operator with an additional task to track an unrelated object during the procedure. METHODS: Two aspects of performance are measured: (1) using eye gaze and psychophysiology metrics and (2) measuring attentional capacity via an additional unrelated task (to monitor a visual stimulus/playing cards). The aim was to identify metrics that can be used to automatically discriminate between levels of performance or at least between novices and experts. The study was conducted using two groups: (1) novice operators and (2) expert operators. Both groups made two attempts at a coronary angiography procedure using a full-physics virtual reality simulator. Participants wore eye tracking glasses and an E4 wearable wristband. Areas of interest were defined to track visual attention on display screens, including: (1) X-ray, (2) vital signs, (3) instruments and (4) the stimulus screen (for measuring attentional capacity). RESULTS: Experts provided greater dwell time (63% vs 42%, p = 0.03) and fixations (50% vs 34%, p = 0.04) on display screens. They also provided greater dwell time (11% vs 5%, p = 0.006) and fixations (9% vs 4%, p = 0.007) when selecting instruments. The experts' performance for tracking the unrelated object during the visual stimulus task negatively correlated with total errors (r = - 0.95, p = 0.0009). Experts also had a higher standard deviation of EDA (2.52 µS vs 0.89 µS, p = 0.04). CONCLUSIONS: Eye tracking metrics may help discriminate between a novice and expert operator, by showing that experts maintain greater visual attention on the display screens. In addition, the visual stimulus study shows that an unrelated task can measure attentional capacity. Trial registration This work is registered through clinicaltrials.gov, a service of the U.S. National Health Institute, and is identified by the trial reference: NCT02928796.


Assuntos
Atenção/fisiologia , Cateterismo Cardíaco/métodos , Competência Clínica , Simulação por Computador , Fixação Ocular/fisiologia , Dispositivos Eletrônicos Vestíveis , Feminino , Humanos , Masculino
12.
Ir J Med Sci ; 188(3): 807-813, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30610680

RESUMO

INTRODUCTION: The American College of Cardiology Foundation (ACCF) with other professional societies developed appropriate use criteria (AUC) for diagnostic coronary angiography. This study aims to examine the appropriate use of elective coronary angiography for patients with suspected stable coronary artery disease in an Irish tertiary referral center. METHODS: A retrospective chart review of all elective outpatient diagnostic coronary angiograms performed in Cork University Hospital in 2014 was carried out. Data on demographics, risk factors, clinical presentation, and prior non-invasive investigations were extracted. Each patient was evaluated according to the 2012 ACCF appropriate use criteria and classified as appropriate, uncertain, or inappropriate. Univariable and multivariable logistic regression analysis was performed to investigate the factors that predict patients undergoing appropriate diagnostic coronary angiography. RESULTS: Of 417 elective outpatient diagnostic coronary angiograms, 259 (62%) were included in the analysis. Of these, 108 (42%) were classified as appropriate, 97 (37%) as uncertain, and 54 (21%) as inappropriate. In multivariable analysis, those with private health insurance were more likely to have an appropriate indication for coronary angiogram (OR 2.1, 95% CI 1.2-3.7) as were those with atrial fibrillation (OR 3.9, 95% CI 1.2-12.8). Ever smokers were less likely to have an appropriate indication for coronary angiogram than never smokers (OR 0.5, 95% CI 0.3-0.9). CONCLUSION: This is the first Irish study to evaluate the appropriate use of elective coronary angiography. Rates were similar to those of studies in other jurisdictions; however, there remains significant potential for quality improvement.


Assuntos
Angiografia Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Procedimentos Cirúrgicos Eletivos/métodos , Idoso , Doença da Artéria Coronariana/patologia , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Estados Unidos
13.
Ergonomics ; 62(2): 305-318, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29943681

RESUMO

This research investigated controller' situation awareness by comparing COOPANS's acoustic alerts with newly designed semantic alerts. The results demonstrate that ATCOs' visual scan patterns had significant differences between acoustic and semantic designs. ATCOs established different eye movement patterns on fixations number, fixation duration and saccade velocity. Effective decision support systems require human-centered design with effective stimuli to direct ATCO's attention to critical events. It is necessary to provide ATCOs with specific alerting information to reflect the nature of the critical situation in order to minimise the side effects of startle and inattentional deafness. Consequently, the design of a semantic alert can significantly reduce ATCOs' response time, therefore providing valuable extra time in a time-limited situation to formulate and execute resolution strategies in critical air safety events. The findings of this research indicate that the context-specified design of semantic alerts could improve ATCO's situational awareness and significantly reduce response time in the event of Short Term Conflict Alert (STCA) activation which alerts to two aircraft having less than the required lateral or vertical separation. Practitioner Summary: Eye movements are closely linked with visual attention and can be analysed to explore shifting attention whilst performing monitoring tasks. This research has found that context-specific designed semantic alerts facilitated improved ATCO cognitive processing by integrating visual and auditory resources. Semantic designs have been demonstrated to be superior to acoustic design by directing the operator's attention more quickly to critical situations.Abbreviations: APW: area proximity warning; ASRS: aviation safety reporting system; ATC: air traffic control; ATCO: air traffic controller; ATM: air traffic management; COOPANS: cooperation between air navigation service providers; HCI: human-computer interaction; IAA: irish aviation authority; MSAW: minimum safe altitude warning; MTCD: medium-term conflict detection; SA: situation awareness; STCA: short term conflict alert; TP: trajectory prediction.


Assuntos
Aviação , Conscientização/fisiologia , Movimentos Oculares , Trabalho/fisiologia , Trabalho/psicologia , Adulto , Atenção/fisiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Reação , Treinamento por Simulação , Análise e Desempenho de Tarefas , Interface Usuário-Computador , Adulto Jovem
14.
Eur Heart J ; 40(21): 1728-1738, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30226525

RESUMO

AIMS: The provision of high-quality education allows the European Society of Cardiology (ESC) to achieve its mission of better cardiovascular practice and provides an essential component of translating new evidence to improve outcomes. METHODS AND RESULTS: The 4th ESC Education Conference, held in Sophia Antipolis (December 2016), brought together ESC education leaders, National Directors of Training of 43 ESC countries, and representatives of the ESC Young Community. Integrating national descriptions of education and cardiology training, we discussed innovative pathways to further improve knowledge and skills across different training programmes and health care systems. We developed an ESC roadmap supporting better cardiology training and continued medical education (CME), noting: (i) The ESC provides an excellent framework for unbiased and up-to-date cardiovascular education in close cooperation with its National Societies. (ii) The ESC should support the harmonization of cardiology training, curriculum development, and professional dialogue and mentorship. (iii) ESC congresses are an essential forum to learn and discuss the latest developments in cardiovascular medicine. (iv) The ESC should create a unified, interactive educational platform for cardiology training and continued cardiovascular education combining Webinars, eLearning Courses, Clinical Cases, and other educational programmes, along with ESC Congress content, Practice Guidelines and the next ESC Textbook of Cardiovascular Medicine. (v) ESC-delivered online education should be integrated into National and regional cardiology training and CME programmes. CONCLUSION: These recommendations support the ESC to deliver excellent and comprehensive cardiovascular education for the next generation of specialists. Teamwork between international, national and local partners is essential to achieve this objective.


Assuntos
Cardiologia , Educação Médica Continuada/organização & administração , Sociedades Médicas/organização & administração , Cardiologia/educação , Cardiologia/organização & administração , Europa (Continente) , Humanos , Guias de Prática Clínica como Assunto
16.
Lancet ; 392(10146): 521-530, 2018 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-30017550

RESUMO

To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed-with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property-and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible.


Assuntos
Equipamentos e Provisões , Medicina Baseada em Evidências , Acesso à Informação , Aprovação de Equipamentos , Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/normas , Europa (Continente) , União Europeia , Medicina Baseada em Evidências/normas , Humanos
17.
Am Heart J ; 200: 110-117, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29898838

RESUMO

BACKGROUND: Residual and significant postinfarction left ventricular (LV) dysfunction, despite technically successful percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), remains an important clinical issue. In preclinical models, low-dose insulin-like growth factor 1 (IGF1) has potent cytoprotective and positive cardiac remodeling effects. We studied the safety and efficacy of immediate post-PCI low-dose intracoronary IGF1 infusion in STEMI patients. METHODS: Using a double-blind, placebo-controlled, multidose study design, we randomized 47 STEMI patients with significantly reduced (≤40%) LV ejection fraction (LVEF) after successful PCI to single intracoronary infusion of placebo (n = 15), 1.5 ng IGF1 (n = 16), or 15 ng IGF1 (n = 16). All received optimal medical therapy. Safety end points were freedom from hypoglycemia, hypotension, or significant arrhythmias within 1 hour of therapy. The primary efficacy end point was LVEF, and secondary end points were LV volumes, mass, stroke volume, and infarct size at 2-month follow-up, all assessed by magnetic resonance imaging. Treatment effects were estimated by analysis of covariance adjusted for baseline (24 hours) outcome. RESULTS: No significant differences in safety end points occurred between treatment groups out to 30 days (χ2 test, P value = .77). There were no statistically significant differences in baseline (24 hours post STEMI) clinical characteristics or LVEF among groups. LVEF at 2 months, compared to baseline, increased in all groups, with no statistically significant differences related to treatment assignment. However, compared with placebo or 1.5 ng IGF1, treatment with 15 ng IGF1 was associated with a significant improvement in indexed LV end-diastolic volume (P = .018), LV mass (P = .004), and stroke volume (P = .016). Late gadolinium enhancement (±SD) at 2 months was lower in 15 ng IGF1 (34.5 ± 29.6 g) compared to placebo (49.1 ± 19.3 g) or 1.5 ng IGF1 (47.4 ± 22.4 g) treated patients, although the result was not statistically significant (P = .095). CONCLUSIONS: In this pilot trial, low-dose IGF1, given after optimal mechanical reperfusion in STEMI, is safe but does not improve LVEF. However, there is a signal for a dose-dependent benefit on post-MI remodeling that may warrant further study.


Assuntos
Ventrículos do Coração , Fator de Crescimento Insulin-Like I/administração & dosagem , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST , Disfunção Ventricular Esquerda , Citoproteção/efeitos dos fármacos , Relação Dose-Resposta a Droga , Esquema de Medicação , Monitoramento de Medicamentos , Feminino , Substâncias de Crescimento , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/efeitos dos fármacos , Ventrículos do Coração/patologia , Humanos , Infusões Intra-Arteriais , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Miócitos Cardíacos/efeitos dos fármacos , Tamanho do Órgão , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologia , Disfunção Ventricular Esquerda/prevenção & controle , Remodelação Ventricular/efeitos dos fármacos
18.
Brain Behav Immun ; 43: 27-32, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25064176

RESUMO

Cardiac Syndrome X (CSX), the presence of angina pectoris despite normal epicardial coronary arteries seen on invasive angiography, is known to be associated with an elevation of several inflammatory biomarkers, suggesting a possible role for inflammation in its pathogenesis. We sought to establish if C-reactive protein (CRP) levels varied with disease severity and so whether it is a state or trait marker. We studied 16 CSX patients with typical angina pectoris, normal coronary arteries and an electrically positive exercise stress test (EST) and 13 age- and sex-matched healthy controls (HC). CSX patients were followed up at a subsequent visit with repeated exercise stress testing and CRP measurement. We found that CRP levels were significantly higher in the CSX group compared to the HC (1.5 [0.8-4.5] v 0.8 [0.4-1.4] mg/L, p=0.02). This elevation in CRP persisted throughout the study length. CRP correlated with time to symptoms on EST at enrolment and at the second visit (r=-0.690, df=10, p=0.013 and r=-0.899, df=4, p=0.015, respectively). At the follow-up visit, 50% of CSX patients developed electrically and symptomatically negative ESTs. The mean CRP of this group was significantly lower than that of the CSX patients with ongoing symptoms and positive ESTs (1.2±0.2 v 2.8±0.6mg/L, p=0.018) and did not differ significantly from that of healthy controls. CRP levels also dropped in patients whose symptoms improved while they increased in patients who became more symptomatic (p=0.027). We conclude that the results of this small study support the concept of CSX being an inflammatory-mediated condition with CRP levels prospectively varying with functional measures of disease severity. This indicates that CRP is a state marker in CSX.


Assuntos
Proteína C-Reativa/metabolismo , Angina Microvascular/sangue , Angina Microvascular/diagnóstico , Biomarcadores/sangue , Teste de Esforço , Feminino , Humanos , Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
20.
J Vasc Interv Radiol ; 23(10): 1361-6.e2, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22854318

RESUMO

PURPOSE: To assess the face and content validity of a novel, full physics, full procedural, virtual reality simulation housed in a hybrid procedure suite. METHODS AND MATERIALS: After completing 60 minutes of hands-on training in uterine artery embolization and coronary angioplasty, 24 radiologists and 18 cardiologists with mean 10 years of endovascular experience assessed the functionality of a comprehensive hybrid procedure suite simulation (Orcamp; Orzone, Gothenburg, Sweden). RESULTS: C-arm and operating table functionality and realism were reliably (α = 0.0.89-0.92) rated highly (80/100). Performance realism of the catheter, guide wire, fluoroscopy image, electrocardiogram, and vital signs readout also reliably and statistically significantly predicted subjects' overall positive assessment (mean = 87/100) of the simulation experience in a multiple regression model (α = .83; r = 0.85 and r(2) = 0.67; P < .0001). CONCLUSIONS: This study reports a quantitative evaluation of a comprehensive simulation of an authentic procedure suite for image-guided intravascular procedures. This new facility affords the opportunity for trainers to provide higher fidelity training of operative technical, procedural, and management skills in the realistic context of a complete procedure suite with all its complexities and potential distractions.


Assuntos
Angioplastia/educação , Simulação por Computador , Instrução por Computador , Educação de Pós-Graduação em Medicina/métodos , Embolização da Artéria Uterina/educação , Adulto , Angioplastia/instrumentação , Cateterismo Cardíaco , Cateterismo Periférico , Competência Clínica , Instrução por Computador/instrumentação , Eletrocardiografia , Desenho de Equipamento , Feminino , Fluoroscopia , Humanos , Pessoa de Meia-Idade , Radiografia Intervencionista , Análise e Desempenho de Tarefas , Embolização da Artéria Uterina/instrumentação
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