RESUMEN
Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.
Asunto(s)
Servicios de Salud Mental , Trastornos Relacionados con Sustancias , Adolescente , Canadá , Niño , Servicio de Urgencia en Hospital , Humanos , Salud Mental , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos Relacionados con Sustancias/psicologíaRESUMEN
Background: Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances. Objective: These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO. Methods: SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework. Results: The panel agreed on 13 recommendations to address variations on 5 clinical scenarios. Conclusions: Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field.
RESUMEN
BACKGROUND: Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown. METHODS: In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory. RESULTS: We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group. CONCLUSIONS: Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270 .).
Asunto(s)
Anticoagulantes/uso terapéutico , Foramen Oval Permeable/tratamiento farmacológico , Foramen Oval Permeable/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Prevención Secundaria/métodos , Dispositivo Oclusor Septal , Accidente Cerebrovascular/prevención & control , Adolescente , Adulto , Anticoagulantes/efectos adversos , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/mortalidad , Humanos , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Recurrencia , Dispositivo Oclusor Septal/efectos adversos , Método Simple Ciego , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Tromboembolia Venosa/etiología , Adulto JovenRESUMEN
BACKGROUND: Whether closure of a patent foramen ovale is effective in the prevention of recurrent ischemic stroke in patients who have had a cryptogenic stroke is unknown. We conducted a trial to evaluate whether closure is superior to medical therapy alone in preventing recurrent ischemic stroke or early death in patients 18 to 60 years of age. METHODS: In this prospective, multicenter, randomized, event-driven trial, we randomly assigned patients, in a 1:1 ratio, to medical therapy alone or closure of the patent foramen ovale. The primary results of the trial were analyzed when the target of 25 primary end-point events had been observed and adjudicated. RESULTS: We enrolled 980 patients (mean age, 45.9 years) at 69 sites. The medical-therapy group received one or more antiplatelet medications (74.8%) or warfarin (25.2%). Treatment exposure between the two groups was unequal (1375 patient-years in the closure group vs. 1184 patient-years in the medical-therapy group, P=0.009) owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat cohort, 9 patients in the closure group and 16 in the medical-therapy group had a recurrence of stroke (hazard ratio with closure, 0.49; 95% confidence interval [CI], 0.22 to 1.11; P=0.08). The between-group difference in the rate of recurrent stroke was significant in the prespecified per-protocol cohort (6 events in the closure group vs. 14 events in the medical-therapy group; hazard ratio, 0.37; 95% CI, 0.14 to 0.96; P=0.03) and in the as-treated cohort (5 events vs. 16 events; hazard ratio, 0.27; 95% CI, 0.10 to 0.75; P=0.007). Serious adverse events occurred in 23.0% of the patients in the closure group and in 21.6% in the medical-therapy group (P=0.65). Procedure-related or device-related serious adverse events occurred in 21 of 499 patients in the closure group (4.2%), but the rate of atrial fibrillation or device thrombus was not increased. CONCLUSIONS: In the primary intention-to-treat analysis, there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke. However, closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analyses, with a low rate of associated risks. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270.).
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Fibrinolíticos/uso terapéutico , Foramen Oval Permeable/terapia , Prevención Secundaria , Dispositivo Oclusor Septal , Accidente Cerebrovascular/prevención & control , Adulto , Cateterismo Cardíaco/efectos adversos , Embolia/etiología , Embolia/prevención & control , Femenino , Fibrinolíticos/efectos adversos , Estudios de Seguimiento , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/tratamiento farmacológico , Foramen Oval Permeable/mortalidad , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Riesgo , Dispositivo Oclusor Septal/efectos adversos , Método Simple Ciego , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
High radiation exposure among male radiologists has been reported to result in a significantly higher proportion of female offspring. This study examined whether work-related radiation exposure was associated with a higher propensity for female offspring among male interventional cardiologists. On behalf of the interventional committee of the Society for Cardiovascular Angiography and Interventions, an Internet-based questionnaire was sent to the society's 2063 members. The 402 male respondents had a total of 518 biological offspring; 48.6% of them were female. Among the 172 high-volume male diagnostic operators (those who performed >300 cases annually), there were 218 biological offspring, of whom 46.8% were female. Among the 59 high-volume male interventional operators, there were 70 biological offspring, of whom 45.7% were female. P values were nonsignificant for all three groups. In conclusion, work-related radiation exposure of male invasive and interventional cardiologists was not associated with a statistically significant preponderance of female offspring.
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BACKGROUND: The precise role of arterial barotrauma-mediated apoptosis in causing restenosis is unclear. The purpose of this study was to determine if a link exists between angioplasty-mediated medial smooth muscle cell apoptosis and subsequent neointimal hyperplasia. METHODS AND RESULTS: Bilateral iliac artery angioplasty was performed in 25 male New Zealand White rabbits. Simultaneous with balloon injury, each artery was treated locally with either the caspase inhibitor N-benzyloxycarbonyl-Val-Ala-Asp(Ome)-fluoromethylketone (ZVAD-fmk) or control. In the acute cohort that was survived to 4 hours (n=10, 7 high dose and 3 low dose), an apoptotic index was calculated using the terminal deoxynucleotidyl TUNEL method. In the intermediate cohort that was survived to 2 weeks (n=5), luminal reendothelialization was measured via CD-31 staining. In the chronic cohort that was survived to 4 weeks (n=10), neointimal area was measured. In the acute cohort, there was a 40% reduction in the apoptotic index with high-dose ZVAD-fmk (P=0.008) and a 33% reduction with low-dose ZVAD-fmk (P=0.08). At 2 weeks, there was no significant difference in the degree of luminal reendothelialization. However, at 4 weeks, there was a 33% (0.33+/-0.23 versus 0.22+/-0.20 mm2) (P<0.005) reduction in neointimal area in ZVAD-fmk-treated arteries. CONCLUSIONS: The local delivery of ZVAD-fmk during balloon injury inhibits smooth muscle cell apoptosis. This corresponds to a significant reduction in neointimal proliferation seen at 4 weeks without a significant change in the degree of reendothelialization at 2 weeks.
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Angioplastia Coronaria con Balón/efectos adversos , Apoptosis/fisiología , Caspasas/fisiología , Reestenosis Coronaria/patología , Músculo Liso Vascular/patología , Clorometilcetonas de Aminoácidos/farmacología , Animales , Apoptosis/efectos de los fármacos , Inhibidores de Caspasas , Reestenosis Coronaria/enzimología , Reestenosis Coronaria/prevención & control , Hiperplasia , Masculino , Músculo Liso Vascular/efectos de los fármacos , Músculo Liso Vascular/lesiones , Conejos , Túnica Íntima/patologíaRESUMEN
The low molecular weight heparin enoxaparin is often administered to patients on long-term anticoagulation regimens who temporarily discontinue warfarin prior to undergoing invasive procedures. The clinical outcome of all enoxaparin-treated patients who underwent cardiac catheterization or coronary artery interventional procedures (n = 119) was evaluated. A total of 5 patients (4.2%) requiring anticoagulation (3 with chronic atrial fibrillation and 2 with ventricular thrombi) developed severe late enoxaparin-associated hemorrhagic or vascular complications at the femoral arterial puncture site between 3 and 11 days post-procedure. Complications included development of femoral arterial pseudoaneurysm (n = 3), hypotension (systolic blood pressure < 90 mmHg) (n = 2), acute decrease in hemoglobin levels to < 8.5 mg/dl (n = 4) and cardiac arrest (n = 1). In patients receiving standard dose enoxaparin after percutaneous invasive cardiac procedures, there is the potential for delayed and severe access site hemorrhagic and vascular complications.
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Anticoagulantes/uso terapéutico , Cateterismo Cardíaco , Heparina de Bajo-Peso-Molecular/uso terapéutico , Complicaciones Posoperatorias/tratamiento farmacológico , Complicaciones Posoperatorias/etiología , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/terapia , Femenino , Enfermedades de las Válvulas Cardíacas/complicaciones , Enfermedades de las Válvulas Cardíacas/terapia , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
Whether arterial closure devices can be used safely in a coagulopathic population undergoing cardiac catheterization and at high risk for groin complications, such as liver transplant candidates, is unknown. In this prospective, non-randomized consecutive series of 80 liver transplant candidates undergoing coronary angiography, manual compression and arterial closure devices were compared. Ilio-femoral angiography was performed to determine suitability for use of the closure device. Bleeding and vascular complications were recorded along with time to ambulation. Arterial closure devices were used in 31 patients (39%), whereas manual compression was used in 49 patients (50 procedures) (61%). There were no significant differences between the two groups with respect to age, sex, cardiac risk factors, peripheral vascular disease, baseline platelet count or baseline INR. There were 10 total vascular complications out of 50 procedures (20%) in the manual compression group compared to 2 vascular complications out of 31 procedures in the arterial closure device group (6%; p = 0.12). The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 1.8 hours versus 6.6 3.7 hours, respectively; p = 0.0003). In coagulopathic patients at higher risk for groin complications, arterial closure devices can be safely used and decrease time to ambulation compared to manual compression.