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Statistical models are commonly employed in the estimation of influenza-associated excess mortality that, due to various reasons, is often underestimated by laboratory-confirmed influenza deaths reported by healthcare facilities. However, methodology for timely and reliable estimation of that impact remains limited because of the delay in mortality data reporting. We explored real-time estimation of influenza-associated excess mortality by types/subtypes in each year between 2012 and 2018 in Hong Kong using linear regression models fitted to historical mortality and influenza surveillance data. We could predict that during the winter of 2017/2018, there were ~634 (95% confidence interval (CI): (190, 1033)) influenza-associated excess all-cause deaths in Hong Kong in population ⩾18 years, compared to 259 reported laboratory-confirmed deaths. We estimated that influenza was associated with substantial excess deaths in older adults, suggesting the implementation of control measures, such as administration of antivirals and vaccination, in that age group. The approach that we developed appears to provide robust real-time estimates of the impact of influenza circulation and complement surveillance data on laboratory-confirmed deaths. These results improve our understanding of the impact of influenza epidemics and provide a practical approach for a timely estimation of the mortality burden of influenza circulation during an ongoing epidemic.
Introduction: In Nova Scotia, under the Paramedics Providing Palliative Care program, paramedics can now manage symptom crises in patients with palliative care goals and often at home without the need to transport to hospital. Growing recognition that non-cancer conditions benefit from a palliative approach is expanding the program. Our team previously found treatment of pain and breathlessness is not optimized, pain scores are underutilized, and paramedics were more comfortable (pre-launch) with a palliative approach in cancer versus non-cancer conditions. Our objective was to compare symptom management in cancer versus non-cancer subgroup. Methods: We conducted a retrospective cohort study. The Electronic Patient Care Record and Special Patient Program were queried for patients with palliative goals from July 1, 2015 to July 1, 2016. Descriptive analysis was conducted and results were compared with a t-test and Bonferroni correction (alpha = p < 0.007). Results: 1909 unique patients; 765/1909 (40.1%) cancer and 1144/1909 (59.9%) non-cancer. Female sex: cancer 357/765 (46.7%), non-cancer 538/1144 (47.0%). Mean age cancer: 73.3 (11.65), non-cancer 77.7 (12.80). Top non-cancer conditions: COPD (495/1144, 43.3%), CHF (322/1144, 28.1%), stroke (172/1144, 15.0%) and dementia (149/1144, 13.0%). Comorbidities for cancer patients (range): 0 to 3; non-cancer 0 to 5. Most common chief complaint (CC) for cancer and non-cancer: respiratory distress, 10.8% vs 21.5%. Overall, no difference in proportion treated cancer vs non-cancer, 11.5% vs 10.1%, p = 0.35. Some difference in individual therapies: morphine 83/765 (10.8%) vs 55/1144 (4.8%), p < 0.001, hydromorphone 9/765 (1.2%) vs 2/1144 (0.2%), p = 0.014, salbutamol 38/765 (5.0%) vs 5/1144 (0.4%), p < 0.001 and ipratropium 27/765 (3.5%) vs 134/1144 (11.7%), p < 0.001, in addition to any support with home medication which is not queriable. Pre-treatment pain scores were documented more often than post-treatment in both groups (58.7% vs 25.6% (p < 0.001), 57.4% vs 26.9% (p < 0.001)). Conclusion: Non-cancer patients represent an important proportion of palliative care calls for paramedics. Cancer and non-cancer patients had very similar CC and received similar treatment, although low proportions, despite pre-launch findings that non-cancer conditions were likely to be undertreated. Pain scores remain underutilized. Further research into the underlying reason(s) is required to improve the support of non-cancer patients by paramedics.
Introduction: The Prehospital Evidence-Based Practice (PEP) program is an online, freely accessible, continuously updated Emergency Medical Services (EMS) evidence repository. This summary describes the research evidence for the identification and management of adult patients suffering from sepsis syndrome or septic shock. Methods: PubMed was searched in a systematic manner. One author reviewed titles and abstracts for relevance and two authors appraised each study selected for inclusion. Primary outcomes were extracted. Studies were scored by trained appraisers on a three-point Level of Evidence (LOE) scale (based on study design and quality) and a three-point Direction of Evidence (DOE) scale (supportive, neutral, or opposing findings based on the studies’ primary outcome for each intervention). LOE and DOE of each intervention were plotted on an evidence matrix (DOE x LOE). Results: Eighty-eight studies were included for 15 interventions listed in PEP. The interventions with the most evidence were related to identification tools (ID) (n = 26, 30%) and early goal directed therapy (EGDT) (n = 21, 24%). ID tools included Systematic Inflammatory Response Syndrome (SIRS), quick Sequential Organ Failure Assessment (qSOFA) and other unique measures. The most common primary outcomes were related to diagnosis (n = 30, 34%), mortality (n = 40, 45%) and treatment goals (e.g. time to antibiotic) (n = 14, 16%). The evidence rank for the supported interventions were: supportive-high quality (n = 1, 7%) for crystalloid infusion, supportive-moderate quality (n = 7, 47%) for identification tools, prenotification, point of care lactate, titrated oxygen, temperature monitoring, and supportive-low quality (n = 1, 7%) for vasopressors. The benefit of prehospital antibiotics and EGDT remain inconclusive with a neutral DOE. There is moderate level evidence opposing use of high flow oxygen. Conclusion: EMS sepsis interventions are informed primarily by moderate quality supportive evidence. Several standard treatments are well supported by moderate to high quality evidence, as are identification tools. However, some standard in-hospital therapies are not supported by evidence in the prehospital setting, such as antibiotics, and EGDT. Based on primary outcomes, no identification tool appears superior. This evidence analysis can guide selection of appropriate prehospital therapies.
Introduction: Close to 2 million transgender (trans) individuals live in the United States and Canada. Trans communities frequently report emergency care avoidance and negative health care experiences. Of note, there is currently no research on the paramedic perspective of caring for trans populations. Our objective was to explore paramedic comfort, confidence, and cultural competency in providing emergency care to trans individuals. Methods: A cross-sectional, semi-structured electronic survey was administered by email to paramedics registered with the College of Paramedics of Nova Scotia (n = 1225) from April 9th to May 7th, 2018. The survey included previously validated questions from other medical settings. Three survey reminders were sent at weekly intervals following survey initiation. A 4-point Likert scale and qualitative open-ended questions were included to evaluate paramedic comfort, confidence, and cultural competency. Descriptive statistics were used to describe respondent characteristics. Open ended questions pertaining to paramedic needs were evaluated using constant comparative analyses consisting of open coding to identify themes. Results: Of the 387 paramedics who participated (response rate = 32%), 77.8% (n = 301) worked ground ambulance in a mixed rural/urban location (32.6%, n = 126) within Nova Scotia (94.5%; n = 365). Most respondents were between the ages of 41-50 (29.5%; n = 114), with > 20 years’ experience (25.1%; n = 97), and male sex assigned at birth (56.1%; n = 217). Over half (54.8%; n = 212) identified as cisgender men. The majority (66.1%; n = 256) reported caring for a patient who identified as trans. 74.7% (n = 289) have never had formal education on trans health. Only 4.1% (n = 16) felt very knowledgeable about providing optimal care to trans communities and 26.6% (n = 103) felt very comfortable in providing optimal care. Most (70%; n = 271) were interested in obtaining formal education. 41.9% (n = 162) reported observing transphobia in the work place. Conclusion: The frequency of trans patient contact by paramedics is perceived to be high. Although comfort and knowledge are relatively low and transphobia witnessed in the work place relatively high, there was strong interest and expressed need for education on trans related health.
Introduction: Early and accurate diagnosis of critical conditions is essential in emergency medical services (EMS). Serum lactate testing may be used to identify patients with worse prognosis, including sepsis. Recently, the use of a point-of-care lactate (POCL) test has been evaluated in guiding treatment in patients with sepsis. Operating as part of the Prehospital Evidence Based Practice (PEP) Program, the authors sought to identify and describe the body of evidence for POCL use in EMS and the emergency department (ED) for patients with sepsis. Methods: Following PEP methodology, in May 2018, PubMed was searched in a systematic manner. Title and abstract screening were conducted by the program coordinator. These studies were collected, appraised and added to the existing body of literature contained within the PEP database. Evidence appraisal was conducted by two reviewers who assigned both a level of evidence (LOE) on a novel three tier scale and a direction of evidence (supportive, neutral or opposing; based on primary outcome). Data on setting and study design were also extracted. Results: Eight studies were included in our analysis. Three of these studies were conducted in the ED setting; each investigating the POCL test's ability to predict severe sepsis, ICU admission or death. All three studies found supportive results for POCL. A systematic review on the use of POCL in the ED determined that this test can also improve time to treatment. Five of the total 8 studies were conducted prehospitally. Two of these studies were supportive of POCL use in the prehospital setting; in terms of feasibility and the ability to predict sepsis. Both of these study sites used this early information as part of initiating a “sepsis alert” pathway. The other three prehospital studies provide neutral support for POCL. One study demonstrated moderate ability of POCL to predict severe illness. Two studies found poor agreement between prehospital POCL and serum lactate values. Conclusion: Limited low and moderate quality evidence suggest POCL may be feasible and helpful in predicting sepsis in the prehospital setting. However, there is sparse and inconsistent support for specific important outcomes, including accuracy.
Standards for microprobe analysis can be made to serve two purposes: (a) proposed correction models can be tested with them, and (b) analysis can be performed more accurately in the system which includes the standard. Few microprobe standards presently are available because they must be homogeneous on the micron scale and their composition must be known accurately. A modified Duwez splat cooling method is described which enables the investigator to prepare suitable standards in most cases. The apparatus which is relatively simple and inexpensive is described in detail. The systems Au-Si and Al-Mg were chosen as test cases. Suitable standards were prepared at different concentrations in each system. The analytical results for all compositions in Al-Mg are presented and discussed.
Paramedics Providing Palliative Care at Home was launched in two provinces, including a new clinical practice guideline, database, and paramedic training. The aim of this study was to evaluate patient/family satisfaction and paramedic comfort and confidence.
In Part A, we gathered perspectives of patients/families via surveys mailed at enrolment and telephone interviews after an encounter. Responses were reported descriptively and by thematic analysis. In Part B, we surveyed paramedics online pre- and 18 months post-launch. Comfort and confidence were scored on a 4-point Likert scale, and attitudes on a 7-point Likert scale, reported as the median (interquartile range [IQR]); analysis with Wilcoxon ranked sum/thematic analysis of free text.
In Part A, 67/255 (30%) enrolment surveys were returned. Three themes emerged: fulfilling wishes, peace of mind, and feeling prepared for emergencies. In 18 post-encounter interviews, four themes emerged: 24/7 availability, paramedic professionalism and compassion, symptom relief, and a plea for program continuation. Thematic saturation was reached with little divergence. In Part B, 235/1255 (18.9%) pre- and 267 (21.3%) post-surveys were completed. Comfort with providing palliative care without transport improved post launch (p = < 0.001) as did confidence in palliative care without transport (p = < 0.001). Respondents strongly agreed that all paramedics should be able to provide basic palliative care.
After implementation of the multifaceted Paramedics Providing Palliative Care at Home Program, paramedics describe palliative care as important and rewarding. The program resulted in high patient/family satisfaction; simply registering provides peace of mind. After an encounter, families particularly noted the compassion and professionalism of the paramedics.
Reconstructing access patterns, in particular processional and liturgical movement in ceremonial architecture, can illuminate social processes within expansive states. Extensive excavations from 2010–2012 in the uniquely preserved Tiwanaku temple at the Omo M10 site in Moquegua, Peru (ca. AD 500–1100), shed new light on connectedness and access patterns of the temple. Extensive areal excavations confirm past interpretations of a central axial series of doorways and staircases presided over by stelae and U-shaped, altar-like structures leading from public plazas to the sunken court and a central shrine. However, new findings revealed separate lateral pathways through the structure, which suggest liturgical processions to walled patio groups that were isolated from the central axis. We posit that these small patios and their roofed chambers may have functioned as chapels for distinct groups or pluralistic cultic activities that were separate from those of the central axis. Implications for Tiwanaku social structure are studied in light of other examples of triple entryways in Tiwanaku monumental architecture, and Kolata's suggestion of “Taypi” as a structural amalgam of a center and complementary halves, with implications of mediation and bilateral complementarity between ethnicities, genders, moieties, or other pluralistic entities within Tiwanaku state and society.
Transcatheter right ventricle decompression in neonates with pulmonary atresia and intact ventricular septum is technically challenging, with risk of cardiac perforation and death. Further, despite successful right ventricle decompression, re-intervention on the pulmonary valve is common. The association between technical factors during right ventricle decompression and the risks of complications and re-intervention are not well described.
This is a multicentre retrospective study among the participating centres of the Congenital Catheterization Research Collaborative. Between 2005 and 2015, all neonates with pulmonary atresia and intact ventricular septum and attempted transcatheter right ventricle decompression were included. Technical factors evaluated included the use and characteristics of radiofrequency energy, maximal balloon-to-pulmonary valve annulus ratio, infundibular diameter, and right ventricle systolic pressure pre- and post-valvuloplasty (BPV). The primary end point was cardiac perforation or death; the secondary end point was re-intervention.
A total of 99 neonates underwent transcatheter right ventricle decompression at a median of 3 days (IQR 2–5) of age, including 63 patients by radiofrequency and 32 by wire perforation of the pulmonary valve. There were 32 complications including 10 (10.5%) cardiac perforations, of which two resulted in death. Cardiac perforation was associated with the use of radiofrequency (p=0.047), longer radiofrequency duration (3.5 versus 2.0 seconds, p=0.02), and higher maximal radiofrequency energy (7.5 versus 5.0 J, p<0.01) but not with patient weight (p=0.09), pulmonary valve diameter (p=0.23), or infundibular diameter (p=0.57). Re-intervention was performed in 36 patients and was associated with higher post-intervention right ventricle pressure (median 60 versus 50 mmHg, p=0.041) and residual valve gradient (median 15 versus 10 mmHg, p=0.046), but not with balloon-to-pulmonary valve annulus ratio, atmospheric pressure used during BPV, or the presence of a residual balloon waist during BPV. Re-intervention was not associated with any right ventricle anatomic characteristics, including pulmonary valve diameter.
Technical factors surrounding transcatheter right ventricle decompression in pulmonary atresia and intact ventricular septum influence the risk of procedural complications but not the risk of future re-intervention. Cardiac perforation is associated with the use of radiofrequency energy, as well as radiofrequency application characteristics. Re-intervention after right ventricle decompression for pulmonary atresia and intact ventricular septum is common and relates to haemodynamic measures surrounding initial BPV.
In spring 2013, the Society for American Archaeology created the Task Force on Gender Disparities in Archaeological Grant Submissions because of an apparent disparity in the rates of senior (post-PhD) proposal submissions by men and women to archaeology programs at the National Science Foundation (NSF) and the Wenner-Gren Foundation for Anthropological Research. Although NSF success rates for men and women between 2009 and 2013 were roughly equal, the number of senior women archaeology submissions was half that of men. Given the documented increase in the proportion of women in academic archaeology, this representation of women seemed low. Moreover, submissions for NSF doctoral dissertation improvement grants were evenly divided between men and women. Statistics for Wenner-Gren noted the same general disparity in archaeology. This study examines and integrates a variety of data sources, including interviews with post-PhD women, to determine whether or not there is a problem in research grant submissions. Although the results indicate that there is a problem, it is multifaceted. Women are not well represented at research-intensive universities, and some women instead practice what we term “scaffolding” to integrate smaller pots of money to accomplish their research. Recommendations are provided for female applicants, academic departments, the Society for American Archaeology, and granting agencies.
This paper is concerned with rapid-distortion theory on transversely sheared mean flows which (among other things) can be used to analyse the unsteady motion resulting from the interaction of a turbulent shear flow with a solid surface. It extends previous analyses of Goldstein et al. (J. Fluid Mech., vol. 736, 2013a, pp. 532–569; NASA/TM-2013-217862, 2013b) which showed that the unsteady motion is completely determined by specifying two arbitrary convected quantities. The present paper uses a pair of previously derived conservation laws to derive upstream boundary conditions that relate these quantities to experimentally measurable flow variables. The result is dependent on the imposition of causality on an intermediate variable that appears in the conservation laws. Goldstein et al. (2013a) related the convected quantities to the physical flow variables at the location of the interaction, but the results were not generic and hard to reconcile with experiment. That problem does not occur in the present formulation, which leads to a much simpler and more natural result than the one given in Goldstein et al. (2013a). We also show that the present formalism yields better predictions of the sound radiation produced by the interaction of a two-dimensional jet with the downstream edge of a flat plate than the Goldstein et al. (2013a) result. The role of causality is also discussed.
People with pancreatic cancer have poor survival, and management is challenging. Pancreatic cancer patients' perceptions of their care coordination and its association with their outcomes have not been well-studied. Our objective was to determine if perception of care coordination is associated with patient-reported outcomes or survival.
People with pancreatic cancer who were 1–8 months postdiagnosis (52 with completed resection and 58 with no resection) completed a patient-reported questionnaire that assessed their perceptions of care coordination, quality of life, anxiety, and depression using validated instruments. Mean scores for 15 care-coordination items were calculated and then ranked from highest (best experience) to lowest (worst experience). Associations between care-coordination scores (including communication and navigation domains) and patient-reported outcomes and survival were investigated using general linear regression and Cox regression, respectively. All analyses were stratified by whether or not the tumor had been resected.
In both groups, the highest-ranked care-coordination items were: knowing who was responsible for coordinating care, health professionals being informed about their history, and waiting times. The worst-ranked items related to: how often patients were asked about visits with other health professionals and how well they and their family were coping, knowing the symptoms they should monitor, having sufficient emotional help from staff, and access to additional specialist services. For people who had a resection, better communication and navigation scores were significantly associated with higher quality of life and less anxiety and depression. However, these associations were not statistically significant for those with no resection. Perception of cancer care coordination was not associated with survival in either group.
Significance of results:
Our results suggest that, while many core clinical aspects of care are perceived to be done well for pancreatic cancer patients, improvements in emotional support, referral to specialist services, and self-management education may improve patient-reported outcomes.
Introduction: Collaborative Emergency Centres (CECs) provide access to care in rural communities. After hours, registered nurses (RNs) and paramedics work together in the ED with telephone support by an emergency medical services (EMS) physician. The safety of such a model is unknown. Relapse visits are often used as a proxy measure for safety in emergency medicine. The primary outcome of this study is to measure unscheduled relapses to emergency care. Methods: The electronic patient care record (ePCR) database was queried for all patients who visited two CECs from April 1, 2012 to April 1, 2013. Abstracted data included demographics, time, acuity score, clinical impression, chief complaint, and disposition. Records were searched for each discharged CEC patient to identify unscheduled relapses to emergency care, defined as presenting back to EMS, CEC, or any other ED within the Health Authority within 48 hours of CEC discharge. Results: There were 894 CEC visits, of which 66 were excluded due to missing data. The dispositions from CEC were: 131/828 (15.8%) transferred to regional ED; 264/828 (31.9%) discharged home; 488/828 (58.9%) discharged with follow up visit booked; and 11/82 (1.2%) left the CEC without being seen. There was 37/828 (4.5%) visits which relapsed back to emergency care, all of whom were discharged from CEC or left without being seen: 3/828 (0.4%) relapsed back to EMS (two taken to regional ED and one to CEC); 16/828 (1.9%) relapsed to regional ED (by walking-in); and 18/828 (2.2%) had a relapse to the CEC (walk-in). 516/828 (62.3%) CEC visits were resolved in a single visit. Conclusion: This study was based on only two of the 7 operating CECs due to accessing paper-based charts for multiple health regions. We also acknowledge the limitations of using relapse as a proxy for safety, and that low volumes and acuity will make detection of adverse events challenging. Albeit a proxy measure, the rate of patients who relapse to emergency care was under 5% in this case series of two CECs. Most patients had their concern resolved in a single visit to a CEC. Further research is underway to determine the effectiveness, optimal utilization and safety of this collaborative model of rural emergency care.
Introduction: The Collaborative Emergency Centre (CEC) model of health care delivery was implemented in rural Nova Scotia in July 2011 without an identifiable, directly comparable precedent. It features interprofessional teams working under one roof with the goal of providing improved access to timely primary health care, and appropriate access to 24/7 emergency care. One important component of the CEC model is overnight staffing by a paramedic/registered nurse team consulting with an offsite physician via telephone. Our objective was to ascertain the attitudes, feelings and experiences of paramedics working within the CEC construct. Methods: We conducted a qualitative study, guided by the principles of grounded theory. Semi-structured telephone interviews were carried out by the principal investigator with paramedics with experience working in a CEC in the province of Nova Scotia. Interviews were recorded, transcribed and analyzed. Analysis involved an inductive and deductive grounded approach using constant comparative analysis. Data collection and analysis continued until thematic saturation was reached. Results: Fourteen paramedics participated in the study. The majority were male (n=10, 71%), with a mean age of 44 years (STD=8.8) and mean experience as a paramedic of 14 years (STD=9.7). Four major themes were identified from the data: 1) leadership support, encompassing support from Emergency Health Services and Government prior to and after implementation of the model, 2) team work and collaboration, including interprofessional relationships among members of the healthcare team, 3) value to patients and the communities, and 4) professional and personal benefits of working in CECs. Conclusion: Paramedics have found working in CECs to be both professionally and personally rewarding. They perceive the CEC model to be of great value to the patients and communities it serves. Key lessons that might help future expansion of the model in Nova Scotia and other jurisdictions across the country include the importance of building and strengthening relationships between paramedics and nurses, and the need for greater feedback and support from leadership.
The prenatal environment is now recognized as a key driver of non-communicable disease risk later in life. Within the developmental origins of health and disease (DOHaD) paradigm, studies are increasingly identifying links between maternal morbidity during pregnancy and disease later in life for offspring. Nutrient restriction, metabolic disorders during gestation, such as diabetes or obesity, and maternal immune activation provoked by infection have been linked to adverse health outcomes for offspring later in life. These factors frequently co-occur, but the potential for compounding effects of multiple morbidities on DOHaD-related outcomes has not received adequate attention. This is of particular importance in low- or middle-income countries (LMICs), which have ongoing high rates of infectious diseases and are now experiencing transitions from undernutrition to excess adiposity. The purpose of this scoping review is to summarize studies examining the effect and interaction of co-occurring metabolic or nutritional stressors and infectious diseases during gestation on DOHaD-related health outcomes. We identified nine studies in humans – four performed in the United States and five in LMICs. The most common outcome, also in seven of nine studies, was premature birth or low birth weight. We identified nine animal studies, six in mice, two in rats and one in sheep. The interaction between metabolic/nutritional exposures and infectious exposures had varying effects including synergism, inhibition and independent actions. No human studies were specifically designed to assess the interaction of metabolic/nutritional exposures and infectious diseases. Future studies of neonatal outcomes should measure these exposures and explicitly examine their concerted effect.
This study aimed to extend the current understanding of dissociative symptoms experienced by patients with dissociative (psychogenic, non-epileptic) seizures (DS), including psychological and somatoform types of symptomatology. An additional aim was to assess possible relationships between dissociation, traumatic experiences, post-traumatic symptoms and seizure manifestations in this group.
A total of 40 patients with DS were compared with a healthy control group (n = 43), matched on relevant demographic characteristics. Participants completed several self-report questionnaires, including the Multiscale Dissociation Inventory (MDI), Somatoform Dissociation Questionnaire-20, Traumatic Experiences Checklist and the Post-Traumatic Diagnostic Scale. Measures of seizure symptoms and current emotional distress (Hospital Anxiety and Depression Scale) were also administered.
The clinical group reported significantly more psychological and somatoform dissociative symptoms, trauma, perceived impact of trauma, and post-traumatic symptoms than controls. Some dissociative symptoms (i.e. MDI disengagement, MDI depersonalization, MDI derealization, MDI memory disturbance, and somatoform dissociation scores) were elevated even after controlling for emotional distress; MDI depersonalization scores correlated positively with trauma scores while seizure symptoms correlated with MDI depersonalization, derealization and identity dissociation scores. Exploratory analyses indicated that somatoform dissociation specifically mediated the relationship between reported sexual abuse and DS diagnosis, along with depressive symptoms.
A range of psychological and somatoform dissociative symptoms, traumatic experiences and post-traumatic symptoms are elevated in patients with DS relative to healthy controls, and seem related to seizure manifestations. Further studies are needed to explore peri-ictal dissociative experiences in more detail.
The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.
In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.
We reviewed the United States Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials.
We identified 631 adverse events associated with “on-label” Melody® valve implants and 84 adverse events associated with “off-label” implants. The most frequent “on-label” adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5).
Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with “on-label” Melody® valve implantation. Further study is needed to evaluate safety of “off-label” uses.
The Arcminute Cosmology Bolometer Array Receiver (Acbar) is a multifrequency millimeter-wave receiver optimized for observations of the Cosmic Microwave Background (CMB) and the Sunyaev-Zel'dovich (SZ) effect in clusters of galaxies. Acbar was installed on the 2.1 m Viper telescope at the South Pole in January 2001 and the results presented here incorporate data through July 2002. The power spectrum of the CMB at 150 GHz over the range ℓ = 150 — 3000 measured by Acbar is presented along with estimates for the values of the cosmological parameters within the context of ΛCDM models. The inclusion of ΩΛ greatly improves the fit to the power spectrum. Three-frequency images of the SZ decrement/increment are also presented for the galaxy cluster 1E0657–67.
The Universe is permeated by hot, turbulent, magnetized plasmas. Turbulent plasma is a major constituent of active galactic nuclei, supernova remnants, the intergalactic and interstellar medium, the solar corona, the solar wind and the Earth’s magnetosphere, just to mention a few examples. Energy dissipation of turbulent fluctuations plays a key role in plasma heating and energization, yet we still do not understand the underlying physical mechanisms involved. THOR is a mission designed to answer the questions of how turbulent plasma is heated and particles accelerated, how the dissipated energy is partitioned and how dissipation operates in different regimes of turbulence. THOR is a single-spacecraft mission with an orbit tuned to maximize data return from regions in near-Earth space – magnetosheath, shock, foreshock and pristine solar wind – featuring different kinds of turbulence. Here we summarize the THOR proposal submitted on 15 January 2015 to the ‘Call for a Medium-size mission opportunity in ESAs Science Programme for a launch in 2025 (M4)’. THOR has been selected by European Space Agency (ESA) for the study phase.
Fontan survivors have depressed cardiac index that worsens over time. Serum biomarker measurement is minimally invasive, rapid, widely available, and may be useful for serial monitoring. The purpose of this study was to identify biomarkers that correlate with lower cardiac index in Fontan patients.
Methods and results
This study was a multi-centre case series assessing the correlations between biomarkers and cardiac magnetic resonance-derived cardiac index in Fontan patients ⩾6 years of age with biochemical and haematopoietic biomarkers obtained ±12 months from cardiac magnetic resonance. Medical history and biomarker values were obtained by chart review. Spearman’s Rank correlation assessed associations between biomarker z-scores and cardiac index. Biomarkers with significant correlations had receiver operating characteristic curves and area under the curve estimated. In total, 97 cardiac magnetic resonances in 87 patients met inclusion criteria: median age at cardiac magnetic resonance was 15 (6–33) years. Significant correlations were found between cardiac index and total alkaline phosphatase (−0.26, p=0.04), estimated creatinine clearance (0.26, p=0.02), and mean corpuscular volume (−0.32, p<0.01). Area under the curve for the three individual biomarkers was 0.63–0.69. Area under the curve for the three-biomarker panel was 0.75. Comparison of cardiac index above and below the receiver operating characteristic curve-identified cut-off points revealed significant differences for each biomarker (p<0.01) and for the composite panel [median cardiac index for higher-risk group=2.17 L/minute/m2 versus lower-risk group=2.96 L/minute/m2, (p<0.01)].
Higher total alkaline phosphatase and mean corpuscular volume as well as lower estimated creatinine clearance identify Fontan patients with lower cardiac index. Using biomarkers to monitor haemodynamics and organ-specific effects warrants prospective investigation.