Increased severity of respiratory syncytial virus airway infection due to passive smoke exposure

Objective

Aim of this study was to analyze whether children with objectively measured second‐hand cigarette smoke (SHS) exposure suffer from a more severe course of disease when hospitalized with lower respiratory tract infection (LRTI) due to respiratory syncytial virus (RSV).

Methods

This prospective study was conducted at the Department of Pediatrics, Wilhelminen‐Hospital, Vienna, Austria in children aged below 1 year without a history of preceding lung disease and with acute symptoms of LRTI and a positive nasopharyngeal swab for RSV. On admission, urinary cotinine was measured as a marker of recent SHS and clinical severity of LRTI was assessed by oxygen saturation SpO₂ and the “admission clinical severity score” (CSSA). Parents/caregivers were asked to complete a customized questionnaire assessing risks for SHS and demographic characteristics.

Results

After inclusion of 217 patients, data of 185 patients with a mean (SD) age of 106 days (80) were analyzed. Twenty‐five patients (13.5%) were “cotinine‐positive” (COT+) defined as a urinary cotinine level of ≥7 μg/L. SpO₂ on admission was significantly lower in children recently exposed to SHS defined objectively by COT+ (94.8% ±2.0) in urine on admission compared to children not recently exposed (COT−) (96.8% ±3.0; P < 0.01). Disease severity, assessed via mean clinical severity score on admission (CSSA) for COT+ and COT− was 2.56 and 1.71, respectively (P = 0.03).

Conclusions

Recent exposure to SHS was associated with lower O₂ saturation and higher clinical severity score, measured by urine cotinine levels in children hospitalized for RSV infection under 1 year of age.

     

Risk scoring tool to predict respiratory syncytial virus hospitalisation in premature infants

Background

The objective was to develop a risk scoring tool which predicts respiratory syncytial virus hospitalisation (RSVH) in moderate‐late preterm infants (32‐35 weeks’ gestational age) in the Northern Hemisphere.

Methods

Risk factors for RSVH were pooled from six observational studies of infants born 32 weeks and 0 days to 35 weeks and 6 days without comorbidity from 2000 to 2014. Of 13 475 infants, 484 had RSVH in the first year of life. Logistic regression was used to identify the most predictive risk factors, based on area under the receiver operating characteristic curve (AUROC). The model was validated internally by 100‐fold bootstrapping and externally with data from a seventh observational study. The model coefficients were converted into rounded multipliers, stratified into risk groups, and number needed to treat (NNT) calculated.

Results

The risk factors identified in the model included (i) proximity of birth to the RSV season; (ii) second‐hand smoke exposure; and (iii) siblings and/or daycare. The AUROC was 0.773 (sensitivity: 68.9%; specificity: 73.0%). The mean AUROC from internal bootstrapping was 0.773. For external validation with data from Ireland, the AUROC was 0.707 using Irish coefficients and 0.681 using source model coefficients. Cut‐off scores for RSVH were ≤19 for low‐ (1.0%), 20‐45 for moderate‐ (3.3%), and 50‐56 (9.5%) for high‐risk infants. The high‐risk group captured 62.0% of RSVHs within 23.6% of the total population (NNT 15.3).

Conclusions

This risk scoring tool has good predictive accuracy and can improve targeting for RSVH prevention in moderate‐late preterm infants.

     

Serum soluble receptor for advanced glycation end‐products during acute bronchiolitis in infant: Prospective study in 93 cases

Introduction

Acute bronchiolitis is a major cause of acute respiratory distress in infants. The soluble receptor for advanced glycation end‐products (sRAGE) is a biomarker of pulmonary damage processes, with a diagnostic and a prognostic value in acute respiratory distress syndrome (ARDS). The RAGE pathway is also implicated in the pathogenesis of other respiratory diseases like asthma, but the value of sRAGE levels in acute bronchiolitis remains under‐investigated.

Material and methods

A prospective, observational, and analytical study was conducted at Clermont‐Ferrand University Hospital. The main objective was to evaluate the correlation between serum sRAGE and clinical severity of bronchiolitis in hospitalized infants aged <1 year. We analyzed correlations between serum sRAGE and Wainwright score, short‐term morbidity attributable to bronchiolitis, causal viruses and risk for recurrent wheezing at 1 year.

Results

The study included 93 infants. sRAGE levels were significantly lower in acute bronchiolitis patients (mean 1101 pg/mL) than in controls (2203 pg/mL, P < 0.001) but did not correlate with clinical severity. No correlation was found between serum sRAGE and severity score, respiratory viruses, and recurrent wheezing at 1 year. Serum sRAGE levels were negatively correlated with age (r = −0.45, P < 0.001).

Conclusion

Serum sRAGE levels are decreased in acute bronchiolitis but not correlated with disease severity. sRAGE levels should be age‐adjusted in infants. Serum sRAGE levels measured in the setting of acute bronchiolitis were not predictive of recurrent wheezing.

     

BMI predicts exercise induced bronchoconstriction in asthmatic boys

Background

Exercise induced bronchoconstriction (EIB) is a frustrating morbidity of asthma in children. Obesity has been associated with asthma and with more severe EIB in asthmatic children.

Objectives

To quantify the effect of BMI on the risk of the occurrence of EIB in children with asthma.

Methods

Data were collected from six studies in which exercise challenge tests were performed according to international guidelines. We included 212 Children aged 7‐18 years, with a pediatrician‐diagnosed mild‐to‐moderate asthma.

Results

A total of 103 of 212 children (49%) had a positive exercise challenge (fall of FEV₁ ≥ 13%). The severity of EIB, as measured by the maximum fall in FEV₁, was significantly greater in overweight and obese children compared to normal weight children (respectively 23.9% vs 17.9%; P = 0.045). Asthmatic children with a BMI z‐score around +1 had a 2.9‐fold higher risk of the prevalence of EIB compared to children with a BMI z‐score around the mean (OR 2.9; 95%CI: 1.3‐6.1; P < 0.01). An increase in BMI z‐score of 0.1 in boys led to a 1.4‐fold increased risk of EIB (OR 1.4; 95%CI: 1.0‐1.9; P = 0.03). A reduction in pre‐exercise FEV₁ was associated with a higher risk of EIB (last quartile six times higher risk compared to highest quartile (OR 6.1 [95%CI 2.5‐14.5]).

Conclusions

The severity of EIB is significantly greater in children with overweight and obesity compared to non‐overweight asthmatic children. Furthermore, this study shows that the BMI‐z‐score, even with a normal weight, is strongly associated with the incidence of EIB in asthmatic boys.

     

Children with severe acute asthma admitted to Dutch PICUs: A changing landscape

The number of children requiring pediatric intensive care unit (PICU) admission for severe acute asthma (SAA) around the world has increased.

Objectives

We investigated whether this trend in SAA PICU admissions is present in the Netherlands.

Methods

A multicenter retrospective cohort study across all tertiary care PICUs in the Netherlands. Inclusion criteria were children (2‐18 years) hospitalized for SAA between 2003 and 2013. Data included demographic data, asthma diagnosis, treatment, and mortality.

Results

In the 11‐year study period 590 children (660 admissions) were admitted to a PICU with a threefold increase in the number of admissions per year over time. The severity of SAA seemed unchanged, based on the first blood gas, length of stay and mortality rate (0.6%). More children received highflow nasal cannula (P < 0.001) and fewer children needed invasive ventilation (P < 0.001). In 58% of the patients the maximal intravenous (IV) salbutamol infusion rate during PICU admission was 1 mcg/kg/min. However, the number of patients treated with IV salbutamol in the referring hospitals increased significantly over time (P = 0.005). The proportion of steroid‐naïve patients increased from 35% to 54% (P = 0.004), with a significant increase in both age groups (2‐4 years [P = 0.026] and 5‐17 years [P = 0.036]).

Conclusions

The number of children requiring PICU admission for SAA in the Netherlands has increased. We speculate that this threefold increase is explained by an increasing number of steroid‐naïve children, in conjunction with a lowered threshold for PICU admission, possibly caused by earlier use of salbutamol IV in the referring hospitals.

     

Defining lower airway bacterial infection in children with chronic endobronchial disorders

Background

Differentiating lower airway bacterial infection from possible upper airway contamination in children with endobronchial disorders undergoing bronchoalveolar lavage (BAL) is important for guiding management. A diagnostic bacterial load threshold based on inflammatory markers has been determined to differentiate infection from upper airway contamination in infants with cystic fibrosis, but not for children with protracted bacterial bronchitis (PBB), chronic suppurative lung disease (CSLD), or bronchiectasis.

Methods

BAL samples from children undergoing bronchoscopy underwent quantitative bacterial culture, cytologic examination, and respiratory virus testing; a subset also had interleukin‐8 examined. Geometric means (GMs) of total cell counts (TCCs) and neutrophil counts were plotted by respiratory pathogen bacterial load. Logistic regression determined associations between age, sex, Indigenous status, antibiotic exposure, virus detection and bacterial load, and elevated TCCs (>400 × 10³ cells/mL) and airway neutrophilia (neutrophils >15% BAL leukocytes).

Results

From 2007 to 2016, 655 children with PBB, CSLD, or bronchiectasis were enrolled. In univariate analyses, Indigenous status and bacterial load ≥10⁵ colony‐forming units (CFU)/mL were positively associated with high TCCs. Viruses and bacterial load ≥10⁴ CFU/mL were positively associated with neutrophilia; negative associations were seen for Indigenous status and macrolides. In children who had not received macrolide antibiotics, bacterial load was positively associated in multivariable analyses with high TCCs at ≥10⁴ CFU/mL and with neutrophilia at ≥10⁵ CFU/mL; GMs of TCCs and neutrophil counts were significantly elevated at 10⁴ and 10⁵ CFU/mL compared to negative cultures.

Conclusions

Our findings support a BAL threshold ≥10⁴ CFU/mL to define lower airway infection in children with chronic endobronchial disorders.

     

Potential pathogenicity of Inquilinus limosus in a pediatric patient with cystic fibrosis

Presentation

Patient is a 6‐year‐old male with CF, MRSA colonization, and pancreatic insufficiency that presented with worsening ppFEV1 and systemic symptoms despite multiple interventions. BAL grew NTM, Stenotrophomonas maltophilia, and Inquilinus limosus, a rare organism found in patients with CF.

Course

I. limosus treatment was deferred. Despite treatment of other pathogens, symptoms worsened. I. limosus was targeted with meropenem, amikacin, and ciprofloxacin along with clindamycin for MRSA colonization. Within weeks, symptoms had resolved with ppFEV1 improvement.

Discussion

This case discusses the importance of a rare organism in the CF population. Targeting I. limosus was key to recovery, revealing its potential pathogenicity.

     

Associations between maternal mental health and early child wheezing in a South African birth cohort

Background

Wheezing in early childhood is common and has been identified in high‐income countries (HIC) as associated with maternal antenatal or postnatal psychosocial risk factors. However, the association between maternal mental health and childhood wheezing has not been well studied in low and middle‐income countries (LMIC), such as South Africa.

Methods

A total of 1137 pregnant women over 18 year old, between 20 and 28 weeks’ gestation, and attending either of two catchment area clinics were enrolled in a South African parent study, the Drakenstein Child Health Study (DCHS). Psychosocial risk factors including maternal depression, psychological distress, early adversity, and intimate partner violence (IPV), were measured antenatally and postnatally by validated questionnaires. Two outcomes were evaluated: Presence of wheeze (at least one episode of child wheeze during the first 2 years of life); and recurrent wheeze (two or more episodes of wheezing in a 12‐month period). Logistic regression was used to investigate the association between antenatal or postnatal psychosocial risk factors and child wheeze, adjusting for clinical and socio‐demographic covariates.

Results

Postnatal psychological distress and IPV were associated with both presence of wheeze (adjusted OR = 2.09, 95%CI: 1.16‐3.77 and 1.63, 95%CI: 1.13‐2.34, respectively), and recurrent child wheeze (adjusted OR = 2.26, 95%CI: 1.06‐4.81 and 2.20, 95%CI: 1.35‐3.61, respectively).

Conclusion

Maternal postnatal psychological distress and IPV were associated with wheezing in early childhood. Thus, screening and treatment programs to address maternal psychosocial risk factors may be potential strategies to reduce the burden of childhood wheeze in LMICs.

     

Predictors of repeated acute hospital attendance for asthma in children: A systematic review and meta‐analysis

Background

Asthma attacks are common and have significant physical, psychological, and financial consequences. Improving the assessment of a child's risk of subsequent asthma attacks could support front‐line clinicians’ decisions on augmenting chronic treatment or specialist referral. We aimed to identify predictors for emergency department (ED) or hospital readmission for asthma from the published literature.

Methods

We searched MEDLINE, EMBASE, AMED, PsycINFO, and CINAHL with no language, location, or time restrictions. We retrieved observational studies and randomized controlled trials (RCT) assessing factors (personal and family history, and biomarkers) associated with the risk of ED re‐attendance or hospital readmission for acute childhood asthma.

Results

Three RCTs and 33 observational studies were included, 31 from Anglophone countries and none from Asia or Africa. There was an unclear or high risk of bias in 14 of the studies, including 2 of the RCTs. Previous history of emergency or hospital admissions for asthma, younger age, African‐American ethnicity, and low socioeconomic status increased risk of subsequent ED and hospital readmissions for acute asthma. Female sex and concomitant allergic diseases also predicted hospital readmission.

Conclusion

Despite the global importance of this issue, there are relatively few high quality studies or studies from outside North America. Factors other than symptoms are associated with the risk of emergency re‐attendance for acute asthma among children. Further research is required to better quantify the risk of future attacks and to assess the role of commonly used biomarkers.

     

Pulmonary presentation of Kawasaki disease—A diagnostic challenge

Objectives

Kawasaki disease (KD) is a multisystemic vasculitis with predominant mucocutaneous manifestations. Pulmonary involvement in KD is distinctly uncommon and is not commonly recognized. We describe our experience of managing children with KD wherein the initial presentation was predominantly pulmonary.

Methods

Six hundred and two children have been diagnosed with KD during the period January 1993 to May 2017 in the Allergy Immunology Unit, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh. Data were collected from inpatient records in Allergy Immunology Unit and follow‐up files in the Pediatric Rheumatology Clinic.

Results

Of 602 children, 11 (1.83%) had a predominant pulmonary presentation of KD. Mean age at diagnosis of KD was 2.5 years. Fever, cough and respiratory distress were the presenting complaints in all patients. First sign of KD was noted at a mean duration of 14.5 days from the onset of symptoms. Periungual desquamation was the most common clinical sign (72.7%). Persistent fever in spite of antimicrobials, thrombocytosis, and elevated erythrocyte sedimentation rate and C‐reactive protein levels pointed toward a diagnosis of KD in our patients. Parenchymal consolidation was evident on chest X‐ray in all patients, pleural effusion in six, empyema in three, and pneumothorax in two patients. Coronary artery abnormalities were evident in three patients. Intravenous immunoglobulin was given after a mean period of 22.4 days of onset of fever.

Conclusions

The diagnosis of KD is often delayed in children who have a predominantly pulmonary presentation. This can have adverse clinical consequences.

     

Analysis of viral infection and biomarkers in patients with acute exacerbation of chronic obstructive pulmonary disease

Objective

To investigate viral infection in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in Shanghai, and to analyze the clinical characteristics and biomarkers in viral infection.

Methods

This study included all consecutive patients who were admitted for a diagnosis of AECOPD during June 2013 to May 2015. Thirty‐one stable COPD patients and 31 healthy controls were also recruited. Oropharyngeal samples were assessed, PCR for respiratory viruses were performed. Patients were divided into AECOPD virus‐positive (+) group and AECOPD virus‐negative (?) group according to viral detection. Luminex was used to detect the concentrations of inflammatory cytokines in the serum.

Results

A total of 264 patients were included with a mean age of 75 ± 0.5 years. There were 72 patients (27.3%) identified with viral positive, of whom two patients were detected with double viral infections (FluA + FluB and RSVA + HRV, respectively). The rate of viral detection was associated with season, highest in winter. Comparisons of clinical characteristics showed no significant differences between AECOPD virus+ group and AECOPD virus? group. However, serum concentrations of interferon‐inducible protein‐10 (IP‐10) and interferon‐gamma (IFN‐γ) in virus+ AECOPD patients were significantly higher than those in the virus? AECOPD, stable COPD and healthy control groups (P < .05).

Conclusion

Viral infection was an important pathogen in AECOPD patients; the most common viruses included FluA, HRV and FluB. It was very difficult to diagnose the viral infection according to clinical characteristics. The increased of serum IP‐10 and IFN‐γ levels might be value to indicate viral infection in AECOPD.

     

Increased risk of acute coronary syndrome in patients with bronchiectasis: A population‐based cohort study

Background and objective

There are few studies on the relationship between bronchiectasis and acute coronary syndrome (ACS). We conducted a population‐based cohort study to assess whether bronchiectasis was associated with an increased risk of ACS.

Methods

We identified 3521 patients diagnosed with bronchiectasis between 2000 and 2010 (bronchiectasis cohort) and frequency matched them with 14 084 randomly selected people without bronchiectasis from the general population (comparison cohort) according to sex, age and index year using the Longitudinal Health Insurance Database. Both cohorts were followed until the end of 2010 to determine the ACS incidence. Hazard ratios of ACS were measured.

Results

Based on 17 340 person‐years for bronchiectasis patients and 73 639 person‐years for individuals without bronchiectasis, the overall ACS risk was 40% higher in the bronchiectasis cohort (adjusted hazard ratio (HR) = 1.40; 95% CI: 1.20–1.62). Compared with those in the comparison cohort with one respiratory infection‐related emergency room (ER) visit per year, the ACS risk was 5.46‐fold greater in bronchiectasis patients with three or more ER visits per year (adjusted HR = 5.46, 95% CI: 4.29–6.96). Patients with bronchiectasis and three or more respiratory infection‐related hospitalizations per year had an 8.15‐fold higher ACS risk (adjusted HR = 8.15, 95% CI: 6.27–10.61).

Conclusion

Bronchiectasis patients, particularly those experiencing frequent exacerbations with three or more ER visits and consequent hospitalization per year, are at an increased ACS risk.

     

Atrial Septostomy in Patients with End‐Stage Pulmonary Hypertension. No More Needles but Wires,Energy and Close Anatomical Definition

Objectives

To assess the usefulness of a new approach to atrial septal puncture and septostomy in patients with end‐stage pulmonary hypertension.

Background

Atrial septostomy in end‐stage pulmonary hypertension has high mortality and morbidity rates mainly due to trans‐septal catheterization. New approaches to safety during this technical step are expected.

Methods

Twelve patients with end‐stage pulmonary arterial hypertension (5 males, 7 females, mean age 41, 9 ± 12, 0 years) underwent to balloon atrial septostomy. Intracardiac echography (ICE) was used to localize fossa ovalis while a radiofrequency wire was used to perforate the atrial septum. Then a septostomy was performed by progressive balloon dilatation of atrial septum. Septal perforation was successful at the first attempt in 4 patients and after 5 attempts in a single case, while Bas was successful in all.

Results

Pericardial effusion did not develop in any patient. Complications consisted in transient supraventricular tachyarrhythmia, transient cerebral ischemia and severe hypoxemia with ventricular tachycardia in 3 single patients. In‐procedure death rate was 0%. Systemic cardiac output increased immediately, while systemic O2 saturation decreased significantly in all. Mean follow‐up was 8, 2 ± 3, 8 months. Mortality was 16, 6% (2 patients). NYHA class improved in the rest of patients. Four patients (33, 2%) underwent to pulmonary transplant successfully.

Conclusions

This novel approach for trans‐septal catheterization has shown very low rate of major complication during atrial septostomy in patients with end‐stage pulmonary arterial hypertension. (J Interven Cardiol 2013;26:62–68)

     

Outcome evaluation of a pharmacy‐based therapy management program for patients with cystic fibrosis

Objective

To compare medication adherence, pulmonary exacerbations, healthcare utilization, and costs for patients with cystic fibrosis (CF) who utilized a pharmacy‐based therapy management program to a matched control group. We hypothesized that patient management services would be associated with better medication adherence, and thus require fewer visits to the emergency room or hospitalizations.

Methods

This retrospective, observational cohort study used claims data from the MORE² claims Registry®. The sample consisted of CF patients, aged 6+, who had ≥1 pharmacy claim for inhaled tobramycin, inhaled aztreonam, ivacaftor, or dornase alfa from 6/2/2014‐5/31/2015. Adherence was measured as proportion of days covered (PDC). Propensity score matching and multivariable regression techniques were used to compare outcomes in program participants to matched controls.

Results

Of the 236 intervention and 724 control patients meeting selection criteria, 202 were propensity‐matched from each cohort. Relative to the control cohort, program patients had 23% higher mean PDC for tobramycin (IRR = 1.23, P = 0.01) and were twice as likely to be adherent to tobramycin (PDC ≥ 80%) than matched controls (OR = 2.14, P = 0.04). Program patients had fewer ER visits (IRR = 0.52, P < 0.01) and slightly lower ER costs (IRR = 0.66, P = 0.06) than the control patients.

Conclusion

A pharmacy‐based therapy management program for CF patients was associated with higher adherence to inhaled tobramycin and lower ER rates. Pharmacies that provide therapy management can support effective CF care management.

     

Stenotrophomonas maltophilia: A marker of lung disease severity

Background

While the prevalence of Stenotrophomonas maltophilia lung infection in cystic fibrosis (CF) patients has increased in the last decades, its pathogenicity remains controversial. The aim of this study was to investigate the effects of S. maltophilia initial infection on the progression of lung disease in CF children.

Methods

This case‐control retrospective study took place in a pediatric CF center. A total of 23 cases defined by at least one sputum culture positive for S. maltophilia, were matched for age, sex, and CFTR mutations to 23 never infected CF controls. The clinical data were collected for 2 years before and after S. maltophilia initial infection and comprised lung function analyses, rates of exacerbations and of antibiotic courses.

Results

Compared with controls, cases had lower lung function (P = 0.05), more frequent pulmonary exacerbations (P = 0.01), hospitalizations (P = 0.02), and intravenous antibiotic courses (P = 0.04) before S. maltophilia acquisition. In the year following S. maltophilia initial infection, lung function decline was similar in cases and controls but cases remained more severe, with more frequent pulmonary exacerbations (P = 0.01), hospitalizations (P = 0.02) and intravenous antibiotic courses (P = 0.02).

Conclusions

S. maltophilia seems to be a marker of CF lung disease severity and international recommendations to reduce lung infection by this pathogen should rapidly emerge.

     

A 4 year prospective study to determine risk factors for severe community acquired pneumonia in children in southern China

Background

Pneumonia is the major cause of death under 5 years. With high CAP numbers in China and growing access to PICUs, factors associated with severe CAP need to be determined to optimize care.

Objective

To prospectively determine PICU CAP admission features and outcomes.

Methods

A 4 year prospective study of CAP aged 1 month to <14 years admitted to PICU, Children's Hospital Affiliated to Soochow University, China. All were managed in a standard manner. Clinical, laboratory, and imaging findings were collected systematically. All received antibiotics.

Results

Eight hundred ten (7%) of 10,836 CAP hospital admissions needed PICU. Seven hundred seven (87%) were enrolled. PICU CAP children were young (76% ≤ 12 months) and 33% had co‐morbid conditions; 21% congenital heart disease.21% required mechanical ventilation. The average length of PICU stay was 5 days (range, 3–27). The case fatality rate was 5.8%. Viruses were detected in 38%, RSV 24%; bacteria in 23%, Streptococcus pneumoniae 7%, Haemophilus influenza b 4%, Mycoplasma 11%. On single factor analysis, PICU admission respiratory rate >70/min, grunting/groaning, head nodding, cyanosis, and anemia were associated with respiratory failure and with fatality. On multivariate analysis only presence of congenital heart disease, Trisomy 21 and immunodeficiency correlated with fatality; not microbe nor PICU findings.

Conclusions

Young age and underlying congenital heart disease were associated factors for PICU support in CAP in China. Early referral if altered sensorium, high respiratory rate, head nodding, grunting and anemia, and universal access to conjugated vaccines may decrease morbidity and mortality. Pediatr Pulmonol. 2013; 48:390–397. © 2012 Wiley Periodicals, Inc.

     

Acute effect of multiple ozone metrics on mortality by season in 34 Chinese counties in 2013–2015

Background

Although numerous multicentre studies have estimated the association between ozone exposure and mortality, there are currently no nationally representative multicentre studies of the ozone–mortality relationship in China.

Objective

To investigate the effect on total (nonaccidental) and cause‐specific mortality of short‐term exposure to ambient ozone, and examine different exposure metrics.

Methods

The effects of short‐term exposure to ozone were analysed using various metrics (daily 1‐h maximum, daily 8‐h maximum and daily average) on total (nonaccidental) and cause‐specific (circulatory and respiratory) mortality from 2013 to 2015 in 34 counties in 10 cities across China. We used distributed lag nonlinear models for estimating county‐specific relative risk of mortality and combined the county‐specific relative rates by conducting a random‐effects meta‐analysis.

Results

In all‐year analyses, a 10 μg m^?3 increase in daily average, daily 1‐h maximum and daily 8‐h maximum ozone at lag02 corresponded to an increase of 0.6% (95% CI : 0.33, 0.88), 0.26% (95% CI : 0.12, 0.39) and 0.37% (95% CI : 0.2, 0.55) in total (nonaccidental) mortality, 0.66% (95% CI : 0.28, 1.04), 0.31% (95% CI : 0.11, 0.51) and 0.39% (95% CI : 0.16, 0.62) in circulatory mortality, and 0.57% (95% CI : ?0.09, 1.23), 0.11% (95% CI : ?0.22, 0.44) and 0.22% (95% CI : ?0.28, 0.72) in respiratory mortality, respectively. These estimates had a different seasonal pattern by cause of death. In general, the seasonal patterns were consistent with the times of year when ozone concentrations are highest.

Conclusions

Our findings suggest that in China, the acute effects of ozone are more closely related to daily average exposure than any other metric.

     

The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2‐18 years: Results of two phase 3 studies

Background

Quadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.

Objectives

Evaluate safety and efficacy of Q/LAIV in Japanese children.

Patients/methods

Two phase 3 studies were conducted in the 2014‐2015 influenza season. Study 1 was an open‐label, uncontrolled single arm, multicenter study of Q/LAIV safety in subjects aged 2‐6 years. Study 2 was a randomized, double‐blind, placebo‐controlled multicenter study of Q/LAIV safety and efficacy; subjects aged 7‐18 years were randomized 2:1 to receive Q/LAIV or placebo. Primary efficacy endpoint was laboratory‐confirmed symptomatic influenza infection caused by vaccine‐matched strains; secondary endpoint evaluated efficacy against all strains regardless of match. Both studies reported solicited symptoms, adverse events (AEs), and serious AEs.

Results

In Study 1, 100 subjects received Q/LAIV. In Study 2, 1301 subjects received Q/LAIV (n = 868) or placebo (n = 433). Treatment‐emergent AEs occurred in 42% of subjects in Study 1, and in 24.3% of subjects in the Q/LAIV arm and in 25.9% of subjects in the placebo arm in Study 2. In Study 2, a single infection by a vaccine‐matched strain was reported in the placebo arm, resulting in a vaccine efficacy estimate of 100% (95% CI: ?1875.3, 100.0); efficacy for all strains regardless of match to the vaccine was 27.5% (95% CI: 7.4, 43.0).

Conclusions

Quadrivalent live attenuated influenza vaccine did not meet its primary efficacy endpoint as only a single infection by a vaccine‐matched strain was detected; however, efficacy for the secondary endpoint, all strains regardless of match, was achieved. Q/LAIV was generally well tolerated in the Japanese pediatric population.

     

MGuard Mesh‐Covered Stent for Treatment of ST‐Segment Elevation Myocardial Infarction with High Thrombus Burden Despite Manual Aspiration

Objectives

To assess the usefulness of the MGuard stent in patients with ST‐segment elevation myocardial infarction (STEMI) in whom a high thrombus burden persists after manual aspiration.

Background

In some patients with STEMI, a high thrombus burden may persist after manual aspiration. These patients may be at high risk of distal embolization and therefore impaired myocardial reperfusion. The MGuard is a novel mesh‐covered stent designed to minimize thrombus embolization.

Methods

Single‐arm, prospective registry of patients with STEMI and high thrombus burden after aggressive thrombus aspiration treated with the MGuard stent. High thrombus burden was defined as thrombus burden grade 4 or 5 according to the TIMI score. Lesions with a side branch ≥2 mm and patients with cardiogenic shock were not included. The study end‐points were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST‐segment resolution.

Results

Fifty‐six patients were included. After MGuard stent implantation >85% of cases had thrombus score = 0. Final TIMI 3 flow was achieved in 82% of cases, normal myocardial blush in 55%, and complete ST‐segment resolution in 59%. Occlusion of a side branch (<2 mm) occurred in 2 cases (3.5%), embolization to a distal branch in 5 cases (8.9%), and transient no‐reflow in 4 cases (7.1%). Major adverse cardiac events rate at 9 months was 3.6%, including 1 definite acute stent thrombosis and 1 target‐vessel revascularization.

Conclusions

The MGuard stent may be useful to prevent distal embolization in patients with STEMI and high thrombus burden despite mechanical aspiration.

     

Real‐life data regarding acute procedural success and 1‐year clinical outcome of desolve bioresorbable scaffolds

Objectives

We aimed to evaluate the peri‐procedural success of DESolve bio‐resorbable scaffolds (BRSs) and analyzed real‐life data about major cardiac events during 1‐year follow‐up.

Background

There is little information about real‐life data of DESolve BRS which is a novel stent technology offering various advantages over drug eluting stents and commonly used in daily cardiology practice.

Methods

We conducted this single‐center and non‐randomized cross‐sectional study from June 2015 through August 2016 in Medipol University Department of Cardiology and included 117 patients undergoing single or multivessel percutaneous coronary interventions (PCI) with novolimus‐eluting BRS devices (152 scaffolds) (Elixir Medical Corporation). Study end points were acute device and procedural success, scaffold thrombosis and major adverse cardiac event (MACE) rates of DESolve BRS.

Results

Device success was 96.7% and procedural success was 99.3%. We detected MACE rate as 0.9% while clinical‐driven target lesion revascularization was performed in one patient. None of the patients experienced scaffold thrombosis or death. Peri‐procedural complications were reported in three patients.

Conclusions

High rates of successful scaffold implantations, low rates of peri‐procedural complications, and major cardiac events in long‐term suggest that DESolve scaffolds can safely and effectively be used in daily intervention practice by particularly experienced operators.