Acute Respiratory Events Research Articles

Predicting Acute Exacerbation Phenotype in Chronic Obstructive Pulmonary Disease Patients Using VGG-16 Deep Learning.

Exacerbations of chronic obstructive pulmonary disease (COPD) have a significant impact on hospitalizations, morbidity, and mortality of patients. This study aimed to develop a model for predicting acute exacerbation in COPD patients (AECOPD) based on deep-learning (DL) features. We performed a retrospective study on 219 patients with COPD who underwent inspiratory and expiratory HRCT scans. By recording the acute respiratory events of the previous year, these patients were further divided into non-AECOPD group and AECOPD group according to the presence of acute exacerbation events. Sixty-nine quantitative CT (QCT) parameters of emphysema and airway were calculated by NeuLungCARE software, and 2,000 DL features were extracted by VGG-16 method. The logistic regression method was employed to identify AECOPD patients, and 29 patients of external validation cohort were used to access the robustness of the results. The model 3-B achieved an area under the receiver operating characteristic curve (AUC) of 0.933 and 0.865 in the testing cohort and external validation cohort, respectively. Model 3-I obtained AUC of 0.895 in the testing cohort and AUC of 0.774 in the external validation cohort. Model 7-B combined clinical characteristics, QCT parameters, and DL features achieved the best performance with an AUC of 0.979 in the testing cohort and demonstrating robust predictability with an AUC of 0.932 in the external validation cohort. Likewise, model 7-I achieved an AUC of 0.938 and 0.872 in the testing cohort and external validation cohort, respectively. DL features extracted from HRCT scans can effectively predict acute exacerbation phenotype in COPD patients.

Relationship between Simulated Fire Suppression Activities and Acute Cardiac and Respiratory Events in Firefighters.

Cardiac deaths account for the largest share of on-duty firefighter deaths. To help ensure duty fitness and minimize injury risk, many fire departments require the passing of an annual physical ability test, consisting of a battery of simulated fire suppression activities (sFSAs). The purpose of the study was to determine the relationship of sFSA performance to acute cardiac and respiratory events (ACREs) and the effect that estimated VO2max has on sFSA performance. The study was retrospective. As part of an annual physical ability test, five timed sFSAs were performed, summed for a composite time, and categorized into three performance levels (fast, moderate, and slow). Estimated VO2max was determined using the Forestry Step Test. A significant (p = 0.023) linear trend was observed with higher sFSA performance times being associated with a higher proportion of firefighters going on to suffer an ACRE. The estimated VO2max was significantly (p < 0.001) higher in the fast group compared to the slow group. There was not a significant (p = 0.70) difference in estimated VO2max between the moderate and slow groups. Estimated VO2max performance and sFSA performance were significantly correlated, with rs(488) = -0.272 and p < 0.001. Poorer sFSA performance was found to be associated with a higher proportion of ACREs. The results suggest that sFSA performance may be a valid indicator of ACRE injury risk and aerobic capacity.

Catheter-based pulmonary vein isolation fails to prevent transient atrial arrhythmogenic changes related to acute obstructive respiratory events in a porcine model.

Pulmonary vein isolation (PVI) is the corner stone of modern rhythm control strategies in patients with atrial fibrillation (AF). Sleep-disordered breathing (SDB) is prevalent in more than 50% of patients undergoing AF ablation, and studies have indicated a greater recurrence rate after PVI in patients with SDB. Herein, we study the effect of catheter-based PVI on AF in a pig model for SDB. In 11 sedated spontaneously breathing pigs, obstructive apnoeas were simulated by 75 s of intermittent negative upper airway pressure (INAP) applied by a negative pressure device connected to the endotracheal tube. Intermittent negative upper airway pressures were performed before and after PVI. AF-inducibility and atrial effective refractory periods (aERPs) were determined before and during INAP by programmed atrial stimulation. Pulmonary vein isolation prolonged the aERP by 48 ± 27 ms in the right atrium (RA) (P < 0.0001) and by 40 ± 34 ms in the left atrium (LA) (P = 0.0004). Following PVI, AF-inducibility dropped from 28 ± 26% to 0% (P = 0.0009). Intermittent negative upper airway pressure was associated with a transient aERP-shortening (ΔaERP) in both atria, which was not prevented by PVI (INAP indued ΔaERP after PVI in the RA: -57 ± 34 ms, P = 0.0002; in the LA: -42 ± 24 ms, P < 0.0001). Intermittent negative upper airway pressure was associated with a transient increase in AF-inducibility (from 28 ± 26% to 69 ± 21%; P = 0.0008), which was not attenuated by PVI [INAP-associated AF-inducibility after PVI: 58 ± 33% (P = 0.5)]. Transient atrial arrhythmogenic changes related to acute obstructive respiratory events are not prevented by electrical isolation of the pulmonary veins, which partially explains the increased AF recurrence in patients with SDB after PVI procedures.

Association of Acute Respiratory Disease Events with Quantitative Interstitial Abnormality Progression at CT in Individuals with a History of Smoking.

Background Acute respiratory disease (ARD) events are often thought to be airway-disease related, but some may be related to quantitative interstitial abnormalities (QIAs), which are subtle parenchymal abnormalities on CT scans associated with morbidity and mortality in individuals with a smoking history. Purpose To determine whether QIA progression at CT is associated with ARD and severe ARD events in individuals with a history of smoking. Materials and Methods This secondary analysis of a prospective study included individuals with a 10 pack-years or greater smoking history recruited from multiple centers between November 2007 and July 2017. QIA progression was assessed between baseline (visit 1) and 5-year follow-up (visit 2) chest CT scans. Episodes of ARD were defined as increased cough or dyspnea lasting 48 hours and requiring antibiotics or corticosteroids, whereas severe ARD episodes were those requiring an emergency room visit or hospitalization. Episodes were recorded via questionnaires completed every 3 to 6 months. Multivariable logistic regression and zero-inflated negative binomial regression models adjusted for comorbidities (eg, emphysema, small airway disease) were used to assess the association between QIA progression and episodes between visits 1 and 2 (intercurrent) and after visit 2 (subsequent). Results A total of 3972 participants (mean age at baseline, 60.7 years ± 8.6 [SD]; 2120 [53.4%] women) were included. Annual percentage QIA progression was associated with increased odds of one or more intercurrent (odds ratio [OR] = 1.29 [95% CI: 1.06, 1.56]; P = .01) and subsequent (OR = 1.26 [95% CI: 1.05, 1.52]; P = .02) severe ARD events. Participants in the highest quartile of QIA progression (≥1.2%) had more frequent intercurrent ARD (incidence rate ratio [IRR] = 1.46 [95% CI: 1.14, 1.86]; P = .003) and severe ARD (IRR = 1.79 [95% CI: 1.18, 2.73]; P = .006) events than those in the lowest quartile (≤-1.7%). Conclusion QIA progression was independently associated with higher odds of severe ARD events during and after radiographic progression, with higher frequency of intercurrent severe events in those with faster progression. Clinical trial registration no. NCT00608764 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Little in this issue.

Postoperative residual curarisation in geriatric patients: a prospective, observational cohort study.

To evaluate the occurrence and potential risk factors of residual curarisation after surgery and the subsequent acute respiratory events in elderly patients. The prospective, cohort study was conducted at Ankara City Hospital from July to December 2021, and comprised data of geriatric patients undergoing elective surgery under general anaesthesia using moderate-acting nondepolarising muscle relaxants. Postoperative acute respiratory events in the post-anaesthesia care unit were subsequently noted. Data was analysed using SPSS 25. Of the 185 patients aged >65 years evaluated, 174(94%) were included; 88(50.6%) females and 86(49.4%) males. The incidence of residual curarisation was in 6(3.4%) patients. Postoperative residual curarisation was significantly associated with smooth recovery process (p<0.05). The recovery was associated with intraoperative bleeding, total dose of neuromuscular blocker, and the length of time from the last dose of neuromuscular blocker to antagonist administration (p<0.05). Postoperative critical respiratory events were more common in patients with postoperative residual curarisation (p< 0.001). The length of stay in post-anaesthesia care unit was 1.57 times longer in such patients (p=0.001). Postoperative residual curarisation increased length of hospital stay and respiratory complications.

Retracted: Serum Exosomal MicroRNAs Predict Acute Respiratory Distress Syndrome Events in Patients with Severe Community-Acquired Pneumonia.

[This retracts the article DOI: 10.1155/2019/3612020.].

Effects of Air Pollution on Respiratory Events and Pain Crises Among Children with Sickle Cell Disease in New York City

Introduction: Sickle cell disease (SCD) has the highest U.S. disease burden among Black and Hispanic populations, who more commonly live in urban areas with poor ambient air quality. The effect of air pollution exposure and social environmental factors on health outcomes in SCD have not been extensively studied, especially among children, and may further contribute to health disparities. Objectives: This study aims to examine the associations between air pollution exposure and acute respiratory and pain events and to determine whether neighborhood-level social disadvantage would modify their associations. Methods: We collected retrospective data on unscheduled outpatient visits, emergency department (ED) visits, and hospital admissions for respiratory events (i.e., respiratory tract infections, asthma exacerbation, acute chest syndrome) and vaso-occlusive pain crises requiring hospitalization (VOCs) for children with SCD in a tertiary care center in New York City (NYC) from 2015-2018. A total of 114 children with SCD (Table 1) were included in this study and had between 1-4 annual repeated measures of annual average air pollutants (i.e., black carbon (BC), fine particulate matter (PM 2.5), and nitrogen dioxide (NO 2)) with a total of 425 visits. Using home addresses, modeled data from the NYC Community Air Survey data were used to estimate street-level, annual average exposure to air pollution. The area deprivation index (ADI), a composite index of neighborhood-level social disadvantage, was dichotomized at the upper tertile (higher vs lower). Multivariable Poisson regression in generalized estimating equation (GEE) models were used to estimate relative risks (RR), after adjusting for potential covariates. Results: Overall, there were no significant associations between air pollution levels and acute respiratory and pain events among children with SCD. When stratified by ADI, increased exposure to PM 2.5 and NO 2, but not BC, was significantly associated with more frequent respiratory outpatient and ED visits among children residing in higher ADI neighborhoods (RR (95%CI)= 1.13 (1.00, 1.28) and 1.43 (1.01, 2.02) for PM 2.5 and NO 2, respectively, p&amp;lt;0.05 for all), but not among those in lower ADI neighborhoods (P-value for interaction=0.2 and 0.02 for PM 2.5 and NO 2, respectively) (Figure 1). Associations of air pollution with hospital admissions and VOCs were not observed for neither high ADI nor low ADI neighborhoods (p-value&amp;gt;0.05). Conclusions: Exposure to air pollutants increased respiratory complications among children living in deprived neighborhoods.

Bilirubin-associated single nucleotide polymorphism (SNP) and respiratory health outcomes: a mendelian randomization study

BackgroundObservational studies have shown an association between higher bilirubin levels and improved respiratory health outcomes. Targeting higher bilirubin levels has been proposed as a novel therapeutic strategy in COPD. However, bilirubin levels are influenced by multiple intrinsic and extrinsic factors, and these observational studies are prone to confounding. Genetic analyses are one approach to overcoming residual confounding in observational studies.ObjectivesTo test associations between a genetic determinant of bilirubin levels and respiratory health outcomes.MethodsCOPDGene participants underwent genotyping at the baseline visit. We confirmed established associations between homozygosity for rs6742078 and higher bilirubin, and between higher bilirubin and decreased risk of acute respiratory events within this cohort. For our primary analysis, we used negative binomial regression to test associations between homozygosity for rs6742078 and rate of acute respiratory events.Results8,727 participants (n = 6,228 non-Hispanic white and 2,499 African American) were included. Higher bilirubin was associated with decreased rate of acute respiratory events [incidence rate ratio (IRR) 0.85, 95% CI 0.75 to 0.96 per SD increase in bilirubin intensity]. We did not find significant associations between homozygosity for rs6742078 and acute respiratory events (IRR 0.94, 95% CI 0.70 to 1.25 for non-Hispanic white and 1.09, 95% CI 0.91 to 1.31 for African American participants).ConclusionsA genetic determinant of higher bilirubin levels was not associated with better respiratory health outcomes. These results do not support targeting higher bilirubin levels as a therapeutic strategy in COPD.

Practice of debriefing of critical events: a survey-based cross-sectional study of Portuguese anesthesiologists.

We performed a national cross-sectional online survey exploring the practice of anesthesiologists' debriefing practice after critical events in Portuguese hospitals. The questionnaire was distributed using a snowball sampling technique from July to September 2021. Data were descriptively and comparatively analyzed. We had replies from 186 anesthesiologists (11.3% of the Portuguese pool). Acute respiratory event was the most reported type of critical event (96%). Debriefing occurred rarely or never in 53% of cases, 59% of respondents needed more training in debriefing, and only 4% reported having specific tools in their institutions to carry it out. There was no statistical association between having a debriefing protocol and the occurrence of critical events (P=.474) or having trained personnel (P=.95). The existence of protocols was associated with lower frequencies of debriefing (P=.017). Portuguese anesthesiologists know that debriefing is an essential process that increases patient safety, but among those surveyed, there is a need for an adequate debriefing culture or practice. Research registry 7741 (https://www.researchregistry.com/browse-the-registry#home).

Clinical features and 1-year outcomes of chronic bronchitis in participants with normal spirometry: results from the ECOPD study in China

BackgroundEvidence regarding clinical features and outcomes of individuals with non-obstructive chronic bronchitis (NOCB) remains scarce, especially in never-smokers. We aimed to investigate the clinical features and 1-year outcomes of individuals...

The Impact of a Public Health Emergency on the Demand for Life Insurance – An Empirical Analysis Based on Severe Acute Respiratory Syndrome

AbstractWe examined changes in personal life insurance purchase decisions after a public health event by incorporating perceived health risk and regret into the expected utility function. The model predicts that the epidemic will create incremental insurance demand. Based on the 2003 severe acute respiratory syndrome outbreak in China, we used a panel dataset of 30 provinces from 2000 to 2007 and applied the difference‐in‐differences method to confirm the prediction empirically. The results showed that the epidemic did not significantly impact the demand for life insurance in the short term but played a role in the long term. People increased their health‐care expenditure and premiums for new policies after the severe acute respiratory syndrome event, suggesting that the epidemic changed people's perceived risk and triggered anticipated regret, which increased life insurance demand. Some robustness checks also supported our findings.

Risk Factors of Pertussis Among Older Adults in South Korea: A Nationwide Health Data-Based Case-Control Study.

To better understand the conditions associated with pertussis diagnosis among older adults in South Korea, a matched case-control study was conducted of individuals≥50years diagnosed with pertussis between 2009 and 2018. Pertussis cases were identified using the nationwide Health Insurance Review and Assessment service (HIRA) database. Each case was then matched to up to 10 controls identified using the National Health Insurance Service-National Sample Cohort (NHIS-NSC) by age, sex, and geographic region at index date. In the 12months and 30days prior to index date, the presence of clinical characteristics previously reported to be related to pertussis and pertussis-like conditions were assessed, respectively. A conditional multivariate logistic regression model was then used to calculate odds ratios (ORs) of pertussis diagnosis, adjusted for each of the characteristics. Pertussis cases (n=1004) generally demonstrated a higher prevalence of comorbidities compared to controls (n=9710). Pre-existing asthma and chronic obstructive pulmonary disease (COPD) within 12months of index date were associated with a two-fold increased risk of pertussis with adjusted ORs (95% confidence interval) of 2.08 (1.68-2.58) and 2.32 (1.59-3.39), respectively. Gastroesophageal reflux disease [GERD; 2.67 (2.23-3.19)], cancer [1.68 (1.23-2.31)], cardiovascular disease [1.62 (1.31-2.00)], renal disease [1.56 (1.12-2.16)], autoimmune disease [1.50 (1.25-1.79)], and hyperlipidemia [1.43 (1.16-1.77)] were also associated with pertussis diagnosis. Finally, acute respiratory events within 30days prior to index date, such as pneumonia, acute bronchitis, and upper respiratory tract infection (URTI), were highly associated with increased odds of pertussis diagnosis [adjusted ORs of 8.28 (5.10-13.44), 4.86 (3.84-6.14), and 2.90 (2.30-3.67), respectively]. This study's findings complement and expand upon previous studies on the adult pertussis population, generating real-world data to describe underlying clinical characteristics of those diagnosed with pertussis in South Korea.

The effect of acute respiratory events and respiratory stimulants on EEG-recorded brain activity in neonates: A systematic review

ObjectiveWe conducted a systematic review to investigate electroencephalography (EEG) changes during periods of acute respiratory events such as apnoea and the effect of respiratory stimulants on EEG features in infants. MethodsStudies examining respiration and EEG-recorded brain activity in human neonates between 28 and 42 weeks postmenstrual age were included. Two reviewers independently screened all records and included studies were assessed using the Joanna Briggs Institute Critical Appraisal Tool. The protocol was registered in PROSPERO (CRD42022339873). ResultsWe identified 14 studies with a total of 534 infants. Nine articles assessed EEG changes in relation to apnoea, one assessed hiccups, and four investigated the effect of respiratory stimulants. The relationship between neonatal apnoea and EEG changes was inconsistent; EEG suppression and decreased amplitude and frequency were observed during some, but not all, apnoeas. Respiratory stimulants increased EEG continuity compared with before use. ConclusionsCurrent studies in this area are constrained by small sample sizes. Diverse exposure definitions and outcome measures impact inference. SignificanceThis review highlights the need for further work; understanding the relationship between respiration and the developing brain is key to mitigating the long-term effects of apnoea.

Co-prescribing of Central Nervous System-Active Medications for COPD Patients: Impact on Emergency Room Visits and Hospitalization.

Anxiety and chronic pain are common comorbidities in patients with chronic obstructive pulmonary disease (COPD), which are frequently managed with benzodiazepines (BZDs) and opioids, respectively. The purpose of this study was to determine whether different combinations of opioids, BZD, and their substitutes-gabapentinoids (GABA) and selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)-are associated with lower risk of acute respiratory events in COPD patients with co-occurring chronic pain and anxiety. This retrospective cohort study used a nationally representative sample of Medicare beneficiaries with COPD, chronic pain, and anxiety. Patients were grouped based on drug combination (opioid + BZD/Z-hypnotics, opioid + GABA, opioid + SSRI/SNRI, BZD/Z-hypnotics + GABA, BZD/Z-hypnotics + SSRI/SNRI, GABA + SSRI/SNRI, or ≥3 drugs). The primary outcome was emergency room (ER) visit or hospitalization due to acute respiratory events assessed up to 180 days following initiation of drug combination. Overdose secondary to central nervous system (CNS)-related drugs was also assessed up to 180 days following initiation of drug combination. The drug combination opioid + GABA was associated with decreased risk for ER visit (hazard ratio [HR] = 0.73; 95% CI = 0.61-0.87) and hospitalization (HR = 0.69; 95% CI = 0.55-0.85). Opioid + SSRI/SNRI also showed decreased risk for ER visit (HR = 0.84; 95% CI = 0.71-0.99). There was no significant difference in risk for CNS-related drug overdose among different drug combinations compared with opioid + BZD/Z-hypnotics. Opioids in combination with GABA and SSRI/SNRI demonstrate relatively lower risk for acute respiratory events among patients with COPD and comorbid chronic pain and anxiety. The findings emphasize the need for multimodal management in this vulnerable population.

Red propolis supplementation does not decrease acute respiratory events in stunted preschool children: A paired nonrandomized clinical trial

This study aimed to evaluate the efficacy of "red propolis" supplementation in the frequency of acute respiratory infections incidence in stunted preschool children. We hypothesized that the "red" propolis supplementation is effective in the reduce frequency of acute respiratory complications in stunted children. This is a non-randomized, pair-matched clinical trial with 70 children, ranging from 1 to 5 years old, followed for 1 year, which were paired into two groups according to age, sex, and stunting classification. The children were in the day hospital regimen of CREN and received 5 meals/day and an additional 8ml of honey or honey with "red propolis" in a 3% dilution. The children had access to nutritional, psychological, dental, and physician care. Respiratory complications were recorded in a pre-existing protocol of the institution by the same pediatrician, who was blind for the children's allocation. Anthropometric measurements and biochemical tests such as hemogram, IGF-1, and immunoglobulin E, G, M were conducted. The most prevalent symptoms were coughing, runny nose, nasal congestion and wheezing. The use of "red propolis" did not decrease the frequency of infections between the control and propolis groups, respectively (2 [1-7] vs 3 [1-7], p=0.10), which was within the estimated by the Pan American Health Organization. There were no differences between groups in anthropometric and biochemical parameters. Supplementation with "red propolis" did not reduce the number of infections in stunted children over 1 year. Possibly, the dilution percentage (3%) may have been insufficient to allow effective action. The protocol of published in the Brazilian Registry of Clinical Trials (http://www.ensaiosclinicos.gov.br/rg/RBR-4n7j6h).

Rationale and design of the SARCoidosis Outcomes in all respiratory Viral Infectious Diseases (SARCOVID) Study

IntroductionRespiratory infections are ubiquitous. The COVID-19 pandemic has refocused our attention on how morbid and potentially fatal they can be, and how host factors have an impact on the clinical...

Comparative analysis of respiratory symptom scores to detect acute respiratory events in children with cystic fibrosis

BackgroundPatient-reported outcomes (PROs) are important outcome measures in research and clinical practice. This study describes the longitudinal variability the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory score and the Chronic Respiratory Infection Symptom Score (CRISS), as well as their ability to identify acute respiratory events in children with CF. MethodsIn this prospective observational study, the parent-proxy (6 -13 years) and self-reported (6–18 years) CFQ-R Respiratory score and CRISS (6–18 years) were measured every 3 months over 2 years. The lung clearance index (LCI) and FEV1 were also measured. We compared the diagnostic accuracy of the PROs in distinguishing acute respiratory events and clinically stable visits, using the minimal important difference of each PRO as the threshold. ResultsA total of 98 children with CF were included. On average, the symptom scores did not change between clinically stable visits. The positive predictive value (PPV) and negative predictive value (NPV) of a ≥8.5-point worsening in the parent-proxy CFQ-R score to identify acute respiratory events (n=119) (PPV 70.2% and NPV 87.0%) were higher than for the self-reported CFQ-R score (PPV 58.9% and NPV 72.2%). The PPV and NPV of an ≥11-point change in the CRISS for acute respiratory events (n=137) was 56.5% and 79.6%, respectively. The PPV and NPV of all PROs were increased when combined with the LCI and/or FEV1pp. ConclusionSymptoms scores differ in their ability to identify acute respiratory events in children with CF; PPV and NPV of all PROs were improved when combined with lung function outcomes.

Effects of exposure to air pollution on acute cardiovascular and respiratory admissions to the hospital and early mortality at emergency department.

Particulate matter (PM) and NO2 induce pathophysiological changes which contribute to an increased incidence of acute cardiovascular (CV) and respiratory (Rp) events. To analyze the relationship between air quality and the frequency of admissions to the emergency department (ED) due to the CV diseases and Rp causes. The study analyzed the reasons for admissions to the ED during the cold periods from January 2017 to January 2020. These data were combined with the average daily concentrations of NO2, PM2.5 and PM10, and the individual air quality indexes (IAQIs) for these pollutants. Our analyses have shown that 3468 (11.4%) and 1053 (3.46%) of all 30,419 analyzed patients were admitted to the ED for CV and Rp reasons, respectively. Cardiovascular patients were significantly more often admitted to the ED when the IAQI for NO2 was worse than very good, and the IAQI for PM2.5 or PM10 was worse than good. In such periods, diagnoses such as ischemic heart disease (IHD) or syncope were statistically more common and the risk of admission of a patient with a diagnosis such as IHD, heart failure (HF), syncope, stroke, or transient ischemic attack (TIA) was increased. Registered deaths occurred significantly more often among patients admitted on days with moderate or worse than moderate air quality determined in relation to PM10 in comparison to days with very good or good air quality (0.35% and 0.23%, respectively, p = 0.04). Air quality significantly affects the admissions to the ED for CV and Rp reasons and has an impact on mortality.

Safety of Onasemnogene Abeparvovec for Patients With Spinal Muscular Atrophy 8.5 kg or Heavier in a Global Managed Access Program

BackgroundSpinal muscular atrophy is a rare, neurodegenerative disorder caused by biallelic deletions in the survival motor neuron (SMN1) gene. Onasemnogene abeparvovec is a one-time, intravenous gene replacement therapy designed to deliver the SMN1 transgene. Although available in many geographies, it is not approved globally. The Global Managed Access Program (GMAP) expanded treatment access to patients in countries where treatment was not approved. Previous onasemnogene abeparvovec clinical trials included patients with body weight <8.5 kg. Through GMAP, children weighing ≥8.5 kg received onasemnogene abeparvovec. We describe safety data for heavier patients in GMAP. MethodsGMAP records were reviewed to identify patients weighing ≥8.5 kg at onasemnogene abeparvovec dosing. To obtain corresponding adverse event (AE) data, the Novartis ARGUS safety database was searched using patient identification numbers and birth dates/dosing dates for any reported AE for GMAP patients. ResultsAs of September 2, 2021, 102 patients weighing ≥8.5 kg at time of dosing were identified. Fifty-four (53%) had one or more reported AEs. Three patients were reported to be deceased. All three deaths were assessed to be secondary to acute respiratory events. Most (62%) AEs were non-serious. The most frequently reported AEs included increases in hepatic laboratory values, decreased platelets and thrombocytopenia, pyrexia, vomiting, and decreased appetite. ConclusionsSafety findings for patients weighing ≥8.5 kg administered onasemnogene abeparvovec through GMAP were consistent with those described in clinical trials and included hepatotoxicity, thrombotic microangiopathy, and thrombocytopenia.

Bronchiectasis in Low-Dose CT Screening for Lung Cancer.

Background Bronchiectasis is associated with loss of lung function, substantial use of health care resources, and increased morbidity and mortality in people with cardiopulmonary diseases. Purpose To assess the frequency and severity of bronchiectasis and related clinical findings of participants in a low-dose CT (LDCT) screening program. Materials and Methods The Early Lung and Cardiac Action Program (ELCAP) bronchiectasis score (range, 0-42; higher values indicate more severe bronchiectasis) was developed to facilitate bronchiectasis assessment. This quantitative scoring system screened participants based on accumulated knowledge and improved CT imaging capabilities. Secondary review of LDCT studies from smokers aged 40-90 years was performed when they were initially enrolled in the prospective Mount Sinai ELCAP screening study between 2010 and 2019. Medical records were reviewed to identify associated respiratory symptoms and acute respiratory events during the 2 years after LDCT. Logistic regression analysis was performed to examine factors associated with bronchiectasis. Results LDCT studies of 2191 screening participants (mean age, 65 years ± 9; 1140 [52%] women) were obtained, and bronchiectasis was identified in 504 (23%) participants. Median ELCAP bronchiectasis score was 12 (interquartile range, 9-16). Bronchiectasis was most common in the lower lobes for all participants, and lower lobe prevalence was greater with higher ELCAP score (eg, 91% prevalence with an ELCAP score of 16-42). In the fourth quartile, however, midlung involvement was higher compared with lower lung involvement (128 of 131 participants [98%] vs 122 of 131 participants [93%]). Bronchiectasis was more frequent with greater age (odds ratio [OR] = 2.0 per decade; 95% CI: 1.7, 2.4); being a former smoker (OR = 1.33; 95% CI: 1.01, 1.73); and having self-reported chronic obstructive pulmonary disease (OR = 1.38; 95% CI: 1.02, 1.88), an elevated hemidiaphragm (OR = 4; 95% CI: 2, 11), or consolidation (OR = 5; 95% CI: 3, 11). It was less frequent in overweight (OR = 0.7; 95% CI: 0.5, 0.9) or obese (OR = 0.6; 95% CI: 0.4, 0.8) participants. Two years after baseline LDCT, respiratory symptoms, acute respiratory events, and respiratory events that required hospitalization were more frequent with increasing severity of the ELCAP bronchiectasis score (P < .005 for all trends). Conclusion Prevalence of bronchiectasis in smokers undergoing low-dose CT screening was high, and respiratory symptoms and acute events were more frequent with increasing severity of the Early Lung and Cardiac Action Program Bronchiectasis score. © RSNA, 2022 See also the editorial by Verschakelen in this issue.