American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Dec 2019
Randomized Controlled Trial Multicenter StudySafety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe COPD (AIRFLOW): A Multicenter Randomized Controlled Trial.
Rationale: Targeted lung denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for chronic obstructive pulmonary disease (COPD), which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucus hypersecretion. Objectives: To determine the safety and impact of TLD on respiratory adverse events. Methods: We conducted a multicenter, randomized, sham bronchoscopy-controlled, double-blind trial in patients with symptomatic (modified Medical Research Council dyspnea scale score, ≥2; or COPD Assessment Test score, ≥10) COPD (FEV1, 30-60% predicted). ⋯ There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient-reported symptoms, or other physiologic measures over the 12.5 months of follow-up. Conclusions: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study-defined respiratory adverse events, including hospitalizations for COPD exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT02058459).
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Am. J. Respir. Crit. Care Med. · Dec 2019
Randomized Controlled TrialNintedanib and Sildenafil in Patients with Idiopathic Pulmonary Fibrosis and Right Heart Dysfunction. A Prespecified Subgroup Analysis of a Double-Blind Randomized Clinical Trial (INSTAGE).
Rationale: In the INSTAGE trial in patients with idiopathic pulmonary fibrosis (IPF) and severely impaired gas exchange, nintedanib plus sildenafil was associated with numerical benefits on St. George's Respiratory Questionnaire (SGRQ) total score, brain natriuretic peptide (BNP), and FVC decline versus nintedanib alone. Exploratory analyses of the STEP-IPF (Sildenafil Trial of Exercise Performance in IPF) trial suggested that sildenafil may have a greater effect on SGRQ score in patients with IPF who have right heart dysfunction (RHD). ⋯ Conclusions: In the INSTAGE trial, there were no significant differences in the effects of nintedanib plus sildenafil versus nintedanib alone on changes in SGRQ and FVC between patients with or without echocardiographic signs of RHD at baseline. The benefit of combination therapy on stabilizing BNP was more pronounced in patients with RHD at baseline. Clinical trial registered with www.clinicaltrials.gov (NCT02802345).
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Am. J. Respir. Crit. Care Med. · Dec 2019
Tuberculosis Diagnosis in Children Using Xpert Ultra on Different Respiratory Specimens.
Rationale: Microbiological confirmation of pulmonary tuberculosis in children is desirable. Objectives: To investigate the diagnostic accuracy and incremental yield of Xpert MTB/RIF Ultra (Ultra; Cepheid), a new rapid test, on repeated induced sputum, nasopharyngeal aspirates, and combinations of specimens. Methods: Consecutive South African children hospitalized with suspected pulmonary tuberculosis were enrolled. ⋯ Sensitivity using Ultra on two NPAs was 54.2%, increasing to 87.5% with an IS Ultra. Conclusions: IS provides a better specimen than repeated NPA for rapid diagnosis using Ultra. However, Ultra testing of combinations of specimens provides a novel strategy that can be adapted to identify most children with confirmed pulmonary tuberculosis.
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Am. J. Respir. Crit. Care Med. · Dec 2019
Multicenter StudyVentricular Dysfunction Is a Critical Determinant of Mortality in Congenital Diaphragmatic Hernia.
Rationale: Congenital diaphragmatic hernia (CDH) is an anomaly with a high morbidity and mortality. Cardiac dysfunction may be an important and underrecognized contributor to CDH pathophysiology and determinant of disease severity. Objectives: Our aim was to investigate the association between early, postnatal ventricular dysfunction and outcome among infants with CDH. ⋯ The adjusted risk of death (hazard ratio) for cases with LVdys was 1.96 (95% confidence interval [CI], 1.29-2.98; P = 0.020) and for cases with RV&LVdys was 2.27 (95% CI, 1.77-2.92; P = 0.011). All cardiac dysfunction categories were associated with use of extracorporeal membrane oxygenation (P < 0.005). Conclusions: Early ventricular dysfunction occurs frequently in CDH and is an independent determinant of severity and clinical outcome.