Mallea, Jorge M.

Abstract Rationale Follow-up of patients with emphysema treated with endobronchial valves is limited to 3–12 months after treatment in prior reports. To date, no comparative data exist between treatment and control subjects with a longer follow-up. Objectives To assess the durability of the Spiration Valve System (SVS) in patients with severe heterogeneous emphysema over a 24-month period. Methods EMPROVE, a multicenter randomized controlled trial, presents a rigorous comparison between treatment and control groups for up to 24 months. Lung function, respiratory symptoms, and quality-of-life (QOL) measures were assessed. Results A significant improvement in forced expiratory volume in 1 second was maintained at 24 months in the SVS treatment group versus the control group. Similarly, significant improvements were maintained in several QOL measures, including the St. George’s Respiratory Questionnaire and the COPD Assessment Test. Patients in the SVS treatment group experienced significantly less dyspnea than those in the control group, as indicated by the modified Medical Research Council dyspnea scale score. Adverse events at 24 months did not significantly differ between the SVS treatment and control groups. Acute chronic obstructive pulmonary disease exacerbation rates in the SVS treatment and control groups were 13.7% (14 of 102) and 15.6% (7 of 45), respectively. Pneumothorax rates in the SVS treatment and control groups were 1.0% (1 of 102) and 0.0% (0 of 45), respectively. Conclusions SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL, as well as a statistically significant reduction in dyspnea, for at least 24 months while maintaining an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

Abstract MSC (a.k.a. mesenchymal stem cell or medicinal signaling cell) cell therapies show promise in decreasing mortality in acute respiratory distress syndrome (ARDS) and suggest benefits in treatment of COVID-19-related ARDS. We performed a meta-analysis of published trials assessing the efficacy and adverse events (AE) rates of MSC cell therapy in individuals hospitalized for COVID-19. Systematic searches were performed in multiple databases through November 3, 2021. Reports in all languages, including randomized clinical trials (RCTs), non-randomized interventional trials, and uncontrolled trials, were included. Random effects model was used to pool outcomes from RCTs and non-randomized interventional trials. Outcome measures included all-cause mortality, serious adverse events (SAEs), AEs, pulmonary function, laboratory, and imaging findings. A total of 736 patients were identified from 34 studies, which included 5 RCTs (n = 235), 7 non-randomized interventional trials (n = 370), and 22 uncontrolled comparative trials (n = 131). Patients aged on average 59.4 years and 32.2% were women. When compared with the control group, MSC cell therapy was associated with a reduction in all-cause mortality (RR = 0.54, 95% CI: 0.35-0.85, I 2 = 0.0%), reduction in SAEs (IRR = 0.36, 95% CI: 0.14-0.90, I 2 = 0.0%) and no significant difference in AE rate. A sub-group with pulmonary function studies suggested improvement in patients receiving MSC. These findings support the potential for MSC cell therapy to decrease all-cause mortality, reduce SAEs, and improve pulmonary function compared with conventional care. Large-scale double-blinded, well-powered RCTs should be conducted to further explore these results.

Pulmonary Langerhans cell histiocytosis (PLCH) is a rare inflammatory condition that mostly affects lungs in smokers. On imaging, it usually presents as multiple, upper lobe predominant, solid, and cavitary nodules, but presentation as solitary pulmonary nodule (SPN) is rare. We describe a case of SPN seen on low-dose lung cancer screening CT (LDCT) that was FDG avid on PET/CT. Given concern for malignancy, lobectomy was planned if intraoperative frozen section was consistent with malignancy. Lobectomy was performed based on frozen section; however, on formal pathology review, the nodule was ultimately found to be PLCH. This case illustrates an atypical presentation of PLCH as a solitary nodule. Furthermore, it helps demonstrate how rare etiologies (like PLCH) may be more frequently encountered and should be considered in the differential diagnosis for solitary lung nodules, especially in the era of lung cancer screening.

Introduction Much attention has been focused on decreasing chronic obstructive pulmonary disease (COPD) hospital readmissions. The US health system has struggled to meet this goal. The objective of this study was to assess the efficacy of telehealth services on the reduction of hospital readmission and mortality rates for COPD. Methods We used a cross-sectional design to examine the association between hospital risk-adjusted readmission and mortality rates for COPD and hospital use of post-discharge telemonitoring (TM). Data for 777 hospitals were sourced from the Centers for Medicare & Medicaid Services and the American Hospital Association annual surveys. Propensity score matching using the kennel weights method was applied to calculate the weighted probability of being a hospital that offers post-discharge TM services. Results Hospitals with post-discharge TM had about 34% significantly higher odds (adjusted odds ratio (AOR) = 1.34; 95% confidence interval (CI) 1.06–1.70) of 30-day COPD readmission and 33% significantly lower odds (AOR = 0.67; 95% CI 0.50–0.90) of 30-day COPD mortality compared to hospitals without post-discharge TM services. Discussion Overall, hospitals that offer post-discharge TM services have seen an improvement in 30-day COPD mortality rates. However, those same hospitals have also experienced a significant increase in 30-day COPD readmissions. TM can potentially decrease mortality in patients recently admitted for acute exacerbation of COPD. The results provide further evidence that readmissions present a problematic assessment of health-care quality, as the need for readmission may or may not be directly related to the quality of care received while in hospital.

ABSTRACT Recent years have witnessed evolution of lung allocation strategies to prioritize sicker recipients. In the pre-transplant period, this has translated into increased utilization of invasive extracorporeal or mechanical ventilatory support as a bridge to lung transplantation. The morbidity associated with these strategies warrants consideration to less invasive respiratory support modalities. Herein, we present a case highlighting successful bridge to lung transplantation with a relatively non-invasive negative pressure ventilator.

AbstractSevere cases of COVID-19 infection, often leading to death, have been associated with variants of acute respiratory distress syndrome (ARDS). Cell therapy with mesenchymal stromal cells (MSCs) is a potential treatment for COVID-19 ARDS based on preclinical and clinical studies supporting the concept that MSCs modulate the inflammatory and remodeling processes and restore alveolo-capillary barriers. The authors performed a systematic literature review and random-effects meta-analysis to determine the potential value of MSC therapy for treating COVID-19-infected patients with ARDS. Publications in all languages from 1990 to March 31, 2020 were reviewed, yielding 2691 studies, of which nine were included. MSCs were intravenously or intratracheally administered in 117 participants, who were followed for 14 days to 5 years. All MSCs were allogeneic from bone marrow, umbilical cord, menstrual blood, adipose tissue, or unreported sources. Combined mortality showed a favorable trend but did not reach statistical significance. No related serious adverse events were reported and mild adverse events resolved spontaneously. A trend was found of improved radiographic findings, pulmonary function (lung compliance, tidal volumes, PaO2/FiO2 ratio, alveolo-capillary injury), and inflammatory biomarker levels. No comparisons were made between MSCs of different sources.Significance statement The potential benefits of mesenchymal stromal cell (MSC) therapy for patients with COVID-19 acute respiratory distress syndrome support the rapid commencement of clinical trials, as well as the compassionate use of MSCs that already have documented safety profiles from FDA-approved studies.