Publications by authors named "David Feller-Kopman"

215 Publications

Rebuttal from Drs Brenner, Feller-Kopman, and De Cardenas.

Chest 2021 Feb 27. Epub 2021 Feb 27.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan Medical School, Ann Arbor, MI. Electronic address:

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http://dx.doi.org/10.1016/j.chest.2021.01.076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997601PMC
February 2021

POINT: Tracheostomy in Patients With COVID-19: Should We Do It Before 14 Days? Yes.

Chest 2021 Feb 27. Epub 2021 Feb 27.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan Medical School, Ann Arbor, MI. Electronic address:

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http://dx.doi.org/10.1016/j.chest.2021.01.074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910662PMC
February 2021

Use of fibrinolytics and deoxyribonuclease in adult patients with pleural empyema: a consensus statement.

Lancet Respir Med 2021 Feb 2. Epub 2021 Feb 2.

Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.

Although our understanding of the pathogenesis of empyema has grown tremendously over the past few decades, questions still remain on how to optimally manage this condition. It has been almost a decade since the publication of the MIST2 trial, but there is still an extensive debate on the appropriate use of intrapleural fibrinolytic and deoxyribonuclease therapy in patients with empyema. Given the scarcity of overall guidance on this subject, we convened an international group of 22 experts from 20 institutions across five countries with experience and expertise in managing adult patients with empyema. We did a literature and internet search for reports addressing 11 clinically relevant questions pertaining to the use of intrapleural fibrinolytic and deoxyribonuclease therapy in adult patients with bacterial empyema. This Position Paper, consisting of seven graded and four ungraded recommendations, was formulated by a systematic and rigorous process involving the evaluation of published evidence, augmented with provider experience when necessary. Panel members participated in the development of the final recommendations using the modified Delphi technique. Our Position Paper aims to address the existing gap in knowledge and to provide consensus-based recommendations to offer guidance in clinical decision making when considering the use of intrapleural therapy in adult patients with bacterial empyema.
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http://dx.doi.org/10.1016/S2213-2600(20)30533-6DOI Listing
February 2021

Capping or Suctioning for Tracheostomy Decannulation.

N Engl J Med 2020 12;383(25):2480-2481

Johns Hopkins University, Baltimore, MD

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http://dx.doi.org/10.1056/NEJMc2031385DOI Listing
December 2020

Tracheostomy During the COVID-19 Pandemic: Comparison of International Perioperative Care Protocols and Practices in 26 Countries.

Otolaryngol Head Neck Surg 2020 Nov 3:194599820961985. Epub 2020 Nov 3.

Department of Otolaryngology-Head & Neck Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has led to a global surge in critically ill patients requiring invasive mechanical ventilation, some of whom may benefit from tracheostomy. Decisions on if, when, and how to perform tracheostomy in patients with COVID-19 have major implications for patients, clinicians, and hospitals. We investigated the tracheostomy protocols and practices that institutions around the world have put into place in response to the COVID-19 pandemic.

Data Sources: Protocols for tracheostomy in patients with severe acute respiratory syndrome coronavirus 2 infection from individual institutions (n = 59) were obtained from the United States and 25 other countries, including data from several low- and middle-income countries, 23 published or society-endorsed protocols, and 36 institutional protocols.

Review Methods: The comparative document analysis involved cross-sectional review of institutional protocols and practices. Data sources were analyzed for timing of tracheostomy, contraindications, preoperative testing, personal protective equipment (PPE), surgical technique, and postoperative management.

Conclusions: Timing of tracheostomy varied from 3 to >21 days, with over 90% of protocols recommending 14 days of intubation prior to tracheostomy. Most protocols advocate delaying tracheostomy until COVID-19 testing was negative. All protocols involved use of N95 or higher PPE. Both open and percutaneous techniques were reported. Timing of tracheostomy changes ranged from 5 to >30 days postoperatively, sometimes contingent on negative COVID-19 test results.

Implications For Practice: Wide variation exists in tracheostomy protocols, reflecting geographical variation, different resource constraints, and limited data to drive evidence-based care standards. Findings presented herein may provide reference points and a framework for evolving care standards.
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http://dx.doi.org/10.1177/0194599820961985DOI Listing
November 2020

Comment on Tracheotomy in Ventilated Patients with COVID-19: Is it Time to Rethink Timing?

Ann Surg 2020 Jul 14. Epub 2020 Jul 14.

Department of Otolaryngology - Head & Neck Surgery, University of Michigan Medical School, Ann Arbor, MI Interventional Pulmonology, Johns Hopkins University, Baltimore, MD Department of Surgery, University of Michigan Medical School, Ann Arbor, MI Department of Surgery, Department of Anesthesiology / Critical Care Medicine, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD.

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http://dx.doi.org/10.1097/SLA.0000000000004220DOI Listing
July 2020

AABIP Indwelling Pleural Catheter Guidelines: Another Milestone for the Journal and Our Field.

J Bronchology Interv Pulmonol 2020 Oct;27(4):225-226

Division of Pulmonary and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD.

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http://dx.doi.org/10.1097/LBR.0000000000000712DOI Listing
October 2020

Impact of the Percepta Genomic Classifier on Clinical Management Decisions in a Multicenter Prospective Study.

Chest 2021 Jan 3;159(1):401-412. Epub 2020 Aug 3.

Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Duke University School of Medicine, Durham, NC.

Background: The Percepta genomic classifier has been clinically validated as a complement to bronchoscopy for lung nodule evaluation.

Research Question: The goal of this study was to examine the impact on clinical management decisions of the Percepta result in patients with low- and intermediate-risk lung nodules.

Study Design And Methods: A prospective "real world" registry was instituted across 35 US centers to observe physician management of pulmonary nodules following a nondiagnostic bronchoscopy. To assess the impact on management decisions of the Percepta genomic classifier, a subset of patients was analyzed who had an inconclusive bronchoscopy for a pulmonary nodule, a Percepta result, and an adjudicated lung diagnosis with at least 1 year of follow-up. In this cohort, change in the decision to pursue additional invasive procedures following Percepta results was assessed.

Results: A total of 283 patients met the study eligibility criteria. In patients with a low/intermediate risk of malignancy for whom the clinician had designated a plan for a subsequent invasive procedure, a negative Percepta result down-classified the risk of malignancy in 34.3% of cases. Of these down-classified patients, 73.9% had a change in their management plan from an invasive procedure to surveillance, and the majority avoided a procedure up to 12 months following the initial evaluation. In patients with confirmed lung cancers, the time to diagnosis was not significantly delayed when comparing Percepta down-classified patients vs patients who were not down-classified (P = .58).

Interpretation: The down-classification of nodule malignancy risk with the Percepta test decreased additional invasive procedures without a delay in time to diagnosis among those with lung cancer.
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http://dx.doi.org/10.1016/j.chest.2020.07.067DOI Listing
January 2021

Ambulatory management of primary spontaneous pneumothorax: when less is more.

Lancet 2020 07;396(10243):4-5

Division of Pulmonary and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, MD 21287, USA. Electronic address:

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http://dx.doi.org/10.1016/S0140-6736(20)31306-4DOI Listing
July 2020

Interventional pulmonology: There is no going back, only forward.

Respirology 2020 Sep 1;25(9):909-910. Epub 2020 Jul 1.

Director, Bronchoscopy and Interventional Pulmonology, Professor of Medicine, Anesthesiology, Otolaryngology - Head and Neck Surgery, Johns Hopkins Hospital, Baltimore, MD, USA.

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http://dx.doi.org/10.1111/resp.13896DOI Listing
September 2020

Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician.

Expert Rev Respir Med 2020 10 12;14(10):987-1000. Epub 2020 Jul 12.

Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Interventional Pulmonology , Nashville, TN, USA.

Introduction: Developing a feasible and accurate means of evaluating pleural pathology has been an ongoing effort for over 150 years. Pleural fluid cellular and biomarker analyses are simple ways of characterizing and uncovering pathologic entities of pleural disease. However, obtaining samples of pleural tissue has become increasingly important. In cases of suspected malignancy and certain infections histopathology, culture, and molecular testing are necessary to profile diseases more effectively. The pleura is sampled via several techniques including blind transthoracic biopsy, image-guided biopsy, and surgical thoracotomy. Given the heterogeneity of pleural disease, low diagnostic yields, or invasiveness no procedural gold standard has been established in pleural diagnostics.

Areas Covered: Herein, we provide a review of the literature on medical thoracoscopy (MT), its development, technical approach, indications, risks, current and future role in the evaluation of thoracic disease. Pubmed was searched for articles published on MT, awake thoracoscopy, and pleuroscopy with a focus on reviewing literature published in the past 5 years.

Expert Opinion: As the proficiency and number of interventional pulmonologists continues to grow, MT is ideally positioned to become a front-line diagnostic tool in pleural disease and play an increasingly prominent role in the treatment algorithm of various pleural pathologies.
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http://dx.doi.org/10.1080/17476348.2020.1788940DOI Listing
October 2020

Interventional pulmonology: between ambition and wisdom.

Eur Respir Rev 2020 Jun 16;29(156). Epub 2020 Jun 16.

Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Dept, Johns Hopkins Hospital, Baltimore, MD, USA.

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http://dx.doi.org/10.1183/16000617.0146-2020DOI Listing
June 2020

Immune-related (IR)-pneumonitis during the COVID-19 pandemic: multidisciplinary recommendations for diagnosis and management.

J Immunother Cancer 2020 06;8(1)

Oncology, Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.

Immune-related (IR)-pneumonitis is a rare and potentially fatal toxicity of anti-PD(L)1 immunotherapy. Expert guidelines for the diagnosis and management of IR-pneumonitis include multidisciplinary input from medical oncology, pulmonary medicine, infectious disease, and radiology specialists. Severe acute respiratory syndrome coronavirus 2 is a recently recognized respiratory virus that is responsible for causing the COVID-19 global pandemic. Symptoms and imaging findings from IR-pneumonitis and COVID-19 pneumonia can be similar, and early COVID-19 viral testing may yield false negative results, complicating the diagnosis and management of both entities. Herein, we present a set of multidisciplinary consensus recommendations for the diagnosis and management of IR-pneumonitis in the setting of COVID-19 including: (1) isolation procedures, (2) recommended imaging and interpretation, (3) adaptations to invasive testing, (4) adaptations to the management of IR-pneumonitis, (5) immunosuppression for steroid-refractory IR-pneumonitis, and (6) management of suspected concurrent IR-pneumonitis and COVID-19 infection. There is an emerging need for the adaptation of expert guidelines for IR-pneumonitis in the setting of the global COVID-19 pandemic. We propose a multidisciplinary consensus on this topic, in this position paper.
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http://dx.doi.org/10.1136/jitc-2020-000984DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7316105PMC
June 2020

Chronic immune checkpoint inhibitor pneumonitis.

J Immunother Cancer 2020 06;8(1)

Division of Pulmonary Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA.

Background: Pneumonitis from immune checkpoint inhibitors (ICI) is a potentially fatal immune-related adverse event (irAE) from antiprogrammed death 1/programmed death ligand 1 immunotherapy. Most cases of ICI pneumonitis improve or resolve with 4-6 weeks of corticosteroid therapy. Herein, we report the incidence, clinicopathological features and management of patients with non-small cell lung cancer (NSCLC) and melanoma who developed chronic ICI pneumonitis that warrants ≥12 weeks of immunosuppression.

Methods: Patients with ICI pneumonitis were identified from institutional databases of ICI-treated patients with advanced melanoma and NSCLC between January 2011 and July 2018. ICI pneumonitis was defined as clinical/radiographic evidence of lung inflammation without alternative diagnoses, adjudicated by a multidisciplinary team. Chronic ICI pneumonitis was defined as pneumonitis that persists or worsens with steroid tapering, and necessitates ≥12 weeks of immunosuppression, after ICI discontinuation. Serial chest CT was used to assess radiological features, and tumor response by Response EvaluationCriteria for Solid Tumors V.1.1. Bronchoalveolar lavage fluid (BALF) samples were assessed by cell differential. Lung biopsy samples were evaluated by H&E staining and multiplex immunofluorescence (mIF), where available.

Results: Among 299 patients, 44 developed ICI pneumonitis (NSCLC: 5/205; melanoma: 1/94), and of these, 6 experienced chronic ICI pneumonitis. The overall incidence of chronic ICI pneumonitis was thus 2%. Of those who developed chronic ICI pneumonitis: the majority had NSCLC (5/6), all sustained disease control from ICIs, and none had other concurrent irAEs. Timing of chronic ICI pneumonitis development was variable (range: 0-50 months), and occurred at a median of 12 months post ICI start. Recrudescence of ICI pneumonitis occurred at a median of 6 weeks after initial steroid start (range: 3-12 weeks), with all patients requiring steroid reintroduction when tapered to ≤10 mg prednisone/equivalent. The median total duration of steroids was 37 weeks (range: 16-43+weeks). Re-emergence of radiographic ICI pneumonitis occurred in the same locations on chest CT, in most cases (5/6). All patients who developed chronic ICI pneumonitis had BALF lymphocytosis on cell differential and organising pneumonia on lung biopsy at initial ICI pneumonitis presentation, with persistent BALF lymphocytosis and brisk CD8+ infiltration on mIF at pneumonitis re-emergence during steroid taper.

Conclusions: A subset of patients who develop pneumonitis from ICIs will develop chronic ICI pneumonitis, that warrants long-term immunosuppression of ≥12 weeks, and has distinct clinicopathological features.
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http://dx.doi.org/10.1136/jitc-2020-000840DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304886PMC
June 2020

Tracheostomy in the COVID-19 era: global and multidisciplinary guidance.

Lancet Respir Med 2020 07 15;8(7):717-725. Epub 2020 May 15.

Johns Hopkins University, Baltimore, MD, USA. Electronic address:

Global health care is experiencing an unprecedented surge in the number of critically ill patients who require mechanical ventilation due to the COVID-19 pandemic. The requirement for relatively long periods of ventilation in those who survive means that many are considered for tracheostomy to free patients from ventilatory support and maximise scarce resources. COVID-19 provides unique challenges for tracheostomy care: health-care workers need to safely undertake tracheostomy procedures and manage patients afterwards, minimising risks of nosocomial transmission and compromises in the quality of care. Conflicting recommendations exist about case selection, the timing and performance of tracheostomy, and the subsequent management of patients. In response, we convened an international working group of individuals with relevant expertise in tracheostomy. We did a literature and internet search for reports of research pertaining to tracheostomy during the COVID-19 pandemic, supplemented by sources comprising statements and guidance on tracheostomy care. By synthesising early experiences from countries that have managed a surge in patient numbers, emerging virological data, and international, multidisciplinary expert opinion, we aim to provide consensus guidelines and recommendations on the conduct and management of tracheostomy during the COVID-19 pandemic.
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http://dx.doi.org/10.1016/S2213-2600(20)30230-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228735PMC
July 2020

Management of Malignant Pleural Effusions.

Clin Chest Med 2020 06 16;41(2):259-267. Epub 2020 Apr 16.

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, 1800 Orleans Street, Suite 7-125, Baltimore, MD 21287, USA. Electronic address:

Malignant pleural effusion frequently complicates both solid and hematologic malignancies and is associated with high morbidity, mortality, and health care costs. Although no pleura-specific therapy is known to impact survival, both pleurodesis and indwelling pleural catheter (IPC) placement can significantly alleviate symptoms and improve quality of life. The optimal choice of therapy in terms of efficacy and particularly cost-effectiveness depends on patient preferences and individual characteristics, including lung expansion and life expectancy. Attempting chemical pleurodesis through an IPC in the outpatient setting appears to be a particularly promising approach in the absence of a nonexpandable lung.
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http://dx.doi.org/10.1016/j.ccm.2020.02.009DOI Listing
June 2020

Healthcare Costs and Utilization among Patients Hospitalized for Malignant Pleural Effusion.

Respiration 2020;99(3):257-263. Epub 2020 Mar 10.

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA.

Background: Malignant pleural effusion (MPE) poses a considerable healthcare burden, but little is known about trends in directly attributable hospital utilization.

Objective: We aimed to study national trends in healthcare utilization and outcomes among hospitalized MPE patients.

Methods: We analyzed adult hospitalizations attributable to MPE using the Healthcare Cost and Utilization Project - National Inpatient Sample (HCUP-NIS) databases from 2004, 2009, and 2014. Cases were included if MPE was coded as the principal admission diagnosis or if unspecified pleural effusion was coded as the principal admission diagnosis in the setting of metastatic cancer. Annual hospitalizations were estimated for the entire US hospital population using discharge weights. Length of stay (LOS), hospital charges, and hospital mortality were also estimated.

Results: We analyzed 92,034 hospital discharges spanning a decade (2004-2014). Yearly hospitalizations steadily decreased from 38,865 to 23,965 during this time frame, the mean LOS decreased from 7.7 to 6.3 days, and the adjusted hospital mortality decreased from 7.9 to 4.5% (p = 0.00 for all trend analyses). The number of pleurodesis procedures also decreased over time (p = 0.00). The mean inflation-adjusted charge per hospitalization rose from USD 41,252 to USD 56,951, but fewer hospitalizations drove the total annual charges down from USD 1.51 billion to USD 1.37 billion (p = 0.00 for both analyses).

Conclusions: The burden of hospital-based resource utilization associated with MPE has decreased over time, with a reduction in attributable hospitalizations by one third in the span of 1 decade. Correspondingly, the number of inpatient pleurodesis procedures has decreased during this time frame.
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http://dx.doi.org/10.1159/000506210DOI Listing
April 2021

Indwelling Pleural Catheter Drainage Strategy for Malignant Effusion: A Cost-Effectiveness Analysis.

Ann Am Thorac Soc 2020 06;17(6):746-753

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.

The likelihood of achieving pleurodesis after indwelling pleural catheter (IPC) placement for malignant pleural effusion varies with the specific drainage strategy used: symptom-guided drainage, daily drainage, or talc instillation through the IPC (IPC + talc). The relative cost-effectiveness of one strategy over the other is unknown. We performed a decision tree model-based analysis to ascertain the cost-effectiveness of each IPC drainage strategy from a healthcare system perspective. We developed a decision tree model using theoretical event probability data derived from three randomized clinical trials and used 2019 Medicare reimbursement data for cost estimation. The primary outcome was incremental cost-effectiveness ratio (ICER) over an analytical horizon of 6 months with a willingness-to-pay threshold of $100,000/quality-adjusted life-year (QALY). Monte Carlo probabilistic sensitivity analysis and one-way sensitivity analyses were conducted to measure the uncertainty surrounding base case estimates. IPC + talc was a cost-effective alternative to symptom-guided drainage, with an ICER of $59,729/QALY. Monte Carlo probabilistic sensitivity analysis revealed that this strategy was favored in 54% of simulations. However, symptom-guided drainage was cost effective for pleurodesis rates >20% and for life expectancy <4 months. Daily drainage was not cost effective in any scenario, including for patients with nonexpandable lung, in whom it had an ICER of $2,474,612/QALY over symptom-guided drainage. For patients with malignant pleural effusion and an expandable lung, IPC + talc may be cost effective relative to symptom-guided drainage, although considerable uncertainty exists around this estimation. Daily IPC drainage is not a cost-effective strategy under any circumstance.
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http://dx.doi.org/10.1513/AnnalsATS.201908-615OCDOI Listing
June 2020

Acute Upper Airway Obstruction.

N Engl J Med 2020 02;382(8):783

Johns Hopkins University School of Medicine, Baltimore, MD.

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http://dx.doi.org/10.1056/NEJMc1916484DOI Listing
February 2020

The pleura and the endocrine system.

Eur J Intern Med 2020 02 7;72:34-37. Epub 2020 Jan 7.

Division of Pulmonary, Critical Care, and Sleep Medicine, Johns Hopkins Hospital, USA.

The functioning of the pleura and the endocrine system are not entirely independent of each other. Some hormones can reach a greater concentration in the pleural exudate than in the blood. However, the clinical significance of this finding remains unknown. In some circumstances, hormonal changes are responsible for pathological manifestations in the pleura. Hypothyroidism is one of the most common diseases that can cause a pleural effusion, likely resulting from alterations in capillary permeability. The presence of ectopic endometrial tissue within the lung parenchyma, pleura, pericardium or diaphragm is known as thoracic endometriosis and is one of the causes of catamenial pneumothorax and /or catamenial hemothorax, which can affect women of childbearing age and arises within 72 h from the onset of menstruation. Treatment and prevention of recurrent catamenial pneumothorax / hemothorax usually requires an approach that combines surgery and hormone therapy. Malignant pleural effusion from breast cancer may contain estrogen receptor-positive cells. In such a case, endocrine treatment may be effective in reducing the amount of pleural fluid and the associated symptoms. Thyroid cancer and lymphangioleiomyomatosis (LAM) are further hormone-sensitive malignancies in which pleura is frequently involved. The solitary fibrous tumor of pleura (SFPT) is an example of a pleural disease that can cause hormonal balance disorders. It can lead to a rise in the releasing factor for growth hormone (GHRH), human beta chorionic gonadotropin (Beta-hCG), and insulin-like growth factor 2 (IGF2). The consequence of such hormonal imbalance include hypertrophic pulmonary osteoarthropathy, gynecomastia, and refractory hypoglycemia, respectively.
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http://dx.doi.org/10.1016/j.ejim.2019.12.034DOI Listing
February 2020

The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.

Chest 2020 03 9;157(3):702-711. Epub 2019 Nov 9.

Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN. Electronic address:

Background: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration.

Methods: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure.

Results: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications.

Conclusions: Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time.

Trial Registry: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2019.10.025DOI Listing
March 2020

First-in-Human Use of a Hybrid Real-Time Ultrasound-Guided Fine-Needle Acquisition System for Peripheral Pulmonary Lesions: A Multicenter Pilot Study.

Respiration 2019;98(6):527-533. Epub 2019 Nov 8.

Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.

Background: The ability to successfully perform a biopsy on pulmonary lesions by means of bronchoscopy varies widely due to anatomic and technological limitations. One major limitation is the lack of the ability to utilize real-time guidance during tissue sampling in the periphery. A novel system has been developed that enables real-time visualization and sampling of peripheral lesions by displaying an ultrasound image of the lesion and needle simultaneously.

Methods: We performed a multicenter, prospective pilot in patients with peripheral pulmonary lesions undergoing a clinically indicated bronchoscopy. The purpose of this study was to demonstrate the feasibility of visualizing, accessing, and obtaining specimens adequate for the cytology of lung lesions when using a novel hybrid real-time ultrasound-guided fine-needle aspiration system for peripheral pulmonary lesions.

Results: Twenty-three patients underwent bronchoscopic sampling of a peripheral pulmonary lesion with the study device. Mean lesion size was 3.6 (range 1.7-5.7) cm. Targeted lesions were located in all lobes of the lung. All lesions were successfully visualized and sampled under real-time visualization with specimens adequate for cytological evaluation. The needle was visualized in all lesions throughout targeting and sampling. There were no incidents of pneumothorax or moderate-to-severe bleeding.

Conclusion: In this feasibility study, we report the first-in-human use of a continuous real-time endobronchial ultrasound guidance system to sample peripheral pulmonary lesions. Future generations of this device may improve usability and further studies are needed to determine the true diagnostic capabilities of this novel technique.
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http://dx.doi.org/10.1159/000504025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6940022PMC
September 2020

A Prediction Model to Help with Oncologic Mediastinal Evaluation for Radiation: HOMER.

Am J Respir Crit Care Med 2020 01;201(2):212-223

Department of Pulmonary Medicine and.

When stereotactic ablative radiotherapy is an option for patients with non-small cell lung cancer (NSCLC), distinguishing between N0, N1, and N2 or N3 (N2|3) disease is important. To develop a prediction model for estimating the probability of N0, N1, and N2|3 disease. Consecutive patients with clinical-radiographic stage T1 to T3, N0 to N3, and M0 NSCLC who underwent endobronchial ultrasound-guided staging from a single center were included. Multivariate ordinal logistic regression analysis was used to predict the presence of N0, N1, or N2|3 disease. Temporal validation used consecutive patients from 3 years later at the same center. External validation used three other hospitals. In the model development cohort ( = 633), younger age, central location, adenocarcinoma, and higher positron emission tomography-computed tomography nodal stage were associated with a higher probability of having advanced nodal disease. Areas under the receiver operating characteristic curve (AUCs) were 0.84 and 0.86 for predicting N1 or higher (vs. N0) disease and N2|3 (vs. N0 or N1) disease, respectively. Model fit was acceptable (Hosmer-Lemeshow,  = 0.960; Brier score, 0.36). In the temporal validation cohort ( = 473), AUCs were 0.86 and 0.88. Model fit was acceptable (Hosmer-Lemeshow,  = 0.172; Brier score, 0.30). In the external validation cohort ( = 722), AUCs were 0.86 and 0.88 but required calibration (Hosmer-Lemeshow,  < 0.001; Brier score, 0.38). Calibration using the general calibration method resulted in acceptable model fit (Hosmer-Lemeshow,  = 0.094; Brier score, 0.34). This prediction model can estimate the probability of N0, N1, and N2|3 disease in patients with NSCLC. The model has the potential to facilitate decision-making in patients with NSCLC when stereotactic ablative radiotherapy is an option.
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http://dx.doi.org/10.1164/rccm.201904-0831OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961739PMC
January 2020

Nonexpandable Lung: More Than Just a Call from Radiology.

Ann Am Thorac Soc 2019 Oct;16(10):1240-1242

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

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http://dx.doi.org/10.1513/AnnalsATS.201907-553EDDOI Listing
October 2019

Physiologic Basis of Symptoms in Pleural Disease.

Semin Respir Crit Care Med 2019 06 16;40(3):305-313. Epub 2019 Sep 16.

Division of Pulmonary, Critical Care and Sleep Medicine, Johns Hopkins Hospital, Baltimore, Maryland.

Pleural effusions are commonly encountered and have a significant impact on the respiratory system. The reported effect of thoracentesis on physiologic parameters including oxygenation, lung volumes, and respiratory mechanics is variable likely owing to studies with a small, heterogeneous population of patients.Most patients who are short of breath from pleural effusion experience relief following drainage due to improvement in the length-tension relationship of the respiratory muscles. An observed increase in oxygenation following thoracentesis is likely due to improved ventilation and perfusion matching. Recent advances in methods of measuring pleural pressure provide a greater understanding of the impact of pleural effusion on pleural pressure and changes in pleural pressure with thoracentesis; however, there has been no demonstrated benefit of routine monitoring of pleural pressure to reduce complications from thoracentesis. Manometry does allow for the identification of patients with unexpandable lung which is useful when determining options for pleural palliation. The following article will review the pathophysiological effects of pleural effusion and thoracentesis.
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http://dx.doi.org/10.1055/s-0039-1693648DOI Listing
June 2019

Voice-Related Quality of Life Increases With a Talking Tracheostomy Tube: A Randomized Controlled Trial.

Laryngoscope 2020 05 6;130(5):1249-1255. Epub 2019 Aug 6.

The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.

Objective: The primary objective of our study was to determine the quality of life (QOL) using a talking tracheostomy tube.

Methods: Randomized clinical trial (NCT2018562). Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included. Intervention comprised a Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube (Smiths Medical, Dublin, OH, US). Outcome measures included QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction.

Results: The change in V-RQOL scores from pre- to postintervention was higher among patients using a BLUSA (Smiths Medical) compared to those who did not (P = 0.001). The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04). SIT scores decreased by 6.4 points for each 1-point increase in their Sequential Organ Failure Assessment scores (P = 0.04). The overall QOL-MV scores correlated moderately with the overall V-RQOL scores (correlation coefficient = 0.59). Cronbach alpha score for overall QOL-MV was 0.71. Seventy-three percent of the 22 intervention patients reported the ability to use the BLUSA (Smiths Medical) with some level of independence, whereas 41% reported some level of satisfaction with the use of BLUSA (Smiths Medical). The lengths of stay was longer in the intervention group.

Conclusion: Our study suggests that BLUSA (Smiths Medical) talking tracheostomy tube improves patient-reported QOL in mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation.

Level Of Evidence: I Laryngoscope, 130:1249-1255, 2020.
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http://dx.doi.org/10.1002/lary.28211DOI Listing
May 2020

The alveolar immune cell landscape is dysregulated in checkpoint inhibitor pneumonitis.

J Clin Invest 2019 07 16;129(10):4305-4315. Epub 2019 Jul 16.

Division of Pulmonary Critical Care Medicine, and.

Background: Checkpoint inhibitor pneumonitis (CIP) is a highly morbid complication of immune checkpoint immunotherapy (ICI), one which precludes the continuation of ICI. Yet, the mechanistic underpinnings of CIP are unknown.

Methods: To better understand the mechanism of lung injury in CIP, we prospectively collected bronchoalveolar lavage (BAL) samples in ICI-treated patients with (n=12) and without CIP (n=6), prior to initiation of first-line therapy for CIP (high dose corticosteroids. We analyzed BAL immune cell populations using a combination of traditional multicolor flow cytometry gating, unsupervised clustering analysis and BAL supernatant cytokine measurements.

Results: We found increased BAL lymphocytosis, predominantly CD4+ T cells, in CIP. Specifically, we observed increased numbers of BAL central memory T-cells (Tcm), evidence of Type I polarization, and decreased expression of CTLA-4 and PD-1 in BAL Tregs, suggesting both activation of pro-inflammatory subsets and an attenuated suppressive phenotype. CIP BAL myeloid immune populations displayed enhanced expression of IL-1β and decreased expression of counter-regulatory IL-1RA. We observed increased levels of T cell chemoattractants in the BAL supernatant, consistent with our pro-inflammatory, lymphocytic cellular landscape.

Conclusion: We observe several immune cell subpopulations that are dysregulated in CIP, which may represent possible targets that could lead to therapeutics for this morbid immune related adverse event.
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http://dx.doi.org/10.1172/JCI128654DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6763233PMC
July 2019

Real-World Application of the NAVIGATE Trial.

J Thorac Oncol 2019 07;14(7):e146-e147

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.

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http://dx.doi.org/10.1016/j.jtho.2019.02.020DOI Listing
July 2019

Recent Advances in Interventional Pulmonology.

Ann Am Thorac Soc 2019 07;16(7):786-796

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.

The field of interventional pulmonology has grown rapidly since first being defined as a subspecialty of pulmonary and critical care medicine in 2001. The interventional pulmonologist has expertise in minimally invasive diagnostic and therapeutic procedures involving airways, lungs, and pleura. In this review, we describe recent advances in the field as well as up-and-coming developments, chiefly from the perspective of medical practice in the United States. Recent advances include standardization of formalized training, new tools for the diagnosis and potential treatment of peripheral lung nodules (including but not limited to robotic bronchoscopy), increasingly well-defined bronchoscopic approaches to management of obstructive lung diseases, and minimally invasive techniques for maximizing patient-centered outcomes for those with malignant pleural effusion.
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http://dx.doi.org/10.1513/AnnalsATS.201901-044CMEDOI Listing
July 2019

Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

Chest 2019 09 15;156(3):562-570. Epub 2019 Feb 15.

Section of Interventional Pulmonology, Division of Pulmonary, Allergy and Critical Care Medicine, Duke University, Durham, NC.

Background: Malignant airway obstruction (MAO) occurs in 30% of patients with advanced-stage lung cancer, leading to debilitating dyspnea, cough, and hemoptysis. Other than recanalization of the airways, these patients lack long-lasting palliative therapy. The goal of this study was to determine the safety and feasibility of local injection of paclitaxel into the airway wall with a novel microinjection catheter.

Methods: In this multicentered prospective trial, 23 patients with non-small cell lung cancer and MAO were enrolled from July 2014 through June 2016 to undergo rigid bronchoscopy with recanalization, followed by injection of 1.5 mg of paclitaxel with a novel injection catheter. Primary end points consisted of safety (adverse events, severe adverse events, and unanticipated adverse device effects) as well as feasibility (number of injections, injection success). Secondary end points consisted of airway patency improvement, quality of life metrics, and need for further interventions and/or stenting.

Results: Nineteen patients underwent rigid bronchoscopy with successful recanalization and paclitaxel injection. There were no adverse events, severe adverse events, or unanticipated adverse device effects. There was an average of 3.4 injections given for a total dose of 1.5 mg of paclitaxel in all patients. There was significantly less stenosis postprocedure vs preprocedure (25%-50% vs 75%-90%; P < .001), which was unchanged at 6 weeks (25%-50%). None of the participants required further interventions or airway stenting.

Conclusions: The injection of paclitaxel after recanalization of MAO in patients with non-small cell lung cancer is safe and feasible, using a novel airway injection device.

Trial Registry: ClinicalTrials.gov; No.: NCT02066103; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2019.02.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717117PMC
September 2019