Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial

Garner, Justin; Bhatt, Surya P.; Slebos, Dirk‐Jan; Klooster, Karin; Sciurba, Frank C.; Shah, Pallav L.; Marchetti, Nathaniel; Sue, Richard; Wright, Shawn E.; Rivas-Perez, Hiram; Wiese, Tanya; Wahidi, Momen M.; Oliveira, Hugo Goulart de; Radhakrishnan, S.; Shargill, Narinder S.; Criner, Gerard J.

doi:10.1513/annalsats.201909-666oc

Cited by 19 publications

(13 citation statements)

References 53 publications

(61 reference statements)

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“…COPD patients with severe emphysema can be treated with lung reduction surgery or endobronchial valve or coil placement to remove or reduce the emphysematous tissue, thereby decreasing hyper-inflation and providing the space of more functional lung tissue. These procedures have been shown to be beneficial for certain subgroups of COPD patients [ 92 , 93 , 94 , 95 , 96 , 97 ].…”

Section: Current Treatment Options For Individuals With Copdmentioning

confidence: 99%

Targeting Aging Pathways in Chronic Obstructive Pulmonary Disease

Easter

Bollenbecker

Barnes

et al. 2020

IJMS

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Chronic obstructive pulmonary disease (COPD) has become a global epidemic and is the third leading cause of death worldwide. COPD is characterized by chronic airway inflammation, loss of alveolar-capillary units, and progressive decline in lung function. Major risk factors for COPD are cigarette smoking and aging. COPD-associated pathomechanisms include multiple aging pathways such as telomere attrition, epigenetic alterations, altered nutrient sensing, mitochondrial dysfunction, cell senescence, stem cell exhaustion and chronic inflammation. In this review, we will highlight the current literature that focuses on the role of age and aging-associated signaling pathways as well as their impact on current treatment strategies in the pathogenesis of COPD. Furthermore, we will discuss established and experimental COPD treatments including senolytic and anti-aging therapies and their potential use as novel treatment strategies in COPD.

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Section: Current Treatment Options For Individuals With Copdmentioning

confidence: 99%

Targeting Aging Pathways in Chronic Obstructive Pulmonary Disease

Easter

Bollenbecker

Barnes

et al. 2020

IJMS

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“…PROs collected using the EXACT and E-RS:COPD have been used as co-primary and secondary endpoints to assess drug effect in COPD in phase II and phase III randomized clinical trials (4)(5)(6)(7)(8). For E-RS:COPD, some of these trials (6,7) have anticipated that a reduction of two points or more in the total score is indicative of a clinically meaningful improvement in symptoms.…”

Section: Introductionmentioning

confidence: 99%

Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial

Llanos-Paez

Ambery

Yang

et al. 2021

AAPS J

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This study aimed to illustrate how a new methodology to assess clinical trial outcome measures using a longitudinal item response theory–based model (IRM) could serve as an alternative to mixed model repeated measures (MMRM). Data from the EXACT (Exacerbation of chronic pulmonary disease tool) which is used to capture frequency, severity, and duration of exacerbations in COPD were analyzed using an IRM. The IRM included a graded response model characterizing item parameters and functions describing symptom-time course. Total scores were simulated (month 12) using uncertainty in parameter estimates. The 50th (2.5th, 97.5th) percentiles of the resulting simulated differences in average total score (drug minus placebo) represented the estimated drug effect (95%CI), which was compared with published MMRM results. Furthermore, differences in sample size, sensitivity, specificity, and type I and II errors between approaches were explored. Patients received either oral danirixin 75 mg twice daily (n = 45) or placebo (n = 48) on top of standard of care over 52 weeks. A step function best described the COPD symptoms-time course in both trial arms. The IRM improved precision of the estimated drug effect compared to MMRM, resulting in a sample size of 2.5 times larger for the MMRM analysis to achieve the IRM precision. The IRM showed a higher probability of a positive predictive value (34%) than MMRM (22%). An item model–based analysis data gave more precise estimates of drug effect than MMRM analysis for the same endpoint in this one case study.

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“…Slebos et al (19) identified that CT screening and significant hyperinflation (residual volume≥200% of predicted) are essential for identifying the population that is suitable for endobronchial coil therapy. Other trials (20)(21)(22) have also indicated the efficiency of implantation of endobronchial valves. As a result, multiple therapeutic approaches may potentially be effective for advanced emphysema and pulmonary bullae, though the REVOLENS trial (23) indicated that endobrochial coil required a higher short-term cost which may influence the cost-effectiveness.…”

Section: Discussionmentioning

confidence: 99%

Thermal Volume Reduction Surgery for Surgical Treatment of Pulmonary Bullae: A Single-Center Treatment Experience of 276 Cases Accompany With Primary Lung Cancer

Wei-ping

2021

Front. Surg.

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Objective: Lung volume reduction surgery (LVRS) has been regarded as an effective surgical procedure for severe emphysema (including pulmonary bullae). However, there still remain controversial that its applications limited that only patients with a specific clinical situation may benefit from LVRS, and so did other non-surgical treatments. The current study aims to introduce some initial experience of new technique for treating pulmonary bullae, including using thermal surgical instruments to reduce enlargement of lung tissue in a specific group that diagnosed with lung cancer accompany with pulmonary bullae.Methods: This retrospective study included 276 patients undergoing emphysema reducing surgery between 2010 and 2020. All procedure were performed by thermal volume reduction surgery of using thermal surgical instruments to reduce pulmonary bullae.Results: The average time required for operating single pulmonary bullae was <10 min. Median operative time was 106 min (range 85 to 191 min). No intraoperative air leak, massive blood loss, or other severe complications occurred. The estimated blood loss for TVRS was about 40 ml (range 15 to 120 ml). Postoperative complications included atelectasis (n = 8), pulmonary infection (n = 17), bleeding (n = 5), delayed air leak (n = 7) among the cohort. The postoperative lung function at 1-year post surgery in TVRS group recovered faster with a better recovery that achieving an FEV1 of 1.95 ± 0.46 L, TLC of 6.36 ± 0.79 L, RV of 3.56 ± 0.81 L, PO2 of 60 ± 8 mmHg, PCO2 of 37 ± 6 mmHg, and 6 MWD (6-min walk distant) of 305 ± 22 m. The 1-year QOL score was elevated comparing with preoperative period.Conclusion: This single-center study reported a new thermal-based surgical approach to treat pulmonary bullae by reducing abnormally enlarged lung tissue in specific patients diagnosed with lung cancer accompany with pulmonary bullae.

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Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial

Abstract: Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation.

Cited by 19 publications

References 53 publications

Targeting Aging Pathways in Chronic Obstructive Pulmonary Disease

Targeting Aging Pathways in Chronic Obstructive Pulmonary Disease

Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial

Thermal Volume Reduction Surgery for Surgical Treatment of Pulmonary Bullae: A Single-Center Treatment Experience of 276 Cases Accompany With Primary Lung Cancer

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