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  • S. Karger AG  (5)
  • Hetzel, Martin  (5)
  • 1
    Online Resource
    Online Resource
    Bronchoscopic Coil Treatment for Patients with Severe Emphysema: A Meta-Analysis
    S. Karger AG ; 2015
    In:  Respiration Vol. 90, No. 2 ( 2015), p. 136-145
    Details
    In: Respiration, S. Karger AG, Vol. 90, No. 2 ( 2015), p. 136-145
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Bronchoscopic coil treatment has been shown to improve pulmonary function, exercise capacity, and quality of life in patients with severe emphysema. 〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 To perform a meta-analysis of the results of four independent European clinical trials investigating this coil therapy for emphysema. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 Data on all patients included in the four European clinical trials were analyzed for efficacy and safety outcomes. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 A total of 2,536 coils were placed during 259 procedures in 140 patients. A total of 37 chronic obstructive pulmonary disease exacerbations and 27 pneumonias were recorded as serious adverse events up to 1 year after treatment. The pneumothorax rate was 6.4%. Both 6 and 12 months after treatment, significant (all p 〈 0.001) improvements were observed for: forced expiratory volume in 1 s [+0.08 liters (±0.19) and +0.08 liters (±0.21)], residual volume [RV; -510 ml (±850) and -430 ml (±720)] , 6-min walking distance [6MWD; +44.1 m (±69.8) and +38.1 m (±71.9)], and St. George's Respiratory Questionnaire score [SGRQ; -9.5 points (±14.3) and -7.7 points (±14.2)] . No differences in any outcome measures were observed between heterogeneous and homogeneous emphysema patients. Only a high baseline RV was found to be an independent predictor of successful treatment. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Bronchoscopic coil treatment improves pulmonary function, 6MWD, and quality of life in patients with severe emphysema up to 1 year after treatment, independent of the distribution of the disease.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    URL: Article
    DOI: 10.1159/000431384
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2015
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  • 2
    Online Resource
    Online Resource
    Endobronchial Coils for Endoscopic Lung Volume Reduction: Best Practice Recommendations from an Expert Panel
    S. Karger AG ; 2018
    In:  Respiration Vol. 96, No. 1 ( 2018), p. 1-11
    Details
    In: Respiration, S. Karger AG, Vol. 96, No. 1 ( 2018), p. 1-11
    Abstract: Endobronchial coils are an additional treatment option for lung volume reduction in patients with severe emphysema. Patient selection should be focused on patients with severe emphysema on optimal medical therapy and with evidence of severe hyperinflation. The technique is suitable in a broad range of patients with emphysema; however, patients with paraseptal emphysema, large focal (giant) bullae, significant co-morbidity and airway-predominant disease should be avoided. Treatment involves placing between 10 and 14 coils by bronchoscopy in the selected treatment lobe, with 2 lobes being treated sequentially. Lobe selection for treatment should be based on quantitative computed tomography, and the lobes with the greatest destruction should be targeted (excluding the right middle lobe). The treatment results in an improvement in pulmonary function, exercise performance and quality of life, particularly in patients with severe hyperinflation (residual volume & #x3e; 200% predicted) and upper-lobe heterogeneous emphysema, but will also be of benefit in lower-lobe predominant and homogeneous emphysema. Finally, it has an acceptable safety profile, although special attention has to be paid to coil-associated opacity which is an inflammatory response that occurs in some patients treated with endobronchial coils.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    URL: Article
    DOI: 10.1159/000490193
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2018
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  • 3
    Online Resource
    Online Resource
    Protocol of a Randomized Controlled Study of the PneumRx Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema (ELEVATE)
    S. Karger AG ; 2019
    In:  Respiration Vol. 98, No. 6 ( 2019), p. 512-520
    Details
    In: Respiration, S. Karger AG, Vol. 98, No. 6 ( 2019), p. 512-520
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 The PneumRx endobronchial coil system for patients with severe emphysema has been shown to improve quality of life, exercise capacity, and pulmonary function in patients with emphysema. A post hoc analysis of the RENEW trial has identified patient characteristics and lobar selection methods associated with improved outcomes, which have to be confirmed prospectively. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 The ELEVATE trial is a prospective, multicenter, open label, randomized (2:1), controlled trial comparing outcomes in patients treated with endobronchial coils (treatment) to a medically managed control group (control). The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema. Control patients will be eligible to crossover to coil treatment after 6 months of follow-up. The co-primary effectiveness endpoints are percent change in forced expiratory volume in 1 s and quality of life measured by change in St. George’s Respiratory Questionnaire from baseline to 6 months. Secondary objectives are determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints. All patients will be followed for 24 months after initial treatment. Adverse events will be collected on an ongoing basis throughout the trial. 〈 b 〉 〈 i 〉 Discussion: 〈 /i 〉 〈 /b 〉 The primary objective of the ELEVATE trial is to prospectively confirm the safety and effectiveness profile of the coil system for the treatment of severe emphysema in consideration of the findings of previous randomized controlled trials. Secondary objectives are the determination of responder rates in all clinical endpoints and mean change in physiologic endpoints.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    URL: Article
    DOI: 10.1159/000502100
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2019
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  • 4
    Online Resource
    Online Resource
    Transbronchial Cryobiopsies for the Diagnosis of Diffuse Parenchymal Lung Diseases: Expert Statement from the Cryobiopsy Working Group on Safety and Utility and a Call for Standardization of the Procedure
    S. Karger AG ; 2018
    In:  Respiration Vol. 95, No. 3 ( 2018), p. 188-200
    Details
    In: Respiration, S. Karger AG, Vol. 95, No. 3 ( 2018), p. 188-200
    Abstract: Transbronchial cryobiopsies (TBCB) have recently been introduced as a promising and safer alternative to surgical lung biopsy in the diagnostic approach to diffuse parenchymal lung diseases (DPLD). Despite a substantial and expanding body of literature, the technique has not yet been standardized and its place in the diagnostic algorithm of DPLD remains to be defined. In part, this reflects concerns over the diagnostic yield and safety of the procedure, together with the rapid spread of the technique without competency and safety standards; furthermore, there is a substantial procedural variability among centers and interventional pulmonologists. We report this expert statement proposed during the third international conference on “Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Disease” (Ravenna, October 27–28, 2016), which formulates evidence- and expert-based suggestions on the indications, contraindications, patient selection, and procedural aspects of the procedure. The following 5 domains were reviewed: (1) what is the role of TBCB in the diagnostic evaluation of DPLD: patient selection; (2) pathological considerations; (3) contraindications and safety considerations; (4) how should TBCB be performed and in what procedural environment; and (5) who should perform TBCB. Finally, the existence of white paper recommendations may also reassure local hospital credentialing committees tasked with endorsing an adoption of the technique.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    URL: Article
    DOI: 10.1159/000484055
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2018
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  • 5
    Online Resource
    Online Resource
    Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema
    S. Karger AG ; 2021
    In:  Respiration Vol. 100, No. 8 ( 2021), p. 804-810
    Details
    In: Respiration, S. Karger AG, Vol. 100, No. 8 ( 2021), p. 804-810
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. 〈 b 〉 〈 i 〉 Objective: 〈 /i 〉 〈 /b 〉 We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. 〈 b 〉 〈 i 〉 Method: 〈 /i 〉 〈 /b 〉 Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] & #x3e;55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV 〈 sub 〉 1 〈 /sub 〉 ) and St George’s Respiratory Questionnaire (SGRQ) total score at 6 months. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV 〈 sub 〉 1 〈 /sub 〉 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV 〈 sub 〉 1 〈 /sub 〉 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by −10.6 [−15.9 to −5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    URL: Article
    DOI: 10.1159/000515744
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2021
    detail.hit.zdb_id: 1464419-8
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