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Dirkjan Slebos - One of the best experts on this subject based on the ideXlab platform.
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Endobronchial Valve zephyr treatment in homogeneous emphysema one year results from the impact randomized clinical trial
Respiration, 2021Co-Authors: Ralf Eberhardt, Joachim H Ficker, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Narinder S ShargillAbstract:RATIONALE The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr Endobronchial Valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established. METHODS Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr Valves or standard of care (SoC) (1:1). Zephyr Valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr Valve treatment. RESULTS The mean group difference (Zephyr Valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr Valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr Valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr Valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr Valve and SoC groups from 31 days to 6 months, and stable in the Zephyr Valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr Valve group out to 12 months. CONCLUSIONS Bronchoscopic lung volume reduction with Zephyr Valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.
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patient satisfaction and attainment of patient specific goals after Endobronchial Valve treatment
Annals of the American Thoracic Society, 2021Co-Authors: Jorine E Hartman, Karin Klooster, Nick Ten H T Hacken, Marlies Van Dijk, Dirkjan SlebosAbstract:Rationale: Bronchoscopic lung volume reduction with Endobronchial Valves (EBVs) significantly improves clinical outcomes in patients with severe emphysema. However, patient-reported outcomes like p...
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Endobronchial Valve therapy for severe emphysema: an overview of Valve-related complications and its management.
Expert Review of Respiratory Medicine, 2020Co-Authors: T. David Koster, Karin Klooster, Marlies Van Dijk, Nick H. T. Ten Hacken, Dirkjan SlebosAbstract:Bronchoscopic lung volume reduction treatment with one-way Valves is an effective guideline treatment option for patients with severe emphysema. However, important challenges and adverse reactions ...
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an integrative approach of the fissure completeness score and chartis assessment in Endobronchial Valve treatment for emphysema
International Journal of Chronic Obstructive Pulmonary Disease, 2020Co-Authors: Karin Klooster, Dirkjan Slebos, David T Koster, Huib A M Kerstjens, Dorothea Theilig, Felix Doellinger, Christoph Ruwweglosenkamp, J Saccomanno, Ralfharto HubnerAbstract:Purpose Lung volume reduction using one-way Endobronchial Valves is a bronchoscopic treatment for patients with severe emphysema without collateral ventilation between the treatment target lobe and the ipsilateral lobe(s). CT-scan fissure analysis is often used as a surrogate to predict the absence of collateral ventilation. We aimed to evaluate the predictive value of the fissure completeness score (FCS) compared to the functional Chartis measurement of collateral ventilation and to provide cut-off values of the FCS in patient selection. Patients and methods Multicenter study in patients eligible for treatment with one-way Valves. The FCS was calculated by quantitative CT analysis (Thirona, the Netherlands) and compared to status of interlobar collateral ventilation measured with Chartis system (PulmonX, USA). Thresholds were calculated for the predictive values of the presence of collateral ventilation. Results An FCS >95% of the left major fissure had a positive predictive value (PPV) of 91%, with 1 in 11 fissures demonstrating collateral ventilation with Chartis measurement, whereas an FCS of ≤80% had a negative predictive value (NPV) of 100% for the presence of collateral ventilation. For the right major fissure, the NPV was 100% for an FCS ≤90%, but 69.7% for the right upper lobe fissure. Conclusion Quantitative CT analysis is recommended in all patients evaluated for Endobronchial Valves. Patients with incomplete fissures (left major fissure: FCS 95%.
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Endobronchial Valve Treatment in Emphysema Patients with a Very Low DLCO
Respiration; international review of thoracic diseases, 2020Co-Authors: Marlies Van Dijk, Jorine E Hartman, Karin Klooster, Nick Ten H T Hacken, Huib A M Kerstjens, Dirkjan SlebosAbstract:Background: For selected patients with severe emphysema, bronchoscopic lung volume reduction with Endobronchial Valves (EBV) is recognized as an additional treatment option. In most trials investigating EBV treatment, patients with a very low diffusing capacity (DLCO) were excluded from participation. Objectives: Our goal was to investigate whether EBV treatment in patients with emphysema with a very low DLCO is safe and effective. Methods: This was a single-center retrospective analysis including patients with emphysema and a DLCO ≤20%pred who underwent EBV treatment. Follow-up was performed 6 months post-treatment. Outcome parameters were compared to a historical matched control group (DLCO >20%pred, matched for sex, age, forced expiratory volume in 1 s [FEV1], and residual volume [RV]). Results: Twenty patients (80% female, 64 ± 6 years, FEV1 26 ± 6%pred, RV 233 ± 45%pred, DLCO 18 ± 1.6%pred) underwent EBV treatment. At 6 months follow-up, we found a statistically significant improvement in FEV1 (0.08 ± 0.12 L), RV (–0.45 ± 0.95 L), 6-min walking distance (38 ± 65 m), and St. George’s Respiratory Questionnaire (–12 ± 13 points). With the exception of FEV1, all exceeded the minimal clinically important difference. The most common serious adverse event was a pneumothorax requiring intervention (15%). There were no significant differences in outcome compared to the DLCO >20%pred control group. Conclusions: In this single-center retrospective analysis, we showed statistically significant and clinically relevant improvements in lung function, exercise capacity, and quality of life up to 6 months after EBV treatment in emphysema patients with a DLCO ≤20% (14–20%) of predicted with no increased risk of serious adverse events.
Felix J F Herth - One of the best experts on this subject based on the ideXlab platform.
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risk of complications rise with coronary artery disease and diabetes mellitus after Endobronchial Valve placement in severe heterogeneous emphysema
Clinical Respiratory Journal, 2021Co-Authors: Sebastian Fernandezbussy, Gonzalo Labarca, Anna Kornafeld, David Abiatrujillo, Neal M Patel, Margaret M Johnson, Janani S Reisenauer, Felix J F HerthAbstract:BACKGROUND Patients with chronic obstructive pulmonary disease (COPD) commonly have comorbidities which may impact both symptoms and prognosis. Endoscopic lung volume reduction (ELVR) with Endobronchial Valves (EBV) is an innovative, effective and safe treatment for patients with severe emphysema who remain symptomatic despite optimal medical therapy. OBJECTIVES To evaluate medical comorbidities associated with increased risk of complications after EBV procedure. METHOD This was a retrospective cohort review of patients with severe, heterogeneous emphysema who underwent Zephyr® EBV installation for ELVR. Demographics, baseline comorbidities, dyspnea scores, data regarding procedure, pulmonary function test, minimal clinically important difference and post-EBV complications were recorded. RESULTS Of a total 82 participants, 24 were identified as having a post procedure complication. There was a significant difference in the incidence of type 2 diabetes mellitus (T2DM) at baseline (25%) in complication group compared with non-complication group (5.1%) (p value = 0.01). There was also a significant difference between baseline coronary artery disease (CAD) in those with (58.3%) or without (29.3%) complication (p = 0.01). Multivariate analysis of other covariables, identified associations of both CAD and T2DM with a heightened risk of complication (adjusted OR 4.19 CI: 1.23-14.2, p value = 0.02 and adjusted OR of 6.1 CI: 1.3-26.1, p value = 0.02 respectively). CONCLUSIONS Our study found that patients with severe, heterogeneous emphysema who undergo ELVR utilizing Zephyr® EBV and suffer complications during post-procedure period are more likely to have CAD or T2DM as baseline comorbidity. These data suggest that baseline CAD and T2DM might be predictive of increased risk of complications following ELVR with EBV.
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Endobronchial Valve zephyr treatment in homogeneous emphysema one year results from the impact randomized clinical trial
Respiration, 2021Co-Authors: Ralf Eberhardt, Joachim H Ficker, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Narinder S ShargillAbstract:RATIONALE The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr Endobronchial Valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established. METHODS Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr Valves or standard of care (SoC) (1:1). Zephyr Valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr Valve treatment. RESULTS The mean group difference (Zephyr Valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr Valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr Valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr Valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr Valve and SoC groups from 31 days to 6 months, and stable in the Zephyr Valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr Valve group out to 12 months. CONCLUSIONS Bronchoscopic lung volume reduction with Zephyr Valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.
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non answered questions in patients with Endobronchial Valve placement for lung volume reduction
Respiration, 2018Co-Authors: Ivan Caviedes, Felix J F Herth, Hugo Oliveira, Gonzalo Labarca, Sebastian FernandezbussyAbstract:Endoscopic lung volume reduction is a minimally invasive procedure performed to reduce the space occupied by the emphysemas' lobes. This procedure has been demonstrated to be beneficial for patients with advanced chronic obstructive pulmonary disease and severe hyperinflation. The use of Endobronchial Valves is increasing, as well as the number of reports of adverse events. The most common complications after the procedure are a pneumothorax, bleeding, infections, the need for Valve removal, and Valve expulsion. We have recently treated a patient who achieved immediate left upper lobe atelectasis but developed a pneumothorax on the 6th day and near-fatal kinking of the left lower lobe bronchus. This patient had asphyctic episodes probably due to a functional left pneumonectomy. We should consider this unusual complication in patients undergoing endoscopic lung volume reduction whose condition worsens after achieving complete lobar atelectasis.
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Endobronchial Valve therapy in patients with homogeneous emphysema results from the impact study
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Arschang Valipour, Joachim H Ficker, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Ralf EberhardtAbstract:Rationale: Endobronchial Valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema.Objectives: To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system.Methods: Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George’s Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction.Measurements and Main Results: Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC gr...
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late breaking abstract a multicenter prospective randomized controlled trial of Endobronchial Valve therapy vs standard of care in homogeneous emphysema impact
European Respiratory Journal, 2016Co-Authors: Ralf Eberhardt, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Arschang ValipourAbstract:Background: Endobronchial Valve (EBV) therapy improves lung function, exercise capacity and quality of life in patients with advanced heterogeneous emphysema. Limited data exist on the use of EBV in patients with homogeneous emphysema. Aims and Objectives: Evaluate effectiveness of EBV placement in patients with severe homogeneous emphysema. Methods: Prospective multicenter RCT enrolled 183 patients with hyperinflation (FEV 1 ≤45% pred., RV ≥200% pred.), and severe homogeneous emphysema, confirmed by quantitative HRCT and perfusion scan. 93 patients ([male]/[female]:36/57; mean age: 63.8y) with negative collateral ventilation (assessed by Chartis System) were randomized to either unilateral complete EBV treatment (Zephyr Valves; n=43) or standard medical care (SoC; n=50) at 8 centres. The primary end point was ΔFEV 1 % at 90 days. Secondary endpoints were pulmonary function tests (PFT), 6-Minute-Walk-Distance (6MWD), SGRQ (St. Georges Respiratory Questionnaire), and safety. Results: Outcome measures for ITT population at 90 days were: Serious adverse events (EBV vs SoC patients) included: pneumothorax 25.6% vs 0% and COPD exacerbation 18.6% vs 12.0%. There were no deaths in the EBV group and 2 deaths in the SoC group. Conclusion: EBV treatment resulted in clinically and statistically significant improvements in pulmonary function, exercise capacity and quality of life in patients with severe homogenous emphysema and negative collateral ventilation.
Karin Klooster - One of the best experts on this subject based on the ideXlab platform.
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revision bronchoscopy after Endobronchial Valve treatment for emphysema indications findings and outcomes
International Journal of Chronic Obstructive Pulmonary Disease, 2021Co-Authors: Jorine E Hartman, Karin Klooster, Sharyn A Roodenburg, David T Koster, Marlies Van DijkAbstract:Background Endobronchial Valve (EBV) treatment is an effective treatment for patients with severe emphysema. Revision bronchoscopies after Endobronchial Valve treatment can be essential to prolong the effect of treatment or address long-term complications. Purpose To evaluate the indications, endoscopic findings and outcomes of revision bronchoscopies and investigate if any predictors for granulation tissue formation, after EBV treatment, can be identified. Patients and methods Patients who underwent EBV treatment between 2016 and 2019 in our hospital, as routine care, were included. If a patient underwent a revision bronchoscopy, data regarding revision bronchoscopies, including indication, finding, intervention and pulmonary function testing (PFT) after revision bronchoscopy were analysed. Results One hundred seventy-nine patients were included of which 41% required at least one revision bronchoscopy. In 43% of the revision bronchoscopy patients, the indication was loss of initial treatment effect. In 53% of the revision bronchoscopy patients, granulation tissue was found to be the underlying cause. Valve replacement(s) were performed in 51% of the revision bronchoscopy cases. Permanent Valve removal was required in 13% of all patients. Overall, revision bronchoscopies led to improvements in PFT outcomes for patients experiencing no or a loss of initial treatment effect. No clinically relevant predictors for granulation tissue formation were identified. Conclusion Performing a revision bronchoscopy after EBV treatment is a useful procedure leading to an improved treatment effect in most patients. Granulation tissue formation, causing Valve dysfunction, is the most common cause of longer term problems.
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patient satisfaction and attainment of patient specific goals after Endobronchial Valve treatment
Annals of the American Thoracic Society, 2021Co-Authors: Jorine E Hartman, Karin Klooster, Nick Ten H T Hacken, Marlies Van Dijk, Dirkjan SlebosAbstract:Rationale: Bronchoscopic lung volume reduction with Endobronchial Valves (EBVs) significantly improves clinical outcomes in patients with severe emphysema. However, patient-reported outcomes like p...
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Endobronchial Valve therapy for severe emphysema: an overview of Valve-related complications and its management.
Expert Review of Respiratory Medicine, 2020Co-Authors: T. David Koster, Karin Klooster, Marlies Van Dijk, Nick H. T. Ten Hacken, Dirkjan SlebosAbstract:Bronchoscopic lung volume reduction treatment with one-way Valves is an effective guideline treatment option for patients with severe emphysema. However, important challenges and adverse reactions ...
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an integrative approach of the fissure completeness score and chartis assessment in Endobronchial Valve treatment for emphysema
International Journal of Chronic Obstructive Pulmonary Disease, 2020Co-Authors: Karin Klooster, Dirkjan Slebos, David T Koster, Huib A M Kerstjens, Dorothea Theilig, Felix Doellinger, Christoph Ruwweglosenkamp, J Saccomanno, Ralfharto HubnerAbstract:Purpose Lung volume reduction using one-way Endobronchial Valves is a bronchoscopic treatment for patients with severe emphysema without collateral ventilation between the treatment target lobe and the ipsilateral lobe(s). CT-scan fissure analysis is often used as a surrogate to predict the absence of collateral ventilation. We aimed to evaluate the predictive value of the fissure completeness score (FCS) compared to the functional Chartis measurement of collateral ventilation and to provide cut-off values of the FCS in patient selection. Patients and methods Multicenter study in patients eligible for treatment with one-way Valves. The FCS was calculated by quantitative CT analysis (Thirona, the Netherlands) and compared to status of interlobar collateral ventilation measured with Chartis system (PulmonX, USA). Thresholds were calculated for the predictive values of the presence of collateral ventilation. Results An FCS >95% of the left major fissure had a positive predictive value (PPV) of 91%, with 1 in 11 fissures demonstrating collateral ventilation with Chartis measurement, whereas an FCS of ≤80% had a negative predictive value (NPV) of 100% for the presence of collateral ventilation. For the right major fissure, the NPV was 100% for an FCS ≤90%, but 69.7% for the right upper lobe fissure. Conclusion Quantitative CT analysis is recommended in all patients evaluated for Endobronchial Valves. Patients with incomplete fissures (left major fissure: FCS 95%.
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Endobronchial Valve Treatment in Emphysema Patients with a Very Low DLCO
Respiration; international review of thoracic diseases, 2020Co-Authors: Marlies Van Dijk, Jorine E Hartman, Karin Klooster, Nick Ten H T Hacken, Huib A M Kerstjens, Dirkjan SlebosAbstract:Background: For selected patients with severe emphysema, bronchoscopic lung volume reduction with Endobronchial Valves (EBV) is recognized as an additional treatment option. In most trials investigating EBV treatment, patients with a very low diffusing capacity (DLCO) were excluded from participation. Objectives: Our goal was to investigate whether EBV treatment in patients with emphysema with a very low DLCO is safe and effective. Methods: This was a single-center retrospective analysis including patients with emphysema and a DLCO ≤20%pred who underwent EBV treatment. Follow-up was performed 6 months post-treatment. Outcome parameters were compared to a historical matched control group (DLCO >20%pred, matched for sex, age, forced expiratory volume in 1 s [FEV1], and residual volume [RV]). Results: Twenty patients (80% female, 64 ± 6 years, FEV1 26 ± 6%pred, RV 233 ± 45%pred, DLCO 18 ± 1.6%pred) underwent EBV treatment. At 6 months follow-up, we found a statistically significant improvement in FEV1 (0.08 ± 0.12 L), RV (–0.45 ± 0.95 L), 6-min walking distance (38 ± 65 m), and St. George’s Respiratory Questionnaire (–12 ± 13 points). With the exception of FEV1, all exceeded the minimal clinically important difference. The most common serious adverse event was a pneumothorax requiring intervention (15%). There were no significant differences in outcome compared to the DLCO >20%pred control group. Conclusions: In this single-center retrospective analysis, we showed statistically significant and clinically relevant improvements in lung function, exercise capacity, and quality of life up to 6 months after EBV treatment in emphysema patients with a DLCO ≤20% (14–20%) of predicted with no increased risk of serious adverse events.
Ralf Eberhardt - One of the best experts on this subject based on the ideXlab platform.
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Endobronchial Valve zephyr treatment in homogeneous emphysema one year results from the impact randomized clinical trial
Respiration, 2021Co-Authors: Ralf Eberhardt, Joachim H Ficker, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Narinder S ShargillAbstract:RATIONALE The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr Endobronchial Valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established. METHODS Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr Valves or standard of care (SoC) (1:1). Zephyr Valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr Valve treatment. RESULTS The mean group difference (Zephyr Valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr Valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr Valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr Valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr Valve and SoC groups from 31 days to 6 months, and stable in the Zephyr Valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr Valve group out to 12 months. CONCLUSIONS Bronchoscopic lung volume reduction with Zephyr Valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.
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Endobronchial Valve therapy in patients with homogeneous emphysema results from the impact study
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Arschang Valipour, Joachim H Ficker, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Ralf EberhardtAbstract:Rationale: Endobronchial Valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema.Objectives: To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system.Methods: Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George’s Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction.Measurements and Main Results: Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC gr...
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late breaking abstract a multicenter prospective randomized controlled trial of Endobronchial Valve therapy vs standard of care in homogeneous emphysema impact
European Respiratory Journal, 2016Co-Authors: Ralf Eberhardt, Dirkjan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Christoph Petermann, Ralfharto Hubner, Franz Stanzel, Arschang ValipourAbstract:Background: Endobronchial Valve (EBV) therapy improves lung function, exercise capacity and quality of life in patients with advanced heterogeneous emphysema. Limited data exist on the use of EBV in patients with homogeneous emphysema. Aims and Objectives: Evaluate effectiveness of EBV placement in patients with severe homogeneous emphysema. Methods: Prospective multicenter RCT enrolled 183 patients with hyperinflation (FEV 1 ≤45% pred., RV ≥200% pred.), and severe homogeneous emphysema, confirmed by quantitative HRCT and perfusion scan. 93 patients ([male]/[female]:36/57; mean age: 63.8y) with negative collateral ventilation (assessed by Chartis System) were randomized to either unilateral complete EBV treatment (Zephyr Valves; n=43) or standard medical care (SoC; n=50) at 8 centres. The primary end point was ΔFEV 1 % at 90 days. Secondary endpoints were pulmonary function tests (PFT), 6-Minute-Walk-Distance (6MWD), SGRQ (St. Georges Respiratory Questionnaire), and safety. Results: Outcome measures for ITT population at 90 days were: Serious adverse events (EBV vs SoC patients) included: pneumothorax 25.6% vs 0% and COPD exacerbation 18.6% vs 12.0%. There were no deaths in the EBV group and 2 deaths in the SoC group. Conclusion: EBV treatment resulted in clinically and statistically significant improvements in pulmonary function, exercise capacity and quality of life in patients with severe homogenous emphysema and negative collateral ventilation.
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comparing clinical outcomes in upper versus lower lobe Endobronchial Valve treatment in severe emphysema
Respiration, 2015Co-Authors: Ralf Eberhardt, Felix J F Herth, Sri Radhakrishnan, Daniela GompelmannAbstract:Background: Lung volume reduction surgery has been recommended for patients with upper lobe predominant emphysema and was associated with less favorable outcomes in patients with non-upper lobe predominant emphysema. The value of Endobronchial Valve (EBV) treatment in lower lobe predominant emphysema has not been studied. Objectives: To confirm the equivalence of upper and lower lobe Valve treatments in patients with heterogeneous emphysema. Methods: A retrospective analysis from the Endobronchial Valve for Emphysema Palliation Trial (VENT), where patients with heterogeneous emphysema received Zephyr® EBV (Pulmonx Corp., Redwood City, Calif., USA) or medical treatment, was performed. Patients with low interlobar collateral ventilation and accurate placement of Valves in the target lobes were identified. Safety and efficacy were compared between patients who underwent upper versus lower lobe treatment. Results: Of the 331 patients, 60 had low interlobar collateral ventilation and successful lobar exclusion (45 patients with upper lobe treatment and 15 patients with lower lobe treatment). There was no difference in baseline characteristics between the groups except for a higher destruction score (70.3 vs. 60.7%; p = 0.0010) and a higher heterogeneity index (24 vs. 13%; p = 0.0005) for the upper lobe cohort. At 180 days, both groups had improved clinically. There were no significant differences in mean changes or responder rates of forced expiratory volume in 1 s (+23.8 vs. +22.9%), the St. Georges Respiratory Questionnaire (-6.50 vs. -7.53 points), the 6-min walk test (+24.1 vs. +44.0 m), target lobe volume reduction (-1,199 vs. -1,042 ml), or in the adverse event rate between both cohorts. Conclusion: Patients with lower and upper lobe predominant emphysema benefit equally from EBV therapy when interlobar collateral ventilation is low and lobar exclusion is achieved. Patients with lower lobe disease did not have increased adverse events compared to patients with upper lobe emphysema.
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ct predictors of vq perfusion application to Endobronchial Valve lung reduction treatment
European Respiratory Journal, 2015Co-Authors: Maren Schuhmann, Daniela Gompelmann, Ralf Eberhardt, Philippe Raffy, Youbing Yin, Juerg Tschirren, Dominik Harzheim, Felix J F HerthAbstract:Introduction: Lung perfusion scintigraphy (Q-scan) is used to assess perfusion prior to thoracic procedures, including endoscopic lung volume reduction (ELVR). Q-scan, however, involves radiation exposure and provides regional estimates by lung thirds rather than lobes. Objective: Evaluate quantitative CT (QCT) surrogates of perfusion at the lobar level that can be used in lieu of Q-scans. Methods: Pairs of Q/CT scans of 127 subjects with severe emphysema who underwent ELVR were analyzed retrospectively using dedicated lung quantitative imaging software (Apollo®, VIDA Diagnostics, Iowa). Independent lobar QCT predictors of perfusion were identified through stepwise linear regression analysis. The agreement between the derived QCT model and Q-scan in selecting lobes with lowest perfusion was assessed, and each imaging method rated against the choice of lobes selected for ELVR (RUL: 44, RLL: 16, LUL: 21, LLL: 46). Results: Contributions of each lobe to overall %emphysema (%Emph_r) and overall %vascular volume (%Vessel_r) were identified as QCT predictors of perfusion (p Conclusion: QCT modeling of perfusion can aid in deciding on the least perfused lobes prior to ELVR. QCT has promise to replace VQ scanning in the assessment algorithm of these patients.
Gerard J Criner - One of the best experts on this subject based on the ideXlab platform.
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device profile of the zephyr Endobronchial Valve in heterogenous emphysema overview of its safety and efficacy
Expert Review of Medical Devices, 2021Co-Authors: S Verga, Gerard J CrinerAbstract:INTRODUCTION Emphysema affects millions of people; the underlying pathophysiology is hyperinflation due to destruction of lung parenchyma. The mainstay of treatment is medical therapy however there are two surgical treatment strategies approved by the FDA to reduce lung hyperinflation. First being lung volume reduction surgery (LVRS), which carries higher risk of mortality versus bronchoscopic lung volume reduction (BLVR). BLVR has reduced peri-operative morbidity without compromising improvement in post-bronchodilator forced expiratory volume 1s (FEV1) and patient-reported outcomes. The added benefit of BLVR is that older adults who have end-stage emphysema who otherwise would not be appropriate surgical candidates for LVRS or transplant have an alternative treatment option. AREAS COVERED This is a review paper focusing on Zephyr® Endobronchial Valves (EBV). Specifically, clinical outcomes of major trials, selection criteria, Valve/deployment catheter features, description of procedure, discussing the Chartis™ Pulmonary Assessment System and StratX report, management of complications and discussing next steps in protocolizing post-EBV care. EXPERT OPINION The expert opinion section focuses on outcomes from the LIBERATE Trial and 1-yr post-hoc analysis. Further 5-year follow-up post Zephyr® EBV placement along with protocolization post-EBV placement are needed to minimize adverse events and/or be able to manage, especially with high risk of pneumothorax (PTX).
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role of imaging in bronchoscopic lung volume reduction using Endobronchial Valve state of the art review
Journal of Thoracic Imaging, 2021Co-Authors: Chandra Dass, Alyssa R Goldbach, Farouk Dako, Maruti Kumaran, Robert M Steiner, Gerard J CrinerAbstract:Chronic obstructive pulmonary disease (COPD) is becoming one of the leading causes of mortality and morbidity throughout the world. The National Emphysema Treatment Trial demonstrated that lung volume reduction surgery can improve pulmonary function, exercise capacity, and quality of life in select subgroups of patients with COPD. In recent years, few bronchoscopic lung volume reduction (BLVR) procedures have undergone clinical trials with the goal of establishing an effective and safe alternative approach for reducing hyperinflation in patients with severe emphysema who are symptomatic despite optimal medical management, but are poor surgical candidates. Of these BLVR procedures, only deployment of 1-way Endobronchial Valves (EBVs) has the largest pool of scientific data available to date to support its clinical utility. Two EBV systems have been food and drug administration-approved within the last year to meet the clinical demands of this select group of patients with COPD. On the basis of the results of multiple randomized clinical trials, the recommendations of the original 2016 Expert Panel Report on BLVR usage criteria of EBV have been updated in 2019. The outcome of EBV therapy is maximized in certain image-based COPD phenotypes. Imaging plays a major role in patient selection, target lobe identification, and in the management of postprocedural adverse events. With the expected widespread use of EBV therapy in the coming years, knowledge and familiarity of the Role of Imaging in BLVR using EBVs is essential for radiologists attempting to make meaningful contribution toward improving clinical outcomes.
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patient preferences for Endobronchial Valve treatment of severe emphysema
Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, 2018Co-Authors: Carol Mansfield, Gerard J Criner, Jessie Sutphin, Kelly Shriner, Bartolome R CelliAbstract:Background: Patients with severe emphysema have limited treatment options. Little is known about patients' willingness to accept risks for new treatments that offer meaningful benefits. Methods: We determined treatment preferences of patients with severe emphysema using a web-based discrete-choice experiment survey. Respondents answered 9 questions that offered choices between 2 hypothetical interventional treatments or continuing current medical management. Variations in 5 attributes defined the 2 interventional treatments: improvement in ability to breathe and carry out day-to-day activities, frequency of hospitalized exacerbations, treatment type, risk of pneumothorax within 30 days of procedure, and risk of death within 3 months. Respondents were recruited through the COPD Foundation's COPD Patient-Powered Research Network and had a self-reported emphysema diagnosis and 2+ score on the modified Medical Research Council Dyspnea Scale. The relative importance of the attributes and the percentage of respondents who would select different treatment options was modeled using random-parameters logit. Results: Among 294 respondents, 51% always chose an interventional treatment option, while 19% always selected continued medical management. The most important change on average was moving from continued medical management (with no improvement in breathlessness) to an interventional treatment with improvement in breathlessness. The model predicted 71% of respondents would select a treatment option similar to removable Endobronchial Valve implants, 6% would select lung volume reduction surgery (LVRS), and 23% continued medical management. Conclusion: Patients with severe emphysema perceive that a procedure with risks and benefits similar to the Zephyr® Endobronchial Valve implants is desirable over continued medical management or LVRS.
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a multicenter rct of zephyr Endobronchial Valve treatment in heterogeneous emphysema liberate
American Journal of Respiratory and Critical Care Medicine, 2018Co-Authors: Gerard J Criner, Richard Sue, Shawn Wright, Mark T Dransfield, Hiram Rivasperez, Tanya Wiese, Frank C Sciurba, Pallav L Shah, Momen M Wahidi, Hugo OliveiraAbstract:Rationale: This is the first multicenter RCT to evaluate effectiveness and safety of Zephyr® Endobronchial Valve EBV® out to 12-months. Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation (CV) in the treated lobe. Methods: Subjects were enrolled with a 2:1 randomization (EBV: Standard-of-Care (SoC)) at 24 sites. Primary outcome at 12-months was the ΔEBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of ≥15%. Secondary endpoints included absolute changes in post-BD FEV1, Six-Minute Walk Distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) scores. Results: 190 subjects, 128 EBV and 62 SoC were randomized. At 12-months, 47.7% EBV and 16.8% SoC subjects had a ΔFEV1 ≥15% (p<0.001). ΔEBV-SoC at 12-months was statistically and clinically significant: for FEV1 (L), 0.106L (p<0.001); 6MWD, +39.31m (p=0.002); and SGRQ, -7.05 points (p=0.004). Significant ΔEBV-SoC were also observed in hyperinf...
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a multicenter randomized controlled trial of zephyr Endobronchial Valve treatment in heterogeneous emphysema transform
American Journal of Respiratory and Critical Care Medicine, 2017Co-Authors: Gerard J Criner, Richard Sue, Shawn Wright, Mark T Dransfield, Hiram Rivasperez, Tanya Wiese, Frank C Sciurba, Pallav L Shah, Momen M Wahidi, Hugo OliveiraAbstract:Rationale: This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilatio...
