A Randomized Trial Comparing Lung-Volume–Reduction Surgery with Medical Therapy for Severe Emphysema

Fishman, Alfred P.; Martínez, Fernando J.; Naunheim, Keith S.; Piantadosi, Steven; Wise, Robert A.; Ries, Andrew L.; Weinmann, Gail G.; Wood, Douglas E.

doi:10.1056/nejmoa030287

Cited by 1,748 publications

(377 citation statements)

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“…Examples of tailored treatment in COPD include roflumilast for patients with chronic bronchitis 125 and lung volume reduction surgery for patients with both predominantly upper-lobe emphysema and low baseline exercise capacity. 126 Effect of different pressure settings on effectiveness of non-invasive ventilation Non-invasive ventilation pressure settings may influence effectiveness, and this report identified three RCTs directly comparing different settings. The main outcomes of interest of these small, short-term crossover RCTs were lung function, blood gases and adherence.…”

Section: Effect Of Patient Characteristics On Effectiveness Of Non-inmentioning

confidence: 99%

The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation

Dretzke

Blissett

Dave

et al. 2015

Health Technol Assess

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BackgroundChronic obstructive pulmonary disease (COPD) is a chronic progressive lung disease characterised by non-reversible airflow obstruction. Exacerbations are a key cause of morbidity and mortality and place a considerable burden on health-care systems. While there is evidence that patients benefit from non-invasive ventilation (NIV) in hospital during an acute exacerbation, evidence supporting home use for more stable COPD patients is limited. In the UK, domiciliary NIV is considered on health economic grounds in patients after three hospital admissions for acute hypercapnic respiratory failure.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of domiciliary NIV by systematic review and economic evaluation.Data sourcesBibliographic databases, conference proceedings and ongoing trial registries up to September 2014.MethodsStandard systematic review methods were used for identifying relevant clinical effectiveness and cost-effectiveness studies assessing NIV compared with usual care or comparing different types of NIV. Risk of bias was assessed using Cochrane guidelines and relevant economic checklists. Results for primary effectiveness outcomes (mortality, hospitalisations, exacerbations and quality of life) were presented, where possible, in forest plots. A speculative Markov decision model was developed to compare the cost-effectiveness of domiciliary NIV with usual care from a UK perspective for post-hospital and more stable populations separately.ResultsThirty-one controlled effectiveness studies were identified, which report a variety of outcomes. For stable patients, a modest volume of evidence found no benefit from domiciliary NIV for survival and some non-significant beneficial trends for hospitalisations and quality of life. For post-hospital patients, no benefit from NIV could be shown in terms of survival (from randomised controlled trials) and findings for hospital admissions were inconsistent and based on limited evidence. No conclusions could be drawn regarding potential benefit from different types of NIV. No cost-effectiveness studies of domiciliary NIV were identified. Economic modelling suggested that NIV may be cost-effective in a stable population at a threshold of £30,000 per quality-adjusted life-year (QALY) gained (incremental cost-effectiveness ratio £28,162), but this is associated with uncertainty. In the case of the post-hospital population, results for three separate base cases ranged from usual care dominating to NIV being cost-effective, with an incremental cost-effectiveness ratio of less than £10,000 per QALY gained. All estimates were sensitive to effectiveness estimates, length of benefit from NIV (currently unknown) and some costs. Modelling suggested that reductions in the rate of hospital admissions per patient per year of 24% and 15% in the stable and post-hospital populations, respectively, are required for NIV to be cost-effective.LimitationsEvidence on key clinical outcomes remains limited, particularly quality-of-life and long-term (> 2 years) effects. Economic modelling should be viewed as speculative because of uncertainty around effect estimates, baseline risks, length of benefit of NIV and limited quality-of-life/utility data.ConclusionsThe cost-effectiveness of domiciliary NIV remains uncertain and the findings in this report are sensitive to emergent data. Further evidence is required to identify patients most likely to benefit from domiciliary NIV and to establish optimum time points for starting NIV and equipment settings.Future work recommendationsThe results from this report will need to be re-examined in the light of any new trial results, particularly in terms of reducing the uncertainty in the economic model. Any new randomised controlled trials should consider including a sham non-invasive ventilation arm and/or a higher- and lower-pressure arm. Individual participant data analyses may help to determine whether or not there are any patient characteristics or equipment settings that are predictive of a benefit of NIV and to establish optimum time points for starting (and potentially discounting) NIV.Study registrationThis study is registered as PROSPERO CRD42012003286.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Effect Of Patient Characteristics On Effectiveness Of Non-inmentioning

confidence: 99%

The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation

Dretzke

Blissett

Dave

et al. 2015

Health Technol Assess

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show abstract

“…For comparison, mean 6-min walking distance of all patients undergoing LVRS in the NETT was higher, i.e. 378 (1,239 ft) and 332 m (1,089 ft) in the low exercise capacity subgroup [9]supplementary appendix 3].…”

Section: Discussionmentioning

confidence: 99%

“…Experience from case series [1, 2, 3, 4]and data from randomized, controlled trials [5, 6, 7, 8, 9]including the National Emphysema Treatment Trial (NETT) demonstrate that lung volume reduction surgery (LVRS) may improve symptoms, lung function, and exercise capacity in selected patients with advanced emphysema. Yet, the amount of functional improvement achieved by LVRS as well as the perioperative mortality have varied among the study patients.…”

Section: Introductionmentioning

confidence: 99%

“…This led to the exclusion of patients with such characteristics from recruitment. Post hoc analysis of the NETT data suggested that the distribution of emphysema and exercise capacity were important determinants of the outcome of surgery [9]. A prospective validation of potential functional and radiologic predictors of the spirometric response to LVRS has not been performed.…”

Section: Introductionmentioning

confidence: 99%

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Model-Based versus Clinical Prediction of the Spirometric Response to Lung Volume Reduction Surgery

Bloch

Weder²,

Bachmann³

et al. 2004

Respiration

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Background: Lung volume reduction surgery (LVRS) improves symptoms and lung function in selected patients with severe emphysema. Objectives: We investigated whether models based on physiologic and radiologic predictors discriminated patients with a favorable from those with a poor spirometric response to LVRS. Methods: Data of a derivation cohort of 70 patients who had previously undergone LVRS served to develop two types of prediction models, lookup functions and logistic regression equations. Presence or absence of improvement in forced expiratory volume in 1 s (FEV₁) ≧300 ml and forced vital capacity (FVC) ≧500 ml represented dichotomous outcomes. The residual volume/total lung capacity ratio, CT-radiological emphysema heterogeneity scores and diffusing capacity, a marker of emphysema severity, were the predictors. Models were used to predict spirometric outcomes for a validation cohort of 60 emphysema patients referred for LVRS. Furthermore, the surgeon preoperatively estimated outcomes based on all available clinical data but blinded to model predictions. Spirometric changes within 6 months following surgery were compared to predictions. Results: Median FEV₁ in the validation cohort increased from 0.69 to 1.00 liters (+41%), and FVC from 2.07 to 2.78 liters (+29%; p < 0.05 for changes). Lookup functions and logistic regression equations identified patients experiencing major increases in FEV₁ ≧300 ml and FVC ≧500 ml with an accuracy quantified by areas under the receiver-operating characteristic curves of 0.72 to 0.76 (all areas >0.5, p < 0.05). Predictions by the surgeon had an accuracy of 0.71 to 0.78 (p = NS vs. models). Conclusions: The accuracy of models based on three predictors was fair and similar to assessment by an experienced surgeon based on all available clinical information. Prediction models may contribute to the consistent assessment of LVRS candidates.

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“…[1] LVRS has been marked by a significant 90-day mortality rate in experienced hands (4%) as well as post-procedural morbidity. [2] Interest has grown in the development of a minimally invasive way to reduce lung volume, which can minimise morbidity and mortality.…”

mentioning

confidence: 99%

Endoscopic lung volume reduction with coils

Vorster

2015

S Afr Res J

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The use of endoscopic lung volume reduction (ELVR) as a minimally invasive procedure with significantly lower morbidity and mortality than surgery, is fast becoming a new treatment modality for a select group of patients with severe emphysema. Lung volume reduction can be achieved either by surgery (LVRS) or the use of endoscopic techniques. Although LVRS offers survival benefit and increased exercise capacity in selected patients, this comes at a price with significant associated morbidity and mortality. The use of endoscopic lung volume reduction (ELVR) aims to reduce the risks and costs of surgery with comparable physiological benefits. Current evidence suggests that not all classes and phenotypes of emphysema will benefit from lung volume reduction, and that individual techniques may benefit different subgroups of patients. It therefore remains paramount that a systematic approach is followed and selection criteria are met, given the high costs and potential complications related to both LVRS and ELVR.

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A Randomized Trial Comparing Lung-Volume–Reduction Surgery with Medical Therapy for Severe Emphysema

Cited by 1,748 publications

References 22 publications

The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation

The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation

Model-Based versus Clinical Prediction of the Spirometric Response to Lung Volume Reduction Surgery

Endoscopic lung volume reduction with coils

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