Project description:Resectional lung volume reduction has proven to be superior to medical treatment in reducing dyspnoea and in increasing lung function, survival and quality of life in a very well selected, low risk group of hyperinflated patients with heterogeneous emphysema predominantly in the upper lobe. Nevertheless, this intervention is hampered by an important pulmonary (30%) and cardiovascular (20%) morbidity, mainly as a result of prolonged (>7 days) air leak, and a 5% risk of death as a result of the surgical intervention. Results from ongoing randomised trials are awaited in order to determine whether less invasive, non-resectional lung volume treatment of emphysema via the bronchoscope using endobronchial valves, airway bypass stents or biological adhesives/heated water vapour will yield similar improvement with less morbidity and reduced mortality, compared with surgical resection. Furthermore, it is hoped that endoscopic lung volume reduction techniques may help patients with homogeneous emphysema currently excluded by most teams for the resectional procedure.
Project description:RationaleTo determine the effect of medical treatment versus lung volume reduction surgery (LVRS) on pulmonary hemodynamics.MethodsThree clinical centers of the National Emphysema Treatment Trial (NETT) screened patients for additional inclusion into a cardiovascular (CV) substudy. Demographics were determined, and lung function testing, six-minute-walk distance, and maximum cardiopulmonary exercise testing were done at baseline and 6 months after medical therapy or LVRS. CV substudy patients underwent right heart catheterization at rest prerandomization (baseline) and 6 months after treatment.Measurements and main resultsA total of 110 of the 163 patients evaluated for the CV substudy were randomized in NETT (53 were ineligible), 54 to medical treatment and 56 to LVRS. Fifty-five of these patients had both baseline and repeat right heart catheterization 6 months postrandomization. Baseline demographics and lung function data revealed CV substudy patients to be similar to the remaining 1,163 randomized NETT patients in terms of age, sex, FEV(1), residual volume, diffusion capacity of carbon monoxide, Pa(O(2)), Pa(CO(2)), and six-minute-walk distance. CV substudy patients had moderate pulmonary hypertension at rest (Ppa, 24.8 +/- 4.9 mm Hg); baseline hemodynamic measurements were similar across groups. Changes from baseline pressures to 6 months post-treatment were similar across treatment groups, except for a smaller change in pulmonary capillary wedge pressure at end-expiration post-LVRS compared with medical treatment (-1.8 vs. 3.5 mm Hg, p = 0.04).ConclusionsIn comparison to medical therapy, LVRS was not associated with an increase in pulmonary artery pressures.
Project description:BackgroundThe lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial in patients with severe emphysema.MethodsPatients were treated in 11 centres. Safety was evaluated by recording all adverse events, efficacy by the St George's Respiratory Questionnaire (SGRQ) as primary endpoint, and pulmonary function testing, modified Medical Research Council dyspnoea score (mMRC) and 6-min walk distance (6MWD) up to 12 months after the final treatment.ResultsSixty patients (60.9 ± 7.5 years, forced expiratory volume in 1 s (FEV(1)) 30.2 ± 6.3% pred) were bronchoscopically treated with coils (55 bilateral, 5 unilateral), with a median of 10 (range 5-15) coils per lobe. Within 30 days post-treatment, seven chronic obstructive pulmonary disease exacerbations (6.1%), six pneumonias (5.2%), four pneumothoraces (3.5%) and one haemoptysis (0.9%) occurred as serious adverse events. At 6 and 12 months, respectively, ΔSGRQ was -12.1±12.9 and -11.1±13.3 points, Δ6MWD was +29.7±74.1 m and +51.4±76 m, ΔFEV(1) was +0.11±0.20 L and +0.11±0.30 L, and ΔRV (residual volume) was -0.65±0.90 L and -0.71±0.81 L (all p<0.01). Post hoc analyses showed significant responses for SGRQ, 6MWD and RV in patients with both heterogeneous and homogeneous emphysema.ConclusionsLVR coil treatment results in significant clinical improvements in patients with severe emphysema, with a good safety profile and sustained results for up to 1 year.Trial registration numberNCT01328899.
Project description:BackgroundLung volume reduction (LVR) techniques improve lung function in selected patients with emphysema, but the impact of LVR procedures on the asynchronous movement of different chest wall compartments, which is a feature of emphysema, is not known.MethodsWe used optoelectronic plethysmography to assess the effect of surgical and bronchoscopic LVR on chest wall asynchrony. Twenty-six patients were assessed before and 3 months after LVR (surgical [n = 9] or bronchoscopic [n = 7]) or a sham/unsuccessful bronchoscopic treatment (control subjects, n = 10). Chest wall volumes were divided into six compartments (left and right of each of pulmonary ribcage [Vrc,p], abdominal ribcage [Vrc,a], and abdomen [Vab]) and phase shift angles (θ) calculated for the asynchrony between Vrc,p and Vrc,a (θRC), and between Vrc,a and Vab (θDIA).ResultsParticipants had an FEV₁ of 34.6 ± 18% predicted and a residual volume of 217.8 ± 46.0% predicted with significant chest wall asynchrony during quiet breathing at baseline (θRC, 31.3° ± 38.4°; and θDIA, -38.7° ± 36.3°). Between-group difference in the change in θRC and θDIA during quiet breathing following treatment was 44.3° (95% CI, -78 to -10.6; P = .003) and 34.5° (95% CI, 1.4 to 67.5; P = .007) toward 0° (representing perfect synchrony), respectively, favoring the LVR group. Changes in θRC and θDIA were statistically significant on the treated but not the untreated sides.ConclusionsSuccessful LVR significantly reduces chest wall asynchrony in patients with emphysema.
Project description:BackgroundPharmacologic therapeutics for advanced emphysema have limited benefit. Bronchoscopic lung volume reduction with endobronchial valves (EBVs) have reported improvements in lung function, breathlessness, and quality of life through randomized clinical trials, with less morbidity as comparted to Surgical Lung volume Reduction. We here present a Meta-analysis and systematic review of bronchoscopic lung volume reduction in advanced chronic obstructive lung disease patients.MethodsPubMed (NLM), Embase (Elsevier), and Web of Science (Clarivate Analytics) search was conducted using a combination of keywords and subject headings. The search was confined to the last 15 years and was completed on October 23, 2020. Only placebo-controlled randomized control trials of emphysema patients with EBV were included. Quality assessment was done by 2 independent reviewers.ResultsNine studies were included for the meta-analysis with a total number of 1383 patients of whom 888 received EBV and 495 standard of care (SOC) medications. Our Metanalysis show statistically significant improvement in forced expiratory volume in first second, percentage forced expiratory volume in first second, St. George's respiratory questionnaire, and 6-minute walk distance in EBV group compared with SOC. Residual volume had statistically significant reduction after EBV placement compared with SOC. These differences continued to be present during short-term (<=6 mo) and long-term follow-up (>=6 mo). These improvements were even higher when the EBV patients'. Collateral ventilation was negative/fissure was intact (CV-/FI >90%). The rate of hemoptysis and pneumothorax was higher in the EBV group compared with SOC, however, did not lead to increased fatal outcomes.ConclusionIn conclusion, EBV has favorable effects on patients' outcomes in patients who have heterogeneous emphysema particularly with no collateral ventilation.
Project description:IntroductionEndoscopic lung volume reduction (ELVR) aims to improve pulmonary function in severe emphysema. Physical activity (PA) coaching is expected to improve daily life PA. When improving ventilatory constrains in severe COPD, a better response to PA coaching is expected. The present study investigated the impact of PA coaching in addition to ELVR in severe emphysema.MethodsPatients allocated, based on fissure integrity, in the ELVR or no-ELVR cohort, received the PA coaching intervention with a step counter and smartphone application from 3 to 6 months follow-up. The primary end-point of this research question was the change in daily step count from baseline to 6 months follow-up compared between the ELVR and no-ELVR cohort. The secondary end-points were time spent in moderate to vigorous PA, movement intensity and patient-reported experience with PA between ELVR and no-ELVR.ResultsAt 6 months, PA in both ELVR+coaching (1479±460 steps·day-1; p=0.001) and no-ELVR+coaching (1910±663 steps·day-1; p=0.004) improved within group, without significant between-group differences (-405±781 steps·day-1; p=0.60). Patients in the ELVR group tended to experience less difficulty with PA compared to no-ELVR+coaching (7±4 points, p=0.08).ConclusionWe found that PA coaching is feasible and can help to enhance PA in patients with severe emphysema. Improving the ventilatory capacity through ELVR is not a prerequisite for a successful coaching intervention to increase objectively measured PA, although it alleviates patients' experienced difficulty with PA in those with severe COPD.
Project description:The lung volume reduction coil treatment is a minimally invasive bronchoscopic treatment option for emphysema patients who suffer from severe hyperinflation. The treatment is aimed at a large group of patients where lung volume reduction surgery and bronchoscopic lung volume reduction using endobronchial valves are no option, or alternatively, can be offered as a bridge to lung transplantation. The nitinol coil exhibits a shape memory effect and is biologically inert. The lung volume reduction coil procedure is performed in two separate treatment sessions, targeting one lobe per session, with the contralateral lobe being treated 4 to 8 weeks after the first session. In one treatment session, around 10 to 14 coils, thereby treating an entire lobe, are being placed. Selecting optimally treated, symptomatic chronic obstructive pulmonary disease (COPD) patients with emphysema and severe hyperinflation, while avoiding significant airway disease such as asthma, chronic bronchitis and bronchiectasis, is key to achieve treatment success. Three randomized clinical trials investigating lung volume reduction coil treatment have been published until now, reporting the results of 452 treated patients up to 12 months after coil treatment. Lung volume reduction coil treatment results in significant improvement of pulmonary function outcomes and quality of life in patients with severe hyperinflation. The most common complications of lung volume reduction coil treatment are: COPD exacerbations, pneumonia, Coil Associated Opacity and an increased risk of pneumothorax. The purpose of this article is to describe the coil technique and review the available literature regarding effect, safety and future perspectives of lung volume reduction with coils for emphysema patients.
Project description:BackgroundBronchoscopic lung volume reduction (BLVR), using biological agents, is one of the new alternatives to lung volume reduction surgery.ObjectivesTo evaluate efficacy and safety of biological BLVR using low cost agents including autologous blood and fibrin glue.MethodsEnrolled patients were divided into two groups: group A (seven patients) in which autologous blood was used and group B (eight patients) in which fibrin glue was used. The agents were injected through a triple lumen balloon catheter via fiberoptic bronchoscope. Changes in high resolution computerized tomography (HRCT) volumetry, pulmonary function tests, symptoms, and exercise capacity were evaluated at 12 weeks postprocedure as well as for complications.ResultsIn group A, at 12 weeks postprocedure, there was significant improvement in the mean value of HRCT volumetry and residual volume/total lung capacity (% predicted) (P-value: <0.001 and 0.038, respectively). In group B, there was significant improvement in the mean value of HRCT volumetry and (residual volume/total lung capacity % predicted) (P-value: 0.005 and 0.004, respectively). All patients tolerated the procedure with no mortality.ConclusionBLVR using autologous blood and locally prepared fibrin glue is a promising method for therapy of advanced emphysema in term of efficacy, safety as well as cost effectiveness.
Project description:Limited guidance exists for the implementation of lung volume reduction interventions in routine clinical care. We designed a pragmatic study to evaluate a strategy including endoscopic lung volume reduction (ELVR) and lung volume reduction surgery (LVRS) in heterogeneous emphysema. This prospective monocentre cohort study evaluated ELVR versus no-ELVR, followed by a cohort study evaluating LVRS. Primary outcome was the proportion of subjects with a forced expiratory volume in 1 s (FEV1) improvement of ⩾100 mL at 3-month follow-up. Changes in FEV1, residual volume (RV), 6-min walk distance (6MWD) and quality of life (St George's Respiratory Questionnaire (SGRQ)) were evaluated at 6-month follow-up. Hospital stay and treatment-related serious adverse events were monitored. From 106 subjects screened, 38 subjects were enrolled comparing ELVR (n=20) with no-ELVR (n=18). After 6 months' follow-up, eligible patients were referred for LVRS (n=16) with another 6-month follow-up. At 3-month follow-up, 70% of ELVR compared to 11% of no-ELVR (p<0.001) and 69% of LVRS had an FEV1 improvement of ⩾100 mL. Between-group differences (mean±sem) for ELVR versus no-ELVR at 6-month follow-up were FEV1 +0.21±0.05 L; RV -0.95±0.21 L; 6MWD 58±17 m and SGRQ -18±5 points. At 6-month follow-up, within-group differences (mean±sem) for LVRS showed FEV1 +0.27±0.06 L; RV -1.49±0.22 L and 6MWD +75±18 m. Serious adverse events in 81% versus 45% of subjects (p=0.04) and a median hospital stay of 15 versus 5 days (p<0.001) were observed for LVRS versus ELVR, respectively. This pragmatic prospective cohort study supports a clinical approach with ELVR as a less invasive first option and LVRS as powerful alternative in severe heterogeneous emphysema.