A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).

RATIONALE: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. OBJECTIVES: To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation. METHODS: This was a prospective, multicenter 2:1 randomized controlled trial of EBVs plus standard of care or standard of care alone (SoC). Primary outcome at 3 months post-procedure was the percentage of subjects with FEV1 improvement from baseline of 12% or greater. Changes in FEV1, residual volume, 6-minute-walk distance, St. George's Respiratory Questionnaire score, and modified Medical Research Council score were assessed at 3 and 6 months, and target lobe volume reduction on chest computed tomography at 3 months. MEASUREMENTS AND MAIN RESULTS: Ninety seven subjects were randomized to EBV (n = 65) or SoC (n = 32). At 3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV1 improvement of 12% or more (P < 0.001). Improvements were maintained at 6 months: EBV 56.3% versus SoC 3.2% (P < 0.001), with a mean ± SD change in FEV1 at 6 months of 20.7 ± 29.6% and -8.6 ± 13.0%, respectively. A total of 89.8% of EBV subjects had target lobe volume reduction greater than or equal to 350 ml, mean 1.09 ± 0.62 L (P < 0.001). Between-group differences for changes at 6 months were statistically and clinically significant: ΔEBV-SoC for residual volume, -700 ml; 6-minute-walk distance, +78.7 m; St. George's Respiratory Questionnaire score, -6.5 points; modified Medical Research Council dyspnea score, -0.6 points; and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, -1.8 points (all P < 0.05). Pneumothorax was the most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects. CONCLUSIONS: EBV treatment in hyperinflated patients with heterogeneous emphysema without collateral ventilation resulted in clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT02022683).

Long-Term Follow-Up of Intralobar Bullae After Endobronchial Valve Treatment for Emphysema.

Endoscopic lung volume reduction using unidirectional endobronchial valves is a new technique in the treatment of patients with severe emphysema. However, the movements of the thoracic structures after endobronchial valves insertion are still unpredictable We report the unusual outcome of six patients after valves insertion in the left upper lobe. They all developed a complete atelectasis of the target lobe, a pneumothorax and sequential genuine bullae in the treated left lung of unknown etiology. The chest CT scan prior to the valves insertion was unremarkable. Three patients developed an air-liquid level in the bullae the day before a bacterial infection of their left lower lobe. The three other patients had an uneventful spontaneous resolution of their bullae at long-term follow-up. Therefore, a conservative attitude should be followed in this particular setting.

Clinical implementation of value based healthcare: Impact on outcomes for lung cancer patients.

Value based Healthcare (VBHC) focuses on patient centered outcomes, by incorporating Patient Reported Outcome Measures (PROMS). Expectations on the benefits of VBHC are high, but few data are available that validate its routine use. We wanted to investigate if VBHC is feasible and beneficial for lung cancer patients in clinical practice. METHOD: We developed a digital transmural care pathway for lung cancer patients. During systemic therapy, patients digitally reported side effects weekly. Every six weeks, quality of life was reported trough EORTC questionnaires. Case-mix variables, treatment approaches and outcome indicators were systematically collected. We evaluated the compliance of the patients with the digitally reporting system and the impact of the care pathway on patient centered outcomes such as emergency department (ED) visits, time spent on the oncology day clinic, survival and quality of death. RESULTS: 221 lung cancer patients were included in the care pathway. 3091 weekly questionnaires were digitally collected. Compliance with the weekly digital follow-up was 92%: 2835 of 3091 questionnaires were completed. Patients in the care pathway had significantly less ED visits (3.5% vs 4.8%, p 0.04) and a shorter length of stay at the day clinic (2.5 h vs 4.1 h, p < 0,05) compared to routine clinical care. In stage IV lung cancer patients, overall survival was significantly higher in the care pathway (447 days (95% CI 379-663)) compared to routine care (286 days (95% CI 191-400)) (p = 0,025). CONCLUSION: Implementation of value based healthcare is feasible and beneficial in daily clinical care for lung cancer patients.

Treatment of persistent air leak with endobronchial valves.

Persistent pulmonary air leaks are usually treated conservatively with prolonged thoracostomy tube drainage. In case this approach fails, surgical revision used to be the only option. This case report describes the successful treatment of a 66-year old patient who developped a pulmonary air leak after cardiothoracic surgery that persisted despite attempted surgical repair and talc pleurodesis. The treatment was successfully completed with endobronchial valves thereby demonstrating that treatment with endobronchial valves doesn't only represent an alternative to surgery, but that it can also be successful in case surgical intervention fails.

Performance of fully covered self-expanding metallic stents in benign airway strictures.

BACKGROUND: Airway stenting has become a common technique in inoperable benign strictures. An ideal stent does not yet exist for these conditions. Recently, fully covered self-expandable metallic stents (SEMS) have been commercialized with potential use in benign airway strictures. OBJECTIVE: We retrospectively reviewed the clinical effectiveness of fully covered SEMS in the management of benign strictures. METHODS: A total of 17 patients received 20 stents: 7 Silmet, 8 Taewoong and 5 Alveolus stents. Ten stents were deployed in a structural postintubation tracheal stenosis. Other indications were multinodular goiter, anastomotic stricture, endobronchial posttuberculosis scar, damaged cartilage and relapsing polychondritis. RESULTS: In our series, the short-term (<12 weeks after stent deployment) complication rate was 75%, requiring stent removal in 60%. Overall, stent migration was observed in 65%, stent fracture in 15%, shriveling of the stent in 10% and granulation formation in 10%. CONCLUSION: The use of fully covered SEMS for the treatment of benign airway strictures is associated with a high short-term complication rate requiring stent removal. We have abandoned in our clinical practice the use of fully covered SEMS for benign airway strictures.

[Placement of one-way endobronchial valves to treat severe pulmonary emphysema in an 84-year-old]. / Ernstig longemfyseem bij een 84-jarige behandeld door endobronchiale plaatsing van éénrichtingsklepjes.

An 84-year-old man with end-stage emphysema was hospitalised on two occasions because of an episode of severe COPD exacerbation, each time successfully treated in a classical pharmacological manner. Further analysis of a high-resolution CT chest scan revealed very pronounced destruction of the lung parenchyma in the left lower lobe. Moreover, the degree of destruction in the left lung was of a highly heterogeneous nature and fissure analysis revealed a complete left major fissure. After carefully weighing up the costs against the benefits, two one-way valves of different sizes were implanted in the orifices of the left lower lobe using video bronchoscopy. This intervention had a very satisfactory outcome with positive changes in the lung function parameters, imaging studies and quality of life. The inevitable placement in a nursing home could consequently be postponed and, at follow-up one year later, no exacerbation or pneumonia had developed since the intervention.