Zephyr® valves system in the treatment of emphysema: A single technology assessment

• Main Authors: Chaudhry, Fawaz Tariq, Gomez Castaneda, Monica, Næss, Gunn Eva, Brurberg, Kjetil Gundro
• Format: Report
• Language: English
• Subjects: Behandlingsresultat; Bronchoscopy; Bronkoskopi; Emfysem; Emphysema; Kols; Lungeemfysem; Pneumothorax; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Treatment Outcome

Background Chronic obstructive pulmonary disease (COPD) is a collective term for a group of chronic lung diseases that leads to obstructed airflow through an individual’s airways and causes permanent impaired lung function. One of these diseases is emphysema, which causes the alveoli in the lungs to lose surface area and elasticity. Reduced surface area reduced the gas exchange, and reduced elasticity prevents the lung from fully emptying the air, leading to hyperinflation. There is no curative treatment for COPD, however, smoke cessation, symptomatic medication, training, and lung rehabilitation can slow down further exacerbations and loss of lung function. In specific cases, the use of endobronchial valves may be considered as a surgical alternative in some patients with severe or very severe emphysema. The Zephyr® Valve system is a type of endobronchial valve that is implanted during bronchoscopy. The valve is intended to selectively shut off air supply to an affected area while trapped air can escape. The affected area of the lung will then collapse fully or partially, freeing up space so that healthier parts of the lung have more room to expand. The Division for Health Services at the Norwegian Institute of Public Health (NIPH) was commissioned by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway to conduct a single health technology assessment of Zephyr® valve system for patients with severe or very severe emphysema. Objective The manufacturer, PULMONX submitted a single-technology assessment (STA) of Zephyr® valve system to the Norwegian Institute of Public Health for evaluation of effect, safety, and health economics. The present report is an appraisal of this STA. Method We used the documentation provided by the manufacturer. The literature search was checked by two librarians at NIPH. The manufacturer did not report whether they used independent screening and data extraction. We used the risk of bias assessments provided by the manufacturer. The manufacturer did not use GRADE, but we have graded the evidence. One researcher did the GRADE assessments, and another researcher checked the assessments. We categorized the certainty of evidence as high (⨁⨁⨁⨁), moderate (⨁⨁⨁◯), low (⨁⨁◯◯) or very low (⨁◯◯◯) according to GRADE. According to information in the submission file , the following databases were searched in April 2020: MEDLINE, EMBASE, Cochrane (CENTRAL) and ClinicalTrials.gov.