Expert review of medical devices · 2021
Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy.
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Verga Steven R, Criner Gerard J
Аннотация
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).
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).