First in Human Experience of the Performance of the New 5.5-LP Size Zephyr Endobronchial Valve

BACKGROUND: Bronchoscopic lung volume reduction using the Zephyr® endobronchial valve (EBV) is a guideline treatment for patients with advanced emphysema. To achieve volume reduction, it is crucial that there is absence of collateral ventilation and a complete occlusion of the target lobe. While 3 EBV sizes (4.0; 4.0-LP; and 5.5) are currently available to accommodate all airway sizes, local anatomical variations sometimes warrant a valve with a wide diameter but shorter length. To address this, a new "low profile" 5.5-LP EBV has been introduced.

OBJECTIVE: In this study, we evaluated the feasibility, safety, and efficacy of this new 5.5-LP EBV.

METHODS: This was a single-center, prospective, open-label study. Patients were included if eligible for valve treatment with a local anatomy suitable to place at least one 5.5-LP EBV. Feasibility of placement of the 5.5-LP EBV was reported. Safety, CT parameters, pulmonary function tests, and St. George's Respiratory Questionnaire (SGRQ) were assessed at baseline and 6 weeks after treatment.

RESULTS: We included 30 patients with severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s [FEV1] 29 ± 10%; [RV] 242 ± 46%; and SGRQ 56 ± 11 points). Besides the regular EBV sizes, a median of 1 (1-3) of the new 5.5-LP EBV was placed. No valve adjustment was needed during the initial procedure. A single asymptomatic small pneumothorax was observed in 1 patient. In 4 patients, a revision bronchoscopy was performed due to absence of clinical benefit. In 1 patient, this was related to a dislocation of the 5.5-LP EBV. Clinically relevant improvements were seen in target lobar volume reduction (-1,554 mL), FEV1 +39%, RV -960 mL, and SGRQ -18 points.

CONCLUSIONS: In this first in human study, the 5.5-LP EBV could be placed into wide segments with a shorter landing length without unexpected complications and with good efficacy outcomes.