First in human experience of placement of a new size endobronchial valve 5.5LP

Abstract

Introduction: Bronchoscopic Lung Volume Reduction using Zephyr® 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 full occlusion of the target lobe. While 3 EBV sizes (4.0;4.0LP;5.5) are currently available to accommodate all airway sizes, local anatomical variations sometimes warrant a wide but shorter valve. To address this, a new ‘low profile’ 5.5LP EBV has been introduced. Aim: We evaluated feasibility, safety and efficacy of this 5.5LP EBV. Method: 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 EBV5.5LP to achieve complete lobar occlusion. Feasibility of placement of the EBV5.5LP was reported. Safety, CT and PFT were assessed at baseline and 45day post treatment. Results: Fourteen patients (FEV1 27±10%;RV 254±39%) were included. Besides the regular EBV sizes, the 5.5LP EBV were placed into the segments: RB(2), RB6(3), RB9/10(1), LB3(1),LB6(7),LB8-10(3). No valve adjustment was needed, no dislocation occurred up to 45 day post treatment. One asymptomatic small pneumothorax was observed. See figure for procedure and efficacy. Conclusion: In this first in human study the 5.5LP EBV was feasible and could be placed into wide segments with a shorter landing space without complications and with good efficacy outcomes.