Supplementary Material for: Lung tensioning device coil treatment in patients with severe emphysema: a prospective safety and feasibility trial (EFFORT)

Introduction: Currently, there is a lack of bronchoscopic lung volume reduction options that do not depend on fissure integrity. Endobronchial coils have been extensively studied to address this need, but exhibited variable patient response and have been discontinued. Lung Tension Device (LTD) coils represent the next-generation coil treatment. This study aimed to evaluate safety, feasibility, and efficacy of LTD-coil treatment. Methods: Patients with advanced emphysema and hyperinflation were enrolled at two European sites. LTD-coils (FreeFlow Medical, CA, USA) were implanted in the two most destructed lobes, as determined by quantitative CT analysis, in two separate procedures. The primary endpoint was 3-month follow-up after the last treatment. Results: Fourteen patients (50% male, median age 64 years, FEV1 23%predicted, RV 249%predicted) received LTD-coil treatment: 12 received bilateral and 2 unilateral treatment. Six serious respiratory adverse events occurred within the initial 3 months post-treatment, including one device-associated death. Treatment significantly reduced in- and expiratory volume of the treated lobes (-410[-710,-340], p=.004 and -650[-730,-190] mL, p