Long-Term Follow-up of Severe Emphysema Patients Treated with Zephyr Valves in the Multicenter, Randomized TRANSFORM Study

Abstract

Background: Six-month outcomes in the TRANSFORM Study, the first multicenter RCT evaluating the effectiveness of Zephyr Valves in patients with heterogeneous emphysema and prospectively identified for absence of collateral ventilation in target lobe have been reported 1. Zephyr valve treated patients were followed out to 24-months. Aims and Objectives: Determine the long-term clinical outcomes and safety profile of Zephyr Valve treated patients out to 24-months and long-term results have not been previously reported. Methods: 97 patients (58Male/39Female; mean age, 64.3±7.4yrs) with hyperinflation and severe heterogeneous emphysema confirmed by quantitative HRCT and FEV1, 30.5±8.9 % pred., RV, 246.6±48.5% pred.; and TLC, 138.4±17.0 % pred. were randomized (2:1) to Zephyr Valve treatment plus optimal medical management (n=65) or optimal medical management alone (n=32) after confirmation of absence of collateral ventilation using Chartis. Control group patients exited the study after the 6-month evaluation (data previously reported 1), and Zephyr Valve treated patients were followed out to 24-months. Results: Patients with complete data (no imputations) at 12- months (n=48), 18-months (n=40), and 24-months (n=39) were included in the analysis. Clinically and statistically significant improvements over Baseline were maintained out to 18 months for FEV1, SGRQ, 6MWD, RV and BODE Index, and for FEV1 (percent change), SGRQ, and RV at 24-months (see table below). During the period beyond 6-months out to 24-months the most common adverse event was COPD exacerbation. There were 8 deaths during the 6- to 24-month period that were all deemed to be “Not related” to the Zephyr Valves (cardiac arrest, 3; myocardial infarction, 1; pneumonia, 2; end stage respiratory disease, 1; and hemoptysis in contralateral lung, 1). Conclusions: Zephyr Valve treatment in patients with severe heterogenous emphysema provides durable reduction in hyperinflation out to at least 24-months with resultant improvements in lung function, quality of life and exercise capacity out to at least 18-months, and for lung function and quality of life out to at least 24-months with an acceptable safety profile. These improvements in clinical outcomes are contrasted by an expected decrease in these measures over 24 months given the degenerative nature of this disease.