According to research published in AJRCCM, Zephyr Endobronchial Valve (EBV) treatment “results in clinically meaningful and statistically significant benefits in lung function, dyspnea, exercise tolerance and quality of life over current standard of care medical therapy” when used in heterogeneous emphysema patients with hyperinflation and no collateral ventilation in the target lung lobe. The results were announced by EBV manufacturer Pulmonx Inc.
The TRANSFORM trial was conducted at 17 centers in six European countries and enrolled 97 patients with heterogeneous emphysema and no collateral ventilation in the target lobe, as determined by the company’s Chartis System. Patients were randomized 2:1 to Zephyr EBV treatment versus optimal medical therapy.
The study met its primary endpoint, with 67 percent of patients having a 12 percent or greater improvement in lung function (FEV1) at three months in the per protocol group, compared to seven percent in the control group. In the intention-to-treat population at six months, Zephyr EBV patients experienced clinically and statistically greater improvements over the control group across multiple outcome measures, including lung function (29.3 percent increase in FEV1), exercise capacity (78.7m increase in 6MWD), and quality of life (6.5 point decrease in SGRQ score). A majority of EBV patients had an improvement of one or more points in the BODE index, an aggregate measure of health status, which has been associated with a significant decrease in mortality in this population.
Patients in the control arm were allowed to cross over to Zephyr EBV treatment at six months, if desired; 94% of control patients opted for Zephyr treatment following their assessments at six months.
The authors conclude that, “Benefits are in line with those seen with LVRS (lung volume reduction surgery), and the consistent trial results, potential reduction in post-procedure morbidity, and reversibility of the procedure position Zephyr EBV as a viable treatment option in those who remain symptomatic on maximal medical therapy.”