NEW YORK (Reuters Health) – Patients with pulmonary hyperinflation due to advanced emphysema have a modest improvement in lung function and exercise tolerance after placement of endobronchial valves to reduce lobar volume. However, they also experience more frequent exacerbations, hemoptysis and pneumonia, according to trial results published in the New England Journal of Medicine for September 23.
The authors explain that uncontrolled trials have indicated that one-way valves placed in lung airways to block regional inflation while allowing exhalation produce benefits in emphysema patients.
In the current randomized study — the Endobronchial Valve for Emphysema Palliation Trial (VENT) — Dr. Frank C. Sciurba at the University of Pittsburgh School of Medicine, Pennsylvania, and colleagues compared endobronchial valves against standard medical care in 321 patients with advanced emphysema.
Valves were inserted in one lobe in 220 of the patients. At 6 months, the mean absolute percent change in FEV1 was +4.3% in the valve group and -2.5% in the standard-care control group (p=0.005). Similarly, the median absolute percent change in distance on the 6-minute walk test was +2.5% and -3.2% in the two groups, respectively (p=0.04).
However, the team found, “At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, p=0.03) and hemoptysis (6.1% vs. 0%, p=0.01).”
The primary safety end point was a composite of six major complications at 6 months — death, empyema, massive hemoptysis, pneumonia distal to valves, pneumothorax or air leak, or ventilator-dependent respiratory failure. The rate was 6.1% in the valve group and 1.2% in the control group (p=0.08),
Dr. Sciurba and colleagues conclude that endobronchial valves produced modest improvements, but “these benefits came at a cost.”
Nonetheless, the team did identify a subgroup that appeared to benefit most — those with greater heterogeneity of emphysema between lobes and intact interlobar fissures.
In an accompanying editorial, Dr. Antonio Anzueto, from the University of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care Center, San Antonio, points to several limitations of the study and advises that “it is premature to recommend the routine use of endobronchial valves in patients with COPD.”
N Engl J Med 2010;363:1233-1244,1280-1281.
