Researchers found that selective treatment with vapor ablation improved forced expiratory volume in 1 second (FEV1) and respiratory questionnaire scores in emphysema patients.
The research team, led by Professor Felix J. F. Herth, MD, of the department of pneumology and critical care medicine at Thoraxklinik, University of Heidelberg, designed and conducted a multicentre, parallel-group, randomized, controlled, open-label clinical trial — the Sequential Staged Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial (NCT01719263).
The clinical trial included 70 adult patients, ages 45-75, with severe upper lobe-predominant emphysema. Patients were randomly assigned — 46 to the segmental vapor ablation treatment group, and 24 to the control group, where patients received standard medical management.
The results indicated that the mean relative improvement in FEV1 between the treatment group versus the control group was 14.7 percent. The most common adverse event reported was chronic obstructive pulmonary disease (COPD) exacerbation, which occurred in 11 of 45 patients (24 percent) in the treatment group and one of 24 (4 percent) in the control group. One patient died 84 days after treatment due to an exacerbation, which the data and safety monitoring board ruled to be possibly related to treatment. Neither group experienced an occurrence of pneumothorax.