12-month results confirm thermal vapor ablation benefit in emphysema

By Reuters Staff

NEW YORK (Reuters Health) - Thermal vapor ablation for lung volume reduction in emphysema improves lung function and quality of life, 12-month results from the STEP-UP study confirm.

"Compared with standard medical management, targeted thermal vapour ablation of more diseased segments and preservation of less diseased segments resulted in clinically meaningful and statistically significant improvements in lung function and quality of life at 6 months and 12 months, with an acceptable safety profile," Dr. Pallav Shah of the National Institute for Health Research Respiratory Biomedical Research Unit at Royal Brompton in London and colleagues report in The Lancet Respiratory Medicine, online July 20.

The six-month results from the trial appear in the March issue of the same journal (http://bit.ly/1oYzpEI).

Lung volume reduction for emphysema can improve quality of life and pulmonary function, but is not widely used, likely due to high mortality and morbidity from the procedure, the researchers note.

Non-surgical techniques such as valve implantation and coil implantation are less risky, they add, but require treating an entire lobe at once, even though a lobe will often contain healthy as well as diseased tissue. Valve implants may also not adequately reduce volume when there is collateral ventilation due to incomplete fissures.

Early studies with vapor ablation suggested that treating a greater volume of lung per session led to more severe serious adverse events (SAEs), the researchers note. To address this concern, they developed a segmented approach allowing a smaller volume to be treated per session.

In the STEP-UP trial, Dr. Shah and colleagues randomly assigned 45 patients to treatment and 24 to usual care. Treatment involved ablating the most diseased segments of one upper lobe, and treating the contralateral lobe 13 weeks later.

At six months, forced expiratory volume in one second (FEV1) showed a 14.7% greater improvement from baseline in treated patients (p<0.0001), while the between-group difference at 12 months was 12.8% (p=0.0039). Improvement based on the Saint George's respiratory questionnaire was 9.7 points greater in the treatment group at six months (p=0.0021), and 12.1 points greater at 12 months (p=0.0021).

There was a mean reduction of 237 ml in residual volume among treated vs. control patients at 12 months, the study's secondary endpoint. However, there were no between-group differences in 6-minute walk test performance.

Twenty-four respiratory-related SAEs occurred, 17 within 90 days of treatment. Three patients in the treatment group had SAEs possibly related to treatment, including one case of pneumonia, one case of hemoptysis, and one death. From 90 to 360 days of treatment, the rate of respiratory-related SAEs was similar for the treatment and control groups.

"These 12 month controlled results reinforce the conclusion of the original manuscript," Dr. Shah and colleagues conclude.

Uptake Medical, which developed the therapy used in STEP-UP, funded the trial. Dr. Shah was not available for an interview by press time.

SOURCE: http://bit.ly/2arG034

Lancet Respir Med 2016.

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