Berlin, Germany – Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) recently published a commissioned study that assessed the available surgical and bronchoscopic lung volume reduction options for patients with severe pulmonary emphysema. Uptake Medical’s recent randomized controlled trial (STEP-UP) of its Bronchoscopic Thermal Vapor Ablation (BTVA) InterVapor therapy was included in the German analysis.
The report included an analysis of patient relevant safety outcomes for each method analyzed. Of the bronchoscopic methods actively being used in Germany (vapor, EBV valves, IBV valves, and coils) vapor has the strongest safety profile. The comparison in Table 13 of the report concludes that coils and valves have “evidence [or] indication of harm to the treatment group as compared to the control group” in the category of “other adverse effects and complications of therapy.” This is related to the high rates pneumothorax, hemoptysis, and other complications following successful LVR in valve and coil patients. In the same category, vapor is concluded to have “no indication of harm”. This is due to the appreciably lower rate of pneumothorax and other severe complications following BTVA. In the other categories of safety comparison there are also “no indications of harm” or the effect is comparable to the other methods for the BTVA therapy.
Additionally, the report shows that BTVA has “evidence of benefit” in the quality of life category of the comparison table.
STEP-UP RCT Principle Investigator Prof Felix Herth, Thoraxklinik Heidelberg, Germany stated “This report further validates the STEP-UP trial results which showed an improvement to the side effect profile of BTVA by treating individual segments in a more targeted and staged step-wise manner, while maintaining the strong functional improvements seen in pulmonary function and quality life from previous lobar only approach trials. The report indicates that BTVA vapor has the safest bronchoscopic lung volume reduction profile on the market in Germany, thanks in large part to its low risk of pneumothorax or other major medical complications.” BTVA is also the only technology that allows physicians to tailor the treatment to each patient. The physician can target the most diseased lung segments over multiple procedures, thus creating a personalized treatment for the patient to achieve a clinically significant improvement in pulmonary function and quality of life.