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The Coming of Age of Endoscopic Lung Volume Reduction.

T. Toma

Published 2019 in Journal of Bronchology & Interventional Pulmonology

ABSTRACT

O n June 29, 2018, the Food and Drug Administration (FDA) from United States approved the Zephyr valve for the treatment of breathing difficulty associated with severe emphysema (www.accessdata.fda.gov/cdrh_docs/ pdf18/P180002a.pdf). It happened almost 15 years after the first publication of a case series suggesting that lung volume reduction can be achieved with bronchoscopically placed valve implants in patients with severe emphysema, with acceptable short-term safety and worthwhile functional benefits.1 This is an important milestone after a long period of waiting for patients with severe shortness of breath for a new treatment that can help their symptoms, but, in the era of evidence-based medicine and strict regulations, we need to be absolutely sure that the treatment works and is not harmful. Was it worth the wait? Zephyr valves are the most studied devices for endoscopic lung volume reduction (ELVR), but are not the only devices for treating symptoms in chronic obstructive pulmonary disease (COPD) patients. The initial observations of safety with Zephyr valves, the need for new emphysema treatments, and the creativity of startup device companies open up the possibility of diversifying the ELVR options to different valves, coils, spigots, steam, and glue —all commercial ventures funded by the US capital market. Very recently, on December 5, 2018, the FDA announced the approval of Spiration valve system for the treatment of severe emphysema, which is similar to Zephyr technology, but with a differently designed valve. However, treatments for severe emphysema remain very limited (www.prnewswire.com/news-releases/ olympus-spiration-valve-system-is-fda-approved-for-the-endobronchial-treatmentof-emphysema-300760510.html). FDA approves devices based on clear, mathematical evidence on patient selection, safety, and benefit, and this can only come from a large volume of information and large randomized trials. But for these trials to be successful and relevant, we need to first have a clear understanding of the procedure. The failure of the VENT trial to convince FDA to approve Zephyr valves for endoscopic treatment in 2010 is a reminder, both for medics and for venture capitalist investors, of the risks of perhaps going too early into an expensive randomized trial.2 One needs to know first how the procedure should be correctly performed, who would benefit most, and what are the most relevant outcome measures. This information usually comes from case series, retrospective analyses, and meta-analyses. Meta-analyses are studies that sum multiple studies and pool the data with the major benefit that they can offer a more powerful evidence by a higher statistical power than is not possible from individual studies. Studies of

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