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Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. | LitMetric

AI Article Synopsis

  • A multicenter trial assessed the Spiration Valve System (SVS) against standard medical care for treating severe emphysema in patients aged 40 and older.
  • The study found that the SVS led to significant improvements in lung function (FEV) and other health measures after 6 and 12 months, although it increased the risk of serious adverse events, particularly pneumothorax.
  • Overall, while SVS showed effective results for managing severe emphysema, the safety concerns highlighted the need for careful patient monitoring.

Article Abstract

Less invasive, nonsurgical approaches are needed to treat severe emphysema. To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management. In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). The primary efficacy outcome was the difference in mean FEV from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment ( = 113) or control ( = 59). Mean FEV showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060-0.141) and 0.099 L (95% BCI, 0.048-0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax. In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6884033PMC
http://dx.doi.org/10.1164/rccm.201902-0383OCDOI Listing

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