Durable effect of endobronchial valves in severe emphysema 

The randomised-controlled EMPROVE trial demonstrated long-term added clinical benefits of bronchoscopic placement of endobronchial one-way valves with the Spiration® Valve System (SVS) over medical management alone in treating hyperinflation in patients with severe heterogenous emphysema.

Minimally-invasive, bronchoscopic placement of endobronchial one-way valves has been demonstrated to improve pulmonary function, reduce hyperinflation, and improve dyspnoea severity in patients with COPD and emphysema [1]. However, it is not established whether this treatment is superior to ‘no intervention’ in the long term. The EMPROVE trial (NCT01812447) randomised 174 patients with severe, heterogenous emphysema 2:1 to active treatment with the SVS on top of medical management or to medical management alone. Assessed were several quality-of-life endpoints to compare the 2 arms of the trial. The positive primary results of the trial were published in 2019 [2]. Prof. Gerard Criner (Temple University, PA, USA) presented the results after 24 months of follow-up [3].

The results displayed significant benefits of the intervention arm over the control arm in terms of severe dyspnoea (P<0.01), St. George’s Respiratory Questionnaire (SGRQ) total score (P<0.05), the COPD assessment test score (P<0.05), and forced expiratory volume in 1 second (FEV₁) (P<0.05). Although the intervention arm was associated with a higher rate of serious adverse events in the short term (0–6 months; 28.3% vs 8.5%; P=0.003), this pattern was no longer significant in the long term (12–24 months; 29.6% vs 20.5%; P=0.309), indicating durability of the procedure.

“The EMPROVE trial demonstrated that SVS treatment provides a long-term clinical benefit in disease-specific, health-related quality-of-life, dyspnoea, and lung function in patients with severe heterogenous emphysema,” concluded Prof. Criner.

1. Hartman JE, et al. Eur Respir Rev.2019;28(152):180121.
2. Criner GJ, et al. Am J Respir Crit Care Med. 2019; 200(11):1354–1362.
3. Criner GJ, et al. Sustained health-related quality of life in patients with severe heterogenous emphysema treated with spiration valve system at 24-month follow-up (EMPROVE). ALERT 4, RCT4449, ERS International Congress 2022, Barcelona, Spain, 4–6 September.

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Posted on 30 October 2022