Home > Pulmonology > ERS 2022 > Focus on Interventional Pulmonology > Durable effect of endobronchial valves in severe emphysema 

Durable effect of endobronchial valves in severe emphysema 

Presented by
Prof. Gerard Criner, Temple University, PA, USA
Conference
ERS 2022
Trial
EMPROVE
Doi
https://doi.org/10.55788/ef938102

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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