The Spiration Valve System (SVS) was associated with improved lung function and quality of life (QOL) at 24 months in patients with severe emphysema, according to study findings published in the Annals of the American Thoracic Society.
The study authors reported 24-month follow-up data from the prospective, randomized controlled EMPROVE trial (ClinicalTrials.gov Identifier: NCT01812447), which compared the efficacy and safety of SVS to standard care for emphysema. Outcomes evaluated included lung function, dyspnea, and QOL.
SVS, a novel, minimally invasive therapy for severe emphysema developed by the Olympus Corporation, blocks inhaled airflow using a “flexible umbrella, thereby allowing bronchoscopic placement in selected airway regions and restricting airflow to the distal portions of the lungs affected by emphysema,” said study authors.
EMPROVE was conducted at 31 sites in the US and Canada from October 8, 2013, to December 16, 2019. The participants were at least 40 years of age and had severe heterogeneous emphysema with little to no collateral ventilation. Efficacy was evaluated at 24 months. The primary outcome was forced expiratory volume in 1 second (FEV1).
“
The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months.
A total of 476 valves (mean [SD] number per patient, 3.83 [1.48]) were implanted with a mean procedural time of 24.3 minutes. After the 24-month follow-up, 80 patients in the SVS treatment group (81.6% of total cohort; mean age, 65.1 [6.3] years; 51% female) and 34 patients in the standard-of-care control group (77.3% of total cohort; mean age, 66.7 [6.4] years; 59% male) had data for evaluation.
A significant (P =.01) improvement in FEV1 at 24 months was observed in the SVS treatment group (mean change, 0.005 [0.163] L; n=71) compared with the control group (mean change, −0.082 [0.156] L; n=30). In the SVS treatment group, 19.7% (14/71) of patients showed an FEV1 response (defined as ≥15% improvement) at 24 months, although it was not statistically significant vs the control group (P =.57).
Significant differences continued through 24 months in QOL measures, including the St. George’s Respiratory Questionnaire (SGRQ; P =.03) and COPD Assessment Test (CAT; P =.03). The mean change on the SGRQ total score for the SVS treatment cohort (n=78) was −2.802 (−14.781) points vs the control cohort (n=33) score of 4.187 (14.339) points. The mean change in CAT score was −0.355 (7.825) for the SVS group (n=78) vs 2.346 (4.694) for the control group (n = 31).
A mean change in the modified Medical Research Council (mMRC) Dyspnea Scale of −0.378 (1.069) was seen in the treatment group (n=74) vs a change of 0.226 (0.617) points in the control group (n=31), with a significant difference noted between groups (P =.001).
From 12 to 24 months, the pneumothorax rate was 1.0% (1/102) in the treatment group and 0.0% (0/45) in the control group. At 24 months, acute COPD exacerbations occurred in 13.7% (14/102) of treatment group participants and 15.6% (7/45) of control group participants. No unexpected serious adverse events associated with the device occurred. Mortality rates at 24 months in the treatment and control groups were 18% and 15%, respectively (P =.81)
A potential study limitation is the unblinded study design, which may affect patient-reported parameters, such as QOL scores.
“The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months,” the investigators concluded. “The safety profile remains satisfactory, with minimal device-related issues in this longer follow-up period.”
Disclosure: This study was funded by Olympus Corporation, maker of the Spiration Valve System. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
