Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study

Abstract

Severe emphysema is a difficult to treat condition with limited efficacy of currently available treatments. Endobronchial coil treatment (ECT) is a minimally invasive endobronchial treatment which consists of placing shape-memory nitinol coils in emphysematous lobes to enhance lung recoil and reduce lung hyperinflation at rest and during exercise [1, 2]. Randomised studies demonstrated an improvement in exercise capacity, lung function and quality of life, and showed an acceptable safety profile at 1 year [3][4][5][6]. However, to our best knowledge, longer term safety and effectiveness results beyond 1 year have not been reported thus far. REVOLENS (Réduction volumique endobronchique par spirales) (NCT01822795) is a 1:1 randomised controlled study of 100 patients (50 patients treated with coils and optimal medical management and 50 patients treated with optimal medical management only) in 10 centres across France. Patients treated with optimal medical management only were offered coil treatment after 1 year. The study protocol [7] and 1-year results [5] of the REVOLENS study have been previously described, demonstrating a decrease in lung hyperinflation and improvement in quality of life. In the present study, we analysed efficacy and safety data at 2 years in the 50 patients randomised to the ECT group. The ethics committee of Dijon Est I and the French Agency for Medicines and Health Products Health approved the study protocol. Among 50 patients treated by ECT, vital status at 2 years was determined for 49 patients. Four patients died within the first year (one each from peritonitis, mesenteric ischaemia, and chronic obstructive pulmonary disease (COPD) exacerbation; one cause was undetermined) and two patients died within the second year (one from COPD exacerbation and the other from undetermined causes). One patient underwent lung transplantation within the second year. 32 patients attended the 2-year follow-up visit and 11 patients did not. Patients who died or underwent lung transplantation within 2 years (n=7) had lower body mass index (23±4 versus 19±3 kg•m −2 , p=0.03) and forced expiratory volume in 1 s (FEV1) (27±7 versus 20±4%, p=0.02) and higher residual volume (RV)/total lung capacity ratio (0.69±0.06 versus 0.75±0.05, p=0.03) at baseline, respectively, than those who attended the 2-year follow-up visit (n=32). We also analysed the baseline Saint George's Respiratory Questionnaire (SGRQ) in patients who did not attend the 2-year follow-up (n=11) and found a higher score indicating worse quality of life (70±10 versus 58±12, p=0.04). Changes from baseline at 6 months, 1 year and 2 years are shown in table 1. The 6-month and 1-year results were comparable for the overall group and for the group of patients attending the 2-year follow-up visit. At 2 years, both RV and SGRQ improvements remained significant, whereas the 6-min walking test (6MWT), modified Medical Research Council dyspnoea scale, and FEV1 were not statistically different from baseline. While 45 serious adverse events (SAEs) occurred in 2...

Importance of bronchoscopic lung volume reduction coil therapy in potential candidates for lung transplantation

“…In addition, the fewer number of donor lungs available can be used for transplantation in those with more serious diseases. BLVR coil therapy has been increasingly used in recent years, and studies have shown improvement in 6-MWT, PFT parameters, and quality of life with this treatment (11,12,(18)(19)(20)(21)(22)(23)(24)(25)(26). This treatment method is an alternative and effective treatment option for emphysema patients.…”

“…This treatment method is an alternative and effective treatment option for emphysema patients. The most recent and largest studies are the REVOLENS study and the RENEW study (11,24). In these studies, 50 patients and 158 patients were treated with BLVR coil therapy, respectively.…”

“…Patients who were treated for BLVR coil treatment in the Department of Pneumology of the Şifa University Hospital, Bornova-Izmir, Turkey were included in the study. The inclusion and exclusion criteria were similar to those of some of the recent studies in the literature (6,7,11,12). Inclusion criteria were as follows: (i) bilateral emphysema diagnosed by CT; (ii) postbronchodilator (salbutamol) FEV 1 of 15-45%; (iii) RV > 175%; (iv) arterial partial pressure of carbon dioxide (PaCO 2 ) < 55 mmHg; (v) 6-MWT: 150-450 m; (vi) modified Medical Research Council scores ≥ 2; (vii) smoking cessation for > 8 weeks before treatment.…”

“…Studies have shown that this treatment is useful and safe in the short and medium term (6,7). Furthermore, improvements in quality of life, 6-minute walk test (6-MWT), and pulmonary function tests (PFT) were reported in recent studies (7,11,12). In addition, these treatments were also applied to patients who were potential candidates for lung transplantation, with very low FEV 1 values.…”

Lung Volume Reduction in Pulmonary Emphysema

“…A 2-year followup confirms durable benefits in volume reduction, QoL, and safety profile. 56 RENEW in 2016 is the largest multicenter, randomized controlled, assessor-blinded, study of 315 patients with severe emphysema (heterogeneous and homogeneous using a semiquantitative visual assessment) and hyperinflation comparing bilobar coil implantation (n ¼ 158) to SoC (n ¼ 157). 57 LVRCs were implanted in one lobe of each lung in sequential operations.…”