Results
death, illness or injury, pneumothorax, atelectasis, lung volume reduction, disability/incapacity, deaths, COPD, coronavirus disease 2019
SUBCUTANEOUS EMPHYSEMA, CORONAVIRUS DISEASE 2019, PNEUMOTHORAX, ADVERSE EVENTS, ATELECTASIS, COMPLICATION, ACUTE EXACERBATION OF COPD, COPD, SECONDARY, EVENTS, COMPLICATIONS
Between 16 September 2016 and 22 July 2019, 163 patients were assessed for their eligibility to be enrolled in the trial. Of 149 patients who were screened and thought on the basis of their CT scan to be collateral ventilation-negative, 38 (26%) were collateral ventilation-positive on Chartis assessment and nine (6%) had a low flow or indeterminate Chartis. 88 eligible participants were randomly assigned to either LVRS (n=41) or BLVR (n=47) (Trial profile. BLVR: bronchoscopic lung volume reduction; LVRS: lung volume reduction surgery.Baseline characteristics of whole cohort and by treatment allocationData are presented as mean±80 participants received treatment (34 LVRS/46 BLVR). Six randomised to the LVRS group and one randomised to the BLVR group decided against having the procedure post-randomisation and therefore exited the trial prior to treatment. One trial participant randomised to the LVRS group died before surgery was performed. These participants were not included in the intention-to-treat analysis. Follow-up of patients was interrupted due to the coronavirus disease 2019 (COVID-19) pandemic. Some in-person research visits were missed as they were not possible or considered unsafe in this vulnerable patient group. Where able, outcomes were collected over the phone. The COVID-19 pandemic also meant that access to some trial data was delayed, because research staff had been redeployed. Survival data at 12 months were available for all participants. Outcome data were available for 71 participants at 3 months (32 LVRS/39 BLVR) and 63 participants at 12 months (26 LVRS/37 BLVR). Complete primary end-point data (all i-BODE items at 12 months) were available for 49 participants (21 LVRS/28 BLVR) (At 12 months post-procedure both intervention groups showed an improvement in i-BODE score (LVRS −1.10±1.44 Effect of lung volume reduction interventions on i-BODE score. Data are presented as mean±Primary and secondary outcomes: change from baseline to 12 months follow-upChange from baseline data are presented as number of participants data collected for, followed by mean±Effect of lung volume reduction procedures on i-BODE score component measures: a) body mass index (BMI), b) forced expiratory volume in 1 s (FEVResponders based on minimal clinically important difference (MCID) for the i-BODE index (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for the i-BODE index (−1 point). Black bars represent subjects who did not meet the MCID. Dotted line represents the MCID. Red bars represent those patients that either crossed over or had valves removed, where data was collected. LVRS: lung volume reduction surgery; BLVR: bronchoscopic lung volume reduction.Responders based on minimal clinically important difference (MCID): i-BODE index components (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for the specific outcome: a) body mass index (BMI) (no established MCID), b) forced expiratory volume in 1 s (FEVResponders based on minimal clinically important difference (MCID): important secondary outcomes (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for a) residual volume (RV) % pred (−6.1%) and b) COPD Assessment Test (CAT) score (−2 points). Black bars represent subjects who did not meet the MCID. Dotted line represents the MCID. Red bars represent those patients that either crossed over or had valves removed, where data was collected. BLVR: bronchoscopic lung volume reduction; LVRS: lung volume reduction surgery.Both the LVRS and BLVR groups showed improvements in all secondary outcomes: RV % pred (LVRS −36.1% (95% CI −54.6– −10%) There were no differences at baseline between those with and without complete data at 12 months (Median (IQR) length of stay for the initial procedure was 9 (16.5) days in the LVRS group and 3 (2) days in the BLVR group (p=0.006). There were two deaths during the 12-month follow-up period. One occurred in the BLVR arm 44 days after valve insertion due to complications related to the procedure and one in the LVRS arm at 5 months post-intervention due to a non-infective acute exacerbation of COPD which was not thought to be related. At 12 months follow-up there were 29 respiratory-related adverse events in 17 participants undergoing LVRS (50.0%) The most common complication was subcutaneous emphysema (29.3%) in the LVRS group and pneumothorax (30.4%) in the BLVR group. Of those who had a pneumothorax, nine (81.8%) occurred while still an inpatient post-procedure, median (IQR) time to onset 2 (3) days and drain removed after median (IQR) 10 (12) days. The median (IQR) number of days with a chest drain post-LVRS was 8.0 (11.0) days. 26 (59.1%) BLVR patients achieved complete lobar atelectasis and a further 10 (21.7%) partial atelectasis. Seven (15.0%) BLVR recipients required at least one further bronchoscopy or procedure following initial intervention and four (8.7%) crossed over to LVRS, within the 12-month follow-up period. In the LVRS arm, two (4.9%) required a further bronchoscopy or procedure and one (2.4%) crossed over to BLVR. Safety outcomes are presented in Safety outcomesData are presented as n (%) or n. LVRS: lung volume reduction surgery; BLVR: bronchoscopic lung volume reduction; AE: acute exacerbation; NIV: non-invasive ventilation; ICU: intensive care unit. Serious adverse events were events leading to death, hospitalisation or prolongation of existing hospitalisation, persistent or significant disability/incapacity, or to serious deterioration in health that resulted in a life-threatening illness or injury, a permanent impairment of a body structure or body function. Prolonged length of stay defined as >10 days in LVRS and >4 days in BLVR.