Abstract

Background Targeted BTVA can lead to lung volume reduction. Previous data from a prospective RCT demonstrated lung function (PFTs) and quality of life improvements. This study looks at the longer-term effects of BTVA with regard to PFTs, exercise capacity, and QoL from an ongoing international registry.

Methods Data from 10 clinical sites were analysed. Measurements included FEV1, RV, 6-MWT and SGRQ prior to treatment and up to 36months (M) later. 204 treated patients (age 64.4 ± 6.81 yrs; FEV1 30.2 ± 8.33 % pred) undergoing 314 BTVA procedures from 05/2017 to 01/2023 were included. Missing data were not inputed.

Results Of the 204 patients, 116 underwent 12M-Follow-up (FU), 63 24M-FU, and 42 patients 36M-FU. In a total of 314 BTVA procedures, 97 procedure-related serious adverse events (SAEs), amongst them 26 COPD exacerbations, 30 pneumonias, 6 haemoptysis, were reported. 28 out of a total of 46 severe SAEs resolved without sequelae. Statistically significant improvements for SGRQ and RV were observed at 12M (SGRQ, RV) and 24M (SGRQ). Changes in FEV1 and 6-MWT did not achieve statistical significance.

Conclusions FU of patients treated with BTVA in a real-world cohort. The data show safety and improvements in some COPD outcomes at 12M and 24M, however, waning treatment effects during longer-term FU.

Parameter

Baseline

n=204

? 12 month

n=94

? 24 month

n = 53

? 36 month

n = 30

FEV1, L 0.847± 0.2794 0.002± 0.2108 -0.027± 0.1892 -0.070± 0.1824
Residual Volume, L 5.48± 1.481 -0.43± 1.436 -0.27± 1.326 0.37± 1.293
SGRQ 63.68 ± 15.273 -5.05± 17.189 -5.63± 18.249 -2.50± 17.125

6-MWT, m

299.3± 88.11 14.2± 76.58 -8.2± 98.14 -39.4± 80.21