Original Abstract
BACKGROUND: The optimal intervention for refractory bullae lung disease remains debated, with a choice between invasive surgical operation (SO) and the minimally invasive endobronchial valve (EBV). A comprehensive comparison of their long-term efficacy, safety, and cost is crucial for clinical decision-making. OBJECTIVE: To compare perioperative outcomes, 1-year efficacy, long-term recurrence-free survival, and economic impact between surgical bullectomy (SO) and endobronchial valve (EBV) placement. METHODS: In this comparative study, 673 patients with refractory bullae disease from two Chinese centers were enrolled (SO: n = 436; EBV: n = 237). This study enrolled patients with refractory bullous disease, defined by HRCT-confirmed bullae > 10 cm in diameter or concomitant symptoms impacting daily life, and an inadequate clinical response to a minimum of 3 months of optimized medical management. After applying propensity score matching (PSM) to control for confounding factors, perioperative outcomes, 1-year efficacy, and long-term recurrence‑free survival were compared between the two groups. Analyses employed analyses of covariance (ANCOVA), mixed-effects models, Kaplan-Meier estimates, Cox regression, and logistic regression. RESULTS: Following PSM, excellent balance in baseline characteristics was achieved between the surgical (SO, n = 237) and endobronchial valve (EBV, n = 237) groups. Regarding perioperative outcomes, EBV was associated with a lower risk of complications (OR = 0.33), shorter operation time (mean difference: -0.72 h), less blood loss (mean: -48.00 ml), and a reduced hospital stay (mean: -7.61d) compared to SO (all p < 0.001). However, total hospitalization costs were significantly higher for EBV (mean increase: ¥104,502). For secondary outcomes, EBV demonstrated lower rates of radiologic lung re-expansion based on the semi-quantitative imaging assessment used in this study (OR = 0.15, p < 0.001) and bulla volume reduction (mean difference: -29.02%, p < 0.001) at 1 year, and was associated with a higher 1-year readmission risk (OR = 3.21, p < 0.001). For the primary outcomes at 1 year, SO demonstrated superior improvement in both lung function (adjusted mean difference in forced expiratory volume in one second (FEV1)%: -9.71%, p < 0.001) and exercise capacity (adjusted mean difference in 6-minute walk distance (6MWD): -53.04 m, p < 0.001). Mixed-effects models confirmed that SO's advantages in FEV1% were significant at all time points, while its 6MWD benefit became fully apparent only by 1 year. Long-term recurrence-free survival was significantly higher in the SO group (2-year rate: 86.5% vs. 70.0%; HR for EBV: 2.48, p < 0.001). Subgroup analysis revealed this survival advantage was most pronounced for giant bullae (≥ 10 cm), where the recurrence risk with EBV was 3.49-fold higher (HR 3.49, p < 0.001), whereas for smaller bullae (< 10 cm) the risk was comparable between groups (HR 1.32, p = 0.426). CONCLUSION: SO was associate