Table 4– Serious complications in endobronchial valve (EBV) therapy and control patients (0–386 days)
EventUp to 3 months (<97 days)3–6 months (98–194 days)6–9 months (195–284 days)9–12 months (285–386 days)
EBV therapyControlp-valueEBV therapyControlp-valueEBV therapyControlp-valueEBV therapyControlp-value
Patients n11160111601116011160
Death1 (0.9)1 (1.7)1.002 (1.8)00.542 (1.8)00.541 (0.9)3 (5.0)0.12
Respiratory failure4 (3.6)1 (1.7)0.663 (2.7)3 (5.0)0.423 (2.7)1 (1.7)1.0001 (1.7)0.35
≥24 h ventilation2 (1.8)00.542 (1.8)1 (1.7)1.003 (2.7)00.5501 (1.7)0.35
Haemoptysis6 (5.4)1 (1.7)0.424 (3.6)00.301 (0.9)01.003 (2.7)00.55
 Massive001 (0.9)01.000000
Pneumothorax or air leak5 (4.5)00.161 (0.9)01.001 (0.9)01.002 (1.8)00.54
>7 days4 (3.6)00.301 (0.9)01.001 (0.9)01.0000
Empyema0000001.0000
Pneumonia not distal to valve4 (3.6)1 (1.7)0.662 (1.8)00.544 (3.6)1 (1.7)0.663 (2.7)00.55
Pneumonia distal to valve4 (3.6)2 (1.8)01 (0.9)0
COPD exacerbation47 (42.3)28 (46.7)0.6336 (32.4)19 (31.7)1.0016 (14.4)9 (15.0)1.0017 (15.3)12 (20.0)0.52
 With hospitalisation13 (11.7)6 (10.0)0.8013 (11.7)7 (11.7)1.0012 (10.8)3 (5.0)0.264 (3.6)2 (3.3)1.00
 Without hospitalisation31 (27.9)23 (38.3)0.1721 (18.9)13 (21.7)0.696 (5.4)6 (10.0)0.3513 (11.7)10 (16.7)0.36
  • Data are presented as n (%), unless otherwise stated. COPD: chronic obstructive pulmonary disease.