BACKGROUND AND OBJECTIVE: We evaluated long-term safety and lung function outcomes in a cohort of patients with severe upper-zone heterogeneous emphysema who underwent bronchoscopic lung volume reduction (BLVR) performed with the Emphasys one-way valve. METHODS: A retrospective cohort study was undertaken to assess long-term outcomes in 23 consecutive patients who underwent upper lobe BLVR between July 2001 and November 2003 as part of a first-in-humans study. Long-term follow up (>12 months) was available in 16/23 patients (median duration of follow up 64 months (range 15-90 months)). Both unilateral (n=4) and bilateral (n=12) BLVR procedures were performed with a mean of 6 (range 3-11) valves being inserted. Changes in pulmonary function tests were assessed longitudinally following the procedure. RESULTS: 13/16 and 11/16 patients showed post-procedure improvements in FEV1 and DL(CO) , respectively. However, early improvements in pulmonary function were not sustained with only 6/16 patients still showing improved lung function at the end of follow up. There were no significant improvements in other indices of pulmonary function. Three patients, in the absence of clinical benefit, proceeded to lung transplantation at 15, 16 and 44 months post BLVR. Four patients died during the course of the study at 27, 29, 39 and 50 months post procedure. CONCLUSIONS: BLVR with the Emphasys one-way valve has an acceptable safety profile and in select patients may achieve long-term sustained improvements in pulmonary function.
BACKGROUND AND OBJECTIVE: We evaluated long-term safety and lung function outcomes in a cohort of patients with severe upper-zone heterogeneous emphysema who underwent bronchoscopic lung volume reduction (BLVR) performed with the Emphasys one-way valve. METHODS: A retrospective cohort study was undertaken to assess long-term outcomes in 23 consecutive patients who underwent upper lobe BLVR between July 2001 and November 2003 as part of a first-in-humans study. Long-term follow up (>12 months) was available in 16/23 patients (median duration of follow up 64 months (range 15-90 months)). Both unilateral (n=4) and bilateral (n=12) BLVR procedures were performed with a mean of 6 (range 3-11) valves being inserted. Changes in pulmonary function tests were assessed longitudinally following the procedure. RESULTS: 13/16 and 11/16 patients showed post-procedure improvements in FEV1 and DL(CO) , respectively. However, early improvements in pulmonary function were not sustained with only 6/16 patients still showing improved lung function at the end of follow up. There were no significant improvements in other indices of pulmonary function. Three patients, in the absence of clinical benefit, proceeded to lung transplantation at 15, 16 and 44 months post BLVR. Four patients died during the course of the study at 27, 29, 39 and 50 months post procedure. CONCLUSIONS: BLVR with the Emphasys one-way valve has an acceptable safety profile and in select patients may achieve long-term sustained improvements in pulmonary function.
Authors: Alfonso Fiorelli; Carlo Santoriello; Alberto De Felice; Francesco Ferrigno; Annalisa Carlucci; Emanuele De Ruberto; Rossella Mastromarino; Lisa Occhiati; Gaetana Messina; Elena Santoriello; Giovanni Vicidomini; Mario Polverino; Mario Santini Journal: J Vis Surg Date: 2017-11-17
Authors: Jorine E Hartman; Karin Klooster; Kiki Gortzak; Nick H T ten Hacken; Dirk-Jan Slebos Journal: Respirology Date: 2014-11-23 Impact factor: 6.424