Guidance
5 Safety
5 Safety
This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Pneumothorax was reported after 5% (2/44) of endobronchial nitinol coil procedures and in no patients who had usual care (including inhalers, bronchodilators, inhaled steroids and pulmonary rehabilitation) at 1‑month follow‑up in a randomised controlled trial of 47 patients with emphysema treated by endobronchial nitinol coils (n=24) or usual care (n=23).
5.2 Exacerbations of chronic obstructive pulmonary disease (COPD) were reported in the randomised controlled trial of 47 patients after 5% (2/44) of endobronchial nitinol coil procedures and in 4% (1/23) of patients who had usual care, at 1‑month follow‑up. At 3‑month follow‑up, exacerbations of COPD were reported after 7% (3/44) of endobronchial nitinol coil procedures and in 9% (2/23) of patients who had usual care. Serious exacerbations of COPD were reported in 17.2% (10/58) of patients, between 1 and 6 months after treatment, in a case series of 60 patients.
5.3 Chest pain was reported after 14% (4/28) of endobronchial nitinol coil procedures, within 1 month of first or second treatment, in a case series of 16 patients. In the same study, chest pain was reported after 7% (2/28) of endobronchial nitinol coil procedures between 1 and 6 months after treatment.
5.4 Pneumonia was reported after 7% (2/28) of endobronchial nitinol coil procedures, within 1 month of first or second treatment, in the case series of 16 patients. In the same study, pneumonia was reported after 11% (3/28) of endobronchial nitinol coil procedures between 1 and 6 months after treatment.
5.5 Lower respiratory tract infections were reported in the randomised controlled trial of 47 patients after 5% (2/44) of endobronchial nitinol coil procedures and in no patients who had usual care at 1‑month follow‑up. At 3‑month follow‑up, lower respiratory tract infections were reported after 0% of endobronchial nitinol coil procedures and in 4% (1/23) of patients who had usual care.
5.6 Specialist advisers listed bleeding, infection and pneumothorax as anecdotal adverse events. Haemorrhage, coil migration, pneumomediastinum, respiratory failure and the erosion of coils into major vessels were identified as theoretical adverse events.