Introduction and Objectives NICE Guidance for bronchial thermoplasty (BT) recommended the collection of safety and efficacy outcomes through the BTS Difficult Asthma Registry. This study summarises the data collected to June 2013, with objectives of describing the demographic and baseline characteristics of patients undergoing BT and early consideration of safety and efficacy, which will be updated for presentation at the December 2013 meeting.
Methods Records for 21 patients from 5 UK centres were studied. Age, gender, lung function and quality of life were compared to those reported in two previous clinical trials. Potential safety issues were examined and efficacy outcomes compared to baseline.
Results Data:20 baseline records, 62 BT procedure records, 9 patients followed up to 6 months, 7 followed up to 12 months. At follow-up, 12 patients had data at 6 and/or 12 months for pre bronchodilator FEV1 and AQLQ to enable comparison with baseline. Baseline demographics and characteristics are presented in Table 1.
Outcomes: one patient was re-admitted to hospital for 3 days with an exacerbation after the second of three routine BT procedures, but recovered to complete the final procedure. 17 patients were admitted post-procedure (max 8 days) but no adverse outcomes were reported. Mean AQLQ score at 6 months was 4.61 ± 1.80 (n = 10). 6/10 patients had improved AQLQ (> 0.5 above baseline) at 6 months and 2/3 at 12 months. 1/10 patients had worse AQLQ (> than 0.5 below baseline) at 6 months and 0/3 at 12 months. Mean pre-bronchodilator FEV1 (% of predicted) at 6 months was 64.88 ± 26.57 (n = 8) and at 12 months 75.20 ± 13.77 (n = 5).
Conclusions Early indications are that this cohort are marginally older and have worse mean lung function and AQLQ scores at baseline than patients in two previous clinical trials.No serious issues relating to equipment or adverse outcomes were observed. Patients were often admitted post-procedure - this may have been precautionary, as there were no reports of unanticipated procedural morbidity. To date, efficacy outcomes appear consistent with those observed in previous clinical trials, with a suggestion of smaller improvement in AQLQ score.