Chest
Clinical InvestigationsA Prospective Feasibility Study of Bronchial Thermoplasty in the Human Airway
Section snippets
Materials and Methods
The protocol for this clinical study was approved by the Research Ethics Board of St. Joseph's Healthcare, Hamilton, ON, and the Medical Devices Bureau, Therapeutic Products Division, of Health Canada. Informed consent was obtained from all subjects prior to their participation in the study.
Results
A total of nine patients gave consent for their participation in the study between January and May 2000. Of these, eight patients were treated. Patient 4–07 was not treated because the geometry of airways in right upper lobe made it difficult to place the bronchoscope and catheter at the targeted sites. The treated patients included four male and four female white patients ranging in age from 52 to 78 years (mean age, 65 ± 8.3 years SD). Pertinent patient demographics are shown in Table 1.
All
Discussion
This study reports the first deployment in humans of the Alair System, a novel device for performing bronchial thermoplasty that involves the delivery of mild, controlled heat to the airway wall. The delivery of radiofrequency energy to the airway wall reduces the amount of ASM. We hypothesize that such a physical approach could be an effective treatment for asthma if it results in a diminished potential for airway narrowing due to bronchoconstriction.5 Radiofrequency energy has been safely and
Conclusion
We have demonstrated that bronchial thermoplasty is well tolerated in humans. There were no clinically significant adverse events associated with this treatment, either acutely or during follow-up periods of up to 20 days. There were no unexpected findings at histology, and the anticipated potentially beneficial effect of this treatment to reduce the amount of ASM in the bronchial wall was observed. These observations provide a strong impetus for further studies of bronchial thermoplasty as a
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2020, Paediatric Respiratory ReviewsCitation Excerpt :Research has shown that bronchial thermoplasty can greatly improve asthma control up to 5 years post-procedure in severe asthmatics, and results are similar between allergic and non-allergic patients [58]. Histologically, there is no evidence of scarring post-procedure [59]. There is, however, a lack of data on the efficacy of bronchial thermoplasty in different asthma endotypes.
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