title: Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma.
abstract: BACKGROUND
  Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.
  
  
  OBJECTIVE
  We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.
  
  
  METHODS
  BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.
  
  
  RESULTS
  One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.
  
  
  CONCLUSIONS
  These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colo. Electronic address: mikewechsler@gmail.com.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Wechsler
authors.forename: Michel
authors.initials: M
authors.lastname: Laviolette
authors.forename: Adalberto S
authors.initials: AS
authors.lastname: Rubin
authors.forename: Jussara
authors.initials: J
authors.lastname: Fiterman
authors.forename: Jose R
authors.initials: JR
authors.lastname: Lapa e Silva
authors.forename: Pallav L
authors.initials: PL
authors.lastname: Shah
authors.forename: Elie
authors.initials: E
authors.lastname: Fiss
authors.forename: Ronald
authors.initials: R
authors.lastname: Olivenstein
authors.forename: Neil C
authors.initials: NC
authors.lastname: Thomson
authors.forename: Robert M
authors.initials: RM
authors.lastname: Niven
authors.forename: Ian D
authors.initials: ID
authors.lastname: Pavord
authors.forename: Michael
authors.initials: M
authors.lastname: Simoff
authors.forename: Jeff B
authors.initials: JB
authors.lastname: Hales
authors.forename: Charlene
authors.initials: C
authors.lastname: McEvoy
authors.forename: Dirk-Jan
authors.initials: DJ
authors.lastname: Slebos
authors.forename: Mark
authors.initials: M
authors.lastname: Holmes
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Phillips
authors.forename: Serpil C
authors.initials: SC
authors.lastname: Erzurum
authors.forename: Nicola A
authors.initials: NA
authors.lastname: Hanania
authors.forename: Kaharu
authors.initials: K
authors.lastname: Sumino
authors.forename: Monica
authors.initials: M
authors.lastname: Kraft
authors.forename: Gerard
authors.initials: G
authors.lastname: Cox
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Sterman
authors.forename: Kyle
authors.initials: K
authors.lastname: Hogarth
authors.forename: Joel N
authors.initials: JN
authors.lastname: Kline
authors.forename: Adel H
authors.initials: AH
authors.lastname: Mansur
authors.forename: Brian E
authors.initials: BE
authors.lastname: Louie
authors.forename: William M
authors.initials: WM
authors.lastname: Leeds
authors.forename: Richard G
authors.initials: RG
authors.lastname: Barbers
authors.forename: John H M
authors.initials: JH
authors.lastname: Austin
authors.forename: Narinder S
authors.initials: NS
authors.lastname: Shargill
authors.forename: John
authors.initials: J
authors.lastname: Quiring
authors.forename: Brian
authors.initials: B
authors.lastname: Armstrong
authors.forename: Mario
authors.initials: M
authors.lastname: Castro
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000453:epidemiology / Q000628:therapy*; D018450:Disease Progression; D004351:Drug Resistance; D004599:Electric Stimulation Therapy / Q000379:methods*; D004632:Emergency Medical Services / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists
keywords: AE; AIR2; AQLQ; Adverse event; Alair System; Asthma Intervention Research 2; Asthma Quality of Life Questionnaire; BT; Bronchial thermoplasty; ED; Emergency department; HRCT; High-resolution computed tomography; ICS; Inhaled corticosteroid; LABA; Long-acting β(2)-agonist; NAEPP; National Asthma Education and Prevention Program; OCS; Oral corticosteroid; asthma; asthma exacerbation; bronchoscopic procedure