Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:132

Article

Wechsler, Michael E.¹  Laviolette, Michel²  Rubin, Adalberto S.³  Fiterman, Jussara⁴  Silva, Jose R. Lapa e⁵  Shah, Pallav L.⁶  Fiss, Elie⁷  Olivenstein, Ronald⁸  Thomson, Neil C.⁹  Niven, Robert M.^10,11  Pavord, Ian D.¹²  Simoff, Michael¹³  Hales, Jeff B.¹⁴  McEvoy, Charlene¹⁵  Slebos, Dirk-Jan¹⁶  Holmes, Mark¹⁷  Phillips, Martin J.¹⁸  Erzurum, Serpil C.¹⁹  Hanania, Nicola A.²⁰  Sumino, Kaharu²¹  Kraft, Monica²²  Cox, Gerard²³  Sterman, Daniel H.²⁴  Hogarth, Kyle²⁵  Kline, Joel N.²⁶  Mansur, Adel H.²⁷  Louie, Brian E.²⁸  Leeds, William M.²⁹  Barbers, Richard G.³⁰  Austin, John H. M.³¹  Shargill, Narinder S.³²  Quiring, John³³  Armstrong, Brian³³  Castro, Mario²¹ 

[1] Natl Jewish Hlth, Div Pulm Crit Care & Sleep Med, Denver, CO 80206 USA

[2] Univ Laval, IUCPQ Hop Laval, Dept Pneumol, Quebec City, PQ G1K 7P4, Canada

[3] Irmandade Santa Casa Misericordia Porto Alegre, Serv Pneumol, Porto Alegre, RS, Brazil

[4] Pontificia Univ Catolica Rio Grande do Sul, Hosp Sao Lucas, Porto Alegre, RS, Brazil

[5] Hosp Univ Clementino Fraga Filho, Rio De Janeiro, Brazil

[6] Chelsea & Westminster Hosp NHS Fdn Trust, London, England

[7] Fac Med ABC, Sao Paulo, Brazil

[8] Montreal Chest Inst, Montreal, PQ, Canada

[9] Univ Glasgow, Gartnavel Gen Hosp, Dept Resp Med, Glasgow G12 8QQ, Lanark, Scotland

[10] Univ Manchester, MAHSC, Manchester, Lancs, England

[11] Univ S Manchester Hosp, Manchester M20 8LR, Lancs, England

[12] Univ Hosp Leicester NHS Trust, Glenfield Gen Hosp, Div Resp Med, Leicester, Leics, England

[13] Henry Ford Med Ctr, Div Pulm & Crit Care Med, Detroit, MI USA

[14] Pulm & Med Associate Northern Virginia, Arlington, TX USA

[15] HealthPartners Specialty Ctr Lung & Sleep Hlth, St Paul, MN USA

[16] Univ Groningen, Univ Med Ctr Groningen, Dept Pulm Dis, NL-9713 AV Groningen, Netherlands

[17] Royal Adelaide Hosp, Resp Clin Trials Unit, Adelaide, SA, Australia

[18] Sir Charles Gairdner Hosp, Western Australia Lung Res, Perth, WA, Australia

[19] Cleveland Clin, Dept Pulm & Crit Care Med, Cleveland, OH USA

[20] Baylor Coll Med, Sect Pulm Crit Care & Sleep Med, Houston, TX 77030 USA

[21] Washington Univ, Div Pulm & Crit Care Med, St Louis, MO 63130 USA

[22] Duke Univ, Med Ctr, Dept Pulm Med, Durham, NC 27706 USA

[23] McMaster Univ, Firestone Inst Resp Hlth, St Josephs Healthcare, Hamilton, ON L8S 4L8, Canada

[24] Univ Penn Hlth Syst, Pulm Allergy & Crit Care Div, Sect Intervent Pulmonol & Thorac Oncol, Philadelphia, PA USA

[25] Univ Chicago, Dept Pulm & Crit Care Med, Chicago, IL 60637 USA

[26] Univ Iowa, Iowa City, IA USA

[27] Univ Birmingham, Resp Unit, Birmingham Heartlands Hosp, Birmingham B15 2TT, W Midlands, England

[28] Swedish Med Ctr, Sect Thorac & Foregut Surg, Seattle, WA USA

[29] Veritas Clin Specialties, Topeka, KS USA

[30] Univ So Calif, Keck Sch Med, Div Pulm & Crit Care Med, Los Angeles, CA 90033 USA

[31] Columbia Univ, Med Ctr, Div Radiol, New York, NY USA

[32] Boston Sci Corp, Sunnyvale, CA USA

[33] QST Consultat Ltd, Allendale, MI USA

关键词: Bronchial thermoplasty;    asthma;    bronchoscopic procedure;    Alair System;    asthma exacerbation;   

DOI  :  10.1016/j.jaci.2013.08.009

来源: Elsevier

【 摘 要 】

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.gov NCT01350414) 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 beta(2)-agonists.

【 授权许可】

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