is bronchial thermoplasty safe

National Library of Medicine First of all, the diagnosis of asthma should be confirmed and should be based on the history of variable and reversible respiratory asthma symptoms with evidence of (reversible) airway obstruction by pulmonary function tests. BT offers clinicians a novel, procedure-based, add-on therapy beyond the current use of high-dose ICS and LABA to decrease the morbidity of severe asthma. These clinical best practice recommendations should aid physicians in patient selection, maximizing response rates and patient outcomes with BT treatment. Watchorn DC, Sahadevan A, Egan JJ, Lane SJ. The map represents the bronchial tree and is divided into 3 procedures (procedures 13). The Asthma Intervention Research (AIR2) Trial is the largest sham-controlled trial to test a new device for the treatment of severe asthma in adults. Clinical management of severe therapy-resistant asthma. BT therapy is delivered in 3 separate bronchoscopy sessions at least 3 weeks apart, covering different regions of the lung separately. Randomized, controlled clinical trials have shown BT to be safe and effective in reducing severe exacerbations, improving quality of life, and decreasing emergency department visits. Bronchial thermoplasty: State of the art - Hashmi - 2022 - Respirology Bronchial Thermoplasty is performed by a specially trained pulmonologist over the course of 3 sessions, scheduled about 3 weeks apart. OCS were allowed at a maximum of 30 mg/day, and biological therapy including omalizumab was permitted. Control group subjects in this study underwent three sham bronchoscopy procedures, each separated by at least 3 weeks. All rights reserved. Improvement in mild exacerbation rate (per patient/week) 0.16 vs. 0.04 (, Improvement in AQLQ, ACQ, morning peak expiratory flow, asthma symptom-free days, and symptom scores, Safety: short-term increase in asthma-related morbidity; long-term improvement, Improvement in AQLQ (1.35 vs. 1.16) (PPS 0.96), Reduction in severe exacerbations, emergency department visits, and days missed from work/school, Stable FEV1 and long-term safety profile including chest HRCT, BT, bronchial thermoplasty; ICS, inhaled corticosteroids; LABA, long-acting -adrenoceptor agonists; OCS, oral corticosteroids; FEV. The performance of the bronchoscopic procedures did not allow for the subjects to be unblinded, as evidenced by the inability of the subjects in the BT or the sham group to correctly guess their treatment assignment after the first procedure (within-group comparison P values: BT, 0.135; sham, 0.128). Some improvement in a control group of patients with asthma can be expected from participation in a clinical trial (31), most likely due to the regression effect. Bronchial thermoplasty is a safe and efficacious treatment modality for patients with . On the other hand, general anesthesia including intubation and ventilation could be seen as overtreatment, since this is associated with higher complication risks, including hemodynamic instability, and requires a more complex infrastructure incurring higher costs. The mean change in integrated AQLQ score in the ITT population was greater in the BT group (1.35 1.10) than in the sham group (1.16 1.23; PPS, 96.0%; Table 2). Before Furthermore, the recently published results of a nonrandomized French study showed that patients with an FEV1 as low as 30% with high exacerbation rates were BT treated with a favorable clinical response and acceptable safety profile [15, 16]. Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, et al. All rights reserved. official website and that any information you provide is encrypted Over the entire study period (from the day of first bronchoscopy to the 12-month follow-up), the number of severe exacerbations per subject in the BT group was 1.02 (53.6% of subjects) and in the sham group was 0.91 (45.9% of subjects) (pp superiority sham >BT = 25.8%); the number of ED visits for respiratory symptoms per subject in the BT group was 0.13 (8.4% of subjects) and in the sham group was 0.45 (15.3% of subjects) (pp superiority sham >BT = 99.7%); and the number of respiratory-related hospitalizations per subject in the BT group was 0.13 (10.5% of subjects) and in the sham group was 0.14 (5.1% of subjects) (pp superiority sham >BT = 57.2%). R.M.N. served as a consultant for the Olympus Corporation but received no financial remuneration, served as an expert witness for the Olympus Corporation, with travel expenses paid for to and from CMS in Baltimore, MD (coach flight, hotel for one night), more than $100,001 from Asthmatx, and $50,001$100,000 from Broncus; Henry Ford Health System and Hospital received research funding as per contracted relationship. Then the basket catheter is opened and the activation is provided for about 10 s by pressing the foot switch (Fig. The use of sham control subjects for interventional procedures poses risks to research subjects without the prospect of direct benefit from participation in trials (21). This improvement occurred in subjects who were already taking high doses of ICS and LABA and yet is of similar magnitude to that seen in previous asthma studies where subjects were taking less medication (28, 29). The treatment was administered by an unblinded bronchoscopy team. Careers, Unable to load your collection due to an error. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All rights reserved. Five-year follow-up studies have provided evidence of the functional stability of BT-treated patients with persistence of a clinical benefit. received $1,001$5,000 from Asthmatx in institutional consultancy fees, up to $1,000 from Pfizer and $1,001$5,000 from Boehringer Ingelheim in lecture fees, more than $100,001 from Asthmatx, $10,001$50,000 from Pfizer, more than $100,001 from Spiration, and $5,001$10,000 in industry-sponsored grants (Institutional, PI). (BT) has been shown to be an effective and safe additional modality for the management of patients with poorly controlled asthma despite standard therapy [3,4,5]. Furthermore, subjects in the BT group reported fewer exacerbations and better quality of life scores in this posttreatment period. Key patient selection criteria for BT will be reviewed. The majority of respiratory adverse events occurred within 1 day of the bronchoscopy and resolved within 7 days. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. A.S.R. Annual Meeting, San Diego, CA; 2006. If the post-bronchodilator FEV1 is < 80% of a subject's baseline value, postponing the BT procedure should be considered. Asthma experts around the word say BT safe. Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, et al. Accessibility The procedure uses radio frequency to narrow the muscle walls in your airways without damaging them. The treatment approach for severe asthma is described in the Global Initiative for Asthma (GINA) guideline steps 4 and 5. 90713477), and research grants from the Dutch Lung Foundation (grant No. Measurements and Main Results: The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 1.10; sham, 1.16 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Mayse M, Laviolette M, Rubin A, Lampron N, Simoff M, Duhamel D, Musani A, Yung R, Mehta A. The real-world PAS2 registry mirrors the results seen in the RCTs for BT regarding severe exacerbations, emergency department visits, and hospitalizations. National Library of Medicine Bronchial thermoplasty is a generally safe procedure. Bronchial thermoplasty (BT) is a safe outpatient bronchoscopy procedure that uses mild heat to reduce excessive smooth muscle in the airways, which helps reduce severe asthma attacks. Schatz M, Zeiger R, Mosen D, Vollmer W. Asthma-specific quality of life and subsequent asthma emergency hospital care. Key exclusion criteria were: life-threatening asthma; chronic sinus disease; respiratory diseases such as emphysema; use of immunosuppressants, -adrenergic blocking agents, or anticoagulants; and history in the previous year of three or more hospitalizations for asthma, three or more lower respiratory tract infections, and four or more pulses of OCS use for asthma. Bronchial thermoplasty (BT) is an interventional asthma procedure in which a tube called a bronchoscope is inserted into a person's mouth or nose and threaded through the bronchi (airways) to the lungs. 8600 Rockville Pike Increased mass and contractility of ASM augments asthma morbidity by causing greater bronchoconstriction and airflow obstruction (3). The Alair catheter was deployed into the airways through the bronchoscope, the electrode array expanded, and the sham RF controller activated. Szefler S, Mitchell H, Sorkness C, Gergen P, O'Connor G, Morgan W, Kattan M, Pongracic J, Teach S, Bloomberg G. Wise R, Anthonisen N, Castro M, Holbrook J, Irvin CSL, or the American Lung Association Asthma Clinical Research Centers (ALA-ACRC). This paper discusses the background, practical and effective approaches to patient selection, patient preparation, procedural tips and tricks, patient management, and postprocedural care and follow-up in BT. BT may be performed as day care treatment with a minimum of 4 h of observation after treatment or include overnight admission based on local treatment protocols and experience. Therefore, bronchial thermoplasty is a long-acting therapeutic option for patients with asthma that remains uncontrolled despite optimised medical treatment. What to know about bronchial thermoplasty - Medical News Today 2021 May. During general anesthesia, minimal ventilator settings with low-frequency ventilator settings (810 times/min) and long expiration times (inspiration-to-expiration ratios of 1: 34) are normally recommended. In RCTs and (large) cohort studies, BT has been shown to be effective in reducing severe exacerbations, improving quality of life, and decreasing emergency department visits in severe asthma patients. Arrigo R, Failla G, Scichilone N, La Sala A, Galeone C, Battaglia S, et al. Asthma control can be assessed in various ways including asthma exacerbation rates and composite questionnaires of daily symptoms such as the ACT and ACQ. Pretolani M, Bergqvist A, Thabut G, Dombret MC, Knapp D, Hamidi F, et al. The improvement in the AQLQ score of 1.35 1.10 in the BT group is consistent with changes that were previously observed after BT in patients with moderate to severe asthma (5) and in patients with severe-persistent asthma (6). There was a 36% risk reduction in the proportion of subjects reporting worsening of asthma (multiple symptoms) in the BT group than in the sham group (27.3 vs. 42.9%, respectively; PPS 99.7%). BT is a clinically proven non-drug therapy for patients with severe asthma, with benefits demonstrated out to 5 years. The results of additional real-world registries are expected, and hopefully some of these will include radiological and even pathological data. Each session focuses on a different part of the lungs and usually lasts about an hour. An important goal of asthma management strategies is to improve health-related quality of life (25, 26). The Alair System uses mild heat to reduce the amount of excess airway smooth muscle tissue in the airways. Debray MP, Dombret MC, Pretolani M, Thabut G, Alavoine L, Brillet PY, et al. Bronchial thermoplasty (BT) delivers targeted radiofrequency energy to bronchial airway walls and results in the partial ablation of the airway smooth muscle that is responsible for bronchoconstriction. 2013 Dec; 132(6):1295-302. BT has been applied to patients with moderate-to- severe asthma, but it is currently mainly used for patients with severe asthma refractory to the available optimal medical maintenance therapy, including biologics. Bronchial thermoplasty is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures. Bronchial Thermoplasty (BT), delivered by the Alair System, is a safe outpatient procedure for adult patients with severe asthma. AlairTM Bronchial Thermoplasty System. . During bronchoscopy, RF energy activations are delivered using the basket catheter in airways 2 mm or larger, and each activation heats the exposed airway section to approximately 65C. Although the mechanism of action of BT is incompletely understood, there is evidence that BT mainly acts through intervening in airway remodeling by reducing airway smooth muscle (ASM) and potentially by modulating the composition of the extracellular matrix [2]. Alair and The Alair(tm) symbol are registered trademarks of Boston Scientific Corporation or its affiliates. received more than $100,001 from Asthmatx in industry-sponsored grants. Juniper E, Guyatt G, Willan A, Griffith L. Determining a minimal important change in a disease-specific quality of life questionnaire. Atlanta, GA; Centers for Disease Control and Prevention: 2002.

Is Bronchial Thermoplasty Safe, Articles I