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Bronchial thermoplasty

PROCEDURE OVERVIEW

Bronchial thermoplasty is a bronchoscopic procedure for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta-agonists. Bronchial thermoplasty uses thermal energy to reduce the excessive airway smooth muscle responsible for airway constriction in asthma patients, thereby helping to gain long-lasting control in adults with severe asthma.

Bronchial thermoplasty involves introducing a catheter into the patient’s lungs through a standard flexible bronchoscope inserted through the nose or mouth. The tip of the catheter is expanded to touch the walls of the airway. The catheter delivers controlled radiofrequency energy along the length of the airway walls in 10 second bursts, causing a reduction in excessive airway smooth muscle.

The procedure is typically done under moderate sedation in the hospital outpatient clinic, and the patient returns home the same day. In the period immediately following bronchial thermoplasty, there is an expected increase in the frequency and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within seven days with standard care. Patients identified with increased risk factors associated with adverse events according to product labeling might be considered for inpatient stay.

The treatment is currently performed with three separate bronchoscopic sessions, each scheduled approximately three weeks apart and treating a different section of the lung. Each session lasts about an hour, and following hospital discharge and instructions from their treating physician, patients can usually resume their everyday activities at home.

Lung-Illustration-with-BT-CatheterLONG-LASTING CONTROL FOR SEVERE ASTHMA

The AIR2 Trial evaluated the safety and effectiveness of bronchial thermoplasty in patients with severe asthma, and demonstrated that treatment resulted in improved asthma quality of life, as well as in the following clinically meaningful benefits over sham at one-year post-treatment:

  • 32 % reduction in asthma attacks
  • 84 % reduction in emergency room visits for respiratory symptoms
  • 66 % reduction in days lost from work/school or other daily activities due to asthma

Additionally, data from a recently concluded five-year study, the AIR2 Extension Study, has shown:

  • Effectiveness of BT is maintained out to five years
  • A 48% average decrease over five years in severe exacerbation event rates
  • A reduction in severe exacerbation requiring oral corticosteroids
  • A 88% average decrease over five years in the rate of ER visits for respiratory symptoms
  • Long-term patient safety is maintained

UNMET CLINICAL NEED

Asthma is a serious public health problem. It is one of the top five chronic diseases globally. In patients with severe asthma, even the highest doses of standard of care medications taken daily do not liberate patients from frequent and life-threatening asthma attacks. The increased burden of severe asthma can lead to a substandard quality of life for these patients, and few treatment options exist to adequately control their disease.

In the United States, asthma affects almost 25 million Americans, and in 2007, resulted in approximately:

  • 8 million people experiencing asthma attacks
  • 75 million emergency room visits
  • 456,000 hospitalizations
  • 3,447 asthma-related deaths

Source: Centers for Disease Control and Prevention National Center for Health Statistics,
National Health Statistics Report: Asthma Prevalence, Health Care Use, and Mortality:
United States, 2005–2009: http://www.cdc.gov/nchs/data/nhsr/nhsr032.pdf

LONG-TERM SAFETY AND EFFECTIVENESS

Bronchial thermoplasty has demonstrated a strong long-term safety profile with follow up out to five years in three consecutive clinical trials. In addition to safety, the five-year results from the AIR2 Trial also demonstrate long-term persistence of effect.

The November 2013 issue of the Journal of Allergy and Clinical Immunology the author Dr. Wechsler et al., stated that Bronchial Thermoplasty demonstrated:

  • Long-term effectiveness maintained, demonstrated by reduction in the percentage of patients with severe exacerbations maintained out to 5 years
  • Reduction in ER visits maintained out to 5 years
  • Stable long-term safety profile (out to 5 years)

SCIENTIFIC EVIDENCE

Experience with bronchial thermoplasty has been described in more than 15 peer reviewed publications including the New England Journal of Medicine, CHEST, Annals of Allergy, Asthma and Immunology and the American Journal of Respiratory and Critical Care Medicine. Bronchial Thermoplasty is now available in over 270 medical centers in 28 countries and over 2000 patients have been treated.

REGULATORY STATUS

Bronchial thermoplasty is approved by the FDA and is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long-acting betaagonists.

For more information, contact MountainView Hospital’s Cardiovascular & Thoracic Surgery Associates

702-962-5920