Virginia Hospital Center The First In The United States To Offer Bronchial Thermoplasty To Patients With Severe Asthma

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 04 May 2010 - 5:00 PDT


Virginia Hospital Center announced that it will be the first Hospital in the United States to offer a new procedure for severe asthma patients known as bronchial thermoplasty. The Alair® Bronchial Thermoplasty System was recently approved by the U.S. Food and Drug Administration (FDA). Patients who are 18 years and older and suffer from severe persistent asthma that is not well controlled with inhaled corticosteroids and long acting beta agonists, the current standard-of-care treatments, will be eligible for the procedure. The first procedure will be done at Virginia Hospital Center on Thursday, May 6, 2010.

Dr. David R. Duhamel, Director of Pulmonary Special Procedures and the Lung Cancer Center at Virginia Hospital Center was one of the principal investigators, and Dr. Jeff B. Hales, Chief, Division of Pulmonary Critical Care and Sleep Medicine at Virginia Hospital Center was a co-investigator in the Asthma Intervention Research 2 (AIR2) Trial, which evaluated the device's safety and effectiveness. The data from that study was submitted to the FDA and was the basis for the agency's approval of the first-of-its-kind device for the treatment of asthma. The AIR2 data was also published in the January 15, 2010 issue of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The trial demonstrated that treatment with the Alair System resulted in improved asthma quality of life, as well as considerable reductions in asthma attacks, ER visits, hospitalizations, and days lost from work, school or other daily activities due to asthma.

"We are honored to be the first Hospital offering this revolutionary new procedure to adults suffering with severe asthma in the DC Metro area," said Dr. Duhamel. "Bronchial thermoplasty is a promising new tool in the arsenal that has the potential to reduce hospital visits, out-of-pocket healthcare costs, and days missed from work. This definitive intervention provides a long-term benefit to adult asthma patients and significantly improves the quality of life for those suffering from this chronic condition."

Millions of patients with asthma struggle to keep their disease under control. Asthma accounts for 2 million emergency room visits in the US each year. Each day, roughly 40,000 unscheduled physician office visits, 5,000 emergency room visits, and 1,000 hospitalizations occur due to asthma. The Alair Bronchial Thermoplasty System has been shown to help patients with severe asthma gain substantially better control over their disease.

About Bronchial Thermoplasty Delivered by the Alair System

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 is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient's nose or mouth, and into their lungs. The tip of the small diameter Alair® catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under moderate sedation, and the patient returns home the same day.

About the AIR2 Trial

In the pivotal clinical trial, adults with severe asthma who underwent bronchial thermoplasty demonstrated that treatment with the Alair System resulted in improved asthma quality of life, as well as in the following clinically significant benefits over sham during long-term follow-up:

-- 32 % reduction in asthma attacks

-- 84 % reduction in emergency room visits for respiratory symptoms

-- 73 % reduction in hospitalizations for respiratory symptoms

-- 66 % reduction in days lost from work/school or other daily activities due to asthma

In the period immediately following bronchial thermoplasty, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. These events typically occurred within a day of the procedure and resolved on average within seven days with standard care. In the long-term after treatment, fewer bronchial thermoplasty treated patients reported respiratory adverse events. Investigators in the AIR2 Trial concluded that the increased risk of adverse events in the short-term following bronchial thermoplasty is outweighed by the benefits, which persist for at least one year.

About Asthma

Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the American Lung Association, more than 20 million Americans have asthma, and managing unstable asthma consumes over $18 billion of healthcare resources each year. In the U.S. each year, asthma attacks result in approximately 14 million unscheduled doctor office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths.

About Virginia Hospital Center:

For over 60 years, Virginia Hospital Center has provided exceptional medical services to the Washington metropolitan area. Virginia Hospital Center's $150 million state-of-the-art facility offers comprehensive healthcare and multiple Centers of Excellence including Cardiology & Cardiovascular Surgery, the first NAPBC-accredited Center for Breast Health in Virginia, Neuroscience, Oncology, Total Joint Replacement (hip and knee), Women & Infant Health and Urology. Growing service lines include Executive Health and the only Lung Cancer Center in northern Virginia. Virginia Hospital Center is a teaching hospital, long-associated with Georgetown University's School of Medicine, and accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Licensed by the Commonwealth of Virginia Department of Health.

Source: Virginia Hospital Center

• Additional
• References
• Citations