Surgery Uses Heat To Enlarge The Airway And Help Breathing, But Long-Term Effects Unknown
NEW HAVEN —— A surgical procedure that shrinks muscle tissue in the windpipe is offering hope for people with severe asthma.
There has been frustratingly limited treatment for asthma, a chronic condition in which restricted airflow causes breathing problems. "That's it," said Dr. Geoffrey Chupp, pointing to bags of inhaler devices in the corner of his office.
Chupp, who is director of the Yale Center for Asthma and Airways Disease, said the new procedure, known as bronchial thermoplasty, is the first to directly go to the root of the problem — the lungs.
The treatment is being offered at Yale-New Haven Hospital as part of a Phase IV study being conducted on the procedure. The FDA approved the procedure in April 2010 with the proviso that follow-up studies be done for five years to examine its long-term safety.
The procedure involves inserting a bronchoscope into the airway through the mouth or nose. Once it reaches specific points of the airway, a device known as the Alair Bronchial Thermoplasty System attached at the end of the scope expands to make contact with the interior walls. It then delivers radio-frequency waves for 10 seconds at a time. The heat essentially melts off some of the smooth muscle tissue.
In asthmatics, the thick layer of muscle tissue is responsible for the constriction of the airway, leading to asthma attacks.
It took 10 years of study for the FDA to approve the treatment, which was developed by the company Asthmatx. Although asthma specialists say the development of a device and surgical procedure for the condition could be a major breakthrough, there are still some concerns about it.
Dr. Norman Edelman, chief medical officer for the American Lung Association, agreed that the procedure appears to be effective but cautioned that there's still a lot more to learn about it.
"The short-term effects appear to be positive, but we don't know the long-term effects," he said. Like any surgical procedure, it has risks, he said, but for now it's suitable only for people with severe asthma. If an asthmatic can control his or her condition with medications, they should stay with that remedy.
At Hartford Hospital, Dr. James Pope, who specializes in pulmonary disease, calls himself a "hopeful skeptic" about the treatment. Considering how serious a physiological change the surgery causes, he said his hospital is waiting to see the results of the study on long-term effects before deciding whether to offer it to patients.
"It's a totally novel and fascinating way to treat asthma," he said. "But if we do this to the airway, what does it do to it 10 years from now? We don't know."
Typically, the entire procedure is done in three sessions about one month apart. One of the downsides is that after each session, the patient's asthma worsens. Conditions return to normal in one to seven days, and then steadily improve, Chupp said. That's why the sessions are scheduled one month apart; doing it all at once could be too much for the patient.
For each session, the surgery takes about an hour, plus two to four hours of post-surgery observation.
Chupp said that it's unlikely that patients will improve to the point that they can do away with their inhalers. But it appears to control symptoms enough so that their quality of life significantly improves. One of his patients, he said, completed the procedure six months ago and the improvements in his condition still have not leveled off. He still carries an inhaler, but he now can play a game of basketball without frequent breaks and is able to get his heart rate to a higher level on the treadmill.
The procedure can cost up to $20,000, and it's not automatically covered by insurance companies.
"What happens with this kind of new technology is that there's always some resistance from the insurance companies," Chupp said. He added, though, that sometimes insurers can be convinced to cover it after consulting the doctors.
source: courant
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