|
 The technique is designed to replace risky surgery in which doctors
remove a damaged lobe of the lung to literally give healthier areas
more breathing room. Once the expandable valves are in place, fresh
air can't flow in and old air flows out, collapsing the inefficient
area.
"We now have proof that this is a workable therapy," chief author
Karin Klooster of the University of Groningen told Reuters Health.
"We can't cure the patient, but we can relieve symptoms. These
patients really have life-changing benefits."
The technique only works in patients whose badly-damaged lung tissue
is isolated, and air isn't sneaking in from healthier tissue. That's
why an earlier test of the valves only produced modest results, she
said. A new screening test can determine if the damaged lung tissue
is isolated.
In part because of that limitation, only about one in 10 patients
with severe emphysema would be candidates for the implanted valves,
Klooster estimated.
"It's a limited group, but the benefit will be real," Dr. Norman
Edelman, senior scientific advisor for the American Lung
Association, who was not involved in the research, told Reuters
Health. "It's hardly the Holy Grail. It's not likely to extend life
or anything like that. But if patients are carefully selected, it
will help them get less short of breath for at least six months,"
which was the duration of the study.
Klooster speculated that, if approved, the therapy would cost
roughly 20,000 to 25,000 euros ($22,000 to $27,500), including costs
of screening to make sure the therapy is likely to be effective,
along with follow-up care.
"We've known for a while that among people with really bad
emphysema, if we can take out the big air sacs and reduce the total
lung volume, it will make people feel better, less short of breath,"
Edelman said. "This is a way to do that without actually opening up
the chest."
The results of the trial, known as STELVIO, are based on 68
patients, 34 of whom received valves in the airways leading to the
least-healthy lung tissue. The rest were in the control group,
receiving standard medical care, but not lung reduction surgery.
Improvements in breathing - when they came - often appeared within
days. With the valves in place, patients released 21 percent more
air in the first second when they tried to exhale. With standard
care the increase was just 3 percent, according to the results in
the New England Journal of Medicine.
[to top of second column] |
The distance patients could walk improved by nearly 20 percent. It
declined by more than 3 percent in the control group.
But 23 serious problems were reported in the valve group, compared
to only five among those who received standard care. The biggest
problem was unwanted air in the chest, which happened in 18 percent
of patients. The condition, known as pneumothorax, can be deadly.
Twelve percent of the volunteers who received the valves needed them
replaced, and 15 percent of the patients required removal. The one
death during the study was in the valve group.
"The nice thing about this treatment is that it's reversible, so if
you get complications it is possible to remove the valves," Klooster
said.
The findings were originally released in May at a meeting of the
American Thoracic Society.
The valves have not been approved in the U.S. They are being tested
at 21 U.S. centers as part of the LIBERATE study, for which doctors
are still seeking volunteers (http://1.usa.gov/1XZLhAr).
Pulmonx, the valve manufacturer, is financing LIBERATE. It was not
involved in STELVIO.
SOURCE: http://bit.ly/1HR3qyv New England Journal of Medicine,
online December 9, 2015.
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
