A new study finds that an
experimental device implanted in the heart can relieve the chest pain of heart
disease in people who aren't candidates for stents or surgery.
Instead of opening up a blood
vessel, the novel device narrows it.
It's called the Reducer, and
it restricts the flow of blood leaving the heart, causing blood to back up into
areas of the heart muscle that aren't getting enough nourishment, which
relieves the angina.
In a small test published in the New
England Journal of Medicine, more than a third of 52 angina patients found
major relief six months after the reducer was implanted, compared to 15 percent
of 52 volunteers who underwent a fake implantation procedure.
In an editorial, the research team the Duke Clinical Research Institute in Durham, North Carolina, and
Bernard Gersh of the Mayo Clinic in Rochester, Minnesota, said that if the
results are confirmed in larger trials, the technique "may be a welcome
and needed addition to the options to improve the quality of life of patients
with refractory angina."
All the patients had previously
failed to get relief with drug therapy. Most had already been treated with
stents or bypass surgery.
These patients have chest pain in
every minor physical activity and they don't have any other options for
treatment.
Overall, there was no significant
improvement in the amount of time that device recipients could exercise, a key
yardstick for measuring the debilitating effects of angina.
In the device group, exercise time,
which averaged 7 minutes 21 seconds before implantation, increased by only 59
seconds. In the control group, it rose by just 4 seconds.
The device is made of stainless
steel mesh, like early stents. But in this case, once expanded in the blood
vessel the device assumes the shape of an hour glass.
Eventually, tissue from the wall of
the blood vessel grows over the mesh, leaving only a narrow passage in the
center. That shape constricts the flow of blood leaving the heart muscle..
Right after implantation, nothing
happens. If you ask the patient two or three weeks after implantation, he/she doesn't see any improvement. Then, after a month or six weeks, after the mesh
is covered with tissue, there is a pressure gradient. Then it becomes beneficial
and improves symptoms.
This is a simple procedure.
Implantation takes 10 to 20 minutes. The patient goes home the same day. A
month or two after implantation, their quality of life is markedly improved.
Success was judged by a four-point
scale of angina symptoms that assessed whether the degree to which a person's
physical activity was limited because of chest pain. While only 15 percent of
those getting fake surgery improved by 2 points on the scale, 35 percent of the
reducer recipients did.
When success was measured by an
improvement of 1 point, 71 percent of the people who got the device improved
versus 42 percent in the fake-treatment group.
A high rate of success in the sham
treatment group was expected.
These chronic, no-option patients
are very eager to believe they feel better, and some of that is in the brain. The
research team anticipated about 30 percent (improvement with sham therapy).
However,
they got more than 40 percent, which is a bit surprising. Yet despite this huge
placebo effect, the fact that the study was positive was amazing. This means the
device is really effective.
The study was financed by Neovasc
Inc., which makes the device. It has been approved for use in the European
Union but is not yet for sale. It has not been approved by the U.S. Food and
Drug Administration.
It is important to realize that the
results of this small study are preliminary and depend heavily on the
subjective report of relief of discomfort by the study subjects.
Before thinking about using the
device in patients, doctors need to know more about how it works and its long-term
safety.
Reference:
Fox News
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