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 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, Drs. Christopher Granger of 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," the study’s senior
author Dr. Shmuel Banai of the Tel Aviv Medical Center in Israel
told Reuters Health. "I had a patient who had angina with minimal
effort. Today he is an instructor of classical dance. It really
makes a difference. It may not prolong life, but it really improves
quality of life."
But that example may not be typical.
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," said Banai. "If you ask
the patient two or three weeks after implantation, he 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," he said.
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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,
Banai said.
"These chronic, no-option patients are very eager to believe they
feel better, and some of that is in the brain," he said. "We
anticipated about 30 percent (improvement with sham therapy). We 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.
Dr. Elliott Antman, a senior physician in the Cardiovascular
Division of the Brigham and Women's Hospital in Boston who was not
connected with the study, advised caution.
"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." he told Reuters Health in an
email.
Before thinking about using the device in patients, Antman said,
doctors need to know more about how it works and its longterm
safety.
SOURCE: http://bit.ly/1 AhcmIe New
England Journal of Medicine, online February 4, 2015.
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