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Improved Foam
for Varicose Veins found to be safe in
preliminary results from Phase II Trial
Newswise — A
small group of patients with a common heart
defect which was treated for varicose
veins with an injectable microfoam
experienced no neurological, visual or
cardiac changes as a result of the
treatment, according to preliminary results
from a phase II trial.
The results were
presented in Washington, D.C., at the
annual scientific meeting of the Society of
Interventional Radiology (SIR).
Injectable foams are
usually made by mixing a sclerosant, an
irritant that causes damage to the vein wall
and subsequent scarring, with room air.
Sclerosant foams have
been a standard treatment since 1997 for
spider veins and small varicose veins.
Varisolve®, a foam made with carbon dioxide,
is relatively painless compared to other
sclerosants, which can cause burning, said
John D. Regan, M.D., clinical director of
the Interventional Section in the Department
of Radiology at Wake Forest University
Baptist Medical Center.
Veins in the leg have
valves that are designed to prevent blood
from flowing backward as it returns to the
heart.
Varicose veins
are caused by weakened valves (commonly in
the great saphenous vein, the large vein
running up the inner side of the leg) which
allow blood to flow backward and pool in the
veins in the leg.
The resulting high
pressure causes veins to expand like
balloons and become tortuous or twisted. The
latest treatments involve blocking the great
saphenous vein (GSV) to prevent the
backflow, called reflux.
The Varisolve foam
injection procedure is a less invasive
alternative to surgical techniques and
intravenous techniques that close the vein
with radiofrequency ablation or laser
energy.
Although any air-based
foam carries a theoretical risk to the
patient because of the insolubility of air
in the blood, the risk is small, said Regan,
the presenting author of the phase II
trial’s preliminary results.
“We believe that the
carbon-dioxide-based foam used in Varisolve
will be totally safe due to the small size
of the bubbles, the consistency of the foam
and the solubility of carbon dioxide.”
However, patients with
a right-to-left shunt in their hearts – a
common, usually asymptomatic heart defect in
about one-fourth of the population – are at
increased risk of foam bubbles crossing the
shunt and going to the brain or heart
without being filtered in the lungs,
according to Regan.
These patients,
the subjects of the study, are continuously
monitored by transcranial Doppler ultrasound
of the brain before, during and after the
procedure.
They also undergo
magnetic resonance imaging (MRI) of the
brain, visual testing, neurological
examinations and examinations for changes in
cardiac markers in the blood.
During the procedure, a small catheter is
placed in the malfunctioning GSV, and the
Varisolve foam is injected into the vein.
The GSV is compressed
in the groin to trap the foam in the leg and
additional foam is injected. The patient’s
leg is then put in a compression dressing
and stocking, and the patient is able to get
up and walk immediately.
In more than 90 percent
of the 28 patients studied so far (13 at
Wake Forest Baptist) at six research sites
across the country, tiny bubbles have been
detected in the blood during the procedure.
However, no
neurological, visual or cardiac changes were
observed in the monitoring. The study will
continue until a total of 50 patients have
been treated and monitored.
The study was funded by
a grant from BTG International, the maker of
the Varisolve foam. Co-researchers include
Brian Kouri, M.D., of Wake Forest Baptist,
Kathleen D. Gibson, M.D., and Brian Ferris,
M.D., of Lake Washington Vascular, Bellevue,
Wash., Vincent L. Rowe, M.D., and Fred A.
Weaver, M.D., of Southern California
University Hospitals, Los Angeles, and Janet
E. Rush, M.D., and David D. Wright, M.B.,
F.R.C.S., of BTG International, West
Conshohocken, Pa.
Wake Forest University
Baptist Medical Center is an academic health
system comprised of North Carolina Baptist
Hospital and Wake Forest University Health
Sciences, which operates the university’s
School of Medicine.
U.S. News & World
Report ranks Wake Forest University School
of Medicine 18th in family medicine, 20th in
geriatrics, 25th in primary care and 41st in
research among the nation's medical schools.
It ranks 35th in
research funding by the National Institutes
of Health. Almost 150 members of the medical
school faculty are listed in Best Doctors in
America.
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