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New Deep Vein
Thrombosis (DVT) Registry data show clot
quickly removed, blood flow restored in
large Patient Registry
Newswise
— Registry data for more than 500 patients
presented at the Society of Interventional
Radiology’s 33rd Annual Scientific Meeting
show deep vein thrombosis (DVT) treatment
with the Trellis device breaks up a blood
clot in most patients much quicker than
using a drug alone.
Using imaging, the
device is guided directly to the clot via a
catheter in the vein. DVT occurs when the
blood clot either partially or completely
blocks the flow of blood in the vein.
The Trellis device
removes the blood clot and restores blood
flow much quicker than the current
catheter-directed thrombolysis (CDT)
technique, which uses a drug alone and can
take as long as two to three days to be
effective with the patient in an intensive
care unit.
“It gets the clot out
right away, restoring blood flow in the vein
while the patient’s blood becomes
sufficiently thinned by anticoagulation
medication to prevent blood clots in the
future.
"Patients experience dramatic relief
of pain, swelling and skin discoloration in
just a few hours,” says Gerard J.
O’Sullivan, M.D., interventional
radiologist.
Presently, this is the largest
commercial data registry by a manufacturer
to assess the effectiveness and safety of
this type of treatment for DVT.
“This is a very
significant advance in DVT treatment, which
hasn’t changed in more than 40 years,” added
O’Sullivan.
“The procedure is now so
commonplace where I work that the ER,
oncology and general medicine doctors all
refer patients directly to me for this
procedure because it works so well and is so
safe.
"With the aid of the Trellis device,
this interventional radiology procedure
could really change the way DVT patients are
treated and should become a standard of
care,” he said.
The Trellis device
combines the use of clot-busting drugs with
a drug dispersion device to break up the
clot, providing interventional radiologists
with physical assistance to break up the
clot faster.
Because the device disperses
the drug throughout the clot, it allows the
clot-dissolving drug to work much more
quickly—and often less drug is used, which
may lead to a decrease in the risk of
bleeding.
Currently, most
patients are put on anticoagulation
medication (blood thinners), which prevents
future clots but does not break up the
existing clot.
DVT can lead to serious
consequences, including pulmonary embolism
(PE) or post-thrombotic syndrome (PTS).
Approximately 200,000 individuals die
annually as a result of pulmonary embolism.
The standard initial treatment with blood
thinners is important to prevent a
life-threatening pulmonary embolism, but
does not treat the existing clot.
Removing these clots is
important because about 50 percent of the
time, untreated clots will cause PTS, a
condition characterized by chronic leg pain,
swelling and ulcers.
The clot may eventually
dissolve on its own, but in the meantime the
veins are permanently damaged. PTS is caused
by a combination of vein valve damage and
blocked blood flow in the vein from residual
thrombus (clot).
“My Trellis patients
not only felt better right away, but they
continued to feel good months later. With
anticoagulation alone, it may take days to
months for patients to feel better, and some
never feel better,” said O’Sullivan.
Some
larger clots do not break up on their own.
This leaves the patient with an underlying
obstruction or lesion that should be
corrected to prevent a future clot.
PTS—while not life threatening—limits a
person’s ability to walk or stand for a
period of time and can be disabling.
There is growing
awareness in the medical community about the
need to aggressively treat DVT. Increased
focus and awareness of DVT is being brought
by new initiatives and standards from a
variety of organizations including the
Office of the U.S. Surgeon General, the
Joint Commission and the American College of
Chest Physicians.
“All acute DVT patients
should be sent to the interventional
radiology department for a consult. We can
help their physicians determine the best
course of action. If the vein is completely
or severely blocked, immediate treatment is
needed.
Not all partial clots will require
treatment, but if the area is still swollen
after five to seven days, patients should
ask for an appointment with an
interventional physician at the hospital,”
said O’Sullivan. Interventional radiologists
are widely available across the United
States in most hospital radiology
departments.
Abstract 4: “An
Endovascular Approach to Deep Venous
Thrombosis Utilizing Isolated Thrombolysis
and Adjunctive Measures,” can be found at
http://www.SIRmeeting.org.
About the Study
There were 565 limbs treated in 532
patients. The vein was reopened in all
cases, and the treatment worked on acute or
chronic clots, which is important because
acute, fresh clots are more easily treated.
Sixty-eight percent of the patients’ thrombi
were in the iliac vein (large thigh vein),
19 percent in the smaller femoropoliteal
veins (in the leg area), and 13 percent in
the subclavian vein (arm and neck area).
Thrombus is generally
classified by how long it has been present
in the body; SIR’s Reporting Standards
define acute as 14 days or fewer, subacute
as 15 to 28 days and chronic as more than 28
days.
Thrombus was acute in
28 percent, acute on chronic in 44 percent,
11 percent subacute, 12 percent subacute on
chronic and chronic in 6 percent, per the
SIR clot-age classification guidelines.
Combined Grades II and III lysis (> 50 to
100 percent thrombus removal) were
established in 96.8 percent of acute onset
of symptoms, 93.6 percent in acute on
chronic, 96.7 percent in subacute, 89.2
percent in subacute on chronic and 90.9
percent with chronic onset of symptoms, with
venous patency achieved in all cases. No
adverse events were reported in the acute
procedural follow-up period.
Venous
angioplasty, and/or stenting, were also used
in the study in conjunction with the Trellis
procedure to treat underlying problems
depending on individual patient needs, such
as a narrow area in the vein that would make
a person susceptible to future clots.
About The Trellis®-8
Infusion System
The Trellis®-8 Infusion System is positioned
at the site of the clot and a balloon is
inflated on both sides of the clot to
prevent pieces of the clot from traveling to
other parts of the body and to isolate the
treatment zone, so that there is less chance
the infused drug will cause bleeding.
Then a
“dispersion wire” is fed through the
catheter of the system. The wire begins to
rotate, mixing the clot-busting drug within
the clot; the clot pieces are aspirated into
the catheter and removed from the body.
The Trellis is approved
by the Food and Drug Administration (FDA) as
a drug-infusion catheter for peripheral
vascular clots. The drug and device have
been used for years to remove blood clots
from arteries and veins. The data are
specific to DVT, showing that it works and
is safe.
About the Society of
Interventional Radiology
Interventional radiologists are physicians
who specialize in minimally invasive,
targeted treatments. They offer the most
in-depth knowledge of the least invasive
treatments available coupled with diagnostic
and clinical experience across all
specialties.
They use X-ray, MRI and other
imaging to advance a catheter in the body,
usually in an artery, to treat at the source
of the disease internally. As the inventors
of angioplasty and the catheter-delivered
stent, which were first used in the legs to
treat peripheral arterial disease,
interventional radiologists pioneered
minimally invasive modern medicine.
Today many conditions
that once required surgery can be treated
less invasively by interventional
radiologists. Interventional radiology
treatments offer less risk, less pain and
less recovery time compared to open surgery.
Visit
http://www.SIRweb.org.
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