Patient Information Brochure Abdominal Aortic Aneurysms

Patient Information Brochure
Abdominal Aortic Aneurysms
T
his brochure is provided by Bolton Medical to offer you information about the Abdominal
Stent Grafting repair and the Treovance® Stent-Graft System to treat your abdominal aortic
aneurysm.
Please read this information and discuss any questions you may have with your doctor.
“An Abdominal Aortic
Aneurysm is an
abnormal swelling
or bulge in your
abdominal aorta.”
Abdominal Aortic Aneurysm
What Is an Abdominal Aortic Aneurysm or AAA?
An Abdominal Aortic Aneurysm or AAA is an abnormal swelling or bulge in your abdominal
aorta. The aorta is your body’s largest artery and carries oxygen-filled blood from your heart to
all parts of your body. In your abdomen, the aorta splits into the iliac arteries, which carry blood
to your legs and lower areas of your body.
The abdominal aorta normally ranges in diameter from 2 to 2.5cm, roughly the size of a 2 Euros
coin. An aneurysm can cause it to grow to several times its natural size, weakening it, and possibly causing it to rupture, depending on the size. A rupture can lead to internal bleeding, and
possibly death.
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abdominal aortic aneurysm
CAUSES
What Causes an Abdominal Aortic Aneurysm?
Abdominal aortic aneurysms are most often caused by a weakening in the aorta, resulting from
vascular disease, traumatic injury or a genetic defect.
In addition, as you age, continuous high blood pressure can cause the aorta to bulge out, thin
and weaken, resulting in an aneurysm. Those primarily at risk are men over 60, smokers, and
those with a family history..
Your risk for an abdominal aortic aneurysm increases if you:
• Are a smoker
• Are overweight
• Have high blood pressure
• Have a family history of cardiovascular or
peripheral vascular disease (a narrowing of
• Have high cholesterol
the blood vessels)
SYMPTOMS
What Are the Symptoms of an Abdominal Aortic Aneurysm?
Abdominal aortic aneurysms may go unnoticed initially because patients may not feel any symptoms.
When symptoms are experienced, the most common are
• Pain in the chest, abdomen, or lower back, possibly spreading to the groin, buttocks, or legs.
The pain may be deep, aching, gnawing, and/or throbbing, and may last for hours or days.
It is generally not affected by movement, although certain positions may be more comfortable
than others.
• A pulsating sensation in the abdomen.
• Back pain, if the aneurysm is pressing on the spine.
• A “cold foot” or a black or blue painful toe if an AAA produces a blood clot that breaks off
and blocks blood flow to the legs or feet.
• Fever or weight loss, if it is an inflamed/infected aortic aneurysm.
*EMedicineHealth Online 2011.
prevalence & causes/symptoms
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TREATMENT
How Is an Abdominal Aortic Aneurysm Treated?
Treatment for an abdominal aneurysm depends on its size, location and your overall health. If
your doctor feels the aneurysm is at risk to burst or rupture, the treatment is generally either open
surgery or endovascular surgery, a newer and less invasive treatment.
Conventional Open Surgery
In conventional or open surgery, the surgeon reaches the aneurysm through a large incision in the
abdomen. The weakened section of the vessel, where the aneurysm has formed, is usually surgically
removed and replaced with a synthetic material. Open surgery is usually performed under general anesthesia and takes about three or four hours to complete. Repairing the aneurysm surgically is complex
and requires an experienced vascular surgical team. After your
surgery, you would normally stay
in the Intensive Care Unit a day or
two, and then another five to seven days in the hospital, depending on how your body heals. Your
recovery time may be about 3 to
6 months before you feel able to
resume your normal activities.
Endovascular
Abdominal Stent-Grafting
In recent years, an alternate treatment known as Endovascular Abdominal Stent-Grafting has
been developed. It involves two small incisions in the groin area, where the stent-graft is inserted
into the femoral artery via a catheter to reline the abdominal aorta. By avoiding major surgery,
this less invasive procedure may result in less blood loss, less trauma to the heart valve, fewer
days of hospitalization and a potentially faster recovery time.
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treatment
The Bolton Difference
Abdominal Stent-Grafting with the Treovance® Stent-Graft
Endovascular Abdominal Stent-Grafting is a treatment modality invented in the early 1990s by
vascular surgeons as a less invasive endovascular method of repair of an abdominal aortic aneurysm (AAA) and has rapidly expand as a treatment of choice due to its clinical benefits.
Now Bolton Medical is offering an updated an improved device for the abdominal stent-graft repair.
The Treovance® Abdominal Stent-Graft
is a woven fabric tube supported by
a tubular metal scaffold. The device is
placed inside the diseased abdominal
aorta without a major surgical incision
and seals off the aneurysm by fitting
inside the diseased part of the aorta,
making a new path for blood to flow.
The procedure begins with the Treovan­
ce Abdominal Stent-Graft being inserted
through small incisions in the groin.
Catheters are used to guide and deliver
a stentgraft through the blood vessels to
the site of the aneurysm. It is then positioned in the diseased part of aorta to
isolate it and divert blood flow away
from the aneurysm.
The Treovance® Abdominal Stent-Graft surgery can be done under general, regional or local
anesthesia and typically takes 1 to 3 hours to complete. Your hospital stay may only last a few
days, and you should be back to your normal activities within 2-6 weeks after the procedure. Of
course, you’ll need to follow up regularly with your doctor, so they may evaluate the success of
your treatment over time.
the Bolton difference
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The Recovery
What Should I Expect After the Procedure?
Immediately after the procedure, your doctor may ask you to lay flat for several hours, allowing the
healing process to begin. Once you start getting up and around, any pain or swelling you experience should begin to decrease and you should be released from the hospital within a few days.
Your doctor will discuss your follow-up plan,
which will probably include check-ups at
one month, six months, twelve months, and
annually thereafter
“ENDOVASCULAR
ABDOMINAL
STENT-GRAFTING IS A
TREATMENT MODALITY
THAT INVENTED
IN THE EARLY 1990s
AND HAS RAPIDLY EXPAND
AS THE TREATMENT
OF CHOICE DUE TO
ITS CLINICAL BENEFITS”
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the recovery
PARTICIPANTS
Who Can Participate in the
Treovance® Stent-Graft Clinical Trial?
Main Criteria for Inclusion
You may be considered for the Bolton AAA trial if you are:
1. Between the ages of 18 and 85
3. Willing and able to comply with 1-month,
6-month, and 12-month follow-up visits.
2. Diagnosed with an infrarenal abdominal
aortic aneurysm (AAA), with or without
.
iliac artery involvement, by CT with contrast performed within 3 months of planned
implant procedure.
Main Criteria for Exclusion
Subjects may not enroll into the study if any of the following apply:
1.Subject has a ruptured or symptomatic
aneurysm
2. Subject has severe untreated coronary artery
disease and/or unstable angina, significant
areas of myocardium at risk (based on coronary angiogram or radionuclide scans),
left ventricular ejection fraction <20%, or
recent diagnosis of CHF
3. Subject has had a stroke or MI within 6
months of the planned treatment date
4. Subject has chronic obstructive pulmonary
disease requiring routine need for oxygen
therapy outside the hospital setting (e.g.,
daily or nightly home use)
6. Subject is morbidly obese (more than 100%
over the ideal body weight or as defined by
institutional standards) or has other clinical
conditions that severely compromise or impair x-ray visualization of the aorta
7. Subject is in acute or chronic renal failure
(creatinine > 2.5 mg/dL)
8. Subject is participating in another research
study, has received investigational study
drug within 30 days of screening, or has received an investigational device within one
year of screening
9. Subject has had a prior AAA repair (endovascular or surgical)
5. Subject has an active systemic infection or
10.Subject has an untreatable allergy or sen-
is suspected of having an active systemic
sitivity to contrast media, nitinol/nickel, or
infection (e.g., AIDS/HIV, sepsis)
polyester
participants
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The Treovance ® Abdominal Stent-Graft
by Bolton Medical
www.treovance.com
www.boltonmedical.com
Manufacturer: Bolton Medical España S.L.U. C/Newton, 18-24, 08635 Sant Esteve Sesrovires, Barcelona, Spain +34-93-817-63-00
Exclusively for Clinical Investigations. CAUTION - Limited by U.S. Law to investigational use
Other Premises: Bolton Medical, Inc. 799 International Parkway, Sunrise, FL 33325 +1-954-838-9699.