Patient Information Brochure Abdominal Aortic Aneurysms

Transcription

1 Patient Information Brochure Abdominal Aortic Aneurysms

2 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. 2 abdominal aortic aneurysm

3 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 Have high blood pressure Have high cholesterol Are overweight Have a family history of cardiovascular or peripheral vascular disease (a narrowing of 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 prevalence & causes/symptoms 3

4 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. 4 treatment

5 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 Treovance 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 5

6 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 6 the recovery

7 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 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. 3. Willing and able to comply with 1-month, 6-month, and 12-month follow-up visits.. 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) 5. Subject has an active systemic infection or is suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis) 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) 10. Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester participants 7

8 The Treovance Abdominal Stent-Graft by Bolton Medical Manufacturer: Bolton Medical España S.L.U. C/Newton, 18-24, Sant Esteve Sesrovires, Barcelona, Spain Exclusively for Clinical Investigations. CAUTION - Limited by U.S. Law to investigational use Other Premises: Bolton Medical, Inc. 799 International Parkway, Sunrise, FL