PATIENT INFORMATION BOOKLET Edovascular Stet Grafts: A Treatmet for Abdomial Aortic Aeurysms
TABLE OF CONTENTS Itroductio 1 Glossary 2 Abdomial Aorta 4 Abdomial Aortic Aeurysm 5 Causes 6 Symptoms 6 Treatmet Optios 6 Ope Surgery 7 Edovascular Stet Graftig 8 Abdomial Stet Graft 9 Risks 11 Beefits 12 Abdomial Stet Graft Procedure 13 What Symptoms Should Prompt You to Call Your Doctor After the Procedure? 16 Follow-Up 16 Implated Device Idetificatio Card 16 Magetic Resoace Imagig 17 Lifestyle Chages 17 Questios You May Wat to Discuss with Your Doctor 17 Additioal Iformatio 19 INTRODUCTION You have discussed havig a stet graft procedure to treat a abdomial aortic aeurysm (AAA) with your doctor. Your doctor has give you this guide to help you further uderstad the device ad procedure. Oly a doctor ca determie if you are a good cadidate for a abdomial stet graft procedure. A Glossary is provided i the ext sectio to help you uderstad the medical terms used i this book. Words that are bolded i the text are defied i the Glossary. There are two stet graft types available: bifurcated ad aorto-ui-iliac (AUI). Your physicia will determie which stet graft is best for you but i geeral, a AUI stet graft is used whe a bifurcated stet graft caot be used. This booklet will provide you with more iformatio about the stet graft types. Please ote that additioal procedures may be eeded with the use of a AUI stet graft, which you should discuss with your doctor. The image o the cover is the Edurat Stet Graft. This booklet applies to all Medtroic abdomial aortic stet grafts. 1
GLOSSARY Abdomial aortic aeurysm (AAA): A bulgig or ballooig of a weakeed area of the abdomial aorta. This term is ofte called AAA. Aatomy: The study of parts of the body. Aeurysm rupture/rupture: A tear i the blood vessel wall ear or at the locatio of the weakeed area of the blood vessel. Aorta: The mai artery that carries blood from the heart to the rest of the body. Aorto-ui-iliac (AUI) stet graft: A type of stet graft used to treat abdomial aortic aeurysms. This type of stet graft exteds from the aorta dow to oe of the two iliac arteries that supply blood to the legs. Refer to Figure 5 for illustratio of the AUI stet graft. Bifurcated stet graft: A type of stet graft used to treat abdomial aortic aeurysms. This type of stet graft exteds from the aorta dow to the two iliac arteries that supply blood to the legs. Refer to Figure 5 for illustratio of the bifurcated stet graft. Computed Tomography (CT) sca: A sca that creates a series of X-rays that form a picture of the aeurysm ad earby blood vessels. Edoleak: Blood flow ito the aeurysm (bulge or ballooig of the weakeed area of the blood vessel) after placemet of a stet graft. Edovascular: Iside or withi a blood vessel. Edovascular stet graftig: A procedure i which a tube-shaped device is placed iside a diseased vessel without surgically opeig the tissue surroudig the diseased vessel. Exclude: Shuttig off or removig from the mai part. Femoral arteries: Blood vessels that carry blood to the thigh regio of each leg. Doctors ca use these arteries as pathways to reach the aorta. Refer to Figures 4 ad 6 for a illustratio of the locatio of the femoral arteries. Femoral-femoral artery bypass: A type of surgery that is performed as part of some edovascular stet graft procedures. A portio of oe iliac artery o oe side of the patiet is itetioally blocked if required ad if ot already blocked. Blood flow to the leg o this side is preserved by surgically coectig the femoral artery that is below the blocked portio to the femoral artery of the other leg, usig a fabric graft. Refer to Figure 8 for illustratio of the femoral-femoral artery bypass. Fluoroscopy: A real-time X-ray image that is viewed o a moitor. This is a imagig techique geerally used by doctors to see the placemet of the stet graft durig edovascular procedures. Iliac arteries: Blood vessels that carry blood to the lower back, groi, ad buttocks. Refer to Figures 1 ad 2 for a illustratio of the locatio of the iliac arteries. Imagig: The use of X-rays, CT scas, MRI scas or other techiques to obtai pictures of the iside of the body. Miimally ivasive: Ivolvig a pucture or cut of the ski without exposig the iteral orgas. Magetic resoace imagig (MRI): A techique that uses magetic fields to form images of structures withi the body. Occlusio device: Device used durig some edovascular procedures to stop or prevet backward flow of blood ito a artery. Ope surgery/ope surgical repair: A type of surgery performed to repair a aeurysm. The doctor repairs the aorta by makig a large cut i the abdome. The weakeed area of the aorta is removed ad replaced with a fabric graft. The graft is sew ito place ad acts as a replacemet blood vessel. Stet graft/abdomial stet graft: A wove polyester tube supported by a tubular metal web that is placed iside of a diseased vessel without surgically opeig the surroudig tissue. After beig placed i the artery, the stet graft expads ad relieves the pressure o the aeurysm by providig a ew pathway for blood flow. Ultrasoud: A imagig techique that creates a image through the use of high-frequecy soud waves. 2 3
ABDOMINAL AORTA The aorta is the largest blood vessel i the body. It carries blood away from the heart to the rest of the body. The abdomial aorta is the part of the aorta located i the abdome (see Figure 1). ABDOMINAL AORTIC ANEURYSM A aeurysm is the bulgig or ballooig of a weakeed area of a blood vessel. The wall of the aorta ca become weak due to age, disease or trauma. This may cause the aortic wall to bulge, leadig to a AAA (see Figure 2). As the bulge grows, the wall of the aorta becomes weaker. This may cause the aorta to rupture ad lead to massive iteral bleedig. A aeurysm rupture ca cause death ad eeds immediate medical attetio. Heart Heart Real arteries Real Arteries Kidey Iliac arteries Abdomial aorta Iliac arteries AAA FIGURE 1 Abdomial Aorta (ormal) FIGURE 2 Abdomial Aortic Aeurysm 4 5
CAUSES The risk of developig a AAA icreases with age. AAA usually affects people over 50 years of age ad is more commo i me tha i wome. Other risks iclude smokig ad high blood pressure. A patiet with a family history of AAA is at higher risk ad should cosult a doctor. SYMPTOMS I most cases, patiets have o symptoms of a AAA. However, for those patiets with symptoms, the most commo oe is pai i the abdome, back or chest. The pai may rage from mild to severe. Some patiets might feel the aeurysm as a throbbig mass i their abdome. A AAA is ofte discovered durig a examiatio beig doe for other urelated health reasos. Your doctor may feel a bulge or pulsatio (throbbig) i your abdome. Most ofte, aeurysms are foud durig a medical test such as a CT sca or ultrasoud. TREATMENT OPTIONS If your doctor thiks there is a risk that your AAA may rupture, he/she may recommed treatmet. There are two primary treatmet optios available depedig o your doctor s diagosis: OPEN SURGERY or ENDOVASCULAR STENT GRAFTING OPEN SURGERY I this treatmet optio, the doctor repairs the aorta by makig a large cut i the abdome (see Figure 3). The aeurysm sectio of the aorta is removed ad replaced with a fabric graft. The fabric graft is sew ito place ad acts as a replacemet blood vessel. The blood flow through the aorta is stopped while the graft is put i place. Ope surgery is typically performed uder geeral aesthesia. It takes about three to four hours to complete. Patiets typically sped oe to two days i a itesive care uit ad typically remai i the hospital for oe week. Patiets may require two to three moths to recover completely. Ope repair is a prove medical procedure. Icisio made i the abdome to repair the AAA AAA Kidey FIGURE 3 Ope Surgical Repair 6 7
ENDOVASCULAR STENT GRAFTING This is a miimally ivasive procedure. A stet graft (such as the abdomial stet graft) is placed iside the aeurysm without surgically opeig the tissue surroudig it (see Figure 4). The stet graft is a fabric tube supported by a metal framework. The placemet of a AUI stet graft may require a additioal procedure, such as femoral-femoral artery bypass ad/or placemet of a occlusio device i your iliac artery (see Figure 8). Miimally ivasive edovascular aeurysm repair usig the abdomial stet graft This procedure is typically performed uder local, regioal or geeral aesthesia. It takes about oe to three hours to complete. Patiets typically sped a few hours i the itesive care uit ad typically remai i the hospital for oe to two days. Patiets may require four to six weeks to recover completely. Catheters Femoral arteries AAA Kidey The recovery time for a patiet who receives a AUI stet graft device alog with a femoral-femoral artery bypass would be differet tha if you received a bifurcated stet graft device because of the additioal femoralfemoral artery bypass beig performed. The typical hospital stay would be approximately 4-7 days for a patiet receivig a AUI stet graft device ad a femoral-femoral artery bypass, with the full recovery lastig as log as the bypass icisios take to fully heal which could be about 4-6 weeks. Your medical history i combiatio with your arterial aatomy may make you a better cadidate for a AUI stet graft rather tha a bifurcated stet graft ad/or ope surgical repair. Risks ad beefits are associated with both treatmet optios. Patiets should talk with their doctors about which optio is best for them. ABDOMINAL STENT GRAFT FIGURE 4 Edovascular Stet Graftig The abdomial stet graft is a fabric tube supported by a metal framework (see Figure 5). It is placed i the aorta usig a catheter. The stet graft is desiged to exclude the aeurysm. The stet graft reduces the pressure o the aeurysm ad provides a ew pathway for blood flow. This reduces the risk of rupture. The abdomial stet grafts maufactured by Medtroic are typically made from itiol (ickel-titaium), polyester ad platium-iridium. Do ot get the abdomial stet graft if: You have a coditio that ca ifect the stet graft You are allergic to the stet graft materials 8 9
There are two stet graft types available: Bifurcated ad AUI. Your medical history i combiatio with your arterial aatomy may make you a better cadidate for a AUI stet graft rather tha a bifurcated stet graft ad/or a ope surgical repair. Your doctor ca help determie if the abdomial stet graft is suitable for you. Edurat II Bifurcated Stet Graft System Tubular metal web Wove polyester tube (white portio) Edurat II Aorto-Ui-Iliac Stet Graft System FIGURE 5 Edurat II AAA Stet Graft System* I some cases, your physicia may choose to implat EdoAchor implats at oe ed of the stet graft to help keep it i place ad reduce the potetial for edoleaks. EdoAchor implats are a series of small metallic coils that hold the stet graft to the artery wall to keep the stet graft from movig. If this occurs, you ca expect the same basic risks ad beefits from the treatmet ad the same precautios ad follow-up istructios would apply. * NOTE: The stet grafts show i the figure above are ot represetative of the actual size. The bifurcated stet grafts maufactured by Medtroic rage i legth from 124 mm (4.88 i.) to 166 mm (6.54 i). The aorto-ui-iliac (AUI) stet grafts maufactured by Medtroic have a legth of 102 mm (4.02 i). 10 RISKS As with ay edovascular stet graft, the abdomial stet graft comes with risks. Please discuss all risks with your doctor. Major risks associated with abdomial edovascular stet grafts iclude, but are ot limited to: Edoleaks A edoleak is the leakig of blood aroud the graft ito the aeurysm. Edoleaks ca be detected usig CT scas. Most edoleaks do ot require treatmet. Your doctor ca decide if you eed ay treatmet. Stet graft movemet This is the movemet of the stet graft from its origial positio over time. This ca be assessed usig imagig techiques like CT scas. Your doctor ca decide if you eed ay treatmet. Device-related issues (for example, breakig sutures or the metal portio of the stet graft or the EdoAchor implat (if used)) These issues may be detected usig imagig techiques such as X- rays. Your doctor ca decide if you eed ay treatmet. Aeurysm rupture The use of this device requires fluoroscopy ad use of dyes for imagig.patiets with kidey problems may be at risk of kidey failure due to the use of dyes. Swellig of the groi area Nausea ad vomitig A hole or a tear of the blood vessels are risks associated with ay catheter-based procedure. These risks may icrease with the use of large-sized catheters. Formatio of a abormal passage betwee your arteries ad veis Bowel complicatios icludig death of a portio of your bowel tissue requirig surgical removal Crampig pai ad weakess i the legs ad especially the calves Formatio of blood clots that block the flow of blood to your orgas Fever ad iflammatio Problems affectig your uriary ad reproductive orgas icludig ifectio ad tissue death Impotece Ifectio of the aeurysm ad device access site 11
ABDOMINAL STENT GRAFT PROCEDURE Complicatios of the ervous system icludig total or partial paralysis of the lower half of the body with ivolvemet of both legs, cofusio, stroke, ad trasiet ischemic attack Blockage of the device or blood vessel Kidey problems Liver problems Additioal edovascular procedures Surgical coversio to ope surgical repair Ifectio, pai or bleedig i wouds Reduced blood flow to the legs resultig from complicatios of the femoralfemoral artery bypass or ay device used durig the edovascular procedure Death BENEFITS There are a umber of beefits 1 to havig a abdomial stet graft procedure. Some of these are listed below: The procedure is miimally ivasive. The procedure ca be performed uder local aesthesia. There is a lower surgical complicatio rate. The patiet may lose less blood durig the procedure. This reduces the risk of blood trasfusio. The patiet may sped less time i the itesive care uit after the procedure, ad have a short hospital stay. BEFORE THE PROCEDURE: Prior to the procedure, imagig tests like CT scas are performed. These tests allow the doctor to assess the aeurysm. Your physicia will determie which stet graft is best for you based o your pre-procedure imagig. DURING THE PROCEDURE: This procedure is performed usig aesthesia. A small cut is made o both sides of the groi to prepare for the stet graftig procedure. Fluoroscopy is used to guide the catheter to the AAA. The catheter is a log, thi tube-like device used to place the stet graft i the aorta. The catheter is advaced through the large vessel i the patiet s groi (femoral artery) to reach the abdomial aeurysm (see Figure 6). Femoral arteries Catheters beig iserted ito a patiet s groi Kidey AAA 1 Based o cliical study data for abdomial stet grafts maufactured by Medtroic. The log-term results of the abdomial stet graft have ot yet bee established. FIGURE 6 Isertio of the Catheters 12 13
The stet graft is slowly released from the catheter ito the aorta. As the stet graft is released, it expads to its proper size so that it sugly fits ito the aorta both above ad below the aeurysm. The catheter is the removed from the body. The stet graft remais iside the aorta permaetly (see Figure 7). Additioal stet grafts may be required to completely exclude the aeurysm. Imagig procedures are ofte performed to check whether the stet graft is properly placed. AFTER THE PROCEDURE: Immediately after recovery from the stet graftig procedure, you may be required to lay flat for four to six hours. This will allow the leg wouds to start healig. Some mild discomfort may be felt at the wouds i the groi. This usually resolves i two days. Side effects may iclude swellig of the groi area, umbess of the legs, ausea, vomitig, leg pai or throbbig, lack of appetite, fever ad/or absece of bowel movemet for oe to three days. AAA Abdomial stet graft AAA Aorto-Ui-Iliac stet graft Femoral- Femoral Artery Bypass** Talet Occluder* FIGURE 7 Abdomial Stet Graft Iside the Aeurysm FIGURE 8 Abdomial AUI Stet Graft Iside the Aeurysm with a Femoralfemoral Artery Bypass I situatios where oly oe iliac artery is available, your doctor may decide to use a AUI stet graft. This device may treat the aeurysm without requirig two ope iliac arteries. I this situatio, a occlusio device is typically placed i oe iliac artery (if it is ot already blocked) ad a femoral-femoral artery bypass is performed to maitai blood flow to both legs. 14 * Ay commercialized occludig devices or occludig techique ca be used ** Femoral-femoral Artery Bypass is a additioal surgical procedure which may be required i some cases based o physicia s discretio. 15
WHAT SYMPTOMS SHOULD PROMPT YOU TO CALL YOUR DOCTOR AFTER THE PROCEDURE? If you experiece ay of the followig symptoms, cotact your doctor immediately: Pai, umbess, coldess or weakess i the legs or buttocks Ay back, chest, abdomial or groi pai Dizziess, faitig, rapid heartbeat or sudde weakess A doctor should also be called if you eed to reschedule a follow-up visit for ay reaso. FOLLOW-UP It is importat to schedule regular follow-up visits with your doctor. Log-term results of the stet graft have ot yet bee established. Most problems with edovascular repair do ot have symptoms. Thus, follow-up is importat to determie the success of your stet graft. Follow-up visits will help the doctor to check your aeurysm ad stet graft o a regular basis. Some problems that might occur are listed i the Risks sectio of this booklet. Your doctor will schedule follow-up visits depedig o your coditio. Most ofte these will occur at oe moth, oe year ad aually thereafter. At each visit, imagig such as CT scas will be carried out to determie the performace of the stet graft. If you have poor kidey fuctio, you should ask your doctor about the dyes used i some of these imagig studies, as they may be harmful. Alog with other imagig to assess the stet graft device type, your physicia will ask you to have a ultrasoud to assess the femoral-femoral artery bypass. Your physicia will work with you to provide you with the appropriate timig ad frequecy of follow-up imagig for both the femoral-femoral artery bypass ad the stet graft device. IMPLANTED DEVICE IDENTIFICATION CARD After your abdomial stet graft procedure, your doctor will give you a temporary implated device idetificatio (ID) card. The temporary implated device ID card will tell you the size ad umber of your abdomial aortic stet graft implats. Medtroic will mail you a permaet implated device ID card to carry i your wallet. Your permaet ID card will list the followig iformatio: Type of device implated Date of implat Your doctor s iformatio Magetic Resoace Imagig (MRI) iformatio Be sure to tell all of your healthcare providers that you have the stet graft ad show them your implated device ID card. You should keep your patiet ID card available at all times. MAGNETIC RESONANCE IMAGING After beig implated with the abdomial stet graft maufactured by Medtroic, it is still safe to have MRI procedures, uder certai coditios. MRI iformatio is provided o your implated device ID card. Show this ID card to your healthcare providers. LIFESTYLE CHANGES You will eed to go for regular follow up visits to check your stet graft. Please cosult your doctor about your ability to perform streuous physical activities. The abdomial stet graft is ot expected to trigger ay passeger screeig devices such as airport security scaers. Please cosult your doctor to reschedule ay follow up visits if you are travelig. QUESTIONS YOU MAY WANT TO DISCUSS WITH YOUR DOCTOR What are the other optios for treatig AAA? Which stet grafts are approved for treatig AAA? 16 17
What are all of the risks associated with a abdomial stet graft procedure? What are all of the risks associated with ope surgical repair? Will health isurace pay part or all of the costs associated with this procedure? After the procedure, how ofte must a doctor follow up with the patiet, ad which tests will be performed? Does a patiet have to limit activities after treatmet? If so, for how log? How log ca the stet graft remai implated i the body? How may stet graft procedures has this facility performed? If I am havig a AUI stet graft procedure, what additioal procedures might be required? If a femoral-femoral artery bypass is required, whe will this be doe ad what are the risks associated with this procedure? If a occlusio device is required, what does this procedure ivolve ad what are the risks associated with this procedure? This guide is ot a substitute for detailed discussios betwee you ad your doctor. Oly your doctor ca decide if this procedure is suitable for you. This therapy is ot for everyoe. Please cosult your doctor. Prescriptio is required. ADDITIONAL INFORMATION Additioal iformatio regardig AAA ca be foud at: www.medlieplus.gov www.fda.gov CONTACTING MEDTRONIC: If you have ay questios cocerig a abdomial stet graft maufactured by Medtroic, you should cotact your doctor. It is Medtroic s missio to alleviate pai, restore health ad exted life. If there is aythig that we as a compay ca do to assist you, please feel free to cotact us at: Medtroic 3576 Uocal Place Sata Rosa, CA 95403 USA CardioVascular LifeLie Customer Support Tel: 877.526.7890 Tel: 763.526.7890 18 19
NOTES NOTES
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