A Patient’s Guide To Minimally Invasive Abdominal Aortic .
A Patient’s Guide to Minimally InvasiveAbdominal Aortic Aneurysm Repair
Table of ContentsThe AFX Endovascular AAA System* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1What is an Abdominal Aortic Aneurysm (AAA)?. . . . . . . . . . . . . . . . . . . . . . . . . . . . .What Causes an AAA?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .What are the Symptoms of AAA?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Is This a Serious Condition?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2223AAA Diagnosis and Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3The Screening Abdominal Aortic Aneurysms Very Efficiently Act (SAAAVE). . . . 3Treatment of Abdominal Aortic Aneurysm (AAA) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Medical Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Open Surgical Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Endovascular Repair: Traditional EVAR and PEVAR. . . . . . . . . . . . . . . . . . . . . . . . . . . 5What are the Advantages and Disadvantages of the Different Treatment Options?Open Surgical Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5EVAR and PEVAR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6The AFX Endovascular AAA System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6How is AFX Implanted? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6What Should I Expect After the Endovascular Procedure? . . . . . . . . . . . . . . . . . . . . 8Why is Follow-up Important?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8When Should I Call My Doctor?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9What Do I Do With My Patient Implant Card? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9What if I Need Magnetic Resonance Imaging (MRI)? . . . . . . . . . . . . . . . . . . . . . . . . . 9Definition of Medical Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Where Can I Get More Information?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Questions for My Doctor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13*The AFX trademark is registered in the United States, European Community and Argentina. Other foreign applications pending.
The AFX Endovascular AAA SystemThis Patient’s Guide has been provided to you on behalf of Endologix, Incorporated.The goal of this Guide is to help you learn more about your abdominal aorticaneurysm (AAA). You will learn about the symptoms of abdominal aortic aneurysms,how they are diagnosed, how they are treated with the AFX System, and what toexpect after your surgery.As with any surgery, the best source of information and advice is your doctor. Afterreading this Guide, you may have questions to ask your doctor – page 13 providesspace for you to write your questions. This Guide also provides definitions formedical terms indicated in bold throughout the Guide – refer to pages 10 and 11 fordefinitions of terms, as well as page 12 for additional information resources.1
What is an Abdominal AorticAneurysm (AAA)?The aorta is the largest blood vessel inyour body. It carries blood from your heartto the rest of your body. The aorta extendsfrom the chest to the abdomen, where itbranches into the iliac arteries. The iliacarteries carry blood to the lower parts ofthe body and to the legs. An abdominalaortic aneurysm (AAA) occurs when theportion of the aorta passing through theabdomen bulges because of a weakening ofthe vessel wall. The walls become thin andlose their ability to stretch. The weakenedsections of the wall may become unable tosupport the flow of blood through it andcan burst. When an aneurysm bursts, itcauses serious internal bleeding.What Causes an AAA?The condition is fairly common in olderadults and is more common in men than .in women. Risk factors for developing it .are age, smoking, family history of .AAA, atherosclerotic disease, and highblood pressure.What are the Symptoms of AAA?Most patients diagnosed with AAA have .no symptoms. However, for those patientsthat do have symptoms, the most commonone is pain in the abdomen, back, or chest.The pain may range from mild to severe. .In some patients, the pain in theirabdomen spreads to their back. Othersfeel the aneurysm as a throbbing mass .in their abdomen.The AAA is often foundduring an examination for anunrelated health condition.During the examination, thepatient may feel tenderness,back pain, abdomen pain, orpain in their legs. Your doctormay feel a bulge or throbbingin your abdomen.Normal Aorta2Aorta with LargeAbdominal AneurysmIf you have been diagnosedwith an AAA and you developback pain, abdomen pain,muscle pain, weakness in thelegs, or dizziness, call yourdoctor immediately, or go tothe closest emergency room.
Is This a Serious Condition?In the early stages, when the AAA is smallin size, it may not be an immediate healthrisk to you. However, your doctor will wantto check your condition on a regular basisto see if your AAA is growing.In later stages, if the AAA continues togrow, it needs to be treated in order toprevent it from bursting and causingserious internal bleeding. The risk ofan aneurysm bursting increases as theaneurysm grows in size, and with highblood pressure. Aneurysms that burstare very serious and may be fatal.AAA Diagnosis and ScreeningIf you have been diagnosed in the earlystages with a small aneurysm, your doctorwill recommend periodic examinations.Your doctor may also recommend regularscreening if you have risk factors fordeveloping an aneurysm (family history ofAAA, high blood pressure, smoking andheart disease).This screening is commonly donewith medical tests such as CT scan,angiography, and ultrasound. These testscan confirm the presence of the AAA andcan determine its location, shape, size, .and if it is in an early or late stage.CT Scan3D ReconstructionThe Screening Abdominal AorticAneurysms Very Efficiently Act(SAAAVE) was signed into law onFebruary 8, 2006 in the United States. TheAct will provide one-time abdominal aorticaneurysm (AAA) screening for men whohave smoked some time in their life andmen or women who have a family history ofthe disease. Screening will be provided aspart of the Welcome to Medicare physicaland coverage begins on January 1, 2007.Treatment of Abdominal AorticAneurysm (AAA)The goal of all AAA treatment is to preventthe aneurysm from bursting. The sizeand location of the aneurysm within yourbody, as well as your general health, willdetermine how your doctor treats it.3
Medical ManagementIf your aneurysm is small, your doctor mayonly recommend regular examinationsto monitor the size ofthe aneurysm. A largeaneurysm, or one .that is rapidly growing,poses a risk of bursting .and requires treatment.There are two options available for thetreatment of abdominal aortic aneurysms:Open Surgical Repair and EndovascularRepair (EVAR), which includes traditionalEVAR and Percutaneous EndovascularRepair (PEVAR)Open Surgical RepairIn Open Surgical Repair, the doctor makes .a cut in the abdomen or side of the patientand repairs the section of the aorta thathas an aneurysm. The repair is done byreplacing the aneurysm section with aOpen Surgical Repair4fabric tube called a graft. The graft is .sewn into place with sutures and acts as areplacement blood vessel. This procedurerequires stopping of the flow of bloodthrough the aorta while the graft is beingsewn in place. The surgery is performedunder general anesthesia and takes about .2 to 4 hours to complete. Patients willusually stay overnight in the intensive careunit and another 5 to 7 days in the hospital.Depending on how your body heals, theoverall recovery time may take up to .3 months or longer.Open Surgical Repair is a well knownsurgical procedure that works. However,it involves major surgery and is not welltolerated by all patients, depending ontheir overall health conditions. Additionally,Open Surgical Repair has a long recoveryperiod, and with a risk that you may notreturn to full function after the recoveryperiod. As with any medical procedure,Traditional EVARPercutaneous EVAR
Open Surgical Repair has a risk forcomplications. Ask your doctor about therisks of Open Surgical Repair as they relateto your own health conditions.Endovascular Repair: Traditional EVARand PEVARA minimally invasive alternative to OpenSurgical Repair, Endovascular Repair (EVAR)includes traditional EVAR and PercutaneousEndovascular Repair (PEVAR). Withtraditional EVAR, instead of making a largecut in the abdomen, the doctor makes asmall cut in each groin to gain access to thefemoral arteries (blood vessels).An endovascular stent graft is insertedthrough the small cut in the leg and placedinside the aneurysm in the aorta. Bloodthen flows through the endovascular stentgraft rather than the weakened aneurysmpart of the aorta. The endovascular stentgraft (the AFX graft) remains inside theaorta permanently. The EVAR proceduremay be done under local anesthesia andtakes about 1 to 3 hours to complete.Patients will usually have a hospital stay ofonly a few days. Depending on how yourbody heals, the overall recovery time isusually 4 to 6 weeks.In PEVAR, the doctor makes a smallpuncture incision across the skin in eachgroin. Approved suture-based closuredevices are delivered across the skinbefore the stent graft is inserted. After theaneurysm is repaired, the closure devicesutures are tied to close the puncture sitethrough which the stent graft was delivered.Not every patient is a candidatefor EVAR or PEVAR. As with any surgicalprocedure, EVAR and PEVAR have a risk ofcomplications. Open Surgical Repair andEndovascular Repair both have advantagesand disadvantages based upon eachpatient’s health condition and needs. Askyour doctor about the possible risks ofEndovascular Repair as they relate to yourown health conditions.What are the Advantages andDisadvantages of the DifferentTreatment Options?Open Surgical Repair Advantages Standard method of treatment Well-proven surgical procedure Lasting results Long-term follow-up examinationsof patient generally not requiredOpen Surgical Repair Disadvantages General anesthesia required Major abdominal surgery/longabdominal cut Surgical complication rate is higherthan Endovascular Repair Longer hospital stay and recoverytime than Endovascular Repair5
EVAR and PEVAR Advantages Minimally invasive procedure Local anesthesia may be used Small cut in one groin, small puncturein the other groin for EVAR, or two smallpunctures in groin for PEVAR Lower surgical complication rate thanOpen Surgical Repair Shorter hospital stay and shorterrecovery than Open Surgical RepairEVAR and PEVAR Disadvantages Higher potential for endoleak oraneurysm bursting than with OpenSurgical Repair Long-term follow-up examinationsare required Possibility of additional endovascularor surgical procedures.The AFX Endovascular AAA SystemYour doctor has chosen the EndologixAFX System to perform your EndovascularRepair procedure. AFX is a stent graftmade in one-piece, with a main bodyand two limbs. AFX is also made of afabric tube (called the graft) which ismade of ePTFE, a Teflon type of material.It is called a stent graft because it has ametallic structure which is made of a cobaltchromium alloy that is attached inside thegraft for full support.6How is AFX Implanted?The entire AFX graft is compressed intoa long, thin plastic tube called a deliverycatheter. Depending upon the procedure,your doctor will insert thin wires into yourfemoral arteries through a small cut (EVAR)in one groin (see Figure A) and a smallpuncture in the other groin, or just twosmall punctures (PEVAR).The delivery catheter is inserted andadvanced over the wire into position inyour aorta (see Figure B). The stent graftis placed into position within your bodyso that the main body of the stent graft ispositioned in the aneurysm of the aorta,with the two limbs of the stent graftextending from the aorta into the iliacarteries. When the main body and limbs ofthe stent graft are in proper position, the
Figure AFigure Bstent portion of the stent graft is allowedto expand (see Figure C). This expansionof the stent graft holds it in place withinyour aorta. The wire and delivery catheterare then withdrawn from the body. Thestent graft reinforces the aorta that isweakened by the aneurysm and bloodflows through the device to the arteriesthat go to the legs.The doctor uses a visualization methodduring this process known as fluoroscopy(real time X-ray images) viewed on amonitor in order to place the stent graft inthe proper position within your body.Before the Endovascular Repairprocedure, your doctor will use diagnosticmeasurements (CT scan, angiography,and/or ultrasound) of your aorta tovisualize the aneurysm and to select theFigure Cproper size of the stent graft to fit yourbody. At the end of the procedure, yourdoctor will confirm the correct positionof the stent graft and the prevention ofblood flow to the aneurysm using X-rayangiography before closing the cut in yourleg with a few sutures.As always, X-ray types of imaging, CTscans, and angiograms carry potentialrisks of either radiation exposure,or allergic reactions related to thecontrast dye used during the tests. Theoccurrence of an allergic reaction tothe contrast dye is a rare condition. Thebenefits of these tests in viewing yourabdominal aortic aneurysm far outweighthe risk posed by the test. Speak withyour doctor about any concerns you mayhave about the follow-up tests.7
What Should I Expect After theEndovascular Procedure?Endovascular Repair may result in lessdiscomfort, shorter procedure timesand hospital stays and faster recoveryin comparison to Open Surgical Repair.Your hospital stay may be only a few days.You may be able to return to your normalactivities within 4 to 6 weeks after theprocedure and Endovascular Repair .requires regular follow-up examinations .by your doctor.The PEVAR option of the EndovascularRepair is even less invasive thantraditional EVAR.8Why is Follow-up Important?There are some problems associated withEndovascular Repair which cannot befelt. The most serious of these would becontinued aneurysm growth. This is whyyour regular follow-up examinations are .so important.Below is a list of problems that could leadto continued aneurysm growth:Endoleak - occurs when blood from theaorta continues to leak into the abdominalaneurysm. Most endoleaks cannot be feltand do not require treatment. However,an endoleak may lead to aneurysm growthand should be carefully followed overtime. A small number of endoleaks requirefurther treatment.
Graft movement - this is when the positionof the stent graft after placement in yourbody shifts over time. You cannot feelwhen the graft moves, however it can beseen with a CT scan.Your doctor will order regular follow-upexaminations with medical tests such asa physical exam, CT scan, angiography,and/or ultrasound to view the results ofyour treatment and any changes that mayoccur over time. It is important that yougo to all of the follow-up examinationsrecommended by your doctor. Theseexaminations are generally required at onemonth, six months, one year, and yearlythereafter following your AAA procedure.Your doctor may require additional followup tests based on the findings at theregular follow-up visits.When Should I Call My Doctor?Although most of the problems associatedwith Endovascular Repair cannot be felt,call your doctor immediately if youexperience any of the following symptoms,or go to the closest emergency room. Thefollowing symptoms are the most commonpotential problems as a result of yourEndovascular Repair:Aneurysm growth - symptoms are: Pain in the legs, back, chest or abdomen Numbness in the legs, back, chest,or abdomen Weakness in the legs, back, chest,or abdomenAneurysm bursting (rupture) - a veryserious condition that results in internalbleeding. Symptoms are: Dizziness Fainting Rapid heartbeat Sudden weaknessStent Graft Blockage - symptoms are: Pain in the legs or hip during walking Discoloration or coolness in the legWhat Do I Do with myPatient Implant Card?If you receive an AFX stent graft, you willreceive an AFX Card. Keep this card handyat all times. The card provides valuableinformation on: The type of device implanted The date of your implantation Your doctor’s name and phone number MRI information Recommended follow-upTell all of your healthcare providers thatyou have a stent graft and show themyour AFX Card.What if I Need MagneticResonance Imaging (MRI)?Following implantation with the stent graft,it is still safe for you to have most MRIprocedures. MRI safety information isprovided on your AFX Card. Be sure to tellall of your healthcare providers that youhave a stent graft and show them your .AFX Card.9
Burst - a tear in the vessel wall that allowsblood to spill into the abdominal cavityresulting in serious internal bleeding. Thistype of tear may occur in the location ofthe ballooning of an aneurysm.Contrast Dye - a drug that is injected intothe blood system to show blood flowthrough the blood vessels under X-raytypes of imaging or CT scan.Definition of Medical TermsAbdominal Aortic Aneurysm (AAA) a ballooning (enlarging or thinning) thatoccurs in the part of the aorta that passesthrough the abdomen (stomach area). Theballooning is due to a weakening in thearterial wall.Aneurysm - a ballooning (enlargement ofthe vessel diameter and/or thinning ofthe vessel wall) of a weakened area of ablood vessel.Angiography/Angiogram - angiography isan X-ray method that uses contrast (dye)injected into the bloodstream to see bloodflow through blood vessels. The resultingimage is an angiogram.Aorta - the main artery that carries bloodfrom the heart to the rest of the body.10CT Scan (Computed Tomography Scan) an imaging technique that creates aseries of computerized x-rays that form apicture of your aneurysm. Also known as .a “CAT scan.”Delivery Catheter - a long, thin tube-likedevice, that the doctor uses in deliveringand positioning the stent graft during theEndovascular Repair procedure.Endoleak - blood flow into the abdominalaortic aneurysm after placement of a .stent graft.Endovascular Stent Graft - a stentgraft placed within a diseased vessel torepair an aneurysm without the use of .Open Surgical Repair.Endovascular Repair (EVAR) - involvesthe placement of an endovascular stentgraft to seal off an aneurysm and create .a new blood flow pa
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