Doenças do quadril

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Endovascular Repair of Abdominal and Thoracic Aortic Aneurysms Barry T. Katzen, MD; Michael D. Dake, MD; Alexandra A. MacLean, MD; David S. Wang, MD A ortic aneurysms remain a challenging problem for pa- tients and physicians. There have been major advances in the treatment of large-vessel aneurysms during the past 10 years. The surgical armamentarium used to treat these aneu- rysms now includes an endovascular approach that allows the insertion of a graft to exclude the aneurysm sac from blood flow. The endovascular repair of abdominal and thoracic aortic aneurysms has become a viable alternative to open repair and is often the approach of choice for high-risk patients. In this review, we examine the endovascular treat- ment of abdominal and thoracic aortic aneurysms. Endovascular Repair of Abdominal Aortic Aneurysms Abdominal aortic aneurysms (AAAs) are a formidable diag- nosis for patients. This is a life-threatening condition that mandates consideration of repair. A ruptured AAA has a mortality rate approaching 90%; however, when an AAA is repaired electively, the mortality drops to less than 5%. 1–3 There is, therefore, a clear advantage to treating these aneurysms before they rupture. Because this disease affects 4% to 7% of adults over the age of 65 years, with a far greater prevalence in males than females, clinicians will encounter this problem more frequently as the population ages. 4 AAAs usually develop in patients with a history of arte- riosclerosis or smoking. Patients present for repair when it is discovered that there is a dilation of their abdominal aorta to a diameter 1.5 times normal. The result is a weakened aortic wall that is at increased risk of rupture. The pathogenesis of this aortic wall change likely involves enzymes responsible for elastin and collagen breakdown. 5 Recent research has focused on the role of metalloproteinase-9 (MMP-9). Aneu- rysm presence and size have been correlated with MMP-9 levels. Other investigators are looking into the inflammatory and autoimmune mechanisms involved in aneurysmal dis- ease. 6 Another area of research is in the molecular genetics of AAAs, because these aneurysms have a well-recognized familial nature. There is also an interest in the analysis of aortic wall stress distribution from a biomechanical approach. Ongoing studies have found that peak wall stress can predict those patients who will experience AAA rupture. 7,8 Patients with symptomatic aneurysms should be offered repair, after careful consideration of comorbidities, even if the aneurysm is not of usual elective operative size. For patients with asymptomatic AAAs, there are guidelines to help plan further surveillance or operative repair. The size of the aneurysm is one factor, and the operative approach is another. In the past, the fitness of patients for a transabdom- inal or retroperitoneal operation was of paramount concern. High-risk patients faced the choice of a morbid operation with a not insignificant mortality rate or the risk of rupture. The treatment option for this population was not satisfactory, and the development of a lower-risk operation was a neces- sity to adequately treat this population. Over the past 15 years, the management of AAAs has changed dramatically because of the development of the technique of endovascular aneurysm repair (EVAR; Figures 1 and 2). Patients and physicians have embraced EVAR as the method of choice to treat high-risk patients with AAAs. EVAR has great appeal for this older population because it leads to faster recovery with fewer systemic complications than open repair. 9 –14 Parodi et al 15 reported the first endovascular repair of an AAA in a human in 1991 using a graft fashioned from prosthetic vascular grafts and expandable stents. Current estimates are that more than 20 000 EVAR procedures take place each year in the United States, which represents 36% of all AAA repairs. The estimate is that 12% of all procedures in Europe are with EVAR, and expected annual growth is 15% at this time (Medtronic Marketing Depart- ment, personal communication, 2004). EVAR is the method of choice in high-risk older patients because of its minimal incisions, shorter operating time, and reduced blood loss. Three EVAR devices are available commercially in the United States at this time, and several more are under evaluation in clinical trials. The Food and Drug Administra- tion (FDA), well aware of the many confounding variables in an EVAR-to-surgery comparison, permitted the use of concurrent surgical controls. The large deposit of multi- center, prospectively collected data on the European EVAR experience also provides a great source for analy- ses: the EUROSTAR (EUROpean collaborators on Stent- graft Techniques for abdominal aortic Aneurysm Repair) Registry (4392 patients, 1996 to 2002). 17–20 In the present review, we will address EVAR indications, contraindications, devices, outcomes, complications, en- From the Baptist Cardiac and Vascular Institute (B.T.K., A.A.M.), Miami, Fla; University of Virginia Health System (M.D.D.), Charlotteville ; and Stanford University School of Medicine (D.S.W.), Stanford, Calif. Correspondence to Barry T. Katzen, MD, Founder and Medical Director, 8900 N Kendall Dr, Miami, FL 33176-2197. E-mail [email protected] (Circulation. 2005;112:1663-1675.) © 2005 American Heart Association, Inc. Circulation is available at http://www.circulationaha.org DOI: 10.1161/CIRCULATIONAHA.105.541284 1663 New Drugs and Technologies by guest on January 28, 2015 http://circ.ahajournals.org/ Downloaded from

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Doenças do quadril

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Endovascular Repair of Abdominal and ThoracicAortic Aneurysms

Barry T. Katzen, MD; Michael D. Dake, MD; Alexandra A. MacLean, MD; David S. Wang, MD

Aortic aneurysms remain a challenging problem for pa-tients and physicians. There have been major advances

in the treatment of large-vessel aneurysms during the past 10years. The surgical armamentarium used to treat these aneu-rysms now includes an endovascular approach that allows theinsertion of a graft to exclude the aneurysm sac from bloodflow. The endovascular repair of abdominal and thoracicaortic aneurysms has become a viable alternative to openrepair and is often the approach of choice for high-riskpatients. In this review, we examine the endovascular treat-ment of abdominal and thoracic aortic aneurysms.

Endovascular Repair of AbdominalAortic Aneurysms

Abdominal aortic aneurysms (AAAs) are a formidable diag-nosis for patients. This is a life-threatening condition thatmandates consideration of repair. A ruptured AAA has amortality rate approaching 90%; however, when an AAA isrepaired electively, the mortality drops to less than 5%.1–3

There is, therefore, a clear advantage to treating theseaneurysms before they rupture. Because this disease affects4% to 7% of adults over the age of 65 years, with a far greaterprevalence in males than females, clinicians will encounterthis problem more frequently as the population ages.4

AAAs usually develop in patients with a history of arte-riosclerosis or smoking. Patients present for repair when it isdiscovered that there is a dilation of their abdominal aorta toa diameter 1.5 times normal. The result is a weakened aorticwall that is at increased risk of rupture. The pathogenesis ofthis aortic wall change likely involves enzymes responsiblefor elastin and collagen breakdown.5 Recent research hasfocused on the role of metalloproteinase-9 (MMP-9). Aneu-rysm presence and size have been correlated with MMP-9levels. Other investigators are looking into the inflammatoryand autoimmune mechanisms involved in aneurysmal dis-ease.6 Another area of research is in the molecular genetics ofAAAs, because these aneurysms have a well-recognizedfamilial nature. There is also an interest in the analysis ofaortic wall stress distribution from a biomechanical approach.Ongoing studies have found that peak wall stress can predictthose patients who will experience AAA rupture.7,8

Patients with symptomatic aneurysms should be offeredrepair, after careful consideration of comorbidities, even if

the aneurysm is not of usual elective operative size. Forpatients with asymptomatic AAAs, there are guidelines tohelp plan further surveillance or operative repair. The size ofthe aneurysm is one factor, and the operative approach isanother. In the past, the fitness of patients for a transabdom-inal or retroperitoneal operation was of paramount concern.High-risk patients faced the choice of a morbid operationwith a not insignificant mortality rate or the risk of rupture.The treatment option for this population was not satisfactory,and the development of a lower-risk operation was a neces-sity to adequately treat this population.

Over the past 15 years, the management of AAAs haschanged dramatically because of the development of thetechnique of endovascular aneurysm repair (EVAR; Figures 1and 2). Patients and physicians have embraced EVAR as themethod of choice to treat high-risk patients with AAAs.EVAR has great appeal for this older population because itleads to faster recovery with fewer systemic complicationsthan open repair.9–14

Parodi et al15 reported the first endovascular repair of anAAA in a human in 1991 using a graft fashioned fromprosthetic vascular grafts and expandable stents. Currentestimates are that more than 20 000 EVAR procedures takeplace each year in the United States, which represents �36%of all AAA repairs. The estimate is that �12% of allprocedures in Europe are with EVAR, and expected annualgrowth is �15% at this time (Medtronic Marketing Depart-ment, personal communication, 2004). EVAR is the methodof choice in high-risk older patients because of its minimalincisions, shorter operating time, and reduced blood loss.

Three EVAR devices are available commercially in theUnited States at this time, and several more are underevaluation in clinical trials. The Food and Drug Administra-tion (FDA), well aware of the many confounding variablesin an EVAR-to-surgery comparison, permitted the use ofconcurrent surgical controls. The large deposit of multi-center, prospectively collected data on the EuropeanEVAR experience also provides a great source for analy-ses: the EUROSTAR (EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair)Registry (4392 patients, 1996 to 2002).17–20

In the present review, we will address EVAR indications,contraindications, devices, outcomes, complications, en-

From the Baptist Cardiac and Vascular Institute (B.T.K., A.A.M.), Miami, Fla; University of Virginia Health System (M.D.D.), Charlotteville ; andStanford University School of Medicine (D.S.W.), Stanford, Calif.

Correspondence to Barry T. Katzen, MD, Founder and Medical Director, 8900 N Kendall Dr, Miami, FL 33176-2197. E-mail [email protected](Circulation. 2005;112:1663-1675.)© 2005 American Heart Association, Inc.

Circulation is available at http://www.circulationaha.org DOI: 10.1161/CIRCULATIONAHA.105.541284

1663

New Drugs and Technologies

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dograft surveillance, and future directions. This is an excitingtime for the management of AAAs, because there are manymore options for high-risk patients. The field is rapidlyevolving, and patients expect to be informed of the currenttechnology.

Indications for AAA TreatmentMost asymptomatic AAAs are discovered serendipitously,often on imaging examinations for other complaints. Increas-ing evidence indicates that there is value to screening patientsfor AAAs, and it is likely that screening will be approved inthe near future.21 Once the diagnosis of AAA is made, 2critical questions need to be answered: when to intervene andhow to intervene. The availability of EVAR has made thesedecisions somewhat more complex while adding a significanttreatment option.

Recent studies have questioned whether aneurysms smallerthan 5 cm should be treated.22 However, in general, theclinical recommendation remains to offer treatment for aneu-

rysms between 5 and 5.5 cm, depending on the results ofclinical trials.23 An exception to this guideline is that inter-vention should be offered despite the size of the aneurysm ifsymptoms develop or the aneurysm increases in size by 1 cmper year.24 In addition, if the patient is a woman with smallernative vessels, the relative size that represents aneurysmaldisease may be less than the conventional 5 to 5.5 cm range.

Clinical and Anatomic Selection FactorsPatient selection has emerged as the most important factorrelated to successful EVAR. The assessment begins withconsideration of the body habitus and sex of the patient; smallbody size and female sex have been associated with a higher

Figure 1. 3D rendering of 6-cm AAA.

Figure 2. 3D rendering of AAA 1 year after therapy with thetrivascular stent graft (treated [or evaluated] under a phase Iinvestigational device exemption clinical trial); note shrinkage ofsac.

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risk of procedure abortion.25,26 In addition, the comorbiditiesof the patients must be assessed, with careful attention tocardiac, pulmonary, and renal conditions. In general, opensurgical repair is advocated for younger, lower-risk patients,and EVAR is preferred for older, higher-risk patients. Opensurgical repair of AAA has proven long-term durability;EVAR follow-up is now at 10 years. The use of riskstratification to analyze outcomes clearly indicates that sur-vival for those at low to minimal risk is excellent over 10years; those at highest risk succumb to cardiac disease orcancer, and for those patients, survival is poorest.27 EVARhas shown a reduction in 30-day mortality relative to thatachieved with open repair (1.2% versus 4.6%). Further studyis required to determine whether there is a long-term survivaladvantage. Risk stratification determines survival in generaland shows that both open surgery and EVAR decrease therisk of death from AAA rupture.28

The characteristics of the aneurysm must be matched to themost suitable device; this has a direct impact on outcomesand the complication profile of the procedure. The aneurysmis evaluated from a 3D reconstruction CT scan or aortographywith a calibrated catheter. There are at least 4 importantfeatures that must be assessed before one determines apatient’s eligibility for EVAR, and this analysis leads to a listof contraindications29 (Table 1). Experienced interventional-

ists can deal with some of these challenges, but morpholog-ical features of the aneurysm and access vessels may precludeEVAR.

Currently, we use EVAR primarily to treat patients at highsurgical risk. We are confident that EVAR protects patientsfrom aneurysm rupture, but we cannot yet extend the offer ofEVAR to young, healthy patients, because we do not havedata on long-term durability to support this practice.

DevicesEndografts have developed from simple tube grafts suitablefor a small subset of aneurysms to complex bifurcated graftswith a range of sizing and extensions that can be used to treatthe morphological challenges of aneurysmal disease. Thelanguage used to describe the devices has also evolved overtime.

There are 2 types of device bodies: unibody and modular.The former comes in 1 piece, and although easy to deploy, itrequires contralateral occlusion and bypass grafting. Modulardevices are composed of more than 1 piece, and the compo-nents are deployed through both groins. There is greaterflexibility associated with the modular devices, and theydominate the market. The endograft fabric is either a wovenpolyester or PTFE (polytetrafluoroethylene). The differencebetween these is the degree of porosity (PTFE � wovenpolyester), and some believe this affects the rate of type IVendoleaks.

The key features of endovascular repair of AAAs thatdetermine procedural success and long-term outcomes areproximal and distal fixation and sealing. Various devicemodifications and designs address this need; there are now 3FDA-approved endografts and several others in variousstages of development (Table 2). Early devices were securedproximally and distally with the aid of expandable stents.Now, most of the devices use a metal skeleton throughout thegraft that is made from stainless steel, nitinol, or Elgiloy.Attachment is facilitated by the use of hooks or radial force.

Once the graft is inserted through the sheath, it can bedeployed by a self-expanding mechanism or balloon expan-sion. Some grafts attach superior to the renal arteries (supra-renal attachment), whereas most of the devices require at least15 mm of proximal neck to achieve fixation and sealing in the

TABLE 1. Evaluation for EVAR

CT scan assessment for EVAR eligibility

Proximal neck: diameter, length, angle, presence or absence of thrombus

Distal landing zone: diameter and length

Iliac arteries: presence of aneurysms and occlusive disease

Access arteries: diameter, presence of occlusive disease

Contraindications for EVAR

Short proximal neck

Thrombus presence in proximal landing zone

Conical proximal neck

Greater than 120° angulation of the proximal neck

Critical inferior mesenteric artery

Significant iliac occlusive disease

Tortuosity of iliac vessels

TABLE 2. Endograft Devices

Device (Company)/Market FDA ApprovalMain Body

Diameter, mm Fixation Profile

Ancure (Guidant)/off-market 2003 September 1999 20–26 Infrarenal 21F

AneuRx (Medtronic)/worldwide September 1999 22–28 Infrarenal 21F

Excluder (Gore)/worldwide November 1999 23–31 Infrarenal 18F

Fortron (Cordis)/Europe No 26–34 Suprarenal NA

Lifepath (Edwards)/Europe, Australia No 21–29 Infrarenal 21F

Powerlink (Endologix)/Europe No 25–34 Infrarenal; suprarenal 21F

Stentor/Vanguard (Boston Scientific)/off-market 1999 No 22–26 Infrarenal 21F

Talent (Medtronic)/Europe, Australia, Asia No 24–34 Suprarenal 22F/24F

Trivascular (Boston Scientific)/in research No 16–26 Infrarenal 16F

Zenith (Cook)/worldwide May 2003 22–32 Suprarenal 18F/20F

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infrarenal position. The grafts also differ in their “profile” orthe size of the delivery system. Low-profile devices permitaccess through smaller arteries.

The importance of choosing the appropriate device to fitthe characteristics of the aneurysm cannot be overempha-sized. With a short proximal neck, the suprarenal Talentdevice proves useful, and when small access arteries areencountered (especially in females), the low-profile Excluderendograft is appealing. The Lifepath device has been usedwith some success in the difficult angulated neck.

OutcomesTable 3 describes the published literature from large device-specific series.9,10,12–14,30–32 Some of the series compare theEVAR data with that obtained from open surgical repair.Recently, a prospective, randomized trial of EVAR and openrepair demonstrated a two thirds reduction in early mortalitywith EVAR.33 All studies have shown excellent rupture-freesurvival and significant reduction in blood loss, cardiovascu-lar events, and intensive care unit stay. High-volume institu-tions with experience using multiple types of endografts areable to optimize the matching of the device to the character-istics of the aneurysm.

ComplicationsMost of the complications associated with EVAR are minorand can be watched carefully or treated easily with additionalinterventional procedures. Some complications occur duringor soon after the procedure, whereas others are only noticedduring graft surveillance (Table 4).34 A study by Ohki et al35

analyzed complication and death rates within 30 days ofEVAR and found the major complication and death rates

were 17.6% and 8.5%, respectively. This remains an activeand important area of EVAR research, and standards havebeen developed to facilitate reporting of endovascular ab-dominal aortic repair complications.36

Endoleaks can have substantial clinical significance be-cause of an increased risk of becoming symptomatic orleading to aneurysm rupture. Endoleak describes the contin-uation of blood flow into the extragraft portion of theaneurysm; this flow increases the size of the aneurysmalsac.37 Endoleaks occur in either the acute setting during graftimplantation or during the postoperative surveillance period.The majority of procedural endoleaks will disappear withoutintervention.

Endoleaks are either graft-related or nongraft-related, and aclassification system has been developed (Table 5).38 Type Iendoleaks occur when the attachment is not complete, eitherproximally or distally; blood is able to flow into the aneu-rysmal sac and is not completely occluded by endograftattachment to the arterial wall. Type II endoleaks result fromcontinued back flow from aortic branches such as the inferiormesenteric artery and lumbar arteries. This flow occursretrograde into the aneurysmal sac around the endograft.Type III endoleaks are caused by defects in the endograftstructure that lead to leakage of blood flow from inside theendograft to the aneurysmal sac. Finally, type IV endoleaksare noted early after endograft placement and resolve whenthe fabric porosity is decreased by clotted blood. Becauseendovascular repair uses a relatively new technology, graftsurveillance for complications such as endoleaks is essential.Endoleaks are diagnosed by a variety of techniques: arteriog-raphy, pressure monitoring during or after the procedure, CTscan, and duplex scanning. The preferred method of detecting

TABLE 3. EVAR Outcomes

Device (Company) EVAR Cases, n Conversion Rate Endoleak Delayed Rupture Mortality

Ancure/EGS (Guidant),compared with open surgery12

309 Patients; 5-yearfollow-up

2.80% 25.60% at 60 months 0 1.7% 30-Day rate

AneuRx (Medtronic)13 1192 Patients; 4-yearfollow-up

93% Freedom fromopen conversion at 3

years

13% at 1 month 99.5% Freedom fromrupture at 3 years

2% 30-Day rate

Excluder (Gore), compared withopen surgery10

235 patients; 2-yearfollow-up

0 20% at 2 years 0 1% 30-Day rate

Fortron (Cordis)study results not yet available

NA NA NA NA NA

Lifepath (Edwards)30 227 Patients; 11months (mean)

follow-up

2.20% 5.90% at 6 months 0 1.3% Perioperative

Powerlink (Endologix)31 118 Patients; 16months (mean)

follow-up

3.30% 5.90% at 30 days 0 0.8% Perioperative

Stentor/Vanguard (BostonScientific)32

23 Patients; 3-year(median) follow-up

30% 65% NA NA

Talent (Medtronic), comparedwith open surgery9

240 Patients; 406 days(mean) follow-up

2.50% 10% at 12 months 0 0.8% 30-Day rate

Trivascular (Boston Scientific),study results not yet available

NA NA NA NA NA

Zenith (Cook), compared withopen surgery14

200 Patients 1.50% 7.40% at 12 months 98.9% Freedom fromrupture at 1 year

0.5% 12 Months

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endoleaks is by CT scanning, An analysis of 2463 patientsfrom the EUROSTAR registry revealed that 171 had anendoleak by the time of their first-month postoperativeevaluation, and 317 patients developed one at a later date.39

Of these, 7.8% had a type II endoleak, and 12% had a type I,type III, or combination of endoleaks.

There are many different ways to treat endoleaks, includingcoil embolization, placement of stent-graft cuffs and exten-sions, laparoscopic ligation of inferior mesenteric and lumbararteries, open surgical repair, and EVAR redo procedures.Type I and III endoleaks require fairly urgent intervention,because blood flow and sac pressure will continue to increaseand lead to rupture. Type IV endoleaks usually resolve ontheir own.

The management of type II endoleaks is more controver-sial, because some of them will thrombose on their own,whereas others will lead to sac enlargement. There are 2critical questions that must be addressed at this juncture: (1)Should an intervention be entertained, and (2) when shouldthe intervention be performed?40 One approach is to monitorthe patient with a postprocedure 6-month CT scan, and if theaneurysm has increased in size, then a plan for intervention isformulated. There are at least 3 approaches to manage type IIendoleaks: transarterial, translumbar embolization, and lapa-roscopic ligation.41 Another approach to eliminate endoleaksis to perform preoperative embolization of feeding arteries. Astudy by Bonvini et al42 analyzed 23 consecutive patients whounderwent preoperative embolization to reduce type II en-doleaks. They monitored the patients for a mean of 17 monthsand found 1 type II endoleak (4.5%). During a consensusconference in 2000, 23 of 26 international leaders in EVARdisagreed with the preoperative approach to endoleaks.38

SurveillanceEndograft surveillance is important to document normal andabnormal morphological changes in the repair and the in-volved vessels. This process is vital for the detection ofendoleaks, increased aneurysm diameter, and possible devicemigration.43 The study by Corriere et al43 showed that 24% ofthe patients had an endoleak detected during surveillance thataveraged 19 months. In that study, 3 endoleaks were detected2 years after repair, with 1 at 7 years. Other findings,including perigraft air, accompanied by leukocytosis andfever, can be detected after repair and have been shown to benonspecific and not indicative of graft infection.44

The recommended surveillance routine is for a CT scan at1, 6, and 12 months and annually thereafter. If an endoleak isdetected, the frequency of the scans increases to every 6months until resolution of the endoleak is detected. Investi-gators have compared duplex ultrasound with CT scan forsurveillance and found that CT scan is superior for endoleakdetection.45 MRI can also be used for graft surveillance,especially in older patients with decreased renal function.46 Arecent development for endograft surveillance is the monitor-ing of sac pressure within treated aneurysms through animplanted sensor device.47,48 Trials with this implanted sensorare currently being conducted.

The use of EVAR technology has led to a greater under-standing of the basic science of aneurysmal disease. Forexample, Curci and Thompson6 have been studying therelationship between the secretion of matrix metalloprotein-ases (MMPs) and AAAs. They have measured increasedlevels in the aneurysmal rather than the normal arterial wall.

TABLE 4. EVAR Complications

Deployment related

Failed deployment

Bleeding

Hematoma

Lymphocele

Infection

Embolization

Perforation

Arterial rupture

Dissection

Device related

Structural failure

Implant related

Endoleaks

Limb occlusion/stent-graft kink

Sac enlargement/proximal neck dilatation

Stent migration

AAA rupture

Infection

Buttock/leg claudication

Systemic

Cardiac

Pulmonary

Renal insufficiency

Cerebrovascular

Deep vein thrombosis

Pulmonary embolus

Coagulopathy

Bowel ischemia

Spinal cord ischemia

Erectile dysfunction

TABLE 5. Classification of Endoleaks

I: Attachment site leaks

A: Proximal end of endograft

B: Distal end of endograft

C: Iliac occluder (plug)

II: Branch leaks (without attachment site connection)

A: Simple or to-and-fro (from only 1 patent branch)

B: Complex or flow-through (with 2 or more patent branches)

III: Graft defect

A: Junctional leak or modular disconnect

B: Fabric disruption (midgraft hole)

Minor (�2 mm; eg, suture holes)

Major (�2 mm)

IV: Graft wall (fabric) porosity (�30 days after graft placement)

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This finding may lead to a simple test for increased aneurysmsac growth after endograft repair.49 Advances in the basicscience of aneurysm disease are helping us better manage thisdisease.

Future DirectionsEVAR has clear benefits, especially in high-risk patients.After long-term durability studies have been completed, wewill have a better idea of the role of EVAR in young, healthypatients. The future of EVAR is exciting, with many newdevelopments on the horizon. The next generation of en-dografts will have smaller delivery systems that will permitthe application of this technology to a broader group ofpatients. There are endograft designs in development that willallow us to better treat aneurysms with short proximal necksand tortuous iliac arteries. The results of ongoing clinicaltrials will help elucidate the role of branched endografts thatfacilitate treatment of suprarenal aneurysms. A new implant-able sac pressure–monitoring device is being studied, and theutility of this device in the surveillance of the endovascularrepair may help decrease the frequency of follow-up CTscans. The EVAR story is still being written. This technologyis helpful to a segment of the population of patients withAAAs, and more study will only broaden its application.

Endovascular Repair of ThoracicAortic Aneurysms

Aortic aneurysms, both thoracic and abdominal, generallyoccur in the elderly and have thus been increasing inincidence as the population ages and diagnostic capabilitiesadvance.50 With an incidence of 6 to 10 per 100 000 person-years, thoracic aortic aneurysms (TAAs) are less commonthan AAAs but remain life-threatening.50,51 The natural his-tory of TAAs is one of progressive expansion and weakeningof the aortic wall, leading to eventual rupture.52–54 With anassociated mortality rate of 94%, TAA rupture is usually afatal event.51,55 The 5-year survival rate of unoperated TAApatients approximates 13%, whereas 70% to 79% of thosewho undergo elective surgical intervention are alive at 5years.56–58 The risk of rupture mandates consideration forsurgical treatment in all patients who are suitable candidatesfor operation. Specific indications for operative repair arelisted in Table 6. The use of endovascular stent grafts forrepair of TAAs is emerging as a promising, less invasivetherapeutic alternative to conventional surgical treatment.

Endovascular treatment of aortic aneurysms is achieved bytransluminal placement of 1 or more stent-graft devicesacross the longitudinal extent of the lesion (Figure 3). Theprosthesis bridges the aneurysmal sac to exclude it fromhigh-pressure aortic blood flow, thereby allowing for sacthrombosis around the endograft and possible remodeling ofthe aortic wall. Although the advent and ensuing rapid

evolution of endovascular aortic repair occurred initially inthe abdominal aorta, efforts to adapt this technology for thethoracic aorta are ongoing. As is the case for AAA, a lessinvasive approach to TAA repair is highly desirable, becausethe patient population tends to be elderly and harbors multiplecomorbidities.54,58,59 Continued development of endovasculartherapy for thoracic aneurysms, however, is likely to providegreater benefits in patient outcomes than those observed withAAAs. Conventional surgical treatment of TAA is physio-

TABLE 6. Indications for TAA Repair

�60-mm diameter or �2� transverse diameter of an adjacent normalaortic segment

Symptomatic regardless of size

Growth rate of aneurysm to �3 mm/y

Figure 3. Stent-graft repair of thoracic aortic pseudoaneurysm.A, Thoracic aortogram illustrates large aneurysm in a 58-year-old man who had surgery 22 years earlier to repair a traumaticaortic injury from a motor vehicle accident. B, Aortogram afterstent-graft placement shows widely patent device without evi-dence of contrast media endoleak into the aneurysm sac.

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logically more demanding and carries a greater operative risk.It mandates open thoracotomy, aortic cross-clamping, resec-tion of the aneurysm, and replacement with a prosthetic graft,and it often requires cardiopulmonary bypass.60 Despiteadvances in operative technique, intraoperative monitoring,and postoperative care, the mortality and morbidity of surgeryremain substantial and less favorable than outcomes for openAAA repair. Mortality for TAA surgical repair ranges from5% to 20% in elective cases and to 50% in emergentsituations.58,61–63 Major complications associated with surgi-cal TAA treatment include renal and pulmonary failure,visceral and cardiac ischemia, stroke, and paraplegia. Para-plegia is a particularly devastating complication nearly uniqueto the surgical treatment of thoracic aneurysms, occurring in 5%to 25% of cases versus �1% for AAAs.56,58,64–67 For thesereasons, a significant population of TAA patients are notcandidates for open repair and have been without a treatmentoption until recently.

Endovascular aneurysm repair of the thoracic aorta iscurrently focused on the descending portion, defined as beingdistal to the left subclavian artery. Approximately half ofTAAs are located in the descending thoracic aorta.51,59

Anatomically, this aortic segment provides a substrate moreamenable for endovascular stent-graft repair given its avoid-ance of the great vessels proximally and major visceralbranches and aortic bifurcation distally. Despite these ana-tomic advantages and the ability to draw from early experi-ences with endovascular AAA repair, the development ofstent grafting in the thoracic aorta has progressed moreslowly than that of its infrarenal counterpart. The thoracicaorta poses several unique challenges that have impededsimple adaptation of endovascular devices and techniquesdeveloped for the abdominal aorta.68 First, the hemodynamicforces of the thoracic aorta are significantly more aggressiveand place greater mechanical demands on thoracic en-dografts. The potential for device migration, kinking, and latestructural failures are important concerns. Second, greaterflexibility is required of thoracic devices to conform to thenatural curvature of the proximal descending aorta and tolesions with tortuous morphology. Third, because largerdevices are necessary to accommodate the diameter of thethoracic aorta, arterial access is more problematic. This is animportant concern given the greater proportion of TAApatients, relative to AAA patients, who are women, in whomaccess vessels tend to be smaller. Fourth, as with conven-tional open TAA repair, paraplegia remains a potentialcomplication in the endovascular approach despite the ab-sence of aortic cross-clamping.69,70 Lastly, the extent ofTAAs can often extend beyond the boundaries of the de-scending thoracic aorta and involve more proximal or distal

aorta than desired. Management of the left subclavian artery,in particular, has gained considerable attention.71–73

With these challenges in mind, significant progress hasbeen achieved since the first stent graft was deployed forTAA exclusion in 1992.69,74 Although the development ofthoracic stent-graft technology remains in its adolescentstages, the cumulative clinical experience with an estimated5000 implants worldwide has yielded short- to mid-term datathat demonstrate promising results. This review will providean update on the current state of endovascular management ofaneurysms in the descending thoracic aorta.

DevicesEarly clinical experiences with stent grafting of the thoracicaorta were based on the use of first-generation, homemadedevices that were rigid and required large delivery systems(24F to 27F).74,75 Fortunately, several commercial manufac-turers of abdominal endografts have created derivatives forthe thoracic aorta with dramatic improvements over home-made devices. To date, none have been approved for use inthe United States, but 3 are undergoing clinical trials for FDAapproval (Figure 4; Table 7): TAG (W.L. Gore and Associ-ates, Inc), Talent (Medtronic, Inc), and TX2 (Cook, Inc).

Although each device has unique features, all 3 employ thesame basic structural design. The endoprostheses are com-posed of a stent (nitinol or stainless steel) covered with fabric(polyester or PTFE). The modular design of the TX2 systemrenders it less flexible than the TAG but more so than theTalent. The TAG device uses a delivery system that isspecifically designed to limit distal migration. The design of

Figure 4. Current thoracic stent grafts undergoing US clinicaltrials. Left, TAG device manufactured by WL Gore & Associates,Inc is composed of PTFE graft material and nitinol stent forms.Middle, Talent thoracic graft from Medtronic, Inc is fabricatedfrom nitinol and polyester graft. Right, TX2 Zenith device cre-ated by Cook, Inc is a 2-component endograft with stainlesssteel stent bodies and polyester graft material.

TABLE 7. Devices Undergoing FDA Review for TAA Repair

Device (Company) Stent/Graft Material Delivery Profile Unique Properties

TAG (Gore) Nitinol/PTFE 20F to 24F Flexible

Talent (Medtronic) Nitinol/polyester 22F to 27F Uncovered proximally

TX2 (Cook) Stainless steel/polyester 20F to 22F Fixation barbs

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the proximal and distal ends varies, and some of the stents areuncovered proximally and distally (TX2), whereas othershave an uncovered proximal end (Talent). In addition, theTX2 stent uses barbs to facilitate fixation proximally anddistally. Ultimately, each device has its advantages anddisadvantages.

Requirements for Endovascular RepairThe evaluation of a patient for repair of their TAA considerstheir overall risk profile, evidence of rapid enlargement of theaneurysm, diameter �6 cm, or presence of symptoms. Thesuitability of the patient for endovascular repair is based onboth clinical and anatomic considerations. Clinical parame-ters indicating a preference for the endovascular approachover the traditional approach remain to be defined but shouldbe based on comparison of respective risk-benefit ratios.Although data from long-term follow-up studies and random-ized, controlled trials are pending, endovascular stent graftingis currently reserved for high-surgical-risk and nonoperativepatients who have suitable anatomic features.

General consensus has been established for anatomicprerequisites for endovascular repair (Table 8). Thoroughpreprocedural imaging is essential to fully characterize thelesion and access route. Detailed imaging evaluation can beobtained with spiral CT or MRI; however, without theavailability of high resolution 3D renderings of the aorta,catheter-based angiography remains the “gold standard.”Measurements from imaging data are used to select theappropriate device diameter and length.

Determination of aneurysm location in relation to the leftsubclavian artery and celiac axis is of upmost importance.Successful TAA exclusion requires normal segments ofnative aorta at both ends of the lesion (the so-called landingzone or neck) of at least 15 to 25 mm to ensure adequateendoprosthesis–aortic wall contact and formation of a tightcircumferential seal. Landing zones that are markedly angledor conical or that contain thrombus can result in poor fixation.Devices are oversized by 10% to 20% in diameter to providesufficient radial force for adequate fixation.

The vascular access route for device introduction anddelivery to the pathological target must be of sufficient sizeand of suitable morphology. Stent grafts are most commonlyintroduced through the femoral artery. Small-diameter, tortu-ous, and excessively calcified iliac arteries may preclude suchaccess, requiring more proximal retroperitoneal exposure anddirect cannulation of or creation of a graft conduit to the

common iliac or abdominal aorta. Additionally, severe ste-nosis and tortuosity of the abdominal and thoracic aorta distalto the target are contraindications for endovascular repair.

In spite of the use of these criteria, treatment failures canoccur, but the specific contributing factors and frequenciesare currently unknown, particularly over the long-term. Thus,follow-up surveillance with serial CT scans at 1, 6, and 12months and annually thereafter is recommended to monitorchanges in aneurysm morphology, identify device failures,and detect endoleaks.

Clinical ExperienceThe literature on thoracic stent grafting consists mostly ofsmall to medium-sized case series with short- to medium-term follow-up (Table 9). Nevertheless, these studies illus-trate a consensual pattern of outcomes when viewed inaggregate. Overall, successful device deployment is achievedin 85% to 100% of cases, and periprocedural mortality rangesfrom 0% to 14%, falling within or below elective surgerymortality rates of 5% to 20%.68,75–90 As expected, outcomeshave improved over time with accumulated technical exper-tise, use of commercially manufactured devices, and im-proved patient selection criteria. The recently publishedcollective experiences of the EUROSTAR and United King-dom Thoracic Endograft registries, the largest series to date(n�249), demonstrate successful deployment in 87% ofcases, 30-day mortality of 5% for elective cases, and para-plegia and endoleak rates of 4%.90 FDA phase II trial datafrom exclusive deployment of the Gore TAG endograft in142 TAA patients reveal similar results: technical success in98%, 30-day mortality of 1.5%, paraplegia in 3.5%, andendoleak in 8.8%.89

These results cannot be directly compared with theoutcomes of contemporary surgical studies. The majorityof TAA patients who were repaired by the endovascularapproach in these studies were older and sicker, havingbeen deemed either high risk or not suitable for opensurgical repair. For example, 52% of patients in the combinedEUROSTAR and United Kingdom registries were preopera-tively classified as ASA 3 or above (American Society ofAnesthesiologists’ physical status classification that predictsprocedural risk: 1 to 2 indicates low risk; 3, intermediate risk;4 to 5, high risk; and 6, organ donor).90 In light of thesepatient substrate differences, endovascular TAA repair willlikely play a substantial role in the management of high-riskpatients. Furthermore, the applications of this less invasivetherapeutic modality may broaden if endograft studies withlower-risk surgical candidates result in favorable mortalityand morbidity gains, particularly as devices and techniquescontinue to evolve.

True comparisons between conventional therapy and theendovascular alternative can only be achieved after thecompletion of prospective, randomized, controlled trials.Although such trials are under way, a few studies havecompared endovascular treatment with anatomically similaropen-surgery historic controls. As part of the phase II GoreExcluder study, 19 TAA patients who were candidates foropen repair received stent-graft therapy and were comparedwith a nonrandomized cohort of 10 patients who had under-

TABLE 8. Anatomic Requirements for Endovascular Repairof TAA

A proximal neck at least 15 to 25 mm from the origin of the left subclavianartery

A distal neck at least 15 to 25 mm proximal to the origin of the celiacartery

Adequate vascular access: absence of severe tortuosity, calcification, oratherosclerotic plaque burden involving the aortic or pelvic vasculature

The transverse diameter of the proximal and distal neck should be withinthe range that available devices can appropriately accommodate

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gone open repair before the availability of thoracic stentgrafts.81 All aneurysms met the same inclusion/exclusioncriteria for anatomic involvement. One-year survival was89.5% in the endovascular group and 70% in the operativegroup. As expected, mean hospital stay (6.2 versus 16.3 days)and length of intervention (155 versus 256 minutes) weresignificantly less among those treated endovascularly. In asimilar study, Ehrlich and colleagues found decreased 30-daymortality (10% versus 31%), mean hospital stay (6 versus 10days), and mean intervention time (150 versus 325 minutes)in the endovascular group; the paraplegia rate was alsodecreased (0% versus 12%).76

ComplicationsWith the avoidance of aortic cross-clamping and prolongediatrogenic hypotension, endovascular TAA repair was ex-pected to result in lower incidences of paraplegia relative toconventional treatment. Indeed, this has held true, withparaplegia rates generally ranging from 0% to 5% in endo-vascular studies,68,75–90 whereas paraplegia occurs in 5% to25% of open repair cases.56,58,64,65 Although low, these ratesremain significant, especially because it is impossible toreimplant intercostal arteries in this setting. Some evidencesuggests that the occurrence of paraplegia is associated withconcomitant or prior surgical AAA repair and increasedexclusion length because of the absence of lumbars andhypogastric collateral circulation.79,91 Adjunctive measures tofurther reduce spinal cord ischemic complication rates inendovascular TAA repair are being investigated.92

Endoleaks are the most prevalent of TAA stent-grafttreatment complications. However, their observed frequencyis substantially less than that reported for AAA endograft

repair.93 Interestingly, the distribution of endoleak types alsodiffers. TAA endoleaks occur more commonly at the proxi-mal or distal attachment sites (type I endoleak), whereas themajority of AAA endoleaks are type II.94 It is generallyaccepted that type I endoleaks are more serious and requireexpeditious intervention because they represent direct com-munications between the aneurysm sac and aortic bloodflow.95 Treatment options include transcatheter coil or glueembolization, balloon angioplasty, placement of endovascu-lar graft extensions, and open repair.96,97

Despite the hostile hemodynamic conditions of the thoracicaorta, the anticipated complications of device migration andkinking have occurred infrequently and have been observedprimarily with homemade devices and those with unsup-ported mid-graft segments.70 For both homemade and com-mercial endografts, however, questions about device durabil-ity and stability over the long term remain unanswered.

Future DirectionsThe cumulative worldwide experience with endovascularrepair of thoracic aneurysms has highlighted not only itspotential as an advance in treatment but also its limitations.Efforts are under way to expand the applicability of endovas-cular stent-graft technology in the thoracic aorta, challengingcurrent anatomic constraints and clinical indications. A vari-ety of exciting strategies are being explored and deservemention.

Although current anatomic criteria limit thoracic stent-graft exclusion to lesions located at least 15 to 25 mm awayfrom the origin of the left subclavian artery and celiac trunk,it is common for descending TAAs to be located within theproximal or distal neck length necessary for adequate fixa-

TABLE 9. Summary Data on Studies of Endovascular Repair of TAA

First Author and Yearof Study Publication n

MeanFollow-Up,

mo Devices Technical Success30-Day Mortality,

%Long-TermSurvival, %

Paraplegia,%

Endoleak,%

Dake 199875 103 22 Homemade 83% Complete thrombosis 9 73 (Actuarial 2 year) 3 24

Ehrlich 199876 10 NA Talent 80% Complete thrombosis 10 NA 0 20

Cartes-Zumelzu 200077 32 16 Excluder, Talent 90.6% 9.4 90.6 (32 Months) 3.1 15.4

Grabenwoger 200078 21 NA Talent, Prograft 100% 9.5 NA 0 14.3

Greenberg 200079 25 15.4 Homemade NA 20 (12.5 for elective,33 for emergent)

NA 12 12

Temudom 200080 14 5.5 Homemade, Vanguard,Excluder

78.6% 14.3 NA 7.1 14.3

Najibi 200281 24 12 Excluder, Talent 94.7% 5.3 89.5 (1 Year) 0 0

Heijmen 200282 28 21 Talent, AneuRx, Excluder 96.4% 0 96.4 (Mean 21 months) 0 28.6

Schoder 200383 28 22.7 Excluder 100%, 89.3% Completeexclusion

0 96.1 (1 Year), 80.2 (3 years) 0 25

Marin 200384 94 15.4 Excluder, Talent 85.1% NA NA NA 24

Lepore 200385 21 12 Excluder, Talent 100% 9.5 76.2 (1 Year) 4.8 19

Sunder-Plassman 200386 45 21 Corvita, Stenford, Vanguard,AneuRx, Talent, Excluder

NA 6.7 NA 2.2 22.2

Ouriel 200368 31 6 Excluder, Talent,Other commercial

NA 12.9 81.6 (1 Year) 6.5 32.3

Bergeron 200387 33 24 Excluder, Talent NA 9.1 75.8 (Mean 24 months) 0 0

Czerny 200488 54 38 Excluder, Talent 94.4% 9.3 63 (3 Years event free) 0 27.8

Makaroun 200489 142 29.6 TAG 97.9% 1.5 75 (2-Year freedom from death) 3.5 8.8

Leurs 200490 249 1–60 Excluder, Talent,Zenith, Endofit

87% 10.4 (5.3 for elective,27.9 for emergent)

80.3 (1 Year) 4 4.2

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tion. At the proximal end, the landing zone can be extendedby prophylactic left subclavian to left carotid artery transpo-sition or bypass graft placement.69 Alternatively, the uncov-ered proximal portion of the Talent endograft can be placedacross the left subclavian origin to achieve fixation withoutblocking flow. However, because case reports of inadvertentcoverage of the left subclavian artery origin found no result-ing complications,98 subsequent studies determined that suchmaneuvers may not be necessary as long as there is noobstruction of the right vertebral or carotid artery and the leftinternal mammary artery is not used as a coronary bypassconduit.71–73 Complications such as left arm ischemia werefound to be rare, possibly owing to collateral blood supply viaretrograde left vertebral flow. This is commonly referred to asthe “subclavian steal” phenomenon. Most centers now inten-tionally cover the left subclavian origin when necessary andreserve secondary revascularization procedures for whenrelated symptoms develop.69

For even more proximal thoracic aneurysms involving theaortic arch, branched and fenestrated stent grafts are beingdeveloped to accommodate perfusion through the great ves-sels.99,100 Although feasibility has been demonstrated, it isalready apparent that the required implantation techniqueswould have to be highly complex and demand considerabletechnical expertise. Some centers have thus been investigat-ing techniques to create fenestrations intraoperatively afterdevice deployment and coverage of critical branches.101

In contrast, there are no easy management strategies to dealwith a short distal neck. In this setting as well, fenestrated andbranched grafts have been used in isolated cases, but theoverall experience is very limited. Intentional coverage of theceliac artery is not recommended given the risk of hepatic andvisceral ischemia. Although a normal superior mesentericartery may provide collateral flow, no methods exist topredetermine whether such collateral supply would be suffi-cient. Furthermore, the celiac trunk may serve as a prominentsource of retrograde endoleak if covered without adjunctivetranscatheter occlusion. In distal aneurysms that involve boththe descending thoracic and abdominal aorta, combined openAAA repair and endovascular TAA exclusion is a noveltreatment approach under investigation.

Stent grafts are also being used to treat patients with diffuseaneurysmal disease involving the entire thoracic aorta. Insuch patients, the traditional surgical treatment is a 2-stagedprocedure named the “elephant trunk technique.”102 In thefirst stage, the ascending aorta and aortic arch are repaired viaa median sternotomy, and an extra-long graft is used forreconstruction, which leaves the excess portion of the graft,the elephant trunk, dangling within the lumen of the remain-ing diseased aorta. In the second stage, the lesion in thedescending aorta is repaired via a left thoracotomy, and thegraft replacement is connected to the elephant trunk proxi-mally. To bypass the need for thoracotomy, a few centershave successfully deployed thoracic stent grafts into theelephant trunk extension, altogether replacing the secondstage of the traditional elephant trunk procedure.103

Following closely on the heels of early clinical experienceswith stent grafting for TAA repair, experimental applicationof this less invasive approach has been extended to a growing

number of other pathologies of the thoracic aorta. Mostnoteworthy among these are aortic dissection,104 traumaticaortic injury,105 penetrating atherosclerotic ulcer,106 and aor-tic rupture.107 Some investigators believe that thoracic stent-graft technology may eventually yield the greatest impact onclinical care in the management of aortic dissections, becausecurrent treatment standards are far from optimal.

ConclusionsThe emergence of endovascular stent grafting as an alterna-tive therapy to open surgical repair of abdominal and thoracicaneurysms is an exciting advance. Although it is apparent thathigh-operative-risk patients will benefit from this technology,the exact role of stent grafting remains to be defined as wecontinue to accumulate long-term data and experience and asdevices and techniques evolve. Instead of replacing conven-tional surgical treatment, endovascular repair will likely playa complementary role and offer a less invasive option in ourtreatment armamentarium. It is clear that the limitations ofboth approaches are distinct. Although what is consideredhigh risk for surgery is defined by clinical parameters in termsof comorbidities and physiological reserve, contraindicationsfor endovascular stent-graft treatment are defined by anatom-ical constraints. In this regard, each may fulfill the treatmentgaps left by the other.

DisclosuresDr Dake has received research grants from Cook and W.L. Gore; hasserved on the speakers’ bureau of Cook; and has consulted for W.L.Gore. Dr Katzen has consulted for and received educational grantsfrom Cook, Boston Scientific, W.L. Gore, and Medtronic.

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Katzen et al Endovascular Aneurysm Report 1675

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Barry T. Katzen, Michael D. Dake, Alexandra A. MacLean and David S. WangEndovascular Repair of Abdominal and Thoracic Aortic Aneurysms

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