Endovascular Abdominal Aortic Aneurysm Repair

14 Pages·2009·0.29 MB·English

Basic Data Underlying Clinical Decision Making in
Endovascular Therapy
Endovascular Abdominal Aortic Aneurysm
Repair: Part I
Joseph J. Ricotta II, Rafael D. Malgor, and Gustavo S. Oderich, Rochester, Minnesota
Endovascular repair of infrarenal abdominal aortic aneurysms has become a well-established
and safe treatment modality. Since its development in 1991 by Juan Parodi, an increasing
number of procedures have been performed worldwide. The advantages of an endovascular
approach include decreased blood loss, length of hospitalization, and early morbidity and
mortality. Endovascular therapy is particularly well-suited for the elderly, higher-risk patient
and for those with prior aortic operations. This review summarizes the world’s literature to
dateregardingendovascularaorticaneurysmrepairintableformandshouldserveasapractical
andprompt literature search tool.
INTRODUCTION endovascular practice by most vascular surgeons.
In the United States, there are currently five stent
Endovascular repair has become a widely accepted
grafts approved by the Food and Drug Administra-
treatment for abdominal aortic aneurysms. The
tion for treatment of abdominal aortic aneurysms:
advantages of an endovascular approach include Zenith(cid:2) (Cook, Bloomington, IN), Excluder(cid:2)
decreased blood loss, length of hospitalization, and (Gore, Flagstaff, AZ), AneuRx(cid:2) and Talent(cid:2) (Med-
earlymorbidityandmortality.Endovasculartherapy tronic, Sunnyvale, CA), and Powerlink(cid:2) (Endolo-
is ideally suited for the elderly, higher-risk patient
gix, Irvine, CA). Anatomic limitations are similar
and for those with prior aortic operations. Properly
for all devices, including the minimum proximal
selected patients have a relatively low incidence of
neck length of 1.5cm for abdominal and 2.0cm
secondary problems including migration, endoleak,
forthoracicaneurysms.TheTalentabdominalaortic
andsacexpansion.Aneurysmruptureisuncommon
stent graft is approved for use in patients with
inpatientswhoadheretofollow-upsurveillance.
ashorternecklengthof1cm.
Since the first report on the use of endovascular
In this summary, we have reviewed the world’s
stent grafts by Juan Parodi and associates in 1991,
literature regarding endovascular aneurysm repair
substantial advances have been made in every
(EVAR). For the sake of clarity, we have elected to
aspect of endovascular technology. Innovations in
separate our review into two sections: (1) elective
catheters, wires, balloons, stent grafts, smaller
profile and rapid exchange systems, and intravas- Table I. Epidemiologic Data (EVAR trials)
cular ultrasound have been incorporated into the
References
Overall 12-15/100,000persons-year 4
Division of Vascular and Endovascular Surgery, Mayo Clinic,
incidence of
Rochester,Minnesota.
AAA
Correspondence to: Joseph J. Ricotta II, MD, School of Graduate Age Mean Range 5-79
Medical Education, College of Medicine, Mayo Clinic, 200 First Street
Southwest,Rochester,MN55905,USA,E-mail:[email protected] 73.7yr (47-98)
Gender Male:Female ratio 5-57, 61-79
AnnVascSurg2009;23:799-812
DOI:10.1016/j.avsg.2009.03.003 Average:6:1
(cid:3)AnnalsofVascularSurgeryInc. (49031males/8556females)
Publishedonline:May21,2009
799
800 Ricottaetal. AnnalsofVascularSurgery
Table II. Risk Factors
Incidence
RiskFactor Range Average(n) References
Chronic Renal Failure 3-38% 6%(1023/16926) 5, 8, 10,12-14, 19,25,28-32, 34,35,41,45,46,50,57,60-64, 79,80
Carotid Artery Disease 5-65% 8%(742/8845) 5, 12-14, 24,28,45,46,59,61
Obesity 2-27% 8%(2843/37659) 5, 17,22,46,81
Family History 2-13% 10%(110-1143) 6, 22,26,37,81
Valvular Disease 11-38% 12%(3828/30685) 22, 32,67,81
Diabetes Mellitus 4-55% 15%(7200/47880) 5,6,12-16,18,19,22,24-26,28-32,35,41,43,45-47,50,57,59,61,62,64,
67,69,70,79
Congestive HeartFailure 4-52% 15%(5366/34639) 10, 22,26,31, 32,37,58, 60,67
Cerebrovascular Disease 2-26% 16%(4997/31705) 16, 18,19,22, 29,31,47, 57,60,67,79,80
PAD* 10-39% 21%(6764/31777) 8, 22,26,29,34,35,57,63,67,72,80,81
Chronic Pulmonary 8-70% 29%(13747/47523) 5,6,10,12-14,16-19,22,26,28,29,31,32,34,35,37,41,45-47,50,53,57,
Obstructive Disease 59-61, 63,64,69,70,79
Hyperlipidemia 14-56% 34%(3784/11080) 5, 13,14,16,19,28,29,31,35,45,46,61,62,64,79,80
CurrentSmoker 11-87% 38%(4844/12835) 5, 6, 8,13-16, 22,24,28,29,31,32,35,43, 45-47, 59,61, 62,69,70, 81
Ischemic HeartDisease 13-83% 45%(8846/19411) 5, 6, 8,10,12-19, 25-32, 34,35,37, 41,45-47, 50, 53,57-64, 70, 79,80
Previous Smoker 23-82% 64%(1596/2506) 6, 8, 12,13,15,22,24,37,47,81
Hypertension 27-85% 60%(27469/45482) 5,6,8,12-14,16,18,19,22,25,26,28-32,35,37,39,41,45-47,58,60-63,
67,70,79-81
*PAD¼PeripheralArterialDisease
Table III. Aneurysm Features
Incidence
RiskFactor Range Average References
Neck diameter(mm) 17.9-25.3 23.7 12,22,23,26,27,42,53,55,57,
79,82-86
Neck length(mm) 8-70 24.6 6, 26,68,79,82,86-89
Neck Angle(degrees) 5-90 31 6, 68,79,82,86,90
Largest Diameter (mm)* 50-110 58 5,6,8,10,12,15,18,19,21,22,
24-29, 32,33, 35-39, 42,45-
48,51,53,55,57,59,60,63,
69,74,77,79,84,91
LengthRenal-Iliac 119-188 164 53,82,90
artery(mm)
*StudiesincludingAAA(cid:2)5cm
Table IV. Type of Anesthesia and Risk Stratification
Incidence
TypeofAnesthesia Range Average(n) References
General 4-100% 61% (6569/10744) 5, 11-14, 17, 19,24,27, 32,46,55, 58,61,81, 88,92
Regional 2-95% 34% (3491/10319) 5, 11-14, 17, 19,27,35, 46,58,61, 88,92
Local 1-71% 8% (705/8684) 5, 11-13, 19, 28,46,61, 92
Conversion LA to GA* 0-15% 3% (15/561) 28,93-95
ASAI 0-42% 10% (342/3453) 22,28,45,46,57,61,75,91
ASAII 5-70% 34% (1544/4557) 13,22,28,29,42,45,46,57,61,70, 75,81,91
ASAIII 8-91% 52% (2721/5245) 13,22,27-29, 39,42,45,46,57,61,70, 75,81,91, 96
ASAIV 4-57% 17% (906/5290) 12,13,19,22,27-29, 42,57,70,75,81, 91,96
SVS (median score)z 12-25 14 5, 28,43
*LA/GA¼LocalAnesthesia/GeneralAnesthesia;
zSocietyforVascularSurgeryScore
Vol.23,No.6,November2009 Endovascularabdominalaorticaneurysmrepair:I 801
Table V. Procedure Data
Incidence
Variables Range Average(N) References
DeploymentSuccess, % 85-100 95 7,8,11,12,15,21,24,33,35,38,42,46,48,51,52,57,59,60,65,
69, 75,80,90, 97,98
Durationof Procedure,min 35-846 168 5,11,12,15,17-19,36,38,43,46,49,55,58,59,76,78,80,92,99
Blood Loss,ml 50-1700 354 11,12,16,18,19,24,26,36,37,43,58,59,76, 80,92
Media Contrast,ml 88-195 145 15,30,41,53,55,81,100, 101
Anyiliacintervention %* 2-17 8(176/2134) 10,13,24,26,29,35,38,97,99
Additional Procedure,% 2-31 23(2118/9045) 5, 8, 10,11,21, 24,28
Conversion to open repair% 0-5.5 2(859/48637) 5,7,8,10,11,13,16,17,19,21,24-26,29,33,35,38-40,42,47,48,
51, 57,59,66, 67,73,77, 98,102-104
Transfusion, [U] 0-4.8 0.6 13,17,24,28,55,60,63,92,95
ICU lengthof Stay(days) 0-48 2.3 10,11,15,23,29,31,32,46,49,59,60,80,86, 92
Hospital lengthof Stay(days) 1-43 5 5,6,10-12,15,16,19,20,26,29,31,34,37,41-44,46,49,55,59,
63, 67,70,72, 76,80,86, 92,105
*NeedforIliacarteryangioplasty/stentingorendarterectomypriortoEVAR
Table VI. Incidence according to model and US-commercially available devices*
Incidence
Pattern Range Average(N) References
Bifurcated 52-98% 86%(11266/13048) 7,11,12,14,15,18,19,21,24,26,34-36,46,57,66,75,81,82,91
Tubular 1-48% 9%(1013/11538) 7, 11,14,18,19,21, 34-36, 46,57, 66,75,81, 82,91
Aortouniiliac+Crossover 0-26% 5%(470/10100) 7, 11,12,14,15,19, 21,26,34-36, 46,66,75
Devices (Company)
Zenith(cid:2)(CookMedical,Inc) 6-82% 35%(4316/12483) 11,13-15,19,21,24,25,28,29,32,35,37,39,55,56,66,70,71,92,
98, 106
AneuRx(cid:2)(Medtronic, Inc) 4-86% 29%(4552/15516) 10,11,13-15,17,19,21,24-26,32,35,37,39,55-57,59,62,66,70-
72, 74,98,106
Talent(cid:2)((Medtronic, Inc) 0.5-65% 22%(2682/12419) 5, 7, 11,12,14, 15,19,21, 24,26,28, 29,37,39,56,57,106
Excluder(cid:2)(Gore Medical,Inc) 1-40% 12%(1928/15841) 13-15,19,21,24-26,28,29,32,35,37,39,55,56,62,66,70,71,74,
92, 98,106
Powerlink(cid:2)(Endologix,Inc) 1-38% 4%(400/10823) 10,19,25,32,35,57,66,71,98,106
*DatafromMixedGrafttrials(FortheUSPivotal/MulticentertrialsrefertoTableXVIIA/B)
Table VII. Early Complications (<30 days)
Incidence
Range Average(Noofpatients) References
Respiratory Impairment 1-12% 9% (2818/32582) 8-10,12,17,28, 36,44,64, 67,72,78, 98
Unstable Angina/MI* 1-5% 7% (2114/31559) 7,10,12,28,36,48,51,63,64,67, 73,80,86, 98
Access hematoma 1-5% 4% (23/560) 11,34,51,57,75
Lymphocele/leak 0-5% 3% (32/1054) 10,12,48,51,64,75,80,107
Wound Infection 0-11% 3% (119/3744) 8,10-12, 28,31,44,46,51,64,72,78, 80,98
Graft LimbThrombosis 0-7% 3% (110/4232) 10-12,15,31,33,38,40,46,47,51,57,59,60,64,65,69,
86,104
Access-related rupture/dissection 1-4% 2% (13/695) 6,10,12,51,57,81
Pseudoaneurysm 0-1% 1% (6/554) 26,57,108
Ileus 0-1% 1% (4/486) 12,57,72
Stroke 0-1% 0.6%(5/865) 8,12,36,58,64,80
Bowel Ischemia 0-2% 0.4%(36/8806) 8,36,42,57,59,86,109, 110
Paraplegia 0-1% 0.2%(7/2923) 17,111
AAA Rupture 0-0.5% 0.1%(8/10025) 22,32,39,91
*MI¼MiocardialInfarction
802 Ricottaetal. AnnalsofVascularSurgery
Table VIII. Late Complications (>30 days)
Incidence
Range Average(Noofpatients) References
Secondary Procedure 4-82% 13% (1146/8789) 9,10,12,15,17,19,25,26,35,40,46,52,53,55-57,59,
60,68,78,81,84,105,112,113
AAA enlargement* 1-11% 6%(139/2442) 12,26,32,34,40,56,57,68,81,113, 114
GraftMigrationy 0-16% 3%(299/8917) 6,12,15,27,32,33,35,38,40,42,46,51,56,58,68,71,
77,78,83,105, 115, 116
AAA Rupture 0-2% 2%(471/29406) 10,12,22,32,35,39,40,51,59,67,79,91,112
GraftInfection 0-1% 0.5%(12/2265) 15,40,57,71,112, 117, 118
*AAAmeasurement-followup(cid:3)2years
yMigration>5mm
Table IX. Internal Iliac Artery and Buttock Claudication postEvar
Incidence
Variable Range Average(N) References
Intentional IIA Occlusion 4-69% 11%(1287/11431) 97,119-138
ButtockClaudication* 2-50% 18%(233/1287) 97,119-138
IIA ¼InternalIliacArtery
*Postunilateraland/orbilateralIIAocclusion
Table X. Sexual Dysfunction postEVAR and Open Repair
PreoperativeSexual PostoperativeSexual
Dysfunction Dysfunction(newonset)
EVAR(n) OR(n) EVAR% OR% EVAR% OR% P-Value
Mehta etal, 2001 108 34 - - 6 4 -
Mehta etal, 2004 18 10 - - 11 20 -
Prinssen etal, 2004x 77 76 74 66 53 66 NS
Kooet al,2007 21 26 27 62* 76 58* NS
Total % 224 146 42 64 40 33
QoL¼QualityofLife;OR¼OpenRepair
xDatafromDREAMtriale3-months-follow-up
*p<0.05
Table XI. Renal Failure
Incidence
Range Average(N) References
AcuteRenal Failure 0-17% 5%(1811/33687) 7, 8,10-12, 21,24,28,30,31,36,48,51,
63,67,72,73,86
Need fordialysis 0-3% 0.4%(130/30665) 7, 8,11,12,30,51,67,86,98
EVARfornonrupturedabdominalaorticaneurysms form. The data for EVAR of ruptured AAAs will be
(AAAs) and (2) EVAR for ruptured AAAs. This includedinaseparatesummary.
reviewwillattempttosummarizeallavailabledata The literature search for this review was per-
for elective EVAR of nonruptured AAAs in table formedusingtheMEDLINEandEMBASEdatabases
Table XII. Early Endoleak (<30 days)
Incidence
Range Average(n) References
Classification
TypeI 0-26% 4%(473/11411) 5,8,10,12,14,17,19,21,26,34,38,46,48,62,80,
102, 115, 139
TypeIa 1-5% 3%(264/8688) 5,21,65,140, 141
TypeII 1-26% 9%(1032/11304) 5,8,10,14,17,19,21,26,34,38,46,48,62,65,80,
102, 115, 139
TypeIII 0-5% 2%(165/9360) 5,10,17,21,26,38,46,48,65,80,102,139
Overall Endoleak 0-23% 15% (1635/11234) 5,7, 14,17,19,21,26,32-34, 38,46,57,
62,73,102,139
Table XIII. Late Endoleak (>30 days)
Incidence
Range Average(n) References
Classification
TypeI 0-25% 6% (248/4477) 12,14,33,38,51,56,57,62,68,73,74,76,84,88,102,
115, 142
TypeIa 0-8% 4% (43/1212) 19,46,73,143
TypeII 1-81% 12% (377/3205) 12,14,33,38,51,57,62,68,73,74,76,84,
88,102, 115, 142
TypeIII 0-7% 1% (22/1767) 12,14,33,38,57,69,73,74,102
Overall Endoleak 4-38% 17% (795/4712) 6,7,10,12,14,22,32,35,40,51,53,57,58,62,73,74,
78,88, 102,142
Table XIV. Early Mortality Causes (<30 days)
Incidence
Range Average(n) References
Procedure-related 1-7% 2%(71/4059) 15,24,35,39,63,65,86
Mortality 0-9% 2%(1020/53430) 6,9-12,15-19,24-26,30-33,35,36,38,39,42-46,48-51,
53,56, 57,60,65, 67,70,72, 73,75-77, 80, 97,98,
102, 105, 113, 144
Cardiac 1-4% 1%(54/7833) 15,26,38,42,57,73,145, 146
Multiorgan Failure 0-3 0.4%(33/7730) 17,26,35,36,42,57,147
Pulmonary 0-1% 0.3%(19/6232) 26,146, 147
Rupture 0-2% 0.1%(11/11908) 5,15,24,25,38,48,144
Table XV. Late Mortality Causes (>30 days)
Incidence
Range Average(n) References
Causes
Cardiac 1-54% 5%(150/2828) 11,15,22,24,28,40,42,51,57,58,70,117,148
Pulmonary 0-9% 2%(31/1765) 11,15,24,40,42,46,51,70,105
Procedure related-death 0-6% 2%(119/7632) 11,13,19,21,22,24,25,32,34,40,42,46,48,51,56,
57,59, 60,71,117
Multiorgan Failure 0-2% 1%(7/883) 11,40,51,57,58
Stroke 0-4% 1%(15/1084) 11,15,24,42,46,51
AAA Rupture 0-2% 1%(53/5445) 13,15,22,25,42,56,57,70,71,112, 117
Overall Mortality 0-50% 9%(787/8609) 6,11,14,20-22,24,29,31,33-35,37,38,42,45,46,53,
57,58, 75,76,79, 98,102
8
0
4
R
ico
tta
e
t
a
l.
Table XVI. Mortality and Survival Analysis Comparison between EVAR and Open Repair e EBM* Level I and II Trials
n OperativeMortality 1-yrSurvival 5-yrSurvival
LevelofEBM EVAR OR EVAR(%) OR(%) p EVAR OR EVAR OR
Trials
EVAR-1 I 610 596 10(1.6) 25(4.2) .011 93 90 74z 71z
DREAM I 171 174 2(1.2) 8(4.6) .1 89.6y 89.7y - -
Greenberget al, 2004 II-1 152 80 1(0.5) 2(2.5) NS 96.5 96.2 83x -
Zarins etal, 1999 II-1 416 66 5(3) 0(0) NS 96 97 62.4[] -
Petersonet al,2007 II-1 235 99 2(1) 0(0) NS 95 94 72 81
Criadoet al,2001 II-1 240 126 1(0.8) 0(0) NS 91.7 95.2 - -
Mooreet al,2003 II-1 573 111 1.7(10) 2.7 (3) NS 94 95 68.1 77.2
Wanget al,2008 II-1 192 66 2(1) 4(6) NS 94 87.5 69.6 -
Hyneset al,2007 II-1 66 52 2(3) 3(5.8) .007 90 89 78.8 84.9
Schermerhorn etal, 2008jj II-3 29542 32056 354(1.2) 1539(4.8) <0.001 94 89 63 63
Cao Petal, 2004 II-3 534 585 5(0.9) 24(4.1) .001 97 98 70 97
Bushet al, 2006{ II-3 717 1187 22(3.1) 66(5.6) .01 91.3 87.9 - -
Wanhainemet al,2008 II-3 1064 9627 56(5.3) 347(3.6) .004 - - - -
TableRefs.15,19,31,50,60,61,67,92,149-157
*EBM¼Evidence-basedMedicine
yDREAMtrial-2yrdataavailabl
z4yrdata
xGreenbergetal,2008
[]Zarinsetal,2003
jjUS-Medicaredata
{Veteran’sAffair(VA)NationalSurgicalQualityImprovementProgram(NSQIP)data A
n
n
a
ls
o
f
V
a
s
c
u
la
r
S
u
r
g
e
r
y
V
o
l.
2
3
,
N
o
.
6
,
N
o
v
e
Table XVII.A. Device-related outcomes (the US Pivotal/Multicenter Trials) m
b
e
r
AneuRx* Excludery Zenithz Talentx Powerlink[] 2
0
0
9
DeploymentSuccess Rate 97% 100% 99.6% 98.7% 97.9
Conversion toOR* 4.5%(53/1193) 4.3%(10/235) 1.3%(8/625) 2.5%(6/240) 6.8%(13/192)
AAA rupture 1.3%(15/1193) 0(0/235) 0.1%(1/632) 0(0/237) 0(0/190)
AAA-related death 2.5%(30/1193) 2.5%(6/235) 2.9%(18/615) - -
Mortality 21%(250/1193) - 25% (125/508) 8.3%(20/241) 21.9%(42/192)
Endoleak 13.9%(19/137) 3% (2/68) 6% (36/619) 10% (16/159) 14.3%(4/35)
TypeI Endoleak 1%jj(5/499) 0(0/68) - 9%#(29/320) 0.8%(1/123)
AAA Enlargement 11.5%(15/130) 38% (30/79) 6% (31/489) 1.2%(2/159) 10.3%(3/29)
Sac Shrinkage 36%**(138/383) 21% (16/76) 73%yy (128/175) 59%# (192/323) 82.8%(53/64)
Graft Migration 9.5%(13/137) 0(0/235) 2.6%(19/736) 1.9%(3/159) 1.6%(3/190)
Need for SecondIntervention 8%(94/1192) 24% (57/235) 19% (64/555) - 18% (34/192)
Proximal.Extension 22%(202/1119) 33% (77/235) - - 42% (79/188)
Fracture Rate 0.16%(18/1119) 0(0/74) 0(0/376) 4.6%(11/237) 0(0/190)
Survival Rate 62.4% 72% 61%U - 69.6%
Freedom fromAAA Rupture 98.4% - 100% - -
Freedom fromconversion 90.4% - 98.2% - -
Freedom fromAAA-related death 96.9 97% 97.8% - - E
n
d
o
*6yrdata155,156 va
y5yrdata149 scu
z5yrdata157 lar
x1yrdata153,154 ab
d
[]6yrdata150,161 om
jj2yrdata158 in
a
#143 l
**1yrdata159 a
o
yy2yrdata160 rtic
UHigh-riskpatients a
n
e
u
r
y
sm
r
e
p
a
ir
:
I
8
0
5
806 Ricottaetal. AnnalsofVascularSurgery
Table XVII.B. Device-related outcomes (the US Pivotal/Multicenter Trials)*
Guidant/EVTy Ancurey Lifepathz
DeploymentSuccess Rate, % 90.3 95.1 98.7
Conversion to OR 9.7%(26/268) 4.9%(15/305) 2.2%(5/227)
AAA rupture 0(319/319) 0(111/111) 0(0/227)
AAA-relateddeath - - -
Mortality 7%(19/268) 3%(9/305) 6.6%(15/227)
Overall Endoleak - - 6.8%(15/227)
Type1Endoleak 5%(12/242) 6.3%(18/290) 2.9%(7/224)
AAA Enlargement 2.4%(1/42)[ ] 2.4%(1/42)[ ] 3%(7/227)
Sac Shrinkage 78% (33/42)[ ] 78% (33/42) [] 58%(140/242)
Graft Migration 0.6%(2/319) 0.6%(2/319) 2.2%(5/227)
Need forSecond Intervention 9.1%(22/242) 10.3%(30/290) 7.5%(17/224)
Proximal.Extension - - 17.6%(40/227)
Fracture Rate - - 21.9%(43/196)
Survival Rate 68.1 77.2 -
Freedom fromAAA Rupture 100% 100% -
Freedom fromconversion 99.4% 99.4% -
Freedom fromAAA-relateddeath - - -
x4yeardata161
*Stent-graftsnotcommerciallyavailableintheUS
yCombinedAnalysisEVT/Ancure151,152
z2yeardata162
[]5-yearfollow-updatafromGuidant/EVTandAncuregroups152
Table XVIII. AAA Size-related Outcomes data
SMALL(<5cm) MEDIUM/LARGE((cid:2)5cm)
Range Average(n) Range (n)Average Ref.
Conversion to open repair 1-3% 1%(38/2802) 2-8% 2% (75/3152) 35,56,163
Second Procedure 10-22% 14%(183/1318) 10-29% 18% (127/722) 35,56,164
Type1Endoleak 1-4% 3%(92/2856) 6-8% 8% (211/2713) 56,163, 164
Earlymortality 1-2% 1%(43/3280) 2-4% 3% (97/3152) 35,56,163, 164
AAA Enlargement 9-10% 9.5%(85/894) 10% 10%(28/283) 56,163, 164
Endograft Migration 4.4% 4.4%(18/416) 13% 13% (37/283) 56
AAA Rupture 0-2% 1%(9/857) 1-6% 4% (27/765) 56,165
Table XIX. Costs Analysis
n Preoperativeworkup HospitalCharges Postoperativecosts TotalCosts
EVAR OR EVAR OR EVAR OR EVAR OR EVAR OR
Values in US$
Holzenbein etal, 1997 22 22 - - - 23381 26642
Patelet al, 1999 -* 3228 1324 7764 15428 6928 2482 16016 20083
Seiwert etal, 1999 16 16 - - - 12714 12905
Sternbergh III etal, 2000 131 49 - - - 12546 19985
Bosch etal, 2001 181 273 - - - 20716 18484
Berman etal, 2002 9 11 - - - 20247 17576
Dryjskiet al, 2003 73 57 - - - 17539 9042
Rosenberg etal, 2005 34 54 - 15049 12733 - 28960 37137
Hayter etal, 2005 55 140 733 663 12297 4635 3599 8764 16631 14063
Fotis etal, 2008 37 21 - - - 29287 7643
(Continued)
Vol.23,No.6,November2009 Endovascularabdominalaorticaneurysmrepair:I 807
Table XIX.Continued
n Preoperativeworkup HospitalCharges Postoperativecosts TotalCosts
EVAR OR EVAR OR EVAR OR EVAR OR EVAR OR
Total (Averages) 524 589 1980 993 11703 10932 5263 5803 19804 18356
Values in Euros(V)
Hynesat al, 2007 66 52 415 415 17108 24181 1368y 70y 18476 24252
Mani etal, 2008 51 58 1494 415 20484 24512 4515 4613 26382 29786
Total (Averages) 117 110 954 538 18796 24346 2941 2341 22429 27019
Ref.29,47,49,60,166-174;OR¼OpenRepair
*Costscalculatedbasedonahypotheticalcohortofpatients
yFollow-upvaluesconsideringonlynoninvasiveexams
focusing on keywords such as ‘‘abdominal aortic efficientprocedureinboththeshortandlongterms.
aneurysm,’’ ‘‘EVAR,’’ ‘‘endovascular,’’ ‘‘endog- ThesedataaresummarizedinTablesXVIIIandXIX.
raft,’’and‘‘stentgraft.’’Thisyieldedan abundance Thepurposeofthisreportistonottoanalyzeall
of matches consisting of a few thousand papers data but to provide readers with a synopsis of the
that have been published over the past 17 years. most current andimportantdataregardingthekey
Werefinedoursearchbasedonnumberofpatients issues in EVAR. We hope that readers find it to be
(>30 patients), rationale and design of the study, informative,insightful,andhelpfultotheirpractice.
andtypeofstudy(clinicaltrials,mega-trials,pivotal
studies) to include the most practical and current
REFERENCE
issuesrelatedtoEVAR.
Data extracted from selected papers were allo-
1. LederleFA,WilsonSE,JohnsonGR,etal.Immediaterepair
catedastheyappearincrudevaluesorpercentages. compared with surveillance of small abdominal aortic
Specifickeywordswereusedtoenrichtablesrelated aneurysms.NEnglJMed2002;346:1437-1444.
to endoleak and specific complications like bowel 2. Lederle FA, Powell JT, Greenhalgh RM. Repair of small
abdominal aortic aneurysms. N Engl J Med 2006;354:
ischemia, buttock claudication, and sexual
1537-1538.
dysfunction.
3. PowellJT,BrownLC,ForbesJF,etal.Final12-yearfollow-
We allocated information in tables regarding up of surgery versus surveillance in the UK Small Aneu-
epidemiology(TableI),riskfactors(TableII),aneu- rysmTrial.BrJSurg2007;94:702-708.
rysmfeatures(TableIII),anesthesiaandriskstratifi- 4. CowanJA,Jr,DimickJB,HenkePK,RectenwaldJ,StanleyJC,
UpchurchGR,Jr.Epidemiologyofaorticaneurysmrepairin
cation (Table IV), procedure data (Table V), device
the United States from 1993 to 2003. Ann N Y Acad Sci
and graft data (Table VI), and early and late
2006;1085:1-10.
morbidity and mortality results of EVAR including 5. RuppertV,LeursLJ,HoboR,ButhJ,RiegerJ,UmscheidT.
endoleakanalysis,sexualdysfunction,buttockclau- Tube stent-grafts for infrarenal aortic aneurysm:
dication,andrenalfailure(TablesVIIeXV).Intable amatched-pairedanalysisbasedonEUROSTARdata.Car-
diovascInterventRadiol2007;30:611-618.
XVI, we summarized the mortality and survival
6. DillavouED,MulukSC,RheeRY,etal.Doeshostileneck
results from the available level I and II evidence
anatomyprecludesuccessfulendovascularaorticaneurysm
based on multicenter trials which compared EVAR repair?JVascSurg2003;38:657-663.
to open repair (OR). To further compare data for 7. Wyers MC, Fillinger MF, Schermerhorn ML, et al. Endo-
each specific endograft that has been tested and vascular repair of abdominal aortic aneurysm without
preoperativearteriography.JVascSurg2003;38:730-738.
commercially available in the United States, we
8. Nordness PJ, Carter G, Tonnessen B, Charles
summarized the device-specific outcomes from the
Sternbergh W, 3rd, Money SR. The effect of gender on
respective U.S. pivotal and multicenter trials with early and intermediate results of endovascular aneurysm
long-term results out to 5 years and compared the repair.AnnVascSurg2003;17:615-621.
resultsforeachendovasculardeviceinTablesXVIIA 9. Simons P, van Overhagen H, Nawijn A, Bruijninckx B,
KnippenbergB.Endovascularaneurysmrepairwithabifur-
andXVIIB.
catedendovasculargraftataprimaryreferralcenter:influ-
Controversy still exists over the appropriate
ence of experience, age, gender, and aneurysm size on
aneurysm size threshold for repair of AAA. suitability.JVascSurg2003;38:758-761.
Currently, the prevailing dogma is to repair AAAs 10. ElkouriS,GloviczkiP,McKusick MA,etal. Perioperative
(cid:2)5.5cm based on population-based study trials.1-3 complications and early outcome after endovascular and
opensurgicalrepairofabdominalaorticaneurysms.JVasc
In addition to indications, costs of EVAR have
Surg2004;39:497-505.
been scrutinized and compared with those of OR
11. Zeebregts CJ, Geelkerken RH, van der Palen J,
in order to assess the most efficacious and cost- Huisman AB, de Smit P, van Det RJ. Outcome of
808 Ricottaetal. AnnalsofVascularSurgery
abdominalaorticaneurysmrepairintheeraofendovascu- between endovascular and open abdominal aortic aneu-
lartreatment.BrJSurg2004;91:563-568. rysmrepair.JVascSurg2005;42:912-918.
12. BieblM,HakaimAG,OldenburgWA,etal.Midtermresults 30. Parmer SS, Carpenter JP. Endovascular aneurysm repair
of a single-center experience with commercially available with suprarenal vs infrarenal fixation: a study of renal
devicesforendovascularaneurysmrepair.Mt.SinaiJMed effects.JVascSurg2006;43:19-25.
2005;72:127-135. 31. BushRL,JohnsonML,CollinsTC,etal.Openversusendo-
13. Biebl M, Lau LL, Hakaim AG, et al. Midterm outcome of vascularabdominalaorticaneurysmrepairinVAhospitals.
endovascularabdominalaorticaneurysmrepairinoctoge- JAmCollSurg2006;202:577-587.
narians: a single institution’s experience. J Vasc Surg 32. SicardGA,ZwolakRM,SidawyAN,WhiteRA,SiamiFS.
2004;40:435-442. Endovascular abdominal aortic aneurysm repair: long-
14. Garcia-Madrid C, Josa M, Riambau V, Mestres CA, term outcome measures in patients at high-risk for open
Muntana J, Mulet J. Endovascular versus open surgical surgery.JVascSurg2006;44:229-236.
repairofabdominalaorticaneurysm:acomparisonofearly 33. Seriki DM, Ashleigh RJ, Butterfield JS, et al. Midterm
andintermediateresultsinpatientssuitableforbothtech- follow-up of a single-center experience of endovascular
niques.EurJVascEndovascSurg2004;28:365-372. repair of abdominal aortic aneurysms with use of the
15. Endovascular aneurysm repair versus open repair in Talentstent-graft.JVascIntervRadiol2006;17:973-977.
patients with abdominal aortic aneurysm (EVAR trial 1): 34. Baril DT, Palchik E, Carroccio A, et al. Experience with
randomisedcontrolledtrial.Lancet2005;365:2179-2186. endovascularabdominalaorticaneurysmrepairinnonage-
16. RigbergDA,DorafsharA,SridharA,Quinones-BaldrichW, narians.JEndovascTher2006;13:330-337.
MooreWS.Abdominalaorticaneursym:stentgraftvsclin- 35. Brewster DC, Jones JE, Chung TK, et al. Long-term
ical pathway for direct retroperitoneal repair. Arch Surg outcomes after endovascular abdominal aortic aneurysm
2004;139:941-946. repair:thefirstdecade.AnnSurg2006;244:426-438.
17. Tefera G, Carr SC, Turnipseed WD. Endovascular aortic 36. Chan YC, Morales JP, Gulamhuseinwala N, et al. Large
repairorminimalincisionaorticsurgery:whichprocedure infra-renal abdominal aortic aneurysms: endovascular vs.
to choose for treatment of high-risk aneurysms? Surgery open repairdsingle centre experience. Int J Clin Pract
2004;136:748-753. 2007;61:373-378.
18. Angle N, Dorafshar AH, Moore WS, et al. Open versus 37. Chahwan S, Comerota AJ, Pigott JP,
endovascular repairof abdominal aorticaneurysms:what Scheuermann BW, Burrow J, Wojnarowski D. Elective
doeseachreallycost?AnnVascSurg2004;18:612-618. treatment of abdominal aortic aneurysm with endovas-
19. CaoP,VerziniF,ParlaniG,etal.Clinicaleffectofabdominal cular or open repair: the first decade. J Vasc Surg
aorticaneurysmendografting:7-yearconcurrentcompar- 2007;45:258-262.
isonwithopenrepair.JVascSurg2004;40:841-848. 38. QuL,HetzelG,RaithelD.Sevenyears’singlecenterexpe-
20. Leon LR, Jr, Labropoulos N, Laredo J, Rodriguez HE, rienceofPowerlinkunibodybifurcatedendograftforendo-
Kalman PG. To what extent has endovascular aneurysm vascularaorticaneurysmrepair.JCardiovascSurg(Torino)
repair influenced abdominal aortic aneurysm manage- 2007;48:13-19.
ment in the state of Illinois? J Vasc Surg 2005;41: 39. Boult M, Maddern G, Barnes M, Fitridge R. Factors
568-574. affecting survival after endovascular aneurysm repair:
21. ThomasSM,BeardJD,IrelandM,AyersS.Resultsfromthe resultsfromapopulationbasedaudit.EurJVascEndovasc
prospective registry of endovascular treatment of abdom- Surg2007;34:156-162.
inal aortic aneurysms (RETA): mid term results to five 40. HuglB,HakaimAG,BieblM,etal.Impactofgenderonthe
years.EurJVascEndovascSurg2005;29:563-570. outcomeofendovascularaorticaneurysmrepairusingthe
22. ZarinsCK,CrabtreeT,ArkoFR,etal.Endovascularrepair Zenith stent-graft: midterm results. J Endovasc Ther
or surveillance of patients with small AAA. Eur J Vasc 2007;14:115-121.
EndovascSurg2005;29:496-504. 41. WaasdorpE, van’t Hullenaar C, van HerwaardenJ, et al.
23. AzizzadehA,SanchezLA,RubinBG,etal.Aorticneckattach- Renalfunctionafterendovascularaorticaneurysmrepair:
ment failure and the AneuRx graft: incidence, treatment asingle-centerexperiencewithtransrenalversusinfrarenal
options,andearlyresults.AnnVascSurg2005;19:516-521. fixation.JEndovascTher2007;14:130-137.
24. Endovascularaneurysmrepairandoutcomeinpatientsunfit 42. vanHerwaardenJA,vandePavoordtED,WaasdorpEJ,etal.
foropenrepairofabdominalaorticaneurysm(EVARtrial2): Long-termsingle-centerresultswithAneuRxendograftsfor
randomisedcontrolledtrial.Lancet2005;365:2187-2192. endovascularabdominalaorticaneurysmrepair.JEndovasc
25. Lifelineregistryofendovascularaneurysmrepair:long-term Ther2007;14:307-317.
primaryoutcomemeasures.JVascSurg2005;42:1-10. 43. Gawenda M, Brunkwall J. Renal response to open and
26. AartsF,vanSterkenburgS,BlankensteijnJD.Endovascu- endovascular repair of abdominal aortic aneurysm:
laraneurysmrepairversusopenaneurysmrepair:compar- aprospectivestudy.AnnVascSurg2008;22:1-4.
ison of treatment outcome and procedure-related 44. VogelTR,SymonsR,FlumDR.Theincidenceandfactors
reinterventionrate.AnnVascSurg2005;19:699-704. associatedwithgraftinfectionafteraorticaneurysmrepair.
27. TonnessenBH,SternberghWC,3rd,MoneySR.Mid-and JVascSurg2008;47:264-269.
long-term device migration after endovascular abdominal 45. Baas AF, Janssen KJ, Prinssen M, Buskens E,
aortic aneurysm repair: a comparison of AneuRx and BlankensteijnJD.TheGlasgowAneurysmScoreasatool
Zenithendografts.JVascSurg2005;42:392-401. to predict 30-day and 2-year mortality in the patients
28. VerhoevenEL,CinaCS,TielliuIF,etal.Localanesthesiafor from the Dutch Randomized Endovascular Aneurysm
endovascularabdominalaorticaneurysmrepair.JVascSurg Managementtrial.JVascSurg2008;47:277-281.
2005;42:402-409. 46. CoppiG,SilingardiR,SaittaG,GennaiS.Single-centerexpe-
29. Hayter CL, Bradshaw SR, Allen RJ, Guduguntla M, riencewiththeTalentLPSendograftinpatientswithatleast
Hardman DT. Follow-up costs increase the cost disparity 5yearsoffollow-up.JEndovascTher2008;15:23-32.