Congress presentation in S.PAULO 2010 DOES ANEURYSM SAC STABILIZATION DURING EVAR REDUCE THE INCIDENCE OF ENDOLEAKS? Presentazione al congresso di S.Paulo 2010 (Chirurgia Vascolare-ULSS 15 Alta Padovana) (Vascular Surgery -ULSS 15 Alta Padovana)

1. DOES ANEURYSM SAC STABILIZATION DURING EVARDOES ANEURYSM SAC STABILIZATION DURING EVAR
REDUCE THE INCIDENCE OF ENDOLEAKS?REDUCE THE INCIDENCE OF ENDOLEAKS?
SEVEN YEARS EXPERIENCESEVEN YEARS EXPERIENCE
DEPARTMENT OF CARDIOVASCULAR DISEASES
DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY
Chief: Salvatore Ronsivalle, MD
S.Paulo April 20-24
CICE2010CICE2010

2. BACKGROUNDBACKGROUND
EVAREVAR (endovascular aneurysm repair) is an increasingly used method of(endovascular aneurysm repair) is an increasingly used method of
repairing aortic abdominal aneurysmrepairing aortic abdominal aneurysm
TYPE II ENDOLEAK isTYPE II ENDOLEAK is
 the most common form of complication (20-30%), due to partial andthe most common form of complication (20-30%), due to partial and
incomplete spontaneously early or late “ thrombization” of the aneurysmincomplete spontaneously early or late “ thrombization” of the aneurysm
sac after EVAR; it is joined by its retrograde perfusion from aortic collateralsac after EVAR; it is joined by its retrograde perfusion from aortic collateral
branchesbranches
 Its management is still debatedIts management is still debated

3. TREATMENTTREATMENT TYPE II ENDOLEAKTYPE II ENDOLEAK
 Preoperative embolization (IMA, LA)Preoperative embolization (IMA, LA)
 Embolization therapy (transarterial, translumbar)Embolization therapy (transarterial, translumbar)
 Laparoscopic retroperitoneal lumbar branches ligationLaparoscopic retroperitoneal lumbar branches ligation
 Open traditional surgeryOpen traditional surgery

4. PRESENT AND FUTUREPRESENT AND FUTURE
 Prevention is the best strategy to use in managing this complicationPrevention is the best strategy to use in managing this complication
 The stimulation and acceleration of a complete aneurysmThe stimulation and acceleration of a complete aneurysm
sac “ thrombization “ with the introduction of biocompatiblesac “ thrombization “ with the introduction of biocompatible
materialsmaterials
in the aneurysm sac performed during EVAR seems to be promisingin the aneurysm sac performed during EVAR seems to be promising

5. BIOMATERIALSBIOMATERIALS
FIBRIN SEALANTFIBRIN SEALANT is a fully absorbable biologic adhesive matrixis a fully absorbable biologic adhesive matrix
made of two main components 1)made of two main components 1) fibrinogen solutionfibrinogen solution containingcontaining
plasma coagulation proteins and 2)plasma coagulation proteins and 2) thrombin solutionthrombin solution containingcontaining
aprotinin (antifibrino-litic agent)aprotinin (antifibrino-litic agent)
INCONELINCONEL (nickel and cobalt alloy)(nickel and cobalt alloy) COILSCOILS are radiopaque, alloware radiopaque, allow
MRI scanning, CT and CDU imagingMRI scanning, CT and CDU imaging

6. CT SCANCT SCAN
Control CT scan with evident inconel coils

7. ANGIOGRAPHY DURING EVARANGIOGRAPHY DURING EVAR
Final angiography performed to verify sac thrombization and root occlusion
of lumbar and inferioir mesenteric arteries

8. September 1999September 1999
December 2009December 2009
545 patients545 patients
underwent EVARunderwent EVAR
September 1999September 1999
May 2003May 2003
228 pts: EVAR standard procedure228 pts: EVAR standard procedure
June 2003June 2003
December 2006December 2006
131 pts: EVAR plus fibrin glue131 pts: EVAR plus fibrin glue
January 2007January 2007
December 2009December 2009
186 pts: EVAR186 pts: EVAR
plus inconel coils and fibrin glueplus inconel coils and fibrin glue
POPULATIONPOPULATION

9. STUDY COHORT BASELINE DEMOGRAPHIC CHARATERISTICSSTUDY COHORT BASELINE DEMOGRAPHIC CHARATERISTICS
GROUP I (EVAR
alone)
GROUP II (EVAR
plus thrombization)
(N 228) (N 254)
MALE 213 (93.4%) 232 (91.3%) §
FEMALE 15 (6.6%) 22 (8.7 %) §
AGE (YEARS) + SD 71.8 ± 8.5 72.5 ± 7.5 **
SMOKE 53 (23.2%) 32 (12.6%) *
FAMILIARITY FOR AAA 2 (0.8%) 2 (0.7%) §
CHRONIC RENAL FAILURE 54 (23.7%) 46 (18.1%) §
CAROTID ARTERY DISEASE 91 (39.9%) 150 (59.1%) *
PERIFERIC ARTERY DISEASE 80 (35.1%) 36 (14.2%) *
BMI > 30 47 (20.6%) 52(20.5%) §
HYPERTENSION 193 (84.6%) 240 (94.5%) *
CARDIAC DISEASE 126 (55.3%) 161 (63.4%) §
DIABETES MELLITUS 41 (18.0%) 50 (19.7%) §
HYPERLIPIDEMIA 152 (66.7%) 215 (84.6%) *
§ Pearson χ2
: p>0.05
* Pearson χ2
: p<0.05
** t-test : p>0.005 Armando Olivieri MD, Department of Prevention - Epidemiology Unit

10. STUDY COHORT ANATOMIC PARAMETERSSTUDY COHORT ANATOMIC PARAMETERS
group
AAA NECK
common
right iliac
common
left iliac
diam. length diam length
EVAR alone 58.0 ± 13.0 70.8 ± 24.9 23.1 ± 2.7 27.3 ± 10.7 15.5 ± 6.7 17.1 ± 10.1
EVAR plus thrombization 58.4 ± 14.1 71.6 ± 21.3 23.4 ± 2.8 28.8 ± 13.1 17.0 ± 10.9 15.6 ± 5.7
t-test p=0.7187 p=0.7167 p=0.1989 p=0.1729 p=0.0714 p=0.0588
Armando Olivieri MD, Department of Prevention - Epidemiology Unit

11. STUDY COHORT ANATOMIC PARAMETERSSTUDY COHORT ANATOMIC PARAMETERS
group
main stent
graft
AAA NECK
common
right iliac
common
left iliacdiam. length diam length
EVAR alone
suprarenal
graft
60.5 ±
12.6
71.1 ±
2614
23.5 ±
2.8 27.0 ± 9.7 15.4 ± 6.4
17.5 ±
10.8
EVAR plus
thrombization
suprarenal
graft
58.9 ±
13.4
71.8 ±
21.6
23.5 ±
2.9
27.2 ±
12.6
17.3 ±
11.3 15.7 ± 5.6
EVAR alone
infrarenal
graft
52.9 ±
12.5
70.1 ±
22.5
22.3 ±
2.6
28.1 ±
12.6
15.8 ±
7.4
16.2 ±
8.5
EVAR plus
thrombization
infrarenal
graft
57.5 ±
15.6
71.0 ±
20.6
23.2 ±
2.7
32.5 ±
13.5
16.1 ±
6.9
15.3 ±
6.0
Armando Olivieri MD, Department of Prevention - Epidemiology Unit

12. INCIDENCE RATEINCIDENCE RATE
cohort
person-time
(months)
failures
(num)
rates (x 1000
person-months)
EVAR alone 15770 34 2,16
EVAR plus sac thrombization 8539 7 0,82
total 24309 41 1,69
Incidence rate was 2.16 rates * 1000 person-month for EVAR alone group and 0.82 rates * 1000 person-months
for EVAR plus thrombization
Armando Olivieri MD, Department of Prevention - Epidemiology Unit

13. KAPLAN MAYER SURVIVING CURVEKAPLAN MAYER SURVIVING CURVE
Armando Olivieri MD, Department of Prevention - Epidemiology Unit
0.000.250.500.751.00
cumulativeprobability
253 230 152 95 74 43 12 0 0 0 0EVAR plus thrombization
227 188 174 167 162 154 148 119 61 44 20EVAR alone
Number at risk
0 12 24 36 48 60 72 84 96 108 120
follow up in months
EVAR alone EVAR plus sac thrombization
log-rank test p=0.0000
Kaplan–Meier Curves for the Primary End Point (endoleak type II)

14. RISK (HAZARD RATIO) FOR TYPE II ELRISK (HAZARD RATIO) FOR TYPE II EL
ADJUSTED FOR SURGICAL TECHNIQUE,GENDER AND OBESITYADJUSTED FOR SURGICAL TECHNIQUE,GENDER AND OBESITY
Armando Olivieri MD, Department of Prevention - Epidemiology Unit
Hazard
Ratio p
I.C. 95%
surgical technique
EVAR alone 1,00
EVAR plus sac thrombization 0,13 0,000 0,05 0,36
gender
male 1,00
female 0,32 0,007 0,14 0,74
obesity
normal/overweight 1,00
BMI>30 0,10 0,023 0,01 0,73

15. SEPT 1999-MAY 2003
228 pts
JUNE 2003-DEC 2008
254 pts
TYPE II ENDOLEAK
TOTAL
34 7
STABLE IN FOLLOW UP 6 (18 %) 3 (43 %)
SPONTANEUSLY
RESOLVED
11 (32 %) 3 (43 %)
SPONTANEUSLY RETIRED
5 (15 %) 1 (14 %)
TREATED WITH SURGERY
(CONVERTION)
3 (9%) -
TREATED WITH SURGERY
(PARTIAL CONVERTION) 1 (3%) -
DIED 8 (23%)
-
TYPE II ENDOLEAKTYPE II ENDOLEAK
September 1999 – December 2008

16. DISCUSSIONDISCUSSION
 Biomaterials used for intrasac thrombization are inserted between main stentgraftBiomaterials used for intrasac thrombization are inserted between main stentgraft
and aneurysmal wall as a means or method to form an enclosureand aneurysmal wall as a means or method to form an enclosure
 Due to a fibrin sealant injection, the coils form a structure that accelerates andDue to a fibrin sealant injection, the coils form a structure that accelerates and
consolidates the clot formation process forming a “concrete” compound, resultingconsolidates the clot formation process forming a “concrete” compound, resulting
in manifesting a durable, long lasting, sturdy stabilization of the whole complexin manifesting a durable, long lasting, sturdy stabilization of the whole complex
fixed en blocfixed en bloc
 Fibrin glue injection did not cause microembolization or any allergic orFibrin glue injection did not cause microembolization or any allergic or
anaphilactic reactionsanaphilactic reactions

17. TREATMENT VERSUS PREVENTIONTREATMENT VERSUS PREVENTION
 Previous studies have demonstrated a high rate of success (92% Baum et al JPrevious studies have demonstrated a high rate of success (92% Baum et al J
Vasc Interv Radiol 2001; 12:111-6 and 71 % Timaran et al J Vasc Surg 2004;Vasc Interv Radiol 2001; 12:111-6 and 71 % Timaran et al J Vasc Surg 2004;
39:1157-62) using translumbar embolization in the treatment of persistent EL39:1157-62) using translumbar embolization in the treatment of persistent EL
type II with sac enlargementtype II with sac enlargement
 After the introduction of our preventive technique we had a significantly lowerAfter the introduction of our preventive technique we had a significantly lower
incidence of EL II which accords with the high percentage of success rate inincidence of EL II which accords with the high percentage of success rate in
translumbar embolizationtranslumbar embolization
 We prevent complications in almost all treated patients as translumbarWe prevent complications in almost all treated patients as translumbar
embolization resolves EL II in a high percentage of treated casesembolization resolves EL II in a high percentage of treated cases

18. WHY PREVENTION ?WHY PREVENTION ?
EVAR plus a preventive aneurysm sac “ thrombization “ costs about 630EVAR plus a preventive aneurysm sac “ thrombization “ costs about 630
dollars more than EVAR alone, but EL type II reduction saves moneydollars more than EVAR alone, but EL type II reduction saves money
and time becauseand time because
 we have primary clinical successwe have primary clinical success
 we do not have to treat the complicationswe do not have to treat the complications
 we can modify the terms of follow upwe can modify the terms of follow up

19. Prevention of type II endoleak with biomaterals isPrevention of type II endoleak with biomaterals is
●● SimpleSimple
●● SafeSafe
●● Low costLow cost
●● Independent of stent graft usedIndependent of stent graft used
●● Reduces frequency ofReduces frequency of
follow-upfollow-up
●● Increases EVAR successIncreases EVAR success
CONCLUSIONCONCLUSION

20. DRASTICDRASTIC
TYPE II ENDOLEAKTYPE II ENDOLEAK
REDUCTIONREDUCTION
Manifesting, durable, long lasting, sturdy stabilization ofManifesting, durable, long lasting, sturdy stabilization of
whole complex fixed en bloc could probably also reduce thewhole complex fixed en bloc could probably also reduce the
incidence of type IA and III endoleaksincidence of type IA and III endoleaks