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 DISEASESDIVISION OF VASCULAR AND ENDOVASCULAR SURGERY
Chief: Salvatore Ronsivalle, MD
S.Paulo April 20-24
CICE2010
CICE2010
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 is TYPE II ENDOLEAK is
the most common form of complication (20-30%), due to partial and the most common form of complication (20-30%), due to partial and
incomplete spontaneously early or late “ thrombization” of the aneurysm incomplete spontaneously early or late “ thrombization” of the aneurysm
sac after EVAR; it is joined by its retrograde perfusion from aortic collateral sac after EVAR; it is joined by its retrograde perfusion from aortic collateral
branches branches
Its management is still debatedIts management is still debated
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
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 aneurysm The stimulation and acceleration of a complete aneurysm
sac “ thrombization “ with the introduction of biocompatible sac “ thrombization “ with the introduction of biocompatible materials materials
in the aneurysm sac performed during EVAR seems to be promisingin the aneurysm sac performed during EVAR seems to be promising
BIOMATERIALSBIOMATERIALS
FIBRIN SEALANT FIBRIN SEALANT is a fully absorbable biologic adhesive matrix is a fully absorbable biologic adhesive matrix
made of two main components 1) made of two main components 1) fibrinogen solutionfibrinogen solution containing containing plasma coagulation proteins and 2) plasma coagulation proteins and 2) thrombin solution thrombin solution containing containing
aprotinin (antifibrino-litic agent)aprotinin (antifibrino-litic agent)
INCONEL INCONEL (nickel and cobalt alloy) (nickel and cobalt alloy) COILS COILS are radiopaque, allow are radiopaque, allow
MRI scanning, CT and CDU imagingMRI scanning, CT and CDU imaging
CT SCANCT SCAN
Control CT scan with evident inconel coils
ANGIOGRAPHY DURING EVARANGIOGRAPHY DURING EVAR
Final angiography performed to verify sac thrombization and root occlusion of lumbar and inferioir mesenteric arteries
September 1999 September 1999 December 2009December 2009
545 patients 545 patients underwent EVARunderwent EVAR
September 1999 September 1999 May 2003May 2003
228 pts: EVAR standard procedure228 pts: EVAR standard procedure
June 2003June 2003December 2006December 2006
131 pts: EVAR plus fibrin glue 131 pts: EVAR plus fibrin glue
January 2007January 2007December 2009December 2009186 pts: EVAR 186 pts: EVAR
plus inconel coils and fibrin glue plus inconel coils and fibrin glue
POPULATIONPOPULATION
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
STUDY COHORT ANATOMIC PARAMETERSSTUDY COHORT ANATOMIC PARAMETERS
group
AAA NECKcommon 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
STUDY COHORT ANATOMIC PARAMETERSSTUDY COHORT ANATOMIC PARAMETERS
groupmain stent
graft
AAA NECK
common right iliac
common left iliacdiam. length diam length
EVAR alonesuprarenal
graft60.5 ± 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 aloneinfrarenal
graft52.9 ± 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
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
KAPLAN MAYER SURVIVING CURVEKAPLAN MAYER SURVIVING CURVE
Armando Olivieri MD, Department of Prevention - Epidemiology Unit
0.0
00.2
50.5
00.7
51.0
0
cum
ula
tive p
roba
bili
ty
253 230 152 95 74 43 12 0 0 0 0EVAR plus thrombization227 188 174 167 162 154 148 119 61 44 20EVAR alone
Number at risk
0 12 24 36 48 60 72 84 96 108 120follow 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)
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
SEPT 1999-MAY 2003
228 ptsJUNE 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 RETIRED5 (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
DISCUSSION DISCUSSION
Biomaterials used for intrasac thrombization are inserted between main stentgraft Biomaterials 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 and Due to a fibrin sealant injection, the coils form a structure that accelerates and
consolidates the clot formation process forming a “concrete” compound, resulting consolidates the clot formation process forming a “concrete” compound, resulting
in manifesting a durable, long lasting, sturdy stabilization of the whole complex in manifesting a durable, long lasting, sturdy stabilization of the whole complex
fixed en bloc fixed en bloc
Fibrin glue injection did not cause microembolization or any allergic or Fibrin glue injection did not cause microembolization or any allergic or
anaphilactic reactionsanaphilactic reactions
TREATMENT VERSUS PREVENTIONTREATMENT VERSUS PREVENTION
Previous studies have demonstrated a high rate of success (92% Baum et al J Previous 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 EL 39:1157-62) 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 lower After the introduction of our preventive technique we had a significantly lower
incidence of EL II which accords with the high percentage of success rate in incidence 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 translumbar We 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
WHY PREVENTION ?WHY PREVENTION ?
EVAR plus a preventive aneurysm sac “ thrombization “ costs about 630 EVAR plus a preventive aneurysm sac “ thrombization “ costs about 630
dollars more than EVAR alone, but EL type II reduction saves money dollars more than EVAR alone, but EL type II reduction saves money
and time because and time because
we have primary clinical successwe have primary clinical success
we do not have to treat the complications we do not have to treat the complications
we can modify the terms of follow upwe can modify the terms of follow up
Prevention of type II endoleak with biomaterals is Prevention of type II endoleak with biomaterals is
●● SimpleSimple
●● SafeSafe
●● Low costLow cost
●● Independent of stent graft usedIndependent of stent graft used
●● Reduces frequency of Reduces frequency of follow-upfollow-up
●● Increases EVAR successIncreases EVAR success
CONCLUSIONCONCLUSION
DRASTIC DRASTIC TYPE II ENDOLEAKTYPE II ENDOLEAK
REDUCTIONREDUCTION
Manifesting, durable, long lasting, sturdy stabilization of Manifesting, durable, long lasting, sturdy stabilization of whole complex fixed en bloc could probably also reduce the whole complex fixed en bloc could probably also reduce the
incidence of type IA and III endoleaksincidence of type IA and III endoleaks