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MODULAR EXTENSION INTO
EXTERNAL ILIAC ARTERY +
HYPOGASTRIC ARTERYEMBOLIZATION
PHOENIX 2008: PREVENTIVE TREATMENT OF TYPE II ENDOLEAK WITH BIOMATERIAL
variation of technique
WHEN TO COIL WHEN TO COIL
THE ANEURYSM SAC ?THE ANEURYSM SAC ?
DEPARTMENT OF CARDIOVASCULAR DISEASESDIVISION OF VASCULAR AND ENDOVASCULAR SURGERY
Chief: Salvatore Ronsivalle, MD
Cannes Juny 18-22
BACKGROUND BACKGROUND EVAREVAR (endovascular aneurysm repair) is a current (endovascular aneurysm repair) is a current
therapeutic alternative to open traditional surgery therapeutic alternative to open traditional surgery TYPE II EL is TYPE II EL is
The most frequent The most frequent complication complication after EVAR with a after EVAR with a
rate between 10-30%rate between 10-30%
Due to Due to incomplete incomplete (early or late) (early or late) intra-sacintra-sac thrombization processthrombization process after EVAR joined to its after EVAR joined to its retrograd perfusion from aorta ‘s collateral branchesretrograd perfusion from aorta ‘s collateral branches
Its significance and treatment is still debatedIts significance and treatment is still debated
PAST : TREATMENTPAST : TREATMENT TYPE II ELTYPE II EL
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
PREVENTIVE BEHAVIOUR PREVENTIVE BEHAVIOUR COULD REPRESENT THE COULD REPRESENT THE
BEST STRATEGY TO MANAGE THIS COMPLICATIONBEST STRATEGY TO MANAGE THIS COMPLICATION
INTRA-SAC INTRODUCTION OF INTRA-SAC INTRODUCTION OF BIOMATERALS BIOMATERALS
PERFORMED DURING EVAR SO TO STIMULATE, PERFORMED DURING EVAR SO TO STIMULATE,
ACCELERATE AND STABILIZE THE ACCELERATE AND STABILIZE THE THROMBIZATION THROMBIZATION
PROCESSPROCESS SEEMS TO BE PROMISING SEEMS TO BE PROMISING
BIOMATERIALSBIOMATERIALS
FIBRIN SEALANT FIBRIN SEALANT is an adsorbable biologic is an adsorbable biologic adhesive matrix made of two main adhesive matrix made of two main components: 1) components: 1) fibrinogen solution fibrinogen solution containing plasma coagulation proteins and containing plasma coagulation proteins and 2) 2) thrombin solution thrombin solution containing aprotinin containing aprotinin (antifibrino-litic agent)(antifibrino-litic agent)
INCONEL INCONEL (nichel and cobalt alloy) (nichel and cobalt alloy) COILSCOILS are radiopaque, allow MRI scanning, CT and are radiopaque, allow MRI scanning, CT and CDU imagingCDU imaging
CONTROL ANGIOGRAPHY CONTROL ANGIOGRAPHY DURING EVARDURING EVAR
FINAL ANGIOGRAPHY PERFORMED TO VERIFY SAC THROMBIZATION AND ROOT OCCLUSION
OF LUMBAR AND INFERIOR MESENTERIC ARTERIES
FINAL ANGIOGRAPHY PERFORMED TO VERIFY SAC THROMBIZATION AND ROOT OCCLUSION
OF LUMBAR AND INFERIOR MESENTERIC ARTERIES
September 1999 September 1999 December 2008December 2008
469 patients 469 patients undergone EVARundergone EVAR
September 1999 September 1999 May 2003May 2003
224 pts: EVAR standard procedure224 pts: EVAR standard procedure
June 2003June 2003December 2006December 2006
124 pts: EVAR plus fibrin glue 124 pts: EVAR plus fibrin glue
January 2007January 2007December 2008December 2008
121 pts: EVAR plus inconel coils and fibrin glue 121 pts: EVAR plus inconel coils and fibrin glue
POPULATIONPOPULATION
STUDY COHORT BASELINE STUDY COHORT BASELINE DEMOGRAPHIC DEMOGRAPHIC
CHARATERISTICSCHARATERISTICSGROUP I GROUP I
(EVAR alone)(EVAR alone) (N 224) (N 224)
GROUP II GROUP II (EVAR plus (EVAR plus
thrombization) thrombization) (N 180)(N 180)
MALEMALE 210 (93.7%)210 (93.7%) 161 (89.4%)161 (89.4%)
FEMALE FEMALE 14 (6.2%)14 (6.2%) 19 (10.5 %)19 (10.5 %)
AGE (YEARS) AGE (YEARS) ++ SD SD 71.9 71.9 ++ 8.5 8.5 72.6 72.6 ++ 8 8
SMOKESMOKE 51 (22.7%)51 (22.7%) 19 (10.5%)19 (10.5%)
FAMILIARITY FOR AAAFAMILIARITY FOR AAA 2 (0.8%)2 (0.8%) 1 (0.5%)1 (0.5%)
RENAL DISEASERENAL DISEASE 54 (24.1%)54 (24.1%) 38 (21.1%)38 (21.1%)
CADCAD 88 (39.2%)88 (39.2%) 103 (57.2%)103 (57.2%)
PAD PAD 80 (35.7%)80 (35.7%) 24 (13.3%)24 (13.3%)
BMI > 30BMI > 30 47 (20.9%)47 (20.9%) 41(22.7%)41(22.7%)
HYPERTENSIONHYPERTENSION 190 (84.8%)190 (84.8%) 172 (95.5%)172 (95.5%)
CARDIAC DISEASECARDIAC DISEASE 125 (55.8%)125 (55.8%) 130 (72.2%)130 (72.2%)
DIABETES MELLITUSDIABETES MELLITUS 40 (17.8%)40 (17.8%) 26 (14.4%)26 (14.4%)
HYPERLIPIDEMIAHYPERLIPIDEMIA 150 (66.9%)150 (66.9%) 158(87.7%)158(87.7%)
AAA diam mm
AAA lenght mm
NECK diammm
NECK lenghmm
CRIdiammm
CLI diammm
LUMBAR(mean)
IMA, RENAL, SACRAL
GROUP I (suprarenal graft )
60.7 + 12.6
71.1+ 26.4
23.5+ 2.7
27+ 9.8
15.4+ 6.4
17.6+ 10.9
3 55 (37%)
GROUP I (infrarenal graft)
52.9+ 12.5
70.4+ 22.5
22.4+ 2.6
28+ 12.9
15.8+ 7.5
16.2+ 8.6
2.9 28 (38%)
GROUP II (suprarenal graft)
59.1+ 14
69.6+ 22.7
23.7+ 2.9
26.5+ 12.4
17.3+ 11.7
15.6+ 5.8
3.6 42 (31%)
GROUP II (infrarenal graft)
55.4+ 14.4
67.2+ 21.1
22.4+ 2.6
31.7+ 13.3
16.4+ 6.2
15.8+ 7
3.6 17 (40%)
STUDY COHORT ANATOMIC STUDY COHORT ANATOMIC PARAMETERSPARAMETERS
SEPT 1999-MAY 2003
224 ptsJUNE 2003-DEC 2007
180 pts
TYPE II ENDOLEAK TOTAL
34 4
STABLE IN FOLLOW UP 10 (29.4 %) 2 (50 %)
SPONTANEUSLY RESOLVED 16 (47 %) 1 (25 %)
SPONTANEUSLY RETIRED4 (11.7 %) 1 (25 %)
TREATED WITH SURGERY(CONVERTION)
3 (8.8%) -
TREATED WITH SURGERY(PARTIAL CONVERTION) 1 (2.9%) -
TYPE II ENDOLEAKTYPE II ENDOLEAK September 1999 – December 2007
Incidence rate was 0.25*100 person-month for EVAR alone group and 0.07*100 person-months for EVAR plus thrombization
Incidence rate was 0.25*100 person-month for EVAR alone group and 0.07*100 person-months for EVAR plus thrombization
0.0
00
.25
0.5
00
.75
1.0
0cu
mu
lativ
e p
rob
abili
ty
0 12 24 36 48 60 72 84 96 108 120follow up un months
EVAR alone EVAR plus sac thrombization
log-rank test p = 0.0000
Kaplan-Meier survival estimates (endoleak type II)
KAPLAN MAYER SURVIVING KAPLAN MAYER SURVIVING CURVECURVE
Armando Olivieri MD, Department of Prevention - Epidemiology UnitArmando Olivieri MD, Department of Prevention - Epidemiology Unit
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
Hazard RatioHazard Ratio pp C.I. 95%C.I. 95%
SURGICAL TECHNIQUE SURGICAL TECHNIQUE
EVAR aloneEVAR alone 1,001,00
EVAR plus sac thrombizationEVAR plus sac thrombization 0,130,13 0,0000,0000,00,0
550,30,3
66
GENDER GENDER
MaleMale 1,001,00
FemaleFemale 0,320,32 0,0070,0070,10,1
440,70,7
44
OBESITY OBESITY
normal/overweightnormal/overweight 1,001,00
BMI>30BMI>30 0,100,10 0,0230,0230,00,0
110,70,7
33Armando Olivieri MD, Department of Prevention - Epidemiology Unit
Armando Olivieri MD, Department of Prevention - Epidemiology Unit
DISCUSSION DISCUSSION
BIOMATERIALS ARE INSERTED BETWEEN BIOMATERIALS ARE INSERTED BETWEEN
MAIN STENT- GRAFT AND SAC WALL AS MAIN STENT- GRAFT AND SAC WALL AS ENCLOSE ENCLOSE
SYSTEMSYSTEM
MICROCOILS AND FIBRINE SEALANT FORM A MICROCOILS AND FIBRINE SEALANT FORM A
SCAFFOLD SCAFFOLD THAT STABILIZE ALL SYSTEM BY THAT STABILIZE ALL SYSTEM BY
ACCELERATION AND CONSOLIDATION OF ACCELERATION AND CONSOLIDATION OF
THROMBIZATION PROCESSTHROMBIZATION PROCESS
DISCUSSION (II)DISCUSSION (II)
FIBRINE GLUE INJECTION FIBRINE GLUE INJECTION DOESN’T CAUSE DOESN’T CAUSE
PERIPHERAL PERIPHERAL MYCROEMBOLIZATIONMYCROEMBOLIZATION
FIBRIN GLUE FIBRIN GLUE DOESN’T CAUSE DOESN’T CAUSE ALLERGIC, ALLERGIC,
ANAPHYLACTIC, LOCAL TISSUE ANAPHYLACTIC, LOCAL TISSUE REACTIONSREACTIONS
TREATMENT OF TYPE II ENDOLEAK WITH TREATMENT OF TYPE II ENDOLEAK WITH BIOMATERIALS IS BIOMATERIALS IS
● ● SimpleSimple
●● Safe Safe
●● 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
Reduced rate incidence of type IA Reduced rate incidence of type IA endoleak endoleak
CONCLUSIONCONCLUSION
WHEN TO COIL WHEN TO COIL
THE ANEURYSM SAC ?THE ANEURYSM SAC ?
ALWAYS ALWAYS throught throught introduction of introduction of biocompatible biocompatible
materials performed materials performed during EVARduring EVAR
ALWAYS ALWAYS throught throught introduction of introduction of biocompatible biocompatible
materials performed materials performed during EVARduring EVAR
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