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 TACCONTROL TAC

CONTROL CT WITH EVIDENT INCONEL COILSCONTROL CT WITH EVIDENT INCONEL COILS

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

DRASTIC DRASTIC TYPE II ENDOLEAKTYPE II ENDOLEAK

REDUCTIONREDUCTION

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

Thank youFor Your attention