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Phoenix 2008 Cannes Meet 2009 PREVENTION OF ENDOLEAK TYPE II WITH BIOMATERIALS

Salvatore Ronsivalle
Salvatore Ronsivalle
Salvatore RonsivalleVascular Surgeon at currently retired

INTERNATIONAL PRESENTATIONS ABOUT PREVENTION OF ENDOLEAK TYPE II WITH BIOMATERIALS - PRESENTAZIONI UFFICIALI SULLA PREVENZIONE DELL'ENDOLEAK DI TIPO II MEDIANTE UTILIZZO DI BIOMATERIALI (Chirurgia Vascolare-ULSS 15 Alta Padovana) (Vascular Surgery -ULSS 15 Alta Padovana)

Phoenix 2008 Cannes Meet 2009 PREVENTION OF ENDOLEAK TYPE II WITH BIOMATERIALS

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MODULAR EXTENSION
INTO
EXTERNAL ILIAC ARTERY
+
HYPOGASTRIC ARTERY
EMBOLIZATION
PHOENIX 2008: PREVENTIVE TREATMENT
OF TYPE II ENDOLEAK WITH BIOMATERIAL
variation of technique
WHEN TO COILWHEN TO COIL
THE ANEURYSM SAC ?THE ANEURYSM SAC ?
DEPARTMENT OF CARDIOVASCULAR DISEASES
DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY
Chief: Salvatore Ronsivalle, MD
Cannes Juny 18-22
BACKGROUNDBACKGROUND
EVAREVAR (endovascular aneurysm repair) is a current(endovascular aneurysm repair) is a current
therapeutic alternative to open traditional surgerytherapeutic alternative to open traditional surgery
TYPE II EL isTYPE II EL is
 The most frequentThe most frequent complicationcomplication after EVAR with aafter EVAR with a
rate between 10-30%rate between 10-30%
 Due toDue to incompleteincomplete (early or late)(early or late) intra-sacintra-sac
thrombization processthrombization process after EVAR joined to itsafter 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 BEHAVIOURPREVENTIVE BEHAVIOUR COULD REPRESENT THECOULD REPRESENT THE
BEST STRATEGY TO MANAGE THIS COMPLICATIONBEST STRATEGY TO MANAGE THIS COMPLICATION
 INTRA-SAC INTRODUCTION OFINTRA-SAC INTRODUCTION OF BIOMATERALSBIOMATERALS
PERFORMED DURING EVAR SO TO STIMULATE,PERFORMED DURING EVAR SO TO STIMULATE,
ACCELERATE AND STABILIZE THEACCELERATE AND STABILIZE THE THROMBIZATIONTHROMBIZATION
PROCESSPROCESS SEEMS TO BE PROMISINGSEEMS TO BE PROMISING
BIOMATERIALSBIOMATERIALS
FIBRIN SEALANTFIBRIN SEALANT is an adsorbable biologicis an adsorbable biologic
adhesive matrix made of two main components:adhesive matrix made of two main components:
1)1) fibrinogen solutionfibrinogen solution containing plasmacontaining plasma
coagulation proteins and 2)coagulation proteins and 2) thrombin solutionthrombin solution
containing aprotinin (antifibrino-litic agent)containing aprotinin (antifibrino-litic agent)
INCONELINCONEL (nichel and cobalt alloy)(nichel and cobalt alloy) COILSCOILS
are radiopaque, allow MRI scanning, CT and CDUare radiopaque, allow MRI scanning, CT and CDU
imagingimaging
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Phoenix 2008 Cannes Meet 2009 PREVENTION OF ENDOLEAK TYPE II WITH BIOMATERIALS

  • 1. MODULAR EXTENSION INTO EXTERNAL ILIAC ARTERY + HYPOGASTRIC ARTERY EMBOLIZATION PHOENIX 2008: PREVENTIVE TREATMENT OF TYPE II ENDOLEAK WITH BIOMATERIAL variation of technique
  • 2. WHEN TO COILWHEN TO COIL THE ANEURYSM SAC ?THE ANEURYSM SAC ? DEPARTMENT OF CARDIOVASCULAR DISEASES DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY Chief: Salvatore Ronsivalle, MD Cannes Juny 18-22
  • 3. BACKGROUNDBACKGROUND EVAREVAR (endovascular aneurysm repair) is a current(endovascular aneurysm repair) is a current therapeutic alternative to open traditional surgerytherapeutic alternative to open traditional surgery TYPE II EL isTYPE II EL is  The most frequentThe most frequent complicationcomplication after EVAR with aafter EVAR with a rate between 10-30%rate between 10-30%  Due toDue to incompleteincomplete (early or late)(early or late) intra-sacintra-sac thrombization processthrombization process after EVAR joined to itsafter 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
  • 4. 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
  • 5. PRESENT AND FUTUREPRESENT AND FUTURE  PREVENTIVE BEHAVIOURPREVENTIVE BEHAVIOUR COULD REPRESENT THECOULD REPRESENT THE BEST STRATEGY TO MANAGE THIS COMPLICATIONBEST STRATEGY TO MANAGE THIS COMPLICATION  INTRA-SAC INTRODUCTION OFINTRA-SAC INTRODUCTION OF BIOMATERALSBIOMATERALS PERFORMED DURING EVAR SO TO STIMULATE,PERFORMED DURING EVAR SO TO STIMULATE, ACCELERATE AND STABILIZE THEACCELERATE AND STABILIZE THE THROMBIZATIONTHROMBIZATION PROCESSPROCESS SEEMS TO BE PROMISINGSEEMS TO BE PROMISING
  • 6. BIOMATERIALSBIOMATERIALS FIBRIN SEALANTFIBRIN SEALANT is an adsorbable biologicis an adsorbable biologic adhesive matrix made of two main components:adhesive matrix made of two main components: 1)1) fibrinogen solutionfibrinogen solution containing plasmacontaining plasma coagulation proteins and 2)coagulation proteins and 2) thrombin solutionthrombin solution containing aprotinin (antifibrino-litic agent)containing aprotinin (antifibrino-litic agent) INCONELINCONEL (nichel and cobalt alloy)(nichel and cobalt alloy) COILSCOILS are radiopaque, allow MRI scanning, CT and CDUare radiopaque, allow MRI scanning, CT and CDU imagingimaging
  • 7. CONTROL TACCONTROL TAC CONTROL CT WITH EVIDENT INCONEL COILS
  • 8. CONTROL ANGIOGRAPHY DURINGCONTROL ANGIOGRAPHY DURING EVAREVAR FINAL ANGIOGRAPHY PERFORMED TO VERIFY SAC THROMBIZATION AND ROOT OCCLUSION OF LUMBAR AND INFERIOR MESENTERIC ARTERIES
  • 9. September 1999September 1999 December 2008December 2008 469 patients469 patients undergone EVARundergone EVAR September 1999September 1999 May 2003May 2003 224 pts: EVAR standard procedure224 pts: EVAR standard procedure June 2003June 2003 December 2006December 2006 124 pts: EVAR plus fibrin glue124 pts: EVAR plus fibrin glue January 2007January 2007 December 2008December 2008 121 pts: EVAR plus inconel coils and fibrin glue121 pts: EVAR plus inconel coils and fibrin glue POPULATIONPOPULATION
  • 10. STUDY COHORT BASELINESTUDY COHORT BASELINE DEMOGRAPHIC CHARATERISTICSDEMOGRAPHIC CHARATERISTICS GROUP IGROUP I (EVAR alone)(EVAR alone) (N 224)(N 224) GROUP IIGROUP II (EVAR plus thrombization)(EVAR plus thrombization) (N 180)(N 180) MALEMALE 210 (93.7%)210 (93.7%) 161 (89.4%)161 (89.4%) FEMALEFEMALE 14 (6.2%)14 (6.2%) 19 (10.5 %)19 (10.5 %) AGE (YEARS)AGE (YEARS) ++ SDSD 71.971.9 ++ 8.58.5 72.672.6 ++ 88 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%) PADPAD 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%)
  • 11. AAA diam mm AAA lenght mm NECK diam mm NECK lengh mm CRI diam mm CLI diam mm 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 ANATOMICSTUDY COHORT ANATOMIC PARAMETERSPARAMETERS
  • 12. SEPT 1999-MAY 2003 224 pts JUNE 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 RETIRED 4 (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
  • 13. 0.000.250.500.751.00 cumulativeprobability 0 12 24 36 48 60 72 84 96 108 120 follow 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 CURVEKAPLAN MAYER SURVIVING CURVE Armando Olivieri MD, Department of Prevention - Epidemiology Unit
  • 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    Hazard RatioHazard Ratio pp C.I. 95%C.I. 95%                SURGICAL TECHNIQUESURGICAL TECHNIQUE             EVAR aloneEVAR alone 1,001,00          EVAR plus sac thrombizationEVAR plus sac thrombization 0,130,13 0,0000,000 0,050,05 0,360,36                GENDERGENDER             MaleMale 1,001,00          FemaleFemale 0,320,32 0,0070,007 0,140,14 0,740,74                OBESITYOBESITY             normal/overweightnormal/overweight 1,001,00          BMI>30BMI>30 0,100,10 0,0230,023 0,010,01 0,730,73 Armando Olivieri MD, Department of Prevention - Epidemiology Unit
  • 15. DISCUSSIONDISCUSSION  BIOMATERIALS ARE INSERTED BETWEENBIOMATERIALS ARE INSERTED BETWEEN MAIN STENT- GRAFT AND SAC WALL ASMAIN STENT- GRAFT AND SAC WALL AS ENCLOSEENCLOSE SYSTEMSYSTEM  MICROCOILS AND FIBRINE SEALANT FORM AMICROCOILS AND FIBRINE SEALANT FORM A SCAFFOLDSCAFFOLD THAT STABILIZE ALL SYSTEM BYTHAT STABILIZE ALL SYSTEM BY ACCELERATION AND CONSOLIDATION OFACCELERATION AND CONSOLIDATION OF THROMBIZATION PROCESSTHROMBIZATION PROCESS
  • 16. DISCUSSION (II)DISCUSSION (II)  FIBRINE GLUE INJECTIONFIBRINE GLUE INJECTION DOESN’T CAUSEDOESN’T CAUSE PERIPHERALPERIPHERAL MYCROEMBOLIZATIONMYCROEMBOLIZATION  FIBRIN GLUEFIBRIN GLUE DOESN’T CAUSEDOESN’T CAUSE ALLERGIC,ALLERGIC, ANAPHYLACTIC, LOCAL TISSUEANAPHYLACTIC, LOCAL TISSUE REACTIONSREACTIONS
  • 17. DRASTICDRASTIC TYPE II ENDOLEAKTYPE II ENDOLEAK REDUCTIONREDUCTION
  • 18. TREATMENT OF TYPE II ENDOLEAK WITHTREATMENT OF TYPE II ENDOLEAK WITH BIOMATERIALS ISBIOMATERIALS 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 Reduced rate incidence of type IA endoleakReduced rate incidence of type IA endoleak CONCLUSIONCONCLUSION
  • 19. WHEN TO COILWHEN TO COIL THE ANEURYSM SAC ?THE ANEURYSM SAC ? ALWAYSALWAYS throughtthrought introduction ofintroduction of biocompatible materialsbiocompatible materials performed during EVARperformed during EVAR
  • 20. Thank you For Your attention

Editor's Notes

  1. Endovascular aneurysm repair (EVAR) presents undoubted advantages in invasivity and morbidity
  2. Techniques today available consisting of early to late percutaneous trans-arterial and direct trans-lumbar embolization with microcoils or liquid embolic agents, or surgical approaches such as laparoscopic retroperitoneal branch ligation or endoscopic aneurysm sac fenestration, all of these seldom able to resolve the problem, open surgery being in most cases the best solution.
  3. Natural history of type II endoleak leads us to believe that a preventive behaviour could represent the best strategy to manage this complication: stimulation and acceleration of complete aneurysm sac thrombization with introduction of biocompatible materials performed during EVAR seems to be promising.
  4. In this observational study our population study was represented by all patients undergoing endovascular AAA repair at Depatment of Cardiovascular Diseases of Cittadella Hospital-Padova from September 1999 to December 2008. All these patients were characterized by sequential temporally surgical technique: 224 patients underwent standard EVAR alone (Sept 99 - May 03); 124 patients underwent EVAR with preventive fibrin glue intra-sac thrombization (Jun 03 – Dec 06); 121 patients underwent EVAR with preventive intra-sac thrombization by one or more INCONEL coils insertion followed by fibrin glue injection for a better aneurysm sac stabilization (Jan 07-Dec8)
  5. For the purpose of the study we enrolled all people who underwent endovascular AAA repair from September 1999 to December 2007 to allow al least 12 months follow up. Our cohort study therefore included 404 subjects divided into two groups: 224 patients (group I) treated with standard EVAR alone and 180 patients (group II) treated with standard EVAR combined with aneurysm sac thrombization (fibrin glue injection with or without coils insertion)
  6. All groups considered were homogeneous for all anatomic parameters assessed (sac and neck size, diameter of iliac arteries, number of sacral and/or renal accessory arteries). Anatomic parameters detected in patients with supra-renal fixation of main stent graft (Talent, Endurant) and infra-renal fixation of main stent graft (AneuRx, Excluder, Anaconda) were homogeneous for all anatomic parameters assessed. Patients had an average of 3-4 lumbar arteries patency and a 30-40% of inferior mesenteric artery, sacral artery and/or renal accessory arteries patency.
  7. There were 38 episodes of endoleak type II, 34 in group I and 4 in group II. Incidence rate was 0.25*100 person-month for EVAR alone group and 0.07*100 person-months for EVAR plus thrombization
  8. The Kaplan-Meier survival curve showed a clear difference between the two groups ; log rank test p = 0.0000).
  9. We used Cox proportional hazard model to compare survival between the two groups after adjusting for potential confounders: in stepwise analysis, only gender and obesity remained as independent predictors of EL type II. Patients with preventive sac thrombization showed a highly significant protection against the development of type II endoleak (hazard ratio 0.13 , 95% confidence interval 0.05-0.36).
  10. Biomaterials used for intra-sac embolization are inserted between main stentgraft and aneurismal wall as enclosed system. Coils form a scaffold that accelerates and consolidates thrombization process due to fibrin sealant injection with a consequent durable stabilization of whole complex fixed en bloc.
  11. All these aspects, associated with centripetal backflow inside aortic collateral branches, also allow to reduce risk of peripheral microembolization.
  12. Rate of type type IA endoleak depends on surgeon experience, type of graft, follow up period, but in our experience 40% of type IA endoleak was a type II endoleak evolution. A lower occurrence of type IA endoleak has been detected in all patients of group II (1.1%) compared to group I (2.6 %). These data could be explained by wall sac stabilization due to complete thrombization process at the point of proximal neck insertion avoiding the risk of wall dilatation with consequent stent graft migration; of course longer follow-up period is needed in order to confirm these results.