SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL

 
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SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
SaC embOlization Per EVAR: results from a prospective
                randomized study
                      SCOPE 1

Dominique Fabre, Frederic Cochennec, Claude Angel, Eric
  Allaire, Philippe Brenot, Riyad Bourkaib,Jean-yves Riou,
  Pascal Desgranges, Benoit Gerardin, Delphine Mitilian,
             Carlos Garcia Alonzo, Sarah Hamdi,
          Jean-pierre Becquemin, Stephan Haulon.

                     HOPITAL MARIE LANNELONGUE
                     UNIVERSITE PARIS-SUD SACLAY
                       HOPITAL HENRI MONDOR
                         UNIVERSITE PARIS-EST
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Background
• Open repair (OR) /
  reference
  treatment for AAA
• Two step procedure
  – aneurysm
      opening (lumbar
      arteries ligation)
  – aortic graft
      replacement
• Definitive treatment
• No need for a close
  follow-up

         Aneurysm opening is the main difference between EVAR or OR
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Do we have to prevent endoleaks?
   First, we have to respect IFU

   10 228 patients undergoing EVAR
         5-year post-EVAR rate
     of AAA sac enlargement 41%.
    Schanzer Circulation 2011
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Remenber this point / IFU Vanguard graft
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Meta-analysis / Actual level of endoleak in 2019

                                     Early and Late T2EL
                                     Only 20% of patients
                                    require reintervention

                                            Pineda, JVS 2018
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
At risk patients!
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
At risk patients for T2EL
    associated with aneurysm sac expansion
Independent predictors of type II endoleak:

   –   Patency of the IMA (p
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Prospective randomized study
          Coil Glue during EVAR

 T2EL
 complications
during early and midterm
follow-up in patients
considered at risk.

                           Piazza. JVS 2015
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Coil Glue during EVAR
        Prospective randomized study

 REINTERVENTIONS
    after EVAR
during early and midterm
follow-up
in patients considered at risk.

                                  Piazza. JVS 2015
SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
Sac embolisation Technique during EVAR
TERUMO GUIDE IN ANEURYSM SAC BEFORE
 CONTROLATERAL ILIAC LEG DEPLOYMENT
COIL EMBOLIZATION / Second step

             AFTER CONTROLATERAL ILIAC LEG DEPLOYMENT
         USING MICROCATHETER / 10 TO 18 COILS (30 cm lenght)
COIL EMBOLIZATION / Third step

 Ballooning, angiographic control and microcatheter withdrawal
SCOPE 1
           P12-37813003/2012-A01258-35

           Type II Endoleak prevention
          during EVAR for at risk patient
                 coil embolization

Marie Lannelongue Hospital / henri Mondor Hospital

                     Dr Dominique FABRE
                         Investigator

                    Dr Frederic Cochennec
                        coinvestigator
SCOPE 1 STUDY

◼  Interventional, prospective, randomized, comparative and open study.
Principal Investigator: Dominique Fabre
◼ Duration of the study: 4 years

◼   100 evaluable patients
◼   Duration of participation of patients: 2 years
◼   Estimated duration of inclusions: 1 year and ½
◼   Multicenter, 2 centers,

◼   Authorization of the Franch Authority (ANSM since 26/12/2012)

◼   Ethical comittee approved (CPP-Bicêtre IDF VII)
◼   Report on the SIGREC database and on clinical Trials.
Sponsor :              Centre chirurgical Marie Lannelongue

         Collaborators :               Henry Mondor University Hospital
                                 Unite de recherche clinique centre chirurgical
                                              Marie Lannelongue
     Information provided by              Centre chirurgical Marie Lannelongue
       (Responsable party):
ClinicalTrials.gov Identifier:                NCT01878240
CCML
   133,av de la Resistance
                               AIM OF THE STUDY
  92350, Le Plessis Robinson
     Tél : 01 40 94 25 96

◼ Primary objective

   Compare the conventional treatment (Group       I: without coils)
   Versus with embolization of the aneurysm sac by coils (Group II: with coils).

◼ Secondary objectives
   Compare Level of endoleak with CT and Doppler at 6, 12 and 24 months.
   During both examinations, the diameter and volume of the aneurysmal sac will
   be measured and collected.
INCLUSION CRITERIA

◼ Consecutive patients aged 18 years or older,

◼ Carriers of a renal AAA > 5 cm or with a growth rate of diameter >1 cm / year

◼ Patients at high risk of type II endoleak (opacification of the aneurysmal sac by aortic

collateral branch), responding to at least one of the following criteria on the scanner:
◼ The presence of a pair of permeable lumbar arteries.
◼ Patent inferior mesenteric artery.
CCML
 133,av de la Resistance
                                    EXCLUSION CRITERIA
92350, Le Plessis Robinson
   Tél : 01 40 94 25 96

         ◼ Neck under renal  60 °

         ◼ No collaterals arising from the aneurysm sac

         ◼ Associated iliac aneurysms

         ◼ Ruptured AAA

         ◼ Pregnant women

         ◼ Absence of consent

         ◼ Absence of social security
CCML
 133,av de la Resistance
                                                            ENROLLMENT
92350, Le Plessis Robinson
   Tél : 01 40 94 25 96

                                                             Patient selection

                                                           Information and consent

                                                                   Inclusion

                                                               Randomisation

                             GROUP I without coils                                           GROUP II with coïls
                               Standart EVAR                                                   EVAR + Coïls

                                                     Follow up at 1 , 6, 12 and 24 Months.
Flowchart
                         102 pts included
                                                               8 pts excluded
                                                              1 lost during FU
                                                                   3 Nellix

                        93 pts with analyzed
                               datas

                                                                2 deaths

                        91 pts with analyzed
45 gp I EVAR                   datas
                                                   46 gp II EVAR+ coils

         No statistical difference carateristics/ sizing/ only BMI p= 0.049
RESULTS
    SaC embOlization Per EVAR: results from a prospective randomized
                                  study
                                SCOPE 1

•   No complications
•   No Spinal Cord Ischemia
•   No colonic ischemia
•   No migration
Endoleaks
            M1: p= 0.001
            OR = 0.1

            M6: p=0.049
            0R= 0.13

            M12: p NS

            M24: p NS
Endoleaks 22 % at 6 Months
25
             * p= 0.001 at M1
             ** p= 0.049 at M6
20           NS at M 12 / M24

15                                       EL at M1
                                         EL at M6
10                                       EL at M12
                                         EL at M24

 5

 0
     EVAR       EVAR + Coils     Total
Secondary operations

                                     SO 12 M
                                     SO 24 M
                                     Total

EVAR                  EVAR + coils
Endoleak / Secondary operations
Survival free from endoleak and reintervention
AAA size evolution

Before EVAR         After 1 year   After 2 years
53.2 mm             37.5 mm        28.2 mm
AAA diameter evolution

                    •   M1: NS
                    •   M6: NS
                    •   M 12: p=0.002
                    •   M 24: p= 0.004
AAA volume evolution

                   •   M1: NS
                   •   M6: NS
                   •   M 12: p=0.006
                   •   M 24: p= 0.001
Discussion
• Embolization variable / Number of
  coils/ position /intra sac pressure /
  residual perfusion / operators
  feelings
• Artifacts coils / Metal artifacts
  reduction method for CT imaging
• Cost of embolization / cost of
  follow-up
Conclusions

• Coils embolization for at risk patients during EVAR is a safe and
  reproducible procedure
• It is statistically effective in term of decrease of endoleak at 1
  and 6 months
• The freedom from endoleak and reintervention is significantly
  improved by the coil embolization
• The diameter and volume of the AAA is significantly
  decreased at 12 months and 24 months
Conclusions
• Coils embolization for at risk patients during EVAR must be
  discussed for each case to improve the post-operative results
  and improve the mid-term results
• Thanks to all the actors of this study: Dr Angel, Dr Allaire, Dr
  Brenot, Pr Becquemin, Dr Bourkaib, Pr Cochennec, Pr
  Desgranges, Dr Garcia Alonzo, Dr Hamdi, Pr Haulon.
• Thanks to the Research Unit Actors, statistician, fellows,
  residents and paramedics.
Conclusions
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