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

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

10 228 patients undergoing EVAR

5-year post-EVAR rate

of AAA sac enlargement 41%.

Schanzer Circulation 2011

Do we have to prevent endoleaks?First, we have to respect IFU

Remenber this point / IFU Vanguard graft

Pineda, JVS 2018

Meta-analysis / Actual level of endoleak in 2019

Early and Late T2ELOnly 20% of patientsrequire reintervention

At risk patients!

At risk patients for T2EL

associated with aneurysm sac expansion

Independent predictors of type II endoleak:

– Patency of the IMA (p<0.001)

– mural thrombus (p<0.001)

– > 4 patent lumbar arteries (p = 0.004),

– aneurysm length (p = 0.011)

– iliac artery length (p = 0.004).

– Aneurysm volume

Seike Ann Vasc Sur 2018

Prospective randomized study

Coil Glue during EVAR

Piazza. JVS 2015

T2EL complicationsduring early and midtermfollow-up in patients considered at risk.

Coil Glue during EVAR

Prospective randomized study

Piazza. JVS 2015

REINTERVENTIONSafter EVAR

during early and midterm

follow-up

in patients considered at risk.

Sac embolisation Technique during EVAR

TERUMO GUIDE IN ANEURYSM SAC BEFORE

CONTROLATERAL ILIAC LEG DEPLOYMENT

AFTER CONTROLATERAL ILIAC LEG DEPLOYMENT

USING MICROCATHETER / 10 TO 18 COILS (30 cm lenght)

COIL EMBOLIZATION / Second step

COIL EMBOLIZATION / Third step

Ballooning, angiographic control and microcatheter withdrawal

Type II Endoleak prevention

during EVAR for at risk patientcoil embolization

Marie Lannelongue Hospital / henri Mondor Hospital

SCOPE 1

P12-37813003/2012-A01258-35

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 HospitalUnite de recherche clinique centre chirurgical

Marie Lannelongue

Information provided by (Responsable party):

Centre chirurgical Marie Lannelongue

ClinicalTrials.gov Identifier: NCT01878240

AIM OF THE STUDY

◼ Primary objective

◼ Secondary objectives

Compare the conventional treatment (Group I: without coils)

Versus with embolization of the aneurysm sac by coils (Group II: with coils).

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.

CCML

133,av de la Resistance

92350, Le Plessis Robinson

Tél : 01 40 94 25 96

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

92350, Le Plessis Robinson

Tél : 01 40 94 25 96

EXCLUSION CRITERIA

◼ Neck under renal <10 mm

◼ Angled collar> 60 °

◼ No collaterals arising from the aneurysm sac

◼ Associated iliac aneurysms

◼ Ruptured AAA

◼ Pregnant women

◼ Absence of consent

◼ Absence of social security

Inclusion

Patient selection

Information and consent

Randomisation

GROUP I without coilsStandart EVAR

CCML

133,av de la Resistance

92350, Le Plessis Robinson

Tél : 01 40 94 25 96

ENROLLMENT

GROUP II with coïlsEVAR + Coïls

Follow up at 1 , 6, 12 and 24 Months.

Flowchart

102 pts included

93 pts with analyzed

datas

45 gp I EVAR 46 gp II EVAR+ coils

No statistical difference carateristics/ sizing/ only BMI p= 0.049

8 pts excluded

1 lost during FU

3 Nellix

91 pts with analyzed

datas

2 deaths

• No complications

• No Spinal Cord Ischemia

• No colonic ischemia

• No migration

RESULTSSaC embOlization Per EVAR: results from a prospective randomized

study

SCOPE 1

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

0

5

10

15

20

25

EVAR EVAR + Coils Total

EL at M1

EL at M6

EL at M12

EL at M24

* p= 0.001 at M1** p= 0.049 at M6

NS at M 12 / M24

Secondary operations

EVAR EVAR + coils

SO 12 M

SO 24 M

Total

Endoleak / Secondary operations

Survival free from endoleak and reintervention

AAA size evolution

Before EVAR

53.2 mmAfter 1 year

37.5 mm After 2 years

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 / operatorsfeelings

• Artifacts coils / Metal artifactsreduction 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