SAC EMBOLIZATION PER EVAR: RESULTS FROM A PROSPECTIVE - AFFLUENT MEDICAL
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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
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
Remenber this point / IFU Vanguard graft
Meta-analysis / Actual level of endoleak in 2019
Early and Late T2EL
Only 20% of patients
require reintervention
Pineda, JVS 2018
At risk patients!
At risk patients for T2EL
associated with aneurysm sac expansion
Independent predictors of type II endoleak:
– Patency of the IMA (p
Prospective randomized study
Coil Glue during EVAR
T2EL
complications
during early and midterm
follow-up in patients
considered at risk.
Piazza. JVS 2015
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 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
coinvestigatorSCOPE 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: NCT01878240CCML
133,av de la Resistance
AIM OF THE STUDY
92350, Le Plessis Robinson
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◼ 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
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EXCLUSION CRITERIA
92350, Le Plessis Robinson
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◼ Neck under renal 60 °
◼ No collaterals arising from the aneurysm sac
◼ Associated iliac aneurysms
◼ Ruptured AAA
◼ Pregnant women
◼ Absence of consent
◼ Absence of social securityCCML
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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= 0.049RESULTS
SaC embOlization Per EVAR: results from a prospective randomized
study
SCOPE 1
• No complications
• No Spinal Cord Ischemia
• No colonic ischemia
• No migrationEndoleaks
M1: p= 0.001
OR = 0.1
M6: p=0.049
0R= 0.13
M12: p NS
M24: p NSEndoleaks 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 TotalSecondary operations
SO 12 M
SO 24 M
Total
EVAR EVAR + coilsEndoleak / 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= 0.004AAA volume evolution
• M1: NS
• M6: NS
• M 12: p=0.006
• M 24: p= 0.001Discussion • 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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