SaC embolization Per EVAR: results from a prospective randomized study SCOPE 1
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1 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
2 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
3 Do we have to prevent endoleaks? First, we have to respect IFU patients undergoing EVAR 5-year post-evar rate of AAA sac enlargement 41%. Schanzer Circulation 2011
4 Remenber this point / IFU Vanguard graft
5 Meta-analysis / Actual level of endoleak in 2019 Early and Late T2EL Only 20% of patients require reintervention Pineda, JVS 2018
6 At risk patients!
7 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
8 Prospective randomized study Coil Glue during EVAR T2EL complications during early and midterm follow-up in patients considered at risk. Piazza. JVS 2015
9 Coil Glue during EVAR Prospective randomized study REINTERVENTIONS after EVAR during early and midterm follow-up in patients considered at risk. Piazza. JVS 2015
10 Sac embolisation Technique during EVAR
11
12 TERUMO GUIDE IN ANEURYSM SAC BEFORE CONTROLATERAL ILIAC LEG DEPLOYMENT
13
14 COIL EMBOLIZATION / Second step AFTER CONTROLATERAL ILIAC LEG DEPLOYMENT USING MICROCATHETER / 10 TO 18 COILS (30 cm lenght)
15 COIL EMBOLIZATION / Third step Ballooning, angiographic control and microcatheter withdrawal
16 SCOPE 1 P /2012-A 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
17 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.
18 Sponsor : Collaborators : Information provided by (Responsable party): ClinicalTrials.gov Identifier: Centre chirurgical Marie Lannelongue Henry Mondor University Hospital Unite de recherche clinique centre chirurgical Marie Lannelongue Centre chirurgical Marie Lannelongue NCT
19 CCML 133,av de la Resistance 92350, Le Plessis Robinson Tél : AIM OF THE STUDY 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.
20 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.
21 CCML 133,av de la Resistance 92350, Le Plessis Robinson Tél : 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
22 CCML 133,av de la Resistance 92350, Le Plessis Robinson Tél : ENROLLMENT Patient selection Information and consent Inclusion Randomisation GROUP I without coils Standart EVAR GROUP II with coïls EVAR + Coïls Follow up at 1, 6, 12 and 24 Months.
23 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
24 RESULTS SaC embolization Per EVAR: results from a prospective randomized study SCOPE 1 No complications No Spinal Cord Ischemia No colonic ischemia No migration
25 Endoleaks M1: p= OR = 0.1 M6: p= R= 0.13 M12: p NS M24: p NS
26 Endoleaks 22 % at 6 Months * p= at M1 ** p= at M6 NS at M 12 / M EL at M1 EL at M6 EL at M12 EL at M EVAR EVAR + Coils Total
27 Secondary operations SO 12 M SO 24 M Total EVAR EVAR + coils
28 Endoleak / Secondary operations
29 Survival free from endoleak and reintervention
30 AAA size evolution Before EVAR 53.2 mm After 1 year 37.5 mm After 2 years 28.2 mm
31 AAA diameter evolution M1: NS M6: NS M 12: p=0.002 M 24: p= 0.004
32 AAA volume evolution M1: NS M6: NS M 12: p=0.006 M 24: p= 0.001
33 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
34 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
35 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.
36 Conclusions
37
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