Conflicts of Interest. When and Why Complex EVAR in Tx of juxta/suprarenal AAA? Summary. Infrarenal EVAR for short necks 2y postop

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When and Why Complex EVAR in Tx of juxta/suprarenal AAA? Tim Resch MD Vascular Center Skane University Hospital Conflicts of Interest COOK Medical - Consulting, Speakers Bureau, IP, Research support Medtronic Advisory Board Aortica Advisory Board Cordis Research Support GORE Research Support, Speakers Bureau Summary Hostile Sealing Zone Anatomy affects outcome of EVAR negatively both short and longterm Endovascular Repair Should Aim to Seal the Repair in Healthy Aorta FEVAR is an established therapy for endo Tx of juxtarenal aneurysms Custom Made devices allow perfect tailoring of graft to patient to achieve a durable repair ChEVAR for juxtarenal aneurysms should be reserved mainly for cases not suitable for fevar/open repair using max 1 2 chimneys Infrarenal EVAR for short necks 2y postop 10 20% of EVAR patients have necks < 15mm Short infrarenal necks are predictive of initial technical failure Increased incidence of early and late type 1 EL Increased use of intraoperative adjunctiveprocedures Longterm outcome impaired Endoleaks, migration, late rupture AbuRhama JVS 2009 Leurs et al JEVT 2006 Boult EJVES 2006 1

IFUs 8920 patients with Favorable necks 3039 patients with Hostile Necks Increase in 30d mortality, intraoperative adjuncts, 30d migration Increase in type 1 EL at 30d and 1y Company Device Angulation Neck Length Neck Diameter Endologix AFX <60 15mm 32mm Medtronic Endurant <60 (5)10(15)mm 32mm COOK Zenith LP <60 15mm 32mm GORE C3 <60 15mm 32mm Trivascular Ovation <60 7mm 30mm Endologix Nellix <60 10mm 34mm Cordis Incraft <60 15mm 31mm Terumo Anaconda <60 15mm 31mm Lombard Aorfix 90 15mm 29mm COOK Fenestrated <60 4mm 32mm Graft Author Year Neck def n short neck n FU mon Technical 1A Early (%) 1A Late (%) (Median) success % Nellix Krievins 2011 < 10 mm 34 8 15 100 0 (0) 1 (12,5) Excluder Hager et al 2012 < 15 mm 60 60 18,6 100 11 (18,3) 5 (8,3) Ovation Ovation 2014 < 10 mm 161 25 12 100 NA 3 (12)* Mehta et al Zenith Zenith 2013 < 15 mm 27 17 18 100 2 (11,7) 1 (5,9) Antoniou et al Zenith 2012 < 15 mm 24 24 18,5 100 3 (12,5) 1 (4,2) Hager et al Endurant Setacci et al 2014 < 15 mm 137 72 12 100 0 (0) 0 (0) Matsagkas 2014 < 10 mm 57 19 24 100 2 (10,5) 0 (0) et al Hyhlik Durr 2011 < 15 mm 90 19 15 92 0 (0) 1 (5,3) et al Antoniou et 2013 < 15 mm 33 17 14 100 3 (17,7) 0 (0) al Troisi et al 2014 < 10 mm 175 56 31,2 96,4 1 (1,8) 2 (3,6) Goncalves et al 2014 < 10 mm 1263 27 12 99,6 2 (7,4) NA JVS 2015 In Press ANCHOR Registry 221 patients 100 patients w type 1a EL Logistic regression and ROC analysis 2

Proximal EL after FEVAR Year N Short neck def Follow up (mo) Technical Success 1a early(n) O Neill 2006 70 10 19 100 5 0 (119) Verhoeven 2010 100 4 12 24 95 2 0 Semmens 2006 58 4 15 14 83 4 0 Ziegler 63 4 15 3 1 1a late (n) Conical Thrombuslined Short Angulated Wide It s All About The Seal! Kristmundsson 2014 54 8 67 91 11 0 Oderich 2014 67 4 15 44 100 0 1 Long term results after juxtarenal FEVAR Type 1a EL after FEVAR N=54 5 Type 1/3 EL All Distal! 924 patients 2.8% Type 1a EL 10/26 > 12month EASE OF IMPLANTATION SHOULD NOT DRIVE DESIGN Kristmundsson JVS 2014 O'Callaghan A, Mastracci TM, Greenberg RK, Eagleton M, Bena J 3

5y FU FEVAR/BEVAR Specific Endoleaks Mastracci et al JVS 2013;57 Risk factors for Type 1 EL Poor sealing zone >10% diameter change in sealing zone 15mm Sealing Zone site Juxta renal aorta more vulnerable Endoleak had no effect on Overall survival Number of fenestrations (n=288) 2.7 0.8 vs. 3.2 0.7, p<.001 Higher Placement of Stentgraft WHEN DO WE USE FEVAR OR BEVAR OR CHEVAR? Sveinson, Sobocinski, Resch et al JVS 2015;61 4

Directional Branches vs. Branch Fenestrations Branch Fenestration?? Space Considerations Target Vessel Anatomy Crainocaudal Ant-Post Branches vs. Fenestrations Often A Combination Is The Best Fit Custom Made Design Type IV TAA Directional Branches TV in wide aorta >35 TAAA Caudally oriented TV SMA, CA Renals in type 4 TAAA Emergency cases? Off the Shelf Fenestrations TV in narrow aorta Juxtarenal/short neck AAA Type 1 TAAA Chronic dissections Cranially oriented TV Renals in type 2 TAAA Juxta/Suprarenal AA Type II/III TAA Branches in juxtarenal repair? 99mm 135mm Lower extremity weakness 21% 13% full recovery 8% persistent deficit No Bias based on Crawford extent of aneurysm Included Type II IV aneusyms and juxta/suprarenal 5

Fenestrations vs. Chimneys Chuter et al JVS 2012;56 81pat, 306 Branches Mean FU 21months 100% Technical Branch Success 9% renal branch occlusion Considerations Availiability Applicability Equiptment Availability Anatomic suitability Cost Efficacy Technical Success Endoleaks TV Patency Durability 2nd interventions Renal function Chimney Standard Components? EVAR grafts Covered stents *Mendez JVS 2014, Chuter JVS Fenestrated 6 8week delivery T Branch Suitability 50 80%* More extensive repair P Branch Suitability 40 50%* Anatomic suitability Caution Chimney Cranial access Stroke risk More chimneys more endoleak Fenestrated Multiple renals Poor iliac access Excessive angulation in aortic neck 6

JVS 2016) Renal diameter >4mm RA length to bifurcation < 13mm Preservation of >75% single kidney OR >60% of 2 kidneys JVS 2016) N=520 1009 Main renal arteries 177 accessory renals 18% non suitable for endo due to renal issues JVS 2016) 125 patients (24%) excessive downward angle ChEVAR or BEVAR case??? 129 patients (25%) at least one upward facing RA FEVAR??? Proximal aneurysm extent impacts RA angle Anatomic Turndowns 195 patients screened 67 patients included (34%) Considerations Applicability Equiptment Availability Anatomic suitability Cost Efficacy Technical Success Endoleaks TV Patency Durability 2nd interventions Renal function 7

Fenestrated repair Operative mortality 2.0% vs. 2.1% (ns) 1 year outcome Mortality 4% vs. 7% (ns) Reintervention 8% vs. 12% (ns) Type 1 EL 1.1% (ns) TVP 98.4% @ 1y Long term results after juxtarenal FEVAR TVP 94% @ 5y Kristmundsson JVS 2014 Freedom from Composite Endpoint (Overall and by Device Type) 517 patients, 13 centers Only 3 centers had access to FEVAR/BEVAR?? Mean FU 17months 95% juxta/suprarenal AAA, 5% rupture Twelve year experience with fenestrated endografts for juxtarenal and type IV thoracoabdominal aneurysms. TM Mastracci, MJ Eagleton, Y Kuramochi, S Bathurst, K Wolski Survival Chimney Patency 8

30d mortality (elective) 3,7% 7.9% type 1 EL 1,7% stroke Multiple Chimneys (3 4) = high failure risk Multiple Chimneys = Higher mortality 128 patients Endurant + V12 Advanta 1,5 chimney s/pt Mean preop neck length 5mm FU 2years All High risk All unsuitable for FEVAR! 70% had 1 chimney and increased neck lenght by 13mm! All imaging reviewed in house Short FU 9

COMPARATIVE STUDIES FEVAR (N=542) ChEVAR N=158 Meta analysis of 1725 open surgical, 931 fenestrated EVAR, 94 chimney EVAR patients undergoing repair of juxtarenal AAA Chimney EVAR has higher type I endoleak rate (10%) than fenestrated EVAR (4.3%) (p=0.002) Chimney EVAR requires brachial access and manipulation from the arch Chimney EVAR has a higher stroke rate (3.2%) when compared to for open surgery (0.1%) and for fenestrated EVAR (0.3%) (p<0.01) FEVAR n=1748 (FU 21month) ChEVAR n=757 (including 7% ruptured) (FU 17month) 10

FEVAR Delivery Time Less 30d Mortality Better TVP Less Type 1 EL More type 3 EL Reach higher seal ChEVAR Highly accessible Higher Technical Success More Reinterventions More Aneurysm Growth Limited TV incorporation 11

Summary Hostile Sealing Zone Anatomy affects outcome of EVAR negatively both short and longterm Endovascular Repair Should Aim to Seal the Repair in Healthy Aorta FEVAR is an established therapy for endo Tx of juxtarenal aneurysms Custom Made devices allow perfect tailoring of graft to patient to achieve a durable repair ChEVAR for juxtarenal aneurysms should be reserved mainly for cases not suitable for fevar/open repair using max 1 2 chimneys 12