Endoleaks after F-BEVAR How to Assess & Treat? Gustavo S. Oderich, MD Mayo Clinic Rochester, MN
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1 Endoleaks after F-BEVAR How to Assess & Treat? Gustavo S. Oderich, MD Mayo Clinic Rochester, MN
2 FACULTY DISCLOSURE Gustavo S. Oderich MD Consulting, DSMB, CEC* Cook Medical Inc., WL Gore, Lombardi Honoraria WL Gore, Endologix Research grants* Cook Medical Inc., WL Gore, Atrium Maquet * All consulting fees and grants paid to Mayo Clinic
3 DISEASE PROGRESSION Above endograft mm At right renal artery origin mm Postprocedure 24 months mm mm Post-procedure 60 months 60 months mm mm
4 EVOLVING SELECTION OF LANDING ZONES
5 Surgeries (%) Endoleak rate MORE VESSELS, LESS LEAKS Fen 3 Fen + Scallop 4 Fen/Br Endoleak Year 0 O Callaghan A, et al: J Vasc Surg; 61:908, 2015
6 F-BEVAR FAILURE MODES Days Months Years Kinks, compression - Edge kinks - Dilator injury Endoleaks In-stent stenosis - Bare-metal Endoleaks Infection Distal edge stenosis - Covered - Self-expandable Compression, separation - Migration - Remodeling Endoleaks Infection
7 ENDOLEAK CLASSIFICATION
8 Prospective Non Randomized Trial to Evaluate F-BEVAR of Pararenal and TAAAs using Supra-Celiac Sealing Zones Gustavo S. Oderich MD, Mauricio Ribeiro MD PhD, Jan Hofer RN, Jean Wigham RN, Leonardo Reis de Souza MD, Julia Chini, Stephen Cha MS, Thanila A. Macedo MD and Peter Gloviczki MD Division of Vascular and Endovascular Surgery and Departments of Radiology, Epidemiology and Biostatistics WASHINGTON, DC Journal of Vascular Surgery 2017
9 TRIAL DESIGN Prospective, non-randomized study Cook manufactured F-BEVAR for pararenal and TAAAs Imaging follow up: CBCT intra-operative CTA Dismissal, 1 month, 6 month and yearly Duplex US preop, 1 month, 6 month and yearly Clinical examination and labs Independent imaging review (Vascular CTA lab) Independent DSMB adjudication of clinical events
10 ENDOLEAKS AFTER F-BEVAR 127 patients 46% had any endoleak 40% 35% 30% 25% 20% 15% 10% 5% 0% 27% 6% 2% 2% 23% 25% 32% 1% 0% 2% 0% 2% 2% 34% Dismissal 1 month 6 months 12 months All patients Patients at risk % Type I Type II Type III Oderich et al. Journal of Vascular Surgery 2017 (in press)
11 F-BEVAR REINTERVENTIONS Reintervention Total <30 days >30 days Aortic 14 (11%) 5 (4%) 9 (7%) Branch stenosis 4 (3%) 0 4 (3%) Iliac limb stenosis 2 (2%) 2 (2%) 0 Endoleak 7 (6%) 2 (2%) 2 (2%) Type IA 2 (2%) 1 (1%) 1 (1%) Type IC 1 (1%) 0 1 (1%) Type III 6 (5%) 2 (2%) 4 (4%) Non-aortic 8 (6%) 6 (5%) 2 (2%) Access related 4 (3%) 2 (2%) 2 (2%) Laparotomy 4 (3%) 4 (3%) 0 Total 23 (18%) 11 (9%) 12 (9%) Oderich et al. Journal of Vascular Surgery 2017 (in press)
12 TREATMENT CONSIDERATIONS Endoleak mechanism or type? Antegrade or attachment related? Retrograde? Associated device integrity or structural issues Sac enlargement? Endovascular solution? Is there a new achievable sealing zone? What are complicating factors imposed by prior FEVAR? Open surgical solution? Can the patient handle explantation? Clamp site? Side branch reconstruction?
13 TYPE IA ENDOLEAKS
14 TYPE IA ENDOLEAK Proximal TEVAR attachment Need for brachial access
15 TYPE IA ENDOLEAK Proximal TEVAR attachment Arch extension with C-TAG and anchors
16 TYPE IA ENDOLEAK Progression of aortic disease mm 40-mm mm Reverse Frozen elephant trunt technique
17 TYPE IA ENDOLEAK Device infolding
18
19
20 TYPE IC ENDOLEAKS
21 TYPE IC ENDOLEAK SMA and L renal branch stents Contrast outside SMA distal attachment site SMA branch L renal branch Left renal stent barely into renal artery
22 SMA angiography confirmed filling of the excluded sac Parallel sandwich stents into SMA and replaced RHA LRA angiography confirms filling of the excluded sac
23 LRA sacrifice with Amplatz plug SMA and Replaced RHA parallel stents
24 TYPE III ENDOLEAKS
25 TYPE III ENDOLEAK Thoracic stent overlap Interval repair with extension of fenestrated and branched endograft Large type III endoleak between the outer most stent from prior repair and inner stent from extension fenestrated/branched repair
26 Spontaneous resolution on first follow up CTA Interval spontaneous resolution of Type III endoleak
27 TYPE IIIC ENDOLEAK Bifurcated component separation cm cm
28 TYPE IIIC ENDOLEAK SMA fenestrated-branch stent disconnection
29 TYPE III/II ENDOLEAK Celiac fenestration and IMA Large endoleak without definitive connection to the SMA or Celiac attachments. Guide-wire celiac fenestration Inside aneurysm sac confirmed type III endoleak IMA IMA angiography
30 TYPE IIID ENDOLEAK Fabric tear (probably from posterior diameterreducing ties) Probable fabric tear
31 TYPE II ENDOLEAKS
32 TYPE II ENDOLEAKS Patent IMA or Hypogastric collaterals Trans-arterial Occluded IMA or Hypogastric collaterals Trans-lumbar
33 TYPE II ENDOLEAKS Needle assist Bulls Eye View Progression View
34 TYPE II ENDOLEAKS Recalcitrant endoleak after multiple prior interventions 66mm 100mm
35 TYPE II ENDOLEAKS Recalcitrant endoleak after multiple prior interventions Date mm Finding Intervention Preop 62 - FEVAR Dismissal 62 Type II - 1 month 66 Type II - 12 month 72 Type II Coiling/Onyx 18 month 79 Type II Onyx 24 month 82 Type II Onyx 30 month 82 Type II? - 48 month 95 Type II? Stent realinment 60 month 100 Type II??
36
37 HIGH-DEFINITION CONE BEAM CT * GE Discovery 740 (7 sec Spin)
38 CONCLUSION Most common endoleaks are type II and type III from fenestration attachments, which can be treated by embolization and stent reinforcement Rates of type Ia endoleak are low when repairs are planned with supra-celiac sealing zones, but likely are more frequent with less extensive repairs Options are limited once there is failure of proximal neck after FEVAR (e.g explant, branch, CHIMPS), so it is better to prevent this complication!
39
40 VISCERAL BRANCH DEVICES PATIENT-SPECIFIC OFF-THE-SHELF Cook Zenith Fenestrated Anaconda JOTEC Endolgix Ventana Cook p-branch Cook t-branch Gore TAMBE FDA APPROVED Juxtarenal CE MARK CE MARK CE MARK Pararenal TAAA PIVOTAL TRIAL TERMINATED PIVOTAL TRIAL TRIAL DESIGN Pararenal TAAA Juxtarenal Pararenal TAAA TRIAL DESIGN Pararenal TAAA
41
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