Faculty Disclosure. Glue, Particulates, Thrombin, Coils and the Kitchen Sink for Type II Endoleak Management. Background.

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1 Glue, Particulates, Thrombin, Coils and the Kitchen Sink for Type II Endoleak Management Faculty Disclosure I disclose the following financial relationships: UCSF Vascular Symposium 2013 Receive grant/research support: Abbott, Aptus, Bolton, Cook, Cordis, Endologix, Medtronic, Pathway, Silk Road Medical, Terumo, Trivascular, Vortex, WL Gore Christopher J. Kwolek, M.D. Background EVAR is an established therapy for the treatment of AAA 65-70% reduction in 30-day mortality Decreased overall aneurysm related mortality (OVER Trial) EVAR is associated with an increase in the number of secondary interventions Background 3595 Eurostar Registry patients Type 2 endoleaks associated with 1. Aneurysm enlargement 2. Need for reintervention 1

2 Background Results 164 (18.9%) immediate type 2 endoleaks Early type 2 endoleak (<6 months) Persistent type 2 endoleak ( 6 months) PT2 endoleaks associated with 1. Aneurysm sac growth 2. Reintervention 3. Conversion to open repair 4. Rupture 33 persistent (> 6 months) endoleaks 20.1% of type 2 leaks 3.8% of all EVARs Only 6.1% (2 patients) of endoleaks persistent > 6 months spontaneously resolved Results Mean follow-up: 43.1 months for persistent (>6 months) endoleak patients 32 months for transient (<6 months) endoleak patients Late Outcomes Associated with Persistent Leaks Outcome Odds Confidence Ratio Interval Rupture Aneurysm Sac Growth Reintervention Rate Conversion to Open Repair p

3 Aneurysm Rupture 3 out of 4 ruptures confirmed in O.R. to have 2 in transient leaks ONLY 2 in persistent (>6mos.) type 2 endoleaks 4 ruptures associated with type 2 endoleaks 4 th - Expired without 2 ruptures NOT associated with aneurysm enlargement intervention Mean time to (CT rupture showed type 2 leak only) Persistent: 595 days No Type 2 Leak: 1175 days Persistent Endoleak: Aneurysm Sac Growth 55% of patients: 18 of 33 patients 5.9% no type 2 endoleak Mean time to increase: 21 months % Free From Sac Growth Freedom From Aneurysm Sac Growth No Early Type 2 Leak Transient Type 2 Leak Persistent Type 2 Leak Days Post EVAR p= % 28% Persistent Endoleak: Conversion to Open Repair 3 out of 33 patients (9.1% ) 1.7% no type 2 endoleak Reasons for conversion 2 patients: increased sac size 1 failed catheter based approach 1 rupture 3

4 1.1 Freedom From Conversion to Open 93.7% Persistent Endoleaks Reintervention Group % Free From Conversion No Early Type 2 Leak Transient Type 2 Leak Persistent Type 2 Leak Days From EVAR p= % 15 Catheter based reinterventions 5 Successful reinterventions 16 Patients 1 Open lumbar ligation 10 unsuccessful reinterventions 3 developed type 1 leaks: Redo stent grafts 4 successful percutaneous reinterventions 2 conversions to open repair (1 rapid expansion) Methods All patients with PT2 undergoing reintervention for an expanding aneurysm sac from January 1999 to December 2007 Demographic, pre-, peri-, and postoperative data Medical history Laboratory data CT scans Maximum aneurysm/luminal diameter, aneurysm sac volume, side branch patency, percent aneurysm sac thrombosis Methods: Aneurysm sac access Direct translumbar puncture Right lateral decubitus position 6Fr mini-access trocar SMA to IMA via Marginal Artery of Drummond microcatheter Hypogastric branches microcatheter 4

5 Methods: PT2 treatment Aneurysm sac coil embolization Lumbar artery coil embolization IMA coil embolization Onyx glue embolization Non-Onyx glue embolization Open lumbar ligation Graft explant Methods: Onyx glue embolization Aneurysm sac access with DMSO compatible microcatheter directly into the flow channel of the endoleak Injection of Onyx filling both the flow channel within the aneurysm sac and the feeding vessels Onyx 34 until cast of the feeding vessels achieved Switch to less viscous Onyx 18 Methods: Onyx glue embolization Methods: Endpoints Reinterventional Success Resolution of PT2 Change in aneurysm sac diameter Axial CT scan Change in aneurysm sac volume M2S Survival Obtained from medical records and the Social Security Database 5

6 Reinterventions Endovascular Reinterventions n Long-term Success P Onyx embolization (76%) Reinterventions Lumbar coil embolization 7 3 (43%) Sac coil embolization 11 4 (36%) 65 Endovascular Reinterventions 2 Open Lumbar Ligations 1 Explant 9 Failed Attempts IMA coil embolization 20 4 (20%) Non-Onyx glue embolization 10 2 (20%) Overall endovascular success: 40% Endovascular Reinterventions Reintervention Failures Onyx embolization Other embolization P Persistent Type 2 Endoleak 136 Patients 1 Onyx Patient Success 76% 31%.0005 Mean Change Sac Diameter (mm) -2.25± ± Mean Change Sac Volume (cc) 5.65± ±7.67 NS No Reintervention 85 Patients (62%) Reintervention 51 Patients (38%) 2 Reinterventions 25 Patients 3 Reinterventions 3 Patients 6

7 Survival Summary P =.84 Endovascular reinterventions for PT2 without Onyx were successful in < 1/3 of cases The use of Onyx doubled the success rate to > 75%, while demonstrating a decrease in aneurysm sac diameter The method of endovascular reintervention used did not impact overall mortality Conclusion The use of Onyx provides a more effective method to treat Type II endoleaks, simultaneously occluding the feeding vessels and the main endoleak channel in a flow directed fashion Further evaluation of Onyx embolization via a clinical trial may be warranted for the management of endoleaks 7

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