Hostile Neck During EVAR, The Role Of Endoanchores Samer Koussayer, MD, FACS, RVT Prof, Al Faisal University Section Head and consultant Vascular & Endovascular Surgery Division King Faisal Specialist Hospital & Research Center Riyadh, KSA
Straight Tapered R. tapered Angulated <30 Bulge Short Source: Ionel Droc, Dieter Raithel and Blanca Calinescu (2012). Abdominal Aortic Aneurysms - Actual Therapeutic Strategies, Aneurysm, Dr. Yasuo Murai (Ed.), ISBN: 978-953-51-0730-9, InTech, DOI: 10.5772/48596
DREAM EVAR-1 ACE De Bruin et al. NEJM 2010 Greenhalgh et al. NEJM 2010 Becquemin et al. JVS 2011 Late ruptures in EVAR, none in open surgery Unlike open repair, endoleaks and migration are major complications of EVAR Open surgery remains a more durable option
Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1 compared outcomes in hostile vs. friendly neck anatomies (total patients N = 1559) Study Sample Size Endografts Torsello et al, 2011 177 Endurant Type AbuRahma I endoleaks et al, 4.5x 2010 more likely 238 at 1-year AneuRx, after endograft Excluder, implantation Zenith, in hostile proximal aortic neck anatomy (P = Talent.010) Hoshina et al, 2010 129 Excluder, Zenith Aneurysm-related mortality risk 9x greater in hostile neck anatomy (P=.013) Abbruzzese et al, 565 AneuRx, Excluder, Zenith 2008 Choke et al, 2006 147 Talent, Zenith, Excluder, AneuRx Fulton et al, 2006 84 AneuRx Fairman et al, 2004 219 Talent 1 Antoniou GA et al. JVS. 2013;57(2):527-38.
Another similar meta-analysis by Stather et al. of 16 major studies confirms higher risks in hostile necks Total sample size: N=11,959 patients EVAR still faces significant challenges in hostile proximal neck anatomy Stather et al. JEVT. 2013;20:623 637
Influence of multiple hostile neck parameters Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases Neck hostility Intra-op adjunctive procedure s Intra-op endoleaks All cause mortality >2 PARAMETERS RISK On label 9.9% 0.5% 1.1% 2 hostile neck parameters 26.7% 6.7% 13.3% >2 hostile neck parameters 50% 16.7% 16.7% Greater than 1 hostile neck parameter substantially increases mortality, major adverse events, intra-op endoleaks and adjunctive procedures Speziale et al, Annals VS. 2014
Type I Endoleak? What have been our options Image courtesy of National Institute of Health TAA Classification Ascending Aortic Arch Possible Type I EL TX Options Open surgical conversion TEVAR Revision*, hybrid What do we do when: Image courtesy of National Institute of Health Descending AAA Classification Juxta-renal Supra-renal TEVAR Revision* Possible Type I EL TX Options Standard revision techniques cannot be used or don t seal the Infra-renal endoleak? Patients are unfit for FEVAR or open surgical conversion? EVAR Revision*, open surgical conversion, FEVAR conversion Open surgical conversion, FEVAR conversion, parallel grafts Open surgical conversion, FEVAR conversion, parallel grafts *Ballooning, cuffs, Palmaz, coils, Onyx and/or CHIMPs may be considered in EVAR/TEVAR revision
3 mm Cross Bar 1.0 mm 3.5 mm
Displacement force in Newtons IT Create the stability of a surgical anastomosis in EVAR and TEVAR Surgical Anastomosis EndoAnchoring Endoanchores bring the stability of the surgical anastomosis to EVAR and TEVAR. 150 100 50 0 Talent Endurant Excluder Zenith Mean Hand No EndoAnchors With EndoAnchors Sewn Case images from John Aruny MD, Bart Edward Muhs, MD, PhD. Melas et al. JVS 2012;55(6):1726-33
Aptus Heli-FX Thoracic EndoAnchor System 18Fr OD, 90cm working length Aptus Heli-FX EndoAnchor System 16Fr OD, 62cm working length
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How to Manage EVAR with EndoAnchors? Select Subset of Endovascular Patients Existing Seal Complications Highly Challenging Anatomies A B C Mitigating Risk Factors Acute & late type I endoleaks 2 Type I endoleaks in urgent or ruptured EVAR Augmenting stability in migrated grafts 1 Secondary Irregularly shaped necks (short, wide, highly angulated, conical) 1 Difficult landing zones 2 Primary Severe comorbidities Patients potentially lost during F/U 3 Long remaining life expectancy 3 Primary 1 Jordan et al. J Vasc Surg. 2015:61(6):1383-90 2 de Vries. JEVT. 2013;20(4):481-3 3 Schanzer et al. Circulation 2011;123:2848-2855.
To Lock Graft to the Aorta, EndoAnchors Must Penetrate Aortic Tissue Areas to avoid: Mural thrombus >2mm thick and 180º of circumference Porcelain aorta (severe circumferential calcification) Loss of graft apposition with resulting gap Nellx EVAS System 5/26/2018 1
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ANCHOR Registry Primary Arm Revision Arm Prophylactic Use Intraprocedural Type Ia Endoleaks
ANCHOR Registry Enrollment Status (Aug 10, 2015) ANCHOR Registry 593 Subjects (74.9% US/25.1% OUS) Primary Arm 439 Subjects Revision Arm 154 Subjects Stent Grafts - Primary Arm Medtronic Endurant Gore Excluder Cook Zenith Stent Grafts - Revision Arm Metronic Endurant Medtronic Talent Medtronic AneuRx Gore Excluder Cook Zenith Jotec
ANCHOR Registry Prophylactic Use Data Highlights Prophylactic Use 269 patients Clinical follow-up: 21.3 months CT follow-up: 8.2 months Sites Excludes revisions or treatment of Type Ia endoleaks at Index 11.2% urgent cases (rupture or symptomatic) Subjects U.S., 72.5% E.U., 27.5% U.S., 84.4% E.U., 15.6%
Baseline Characteristics Male (n/n, %) 77.7% (209/269) Age 74.4 Aneurysm Measurements (Core Lab) Number with Baseline CT Scans 205 Aneurysm Diameter 55.5 mm Proximal Neck Length 16.6 mm Infrarenal Diameter 25.7 mm Suprarenal Angulation 15 Infrarenal Angulation 35 Average Neck Calcium Thickness 1.1 mm Conical Neck (>10%/10mm) 41.0% Hostile Necks 77.6% Definitions for HOSTILE NECK Criteria Threshold Aortic Diameter at Renals 28 Proximal Neck Length 10 Infrarenal Angulation to Bifurcation 60 Neck Thrombus Avg Thickness 2 Neck Thrombus Circum >1mm 180 Neck Calcium Avg Thickness 2 Neck Calcium >1mm 180
ANCHOR Registry Prophylactic Subjects PROXIMAL ENDOLEAKS AND MIGRATION MEAN FOLLOW-UP 8.2 MONTHS All Primary Cases Type Ia Endoleaks 1a ELs CTs % 3 177 1.7% Endograft Migration (>10mm) All Primary Cases Migration CTs % 0 112 0.0% Migration was assessed in comparison to the 1-month CT scan
ANCHOR Registry Prophylactic Subjects Sac Diameter Changes All Prophylactic Patients Mean 8 months Prophylactic Patients with 1-Year CTs 9-12 month window SAC DIAMETER CHANGES Patients >5mm Regression 42 27.3% >5mm Enlargement 1 0.6% Patients N=154 >5mm Regression 25 64.1% >5mm Enlargement 0 0.0% Patients N=39 Sac regression/enlargement was assessed in comparison to the 1-month CT scan. Analysis includes only those patients with a 1-month CT and at least one more CT obtained after 1 month.
ANCHOR Registry Prophylactic Subjects WHEN TO USE ENDOANCHORS? TO PREVENT /MITIGATE RISK FOR TYPE 1A ENDOLEAKS To improve durability of EVAR for hostile necks Calcium, thrombus, angulated, conical, short Current ANCHOR registry analysis demonstrates no migration and <2% Type 1a EL in Primary Prophylactic cases (8.2 month mean f/u)
ANCHOR Registry Therapeutic Use ANCHOR Registry Primary Arm Revision Arm Prophylactic Use Type Ia Endoleaks Intraprocedural Type Ia Endoleaks Re-intervention
Adjunctive Devices Primary (N=141) Revision (N=122) All (N=263) Aortic Extender Cuff 25 (17.7%) 62 (50.8%) 87 (33.1%) Giant bare stent (e.g. Palmaz) 2 (1.4%) 4 (3.3%) 6 (2.3%) Cuff + Palmaz 0 (0%) 2 (0.8%) 2 (0.8%) Chimney 0 (0%) 2 (0.8%) 2 (0.8%) Fenestrated 0 (0%) 1 (0.4%) 1 (0.4%) Debranching 0 (0%) 1 (0.4%) 1 (0.4%) EndoAnchors alone 114 (80.9%) 50 (41.0%) 164 (62.4%)
CORE LAB MEAN CT FOLLOW-UP 10.4 MONTHS Cohort All Cases 1a ELs CTs % All 24 142 16.9% Primary 3 76 3.9% Revision 21 66 31.8%
Regression >5mm Enlargement >5mm Regressed % Enlarged % All 27/132 20.5% 10/132 7.6% Primary 21/84 25.0% 4/84 4.8% Revision 6/48 12.5% 6/48 12.5% Core Lab Analysis Diameter change between 1-month (0-60d) and 1-year (9-12m) CTs
Reinterventions* Number (%) Successful** Open surgical conversion 2/24 (8%) 2/2 Fenestrated graft 2/24 (8%) 0/2 Additional EndoAnchors 1/24 (4%) 0/1 Aortic extension cuff 1/24 (4%) No Imaging No additional procedures reported 18/24 (75%) N/A *Data from 24 patients with persistent Type Ia endoleaks reported by the Core Laboratory. **Successful is defined by no type Ia endoleak on imaging studies after the reintervention.
The use of EndoAnchors for treatment of proximal (Type Ia) endoleaks at the time of initial endovascular aneurysm repair ( Primaries ) is associated with excellent results, at least through 1-year follow-up. 96% of patients remain free of recurrent proximal endoleaks through 1-year CT imaging follow-up. The use of EndoAnchors for Type Ia endoleak remote from an EVAR procedure ( Revisions ) is successful in the majority of cases, but persistent endoleaks remain in 32% of such patients. Of note, 75% of these patients with persistent endoleaks did not undergo further reinterventions despite the leak.
Endoanchoes provide additional endovascular option for prevention or treatment of stentgraft nonalignment, migration or type I endoleak. Other therapeutic options have to be considered. No EndoAnchor application in patients anatomically unsuitable (very short or no neck). Long term data are required.
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