Improving Endograft Durability with EndoAnchors William D. Jordan, Jr., M.D. John E. Skandalakis Chair in Surgery Professor and Chief Division of Vascular Surgery and Endovascular Therapy Emory University Atlanta, Georgia
DISCLOSURES CME standards NONE Clinical Investigator paid to Emory Gore, Medtronic, Endologix, Cook Consultant paid to Emory Medtronic Equity Shareholder None 2
PROBLEM PERSISTS DESPITE EVAR : DURABILITY 2002 2008 Unibody endograft Aneurysm wall Aneurysm wall 3
LONG TERM OUTCOMES FOR AAA REPAIR: MEDICARRE PATIENTS NEJM 2015 39,966 matched patients; 2001-2008 30 day mortality: 5.2% vs 1.6% 3 year survival better survival after open repair Conversion rate declines from 2.2% to 0.3% Rupture occurred 5.4 % after EVAR; 1.4% after open Reinterventions have improved 10.4% 9.1% 4
Legacy Studies Highlight Need for Lifelong Surveillance and Re-intervention after EVAR DREAM De Bruin et al. NEJM 2010 EVAR-1 Greenhalgh et al. NEJM 2010 ACE Becquemin et al. JVS 2011 Late ruptures in EVAR, none in open surgery With EVAR, predictors for rupture (endoleaks and migration) increase with time In ACE, 16% reinterventions in EVAR vs. 2.4% for open repair at 3 yr median f/u 5
Hostile Proximal Neck Predicts Challenges diameter, shape, length, thrombus, calcium Type I endoleaks 4.5x more likely at 1-year after EVAR in hostile proximal neck anatomy (P =.010) 4.5x 9x Aneurysm-related mortality risk 9x greater in hostile neck anatomy at 1-year (P=.013) Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1 compared outcomes in hostile vs. friendly neck anatomies (total pts N = 1559) Study Sample Size Endografts Torsello et al, 2011 177 Endurant AbuRahma et al, 2010 238 AneuRx, Excluder, Zenith, Talent Hoshina et al, 2010 129 Excluder, Zenith Abbruzzese et al, 2008 565 AneuRx, Excluder, Zenith 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. 6
Influence of Multiple Hostile Neck Parameters Neck Hostility Intra-op Adjunctive Procedures Intra-op Endoleaks All Cause Mortality On Label 9.9% 0.5% 1.1% 2 Hostile Neck Parameters Straight Tapered Reverse Angulate d d* Tapered >2 Hostile Neck Parameters Bulge Short + Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases 26.7% 6.7% 13.3% 50% 16.7% 16.7% >1 Greater than 1 hostile neck parameter substantially increases: Mortality MAEs Endoleaks Adjunctive procedures Speziale et al, Annals VS. 2014 7
Displacement Force (Newtons) Recreating the Stability of Surgical Anastomosis EndoAnchor implants establish surgical anastomosis strength in EVAR & TEVAR Surgical Anastomosis EndoAnchor implant fixation 150 100 50 0 Case images from John Aruny MD, Bart Edward Muhs, MD, PhD. No EndoAnchor implants Melas et al. JVS 2012;55(6):1726-33 8
Heli-FX System: Applier + Guide + 10 EndoAnchor Implants 3 mm Cross Bar 1.0 mm 3.5 mm 9
ANCHOR Registry: Capturing Real-World Usage Registry Design Registry Principal Investigators Treatment Arms* Enrollment & Duration Follow-up Prospective & Observational, International & Multi-Center, Dual-arm Registry with Core Lab Analysis Europe: Dr Jean-Paul de Vries Chief of Vascular Surgery, St. Antonius Hospital US: Dr William Jordan Chief of Vascular Surgery/Endovascular Therapy, Emory University School of Medicine Primary Revision Enrollment began 2012 and patients will be followed for 5 years Per Standard of Care at each center & discretion of Investigator *Expanded registry to include Thoracic and Advanced Disease arms. ~ 780 Patients Enrolled 10
ANCHOR Registry* Primary Arm represents 72.4% of pts Stent Grafts - Primary Arm 604 ANCHOR REGISTRY 604 Subjects Medtronic Endurant Gore Excluder Cook Zenith Jotec Other *Data cut June 15, 2016 437 PRIMARY ARM 167 REVISION ARM Stent Grafts - Revision Arm Metronic Endurant Medtronic Talent Medtronic AneuRx Gore Excluder Cook Zenith Jotec Other 11
ANCHOR Registry Primary Arm EndoAnchor implants without evidence of type 1a endoleak, but concern for late failure and/or prevention of neck dilatation ANCHOR REGISTRY PRIMARY ARM N=437 REVISION ARM N=167 PROPHYLACTIC USE (72%, N=314) INTRA-OP TYPE IA ENDOLEAKS (28%, N=123) 1 Data cut June 15, 2016 12
72 YO, 6.3 CM AAA, CREAT 2.4 2011 2011 2015 5.3 cm 13
ANCHOR Registry Prophylactic Use (N=314) Indications for EndoAnchor Implants Hostile Necks: 91.2% Per the SVS definition Per treating physician, patients at risk of late failure Short, Wide, Angulated, Conical, Young (SWACY) Infrarenal Diameter: 25.6 mm Infrarenal Angulation: 24.6 Conical Neck: (>10%/10mm): 41.4% Neck Length: 11.5 mm (median) Aneurysm Diameter: 55.7 mm Avg Neck Calcium Thickness: 1.2 mm Male: 78% Female: 22% Mean Age: 72.4 Years * Mean Core Lab measurements based on 251 pts with baseline CTs 14
ANCHOR Registry Prophylactic Use Technical Success Successful deployment of EndoAnchor implants with adequate penetration into aortic wall Procedural Success Technical success without type Ia endoleak at completion arteriography 94.9% Prophylactic 94.6% Prophylactic Avg. duration Avg. time to Avg. number of EndoAnchor implants of Procedure (min) EndoAnchor implants (min) 141 15.8 5.5 At 12 months N=182 At 24 months N=85 Core Lab 12 months 24 months Type 1a Endoleak 0.6% (1/181) 0.0% (0/86) Endograft Migration 0.0% (0/129) 0.0% (0/43) Decre ase 45. Incre ase 1.6% Stabl e 52. Decre ase 61.2% Increa se 1.2% Stable 37.6% 15
ANCHOR Registry Prophylactic Use Hostile Necks: 91.2% Per the SVS definition Kaplan-Meier Estimates 1 Year (N=301) 2 Year (N=214) Freedom from ACM 94.5% 90.6% Freedom from ARM 98.4% 98.4% Freedom from 2 nd Procedures 95.9% 92.1% Adverse Events through 2 Years Patients with Events Procedure-Related SAE 27 8.6% EndoAnchor implant-related SAE 0 0.0% Aneurysm Rupture 0 0.0% AAA-Related Mortality 5 1.6% Open Surgical Conversion 1 0.3% 16
In the absence of randomized prospective clinical trial (RCT), how can we really compare the results? Do EndoAnchors Have Value in Preventing Proximal Neck Complications in Patients Undergoing EVAR? 17
METHODOLOGY Pre-EVAR baseline CT scans evaluated by a Core Laboratory for both groups 19 baseline variables entered into a propensity matching algorithm (SPSS v22; binary logistic regression with group as the independent variable) Match: 198 patients matched (99 patients in EndoAnchor; 99 in Control) Well-matched by the 19 baseline variables Analysis: Primary endpoints indicative of proximal neck failure Including Type 1a endoleak, sac enlargement, sac regression, endograft migration and neck dilation Mean follow-up Control (26.2 months; range 0.5 64.5 months) EndoAnchor (13.7 months; range 0.1 39.9 months) 18
BASELINE ANATOMY IN PROPENSITY-MATCHED COHORTS Anatomic Measures for Propensity Matching Controls N =91 EndoAnchor implants N = 87 P Value Max AAA Diameter 56 ± 13 mm 56 ± 10 mm.674 Suprarenal Diameter 27 ± 4 mm 27 ± 3 mm.999 Diameter at Lowest Renal 25 ± 4 mm 26 ± 4 mm.458 Proximal Neck Length 23 ± 14 mm 20 ± 13 mm.093 Suprarenal Angulation 16 ± 11 17 ± 13.664 Infrarenal Angulation 37 ± 16 37 ± 18.885 Neck Thrombus 23± 54 38 ± 71.107 Neck Calcium 20± 29 19 ± 30.845 Necks <10mm Length 18.4% 26.5%.097 19
NECK DILATION EndoAnchor FF 98.4% ±1.6% Improving Durability with EndoAnchors 1-YEAR RESULTS TYPE 1A ENDOLEAK EndoAnchor FF 97.0% ±2.1% Control FF 94.9% ±2.5% Control FF 94.1% ±2.5% P-value =.725 P-value =.350 Observations: there was a trend in reduction of Neck Dilation 3.0% Risk at 2 years in the EndoAnchor Group 5.9% risk in the control group 20
Transmural Fixation of EndoAnchor TM Implants Has Unique Benefits Propensity matched comparison of those treated without EndoAnchors Promotes increased rate of sac regression: In a propensity-matched study design, significantly greater AAA sac regression with EndoAnchor fixation at 2 years post-evar (81.1% vs. 48.7% without EndoAnchor fixation, p=.01) 1 Methodology Pre-EVAR CTs core lab evaluated Propensity matching on 19 variables 2 cohorts: 99pts EVAR 99pts EVAR+EndoAnchor P-value = 0.01 EndoAnchor +EVAR 81.1% ± 9.5% 1. Muhs, BE et al. J Vasc Surg. 2017, Article in press EVAR 48.7% ± 5.9% 21
SUMMARY OF RESULTS FROM PROPENSITY ANALYSIS Sac regression better the EndoAnchor group compared to anatomically match control cohorts 28.6% in EndoAnchor implant group vs. 20.3% in the non- EndoAnchor implant group (p=.017) Type 1A endoleak better in EndoAnchor group 3.0% vs 5.9% Early results not statistically significant Less proximal neck dilation in EndoAnchor group 2.6% in the EndoAnchor test group vs. 5.1% in the control group Early results not statistically significant 22 Do not distribute, for internal educational purposes only
July 2017 What are predictors for Aortic Neck Dilatation? Is Aortic Neck Dilatation impacted by EndoAnchors? 23 Do not distribute, for internal educational purposes only
METHODS 267 patients prospectively enrolled in ANCHOR Indication for EndoAnchor Use Repair of intraoperative Type Ia endoleak Prophylactic in patients with hostile neck anatomy Aortic diameter measured by independent core lab at: Suprarenal level (20mm proximal to lowest main renal artery) Three (3) levels within proximal neck (distal to lowest main renal artery) 0mm 5mm 10mm 24 Do not distribute, for internal educational purposes only
METHODS Baseline of aortic neck diameter measured on preoperative CT angiogram Same level measured at 1-month and 12-month postoperative CT scan Dilatation expressed as the difference between 1-month and 12- month post-evar Multivariable analyses (backward stepwise linear regression) performed 25
RESULTS NECK DILATATION Aortic Level Predictors of Dilatation at Specified Level Coefficient* Effect P Value Lowest renal Endograft type 0.62 (0.12, 1.04) *.006 Aortic aneurysm sac diameter -0.04 (-0.07, 0.00) Protective.020 Aortic diameter at lowest renal 0.16 (0.08, 0.24) Risk factor <.001 Aortic neck length -0.02 (-.04, 0.00) Protective.021 Infrarenal Angulation 0.02 (0.00, 0.04) Risk factor.016 Endograft oversizing 5.37 (2.34, 8.39) Risk factor.001 5mm distally Aortic diameter at lowest renal 0.17 (0.07, 0.26) Risk factor.001 Endograft oversizing 6.00 (2.68, 9.31) Risk factor.001 10mm distally Aortic diameter at lowest renal 0.17 (0.04, 0.29) Risk factor.003 Endograft oversizing 4.86 (0.13, 9.58) Risk factor.032 Number of EndoAnchors placed -0.29 (-0.55, -0.04) Protective.037 Suprarenal level Suprarenal aortic diameter 0.08 (0.01, 0.16) Risk factor.021 26
SUMMARY OF NECK DILATATION ASSESSMENT Aggressive endograft oversizing and larger baseline aortic neck diameter at the lowest renal artery appear to be independent predictors of Early Proximal Aortic Neck Dilatation (1-month to 12-months to post EVAR) EndoAnchors appear to offer a PROTECTIVE EFFECT towards aortic neck dilatation Long-term follow-up studies necessary for more conclusive results 27
Can EndoAnchors Improve Endograft Durability? Consider the Long Term Outlook... Select Subset of Endovascular Patients Existing Seal Complications Highly Challenging Anatomies ANCHOR Registry A B C Improves Durability Acute & late type I endoleaks 2 Type I endoleaks in urgent or ruptured EVAR Augmenting stability in migrated grafts 1 Irregularly shaped necks (short, wide, highly angulated, conical) 1 Difficult landing zones 2 Few re-interventions Better sac regression Less neck dilatation Consider for younger patients with long remaining life expectancy 3 Primary/Secondary Primary 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. 28
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