Mid-term results of the global ANCHOR registry regarding the treatment of type I endoleaks
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1 Mid-term results of the global ANCHOR registry regarding the treatment of type I endoleaks Jean-Paul P.M. de Vries, MD, PhD St. Antonius Hospital, Nieuwegein, The Netherlands On behalf of the ANCHOR Collaborators LINC, Leipzig Jan 2015
2 Disclosures Consultant: Aptus Endosystems, Endologix Inc, Medtronic Research funding: Cardionovum, Vascular Insights Speakers fee: BTG
3 Without EndoAnchors, What Are Our Treatment Options? * When they can be placed, Cuff/Palmaz do not always work * Greater radial force may not resolve focal issue * Additional components place greater dilating force on a diseased aorta * Limited viable options for treating type I endoleak in short necks * Coils/Onyx require precise ID of leak paths, carry nontarget embolization risk * Patient may be unfit for more complex procedures * How do we prevent further disease progression & complications? * Cuffs, Palmaz, Coils, Onyx cannot resist neck dilatation
4 What New Capabilities Can We Achieve With EndoAnchors? * Target and close type I endoleak paths * Analogous to an interrupted suture * Provide an adjunctive treatment where options can be limited * Such as short, hostile infra-renal necks * Augment seal strength without increasing seal area EndoAnchors do not inhibit other adjunctive or future options 4
5 >4,000 PATIENTS TREATED, >23,000 ENDOANCHORS IMPLANTED TO-DATE PROPHYLAXIS TREATMENT Hostile Anatomy Overcoming concerns for implant stability Normal Anatomy Mitigating risk of reinterventions Resolve proximal seal failures Challenging neck anatomies (e.g. wide, short, conical, angulated) Difficult landing Severe comorbidities that preclude safe reintervention Patients potentially lost during F/U Targeted sealing of acute type I endoleaks Targeted sealing of late type I endoleaks (e.g. birdbeaking, close to branched vessels) Long remaining life expectancy (young pts) Augmented stability in migrated grafts Case image from Gandhi RT, Katzen BT Treating a Type 1A Endoleak Using EndoAnchors. Endovascular Today March :26. 5
6 ANCHOR Registry: A Study of the Real-World Usage & Outcomes of the Heli-FX EndoAnchor System Registry Design Current Enrollment Prospective, observational, international, multi-center, dual-arm 509 patients as of 31 Dec US Sites, 24 European Sites Treatment Arms Duration Follow-up Primary Up to 1000 pts Revision Up to 1000 pts 5 Years Per Standard of Care at each center & investigator discretion 6
7 Indicated Reasons for EndoAnchoring in ANCHOR: Complications and Concerns for Failure Primary Arm (N=361) Revision Arm (N=123) Acute Type Ia Endoleak Treatment 35% Migration +/- Endoleak 38% Concern for Late Failure 65% Late Type Ia Endoleak Treatment 62% 48.6% prophylaxis (n=235) 51.4% treatment (n=249): Acute + Late Type Ia Endoleaks, Migration +/- Endoleak Median # EndoAnchors Implanted Primary Arm: 6 Revision Arm: 7 Combined: 7 7
8 Majority Proximal Necks in ANCHOR are Hostile per Corelab Proximal Neck Anatomical Characteristics Primary N = 237 Revision N = 92 Max Aneurysm Diameter [mean] 56 mm 69 mm Neck Length [mean] 17 mm 14 mm Neck Length 10mm 88/237 (37.1%) 45/92 (48.9%) Necks Length 15mm 127/237 (53.6%) 60/92 (65.2%) Neck Diameter [mean] 26 mm 30 mm Conical Neck (10% increase over 10mm) 36.7% 48.9% Neck Thrombus [mean thickness over circumference] 0.7 mm 1.0 mm Neck Calcium [mean thickness over circumference] 1.2 mm 0.3 mm Hostile Neck* 91.6% 84.8% *Hostile neck defined by neck diameter >28mm, length <10mm, angulation >60 o, thrombus or calcium over >180 degrees of circumference 8
9 All Major Endografts Have Required EndoAnchors to Treat Complications and Address Concerns Primary Arm n=361 (75%) Revision Arm n=123 (25%) Zenith 14% Other 2% Endurant 48% Excluder 36% Zenith 15% AneuRx 23% Other 6% Talent 16% Excluder 20% Endurant 20% 9
10 Low Proximal Seal-Related Events in Midterm Follow-Up Despite Hostile Neck Anatomy Length of clinical follow-up 14.9± 7.7 months Primary Revision Mean ± SD Min - Max Mean ± SD Min - Max months 15.0 ± 7.9 months Rupture post-repair 0/361 (0.0%) 0/123 (0.0%) Aneurysm-related reinterventions months 16/361 (4.4%) 21/123 (17.1%) Proximal-seal related 3/361 (0.8%) 10/123* (8.1%) re-interventions 1 Aneurysm-related deaths 4/361** (1.1%) 0/123 (0.0%) 1 Includes total re-interventions for type Ia endoleaks, type III endoleaks and graft migrations * 10 patients with 16 re-interventions. 2 patients with multiple revisions: 1 with 4, another with 2 **Site reported cause of death: left sided ischemic bowel, respiratory failure, MOF 10
11 High Success Treating Type Ia Complications Despite Hostile Neck Anatomy Freedom from Type Ia Endoleak at Final Angio by complication type 100% 80% 60% 40% 20% 0% 100% 98% 100% 97/97 50/51 18/18 Acute type Ia endoleak Late type Ia endoleak Migration with endoleak Based on Corelab, 99.3% of proximal necks meet criteria for hostile* *Hostile necks are based on CT images available for Corelab analysis and presence of type Ia endoleaks are based on site reported angio results. Defined by neck diameter >28mm, length <10mm, angulation >60 o, thrombus or calcium over >180 degrees of circumference 11
12 Low Proximal Seal Re-Interventions in F/U Despite Hostile Neck Anatomy Freedom from Type 1a Endoleak Related Re-interventions, by type of complication treated 100% 80% 60% 40% 20% 0% 95% 91% 100% 100% 120/126 69/76 17/17 30/30 Acute type Ia endoleak Late type Ia endoleak Endograft migration Migration with endoleak Mean follow-up (CT-scans): 15 ± 8 months 12
13 What We ve Learned to Further Improve Outcomes Lack of EndoAnchor penetration in aortic tissue may increase risk of developing/re-developing type I endoleaks CoreLab assessment of etiology of residual type 1A after EndoAnchor placement (N =17) Reason for persistent type 1a endoleak Number of cases Calcified Rim 5 Gap between graft and aortic wall 6 EndoAnchor deployed above graft fabric 3 EndoAnchor deployed in aneurysm sac 4 EndoAnchor not oriented perpendicular to graft wall 2 4 subjects had two reasons identified for persistent type 1a endoleak 13
14 Conversions in the ANCHOR registry Arm 1 Primary Cause Type Ib endoleak, rupture of iliac artery during attempted repair Days After EA 2 Revision Probably type Ib endoleak with sac enlargement Revision Type Ia endoleak with sac enlargement Revision Endograft infection Revision Type Ia endoleak Revision Type II endoleak with sac enlargement
15 Can It Fix Type I Endoleaks and Graft Migration: Can It Be Proven? What we ve learned * EndoAnchors can be a powerful tool in fixing complications * High success in treating type Ia endoleaks (>90%) * Zero re-interventions for endograft migration in f/u * Can enable viable treatment, especially when options are limited * High seal integrity despite high-risk neck anatomy * Maturing follow-up data are in-process 15
16 Total Enrolle d % of Total Total Enrolle d % of Total Site Name Site Name University of Alabama % St. Antonius Hospital % El Camino Hospital % Technical University Munich % University Medical Center Utrecht 1 0.2% Carolinas Health Care System % William Beaumont Hospital 6 1.2% Scott & White Medical Center 9 1.9% Maasstad Medical Hospital Rotterdam 5 1.0% University of Siena 2 0.4% Malmo University Hospital 1 0.2% Thorax Institute Hospital Clinic 4 0.8% Park Hospital Leipzig 3 0.6% NYU School of Medicine 1 0.2% Cleveland Clinic 6 1.2% Central Arkansas Veterans Health System (CAVHS) 2 0.4% University of North Carolina 2 0.4% St. Bonifatius Hospital 4 0.8% St. Franziskus-Hospital GmbH Munster 7 1.4% Dartmouth-Hitchcock Medical Center 5 1.0% Sentara Heart Hospital - Norfolk % Carolina Vascular-Mission Hospital % Southern Illnois University School of Medicine 1 0.2% Washington University School of Medicine 9 1.9% Baptist Hospital 4 0.8% Montefiore Medical Center 3 0.6% Duke University Medical Center 6 1.2% Vanderbilt University Medical Center 9 1.9% Arizona Heart 2 0.4% Beth Israel Deaconess Medical Center (BIDMC) 2 0.4% Hawaii Permanente Medical Group % Harbor - UCLA Medical Center 1 0.2% Albany Medical Center % Deutsches Herzzentrum Berlin 5 1.0% Michigan Vascular Center % Florida Hospital % Lexington Medical Center % Imperial College London 8 1.7% University of South Florida 3 0.6% Yale 7 1.4% Baptist Memphis 4 0.8% Johns Hopkins 6 1.2% HeartCare Peoria 3 0.6% Mount Sinai 3 0.6% NorthShore University 1 0.2% University of Heidelberg 7 1.4% LMU Munich 2 0.4% Klinikum Nürnberg 3 0.6% Klinikum Ludwigsburg 1 0.2% Rijnstate Hospital 7 1.4% PinnacleHealth 3 0.6% Loma Linda VA 4 0.8% SUNY Stony Brook 5 1.0% Total %
17 Case Examples
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23 Case Examples
24 Mid-term results of the global ANCHOR registry regarding the treatment of type I endoleaks Jean-Paul P.M. de Vries, MD, PhD St. Antonius Hospital, Nieuwegein, The Netherlands On behalf of the ANCHOR Collaborators LINC, Leipzig Jan 2015
LINC James F. McKinsey, M.D.
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