Analysis of Type IIIb Endoleaks Encountered with Endologix Endografts
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1 Analysis of Type IIIb Endoleaks Encountered with Endologix Endografts Alan R. Wladis, MD, FACS, David Varnagy, MD, FACS, Manuel R. Perez-Izquierdo, MD, Mark Ranson, MD FACS, Delos Clift, MD FACS, Rebecca Rowen, MD, Evan Westrick, MD
2 None Financial Disclosures
3 Endoleaks Type Ia, Ib Type II Type III Type IV Proximal and Distal Graft Seal Sac Filling via Branch Junctional component separation (IIIa) Material fatigue (IIIb) Fabric Porosity
4 Endoleaks Type Ia proximal graft seal Type Ib distal graft seal Type II sac filling via branch Type IIIa junctional separation of components Type IIIb material fatigue Type IV fabric holes Type V endotension
5 1998: Initial Reports of Type III Endoleak98;5: White et al. J Endovasc Surg 1998;5: Type III endoleak arises from a defect in the graft fabric, inadequate seal, or disconnection of modular components.
6 2002: Type IIIa and IIIb Endoleak Sub-classification Chaikof et al. J Vasc Surg 2002;35:
7 Limited Literature on Type III Endoleak Type I and III often reported together Common to fail to separate Type III endoleaks Literature largely limited to case reports Jones et al. J Endovasc Ther 2014;21: Abouliatim et al. J Vasc Surg 2010;52:1665-7
8 Type III Endoleak: Cumulative Rate across EVAR Devices at 3 years EVAR Type III endoleak 4.0% 95% CI: 3.8%, 4.3% Maitrias, 2016, JVS Kouvelos, 2015, JVS Sirignano, 2015, JVIR Zhou, 2014, JVS Chaar, 2012 JVS Jim, 2011, JET Gambardella, 2010 Annals Mehta, 2010, JVS AbuRahma, 2009, JVS Hobo, 2006, JVS Drury, 2005, BJS Haulon, 2003, EJVES 12% (3/28) 6% (36/641) 0.5% (1/191) 1% (2/213) 5% (2/44) 0% (0/156) 0.4% (1/238) 0.3% (5/1768) 0.4% (1/238) 5% (138/2846) 4% (832/19804) 6% (6/96) Multicenter, Prospective (France) Systematic review, 26 articles (Greece) Single center; Prospective (Italy) VA study, single center (Palo Alto, CA) Single center; Retrospective (Pgh, PA) Multicenter, Prospective Talent trial Single center; Retrospective (Ireland) Single center, Retrospective (Albany, NY) Single center; Retrospective (WV) Eurostar Registry Systematic review, 61 articles (UK) Single center; Prospective (France) Summary of outcomes from an independent, systematic cumulative rate data synthesis comparing published rates specific to EVAR devices. Analysis conducted in February, Publication dates range from Across 66 publications and 97,000 patients, 12 articles across 26,000 patients report Type III endoleak rates. Rates reflect incidence from implant through 3 years.
9 Type III Endoleak with Powerlink Five Year Results from Multicenter Clinical Trials 157 Patients at 28 U.S. Centers 0% Aneurysm Ruptures 0% Conversion to Open Repair 0% Device Migration 0% Stent Fractures 0% Aneurysm-Related Mortality 0% Type III Endoleak Secondary Intervention 1.2% Limb Occlusions Reduced or Stable Aneurysm Sacs in 93% of Patients at 5 Years
10 Type III Endoleak with Powerlink/AFX Real World, Single Center 8 Year Experience Skibba et al. J Vasc Surg 2015;62(4) Reinterventions for endoleak Type IA = 2 (0.3%) Type IB = 8 (1.1%) Type II = 1 (0.1%) Type IIIA = 17 (2.4%) Type IIIB = 2 (0.3%) Type IV = 0 (0%)
11 Type IIIa and IIIb Endoleak: AFX with Strata Real World, Single Center Experience Lemmon et al. J Vasc Surg 2016;64: patients, % Type 3a endoleak 9.6% Type 3b endoleak Type 3a associated with AAA dia >65 mm Type 3b also associated with large AAA, but occurrence is sporadic and unpredictable Results call for continued CT surveillance
12 When and Why Type IIIa Endoleaks Occur Skibba et al. J Vasc Surg 2015;62(4) Lateral forces do and will occur need to plan ahead for them Especially true in larger aneurysms Even in presence of large thrombus burden Neck angulation and AAA angulation will exacerbate the risk of Type III Distal neck and top of main body (gap) also very important Excessive oversizing may contribute to and increase propensity for displacement
13 When and Why Type IIIa Endoleaks Occur Importance of Maximizing Component Overlap Instructions for Use Guidance
14 AFX with Strata 3 US Centers, n=181, 167 elective EVAR Huntsville, AL, Jackson, MS, Indianapolis, IN Welborn et al., J Vasc Surg 2014;4:
15 AFX with Strata Welborn et al. J Vasc Surg 2014;4: Variable % Aortic Neck Length (mm) <10mm 26% <15mm 38% Hostile Neck Diameter >32mm Length <15mm Angulation > 60 Reverse Conical Ca/ Thrombus 47% Variable % Endoleaks Ia 2.4% Ib 0% II 5.5% III 3.1% Aneurysm Sac Regression Regression 20% Stabilization 76% Increase 4% Migration 1%
16 Product Timeline POWERLINK US APPROVAL AFX Strata
17 Vascular Institute of Central Florida Study Data Physician Selection of Endograft Follow up per physician discretion All ultrasounds were done in ICAVL certified lab CT Scans were done with 64 slice scanner and 1mm slices
18 Vascular Institute of Central Florida Experience Characteristic Number Total cases (AFX + Powerlink) 138 Cases with AFX with Duraply 130 Date Range March 2013 December 2016 Male: Female 101 (75.9%) : 32 (24.1%) Elective : Ruptured 122 (93.8%) : 8 (6.2%) Fusiform : Saccular : Other* 88 (80%) : 11 (10.0%) : 11 (10.0%) *Other- primarily atherosclerotic disease or penetrating atherosclerotic ulcer
19 Patient Demographics Comorbidity N (% of Total) ASA Class N (% of Total) Arrhythmia 24 (16.9%) Coronary artery disease 60 (42.6%) Congestive heart failure 14 (9.9%) COPD 24 (16.9%) Diabetes 32 (22.5%) Hyperlipidemia 85 (59.9%) Hypertension 106 (74.6%) Malignancy 27 (31.8%) Renal insufficiency 27 (19.0%) Smoking history 88 (62.0%) Stroke/TIA 10 (7.0%) 2 3 (6.4%) 3 36 (76.6%) 4 3 (6.4%) 5 0 (0%) 3E 2 (4.3%) 4E 2 (4.3%) 5E 1 (2.1%)
20 Baseline Anatomic Characteristics Characteristic Mean ± SD (Median, Range) Max Aneurysm Diameter 54.0 ± 10.6 mm (54, 23-80) Proximal Neck Diameter 23.8 ± 4.6 mm (23, 16-39) Proximal Neck Length 28.9 ± 16.2 mm (27, 0-80) Proximal Neck Angulation 23.0 ± 25.6 degrees (10, 0-93) Aortic Bifurcation Diameter 26.8 ± 10.4 mm (25, 11-58) On-Label : Off-Label 51/108 (47.2%) : 57/108 (52.8%)
21 Procedural Characteristics Characteristic Value* Anesthesia (general) 100% Access (bilat perc : bilat open) 35 (28.5%) : 57 (46.3%) Contrast (ml) 84 ± 45 (80, ) Fluoroscopy time (min) 15 ± 9 (11, 3 32) Procedure duration (min) 77 ± 31 (71, ) Estimated blood loss (cc) 154 ± 167 (100, ) Transfusion 19 (14.6%) Devices deployed 2.2 ± 0.7 (2, 1 5) *frequency (%) or mean ± SD (median, range)
22 In-Hospital Outcomes Characteristic n/n (%) Endoleak on completion angio Type Ia 2 (1.6%) Type Ib 0 (0%) Type II 17 (13.8%) Type III 0 (0%) Unknown type 4 (3.3%) Major Adverse Event Rate 10/130 (7.7%) Elective : Ruptured 6/122 (4.9%) : 5/8 (63%)
23 30d Outcomes Characteristic n/n (%) Endoleak (CT imaging) 2/34 (5.9%) Type Ia 0/34 (0.0%) Type Ib 0/34 (0.0%) Type II 2/34 (5.9%) Type III 0/34 (0.0%) Death within 30 days 3/130 (2.3%) Elective : Ruptured 0/122 (0%) : 3/8 (38%) 30-day Major Adverse Event Rate 10/130 (7.7%) Elective : Ruptured 6/122 (4.9%) : 5/8 (63%)
24 1 Year Outcomes Characteristic n/n (%) Endoleak (CT imaging) 4/30 (13.3%) Type Ia 1/30 (3.3%) Type Ib 0/30 (0.0%) Type II 3/30 (10.0%) Type III 0/28 (0.0%) Limb Occlusions 1/30 (3.3%) Sac Regression (>5mm) 13/24 (52.0%) Sac Enlargement (>5mm) 0/24 (0.0%)
25 Last Follow-Up Imaging Characteristic n/n (%) Endoleak 5/50 (10.0%) Type Ia 2/50 (4.0%) Type Ib 0/50 (0.0%) Type II 3/50 (6.0%) Type III 0/50 (0.0%) Limb Occlusions 1/50 (2.0%) Sac Regression (>5mm) 20/43 (46.5%) Sac Enlargement (>5mm) 5/43 (11.6%) *Includes only those subjects with imaging beyond 6 months
26 1 Year Clinical Outcomes Characteristic Through 1 Year n/n (%) Secondary Aneurysm-Related Procedures 1/127 (0.8%) Open Surgical Conversion 0/127 (0.0%) Aneurysm Rupture 0/127 (0.0%) Death 3/130 (2.3%) Elective : Ruptured 2/122 (1.6%) : 3/8 (38%) Major Adverse Events (Composite) 11/127 (8.7%) Elective : Ruptured 6/113 (5.0%) : 5/8 (63%)
27 Imaging Outcomes Characteristic 30d 1yr Last Followup Endoleak 2/34 (5.9%) 4/30 (13.3%) 5/50 (10.0%) Type Ia 0/34 (0.0%) 1/30 (3.3%) 2/50 (4.0%) Type Ib 0/34 (0.0%) 0/30 (0.0%) 0/50 (0.0%) Type II 2/34 (5.9%) 3/30 (10.0%) 3/50 (6.0%) Type III 0/34 (0.0%) 0/28 (0.0%) 0/50 (0.0%) Limb Occlusions 1/30 (3.3%) 1/50 (2.0%) Sac Regression (>5mm) 13/24 (52.0%) 20/43 (46.5%) Sac Enlargement (>5mm) 0/24 (0.0%) 5/43 (11.6%)
28 Clinical Outcomes Characteristic 30d 1yr Death 3/130 (2.3%) 5/130 (3.8%) Elective : Ruptured 0/122 (0%) : 3/8 (38%) 2/122 (1.6%) : 3/8 (38%) 30-day MAE 10/130 (7.7%) 11/127 (8.7%) Elective : Ruptured 6/122 (4.9%) : 5/8 (63%) 6/113 (5.0%) : 5/8 (63%) AAA-Related Reintervention 0/130 1/127 (0.8%) Open Surgical Conversion 0/130 0/127 (0.0%) Aneurysm Rupture 0/130 0/127 (0.0%)
29 Conclusions No incident type III endoleak in our institution after EVAR with the Endologix AFX platform, likely due to utilization of the latest generation graft material and adherence to IFU guidance with regard to overlap. Use of high-resolution CT scan and/or ultrasound follow-up imaging performed at one month, six months, one year, and annually thereafter allow for examination of early signs of future type IIIa endoleak. Endovascular treatment of a type IIIb endoleak is possible with distal endograft relining with main-body endograft components.
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