Hostile Aortic Anatomy in EVAR: Challenges and Solutions

1. Παρασκευή 7Οκτωβρίου 2016 «Εχθρική Ανατομία» ΑΚΑ: Γωνιώδεις, κοντοί και κωνικοί αυχένες» Στέλιος Κούτσιας , MD, MSc, PhD Λέκτορας Αγγειοχειρουργικής - Ενδοαγγειακής Χειρουργικής ΙΑΤΡΙΚΗ ΣΧΟΛΗ ΘΕΣΣΑΛΙΑΣ Π.Γ.Ν.ΛΑΡΙΣΑΣ

2. ……prevent stent graft migration, often dubbed the Achilles’ heel of EVAR….

4. Morphology of AAA Neck Fixation • Length • Diameter • Angulation • Suprarenal vsinfrarenal fixation Seal • Length • Diameter • Angulation • Calcification • Thrombus

5. Morphology of AAA Neck Diameter • Axial vs. orthogonal (3D) slices • Outer wall vs. inner wall vs. mid-wall • True wall (CT) vs. patent lumen diameter (angio) • Measure at least 5-mm intervals (minimum number of measurements = 3) • Determine neck morphology (shape) • Straight, conical, funnel, hourglass, barrel

6. Morphology & Sizing Circumference = 78.5 mm 0º angle R = 12.5 mm Frans Moll UniversitairMedisch Centrum Utrecht

7. Morphology & Sizing 0º angle Stentgraft Aorta Oversize = 20 %

8. Morphology & Sizing 20º angle Circumference = 81.2 mm (instead of 78.5 mm) Circle: 2πR = 81.2 mm R = 12.9 mm Diameter: 25.8 mm

9. Morphology & Sizing 20º angle Stentgraft AORTA X Oversize = 20 16 % R=12,9 mm

10. Definitions of hostile neck anatomy 1.Short neck—a distance of less than or equal to 10 mm (diameter:26 mm) 2.Neck bulge—a focal enlargement of the aneurysm neck of at least 3 mm within the first 15 mm after the most caudal renal artery 3.Reverse taper—gradual neck dilation of greater than or equal to 2 mm within the first 10 mm after the most caudal renal artery J Vasc Surg 2003;38:657-63. Ellen D. Dillavou, et all

11. Definitions of hostile neck anatomy 4.Angulated neck—aortic angle of at least 60 degrees within the first 30 mm after the most caudal renal artery 5.Significant neck thrombus— thrombus covering more than 50% of the circumference of the aortic diameter in the proximal neck. Ellen D. Dillavou, et all J Vasc Surg 2003;38:657-63.

12. IFU GUIDELINES

13. IFU GUIDELINES

15. JOURNAL OF VASCULAR SURGERY October 2003 Dillavou et al

16. SEVERELY ANGULATED NECK

18. HOSTILE NECK OF INFRARENAL AAA 1.Alterations in neck composition (such as the presence of thrombus or calcification) 2.Neck angulation> 600 3. Undesirable neck length< 10mm 4. Diameter > 32 mm

20. > 600 Neck Length < 15mm Data from the EUROSTAR registry were used to assess outcomes for patients with short infrarenal necks. Patients were categorized into one of three groups according to the neck length: > 15 mm, 11 to 15 mm, and ≤ 10 mm. The rate of type IA endoleaks was significantly greater for patients with neck lengths ≤ 10 mm (11%). At follow-up, freedom from type I endoleak was 97% in those with > 15 mm necks, but only 90% in those with 11- to 15-mm necks, and 89% in those with ≤ 10-mm necks.

22. J Vasc Surg 2011;54:609-15 11. vanMarrewijkCJ,LeursLJ,VallabhaneniSR,HarrisPL,ButhJ,Laheij RJ, et al. Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts com- pare? J Endovasc Ther 2005;12:417-29. 12. DeBruinJL,BaasAF,ButhJ,PrinssenM,VerhoevenEL,CuypersPW, et al. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med 2010;362:1881-9. 13. United Kingdom EVAR Trial Investigators, Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, et al. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med 2010;362: 1863-71. 14. Espinosa G, Ribeiro M, Riguetti C, Caramalho MF, Mendes WD, Santos SR. Six-year experience with talent stent-graft repair of abdom- inal aortic aneurysms. J Endovasc Ther 2005;12:35-45. 15. Greenberg RK, O’Neill S, Walker E, Haddad F, Lyden SP, Svensson LG, et al. Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. J Vasc Surg 2005;41:589-96.

23. EVAR Deployment in Anatomically Challenging Necks Outside the IFU J.T. Lee *, B.W. Ullery, C.K. Zarins, C. Olcott, IV, E.J. Harris, Jr., R.L. Dalman Division of Vascular Surgery, Stanford University Medical Center, Stanford, CA, USA 2013 European Society for Vascular Surgery. Methods: A total of 218 patients (197 men, 21 women) at a single academic center underwent endovascular aneurysm repair (EVAR) with a commercially available device between January 2004 and December 2007. Available medical records, pre- and postoperative imaging, and clinical follow-up were retrospectively reviewed. Patients were divided into those with suitable anatomy (instructions for use, IFU) for EVAR and those with high- risk anatomic aneurysm characteristics (non-IFU). Results: There were no early or late surgical conversions. Rates of migration, endoleak, need for reintervention, sac regression, and freedom from aneurysm-related death were similar between the groups (p > .05). Conclusions: EVAR may be performed safely in high-risk patients with unfavorable neck anatomy using particular commercially available endografts. In our experience, the preferential use of active suprarenal fixation and aggressive use of proximal cuffs is associated with optimal results in these settings. Mid-term outcomes are comparable with those achieved in patients with suitable anatomy using a similar range of EVAR devices. Careful and mandatory long-term follow-up will be necessary to confirm the benefit of treating these high-risk anatomic patients.

24. From the Society for Clinical Vascular Surgery Does hostile neck anatomy preclude successfulendovascular aortic aneurysm repair? Ellen D. Dillavou, MD, Satish C. Muluk, MD, Robert Y. Rhee, MD, Edith Tzeng, MD, Jonathan D. Woody, MD, Navyash Gupta, MD, and Michel S. Makaroun, MD, Pittsburgh, Pa Vasc Surg 2003;38:657-63. CONCLUSION Neck anatomy is the major determinant for suitability of patients for endovascular repair. With careful selection, many patients with classic “hostile necks” can be successfully repaired using an unsupported unibody endograft with active proximal fixation. Despite good success with an ever-increasing number of patients, hostile neck anatomy remains the predominant reason that patients are denied EVAR.

28. LENGTH < 1mm REVERSED TAPER IN AAA NECK

29. Endurant endograft is also a highly conformable device that is equipped with an enhanced fixation mechanism, which has been found to be advantageous in the treatment of severely angulated proximal neck

30. One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft Jasper W. van Keulen, MD,a,b,….MD,b Frans L. Moll, MD, PhD,a Hence J. Verhagen, MD, PhD,b and Joost A. van Herwaarden, MD, PhD,a Utrecht, Nieuwegein, and Rotterdam, The Netherlands J Vasc Surg 2011;54:609-15. Proximal neck length of 33 +/- 14 mm (9 to 82 mm), and an infrarenal angulation of 44 +/- 25° (0°-108°). Nineteen of the 100 included patients had at least one anatomic characteristic that was considered a violation of the instructions for use (IFU) of the Endurant stent graft. Conclusion: The treatment of patients with AAAs with the Endurant stent graft seems to be successful and durable during the first year after EVAR. Despite the wider inclusion criteria for the Endurant, and with 19% of our patients treated outside the IFU, the AAA-related mortality, number of type I or III endoleaks, and reintervention rates are comparable to the results of other stent grafts.

31. ? One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft Jasper W. van Keulen, MD,a,b,….MD,b Frans L. Moll, MD, PhD,a Hence J. Verhagen, MD, PhD,b and Joost A. van Herwaarden, MD, PhD,a Utrecht, Nieuwegein, and Rotterdam, The Netherlands J Vasc Surg 2011;54:609-15.

32. One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft Jasper W. van Keulen, MD,a,b,….MD,b Frans L. Moll, MD, PhD,a Hence J. Verhagen, MD, PhD,b and Joost A. van Herwaarden, MD, PhD,a Utrecht, Nieuwegein, and Rotterdam, The Netherlands J Vasc Surg 2011;54:609-15.

33. Proximal Seal in Angulated Proximal Necks The Aorfix endograft (Lombard Medical Technologies PLC, Oxfordshire, UK) received US Food and Drug Administration approval in 2013 for the treatment of angulated necks (up to 90°) Weale et al: 30 patients with more challenging proximal neck anatomies ( mean infrarenal angle, 81.2°; range, 63°–110°). After a follow-up of 6 months, two cases (6.7%) of primary proximal type I endoleaks were found to persist despite intraoperative ballooning of the proximal stent. .WealeAR,BalasubramaniamK,MacierewiczJ,etal.OutcomeandsafetyofAorfixstentgraftinhighlyangulatedneck-a prospectiveobservationalstudy(arbiter2). EurJVascEndovascSurg.2011;41:337-343.

35. OVATION

42. ( J Vasc Surg 2011;54:616-27.)

43. Current Endograft Options Proximal Design Characteristics: Of the current commercially available endograft designs, the Medtronic Endurantendograft was specifically designed to treat many of these hostile neck condition 1. Suprarenal stents with hooks provide high level active fixation for migration resistance 2. One piece laser cut stent with anchoring pins designed for better structural integrity and durability. 3. Lower amplitude stent provides better sealing with short necks 4. M-shaped stents provide high conformability 5. Engineered and tested to treat 1cm necks at up to 60° neck angulation

45. ΕΝΔΟΔΙΑΦΥΓΗ ΤΥΠΟΥ Ι ΑΥΞΗΣΗ ΤΟΥ ΣΑΚΟΥ >0,5 CM ΚΑΤΑ ΤΗΝ ΤΕΛΕΥΤΑΙΑ CT ΑΓΓΕΙΟΓΡΑΦΙΑ ΤΟΥ 4ΟΥ ΕΤΟΥΣ ΠΑΡΑΚΟΛΟΥΘΗΣΗΣ

46. 4 χρόνια χωρίς ενδοδιαφυγή ΑΡΧΙΚΟΣ ΑΥΧΕΝΑΣ ΔΙΑΜΕΤΡΟΣ: 28 mm ΜΗΚΟΣ: 12-15mm ΓΩΝΙΑ: > 60Ο

50. CONCLUSIONS Insufficient high-level evidence exists to demonstrate safe use of standard EVAR in patients with hostile neck anatomy. From the present analysis, it may be concluded that EVAR should be used cautiously in patients with unfa-vorableaneurysm neck anatomy. EVAR should be applied only in patients with high surgical risk in whom all other alternative endovascular treatments, such as fenestrated repair, are not feasible.