ENDOVASCULAR ANEURYSM REPAIR: CURRENT STATUS ON DEVICE SPECIFICATIONS AND OUTCOMES

Authors

  • Filipa Cordeiro Departamento de Cirurgia e Fisiologia, Faculdade de Medicina da Universidade do Porto
  • José Oliveira-Pinto Departamento de Cirurgia e Fisiologia, Faculdade de Medicina da Universidade do Porto; Departamento de Angiologia e Cirurgia Vascular, Centro Hospitalar de São João; Serviço de Angiologia e Cirurgia Vascular, Hospital CUF, Porto
  • Armando Mansilha Departamento de Cirurgia e Fisiologia, Faculdade de Medicina da Universidade do Porto; Departamento de Angiologia e Cirurgia Vascular, Centro Hospitalar de São João; Serviço de Angiologia e Cirurgia Vascular, Hospital CUF, Porto

DOI:

https://doi.org/10.48750/acv.135

Keywords:

Abdominal aortic aneurysm, Endovascular aneurysm repair, endograft

Abstract

Introduction: Since its first introduction in 1991, endovascular aneurysm repair (EVAR) became the preferred modality for abdominal aortic aneurysms (AAA) repair. Several devices have been launched over the years addressing progressively more complex anatomies. The aim of this review is to provide an update on current endografts and compare their results.

Methods: MEDLINE databases were searched for endografts features and respective outcomes.

Results: Currently, a significant variety of grafts is approved for clinical use, targeting different anatomic properties. There are presently six CE and FDA approved devices: Zenith®, AFX®, C3 EXCLUDER®, Endurant® II, Ovation® and Aorfix™; while six more have only the CE mark: Anaconda™, E-vita ABDOMINAL XT®, E-tegra®, Incraft®, TREOVANCE® and Altura™. Also, there are four fenestrated and branched endografts available for treating thoracoabdominal aneurysms: Zenith® Fenestrated, Fenestrated Anaconda™, Zenith® p-Branch® and Zenith® t-Branch®. The Endurant II and Treovance stent grafts can accommodate neck lengths ≥10 mm; Aorfix and Anaconda are more liberal regarding neck angulation, extending of infrarenal neck angulation up to 90º. Finally, Zenith, C3 Excluder, Ovation and Incraft stent grafts can be used with distal fixation length ≥10 mm.

Conclusion: New-generation endografts perform better than the older ones, especially in challenging anatomies. Mid-term outcomes between contemporary stent-grafts seem to be similar for most of the outcomes. However, no randomized controlled trials exist comparing different contemporary stent grafts, making conclusions difficult to accomplish. Longterm follow-up reviews are required to assertively take assumptions about different stent grafts performance.

Downloads

Download data is not yet available.

References

1. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft
implantation for abdominal aortic aneurysms. Ann Vasc Surg.
1991;5(6):491-9.
2. Schoretsanitis N, Georgakarakos E, Argyriou C, Ktenidis K, Georgiadis
GS. A critical appraisal of endovascular stent-grafts in
the management of abdominal aortic aneurysms. Radiol Med.
2017;122(4):309-18.
3. Bastos Goncalves F, Rouwet Ellen V, Metz R, Hendriks JM, Vrancken
Peeters M, Muhs BE, et al. Device-specific outcomes after
endovascular abdominal aortic aneurysm repair. J Cardiovasc
Surg (Torino). 2010;51(4):515-31.
4. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG,
participants Et. Comparison of endovascular aneurysm repair
with open repair in patients with abdominal aortic aneurysm
(EVAR trial 1), 30-day operative mortality results: randomised
controlled trial. Lancet. 2004;364(9437):843-8.
5. Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised
Endovascular Aneurysm Management (DREAM) trial.
Background, design and methods. J Cardiovasc Surg (Torino).
2002;43(3):379-84.
6. Schermerhorn ML, O'Malley AJ, Jhaveri A, Cotterill P, Pomposelli
F, Landon BE. Endovascular vs. open repair of abdominal
aortic aneurysms in the Medicare population. N Engl J Med.
2008;358(5):464-74.
7. Oliveira-Pinto J ON, Bastos-Gonçalves F, Hoeks S, Van Rijn MJ, Ten
Raa S. Long term results of outside "instructions for use" EVAR.
The Journal of Cardiovascular Surgery. 2017.
8. Bryce Y, Rogoff P, Romanelli D, Reichle R. Endovascular repair of
abdominal aortic aneurysms: vascular anatomy, device selection,
procedure, and procedure-specific complications. Radiographics.
2015;35(2):593-615.
9. Michael Marin CC, Daniel Fremed, Daniel Han, Peter Faries. Update
on the use of abdominal and thoracic endografts for treating
aortic aneurysms. Expert Review of Medical Devices. 2016.
10. Ricotta JJ, 2nd, Oderich GS. The Cook Zenith AAA endovascular
graft. Perspect Vasc Surg Endovasc Ther. 2008;20(2):167-73.
11. Welborn MB, III, McDaniel HB, Johnson RC, Kennedy RE, Knott A,
Mundinger GH, et al. Clinical outcome of an extended proximal
seal zone with the AFX endovascular aortic aneurysm system.
Journal of Vascular Surgery. 2014;60(4):876-84.
12. Kouvelos GN, Nana P, Bouris V, Peroulis M, Drakou A, Rousas N,
et al. Initial Clinical Experience with the Endologix AFX Unibody
Stent Graft System for Treating Patients with Abdominal Aortic
Aneurysms: A Case Controlled Comparative Study. Vasc Specialist
Int. 2017;33(1):16-21.
13. Eckroth-Bernard K, Garvin R, Ryer E. Current status of endovascular
devices to treat abdominal aortic aneurysms. Biomed Eng
Comput Biol. 2013;5:25-32.
14. Bergonti M, Teruzzi G, Santagostino G, Grancini L, Ferrari C,
Trabattoni D, et al. Third- versus Second-Generation Stent Graft
for Endovascular Aneurysm Repair: A Device-Specific
Analysis. Annals of Vascular Surgery. 2017.
15. Katsargyris A, Mufty H, Wojs R, Utech G, Verhoeven EL. Single-
-centre experience with the Gore C3 Excluder stent-graft
in 200 consecutive patients. J Cardiovasc Surg (Torino).
2016;57(4):485-90.
16. Michael M. McNally SLS. The story of evolution of endovascular
aneurysm repair and the Gore Excluder Device. Supplement to
Endovascular Today. 2017;16(3):4.
17. Carpenter JP, Baum RA, Barker CF, Golden MA, Mitchell ME, Velazquez
OC, et al. Impact of exclusion criteria on patient selection
for endovascular abdominal aortic aneurysm repair. J Vasc Surg.
2001;34(6):1050-4.
18. Sirignano P, Mansour W, Pranteda C, Siani A, Accrocca F, d’Adamo
A, et al. Real life experience with Ovation stent-graft: lesson
learned from first hundred-fifty treated patients. Annals of
Vascular Surgery. 2017.
19. Perdikides T, Georgiadis GS, Avgerinos ED, Fotis T, Verikokos
C, Hopkinson BR, et al. The Aorfix stent-graft to treat infrarenal
abdominal aortic aneurysms with angulated necks and/
or tortuous iliac arteries: midterm results. J Endovasc Ther.
2009;16(5):567-76.
20. Rodel SG, Geelkerken RH, Prescott RJ, Florek HJ, Kasprzak P,
Brunkwall J, et al. The Anaconda AAA stent graft system: 2-year
clinical and technical results of a multicentre clinical evaluation.
Eur J Vasc Endovasc Surg. 2009;38(6):732-40.
21. Rodel SG, Zeebregts CJ, Huisman AB, Geelkerken RH, Multicenter
Angulated Neck Study with the Anaconda study p. Results
of the Anaconda endovascular graft in abdominal aortic
aneurysm with a severe angulated infrarenal neck. J Vasc Surg.
2014;59(6):1495-501, 501 e1.
22. Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek
G, et al. First-in-human study of the INCRAFT endograft in
patients with infrarenal abdominal aortic aneurysms in the INNOVATION
trial. J Vasc Surg. 2013;57(4):906-14.
23. Sugimoto M, Torsello GF, Torsello GB, Austermann M, Stachmann
A, Bisdas T. Postmarket Clinical Experience with the INCRAFT
AAA Stent Graft System for Challenging Access Routes. Ann
Vasc Surg. 2017;40:120-7.
24. Chiesa R, Riambau V, Coppi G, Zipfel B, Llagostera S, Marone EM, et
al. The Bolton Treovance abdominal stent-graft: European clinical
trial design. J Cardiovasc Surg (Torino). 2012;53(5):595-604.
25. Rylski B, Czerny M, Sudkamp M, Russe M, Siep M, Beyersdorf
F. Fenestrated and Branched Aortic Grafts. Dtsch Arztebl Int.
2015;112(48):816-22.
26. Graves HL, Jackson BM. The Current State of Fenestrated and
Branched Devices for Abdominal Aortic Aneurysm Repair. Semin
Intervent Radiol. 2015;32(3):304-10.
27. Oderich GS, Correa MP, Mendes BC. Technical aspects of repair of
juxtarenal abdominal aortic aneurysms using the Zenith fenestrated
endovascular stent graft. J Vasc Surg. 2014;59(5):1456-61.
28. Bungay PM, Burfitt N, Sritharan K, Muir L, Khan SL, De Nunzio MC,
et al. Initial experience with a new fenestrated stent graft. J Vasc
Surg. 2011;54(6):1832-8.
29. Bakoyiannis CN, Economopoulos KP, Georgopoulos S, Klonaris C,
Shialarou M, Kafeza M, et al. Fenestrated and branched endografts
for the treatment of thoracoabdominal aortic aneurysms: a
systematic review. J Endovasc Ther. 2010;17(2):201-9.
30. Shahverdyan R, Gray D, Gawenda M, Brunkwall J. Technical feasibility
of endovascular aortoiliac aneurysm repair combining
Anaconda fenestrated and Zenith iliac side-branched stent
grafts. J Vasc Surg. 2015;61(5):1324-8.
31. Rolls AE, Jenkins M, Bicknell CD, Riga CV, Cheshire NJ, Burfitt N, et
al. Experience with a novel custom-made fenestrated stent graft
in the repair of juxtarenal and type IV thoracoabdominal aneurysms.
J Vasc Surg. 2014;59(3):615-22.
32. Dijkstra ML, Tielliu IF, Meerwaldt R, Pierie M, van Brussel
J, Schurink GW, et al. Dutch experience with the fenestrated
Anaconda endograft for short-neck infrarenal and juxtarenal
abdominal aortic aneurysm repair. J Vasc Surg. 2014;60(2):301-7.
33. Tim Resch M, PhD. Global Experience With the Zenith p-Branch
Device. Endovascular Today. 2015.
34. Mark Farber M. Current State and Future of Fenestrated Technology.
Endovascular Today. 2013.
35. Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith
p-branch standard fenestrated endovascular graft for juxtarenal
abdominal aortic aneurysms. J Vasc Surg. 2013;58(2):291-300.
36. Nordon IM, Thompson MM, Loftus IM. Are concerns about EVAR
durability relevant with modern devices? J Cardiovasc Surg (Torino).
2013;54(2):181-9.
37. Bisdas T, Weiss K, Eisenack M, Austermann M, Torsello G, Donas
KP. Durability of the Endurant stent graft in patients undergoing
endovascular abdominal aortic aneurysm repair. J Vasc Surg.
2014;60(5):1125-31.
38. Verzini F, Romano L, Parlani G, Isernia G, Simonte G, Loschi D, et al.
Fourteen-year outcomes of abdominal aortic endovascular repair
with the Zenith stent graft. J Vasc Surg. 2017;65(2):318-29.
39. t Mannetje YW, Cuypers PWM, Saleem BR, Bode AS, Teijink JAW,
van Sambeek M. Comparison of midterm results for the Talent and
Endurant stent graft. J Vasc Surg. 2017;66(3):735-42.
40. Verhoeven EL, Katsargyris A, Bachoo P, Larzon T, Fisher R, Ettles
D, et al. Real-world performance of the new C3 Gore Excluder
stent-graft: 1-year results from the European C3 module of the
Global Registry for Endovascular Aortic Treatment (GREAT). Eur J
Vasc Endovasc Surg. 2014;48(2):131-7.
41. Mertens J, Houthoofd S, Daenens K, Fourneau I, Maleux G, Lerut
P, et al. Long-term results after endovascular abdominal aortic
aneurysm repair using the Cook Zenith endograft. J Vasc Surg.
2011;54(1):48-57 e2.
42. Melas N, Stavridis K, Saratzis A, Lazarides J, Gitas C, Saratzis N.
Active proximal sealing in the endovascular repair of abdominal
aortic aneurysms: early results with a new stent-graft. J Endovasc
Ther. 2015;22(2):174-8.
43. Verhoeven EL KA, Milner R. The GREAT registry: lessons learned
from real-world experience with the GORE® C3® delivery system.
Endovascular Today. 2013.
44. Bastos Goncalves F, Jairam A, Voute MT, Moelker AD, Rouwet EV,
ten Raa S, et al. Clinical outcome and morphologic analysis after
endovascular aneurysm repair using the Excluder endograft. J
Vasc Surg. 2012;56(4):920-8.
45. Pratesi C, Piffaretti G, Pratesi G, Castelli P, Investigators ITER.
ITalian Excluder Registry and results of Gore Excluder endograft
for the treatment of elective infrarenal abdominal aortic
aneurysms. J Vasc Surg. 2014;59(1):52-7 e1.
46. Rouwet EV, Torsello G, de Vries JP, Cuypers P, van Herwaarden JA,
Eckstein HH, et al. Final results of the prospective European trial
of the Endurant stent graft for endovascular abdominal aortic
aneurysm repair. Eur J Vasc Endovasc Surg. 2011;42(4):489-97.
47. Stokmans RA, Teijink JAW, Forbes TL, Böckler D, Peeters PJ, Riambau
V, et al. Early Results from the ENGAGE Registry: Real-world
Performance of the Endurant Stent Graft for Endovascular AAA
Repair in 1262 Patients. European Journal of Vascular and Endovascular
Surgery. 2012;44(4):369-75.
48. 4Zandvoort HJ, Goncalves FB, Verhagen HJ, Werson DA, Moll
FL, de Vries JP, et al. Results of endovascular repair of infrarenal
aortic aneurysms using the Endurant stent graft. J Vasc Surg.
2014;59(5):1195-202.
49. Singh MJ, Fairman R, Anain P, Jordan WD, Maldonado T, Samson
R, et al. Final results of the Endurant Stent Graft System in the
United States regulatory trial. J Vasc Surg. 2016;64(1):55-62.
50. Hyhlik-Durr A, Weber TF, Kotelis D, Rengier F, Gahlen J, Bock S, et al.
The Endurant Stent Graft System: 15-month follow-up report in
patients with challenging abdominal aortic anatomies. Langenbecks
Arch Surg. 2011;396(6):801-10.
51. Mehta M, Valdes FE, Nolte T, Mishkel GJ, Jordan WD, Gray B, et al.
One-year outcomes from an international study of the Ovation
Abdominal Stent Graft System for endovascular aneurysm repair.
J Vasc Surg. 2014;59(1):65-73 e1-3.
52. Malas MB, Hicks CW, Jordan WD, Jr., Hodgson KJ, Mills JL, Sr., Makaroun
MS, et al. Five-year outcomes of the PYTHAGORAS U.S.
clinical trial of the Aorfix endograft for endovascular aneurysm
repair in patients with highly angulated aortic necks. J Vasc Surg.
2017;65(6):1598-607.
53. Volpe P, Massara M, Alberti A, Marino S, Volpe A, Mazzaccaro D, et
al. Preliminary Results of Aorfix Stent Graft to Treat Infrarenal
Abdominal Aortic Aneurysms with Severe Proximal Aortic Neck
Angulation. Ann Vasc Surg. 2017.
54. Weale AR, Balasubramaniam K, Macierewicz J, Hardman J,
Horrocks M. Outcome and safety of Aorfix stent graft in highly
angulated necks - a prospective observational study (arbiter 2).
Eur J Vasc Endovasc Surg. 2011;41(3):337-43.
55. Georgakarakos E, Pitoulias G, Schoretsanitis N, Argyriou C,
Mavros DM, Lazarides MK, et al. Early Results of the Bolton Treovance
Endograft in the Treatment of Abdominal Aortic Aneurysms.
J Endovasc Ther. 2017:1526602817713736.
56. Paul Heyes M. Evolution Not Revolution: The Altura Stent Graft.
Insert to Endovascular Today Europe.5(2):5.
57. Hu Z, Li Y, Peng R, Liu J, Zhang T, Guo W. Experience With Fenestrated
Endovascular Repair of Juxtarenal Abdominal Aortic Aneurysms
at a Single Center. Medicine (Baltimore). 2016;95(10):e2683.
58. Oderich GS, Greenberg RK, Farber M, Lyden S, Sanchez L, Fairman
R, et al. Results of the United States multicenter prospective
study evaluating the Zenith fenestrated endovascular graft for
treatment of juxtarenal abdominal aortic aneurysms. J Vasc Surg.
2014;60(6):1420-8 e1-5.
59. Colgan FE, Bungay PM, Burfitt N, Hatrick A, Clarke MJ, Davies AH,
et al. Operative and 1-Year Outcomes of the Custom-Made Fenestrated
Anaconda Aortic Stent Graft-A UK Multicenter Study. Ann
Vasc Surg. 2018;46:257-64.
60. Farber MA, Eagleton MJ, Mastracci TM, McKinsey JF, Vallabhaneni
R, Sonesson B, et al. Results from multiple prospective single-
-center clinical trials of the off-the-shelf p-Branch fenestrated
stent graft. J Vasc Surg. 2017;66(4):982-90.
61. Spanos K, Kolbel T, Theodorakopoulou M, Heidemann F, Rohlffs
F, Debus ES, et al. Early Outcomes of the t-Branch Off-the-Shelf
Multibranched Stent-Graft in Urgent Thoracoabdominal Aortic
Aneurysm Repair. J Endovasc Ther. 2018;25(1):31-9.
62. Bosiers MJ, Bisdas T, Donas KP, Torsello G, Austermann M. Early experience
with the first commercially available off-the-shelf multibranched
endograft (t-branch) in the treatment of thoracoabdominal
aortic aneurysms. J Endovasc Ther. 2013;20(6):719-25.
63. Verzini F, Isernia G, De Rango P, Simonte G, Parlani G, Loschi D, et
al. Abdominal aortic endografting beyond the trials: a 15-year
single-center experience comparing newer to older generation
stent-grafts. J Endovasc Ther. 2014;21(3):439-47.
64. Mensel B, Kuhn JP, Trager T, Duhrkoop M, von Bernstorff W, Rosenberg
C, et al. Technical and clinical outcome of Talent versus Endurant
endografts for endovascular aortic aneurysm repair. PLoS
One. 2012;7(6):e38468.
65. Kontopodis N, Papadopoulos G, Galanakis N, Tsetis D, Ioannou CV.
Improvement of patient eligibility with the use of new generation
endografts for the treatment of abdominal aortic aneurysms.
A comparison study among currently used endografts and literature
review. Expert Rev Med Devices. 2017;14(3):245-50.
66. Lee JT, Ullery BW, Zarins CK, Olcott Ct, Harris EJ, Jr., Dalman RL.
EVAR deployment in anatomically challenging necks outside the
IFU. Eur J Vasc Endovasc Surg. 2013;46(1):65-73.
67. JESSICA P. SIMONS M, ANDRES SCHANZER, MD. Exploring EVAR
Instructions for Use in 2016. Endovascular Today. 2016;15.
68. Schanzer A, Messina L. Two decades of endovascular abdominal
aortic aneurysm repair: enormous progress with serious lessons
learned. J Am Heart Assoc. 2012;1(3):e000075.
69. Lee GK, Ullery BW, Lee JT. Elective EVAR in nonagenarians is safe
in carefully selected patients. Ann Vasc Surg. 2014;28(6):1402-8.

Downloads

Published

2018-06-07

How to Cite

1.
Cordeiro F, Oliveira-Pinto J, Mansilha A. ENDOVASCULAR ANEURYSM REPAIR: CURRENT STATUS ON DEVICE SPECIFICATIONS AND OUTCOMES. Angiol Cir Vasc [Internet]. 2018 Jun. 7 [cited 2024 Apr. 19];14(2):121-32. Available from: https://acvjournal.com/index.php/acv/article/view/135

Issue

Section

Review Article