Two Decades of Abdominal Aortic Endovascular Repair With the Anatomical FiXation at the Aortic Bifurcation in a Large Single-Center Experience

Abstract

Objective:

The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort.

Materials and Methods:

In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks.

Results:

Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006).

Conclusion:

EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.

Keywords

abdominal aortic aneurysm aneurysm sac bifurcated stent-graft endoleak endograft endovascular aneurysm repair fixation migration aneurysm aneurysm neck

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References

Parodi

Palmaz

Barone

HD.

Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg. 1991;5:491–499. doi:10.1007/BF02015271

Volodos

Karpovich

Troyan

, et al. Clinical experience of the use of self-fixing synthetic prostheses for remote endoprosthetics of the thoracic and the abdominal aorta and iliac arteries through the femoral artery and as intraoperative endoprosthesis for aorta reconstruction. Vasa Suppl. 1991;33:93–95.

Chaikof

Dalman

Eskandari

, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018;67:2–77.e2. doi:10.1016/j.jvs.2017.10.044

Wanhainen

Verzini

Van Herzeele

, et al. Editor’s Choice. European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg. 2019;57:8–93. doi:10.1016/j.ejvs.2018.09.020

Cao

Verzini

Parlani

, et al. Predictive factors and clinical consequences of proximal aortic neck dilatation in 230 patients undergoing abdominal aorta aneurysm repair with self-expandable stent-grafts. J Vasc Surg. 2003;37:1200–1205. doi:10.1016/s0741-5214(02)75340-8

Coppi

Silingardi

Tasselli

, et al. Endovascular treatment of abdominal aortic aneurysms with the Powerlink Endograft System: influence of placement on the bifurcation and use of a proximal extension on early and late outcomes. J Vasc Surg. 2008;48:795–801. doi:10.1016/j.jvs.2008.05.011

Silingardi

Azzoni

Giuliani

, et al. Unibody endografts for abdominal aortic aneurysm repair reduce radiation and nephrotoxic exposure compared with modular endografts. Ann Vasc Surg. 2015;29:751–757. doi:10.1016/j.avsg.2014.11.011

Raithel

From clinical trials to clinical practice: 612 cases treated with the Powerlink stent-graft for endovascular repair of AAA. J Cardiovasc Surg (Torino). 2009;50:131–137.

Hetzel

Raithel

Seven years’ single center experience of Powerlink unibody bifurcated endograft for endovascular aortic aneurysm repair. J Cardiovasc Surg (Torino). 2007;48:13–19.

10.

Silingardi

Andreoli

Saitta

, et al. Twenty years outcomes in a single center experience after endovascular aneurysm repair with unibody endograft and anatomical fixation. J Cardiovasc Surg (Torino). 2020;61:720–728. doi:10.23736/S0021-9509.19.11076-2

11.

Albertini

Lahlou

Magnan

, et al. Endovascular repair of abdominal aortic aneurysms with a unibody stent-graft: 3-year results of the French Powerlink Multicenter Trial. J Endovasc Ther. 2005;12:629–637.

12.

Wang

Carpenter

JP.

The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008;48:535–545.e3. doi:10.1016/j.jvs.2008.04.031

13.

Hansen

Aziz

Kim

, et al. Results from the Endologix Powerlink multicenter trial. Semin Vasc Surg. 2003;16:166–170. doi:10.1016/S0895-7967(03)00004-8

14.

Chaikof

Blankensteijn

Harris

, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35:1048–1060.

15.

Hackett

De Oliveira

Jain

, et al. ASA class is a reliable independent predictor of medical complications and mortality following surgery. Int J Surg. 2015;18:184–190. doi:10.1016/j.ijsu.2015.04.079

16.

Sirignano

Silingardi

Mansour

, et al. Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives. Future Cardiol. Published online November 23, 2020. doi:10.2217/fca-2020-0119

17.

Silingardi

Sirignano

Andreoli

, et al. Unibody endograft using AFX 2 for less invasive and faster endovascular aortic repair: protocol for a multicenter nonrandomized study. JMIR Res Protoc. 2020;9:e16959. doi:10.2196/16959

18.

Maldonado

Westin

Jazaeri

, et al. Treatment of aortoiliac occlusive disease with the Endologix AFX unibody endograft. Eur J Vasc Endovasc Surg. 2016;52:64–74. doi:10.1016/j.ejvs.2016.04.003

19.

Zarbock

John

Jörres

, et al. Kidney Disease: Improving Global Outcome. New KDIGO guidelines on acute kidney injury. Practical recommendations [in German]. Anaesthesist. 2014;63:578–588. doi:10.1007/s00101-014-2344-5

20.

Torella

Effect of improved endograft design on outcome of endovascular aneurysm repair. J Vasc Surg. 2004;40:216–221. doi:10.1016/j.jvs.2004.04.017

21.

Prinssen

Verhoeven

ELG

Buth

, et al; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004;351:1607–1618. doi:10.1056/NEJMoa042002

22.

Lederle

Freischlag

Kyriakides

, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009;302:1535–1542. doi:10.1001/jama.2009.1426

23.

Becquemin

Pillet

Lescalie

, et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011;53:1167–1173.e1. doi:10.1016/j.jvs.2010.10.124

24.

EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005;365:2179–2186. doi:10.1016/S0140-6736(05)66627-5

25.

Patel

Sweeting

Powell

, et al; EVAR Trial Investigators. Endovascular versus open repair of abdominal aortic aneurysm in 15-years’ follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. Lancet. 2016;388:2366–2374. doi:10.1016/S0140-6736(16)31135-7

26.

Powell

Sweeting

Ulug

, et al; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017;104:166–178. doi:10.1002/bjs.10430

27.

Lederle

Kyriakides

Stroupe

, et al; OVER Veterans Affairs Cooperative Study Group. Open versus endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2019;380:2126–2135. doi:10.1056/NEJMoa1715955

28.

De Bruin

Baas

Buth

, et al. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010;362:1881–1889. doi:10.1056/NEJMoa0909499

29.

Pitton

Scheschkowski

Ring

, et al. Ten-year follow-up of endovascular aneurysm treatment with Talent stent-grafts. Cardiovasc Intervent Radiol. 2009;32:906–917. doi:10.1007/s00270-009-9599-2

30.

Mestres

Zarka

García-Madrid

, et al. Early abdominal aortic endografts: a decade follow-up results. Eur J Vasc Endovasc Surg. 2010;40:722–728. doi:10.1016/j.ejvs.2010.08.018

31.

Verzini

Romano

Parlani

, et al. Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft. J Vasc Surg. 2017;65:318–329. doi:10.1016/j.jvs.2016.07.117

32.

Pratesi

Piffaretti

Verzini

, et al. Ten-year outcome analysis of the Italian Excluder Registry with the gore excluder endograft for infrarenal abdominal aortic aneurysms. J Vasc Surg. 2018;67:740–746. doi:10.1016/j.jvs.2017.07.133

33.

Schermerhorn

Buck

O’Malley

, et al. Long-term outcomes of abdominal aortic aneurysm in the Medicare population. N Engl J Med. 2015;373:328–338. doi:10.1056/NEJMoa1405778

34.

Diethrich

EB.

Novel sealing concept in the Endologix AFX unibody stent-graft. J Cardiovasc Surg (Torino). 2014;55:93–102.

35.

Welborn

McDaniel

Johnson

, et al. Clinical outcome of an extended proximal seal zone with the AFX endovascular aortic aneurysm system. J Vasc Surg. 2014;60:876–884. doi:10.1016/j.jvs.2014.04.017

36.

Skibba

Evans

Greenfield

, et al. Management of late main-body aortic endograft component uncoupling and type IIIa endoleak encountered with the Endologix Powerlink and AFX platforms. J Vasc Surg. 2015;62:868–875. doi:10.1016/j.jvs.2015.04.454

37.

Lemmon

Motaganahalli

Chang

, et al. Failure mode analysis of the Endologix endograft. J Vasc Surg. 2016;64:571–576. doi:10.1016/j.jvs.2016.03.416

38.

Endologix. Multicenter, post-market study to assess outcomes of patients treated with the AFX system compared to other EVAR devices (LEOPARD). Accessed October 7, 2020. https://clinicaltrials.gov/ct2/show/NCT02407457

39.

Hogg

Morasch

Park

, et al. Long-term sac behavior after endovascular abdominal aortic aneurysm repair with the Excluder low-permeability endoprosthesis. J Vasc Surg. 2011;53:1178–1183. doi:10.1016/j.jvs.2010.11.045