Infrarenal Aortic Treatment With AFX2 Endograft: Results From a Multicentric,International,Non-Randomized,Prospective Registry

Abstract

Introduction:

To confirm real-world clinical practice results reported with anatomically fixed bifurcated endograft, a physician-initiated study was designed—AFX2-LIVE registry.

Materials and Methods:

From November 2019 to August 2021, investigators enrolled all consecutive patients treated with AFX2 (Endologix Inc., Irvine, CA, USA) endograft. Patients with abdominal aortic aneurysms (AAAs), penetrating aortic ulcers (PAU), and isolated infrarenal aortic dissections were included. Clinical and anatomical data, including baseline, intraoperative, and in-hospital details, as well as follow-up data, were collected in an anonymized prospectively compiled database. The primary endpoint of this study was to evaluate the technical and clinical success of endovascular aortic repair (EVAR) using AFX2 endograft.

Results:

A total of 535 patients were enrolled from 43 Italian and Spanish centers and analyzed according to the protocol. Four hundred eighty-nine patients were male (91.4%), with a mean age of 75±8.92 years (range 52-94). Four hundred sixty-six patients (87.1%) were treated for AAA, 49 (9.3%) for PAU, and 20 (3.6%) for isolated abdominal aortic dissection. A proximal extension was needed in 48% of the cases. Assisted technical success was achieved in all but one patient (99.8%). At 30 days follow-up, no AAA-related deaths were recorded, and nine patients (1.6%) required reintervention. At a mean follow-up period of 15.22±13.65 (range 1-53) months, data were available for 479 patients (89.5%). Clinical success was achieved in 98.2% (95% confidence interval [CI]: 96.4-99.1) at 3 months, 93.9% (95% CI: 90.1-96.1) at 1 year, and 74.1% (95% CI: 62.8-82.4) at 4 years follow-up. The estimated freedom from all-cause mortality was 97.7%, 93.4%, 81.6%, 77.5%, and 70.9%, and freedom from AAA-related mortality was 100%, 99.6%, 99.6%, 99.6%, and 97.3% at 3, 12, 24, 36, and 48 months, respectively. Twenty reinterventions (3.7%) were required in 19 patients, of which 3 late open conversions (0.6%) were performed, and 2 AAA-related deaths were observed.

Conclusion:

This study demonstrated excellent clinical and technical success rates of EVAR with anatomically fixed endografts, providing valuable insights into real-world clinical outcomes.

Clinical Impact

The AFX2-LIVE study could have a significant impact by providing robust evidence supporting the effectiveness and safety of EVAR using bifurcated endografts with anatomical fixation in real-world clinical practice, ultimately leading to improved outcomes and enhanced patient care in the management of abdominal aortic pathologies.

Visual Abstract

Keywords

bifurcated stent-graft endograft endovascular aneurysm repair polytetrafluoroethylene graft registry self-expanding stent type B dissection abdominal aortic aneurysm fluoroscopy contrast media

Get full access to this article

View all access options for this article.

References

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(10058):2366–2374.

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(22):2126–2135.

Blankensteijn

de Jong

Prinssen

, et al; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005;352(23):2398–2405.

Pratesi

Esposito

Apostolou

, et al; Italian Guidelines for Vascular Surgery Collaborators–AAA Group Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE). J Cardiovasc Surg (Torino). 2022;63(3):328–352.

Wanhainen

Van Herzeele

Bastos Goncalves

, et al Editor’s choice—European Society for Vascular Surgery (ESVS) 2024 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg. 2024;67(2):192–331.

Sirignano

Silingardi

Mansour

, et al Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives. Future Cardiol. 2021;17(5): 793–804.

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(4):795–801.

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(4):751–757.

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(2): 131–137.

10.

Hetzel

Raithel

Seven years’ single center experience of Powerlink unibody bifurcated endograft for endovascular aortic aneurysm repair. J Cardiovasc Surg (Torino). 2007;48(1):13–19.

11.

Albertini

Lahlou

Magnan

, et al; French Powerlink Multicenter Trial Investigators. 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(6):629–637.

12.

Wang

Carpenter

; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008;48(3):535–545.

13.

Gennai

Andreoli

Saitta

, et al Two decades of abdominal aortic endovascular repair with the anatomical FiXation at the aortic bifurcation in a large single-center experience. J Endovasc Ther. 2022;29(1):42–56.

14.

Kwolek

Ouriel

Stucky

, et al Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023;78(2):324–332.e2.

15.

Silingardi

Sirignano

Andreoli

, et al Correction: unibody endograft using AFX 2 for less invasive and faster endovascular aortic repair: protocol for a multicenter nonrandomized study. JMIR Res Protoc. 2020;9(6):e20698. doi:10.2196/20698.

16.

Setacci

Sirignano

Kamargianni

, et al Inguinal field block for femoral artery exposure during endovascular aneurysm repair. J Endovasc Ther. 2013;20(5):655–662.

17.

Chaikof

Blankensteijn

Harris

, et al; Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1048–1060.

18.

Chang

Rothenberg

Harris

, et al Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 endovascular AAA systems in an integrated healthcare system. J Vasc Surg. 2021;73(3):856–866.

19.

İşcan

Karahan

Akkaya

, et al Long-term results of endovascular intervention with unibody bifurcation endograft for elective abdominal aortic aneurysm management. Rev Cardiovasc Med. 2021;22(2):453–459.

20.

Vetsch

Garrett

Jr Stout

, et al Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: a retrospective multi-center analysis. PLoS ONE. 2021;16(12):e0261623.

21.

Goodney

Mao

Columbo

, et al Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. BMJ. 2022;379:e071452.

22.

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(4):868–875.

23.

Lemmon

Motaganahalli

Chang

, et al Failure mode analysis of the Endologix endograft. J Vasc Surg. 2016; 64(3):571–576.

24.

Castelli

Pfund

Auza

, et al Predictors of type IIIa endoleak after endovascular aortic repair with anatomic fixation endografts. J Vasc Surg. 2022;75(5):1583–1590.e1.

25.

EU Suspends Endologix’s CE Mark | 2016-12-14 | FDANews | FDAnews. Accessed September 27, 2024. https://www.fdanews.com/articles/179704-eu-suspends-endologixs-ce-mark

26.

Prentice

Paxton

Harris

, et al Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 endovascular AAA systems compared with other devices. J Vasc Surg. 2023;78(2):333–343.e6.

27.

Gennai

Andreoli

Leone

, et al Incidence, long term clinical outcomes, and risk factor analysis of type III endoleaks following endovascular repair of abdominal aortic aneurysm. Eur J Vasc Endovasc Surg. 2023;66(1):38–48.

28.

Del Porto

Cifani

Proietta

, et al MMP-12 and macrophage activation in acute aortic dissection. Cardiology. 2014; 128(4):314–315; discussion 316.

29.

Hasan

Brown

Serna-Gallegos

, et al Association of thoracic aortic aneurysm versus aortic dissection on outcomes after thoracic endovascular aortic repair. J Am Heart Assoc. 2023;12(6):e027641.

Infrarenal Aortic Treatment With AFX2 Endograft: Results From a Multicentric,International,Non-Randomized,Prospective Registry—the AFX2-LIVE Study

Abstract

Introduction:

Materials and Methods:

Results:

Conclusion:

Clinical Impact

Keywords

Get full access to this article

References