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

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.