Outcomes Analysis of 3 Different Device Platforms for the Covered Endovascular Reconstruction of the Aortic Bifurcation.

Abstract

Objectives: To analyze the major aortoiliac obstructive disease (AIOD)-related outcomes after covered endovascular reconstruction of aortic bifurcation (CERAB), comparing 3 different endovascular platforms.

Materials and methods: It is a physician-initiated, unsupported, multicenter, observational, retrospective, cohort study. We identified all CERABs between March 1, 2016 and September 30, 2024. We compared 3 different endovascular platforms: Viabahn VBX (W.L. Gore, Flagstaff; Arizona), AFX/AFX-2 (Endologix, Irvine, California), and BeGraft (Hechingen, Germany). Inclusion criteria were CERAB procedure for primary or de novo AIOD; exclusion criteria were CERAB using a combination of different platforms, traumatic lesions, and missing preoperative/follow-up data. Specifically, for the purposes of this study, the primary outcomes were overall survival and CERAB-related reintervention.

Results: We analyzed 220 (96.9%) CERABs: 132 (60.0%) with the VBX, 60 (27.3%) with the AFX/AFX-2, and 28 (12.7%) with the BeGraft. Patients in the VBX group were older [median-25th-75th interquartile: VBX, 71 [IQR, 65.2-77] vs AFX/AFX-2, 64 [IQR, 59-72] vs BeGraft 68 [IQR, 55.7-73.5], P = .002], whereas AFX/AFX-2 group had the lowest rate of critical limb-threatening ischemia as presenting scenario (VBX, 36.4% vs AFX/AFX-2, 18.2% vs BeGraft 35.7%, while AFX/AFX-2 P = .039). Technical success was achieved in 217 (98.6%) procedures: all 3 failures occurred in the VBX group. The median follow-up was 21 months (IQR, 9-30), with a difference among the groups (months: BeGraft 21 [IQR, 10.7-42] vs VBX, 13.5 [IQR, 6-26] vs AFX/AFX-2, 25 [IQR, 17.2-38.7], P = .001]. Estimated survival was 92% ± 0.2 (95% CI, 87.0-94.9) at 12 months, 87% ± 0.3 (95% CI, 81.4-91.6) at 24 months, and 76 ± 0.5 (95% CI, 64.6-84.2) at 60 months. The freedom from CERAB-related reintervention rate was 94% ± 0.2 (95% CI, 89.7-96.5) at 12 months, 93% ± 0.2 (95% CI, 88.3-95.9) at 24 months, and 89 ± 0.3 (95% CI, 81.4-94.1) at 60 months. Survival and freedom from CERAB-related reintervention did not differ among the groups (P = .696 and P = .497, respectively).

Conclusion: In patients with AIOD, the CERAB technique proved to be safe procedure with acceptable durability at mid- to long-term follow-up independently of the type of endovascular platform.Clinical ImpactWith the current technical expertise and wide availability of a variety of endovascular platforms and geometries of reconstruction, the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) endovascular reconstruction of aorto-iliac obstructive disease proved to be a satisfactory technique based on durable results at mid-term follow-up with independently of the device used.