IF01 - Comparative analysis of three different platforms for the covered endovascular reconstruction of the aortic bifurcation (Multicenter ITalIan Cerab cOmparison – M.IT.I.C.O. data collection group)

Friday, June 6, 2025

6:30 AM – 6:38 AM CT

Location: Morial CC, Second Floor, Room 224

Submitting & Presenting Author(s)

Gabriele Piffaretti, MD, PhD (he/him/his)

Associate Professor of Vascular Surgery
Vascular Surgery - Department of Medicine and Surgery, University of Insubria Faculty of Medicine and Surgery
Varese, Lombardia, Italy

Slides

Co-Author(s)

Sergio Zacà, MD (he/him/his)

Vascular Surgeon
Department of Precision and Regenerative Medicine and Jonic Area (DiMePre-J), Vascular and Endovascular Surgery, University of Bari School of Medicine “Aldo Moro”, Bari, Italy
Bari, Puglia, Italy
Pasqualino Sirignano, MD

Professor of Vascular Surgery
Vascular and Endovascular Surgery Unit – Department of General and Specialistic Surgery, La Sapienza University of Rome
Rome, Italy
Francesco Squizzato, MD

Assistant Professor
Vascular Surgery – Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padua Faculty of Medicine and Surgery; Padua
Padova, Veneto, Italy
FV

Federico Villa

Resident in Vascular Surgery
Vascular Surgery - Department of Medicine and Surgery, University of Insubria Faculty of Medicine and Surgery
Varese, Lombardia, Italy
MP

Martin Palughi

Resident in Vascular Surgery
Vascular and Endovascular Surgery Unit – Department of General and Specialistic Surgery, La Sapienza University of Rome
Rome, Italy
Michele Antonello, MD, PhD

Professor of Vascular Surgery
Vascular Surgery – Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padua Faculty of Medicine and Surgery; Padua
Padua, Veneto, Italy
DA

Domenico Angiletta

Professor of Vascular Surgery
Department of Precision and Regenerative Medicine and Jonic Area (DiMePre-J), Vascular and Endovascular Surgery, University of Bari School of Medicine “Aldo Moro”, Bari, Italy
Bari, Italy

Objectives: The kissing stent (KS) configuration has been regarded as the standard endovascular treatment of aorto-iliac obstructive disease (AIOD) lesions. The covered endovascular reconstruction of aortic bifurcation (CERAB) has been developed to overcome the limitations of the KS configuration. Currently, no dedicated devices have been developed and the literature does not report a clinical comparison of the different platforms used for CERAB. We aimed to analyze the outcomes after CERAB, comparing three different endovascular platforms.

Methods: It is a physician-initiated, unsupported, multicenter, observational, retrospective, cohort study. We identified all CERABs between March 1st, 2016, and September 30th, 2024. We compared three devices: Viabahn VBX® (W.L. Gore – Flagstaff; AZ – USA), AFX/AFX2 (Endologix – Irvine; CA – USA), and BeGraft (Hechingen – Germany). Specifically for this study, the primary outcomes were early survival and CERAB patency rate. Secondary outcomes were freedom from CERAB-related reintervention and freedom from conversion to open surgical aortic repair.

Results: Post-hoc analysis analyzed 220 (96.9%) CERABs: 132 (60.0%) performed with the VBX, 60 (27.3%) with the AFX/AFX2, and 28 (12.7%) with the BeGraft. Patients in the VBX group were older [median, 25th-75th interquartile (IQR): VBX, 71 (65.2-77) vs. AFX/AFX2, 64 (59-72) vs. BeGraft 68 (55.7-73.5), P = 0.002), while AFX/AFX2 group had the lowest rate of critical limb-threatening ischemia as presenting scenario (VBX, 36.4% vs. AFX/AFX2, 18.2% vs. BeGraft 35.7%, while AFX/AFX2, P = 0.039). Technical success was achieved in 217 (98.6%) procedures: all 3 failures occurred in the VBX group. Thirty-day survival was 98.6%: 3 (1.4%) patients died in the VBX group (P = 0.360). The median follow-up of 21 months [VBX, 13.5 (IQR, 6-26) vs. AFX/AFX2, 25 (IQR, 17.2-38.7) vs. BeGraft 21 (IQR, 10.7-42), P = 0.001]. Estimated primary patency was 97% ± 1 (95%CI: 93.6-98.5) at 12 months, and 83 ± 7 (95%CI 64.8-92.4) at 60 months. Estimated freedom from reintervention was 94% ± 2 (95%CI: 89.7-96.5) at 12 months, and 89 ± 3 (95%CI: 81.4-94.1) at 60 months. Estimated freedom from conversion to open repair was 99% ± 0.1 (95%CI: 98.6-99.0) at 12 months, and 97 ± 2 (95%CI: 87.8-99.1) at 60 months. Primary patency, freedom from CERAB-related intervention, and open conversion did not differ among the groups (P = 0.904, P = 0.497, and P = 0.214, respectively).

Conclusions: In patients with AIOD, the CERAB technique proved to be a safe procedure with acceptable durability at mid-to-long-term follow-up independently of the type of endovascular platform.