Outcomes of Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Procedure for the Treatment of Extensive Aortoiliac Occlusive Disease Using the BeGraft Balloon-Expandable Covered Stent: A Multicenter Observational Study.

PURPOSE: The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique offers an alternative for Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions involving the aortic bifurcation. The study aims to evaluate the outcomes of the CERAB technique for extensive aortoiliac occlusive disease (AIOD) using the BeGraft balloon-expandable covered stent (BECS).

MATERIALS AND METHODS: This is a physician-initiated, multicenter, retrospective, observational study. Between June 2017 and June 2021, all consecutive patients who underwent the CERAB procedure using the BeGraft stent (Bentley InnoMed, Hechingen, Germany) in 3 clinics were enrolled. Patients' demographics, lesion characteristics, and procedural results were collected and retrospectively analyzed. Follow-up was done at 1, 6, and 12 months and then annually with clinical examination, ankle-brachial index (ABI), and duplex ultrasound. The primary endpoint was the patency at 12 months. Secondary endpoints included procedural-related complications, secondary patency, freedom from target lesion revascularization (TLR), and clinical improvement.

RESULTS: In all, 120 patients (64 men) with a median age of 65 years (range: 34-84 years) were analyzed. Most patients had extensive AIOD classified as TASC II C (n=32; 26.7%) or TASC II D (n=81; 67.5%). The median duration of the procedure was 120 minutes (interquartile range [IQR]: 80-180 minutes). All 454 BeGraft stents (137 aortic and 317 peripheral) were successfully delivered and deployed. The overall procedural complication rate was 14 (11.7%). The median hospital length of stay was 5 days (IQR: 3-6 days). All patients improved clinically, and the ABI increased significantly (p<0.05). The median follow-up was 19 months (range: 6-56 months). The primary patency rate, secondary patency rate, and freedom from TLR at 12 months were 94.5%, 97.3%, and 93.5%, respectively.

CONCLUSIONS: The CERAB procedure with BeGraft BECSs has a high technical success rate, favorable patency outcomes, and low morbidity, even in relatively ill patients with extensive AIOD. Prospective randomized studies on the CERAB technique are definitely recommended.

CLINICAL IMPACT: This study evaluates the outcomes of BeGraft stents used during the covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure. To date, several balloon-expandable covered stents have been used for this technique with satisfactory results. This study showed the safety and excellent patency of the CERAB technique in extensive AIOD using BeGraft balloon-expandable covered stents.