Three year outcome of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique for aortoiliac occlusive disease

Objective:The objective of the current study was to demonstrate the three year outcome of the CERAB technique for the treatment of extensive aortoiliac occlusive disease (AIOD). Methods:Between February 2009 and July 2016, all patients treated with the CERAB technique for AIOD were identified in the local databases of two centers and analyzed. Demographics and lesion characteristics were scored. Follow-up (FU) consisted of clinical assessment, duplex ultrasound and ankle brachial indices (ABI). Patency rates and clinically driven target lesion revascularization (CD-TLR) were calculated by Kaplan-Meier analysis. Results: 130 patients (69 male and 61 female) were treated of which 68% patients were diagnosed with intermittent claudication and 32% suffered from critical limb ischemia. The vast majority (89%) were TASC-II D lesions and the remaining were TASC-II B and C (both 5%). Median follow-up was 24 months (range 0-67 months). The technical success rate was 97% and 67% of cases were performed completely percutaneously. The ABI improved significantly from 0.65 plusminus 0.22 preoperatively to 0.88 plusminus 0.15 after the procedure. The 30-day minor and major complication rate was 33% and 7%. The median hospital stay was 2 days (range 1-76 days). At 1 and 3-years FU 94% and 96% of the patients clinically improved at least 1 Rutherford category (2% and 0% unchanged, 4% and 4% worsened). Limb salvage rate at 1-year was 98% and 97% at three year follow-up. Primary, primary-assisted and secondary patency was 86%/91%/97% at 1-year, 84%/89%/97% at 2-year and 82%/87%/97% at 3-year FU. Freedom from CD-TLR was 87% at 1-year and 86% at both 2 and 3-year FU. Conclusions:The CERAB technique is a safe and feasible technique for the treatment of extensive aortoiliac occlusive disease with good three year results regarding patency and clinical improvement.

💡 Research Summary

The present study retrospectively evaluated the three‑year outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique in a cohort of 130 patients treated for extensive aorto‑iliac occlusive disease (AIOD) at two European centers between February 2009 and July 2016. The majority of lesions were advanced (TASC‑II D, 89 %), and patients presented with either intermittent claudication (68 %) or critical limb ischemia (32 %).

Procedurally, the CERAB approach uses a 12‑mm balloon‑expandable ePTFE covered stent placed in the distal aorta, flared proximally to create a conical “funnel” shape, followed by simultaneous deployment of two 8‑mm covered stents into the iliac limbs. This configuration aims to eliminate the geometric mismatch and flow disturbances inherent to the traditional kissing‑stent (KS) technique. Technical success was achieved in 97 % of cases; all failures occurred within the first 40 procedures, indicating a short learning curve. Two‑thirds of the interventions were performed percutaneously, with a mean operative time of 152 minutes and an average contrast volume of 123 mL.

Peri‑operative morbidity was modest: minor complications (hematoma, ecchymosis, leg edema) occurred in 33 % of patients, while major complications (stent collapse, early thrombosis, access‑site injury) were observed in 7 %. One patient suffered a life‑threatening bleed leading to prolonged ICU stay and eventual death three months after discharge; the 30‑day mortality was zero.

Clinical efficacy was evident immediately after the procedure. The ankle‑brachial index (ABI) improved from a mean of 0.65 ± 0.22 pre‑procedure to 0.88 ± 0.15 post‑procedure (p < 0.001) and further rose to 0.97 ± 0.14 at 24 months and 0.99 ± 0.14 at 36 months. Rutherford category improved by at least one stage in 87 % of patients at six weeks, and this benefit persisted, with 94 % and 96 % of patients showing improvement at 1‑ and 3‑year follow‑up respectively. Limb‑salvage rates were 98 % at one year and 97 % at three years.

Patency outcomes, calculated by Kaplan‑Meier analysis, were 86 % primary patency at 12 months, 84 % at 24 months, and 82 % at 36 months. Primary‑assisted patency rates were 91 %, 89 % and 87 % at the same intervals, while secondary patency remained high at 97 % throughout the three‑year period. Freedom from clinically driven target lesion revascularization (CD‑TLR) was 87 % at one year and 86 % at both two and three years. Reinterventions related to the CERAB construct were required in 14 % of patients, the majority (88 %) occurring within the first year.

Univariate analysis revealed no significant association between primary patency and traditional cardiovascular risk factors (smoking, diabetes, hypertension, renal insufficiency, coronary disease), prior vascular interventions, runoff score, or initial presentation (claudication versus critical limb ischemia). This suggests that the CERAB technique delivers consistent results across a heterogeneous high‑risk population.

When compared with historical data for the KS technique (approximately 79 % primary patency at two years) and open aorto‑bi‑femoral bypass grafts (≈93 % primary patency at two years), the CERAB outcomes are competitive, especially considering its minimally invasive nature, shorter hospital stay (median 2 days), and lower peri‑operative morbidity.

The authors acknowledge limitations inherent to the retrospective design, the absence of a concurrent control group, and incomplete long‑term follow‑up beyond three years for many patients. Nonetheless, the data substantiate that the CERAB configuration provides durable vessel patency, high limb‑salvage rates, and meaningful clinical improvement for patients with complex AIOD, positioning it as a viable alternative to both conventional endovascular kissing stents and open surgical reconstruction.