Long-Term Outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique in Patients With Aorto-Iliac Occlusive Disease.

Background: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency.

Methods: Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure.

Results: One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%.

Conclusion: The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense.

Clinical impact: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.