Suitability of the Zenith p-Branch Standard Fenestrated Endovascular Graft for Treatment of Ruptured Abdominal Aortic Aneurysms

Purpose: To evaluate the anatomic suitability of the Zenith pivot branch (p-branch) fenestrated device in ruptured abdominal aortic aneurysms (rAAA). Methods: Contrast-enhanced computed tomography (CT) images of 206 patients (mean age 75 +/- 8 years; 175 men) with rAAA were evaluated in a dedicated 3-dimensional vascular workstation. All aneurysms found unsuitable for standard infrarenal repair were evaluated for Zenith p-branch suitability according to the Investigational Device Exemption protocol for both device configurations (A, pivot fenestrations at the same level; B, right renal fenestration located more cranially). Results: The suitability of the p-branch (A or B configuration) for short neck aneurysms (<15 mm; n=89) was 49%; of the 26 different combinations of exclusion criteria, a mismatch between a renal artery takeoff and the positioning of the corresponding fenestration was the most common. For juxta- and pararenal aneurysms (neck length <10 mm; n=66), suitability was 48%. Suitability assessed by target vessel positioning only (excluding all other limiting factors) was 58% for short neck aneurysms (n=52) and 55% for juxta- and pararenal aneurysms (n=36). Conclusion: Approximately half of patients with short neck rAAAs would be suitable for the Zenith p-branch fenestrated device according to the instructions for use. In almost 60%, the pivot fenestrations can accommodate the corresponding target vessels. More studies are needed to confirm these findings.