Bernardo Mendes, Gustavo S. Oderich, Stephen Cha, Audra A. Duncan, Manju Kalra, Mark Fleming, Peter Gloviczki, Thanila Macedo, Thomas C. Bower
Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
OBJECTIVES: To evaluate the anatomical feasibility of two off-the-shelf fenestrated stent-grafts to treat juxtarenal (JRA) and pararenal (PRA) abdominal aortic aneurysms (AAAs).
METHODS: Digital computed tomography angiography was analyzed in 520 consecutive patients treated with open or fenestrated endovascular repair for complex AAAs between 2000-2012. The anatomical feasibility of two off-the-shelf fenestrated designs — Endologix Ventana™ (Irvine, California) and Cook p-Branch™ (Brisbane, Australia) — was analyzed using Instructions for Use (IFU) proposed by investigational protocols.
RESULTS: There were 390 patients (75%) with JRA/PRAs considered potential candidates for the two devices. Proximal seal (>15mm) could be achieved in all patients using p-Branch™ and in 61% of the patients using Ventana™ stent-graft (p<0.0001). The ability to incorporate visceral arteries (Figure 1) was greater using Ventana™ (90%) compared to p-Branch™ (61%; p<0.0001) design. Less than a third of patients met strict IFU criteria for using Ventana™ (25%) or p-Branch™ (32%; p<0.05) devices. Using liberal IFU criteria, 42% of patients were candidates for Ventana™ and 49% for p-Branch™ (p<0.03). Overall, 63% of the patients with JRA/PRAs were candidates for endovascular repair using one of the two devices.
CONCLUSIONS: p-Branch™ design has greater anatomical feasibility and achieves proximal seal in all patients with JRA/PRAs, but it is not able to incorporate visceral arteries in 40% of patients. Ventana™ design allows incorporation of the visceral arteries in 90% of patients but fails to provide sufficient seal in 40%. Nearly 40% of JRA/PRAs do not meet anatomical criteria for endovascular repair using one the two devices, justifying need for additional designs.
AUTHOR DISCLOSURES: T. C. Bower: Nothing to disclose; S. Cha: Nothing to disclose; A. A. Duncan: Nothing to disclose; M. Fleming: Nothing to disclose; P. Gloviczki: Nothing to disclose; M. Kalra: Nothing to disclose; T. Macedo: Nothing to disclose; B. Mendes: Nothing to disclose; G. S. Oderich: Cook Medical, Consulting fees or other remuneration (payment); WL Gore, Consulting fees or other remuneration (payment).
Posted April 2013