OBJECTIVE: The objective of this study was to evaluate the anatomic feasibility of two off-the-shelf fenestrated stent graft designs to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). METHODS: Digital computed tomography angiograms were analyzed in 520 consecutive patients treated by open or fenestrated endovascular repair for complex AAAs (2000-2012). The anatomic feasibility of two off-the-shelf fenestrated designs, Endologix Ventana (Endologix Inc, Irvine, Calif) and Cook p-Branch (Cook Medical, Brisbane, Australia), was analyzed with the instructions for use (IFU) proposed by investigational protocols. RESULTS: There were 390 patients (75%) with juxtarenal and pararenal AAAs considered potential candidates for one of the two devices. Proximal seal (>15 mm) was achieved in all patients with the p-Branch and in 61% of the patients with the Ventana stent graft (P < .0001). The ability to incorporate visceral arteries was greater with the Ventana (90% vs 61%) compared with the p-Branch design (P < .0001). Less than a third of patients met strict IFU criteria with Ventana (27%) or p-Branch (33%; P < .05). By liberal IFU criteria, 42% of patients were candidates for Ventana and 49% for p-Branch (P < .03). Overall, 63% of the patients with juxtarenal and pararenal AAAs were candidates for endovascular repair with one of the two devices. CONCLUSIONS: The p-Branch design has greater anatomic feasibility and achieves proximal seal in all patients with juxtarenal and pararenal AAAs but is not able to incorporate visceral arteries in 40% of patients. The Ventana design allows incorporation of the visceral arteries in 90% of patients but fails to provide sufficient seal in 40%. Nearly 40% of juxtarenal and pararenal AAAs do not meet anatomic criteria for endovascular repair with one of the two devices, justifying the need for additional designs.
OBJECTIVE: The objective of this study was to evaluate the anatomic feasibility of two off-the-shelf fenestrated stent graft designs to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). METHODS: Digital computed tomography angiograms were analyzed in 520 consecutive patients treated by open or fenestrated endovascular repair for complex AAAs (2000-2012). The anatomic feasibility of two off-the-shelf fenestrated designs, Endologix Ventana (Endologix Inc, Irvine, Calif) and Cook p-Branch (Cook Medical, Brisbane, Australia), was analyzed with the instructions for use (IFU) proposed by investigational protocols. RESULTS: There were 390 patients (75%) with juxtarenal and pararenal AAAs considered potential candidates for one of the two devices. Proximal seal (>15 mm) was achieved in all patients with the p-Branch and in 61% of the patients with the Ventana stent graft (P < .0001). The ability to incorporate visceral arteries was greater with the Ventana (90% vs 61%) compared with the p-Branch design (P < .0001). Less than a third of patients met strict IFU criteria with Ventana (27%) or p-Branch (33%; P < .05). By liberal IFU criteria, 42% of patients were candidates for Ventana and 49% for p-Branch (P < .03). Overall, 63% of the patients with juxtarenal and pararenal AAAs were candidates for endovascular repair with one of the two devices. CONCLUSIONS: The p-Branch design has greater anatomic feasibility and achieves proximal seal in all patients with juxtarenal and pararenal AAAs but is not able to incorporate visceral arteries in 40% of patients. The Ventana design allows incorporation of the visceral arteries in 90% of patients but fails to provide sufficient seal in 40%. Nearly 40% of juxtarenal and pararenal AAAs do not meet anatomic criteria for endovascular repair with one of the two devices, justifying the need for additional designs.
Authors: Aleem K Mirza; Jussi M Kärkkäinen; Emanuel R Tenorio; Guilherme B Lima; Giuliana B Marcondes; Gustavo S Oderich Journal: EJVES Vasc Forum Date: 2020-09-06