Pasqualino Sirignano1, Laura Capoccia2, Wassim Mansour2, Sonia Ronchey3, Federico Accrocca4, Andrea Siani4, Nicola Mangialardi3, Francesco Speziale2. 1. Vascular and Endovascular Surgery Unit, Department of Surgery "P Stefanini", Policlinico "Umberto I", "Sapienza" University of Rome, Rome, Italy. Electronic address: pasqualino.sirignano@uniroma1.it. 2. Vascular and Endovascular Surgery Unit, Department of Surgery "P Stefanini", Policlinico "Umberto I", "Sapienza" University of Rome, Rome, Italy. 3. Vascular and Endovascular Surgery Unit, San Filippo Neri Hospital, Rome, Italy. 4. Vascular and Endovascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy.
Abstract
BACKGROUND: The aim of this work is describing incidence and fate of type 2 endoleaks (T2ELs) in a multicentric cohort of patients treated by endovascular aneurysms repair using the Ovation device (Endologix) and comparing them with a group treated using the Excluder (W. L. Gore & Associates). METHODS: This is a retrospective study conducted on 261 patients treated using the Ovation device and 203 using the Excluder. Outcomes were intraprocedural, 30-day, 12-month, and mean time follow-up T2EL incidence and related reinterventions. Patent inferior mesenteric artery (IMA), ≥3 lumbar arteries (LAs), intrasac thrombus volume, the mean diameter of common and external iliac arteries, external iliac artery stenosis (>70%), diameter ≤5 mm, iliac tortuosity ratio ≤0.5, thrombosis, and calcification were noted and considered as potentially influencing outcomes. RESULTS: Patients of the Ovation group presented significantly more thrombosed, calcified, and tortuous iliac vessels than those in the Excluder group. No significant differences were noted in sac thrombosis, IMA, and LA patency. At completion angiography, T2EL was evident in 57 Ovation and 46 Excluder patients (P = 0.832). At 1 month, it was evident in 33 Ovation group and 28 Excluder group patients (P = 0.726). At 12-month and mean time (30.14 months) follow-up, no differences were evident between the 2 groups (P = 0.940 and 0.951, respectively). The log-rank test showed that the rate of T2EL-related reintervention was not different between the 2 groups (P = 0.46). Regarding anatomical characteristics, a statistically significant difference was not observed between patients presenting or not with T2EL (P > 0.05). CONCLUSIONS: Data showed no significant differences in terms of T2EL incidence between the 2 study groups. None of preoperative anatomical features were found to be significantly associated with the appearance of T2EL.
BACKGROUND: The aim of this work is describing incidence and fate of type 2 endoleaks (T2ELs) in a multicentric cohort of patients treated by endovascular aneurysms repair using the Ovation device (Endologix) and comparing them with a group treated using the Excluder (W. L. Gore & Associates). METHODS: This is a retrospective study conducted on 261 patients treated using the Ovation device and 203 using the Excluder. Outcomes were intraprocedural, 30-day, 12-month, and mean time follow-up T2EL incidence and related reinterventions. Patent inferior mesenteric artery (IMA), ≥3 lumbar arteries (LAs), intrasac thrombus volume, the mean diameter of common and external iliac arteries, external iliac artery stenosis (>70%), diameter ≤5 mm, iliac tortuosity ratio ≤0.5, thrombosis, and calcification were noted and considered as potentially influencing outcomes. RESULTS:Patients of the Ovation group presented significantly more thrombosed, calcified, and tortuous iliac vessels than those in the Excluder group. No significant differences were noted in sac thrombosis, IMA, and LA patency. At completion angiography, T2EL was evident in 57 Ovation and 46 Excluder patients (P = 0.832). At 1 month, it was evident in 33 Ovation group and 28 Excluder group patients (P = 0.726). At 12-month and mean time (30.14 months) follow-up, no differences were evident between the 2 groups (P = 0.940 and 0.951, respectively). The log-rank test showed that the rate of T2EL-related reintervention was not different between the 2 groups (P = 0.46). Regarding anatomical characteristics, a statistically significant difference was not observed between patients presenting or not with T2EL (P > 0.05). CONCLUSIONS: Data showed no significant differences in terms of T2EL incidence between the 2 study groups. None of preoperative anatomical features were found to be significantly associated with the appearance of T2EL.