Results Of The Iliac Branch Endoprosthesis And Off-label Use: A Single Institutional Experience
Jill Smolevitz, Amani Politano, Ramsey Al-Hakim, Ryan Schenning, Timothy Liem, Gregory Landry, Enjae Jung, Cherrie Abraham.
Oregon Health & Science University, Portland, OR, USA.
OBJECTIVES: Endovascular repair of complex aorto-iliac aneurysms has expanded with the development of iliac branch devices. The Gore Excluder Iliac Branch Endoprosthesis (IBE) is the first commercially available iliac branch device in the United States. Analysis of outcomes in patients treated with IBEs is lacking, especially in cases deviating from approved indications for use (IFU). The purpose of this study was to evaluate real-world outcomes in patients treated with IBEs, including those with off-label application.
METHODS: A retrospective analysis of a single institution's experience with the Gore Excluder IBE was performed. All patients who underwent iliac artery aneurysm repair with the Gore Excluder IBE over a 30-month period were included. Charts were reviewed for baseline demographics, operative details, and post-operative outcomes. Statistical analysis was performed using Fisher's exact tests.
RESULTS: Sixteen patients underwent application of 17 Gore Excluder IBEs for 16 iliac aneurysms between September 2016 and March 2019. Fourteen common iliac artery (CIA) and two internal iliac artery (IIA) aneurysms were repaired. One patient without an iliac aneurysm had a type Ib endoleak from a previous EVAR repaired using an IBE and one had bilateral iliac aneurysms repaired. Mean CIA aneurysm diameter was 37 ± 12 mm; average IIA aneurysm diameter was 66 ± 5.7 mm. Six of 17 IBEs (35%) were performed off-IFU. Postoperative morbidity was low; one on-IFU patient developed a minor wound complication. There were no mortalities or major complications. Aneurysm-related outcomes were similar between on- and off-IFU groups. One off-IFU patient had asymptomatic hypogastric limb thrombosis (6.7%); this difference was not significant between groups (p=0.35). Four type II endoleaks occurred (25%), with no significant difference between groups (p=1), two of which resolved spontaneously. Two patients (12.5%) required reinterventions: one for a type Ib endoleak and one for a retroperitoneal hematoma. Both patients had on-IFU use of the device (p=0.5).
CONCLUSIONS: In our experience, the Gore Excluder IBE is a safe and effective treatment for patients with complex aorto-iliac aneurysms. Postoperative and aneurysm-related complications were low despite off-label use in 35% of cases, and not significantly worse in patients undergoing off-IFU use of the device.
Back to 2020 ePosters