Preliminary Experience with the GORE(®) EXCLUDER(®) Iliac Branch Endoprosthesis for Common Iliac Aneurysm
Antoine Millon1, Nellie Della Schiava1, Matthieu Arsicot1
1Department of Vascular and Endovascular Surgery, Hôpital E Herriot, Lyon Cedex 03, France.
Insights
The GORE EXCLUDER iliac branch endoprosthesis (IBE) shows a 100% technical success rate for treating common iliac artery (CIA) aneurysms. Short-term results are encouraging, with high branch patency and successful aneurysm exclusion.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Medical Device Technology
Background:
- Common iliac artery (CIA) aneurysms pose a significant clinical challenge.
- Endovascular repair offers a less invasive alternative to open surgery.
- The GORE EXCLUDER iliac branch endoprosthesis (IBE) is a novel device for treating CIA aneurysms.
Purpose of the Study:
- To evaluate the safety and short-term outcomes of the GORE EXCLUDER IBE for endovascular repair of CIA aneurysms.
- To assess the technical success and clinical efficacy of this new endoprosthesis.
Main Methods:
- A retrospective, single-arm study with prospective follow-up.
- 10 patients with CIA aneurysms (>30 mm) underwent treatment with the GORE EXCLUDER IBE.
- Computed tomography angiography (CTA) was used for imaging, with follow-up at 30 days and 6 months.
Main Results:
- 100% technical success rate for GORE EXCLUDER IBE implantation.
- No perioperative complications observed; median hospital stay was 4 days.
- 90% branch patency at 6 months; all CIA aneurysms successfully excluded without type Ib or III endoleak.
Conclusions:
- The GORE EXCLUDER IBE demonstrates promising technical success and short-term clinical benefits for CIA aneurysm treatment.
- Further long-term follow-up is necessary to fully establish midterm and long-term outcomes.
Background:
The aim of this study is to assess the safety and the short-term results of endovascular treatment of common iliac artery (CIA) aneurysms using the new GORE EXCLUDER iliac branch endoprosthesis (IBE) device.
Methods:
The study is a retrospective with prospective follow-up nonrandomized, single-arm evaluation. Patients with a CIA aneurysm (diameter >30 mm) extending to the iliac bifurcation underwent endovascular treatment with the Gore IBE. Anatomic and procedural data were collected. Computed tomography angiography (CTA) was performed within the 30 days after the procedure and every 6 month. Thirty-day and at least 6-months outcomes were investigated.
Results:
From February 2014 to December 2014, 10 male patients with aneurysmal CIA (mean age 75 years old) underwent consecutive endovascular treatment with the Gore IBE. The CIA aneurysm (mean diameter 43.2 mm, range 32-49) treated with the Gore IBE was associated with an abdominal aortic aneurysm (AAA) in 5 patients. One patient had a previous AAA open repair. CIA aneurysm was bilateral in 5 patients. Preliminary procedure of internal iliac artery embolization was performed in 3 patients. Technical success rate of the Gore IBE implantation was 100% with a median fluoroscopy time of 35 min (range 12-64, ±16) and median contrast load of 150 mL (range 100-250, ±45). No perioperative complications were observed. Median length of stay was 4 days (range 3-7, ±2). One aortic type Ia endoleak was observed on the postoperative CT scan requiring an aortic extension at day 3. Branch patency was observed in all 10 patients at 1 month and 9 patients at 6 month. All CIA aneurysms were excluded without type Ib or type III endoleak.
Conclusions:
The technical success and short-term results demonstrate encouraging results and clinical benefits of the new GORE EXCLUDER IBE. A longer follow-up is needed to assess midterm and long-term results.
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