Midterm Outcomes of Patients With Complex Aortic Aneurysms Treated Using Mixed and Matched Endoprosthesis From Different Manufacturers

Abstract

Objectives:

To evaluate outcomes of patients with complex aortic aneurysms (cAAs) undergoing fenestrated/branched endovascular aortic aneurysm repair (f/b-EVAR) using a combination of endoprostheses from different manufacturers.

Methods:

The study is a 2-center retrospective analysis of prospectively maintained databases of patients with cAAs undergoing f/b-EVAR using a combination of endoprostheses from different manufacturers from 2013 to 2023. Primary endpoints included technical success, major adverse events and reintervention rates. Technical success was defined as implantation of the device without type I or type III endoleak or conversion to open repair. Secondary endpoints included mortality and mid-term device performance.

Results:

During this time, 353 patients with cAAs underwent f/b-EVARs at both centers. Of these, 80 (22.7%) required use of a combination of devices from 4 different manufacturers for repair. Fifty-one (64%) were treated for thoracoabdominal aortic aneurysms and 29 (36%) for pararenal aneurysms. Majority (74%) were male with a median age of 75 (69, 81) years and aneurysm size of 65 (59, 72) mm. Thirty-five (44%) patients required a proximal thoracic stent graft—W.L. Gore (17), Cook, Medtronic, and Terumo (6), respectively. Seventy-seven (96%) patients required a bifurcated device, including Cook Flex (34), Gore (40), and Medtronic (3). Twelve patients underwent common iliac artery aneurysm repair with a Gore iliac branched endoprosthesis. One hundred fifty-four limbs were implanted: Gore: 68, Cook: 82 and Medtronic: 4. Three hundred fourteen target vessels were incorporated. Median operating room time, estimated blood loss, fluoroscopy time and dose were 209 (186, 278) minutes, 100 (50, 663) mL, 77 (59, 100) minutes, 2385 (1415, 3885) mGy, respectively. Three endoleaks were observed on completion angiography—2 type Ic and 1 type IIIa—all of which resolved at 1 month. Fifteen MAEs were observed in 11 patients at 30 days, including 3 (3.9%) deaths, 7 renal insufficiency, 1 renal failure requiring dialysis, 2 MI and paraplegia, respectively. At a median follow-up of 400 (85, 1132) days, there were 8 reinterventions for endoleaks in 7 patients.

Conclusions:

The use of mixed devices proximal and distal to f/b-devices built to treat patients with cAAs is safe and has good mid-term results.

Clinical Impact

While not yet formally assessed in randomized clinical trials or endorsed by the Food and Drug Administration (FDA), the practice of utilizing devices from various manufacturers to address complex aortic anatomy is widespread in everyday clinical settings, yet outcomes remain insufficiently documented. To our knowledge, ours is the first manuscript demonstrating that the use of endoprostheses from different manufacturers for treating patients with complex aortic aneurysms is both safe and yields favorable mid-term results. This frequently employed strategy warrants further exploration through meticulously designed clinical trials, aiming to furnish vascular specialists with a well-founded guideline based on robust clinical evidence.

Keywords

complex aortic aneurysms endovascular repair mixed and matched endoprosthesis fenestrated/branched endografts

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