Purpose: To evaluate endovascular repair of thoracoabdominal aortic aneurysms (TAAA) and abdominal aortic aneurysms (AAA) using the Multilayer Flow Modulator (MFM) in high-surgical-risk patients with at least one covered branch vessel. Methods: In this prospective single-center nonrandomized trial, 18 patients (mean age 61.1 years; 16 men) with TAAA (n=10, mean diameter 74.4 mm) and AAA (n=8, mean diameter 67.8 mm) were treated with the MFM between June 2009 and September 2012. The primary safety endpoints were all-cause mortality at 30 days and 12 months and neurological complications. The primary efficacy endpoint was overall procedure success, defined as patency of covered branch vessels, reductions in aneurysm diameter, and sac thrombus formation. Results: The technical success rate was 100% (53 study devices implanted, mean stented length 273 mm). Through mean follow-up of 13.4 months, all 61 covered branch vessels remained patent; there were no neurologic complications, ruptures, or instances of device migration, kinking, or fracture. Three patients died, 2 of unrelated causes and one of an undetermined cause. Only one reintervention with an additional MFM implanted at 5 years was required for a type I endoleak in a young patient with natural growth. Carefully planned and executed diameter and volume measurements demonstrated aneurysm shrinkage and progressive sac thrombus formation for both patient groups. Conclusion: Through midterm follow-up, treatment of high-surgical-risk TAAA and AAA patients with the MFM appears to be safe and effective, maintaining branch vessel patency and reducing rupture risk through reduction of aneurysm diameter and modulation of flow dynamics. Longer term follow-up is needed.
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