Objective: There remains a population of patients with aortic aneurysms that cannot be treated by conventional endovascular means. Multi-layer flow modulating stents (MFMS) are a novel approach for the treatment of aortic aneurysm; this study reports outcomes of a UK pilot study of first-generation MFMS in thoraco-abdominal (TAAA) and perirenal aneurysms (PAA) in patients who were also unfit for open surgery.
Methods: Patients with TAAA and PAA unfit for open surgery and with no conventional options for endovascular repair were recruited. Follow-up included CTA at 1, 3, 6, and 12 months, then annually. Outcome measures included 30 day mortality, growth-free survival, branch vessel patency, complications, re-intervention, and maximal aortic diameter.
Results: MFMS were implanted in 14 patients (6 PAA, 8 TAAA) between October 2011 and March 2014 with one (7%) 30 day death and 11 (79%) surviving to 12 months. The median aneurysm growth was 9 mm in the first 12 months following implantation. On mean follow-up of 22.8 months, seven (50%) patients had died including one confirmed rupture. AAA diameter remained stable in only two of the surviving patients. Fifty of 51 covered aortic branches remained patent with no embolic episodes or symptoms of ischaemia in any patient. MFMS dislocation occurred in four patients, leading to re-intervention in two. A total of six re-interventions were performed in five patients (35%) with one post-re-intervention death.
Conclusion: These first-generation MFMS were unstable and dislocated frequently. It is uncertain whether MFMS implantation influenced the natural history of these aneurysms as none decreased in size, but two remain stable after a mean of 22.8 months. Although side branch patency was maintained, our results do not support the continued use of these first-generation devices. Further development is needed if this technology is to have a role in treatment of aortic aneurysm.
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