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Multi-layer Flow-modulating Stents for Thoraco-abdominal and Peri-renal Aneurysms: The UK Pilot Study
C Lowe1, A Worthington2, F Serracino-Inglott3
1Department of Academic Surgery, Institute of Cardiovascular Sciences, University of Manchester, Education and Research Centre, University Hospital South Manchester, Manchester, UK; Department of Vascular and Endovascular Surgery, University Hospital South Manchester, Manchester, UK.
Summary
First-generation multi-layer flow modulating stents (MFMS) showed instability and frequent dislocation in treating aortic aneurysms. These devices did not reduce aneurysm size, indicating a need for further development.
Area of Science:
- Vascular Surgery
- Medical Devices
- Aortic Aneurysm Treatment
Background:
- A significant patient population with aortic aneurysms lacks conventional endovascular treatment options.
- Multi-layer flow modulating stents (MFMS) represent a novel therapeutic approach for aortic aneurysms.
Purpose of the Study:
- To report the outcomes of a UK pilot study evaluating first-generation MFMS in patients with thoraco-abdominal (TAAA) and perirenal aneurysms (PAA).
- To assess MFMS efficacy in patients unfit for open surgery and unsuitable for conventional endovascular repair.
Main Methods:
- 14 patients (8 TAAA, 6 PAA) unfit for open surgery received MFMS implantation.
- Follow-up included computed tomography angiography (CTA) at regular intervals (1, 3, 6, 12 months, then annually).
- Outcome measures comprised 30-day mortality, aneurysm growth, branch vessel patency, complications, and re-intervention rates.
Main Results:
- One (7%) 30-day death occurred; 11 (79%) patients survived to 12 months.
- Median aneurysm growth was 9 mm within the first 12 months; diameter remained stable in only two surviving patients.
- Despite frequent MFMS dislocation (4 patients) and re-interventions (6 in 5 patients), 50 of 51 covered branches remained patent without ischemia.
Conclusions:
- First-generation MFMS demonstrated significant instability and frequent dislocation.
- The study did not show aneurysm size reduction, questioning the influence of MFMS on natural history.
- While side branch patency was maintained, the high complication rate suggests these devices require further development for aortic aneurysm treatment.
