Multi-layer Flow-modulating Stents for Thoraco-abdominal and Peri-renal Aneurysms: The UK Pilot Study.
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.


CONCLUSIONS
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.
Department 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. Electronic address: chris.lowe@doctors.org.uk.
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Lowe
Department of Academic Surgery, Institute of Cardiovascular Sciences, University of Manchester, Education and Research Centre, University Hospital South Manchester, Manchester, UK.
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Worthington
Department of Vascular and Endovascular Surgery, Manchester Royal Infirmary, Manchester, UK.
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Serracino-Inglott
Department of Vascular and Endovascular Surgery, University Hospital South Manchester, Manchester, UK.
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Ashleigh
Department 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.
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McCollum
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology / Q000628:therapy; D001027:Aortography / Q000379:methods; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D004739:England; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011474:Prosthesis Design; D012039:Regional Blood Flow; D019233:Retreatment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014654:Vascular Patency
Aortic aneurysm; Endovascular repair; Multi-layered stent