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One-Year Results of the Multilayer Flow Modulator Stent in the Management of Thoracoabdominal Aortic Aneurysms
Sherif Sultan, MD FRCS FACS, Niamh Hynes.
Western Vascular Institute, Galway, Ireland.
OBJECTIVES:
We report early results from the Global Independent MFM Registry using a uni-modular multi-layer flow modulator stent technology.
METHODS:
We present the first 55 thoracoabdominal aortic cases that were implanted under indication for use. All were done on compassionate basis, in 11 countries, and were fully analyzed through the MFM registry. Mean age of 64.5 years +/- 18years; mean aneurysm diameter was 6.04cm+/-1.66cm (Median 5.76cm) Primary Endpoints are Freedom from Rupture and Aneurysm-related Death.
They were 31 Crawford Thoraco-abdominal aortic aneurysms (8 Type I, 3 Type II, 9 Type III, and 11 Type IV), 7 arch aneurysms, 3 abdominal aortic aneurysms, 8 suprarenal aortic aneurysms and 6 type B dissections.The mean number of side branches covered was 3.7 per case (SD 1.3, SE 0.18, median 4, range 0-6) for a total number of 202branches. The Total numbers of stent used were 108 with mean of 1.96 MFM stents per case.(SD1.09, SE 0.15, Median 2, range 1-5)
Results:
Aneurysm-related survival 93.7% (SE+/-4.44%) at one year. No rupture occurred. Four cases of consumptive coagulopathy were observed, two of which resulted in death from hemorrhagic cerebrovascular stroke and one of which resulted in death from a gastrointestinal bleed.
Technical success was 98.2%. One-year all-cause survival was 84.8% (SE+/-6.25%). There was no paraplegia No peri-operative visceral or renal insult occurred. At 12 months all of the 202 side branches were patent. There were no stent fractures.
One-year intervention free survival was 92.4% (SE+/-5.09%) At six months the mean rate of sac volume increase was 0.36% per month, resulting in a mean volume increase of 2.14%. At twelve months the rate of increase had slowed to 0.28% per month, resulting in a total average increase in sac volume of 3.26%. The ratio of thrombus to total volume stayed almost constant over the 12 months at 0.48, while the ratio of flow to total volume fell from 0.21 to 0.12 at 12 months.
Conclusions:
Increasing sac size did not herald rupture. MFM implantation instigates a process of aortic remodeling involving initial thrombus deposition, which slowed between six and twelve months. With physiological modulation of the aneurysm, MFM offers immense promise for resolution of complex thoraco-abdominal pathology with off-the-shelf availability.
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