Sherif Sultan1, Niamh Hynes2
1Vascular & Endovascular Surgery, Western Vascular Institute, Galway, Ireland; 2Galway Clinic, Galway, Ireland.
OBJECTIVES: We report early results using multilayer flow modulator (MFM) stent technology for aortic repair.
METHODS: Out of 243 cases implanted worldwide, we present the first 55 cases that were implanted under indication for use. All were done on compassionate basis, in 11 countries. Primary endpoints are freedom from rupture and aneurysm-related death.
RESULTS: They were 31 thoracoabdominal (8 Type I, 3 Type II, 9 Type III and 11 Type IV), 7 arch, 3 abdominal and 8 suprarenal aneurysms and 6 Type B dissections. Mean age of 64.5 years; mean aneurysm diameter was 6.04cm+/-1.66cm and mean length was 11.58cm+/-7.62cm. The mean number of side branches covered was 3.7 per case for a total number of 202 branches. Mean stents per case was 1.96. 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 perioperative 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 6 months, the mean rate of sac volume increase was 0.36% per month, resulting in a mean volume increase of 2.14%. At 12 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 6 and 12 months. The MFM was not associated with loss of native side branches.
AUTHOR DISCLOSURES: N. Hynes: Nothing to disclose; S. Sultan: Nothing to disclose.
Posted April 2013