Wadi Gomero-Cure1, Manish Mehta2, Ronald M. Fairman3, John P. Henretta4, Marc H. Glickman5, David H. Deaton6
1Washington Hospital Center / Georgetown University Hospital, Washington DC; 2Albany Medical College, Albany, NY; 3Hospital of the University of Pennsylvania, Philadelphia, PA; 4Carolina Vascular, Asheville, NC; 5Sentara Norfolk General Hospital, Norfolk, VA; 6Georgetown University Hospital, Washington DC.
OBJECTIVES: Long-term durability of EVAR is impaired by aortic neck dilatation (AND) that is associated with late Type 1 endoleak, migration and aneurysm rupture. Current endografts employ radial force, barbs and columnar rigidity for fixation. Metal helical Endostaples provide longitudinal fixation and radial fixation to resist vascular dilatation. AND greater >15 % is reported in a range of 21%-28% at 2 years in the three largest studies. We analyzed the core lab imaging data from the Phase II IDE STAPLE-2 trial to evaluate the effect of helical Endostaple fixation on AND.
METHODS: 155 subjects were enrolled at 25 sites in the STAPLE-2 trial (Aptus Endosystems, Sunnyvale, CA) between September 2007 and January 2009. A mean of 5.5 and median of 5 Aptus Endostaples (0.5 mm x 3 mm x 4.5 mm MP35N-LT wire helices) were implanted. An imaging core lab (M2S, Lebanon, NH) analyzed aortic neck diameters at 1 month, 6 months and annually. Aortic neck diameter relative to both the 1 month CT and to the main body nominal diameter was analyzed.
RESULTS: Complete data sets were available for 141 subjects (91.0%) at 6 months, 133 (85.8%) at 1 year, and 106 (68.4%) at 2 years. Mean follow-up was 2 years. AND >15% relative to 1 month imaging is present in 5 of 106 (4.7%) patients at 2 years. AND >10% of the nominal diameter of the endograft is present in 0 of 106 (0.0%) at 2 years. There were no occurrences of late Type-1 (new Type 1 after 1 month) or aortic rupture in any trial patient. A single case of migration was documented. Aortic neck stability (AND <15%) was documented in 101 (95.3%) of patients at 2 years.
CONCLUSIONS: Helical Endostaple fixation is associated with a significant reduction in AND compared to historical aortic endograft AND data. Metal helical Endostaples may prevent AND as an etiology of late-term endograft failure.
AUTHOR DISCLOSURES: D. H. Deaton, Aptus Endosystems, Consulting fees or other remuneration (payment); R. M. Fairman, Nothing to disclose; M. H. Glickman, Nothing to disclose; W. Gomero-Cure, Nothing to disclose; J. P. Henretta, Nothing to disclose; M. Mehta, Nothing to disclose.
Posted April 2012