Initial Clinical Results with the New BeGraft Aortic Covered Stent in Native Coarctation of the Aorta, Restenoses and Aneurysms

Aims: Report initial experience with the new BeGraft Aortic covered stent in treatment for aortic coarctation. Transcatheter treatment of aortic coarctation with covered stents is safe, effective and reduces the probability of aortic wall injury. However, relatively large delivery systems causing femoral arterial damage, rigid stents and flimsy PTFE covering are limitations for use and success.

Methods: The BeGraft Aortic Stent Graft System consists of a balloon delivery catheter with a premounted ePTFE-covered balloon-expandable Cobalt Chromium stent. Balloon sizes range from 12[9Fr] - 24mm[14Fr] and stent length ranges from 19 - 59 mm. Results: 13 patients [11M, 2F] of median age 17.1 years [9.2-37.8] and weight 63.6kgs [26.3-104.7] with aortic coarctation[4 native, 4 s/p surgical repair, 3 s/p stent, 2 with aneurysms s/p CP stent] underwent stent implantation via a 9-11Fr femoral arterial access. In all cases a Begraft Aortic [12 or 14mm] stent was used and post dilated through the delivery sheath as needed.

The stent was successfully implanted in all cases. Systolic peak pressure gradient decreased from 14.7±7.4 to 3.6 ±2.9mmHg [p=0.001] and the diameter of the coarctation increased from 9.8±2.7 to 15.6±1.8mm [p=0.0001]. Final stent diameter was >90% of the transverse arch diameter. There was no acute aortic wall injury nor other immediate complications and 2 patients underwent successful occlusion of the pre-existing aneurysms. At median follow-up of 5.6 months all patients are well with normal femoral pulses and normotensive.

Conclusions: Initial results of treatment of aortic coarctation with the BeGraft Aortic Stent are encouraging. The potential advantage of a relatively low profile [9Fr] delivery system and premounting on a high pressure balloon and ability to post-dilate should allow for safe use in smaller patients. Long term outcome of blood pressure control, stent integrity and prevention of aortic wall injury need to be evaluated.