Background: The endovascular treatment of aortic aneurysm with complex anatomy, requires adjunctive procedures for anchoring, sealing and visceral arteries perfusion, with increase of morbidity and mortality. A new custom-made Aortic Stent Graft (ASG) platform, the Dominus (Braile Biomedica®, São José do Rio Preto, Brasil) modified on the design of Endovsmarts.r.l.™ (Bergamo, Italy), based on the principle of the radial force modulation, is available in the market, simplifying the procedure. The study focuses on device design, technical features and results.
Methods: We treated 4 patients: 2 with abdominal aortic aneurysm and 2 with thoraco-abdominal aortic aneurysm, previously rejected by the others manufacturers, due to at least one of the following anatomical complexities: 78° aortic arch angle, 30° descending thoracic aorta angle, 40 mm aortic diameter at the level of renal arteries, 90° alfa angle, 60° abdominal aortic angle, and 6 mm iliac access diameter.
The primary endpoints were 30-day clinical and technical success. The follow-up was made by physical examination and computed tomography angiography at 1,3,6 months and then yearly.
Results: The thirty-day clinical and technical success was 100%. There was not any neurologic event. The mean fluoroscopy time, contrast medium volume and, time of procedure, were respectively 17.2 min, 300 ml, and 228 min.
In 1 case occurred the postoperative laceration of the external iliac artery, treated by a covered stent. Themean time of hospitalization was4.4 days. During the 16 months median follow-up the patients were well and the computed tomography angiography confirmed the exclusion of the aneurysms and supraortic and abdominal visceral arteries patency.
Conclusions: In this preliminary experience, the new Dominus ASG platform allowed the effective endovascular exclusionof complex aortic aneurysms, otherwise un-treatable with the current available devices. More cases and longer follow-up are required for validating these encouraging outcomes.
Talarico Francesco, La Barbera Gaetano, Valentino Fabrizio, Filippone Gianfranco, Ferro Gabriele and Riggi Melania Monja