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
Journal of Vascular and Endovascular Therapy received 177 citations as per google scholar report