Evaluation of a new disease-specific endovascular device for type B aortic dissection

Objective: The study objective was to evaluate the feasibility, safety, and early technical and clinical success rate of a new endovascular device specifically designed for aortic dissection that has recently become available in Europe. Methods: From June of 2005 to the present, the Zenith Dissection Endovascular System (William Cook Europe, Bjaerverskov, Denmark) was used in 11 selected patients (all male, with a median age of 58 years [range, 45-76 years]) with type B chronic aortic dissection with a compression or collapse of the true lumen. All procedures were performed under general anesthesia with preoperative cerebrospinal fluid drainage in 4 patients. One-step open surgical supra-aortic vessels re-routing was performed in 6 patients to obtain an adequate proximal landing zone: Left carotid-subclavian artery bypass was performed in 5 patients, and right-to-left common carotid artery bypass and left subclavian to common carotid artery transposition was performed in 1 patient. Clinical follow-up visits and computed tomography scans were obtained at 1, 6, and 12 months, and yearly thereafter. Results: A secondary technical success was obtained in all patients (100%), and 30-day clinical success was achieved in 10 patients (91%). A type IA entry flow was observed in 1 patient. No mortality was recorded. Occlusion of visceral/renal arteries, retrograde dissections, and device-induced tears in the intimal lamellae were not observed. Periprocedural morbidity included temporary renal failure in 1 patient and postimplantation syndrome with fever and leukocytosis for 23 days in 1 patient. No cases of paraplegia were recorded. At a median follow-up of 12 months ( range, 2 30 months), we observed a clinical success rate of 91%. No migration of the device was observed. No late occlusion of the visceral or renal arteries was recorded at follow-up. Conclusion: The perioperative and short-term follow-up results showed that the Zenith Dissection Endovascular System for the treatment of aortic dissection can be safely used without affecting the patency of the branches covered by the bare stent. However, these results need to be validated in a larger group of patients with a mid-term follow-up.