The first commercial use of the Valiant Navion stent graft system for endovascular repair of a descending thoracic aortic aneurysm

Objectives Thoracic endovascular aortic repair (TEVAR) is the standard of care for descending thoracic aortic aneurysms (DTAA), and newer generation stent grafts have significant design improvements compared to earlier generation devices. Methods We report the first commercial use of the Medtronic Valiant Navion stent graft for treatment of an 85-year-old woman with a 5.8 cm DTAA and a highly tortuous thoracic aorta. Results A percutaneous TEVAR was performed using a two-piece combination of the Valiant Navion FreeFlo and CoveredSeal stent graft configurations for zones 2–5 coverage. The devices were successfully delievered through highly tortuous anatomy and deployed, excluding the entire length of the aneurysm with precise landing, excellent apposition and no evidence of endoleak. The patient tolerated the procedure well and has had no stent graft-related complications through one-year follow-up. Conclusions Design enhancements such as a lower profile delivery system, better conformability, and a shorter tapered tip are some of the improvements to this third-generation TEVAR device. Coupled with the multiple configuration options available, this gives physicians a better tool to treat thoracic aortic pathologies in patients with challenging anatomy. The early results are encouraging, and evaluation of long-term outcomes will continue. </jats:sec

Polymer leak with the Ovation Abdominal Stent Graft System: Early recognition and treatment

Objective Endovascular aneurysm repair can be performed using multiple commercially available stent graft systems, each with their own unique design features and potential complications. This study evaluated the incidence, risk factors and outcomes of patients who developed an anaphylactic reaction following systemic exposure to the polymer used with the Ovation Abdominal Stent Graft System (Endologix Inc., Irvine, CA). Methods We reviewed all reports related to polymer leak with the device received by the manufacturer (formerly known as TriVascular, Santa Rosa, CA). Patients who developed an anaphylactic or hypersensitivity reaction were evaluated for root cause. The manufacturer was contacted to assemble all available data and outcomes related to the case reports. Results Between November 2009 and August 2016, polymer leak was reported in 26 patients (mean age, 77, range 61–100 years) from approximately 10,000 device implants (reported incidence, 0.26%). Symptoms occurred in 24 patients, with hypotension being the primary symptom. Treatment was in accordance for an anaphylactic reaction. There were no deaths, and the aneurysm sac remained unexcluded in three patients at the end of the case. Of these, one patient underwent successful endovascular re-intervention, one was converted to open surgical repair and one patient continued to be monitored. Factors that appear to contribute to the risk of polymer leak include initial manufacturing process for the device, excessive graft manipulation, early ballooning prior to complete polymer cure and lower body temperature, which can slow the polymer cure rate. Conclusion Although polymer leak and anaphylaxis appear to be an infrequent event associated with use of the Ovation graft, awareness of this complication and prompt recognition can allow for timely treatment. Returning the patient to hemodynamic stability can allow for completion of the procedure and successful exclusion of the aneurysm sac. </jats:sec

Physiologic coarctation of the aorta resulting from proximal protrusion of thoracic aortic stent grafts into the arch

Graft collapse is a known complication of thoracic aortic stent grafting, particularly in cases of traumatic thoracic aortic transection, when a typically smaller diameter aorta is repaired with a relatively large diameter device. In contrast, obstruction of the aorta from a stent graft that protrudes into the aortic arch but does not collapse is a less common complication of thoracic aortic stent grafting that can present as a functional aortic coarctation. We describe here two cases of physiologic coarctation of the aorta caused by stent graft protrusion into the arch that were successfully treated with stent graft explantation and open aortic reconstruction