Incidence of and outcomes after misaligned deployment of the Talent Thoracic Stent Graft System

ObjectiveVarious types of device-specific adverse events can occur during deployment of thoracic stent grafts due to the high flow rate and severe aortic angulation that is often encountered in the thoracic aorta. This study assessed the incidence, etiology, and overall effect of misaligned deployment of the Talent Thoracic Stent Graft (TSG) System. Techniques to predict and avoid this complication are discussed.MethodsData collection included pivotal-trial follow-up, direct surveys of centers inside and outside the United States and principal investigators, a targeted literature search, and review of complaint files. Misaligned deployment was considered to occur when the proximal covered or uncovered stent apices of a thoracic stent graft folded back on itself and remained nonparallel to the wall of the aorta after deployment had been completed.ResultsOf about 20,305 deployments to date of the Talent TSG, 24 misaligned deployments were identified for an incidence of 0.1%. Nineteen (79%) events occurred during treatment of degenerative aneurysms or penetrating ulcers, four (17%) during treatment of dissections, and the underlying pathology could not be determined for one patient. The misalignment was noted at the proximal end of the stent graft in 15 patients (63%), and the other 9 events (37%) occurred at the graft overlap junction. Two events were treated intraoperatively, with a second overlapping device placed in one patient and a snare used to reposition the proximal stent in another. Adverse clinical events occurred in three patients and included a persistent type I endoleak, continued false lumen perfusion in a patient with dissection, and delayed retrograde type A dissection in a patient undergoing total arch repair. No intraoperative contrast extravasation or computed tomography evidence of perforation was noted. There were no perioperative deaths or cerebrovascular events, with one report of paraplegia among the 24 patients in this series.ConclusionMisaligned deployment is an unusual phenomenon that tends to occur in the context of certain well-defined anatomic conditions in the thoracic aorta. To date, most of these events have not led to significant adverse sequelae. However, careful patient selection, periprocedural imaging, and case planning can help to identify anatomies in which misaligned opening is likely to occur, allowing physicians to avoid this complication

The phase I multicenter trial (STAPLE-1) of the Aptus Endovascular Repair System: Results at 6 months and 1 year

Objective: This phase I IDE study (STAPLE-1) evaluated the primary endpoints of safety (major device-related adverse events at 30 days) and feasibility (successful deployment of all endograft components) of the Aptus Endovascular abdominal aortic aneurysm (AAA) Repair System (Aptus Endosystems, Inc, Sunnyvale, Calif) to treat AAAs. Methods: A prospective, single arm Federal Drug Administration (FDA) Phase I IDE study was performed. The Aptus endograft is a three-piece modular device with a flexible unsupported main body and two fully supported limbs in a 5.3 mmouter diameter (OD) (16F) delivery system for all iliac limbs and two of three main body sizes. The largest main body (29 mm diameter) is in a 6 mm (18 F OD) delivery system. EndoStaples measuring 4 mm (length) by 3 mm (diameter) designed to provide transmural graft fixation to the adventitia are applied independent of the endograft delivery system. Inclusion criteria included a proximal aortic neck length of 12 mm and iliac landing zone of 10 mm. Secondary endpoints included freedom from endoleaks, rupture, migration, and device integrity. Results: Twenty-one (21) patients were enrolled at five centers. All patients received the Aptus Endograft and EndoStaples. Ninety-six EndoStaples (range, 2-10; median, 4) were implanted. All patients (n = 21) completed 1-month and 6-month follow-up evaluation and 14 completed 1-year follow-up. Two proximal cuffs and one limb extension were used as adjunctive endograft components at implantation. Three secondary interventions were performed in 2 patients for limb thrombosis. There were no EndoStaple-related adverse events, device integrity failures, migrations, or conversions. Conclusion: These results of the STAPLE-1 trial document the acute safety and feasibility of the Aptus Endograft and EndoStaples. Early follow-up demonstrates excellent 6-month and 1-year results. A pivotal phase II trial is underway at 25 US centers. ( J Vasc Surg 2009;49:851-8.