Initial Clinical Experience With the Modified Zenith "Pro-Form" TX2 Thoracic Endograft

Purpose: To assess the safety and efficacy of thoracic aortic endovascular repair (TEVAR) with the newly introduced Zenith TX2 thoracic stent-graft with Pro-Form. Methods: From March 2009 to present, the Zenith TX2 with Pro-Form was used to treat 27 patients (23 men; median age 65 years, range 22-77) suffering from descending thoracic aortic disease: 20 degenerative aneurysms, 3 chronic type B dissections, 2 type I endoleaks following previous endograft repair, 1 aortic ulcer, and 1 traumatic isthmic rupture. According to Ishimaru's classification, the distribution of the proximal landing zone was zone 0 in 4 cases, zone 1 in 2 cases, zone 2 in 9 cases, zone 3 in 7 cases, and zone 4 in 5 cases. One aneurysm distally involved the thoracoabdominal aorta. An acutely angulated (<90 degrees) proximal landing zone was found in 9 patients. Results: The device was safely and effectively deployed in all cases, with no problems during sheath retrieval. The postoperative course was free from major complications in all cases, and there was no perioperative mortality. Postoperative morbidity included respiratory failure in 1 case, transient acute renal failure in 3 cases, and post-implantation syndrome in 2 cases. Postoperative computed tomography at 1 and 6 months confirmed 100% clinical success with the absence of device-related complications. No type I endoleak was documented. The proximal sealing stent fitted well with the aortic profile in all cases except one, in which malapposition was seen in a severely angulated aorta at 6-month follow-up. Conclusion: Based on this preliminary experience, the TX2 thoracic stent-graft with Pro-Form can be safely and effectively deployed to satisfactorily repair thoracic aortic pathology, including lesions in the arch. Stent-graft conformance to the aorta was excellent even in cases with unfavorable anatomy. These encouraging results will need to be confirmed in larger series with larger follow-up. J Endovasc Ther. 2010;17:463-470