Thoracic aortic lesions treated with the Zenith TX1 and TX2 thoracic devices: Intermediate- and long-term outcomes
Presented at the Thirty-First Annual Meeting of the Southern Association for Vascular Surgery, Rio Grande, Puerto Rico, Jan 17-20, 2007.
Received 24 October 2007; accepted 15 February 2008. published online 27 May 2008.
Objective
Little data exist to support the durability of thoracic endovascular repair during prolonged periods of follow-up. This study examines the durability and long-term results with the Zenith TX1 and TX2 thoracic devices (Cook Inc, Bloomington, Ind) in high-risk patients.
Methods
Data were collected prospectively from 2001 to 2007 on high-risk patients who presented with thoracic aneurysms, chronic aortic dissection, or fistulas treated with a Zenith thoracic device. Surgical modifications of proximal or distal landing zones were performed when necessary. Computed tomography follow-up scans were performed before discharge, at 1, 6, and 12 months, and yearly thereafter. Three-dimensional reconstruction software with central line of flow measurements was used to assess aortic morphologic characteristics. Kaplan-Meier analysis was used to assess survival, freedom from reintervention, predictive factors of poor outcome, and morphologic changes, including aneurysm sac behavior.
Results
A total of 160 patients (44% women; mean age, 70) were treated for 130 thoracic aneurysms, 25 aortic dissections with aneurysm, 2 fistulas, and 3 symptomatic or aortic ruptures, or both. Mean follow-up was 36 months, and aneurysm size was 67 mm. Seventy-five patients (47%) had undergone prior aortic aneurysm repair. Surgical modifications were required to create adequate landing zones in 33% patients, including 28 elephant trunk/arch reconstruction, 22 carotid-subclavian bypasses, and seven visceral vessel bypasses. Iliac conduits were required in 31 patients. Early mortality (<30 days) occurred in 11 patients (6.9%). Overall mortality at 1 year was 16%. Aneurysm sac increase (>5 mm) requiring intervention was observed only in one patient in the settings of component separation and type III endoleak that was treated; the sac is now stable. Twenty-seven endoleaks were detected in 25 patients: 15 primary endoleaks (9.4%) <30 days and 12 secondary endoleaks (7.5%) >30 days. Secondary interventions were required in 42 patients (26%).
Conclusion
Endovascular treatment of thoracic aortic pathologies with the Zenith TX1 and TX2 devices is feasible and durable. The mid- to long-term results are encouraging, with acceptable low reintervention rates and with good survival within high-risk patients.
aDepartment of Vascular and Endovascular Surgery, Cleveland, Ohio
bDepartment of Thoracic and Cardiovascular Surgery, Cleveland, Ohio
cDepartment of Quantitive Health Science, Cleveland Clinic, Cleveland, Ohio.
Reprint requests: Roy K. Greenberg, MD, Cleveland Clinic, 9500 Euclid Ave, Desk S40, Cleveland, OH 44195.
Competition of interest: Dr Greenberg receives grants and research support from Cook Inc, W. L. Gore & Assoc, and Terarecon, is a consultant for Cook Inc and Boston Scientific, and receives other financial or material support from Cook Inc, Intellectual Property. Dr Clair is a paid consultant for Cordis, an unpaid consultant for Timna and Minnow Medical, is a speaker for FoxHollow, Cook Inc, W. L. Gore & Assoc, and OmniSonics, and is an advisory board member for Medtronic and Boston Scientific. Dr Lyden is a consultant for Cook Inc.
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