Gustavo S Oderich1, Mark A Farber2, Darren Schneider3, Michel Makaroun4, Luis A Sanchez5, Andres Schanzer6, Adam W Beck7, Benjamin W Starnes8, Mark Fillinger9, Emanuel R Tenorio10, Min Chen11, Qing Zhou11. 1. Department of Cardiothoracic & Vascular Surgery, Advanced Aortic Research Program at the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, Tex. Electronic address: gustavo.oderich@uth.tmc.edu. 2. Division of Vascular Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC. 3. Division of Vascular and Endovascular Surgery, Department of Surgery, Cornell-Weil Medical Center, New York, NY. 4. Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. 5. Center for Advanced Medicine Heart & Vascular Center, Washington University, St Louis, Mo. 6. Division of Vascular Surgery, Department of Surgery, University of Massachusetts Medical School, Worcester, Mass. 7. Division of Vascular and Endovascular Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Ala. 8. Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash. 9. Division of Vascular Surgery, Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH. 10. Department of Cardiothoracic & Vascular Surgery, Advanced Aortic Research Program at the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, Tex. 11. Cook Research Incorporated, West Lafayette, Ind.
Abstract
PURPOSE: To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane, Australia) for juxtarenal abdominal aortic aneurysms (AAAs). METHODS: Sixty-seven patients (54 male, mean age 74 ± 8 years) were prospectively enrolled at 14 U.S. centers from 2005 to 2012. Fenestrated stent grafts were used in patients with infrarenal aortic neck lengths of 4 to 14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At 5 years, 42 of the 67 patients completed the final study follow-up, with clinical examination obtained in 41 and computed tomography imaging in 39. Outcomes adjudicated by a clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5 mm), device migration (≥10 mm), type I/III endoleak, and secondary interventions. RESULTS: Median follow-up was 59.8 months (range, 0.1-67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related) and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8 ± 4.2% and freedom from aneurysm-related mortality was 96.8 ± 2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, five (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in 2 vessels, and failed thrombectomy in 1 vessel. Primary and secondary renal target patency was 82.7 ± 4.1% and 95.7 ± 2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was 1 type IA endoleak (1.5%), 1 type IB endoleak (1.5%), 2 device migrations (3%), and 4 aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of 20 patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and 1 was for both indications. Freedom from secondary intervention was 63.5 ± 7.2% at 5 years. CONCLUSIONS: These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.
PURPOSE: To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane, Australia) for juxtarenal abdominal aortic aneurysms (AAAs). METHODS: Sixty-seven patients (54 male, mean age 74 ± 8 years) were prospectively enrolled at 14 U.S. centers from 2005 to 2012. Fenestrated stent grafts were used in patients with infrarenal aortic neck lengths of 4 to 14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At 5 years, 42 of the 67 patients completed the final study follow-up, with clinical examination obtained in 41 and computed tomography imaging in 39. Outcomes adjudicated by a clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5 mm), device migration (≥10 mm), type I/III endoleak, and secondary interventions. RESULTS: Median follow-up was 59.8 months (range, 0.1-67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related) and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8 ± 4.2% and freedom from aneurysm-related mortality was 96.8 ± 2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, five (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in 2 vessels, and failed thrombectomy in 1 vessel. Primary and secondary renal target patency was 82.7 ± 4.1% and 95.7 ± 2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was 1 type IA endoleak (1.5%), 1 type IB endoleak (1.5%), 2 device migrations (3%), and 4 aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of 20 patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and 1 was for both indications. Freedom from secondary intervention was 63.5 ± 7.2% at 5 years. CONCLUSIONS: These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.
Authors: Theresa-Marie Dachs; Sven Rudolf Hauck; Maximilian Kern; Catharina Klausenitz; Martin A Funovics Journal: Radiologie (Heidelb) Date: 2022-06-20
Authors: Matti Jubouri; Abedalaziz O Surkhi; Sven Z C P Tan; Damian M Bailey; Ian M Williams; Mohamad Bashir Journal: Front Cardiovasc Med Date: 2022-07-14