Gustavo S Oderich1, Mark A Farber2, Pierre Galvagni Silveira3, Rami Tadros4, Michael Marin4, Mark Fillinger5, Michel Makaroun6, Jason Hemmer7, Meghan Madden7. 1. Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: oderich.gustavo@mayo.edu. 2. Division of Vascular and Endovascular Surgery, University of North Carolina, Chapel Hill, NC. 3. Department of Surgery, Universidade Federal de Santa Catarina, Florianopolis, Brazil. 4. Division of Vascular and Endovascular Surgery, Mount Sinai Medical Center, New York, NY. 5. Division of Vascular and Endovascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH. 6. Division of Vascular and Endovascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. 7. W. L. Gore & Associates, Inc, TAMBE Team, Flagstaff, Ariz.
Abstract
OBJECTIVE: This study reports the technical aspects and 30-day outcomes of the prospective, multicenter early feasibility study designed to evaluate the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz). METHODS: Thirteen patients with pararenal or extent IV thoracoabdominal aortic aneurysms were prospectively enrolled at five U.S sites and one non-U.S. site from 2014 to 2016. The TAMBE included four portals with either retrograde or antegrade renal portal configuration and used GORE VIABAHN Balloon-Expandable Endoprosthesis (W. L. Gore & Associates) for stenting of the renal and mesenteric arteries. The primary end point was procedural safety at 30 days, defined by absence of major adverse events, including any-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, severe acute kidney injury (>50% decline in estimated glomerular filtration rate), dialysis, and procedural blood loss >1000 mL. RESULTS: There were 11 male and two female patients with a mean age of 69 ± 8 years. Mean aneurysm diameter was 61 ± 13 mm. A total of 52 renal and mesenteric arteries were incorporated (4 vessels/patient). Technical success was achieved in 12 patients (92%). One patient had inadvertent occlusion of a right renal artery due to dissection. There was no mortality, aneurysm rupture, conversion to open repair, dialysis, or spinal cord injury. Mean length of hospital stay was 5 ± 3 days. At 30 days, four patients (31%) had major adverse events, all due to procedural blood loss >1000 mL. One patient had a type I endoleak at the distal renal branch, which was successfully treated by placement of an additional renal stent before dismissal. Computed tomography angiography at 30 days showed patent target vessels and no type I or type III endoleak. CONCLUSIONS: This study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms. The high technical success, no mortality, and low morbidity rate support continuation of clinical investigation in a larger population of patients.
OBJECTIVE: This study reports the technical aspects and 30-day outcomes of the prospective, multicenter early feasibility study designed to evaluate the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz). METHODS: Thirteen patients with pararenal or extent IV thoracoabdominal aortic aneurysms were prospectively enrolled at five U.S sites and one non-U.S. site from 2014 to 2016. The TAMBE included four portals with either retrograde or antegrade renal portal configuration and used GORE VIABAHN Balloon-Expandable Endoprosthesis (W. L. Gore & Associates) for stenting of the renal and mesenteric arteries. The primary end point was procedural safety at 30 days, defined by absence of major adverse events, including any-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, severe acute kidney injury (>50% decline in estimated glomerular filtration rate), dialysis, and procedural blood loss >1000 mL. RESULTS: There were 11 male and two female patients with a mean age of 69 ± 8 years. Mean aneurysm diameter was 61 ± 13 mm. A total of 52 renal and mesenteric arteries were incorporated (4 vessels/patient). Technical success was achieved in 12 patients (92%). One patient had inadvertent occlusion of a right renal artery due to dissection. There was no mortality, aneurysm rupture, conversion to open repair, dialysis, or spinal cord injury. Mean length of hospital stay was 5 ± 3 days. At 30 days, four patients (31%) had major adverse events, all due to procedural blood loss >1000 mL. One patient had a type I endoleak at the distal renal branch, which was successfully treated by placement of an additional renal stent before dismissal. Computed tomography angiography at 30 days showed patent target vessels and no type I or type III endoleak. CONCLUSIONS: This study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms. The high technical success, no mortality, and low morbidity rate support continuation of clinical investigation in a larger population of patients.
Authors: Emanuel R Tenorio; Marina F Dias-Neto; Guilherme Baumgardt Barbosa Lima; Anthony L Estrera; Gustavo S Oderich Journal: Ann Cardiothorac Surg Date: 2021-11
Authors: Christopher A Latz; Laura Boitano; Samuel Schwartz; Nicholas Swerdlow; Kirsten Dansey; Rens R B Varkevisser; Virendra Patel; Marc Schermerhorn Journal: J Vasc Surg Date: 2020-04-29 Impact factor: 4.268