Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms

Gustavo Oderich, Mark A. Farber, Pierre Galvagni Silveira, Rami Tadros, Michael Marin, Mark Fillinger, Michel Makaroun, Jason Hemmer, Meghan Madden

Research output: Contribution to journalArticle

1 Citation (Scopus)

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 2 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.

Original languageEnglish (US)
JournalJournal of Vascular Surgery
DOIs
StateAccepted/In press - Jan 1 2019

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Thoracic Aortic Aneurysm
Feasibility Studies
Renal Artery
Endoleak
Mesenteric Arteries
Kidney
Aneurysm
Mortality
Dialysis
Length of Stay
Paraplegia
Glomerular Filtration Rate
Spinal Cord Injuries
Acute Kidney Injury
Respiratory Insufficiency
Stents
Dissection
Rupture
Ischemia
Stroke

Keywords

  • Feasibility
  • Thoracoabdominal aneurysm
  • Thoracoabdominal Branch Endoprosthesis (TAMBE)

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. / Oderich, Gustavo; Farber, Mark A.; Silveira, Pierre Galvagni; Tadros, Rami; Marin, Michael; Fillinger, Mark; Makaroun, Michel; Hemmer, Jason; Madden, Meghan.

In: Journal of Vascular Surgery, 01.01.2019.

Research output: Contribution to journalArticle

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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 2 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.",
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AU - Farber, Mark A.

AU - Silveira, Pierre Galvagni

AU - Tadros, Rami

AU - Marin, Michael

AU - Fillinger, Mark

AU - Makaroun, Michel

AU - Hemmer, Jason

AU - Madden, Meghan

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