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1-year Safety and efficacy of thoracic aortic stent grafting (TEVAR) in patients who are poor open surgical candidates: Results of the High Risk arm of the Valor Trial
Mark F. Conrad, MD1, Ronald M. Fairman, MD2, Richard P. Cambria, MD1, Mark Farber, MD3, Alan Matsumoto, MD4, David Williams, MD5, Frank J. Criado, MD6, Christopher J. Kwolek, MD1.
1Massachusetts General Hospital, Boston, MA, USA, 2University of Pennsylvania Hospital, Philadelphia, PA, USA, 3University of NOrth Carolina, Chapel Hill, NC, USA, 4University of Virginia, Charlottesville, VA, USA, 5University of Michigan, Ann Arbor, MI, USA, 6Union Memorial Hospital, Baltimore, MD, USA.

OBJECTIVES: The high risk arm of the Valor trial was designed to include patients who are poor open surgical candidates, have an acute aortic dissection with malperfusion syndrome/impending aortic rupture, and traumatic aortic injuries. The 1-year results of this trial are contained herein. METHODS: This is a prospective, non-randomized, multi-center trial designed to evaluate the safety and efficacy of TEVAR for several high risk aortic pathologies. Primary endpoints included all cause mortality and successful aneurysm exclusion at 30 days and 1 year. Secondary outcomes were freedom from major adverse events (MAE) and secondary procedures at 1 year. RESULTS: There were 137 patients enrolled in the study (102 (75%) high risk aneurysms, 18 (13%) dissections and 17 (12%) traumatic injuries). Clinical factors include: average age 72 yrs, 58% male, 20% diabetic, 48% with coronary disease and 46% were symptomatic. The paraplegia rate was 0.7% (1/137) and the stroke rate was 9% (12/137) with no difference by etiology. The 30 day mortality was 7% (12% trauma, 6% aneurysm, 11% dissection) while the 1 year mortality rate was 25% (33% dissection, 25% aneurysm, 18% trauma, ). Predictors of all cause mortality included: CVA, paraplegia and renal insufficiency. The 1 year aneurysm related mortality was 11%; there were 3 aneurysm ruptures. The majority of deaths in the dissection cohort (5/6) were aneurysm related. Secondary procedures were performed in 14 (10%) patients; 86% (12/14) were for endoleak. MAE occurred in 88 (64%) patients at 1 year with the majority (86%) occurring in the first 30 days. CONCLUSIONS: TEVAR can be accomplished with low mortality and paraplegia in patients who are poor open surgical candidates. MAE are frequent and the 1-year aneurysm related death rate remains 11% in this high risk population.


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