Five-Year Results of the Valor II Trial of the Medtronic Valiant Thoracic Stent Graft

s from the 2015 New England Society for Vascular Surgery Annual Meeting Five-Year Results of the Valor II Trial of the Medtronic Valiant Thoracic Stent Graft Mark F. Conrad, James Tuchek, Robert Feezor, Joseph Bavaria, Ronald Fairman, Rodney White. Massachusetts General Hospital, Boston, Mass; Loyola University, Maywood, Ill; University of Florida, Gainesville, Fla; University of Pennsylvania, Philadelphia, PA; UCLA, Torrance, Calif Objectives: The 1-year results of endovascular exclusion of degenerative descending thoracic aortic aneurysms (DTAs) with the Valiant Thoracic Stent Graft (Medtronic Vascular) have been previously reported. With longterm follow-up now complete, this study reports the 5-year results. Methods: The VALOR II trial was a prospective, nonrandomized trial of the Valiant Thoracic Stent Graft system in patients with degenerative DTA. The trial involved 24 sites in the United States and enrolled patients between December 2006 and September 2009. Standard follow-up included physical examination, computed tomography, and chest radiography through 5 years. Results: The study enrolled 160 patients. The average age was 72.2 years (range, 36-85 years), 95 (59%) were men, 150 (94%) had hypertension, and 26 (16%) had renal insufficiency. There were 50 patients (31%) who presented with symptoms; back pain was the most common (34 [68%]). The average aneurysm diameter was 57 mm (range, 32-96 mm). A fusiform aneurysm was present in 103 patients (64%), and a saccular aneurysm or penetrating ulcer was present in 57 (36%). More than two devices were implanted in 126 patients (79%), and the maximum number of grafts implanted was four. There were 54 deaths during the study. The 5-year survival actuarial was 64%. There were eight aneurysm-related deaths (5 were #30 days of implant), and the 5-year freedom from aneurysm-related death was 95%. There was one conversion to open repair at 36 months. Eleven patients underwent 13 secondary procedures (9 for endoleak, 3 for aneurysm expansion, and 1 rupture). Five-year follow-up imaging was available for 56 patients. The average aortic diameter decreased >5 mm in 27 patients (48%), increased >5 mm in 6 patients (11%), and remained unchanged in 23 patients (41%). Conclusions: The VALOR II 5-year results demonstrate that the reintervention and aneurysm-related death rates are low. The Valiant thoracic stent graft is an effective treatment of degenerative DTA. Disclosures: M. F. Conrad: ConsultanteMedtronic, Volcano, Bard; J. Tuchek: ConsultanteMedtronic; R. Feezor: ConsultanteMedtronic, Advisory BoardeMedtronic; J. Bavaria: None; R. Fairman: None; R. White: ConsultanteMedtronic. High Angulation and Short Neck Length Do Not Impact AAA Sac Expansion After Repair Using the Lombard Aorfix Device Edward A. McGillicuddy, Mark F. Fillinger, William P. Robinson, Kim J. Hodgson, William D. Jordan, Adam W. Beck, Mahmoud B. Malas, Michael Belkin This abstract has been published in the Abstracts of the 2015 Vascular Annual Meeting: The Society for Vascular Surgery DOI: http://dx.doi. org/10.1016/j.jvs2015.04.341. Presentation, Surgical Intervention, and Long-Term Survival in Patients With Marfan Syndrome Nathan J. Aranson, Virendra I. Patel, Christopher A. Durham, Mark F. Conrad, R. Todd Lancaster, Thomas E. MacGillivray, Eric Isselbacher, Richard P. Cambria. Massachusetts General Hospital, Boston, Mass Objectives: Patients with Marfan syndrome (MS) often present with acute catastrophic aortic events at a young age and have a shortened life span. This study examined the effect of presentation and demographics on late survival in MS patients. Methods: Adults with confirmed MS in our thoracic aortic center (TAC) data set were identified, and statistical analysis was performed to identify the incidence and predictors of aortic interventions and late mortality. 1094 Results: We identified 305 patients with an MS diagnosis at age 12 [interquartile range, 6-18] years but presentation into our TAC at 32 [21-43] years. The average follow-up in our TAC was 12 6 9 years. Demographics were 42% male and 83% white race. Clinical features were coronary artery disease in 25%, hypertension in 37%, and peripheral vascular disease in 17%, and an anti-impulse agent in 45% (b-blocker, angiotensin-converting enzyme inhibitor, calcium channel blocker). Distribution of aortic pathology was Stanford type A in 69%, B in 8%, and combined in 23%. Primary aortic surgery was required in 181 patients (60%); 34% were emergency procedures. Primary procedures were cardiac (aortic valve/root) in nature in 94%. Seventy-three patients (40%) required two to three additional aortic procedures at a mean of 8 6 6 years, involving the thoracoabdominal aorta in 41%, thoracic aorta in 37%, and abdominal aorta in 21%. Patients who required distal aortic procedures were more likely (P 10 mm/y; 11% vs 3%). Multivariable analysis identified prior dissection as an independent predictor of additional aortic surgery (odds ratio, 4.2; 95% confidence interval [CI], 1.1-16; P 1⁄4 .03). Kaplan-Meier analysis showed similar 10-year survival with (85% 6 5%) or without (90% 6 3%) aortic interventions (P 1⁄4 not significant). Late mortality was associated with patient age (hazard ratio, 1.08 per year; 95% CI, 1.01-1.17; P < .01) and older age at presentation (hazard ratio, 1.1 per year; 95% CI, 1.06-1.2; P < .01) but was not associated with emergency procedures or multiple procedures. Conclusions: These data indicate that in the modern era, mode of presentation and need for multiple procedures have no effect on late survival. Presence of acute or chronic dissection predicts the need for additional aortic procedures during follow-up. Disclosures: N. J. Aranson: None; V. I. Patel: None; C. A. Durham: None; M. F. Conrad: None; R. Lancaster: None; T. E. MacGillivray: None; E. Isselbacher: None; R. P. Cambria: None. Simple Predictive Model of Early Failure Among Patients Undergoing First Time Arteriovenous Fistula (AVF) Creation Mohammad H. Eslami, Clara K. Zhu, Denis V. Rybin, Gheorghe Doros, Jeffrey Siracuse, Alik Farber. Boston Medical Center, Boston, Mass Objectives: We set out to create a predictive model of early outcomes in patients undergoing first-time arteriovenous fistula (AVF) creation. Methods: The hemodialysis access data set of the Vascular Surgery Group of New England database (2010-2014) was queried to identify patients undergoing first-time AVF creation. Patients with early AVF failure (EF) or no failure (NF) were compared. A multivariable logistic regression predictive model of EF based on perioperative clinical variables was created. Backward elimination with a level 1⁄4 0.2 was used to create a parsimonious model. The discriminatory ability of the parsimonious model was tested using the C statistic, and model fit was tested using Hosmer-Lemeshow goodness of fit test. Results: Of 1516 AVF cases collected in the database, 617 fit the inclusion criteria of first time AVF. Of these, 376 cases with follow-up data were used in our analyses. The early failure rate was 17.5%. Patients in the EF group had lower rates of hypertension (81.5% vs 93.2%; P 1⁄4 .003) and diabetes (46.9% vs 61.29%; P 1⁄4 .039). They were also more likely to have their AVF based on the radial artery (57.6% vs 38.4%; P 1⁄4 .004) and to have forearm cephalic vein outflow (57.6% vs 36.5%; P 1⁄4 .002). The mean diameters of target artery and vein were significantly smaller in the EF group. No differences in the discharge antiplatelet or antiplatelet medications were observed. The Table summarizes the parsimonious model predicting early AVF failure. Presence of hypertension, use of brachial (vs radial) artery, and target vein diameter were significantly protective of EF. The discriminating ability of this model was good (C statistic 1⁄4 0.759) and the model fit the data well (Hosmer-Lemeshow P 1⁄4 .459; Table).