Propensity-matched cohort validates findings of the VALOR trial.

The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial findings noted superior 30-day and 1-year outcomes of the Talent thoracic endograft (Medtronic Vascular, Santa Rosa, Calif) compared with surgical repair of descending thoracic aneurysms (DTAs). Data from 195 prospective thoracic endovascular aneurysm repair (TEVAR) patients treated with the Talent device and 189 retrospective controls undergoing open surgical repair (OSR) from three centers of excellence were included in the trial after completion of TEVAR enrollment and compared. Such comparisons are biased by baseline differences among TEVAR vs OSR, however, propensity score (PS) analysis can reduce bias and validate such comparisons. Logistic regression was used to generate a PS (range, 0-1) to identify baseline characteristics more likely in TEVAR. The PS estimated the probability that any patient would undergo TEVAR (eg, a PS of 0.99 represents a 99% chance a patient belongs to TEVAR). PSs were then generated for all patients, and TEVAR and OSR patients were divided into tertiles based on the PS to reduce up to 80% of inherent bias. Outcomes from the middle tertile (T2), patients equally likely (midrange PS) to be in TEVAR or OSR and therefore best matched, were compared using regression analysis and were also compared with the outcomes in the overall trial group. Correlates of membership in TEVAR were smaller aneurysm (P < .001), anticoagulants (P < .01), no previous abdominal aortic aneurysm (AAA) repair (P < .01), no peripheral vascular disease (P = .001), statin use (P = .002), aspirin use (P = .002), older age (P = .028), race (P = .007), male gender (P = .02), and heart failure (P = .035). T2 included 68 TEVAR (PS, 0.58 ± 0.2) and 67 OSR patients (PS, 0.46 ± 0.2). VALOR overall reported differences in aneurysm size (56 mm TEVAR vs 69 mm open) and prior AAA repair (19% TEVAR vs 37% open), and this adjusted to no differences in T2 patients. In the well-matched T2 cohort, TEVAR patients had similar 30-day mortality (0% vs 3% OSR; P = .2) and improved 1-year aneurysm-related mortality rates (0% TEVAR vs 8% OSR; P = .05) compared with the OSR patients. This finding was in concurrence with the VALOR trial reporting similar benefit in TEVAR patients. The all-cause 1-year mortality showed a favorable trend for TEVAR in the VALOR trial; however, in T2 patients, 1-year all-cause mortality was similar in both groups of patients (17% TEVAR vs 15% OSR; P = .8). Age (P = .01), history of cerebrovascular accident (P < .05), antiarrhythmia medication (P = .04), and renal disease (P < .03) independently predicted all-cause and aneurysm-related mortality by regression analysis. PS analysis is an important tool for elimination of bias inherent when retrospective controls are used. Its application to VALOR validates the long-term benefit in aneurysm-related mortality conferred by TEVAR in patients undergoing endovascular DTA repair.

Patel VI ，Conrad MF ，Kwolek CJ ，Ouriel K ，Fairman RM ，Cambria RP ... -  《-》

Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial.

Fairman RM ，Criado F ，Farber M ，Kwolek C ，Mehta M ，White R ，Lee A ，Tuchek JM ，VALOR Investigators ... -  《-》

Gender analysis of the pivotal results of the Medtronic Talent Thoracic Stent Graft System (VALOR) trial.

This study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial. The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days. VALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day "successful aneurysm treatment," defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004). TEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.

Jackson BM ，Woo EY ，Bavaria JE ，Fairman RM ... -  《-》

Endovascular versus open repair of ruptured descending thoracic aortic aneurysms: a nationwide risk-adjusted study of 923 patients.

Recent studies support the use of endovascular treatment for ruptured abdominal aortic aneurysms, but few studies have examined the use of thoracic endovascular aortic repair (TEVAR) for ruptured descending thoracic aortic aneurysm. We evaluated nationwide data regarding short-term outcomes of TEVAR and open aortic repair (OAR) for ruptured descending thoracic aortic aneurysm. From US Nationwide Inpatient Sample data, we identified 923 patients who underwent ruptured descending thoracic aortic aneurysm repair in 2006-2008 and who had no concomitant aortic disorders. Of these patients, 364 (39.4%) underwent TEVAR and 559 (60.6%) underwent OAR. Multivariable regression was used to assess the effect of TEVAR versus OAR after adjusting for potential confounding factors. Outcomes assessed were in-hospital mortality, complications, failure to rescue (defined as the mortality among patients in whom a complication develops), and disposition. Backward stepwise logistic regression was used to identify independent predictors of outcomes for each approach. Patients undergoing TEVAR were older (72 ± 12 years vs 65 ± 15 years; P < .001) and had a higher Deyo comorbidity index (4.19 ± 1.79 vs 3.14 ± 2.05; P < .001) than patients undergoing OAR. Unadjusted mortality was 23.4% (85/364) for TEVAR and 28.6% (160/559) for OAR. After risk adjustment, the odds of mortality, complications, and failure to rescue were similar for TEVAR and OAR (P > .1 for all), but patients undergoing TEVAR had a greater chance of routine discharge (odds ratio [OR] = 3.3; P < .001). An interaction was identified that linked hospital size and operative approach with risk of complications (P < .001). In smaller hospitals, TEVAR was associated with lower complication rates than OAR (OR = 0.21; P < .05). Regression analysis revealed that smaller hospital size predicted significantly higher rates of mortality (OR = 2.4; P < .05), complications (OR = 4.0; P < .005), and failure to rescue (OR = 51.12; P < .001) in those undergoing OAR but not in those undergoing TEVAR. Preexisting renal disorders substantially increased mortality risk (OR = 10.81; P < .001) and failure to rescue (OR = 309.54; P < .001) in patients undergoing TEVAR. Nationwide data for ruptured descending thoracic aortic aneurysm reveal equivalent mortality, complication rates, and failure to rescue for TEVAR and OAR but more frequent routine discharge with TEVAR. Unlike OAR outcomes, TEVAR outcomes were not poorer in smaller hospitals, where TEVAR produced fewer complications than OAR. Therefore, TEVAR may be an ideal alternative to OAR for ruptured descending thoracic aortic aneurysm, particularly in small hospitals where expertise in OAR may be lacking and immediate transfer to a higher echelon of care may not be feasible.

Gopaldas RR ，Dao TK ，LeMaire SA ，Huh J ，Coselli JS ... -  《-》

Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy.

Turnbull IC ，Criado FJ ，Sanchez L ，Sadek M ，Malik R ，Ellozy SH ，Marin ML ，Faries PL ... -  《-》