Three-Year Results of the Endurant Stent Graft System Post Approval Study.

BACKGROUND: Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system. METHODS: From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was abdominal aortic aneurysm (AAA)-related mortality, and secondary end points were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used for late outcomes. RESULTS: A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality rate was 1.1%, with 2 deceased patients in the perioperative period. All-cause mortality rate at 3 years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair through 3 years of follow-up. Only 11 patients (6.2%) had undergone reintervention at 3 years. Younger age was associated with reintervention (HR 3.3 per younger decade, 95% confidence interval 1.3-7.6, P < 0.01), but neck diameter, length, and angulation were not significantly associated with reintervention. CONCLUSIONS: The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 1 in 16 patients underwent reintervention by 3 years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, despite more liberal "Instructions For Use" parameters, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.

Early reintervention after open and endovascular abdominal aortic aneurysm repair is associated with high mortality.

OBJECTIVE: Although reinterventions are generally considered more common after endovascular aneurysm repair (EVAR) than after open surgical repair (OSR), less is known about reintervention in the early postoperative period. Furthermore, there are few data regarding the impact of early reintervention on 30-day mortality. We sought to evaluate the rates and types of reintervention after abdominal aortic aneurysm (AAA) repair and the impact of reintervention on postoperative mortality. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried from 2012 to 2014 for all intact, infrarenal AAA repairs. The 30-day reintervention was classified by Current Procedural Terminology (CPT) codes. Univariate analysis comparing patients with and without reintervention was performed with the Fisher exact test and Mann-Whitney U test. Logistic regression was used to identify predictors of reintervention and to assess the association between 30-day reintervention and mortality. RESULTS: We identified 5877 patients (OSR, 658 [11%]; EVAR, 5219 [89%]), of whom 261 underwent reintervention (OSR, 7.1%; EVAR, 4.1%; P < .01). Patients who underwent reintervention had larger aortic diameter (median, 5.7 cm vs 5.5 cm; P < .01), were more often symptomatic at presentation (16% vs 9.1%; P < .01), and were more likely to have renal insufficiency (7.7% vs 3.6%; P < .01) and history of prior abdominal operations (32% vs 26%; P = .04). Patients who underwent reintervention had higher 30-day mortality (OSR, 28% vs 2.8% [P < .001]; EVAR, 12% vs 1.0% [P < .001]) and major complications. Factors significantly associated with reintervention included open repair, diameter, symptom status, hypertension, and renal insufficiency. After adjusting for demographics, comorbidities, and type of repair, reintervention was independently associated with 30-day mortality after EVAR and OSR (odds ratio, 13; 95% confidence interval, 8-22; P < .001). CONCLUSIONS: Compared with EVAR, patients undergoing open infrarenal AAA repair were significantly more likely to undergo 30-day reintervention, which could be related to higher open anatomic complexity and lower experience of the surgeon with open repair. Reintervention after both EVAR and OSR was associated with a >10-fold increase in postoperative mortality, emphasizing the need to minimize the complications associated with reintervention.