Survival and Reintervention Risk by Patient Age and Preoperative Abdominal Aortic Aneurysm Diameter after Endovascular Aneurysm Repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the standard of care for abdominal aortic aneurysm (AAA), but questions remain regarding the benefit in high-risk and elderly patients. The purpose of this study was to examine the effect of age, preoperative AAA diameter, and their interaction on survival and reintervention rates after EVAR. METHODS: Our integrated health system's AAA endograft registry was used to identify patients who underwent elective EVAR between 2010 and 2014. Of interest was the effect of patient age at the time of surgery (≤80 vs. >80 years old), preoperative AAA diameter (≤5.5 cm vs. >5.5 cm), and their interaction. Primary endpoints were all-cause mortality and reintervention. Between-within mixed-effects Cox models with propensity score weights were fit. RESULTS: Of 1,967 patients undergoing EVAR, unadjusted rates for survival at 4 years after EVAR was 76.1%, and reintervention-free rate was 86.0%. For mortality, there was insufficient evidence for an interaction between age and AAA size (P = 0.309). Patient age >80 years was associated with 2.53-fold higher mortality risk (hazard ratios [HR] = 2.53; 95% confidence intervals [CI], 1.73-3.70; P < 0.001), whereas AAA > 5.5 cm was associated with 1.75-fold higher mortality risk (HR = 1.75; 95% CI, 1.26-2.45; P = 0.001). For reintervention risk, there were no significant interactions or main effects for age or AAA diameter. CONCLUSIONS: Age and AAA diameter are independent predictors of reduced survival after EVAR, but the effect is not amplified when both are present. Age >80 years or AAA size >5.5 cm did not increase the risk of reintervention. No specific AAA size, patient age, or combination thereof was identified that would contraindicate AAA repair.

A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Registries have been proven useful to assess clinical outcomes, but data entry and personnel expenses are challenging. We developed a registry to track patients undergoing endovascular aortic aneurysm repair (EVAR) in an integrated health care system, leveraging an electronic medical record (EMR) to evaluate clinical practices, device performance, surgical complications, and medium-term outcomes. This study describes the registry design, data collection, outcomes validation, and ongoing surveillance, highlighting the unique integration with the EMR. METHODS: EVARs in six geographic regions of Kaiser Permanente were entered in the registry. Cases were imported using a screening algorithm of inpatient codes applied to the EMR. Standard note templates containing data fields were used for surgeons to enter preoperative, postoperative, and operative data as part of normal workflows in the operating room and clinics. Clinical content experts reviewed cases and entered any missing data of operative details. Patient comorbidities, aneurysm characteristics, implant details, and surgical outcomes were captured. Patients entered in the registry are followed up for life, and all relevant events are captured. RESULTS: Between January 2010 and June 2013, 2112 procedures were entered in the registry. Surgeon compliance with data entry ranges from 60% to 90% by region but has steadily increased over time. Mean aneurysm size was 5.9 cm (standard deviation, 1.3). Most patients were male (84%), were hypertensive (69%), or had a smoking history (79%). The overall reintervention rate was 10.8%: conversion to open repair (0.9%), EVAR revision (2.6%), other surgical intervention (7.3%). Of the reinterventions, 27% were for endoleaks (I, 34.3%; II, 56.9%; III, 8.8%; IV and V, 0.0%), 10.5% were due to graft malfunction, 3.4% were due to infection, and 2.3% were due to rupture. CONCLUSIONS: Leveraging an EMR provides a robust platform for monitoring short-term and midterm outcomes after abdominal aortic aneurysm repair. Use of standardized templates in the EMR allows data entry as part of normal workflow, improving compliance, accuracy, and data capture using limited but expert personnel. Assessment of patient demographics, device performance, practice variation, and postoperative outcomes benefits clinical decision-making by providing complete and adjudicated event reporting. The findings from this large, community-based EVAR registry augment other studies limited to perioperative and short-term outcomes or small patient cohorts.

Early and delayed rupture after endovascular abdominal aortic aneurysm repair in a 10-year multicenter registry.

OBJECTIVE: Rupture after abdominal endovascular aortic aneurysm repair (EVAR) is a function of graft maintenance of the seal and fixation. We describe our 10-year experience with rupture after EVAR. METHODS: From 2000 to 2010, 1736 patients with abdominal aortic aneurysm (AAA) from 17 medical centers underwent EVAR in a large, regional integrated health care system. Preoperative demographic and clinical data of interest were collected and stored in our registry. We retrospectively identified patients with postoperative rupture, characterized as "early" and "delayed" rupture (≤30 days and >30 days after the initial EVAR, respectively), and identified predictors associated with delayed rupture. RESULTS: The overall follow-up rate was 92%, and the median follow-up was 2.7 years (interquartile range, 1.2-4.4 years) in these 1736 EVAR patients. We identified 20 patients with ruptures; 70% were male, the mean age was 79 years, and mean AAA size at the initial EVAR was 6.3 cm. Six patients underwent initial EVAR for rupture (n = 2) or symptomatic presentation (n = 4). Of the 20 post-EVAR ruptures, 25% (five of 20) were early, all occurring within 2 days after the initial EVAR. Of these five patients, four had intraoperative adverse events leading directly to rupture, with one type I and one type III endoleak. Of the five early ruptures, four patients underwent endovascular repair and one received repair with open surgery, resulting in two perioperative deaths. Among the remaining 15 patients, the median time from initial EVAR to rupture was 31.1 months (interquartile range, 13.8-57.3 months). Most of these delayed ruptures (10 of 15) were preceded by AAA sac increases, including three patients with known endoleaks who underwent reintervention. At the time of delayed rupture, nine of 15 patients had new endoleaks. Among all 20 patients, six patients did not undergo repair (all delayed patients) and died, nine underwent repeated EVAR, and five had open repair. For patients who underwent repair for delayed rupture, mortality at 30 days and 1 year were 44.4% and 66.7%, respectively. Multivariable Cox regression analysis identified age 80 to 89 (hazard ratio, 3.3; 95% confidence interval, 1.1-9.4; P = .03), and symptomatic or ruptured initial indication for EVAR (hazard ratio, 7.4; 95% confidence interval, 2.2-24.8; P < .01) as significant predictors of delayed rupture. CONCLUSIONS: Rupture after EVAR is a rare but devastating event, and mortality after repair exceeds 60% at 1 year. Most delayed cases showed late AAA expansion, thereby implicating late loss of seal and increased endoleaks as the cause of rupture in these patients and mandating vigilant surveillance.

Ten-year results of endovascular abdominal aortic aneurysm repair from a large multicenter registry.

OBJECTIVE: To assess outcomes after endovascular abdominal aortic aneurysm repair (EVAR) in an integrated health care system. METHODS: Between 2000 and 2010, 1736 patients underwent EVAR at 17 centers. Demographic data, comorbidities, and outcomes of interest were collected. EVAR in patients presenting with ruptured or symptomatic aneurysms was categorized as urgent; otherwise, it was considered elective. Primary outcomes were mortality and aneurysm-related mortality (ARM). Secondary outcomes were change in aneurysm sac size, endoleak status, major adverse events, and reintervention. RESULTS: Overall, the median age was 76 years (interquartile range, 70-81 years), 86% were male, and 82% were Caucasian. Most cases (93.8%) were elective, but urgent use of EVAR increased from 4% in the first 5 years to 7.3% in the last 5 years of the study period. Mean aneurysm size was 5.8 cm. Patients were followed for an average of 3 years (range, 1-11 years); 8% were lost to follow-up. Intraoperatively, 4.5% of patients required adjunctive maneuvers for endoleak, fixation, or flow-limiting issues. The 30-day mortality rate was 1.2%, and the perioperative morbidity rate was 6.6%. Intraoperative type I and II endoleaks were uncommon (2.3% and 9.3%, respectively). Life-table analysis at 5 years demonstrated excellent overall survival (66%) and freedom from ARM (97%). Postoperative endoleak was seen in 30% of patients and was associated with an increase in sac size over time. Finally, the total reintervention rate was 15%, including 91 instances (5%) of revisional EVAR. The overall major adverse event rate was 7.9% and decreased significantly from 12.3% in the first 5 years to 5.6% in the second 5 years of the study period (P < .001). Overall ARM was worse in patients with postoperative endoleak (4.1% vs 1.8%; P < .01) or in those who underwent reintervention (7.6% vs 1.6%; P < .001). CONCLUSIONS: Results from a contemporary EVAR registry in an integrated health care system demonstrate favorable perioperative outcomes and excellent clinical efficacy. However, postoperative endoleak and the need for reintervention continue to be challenging problems for patients after EVAR.