Anatomic characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular aneurysm repair.

Endovascular aneurysm repair (EVAR) has become the mainstay of treatment for abdominal aortic aneurysms (AAAs) requiring repair. Delayed rupture after EVAR represents a rare but potentially fatal complication. The purpose of this study was to review the frequency and characteristics of patients presenting with secondary rupture and to define the relationship between rupture after EVAR and initial compliance with instructions for use (IFU). This is a retrospective study of a prospectively maintained database. Patients presenting with delayed rupture after EVAR were identified from January 2002 to December 2014. Medical records and imaging were reviewed to define anatomic characteristics and compliance with IFU criteria. Demographics, comorbidities, preoperative imaging, and long-term outcomes were analyzed. Patients were divided into two groups according to compliance with IFU criteria. Outcomes included type of repair (open vs secondary endovascular) as well as perioperative morbidity and mortality. A total of 3081 patients underwent EVAR for AAA from 2002 to 2014. Of the 3081 patients, 45 experienced delayed rupture after EVAR. The mean time interval between initial repair and rupture was 38 months. All patients with delayed ruptures had a type Ia endoleak. Mean follow-up after secondary repair was 44.1 months, and overall mortality was 6.7% (n = 3). Patients were divided in two groups according to compliance with IFU criteria: within the IFU and outside the IFU. There was no significant difference in comorbidities between the two groups except smoking, which was more frequent in the outside the IFU group (25% vs 21%; P = .03). Patients repaired outside the IFU had a higher incidence of type Ia endoleak before presenting with a rupture (44% vs 6%; P = .001), more frequently required open repair (44% vs 12%; P = .002), and had higher perioperative mortality (10.3% vs 0%; P = .01). On review of preoperative computed tomography scans, the outside the IFU group had larger aneurysm sac diameters (7.2 vs 5.6 cm; P = .04), larger proximal neck diameters (28 vs 24 mm; P = .01), shorter proximal necks (12 vs 21 mm; P = .007), and a higher degree of neck angulation >40 degrees (56 vs 11%; P < .001). Delayed rupture after EVAR is a rare but potentially fatal complication. In patients presenting with secondary rupture, EVAR performed outside the IFU was associated with higher perioperative mortality and need for open repair. Careful selection of patients based on AAA anatomy and adherence to the IFU criteria may reduce the incidence of delayed rupture.

Zacharias N ，Warner CJ ，Taggert JB ，Roddy SP ，Kreienberg PB ，Ozsvath KJ ，Sternbach Y ，Darling RC 3rd ... -  《-》

No major difference in outcomes for endovascular aneurysm repair stent grafts placed outside of instructions for use.

Studies have shown that a sizable percentage of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is performed outside the instructions for use (IFU). We report our long-term outcomes after EVAR with respect to device-specific IFU. Computed tomography angiography data from a cohort of 566 patients meeting inclusion criteria who underwent elective EVAR between 2003 and 2014 were examined. Preoperative anatomic measurements for each patient were taken and compared with device-specific IFU. Primary outcomes included all-cause mortality and AAA-related mortality. Secondary outcomes were late-onset rupture, need for reintervention, endoleaks, aneurysm sac enlargement, and intraoperative and perioperative complications. Nine different stent grafts were placed in this set of patients with a mean follow-up of 3.54 ± 2.65 years. Most patients (465; 82.2%) were male, and the mean age was 74.8 ± 8.70 years. Overall, 176 patients (31.1%) fit all IFU anatomic criteria, and 535 patients (94.5%) fit at least half of IFU criteria. In patients, iliac artery diameter was most commonly outside of IFU (253; 44.7%). A total of 1114 iliac arteries were treated, with 463 (41.6%) treated outside of iliac artery diameter IFU; the majority of these (374; 80.7%) were larger than IFU. Demographics and comorbidities were comparable between the groups within and outside of IFU. AAA-related mortality and all-cause mortality were similar between these two groups, as was late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, and major intraoperative and perioperative complications. The sole statistically significant difference in secondary outcomes was increased perioperative blood transfusion needed in those treated outside the IFU, 13.2% vs 6.2% in those treated within IFU (P = .02); however, this was not associated with decreased access vessel diameter or iliac artery rupture. Despite most EVAR patients being treated outside of IFU, there was no difference in outcomes with respect to all-cause mortality or aneurysm-related mortality. In addition, with the exception of perioperative blood transfusions, there was no association between IFU adherence and late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, or most other major complications.

Beckerman WE ，Tadros RO ，Faries PL ，Torres M ，Wengerter SP ，Vouyouka AG ，Lookstein RA ，Marin ML ... -  《-》

Comparison of midterm results of endovascular aneurysm repair for ruptured and elective abdominal aortic aneurysms.

Endovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR. A retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed. The study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30). Durable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.

Oliveira-Pinto J ，Soares-Ferreira R ，Oliveira NFG ，Bastos Gonçalves FM ，Hoeks S ，Van Rijn MJ ，Raa ST ，Mansilha A ，Verhagen HJM ... -  《-》

The Impact of Aneurysm Morphology and Anatomic Characteristics on Long-Term Survival after Endovascular Abdominal Aortic Aneurysm Repair.

Hostile anatomic characteristics in patients undergoing endovascular abdominal aortic aneurysm repair (EVAR) and the placement of endografts not in concordance with the specific device anatomic guidelines (or instructions for use [IFU]) have shown decreased technical success of the procedure. But these factors have never been evaluated in regard to patient postoperative survival. We sought to assess the association between survival and (1) aneurysm anatomy and characteristics and (2) implantation in compliance with manufacturer's anatomic IFU guidelines in patients undergoing endovascular aortic aneurysm repair. The cohort included 273 consecutive patients who underwent EVAR at Baylor Heart and Vascular Hospital between January 1, 2002 and December 31, 2009 and had their preoperative computed tomography (CT) scan digitally retrievable. The CT scans and operative notes were then reviewed, and the anatomic severity grading (ASG) score, maximum aneurysm diameter, thrombus width, patency of aortic side branch vessels, and implantation in compliance with IFU guidelines were assessed. The unadjusted association between survival (assessed until November 1, 2011) and these variables was assessed with the Kaplan-Meier method. Moreover, propensity-adjusted (for a comprehensive array of clinical and nonclinical risk factors) proportional hazard models were developed to assess the adjusted associations. Seven (2.56%) patients died within 30 days from EVAR, and 88 (30.04%) patients died during the study follow-up. Patient mean survival was 6.3 years. The unadjusted analysis showed a statistically significant association between survival and thrombus width (P = 0.007), ASG score (P = 0.004), and implantation in compliance with IFU guidelines (P = 0.007). However, the adjusted analysis revealed that none of the anatomic and compliance factors were significantly associated with long-term survival (ASG, P = 0.149; diameter, P = 0.836; thrombus, P = 0.639; patency, P = 0.219; and implantation compliance, P = 0.219). Unfavorable aneurysm morphologic characteristics and endograft implantation not in compliance with IFU guidelines did not adversely affect patient survival after EVAR in this group of patients. This implies that unfavorable anatomy, even that which would necessitate implantation of the EVAR device outside of the IFU guidelines, should not necessarily contraindicate EVAR.

Mahajan A ，Barber M ，Cumbie T ，Filardo G ，Shutze WP Jr ，Sass DM ，Shutze W Sr ... -  《-》

Reintervention Rate after Open Surgery and Endovascular Repair for Nonruptured Abdominal Aortic Aneurysms.

We aim to determine the reintervention rate after open aortic aneurysm repair (OAR) or endovascular aneurysm repair (EVAR) according to compliance or noncompliance with the instructions for use (IFU) for commercial endovascular stent grafts. After exclusion of those with a ruptured abdominal aortic aneurysm (AAA) and isolated iliac artery aneurysm with or without a small AAA (diameter < 5 cm), 240 patients received OAR or EVAR for a nonruptured AAA between January 2006 and March 2016. EVAR was performed from October 2009. Patients were divided into 3 groups: OAR (n = 146), IFU EVAR (n = 42), and non-IFU EVAR (n = 52). Reintervention was defined as graft-related or laparotomy-related (with an abdominal incision after initial laparotomy) reoperations either during the index admission period or later. Final endoleak after EVAR was defined as persistent type I or III endoleak before exiting operating room after various procedures to eliminate the endoleak. There were 2 in-hospital deaths in the OAR group caused by reperfusion injury or pancreatitis. There was no in-hospital mortality in the EVAR group. Final endoleak was more common in non-IFU EVAR compared with IFU EVAR (17% vs. 0%; P = 0.004). The mean follow-up duration was 42.1 months, 25.3 months, and 25.0 months in the OAR, IFU EVAR, and non-IFU EVAR groups, respectively. Respective reintervention-free survival (RFS) rates at 1 and 3 years differed significantly by group: 97% and 95% in the OAR group, 100% and 96% in the IFU EVAR group, and 89% and 87% for non-IFU EVAR group (P = 0.043) with a higher reintervention rate in the non-IFU EVAR than in the OAR group. There was no significant difference in RFS rate between the OAR and IFU EVAR groups (P = 0.881). Overall survival (OS) rates at 1 and 3 years, respectively, were 94% and 78% in the OAR group, 90% and 86% in the IFU EVAR group, and 93% and 56% in the non-IFU EVAR group (P = 0.098). There were no significant differences between the OAR and IFU EVAR groups (P = 0.890). In contrast to IFU EVAR group, the RFS and OS rates of non-IFU EVAR group were lower than in the OAR group during mid-term follow-up. Final endoleak was more frequent, and reintervention was more commonly performed in the non-IFU group than in the IFU group. Therefore, performing EVAR in non-IFU situations should be planned carefully.

Hwang D ，Park S ，Kim HK ，Lee JM ，Huh S ... -  《-》