Incidence,natural course,and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data

ObjectiveThe purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date.MethodsPatients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak.ResultsThrough 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up.ConclusionsIn the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.     

Sex differences in perioperative outcomes after complex abdominal aortic aneurysm repair

ObjectiveFemale sex is associated with worse outcomes after infrarenal abdominal aortic aneurysm (AAA) repair. However, the impact of female sex on complex AAA repair is poorly characterized. Therefore, we compared outcomes between female and male patients after open and endovascular treatment of complex AAA.MethodsWe identified all patients who underwent complex aneurysm repair between 2011 and 2017 in the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Complex repairs were defined as those for juxtarenal, pararenal, or suprarenal aneurysms. We compared rates of perioperative adverse events between female and male patients stratified by open AAA repair and endovascular aneurysm repair (EVAR). We calculated propensity scores and used inverse probability-weighted logistic regression to identify independent associations between female sex and our outcomes.ResultsWe identified 2270 complex aneurysm repairs, of which 1260 were EVARs (21.4% female) and 1010 were open repairs (30.7% female). After EVAR, female patients had higher rates of perioperative mortality (6.3% vs 2.4%; P = .001) and major complications (15.9% vs 7.6%; P < .001) compared with male patients. In contrast, after open repair, perioperative mortality was not significantly different (7.4% vs 5.6%; P = .3), and the rate of major complications was similar (29.4% vs 27.4%; P = .53) between female and male patients. Furthermore, even though perioperative mortality was significantly lower after EVAR compared with open repair for male patients (2.4% vs 5.6%; P = .001), this difference was not significant for women (6.3% vs 7.4%; P = .60). On multivariable analysis, female sex remained independently associated with higher perioperative mortality (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.3-4.9; P = .007) and major complications (OR, 2.0; 95% CI, 1.3-3.2; P = .002) in patients treated with EVAR but showed no significant association with mortality (OR, 0.9; 95% CI, 0.5-1.6; P = .69) or major complications (OR, 1.1; 95% CI, 0.8-1.5; P = .74) after open repair. However, the association of female sex with higher perioperative mortality in patients undergoing complex EVAR was attenuated when diameter was replaced with aortic size index in the multivariable analysis (OR, 1.9; 95% CI, 0.9-3.9; P = .091).ConclusionsFemale sex is associated with higher perioperative mortality and more major complications than for male patients after complex EVAR but not after complex open repair. Continuous efforts are warranted to improve the sex discrepancies in patients undergoing endovascular repair of complex AAA.     

Risk factors for target vessel endoleaks after physician-modified fenestrated or branched endovascular aortic repair for postdissection thoracoabdominal aortic aneurysms

ObjectivePatients with postdissection thoracoabdominal aortic aneurysms (TAAAs) have been more likely to develop endoleaks than those with degenerative TAAAs after fenestrated or branched endovascular aortic repair (F/BEVAR). In the present study, we aimed to determine the risk factors for target vessel (TV)-related endoleaks after visceral segment F/BEVAR for postdissection TAAAs.MethodsWe performed a retrospective analysis of all patients with degenerative and postdissection TAAAs treated with F/BEVAR between 2017 and 2021. All the patients had undergone computed tomography angiography before and 3 months, 6 months, and annually after discharge. Two experienced vascular surgeons had used data from computed tomography angiography and vascular angiography to judge the presence of endoleaks. The study end points were mortality, aneurysm rupture, and the emergence of and reintervention for TV-related endoleaks.ResultsA total of 195 patients (mean age, 66 ± 10 years; 69% men) had undergone F/BEVAR for 99 postdissection TAAAs and 96 degenerative TAAAs. During a mean follow-up of 16 ± 12 months, we found that the patients with postdissection TAAAs were younger (age, 64 ± 10 years vs 69 ± 9 years; P = .001), had required more prior aortic repairs (58% vs 40%; P = .012), and had had a higher body mass index (26.1 ± 3.4 kg/m² vs 24.8 ± 3 kg/m²; P = .008), a larger visceral segment aortic diameter (47.1 ± 7.5 mm vs 44.5 ± 7.5 mm; P = .016), and more TV-related endoleaks (18% vs 7%; P = .023) compared with those with degenerative TAAAs. Of the 99 patients with postdissection TAAAs, 327 renal–mesenteric arteries were revascularized using 12 scallops, 141 fenestrations, and 174 inner or outer branch stents. A total of 25 TV-related endoleaks were identified among 18 patients during follow-up, including 6 type Ic (retrograde from the distal end of the branch), 3 type IIIb (bridging stent fabric tear), and 16 type IIIc endoleaks (detachment or loose connection of the bridging stent). The patients with an endoleak had had a larger visceral aortic diameter (52.7 ± 6.4 mm vs 45.8 ± 7.2 mm; P < .001) and had undergone revascularization of more TVs (3.7 ± 0.7 vs 3.2 ± 0.9; P = .032). In contrast, true lumen compression did not seem to affect the occurrence of TV endoleaks (39% vs 27%; P = .323). The use of presewn branch stents in the fenestration position was associated with a lower risk of TV-related endoleaks (5% vs 11%; P = .025). In addition, TVs derived entirely or partially from the false lumen were more prone to the development of endoleaks after reconstruction (19% vs 4% [P < .001]; and 15% vs 4% [P = .047], respectively).ConclusionsWe found that patients with postdissection TAAAs were more likely to have TV-related endoleaks after F/BEVAR in the visceral region than those with degenerative TAAAs. Additionally, patients with a larger aortic diameter and a greater number of fenestrations in the visceral region were more likely to have experienced TV-related endoleaks. Branch vessels deriving from the false lumen were also more likely to develop endoleaks after reconstruction, and prefabricated branch stents were related to a lower possibility of TV-related endoleaks.     

Two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal,suprarenal, and thoracoabdominal aneurysms at a single institution

ObjectiveDespite numerous recent pivotal and small-scale trials, real-world endovascular management of juxtarenal aneurysms (JRA), suprarenal aneurysms (SRA), and thoracoabdominal aortic aneurysms (TAAA) remains challenging without consensus best practices. This study evaluated the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs.MethodsThis retrospective review of consecutive included patients with JRA, SRA, or TAAA who underwent complex endovascular repair from August 2014 to March 2017 at one high-volume institution. Treatment modality was a single surgeon decision based on patients anatomy and the urgency of the repair. Patient demographics, hospital course, and follow-up visits inclusive of imaging were analyzed. Ruptured aneurysms were excluded. Survival rates and outcomes were determined using the Kaplan-Meier method with log-rank tests.ResultsSeventy complex endovascular aortic repairs were performed; 38 patients with TAAA were treated with snorkel/sandwich parallel endografts (21 celiac, 28 superior mesenteric arteries, 58 renal arteries) and 32 patients with JRA/SRA were treated by fenestrated endovascular aneurysm repair (FEVAR) with 94 total fenestrations (2 celiac, 30 SMA, 62 renal). The mean patient age was 74.8 ± 10.0 years. Sixty percent were male, and the mean aortic aneurysm diameter was 6.0 ± 1.4 cm. Perioperative mortality was 3.1% (1/32) for FEVAR compared with 2.6% (1/38) for parallel endografts (P = .9). All-cause reintervention rates were 15.6% in FEVAR (5/32) vs 23.6% with parallel endografts (9/38; P = .4). Branch reintervention rates per each branch endograft were 4.3% for FEVAR (4/94; 2 renal stent occlusions, 1 colonic ischemia without technical issue found on reintervention, 1 perinephric hematoma) vs 3.7% for parallel endografts (4/107; 2 renal and 1 celiac stent thromboses, and 1 renal stent kink; P = .41). The endograft branch thrombosis rate was 2.1% in FEVAR (2/94) vs 2.7% in parallel endografts (3/109; P = .77). Reinterventions owing to endoleaks were performed in five patients (2 type I, 2 type III, and 1 gutter endoleak; 13.1%) with parallel grafts vs no endoleak reinterventions in FEVAR. The overall survival and freedom from aneurysm-related mortality at 24 months was 78% and 96.9% in FEVAR vs 73% and 93.4% for parallel endografts (P = .8 and P = .6). The median follow-up was 12 months (range, 1-32 months).ConclusionsParallel and fenestrated endografts have acceptable and comparable mortality and patency rates in endovascular treatment of JRA, SRA, and TAAA. This study reaffirms that parallel endografts are a safe and viable alternative to fenestrated devices for complex aortic aneurysmal disease despite often treating more urgent patients and more complicated anatomy unable to be treated with FEVAR.     

A propensity score-matched comparison of two commercially available iliac branch devices in patients with similar clinical and anatomic preoperative features

ObjectiveThe objective of this study was to compare the perioperative and midterm results of Zenith Bifurcated Iliac Side (ZBIS; Cook Medical, Bloomington, Ind) and Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) iliac branch devices (IBDs) in treatment of dilated iliac bifurcations in patients with similar anatomic and clinical preoperative features.MethodsBetween July 2007 and May 2018, 190 IBDs were implanted at two high-volume Italian vascular and endovascular centers. Among the series, preoperative propensity score matching based on preoperative anatomic and clinical factors was performed, and two homogeneous groups were created: group 1, 35 Cook ZBIS IBD implants; and group 2, 35 Gore IBE devices. Early results were analyzed in terms of technical success, death, conversion to open surgery, and occurrence of major local and systemic complications. Follow-up results were analyzed in terms of patency of the IBD, freedom from type I and type III endoleaks, aneurysm-related reintervention, and aneurysm-related death.ResultsTechnical success was achieved in all implants from both groups. Perioperative IBD-related complications and major complications occurred in one case from group 1 (P = .49). No perioperative mortality was recorded in the two groups. Mean postoperative follow-up was 46.7 months in group 1 (standard deviation, ± 36.3) and 20.8 months in group 2 (standard deviation, ± 15.9; P < .0001). None of the IBDs or target hypogastric arteries occluded during follow-up in this series. Estimated 36-month freedom from type I and type III endoleaks was 97% (standard error [SE], 0.03) in group 1 and 87% (SE, 0.09) in group 2 (P = .34; log-rank, 0.9). Estimated freedom from IBD-related reintervention was 97% (SE, 0.03) in group 1 and 93% (SE, 0.06) in group 2 (P = .81; log-rank, 0.05). The estimated rates of overall survival at 36 months from the IBD implantation were 95% (SE, 0.04) in group 1 and 88% (SE, 0.08) in group 2 (P = .03; log-rank, 4.7); freedom from aneurysm-related death was 100% in group 1 and 93% (SE, 0.06) in group 2 (P = .19; log-rank, 1.7).ConclusionsThe propensity score-matched comparison between the Cook ZBIS and Gore IBE devices showed similar, satisfying perioperative and midterm results in the experience of two high-volume Italian vascular centers.     

Female sex is independently associated with reduced inpatient mortality after endovascular repair of blunt thoracic aortic injury

BackgroundFemale sex has been associated with decreased mortality after blunt trauma, but whether sex influences the outcomes of thoracic endovascular aortic repair (TEVAR) for traumatic blunt thoracic aortic injury (BTAI) is unknown.MethodsIn this retrospective study of a prospectively maintained database, the Vascular Quality Initiative registry was queried from 2013 to 2020 for patients undergoing TEVAR for BTAI. Univariate Student’s t-tests and χ² tests were performed, followed by multivariate logistic regression for variables associated with inpatient mortality.ResultsOf 806 eligible patients, 211 (26.2%) were female. Female patients were older (47.9 vs 41.8 years, P < .0001) and less likely to smoke (38.3% vs 48.2%, P = .044). Most patients presented with grade III BTAI (54.5% female, 53.6% male), followed by grade IV (19.0% female, 19.5% male). Mean Injury Severity Scores (30.9 + 20.3 female, 30.5 + 18.8 male) and regional Abbreviated Injury Score did not vary by sex. Postoperatively, female patients were less likely to die as inpatients (3.8% vs 7.9%, P = .042) and to be discharged home (41.4% vs 52.2%, P = .008). On multivariate logistic regression, female sex (odds ratio [OR]: 0.05, P = .002) was associated with reduced inpatient mortality. Advanced age (OR: 1.06, P < .001), postoperative transfusion (OR: 1.05, P = .043), increased Injury Severity Score (OR: 1.03, P = .039), postoperative stroke (OR: 9.09, P = .016), postoperative myocardial infarction (OR: 9.9, P = .017), and left subclavian coverage (OR: 2.7, P = .029) were associated with inpatient death.ConclusionsFemale sex is associated with lower odds of inpatient mortality after TEVAR for BTAI, independent of age, injury severity, BTAI grade, and postoperative complications. Further study of the influence of sex on postdischarge outcomes is needed.     

Prognosis review and time-to-event data meta-analysis of endovascular aneurysm repair outside versus within instructions for use of aortic endograft devices

BackgroundOur objective was to investigate whether patients undergoing standard endovascular aneurysm repair (EVAR) outside the instructions for use (IFU) have worse outcomes than patients treated within IFU.MethodsWe conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Electronic bibliographic sources were searched up to January 2019 using a combination of controlled vocabulary (thesaurus) and free-text terms to identify studies comparing outcomes of EVAR in patients treated outside versus within IFU. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI). We conducted a time-to-event data meta-analysis using the inverse-variance method and reported the results as summary hazard ratio (HR) and associated 95% CI. Random-effects methods of meta-analysis were applied. We formed meta-regression models to explore heterogeneity as a result of changes in practice over time.ResultsWe identified 17 observational cohort studies published between 2011 and 2017, reporting a total of 4498 patients. The pooled prevalence of EVAR performed outside the IFU was 40% (95% CI, 33-48). Nonadherence to IFU was not associated with increased risk of perioperative mortality (RD, 0.01; 95% CI, −0.00 to 0.01; P = .23), aneurysm rupture (HR, 1.34; 95% CI, 0.30-5.93; P = .70), aneurysm-related mortality (HR, 0.88; 95% CI, 0.20-3.84; P = .86), technical failure (RD, 0.01; 95% CI, −0.03 to 0.05; P = .56), requirement for adjunctive procedures (OR, 1.48; 95% CI, 0.81-2.71; P = .20), type I endoleak (HR, 2.28; 95% CI, 0.58-8.91; P = .24), aneurysm sac expansion (HR, 0.86; 95% CI, 0.55-1.33; P = .49), or aneurysm-related reintervention (HR, 1.04; 95% CI, 0.81-1.34; P = .74). The overall mortality was significantly higher in patients treated outside the IFU (HR, 1.20; 95% CI, 1.02-1.42; P = .03). Meta-regression showed that the prevalence of EVAR performed outside the IFU has increased over time (P = .019).ConclusionsStandard EVAR outside the IFU was not found to have worse aneurysm-related outcomes than treatment within the IFU. Standard EVAR outside the IFU could be considered in selected patients who are deemed high risk for complex open or endovascular surgery.     

Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms

ObjectiveThe objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms.MethodsPatients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention.ResultsThere were 126 patients (61% male; mean age, 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (−7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months vs 8±8 months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% vs 96% ± 2%; P = .004), freedom from TAI (96% ± 2% vs 88% ± 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% ± 1% vs 92% ± 3%; P = .0004), and freedom from target artery reinterventions (98% ± 1% vs 88% ± 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% vs 99% ± 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001).ConclusionsDirectional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.     

One-year sac regression is associated with freedom from fatal adverse events after endovascular aneurysm repair

ObjectiveAlthough the predictors of long-term prognosis after endovascular aneurysm repair (EVAR) have been investigated, several reports have suggested that early sac shrinkage (ESS) is associated with superior long-term prognosis. However, it was not clear whether ESS was associated with aneurysm-related mortality. The aim of this study was to define fatal adverse events and to examine their association with ESS.MethodsAll consecutive patients who underwent EVAR for an abdominal aortic aneurysm at Nagoya University Hospital between June 2007 and August 2018 were identified. We defined ESS as an aneurysm diameter decrease of 10 mm or more at 1 year after EVAR, and we defined fatal adverse events as aneurysm-related death, aneurysm sac rupture, open conversion, secondary type Ia endoleak, or secondary type IIIa/b endoleak. Then, we evaluated the association between ESS and fatal adverse events and identified predictors of ESS.ResultsDuring the study period, 553 patients were identified and included. Fatal adverse events occurred in 42 patients (7.6%), and the details of the fatal adverse events were as follows: 13 aneurysm-related deaths, 17 aneurysm sac ruptures, 14 open conversions, 13 type Ia endoleaks, and 6 type III endoleaks. ESS occurred in 146 patients (26.4%). Kaplan-Meier curves showed that the ESS group had a significantly lower incidence of fatal adverse events (P < .001). Multivariate analysis showed that there were significant differences in terms of 5 or more preoperatively patent lumbar arteries (odds ratio [OR], 0.67; P = .049; 95% confidence interval [CI], 0.45-1.00), chronic kidney disease (OR, 0.49; P < .01; 95% CI, 0.29-0.84), and Zenith endograft use (OR, 1.76; P < .01; 95% CI, 1.16-2.67). Furthermore, the percentage of cases that achieved an aneurysm diameter of less than 40 mm was significantly higher in the ESS group (76.0% vs 15.5%; P < .01). The use of Zenith endografts showed a significantly higher rate of aneurysm disappearance than the use of Endurant endografts (P < .01) and Excluder endografts (P < .01). In addition, it was found that ESS was more likely to occur with the use of Zenith endografts, even when propensity score matching was performed for the neck morphology.ConclusionsESS was associated with a lower rate of life-threatening adverse events after EVAR. The use of Zenith endografts was a predictor of ESS and was associated with increased rates of long-term sac shrinkage and aneurysm disappearance compared with the Endurant and Excluder endografts. Using the predictors of ESS identified in this study, we may be able to expand the indications for EVAR to patients with a longer life expectancy.     

Impact of suprarenal neck angulation on endovascular aneurysm repair outcomes

BackgroundHostile infrarenal proximal neck (β) anatomy of abdominal aortic aneurysm has been associated with increased risk of aneurysm-related complications after endovascular aneurysm repair (EVAR). However, there is a paucity of literature addressing the suprarenal angle (α). The aim of this study was to evaluate short- and long-term outcomes after EVAR in patients with severe suprarenal neck angulation (α >60 degrees).MethodsA retrospective review of the medical records of 561 patients who underwent EVAR between January 2005 and December 2017 was performed. The main exclusion criteria were preoperative aneurysm rupture and fenestrated or branched endograft placement. High-resolution computed tomography images of 452 patients were available. Patients were grouped into angulated (α >60 degrees) and nonangulated (α ≤60 degrees) groups. The primary end point was freedom from type IA endoleak. Secondary end points included 30-day mortality, long-term survival, primary clinical success, and freedom from aneurysm rupture and graft migration. Primary clinical success was defined according to Society for Vascular Surgery guidelines as clinical success without the need for an additional or secondary surgical or endovascular procedure.ResultsOf 452 patients, 45 (10%) were included in the angulated group (α >60 degrees). Median follow-up time was 34 months (interquartile range, 14-56 months). Compared with patients in the nonangulated group, those in the angulated group had larger neck diameter at the level of the renal arteries (mean [standard deviation], 25.6 [3.8] mm vs 24.6 [3.4] mm; P = .06) and increased β angle (mean [standard deviation], 50.5 [22.9] degrees vs 41.6 [23.9] degrees; P = .01). The 3-year freedom from type IA endoleak estimate was 80.2% for the angulated group compared with 97.8% for the nonangulated group (P < .001). The angulated group showed significantly higher 30-day mortality (11.1% vs 0.25%; P < .001).The 3-year results showed that patients in the nonangulated group had higher rates of primary clinical success (90.2% vs 67.1%; P < .001), freedom from rupture (99% vs 97.1%; P = .02), freedom from migration (100% vs 92.4%; P < .001), and long-term survival (91.6% vs 75.8%; P = .006) compared with those in the angulated group. After adjustment for age, sex, neck diameter, and β angle, severe suprarenal neck angulation was associated with higher odds of type IA endoleak (adjusted hazard ratio, 8.9; 95% confidence interval [CI], 2.9-27), loss of primary clinical success (adjusted hazard ratio, 4.8; 95% CI, 2.6-8.9), and 30-day mortality (adjusted odds ratio, 52.5; 95% CI, 5.3-514) compared with α ≤60 degrees (all P < .001).ConclusionsThis is the first report to show a significant increase in operative mortality in patients undergoing EVAR with severely angulated suprarenal neck. Patients who survive the operation are at increased risk of secondary interventions. These findings suggest that EVAR should be used with caution in patients with severe α angulation and underpin the role of close follow-up in this particular population.     

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm

ObjectiveThe aim of this study was to compare midterm results of EndoAnchors in EndoSuture aneurysm repair (ESAR) versus fenestrated endovascular aneurysm repair (FEVAR) in short neck abdominal aortic aneurysm (AAA).MethodsAll patients who underwent an ESAR procedure for a short neck AAA at our center between September 2017 and May 2020 were considered for analysis. To form the control group, preoperative computed tomography angiography of patients who underwent FEVAR for juxtarenal AAA between April 2012 and May 2020 were reviewed and patients who met short neck criteria selected. A propensity-matched score on neck length and neck diameter was calculated, resulting in 18 matched pairs. AAA shrinkage, type Ia endoleaks (EL), AAA-related reinterventions, and AAA-related deaths were compared.ResultsThe median AAA diameter was 54 mm (interquartile range [IQR], 52-61 mm) versus 58 mm (IQR, 53-63 mm) with a median neck length of 8 mm (IQR, 6-12 mm) vs 10 mm (IQR, 6-13 mm) in ESAR and FEVAR patients, respectively. Technical success was 100% in both groups. Procedural success was 94% in the ESAR group versus 100% in the FEVAR group. The median procedure duration was 138 mm (IQR, 113-182 mm) vs 240 mm (IQR, 199-293 mm) ( P < .001) and the median length of stay was 2 days (IQR, 2-3 days) vs 7 days (IQR, 6-7 days) (P < .001) in ESAR and FEVAR patients, respectively. No major hospital complications were observed in ESAR patients compared with two in FEVAR patients (11%) with one transient acute kidney injury and one transient paraplegia. The median follow-up was 23 months (IQR, 19-33 months) vs 36 months (IQR, 22-57 months) with 67% versus 61% AAA shrinkage in the ESAR and FEVAR groups, respectively (P = .73). No type Ia EL, proximal neck-related reinterventions, or AAA-related deaths were observed in either group. No AAA-related reintervention was observed in the ESAR group versus three reinterventions in the FEVAR group (P = .23).ConclusionsESAR seems to be a safe technique with no major postoperative complications or reinterventions observed during follow-up. It seems to offer similar midterm results as FEVAR in terms of type Ia EL, aneurysm shrinkage, and aneurysm-related mortality. ESAR seems to be a good off-the-shelf alternative to FEVAR in case of technical constraints.     

Mortality analysis of endovascular aneurysm sealing versus endovascular aneurysm repair

BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.     

Systematic review and meta-analysis of sex differences in outcomes after endovascular aneurysm repair for infrarenal abdominal aortic aneurysm

ObjectiveWomen face distinctive challenges when they receive endovascular aneurysm repair (EVAR) treatment, and according to the previous studies, sex differences in outcomes after EVAR for infrarenal abdominal aortic aneurysm (AAA) remains controversial. This study aimed to compare the short-term and long-term outcomes between women and men after EVAR for infrarenal AAA.MethodsWe conducted a comprehensive systematic review and meta-analysis of all available studies reporting sex differences after EVAR for infrarenal AAA, which were retrieved from the MEDICINE, Embase, and Cochrane Database. The pooled results were presented as odds ratios (ORs) for dichotomous data and hazard ratios for time-to-event data using a random effect model.ResultsThirty-six cohorts were included in this meta-analysis. The pooled results showed that women were associated with a significantly increased risk of 30-day mortality (crude OR, 1.67; 95% confidence interval [CI], 1.50-1.87; P < .001; adjusted OR, 1.73; 95% CI, 1.32-2.26; P < .001), in-hospital mortality (OR, 1.90; 95% CI, 1.43-2.53; P < .001), limb ischemia (OR, 2.44; 95% CI, 1.73-2.43; P < .001), renal complications (OR, 1.73; 95% CI, 1.12-2.67; P = .028), cardiac complications (OR, 1.68; 95% CI, 1.01-2.80; P = .046), and long-term all-cause mortality (hazard ratio, 1.23; 95% CI, 1.09-1.38; P = .001) compared with men; however, no significant sex difference was observed for visceral/mesenteric ischemia (OR, 1.62; 95% CI, 0.91-2.88; P = .098), 30-day reinterventions (OR, 1.37; 95% CI, 0.95-1.98; P = .095), late endoleaks (OR, 1.18; 95% CI, 0.88-1.56; P = .264), and late reinterventions (OR, 1.05; 95% CI, 0.78-1.41; P = .741). In the intact AAA subgroup, women had a significantly increased risk of visceral/mesenteric ischemia (OR, 1.85; 95% CI, 1.01-3.39; P = .046) and an equivalent risk of cardiac complications (OR, 1.64; 95% CI, 0.85-3.17; P = .138) compared with men.ConclusionsCompared with male sex, female sex is associated with an increased risk of 30-day mortality, in-hospital mortality, limb ischemia, renal complications, cardiac complications, and long-term all-cause mortality after EVAR for infrarenal AAA. Women should be enrolled in a strict and regular long-term surveillance after EVAR.     

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms

ObjectivePhysician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custom-made fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs).MethodsIn this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks.ResultsNinety-seven patients were included (CMSGs, n = 69; PMSGs, n = 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n = 14 [50%] vs n = 16 [23%]; P = .006) and more TAAAs (n = 17 [61%] vs n = 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n = 3) in the CMSG group and 14% in the PMSG group (n = 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P = .004). Rates of postoperative complications were 22% (n = 15) and 25% (n = 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n = 3) and 7% (n = 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n = 11) in the CMSG group and 32% (n = 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n = 207/210). All target vessels (n = 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n = 16) vs 8% of the PMSG group (n = 2).ConclusionsOur study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.     

Clinical presentation,operative management,and long-term outcomes of rupture after previous abdominal aortic aneurysm repair

ObjectiveThe aim of the present study was to evaluate the presentation trends, intervention, and survival of patients who had been treated for late abdominal aortic aneurysm rupture (LAR) after open repair (OR) or endovascular aortic aneurysm repair (EVAR).MethodsWe reviewed the clinical data from a single-center, retrospective database for patients treated for LAR from 2000 to 2020. The end points were the 30-day mortality, major postoperative complication, and survival. The outcomes between LAR managed with EVAR (group I) vs OR were compared (group II).ResultsOf 390 patients with infrarenal aortic rupture, 40 (10%) had experienced aortic rupture after prior aortic repair and comprised the LAR cohort (34 men; age 78 ± 8 years). LAR had occurred before EVAR in 30 and before OR in 10 patients. LAR was more common in the second half of the study with 32 patients after 2010. LAR after prior OR was secondary to ruptured para-anastomotic pseudoaneurysms. After initial EVAR, LAR had occurred despite reintervention in 17 patients (42%). The time to LAR was shorter after prior EVAR than after OR (6 ± 4 vs 12 ± 4 years, respectively; P = .003). Treatment for LAR was EVAR for 25 patients (63%; group I) and OR for 15 (37%, group II). LAR after initial OR was managed with endovascular salvage for 8 of 10 patients. Endovascular management was more frequent in the latter half of the study period. In group I, fenestrated repair had been used for seven patients (28%). Salvage for the remaining cases was feasible with EVAR, aortic cuffs, or limb extensions. The incidence of free rupture, time to treatment, 30-day mortality (8% vs 13%; P = .3), complications (32% vs 60%; P = .1), and disposition were similar between the two groups. Those in group I had had less blood loss (660 vs 3000 mL; P < .001) and less need for dialysis (0% vs 33%; P < .001) than those in group II. The median follow-up was 21 months (interquartile range, 6-45 months). The overall 1-, 3-, and 5-year survival was 76%, 52%, and 41%, respectively, and was similar between groups (28 vs 22 months; P = .48). Late mortality was not related to the aorta.ConclusionsLAR after abdominal aortic aneurysm repair has been encountered more frequently in clinical practice, likely driven by the frequency of EVAR. However, most LARs, including those after previous OR, can now be salvaged with endovascular techniques with lower morbidity and mortality.     

Aortoiliac remodeling and 5-year outcome of an ultralow-profile endograft

BackgroundRemodeling of the aortoiliac anatomy is a challenge to the long-term performance of stent grafts for endovascular aneurysm repair. Changes in vessel diameter and length can result in loss of seal at attachment sites, limb disunion, or kinking, with the development of high-pressure endoleaks, migration, or limb occlusion. The aim of this study was to assess the durability and conformability of the ultralow-profile INCRAFT AAA endograft (Cordis Corporation, Milpitas, Calif) during 5-year follow-up.MethodsFrom 2010 to 2011, there were 60 patients (median age, 74 years; range, 60-94 years) with intact abdominal aortic aneurysms who were enrolled in the INNOVATION trial to evaluate the safety, effectiveness, and durability of the INCRAFT AAA device. Clinical and technical success was assessed with protocol-specified, monitored follow-up clinic visits and core laboratory-assessed computed tomography (CT) at 1 month, 6 months, and 12 months after implantation and annually through 5 years thereafter. Diameter and angulation changes at the proximal aortic neck and diameter changes at the iliac attachment zones were measured in addition to the standard CT assessments.ResultsSignificant aortoiliac remodeling was observed throughout long-term follow-up after endovascular aneurysm repair. Proximal aortic neck diameter 15 mm below the lowest main renal artery increased from 23.5 ± 2.5 mm at 1 month to 27.3 ± 2.8 mm at 5 years (P = .002). Neck dilation >5 mm was observed in 8 of 38 patients with 5-year CT studies (21%). The aortic neck straightened, with angulation decreasing from 34 ± 14 degrees preoperatively to 31 ± 11 degrees at 1 month (P < .001) and to 20 ± 12 degrees at 5 years (P = .018). Straightening of the neck was most prominent in patients who presented with a high degree of preoperative angulation (r = 0.61; P < .001). Between 1 month and 5 years, iliac attachment zone diameter increased from 13.5 ± 1.9 mm to 15.0 ± 2.4 mm on the right (P = .002) and from 13.9 ± 2.3 mm to 16.8 ± 2.7 mm on the left (P < .001). During 5 years, 9 of 72 (13%) iliac arteries enlarged >5 mm. There was a significant relationship between main body oversizing and aortic neck enlargement (r = 0.42; P = .009). No similar association was observed between iliac limb oversizing and iliac dilation over time (r = 0.10 and P = .549, right side; r = 0.14 and P = .400, left side). There were no aneurysm-related deaths in the series. There were two type IA endoleaks, both of which were present on the 1-month CT scan and associated with challenging aortic neck anatomy. No patient experienced endograft migration or rupture through 5 years. Type IB endoleaks occurred in two patients, both accompanied by iliac artery dilation and loss of seal. Stent fracture occurred in two struts of the bare transrenal stent of one patient, without loss of fixation or seal. One patient experienced graft limb occlusion and was observed without intervention. There were three patients (5%) with aneurysm sac enlargement (>5 mm) through 5 years, each of whom had type II endoleak.ConclusionsSignificant aortoiliac remodeling occurs after endograft implantation, including proximal aortic neck dilation, straightening of the neck, and iliac artery enlargement. The ultralow-profile INCRAFT device adapted well to these changes, with acceptably low 5-year rates of device-related endoleaks, endograft migration, and limb occlusion.     

Open surgery versus endovascular approach in treatment of extracranial carotid artery aneurysms

ObjectiveThe objective of this study was to investigate and to compare the early and long-term results of open surgery with endovascular intervention in the treatment of extracranial carotid artery aneurysms (ECCAs).MethodsA retrospective review of patients diagnosed with ECCAs who underwent open surgical or endovascular treatment from 1997 to 2017 was performed. Clinical characteristics, aneurysm profile, and treatment outcomes were recorded. Early results (<30 days) were evaluated in terms of mortality, perioperative stroke or transient ischemic attack, and cranial nerve injury. Late results were analyzed in terms of both overall and stroke-free survival and freedom from reinterventions.ResultsA total of 48 patients with ECCAs including 34 (70.8%) true aneurysms and 14 (29.2%) pseudoaneurysms were treated. The median age was 51 years, and 19 patients (39.6%) were men; 41 patients (85.4%) had symptoms, whereas 7 (14.6%) were asymptomatic. Among 48 patients, 32 patients (66.7%) underwent open surgery; endovascular repair was performed on 16 patients (33.3%). The 30-day stroke or transient ischemic attack rate was not significantly different between the open group (6.3% [2/32]) and the endovascular group (0% [0/16]; P = .307). Cranial nerve injuries occurred in eight patients in the open group (25%) and in no patient in the endovascular group (0%; P = .029). Median length of stay was significantly longer in the open group than in the endovascular group (20 vs 14 days, respectively; P = .013). Median follow-up was 46 months (range, 0-20 years), and no aneurysm-related death occurred during this period. Overall survival rates at 5 years were 88.7% (standard error [SE], 0.08) in the open group and 91.7% (SE, 0.08) in the endovascular group (P = .319; log-rank, .992). For the same time interval, stroke-free survival rates were 85.2% (SE, 0.10) in the open group and 92.2% (SE, 0.07) in the endovascular group (P = .653; log-rank, .201). One patient (1/28 [3.6%]) in the open group and two patients (2/16 [12.5%]) in the endovascular group underwent endovascular reinterventions because of restenosis during the follow-up period. Reintervention-free survival rates were 90.9% in the open group (SE, 0.09) and 69.2% in the endovascular group (SE, 0.21; P = .082; log-rank, 3.016).ConclusionsIn this single-institutional experience, both operative and endovascular interventions for ECCAs provided acceptable early and 5-year results. The endovascular approach had significantly less cranial nerve injury and shorter length of hospital stay.     

Evolution of open aneurysmorrhaphy for management of sac expansion after endovascular repair of abdominal aortic aneurysms

ObjectiveWe evaluated the perioperative and mid-term clinical outcomes of open aneurysmorrhaphy (OA) for the treatment of sac expansion after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms.MethodsOA involves sac exposure without dissection of the proximal or distal neck, sacotomy and ligation of back-bleeding vessels, preservation of the prior stent graft, and tight closure of the sac around the stent graft. We performed a retrospective review of all patients who had undergone OA for nonruptured sac expansion after standard EVAR at our institution between January 2015 and June 2021. The primary end points were 30-day mortality and aneurysm-related death. The secondary end points were postoperative complications, overall survival, freedom from reintervention, and sac regrowth rate.ResultsA total of 28 patients had undergone OA. Their mean age was 76.9 ± 6.7 years. The median sac diameter at OA was 79 mm (interquartile range [IQR], 76-92 mm). The median duration from the index EVAR to OA was 82 months (IQR, 72-104 months). Preoperative computed tomography angiography confirmed a type II endoleak (EL) in 20 patients, 1 of whom had had a coexisting type Ia EL; a type IIIb EL was identified in 1 patient. Concomitant endovascular procedures had been performed in six patients to treat a type I or III EL or reinforce the proximal and distal seals. The OA technique has been modified since 2017, with the addition of more aggressive dissection of the sac and complete removal of the mural thrombus to further decrease the sac diameter. Postoperative complications occurred in two patients and included abdominal lymphorrhea and failed hemostasis of the common femoral artery requiring surgical repair in one patient each. The 30-day mortality was 0%. During the median follow-up of 36 months (IQR, 14-51 months), the overall survival was 92.7% and 86.9% at 12 and 36 months, respectively, without any aneurysm-related death. In the late (2017-2021) treatment group, the median sac diameter immediately after OA was smaller than that in the early (2015-2016) treatment group (early group: median, 50 mm; IQR, 39-57 mm; vs later group: median, 41 mm; IQR, 32-47 mm; P = .083). Furthermore, in the late group, the sac regrowth rate was lower (early group: median, 0.36 mm/mo; IQR, 0.23-0.83 mm/mo; vs late group: median, 0 mm/mo; IQR, 0-0.11 mm/mo; P = .0075) and the freedom from reintervention rate was higher (late group: 94.7% at both 12 and 36 months, respectively; early group: 71.4% and 53.6% at 12 and 36 months, respectively; log-rank P = .070).ConclusionsOur results have shown that OA for the management of post-EVAR sac expansion is feasible with acceptable mid-term outcomes. Aggressive dissection and tight plication of the sac might be imperative for better mid-term outcomes after OA.     

A meta-analysis of translumbar embolization versus transarterial embolization for type II endoleak after endovascular repair of abdominal aortic aneurysm

ObjectiveThis systematic review and meta-analysis aimed to compare the clinical outcomes between transarterial and translumbar (direct aneurysm sac puncture) approaches for persistent type II endoleak after endovascular repair of abdominal aortic aneurysm.MethodsWe searched multiple electronic databases (up to October 31, 2018) for eligible trials in patients with type II endoleaks after endovascular abdominal aortic aneurysm repairs that evaluated the outcomes of translumbar embolization vs transarterial embolization. The primary outcome was clinical success (absence of the endoleak on the last examination); the secondary outcomes were technical success and complication rate. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated.ResultsAmong the 904 studies screened, 9 studies with 354 participants were included in this review. None of the studies reported rupture or mortality. The translumbar group had a relatively higher clinical success rate than the transarterial group, but this difference was not statistically significant (OR, 2.29; 95% CI, 1.00-5.25; P = .05; I² = 52%). The technical success rate was significantly higher in the translumbar group than in the transarterial group (OR, 13.32; 95% CI, 3.41-52.07; P = .0002; I² = 0%). No significant difference was found in the complication rate of the two groups (OR, 1.15; 95% CI, 0.26-4.96; P = .85; I² = 0%). We also included five studies that reported the clinical outcomes of open repair. All patients were technically treated by open repair, and 58 of 60 patients owned clinical success during the follow-up period.ConclusionsThe translumbar route was more successful in obliterating the endoleak on follow-up imaging. When repeated endovascular embolizations fail, a laparotomy should follow.     

Long-term outcomes comparing endovascular and open abdominal aortic aneurysm repair in octogenarians

ObjectivePatients older than 80 years have significantly lower early mortality with endovascular aneurysm repair (EVAR) compared with open repair for abdominal aortic aneurysms (AAAs), but long-term results remain poorly studied. We analyzed the results of both emergent and elective AAA repair in patients aged 80 years or older who had at least 5 years of follow-up.MethodsRetrospective review of a prospectively collected vascular surgery database was performed to identify all patients who underwent elective repair of an AAA between 2007 and 2012 and were 80 years of age or older at the time of surgery. Open and EVAR groups were compared using univariate statistics.ResultsThe study cohort was composed of 314 patients 80 years of age or older (median, 83 years; interquartile range, 5 years) who underwent repair (96 open, 218 EVAR). The groups had similar comorbidities, except that EVAR patients were more likely to be male and open repair patients were more likely to have larger aneurysms. Compared with open repair, elective early postoperative mortality was significantly lower for EVAR patients (1% vs 14%; P < .001). Overall mean life expectancy was 5.9 years (EVAR, 5.8 years; open repair, 5.8 years; P = .98). The 1-year survival was significantly higher for EVAR (92.9%) than for open repair (84.1%; P = .02). The 2-year survival (EVAR, 83.4%; open repair, 74.6%; P = .07) and 5-year survival (EVAR, 57.8%; open repair, 60.3%; P = .98) did not differ between EVAR and open repair. Reintervention rates (EVAR, 18%; open repair, 2%; P = .05) were higher in the endovascular treatment group.ConclusionsEVAR results in an improved 1-year mortality in octogenarians compared with open repair, although 5-year survival is similar between the groups. With average life expectancies of >5 years and an 18% reintervention rate, diligent follow-up is required after EVAR even in elderly patients.