Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair.

Patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms can exhibit variations in sac behavior ranging from complete regression to expansion. We evaluated the impact of sac behavior at 1-year follow-up on late survival. We used the Vascular Study Group of New England (VSGNE) registry from 2003 to 2011 to identify EVAR patients with 1-year computed tomography follow-up. Aneurysm sac enlargement ≥5 mm (sac expansion) and decrease ≥5 mm (sac regression) were defined per Society for Vascular Surgery guidelines. Predictors of change in sac diameter and impact of sac behavior on long-term mortality were assessed by multivariable methods. Of 2437 patients who underwent EVAR, 1802 (74%) had complete 1-year follow-up data and were included in the study. At 1 year, 162 (9%) experienced sac expansion, 709 (39%) had a stable sac, and 931 (52%) experienced sac regression. Sac expansion was associated with preoperative renal insufficiency (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.5-8.0; P < .01), urgent repair (OR, 2.7; 95% CI, 1.4-5.1; P < .01), hypogastric coverage (OR, 1.7; 95% CI, 1.1-2.7; P = .02), and type I/III (OR, 16.8; 95% CI, 7.3-39.0; P < .001) or type II (OR, 2.9; 95% CI, 2.0-4.3; P < .001) endoleak at follow-up, and sac expansion was inversely associated with smoking (OR, 0.6; 95% CI, 0.4-0.96; P = .03) and baseline aneurysm diameter (OR, 0.7; 95% CI, 0.6-0.9; P < .001). Sac regression (vs expansion or stable sac) was associated with female gender (OR, 1.8; 95% CI, 1.4-2.4; P < .001) and larger baseline aneurysm diameter (OR, 1.4; 95% CI, 1.2-1.5; P < .001) and inversely associated with type I/III (OR, 0.2; 95% CI, 0.1-0.5; P < .01) or type II endoleak at follow-up (OR, 0.2; 95% CI, 0.2-0.3; P < .001). After risk-adjusted Cox regression, sac expansion was independently associated with late mortality (hazard ratio, 1.5; 95% CI, 1.1-2.0; P = .01), even with adjustment for reinterventions and endoleak during follow-up. Sac regression was associated with lower late mortality (hazard ratio, 0.6; 95% CI, 0.5-0.7; P < .001). Long-term survival was lower (log-rank, P < .001) in patients with sac expansion (98% 1-year and 68% 5-year survival) compared with all others (99% 1-year and 83% 5-year survival). These data suggest that an abdominal aortic aneurysm sac diameter increase of at least 5 mm at 1 year, although infrequent, is independently associated with late mortality regardless of the presence or absence of endoleak and warrants close observation and perhaps early intervention.

Deery SE ，Ergul EA ，Schermerhorn ML ，Siracuse JJ ，Schanzer A ，Goodney PP ，Cambria RP ，Patel VI ，Vascular Study Group of New England ... -  《-》

Select early type IA endoleaks after endovascular aneurysm repair will resolve without secondary intervention.

Although it is traditionally considered ominous, the natural history of early proximal attachment site endoleaks (IA) after endovascular aneurysm repair (EVAR) is not well known. Our aim was to identify risk factors for persistent type IA endoleaks and to determine their effect on long-term outcomes after EVAR. All patients who underwent infrarenal EVAR at a single institution between 1998 and 2015 were identified. Preoperative axial imaging and intraoperative arteriograms were reviewed, and those patients with a type IA endoleak were further studied. Aneurysm features were characterized by two reviewers and were studied for predictors of persistent endoleaks at the conclusion of the case. Patient records and the Social Security Death Index were used to record 1-year and overall survival. We identified 1484 EVARs, 122 (8%) of which were complicated by a type IA endoleak on arteriography after graft deployment, with a median follow-up of 4 years. The majority of patients underwent additional ballooning of the proximal site (52 [43%]) or placement of an aortic cuff (47 [39%]); 30 patients (25%) received a Palmaz stent, and four patients were treated with coils or anchors. At case end, only 43 (35%) of the type IA endoleaks remained; at 1 month, only 16 endoleaks persisted (13%), and only six persisted at 1 year (6%). In multivariable analysis, the only independent predictor of persistence of type IA endoleak at the conclusion of the case was the presence of extensive neck calcifications (odds ratio [OR], 9.9; 95% confidence interval [CI], 1.4-67.9; P = .02). Thirteen patients (11%) underwent reintervention for type IA endoleaks, with a time frame ranging from 3 days postoperatively to 11 years. There were three patients (2.4%) who experienced aneurysm rupture. Postoperative type IA endoleak was associated with lower survival at 1 year (79% vs 91%; relative risk, 2.5; 95% CI, 1.1-5.4; P = .02), but it did not affect long-term survival (log-rank, P = .45). Both an increase in aneurysm sac size and failure of the endoleak to resolve by case end were independent predictors of a need for reintervention (growth: OR, 8.3; 95% CI, 2.2-31.6; P < .01; persistent endoleak: OR, 7.6; 95% CI, 1.8-31.5; P < .01). A persistent type IA endoleak was not independently associated with an increase in sac size on surveillance imaging (P = .28). Aneurysm rupture secondary to persistent type IA endoleak is rare, and most will resolve within 1 year. Extensive neck calcification is the only independent predictor of persistent type IA endoleak, and an increase in sac size warrants reintervention. These data suggest that select early persistent type IA endoleaks can be safely observed.

O'Donnell TFX ，Corey MR ，Deery SE ，Tsougranis G ，Maruthi R ，Clouse WD ，Cambria RP ，Conrad MF ... -  《-》

Variability in aneurysm sac regression after endovascular aneurysm repair based on a comprehensive registry of patients in Eastern Ontario.

Although the absence of aneurysm-related mortality, postimplantation rupture, and reintervention after endovascular aneurysm repair (EVAR) is desirable, it may not necessarily reflect successful aneurysm sac exclusion. Sac regression may be a more sensitive marker for EVAR success and may be influenced by factors beyond the presence or absence of an endoleak. The objective of this study is to determine the rate of overall long-term sac regression after EVAR and the influence of nonanatomic factors, and endograft devices used at our center. This retrospective cohort study included all EVARs performed for intact and ruptured abdominal aortic aneurysms (AAAs) at a university teaching hospital. Preoperative, operative, and follow-up data were collected using clinical and radiologic institutional databases. Preoperative and post-EVAR sac diameters were determined by a blinded observer in accordance with Society for Vascular Surgery guidelines. Absolute and relative sac regression was determined at the following intervals: 0 to 6 months, 6 to 12 months, 12 to 18 months, 18 months to 2 years, 2 to 5 years, 5 to 10 years, and more than 10 years. From 1999 to 2015, 1060 patients underwent EVAR for an AAA at the Ottawa Hospital. Procedures were performed using a total of nine unique endograft devices, with five devices (Cook Zenith, n = 398; Medtronic Endurant, n = 375; Medtronic Talent, n = 183; Cook Zenith LP, n = 52; and Terumo Anaconda, n = 23) used in 97% of the procedures. The mean preoperative AAA diameter was 61.2 mm, with no detectable differences between endograft devices with respect to age, preoperative AAA diameter, or rupture diagnosis. Overall mean sac regression increased from -1.3 mm at 6 months, to -14.9 mm beyond 10 years. The majority of sac regression was achieved within 2 years. Only 90 of the 1060 patients (8.5%) experienced sac expansion of greater than 5 mm at some point during their follow-up period. Kaplan-Meier analyses revealed statistically significant device-specific variability in sac regression rates, even in the absence of an endoleak. Cox proportional hazard modeling demonstrated that age less than 75 years (hazard ratio [HR], 1.4; P = .001), female sex (HR, 1.4; P = .003), absence of type I endoleak (HR, 4.6; P < .0001), AAA greater than 70 mm (HR, 1.6; P < .0001), and both the Zenith (HR, 2.0; P < .0001) and Endurant (HR, 1.7; P = .001) devices were associated with shorter time to more than 5 mm sac regression. This study demonstrated a pattern of sac diameter change after EVAR, with the majority of sac regression occurring within the first 2 years. Variability in sac regression was influenced by nonanatomic variables including age, sex, original AAA diameter, and specific endograft device, even after controlling for the presence or absence of an endoleak. The biophysical relationship between specific endograft design and materials, and sac regression is yet to be determined.

Jetty P ，Husereau D ，Kansal V ，Zhang T ，Nagpal S ... -  《-》

Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival.

The early survival advantage of endovascular aneurysm repair (EVAR) compared with open repair reverses over time, possibly because of higher rates of reintervention related to endoleaks and aneurysm sac expansion. Therefore, we sought to examine the association between sac behavior, endoleaks, reintervention, and long-term survival. We reviewed all patients undergoing EVAR in the Vascular Quality Initiative between 2003 and 2017 with an imaging study at 1 year postoperatively (±6 months). We defined aneurysm sac changes by Society for Vascular Surgery guidelines (change ≥5 mm) and determined independent predictors of sac behavior, new endoleak, and reintervention using hierarchical logistic regression. We employed Cox regression to examine the association between sac behavior and long-term survival. We performed propensity matching between patients with sac regression and those with failure to regress as a secondary analysis. Of 30,074 EVAR patients, 14,817 (49%) had a 1-year imaging study and were included in this study. At 1 year, 40% of sacs regressed, 35% remained stable, and 25% expanded. Factors independently associated with sac expansion were age (by decade: odds ratio [OR], 1.07; 95% confidence interval [CI], 1.01-1.13; P = .02), appearance of new endoleak (OR, 1.23; 95% CI, 1.10-1.37; P = .001), smaller aortic diameter (diameter <5 cm: OR, 1.37; 95% CI, 1.21-1.55; P < .001), anemia (OR, 1.47; 95% CI, 1.20-1.80; P < .001), rupture (OR, 1.33; 95% CI, 1.07-1.65; P = .01), and chronic kidney disease (OR, 1.15; 95% CI, 1.05-1.25; P < .01), whereas former smoking (OR, 0.86; 95% CI, 0.76- 0.96; P < .01), cerebrovascular disease (OR, 0.82; 95% CI, 0.67-0.99; P = .04), and statin therapy at discharge (OR, 0.83; 95% CI, 0.75-0.91; P < .001) were associated with lower risk of expansion. Both sac expansion (OR, 2.3; 95% CI, 2.0-2.7; P < .001) and a stable sac (OR, 3.1; 95% CI, 2.7-3.5; P < .001) were associated with the development of new endoleaks. Any failure of the aneurysm sac to regress was associated with long-term mortality compared with sac regression (stable sac size: hazard ratio, 1.2; 95% CI, 1.03-1.4; P = .02; sac expansion: hazard ratio, 1.6; 95% CI, 1.3-2.1; P < .001). This association persisted in patients without documented endoleaks and remained robust after accounting for reinterventions and endoleaks seen in follow-up or on completion angiography. In the propensity-matched cohort, patients with failure to regress experienced lower long-term survival (77% at 10 years compared with 82% for patients with sac regression; P = .01). After EVAR, aneurysm sac behavior is associated with the development of new endoleaks, reintervention, and long-term mortality. Not only sac expansion but any failure of the sac to regress is associated with higher long-term mortality, independent of reinterventions or endoleaks, and may be modified by statin therapy. Further study is needed to establish whether patients with stable sacs could benefit from selective reintervention.

O'Donnell TFX ，Deery SE ，Boitano LT ，Siracuse JJ ，Schermerhorn ML ，Scali ST ，Schanzer A ，Lancaster RT ，Patel VI ... -  《-》

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft.

Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention. Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034). EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.

Verzini F ，Romano L ，Parlani G ，Isernia G ，Simonte G ，Loschi D ，Lenti M ，Cao P ... -  《-》