Partial and complete explantation of aortic endografts in the modern era

ObjectiveDespite the progressive advancement of devices for endovascular aortic repair (EVAR), endografts continue to fail, requiring explant. We present a single-institutional experience of EVAR explants, characterizing modern failure modes, presentation, and outcomes for partial and complete EVAR explantation.MethodsA retrospective analysis was performed of all EVARs explanted at an urban quaternary center from 2001 to 2020, with one infected endograft excluded. Patient and graft characteristics, indications, and perioperative and long-term outcomes were analyzed. Partial versus complete explants were performed per surgeon discretion without a predefined protocol. This process was informed by patient risk factors; asymptomatic, symptomatic, or ruptured aneurysm presentation; and anatomical or intraoperative factors, including endoleak type.ResultsFrom 2001 to 2020, 52 explants met the inclusion and exclusion criteria. More than one-half (57.7%) were explants of EVAR devices placed at outside institutions, designated nonindex explants. Most patients were male (86.5%), the median age was 74 years (interquartile range, 70-78 years). More than one-half (61.5%) were performed in the second decade of the study period. The most commonly explanted grafts were Gore Excluder (n = 9 grafts), Cook Zenith (n = 8), Endologix AFX (n = 7), Medtronic Endurant (n = 5), and Medtronic Talent (n = 5). Most grafts (78.8%) were explanted for neck degeneration or sac expansion. Five were explanted for initial seal failure, five for symptomatic expansion, and seven for rupture. The median implant duration was 4.2 years, although ranging widely (interquartile range, 2.6-5.1 years), but similar between index and nonindex explants (4.2 years vs 4.1 years). Partial explantation was performed in 61.5%, with implant duration slightly lower, 3.2 years versus 4.4 years for complete explants. Partial explantation was more frequent in index explants (68.2% vs 56.7%). The median length of stay was 8 days. The median intensive care unit length of stay was 3 days, without significant differences in nonindex explants (4 days vs 3 days) and partial explants (4 days vs 3 days). Thirty-day mortality occurred in two nonindex explants (one partial and one complete explant). Thirty-day readmission was similar between partial and complete explants (9.7% vs 5.0%), without accounting for nonindex readmissions. Long-term survival was comparable between partial and complete explants in Cox regression (hazard ratio, 2.45; 95% confidence interval, 0.79-7.56; P = .12).ConclusionsExplants of EVAR devices have increased over time at our institution. Partial explant was performed in more than one-half of cases, per operating surgeon discretion, demonstrating higher blood loss, more frequent acute kidney injury, and longer intensive care unit stays, however with comparable short-term mortality and long-term survival.     

A systematic review and meta-analysis of proximal aortic neck dilatation after endovascular abdominal aortic aneurysm repair

ObjectiveTo provide an updated systematic literature review summarizing current evidence on aortic neck dilatation (AND) after endovascular aortic aneurysm repair (EVAR) in patients with infrarenal abdominal aortic aneurysm.MethodsAn extensive electronic search in major electronic databases was conducted between January 2000 and December 2021. Eligible for inclusion were observational studies that followed up with patients (n ≥ 20) undergoing EVAR with self-expanding endografts, for 12 or more months, evaluated AND with computed tomography angiography and provided data on relevant outcomes. The primary end point was the incidence of AND after EVAR, and the secondary end points were the occurrence of type Ia endoleak, stent graft migration, secondary rupture, and reintervention.ResultsWe included 34 studies with a total sample of 12,038 patients (10,413 men; median age, 71 years). AND was defined clearly in 18 studies, but significant differences in AND definition were evidenced. The pooled incidence of AND based on quantitative analysis of 16 studies with a total of 9201 patients (7961 men; median age, 72 years) was calculated at 22.9% (95% confidence interval [CI], 14.4-34.4) over a follow-up period ranging from 12 months to 14 years. The risk of a type Ia endoleak was significantly higher in AND patients compared with those without AND (odds ratio, 2.95; 95% CI, 1.10-7.93; P = .030). Similarly, endograft migration was more common in the AND group compared with the non-AND group (odds ratio, 5.95; 95% CI, 1.80-19.69; P = .004). The combined incidence of secondary rupture and reintervention did not differ significantly between the two groups, even though the combined effect was in favor of the non-AND group.ConclusionsProximal AND after EVAR is common and occurs in a large proportion of patients with infrarenal abdominal aortic aneurysm. AND can influence the long-term durability of proximal endograft fixation and is significantly related to adverse outcomes, often leading to reinterventions.     

Infrarenal endovascular aneurysm repair with large device (34- to 36-mm) diameters is associated with higher risk of proximal fixation failure

ObjectiveEndovascular aneurysm repair (EVAR) has become the standard of care for infrarenal aneurysms. Endografts are commercially available in proximal diameters up to 36 mm, allowing proximal seal in necks up to 32 mm. We sought to further investigate clinical outcomes after standard EVAR in patients requiring large main body devices.MethodsWe performed a retrospective review of a prospectively maintained database for all patients undergoing elective EVAR for infrarenal abdominal aortic aneurysms at a single institution from 2000 to 2016. Only endografts with the option of a 34- to 36-mm proximal diameter were included. Requisite patient demographics, anatomic and device-related variables, and relevant clinical outcomes and imaging were reviewed. The primary outcome in this study was proximal fixation failure, which was a composite of type IA endoleak and stent graft migration >10 mm after EVAR. Outcomes were stratified by device diameter for the large-diameter device cohort (34-36 mm) and the normal-diameter device cohort (<34 mm).ResultsThere were 500 patients treated with EVAR who met the inclusion criteria. A total of 108 (21.6%) patients received large-diameter devices. There was no difference between the large-diameter cohort and the normal-diameter cohort in terms of 30-day (0.9% vs 0.95%; P = .960) or 1-year mortality (9.0% vs 6.2%; P = .920). Proximal fixation failure occurred in 24 of 392 (6.1%) patients in the normal-diameter cohort and 26 of 108 (24%) patients in the large-diameter cohort (P < .001). There were 13 (3.3%) type IA endoleaks in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). Stent graft migration (>10 mm) occurred in 15 (3.8%) in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). After multivariate analysis, only the use of Talent (Medtronic, Minneapolis, Minn) endografts (odds ratio [OR], 4.50; 95% confidence interval [CI], 1.18-17.21) and neck diameter ≥29 mm (OR, 2.50; 95% CI, 1.12-5.08) remained significant independent risk factors for development of proximal fixation failure (OR, 3.99; 95% CI, 1.75-9.11).ConclusionsStandard EVAR in patients with large infrarenal necks ≥29 mm requiring a 34- to 36-mm-diameter endograft is independently associated with an increased rate of proximal fixation failure. This group of patients should be considered for more proximal seal strategies with fenestrated or branched devices vs open repair. Also, this group likely needs more stringent radiographic follow-up.     

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.     

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.     

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.     

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.     

Factors associated with elimination of type II endoleak during the first year after endovascular aneurysm repair

ObjectiveThe natural history of endoleak type II (ET II) after endovascular aneurysm repair (EVAR) is still debatable. The aim of this study was to examine the presence of preoperative and postoperative factors associated with persistence of ET II during the initial 12-month follow-up period.MethodsA two-center retrospective study including patients subjected to EVAR from 2006 to 2017 was undertaken. Patients with ET II at 1-month computed tomography angiography (CTA) were categorized into two groups, resolution (group 1) vs persistence (group 2) of ET II at 12-month CTA. Preoperative demographics, comorbidities, aneurysm anatomic details, and pelvic artery index were assessed. Intraoperative details were also recorded.ResultsOf 825 patients, 140 (17%) patients (mean age, 71.7 ± 8.5 years; 94% male) presented with ET II at 1-month CTA. Group 1 included 58 patients (41%) and group 2, 82 patients (59%). The anatomic characteristics of the inferior mesenteric artery and lumbar arteries and the pelvic artery indices were not associated with ET II persistence. All patients in group 1 had presence of intraluminal thrombus (ILT) on preoperative CTA (group 1, 100%; group 2, 67%; P = .001), and the circular pattern of ILT was more common in group 1 (group 1, 44%; group 2, 24%; P = .01). At 12-month CTA, the mean sac regression was higher in group 1 (group 1, −3 ± 4 mm; group 2, 0.55 ± 3 mm; P = .000). After multivariate analysis, persistence of ET II was directly associated only with intraoperative internal iliac occlusion (odds ratio [OR], 0.232; 95% confidence interval [CI], 0.06-0.86; P = .03) and inversely with statin therapy (OR, 2.6; 95% CI, 1.01- 6.8; P = .047) and sac regression (OR, 1.24; 95% CI, 1.11-1.39; P = .001).ConclusionsInduced occlusion of the internal iliac artery during EVAR was the only factor associated with persistence of ET II during the first year after EVAR. The presence and pattern of ILT may play a role in ET II persistence, whereas the number of patent infrarenal aortic branches and their diameter as well as the pelvic artery indices were not associated with ET II. The use of statins may have a positive effect on ET II resolution during the first postoperative year. Sac diameter is more likely to regress in patients with ET II resolution.     

Simple renal cyst and its association with sac shrinkage after endovascular aneurysm repair for abdominal aortic aneurysms

ObjectivePatients with abdominal aortic aneurysm (AAA) frequently have simple renal cyst (SRC), a common manifestation of connective tissue degeneration. This study aimed to determine whether SRC is a risk factor for failure of sac shrinkage after endovascular aneurysm repair (EVAR).MethodsBetween October 2013 and May 2017, there were 155 consecutive patients with an infrarenal AAA or a common iliac artery aneurysm who underwent EVAR with the GORE C3 Excluder (W. L. Gore & Associates, Flagstaff, Ariz) at Tokyo Medical University Hospital. All these patients were registered in a prospectively maintained database. Any kidney lesion >5 mm in diameter, with no evidence of contrast enhancement or septation and with low attenuation, was defined as SRC. A change in sac size of >5 mm from baseline was considered significant. The patients were divided into those with SRC and those without SRC, and sac shrinkage at 1 year and 2 years was compared. The presence of SRC was assessed with respect to being a risk factor for failure of sac shrinkage at 1 year using univariate and multivariable logistic regression analysis.ResultsThe patients were divided into two groups: those with SRC (92 patients [59.0%]) and those without SRC (63 patients [41.0%]). At 1 year and 2 years, significant differences were observed in the proportion of sac shrinkage between patients with SRC and those without SRC (19.2% vs 42.4% [P = .003] and 19.6% vs 53.3% [P = .001], respectively). Patients with SRC showed significantly less sac shrinkage than those without SRC at 1 year and 2 years (−2.0 ± 5.5 mm vs −4.4 ± 6.2 mm [P = .002] and −1.8 ± 6.3 mm vs −6.4 ± 8.6 mm [P = .005], respectively). Multivariable analysis demonstrated that SRC (odds ratio, 0.28; 95% confidence interval, 0.12-0.63; P = .002) and initial sac size (odds ratio, 1.05; 95% confidence interval, 1.01-1.09; P = .027) were positive and negative risk factors for sac shrinkage, respectively.ConclusionsThe presence of SRC is a risk factor for failure of sac shrinkage after EVAR. This suggests that AAA in patients with SRC has a more degenerated wall than in those without SRC. The property of the aneurysm wall may be associated with sac shrinkage after EVAR.     

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.     

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.     

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

BackgroundEndovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS.MethodsData were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates.ResultsThere were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n = 185), juxtarenal and suprarenal (n = 73), ruptured (n = 18), and iliac (n = 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years).Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture.ConclusionsEVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.     

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.     

Perioperative blood transfusion in anemic patients undergoing elective endovascular abdominal aneurysm repair

ObjectiveAlthough blood transfusion can be lifesaving in active hemorrhage or severe anemia, it is also associated with increased morbidity and mortality. Several trials have established this risk and therefore defined a restrictive standard for transfusion, but this threshold and the risk of transfusions have not been specifically examined in vascular surgery patients. We therefore sought to assess transfusion practices and outcomes of anemic patients undergoing elective endovascular aneurysm repair (EVAR).MethodsThe Vascular Quality Initiative database was queried for patients undergoing EVAR between the years 2008 and 2017. Anemic patients were included in the study and were further stratified into mild anemia, defined by a hemoglobin level of 10 to 13 g/dL in men or 10 to 12 g/dL in women, and moderate to severe anemia, defined by a hemoglobin level <10 g/dL. The primary study outcomes were in-hospital mortality and complications.ResultsAmong 27,777 EVAR patients, one-third (n = 9232) were anemic and included in the study. One-fifth (n = 1866) of anemic patients received a perioperative transfusion. Transfused patients were more likely to have a history of cardiovascular disease. In-hospital mortality was significantly higher for anemic patients who received transfusions, both in mild anemia (mortality, 3.6% vs 0.4% in no transfusion; P < .001) and in moderate to severe anemia (4.5% vs 1.3%; P < .01). Morbidity was also significantly higher, with anemic patients who received a transfusion having higher rates of myocardial infarction, congestive heart failure, dysrhythmias, renal complications, leg ischemia, respiratory complications, and reoperation compared with anemic patients who did not receive any transfusion. The 30-day mortality was also higher in transfused patients (P < .001). After adjustment for patients' demographics, comorbidities, and operative factors, transfusion in anemic patients was associated with a nearly 4.4-fold increased odds of in-hospital mortality (odds ratio [OR], 4.38; 95% confidence interval [CI], 2.72-7.05; P < .001) and 4.3-fold higher odds of any in-hospital complication (OR, 4.31; 95% CI, 3.47-5.34; P < .001). This was more pronounced among patients with mild anemia, with 5.7 times (OR, 5.7; 95% CI, 1.78-18.0) and 4.3 times (OR, 4.3; 95% CI, 3.46-5.29) the odds of in-hospital mortality and complications, respectively.ConclusionsAmong anemic patients undergoing elective EVAR, transfusion is associated with an increased risk of death and in-hospital complications, even after controlling for patients' comorbidities and operative factors. These data suggest that the restrictive use of blood transfusions might be safer in vascular surgery EVAR patients. Medical management of anemia may be warranted in these patients to reduce morbidity and mortality; however, further studies are needed to evaluate effectiveness.     

主动脉腔内修复术治疗腹主动脉瘤或夹层合并腹部恶性肿瘤

目的 观察主动脉腔内修复术（EVAR）治疗腹主动脉瘤（AAA）或腹主动脉夹层（AAD）合并腹部恶性肿瘤的价值。方法 回顾性分析17例接受EVAR治疗的AAA（n=14）/AAD（n=3）合并腹部恶性肿瘤患者,其中12例于EVAR后接受腹腔镜肿瘤切除术、1例接受开腹肿瘤切除术,4例因心肺功能欠佳仅接受药物治疗;观察EVAR治疗效果。结果 EVAR成功率为100%,术中无严重不良反应及并发症;术后1个月CTA显示支架位置良好、通畅。术后随访1~28个月,期间均未见明显并发症,亦未见AAA/AAD相关死亡病例。结论 EVAR治疗AAA/AAD合并腹部恶性肿瘤效果较佳。     

Chronic kidney disease impacts outcomes after abdominal aortic aneurysm repair

ObjectiveChronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular and open repair of abdominal aortic aneurysm (AAA). This study stratifies outcomes of AAA repair by approach, CKD severity, and dialysis dependence.MethodsAll patients undergoing elective infrarenal open aneurysm repair (OAR) and endovascular aortic repair (EVAR) with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: CKD stages 1 and 2, CKD stage 3a, CKD stage 3b, CKD stages 4 and 5, and dialysis. Primary outcomes were perioperative and 1-year mortality. Predictors of survival were identified by Cox multivariate regression models.ResultsIn total, 53,867 elective AAA repairs were identified: 5396 (10%) OARs and 48,471 (90%) EVARs. Most patients were White (90%) and male (81%), with a mean age of 73 ± 9 years. Patients who underwent EVAR were older and had more comorbidities. The use of elective EVAR for AAA increased from 52% in 2003 to 91% in 2020 (P < .001). The OAR cohort had more perioperative complications and short-term mortality. The CKD 1 and 2 group had the highest 1-year survival compared with the other groups after both OAR and EVAR. On Cox regression analysis, after EVAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.68; P = .13; CKD 3b: HR, 1.74; 95% CI, 1.23-2.45; P < .050; CKD 4-5: HR, 3.23; 95% CI, 2.13-4.88; P < .001), and dialysis (HR, 4.48; 95% CI, 1.90-10.6; P < .001) were independently associated with worse 1-year survival rates. After OAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: HR, 1.08; 95% CI, 0.96-1.20; P = .20; CKD 3b: HR, 1.60; 95% CI, 1.41-1.81; P < .001; CKD 4-5: HR, 2.85; 95% CI, 2.39-3.41; P < .001), and dialysis (HR, 3.79; 95% CI, 3.01-4.76; P < .001) were independently associated with worse 1-year survival rates.ConclusionsRegardless of the treatment approach, CKD severity is an important predictor of perioperative and 1-year mortality rates after infrarenal AAA repair and may reflect the natural history of CKD. Open repair is associated with high perioperative mortality risk in patients with CKD stages 4 and 5, as well as end-stage renal disease. Individualization of patient decision-making is especially important in patients with a glomerular filtration rate of less than 45 and perhaps consideration should be given to raising the threshold for elective AAA repair in these patients. Further studies focusing on appropriate size threshold for repair in these patients may be warranted.     

Comparable perioperative mortality outcomes in younger patients undergoing elective open and endovascular abdominal aortic aneurysm repair

BackgroundEvidence for benefit of endovascular aneurysm repair (EVAR) over open surgical repair for de novo infrarenal abdominal aortic aneurysms (AAAs) in younger patients remains conflicting because of heterogeneous study populations and small sample sizes. The objective of this study was to compare perioperative and short-term outcomes for EVAR and open surgery in younger patients using a large national disease and procedure-specific data set.MethodsWe identified patients 65 years of age or younger undergoing first-time elective EVAR or open AAA repair from the Vascular Quality Initiative (2003-2014). We excluded patients with pararenal or thoracoabdominal aneurysms, those medically unfit for open repair, and those undergoing EVAR for isolated iliac aneurysms. Clinical and procedural characteristics were balanced using inverse propensity of treatment weighting. A supplemental analysis extended the study to those younger than 70 years.ResultsWe identified 2641 patients, 73% (n = 1928) EVAR and 27% (n = 713) open repair. The median age was 62 years (interquartile range, 59-64 years), and 13% were female. The median follow-up time was 401 days (interquartile range, 357-459 days). Unadjusted perioperative survival was 99.6% overall (open repair, 99.1%; EVAR, 99.8%; P < .001), with 97.4% 1-year survival overall (open repair, 97.3%; EVAR, 97.4%; P = .9). Unadjusted reintervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years (P = .8). After propensity weighting, the absolute incidence of perioperative mortality was <1% in both groups (open repair, 0.9%, EVAR, 0.2%; P < .001), and complication rates were low. Propensity-weighted survival (hazard ratio, 0.88; 95% confidence interval, 0.56-1.38; P = .6) and reintervention rates (open repair, 6; EVAR, 8; reinterventions per 100 person-years; P = .8) did not differ between the two interventions. The analysis of those younger than 70 years showed similar results.ConclusionsIn this study of younger patients undergoing repair of infrarenal AAA, 30-day morbidity and mortality for both open surgery and EVAR are low, and the absolute mortality difference is small. The prior published perioperative mortality and 1-year survival benefit of EVAR over open AAA repair is not observed in younger patients. Further studies of long-term durability are needed to guide decision-making for open repair vs EVAR in this population.     

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.     

Comparative early and midterm results of open juxtarenal and infrarenal aneurysm repair

Background and aims Since the introduction of endovascular aortic aneurysm repair (EVAR) for aortic aneurysms, the number of juxtarenal aortic aneurysms (JRA) has been growing steadily due to selection bias (neck morphology for EVAR). This case-match study compares the perioperative outcome and midterm results of suprarenally clamped JRA with infrarenal aortic aneurysms (AAA). Methods From 1997 to 2004, patients who received open surgery with suprarenal clamping for JRA were included in the study and compared to matched patients with infrarenal clamping (AAA). Measurements analyzed were the in-hospital mortality and morbidity. Midterm results were obtained through clinical investigation and magnetic resonance angiography imaging. Results Thirty-five patients (mean age, 68.4 years; 30 male and 5 female) received suprarenal cross-clamping for JRA. The overall in-hospital mortality for JRA and for the controls (AAA) with elective aortic repair was 4.5% (6.1% JRA; 3% AAA, p = 0.058). The morbidity of JRA was elevated according to the rate of pulmonary complications (p = 0.021) and the need for re-operation (p = 0.019). The mean follow-up time was 2.3 years (range, 8–96 months). At follow-up, 28 patients (80%) from the JRA group and 29 patients from the AAA group (82.9%) were alive. Conclusion Open aortic surgery for JRA with the need for suprarenal cross-clamping shows a slightly elevated in-hospital mortality rate without statistical significance and equal midterm mortality results in comparison with infrarenally clamped aortic aneurysms.