Endovascular repair of abdominal aortic aneurysm in octogenarians: an analysis based on EUROSTAR data

PURPOSE: To investigate the early and late outcome after endovascular treatment of abdominal aortic aneurysm (EVAR) in octogenarians compared with patients aged < 80 years. METHODS: Patients treated for abdominal aortic aneurysm (AAA) with endovascular repair during the period 1996 to 2004 were collated in the EUROSTAR registry. This study group consisted of 697 patients aged > or = 80 years. Comparison was made with 4198 patients aged < 80 years with regard to the incidence of preoperative characteristics and outcomes of the procedure. RESULTS: The proportion of octogenarians treated by EVAR increased during the study period, from 11% in the first year to 18% in the last year. Octogenarians more frequently had cardiac disease, impaired renal function, and pulmonary disease (P = .03, P < .0001 and P = .0001). Thirty-two percent of the octogenarians were recorded unfit for open surgery as opposed to 22% in younger patients (P < .0001); they also had a larger aneurysm diameter (62 vs 58 mm, respectively; P < .0001). The 30-day and in-hospital mortality in octogenarians was 5% vs 2% in the younger group (P < .0001). More device-related complications and systemic complications, including cardiac disease, were noted in octogenarians (7% vs 5% and 19% vs 11%, P = .03 and P < .0001, respectively). This group of patients also had a higher incidence of postoperative hemorrhagic complications, including hematoma (7% vs 3%, P < .0001, respectively). No differences in conversion to open repair and post-EVAR rupture rate were observed. Aneurysm-related mortality and late all-cause mortality was 7% vs 3% and 10% vs 7%, both P < .0001. CONCLUSION: Our study supports that EVAR might be considered when treating elderly patients, provided their aneurysms are anatomically suited for the endovascular technique. The risk for late complications compared with open repair may be outweighed by a lower early mortality as well as a shorter time for physical recovery.     

Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR

OBJECTIVES: This study was undertaken to determine the effect of the preoperative diameter of abdominal aortic aneurysms on the midterm outcome after endovascular abdominal aneurysm repair (EVAR). METHOD: The data for 4392 patients who had undergone EVAR were analyzed. Patients were enrolled over 6 years to June 2002 in the EUROSTAR database. Outcomes were compared between three groups defined by the preoperative diameter of the aneurysm: group A (n = 1962), 4.0 to 5.4 cm; group B (n = 1528), 5.5 to 6.4 cm; and group C (n = 902), 6.5 cm or larger. Patient characteristics, details of aortoiliac anatomy, operative procedures, old or current device generation, and postoperative complications in the three patient groups were compared. Outcome events included aneurysm-related death, unrelated death, conversion, and post-EVAR rupture of the aneurysm. Life table analysis and log-rank tests were used to compare outcome in the three study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcome events. RESULTS: Patients in group C were significantly older than patients in groups A and B (73 years vs 70 and 72 years, respectively; P =.003 - P <.0001 for different group comparisons), and more frequently were at higher operative risk (American Society of Anesthesiologists classification >or=3; 63% vs 48% and 54%; P =.0002-P <.0001). Device-related (type I) endoleaks were more frequently observed at early postoperative arteriography in group C compared with groups A and B (9.9% vs 3.7% and 6.8%; P =.01-P <.0001). Postoperatively systemic complications were more frequently present in group C (17.4% vs 12.0% in group A and 12.6% in group B; P <.0001 and.001). The first-month mortality was approximately twice as high in group C compared with the other groups combined (4.1% vs 2.1%; P <.0001). Late rupture was most frequent in group C. Follow-up results at midterm were less favorable in groups C and B compared with group A (freedom from rupture, 90%, 98%, and 98% at 4 years in groups C, B, and A, respectively; P <.0001 for group C vs groups A and B). Aneurysm-related death was highest in group C (88% freedom at 4 years, compared with 95% in group B and 97% in A; P =.001 and P <.0001, respectively; group B vs A, P =.004). The annual rate of aneurysm-related death in group C was 1% in the first 3 years, but accelerated to 8.0% in the fourth year. Incidence of unrelated death also was higher in groups C and B than in group A (76% and 82% freedom at 4 years vs 87%; P <.0001 for both comparisons). Ratio of aneurysm-related to unrelated death was 23%, 21%, and 50% in groups A, B, and C, respectively. Cox models demonstrated that the correlation between large aneurysms (group C) and all assessed outcome events was independent and highly significant. Older generation devices had an independent association with aneurysm-related and unrelated deaths (P =.02 and P =.04, respectively). However, this correlation was less strong than large aneurysm diameter (P =.0001 and P =.0009, respectively). CONCLUSIONS: The midterm outcome of large aneurysms after EVAR was associated with increased rates of aneurysm-related death, unrelated death, and rupture. Reports of EVAR should stratify their outcomes according to the diameter of the aneurysm. Large aneurysms need a more rigorous post-EVAR surveillance schedule than do smaller aneurysms. In small aneurysms EVAR was associated with excellent outcome. This finding may justify reappraisal of currently accepted management strategies.     

Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair

PURPOSE: We assessed the distribution of secondary interventions after aortic stent grafting (EVAR) performed to treat infrarenal abdominal aortic aneurysm (AAA), and evaluated clinical success and survival in patients who underwent a secondary procedure (group 2) compared with patients who did not undergo a secondary procedure (group 1). METHODS: Two hundred fifty patients (mean age, 71.3 years) with asymptomatic AAAs (mean aneurysm diameter, 54.5 mm) underwent treatment with commercially available stent grafts. Mean follow-up was 28 months (median, 25 months). Secondary procedures were defined as any additional procedures performed after initial graft placement to treat endoleak, migration, kinking, stenosis, or occlusion. Overall clinical success was defined according to reporting standards of the Society for Vascular Surgery/American Association for Vascular Surgery. RESULTS: Sixty-eight patients (27%) required 112 secondary procedures, with a mean time from initial graft placement of 18.2 months. Patients who received grafts since removed from the market required more secondary procedures (59%, procedure:patient ratio) compared with patients who received devices still on the market (21%; P =.001). Thirty-six patients (53%) required a single secondary procedure, 24 patients (35%) required two procedures, 5 patients (10%) required three procedures, 2 patients (3%) required four procedures, and 1 patient required five secondary procedures. Ninety-eight procedures (87%) were performed with endovascular methods, including placement of 42 additional covered stent grafts (36 iliac, 6 aortic), with a success rate of 85%; 35 embolization procedures (21 lumbar, 9 internal iliac artery, 5 mesenteric), with only 23 (65%) successful; 14 angioplasty procedures, with 85% successful; 4 thrombolysis procedures, 2 of them successful (50%); and 3 successfully placed new endografts within a previous endovascular graft. Surgical secondary operations included nine femorofemoral bypass procedures and three femoral thromboendarterectomies, all of which remain patent; one cerclage of an external iliac limb; and one laparoscopic repair of a type II endoleak, which was successful. Overall clinical success rate for EVAR was 84% (211 of 250) in this series. Clinical success rate in groups 1 and 2 was 91% (166 of 182) versus 66% (45 of 68; P =.001) if all endoleaks on the most recent computed tomography scans are taken into account, and 94% (171 of 182) versus 76% (52 of 68; P =.001) if type II endoleak without aneurysm growth is not considered failure. The survival rate and rupture-free survival in groups 1 and 2 were, respectively, 97.7% +/- 1.0% and 98.5% +/- 1.4% at 1 month, 95.9% +/- 1.5% and 96.9% +/- 2.1% at 6 months, 94.4% +/- 2.0% and 93.2% +/- 3.4% at 1 year, and 80.8% +/- 5.2% and 88.5% +/- 5.0% at 3 years (P =.273, log-rank test). CONCLUSION: With close follow-up and a significant number of secondary operations, this 8-year experience has not included any aneurysm ruptures to date. Secondary operations did not lead to increased mortality, but were associated with more surgical conversions and with a higher clinical failure rate.     

Abdominal aortic aneurysm repair in octogenarians: myth or reality?

AIM: We studied the thirty-day mortality and morbidity rate to assess the value of conventional open repair vs endovascular aortic repair (EVAR) in an elderly population presenting with a ruptured, symptomatic or asymptomatic abdominal aortic aneurysm (AAA) undergoing emergency, urgent or elective repair. METHODS: During the period from January 2004 to May 2007, 329 consecutive patients were treated for AAA in our Department. Among these, 81 (24.6%) were aged >80 years (mean age 83.6, range 80-95 years). These older patients were divided into groups according to their clinical presentation: ruptured AAA group (rAAA) - 22 cases (4 emergency EVAR, 18 emergency open repair); symptomatic non-ruptured AAA group (sAAA) - 15 cases (11 urgent EVAR, 4 urgent open repair); asymptomatic AAA group (asAAA) - 44 cases (32 elective EVAR, 12 elective open repair). The main outcome measures were 30-day mortality and 30-day morbidity rate. RESULTS: The mortality rate following open surgery vs EVAR was 66.6% vs 50% (P=NS) in the rAAA group, 25% vs 0% (P=NS) in the sAAA group, and 9% vs 3.2% (P=NS) in the asAAA group. When comparing postoperative morbidities in the octogenarians, 3 of the patients that received EVAR (6.4%) and 15 of those that received open repair (48.4%) had a severe complication (P<0.01). CONCLUSION: The introduction of EVAR has considerably changed the balance of risks and benefits for AAA treatment. Our study confirms the high mortality rate for octogenarians with rAAA and haemodynamic instability, and supports the value of an active EVAR approach for octogenarians with AAA to prevent rupture. Moreover, the introduction of endovascular techniques as part of an overall treatment algorithm for ruptured AAAs appears to be potentially associated with improved outcomes in terms of mortality and morbidity as compared to open surgical repairs alone.     

Gender differences in endovascular abdominal aortic aneurysm repair with the AneuRx stent graft

OBJECTIVE: The objective of this study was to evaluate gender differences in the selection, procedure, and outcome of endovascular abdominal aortic aneurysm repair (EVAR). PATIENTS: Between October 1996 and January 2001, 378 patients were evaluated for EVAR and 189 patients underwent EVAR with the Medtronic AneuRx stent graft at a single center. RESULTS: Women constituted 17% of patients considered for EVAR. Their eligibility rate (49%) did not differ significantly from that of men (57%), and they constituted 14% of patients who underwent EVAR (26/189). Women who underwent EVAR were older (77.9 +/- 6.3 years versus 73.1 +/- 8.1 years; P <.005) with a higher rate of chronic obstructive lung disease (50% versus 28%; P <.05). Maximal aneurysm diameter (57.2 +/- 10.9 mm versus 57.8 +/- 9.4 mm; not significant) did not differ between men and women. Mean diameters of the proximal neck (20.4 +/- 2.3 mm versus 22.3 +/- 2.0 mm; P <.01), common iliac arteries (11.4 +/- 1.2 mm versus 13.5 +/- 3.6 mm; P <.001), and external iliac arteries (7.9 +/- 0.7 mm versus 9.4 +/- 1.4 mm; P <.001) were all smaller in women, and abdominal aortic aneurysm/neck diameter ratio was larger (2.82 +/- 0.59 versus 2.60 +/- 0.49; P <.05). The length of the proximal aortic neck was shorter in women (20.7 +/- 8.2 mm versus 24.5 +/- 11.8 mm; P <.05). Women had significantly more intraoperative complications (31% versus 13%; P <.05), primarily related to arterial access, and needed more frequent arterial reconstruction (42% versus 21%; P <.05), without a difference in postoperative mortality rate (0/26 versus 2/163; not significant) and complication rate (23% versus 20%: not significant). During a follow-up period of 13.8 +/- 11.7 months, no gender-related difference was found in survival rate, endoleak rate, or reintervention rate or in the rate of change in aneurysm diameter or volume. CONCLUSION: Eligibility rates of women for EVAR are similar to those of men. Women are at an increased risk for access-related complications during EVAR, but outcome is equivalent to that of men.     

Clinical effect of abdominal aortic aneurysm endografting: 7-year concurrent comparison with open repair

OBJECTIVE: We compared the effectiveness and clinical outcome of open repair versus endovascular aortic aneurysm repair (EVAR) in achieving prevention of abdominal aortic aneurysm (AAA)-related death and graft-related complications. METHODS: Over 7 years from 1997 to 2003, 1119 consecutive patients underwent elective treatment of infrarenal AAAs, 585 with open repair and 534 with EVAR. Patients were regularly followed up at 1, 6, 12 months, and every 6 months thereafter, in EVAR group, and at 3 and 12 months, and yearly thereafter after open repair. Preoperative, intraoperative, and follow-up data were stored in a prospective database. RESULTS: Median follow-up was similar in the 2 groups: 33 months (interquartile range [IQR], 13-50 months) in the EVAR group vs 35 months (IQR, 15-54 months) in the open repair group. EVAR group patients were older than patients in the open repair group: 73 years vs 72 years (P = .04). There were statistical significant differences between the EVAR group and the open repair group with respect to AAA median diameter (52 mm vs 56 mm), coronary disease rate (46% vs 37%; P = .001), pulmonary disease rate (56% vs 38%; P < .0001), and American Society of Anesthesiologists IV score rate (16% vs 6%; P < .0001). Thirty-day mortality in the EVAR group was 0.9% (5 of 534 patients), compared with 4.1% (24 of 585 patients; P = .001) in the open repair group, and major morbidity was 9.1% (49 of 534 patients) vs 18.6% (109 of 585 patients; P < .0001), respectively. The incidence of secondary procedures in the EVAR group was 15.7%, compared with 3% in the open repair group (P < .0001). There were no deaths related to secondary procedures in either group. Six AAAs (1.1%) ruptured after EVAR, 3 of which were fatal; in the open repair group 1 patient (0.2%) underwent successful repeat operatation to treat iliac pseudoaneurysm rupture 5 years after the original procedure. Kaplan-Meier estimates for freedom from aneurysm-related death at 84 months were 97.5% in the EVAR group and 95.9% in the open repair group (log rank test, P = .008). Kaplan-Meier survival estimates at 84 months were 67.1% in the open repair group and 66.9% in the EVAR group (P = NS). At the same interval the risk for secondary procedures was 49.4% for the EVAR group and 7.1% for the open repair group. Of the 11 variables analyzed with logistic analysis, open surgery (hazard ratio [HR], 11; 95% confidence interval [CI], 2.5-54.2; P = .002), American Society of Anesthesiologists IV score (HR, 7.1; 95% CI, 2.7-18.8; P = .0001), and age (HR, 1.06; 95% CI, 1.04-1.13; P = .04) were positive independent predictors of perioperative mortality. CONCLUSION: Our data suggest that at a maximum follow-up of 7 years, patients who undergo EVAR show lower perioperative and late aneurysm-related mortality compared with a younger and substantially healthier group of patients with aneurysms treated with open repair. The higher need for secondary procedures in the endovascular group did not affect superiority of the overall performance of EVAR in the early and late intervals.     

Persistent type 2 endoleak after endovascular repair of abdominal aortic aneurysm is associated with adverse late outcomes

OBJECTIVE: Type 2 endoleak occurs in up to 20% of patients after endovascular aneurysm repair (EVAR), but its long-term significance is debated. We reviewed our experience to evaluate late outcomes associated with type 2 endoleak. METHODS: During the interval January 1994 to December 2005, 873 patients underwent EVAR. Computed tomography (CT) scan assessment was performed < or =1 month of the operation and at least annually thereafter. Sequential 6-month CT scan follow-up was adopted for those patients with persistent type 2 endoleaks, and reintervention was limited to those with sac enlargement >5 mm. Study end points included overall survival, aneurysm sac growth, reintervention rate, conversion to open repair, and abdominal aortic aneurysm (AAA) rupture. Preoperative variables and anatomic factors potentially associated with these endpoints were assessed using multivariate analysis. RESULTS: We identified 164 (18.9%) patients with early (at the first follow-up CT scan) type 2 endoleaks. Mean follow-up was 32.6 months. In 131 (79.9%) early type 2 endoleaks, complete and permanent leak resolution occurred < or =6 months. Endoleaks persisted in 33 patients (3.8% of total patients; 20.1% of early type 2 endoleaks) for >6 months. Transient type 2 endoleak (those that resolved < or =6 months of EVAR) was not associated with adverse late outcomes. In contrast, persistent endoleak was associated with several adverse outcomes. AAA-related death was not significantly different between patients with and without a type 2 endoleak (P = .78). When evaluating patients with no early endoleak vs persistent endoleak, freedom from sac expansion at 1, 3, and 5 years was 99.2%, 97.6%, and 94.9% (no leak) vs 88.1%, 48.0%, and 28.0% (persistent) (P < .001). Patients with persistent endoleak were at increased risk for aneurysm sac growth vs patients without endoleak (odds ratio [OR], 25.9; 95% confidence interval [CI] 11.8 to 57.4; P < .001). Patients with a persistent endoleak also had a significantly increased rate of reintervention (OR, 19.0; 95% CI, 8.0 to 44.7); P < .001). Finally, aneurysm rupture occurred in 4 patients with type 2 endoleaks. Freedom from rupture at 1, 3, and 5 years for patients with a persistent type 2 endoleak was 96.8%, 96.8%, and 91.1% vs 99.8%, 98.5%, and 97.4% for patients without a type 2 endoleak. Multivariate analysis demonstrated persistent type 2 endoleak to be a significant predictor of aneurysm rupture (P = .03). CONCLUSIONS: Persistent type 2 endoleak is associated with an increased incidence of adverse outcomes, including aneurysm sac growth, the need for conversion to open repair, reintervention rate, and rupture. These data suggest that patients with persistent type 2 endoleak (>6 months) should be considered for more frequent follow-up or a more aggressive approach to reintervention.     

Type II endoleaks: predictable,preventable, and sometimes treatable?

OBJECTIVE: The purpose of this study was to evaluate the effect of preoperative coil embolization of lumbar and inferior mesenteric arteries on the incidence of type II endoleak after endovascular abdominal aortic aneurysm repair. METHODS: The subjects were consecutive patients who underwent EVAR between January 1996 and January 2001. Patent aortic side branches were identified with preprocedural spiral computed tomographic scanning and calibrated angiography. Coil embolization was performed before EVAR. Patients were followed up with plain radiographs and ultrasound and dual phase spiral computed tomographic scans. Digital subtraction angiography was performed when endoleak was suspected. The outcome measures were the incidence of type II endoleaks and changes in maximum aortic sac diameter (Dmax). RESULTS: Forty patients underwent EVAR, with a median duration of follow-up of 24 months (range, 3 to 48 months). Before surgery, the inferior mesenteric artery was patent in 16 patients (45%) and the lumbar arteries in 21 patients (53%). Inferior mesenteric artery embolization was successful in 13 of 16 patients (81%). Lumbar embolization was attempted in 13 patients and was successful in eight (62%). During EVAR, successful sac exclusion was achieved in 38 patients (95%). None of the patients who underwent embolization before EVAR had type II endoleak develop, eight of 13 patients (62%) with patent lumbar arteries had endoleaks develop (P =.006), and three of these patients subsequently underwent successful coil embolization. Type II endoleak was associated with a 2.0-mm median increase in Dmax (P =.045). A 3.0-mm median reduction in Dmax was seen in the absence of type II endoleak (P =.002). CONCLUSION: Type II endoleaks are predictable, preventable, and sometimes treatable. Significant sac shrinkage occurs in the absence of lumbar endoleak but not in the presence of type II endoleak.     

No difference in medium-term outcome between Zenith and Talent stent-grafts in endovascular aneurysm repair

BACKGROUND: Many devices are available for endovascular aneurysm repair (EVAR). Our aim was to analyze morphological effects of the Zenith and Talent systems. METHODS: Patients included underwent EVAR from June 1999 to June 2005 using a Zenith or Talent stent-graft, with computed tomography follow-up. Aortic dimensions over time and clinical outcome were analyzed. RESULTS: Twenty-nine patients with Zenith stent-grafts and 33 with Talent devices were included. Mean preoperative age was similar (75.5+/-6.0 years vs 74.2+/-6.7 years; P=.29). Preoperative neck length was longer in the Zenith group (29.9+/-15.2 mm vs 25.5 +/- 10.8 mm; P=.10), and stent-graft oversizing was greater in the Talent patients (20.2%+/-7.9% vs 23.0% +/- 11.3%). There was proximal aortic dilatation and aneurysm sac shrinkage in each group. Complication rates were comparable, with 83% of both groups free from 10-mm migration. CONCLUSION: Although device designs differ, there is no difference in clinical outcome between Zenith and Talent stent-grafts. Migration rates were not influenced by suprarenal fixation.     

Predicting aneurysm enlargement in patients with persistent type II endoleaks

OBJECTIVE: The clinical significance of type II endoleaks is not well understood. Some evidence, however, indicates that some type II endoleaks might result in aneurysm enlargement and rupture. To identify factors that might contribute to aneurysm expansion, we analyzed the influence of several variables on aneurysm growth in patients with persistent type II endoleaks after endovascular aortic aneurysm repair (EVAR). METHODS: In a series of 348 EVARs performed during a 10-year period, 32 patients (9.2%) developed type II endoleaks that persisted for more than 6 months. Variables analyzed included those defined by the reporting standards for EVAR (SVS/AAVS) as well as other endoleak characteristics. Univariate, receiver operating characteristic curve, and Cox regression analyses were used to determine the association between variables and aneurysm enlargement. RESULTS: The median follow-up period was 26.5 months (range, 6-88 months). Thirteen patients (41%) had aneurysm enlargement by 5 mm or more (median increase in diameter, 10 mm), whereas 19 (59%) had stable or shrinking aneurysm diameter. Univariate and Cox regression analyses identified the maximum diameter of the endoleak cavity, ie, the size of the nidus as defined on contrast computed tomography scan, as a significant predictor for aneurysm enlargement (relative risk, 1.12; 95% confidence interval, 1.04-1.19; P =.001). The median size of the nidus was 23 mm (range, 13-40 mm) in patients with aneurysm enlargement and 8 mm (range, 5-25 mm) in those without expansion (Mann-Whitney U test, P <.001). Moreover, receiver operating characteristic curve and Cox regression analyses showed that a maximum nidus diameter greater than 15 mm was particularly associated with an increased risk of aneurysm enlargement (relative risk, 11.1; 95% confidence interval, 1.4-85.8; P =.02). Other risk factors including gender, smoking history, hypertension, need of anticoagulation, aneurysm diameter, type of endograft used, and number or type of collateral vessels were not significant predictors of aneurysm enlargement. CONCLUSIONS: In patients with persistent type II endoleaks after EVAR, the maximum diameter of the endoleak cavity or nidus is an important predictor of aneurysm growth and might indicate the need for more aggressive surveillance as well as earlier treatment.     

Volumetric analysis of effectiveness of embolization for preventing type II endoleaks following endovascular aortic aneurysm repair

ObjectiveThe presence of endoleak was associated with the failure of endovascular aortic aneurysm repair (EVAR) treatment. The key to eliminating type II endoleak has shifted from reintervention to prevention. This study aimed to evaluate the effectiveness and safety of applying fibrin sealant to prevent type II endoleak in conjunction with EVAR.MethodsAll patients with abdominal aortic aneurysm who underwent EVAR from June 2019 to July 2021 were reviewed. Patients were grouped as Group A: standard EVAR with preemptive embolization and Group B: standard EVAR alone. The primary endpoint was the incidence of type II endoleak. The secondary endpoints were aneurysm sac regression, the inferior mesenteric artery patency, the numbers of patent lumbar arteries, and all-cause mortality.ResultsA total of 104 patients were included in Group A, and 116 were included in Group B. Technical success rate was 100%. The overall incidence of type II endoleak in Group A was significantly lower than that in Group B (4.8% vs 19.0%). The mean time of freedom from type II endoleak was 22.71 months for Group A (95% confidence interval, 21.59-23.83 months) and 19.89 months for Group B (95% confidence interval, 18.08-21.70 months). The Kaplan-Meier estimate of freedom from type II endoleak showed a significantly longer duration of freedom from type II endoleak in Group A (81.0% vs 95.2%). Group A showed a continuous sac regression tendency. In Group B, the sac volume decreased within 12 months but increased by 3.07 cm³ at 24 months. No complications were noted in both groups.ConclusionsNonselective preemptive embolization with porcine fibrin sealant during EVAR was safe and effective in preventing type II endoleak in the short and mid-term. Preemptive embolization can lead to a significantly higher sac regression rate. Larger patient populations and longer follow-ups with randomized control designed trials are expected to verify the long-term effectiveness and safety of preemptive embolization in preventing type II endoleak.     

Endovascular abdominal aortic aneurysm repair: long-term outcome measures in patients at high-risk for open surgery

PURPOSE: The study was conducted to determine the outcome in the United States after endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at high-risk for open surgery by using independently audited, high-compliance, chart-verified data sets, and to compare those results with open surgery. METHODS: High-risk was defined to match a recent European trial (EVAR2) and included age of > or =60 years with aneurysm size of > or =5.5 cm, plus at least one cardiac, pulmonary, or renal comorbidity. Data from five multicenter investigational device exemption clinical trials leading to Food and Drug Administration (FDA) approval were analyzed. Of 2216 EVAR patients, 565 met the high-risk criteria. Of 342 surgical controls (OPEN), 61 met high-risk criteria. Primary outcome comparisons included AAA-related death, all-cause death, and aneurysm rupture. Secondary measures were endoleak, AAA sac enlargement, and migration. RESULTS: Average age of the high-risk EVAR subset was 76 +/- 7 years vs 74 +/- 6 years OPEN (P = 0.07), mean EVAR AAA size was 6.4 +/- 0.8 cm vs 6.6 +/- 1.0 cm OPEN (P = .33), and average EVAR follow-up was 2.7 years vs 2.5 years OPEN. The 30-day operative mortality was 2.9% in EVAR vs 5.1% in OPEN (P = .32). The AAA-related death rate after EVAR was 3.0% at 1 year and 4.2% at 4 years compared with 5.1% at both time points after OPEN (P = .58). Overall survival at 4 years after EVAR was 56% vs 66% in OPEN (P = .23). After treatment, EVAR successfully prevented rupture in 99.5% at 1 year and in 97.2% at 4 years. CONCLUSIONS: Endovascular repair of large infrarenal AAAs in anatomically suited high-surgical-risk patients using FDA-approved devices in the United States is safe and provides lasting protection from AAA-related mortality. EVAR mortality remained comparable with OPEN up to 4 years. The decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered, but repair provides excellent protection from AAA-related death.     

Long-term outcomes after endovascular abdominal aortic aneurysm repair: the first decade

OBJECTIVE: The proper role of endovascular abdominal aortic aneurysm repair (EVAR) remains controversial, largely due to uncertain late results. We reviewed a 12-year experience with EVAR to document late outcomes. METHODS: During the interval January 7, 1994 through December 31, 2005, 873 patients underwent EVAR utilizing 10 different stent graft devices. Primary outcomes examined included operative mortality, aneurysm rupture, aneurysm-related mortality, open surgical conversion, and late survival rates. The incidence of endoleak, migration, aneurysm enlargement, and graft patency was also determined. Finally, the need for reintervention and success of such secondary procedures were evaluated. Kaplan-Meier and multivariate methodology were used for analysis. RESULTS: Mean patient age was 75.7 years (range, 49-99 years); 81.4% were male. Mean follow-up was 27 months; 39.3% of patients had 2 or more major comorbidities, and 19.5% would be categorized as unfit for open repair. On an intent-to-treat basis, device deployment was successful in 99.3%. Thirty-day mortality was 1.8%. By Kaplan-Meier analysis, freedom from AAA rupture was 97.6% at 5 years and 94% at 9 years. Significant risk factors for late AAA rupture included female gender (odds ratio OR, 6.9; P = 0.004) and device-related endoleak (OR, 16.06; P = 0.009). Aneurysm-related death was avoided in 96.1% of patients, with the need for any reintervention (OR, 5.7 P = 0.006), family history of aneurysmal disease (OR, 9.5; P = 0.075), and renal insufficiency (OR, 7.1; P = 0.003) among its most important predictors. 87 (10%) patients required reintervention, with 92% of such procedures being catheter-based and a success rate of 84%. Significant predictors of reintervention included use of first-generation devices (OR, 1.2; P < 0.01) and late onset endoleak (OR, 64; P < 0.001). Current generation stent grafts correlated with significantly improved outcomes. Cumulative freedom from conversion to open repair was 93.3% at 5 through 9 years, with the need for prior reintervention (OR, 16.7; P = 0.001) its most important predictor. Cumulative survival was 52% at 5 years. CONCLUSIONS: EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application of EVAR across a wide spectrum of patients.     

Standard endovascular aneurysm repair in patients with wide infrarenal aneurysm necks is associated with increased risk of adverse events

Objective

Endovascular aneurysm repair (EVAR) has progressively expanded to treat more challenging anatomies. Although EVAR in patients with wide infrarenal necks has been reported with acceptable results, there is still controversy regarding the longer-term outcomes. Our aim is to determine the impact of infrarenal neck diameter on midterm outcome following EVAR with a single endograft with suprarenal fixation.

Increasing use of open conversion for late complications after endovascular aortic aneurysm repair

ObjectiveOpen procedures are often required for late complications after endovascular aneurysm repair (EVAR). Our aim was to describe the indications for open interventions and their postoperative outcomes and to specifically examine our experience with limited conversions in which problem endoleaks are targeted without endograft explantation.MethodsWe reviewed patients from 2002 to 2017 who underwent any surgical abdominal aortic operation after a previous EVAR. Baseline characteristics, preoperative imaging, procedural details, and postoperative outcomes were reviewed. The primary end point was 30-day mortality.ResultsThere were 102 patients who underwent open conversion 3.8 ± 3.1 years after EVAR. The numbers increased significantly in recent years, with 18 cases performed in 2016; 48.5% of patients had undergone 1.9 ± 1.0 prior endovascular interventions. The indication for surgical conversion was an endoleak in 85 patients and infection in 15. One patient had a limb occlusion and another a proximal aneurysm. The 30-day mortality was 6.2% in 65 patients treated electively for endoleak but higher in 20 ruptures (40.0%) and 15 infections (40.0%). In a multivariate logistic regression model, independent predictors of 30-day mortality were rupture (odds ratio [OR], 6.70; 95% confidence interval [CI], 1.75-25.60; P = .005), endograft infection (OR, 8.48; 95% CI, 1.99-36.20; P = .004), and use of a supraceliac clamp (OR, 4.80; 95% CI, 1.47-15.66; P = .009). Transient acute kidney injury (12.8%) and prolonged intubation (11.8%) were the most common postoperative complications. In 65 patients treated for endoleak without rupture, 37 underwent endograft explantation, whereas 28 had a graft-preserving intervention (branch vessel ligation for type II endoleak in 26, external banding of the aneurysm neck for type IA endoleak in 8). Mortality was 8.1% when the endograft was explanted and 3.6% when it was not (P = .63). During 3.0 ± 3.5 years of follow-up, there was one reintervention after endograft explantation (for rupture secondary to type IB endoleak) and two reinterventions after graft preservation (for a new type IA endoleak and a new type II endoleak). Survival was 87.4% at 1 year and 70.9% at 5 years.ConclusionsOpen conversion is playing an increasing role in the management of late EVAR complications. Endoleaks treated electively by open conversion are reasonably safe and show good midterm durability, even with graft-preserving interventions that avoid endograft explantation.     

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.     

Endovascular aneurysm repair: gender-specific results

OBJECTIVES: The outcome for a wide variety of diseases and treatment methods varies by gender. In an effort to determine whether gender has a role in the outcome of endovascular aortic aneurysm repair, we analyzed data from consecutive patients treated at a single institution over 6 years. METHODS: Over 6 years ending in March 2002, 704 patients underwent endovascular repair of an infrarenal abdominal aortic aneurysm at The Cleveland Clinic. Six hundred six patients (86.1%) were men and 98 patients (13.9%) were women. Preprocedure and postprocedure imaging studies were evaluated to determine the frequency of aneurysm sac shrinkage or growth, defined as diameter change equal to or greater than 5 mm. Presence and type of endoleak was assessed with non-contrast material-enhanced, post-contrast-enhanced, and delayed post-contrast-enhanced computed tomography scans. These and other clinical variables were assessed with the Kaplan-Meier method and the Cox-Mantel log-rank test, and values were expressed as mean +/- SE. RESULTS: Male and female patients were comparable with respect to baseline comorbid conditions. Women, however, were slightly older (76.7 +/- 0.7 years vs 74.4 +/- 0.3 years; P =.009), and had slightly smaller aneurysms (5.2 +/- 0.1 cm vs 5.4 +/- 0.04 cm; P =.033). There were no gender-specific differences in perioperative mortality (men, 1.3%; women, 3.1%; P =.197) or mid-term (24 months) survival (men, 80% +/- 2.6%; women, 78% +/- 8.1%). Similarly, there were no differences at 24 months in risk for graft migration (7.5% +/- 2.0% vs 5.4% +/- 3.2%), need for secondary remedial procedures (24% +/- 2.9% vs 21% +/- 6.3%), conversion to open surgery (3.9% +/- 1.5% vs 3.8% +/-2.7%), or post-repair aneurysm rupture (1.1% +/- 0.9% vs 2.2% +/-2.2%) in male and female patients, respectively. In contrast, risk for graft limb occlusion at 24 months was significantly higher in women than in men (11% +/- 5.2% vs 3.3% +/- 1.1%; P =.022). While frequency of endoleak of any type did not differ among male and female patients, aneurysm sac shrinkage at 24 months was more rapid in women (76% +/- 8.1% vs 57% +/- 3.5%; P =.019). CONCLUSIONS: With the exception of slightly older age and somewhat smaller aneurysm, female patients are similar to male patients undergoing endovascular aneurysm repair. A greater frequency of graft limb occlusion was observed in female patients, but no statistically significant differences were detected in survival, rupture risk, or need for secondary procedures. Moreover, a more rapid rate of aneurysm sac shrinkage was detected in women. These observations suggest that endovascular aneurysm repair should be offered to suitable candidates irrespective of gender.     

Carotid endarterectomy in octogenarians: comparison with patient characteristics and outcomes in younger patients

OBJECTIVES: Carotid endarterectomy has been shown to be of clear benefit to selected patients. However, recent trials of carotid endarterectomy versus best medical therapy have excluded octogenarians, and some authors have suggested that carotid endarterectomy would have an unfavorable cost-benefit relationship in octogenarians. We compared patients and results for carotid endarterectomy in octogenarians and younger patients. METHODS: We reviewed the results for 582 primary carotid endarterectomies (90 in octogenarians and 492 in younger patients) performed in 528 patients between February 1, 1985, and January 31, 1998 (all data were collected prospectively for the most recent 301 carotid endarterectomies). Conventional surgical technique was used with general anesthesia, selective shunting, and selective patching. Main outcome measures were perioperative and late ipsilateral stroke and death. RESULTS: The two groups were similar with respect to indications for carotid endarterectomy and patient characteristics, except that octogenarians were more likely to have histories of congestive heart failure or hypertension and less likely to have histories of smoking or chronic lung disease. Carotid endarterectomy was performed for asymptomatic disease in 27% of the octogenarians and 33% of the younger patients (P =.31). Stenosis was >/=80% in 90% of the octogenarians and 78% of the younger patients (P =.014). Perioperative strokes, all of which were ipsilateral, occurred in one octogenarian (1.1%) and eight younger patients (1.6%, P = 1.00). No octogenarians and two younger patients died within 30 days of surgery (P = 1.00). Length of stay and direct costs associated with carotid endarterectomy were similar for octogenarians and younger patients. Late strokes occurred in two octogenarians (one ipsilateral) and four younger patients (two ipsilateral). Life table estimates of freedom from ipsilateral stroke at 2 years were 98% and 97% for octogenarians and younger patients, respectively (log-rank P =.69), and life table estimates of patient survival at 4 years were 81% and 89% for octogenarians and younger patients, respectively (P =.11). Octogenarians represented an increasing fraction of the carotid endarterectomies performed during the study period. CONCLUSIONS: Octogenarians selected for carotid endarterectomy were similar to younger patients with respect to indications for carotid endarterectomy and comorbidities. Early mortality, early and late neurologic outcome, complications, and resource utilization were similar for the two groups, and more than 75% of octogenarians survived 4 years after undergoing carotid endarterectomy. Cost-benefit analyses for carotid endarterectomy, which are highly sensitive to expected patient survival, might not be pertinent to individual patient situations. Intellectually intact octogenarians without unusually severe comorbidities are good candidates for and should be offered the benefits of carotid endarterectomy.     

Elective endovascular and open repair of abdominal aortic aneurysms in octogenarians

OBJECTIVES: Endovascular aortic aneurysm repair (EVAR) is an increasingly popular treatment option for patients with abdominal aortic aneurysms (AAA), although open repair is considered the standard by virtue of its durability. Octogenarians, as a subgroup, may stand to benefit the most by EVAR. The purpose of this study is to review operative results and durability of open AAA repair and EVAR in octogenarians. METHODS: From May 1996 to August 2006, 150 patients aged >or=80 years underwent elective repair of their infrarenal AAA. Eighty-one underwent EVAR and 69 had open repair. Demographic data, aneurysm specifics, comorbidities, operative morbidity and mortality, intensive care unit and hospital length of stay, and late outcomes were analyzed. RESULTS: In the EVAR group, 27 of 81 (33%) patients died during a mean follow-up of 25 months. In the open repair group, 34 of 69 (49%) patients died during a mean follow-up of 43 months. The median survival time for EVAR was 350 weeks (range, 145-404 weeks) compared with 317 weeks (range, 233-342 weeks) for the open repair group. A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between EVAR and open repair (P = .13). EVAR was associated with decreased blood loss, decreased length of intensive care unit and hospital stays, and a greater number of patients discharged to home. CONCLUSIONS: EVAR and open repair are comparable in safety and efficacy in octogenarians. Operative repair outcomes remain acceptable. Mid- and long-term survival are similar, indicating no survival advantage of one procedure compared with the other.