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.     

The rupture rate of large abdominal aortic aneurysms: is this modified by anatomical suitability for endovascular repair?

BACKGROUND: There are no precise estimates of the rate of rupture of large abdominal aortic aneurysms (AAA). There is recent suspicion that anatomic suitability for endovascular repair may be associated with a decreased risk of AAA rupture. METHODS: Systematic literature review of rupture rates of AAA with initial diameter > or =5 cm in patients not considered for open repair, with stratification by size (<6.0 cm and 6.0+ cm), and gender, combined using random-effects meta-analysis. Proportional hazards regression to analyze factors (including gender, diabetes, initial AAA diameter, aneurysm neck, and sac lengths) associated with rupture in patients anatomically suitable for endovascular repair (EVAR 2 trial). RESULTS: Previous studies (2 prospective, 2 retrospective, and 1 mixed) were identified for meta-analysis and patients with elective repair excluded. The pooled rupture rates was 18.2 [95% confidence interval (CI) 13.7-24.1] per 100 person-years. There was a 2.5-fold increase in rupture rates for patients with AAA of 6.0+ cm versus <6.0 cm, rupture rates = 2.54 (95% CI 1.69-3.85). The pooled rupture rates was nonsignificantly higher in women than men, rupture rates = 1.21 (95% CI 0.77-1.90). For EVAR 2 patients with 6+ cm aneurysms the rupture rates was 17.4 [95% CI 12.9-23.4] per 100 person-years significantly lower than the pooled rate from the meta-analysis, rupture rates = 27.0 [95% CI 21.1-34.7] per 100 person-years, P = 0.026. Patients with shorter neck lengths appeared to have a higher rupture rates than those with longer necks, but this was of borderline significance P = 0.10. CONCLUSIONS: Rupture rates of large AAAs reported in different studies are highly variable. There is emerging evidence that patients anatomically suitable for endovascular repair have lower rupture rates.     

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

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

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.     

Randomisierte Studien mit EBM-Level 1 beweisen es

Results have been published of randomised controlled studies on the screening of elderly men for abdominal aortic aneurysms (AAA). A systematic review and meta-analysis was therefore carried out in order to be able to assess the pooled effects. A Medline search (PubMed) for randomised controlled studies was carried out using the key words “screening” and “aortic aneurysms” in English. The medium-term (3.5-5 years) and long-term (7-15 years) effects were calculated as the odds ratio with a 95% confidence interval. Four studies were identified, the “Chichester Study” (UK/England), the “Multicentre Aneurysm Screening Study” (MASS) (UK/England), the “Western Australian Aneurysm Screening Study” (AUS) and the “Viborg Study” (Denmark). The analysis showed that the probability of an AAA rupture fell significantly by 47% as a result of screening, AAA-related mortality (after men over the age of 80 years were excluded) decreased by 49% and overall mortality was also reduced (OR 0.93; 95% CI: 0.90-0.96). The number of planned operations increased 3-fold (p<0.05) and the probability of emergency operations decreased by 45% (p<0.05). The long-term pooled results showed a significant reduction of 47% in the probability of both AAA rupture and AAA-related mortality and a significant decrease in overall mortality (OR 1.77; 95% CI: 0.92-0.97). Overall, 1.7 times more operations were carried out on the men invited for screening than on the controls (OR 1.77; 95% CI: 1.57; 1.99). AAA screening reduces the probability of rupture and AAA-related mortality by about 50% each and overall mortality by about 6-7%, although there are differences which might have an impact on local cost-benefit ratio of the screening.     

Endovascular aneurysm repair at 5 years: does aneurysm diameter predict outcome?

OBJECTIVE: The appropriate size threshold for endovascular repair of small abdominal aortic aneurysms (AAA) is unclear. We studied the outcome of endovascular aneurysm repair (EVAR) as a function of preoperative aneurysm diameter to determine the relationship between aneurysm size and long-term outcome of endovascular repair. METHODS: We reviewed the results of 923 patients treated in a prospective, multicenter clinical trial of EVAR. Small aneurysms were defined according to two size thresholds of 5.5 cm and 5.0 cm. Two-way analysis was used to compare patients with small aneurysms (<5.5 cm, n = 441) to patients with large aneurysms (> or =5.5 cm, n = 482). An ordered three-way analysis was used to compare patients with small AAA (<5.0 cm, n = 145), medium AAA (5.0 to 5.9 cm, n = 461), and large AAA (> or =6.0 cm, n = 317). The primary outcome measures of rupture, AAA-related death, surgical conversion, secondary intervention, and survival were compared using Kaplan-Meier estimates at 5 years. RESULTS: Median aneurysm size was 5.5 cm. The two-way comparison showed that 5 years after EVAR, patients with small aneurysms (<5.5 cm) had a lower AAA-related death rate (1% vs 6%, P = .006), a higher survival rate (69% vs 57%, P = .0002), and a lower secondary intervention rate (25% vs 32%, P = .03) than patients with large aneurysms (> or =5.5 cm). Three-way analysis revealed that patients with small AAAs (<5.0 cm) were younger (P < .0001) and were more likely to have a family history of aneurysm (P < .05), prior coronary intervention (P = .003), and peripheral occlusive disease (P = .008) than patients with larger AAAs. Patients with smaller AAAs also had more favorable aortic neck anatomy (P < .004). Patients with large AAAs were older (P < .0001), had higher operative risk (P = .01), and were more likely to have chronic obstructive pulmonary disease (P = .005), obesity (P = .03), and congestive heart failure (P = .004). At 5 years, patients with small AAAs had better outcomes, with 100% freedom from rupture vs 97% for medium AAAs and 93% for large AAAs (P = .02), 99% freedom from AAA-related death vs 97% for medium AAAs and 92% for large AAAs (P = .02) and 98% freedom from conversion vs 92% for medium AAAs and 89% for large AAAs (P = .01). Survival was significantly improved in small (69%) and medium AAAs (68%) compared to large AAAs (51%, P < .0001). Multivariate Cox proportional hazards modeling revealed that aneurysm size was a significant independent predictor of rupture (P = .04; hazard ratio [HR], 2.195), AAA-related death (P = .03; HR, 2.007), surgical conversion (P = .007; HR, 1.827), and survival (P = .001; HR, 1.351). There were no significant differences in secondary intervention, endoleak, or migration rates between small, medium, and large AAAs. CONCLUSIONS: Preoperative aneurysm size is an important determinant of long-term outcome following endovascular repair. Patients with small AAAs (<5.0 cm) are more favorable candidates for EVAR and have the best long-term outcomes, with 99% freedom from AAA death at 5 years. Patients with large AAAs (> or =6.0 cm) have shorter life expectancy and have a higher risk of rupture, surgical conversion, and aneurysm-related death following EVAR compared to patients with smaller aneurysms. Nonetheless, 92% of patients with large AAAs are protected from AAA-related death at 5 years. Patients with AAAs of intermediate size (5 to 6 cm) represent most of the patients treated with EVAR and have a 97% freedom from AAA-related death at 5 years.     

Endovascular versus open surgical repair of abdominal aortic aneurysm: a comparison of early and intermediate results in patients suitable for both techniques.

PURPOSE: To assess early and intermediate results of endovascular repair of abdominal aortic aneurysms (EVAR), and to compare them with open surgery (OS) in concurrent patients suitable for both types of treatment. METHODS: During 3 years, 180 patients with AAA underwent repair. We excluded patients with ruptured aneurysms (33), juxtarenal aneurysms (11), iliac aneurysms (8), with peripheral embolization (2) and those treated with a cryopreserved homograft (2). From the remaining patients (n=124), we selected those suitable for both techniques (n=83), of which 53 were treated by EVAR and 30 by OS. Analysis was performed using Kaplan-Meier curves and Log Rank tests. RESULTS: Hospital mortality was not significantly higher in the OS group (6.6% OS vs. 3.7% EVAR), p=0.55. The EVAR group had significantly shorter operative time, length of hospital stay and less blood loss. The median follow up time was 2.18 years for OR and 1.58 years for EVAR. There were no conversions from EVAR to OS and no differences in late survival (p=0.255, Cox regression analysis) with a cumulative survival rate at 3 years of 89% for EVAR and 73% for OS. By 3 years 24% (95% CI, 11-47%) of EVAR patients had presented endoleaks with an endovascular re-intervention rate of 27% (95% CI, 13-50%). One patient in the OS group needed a late open intervention. CONCLUSIONS: EVAR compares favourably with OS in terms of reduction of operative time, hospital length of stay and blood loss. This study did not show a difference in early or late mortality. EVAR durability remains the most critical issue to be addressed.     

Informed consent for abdominal aortic aneurysm repair: assessing variations in surgeon opinion through a national survey

OBJECTIVE: Informed consent discussions for elective abdominal aortic aneurysm (AAA) repair should reflect appropriate risks of the open or endovascular repair (EVAR), but few guidelines exist describing what surgeons should discuss. This study examines expert opinion regarding what constitutes informed consent. METHODS: Design. We conducted an anonymous, web-based, national survey of vascular surgeons. Associations between surgeon characteristics and opinions regarding informed consent were measured using bivariate statistics; multivariable logistic regression was performed to estimate effects adjusted for covariates. Setting. Academic and private practice surgeons were surveyed. Subjects. United States members of the International Society for Vascular Surgery membership. Main Outcome Measure. Surgeons' self-reported opinions regarding the content of informed consent for AAA repair. RESULTS: A total of 199 surgeons completed the survey (response rate 51%). More than 90% of respondents reported that it was essential to discuss mortality risk for both procedures. However, only 60% and 30% of respondents reported that it was essential to discuss the risk of myocardial infarction and stroke, respectively. Opinions varied by procedure regarding the risks of impotence (32% vs 62%; EVAR vs open repair), reintervention (78% vs 17%), and rupture during long-term follow-up (57% vs 17%). Younger and private practice surgeons were more likely to discuss complications compared with older surgeons and those in academic practice. Surgeons who perform predominantly EVAR were more likely to quote higher mortality rates for open repair (odds ration [OR] = 3.1, 95% confidence interval [CI] = 1.4-6.4) and lower reintervention rates for EVAR (OR = 0.3, 95% CI = 0.1-0.7) compared with other surgeons. CONCLUSIONS: This is the first study of the practice of informed consent for AAA repair. The only risk that the vast majority of surgeons agreed should be included in informed consent for AAA repair was mortality. Significant variation exists regarding whether other complications should be discussed and what complication rates should be quoted. Surgeon characteristics may influence how risks are presented to patients. Further efforts are needed to develop guidelines to ensure consistent communication of appropriate risk during informed consent for AAA repair.     

The multicenter experience with a third-generation endovascular device for abdominal aortic aneurysm repair. A report from the EUROSTAR database

AIM: The purpose of this study was to evaluate the effect of the preoperative diameter of abdominal aortic aneurysms (AAA) upon the midterm outcome obtained by endovascular AAA repair, using a third-generation endovascular device, the Excluder bifurcated endoprosthesis (W. L. Gore & Associates, Inc. Sunnyvale, CA, USA). METHODS: The data of 676 patients, who had undergone endovascular aneurysm repair (EVAR) were analysed. Patients were enrolled over a 6-year period to April 2004 in the EUROSTAR database. Outcomes were compared between 2 groups defined by the preoperative diameter of the aneurysm: group A (n=300), smaller than 5.5 cm; group B (n=376), 5.5 cm or larger. Patient characteristics, details of aorto-iliac anatomy, operative procedure and postoperative complications in the 2 patient groups were compared. Outcome events included aneurysm-related death, overall death, conversion, and late rupture of the aneurysm. Life table analyses and log rank tests were used to compare outcome in the study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcomes. RESULTS: Patients in group B were significantly older than patients in group A (73 years vs 71 years respectively; p=0.006), and more frequently were at higher operative risk (ASA-classification >3; 44% vs 59%; p<0.0001). Anatomic differences included a higher incidence of aorto-iliac angulation, a wider and shorter infrarenal neck in group B. Risk factors that were more frequently observed in group B included hypertension, carotid disease and pulmonary disorders. Additional operative events including device migration occurred more frequently in group B (0% vs 2%; p=0.03). Device-related (type I and III combined) endoleaks were more frequently observed at completion arteriography in group B compared to group A (2% vs 4%; p=n.s.). Thirty-day mortality was comparable between the 2 study groups. However, the overall death rate after 3 years of follow-up was significantly higher in patients with larger aneurysms, group B (4% vs 14%; p=0.0025). Similarly, aneurysm-related death was significantly higher in group B (after 3 years 0.3% vs 3%; p=0.02). Aneurysm growth after EVAR was modest low in both study groups (after 2 years 6% vs 8%; non-significant). There was no correlation between growth of the sac and aneurysm-related death. CONCLUSIONS: The midterm outcome after endovascular repair by Excluder devices was satisfactory in patients with small and large AAAs. A higher rate in all-cause deaths and aneurysm-related deaths in patients with larger aneurysms was observed. Post-EVAR aneurysm growth was observed in a small percentage of patients but this did not contribute to aneurysm-related death.     

Long-term freedom from aneurysm-related mortality remains favorable after endovascular abdominal aortic aneurysm repair in a 15-year multicenter registry

ObjectiveEndovascular aneurysm repair (EVAR) has become the preferred approach to abdominal aortic aneurysm (AAA) because of lower early morbidity and mortality than open repair. However, the ability of EVAR to prevent long-term aneurysm-related mortality (ARM) has been questioned in light of recent trial data. We have updated our long-term EVAR experience in a large multicenter registry to further examine this issue.MethodsBetween 2000 and 2010, 1736 patients with AAA underwent EVAR in a large integrated regional healthcare system. We extended follow-up in this previously reported cohort through 2015 and identified predictors associated with ARM and need for major reintervention. The primary outcome was ARM. Secondary outcomes were all-cause mortality, delayed aneurysm rupture, major adverse event, major reintervention, sac growth of more than 5 mm, and type I or III endoleak. End points were analyzed for the whole cohort and compared for patients who underwent EVAR during the earlier (2000-2005) and latter (2006-2010) halves of the enrollment period to assess for changes in outcomes over time of repair.ResultsThe overall follow-up rate was 96.3%, and median follow-up was 5.5 years (interquartile range, 2.8-7.7 years). During the study period, 958 patients died, of whom 63 experienced ARM (6.6%). Overall crude rate of freedom from ARM was 96.4%. Delayed aneurysm rupture was seen in 1.3% (n = 23), with a median time to event of 4.1 years (interquartile range, 1.7-7.2 years). Major adverse events occurred in 12.4% of patients, and major reintervention was performed in 10.3%. Overall freedom from major adverse event or major reintervention was seen in 84.0%. Significant predictors of ARM included female sex, age 80 to 89 years, urgent EVAR, and any major reintervention. The unadjusted cumulative probability of all-cause survival was significantly higher in the late group than the early group at 5 years (66.8% vs 59.8%; P = .01, log-rank test); however, freedom from ARM at 5 years was not significantly different (96.5% and 97.1%, respectively; P = .67, log-rank test).ConclusionsOur results demonstrate favorable long-term freedom from major adverse event or major reintervention after EVAR and extremely low rates of ARM and delayed rupture. Our findings support EVAR as a safe, long-term solution for managing patients with AAA and provide insight into clinical parameters that can be used to stratify patients' post-EVAR surveillance and need for reintervention.     

The outcome of endovascular repair of small abdominal aortic aneurysms

OBJECTIVE: To assess the outcome of endovascular repair (EVAR) of small abdominal aortic aneurysms (AAA, 相似文献   

Early outcomes of endovascular versus open abdominal aortic aneurysm repair in the National Surgical Quality Improvement Program-Private Sector (NSQIP-PS)

BACKGROUND: There remains no consensus on the appropriate application of endovascular abdominal aortic aneurysm repair (EVAR). Information from administrative databases, industry-sponsored trials, and single institutions has inherent deficiencies. This study was designed to compare early outcomes of open (OPEN) versus EVAR in a contemporary (2000 to 2003) large, multicenter prospective cohort. METHODS: Fourteen academic medical centers contributed data to the National Surgical Quality Improvement Program-Private Sector (NSQIP-PS), which ensures uniform, comprehensive, prospective, and previously validated data entry by trained, independent nurse reviewers. A battery of clinical and demographic features was assessed with multivariate analysis for association with the principal study end points of 30-day operative mortality and morbidity. RESULTS: One thousand forty-two patients underwent elective infrarenal abdominal aortic aneurysm (AAA) repairs: 460 EVAR and 582 OPEN. EVAR patients were older (74 vs 71 years, P < .0001), included more men (84.6% vs 79.6%, P < .05), and had a higher incidence of chronic obstructive pulmonary disease (25.4% vs 17.9%, P < .01). EVAR resulted in significantly reduced overall morbidity (24% vs 35%, P < .0001) and hospital stay (4 vs 9 days, P < .0001). Cardiopulmonary and renal function-related comorbidities had the expected significant impact on mortality for both procedures at univariate analysis ( P < .05). While crude mortality rates between EVAR and OPEN did not differ significantly (2.8% vs 4.0%) ( P = 0.32). After multivariate analysis, correlates of operative mortality included OPEN (odds ratio [OR], 2.44; 95% confidence interval [CI], 1.03 to 5.78; P < .05), advanced age (OR, 1.11; P < .001), history of angina (OR, 5.54; P < .01), poor functional status (OR, 5.78; P < .001), history of weight loss (OR, 7.42; P < .01), and preoperative dialysis (OR, 51.4; P < .0001). EVAR also compared favorably to OPEN (OR, 2.14; 95% CI, 1.58 to 2.89; P < .0001) for overall morbidity. CONCLUSION: Significant morbidity accompanies AAA repair, even at major academic medical centers. These data strongly endorse EVAR as the preferred approach in the presence of significant cardiopulmonary or renal comorbidities, or poor preoperative functional status.     

Perioperative complications and early outcome after endovascular and open surgical repair of abdominal aortic aneurysms

BACKGROUND: Open repair (OR) of abdominal aortic aneurysms (AAAs) is a major surgical procedure with elevated morbidity and a low but definite mortality. Advocates of endovascular repair (EVAR) claim decreased complication rates and outcome equal to OR. METHODS: Data of all patients with infrarenal AAA that was treated electively, both with OR and EVAR, at Mayo Clinic Rochester between December 1, 1999 and December 1, 2001 were retrospectively reviewed. Thirty-day morbidity and mortality and early clinical outcomes were assessed and compared. RESULTS: Three hundred fifty-five patients underwent treatment: 261 patients, including 229 males and 32 females (mean age: 73 years; range: 52 to 90 years) underwent OR, and 94 patients including 85 males and 9 females (mean age: 77 years; range: 61 to 98 years) underwent EVAR (AneuRx: 53, Ancure: 38, Endologix: 3). Median AAA size was 57 mm in both groups. There were more high-risk patients in the EVAR group (27% vs 14%, P =.007). Thirty-day mortality rates were 1.1 % (3/261) for OR and 0 for EVAR (P = NS). Cardiac and pulmonary complications were less frequent after EVAR (11% vs 22%, P =.02, and 3% vs 16%, P =.001, respectively), but graft-related complications were more frequent (13% vs 4%, P =.002). The association between type of repair and cardiac, pulmonary, and graft complications remained statistically significant after adjusting for age, gender, and high-risk status. The multivariate odds ratios (EVAR vs OR) for cardiac, pulmonary, and graft complications were 0.35 (95% confidence interval [CI]: 0.17 to 0.74), 0.14 (95% CI: 0.04 to 0.47), and 3.81 (95% CI: 1.51 to 9.58), respectively. Primary and secondary patency and freedom-from-reintervention rates at 1 year were lower after EVAR (83% vs 98%, P <.001; 96% vs 99%, P =.02; 65% vs 93%, P <.001, respectively). CONCLUSIONS: Both elective OR and EVAR can be performed with low mortality, but cardiac and pulmonary complications are less frequent and less severe after EVAR. The tradeoff of EVAR is a higher rate of graft-related complications, with more reinterventions and a lower graft patency rate at 1 year. These results should be considered before EVAR is offered to patients with AAA.     

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.     

Elective surgery of abdominal aortic aneurysms in octogenarians: a systematic review

INTRODUCTION: Abdominal aortic aneurysm (AAA) is an age-related disease. In an aging population, the prevalence of AAA is likely to increase. Open AAA repair in patients aged >80 years is often not considered because of their advanced age as such or because of comorbidities. In addition, little is known about the natural history in such patients or survival after successful repair. We performed a systematic review of the literature to determine peri-operative and late survival after AAA repair in octogenarians METHOD: The Medline, Embase, and Cochrane databases were searched to identify all studies reporting on octogenarians undergoing AAA repair published between January 1966 and June 2006. Two independent observers assessed the methodologic quality of the included studies and the data extraction. Outcomes were rates of perioperative mortality, complications, and long-term survival after open or endovascular repair (EVAR). Summary estimates with 95% confidence interval (CI) were calculated using a random effects model. RESULTS: Thirty-nine articles were included. The median aneurysm size was 6.7 cm in the conventional AAA repair group of 1534 patients. The perioperative mortality was 0% to 33%, with a pooled mortality of 7.5% (95% CI, 6.2% to 9.0%). The median 5-year survival rate for this group was 60% (range, 14% to 86%). In the 1045 patients treated with EVAR, the median aneurysm size was 5.9 cm. Their pooled perioperative mortality varied from 0% to 6%, with a pooled mortality of 4.6% (95% CI, 3.4 to 6.0%). We could not derive 5-year survival rates from articles describing endovascular repair of AAA. CONCLUSION: The mortality rate after open or endovascular AAA repair in carefully selected octogenarians seems acceptable but is higher than the mortality rate in younger patients. Long-term survival rates were acceptable, but small sample size, selection, and publication bias must be taken into account. Finally, selection criteria for successful surgery with low mortality and morbidity rates cannot be derived from the literature.     

Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair (CAESAR) trial: study design and progress.

OBJECTIVE: The CAESAR Trial aims to assess the outcome of endovascular repair (EVAR) vs surveillance of small abdominal aortic aneurysms (AAA) with maximum diameter of 4.1-5.4 cm on computerised tomography (CT) scan. DESIGN: Patients between 50 and 80 years of age, with small AAA, anatomically suitable for EVAR, are randomly allocated to early EVAR or surveillance. The primary outcome measure is survival. Secondary endpoints include: aneurysm-related deaths (defined as any death caused directly or indirectly by rupture or endovascular/open aneurysm repair), AAA rupture, peri-operative or late complications, conversion to open repair, complications associated with delayed treatment including loss of treatment options, AAA growth rates and quality of life. Target recruitment is 740 patients to show that early EVAR is associated with a 15% survival benefit at 54 months. PROGRESS: Randomization started in September 2004. By the end of April 2005, 86 patients had been enrolled by 10 active European centres. Completion of recruitment is expected for September 2006 and publication of the results in mid 2007.     

Endovascular stenting versus open surgery for thoracic aortic disease: systematic review and meta-analysis of perioperative results

BACKGROUND: Endovascular stenting has emerged as an alternative to open repair in patients requiring surgery for thoracic aortic pathology. A number of comparative series have been published but, to date, there has been no meta-analysis comparing outcomes following stenting as opposed to open surgery. METHODS: Electronic abstract databases and conference proceedings were searched to identify relevant series. Pooled odds ratios were calculated using random effects models for perioperative mortality, neurological injury, and major reintervention. RESULTS: The search identified 17 eligible series, totaling 1109 patients (538 stenting). Stenting was associated with a significant reduction in mortality (pooled odds ratio 0.36; 95% CI 0.228-0.578; P < .0001) and major neurological injury (pooled odds ratio 0.39; 95% CI 0.25-0.62; P = .0001). There was no difference in the major reintervention rate (pooled odds ratio 0.91; 95% CI 0.610-1.619). There was a reduction in hospital and critical care stay although there was evidence of heterogeneity and bias with respect to these outcomes. Subgroup analyses suggested that endovascular repair reduced mortality (pooled odds ratio 0.25; 95% CI 0.09-0.66) and neurological morbidity (pooled odds ratio 0.28; 95% CI 0.13-0.61) in stable patients undergoing repair of thoracic aortic aneurysms. There was no effect on mortality in patients with thoracic aortic trauma but neurological injury was reduced (pooled odds ratio 0.17; 95% CI 0.03-1.03). Endovascular repair did not confer any apparent benefit over open surgery in patients with thoracic aortic rupture. CONCLUSION: Endovascular thoracic aortic repair reduces perioperative mortality and neurological morbidity in patients with descending thoracic aortic aneurysms. There may be less benefit in other thoracic aortic conditions.     

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.     

Randomisierte Studienlage zur Therapie des Bauchaortenaneurysmas

In four studies (EVAR-1, DREAM, OVER and ACE) on the treatment of asymptomatic infrarenal abdominal aortic aneurysms (AAA) patients were randomly allocated to either endovascular or surgical treatment. Patients with an AAA ≥5 cm, physical fitness and anatomical suitability were included for endovascular aortic repair (EVAR). The EVAR procedure for AAA showed a lower risk of perioperative mortality but was associated with a higher cardiovascular and aneurysm-related complication rate. In mid-term and long-term follow-up there were no differences in survival after EVAR and open aortic repair (OAR). While OAR was associated with higher cardiovascular perioperative mortality, EVAR demonstrated higher mortality in the follow-up period due to cardiac and aneurysm-related complications. Both treatment options can therefore be considered as equal and can both be offered to patients. The EVAR procedure should be the first choice of treatment of AAA in physically fit patients with suitable anatomy and OAR should be preferred when EVAR does not seem to be technically feasible or for patients where lifelong surveillance is not possible. No significant differences were observed regarding quality of life, sexual dysfunction or costs of treatment.     

Predictors of renal dysfunction after endovascular and open repair of abdominal aortic aneurysms

Objective

Renal complications after repair of abdominal aortic aneurysms (AAAs) have been associated with increased morbidity and mortality. However, limited data have assessed risk factors for renal complications in the endovascular era. This study aimed to identify predictors of renal complications after endovascular AAA repair (EVAR) and open repair.