AAA-related Deaths Research Articles

Sideways displacement of the endograft within the aneurysm sac is associated with late adverse events after endovascular aneurysm repair

Previous studies have shown the importance of proximal and distal endograft fixation. There is little information on the middle, unsupported section of endograft within the aneurysm sac. We quantified sideways movement of the endograft within the aneurysm sac and correlated it to late adverse events. Patients who underwent endovascular abdominal aortic aneurysm (AAA) repair with a suprarenal or infrarenal endograft between January 1997 and December 2007 were analyzed for sideways endograft movement. Patients were included if they had a digital preoperative computed tomography angiogram (CTA), a postoperative CTA within 3 months after the index procedure, and at least one follow-up CTA thereafter with a minimal time interval of 6 months. The endograft position within the aneurysm sac was quantitated on cross-sectional images using a fixed vertebral body reference point. Patients with change in endograft position ≥5 mm were placed in the sideways displacement (SD) group and compared with patients with no displacement (ND; <5 mm change in position). The relationship between sideways endograft movement and endovascular aneurysm repair (EVAR)-related complications were noted for AAA rupture, AAA-related death, conversion, secondary procedures, AAA growth (≥5 mm), proximal migration (≥10 mm), and new onset of type I or III endoleaks. The study included 144 patients (mean age, 76 ± 7.6 years). Mean follow-up time was 43 ± 27 months. Fifty patients (35%) had sideways endograft movement ≥5 mm during follow-up. Baseline AAA diameter was larger (SD 60 ± 9 mm vs ND 57 ± 9 mm; P < .05) and proximal and iliac endograft fixation lengths were shorter (SD 18 ± 8 mm vs ND 24 ± 11 mm; P < .05 and SD 35 ± 14 vs ND 42 ± 16 mm; P < .05) in patients with sideways endograft displacement. There was no significant difference between the groups in AAA rupture and AAA-related death (one fatal AAA rupture, ND group). SD patients had a higher surgical conversion rate (10% vs 0%; P = .002), more secondary procedures (44% vs 6%; P < .001), more AAA sac enlargement (42% vs 10%; P < .001), more endograft migration (66% vs 5%; P < .001), and more type I or III endoleaks (36% vs 3%; P < .001). Positional stability of the endograft within the aneurysm sac is critical for the long-term success of EVAR. Sideways movement of the endograft within the aneurysm sac is associated with an increased risk of late adverse events.

Investigation of Current Trend of AAA Treatment in Korea

Purpose: To know the current trend of the annual number of AAA patients in Korea and treatment modality, we attempted to investigate the numbers of patients diagnosed with AAA and the number of patients who underwent open or endovascular treatment of AAA in Korea during the last 6 years. Methods: To investigate the number of AAA patients, we searched for ruptured AAA and AAA without description of rupture disease from the database of Health Insurance Reimbursement Association (HIRA) by searching the disease code of HIRA I71.3 (ruptured AAA) and I71.4 (AAA without description of rupture) during the period between 2003 and 2009. To investigate the number of patients who underwent treatment for AAA, we searched for code O 2036, O 2034, O 0223, O 0224 (open surgical repair) and M 6612 (endovascular aneurysm repair, EVAR). To discern the number of AAA-related deaths in Korea during the same period, we depended on the database of the Statistics Korea. Results: We found that the number of AAA patients and treatment of AAA were rapidly increasing recently after the inception of the reimbursement for EVAR by the HIRA. But the number of AAA-related deaths did not significantly change during the same period in Korea. Conclusion: After observing that the number of patients with AAA and its treatment rapidly increased while the number of AAA-related death did not increase, we can assume that it is the result of increase of patients detection rather than that of prevalence of AAA and also think that many AAA patients are still under-detected in Korea. To cope with the increasing number of AAA patients and to facilitate detection of hidden AAA patients, we would like to propose a nationwide screening program of AAA for a selected group of the population.

Clinical Practice Guidelines for Endovascular Abdominal Aortic Aneurysm Repair: Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association

From the Department of Radiology, Division of Vascular Imaging and Intervention (T.G.W., S.P.K., K.Y., S.W.), Massachusetts General Hospital, Boston, Massachusetts; Department of Medical Imaging (S.K.), Scarborough General Hospital, Toronto, Ontario, Canada; Department of Interventional Radiology (P.D.), West Allis Memorial Hospital, Milwaukee, Wisconsin; Department of Radiology, Division of Interventional Radiology (B.J.D.), University of Maryland Medical Center, Baltimore, Maryland; Department of Radiology (S.C.R.), University of California San Diego Medical Center, San Diego, California; and Department of Radiology (J.F.C.), Geisinger Health System, Danville, Pennsylvania. Received May 4, 2010; final revision received May 24, 2010; accepted July 11, 2010. Address corre-

D-dimer measurement: a useful prognostic marker in surveillance of patients with abdominal aortic aneurysm?

This editorial refers to ‘Evaluation of the diagnostic and prognostic value of plasma D-dimer for abdominal aortic aneurysm’[†][1], by J. Golledge et al. on page 354 Over the last decade, abdominal aortic aneurysm (AAA), defined as an aortic diameter ≥30 mm, has increasingly been recognized as an important cause of mortality, accounting for 2.1% of deaths in men aged >65 years. Large screening studies have suggested a prevalence of 5.1–7.7% in men over the age of 64. Despite advances in surgical and anaesthesiological techniques, mortality remains high in patients with a ruptured AAA. Thus, elective repair in appropriately selected individuals is advantageous, prevents rupture, and thereby improves life expectancy. Simplified abdominal ultrasound is recognized for its accuracy in identifying AAA, with a reported sensitivity of 95% and specificity of 99%. Evidence suggests that a single screening in the highest risk group is sufficient to exclude risk from this disease for >10 years with <2% of examinations insufficient to measure aortic diameters.1 Based on these data, ultrasound screening programmes have been evaluated in an attempt to reduce AAA-related mortality in the general population. The largest of these trials, the Multicentre Aneurysm Screening Study, randomized a population-based sample of 67 800 men aged 65–74 years in the UK. After 4 years of follow-up, relative risk reduction of AAA-related deaths was 42% [95% confidence interval (CI) 22–58%].2 A meta-analysis of further randomized controlled trials subsequently confirmed these results [odds ratio (OR) in AAA-related mortality, 0.56; 95% CI 0.44–0.72]. Moreover, long-term results showed a significant reduction in emergency operations (OR 0.48; 95% CI 0.28–0.83), while the number of elective operations increased significantly (OR 2.81; … [1]: #fn-2

RR4. Sideways Movement of the Endograft Within the Aneurysm Sac Is Associated With Late Adverse Events

Previous studies have shown the importance of proximal and distal endograft fixation. There is little information on the middle, unsupported section of the endograft. We have quantified sideways movement of the endograft within the AAA sac and correlated it to late adverse events. Patients who underwent EVAR between January 1997 and December 2007 were analyzed. Patients with a digital available preoperative CT-angiography (CTA), postoperative CTA and at least one follow-up CTA thereafter were included. Changes in endograft position within the AAA sac were measured. Patients with sideways movement ≥5mm were placed in the movement group (MG) and were compared with patients with no movement (<5mm, NM group). To analyze the association of sideways endograft movement and EVAR related complication the following outcome measures were noted: AAA rupture, AAA-related death, conversion, secondary procedures, AAA growth (≥5mm), proximal migration (≥10mm), and new onset type 1/3 endoleaks. 144 patients (mean age 76 year) were included. Follow-up was 43 ± 27 months. Fifty patients (35%) had sideways endograft movement. AAA diameter (MG 60 ± 9 vs NM 57 ± 9mm, p < 0.05), and proximal and iliac endograft fixation lengths were significantly different between the groups (MG 18 ± 8 vs NM 25 ± 11mm, p < 0.05 and MG 35 ± 15 vs NM 42 ± 16mm, p < 0.05). There was no significant difference between the groups in terms of AAA rupture and AAA-related death (one fatal AAA rupture, NM group). Patients in the MG group had a significantly higher conversion rate (14 vs 0%, p < 0.001) and had more secondary procedures (44 vs 6%, p < 0.001). Patients in the MG had significantly more AAA growth (42 vs 10%, p < 0.001), more proximal migration (66 vs 5%, p < 0.001) and more often type 1/3 endoleaks (36 vs 3%, p < 0.001). Sideways movement of the device within the AAA sac is associated with late adverse events. Conversely, lack of movement is correlated with long-term success.

Screening Men for Abdominal Aortic Aneurysm: 10 Year Mortality and Cost Effectiveness Results from the Randomised Multicentre Aneurysm Screening Study

Conclusion: The mortality benefit of screening men aged 65 to 74 years for abdominal aortic aneurysm (AAA) is maintained up to 10 years after screening. Cost-effectiveness becomes more favorable overtime. Repeat screening of patients whose initial scan result is normal is not justified. Summary: The United Kingdom Multicentre Aneurysm Screening Study (MASS) has provided most of the randomized evidence for mortality benefit for AAA screening (Cochrane Database Syst Rev 2007;CD002945) The authors sought to answer some remaining questions concerning AAA screening, including longer-term benefits of mortality and cost-effectiveness, and whether rescreening after a normal scan result is indicated. The data presented are from the randomized MASS trial with 10 years of follow-up. Data were acquired in four centers in the United Kingdom, with screening and surveillance delivered primarily in primary care centers. The population sample included 67,770 men aged 65 to 70 years. Participants in the original MASS study were allocated to ultrasound screening or to a control group not offered screening. When an AAA was detected, the participants underwent surveillance and were offered surgery if they met prespecified criteria. Main outcome measures have been mortality and costs related to AAA repair and cost per life-year gained. There were 155 deaths related to AAA over 10 years in the group invited for screening (absolute risk, 0.46%) and 296 deaths related to AAA in the control group (0.87%). Relative risk reduction was 45% (95% confidence interval [CI], 37%-57%). The benefits seen in the early years of follow-up were maintained in later years. Incremental cost per man invited to screening was £100 (95% CI, £82-£118), with an incremental cost-effectiveness ratio of £7,600 (95% CI, £5,100-£13,000) per life-year gained. The incidence of ruptured AAA in patients with an originally normal screening result increased after 8 years. Total mortality at 10 years was about 30% in each group, with AAAs comprising about 2% of all deaths. There was no clear difference in any other cause of death, with only a small difference in all-cause mortality (hazard risk, 0.97, 95% CI, 0.95-1.00). There were 25 ruptures that occurred after men had normal initial scan results and 19 were fatal. Rate of ruptures increased noticeably after 8 years of follow-up. Time since initial scan rather than age was the main determinant of the increased risk of rupture. Comment: AAA screening appears to be effective in reducing AAA-related deaths out to 10 years after the initial screening examination. A crucial question is whether rescreening participants is justified at any stage. The authors contend that rescreening is not justified because the number of fatal ruptures occurring after 8 years in the screened group was relatively small. Additional follow-up will be required to determine if there is a noticeable increase in ruptures in the screened group that is not sufficiently offset by the reduction in number of deaths related to the original aortic aneurysm screening.

A 66-Year-Old Man With an Abdominal Aortic Aneurysm

Ruptured abdominal aortic aneurysm (AAA) is a common cause of death. Abdominal aortic aneurysms tend to be asymptomatic until the time of rupture, which has a mortality rate of greater than 80%. Therefore, elective repair prior to rupture is preferred if life expectancy is reasonable and the risk of rupture outweighs the risk of repair. Mr F, a 66-year-old man with a 5.2-cm AAA, illustrates the issues surrounding monitoring and treating AAA. Risk factors for AAA include older age, male sex, smoking history, and a family history of AAA. Screening for AAA with ultrasound has been shown to prevent rupture, prevent AAA-related death, and be cost-effective. Risk factors for rupture include larger diameter, female sex, and smoking history. Endovascular repair has lower operative mortality and complications and has replaced standard open surgery in more than half of patients. However, long-term survival is similar after endovascular and open surgical repair. Those at risk of AAA who would benefit from repair should undergo screening.

Abdominal aortic aneurysm: high prevalence in men over 59 years of age with TIA or stroke, a perspective

Death resulting from a ruptured abdominal aortic aneurysm (AAA) is potentially preventable. Screening for AAA is cost-effective, reducing risk of AAA-related death by 50%. For various reasons screening programs have not been implemented widely. Therefore, the need to identify subgroups with increased prevalence of AAA remains. Recently, men over 59 years of age presenting with stroke or a transient ischemic attack (TIA) at the neurology department were found to have a doubled prevalence of AAA. This confirmed data of another study (SMART), which included broader inclusion criteria (either manifest atherosclerotic disease or only risk factors for atherosclerosis). Incorporation of an aortic ultrasonography into the neurological work up of these patients could result in an effective screening program. However, before that, several cost-effectiveness issues need to be resolved, such as growth rate of the detected aneurysms, risk of death by AAA rupture in this patient group with increased co-morbidity and decreased life expectancy, peri-operative risk of open or endovascular repair.

Randomized Clinical Trials of Endovascular Repair Versus Surveillance for Treatment of Small Abdominal Aortic Aneurysms

The Aneurysm Detection and Management (ADAM) trial and the United Kingdom Small Aneurysm Trial (UKSAT) demonstrated that early open surgical repair of small (<5.5 cm in diameter) abdominal aortic aneurysms (AAAs) conveyed no benefits compared with surveillance. In 2 randomized controlled trials (RTCs), operative mortality rates were significantly lower with endovascular aneurysm repair (EVAR) than with open surgery for treatment of large AAAs. Retrospective analyses of EVAR databases suggested that EVAR outcomes are directly related to aneurysm size and are better for smaller AAAs. It has thus seemed logical that a less invasive treatment strategy might be beneficial in treating patients with small AAAs. Two new RCTs have been initiated to evaluate early EVAR versus surveillance in patients with small AAAs. The European-based 17-site CAESAR (Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair) trial had enrolled 740 patients with small AAAs (4.1-5.4 cm) for surveillance or EVAR with the Zenith stent-graft. The primary endpoint of CAESAR is all-cause mortality at 54 months. The 70-site PIVOTAL (Positive Impact of endoVascular Options for Treating Aneurysm earLy) trial in the United States is enrolling up to 1025 patients with small AAAs (4-5 cm) for surveillance or EVAR with the AneuRx or Talent stent-grafts. The primary endpoints of PIVOTAL are aneurysm rupture and AAA-related deaths at up to 36 months after randomization. CAESAR and PIVOTAL should provide objective evidence to guide the use of EVAR for small AAAs.

Abdominal Aortic Aneurysm Development in Men Following a “normal” Aortic Ultrasound Scan

Objectives To determine predictors related to abdominal aortic aneurysm (AAA) development following a “normal” aortic ultrasound scan. Design, materials & methods Over a 23-year period, 22 961 men participated in an AAA screening programme. Maximum aortic diameter of less than 30 mm was deemed “normal”. 4308 of these “normal” individuals were later re-scanned at intervals for research purposes. Results AAA prevalence was 4.4% at initial scanning. In those with a normal scan, 46 patients subsequently presented with AAAs incidentally detected and 120 (2.8%) had AAAs identified as part of the ongoing surveillance. The median initial aortic size of these 166 men was 25 mm (range 15–29 mm). Over the follow-up period, there have been 24 (14%) AAA-related deaths, 24 patients underwent successful AAA surgery and 36 died of unrelated causes. In those with an initial aortic diameter of <25 mm who later developed an AAA, the odds ratio for AAA-related mortality was 2 (95% CI 1-4.1, p = 0.03, x 2). Conclusion AAAs can develop following an initial “normal” scan and men with an aortic diameters of 25–29 mm appear to be at greater risk. Surveillance for this sub-group may further reduce the incidence of undiagnosed AAA and AAA-related mortality.

Lifeline registry of endovascular aneurysm repair: Open repair surgical controls in clinical trials

The improvement of available endovascular aortic aneurysm repair (EVAR) devices is critical for the advancement of patient care in vascular surgery. The goal of this article is to report a highly detailed, closely monitored, audited, pooled multicenter cohort of open surgical abdominal aortic aneurysm (AAA) repairs that has potential for use in future EVAR studies as a control data set. Open surgical AAA repair data from four investigational device exemption clinical aortic endograft trials were tested for poolability, merged, and analyzed for the intervals of 0 to 30 days and 31 to 365 days. The data set includes 323 open patients (83% men; mean age, 70 years). Operative mortality at 30 days was 2.8%. The mean age of women was 3 years older than men, and mortality at 30 days for women was 5.7% compared with 2.2% for men (P = .18). Operative mortality for patients with large AAAs (>/=5.5 cm, 3.6%) was not different than for patients with small aneurysms (<5.5 cm, 2.4%, P = .54). All-cause mortality at 1 year was 6.7%, with significant predictors including age, sex, and renal failure. Women had 2.6-fold greater 1-year all-cause mortality rate (13.2%) than men (5.4%, P = .04), but statistical significance was lost after correction for age. Two additional AAA-related deaths occurred between days 31 and 365, resulting in a 1-year AAA-related mortality of 3.5%. This data set provides a tightly controlled, thoroughly detailed, and audited experience that has the potential to serve as an open control group for future EVAR trials.

Computed Tomographic Colonography to Screen for Colorectal Cancer, Extracolonic Cancer, and Aortic Aneurysm&lt;subtitle&gt;Model Simulation With Cost-effectiveness Analysis&lt;/subtitle&gt;

In addition to detecting colorectal neoplasia, abdominal computed tomography (CT) with colonography technique (CTC) can also detect unsuspected extracolonic cancers and abdominal aortic aneurysms (AAA).The efficacy and cost-effectiveness of this combined abdominal CT screening strategy are unknown. A computerized Markov model was constructed to simulate the occurrence of colorectal neoplasia, extracolonic malignant neoplasm, and AAA in a hypothetical cohort of 100,000 subjects from the United States who were 50 years of age. Simulated screening with CTC, using a 6-mm polyp size threshold for reporting, was compared with a competing model of optical colonoscopy (OC), both without and with abdominal ultrasonography for AAA detection (OC-US strategy). In the simulated population, CTC was the dominant screening strategy, gaining an additional 1458 and 462 life-years compared with the OC and OC-US strategies and being less costly, with a savings of $266 and $449 per person, respectively. The additional gains for CTC were largely due to a decrease in AAA-related deaths, whereas the modeled benefit from extracolonic cancer downstaging was a relatively minor factor. At sensitivity analysis, OC-US became more cost-effective only when the CTC sensitivity for large polyps dropped to 61% or when broad variations of costs were simulated, such as an increase in CTC cost from $814 to $1300 or a decrease in OC cost from $1100 to $500. With the OC-US approach, suboptimal compliance had a strong negative influence on efficacy and cost-effectiveness. The estimated mortality from CT-induced cancer was less than estimated colonoscopy-related mortality (8 vs 22 deaths), both of which were minor compared with the positive benefit from screening. When detection of extracolonic findings such as AAA and extracolonic cancer are considered in addition to colorectal neoplasia in our model simulation, CT colonography is a dominant screening strategy (ie, more clinically effective and more cost-effective) over both colonoscopy and colonoscopy with 1-time ultrasonography.

Matched-pair Analysis of Endovascular versus Open Surgical Repair of Abdominal Aortic Aneurysms in Young Patients at Low Risk

To compare clinical outcomes of endovascular and open aortic repair of abdominal aortic aneurysms (AAAs) in young patients at low risk. It was hypothesized that endovascular aneurysm repair (EVAR) compares favorably with open aneurysm repair (OAR) in these patients. Twenty-five patients aged 65 years or younger with a low perioperative surgical risk profile underwent EVAR at a single institution between April 1994 and May 2007 (23 men; mean age, 62 years+/-2.8). A sex- and risk-matched control group of 25 consecutive patients aged 65 years or younger who underwent OAR was used as a control group (23 men; mean age, 59 years+/-3.9). Patient outcomes and complications were classified according to Society of Vascular Surgery/International Society for Cardiovascular Surgery reporting standards. Mean follow-up times were 7.1 years+/-3.2 after EVAR and 5.9 years+/-1.8 after OAR (P=.1020). Total complication rates were 20% after EVAR and 52% after OAR (P=.0378), and all complications were mild or moderate. Mean intensive care unit times were 0.2 days+/-0.4 after EVAR and 1.1 days+/-0.4 after OAR (P<.0001) and mean lengths of hospital stay were 2.3 days+/-1.0 after EVAR and 5.0 days+/-2.1 after OAR (P<.0001). Cumulative rates of long-term patient survival did not differ between EVAR and OAR (P=.144). No AAA-related deaths or aortoiliac ruptures occurred during follow-up for EVAR and OAR. In addition, no surgical conversions were necessary in EVAR recipients. Cumulative rates of freedom from secondary procedures were not significantly different between the EVAR and OAR groups (P=.418). Within a multivariable Cox proportional-hazards analysis adjusted for patient age, maximum AAA diameter, and cardiac risk score, all-cause mortality rates (odds ratio [OR], 0.125; 95% CI, 0.010-1.493; P=.100) and need for secondary procedures (OR, 5.014; 95% CI, 0.325-77.410; P=.537) were not different between EVAR and OAR. Results from this observational study indicate that EVAR offers a favorable alternative to OAR in young patients at low risk.

Abdominal Aortic Aneurysms, Increasing Infrarenal Aortic Diameter, and Risk of Total Mortality and Incident Cardiovascular Disease Events

Long-term data describing small abdominal aortic aneurysms (AAAs) and increasing infrarenal aortic diameters and their relationship to future surgical repair, total mortality, and incident cardiovascular disease (CVD) events, particularly among women, are sparse. In 1992 to 1993, 4734 Cardiovascular Health Study participants > or = 65 years old had an abdominal aortic ultrasound evaluation. Of those screened, 416 had an AAA (infrarenal aortic diameter > or = 3.0 cm or an infrarenal/suprarenal ratio > or = 1.2). By 2002, there were 56 surgical AAA repairs and 10 AAA-related deaths. A single ultrasound screening demonstrated that aneurysm dilation > or = 3 cm identified 68% of all AAA repairs over the next 10 years and 6 of the 10 AAA-related deaths in 4% of the total population and that a > or = 2.5-cm dilation identified 91% of all AAA repairs and 9 of the 10 deaths in 10% of the total population. With adjusted Cox proportional hazard models, AAAs were associated with a higher risk of total mortality (hazard ratio 1.44, 95% confidence interval 1.25 to 1.66) and incident CVD events (hazard ratio 1.52, 95% confidence interval 1.25 to 1.85). Compared with diameters < 2.0 cm, infrarenal aortic diameters 2.0 to < 3.0 cm were associated with increased risk of incident CVD events in women and total mortality in men. This study suggests that a 1-time screening of the abdominal aorta can acceptably identify individuals with a clinically significant AAA. Infrarenal aortic diameters > 2.0 cm are associated with a significantly increased risk of future CVD events and total mortality.

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

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. 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. 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). 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.

Fifteen-year follow-up of a randomized clinical trial of ultrasonographic screening for abdominal aortic aneurysms

Long-term benefits of screening for abdominal aortic aneurysm (AAA) are uncertain. These are the final results of a randomized controlled screening trial for AAA in men, updating those reported previously. Benefit and compliance over a median 15-year interval were examined. One group of men were invited for ultrasonographic AAA screening, and another group, who received standard care, acted as controls. A total of 6040 men aged 65-80 years were randomized to one of the two groups. Outcome was monitored in terms of AAA-related events (surgery or death). In the group invited for screening, AAA-related mortality was reduced by 11 per cent (from 1.8 to 1.6 per cent, hazard ratio 0.89) over the follow-up interval. Screening detected an AAA in 170 patients; 17 of these died from an AAA-related cause, seven of which might have been preventable. The incidence of AAA rupture after an initially normal scan increased after 10 years of follow-up, but was still low overall (0.56 per 1000 person-years). Screening with a single ultrasonography scan still conferred a benefit at 15 years, although the results were not significant for this population size. Fewer than half of the AAA-related deaths in those screened positive could be prevented. ISRCTN 00079388 (http://www.controlled-trials.com).

High-risk and Low-risk Screening for Abdominal Aortic Aneurysm Both Reduce Aneurysm-related Mortality. A Stratified Analysis from a Single-centre Randomised Screening Trial

Cardiovascular diseases and chronic obstructive pulmonary disease (COPD) are both associated with abdominal aortic aneurysms (AAA). The aim of this study was therefore to analyse whether screening for AAA could be restricted to men with such diseases (high risk group). Before the date of randomisation of a population screening trial of 12,639 64-73-year-old males, all discharge diagnoses from the National Patient Registry concerning AAA-related diseases were merged with the screening results on attendance, AAA prevalence, and AAA-related mortality and overall mortality. Differences in proportions were compared by Chi square tests and differences in mortality by Cox regression analyses. The attendance rate was 78.8% and 6.7% had an AAA in the high risk group compared to 75.8% attendance (P<0.001) and 2.9% (P<0.001) in the remaining population. Cumulatively, screening of only high risk men with would have required 72.9% (95% C.I.: 72.3-74.5%) fewer screening invitations, would have discovered 46.1% (95% C.I.: 38.9-53.4%) of the AAA cases diagnosed and prevented 46.7% (95% C.I.: 28.3-65.7%) of the AAA-related deaths. However, screening decreased AAA-related mortality both among men with and without known COPD or cardiovascular diseases: mortality ratio: 0.22 (95% C.I.: 0.08-0.65), P=0.006, and 0.24 (95% C.I: 0.09-0.63, P=0.004, respectively. High-risk population screening would prevent less than half of AAA-related deaths. Therefore, restricting screening to such high-risk groups does not seem justified, but cost effectiveness analyses are needed to reach a firm conclusion.

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

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. 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. 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. 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.

Randomized EVAR Trials and Advent of Level I Evidence: A Paradigm Shift in Management of Large Abdominal Aortic Aneurysms?

The recent endovascular aneurysm repair (EVAR) 1 and 2 and Dutch Randomized Endovascular Aneurysm Management (DREAM) trials addressed management of abdominal aortic aneurysms (AAAs) larger than 5.5 cm in diameter. The DREAM and EVAR 1 trials randomized patients appropriate for open repair between endovascular repair (EVAR) and open repair (OR), and the EVAR 2 trial randomized patients unfit for OR between EVAR and conservative nonoperative management (No Rx). The EVAR 1 trial showed a 3% lower initial mortality for EVAR, with a persistent reduction in aneurysm-related death at 4 years. Improvement in overall late survival was not demonstrated. Similarly, the DREAM trial observed an initial mortality advantage for EVAR, but overall 1-year survival was equivalent in both groups. Both trials found significantly higher complication and intervention rates and higher hospital costs with EVAR, and by 1 year a quality of life (QOL) benefit was not evident. The EVAR 2 trial did not demonstrate a survival advantage of EVAR with respect to nonoperative management, while noting that EVAR was associated with greater likelihood of treatment complications, subsequent interventions, and threefold higher costs. Both EVAR trials were limited by long delays between randomization and treatment. Moreover, 27% of patients in EVAR 2 crossed over from nonoperative to endovascular repair, and these patients had a lower procedure mortality from EVAR than those originally assigned to it (2% v 9%). These 47 cases, and the exclusion of 14 patients dying while waiting for EVAR, appears to confer a survival advantage to those receiving EVAR over those receiving no treatment in a post-hoc analysis, but per-protocol analysis of the EVAR 2 trial data performed by the EVAR investigators did not show a significant difference in either all-cause or aneurysm-related mortality. Thus, outcomes of the EVAR 2 trial have not settled the choice between EVAR and no treatment in this scenario to everyone's satisfaction. In patients with large AAAs who are fit for OR, EVAR offers an initial mortality advantage over OR, with a persistent reduction in AAA-related death at 4 years. However, EVAR offers no overall survival benefit, is more costly, and requires more interventions and indefinite surveillance with only a brief QOL benefit. It may or may not offer a mortality benefit over nonoperative management in patients with large AAAs who are unfit for open repair, but the statistical significance of this comparison is inconclusive.

Cost-effectiveness of screening women for abdominal aortic aneurysm

Women are usually not considered for abdominal aortic aneurysm (AAA) screening because of their lower prevalence of disease. This position may, however, be questioned given the higher risk of rupture and the longer life expectancy among women. The purpose of this study was to assess the cost-effectiveness of screening 65-year-old women for AAA. A systematic review of the literature was conducted to obtain data of importance to evaluate the effectiveness of screening women for AAA. Data were entered into a Markov simulation cohort model. The review suggested some main assumptions for women with AAA. Prevalence is 1.1%. In 6.8%, the AAA is of a size that merits surgery, and the patients are fit for a procedure. For patients with an AAA, the yearly risk for elective surgery and the rupture incidence was 3.1% and 2.4%, respectively, in the invited group and 1.1% and 5.7% in the noninvited group. The operative mortality for elective surgery was 3.5%, and the total mortality for ruptured AAA was 86.3%. The long-term mortality for AAA patients was 3.6 times higher than for an age-matched healthy population. Screening reduced the AAA rupture incidence by 33% and the AAA-related death rate by 35%. The cost per life year gained was estimated at $5911. The incremental cost-effectiveness ratio was similar to that found for screening men, which reflects the fact that the lower AAA prevalence in women is balanced by a higher rupture rate. Screening women for AAA may be cost-effective, and future evaluations on screening for AAA should include women.