Draft Recommendation Statement
Abdominal Aortic Aneurysm: Screening
June 18, 2019
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The U.S. Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific preventive care services for patients without obvious related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
An AAA is typically defined by an aortic diameter of 3.0 cm or larger. The prevalence of AAA has declined over the past two decades among screened men age 65 years and older in various countries such as the United Kingdom, New Zealand, Sweden, and Denmark.1-9 Population-based studies in men older than age 60 years have found prevalence ranging from 1.2% to 3.3%.1-9 The reduction in prevalence is attributed to the decrease in smoking prevalence over time. Previous prevalence rates of AAA reported in population-based screening studies ranged from 1.6% to 7.2% of the general population ages 60 to 65 years or older.1 The current prevalence of AAA in the United States is unclear because of the low uptake of screening.1 Most AAAs are asymptomatic until they rupture. Although the risk for rupture varies greatly by aneurysm size, the associated risk for death with rupture is as high as 81%.1, 10
Men Ages 65 to 75 Years Who Have Ever Smoked
AAAs are most prevalent in men who have ever smoked, occurring in approximately 7% of this population.11 This relatively high prevalence increases the importance of screening in these men, because it improves the likelihood that men in this group will benefit from screening. The USPSTF found adequate evidence that ultrasonography is a safe and accurate screening test for AAA. The USPSTF found moderate evidence that screening for AAA in men ages 65 to 75 years who have ever smoked provides a moderate benefit in reducing AAA-specific mortality, rupture, and emergency surgery. The USPSTF found adequate evidence on the harms associated with one-time and repeated screening. Adequate evidence indicates that the harms of treatment of AAA in this population are small to moderate. The USPSTF concludes with moderate certainty that screening for AAA in men ages 65 to 75 years who have ever smoked is of moderate net benefit (Table).
Men Ages 65 to 75 Years Who Have Never Smoked
The lower prevalence of AAA in men who have never smoked (about 2%) lowers the probability that men in this group will benefit from screening.11 The USPSTF found adequate evidence that screening for AAA in men ages 65 to 75 years who have never smoked provides a small benefit in reducing AAA-specific mortality, rupture, and emergency surgery. The USPSTF found adequate evidence on the harms associated with one-time and repeated screening. Adequate evidence indicates that the harms of treatment of AAA in this population are small to moderate. The USPSTF concludes with moderate certainty that screening for AAA in men ages 65 to 75 years who have never smoked is of small net benefit (Table).
Women Ages 65 to 75 Years Who Have Ever Smoked or Have a Family History of AAA
Only one screening trial included women.12 It detected no difference in the rate of AAA rupture, AAA-specific mortality, or all-cause mortality between women invited for screening and women in the control group.1, 13 However, the trial was underpowered to detect differences in health outcomes by sex; as such, the results do not rule out the possibility of a small benefit of screening in this population.
Overall, women have a lower prevalence of AAA than men at any age and appear to develop AAA at an older age than men. Women age 70 years who have ever smoked have a relatively low prevalence of AAA of approximately 0.8% overall and about 2% among current smokers.14 Most AAA ruptures in women occur after age 80 years, when many competing causes of death are present. The USPSTF therefore found inadequate evidence that screening for AAA in women ages 65 to 75 years who have ever smoked provides a benefit in reducing AAA-specific mortality. The USPSTF found adequate evidence on the harms associated with one-time and repeated screening. Adequate evidence indicates that the harms of treatment of AAA in this population are small to moderate and may be higher than those in men because of higher rates of operative mortality. The benefits and harms of screening for AAA in women ages 65 to 75 years who have ever smoked or have a family history are uncertain and cannot be determined. The USPSTF concludes that the evidence is insufficient to determine the net benefit of screening for AAA in women ages 65 to 75 years who have ever smoked or have a family history (Table).
Women Who Have Never Smoked and Have No Family History of AAA
The prevalence of AAA in women ages 50 to 79 years who have never smoked is low (0.03% to 0.60%).11, 14 The USPSTF concludes that the evidence is insufficient to determine the net benefit of screening for AAA in women ages 65 to 75 years who have never smoked. The USPSTF found adequate evidence that the AAA-specific mortality benefit of screening for AAA in women who have never smoked can be bounded as small to none. When direct evidence is limited, absent, or restricted to select populations or clinical scenarios, the USPSTF may place conceptual upper or lower bounds on the magnitude of benefit or harms. Adequate evidence indicates that the harms of treatment in this population are small to moderate and may be higher than those in men because of higher rates of operative mortality. The USPSTF concludes with moderate certainty that the harms of screening for AAA in women ages 65 to 75 years who have never smoked outweigh the benefits.
The USPSTF therefore concludes that adequate evidence shows that the absolute benefit of one-time screening for AAA with ultrasonography in women who have never smoked can effectively be bounded as none or almost none (Table). For more details on the methods the USPSTF uses to determine the net benefit, see the USPSTF Procedure Manual.15
Patient Population Under Consideration
Based on the scope of the evidence review, this recommendation applies to asymptomatic adults age 50 years or older. However, the randomized trial evidence focuses almost entirely on men ages 65 to 75 years. In this recommendation statement, we stratify our recommendations by “men” and “women,” although we believe the net benefit estimates are actually driven by biologic sex (i.e., male/female) rather than gender identity. Persons should consider their sex at birth to determine which recommendation best applies to them.
Assessment of Risk
Important risk factors for AAA include older age, male sex, smoking, and having a first-degree relative with an AAA.16-19 Other risk factors include a history of other vascular aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, hypercholesterolemia, and hypertension.20-22 Factors associated with a reduced risk include African American race, Hispanic ethnicity, Asian ethnicity, and diabetes.16, 23-27 Risk factors for AAA rupture include older age, female sex, smoking, and elevated blood pressure.1
Smoking 100 or more cigarettes is commonly used in epidemiologic literature to define an “ever smoker.” Indirect evidence shows that smoking is the strongest predictor of AAA prevalence, growth, and rupture rates.1 There is a dose-response relationship, as greater smoking exposure is associated with an increased risk for AAA.1
Family history of AAA in a first-degree relative doubles the risk of developing AAA.28 The risk of developing an AAA is stronger with a female first-degree relative (odds ratio [OR], 4.32) than with a male first-degree relative (OR, 1.61).1, 28 However, evidence is lacking on whether persons with family history experience a different natural history or surgical outcomes than those without such a history.1
The primary method of screening for AAA is conventional abdominal duplex ultrasonography.29 Screening with ultrasonography is noninvasive, simple to perform, has high sensitivity (94% to 100%) and specificity (98% to 100%) for detecting AAA,1, 30-34 and does not expose patients to radiation. Computed tomography is an accurate tool for identifying AAA; however, it is not recommended as a screening method because of its potential for radiation exposure.1 Physical examination has also been used in practice but has low sensitivity (ranging from 39% to 68%) and specificity (75%) and is not recommended for screening.35
Evidence is adequate to support one-time screening in men who have ever smoked. All of the population-based randomized, controlled trials (RCTs) of AAA screening used a one-time screening approach; seven fair- to good-quality cohort studies and one fair-quality case-control (n=6,785) study show that AAA-associated mortality over 5 to 12 years is rare (<3%) in men with initially normal results on ultrasonography (AAA <3 cm in diameter).1
Treatment of AAA depends on aneurysm size, the risk of rupture, and the risk of operative mortality. Larger size is associated with an increased risk of rupture risk. The annual risk for rupture is nearly 0% for AAAs between 3.0 and 3.9 cm in diameter, 1% for those between 4.0 and 4.9 cm in diameter, and 11% for those between 5.0 and 5.9 cm in diameter.1 Surgical repair is standard practice in men with an AAA of 5.5 cm or larger in diameter or an AAA larger than 4.0 cm in diameter that has rapidly grown (defined as an increase of 1.0 cm in diameter over a 1-year period). Endovascular aneurysm repair (EVAR) has become the most common approach for elective AAA repair. Open repair is a time-tested, effective treatment for AAA repair. In the United States, 80% of intact AAA repairs and 52% of ruptured AAA repairs are performed by EVAR.1
The majority of screen-detected AAAs (≥90%) are between 3.0 and 5.5 cm in diameter and thus below the usual threshold for surgery. The current standard of care for patients with stable smaller aneurysms is to maintain ultrasound surveillance at regular intervals because the risk of rupture is small. Recommended surveillance intervals for monitoring the growth of small AAAs vary across guideline groups, and compliance with surveillance guidelines has been reported to be as low as 65%.1 Repairing smaller aneurysms with a lower risk of rupture increases the harms and reduces the benefits of screening.
Suggestions for Practice Regarding the I Statement
Potential Preventable Burden
The estimated prevalence of AAA in women is reportedly less than that in men.1 The Chichester trial reported a prevalence in women that was one sixth of the prevalence in men (1.3% vs. 7.6%), and most AAA-related deaths occurred in women age 80 years or older (70% vs. <50% in men).13 In women, small AAAs have an increased risk of rupture, and rupture at an older age than in men.1 Studies estimate that one quarter to one third of women have an AAA with a diameter below the current 5.5 cm threshold at the time of rupture.1
Operative mortality associated with AAA is higher in women than in men. Women had higher 30-day mortality (2.31%) than men (1.37%) after EVAR procedures (OR, 1.67 [95% CI, 1.38 to 2.04]) and open repair (5.37% vs 2.82%; OR, 1.76 [95% CI, 1.35 to 2.30]).1, 36 Women also experience other harms, such as major complications and hospital readmission, after elective open repair or EVAR compared with men.1
Evidence is insufficient to accurately characterize current practice patterns related to screening for AAA in women.
The standard of care for elective repair is that patients with an AAA of 5.5 cm or larger in diameter should be referred for surgical intervention with either open repair or EVAR.1 This recommendation is based on RCTs conducted in men. The AAA size needed for surgical intervention in women may differ. As a result, the Society of Vascular Surgery guidelines recommend repairing AAAs between 5.0 and 5.4 cm in diameter in women.29 However, concerns about poorer surgical outcomes in women, who have more complex anatomy and smaller blood vessels, have led some to caution against lowering the threshold for surgical intervention in women.1
This recommendation incorporates new evidence, and when finalized, will replace the 2014 USPSTF recommendation.37 It is consistent with the 2014 USPSTF recommendation, which was a B recommendation for one-time screening for AAA with ultrasonography in asymptomatic men ages 65 to 75 years who have ever smoked, a C recommendation for selective screening in men ages 65 to 75 years who have never smoked, a D recommendation against routine screening in asymptomatic women who have never smoked, and an I statement for women ages 65 to 75 years who have ever smoked.
Scope of Review
The USPSTF commissioned a systematic evidence review to update its 2014 recommendation on screening for AAA. The USPSTF examined evidence regarding the effectiveness of one-time and repeated screening for AAA, the associated harms of screening, and the benefits and harms of available treatments for small AAAs (3.0 to 5.0 cm in diameter) identified through screening.
Accuracy of Screening Tests and Risk Assessment
Ultrasonography is the primary method used to screen for AAA in primary care because of its high sensitivity (94% to 100%) and specificity (98% to 100%).1 It is also noninvasive, simple to perform, and does not expose patients to radiation.
Benefits of Early Detection and Treatment
Four large, population-based RCTs (n=124,929) that predominantly enrolled men age 65 years or older examined the effectiveness of one-time screening for AAA: the good-quality Multicentre Aneurysm Screening Study (MASS) (n=67,800);38 the good-quality Viborg County, Denmark, screening trial (n=12,639);16 the fair-quality Chichester, United Kingdom, screening trial (n=15,382);12 and the fair-quality Western Australia screening trial (n=38,480).39 Reported mean (or median) ages ranged from 67.7 to 72.6 years; the oldest participants were age 83 years.1 The Western Australia screening trial41 reported outcomes by smoking status in the screened group. The trial was underpowered to detect differences in subpopulations. No comparisons in the unscreened group were reported.1, 40 None of the four population-based screening RCTs reported family history of AAA in the trial populations.1
The prevalence of AAA in male screening participants ranged from 4.0% to 7.6% across the studies. Most screen-detected AAAs were small (≤4 to 4.5 cm in diameter); 0.3% to 0.6% of screened participants had an AAA measuring 5 cm or larger or 5.5 cm or larger in diameter.1 Two of the population-based screening trials analyzed AAA-associated mortality by age. The Viborg trial found similar risk reduction in AAA-related mortality in screening men ages 64 to 65 years compared with men ages 66 to 73 years.16 The Western Australia trial found no AAA-associated mortality benefit in men ages 65 to 74 years (rate ratio, 0.92 [95% CI, 0.62 to 1.36]) at 12.8-year followup; results were similar to findings for men ages 64 to 83 years of age.1, 39
As noted previously, only the Chichester trial included women (ages 65 to 80 years). It found a low prevalence of AAA in women (1.3%), and 75% of screen-detected AAAs in women were 3.0 to 3.9 cm in diameter. Rupture rates (0.2% in both groups), AAA-specific mortality (0.06 vs. 0.04% in both groups), and all-cause mortality (10.7% vs. 10.2%) at 5 years did not statistically significantly differ between the invitation-to-screening and control groups.1, 13 The trial was underpowered to draw definitive conclusions about health outcomes in women. Although the risk for rupture at a smaller aneurysm diameter seems to be higher in women than in men,1, 14 the overall rupture rate in women is low. In the Chichester trial, more than two thirds of deaths from AAA occurred in women age 80 years or older.1, 13
Pooled analysis of AAA-related mortality from the four trials showed a statistically significant 35% reduction associated with invitation to screening (Peto OR, 0.65 [95% CI, 0.57 to 0.74]; I2=80%).1 The number needed to screen was 305 men (95% CI, 248 to 411) to prevent one AAA death. The MASS and Viborg trials each found a statistically significant reduction in AAA-related mortality in the groups invited to screening compared with the control groups up to 13 years after screening (hazard ratio [HR], 0.58 [95% CI, 0.49 to 0.69] vs. 0.34 [95% CI, 0.20 to 0.57], respectively).16, 38 The Chichester trial reported an HR of less than 1, but it was not statistically significant.1, 12 Pooled analysis of all available trials also showed no effect on all-cause mortality (relative risk, 0.99 [95% CI, 0.98 to 1.00]; I2=0%).1 Of the individual trials, only MASS showed a statistically significant benefit of screening for all-cause mortality at up to 15-year follow-up (HR, 0.97 [95% CI, 0.95 to 0.99]).1 Invitation to screening was associated with a statistically significant reduced rate of rupture in the pooled analysis of the four trials (Peto OR, 0.62 [95% CI, 0.55 to 0.70]; I2=53%).1 The number needed to screen was 246 men (95% CI, 207 to 311) to prevent one AAA rupture. Pooled results of the trials showed a reduction in emergency surgery in the invited to screening group (Peto OR, 0.57 [95% CI, 0.48 to 0.68]; I2=27%).1 Screening 1,000 men for AAA would decrease the number of emergency operations by 2 (95% CI, 2 to 2).
Four trials evaluated early surgical intervention compared with surveillance of smaller aneurysms (4 to 5.4 cm in diameter).41-44 Two good-quality open repair trials (n=2,226) and two fair-quality EVAR trials (n=1,088) showed no differences in all-cause and AAA-related mortality. However, there was a reduction in rupture rate with early open surgery compared with surveillance for small AAAs12, 16, 37, 38 in the Aneurysm Detection and Management (ADAM) Veterans Affairs trial (relative risk, 0.18 [95% CI, 0.04 to 0.81]) and the UK Small Aneurysm (UKSAT) trial (relative risk, 0.51 [95% CI, 0.26 to 0.99]).1, 37, 38 Individual patient data meta-analysis of the two early open vs. surveillance trials (ADAM and UKSAT trials) reported no differences in all-cause mortality effect by sex or age.1, 12, 38 The UKSAT trial reported no difference in all-cause mortality by smoking status; there were no analyses stratifying by family history or race/ethnicity.1
Seven pharmacotherapy RCTs (n=1,553) of antibiotics, antihypertensive medications (e.g., angiotensin converting enzyme inhibitors, calcium channel blockers, and propranolol), and a mast cell stabilizer showed no significant effect on AAA growth compared with placebo.1
Harms of Screening and Treatment
Each of the four older screening trials and a more recent population-based screening RCT (n=18,614), the Viborg Vascular (VIVA) trial, showed an increase in elective surgeries in the intervention group compared with the control group.1, 45 There were approximately 40% more surgeries in the invited group than in the control group (five studies; n=175,085; Peto OR, 1.44 [95% CI, 1.34 to 1.55]), driven primarily by an increase in elective surgeries (five studies; n=175,085; Peto OR, 1.75 [95% CI, 1.61 to 1.90]).1 There was no statistically significant difference in 30-day mortality rates between the invited and control groups for either elective surgeries or emergency surgeries at 12- to 15-years of followup.1
Five studies (n=2,734) reported mixed results on quality of life outcomes.1 Overall, there were no substantial differences on quality of life measures or anxiety or depression scores at up to 12 months of followup between patients who screened positive for AAA and patients who screened negative or were unscreened.1
Two trials of early open repair vs. surveillance (ADAM and UKSAT trials) reported a 50% higher rate of procedures in the early intervention group, with no difference in 30-day operative mortality.1, 41, 42 Readmission rates at 30 days were similar, and major surgical complications were lower in the early intervention group. Analysis of quality of life measures showed mixed results; although there was generally a decline in both groups over time, there were no statistically significant differences between the groups for up to 1 to 2 years. Only the ADAM trial showed higher general health scores in the early repair group in the first 2 years, but this difference did not persist over time.1 One trial reported an increased incidence of impotence in the early repair group at up to 4 years.1
Registry harms data were generally comparable to the findings of the two trials with the exception of reintervention rates, which were higher in the registries than in the ADAM trial.1
Two trials of early EVAR vs. surveillance reported approximately 100% more procedures in the early intervention group and similarly rare 30-day operative mortality rates between the groups.1, 43, 44 In the Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR) trial, the early intervention group had a higher percentage of patients with any adverse events (19% vs. 5%; p<0.01), any major morbidity related to repair at 30 days (18% vs. 6%; p=0.01), endoleaks at 1 year (12% vs. 2%; p=0.028), and reintervention (6% vs. 0%; p=0.03) but similar rates of any major morbidity over the trial duration (3.3% vs. 2.8%; p=0.99).1, 43 The Positive Impact of Endovascular Options for Treating Aneurysms Early PIVOTAL trial reported similar rates of adverse events at 30 days (12% vs. 10%) and 1 year (26% vs. 35%) and reintervention (3.7% vs. 4.6%).1, 44 Reported complication rates from registry data were generally comparable to those rates reported in the above trials for 30-day operative mortality and reintervention.1
Two propranolol trials reported high discontinuation rates related to adverse events (38% and 60% of participants in the propranolol arms withdrew from the trials). Other medications (e.g., angiotensin converting enzyme inhibitors, calcium channel blockers, and antibiotics) seemed well tolerated based on rare trial withdrawals reported from one to two studies per drug class.1
There are several key research gaps that could help inform the benefit of screening for AAA in U.S.-based populations:1
- Although evidence shows that women who smoke or have a family history are at increased risk for AAA compared with nonsmoking women without a family history, evidence is insufficient that screening this population confers a net benefit. Ideally, appropriately powered RCTs among women with risk factors could answer these critical gaps in the evidence on screening for AAA. In the absence of new trial data, high-quality, well-calibrated modeling studies based on reliable data on the harms and benefits of screening in women who smoke or in men and women with a family history of AAA may be informative.
- Well-conducted cohort studies examining rescreening benefits (including growth rates and health outcomes) are needed for persons who initially screen negative for AAA to determine the benefit and timing of additional screening ultrasonography.
- External validation of risk prediction models that have already been developed will allow policymakers to assess their value for making more individualized screening recommendations.
- Epidemiologic studies on the current prevalence of AAA in the United States, including in subpopulations, would help inform the applicability of older population-based screening trials to the current U.S. population.
- With evidence suggesting that AAAs in women may rupture at a smaller size than in men, well-designed studies, RCTs, or registry data on the thresholds for repair of AAA in women may inform the benefits and harms of screening in women.
- Studies examining systems approaches to improving implementation of evidence-based AAA screening in the United States are also needed.
- Studies examining the efficacy of screening and treatment in diverse populations to inform the need for specific recommendations in subpopulations of Americans.
The American College of Cardiology and the American Heart Association jointly recommend one-time screening for AAA with physical examination and ultrasonography in men ages 65 to 75 years who have ever smoked or in men age 60 years or older who are the sibling or offspring of a person with AAA. These organizations do not recommend screening for AAA in men who have never smoked or in women.46 The Society for Vascular Surgery recommends one-time ultrasonography screening for AAA in all men and women aged 65 to 75 years with a history of tobacco use, men age 55 years or older with a family history of AAA, and women age 65 years or older who have smoked or have a family history of AAA.47 The American College of Preventive Medicine recommends one-time screening in men ages 65 to 75 years who have ever smoked; it does not recommend routine screening in women.48
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|Rationale||Men, ever smoked||Men, never smoked||Women, ever smoked or family history||Women, never smoked, no family history|
|Detection||Adequate evidence that ultrasonography is a safe and accurate screening test for AA.||Adequate evidence that ultrasonography is a safe and accurate screening test for AA.||Adequate evidence that ultrasonography is a safe and accurate screening test for AA.||Adequate evidence that ultrasonography is a safe and accurate screening test for AA.|
|Benefits of early detection and treatment||Adequate evidence that one-time screening for AAA with ultrasonography results in a moderate benefit in men ages 65 to 75 years who have ever smoked.||Adequate evidence that one-time screening for AAA with ultrasonography results in a small benefit in men ages 65 to 75 years who have never smoked.||Inadequate evidence to conclude whether one-time screening for AAA with ultrasonography is beneficial in women ages 65 to 75 years who have ever smoked or have a family history of AAA.||Adequate evidence that one-time screening for AAA with ultrasonography results in no benefit in women who have never smoked and have no family history of AAA..|
|Harms of early detection and treatment||Adequate evidence that the harms associated with one-time screening for AAA with ultrasonography are small to moderate||Adequate evidence that the harms associated with one-time screening for AAA with ultrasonography are small to moderate||Adequate evidence that the harms associated with one-time screening for AAA with ultrasonography are small to moderate|
|USPSTF assessment||Moderate certainty that screening for AAA with ultrasonography in men ages 65 to 75 years who have ever smoked has a moderate net benefit||Moderate certainty that screening for AAA with ultrasonography in men ages 65 to 75 years who have never smoked has a small net benefit.||Benefits and harms of screening for AAA with ultrasonography in women ages 65 to 75 years who have ever smoked or have a family history are uncertain, and the balance of benefits and harms cannot be determined||Moderate certainty that the harms of screening for AAA with ultrasonography in women who have never smoked and have no family history outweigh the benefits.|