The 2011 Institute of Medicine report titled “Clinical Practice Guidelines We Can Trust”1 recommends that guidelines be updated at a prespecified time and that new evidence be reviewed regularly to determine the need for earlier updating. New evidence, however, is not the only reason for updating guidelines. Another is to reconceptualize benefits and harms with the advantage of more experience and new understanding. This would seem to be the essence of critical thinking, of avoiding the cognitive “confirmation” bias whereby we simply continue to think the way we have, without serious questioning. An article in this issue of the Archives2 considers screening for abdominal aortic aneurysm (AAA). Both new evidence about benefits and new concepts of harms suggest that it may now be time to rethink AAA screening.
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We have read with interest the original publication “Impact of the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act on Abdominal Ultrasonography Use Among Medicare Beneficiaries” by Shreibati et al,  as well as the invited commentary by Harris et al . We would like to comment on both collectively in our correspondence.
First, we note several issues in the original investigation that warrant comment. The objective of the analysis was “to examine the effect of the SAAAVE Act on use of abdominal ultrasonography,” focusing on whether passage of the SAAAVE act increased, decreased, or resulted in no change in the use of ultrasound in the Medicare population for which it is prescribed. Pointedly, the examination of outcomes of aneurysm treatment or incidence of rupture was not the focus of this investigation. While the conclusions drawn and outlined in the paper fully adhere to the data presented, the focus of the article must be remembered, especially in the invited commentary (see below).
We also wonder why all patients with a CT or MRI during the study period were excluded before any subsequent patient analysis. Since it would be extremely unlikely that any patient would go on to aneurysm treatment without these studies being done preoperatively, it is likely that a very large percentage of patients with the diagnosis of AAA were excluded before analysis even began. That is, the 37,963 patients who were excluded in the study population might actually have contained the “lion’s share” of newly diagnosed AAAs. This would ultimately confound the authors’ data on hospitalizations for aneurysm treatment and/or rupture (explaining for example, their quoted very low incidence of elective AAA repairs of only 0.06% in the 65-year old male category).
Next, we believe that, while the inclusion of the control group of 65-year-old women might provide some insight into how the SAAAVE Act might change the penetration of ultrasound use, discussion of the number of hospitalizations for aneurysm repair (either elective or ruptured) is confusing and adds little to the publication. It is well known that the prevalence of AAA in women (without a significant family history) is substantially lower than that of age-matched male cohorts. Therefore, commenting on incidence of hospitalization for rupture in this group is not a valid comparison.
Finally, the prevalence of ever smoking in each of the groups was about 65%, yet the authors found that fewer than 10% of those eligible for the screening ultrasound ultimately received one. We believe this is the main point of this article, which reinforces the authors’ last sentence stating “that simply providing coverage for a screening test may not be sufficient to lead to widespread adoption.”
The ultimate value of the screening program will only be realized by disseminating knowledge of its existence and promoting its overall long-term potential benefit. It is unreasonable to dismiss the screening because it has no effect on overall mortality of this patient population. As the authors correctly point out, screening mammography and fecal occult blood testing also do not alter all-cause mortality. Yet, these programs are widely accepted in medicine and in the eyes of the general public. Moreover, the authors identified that more co-morbid conditions were documented in patients after implementation of the SAAAVE Act. This is may be an added secondary benefit if previously undiagnosed (and therefore untreated) chronic conditions are now identified and managed in these patients.
The invited commentary by Harris, et al., while clearly provocative, fails to back its assertions with data. The authors begin their commentary by suggesting there is a concept of “harm” in screening for AAA. This is based on the idea that a new diagnosis of AAA would cause substantial psychological stress to the newly diagnosed patient. The authors imply that the diagnosis of a small aneurysm will never cause physical harm (rupture) or require repair, leaving the patient only with anxiety about the diagnosis. The literature on this point is sparse and conflicting and certainly does not argue the point well [3, 4]. We can think of no scenario in patient care in which the “ignorance is bliss” philosophy would be widely accepted by caregivers or patients. By this argument, we should not perform screening mammography because of the anxiety caused to women from the identification of a breast mass which might ultimately be benign. By this argument, the time between radiologic identification to excisional biopsy to pathologic confirmation of a benign process would cause enough undo “mental anguish” to some patients that screening should be abandoned. One can see the flaw of the premise by pushing the argument along the slippery slope. Furthermore, any psychological harm caused by the diagnosis of a small aneurysm would be far outweighed by the potential decrease in cardiovascular risk as a result of heightened medical management of smoking, hypertension and hypercholesterolemia, when present.
The authors argue that the mortality from ruptured AAA has decreased in the past 10-15 years. In fact, surgical literature shows that perioperative mortality of ruptured AAA done by open technique has not changed over the last several decades . What the literature has shown is that mortality for ruptured AAA has decreased with increased use of endovascular treatment . The authors correctly suggest a relationship between the decrease in AAA prevalence and reduction of smoking prevalence and increased statin use in this country. This is especially true as it is well established that tobacco use is the highest risk factor for development and expansion of AAA. However, this does not diminish the value of screening in those populations proven to be at greatest risk. The most important comparison to support screening is not the mortality of elective open repair vs. elective endovascular repair (OAR vs. EVAR) but rather, the comparison in mortality of all elective repair (OAR or EVAR) vs. repair for ruptured AAA (OAR or EVAR). The perioperative mortality rates for these two categories (i.e., elective vs. rupture) has been shown to be substantially different . To break it down to its most elemental: screening is done to be able to treat AAA before ruptures occur both to decrease mortality and financial costs to the medical system. The authors also cite EVAR endoleaks as a source of “harm.” The surgical literature is replete with data that show that most endoleaks are benign and cause no “harm” as evidenced by the fact that they require no treatment. Specifically, most endoleaks are “type II” which are identified on surveillance postoperative CT scans and simply followed. The authors correctly identify this fact by quoting that only 4% of endoleaks go on to require additional interventions. Lastly, the authors assert that many patients are having a disservice done to them based on data from Schanze, et al  that reports that 59.4% of patients undergoing EVAR had AAA <5.5cm. However, review of Schanzer’s paper shows that information about this 59.4% is not available to determine how many were 5.0-5.5cm, well within current standards of care for treatment. Also, one cannot determine how many small AAAs were treated simply as a byproduct of a large iliac artery aneurysm as the indication for intervention. In addition, the conclusions drawn from this paper, although worthy of discussion, have generated significant controversy amongst experienced clinicians. The inherent selection bias and lack of detailed information in this review of a voluntary registry challenges the authors’ conclusions about AAA size treatment thresholds [8-10]. Finally, the authors label abdominal aortic aneurysms with dimensions less than 5.5 cm as “overdiagnosis.” A disease entity does in fact exist even if it does not yet rise to severity enough warranting operative intervention. Continued surveillance of patients with AAA <5 cm does indeed show that many of them progress to a size in which treatment is indicated. Perhaps the most contemporary evidence to this point is from the Gloucestershire group, published very recently . During their 20-year screening program, they have noted that a not-insignificant number of patients initially diagnosed with a small aneurysm went on to require repair adhering to the 5.5 cm standard. Even in males diagnosed with an initial aortic diameter of 2.6-2.9 cm, 15% of them progressed to have an AAA measuring at least 5.4 cm. In those males having an initial aortic diameter of 3.0-3.9 cm, 34% went on to develop an AAA of a size warranting repair. Therefore, the assertion that there is “overdiagnosis” of aortic aneurysms should be approached with quite a bit of caution and skepticism. This point will become even more important as this population lives longer. It is intuitive that the worst time to identify patients for the first time with an AAA is when they are hypotensive in the emergency department. The goal of a proper screening program is to identify patients with either an AAA warranting elective repair or those with small AAA which can be methodically followed until rupture risk exceeds surgical risk. In fact, there is literature showing that incomplete monitoring of AAA is associated with a decreased risk of AAA repair and an increased risk of death.In their final paragraph, the authors such words and phrases as “difficult to control,” “harms by labeling,” and “overdiagnosis.” With this type of derogatory wording, a reader might infer that the authors believe that the screening program is part of an agenda from overly-eager interventionalists. At Kaiser Permanente, we feel very strongly that health maintenance, proactive care, and screening are essential. We fully support the AAA screening for those appropriately selected patients felt to be at risk. We adhere to current guidelines for aneurysm size warranting treatment. Most importantly, our support of this screening program is unencumbered. That is, within the Kaiser Permanente system, we surgeons have no financial conflict of interest, since we are not fee-for-service. We have no financial incentive to be performing neither AAA screening, nor aneurysm surgery. Yet, we still support the screening program because it is the right thing to do.
In summary, we agree that any screening program should be regularly reevaluated with diligence to ensure that it is beneficial to the population it serves, and that its original intent is being met. Screening programs are born out of reasonable, robust, or compelling data. This is why Dr. Harris voted in favor of establishing a screening program. Unfortunately, we do not feel the current invited commentary by Dr. Harris brings with it the same level of support.
1. Shreibati, J.B., LC; Hlatky, MA; Mell, MW, Impact of the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act on Abdominal Ultrasonography Use Among Medicare Beneficiaries. Arch Intern Med, 2012: p. E1-E7.
2. Harris, R., S. Sheridan, and L. Kinsinger, Time to Rethink Screening for Abdominal Aortic Aneurysm?: Comment on "Impact of the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act on Abdominal Ultrasonography Use Among Medicare Beneficiaries". Arch Intern Med, 2012: p. 1-2.
3. Lucarotti, M.E., et al., Psychological morbidity associated with abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg, 1997. 14(6): p. 499-501.
4. Lindholt, J.S., et al., Psychological consequences of screening for abdominal aortic aneurysm and conservative treatment of small abdominal aortic aneurysms. Eur J Vasc Endovasc Surg, 2000. 20(1): p. 79-83.
5. Verhoeven, E.L., et al., Mortality of ruptured abdominal aortic aneurysm treated with open or endovascular repair. J Vasc Surg, 2008. 48(6): p. 1396-400.
6. Starnes, B.W., et al., Management of ruptured abdominal aortic aneurysm in the endovascular era. J Vasc Surg, 2010. 51(1): p. 9-17; discussion 17-8.
7. Schanzer, A., et al., Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation, 2011. 123(24): p. 2848-55.
8. Cambria, R.P., Endovascular repair of abdominal aortic aneurysm: no cause for alarm. Circulation, 2011. 123(24): p. 2782-3.
9. Fillinger, M., Letter by Fillinger Regarding Article, “Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair”. Circulation, 2012. 125: p. e341.
10. De Rango, P., Cao, P., Verzini, F., Letter by De Rango et al Regarding Article, “Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair”. Circulation, 2012. 125: p. e340.
11. Darwood, R., et al., Twenty-year review of abdominal aortic aneurysm screening in men in the county of Gloucestershire, United Kingdom. J Vasc Surg, 2012. 56(1): p. 8-13.
12. van Walraven, C., Wong, J., Morant, K., Jennings, A., Austin, P.C., Jetty, P., Forster, A., The influence of incidental abdominal aortic aneurysm monitoring on patient outcomes. J Vasc Surg, 2011. 54(5): p. 1290-1297.
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