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Dense breasts and legislating medicine
Recently, Nevada,1 North Carolina, and Oregon joined a number of other US states (as of this writing, nine other states) in enacting laws that require informing women if they have dense breast tissue detected on mammography.2 Laws are pending in other states. Federal legislation has also been introduced in the US House of Representatives.
THE POWER OF ADVOCACY TO CHANGE MEDICAL PRACTICE
One such bill3 was introduced as a result of the advocacy of a single patient, Nancy Cappello, a Connecticut woman who was not informed that she had dense breasts and was later found to have node-positive breast cancer.4
While new medical practices are rarely credited to the efforts of single physician or researcher, these “dense-breast laws” show the power a single patient may play in health care. The evidence behind these laws and their implications bring to the forefront the role of advocacy and legislation in the practice of medicine.
Dense-breast laws are the latest chapter in how legislative action can change the practice of medicine. Proof that advocacy could use law to change medical practice emerged in the early 1990s in the wake of AIDS activism. Patient-advocacy activists lobbied for early access to investigational agents, arguing that traditional pathways of clinical testing would deprive terminally ill patients of potentially lifesaving treatments. These efforts led the US Food and Drug Administration (FDA) to create the Accelerated Approval Program, which allows new drugs to garner approval based on surrogate end-point data for terminal or neglected diseases. Accelerated approval was codified into law in 1997 in the FDA’s Modernization Act.5 In 2012, legislative action further broadened the ability of the FDA to approve new products based on surrogate data,6 with the FDA’s Safety and Innovation Act, which provides for first-time approval of a drug based on “pharmacologic” end points that are even more limited.6
Although proponents have declared success when legislative action lowers the bar for drug and device approval, independent analyses have been more critical. In 2009, accelerated approval underwent significant scrutiny when the Government Accountability Office issued a report summarizing 16 years of the program.7 Over the program’s life span, the FDA called for 144 postmarketing studies, but more than one-third of these remained incomplete. Moreover, in 13 years, the FDA never exercised its power to expedite the withdrawal of a drug from the market.
Many accelerated approvals have created considerable controversy. Bevacizumab for metastatic breast cancer was ultimately found to confer no survival benefit, and its approval was revoked.8 Gemtuzumab ozogamicin for acute myeloid leukemia may be effective, but not at the dose that was approved.9 And midodrine hydrochloride and many other drugs remain untested.10
DOES THIS INFORMATION HELP PATIENTS? WHAT WOULD THEY DO WITH IT?
The question with dense-breast laws is similar to that facing other legal efforts to change medicine: Does it actually help patents? Will the information doctors disclose lead to appropriate interventions that improve health outcomes, or, instead, lead to cascades of testing and biopsies that worsen overdiagnosis?
Like accelerated approval, mandating disclosure of breast density is an intervention with uncertain efficacy. While increased breast density has been shown to increase a woman’s risk of developing breast cancer, it is also neutral regarding a woman’s chances of dying of breast cancer.11 In other words, it does not identify patients who experience aggressive disease.
Next comes the larger question of what women would do with this information. Will they simply be more compliant with existing screening recommendations, or will they seek additional testing? This is where the greatest uncertainty lies. The utility of additional testing with ultrasonography or magnetic resonance imaging (MRI) remains uncertain in this population. We will certainly find more cancers if we use MRI to screen women, but it remains unclear if this translates to improved outcomes.
A recent study shows just this.12 In Connecticut, breast density notification is mandatory, as is insurance coverage for screening (or whole-breast) ultrasonography. Since the passage of these laws, the Yale Medical Center has screened 935 women with dense breasts using ultrasonography. Over this time, they performed roughly 16,000 mammograms; thus, the breast density law applied roughly to 1 out of 16 (6.25%) studies. Of the 935 women, biopsies were performed in 54 (5.8%). These were mostly needle biopsies (46), but 3 patients underwent surgical excision, and five cysts were aspirated. From these efforts, two sub-centimeter cancers were found and one case of ductal carcinoma in situ was found. Thus, only 3.7% of women undergoing biopsy and fewer than 1% of women undergoing ultrasonography were found to have cancer.
Of course, given the nature of this study, we cannot know what would have happened without referral and testing. However, empirical research suggests that detecting a breast cancer with screening does not mean a life was saved.13 In fact, only a minority of such women (13%) can credit screening with a survival gain.13
In a study14 that compared women with dense breasts who underwent annual vs biannual screening, no difference in the rate of advanced or metastatic disease was seen with more frequent screening, but the rates of false-positive results and biopsies were higher.14
Notably, dense-breast legislation comes at a time when fundamental questions have been raised about the impact of screening on breast cancer. A prominent study of trends in US breast cancer incidence and death rates over the last 30 years shows that even under the most favorable assumptions, mammography has led to a huge surplus in the diagnosis of breast cancer but little change in the breast cancer mortality rate.15 It is entirely possible that more-aggressive screening in women with dense breasts will only exacerbate this problem. Advocacy may harm rather than help these patients.
We are often told that laws such as the dense-breast bills are motivated by the public’s desire and patient advocacy. However, we are unsure if the vocal proponents of dense-breast laws represent the average women’s desires. These efforts may simply be another case of how a vocal and passionate minority can overcome a large and indifferent majority.16
LEGISLATING MEDICAL PRACTICE IS A BOLD STEP
Dense-breast laws present an additional challenge: they cannot be changed as quickly as scientific understanding. In other words, if the medical field comes to believe that notification is generally harmful because it leads to increased biopsies but not better health, can the law be changed rapidly enough to reflect this? There is a large precedent for the reversal of medical practices,17,18 particularly those based on scant evidence, including cases of recommended screening tests (most notably, recent changes to prostate-specific antigen guidelines). But in all these other cases, law did not mandate the practice or recommendation. Laws are often slow to adapt to changes in understanding.
Legislating medical practice is a bold step, and even those who feel it is occasionally warranted must hold themselves to a rational guiding principle. We have incontrovertible evidence that flexible sigmoidoscopy can reduce the number of deaths from colorectal cancer, but no state mandates that doctors inform their patients of this fact. A patient’s ejection fraction serves as a marker of benefit for several lifesaving drugs and devices, yet no state mandates that physicians disclose this information to patients after echocardiography.
All of us in health care—physicians, researchers, nurses, practitioners, and patients—are patient advocates, and we all want policies that promote human health. However, doing so means adhering to practices grounded in evidence. Dense-breast laws serve as a reminder that good intentions and good people may be necessary—but are not sufficient—for sound policy.
- Nevada Legislature. Requires the notification of patients regarding breast density. (BDR 40-172). http://www.leg.state.nv.us/Session/77th2013/Reports/history.cfm?ID=371. Accessed November 7, 2013.
- ImagingBIZ Newswire. Nevada Governor Signs Breast Density Law June 10, 2013. http://www.imagingbiz.com/articles/news/nevada-governor-signs-breast-density-law. Accessed August 1, 2013.
- Are You Dense Advocacy. H.R.3102Latest 112th Congress. Breast Density and Mammography Reporting Act of 2011 http://www.congressweb.com/areyoudenseadvocacy/Bills/Detail/id/12734. Accessed November 7, 2013.
- The New York Times. New Laws Add a Divisive Component to Breast Screening. http://www.nytimes.com/2012/10/25/health/laws-tell-mammogram-clinics-to-address-breast-density.html?pagewanted=all. Accessed November 7, 2013.
- Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2:695–702.
- Kramer DB, Kesselheim AS. User fees and beyond—the FDA Safety and Innovation Act of 2012. N Engl J Med 2012; 367:1277–1279.
- US Government Accountability Office (GAO). New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints. GAO-09-866. http://www.gao.gov/products/GAO-09-866. Accessed November 7, 2013.
- Ocaña A, Amir E, Vera F, Eisenhauer EA, Tannock IF. Addition of bevacizumab to chemotherapy for treatment of solid tumors: similar results but different conclusions. J Clin Oncol 2011; 29:254–256.
- Rowe JM, Löwenberg B. Gemtuzumab ozogamicin in acute myeloid leukemia: a remarkable saga about an active drug. Blood 2013; 121:4838–4841.
- Dhruva SS, Redberg RF. Accelerated approval and possible withdrawal of midodrine. JAMA 2010; 304:2172–2173.
- Gierach GL, Ichikawa L, Kerlikowske K, et al. Relationship between mammographic density and breast cancer death in the Breast Cancer Surveillance Consortium. J Natl Cancer Inst 2012; 104:1218–1227.
- Hooley RJ, Greenberg KL, Stackhouse RM, Geisel JL, Butler RS, Philpotts LE. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012; 265:59–69.
- Welch HG, Frankel BA. Likelihood that a woman with screen-detected breast cancer has had her “life saved” by that screening. Arch Intern Med 2011; 171:2043–2046.
- Kerlikowske K, Zhu W, Hubbard RA, et al; Breast Cancer Surveillance Consortium. Outcomes of screening mammography by frequency, breast density, and postmenopausal hormone therapy. JAMA Intern Med 2013; 173:807–816.
- Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med 2012; 367:1998–2005.
- New York Review of Books. Facing the Real Gun Problem. http://www.nybooks.com/articles/archives/2013/jun/20/facing-real-gunproblem. Accessed November 7, 2013.
- Prasad V, Gall V, Cifu A. The frequency of medical reversal. Arch Intern Med 2011; 171:1675–1676.
- Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA 2012; 307:37–38.
Recently, Nevada,1 North Carolina, and Oregon joined a number of other US states (as of this writing, nine other states) in enacting laws that require informing women if they have dense breast tissue detected on mammography.2 Laws are pending in other states. Federal legislation has also been introduced in the US House of Representatives.
THE POWER OF ADVOCACY TO CHANGE MEDICAL PRACTICE
One such bill3 was introduced as a result of the advocacy of a single patient, Nancy Cappello, a Connecticut woman who was not informed that she had dense breasts and was later found to have node-positive breast cancer.4
While new medical practices are rarely credited to the efforts of single physician or researcher, these “dense-breast laws” show the power a single patient may play in health care. The evidence behind these laws and their implications bring to the forefront the role of advocacy and legislation in the practice of medicine.
Dense-breast laws are the latest chapter in how legislative action can change the practice of medicine. Proof that advocacy could use law to change medical practice emerged in the early 1990s in the wake of AIDS activism. Patient-advocacy activists lobbied for early access to investigational agents, arguing that traditional pathways of clinical testing would deprive terminally ill patients of potentially lifesaving treatments. These efforts led the US Food and Drug Administration (FDA) to create the Accelerated Approval Program, which allows new drugs to garner approval based on surrogate end-point data for terminal or neglected diseases. Accelerated approval was codified into law in 1997 in the FDA’s Modernization Act.5 In 2012, legislative action further broadened the ability of the FDA to approve new products based on surrogate data,6 with the FDA’s Safety and Innovation Act, which provides for first-time approval of a drug based on “pharmacologic” end points that are even more limited.6
Although proponents have declared success when legislative action lowers the bar for drug and device approval, independent analyses have been more critical. In 2009, accelerated approval underwent significant scrutiny when the Government Accountability Office issued a report summarizing 16 years of the program.7 Over the program’s life span, the FDA called for 144 postmarketing studies, but more than one-third of these remained incomplete. Moreover, in 13 years, the FDA never exercised its power to expedite the withdrawal of a drug from the market.
Many accelerated approvals have created considerable controversy. Bevacizumab for metastatic breast cancer was ultimately found to confer no survival benefit, and its approval was revoked.8 Gemtuzumab ozogamicin for acute myeloid leukemia may be effective, but not at the dose that was approved.9 And midodrine hydrochloride and many other drugs remain untested.10
DOES THIS INFORMATION HELP PATIENTS? WHAT WOULD THEY DO WITH IT?
The question with dense-breast laws is similar to that facing other legal efforts to change medicine: Does it actually help patents? Will the information doctors disclose lead to appropriate interventions that improve health outcomes, or, instead, lead to cascades of testing and biopsies that worsen overdiagnosis?
Like accelerated approval, mandating disclosure of breast density is an intervention with uncertain efficacy. While increased breast density has been shown to increase a woman’s risk of developing breast cancer, it is also neutral regarding a woman’s chances of dying of breast cancer.11 In other words, it does not identify patients who experience aggressive disease.
Next comes the larger question of what women would do with this information. Will they simply be more compliant with existing screening recommendations, or will they seek additional testing? This is where the greatest uncertainty lies. The utility of additional testing with ultrasonography or magnetic resonance imaging (MRI) remains uncertain in this population. We will certainly find more cancers if we use MRI to screen women, but it remains unclear if this translates to improved outcomes.
A recent study shows just this.12 In Connecticut, breast density notification is mandatory, as is insurance coverage for screening (or whole-breast) ultrasonography. Since the passage of these laws, the Yale Medical Center has screened 935 women with dense breasts using ultrasonography. Over this time, they performed roughly 16,000 mammograms; thus, the breast density law applied roughly to 1 out of 16 (6.25%) studies. Of the 935 women, biopsies were performed in 54 (5.8%). These were mostly needle biopsies (46), but 3 patients underwent surgical excision, and five cysts were aspirated. From these efforts, two sub-centimeter cancers were found and one case of ductal carcinoma in situ was found. Thus, only 3.7% of women undergoing biopsy and fewer than 1% of women undergoing ultrasonography were found to have cancer.
Of course, given the nature of this study, we cannot know what would have happened without referral and testing. However, empirical research suggests that detecting a breast cancer with screening does not mean a life was saved.13 In fact, only a minority of such women (13%) can credit screening with a survival gain.13
In a study14 that compared women with dense breasts who underwent annual vs biannual screening, no difference in the rate of advanced or metastatic disease was seen with more frequent screening, but the rates of false-positive results and biopsies were higher.14
Notably, dense-breast legislation comes at a time when fundamental questions have been raised about the impact of screening on breast cancer. A prominent study of trends in US breast cancer incidence and death rates over the last 30 years shows that even under the most favorable assumptions, mammography has led to a huge surplus in the diagnosis of breast cancer but little change in the breast cancer mortality rate.15 It is entirely possible that more-aggressive screening in women with dense breasts will only exacerbate this problem. Advocacy may harm rather than help these patients.
We are often told that laws such as the dense-breast bills are motivated by the public’s desire and patient advocacy. However, we are unsure if the vocal proponents of dense-breast laws represent the average women’s desires. These efforts may simply be another case of how a vocal and passionate minority can overcome a large and indifferent majority.16
LEGISLATING MEDICAL PRACTICE IS A BOLD STEP
Dense-breast laws present an additional challenge: they cannot be changed as quickly as scientific understanding. In other words, if the medical field comes to believe that notification is generally harmful because it leads to increased biopsies but not better health, can the law be changed rapidly enough to reflect this? There is a large precedent for the reversal of medical practices,17,18 particularly those based on scant evidence, including cases of recommended screening tests (most notably, recent changes to prostate-specific antigen guidelines). But in all these other cases, law did not mandate the practice or recommendation. Laws are often slow to adapt to changes in understanding.
Legislating medical practice is a bold step, and even those who feel it is occasionally warranted must hold themselves to a rational guiding principle. We have incontrovertible evidence that flexible sigmoidoscopy can reduce the number of deaths from colorectal cancer, but no state mandates that doctors inform their patients of this fact. A patient’s ejection fraction serves as a marker of benefit for several lifesaving drugs and devices, yet no state mandates that physicians disclose this information to patients after echocardiography.
All of us in health care—physicians, researchers, nurses, practitioners, and patients—are patient advocates, and we all want policies that promote human health. However, doing so means adhering to practices grounded in evidence. Dense-breast laws serve as a reminder that good intentions and good people may be necessary—but are not sufficient—for sound policy.
Recently, Nevada,1 North Carolina, and Oregon joined a number of other US states (as of this writing, nine other states) in enacting laws that require informing women if they have dense breast tissue detected on mammography.2 Laws are pending in other states. Federal legislation has also been introduced in the US House of Representatives.
THE POWER OF ADVOCACY TO CHANGE MEDICAL PRACTICE
One such bill3 was introduced as a result of the advocacy of a single patient, Nancy Cappello, a Connecticut woman who was not informed that she had dense breasts and was later found to have node-positive breast cancer.4
While new medical practices are rarely credited to the efforts of single physician or researcher, these “dense-breast laws” show the power a single patient may play in health care. The evidence behind these laws and their implications bring to the forefront the role of advocacy and legislation in the practice of medicine.
Dense-breast laws are the latest chapter in how legislative action can change the practice of medicine. Proof that advocacy could use law to change medical practice emerged in the early 1990s in the wake of AIDS activism. Patient-advocacy activists lobbied for early access to investigational agents, arguing that traditional pathways of clinical testing would deprive terminally ill patients of potentially lifesaving treatments. These efforts led the US Food and Drug Administration (FDA) to create the Accelerated Approval Program, which allows new drugs to garner approval based on surrogate end-point data for terminal or neglected diseases. Accelerated approval was codified into law in 1997 in the FDA’s Modernization Act.5 In 2012, legislative action further broadened the ability of the FDA to approve new products based on surrogate data,6 with the FDA’s Safety and Innovation Act, which provides for first-time approval of a drug based on “pharmacologic” end points that are even more limited.6
Although proponents have declared success when legislative action lowers the bar for drug and device approval, independent analyses have been more critical. In 2009, accelerated approval underwent significant scrutiny when the Government Accountability Office issued a report summarizing 16 years of the program.7 Over the program’s life span, the FDA called for 144 postmarketing studies, but more than one-third of these remained incomplete. Moreover, in 13 years, the FDA never exercised its power to expedite the withdrawal of a drug from the market.
Many accelerated approvals have created considerable controversy. Bevacizumab for metastatic breast cancer was ultimately found to confer no survival benefit, and its approval was revoked.8 Gemtuzumab ozogamicin for acute myeloid leukemia may be effective, but not at the dose that was approved.9 And midodrine hydrochloride and many other drugs remain untested.10
DOES THIS INFORMATION HELP PATIENTS? WHAT WOULD THEY DO WITH IT?
The question with dense-breast laws is similar to that facing other legal efforts to change medicine: Does it actually help patents? Will the information doctors disclose lead to appropriate interventions that improve health outcomes, or, instead, lead to cascades of testing and biopsies that worsen overdiagnosis?
Like accelerated approval, mandating disclosure of breast density is an intervention with uncertain efficacy. While increased breast density has been shown to increase a woman’s risk of developing breast cancer, it is also neutral regarding a woman’s chances of dying of breast cancer.11 In other words, it does not identify patients who experience aggressive disease.
Next comes the larger question of what women would do with this information. Will they simply be more compliant with existing screening recommendations, or will they seek additional testing? This is where the greatest uncertainty lies. The utility of additional testing with ultrasonography or magnetic resonance imaging (MRI) remains uncertain in this population. We will certainly find more cancers if we use MRI to screen women, but it remains unclear if this translates to improved outcomes.
A recent study shows just this.12 In Connecticut, breast density notification is mandatory, as is insurance coverage for screening (or whole-breast) ultrasonography. Since the passage of these laws, the Yale Medical Center has screened 935 women with dense breasts using ultrasonography. Over this time, they performed roughly 16,000 mammograms; thus, the breast density law applied roughly to 1 out of 16 (6.25%) studies. Of the 935 women, biopsies were performed in 54 (5.8%). These were mostly needle biopsies (46), but 3 patients underwent surgical excision, and five cysts were aspirated. From these efforts, two sub-centimeter cancers were found and one case of ductal carcinoma in situ was found. Thus, only 3.7% of women undergoing biopsy and fewer than 1% of women undergoing ultrasonography were found to have cancer.
Of course, given the nature of this study, we cannot know what would have happened without referral and testing. However, empirical research suggests that detecting a breast cancer with screening does not mean a life was saved.13 In fact, only a minority of such women (13%) can credit screening with a survival gain.13
In a study14 that compared women with dense breasts who underwent annual vs biannual screening, no difference in the rate of advanced or metastatic disease was seen with more frequent screening, but the rates of false-positive results and biopsies were higher.14
Notably, dense-breast legislation comes at a time when fundamental questions have been raised about the impact of screening on breast cancer. A prominent study of trends in US breast cancer incidence and death rates over the last 30 years shows that even under the most favorable assumptions, mammography has led to a huge surplus in the diagnosis of breast cancer but little change in the breast cancer mortality rate.15 It is entirely possible that more-aggressive screening in women with dense breasts will only exacerbate this problem. Advocacy may harm rather than help these patients.
We are often told that laws such as the dense-breast bills are motivated by the public’s desire and patient advocacy. However, we are unsure if the vocal proponents of dense-breast laws represent the average women’s desires. These efforts may simply be another case of how a vocal and passionate minority can overcome a large and indifferent majority.16
LEGISLATING MEDICAL PRACTICE IS A BOLD STEP
Dense-breast laws present an additional challenge: they cannot be changed as quickly as scientific understanding. In other words, if the medical field comes to believe that notification is generally harmful because it leads to increased biopsies but not better health, can the law be changed rapidly enough to reflect this? There is a large precedent for the reversal of medical practices,17,18 particularly those based on scant evidence, including cases of recommended screening tests (most notably, recent changes to prostate-specific antigen guidelines). But in all these other cases, law did not mandate the practice or recommendation. Laws are often slow to adapt to changes in understanding.
Legislating medical practice is a bold step, and even those who feel it is occasionally warranted must hold themselves to a rational guiding principle. We have incontrovertible evidence that flexible sigmoidoscopy can reduce the number of deaths from colorectal cancer, but no state mandates that doctors inform their patients of this fact. A patient’s ejection fraction serves as a marker of benefit for several lifesaving drugs and devices, yet no state mandates that physicians disclose this information to patients after echocardiography.
All of us in health care—physicians, researchers, nurses, practitioners, and patients—are patient advocates, and we all want policies that promote human health. However, doing so means adhering to practices grounded in evidence. Dense-breast laws serve as a reminder that good intentions and good people may be necessary—but are not sufficient—for sound policy.
- Nevada Legislature. Requires the notification of patients regarding breast density. (BDR 40-172). http://www.leg.state.nv.us/Session/77th2013/Reports/history.cfm?ID=371. Accessed November 7, 2013.
- ImagingBIZ Newswire. Nevada Governor Signs Breast Density Law June 10, 2013. http://www.imagingbiz.com/articles/news/nevada-governor-signs-breast-density-law. Accessed August 1, 2013.
- Are You Dense Advocacy. H.R.3102Latest 112th Congress. Breast Density and Mammography Reporting Act of 2011 http://www.congressweb.com/areyoudenseadvocacy/Bills/Detail/id/12734. Accessed November 7, 2013.
- The New York Times. New Laws Add a Divisive Component to Breast Screening. http://www.nytimes.com/2012/10/25/health/laws-tell-mammogram-clinics-to-address-breast-density.html?pagewanted=all. Accessed November 7, 2013.
- Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2:695–702.
- Kramer DB, Kesselheim AS. User fees and beyond—the FDA Safety and Innovation Act of 2012. N Engl J Med 2012; 367:1277–1279.
- US Government Accountability Office (GAO). New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints. GAO-09-866. http://www.gao.gov/products/GAO-09-866. Accessed November 7, 2013.
- Ocaña A, Amir E, Vera F, Eisenhauer EA, Tannock IF. Addition of bevacizumab to chemotherapy for treatment of solid tumors: similar results but different conclusions. J Clin Oncol 2011; 29:254–256.
- Rowe JM, Löwenberg B. Gemtuzumab ozogamicin in acute myeloid leukemia: a remarkable saga about an active drug. Blood 2013; 121:4838–4841.
- Dhruva SS, Redberg RF. Accelerated approval and possible withdrawal of midodrine. JAMA 2010; 304:2172–2173.
- Gierach GL, Ichikawa L, Kerlikowske K, et al. Relationship between mammographic density and breast cancer death in the Breast Cancer Surveillance Consortium. J Natl Cancer Inst 2012; 104:1218–1227.
- Hooley RJ, Greenberg KL, Stackhouse RM, Geisel JL, Butler RS, Philpotts LE. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012; 265:59–69.
- Welch HG, Frankel BA. Likelihood that a woman with screen-detected breast cancer has had her “life saved” by that screening. Arch Intern Med 2011; 171:2043–2046.
- Kerlikowske K, Zhu W, Hubbard RA, et al; Breast Cancer Surveillance Consortium. Outcomes of screening mammography by frequency, breast density, and postmenopausal hormone therapy. JAMA Intern Med 2013; 173:807–816.
- Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med 2012; 367:1998–2005.
- New York Review of Books. Facing the Real Gun Problem. http://www.nybooks.com/articles/archives/2013/jun/20/facing-real-gunproblem. Accessed November 7, 2013.
- Prasad V, Gall V, Cifu A. The frequency of medical reversal. Arch Intern Med 2011; 171:1675–1676.
- Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA 2012; 307:37–38.
- Nevada Legislature. Requires the notification of patients regarding breast density. (BDR 40-172). http://www.leg.state.nv.us/Session/77th2013/Reports/history.cfm?ID=371. Accessed November 7, 2013.
- ImagingBIZ Newswire. Nevada Governor Signs Breast Density Law June 10, 2013. http://www.imagingbiz.com/articles/news/nevada-governor-signs-breast-density-law. Accessed August 1, 2013.
- Are You Dense Advocacy. H.R.3102Latest 112th Congress. Breast Density and Mammography Reporting Act of 2011 http://www.congressweb.com/areyoudenseadvocacy/Bills/Detail/id/12734. Accessed November 7, 2013.
- The New York Times. New Laws Add a Divisive Component to Breast Screening. http://www.nytimes.com/2012/10/25/health/laws-tell-mammogram-clinics-to-address-breast-density.html?pagewanted=all. Accessed November 7, 2013.
- Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2:695–702.
- Kramer DB, Kesselheim AS. User fees and beyond—the FDA Safety and Innovation Act of 2012. N Engl J Med 2012; 367:1277–1279.
- US Government Accountability Office (GAO). New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints. GAO-09-866. http://www.gao.gov/products/GAO-09-866. Accessed November 7, 2013.
- Ocaña A, Amir E, Vera F, Eisenhauer EA, Tannock IF. Addition of bevacizumab to chemotherapy for treatment of solid tumors: similar results but different conclusions. J Clin Oncol 2011; 29:254–256.
- Rowe JM, Löwenberg B. Gemtuzumab ozogamicin in acute myeloid leukemia: a remarkable saga about an active drug. Blood 2013; 121:4838–4841.
- Dhruva SS, Redberg RF. Accelerated approval and possible withdrawal of midodrine. JAMA 2010; 304:2172–2173.
- Gierach GL, Ichikawa L, Kerlikowske K, et al. Relationship between mammographic density and breast cancer death in the Breast Cancer Surveillance Consortium. J Natl Cancer Inst 2012; 104:1218–1227.
- Hooley RJ, Greenberg KL, Stackhouse RM, Geisel JL, Butler RS, Philpotts LE. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012; 265:59–69.
- Welch HG, Frankel BA. Likelihood that a woman with screen-detected breast cancer has had her “life saved” by that screening. Arch Intern Med 2011; 171:2043–2046.
- Kerlikowske K, Zhu W, Hubbard RA, et al; Breast Cancer Surveillance Consortium. Outcomes of screening mammography by frequency, breast density, and postmenopausal hormone therapy. JAMA Intern Med 2013; 173:807–816.
- Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med 2012; 367:1998–2005.
- New York Review of Books. Facing the Real Gun Problem. http://www.nybooks.com/articles/archives/2013/jun/20/facing-real-gunproblem. Accessed November 7, 2013.
- Prasad V, Gall V, Cifu A. The frequency of medical reversal. Arch Intern Med 2011; 171:1675–1676.
- Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA 2012; 307:37–38.
Patient-Specific Imaging and Missed Tumors: A Catastrophic Outcome
Noninvasive coronary test accurate for lesion-specific ischemia
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
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Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
AT TCT 2013
Major finding: The per-patient AUC was 0.82 with the FFRCT test, significantly better than 0.63 with CT angiography.
Data source: A prospective, international study of FFRCT in 254 patients who underwent CT and invasive angiography at 10 centers.
Disclosures: HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
Surgeons' Perception of Fluoroscopic Radiation Hazards to Vision
Tibia-Based Referencing for Standard Proximal Tibial Radiographs During Intramedullary Nailing
Occipital headache and unstable gait
A 41-year-old-man with a history of hypertension presented to the ED with a sudden onset of severe occipital headache and unstable gait. On physical examination, right-sided ptosis and miosis (Horner’s syndrome) were noted. An emergent head computed tomography (CT) scan was performed and showed no evidence of hemorrhage or infraction. Magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography (MRA) of the head and neck were also ordered. Noncontrast MRA images of the neck are shown above (Figures 1 and 2).
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|
Figure 1 | Figure 2 |
What is the diagnosis?
What other imaging modalities may be useful for evaluation?
Dr Wladyka is an assistant professor of radiology at Weill Cornell Medical College in New York City and an assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center. Dr Hentel is an associate professor of clinical radiology at Weill Cornell Medical College in New York City. He is also chief of emergency/musculoskeletal imaging and the executive vice-chairman for the department of radiology at New York-Presbyterian Hospital/Weill Cornell Medical Center. He is associate editor, imaging, of the EMERGENCY MEDICINE editorial board.
Answer
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Figure 3 | Figure 4 |
The axial MRA image demonstrates flow in two separate lumens of the right vertebral artery (white arrow, Figure 3), indicating the presence of a dissection. A normal single lumen vertebral artery can be seen on the left (red arrow, Figure 3). This dissection is confirmed on the coronal MRA image (white arrows, Figure 4).
Vertebral artery dissection (VAD) is a common cause of stroke and, less commonly, of transient ischemic attack in patients aged 18 to 45 years. Patients typically present with headache, vertigo, dizziness, and neck pain.1 Additional neurologic signs that may be related to compromise of the posterior cerebral circulation include lateral medullary syndrome (eg, dysphagia, slurred speech, ataxia, facial pain, nystagmus, diplopia, dysphonia) and Horner’s syndrome (eg, ptosis, miosis, anhidrosis). In a small percentage of patients, VAD may present as intracranial subarachnoid hemorrhage.1
VAD can occur spontaneously or following high-energy trauma or minor trauma (eg, resulting from coughing, vomiting, cervical spine manipulation, or sports injury). Approximately 15% of patients have an underlying connective tissue disorder, such as fibromuscular dysplasia.2
The diagnosis of VAD can be made with MRI/MRA or with computed tomography angiography (CTA). A recent review of the literature shows no clear advantage to using either modality; therefore, the choice CTA or MRA should be based on urgency, availability of the imaging modality, and the preferences/expertise of the radiologists.3
|
|
Figure 5 | Figure 6 |
Advantages of CTA include its widespread availability, short examination time, and ability to evaluate for concurrent injuries in a trauma patient. With respect to MRA, in addition the lack of ionizing radiation, images may be performed without intravenous contrast and completed at the same time as MRI, which is useful in detecting alternative or concurrent intracranial abnormalities such as stroke, mass, or demyelination.
In this case, axial and coronal images from follow-up CTA illustrate its ability to depict the dissection of the right vertebral artery (white arrows, Figures 5 and 6). Typical treatment for VAD includes anticoagulation and antiplatelet therapy, though there have also been reports of successful treatment with endovascular stenting and endovascular thrombolysis.4 Since timely and proper treatment decreases the risk of stroke and long-term disabilities, emergent imaging with CTA or MRA should be performed in cases of suspected VAD.
- Gottesman RF, Sharma P, Robinson KA, et al. Clinical characteristics of symptomatic vertebral artery dissection: a systematic review. Neurologist. 2012;18(5):245-254.
- Rodallec MH, Marteau V, Gerber S, Desmottes L, Zins M. Craniocervical arterial dissection: spectrum of imaging findings and differential diagnosis. Radiographics. 2008;28(6):1711-1728.
- Provenzale JM, Sarikaya B. Comparison of test performance characteristics of MRI, MR angiography, and CT angiography in the diagnosis of carotid and vertebral artery dissection: a review of the medical literature. AJR Am J Roentgenol. 2009;193(4):1167-1174.
- Menon R, Kerry S, Norris JW, Markus HS. Treatment of cervical artery dissection: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2008;79(10):1122-1127.
A 41-year-old-man with a history of hypertension presented to the ED with a sudden onset of severe occipital headache and unstable gait. On physical examination, right-sided ptosis and miosis (Horner’s syndrome) were noted. An emergent head computed tomography (CT) scan was performed and showed no evidence of hemorrhage or infraction. Magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography (MRA) of the head and neck were also ordered. Noncontrast MRA images of the neck are shown above (Figures 1 and 2).
|
|
Figure 1 | Figure 2 |
What is the diagnosis?
What other imaging modalities may be useful for evaluation?
Dr Wladyka is an assistant professor of radiology at Weill Cornell Medical College in New York City and an assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center. Dr Hentel is an associate professor of clinical radiology at Weill Cornell Medical College in New York City. He is also chief of emergency/musculoskeletal imaging and the executive vice-chairman for the department of radiology at New York-Presbyterian Hospital/Weill Cornell Medical Center. He is associate editor, imaging, of the EMERGENCY MEDICINE editorial board.
Answer
|
|
Figure 3 | Figure 4 |
The axial MRA image demonstrates flow in two separate lumens of the right vertebral artery (white arrow, Figure 3), indicating the presence of a dissection. A normal single lumen vertebral artery can be seen on the left (red arrow, Figure 3). This dissection is confirmed on the coronal MRA image (white arrows, Figure 4).
Vertebral artery dissection (VAD) is a common cause of stroke and, less commonly, of transient ischemic attack in patients aged 18 to 45 years. Patients typically present with headache, vertigo, dizziness, and neck pain.1 Additional neurologic signs that may be related to compromise of the posterior cerebral circulation include lateral medullary syndrome (eg, dysphagia, slurred speech, ataxia, facial pain, nystagmus, diplopia, dysphonia) and Horner’s syndrome (eg, ptosis, miosis, anhidrosis). In a small percentage of patients, VAD may present as intracranial subarachnoid hemorrhage.1
VAD can occur spontaneously or following high-energy trauma or minor trauma (eg, resulting from coughing, vomiting, cervical spine manipulation, or sports injury). Approximately 15% of patients have an underlying connective tissue disorder, such as fibromuscular dysplasia.2
The diagnosis of VAD can be made with MRI/MRA or with computed tomography angiography (CTA). A recent review of the literature shows no clear advantage to using either modality; therefore, the choice CTA or MRA should be based on urgency, availability of the imaging modality, and the preferences/expertise of the radiologists.3
|
|
Figure 5 | Figure 6 |
Advantages of CTA include its widespread availability, short examination time, and ability to evaluate for concurrent injuries in a trauma patient. With respect to MRA, in addition the lack of ionizing radiation, images may be performed without intravenous contrast and completed at the same time as MRI, which is useful in detecting alternative or concurrent intracranial abnormalities such as stroke, mass, or demyelination.
In this case, axial and coronal images from follow-up CTA illustrate its ability to depict the dissection of the right vertebral artery (white arrows, Figures 5 and 6). Typical treatment for VAD includes anticoagulation and antiplatelet therapy, though there have also been reports of successful treatment with endovascular stenting and endovascular thrombolysis.4 Since timely and proper treatment decreases the risk of stroke and long-term disabilities, emergent imaging with CTA or MRA should be performed in cases of suspected VAD.
A 41-year-old-man with a history of hypertension presented to the ED with a sudden onset of severe occipital headache and unstable gait. On physical examination, right-sided ptosis and miosis (Horner’s syndrome) were noted. An emergent head computed tomography (CT) scan was performed and showed no evidence of hemorrhage or infraction. Magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography (MRA) of the head and neck were also ordered. Noncontrast MRA images of the neck are shown above (Figures 1 and 2).
|
|
Figure 1 | Figure 2 |
What is the diagnosis?
What other imaging modalities may be useful for evaluation?
Dr Wladyka is an assistant professor of radiology at Weill Cornell Medical College in New York City and an assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center. Dr Hentel is an associate professor of clinical radiology at Weill Cornell Medical College in New York City. He is also chief of emergency/musculoskeletal imaging and the executive vice-chairman for the department of radiology at New York-Presbyterian Hospital/Weill Cornell Medical Center. He is associate editor, imaging, of the EMERGENCY MEDICINE editorial board.
Answer
|
|
Figure 3 | Figure 4 |
The axial MRA image demonstrates flow in two separate lumens of the right vertebral artery (white arrow, Figure 3), indicating the presence of a dissection. A normal single lumen vertebral artery can be seen on the left (red arrow, Figure 3). This dissection is confirmed on the coronal MRA image (white arrows, Figure 4).
Vertebral artery dissection (VAD) is a common cause of stroke and, less commonly, of transient ischemic attack in patients aged 18 to 45 years. Patients typically present with headache, vertigo, dizziness, and neck pain.1 Additional neurologic signs that may be related to compromise of the posterior cerebral circulation include lateral medullary syndrome (eg, dysphagia, slurred speech, ataxia, facial pain, nystagmus, diplopia, dysphonia) and Horner’s syndrome (eg, ptosis, miosis, anhidrosis). In a small percentage of patients, VAD may present as intracranial subarachnoid hemorrhage.1
VAD can occur spontaneously or following high-energy trauma or minor trauma (eg, resulting from coughing, vomiting, cervical spine manipulation, or sports injury). Approximately 15% of patients have an underlying connective tissue disorder, such as fibromuscular dysplasia.2
The diagnosis of VAD can be made with MRI/MRA or with computed tomography angiography (CTA). A recent review of the literature shows no clear advantage to using either modality; therefore, the choice CTA or MRA should be based on urgency, availability of the imaging modality, and the preferences/expertise of the radiologists.3
|
|
Figure 5 | Figure 6 |
Advantages of CTA include its widespread availability, short examination time, and ability to evaluate for concurrent injuries in a trauma patient. With respect to MRA, in addition the lack of ionizing radiation, images may be performed without intravenous contrast and completed at the same time as MRI, which is useful in detecting alternative or concurrent intracranial abnormalities such as stroke, mass, or demyelination.
In this case, axial and coronal images from follow-up CTA illustrate its ability to depict the dissection of the right vertebral artery (white arrows, Figures 5 and 6). Typical treatment for VAD includes anticoagulation and antiplatelet therapy, though there have also been reports of successful treatment with endovascular stenting and endovascular thrombolysis.4 Since timely and proper treatment decreases the risk of stroke and long-term disabilities, emergent imaging with CTA or MRA should be performed in cases of suspected VAD.
- Gottesman RF, Sharma P, Robinson KA, et al. Clinical characteristics of symptomatic vertebral artery dissection: a systematic review. Neurologist. 2012;18(5):245-254.
- Rodallec MH, Marteau V, Gerber S, Desmottes L, Zins M. Craniocervical arterial dissection: spectrum of imaging findings and differential diagnosis. Radiographics. 2008;28(6):1711-1728.
- Provenzale JM, Sarikaya B. Comparison of test performance characteristics of MRI, MR angiography, and CT angiography in the diagnosis of carotid and vertebral artery dissection: a review of the medical literature. AJR Am J Roentgenol. 2009;193(4):1167-1174.
- Menon R, Kerry S, Norris JW, Markus HS. Treatment of cervical artery dissection: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2008;79(10):1122-1127.
- Gottesman RF, Sharma P, Robinson KA, et al. Clinical characteristics of symptomatic vertebral artery dissection: a systematic review. Neurologist. 2012;18(5):245-254.
- Rodallec MH, Marteau V, Gerber S, Desmottes L, Zins M. Craniocervical arterial dissection: spectrum of imaging findings and differential diagnosis. Radiographics. 2008;28(6):1711-1728.
- Provenzale JM, Sarikaya B. Comparison of test performance characteristics of MRI, MR angiography, and CT angiography in the diagnosis of carotid and vertebral artery dissection: a review of the medical literature. AJR Am J Roentgenol. 2009;193(4):1167-1174.
- Menon R, Kerry S, Norris JW, Markus HS. Treatment of cervical artery dissection: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2008;79(10):1122-1127.
Challenges in Sports Medicine and Orthopedics
After playing football, an 18-year-old man presented to the ED with severe pain in his right arm. He stated that while throwing a pass, he felt a "snap" in his right arm and has been unable to move the arm since the injury. Radiographs were completed.
What is your interpretation of the radiographic image (Figure 1)?
Dr Patterson, editor of "Challenges in Sports Medicine and Orthopedics," is a sports medicine physician at Florida Sports Injury in Clermont, Florida. Dr Patterson is board certified in family medicine and spinal cord injury medicine, and is a member of the faculty of sports and exercise medicine of the Royal College of Surgeons in Ireland.
The radiograph (Figure 2) revealed a minimally displaced pathologic fracture (red arrow) through the midshaft of the humerus, which resulted from a space-occupying lesion (green arrow) in the humeral diaphysis. Since the radial nerve is commonly affected in this type of injury due to its close proximity to the humeral midshaft, careful neurologic assessment at the wrist and hand is essential. Injury to the nerve can occur during the fracture or reduction of the fracture, causing weakness in the extensors of the hand and numbness in the first dorsal web space. The incidence of radial nerve palsy in midshaft fractures of the humerus is 16%.1
In nondisplaced or minimally displaced fractures of the humeral midshaft, conservative management with a U-shaped (sugar-tong) splint from axilla to shoulder with elasticized wrap and sling is recommended. Surgical management is indicated in comminuted, significantly displaced, nonreducible, pathologic cases or in fractures resulting in neurovascular compromise. The patient in this case was referred to an orthopedic surgeon for open treatment.
- Smith WR, Agudelo JF, Parekh AA, Shank, JR. Musculoskeletal trauma surgery. In: Skinner HB, ed. Current Diagnosis & Treatment in Orthopedics. 4th ed. McGraw Hill Companies, Inc; 2006:121.
After playing football, an 18-year-old man presented to the ED with severe pain in his right arm. He stated that while throwing a pass, he felt a "snap" in his right arm and has been unable to move the arm since the injury. Radiographs were completed.
What is your interpretation of the radiographic image (Figure 1)?
Dr Patterson, editor of "Challenges in Sports Medicine and Orthopedics," is a sports medicine physician at Florida Sports Injury in Clermont, Florida. Dr Patterson is board certified in family medicine and spinal cord injury medicine, and is a member of the faculty of sports and exercise medicine of the Royal College of Surgeons in Ireland.
The radiograph (Figure 2) revealed a minimally displaced pathologic fracture (red arrow) through the midshaft of the humerus, which resulted from a space-occupying lesion (green arrow) in the humeral diaphysis. Since the radial nerve is commonly affected in this type of injury due to its close proximity to the humeral midshaft, careful neurologic assessment at the wrist and hand is essential. Injury to the nerve can occur during the fracture or reduction of the fracture, causing weakness in the extensors of the hand and numbness in the first dorsal web space. The incidence of radial nerve palsy in midshaft fractures of the humerus is 16%.1
In nondisplaced or minimally displaced fractures of the humeral midshaft, conservative management with a U-shaped (sugar-tong) splint from axilla to shoulder with elasticized wrap and sling is recommended. Surgical management is indicated in comminuted, significantly displaced, nonreducible, pathologic cases or in fractures resulting in neurovascular compromise. The patient in this case was referred to an orthopedic surgeon for open treatment.
After playing football, an 18-year-old man presented to the ED with severe pain in his right arm. He stated that while throwing a pass, he felt a "snap" in his right arm and has been unable to move the arm since the injury. Radiographs were completed.
What is your interpretation of the radiographic image (Figure 1)?
Dr Patterson, editor of "Challenges in Sports Medicine and Orthopedics," is a sports medicine physician at Florida Sports Injury in Clermont, Florida. Dr Patterson is board certified in family medicine and spinal cord injury medicine, and is a member of the faculty of sports and exercise medicine of the Royal College of Surgeons in Ireland.
The radiograph (Figure 2) revealed a minimally displaced pathologic fracture (red arrow) through the midshaft of the humerus, which resulted from a space-occupying lesion (green arrow) in the humeral diaphysis. Since the radial nerve is commonly affected in this type of injury due to its close proximity to the humeral midshaft, careful neurologic assessment at the wrist and hand is essential. Injury to the nerve can occur during the fracture or reduction of the fracture, causing weakness in the extensors of the hand and numbness in the first dorsal web space. The incidence of radial nerve palsy in midshaft fractures of the humerus is 16%.1
In nondisplaced or minimally displaced fractures of the humeral midshaft, conservative management with a U-shaped (sugar-tong) splint from axilla to shoulder with elasticized wrap and sling is recommended. Surgical management is indicated in comminuted, significantly displaced, nonreducible, pathologic cases or in fractures resulting in neurovascular compromise. The patient in this case was referred to an orthopedic surgeon for open treatment.
- Smith WR, Agudelo JF, Parekh AA, Shank, JR. Musculoskeletal trauma surgery. In: Skinner HB, ed. Current Diagnosis & Treatment in Orthopedics. 4th ed. McGraw Hill Companies, Inc; 2006:121.
- Smith WR, Agudelo JF, Parekh AA, Shank, JR. Musculoskeletal trauma surgery. In: Skinner HB, ed. Current Diagnosis & Treatment in Orthopedics. 4th ed. McGraw Hill Companies, Inc; 2006:121.
Not all joint pain is arthritis
To the Editor: I was somewhat confused by the Clinical Picture case in the May 2013 issue.1 The caption for Figure 1 stated that the MRI showed erosions and marrow edema, which were “asymmetrical compared with the other wrist, a finding highly suggestive of rheumatoid arthritis.” However, rheumatoid arthritis is generally considered to be symmetrical.2 Was this a typographical error, or did I miss a crucial concept somewhere?
- Kochhar GS, Rizk M, Patil DT. Not all joint pain is arthritis. Cleve Clin J Med 2013; 80:272–273.
- Bukhari M, Lunt M, Harrison BJ, Scott DG, Symmons DP, Silman AJ. Erosions in inflammatory polyarthritis are symmetrical regardless of rheumatoid factor status: results from a primary care-based inception cohort of patients. Rheumatology 2002; 41:246–252.
To the Editor: I was somewhat confused by the Clinical Picture case in the May 2013 issue.1 The caption for Figure 1 stated that the MRI showed erosions and marrow edema, which were “asymmetrical compared with the other wrist, a finding highly suggestive of rheumatoid arthritis.” However, rheumatoid arthritis is generally considered to be symmetrical.2 Was this a typographical error, or did I miss a crucial concept somewhere?
To the Editor: I was somewhat confused by the Clinical Picture case in the May 2013 issue.1 The caption for Figure 1 stated that the MRI showed erosions and marrow edema, which were “asymmetrical compared with the other wrist, a finding highly suggestive of rheumatoid arthritis.” However, rheumatoid arthritis is generally considered to be symmetrical.2 Was this a typographical error, or did I miss a crucial concept somewhere?
- Kochhar GS, Rizk M, Patil DT. Not all joint pain is arthritis. Cleve Clin J Med 2013; 80:272–273.
- Bukhari M, Lunt M, Harrison BJ, Scott DG, Symmons DP, Silman AJ. Erosions in inflammatory polyarthritis are symmetrical regardless of rheumatoid factor status: results from a primary care-based inception cohort of patients. Rheumatology 2002; 41:246–252.
- Kochhar GS, Rizk M, Patil DT. Not all joint pain is arthritis. Cleve Clin J Med 2013; 80:272–273.
- Bukhari M, Lunt M, Harrison BJ, Scott DG, Symmons DP, Silman AJ. Erosions in inflammatory polyarthritis are symmetrical regardless of rheumatoid factor status: results from a primary care-based inception cohort of patients. Rheumatology 2002; 41:246–252.
In reply: Not all joint pain is arthritis
In Reply: We apologize for the confusion. We wanted to convey that, in that patient at that time, synovitis with erosions and edema indicating inflammation (greater on the right than on the left left) was suggestive of rheumatoid arthritis despite the asymmetry seen (findings greater in the right wrist than in the left). Given the patient’s clinical findings at that time and the above imaging findings, the initial diagnosis of rheumatoid arthritis was correct. But since the patient was not responding to therapy and since the abdominal pain was worsening, we probed further. Subsequently, the patient was diagnosed with Whipple disease. The fact that inflammatory arthritis can occur in other conditions that are not rheumatologic is a primary reason we found this case worth sharing.
In Reply: We apologize for the confusion. We wanted to convey that, in that patient at that time, synovitis with erosions and edema indicating inflammation (greater on the right than on the left left) was suggestive of rheumatoid arthritis despite the asymmetry seen (findings greater in the right wrist than in the left). Given the patient’s clinical findings at that time and the above imaging findings, the initial diagnosis of rheumatoid arthritis was correct. But since the patient was not responding to therapy and since the abdominal pain was worsening, we probed further. Subsequently, the patient was diagnosed with Whipple disease. The fact that inflammatory arthritis can occur in other conditions that are not rheumatologic is a primary reason we found this case worth sharing.
In Reply: We apologize for the confusion. We wanted to convey that, in that patient at that time, synovitis with erosions and edema indicating inflammation (greater on the right than on the left left) was suggestive of rheumatoid arthritis despite the asymmetry seen (findings greater in the right wrist than in the left). Given the patient’s clinical findings at that time and the above imaging findings, the initial diagnosis of rheumatoid arthritis was correct. But since the patient was not responding to therapy and since the abdominal pain was worsening, we probed further. Subsequently, the patient was diagnosed with Whipple disease. The fact that inflammatory arthritis can occur in other conditions that are not rheumatologic is a primary reason we found this case worth sharing.
Repeat CT selectively in children with traumatic brain injuries
SAN FRANCISCO – Repeat CT scans in children with mild traumatic brain injury were not justified when done routinely but may be warranted for epidural hematomas, according to a retrospective study of 120 patients.
A comparison of the 106 patients who underwent repeat CT scans and the 14 who did not found that the two groups did not differ significantly based on their Injury Severity Score (ISS), the mechanism of injury, or the type of brain injury. Neurologic symptoms did not worsen in patients who did not get a repeat CT scan, none of whom needed surgery, Dr. Jarett K. Howe and his associates reported.
Repeat CT scans showed injury progression in 7 patients (7%), including 2 with subarachnoid hemorrhage and 5 with epidural hematoma –a third of the 15 epidural hematomas in the study. Two patients with epidural hematoma required craniotomy, one of whom showed worsening of clinical symptoms. All 106 patients who had repeat CT scans were discharged without sequelae, said Dr. Howe of Cardinal Glennon Children’s Medical Center, St. Louis University.
The investigators analyzed records for 435 children admitted with traumatic brain injury (TBI) between July 2004 and July 2012 who had CT evidence of an intracranial hemorrhage and a Glasgow Coma Scale score of 14-15, 120 of whom had complete data and met no exclusion criteria.
Children who got a repeat CT scan were significantly older (8 years of age) than those who didn’t (3 years), Dr. Howe reported at the annual meeting of the American Association for the Surgery of Trauma. "This is particularly interesting since CT scan usage is often justified by the difficulty in examining a young child," he said.
The mean Injury Severity Score was similar between groups: 15 in those scanned and 13 in those not scanned.
Although the type of injury did not influence the likelihood of repeat CT, all 15 patients with epidural hematoma got a repeat CT scan (100%), he noted. Repeat CT scans also were ordered in 94% of patients with subdural hematoma, 71% with contusion, 88% with intraparenchymal hemorrhage, 77% with subarachnoid hemorrhage, and 67% with intraventricular hemorrhage.
The TBIs were caused primarily by falls or motor vehicle accidents but also by assaults, sports, or being hit by a car as a pedestrian.
Every year in the United States approximately 642,000 children are evaluated in emergency departments for TBI, 65,000 are admitted, and 7,400 die of TBI. As many as 70% of these children get imaged, with head CT, the diagnostic modality of choice, Dr. Howe said. A total of 4%-8% of children undergoing a CT will have a skull or intracranial abnormality, and less than 1% will have an injury requiring neurosurgical intervention.
Radiation from the CT scan, however, may cause a fatal cancer later on in 1 of every 1,200 children scanned, an extrapolation of historical data from Hiroshima, Japan suggests, he said.
"A majority of our children with minor physiologic insults can be managed without repeat imaging," he said. The investigators now are organizing a multi-institutional study to validate the findings.
A previous prospective study that evaluated 42,412 children with head injuries found that 90% had isolated head trauma and 97% had a Glasgow Coma Scale score of 15 upon arrival in emergency rooms. Still, 35% underwent head CT scans, which identified TBI in 5%, and 0.4% underwent surgery. No patients died (Lancet 2009;374:1160-70).
Previous studies in adults also suggest that repeat CT is not necessary for mild TBI because patients requiring intervention will show deterioration on physical exam, Dr. Howe added. Repeat CT showed injury progression in 21% of 179 adults in one study, only 7 of whom needed surgical intervention (J. Trauma 2006;60:494-9).
Dr. Howe reported having no financial disclosures.
On Twitter @sherryboschert
Intuitively, this makes sense, and it’s something we want to believe.
No patient in the selective CT group developed progression of neurologic symptoms or required delayed intervention. In contrast, 7% of children undergoing scheduled or routine CT demonstrated progression, and a majority had epidural hematoma. Two required operative intervention, both as a result of expanding epidural hematoma. From this, the authors conclude that routine or scheduled CT is not indicated in absence of progression or epidural hematoma.
As I understand it, the purpose for repeat CT is to detect progression and the need for intervention. A consistent observation in a review of the literature demonstrates a wide discrepancy in the reported rates of CT progression with or without neurologic progression. Can we safely observe all lesions other than subdural hematoma and obtain CT only if neurologic symptoms progress? If so, for how long do we observe these patients?
The study has a limited number of patients. An appropriately powered noninferiority study to show a new treatment, selective CT, is not worse than existing CT would require nearly 6,000 patients in each arm.
The study provides a description of the lesions noted on CT in the two groups by type, yet it is difficult to determine if the two groups were truly comparable, since there’s a great deal of variability between lesions. Further complicating the analysis is not only the type of lesion but the location of the lesion. Outcomes between supratentorial and posterior fossa lesions can be significantly different regardless of the volume of blood. The findings also could have been influenced by the volume of blood and the time from initial injury to evaluation and imaging.
Dr. Denis D. Bensard is chief of pediatric surgery and trauma at Denver Health Medical Center. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
Intuitively, this makes sense, and it’s something we want to believe.
No patient in the selective CT group developed progression of neurologic symptoms or required delayed intervention. In contrast, 7% of children undergoing scheduled or routine CT demonstrated progression, and a majority had epidural hematoma. Two required operative intervention, both as a result of expanding epidural hematoma. From this, the authors conclude that routine or scheduled CT is not indicated in absence of progression or epidural hematoma.
As I understand it, the purpose for repeat CT is to detect progression and the need for intervention. A consistent observation in a review of the literature demonstrates a wide discrepancy in the reported rates of CT progression with or without neurologic progression. Can we safely observe all lesions other than subdural hematoma and obtain CT only if neurologic symptoms progress? If so, for how long do we observe these patients?
The study has a limited number of patients. An appropriately powered noninferiority study to show a new treatment, selective CT, is not worse than existing CT would require nearly 6,000 patients in each arm.
The study provides a description of the lesions noted on CT in the two groups by type, yet it is difficult to determine if the two groups were truly comparable, since there’s a great deal of variability between lesions. Further complicating the analysis is not only the type of lesion but the location of the lesion. Outcomes between supratentorial and posterior fossa lesions can be significantly different regardless of the volume of blood. The findings also could have been influenced by the volume of blood and the time from initial injury to evaluation and imaging.
Dr. Denis D. Bensard is chief of pediatric surgery and trauma at Denver Health Medical Center. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
Intuitively, this makes sense, and it’s something we want to believe.
No patient in the selective CT group developed progression of neurologic symptoms or required delayed intervention. In contrast, 7% of children undergoing scheduled or routine CT demonstrated progression, and a majority had epidural hematoma. Two required operative intervention, both as a result of expanding epidural hematoma. From this, the authors conclude that routine or scheduled CT is not indicated in absence of progression or epidural hematoma.
As I understand it, the purpose for repeat CT is to detect progression and the need for intervention. A consistent observation in a review of the literature demonstrates a wide discrepancy in the reported rates of CT progression with or without neurologic progression. Can we safely observe all lesions other than subdural hematoma and obtain CT only if neurologic symptoms progress? If so, for how long do we observe these patients?
The study has a limited number of patients. An appropriately powered noninferiority study to show a new treatment, selective CT, is not worse than existing CT would require nearly 6,000 patients in each arm.
The study provides a description of the lesions noted on CT in the two groups by type, yet it is difficult to determine if the two groups were truly comparable, since there’s a great deal of variability between lesions. Further complicating the analysis is not only the type of lesion but the location of the lesion. Outcomes between supratentorial and posterior fossa lesions can be significantly different regardless of the volume of blood. The findings also could have been influenced by the volume of blood and the time from initial injury to evaluation and imaging.
Dr. Denis D. Bensard is chief of pediatric surgery and trauma at Denver Health Medical Center. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
SAN FRANCISCO – Repeat CT scans in children with mild traumatic brain injury were not justified when done routinely but may be warranted for epidural hematomas, according to a retrospective study of 120 patients.
A comparison of the 106 patients who underwent repeat CT scans and the 14 who did not found that the two groups did not differ significantly based on their Injury Severity Score (ISS), the mechanism of injury, or the type of brain injury. Neurologic symptoms did not worsen in patients who did not get a repeat CT scan, none of whom needed surgery, Dr. Jarett K. Howe and his associates reported.
Repeat CT scans showed injury progression in 7 patients (7%), including 2 with subarachnoid hemorrhage and 5 with epidural hematoma –a third of the 15 epidural hematomas in the study. Two patients with epidural hematoma required craniotomy, one of whom showed worsening of clinical symptoms. All 106 patients who had repeat CT scans were discharged without sequelae, said Dr. Howe of Cardinal Glennon Children’s Medical Center, St. Louis University.
The investigators analyzed records for 435 children admitted with traumatic brain injury (TBI) between July 2004 and July 2012 who had CT evidence of an intracranial hemorrhage and a Glasgow Coma Scale score of 14-15, 120 of whom had complete data and met no exclusion criteria.
Children who got a repeat CT scan were significantly older (8 years of age) than those who didn’t (3 years), Dr. Howe reported at the annual meeting of the American Association for the Surgery of Trauma. "This is particularly interesting since CT scan usage is often justified by the difficulty in examining a young child," he said.
The mean Injury Severity Score was similar between groups: 15 in those scanned and 13 in those not scanned.
Although the type of injury did not influence the likelihood of repeat CT, all 15 patients with epidural hematoma got a repeat CT scan (100%), he noted. Repeat CT scans also were ordered in 94% of patients with subdural hematoma, 71% with contusion, 88% with intraparenchymal hemorrhage, 77% with subarachnoid hemorrhage, and 67% with intraventricular hemorrhage.
The TBIs were caused primarily by falls or motor vehicle accidents but also by assaults, sports, or being hit by a car as a pedestrian.
Every year in the United States approximately 642,000 children are evaluated in emergency departments for TBI, 65,000 are admitted, and 7,400 die of TBI. As many as 70% of these children get imaged, with head CT, the diagnostic modality of choice, Dr. Howe said. A total of 4%-8% of children undergoing a CT will have a skull or intracranial abnormality, and less than 1% will have an injury requiring neurosurgical intervention.
Radiation from the CT scan, however, may cause a fatal cancer later on in 1 of every 1,200 children scanned, an extrapolation of historical data from Hiroshima, Japan suggests, he said.
"A majority of our children with minor physiologic insults can be managed without repeat imaging," he said. The investigators now are organizing a multi-institutional study to validate the findings.
A previous prospective study that evaluated 42,412 children with head injuries found that 90% had isolated head trauma and 97% had a Glasgow Coma Scale score of 15 upon arrival in emergency rooms. Still, 35% underwent head CT scans, which identified TBI in 5%, and 0.4% underwent surgery. No patients died (Lancet 2009;374:1160-70).
Previous studies in adults also suggest that repeat CT is not necessary for mild TBI because patients requiring intervention will show deterioration on physical exam, Dr. Howe added. Repeat CT showed injury progression in 21% of 179 adults in one study, only 7 of whom needed surgical intervention (J. Trauma 2006;60:494-9).
Dr. Howe reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Repeat CT scans in children with mild traumatic brain injury were not justified when done routinely but may be warranted for epidural hematomas, according to a retrospective study of 120 patients.
A comparison of the 106 patients who underwent repeat CT scans and the 14 who did not found that the two groups did not differ significantly based on their Injury Severity Score (ISS), the mechanism of injury, or the type of brain injury. Neurologic symptoms did not worsen in patients who did not get a repeat CT scan, none of whom needed surgery, Dr. Jarett K. Howe and his associates reported.
Repeat CT scans showed injury progression in 7 patients (7%), including 2 with subarachnoid hemorrhage and 5 with epidural hematoma –a third of the 15 epidural hematomas in the study. Two patients with epidural hematoma required craniotomy, one of whom showed worsening of clinical symptoms. All 106 patients who had repeat CT scans were discharged without sequelae, said Dr. Howe of Cardinal Glennon Children’s Medical Center, St. Louis University.
The investigators analyzed records for 435 children admitted with traumatic brain injury (TBI) between July 2004 and July 2012 who had CT evidence of an intracranial hemorrhage and a Glasgow Coma Scale score of 14-15, 120 of whom had complete data and met no exclusion criteria.
Children who got a repeat CT scan were significantly older (8 years of age) than those who didn’t (3 years), Dr. Howe reported at the annual meeting of the American Association for the Surgery of Trauma. "This is particularly interesting since CT scan usage is often justified by the difficulty in examining a young child," he said.
The mean Injury Severity Score was similar between groups: 15 in those scanned and 13 in those not scanned.
Although the type of injury did not influence the likelihood of repeat CT, all 15 patients with epidural hematoma got a repeat CT scan (100%), he noted. Repeat CT scans also were ordered in 94% of patients with subdural hematoma, 71% with contusion, 88% with intraparenchymal hemorrhage, 77% with subarachnoid hemorrhage, and 67% with intraventricular hemorrhage.
The TBIs were caused primarily by falls or motor vehicle accidents but also by assaults, sports, or being hit by a car as a pedestrian.
Every year in the United States approximately 642,000 children are evaluated in emergency departments for TBI, 65,000 are admitted, and 7,400 die of TBI. As many as 70% of these children get imaged, with head CT, the diagnostic modality of choice, Dr. Howe said. A total of 4%-8% of children undergoing a CT will have a skull or intracranial abnormality, and less than 1% will have an injury requiring neurosurgical intervention.
Radiation from the CT scan, however, may cause a fatal cancer later on in 1 of every 1,200 children scanned, an extrapolation of historical data from Hiroshima, Japan suggests, he said.
"A majority of our children with minor physiologic insults can be managed without repeat imaging," he said. The investigators now are organizing a multi-institutional study to validate the findings.
A previous prospective study that evaluated 42,412 children with head injuries found that 90% had isolated head trauma and 97% had a Glasgow Coma Scale score of 15 upon arrival in emergency rooms. Still, 35% underwent head CT scans, which identified TBI in 5%, and 0.4% underwent surgery. No patients died (Lancet 2009;374:1160-70).
Previous studies in adults also suggest that repeat CT is not necessary for mild TBI because patients requiring intervention will show deterioration on physical exam, Dr. Howe added. Repeat CT showed injury progression in 21% of 179 adults in one study, only 7 of whom needed surgical intervention (J. Trauma 2006;60:494-9).
Dr. Howe reported having no financial disclosures.
On Twitter @sherryboschert
AT THE AAST ANNUAL MEETING
Major finding: Two of 106 children with mild TBI who had repeat CT scans underwent craniotomy (2%), 1 of whom had worsening clinical symptoms.
Data source: Retrospective review of 120 children evaluated for mild TBI at one institution.
Disclosures: Dr. Howe reported having no financial disclosures.