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CME: Current Treatment Strategies for Advanced Prostate Cancer
Click here to read the supplement.
This activity is supported by an educational grant from Astellas and Medivation, Inc. a Pfizer company, Janssen Biotech, Inc., administered byJanssen Scientific Affairs, LLC. and Sanofi Genzyme.
In this CME supplement, you will learn to:
- Identify best practices for integrating currently available treatment options for advanced prostate cancer, including immunologic therapies, new secondary hormonal agents, chemotherapy, and radiopharmaceuticals
- Describe new management options for metastatic hormonesensitive prostate cancer (mHSPC)
- Outline considerations for current and emerging therapies in the management of patients with metastatic castration-resistant prostate cancer (mCSPC)
- Understand how the molecular and biochemical underpinnings of mCRPC can impact treatment course and selection
Click here to read the supplement.
After reading, take the posttest evaluation at https://www.surveymonkey.com/r/WMMYNHP
Click here to read the supplement.
This activity is supported by an educational grant from Astellas and Medivation, Inc. a Pfizer company, Janssen Biotech, Inc., administered byJanssen Scientific Affairs, LLC. and Sanofi Genzyme.
In this CME supplement, you will learn to:
- Identify best practices for integrating currently available treatment options for advanced prostate cancer, including immunologic therapies, new secondary hormonal agents, chemotherapy, and radiopharmaceuticals
- Describe new management options for metastatic hormonesensitive prostate cancer (mHSPC)
- Outline considerations for current and emerging therapies in the management of patients with metastatic castration-resistant prostate cancer (mCSPC)
- Understand how the molecular and biochemical underpinnings of mCRPC can impact treatment course and selection
Click here to read the supplement.
After reading, take the posttest evaluation at https://www.surveymonkey.com/r/WMMYNHP
Click here to read the supplement.
This activity is supported by an educational grant from Astellas and Medivation, Inc. a Pfizer company, Janssen Biotech, Inc., administered byJanssen Scientific Affairs, LLC. and Sanofi Genzyme.
In this CME supplement, you will learn to:
- Identify best practices for integrating currently available treatment options for advanced prostate cancer, including immunologic therapies, new secondary hormonal agents, chemotherapy, and radiopharmaceuticals
- Describe new management options for metastatic hormonesensitive prostate cancer (mHSPC)
- Outline considerations for current and emerging therapies in the management of patients with metastatic castration-resistant prostate cancer (mCSPC)
- Understand how the molecular and biochemical underpinnings of mCRPC can impact treatment course and selection
Click here to read the supplement.
After reading, take the posttest evaluation at https://www.surveymonkey.com/r/WMMYNHP
Acute kidney injury linked with doubled inpatient VTEs
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
[email protected]
On Twitter @mitchelzoler
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
[email protected]
On Twitter @mitchelzoler
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Inpatients with AKI had an adjusted 2.2-fold higher rate of VTE, compared with other inpatients.
Data source: Prospective, observational data from 6,552 inpatients at a single U.S. military hospital.
Disclosures: Dr. McMahon had no disclosures.
From the Editors: Advice to young hopefuls
Most mature surgeons and surgical educators have been asked by hopeful young medical students: “What can I do to improve my chances of becoming a surgeon?” We all want to give our aspiring students encouraging yet truthful answers. The following are typical questions we get from students, and we have tried to provide responses that are both helpful and realistic given the individual circumstances. Do young hopefuls query you about what it takes to become a surgeon? If so, we invite you to let us know what kinds of questions you get and how you respond. We all want “the best and the brightest” to join our profession, and we can help make that happen by offering sound advice to those who come to us asking “How can I become a surgeon?”
Dear Dr. Hughes,
I am a first-year medical student and want to become a surgeon! Everyone tells me I have to have at least two publications to even be considered for an interview. Is this true? What is the best area of research for me to pursue to assure a match in a surgery residency?
Unpublished in the Midwest
Dear Unpublished,
Like almost everything in life, the answer to your question is “It depends.” Surgery is a field that covers such a wide range of opportunities and training options that there is no “perfect” path to residency. More than anything at the M1 level, you need to keep your options open for any discipline. During the next 3 years, you’ll find out much about yourself and about the breadth of medicine. You need to understand who you are as a person before deciding on a specialty and especially before embarking on a research project. Research is a crucial part of surgery, but research just to have a publication for your resume is not a good enough reason to take this on during medical school.
The pursuit of knowledge through research is best undertaken because you have a passion for a particular subject. Most program directors will see right through “insincere” research – that is, research done to puff up a resume but lacking underlying value or relevance to your personal interests.
Tyler Hughes, MD, FACS
Dear Dr. Deveney,
I am in the middle of my third year of medical school. I have wanted to be a rural general surgeon ever since I shadowed the surgeon in my home town and saw the impact he made on the lives of his patients – and they made on his. Unfortunately, I do not do well on standardized tests and scored only 216 on USMLE Step 1. I did earn “Honors” in my surgery clerkship, but only a “Pass” in Medicine, with other clerkships still pending. What can I do to maximize my chances of a successful match in a surgical residency?
Discouraged in Denver
Dear Discouraged,
Since medical students are applying to a larger number of programs every year, surgical training programs receive far more applicants than they can interview. Most programs use USMLE Step 1 score as a convenient way to filter applicants and interview only students who have scored above an arbitrary threshold, such as 220, 230, or 240. We all know that USMLE Step 1 score does not correlate well with how good a surgeon you will be, but it does correlate with the likelihood of passing the American Board of Surgery Qualifying Exam on the first attempt. Programs are in part judged on their Board passage rate by both applicants and by accrediting agencies. Your score of 216 means that you will need to apply widely to programs across the country.
I urge you to join the American College of Surgeons as a student member and attend the 2018 Clinical Congress meeting. Attend its medical student program, and meet as many program directors as you can at the “Meet and Greet” receptions.
Programs in which you will thrive are ones that value a person who pitches in and helps the team get the daily work done. Surgery is a team sport! You need to be unfailingly pleasant and positive and be able to tie a knot and suture an incision smoothly. Chance favors the prepared mind and hands! Good luck!
Karen E. Deveney, MD, FACS
Most mature surgeons and surgical educators have been asked by hopeful young medical students: “What can I do to improve my chances of becoming a surgeon?” We all want to give our aspiring students encouraging yet truthful answers. The following are typical questions we get from students, and we have tried to provide responses that are both helpful and realistic given the individual circumstances. Do young hopefuls query you about what it takes to become a surgeon? If so, we invite you to let us know what kinds of questions you get and how you respond. We all want “the best and the brightest” to join our profession, and we can help make that happen by offering sound advice to those who come to us asking “How can I become a surgeon?”
Dear Dr. Hughes,
I am a first-year medical student and want to become a surgeon! Everyone tells me I have to have at least two publications to even be considered for an interview. Is this true? What is the best area of research for me to pursue to assure a match in a surgery residency?
Unpublished in the Midwest
Dear Unpublished,
Like almost everything in life, the answer to your question is “It depends.” Surgery is a field that covers such a wide range of opportunities and training options that there is no “perfect” path to residency. More than anything at the M1 level, you need to keep your options open for any discipline. During the next 3 years, you’ll find out much about yourself and about the breadth of medicine. You need to understand who you are as a person before deciding on a specialty and especially before embarking on a research project. Research is a crucial part of surgery, but research just to have a publication for your resume is not a good enough reason to take this on during medical school.
The pursuit of knowledge through research is best undertaken because you have a passion for a particular subject. Most program directors will see right through “insincere” research – that is, research done to puff up a resume but lacking underlying value or relevance to your personal interests.
Tyler Hughes, MD, FACS
Dear Dr. Deveney,
I am in the middle of my third year of medical school. I have wanted to be a rural general surgeon ever since I shadowed the surgeon in my home town and saw the impact he made on the lives of his patients – and they made on his. Unfortunately, I do not do well on standardized tests and scored only 216 on USMLE Step 1. I did earn “Honors” in my surgery clerkship, but only a “Pass” in Medicine, with other clerkships still pending. What can I do to maximize my chances of a successful match in a surgical residency?
Discouraged in Denver
Dear Discouraged,
Since medical students are applying to a larger number of programs every year, surgical training programs receive far more applicants than they can interview. Most programs use USMLE Step 1 score as a convenient way to filter applicants and interview only students who have scored above an arbitrary threshold, such as 220, 230, or 240. We all know that USMLE Step 1 score does not correlate well with how good a surgeon you will be, but it does correlate with the likelihood of passing the American Board of Surgery Qualifying Exam on the first attempt. Programs are in part judged on their Board passage rate by both applicants and by accrediting agencies. Your score of 216 means that you will need to apply widely to programs across the country.
I urge you to join the American College of Surgeons as a student member and attend the 2018 Clinical Congress meeting. Attend its medical student program, and meet as many program directors as you can at the “Meet and Greet” receptions.
Programs in which you will thrive are ones that value a person who pitches in and helps the team get the daily work done. Surgery is a team sport! You need to be unfailingly pleasant and positive and be able to tie a knot and suture an incision smoothly. Chance favors the prepared mind and hands! Good luck!
Karen E. Deveney, MD, FACS
Most mature surgeons and surgical educators have been asked by hopeful young medical students: “What can I do to improve my chances of becoming a surgeon?” We all want to give our aspiring students encouraging yet truthful answers. The following are typical questions we get from students, and we have tried to provide responses that are both helpful and realistic given the individual circumstances. Do young hopefuls query you about what it takes to become a surgeon? If so, we invite you to let us know what kinds of questions you get and how you respond. We all want “the best and the brightest” to join our profession, and we can help make that happen by offering sound advice to those who come to us asking “How can I become a surgeon?”
Dear Dr. Hughes,
I am a first-year medical student and want to become a surgeon! Everyone tells me I have to have at least two publications to even be considered for an interview. Is this true? What is the best area of research for me to pursue to assure a match in a surgery residency?
Unpublished in the Midwest
Dear Unpublished,
Like almost everything in life, the answer to your question is “It depends.” Surgery is a field that covers such a wide range of opportunities and training options that there is no “perfect” path to residency. More than anything at the M1 level, you need to keep your options open for any discipline. During the next 3 years, you’ll find out much about yourself and about the breadth of medicine. You need to understand who you are as a person before deciding on a specialty and especially before embarking on a research project. Research is a crucial part of surgery, but research just to have a publication for your resume is not a good enough reason to take this on during medical school.
The pursuit of knowledge through research is best undertaken because you have a passion for a particular subject. Most program directors will see right through “insincere” research – that is, research done to puff up a resume but lacking underlying value or relevance to your personal interests.
Tyler Hughes, MD, FACS
Dear Dr. Deveney,
I am in the middle of my third year of medical school. I have wanted to be a rural general surgeon ever since I shadowed the surgeon in my home town and saw the impact he made on the lives of his patients – and they made on his. Unfortunately, I do not do well on standardized tests and scored only 216 on USMLE Step 1. I did earn “Honors” in my surgery clerkship, but only a “Pass” in Medicine, with other clerkships still pending. What can I do to maximize my chances of a successful match in a surgical residency?
Discouraged in Denver
Dear Discouraged,
Since medical students are applying to a larger number of programs every year, surgical training programs receive far more applicants than they can interview. Most programs use USMLE Step 1 score as a convenient way to filter applicants and interview only students who have scored above an arbitrary threshold, such as 220, 230, or 240. We all know that USMLE Step 1 score does not correlate well with how good a surgeon you will be, but it does correlate with the likelihood of passing the American Board of Surgery Qualifying Exam on the first attempt. Programs are in part judged on their Board passage rate by both applicants and by accrediting agencies. Your score of 216 means that you will need to apply widely to programs across the country.
I urge you to join the American College of Surgeons as a student member and attend the 2018 Clinical Congress meeting. Attend its medical student program, and meet as many program directors as you can at the “Meet and Greet” receptions.
Programs in which you will thrive are ones that value a person who pitches in and helps the team get the daily work done. Surgery is a team sport! You need to be unfailingly pleasant and positive and be able to tie a knot and suture an incision smoothly. Chance favors the prepared mind and hands! Good luck!
Karen E. Deveney, MD, FACS
TNFi response evaluations may conflict when fibromyalgia, axial SpA coexist
The concomitant presence of both axial spondyloarthritis (axSpA) and fibromyalgia affects response to tumor necrosis factor (TNF) blockers through increased symptom severity on patient-reported outcomes but not on more objective measurements, according to findings from a prospective, longitudinal study.
Although reports have less frequently examined the relationship between fibromyalgia diagnosis and disease activity in patients who have rheumatologist-diagnosed axSpA than they have in patients with rheumatoid arthritis, those reports have indicated that patients with axSpA and concomitant fibromyalgia tend to present with higher disease activity on measures such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the investigators wrote in Annals of the Rheumatic Diseases.
In this prospective, longitudinal study, a total of 508 adult patients with axSpA from 65 centers first attended a baseline visit, then 12 weeks after commencing treatment with TNF blockers, they attended an “effectiveness visit” in which they were evaluated for a response on the BASDAI. This response was defined as a reduction of at least 50% or two units, compared with baseline measurements. Furthermore, a total of 37.8% tested positive at baseline on the self-reported Fibromyalgia Rapid Screening Tool (FiRST) questionnaire, defined as a score of 5 or 6 out of 6.
These patients testing positive on FiRST at baseline were more likely to be female (55.7% vs. 41.1%), to have a history of peripheral enthesitis (64.7% vs. 47.8%), and to have a higher disease severity at baseline on the BASDAI and Ankylosing Spondylitis Disease Activity Score at baseline (6.5 vs. 5.1 and 3.5 vs. 3.2, respectively). They were also were more likely to be taking antidepressants (26.8% vs. 16.2%).
Patients who had fibromyalgia according to FiRST presented less frequently with a BASDAI response (87 of 192; 45.3%) after 12 weeks, compared with patients who had only axSpA at baseline (171 of 316; 54.1%). But this difference did not reach statistical significance in both univariate or multivariate analyses. However, nearly all of the secondary endpoints of response, such as various levels of response on the Assessment of SpondyloArthritis international Society criteria and the Ankylosing Spondylitis Disease Activity Score, were achieved significantly less often among patients who also had fibromyalgia.
Although BASDAI response was not different between the groups, the investigators said that fibromyalgia had a negative effect on TNF blocker response that “seems related to the instruments used in its evaluation rather than a different treatment effect of the molecule.”
Sensitivity analyses that used the 1990 American College of Rheumatology criteria to define the presence of fibromyalgia rather than the FiRST questionnaire result at baseline did not find any differences in TNF blocker responses between the groups on the main endpoint and most of the secondary endpoints. The ACR criteria classified fibromyalgia in 16.1% of the patients.
Another set of sensitivity analyses that used only the FiRST results at 12 weeks to diagnose fibromyalgia found that fibromyalgia patients had lower responses to treatment on nearly all endpoints. Only 18.7% of patients tested positive on the FiRST questionnaire at 12 weeks.
The change in C-reactive protein (CRP) levels at 12 weeks was not different between the groups of patients regardless of the definition used for fibromyalgia.
The researchers observed a decreased frequency of HLA-B27 positivity, radiographic sacroiliitis, and MRI sacroiliitis in people with both diseases. The authors called this finding “intriguing” and said it “might suggest that some patients participating in the trial might have been misdiagnosed and were in fact suffering from [fibromyalgia] only.”
But other clinical features suggestive of axSpA, such as uveitis, psoriasis, and inflammatory bowel disease, were equally present across the different groups.
Overall, “these results suggest that there is indeed an impact on the treatment response, but seems more related to the patient-reported outcomes used in the effectiveness endpoints, as suggested by the absence of difference across groups for the objective biological parameters (i.e., CRP).”
Dr. Moltó and her colleagues said their findings highlighted the importance not only of evaluating the presence of coexisting fibromyalgia in patients with axSpA when evaluating treatment response but also in determining treatment targets.
“This seems particularly important for decision of the treatment target in patients with axSpA when applying a treat-to-target strategy: For example, remission might not be a feasible target for these patients [with concomitant fibromyalgia] who will not likely reach this state, but should rather aim for a significant change or focus in only on objective parameters (i.e., CRP),” they concluded.
The study was funded by an unrestricted grant from Merck Sharp & Dohme. The authors declared having no competing interests.
SOURCE: Moltó A et al. Ann Rheum Dis. 2017 Nov 28. doi: 10.1136/annrheumdis-2017-212378.
The concomitant presence of both axial spondyloarthritis (axSpA) and fibromyalgia affects response to tumor necrosis factor (TNF) blockers through increased symptom severity on patient-reported outcomes but not on more objective measurements, according to findings from a prospective, longitudinal study.
Although reports have less frequently examined the relationship between fibromyalgia diagnosis and disease activity in patients who have rheumatologist-diagnosed axSpA than they have in patients with rheumatoid arthritis, those reports have indicated that patients with axSpA and concomitant fibromyalgia tend to present with higher disease activity on measures such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the investigators wrote in Annals of the Rheumatic Diseases.
In this prospective, longitudinal study, a total of 508 adult patients with axSpA from 65 centers first attended a baseline visit, then 12 weeks after commencing treatment with TNF blockers, they attended an “effectiveness visit” in which they were evaluated for a response on the BASDAI. This response was defined as a reduction of at least 50% or two units, compared with baseline measurements. Furthermore, a total of 37.8% tested positive at baseline on the self-reported Fibromyalgia Rapid Screening Tool (FiRST) questionnaire, defined as a score of 5 or 6 out of 6.
These patients testing positive on FiRST at baseline were more likely to be female (55.7% vs. 41.1%), to have a history of peripheral enthesitis (64.7% vs. 47.8%), and to have a higher disease severity at baseline on the BASDAI and Ankylosing Spondylitis Disease Activity Score at baseline (6.5 vs. 5.1 and 3.5 vs. 3.2, respectively). They were also were more likely to be taking antidepressants (26.8% vs. 16.2%).
Patients who had fibromyalgia according to FiRST presented less frequently with a BASDAI response (87 of 192; 45.3%) after 12 weeks, compared with patients who had only axSpA at baseline (171 of 316; 54.1%). But this difference did not reach statistical significance in both univariate or multivariate analyses. However, nearly all of the secondary endpoints of response, such as various levels of response on the Assessment of SpondyloArthritis international Society criteria and the Ankylosing Spondylitis Disease Activity Score, were achieved significantly less often among patients who also had fibromyalgia.
Although BASDAI response was not different between the groups, the investigators said that fibromyalgia had a negative effect on TNF blocker response that “seems related to the instruments used in its evaluation rather than a different treatment effect of the molecule.”
Sensitivity analyses that used the 1990 American College of Rheumatology criteria to define the presence of fibromyalgia rather than the FiRST questionnaire result at baseline did not find any differences in TNF blocker responses between the groups on the main endpoint and most of the secondary endpoints. The ACR criteria classified fibromyalgia in 16.1% of the patients.
Another set of sensitivity analyses that used only the FiRST results at 12 weeks to diagnose fibromyalgia found that fibromyalgia patients had lower responses to treatment on nearly all endpoints. Only 18.7% of patients tested positive on the FiRST questionnaire at 12 weeks.
The change in C-reactive protein (CRP) levels at 12 weeks was not different between the groups of patients regardless of the definition used for fibromyalgia.
The researchers observed a decreased frequency of HLA-B27 positivity, radiographic sacroiliitis, and MRI sacroiliitis in people with both diseases. The authors called this finding “intriguing” and said it “might suggest that some patients participating in the trial might have been misdiagnosed and were in fact suffering from [fibromyalgia] only.”
But other clinical features suggestive of axSpA, such as uveitis, psoriasis, and inflammatory bowel disease, were equally present across the different groups.
Overall, “these results suggest that there is indeed an impact on the treatment response, but seems more related to the patient-reported outcomes used in the effectiveness endpoints, as suggested by the absence of difference across groups for the objective biological parameters (i.e., CRP).”
Dr. Moltó and her colleagues said their findings highlighted the importance not only of evaluating the presence of coexisting fibromyalgia in patients with axSpA when evaluating treatment response but also in determining treatment targets.
“This seems particularly important for decision of the treatment target in patients with axSpA when applying a treat-to-target strategy: For example, remission might not be a feasible target for these patients [with concomitant fibromyalgia] who will not likely reach this state, but should rather aim for a significant change or focus in only on objective parameters (i.e., CRP),” they concluded.
The study was funded by an unrestricted grant from Merck Sharp & Dohme. The authors declared having no competing interests.
SOURCE: Moltó A et al. Ann Rheum Dis. 2017 Nov 28. doi: 10.1136/annrheumdis-2017-212378.
The concomitant presence of both axial spondyloarthritis (axSpA) and fibromyalgia affects response to tumor necrosis factor (TNF) blockers through increased symptom severity on patient-reported outcomes but not on more objective measurements, according to findings from a prospective, longitudinal study.
Although reports have less frequently examined the relationship between fibromyalgia diagnosis and disease activity in patients who have rheumatologist-diagnosed axSpA than they have in patients with rheumatoid arthritis, those reports have indicated that patients with axSpA and concomitant fibromyalgia tend to present with higher disease activity on measures such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the investigators wrote in Annals of the Rheumatic Diseases.
In this prospective, longitudinal study, a total of 508 adult patients with axSpA from 65 centers first attended a baseline visit, then 12 weeks after commencing treatment with TNF blockers, they attended an “effectiveness visit” in which they were evaluated for a response on the BASDAI. This response was defined as a reduction of at least 50% or two units, compared with baseline measurements. Furthermore, a total of 37.8% tested positive at baseline on the self-reported Fibromyalgia Rapid Screening Tool (FiRST) questionnaire, defined as a score of 5 or 6 out of 6.
These patients testing positive on FiRST at baseline were more likely to be female (55.7% vs. 41.1%), to have a history of peripheral enthesitis (64.7% vs. 47.8%), and to have a higher disease severity at baseline on the BASDAI and Ankylosing Spondylitis Disease Activity Score at baseline (6.5 vs. 5.1 and 3.5 vs. 3.2, respectively). They were also were more likely to be taking antidepressants (26.8% vs. 16.2%).
Patients who had fibromyalgia according to FiRST presented less frequently with a BASDAI response (87 of 192; 45.3%) after 12 weeks, compared with patients who had only axSpA at baseline (171 of 316; 54.1%). But this difference did not reach statistical significance in both univariate or multivariate analyses. However, nearly all of the secondary endpoints of response, such as various levels of response on the Assessment of SpondyloArthritis international Society criteria and the Ankylosing Spondylitis Disease Activity Score, were achieved significantly less often among patients who also had fibromyalgia.
Although BASDAI response was not different between the groups, the investigators said that fibromyalgia had a negative effect on TNF blocker response that “seems related to the instruments used in its evaluation rather than a different treatment effect of the molecule.”
Sensitivity analyses that used the 1990 American College of Rheumatology criteria to define the presence of fibromyalgia rather than the FiRST questionnaire result at baseline did not find any differences in TNF blocker responses between the groups on the main endpoint and most of the secondary endpoints. The ACR criteria classified fibromyalgia in 16.1% of the patients.
Another set of sensitivity analyses that used only the FiRST results at 12 weeks to diagnose fibromyalgia found that fibromyalgia patients had lower responses to treatment on nearly all endpoints. Only 18.7% of patients tested positive on the FiRST questionnaire at 12 weeks.
The change in C-reactive protein (CRP) levels at 12 weeks was not different between the groups of patients regardless of the definition used for fibromyalgia.
The researchers observed a decreased frequency of HLA-B27 positivity, radiographic sacroiliitis, and MRI sacroiliitis in people with both diseases. The authors called this finding “intriguing” and said it “might suggest that some patients participating in the trial might have been misdiagnosed and were in fact suffering from [fibromyalgia] only.”
But other clinical features suggestive of axSpA, such as uveitis, psoriasis, and inflammatory bowel disease, were equally present across the different groups.
Overall, “these results suggest that there is indeed an impact on the treatment response, but seems more related to the patient-reported outcomes used in the effectiveness endpoints, as suggested by the absence of difference across groups for the objective biological parameters (i.e., CRP).”
Dr. Moltó and her colleagues said their findings highlighted the importance not only of evaluating the presence of coexisting fibromyalgia in patients with axSpA when evaluating treatment response but also in determining treatment targets.
“This seems particularly important for decision of the treatment target in patients with axSpA when applying a treat-to-target strategy: For example, remission might not be a feasible target for these patients [with concomitant fibromyalgia] who will not likely reach this state, but should rather aim for a significant change or focus in only on objective parameters (i.e., CRP),” they concluded.
The study was funded by an unrestricted grant from Merck Sharp & Dohme. The authors declared having no competing interests.
SOURCE: Moltó A et al. Ann Rheum Dis. 2017 Nov 28. doi: 10.1136/annrheumdis-2017-212378.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: Patients with both axSpA and fibromyalgia presented less frequently with a BASDAI response after 12 weeks than did patients without both diseases (45.3% vs. 54.1%), but the finding did not reach statistical significance.
Data source: Prospective, longitudinal study of 508 adult patients with rheumatologist-diagnosed axSpA.
Disclosures: The study was funded by an unrestricted grant from Merck Sharp & Dohme. The authors declared having no competing interests.
Source: Moltó A et al. Ann Rheum Dis. 2017 Nov 28. doi: 10.1136/annrheumdis-2017-212378.
VIDEO: 5 years of additional AI no better than 2 in HR+ breast cancer
SAN ANTONIO – Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.
In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.
In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.
The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.
In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.
In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.
The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Clinical trials have shown a clear benefit for preventing breast cancer recurrence with aromatase inhibitor (AI) therapy following 5 years of tamoxifen. Yet the optimal duration for additional AI therapy following 5 years of endocrine therapy with tamoxifen, an AI, or sequential therapies is not known, according to Michael Gnant, MD, from the Medical University of Vienna.
In the ABCSG-16 trial, Dr. Gnant and his colleagues reported that 5 years of additional therapy with anastrozole (Arimidex) was no more effective than 2 additional years following the standard 5 years of initial endocrine therapy in postmenopausal women with hormone receptor–positive (HR+) breast cancer.
In this video interview at the San Antonio Breast Cancer Symposium, Dr. Gnant notes that, although some patients may still benefit from 5 years of additional therapy, the trial results suggest that most patients can be spared from such adverse events as risk for fractures associated with three additional and evidently unnecessary years of therapy.
The ABCSG-16 study was supported by AstraZeneca. Dr. Gnant disclosed research funding, honoraria, and travel funding from the company and others.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
Expanded hospital testing improves respiratory pathogen detection
SAN DIEGO – Systematic testing of acute respiratory illness patients can increase the likelihood of finding relevant pathogens, according to a study presented at an annual scientific meeting on infectious diseases.
Currently, hospitals conduct either nonroutine assessments or rely heavily on clinical laboratory testing among severe acute respiratory illness patients, which can lead to missing clinically key viruses.
Systematic testing expands on tests ordered and carried out at hospitals, expanding on them by testing for influenza, respiratory syncytial virus (RSV), human metapneumovirus, rhinovirus and enterovirus, adenovirus, coronavirus, and parainfluenza viruses 1-4. To test the efficacy of systematic testing, investigators studied 2,216 severe acute respiratory illness patients hospitalized in one of three hospitals in Minnesota during September 2015-August 2016. Patients were predominantly younger than 5 years old (57%) and had one or more chronic medical condition (63%).
Detection of at least one virus increased from 1,062 patients (48%) to 1,600 patients (72%) when comparing clinically ordered tests against expanded, systematic RT-PCR testing conducted through the Minnesota Health Department (MDH).
By patient age, viral detection increased by 27%, 24%, 18%, and 21% for patients aged younger than 5 years, 5-17 years, 18-64 years, and 65 years and older, respectively. Except for influenza viruses and RSV, the proportions of viruses identified, regardless of age, were all lower in hospital testing, compared with MDH testing.
“RSV targeting was almost systematic among children less than 5 years, but [accounted for] only 28% of RSV detection,” said Dr. Steffen in her presentation. “A smaller proportion of other respiratory viruses, including the human metapneumovirus, were detected at the hospital, and this was especially true for adults.”
Patients with rhinovirus and enterovirus saw a difference between hospital and expanded testing, increasing from a little over 300 patients detected, to nearly 800 patients.
“Patients admitted to the ICU were less likely to have a pathogen detection than those not admitted to the ICU, and those with one or more chronic medical condition had lower viral detection than those without,” Dr. Steffens said. “While testing at MDH did increase the percent of patients in each category, trends remained consistent and significant.”
Since testing information was only collected for patients with positive test results at the hospital, investigators were not able to compare testing practices between patients with and without viruses. This study may also have underrepresented pathogens detected through means other than the hospital laboratory, like rapid tests in emergency departments. The study was also limited by the short time frame of only 1 year.
The presenters reported no relevant financial disclosures.
SOURCE: Steffens A et al. Abstract 885.
SAN DIEGO – Systematic testing of acute respiratory illness patients can increase the likelihood of finding relevant pathogens, according to a study presented at an annual scientific meeting on infectious diseases.
Currently, hospitals conduct either nonroutine assessments or rely heavily on clinical laboratory testing among severe acute respiratory illness patients, which can lead to missing clinically key viruses.
Systematic testing expands on tests ordered and carried out at hospitals, expanding on them by testing for influenza, respiratory syncytial virus (RSV), human metapneumovirus, rhinovirus and enterovirus, adenovirus, coronavirus, and parainfluenza viruses 1-4. To test the efficacy of systematic testing, investigators studied 2,216 severe acute respiratory illness patients hospitalized in one of three hospitals in Minnesota during September 2015-August 2016. Patients were predominantly younger than 5 years old (57%) and had one or more chronic medical condition (63%).
Detection of at least one virus increased from 1,062 patients (48%) to 1,600 patients (72%) when comparing clinically ordered tests against expanded, systematic RT-PCR testing conducted through the Minnesota Health Department (MDH).
By patient age, viral detection increased by 27%, 24%, 18%, and 21% for patients aged younger than 5 years, 5-17 years, 18-64 years, and 65 years and older, respectively. Except for influenza viruses and RSV, the proportions of viruses identified, regardless of age, were all lower in hospital testing, compared with MDH testing.
“RSV targeting was almost systematic among children less than 5 years, but [accounted for] only 28% of RSV detection,” said Dr. Steffen in her presentation. “A smaller proportion of other respiratory viruses, including the human metapneumovirus, were detected at the hospital, and this was especially true for adults.”
Patients with rhinovirus and enterovirus saw a difference between hospital and expanded testing, increasing from a little over 300 patients detected, to nearly 800 patients.
“Patients admitted to the ICU were less likely to have a pathogen detection than those not admitted to the ICU, and those with one or more chronic medical condition had lower viral detection than those without,” Dr. Steffens said. “While testing at MDH did increase the percent of patients in each category, trends remained consistent and significant.”
Since testing information was only collected for patients with positive test results at the hospital, investigators were not able to compare testing practices between patients with and without viruses. This study may also have underrepresented pathogens detected through means other than the hospital laboratory, like rapid tests in emergency departments. The study was also limited by the short time frame of only 1 year.
The presenters reported no relevant financial disclosures.
SOURCE: Steffens A et al. Abstract 885.
SAN DIEGO – Systematic testing of acute respiratory illness patients can increase the likelihood of finding relevant pathogens, according to a study presented at an annual scientific meeting on infectious diseases.
Currently, hospitals conduct either nonroutine assessments or rely heavily on clinical laboratory testing among severe acute respiratory illness patients, which can lead to missing clinically key viruses.
Systematic testing expands on tests ordered and carried out at hospitals, expanding on them by testing for influenza, respiratory syncytial virus (RSV), human metapneumovirus, rhinovirus and enterovirus, adenovirus, coronavirus, and parainfluenza viruses 1-4. To test the efficacy of systematic testing, investigators studied 2,216 severe acute respiratory illness patients hospitalized in one of three hospitals in Minnesota during September 2015-August 2016. Patients were predominantly younger than 5 years old (57%) and had one or more chronic medical condition (63%).
Detection of at least one virus increased from 1,062 patients (48%) to 1,600 patients (72%) when comparing clinically ordered tests against expanded, systematic RT-PCR testing conducted through the Minnesota Health Department (MDH).
By patient age, viral detection increased by 27%, 24%, 18%, and 21% for patients aged younger than 5 years, 5-17 years, 18-64 years, and 65 years and older, respectively. Except for influenza viruses and RSV, the proportions of viruses identified, regardless of age, were all lower in hospital testing, compared with MDH testing.
“RSV targeting was almost systematic among children less than 5 years, but [accounted for] only 28% of RSV detection,” said Dr. Steffen in her presentation. “A smaller proportion of other respiratory viruses, including the human metapneumovirus, were detected at the hospital, and this was especially true for adults.”
Patients with rhinovirus and enterovirus saw a difference between hospital and expanded testing, increasing from a little over 300 patients detected, to nearly 800 patients.
“Patients admitted to the ICU were less likely to have a pathogen detection than those not admitted to the ICU, and those with one or more chronic medical condition had lower viral detection than those without,” Dr. Steffens said. “While testing at MDH did increase the percent of patients in each category, trends remained consistent and significant.”
Since testing information was only collected for patients with positive test results at the hospital, investigators were not able to compare testing practices between patients with and without viruses. This study may also have underrepresented pathogens detected through means other than the hospital laboratory, like rapid tests in emergency departments. The study was also limited by the short time frame of only 1 year.
The presenters reported no relevant financial disclosures.
SOURCE: Steffens A et al. Abstract 885.
REPORTING FROM ID WEEK 2017
Key clinical point:
Major finding: Among 2,216 patients studied, 1,600 (72%) were found to have at least one respiratory virus through expanded testing, compared with 1,062 (48%) patients tested through clincian-directed testing.
Study details: 2,351 severe acute respiratory illness patients hospitalized in one of three hospitals in Minnesota.
Disclosures: The presenter reported no relevant financial disclosures.
Source: Steffens A et al. Abstract 885.
Does Treating Sleep Apnea Improve Seizure Outcomes?
WASHINGTON, DC—Treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) is associated with better one-year seizure outcomes in patients with epilepsy, according to a study presented at the 71st Annual Meeting of the American Epilepsy Society.
Prior research has suggested that sleep disturbances are more common in people with epilepsy than in age-matched controls and that more than 40% of people with epilepsy have OSA. PAP therapy has been associated with seizure reduction in small case series.
To compare long-term seizure control between patients with PAP-treated OSA, patients with untreated OSA, and patients without OSA, Thapanee Somboon, MD, a research fellow at the Sleep Disorders Center at Cleveland Clinic, and colleagues conducted a retrospective study of adults with epilepsy who underwent polysomnography at Cleveland Clinic between 1997 and 2015. Researchers compared patients’ seizure outcomes at one, three, and five years after polysomnography. 
The study included 197 people with epilepsy, 122 of whom had OSA (ie, an apnea–hypopnea index of 5 or greater). Of the patients with OSA, 73 received PAP therapy. Mean age was about 44, 58% were female, and 70% had focal epilepsy. Patients with OSA were more likely to be older, have a higher BMI, and be male than those without OSA.
At one year, 63% of patients treated with PAP had a 50% or greater reduction in seizures from baseline, compared with 14% of patients with OSA who were not treated and 44% of patients who did not have OSA. Researchers also assessed successful seizure outcomes, which were defined as not having seizures at baseline and remaining seizure-free for a year, or having seizures at baseline but reporting a 50% or greater reduction in seizures over one year. Successful outcomes occurred in 85% of patients who were treated with PAP, 55% of patients with OSA who were untreated, and 65% of patients who did not have OSA.
After adjusting for baseline seizure freedom and antiepileptic drug standardized dose, patients with treated OSA remained more likely to have successful outcomes at one year. Comparisons at three and five years included fewer patients, and the differences at those time points were not statistically significant.
—Jake Remaly
WASHINGTON, DC—Treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) is associated with better one-year seizure outcomes in patients with epilepsy, according to a study presented at the 71st Annual Meeting of the American Epilepsy Society.
Prior research has suggested that sleep disturbances are more common in people with epilepsy than in age-matched controls and that more than 40% of people with epilepsy have OSA. PAP therapy has been associated with seizure reduction in small case series.
To compare long-term seizure control between patients with PAP-treated OSA, patients with untreated OSA, and patients without OSA, Thapanee Somboon, MD, a research fellow at the Sleep Disorders Center at Cleveland Clinic, and colleagues conducted a retrospective study of adults with epilepsy who underwent polysomnography at Cleveland Clinic between 1997 and 2015. Researchers compared patients’ seizure outcomes at one, three, and five years after polysomnography.
The study included 197 people with epilepsy, 122 of whom had OSA (ie, an apnea–hypopnea index of 5 or greater). Of the patients with OSA, 73 received PAP therapy. Mean age was about 44, 58% were female, and 70% had focal epilepsy. Patients with OSA were more likely to be older, have a higher BMI, and be male than those without OSA.
At one year, 63% of patients treated with PAP had a 50% or greater reduction in seizures from baseline, compared with 14% of patients with OSA who were not treated and 44% of patients who did not have OSA. Researchers also assessed successful seizure outcomes, which were defined as not having seizures at baseline and remaining seizure-free for a year, or having seizures at baseline but reporting a 50% or greater reduction in seizures over one year. Successful outcomes occurred in 85% of patients who were treated with PAP, 55% of patients with OSA who were untreated, and 65% of patients who did not have OSA.
After adjusting for baseline seizure freedom and antiepileptic drug standardized dose, patients with treated OSA remained more likely to have successful outcomes at one year. Comparisons at three and five years included fewer patients, and the differences at those time points were not statistically significant.
—Jake Remaly
WASHINGTON, DC—Treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) is associated with better one-year seizure outcomes in patients with epilepsy, according to a study presented at the 71st Annual Meeting of the American Epilepsy Society.
Prior research has suggested that sleep disturbances are more common in people with epilepsy than in age-matched controls and that more than 40% of people with epilepsy have OSA. PAP therapy has been associated with seizure reduction in small case series.
To compare long-term seizure control between patients with PAP-treated OSA, patients with untreated OSA, and patients without OSA, Thapanee Somboon, MD, a research fellow at the Sleep Disorders Center at Cleveland Clinic, and colleagues conducted a retrospective study of adults with epilepsy who underwent polysomnography at Cleveland Clinic between 1997 and 2015. Researchers compared patients’ seizure outcomes at one, three, and five years after polysomnography.
The study included 197 people with epilepsy, 122 of whom had OSA (ie, an apnea–hypopnea index of 5 or greater). Of the patients with OSA, 73 received PAP therapy. Mean age was about 44, 58% were female, and 70% had focal epilepsy. Patients with OSA were more likely to be older, have a higher BMI, and be male than those without OSA.
At one year, 63% of patients treated with PAP had a 50% or greater reduction in seizures from baseline, compared with 14% of patients with OSA who were not treated and 44% of patients who did not have OSA. Researchers also assessed successful seizure outcomes, which were defined as not having seizures at baseline and remaining seizure-free for a year, or having seizures at baseline but reporting a 50% or greater reduction in seizures over one year. Successful outcomes occurred in 85% of patients who were treated with PAP, 55% of patients with OSA who were untreated, and 65% of patients who did not have OSA.
After adjusting for baseline seizure freedom and antiepileptic drug standardized dose, patients with treated OSA remained more likely to have successful outcomes at one year. Comparisons at three and five years included fewer patients, and the differences at those time points were not statistically significant.
—Jake Remaly
New curriculum teaches value-based health care
While value has become an imperative in both training and health care delivery, few tools exist to teach hospitalists and other providers the basic concepts of value.
“Hospitalists are on the front lines of health care value delivery, and it is critical that we understand and embrace the concepts of value; however, we also need to be able to deliver upon these ideals,” said Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin.
“As a hospitalist, I ensured that the content would be specifically applicable to our day-to-day world and experience,” Dr. Moriates said. “Using the modules, hospitalists can better understand how emerging tools, such as the University of Utah’s Value-Drive Outcome tool, can be used by hospitalists to improve value. The modules also dig into thorny subjects like understanding health care costs – for example, what really is the difference between costs and charges?”
The course is adaptive and interactive, using the latest in instructional technology, he said. Hospitalists can take the course independently and earn free CME credits; those who complete all three modules in this first collection will receive a certificate of completion and CME credit.
The goal is to release 10 modules over the course of this academic year, Dr. Moriates said. Future collections will cover “value-based health care delivery,” “how to deliver high-value care at the bedside,” and “how to deliver high-value care in systems.”
“As value-based health care is increasingly taught in medical schools and residency training, it is important for hospitalists – especially any of us that work with trainees – to be able to speak the same language and understand what our trainees now will know,” he said.
While value has become an imperative in both training and health care delivery, few tools exist to teach hospitalists and other providers the basic concepts of value.
“Hospitalists are on the front lines of health care value delivery, and it is critical that we understand and embrace the concepts of value; however, we also need to be able to deliver upon these ideals,” said Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin.
“As a hospitalist, I ensured that the content would be specifically applicable to our day-to-day world and experience,” Dr. Moriates said. “Using the modules, hospitalists can better understand how emerging tools, such as the University of Utah’s Value-Drive Outcome tool, can be used by hospitalists to improve value. The modules also dig into thorny subjects like understanding health care costs – for example, what really is the difference between costs and charges?”
The course is adaptive and interactive, using the latest in instructional technology, he said. Hospitalists can take the course independently and earn free CME credits; those who complete all three modules in this first collection will receive a certificate of completion and CME credit.
The goal is to release 10 modules over the course of this academic year, Dr. Moriates said. Future collections will cover “value-based health care delivery,” “how to deliver high-value care at the bedside,” and “how to deliver high-value care in systems.”
“As value-based health care is increasingly taught in medical schools and residency training, it is important for hospitalists – especially any of us that work with trainees – to be able to speak the same language and understand what our trainees now will know,” he said.
While value has become an imperative in both training and health care delivery, few tools exist to teach hospitalists and other providers the basic concepts of value.
“Hospitalists are on the front lines of health care value delivery, and it is critical that we understand and embrace the concepts of value; however, we also need to be able to deliver upon these ideals,” said Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin.
“As a hospitalist, I ensured that the content would be specifically applicable to our day-to-day world and experience,” Dr. Moriates said. “Using the modules, hospitalists can better understand how emerging tools, such as the University of Utah’s Value-Drive Outcome tool, can be used by hospitalists to improve value. The modules also dig into thorny subjects like understanding health care costs – for example, what really is the difference between costs and charges?”
The course is adaptive and interactive, using the latest in instructional technology, he said. Hospitalists can take the course independently and earn free CME credits; those who complete all three modules in this first collection will receive a certificate of completion and CME credit.
The goal is to release 10 modules over the course of this academic year, Dr. Moriates said. Future collections will cover “value-based health care delivery,” “how to deliver high-value care at the bedside,” and “how to deliver high-value care in systems.”
“As value-based health care is increasingly taught in medical schools and residency training, it is important for hospitalists – especially any of us that work with trainees – to be able to speak the same language and understand what our trainees now will know,” he said.
Clinical trial: Study underway of robot-assisted surgery for pelvic prolapse
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
SUMMARY FROM CLINICALTRIALS.GOV
Timing of Surgical Reduction and Stabilization of Talus Fracture-Dislocations
Take-Home Points
- There is a 41% rate of AVN or PTOA after operatively managed talus fracture.
- Surgical timing does not affect development of AVN or PTOA.
- Open fractures are associated with development of AVN and PTOA.
- Quality of reduction is likely more important than timing of reduction.
- Urgent surgical treatment is necessary for threatened soft tissue or neurovascular compromise.
Talus fractures are rare injuries that present a significant treatment dilemma.1-12 These fractures represent <1% of all fractures4 and are second only to calcaneus fractures in fractures of the hindfoot. Talus fractures with associated dislocations are even rarer and may provide treating surgeons with a significant surgical quandary.6,13-16
Talus fractures historically have been characterized by their anatomical location: head, neck, or body. Two systems are commonly used to classify talus fractures: Hawkins and AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association). The first, developed by Hawkins7 and modified by Canale and Kelly2 and Vallier and colleagues,1 identifies 4 basic fracture types with associated dislocations. The other system, published in 199617 and republished in 2007,18 uses the combined methods of AO and OTA to systematically describe talus fractures. Although these classification systems accurately describe talus fractures with associated dislocation, both have difficulty predicting clinical outcomes.1,19,20
Talus fractures commonly result in avascular necrosis (AVN) of the talus and posttraumatic osteoarthritis (PTOA) of the tibiotalar and subtalar joints.3,8,9,12,14-16 Hawkins7 initially described subchondral lucency as indicating revascularization of the talus after injury. AVN and PTOA rates traditionally have been thought to be related to a blood supply disruption, given the prognostic value of the Hawkins sign.1,7,12,21 New methods, including a dual-incision approach and expedited transfer to foot and ankle surgeons or orthopedic traumatologists, have improved reduction quality21-24 but not patient outcomes.3,5,8,9,12,14
Recently, time from injury to surgical intervention has been a topic of much discussion, and there have been studies on the specific effects of timing with respect to outcome.1,15,16 Vallier and colleagues,1 who wanted to identify injury characteristics predictive of osteonecrosis, found that delaying reduction and surgical fixation did not increase the risk of AVN. Another study found that urgent reduction of fracture-dislocation with delayed open reduction and internal fixation (ORIF) using a dual approach may improve clinical outcomes.21
In this vein, we conducted a study to evaluate the effect of time to surgical reduction of talus fractures and talus fracture-dislocations on the development of AVN and PTOA. We hypothesized that time to surgical reduction of talus fracture-dislocation as classified with the AO/OTA system would have no effect of the development of AVN/PTOA.
Methods
After this study received Institutional Review Board approval, we retrospectively reviewed the records on talus fractures surgically managed at a level I trauma center during the 10-year period 2003 to 2013. Of the 119 potential cases identified using Current Procedural Terminology code 28445 (ORIF of talus), 13 were excluded (12 for inaccurate coding or missing documentation, 1 for being a pediatric case), leaving 106 for analysis. Using the Hawkins and AO/OTA systems, 3 independent reviewers classified the injuries on plain radiographs.
Injury dates and times were obtained from the medical records. Operating room start times were also obtained. Surgical timing was defined as time from injury to operating room start. For cases without an injury time, time of presentation to emergency department was used.
Open fracture-dislocations were managed with intravenous antibiotics, urgent surgical irrigation, débridement, and immediate fixation or temporizing external fixation after reduction. All fractures were definitively managed with standard ORIF with an anteromedial, anterolateral, or dual approach and mini-fragment implants. After fixation, weight-bearing typically was restricted for 6 to 12 weeks.
Follow-up radiographs were evaluated. Presence or absence of Hawkins sign7 was noted on radiographs at 6 or 8 weeks, and all follow-up radiographs were evaluated for AVN as defined by increased radiographic density within the talar dome or collapse of the articular surface. All radiographs were evaluated for PTOA as defined by loss of joint space within the tibiotalar, subtalar, or talonavicular joint on follow-up radiographs.
Clinical outcomes were analyzed for development of AVN, PTOA, or secondary corrective surgery or arthrodesis. Continuous variables were evaluated with the t test, and the χ2 test was used to compare distributions of categorical variables. The Wilcoxon rank sum test was used to compare non-normally distributed variables. Significance was set at P < .05.
Results
Classification Analysis (Table 1)
Subject Analysis (Table 2)
The mechanisms of injury were motor vehicle accident (70/106; 66%), fall from height (25; 24%), misstep (4), sports related (2), object falling on ankle (2), and not reported (3).
Of the 106 patients, 45 (42%) had isolated talus injuries, 35 had concomitant ipsilateral lower extremity injuries, 25 had concomitant contralateral lower extremity injuries, and 1 had a concomitant upper extremity injury.
Smoking status was everyday (14 patients), past (10), never (34), and unreported (48). Five patients reported a history of alcohol abuse, and 4 patients reported illicit drug use. Two had a history of atrial fibrillation, 9 had hypertension, 3 had hyperlipidemia, 3 had renal disease, 3 had heart disease, 4 had diabetes, 3 had lung disease, and 1 had a history of lung cancer.
Overall Analysis of AVN/PTOA (Table 3)
Analysis of AVN/PTOA in 81-B3 Fracture-Dislocations (Table 4)
Analysis of AVN/PTOA in All Other Talus Fractures (Table 5)
Discussion
Our results showed that time from talus fracture-dislocation to surgical reduction had no effect on development of AVN/PTOA. The findings in this largest series to date agree with earlier findings1,8,15,16,24 and add to the volume of literature suggesting that time to surgical reduction of talus fractures and talus fracture-dislocations does not markedly affect outcome.
Talus fractures continue to present a significant treatment dilemma. Despite recent improvements in surgical techniques and overall management of these injuries, rates of AVN and PTOA have not significantly decreased.1,16,23 At most treating facilities, talus fracture-dislocations are considered surgical emergencies/urgencies, and every effort is made to reduce and surgically address these injuries as soon as possible.1,13
In this study, rates of AVN/PTOA were 41% (all talus fractures) and 50% (displaced talar neck fractures), and the difference was not significant (Table 3). These rates are higher but consistent with previously reported rates (range, 14%-49%).1,2,7-9,12,14,24 There was no difference in surgical timing for development of AVN/PTOA. We analyzed the cases of all patients who had talus fractures and developed AVN/PTOA (43/106). Within this group, there were no significant differences in surgical timing, age, sex, polytrauma, or BMI between patients who developed AVN/PTOA and those who did not. Compared with patients who did not develop AVN/PTOA, those who developed AVN/PTOA were significantly more likely to have open injuries. This finding, consistent with those in other reports9,12,13 (Table 3), indicates outcome is more likely related to injury severity and not necessarily injury class.
We retrospectively analyzed talus fractures and talus fracture-dislocations to determine if urgent surgical management affects outcomes. Current practice at our institution is to routinely reduce and surgically address these fractures urgently, often during the middle of the night, when orthopedic resources are reduced. Our study found a significant difference in surgical timing for patients with talus fracture-dislocations and patients with talus fractures without dislocations (Table 2). Given our findings, urgent surgical reduction and fixation are not indicated to preserve the talus blood supply and prevent AVN/PTOA, though we still recommend urgent surgical management in the setting of an open wound, skin necrosis, or soft-tissue/neurovascular compromise.
This study had several limitations, primarily related to its retrospective nature. Surgical timing was defined as time from injury, as noted in the medical record, to operating room start. In some instances, time of injury was not noted in the medical record, and time of presentation to emergency room was used instead. Thus, surgical timing for these patients may have been longer than identified. In addition, given the rare injury pattern and the retrospective design, this study was susceptible to type II error and may have been underpowered to detect whether time to surgical reduction predicted complications. Also, the study did not address functional outcome as measured by validated outcome scores. Outcome measures were obtained in many but not all cases, making functional outcome measurement difficult. Similarly, the quality of the anatomical reductions was not assessed, potentially affecting complication rates. Postoperative reduction assessment, possibly performed with computed tomography, is an avenue of further study.
Strengths of this study include its large sample size (this was one of the largest studies of talus fractures), long follow-up (mean, 150 weeks), and novel use of AO/OTA classification.
We postulate that development of AVN/PTOA is not necessarily related to the urgency or timing of surgical reduction and fixation and is more likely related to injury severity. This idea is supported by the finding that development of AVN/PTOA was significantly correlated to open injuries in all talus fractures, including talus fracture-dislocations and isolated talus fractures.
Conclusion
Talus fracture-dislocations are devastating injuries with high rates of complications. In this study, open talus fractures, and fractures with associated tibiotalar or subtalar dislocations, had higher complication rates. Given the evidence presented, we recommend basing surgical timing on injury severity, not necessarily for AVN/PTOA prevention. Specifically, in the absence of an open wound, skin necrosis, or soft-tissue/neurovascular compromise, talus fracture-dislocations can be surgically reduced and stabilized when optimal resources are available.
1. Vallier HA, Reichard SG, Boyd AJ, Moore TA. A new look at the Hawkins classification for talar neck fractures: which features of injury and treatment are predictive of osteonecrosis? J Bone Joint Surg Am. 2014;96(3):192-197.
2. Canale ST, Kelly FB Jr. Fractures of the neck of the talus. Long-term evaluation of seventy-one cases. J Bone Joint Surg Am. 1978;60(2):143-156.
3. Ebraheim NA, Patil V, Owens C, Kandimalla Y. Clinical outcome of fractures of the talar body. Int Orthop. 2008;32(6):773-777.
4. Fortin PT, Balazsy JE. Talus fractures: evaluation and treatment. J Am Acad Orthop Surg. 2001;9(2):114-127.
5. Fournier A, Barba N, Steiger V, et al. Total talar fracture—long-term results of internal fixation of talar fractures. A multicentric study of 114 cases. Orthop Traumatol Surg Res. 2012;98(4 suppl):S48-S55.
6. Grob D, Simpson LA, Weber BG, Bray T. Operative treatment of displaced talus fractures. Clin Orthop Relat Res. 1985;(199):88-96.
7. Hawkins LG. Fractures of the neck of the talus. J Bone Joint Surg Am. 1970;52(5):991-1002.
8. Lindvall E, Haidukewych G, DiPasquale T, Herscovici D Jr, Sanders R. Open reduction and stable fixation of isolated, displaced talar neck and body fractures. J Bone Joint Surg Am. 2004;86(10):2229-2234.
9. Ohl X, Harisboure A, Hemery X, Dehoux E. Long-term follow-up after surgical treatment of talar fractures: twenty cases with an average follow-up of 7.5 years. Int Orthop. 2011;35(1):93-99.
10. Rammelt S, Zwipp H. Talar neck and body fractures. Injury. 2009;40(2):120-135.
11. Schulze W, Richter J, Russe O, Ingelfinger P, Muhr G. Surgical treatment of talus fractures: a retrospective study of 80 cases followed for 1-15 years. Acta Orthop Scand. 2002;73(3):344-351.
12. Vallier HA, Nork SE, Barei DP, Benirschke SK, Sangeorzan BJ. Talar neck fractures: results and outcomes. J Bone Joint Surg Am. 2004;86(8):1616-1624.
13. Patel R, Van Bergeyk A, Pinney S. Are displaced talar neck fractures surgical emergencies? A survey of orthopaedic trauma experts. Foot Ankle Int. 2005;26(5):378-381.
14. Sanders DW, Busam M, Hattwick E, Edwards JR, McAndrew MP, Johnson KD. Functional outcomes following displaced talar neck fractures. J Orthop Trauma. 2004;18(5):265-270.
15. Elgafy H, Ebraheim NA, Tile M, Stephen D, Kase J. Fractures of the talus: experience of two level 1 trauma centers. Foot Ankle Int. 2000;21(12):1023-1029.
16 Frawley PA, Hart JA, Young DA. Treatment outcome of major fractures of the talus. Foot Ankle Int. 1995;16(6):339-345.
17. Fracture and dislocation compendium. Orthopaedic Trauma Association committee for coding and classification. J Orthop Trauma. 1996;10(suppl 1):v-ix, 1-154.
18. Marsh JL, Slongo TF, Agel J, et al. Fracture and dislocation classification compendium—2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 suppl):S1-S133.
19. Williams T, Barba N, Noailles T, et al. Total talar fracture—inter- and intra-observer reproducibility of two classification systems (Hawkins and AO) for central talar fractures. Orthop Traumatol Surg Res. 2012;98(4 suppl):S56-S65.
20. Zwipp H, Baumgart F, Cronier P, et al. Integral classification of injuries (ICI) to the bones, joints, and ligaments—application to injuries of the foot. Injury. 2004;35(suppl 2):SB3-SB9.
21. Xue Y, Zhang H, Pei F, et al. Treatment of displaced talar neck fractures using delayed procedures of plate fixation through dual approaches. Int Orthop. 2014;38(1):149-154.
22. Vallier HA, Nork SE, Benirschke SK, Sangeorzan BJ. Surgical treatment of talar body fractures. J Bone Joint Surg Am. 2003;85(9):1716-1724.
23. Fleuriau Chateau PB, Brokaw DS, Jelen BA, Scheid DK, Weber TG. Plate fixation of talar neck fractures: preliminary review of a new technique in twenty-three patients. J Orthop Trauma. 2002;16(4):213-219.
24. Vallier HA, Nork SE, Benirschke SK, Sangeorzan BJ. Surgical treatment of talar body fractures. J Bone Joint Surg Am. 2004;86(suppl 1, pt 2):180-192.
Take-Home Points
- There is a 41% rate of AVN or PTOA after operatively managed talus fracture.
- Surgical timing does not affect development of AVN or PTOA.
- Open fractures are associated with development of AVN and PTOA.
- Quality of reduction is likely more important than timing of reduction.
- Urgent surgical treatment is necessary for threatened soft tissue or neurovascular compromise.
Talus fractures are rare injuries that present a significant treatment dilemma.1-12 These fractures represent <1% of all fractures4 and are second only to calcaneus fractures in fractures of the hindfoot. Talus fractures with associated dislocations are even rarer and may provide treating surgeons with a significant surgical quandary.6,13-16
Talus fractures historically have been characterized by their anatomical location: head, neck, or body. Two systems are commonly used to classify talus fractures: Hawkins and AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association). The first, developed by Hawkins7 and modified by Canale and Kelly2 and Vallier and colleagues,1 identifies 4 basic fracture types with associated dislocations. The other system, published in 199617 and republished in 2007,18 uses the combined methods of AO and OTA to systematically describe talus fractures. Although these classification systems accurately describe talus fractures with associated dislocation, both have difficulty predicting clinical outcomes.1,19,20
Talus fractures commonly result in avascular necrosis (AVN) of the talus and posttraumatic osteoarthritis (PTOA) of the tibiotalar and subtalar joints.3,8,9,12,14-16 Hawkins7 initially described subchondral lucency as indicating revascularization of the talus after injury. AVN and PTOA rates traditionally have been thought to be related to a blood supply disruption, given the prognostic value of the Hawkins sign.1,7,12,21 New methods, including a dual-incision approach and expedited transfer to foot and ankle surgeons or orthopedic traumatologists, have improved reduction quality21-24 but not patient outcomes.3,5,8,9,12,14
Recently, time from injury to surgical intervention has been a topic of much discussion, and there have been studies on the specific effects of timing with respect to outcome.1,15,16 Vallier and colleagues,1 who wanted to identify injury characteristics predictive of osteonecrosis, found that delaying reduction and surgical fixation did not increase the risk of AVN. Another study found that urgent reduction of fracture-dislocation with delayed open reduction and internal fixation (ORIF) using a dual approach may improve clinical outcomes.21
In this vein, we conducted a study to evaluate the effect of time to surgical reduction of talus fractures and talus fracture-dislocations on the development of AVN and PTOA. We hypothesized that time to surgical reduction of talus fracture-dislocation as classified with the AO/OTA system would have no effect of the development of AVN/PTOA.
Methods
After this study received Institutional Review Board approval, we retrospectively reviewed the records on talus fractures surgically managed at a level I trauma center during the 10-year period 2003 to 2013. Of the 119 potential cases identified using Current Procedural Terminology code 28445 (ORIF of talus), 13 were excluded (12 for inaccurate coding or missing documentation, 1 for being a pediatric case), leaving 106 for analysis. Using the Hawkins and AO/OTA systems, 3 independent reviewers classified the injuries on plain radiographs.
Injury dates and times were obtained from the medical records. Operating room start times were also obtained. Surgical timing was defined as time from injury to operating room start. For cases without an injury time, time of presentation to emergency department was used.
Open fracture-dislocations were managed with intravenous antibiotics, urgent surgical irrigation, débridement, and immediate fixation or temporizing external fixation after reduction. All fractures were definitively managed with standard ORIF with an anteromedial, anterolateral, or dual approach and mini-fragment implants. After fixation, weight-bearing typically was restricted for 6 to 12 weeks.
Follow-up radiographs were evaluated. Presence or absence of Hawkins sign7 was noted on radiographs at 6 or 8 weeks, and all follow-up radiographs were evaluated for AVN as defined by increased radiographic density within the talar dome or collapse of the articular surface. All radiographs were evaluated for PTOA as defined by loss of joint space within the tibiotalar, subtalar, or talonavicular joint on follow-up radiographs.
Clinical outcomes were analyzed for development of AVN, PTOA, or secondary corrective surgery or arthrodesis. Continuous variables were evaluated with the t test, and the χ2 test was used to compare distributions of categorical variables. The Wilcoxon rank sum test was used to compare non-normally distributed variables. Significance was set at P < .05.
Results
Classification Analysis (Table 1)
Subject Analysis (Table 2)
The mechanisms of injury were motor vehicle accident (70/106; 66%), fall from height (25; 24%), misstep (4), sports related (2), object falling on ankle (2), and not reported (3).
Of the 106 patients, 45 (42%) had isolated talus injuries, 35 had concomitant ipsilateral lower extremity injuries, 25 had concomitant contralateral lower extremity injuries, and 1 had a concomitant upper extremity injury.
Smoking status was everyday (14 patients), past (10), never (34), and unreported (48). Five patients reported a history of alcohol abuse, and 4 patients reported illicit drug use. Two had a history of atrial fibrillation, 9 had hypertension, 3 had hyperlipidemia, 3 had renal disease, 3 had heart disease, 4 had diabetes, 3 had lung disease, and 1 had a history of lung cancer.
Overall Analysis of AVN/PTOA (Table 3)
Analysis of AVN/PTOA in 81-B3 Fracture-Dislocations (Table 4)
Analysis of AVN/PTOA in All Other Talus Fractures (Table 5)
Discussion
Our results showed that time from talus fracture-dislocation to surgical reduction had no effect on development of AVN/PTOA. The findings in this largest series to date agree with earlier findings1,8,15,16,24 and add to the volume of literature suggesting that time to surgical reduction of talus fractures and talus fracture-dislocations does not markedly affect outcome.
Talus fractures continue to present a significant treatment dilemma. Despite recent improvements in surgical techniques and overall management of these injuries, rates of AVN and PTOA have not significantly decreased.1,16,23 At most treating facilities, talus fracture-dislocations are considered surgical emergencies/urgencies, and every effort is made to reduce and surgically address these injuries as soon as possible.1,13
In this study, rates of AVN/PTOA were 41% (all talus fractures) and 50% (displaced talar neck fractures), and the difference was not significant (Table 3). These rates are higher but consistent with previously reported rates (range, 14%-49%).1,2,7-9,12,14,24 There was no difference in surgical timing for development of AVN/PTOA. We analyzed the cases of all patients who had talus fractures and developed AVN/PTOA (43/106). Within this group, there were no significant differences in surgical timing, age, sex, polytrauma, or BMI between patients who developed AVN/PTOA and those who did not. Compared with patients who did not develop AVN/PTOA, those who developed AVN/PTOA were significantly more likely to have open injuries. This finding, consistent with those in other reports9,12,13 (Table 3), indicates outcome is more likely related to injury severity and not necessarily injury class.
We retrospectively analyzed talus fractures and talus fracture-dislocations to determine if urgent surgical management affects outcomes. Current practice at our institution is to routinely reduce and surgically address these fractures urgently, often during the middle of the night, when orthopedic resources are reduced. Our study found a significant difference in surgical timing for patients with talus fracture-dislocations and patients with talus fractures without dislocations (Table 2). Given our findings, urgent surgical reduction and fixation are not indicated to preserve the talus blood supply and prevent AVN/PTOA, though we still recommend urgent surgical management in the setting of an open wound, skin necrosis, or soft-tissue/neurovascular compromise.
This study had several limitations, primarily related to its retrospective nature. Surgical timing was defined as time from injury, as noted in the medical record, to operating room start. In some instances, time of injury was not noted in the medical record, and time of presentation to emergency room was used instead. Thus, surgical timing for these patients may have been longer than identified. In addition, given the rare injury pattern and the retrospective design, this study was susceptible to type II error and may have been underpowered to detect whether time to surgical reduction predicted complications. Also, the study did not address functional outcome as measured by validated outcome scores. Outcome measures were obtained in many but not all cases, making functional outcome measurement difficult. Similarly, the quality of the anatomical reductions was not assessed, potentially affecting complication rates. Postoperative reduction assessment, possibly performed with computed tomography, is an avenue of further study.
Strengths of this study include its large sample size (this was one of the largest studies of talus fractures), long follow-up (mean, 150 weeks), and novel use of AO/OTA classification.
We postulate that development of AVN/PTOA is not necessarily related to the urgency or timing of surgical reduction and fixation and is more likely related to injury severity. This idea is supported by the finding that development of AVN/PTOA was significantly correlated to open injuries in all talus fractures, including talus fracture-dislocations and isolated talus fractures.
Conclusion
Talus fracture-dislocations are devastating injuries with high rates of complications. In this study, open talus fractures, and fractures with associated tibiotalar or subtalar dislocations, had higher complication rates. Given the evidence presented, we recommend basing surgical timing on injury severity, not necessarily for AVN/PTOA prevention. Specifically, in the absence of an open wound, skin necrosis, or soft-tissue/neurovascular compromise, talus fracture-dislocations can be surgically reduced and stabilized when optimal resources are available.
Take-Home Points
- There is a 41% rate of AVN or PTOA after operatively managed talus fracture.
- Surgical timing does not affect development of AVN or PTOA.
- Open fractures are associated with development of AVN and PTOA.
- Quality of reduction is likely more important than timing of reduction.
- Urgent surgical treatment is necessary for threatened soft tissue or neurovascular compromise.
Talus fractures are rare injuries that present a significant treatment dilemma.1-12 These fractures represent <1% of all fractures4 and are second only to calcaneus fractures in fractures of the hindfoot. Talus fractures with associated dislocations are even rarer and may provide treating surgeons with a significant surgical quandary.6,13-16
Talus fractures historically have been characterized by their anatomical location: head, neck, or body. Two systems are commonly used to classify talus fractures: Hawkins and AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association). The first, developed by Hawkins7 and modified by Canale and Kelly2 and Vallier and colleagues,1 identifies 4 basic fracture types with associated dislocations. The other system, published in 199617 and republished in 2007,18 uses the combined methods of AO and OTA to systematically describe talus fractures. Although these classification systems accurately describe talus fractures with associated dislocation, both have difficulty predicting clinical outcomes.1,19,20
Talus fractures commonly result in avascular necrosis (AVN) of the talus and posttraumatic osteoarthritis (PTOA) of the tibiotalar and subtalar joints.3,8,9,12,14-16 Hawkins7 initially described subchondral lucency as indicating revascularization of the talus after injury. AVN and PTOA rates traditionally have been thought to be related to a blood supply disruption, given the prognostic value of the Hawkins sign.1,7,12,21 New methods, including a dual-incision approach and expedited transfer to foot and ankle surgeons or orthopedic traumatologists, have improved reduction quality21-24 but not patient outcomes.3,5,8,9,12,14
Recently, time from injury to surgical intervention has been a topic of much discussion, and there have been studies on the specific effects of timing with respect to outcome.1,15,16 Vallier and colleagues,1 who wanted to identify injury characteristics predictive of osteonecrosis, found that delaying reduction and surgical fixation did not increase the risk of AVN. Another study found that urgent reduction of fracture-dislocation with delayed open reduction and internal fixation (ORIF) using a dual approach may improve clinical outcomes.21
In this vein, we conducted a study to evaluate the effect of time to surgical reduction of talus fractures and talus fracture-dislocations on the development of AVN and PTOA. We hypothesized that time to surgical reduction of talus fracture-dislocation as classified with the AO/OTA system would have no effect of the development of AVN/PTOA.
Methods
After this study received Institutional Review Board approval, we retrospectively reviewed the records on talus fractures surgically managed at a level I trauma center during the 10-year period 2003 to 2013. Of the 119 potential cases identified using Current Procedural Terminology code 28445 (ORIF of talus), 13 were excluded (12 for inaccurate coding or missing documentation, 1 for being a pediatric case), leaving 106 for analysis. Using the Hawkins and AO/OTA systems, 3 independent reviewers classified the injuries on plain radiographs.
Injury dates and times were obtained from the medical records. Operating room start times were also obtained. Surgical timing was defined as time from injury to operating room start. For cases without an injury time, time of presentation to emergency department was used.
Open fracture-dislocations were managed with intravenous antibiotics, urgent surgical irrigation, débridement, and immediate fixation or temporizing external fixation after reduction. All fractures were definitively managed with standard ORIF with an anteromedial, anterolateral, or dual approach and mini-fragment implants. After fixation, weight-bearing typically was restricted for 6 to 12 weeks.
Follow-up radiographs were evaluated. Presence or absence of Hawkins sign7 was noted on radiographs at 6 or 8 weeks, and all follow-up radiographs were evaluated for AVN as defined by increased radiographic density within the talar dome or collapse of the articular surface. All radiographs were evaluated for PTOA as defined by loss of joint space within the tibiotalar, subtalar, or talonavicular joint on follow-up radiographs.
Clinical outcomes were analyzed for development of AVN, PTOA, or secondary corrective surgery or arthrodesis. Continuous variables were evaluated with the t test, and the χ2 test was used to compare distributions of categorical variables. The Wilcoxon rank sum test was used to compare non-normally distributed variables. Significance was set at P < .05.
Results
Classification Analysis (Table 1)
Subject Analysis (Table 2)
The mechanisms of injury were motor vehicle accident (70/106; 66%), fall from height (25; 24%), misstep (4), sports related (2), object falling on ankle (2), and not reported (3).
Of the 106 patients, 45 (42%) had isolated talus injuries, 35 had concomitant ipsilateral lower extremity injuries, 25 had concomitant contralateral lower extremity injuries, and 1 had a concomitant upper extremity injury.
Smoking status was everyday (14 patients), past (10), never (34), and unreported (48). Five patients reported a history of alcohol abuse, and 4 patients reported illicit drug use. Two had a history of atrial fibrillation, 9 had hypertension, 3 had hyperlipidemia, 3 had renal disease, 3 had heart disease, 4 had diabetes, 3 had lung disease, and 1 had a history of lung cancer.
Overall Analysis of AVN/PTOA (Table 3)
Analysis of AVN/PTOA in 81-B3 Fracture-Dislocations (Table 4)
Analysis of AVN/PTOA in All Other Talus Fractures (Table 5)
Discussion
Our results showed that time from talus fracture-dislocation to surgical reduction had no effect on development of AVN/PTOA. The findings in this largest series to date agree with earlier findings1,8,15,16,24 and add to the volume of literature suggesting that time to surgical reduction of talus fractures and talus fracture-dislocations does not markedly affect outcome.
Talus fractures continue to present a significant treatment dilemma. Despite recent improvements in surgical techniques and overall management of these injuries, rates of AVN and PTOA have not significantly decreased.1,16,23 At most treating facilities, talus fracture-dislocations are considered surgical emergencies/urgencies, and every effort is made to reduce and surgically address these injuries as soon as possible.1,13
In this study, rates of AVN/PTOA were 41% (all talus fractures) and 50% (displaced talar neck fractures), and the difference was not significant (Table 3). These rates are higher but consistent with previously reported rates (range, 14%-49%).1,2,7-9,12,14,24 There was no difference in surgical timing for development of AVN/PTOA. We analyzed the cases of all patients who had talus fractures and developed AVN/PTOA (43/106). Within this group, there were no significant differences in surgical timing, age, sex, polytrauma, or BMI between patients who developed AVN/PTOA and those who did not. Compared with patients who did not develop AVN/PTOA, those who developed AVN/PTOA were significantly more likely to have open injuries. This finding, consistent with those in other reports9,12,13 (Table 3), indicates outcome is more likely related to injury severity and not necessarily injury class.
We retrospectively analyzed talus fractures and talus fracture-dislocations to determine if urgent surgical management affects outcomes. Current practice at our institution is to routinely reduce and surgically address these fractures urgently, often during the middle of the night, when orthopedic resources are reduced. Our study found a significant difference in surgical timing for patients with talus fracture-dislocations and patients with talus fractures without dislocations (Table 2). Given our findings, urgent surgical reduction and fixation are not indicated to preserve the talus blood supply and prevent AVN/PTOA, though we still recommend urgent surgical management in the setting of an open wound, skin necrosis, or soft-tissue/neurovascular compromise.
This study had several limitations, primarily related to its retrospective nature. Surgical timing was defined as time from injury, as noted in the medical record, to operating room start. In some instances, time of injury was not noted in the medical record, and time of presentation to emergency room was used instead. Thus, surgical timing for these patients may have been longer than identified. In addition, given the rare injury pattern and the retrospective design, this study was susceptible to type II error and may have been underpowered to detect whether time to surgical reduction predicted complications. Also, the study did not address functional outcome as measured by validated outcome scores. Outcome measures were obtained in many but not all cases, making functional outcome measurement difficult. Similarly, the quality of the anatomical reductions was not assessed, potentially affecting complication rates. Postoperative reduction assessment, possibly performed with computed tomography, is an avenue of further study.
Strengths of this study include its large sample size (this was one of the largest studies of talus fractures), long follow-up (mean, 150 weeks), and novel use of AO/OTA classification.
We postulate that development of AVN/PTOA is not necessarily related to the urgency or timing of surgical reduction and fixation and is more likely related to injury severity. This idea is supported by the finding that development of AVN/PTOA was significantly correlated to open injuries in all talus fractures, including talus fracture-dislocations and isolated talus fractures.
Conclusion
Talus fracture-dislocations are devastating injuries with high rates of complications. In this study, open talus fractures, and fractures with associated tibiotalar or subtalar dislocations, had higher complication rates. Given the evidence presented, we recommend basing surgical timing on injury severity, not necessarily for AVN/PTOA prevention. Specifically, in the absence of an open wound, skin necrosis, or soft-tissue/neurovascular compromise, talus fracture-dislocations can be surgically reduced and stabilized when optimal resources are available.
1. Vallier HA, Reichard SG, Boyd AJ, Moore TA. A new look at the Hawkins classification for talar neck fractures: which features of injury and treatment are predictive of osteonecrosis? J Bone Joint Surg Am. 2014;96(3):192-197.
2. Canale ST, Kelly FB Jr. Fractures of the neck of the talus. Long-term evaluation of seventy-one cases. J Bone Joint Surg Am. 1978;60(2):143-156.
3. Ebraheim NA, Patil V, Owens C, Kandimalla Y. Clinical outcome of fractures of the talar body. Int Orthop. 2008;32(6):773-777.
4. Fortin PT, Balazsy JE. Talus fractures: evaluation and treatment. J Am Acad Orthop Surg. 2001;9(2):114-127.
5. Fournier A, Barba N, Steiger V, et al. Total talar fracture—long-term results of internal fixation of talar fractures. A multicentric study of 114 cases. Orthop Traumatol Surg Res. 2012;98(4 suppl):S48-S55.
6. Grob D, Simpson LA, Weber BG, Bray T. Operative treatment of displaced talus fractures. Clin Orthop Relat Res. 1985;(199):88-96.
7. Hawkins LG. Fractures of the neck of the talus. J Bone Joint Surg Am. 1970;52(5):991-1002.
8. Lindvall E, Haidukewych G, DiPasquale T, Herscovici D Jr, Sanders R. Open reduction and stable fixation of isolated, displaced talar neck and body fractures. J Bone Joint Surg Am. 2004;86(10):2229-2234.
9. Ohl X, Harisboure A, Hemery X, Dehoux E. Long-term follow-up after surgical treatment of talar fractures: twenty cases with an average follow-up of 7.5 years. Int Orthop. 2011;35(1):93-99.
10. Rammelt S, Zwipp H. Talar neck and body fractures. Injury. 2009;40(2):120-135.
11. Schulze W, Richter J, Russe O, Ingelfinger P, Muhr G. Surgical treatment of talus fractures: a retrospective study of 80 cases followed for 1-15 years. Acta Orthop Scand. 2002;73(3):344-351.
12. Vallier HA, Nork SE, Barei DP, Benirschke SK, Sangeorzan BJ. Talar neck fractures: results and outcomes. J Bone Joint Surg Am. 2004;86(8):1616-1624.
13. Patel R, Van Bergeyk A, Pinney S. Are displaced talar neck fractures surgical emergencies? A survey of orthopaedic trauma experts. Foot Ankle Int. 2005;26(5):378-381.
14. Sanders DW, Busam M, Hattwick E, Edwards JR, McAndrew MP, Johnson KD. Functional outcomes following displaced talar neck fractures. J Orthop Trauma. 2004;18(5):265-270.
15. Elgafy H, Ebraheim NA, Tile M, Stephen D, Kase J. Fractures of the talus: experience of two level 1 trauma centers. Foot Ankle Int. 2000;21(12):1023-1029.
16 Frawley PA, Hart JA, Young DA. Treatment outcome of major fractures of the talus. Foot Ankle Int. 1995;16(6):339-345.
17. Fracture and dislocation compendium. Orthopaedic Trauma Association committee for coding and classification. J Orthop Trauma. 1996;10(suppl 1):v-ix, 1-154.
18. Marsh JL, Slongo TF, Agel J, et al. Fracture and dislocation classification compendium—2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 suppl):S1-S133.
19. Williams T, Barba N, Noailles T, et al. Total talar fracture—inter- and intra-observer reproducibility of two classification systems (Hawkins and AO) for central talar fractures. Orthop Traumatol Surg Res. 2012;98(4 suppl):S56-S65.
20. Zwipp H, Baumgart F, Cronier P, et al. Integral classification of injuries (ICI) to the bones, joints, and ligaments—application to injuries of the foot. Injury. 2004;35(suppl 2):SB3-SB9.
21. Xue Y, Zhang H, Pei F, et al. Treatment of displaced talar neck fractures using delayed procedures of plate fixation through dual approaches. Int Orthop. 2014;38(1):149-154.
22. Vallier HA, Nork SE, Benirschke SK, Sangeorzan BJ. Surgical treatment of talar body fractures. J Bone Joint Surg Am. 2003;85(9):1716-1724.
23. Fleuriau Chateau PB, Brokaw DS, Jelen BA, Scheid DK, Weber TG. Plate fixation of talar neck fractures: preliminary review of a new technique in twenty-three patients. J Orthop Trauma. 2002;16(4):213-219.
24. Vallier HA, Nork SE, Benirschke SK, Sangeorzan BJ. Surgical treatment of talar body fractures. J Bone Joint Surg Am. 2004;86(suppl 1, pt 2):180-192.
1. Vallier HA, Reichard SG, Boyd AJ, Moore TA. A new look at the Hawkins classification for talar neck fractures: which features of injury and treatment are predictive of osteonecrosis? J Bone Joint Surg Am. 2014;96(3):192-197.
2. Canale ST, Kelly FB Jr. Fractures of the neck of the talus. Long-term evaluation of seventy-one cases. J Bone Joint Surg Am. 1978;60(2):143-156.
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