The mission of OBG Management is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. As we celebrate the beginning of our 30th anniversary year, we recommit to our mission by providing the highest quality of health information through both print and electronic portals.

OBG Management: Print and electronic portals for knowledge acquisition

Experienced clinicians acquire new knowledge and refresh established concepts through discussions with trusted colleagues and by reading journals and books that contain information relevant to their practice. A continuing trend in professional development is the accelerating transition from a reliance on print media (print journals and books) to electronic information delivery. Many clinicians continue to enjoy reading medical journals and magazines. ObGyns are no different; 96% report reading the print edition of medical journals.¹ At OBG Management we are committed to continue to mail you a monthly copy of our journal.

However, in the time-pressured setting of office- and hospital-based patient care, critical information is now frequently accessed through an electronic portal that is web based and focused on immediately answering a high priority question necessary for optimal patient care. OBG Management provides our community with rapid access to electronic versions of the journal and all previously published editorial material. Many web exclusives are found online as well, including audio and video techniques and commentary. The OBG Management website has a powerful search engine, which permits our readers to rapidly and conveniently access all previously published articles. In addition, our community members that have provided us with electronic contact information receive regular electronic communications about recently published literature (Clinical Edge), highly read articles and topical alerts from the journal, and MD-IQ quizzes to help review recent research and guidelines in an interactive medium.

The information base needed to practice medicine is massive and continues to grow rapidly. No single print textbook or journal can cover this vast information base. Libraries of print material are cumbersome to use and ordinarily not accessible at the site of patient care. Electronic portals are the only means of providing immediate access to all medical knowledge. Electronic technology enables the aggregation of vast amounts of information in a database that is rapidly accessible from anywhere, and new search technology is making it easier to quickly locate the information you need.

The next frontier in medical information exchange is the application of artificial intelligence to cull “answers” from the vast aggregation of data. By combining all available medical information and artificial intelligence processes, in the near future, clinicians will be able to instantaneously get an answer to a question they have about how to care for a specific patient. A decade ago, when a question was entered into an Internet search engine, the response was typically a list of potential websites where the answer might be located. In the past few years, with the integration of huge databases and artificial intelligence, some advanced search engines now provide a specific answer to a question, followed by a list of relevant websites. For example, if you enter this question: “What countries have the greatest number of people?” into the Google search tool, in less than 1 second a direct answer is provided: “China has the world’s largest population (1.4 billion), followed by India (1.3 billion). The next most populous nations—the United States, Indonesia, Brazil and Pakistan—combined have less than 1 billion people.” The next step in medical information communication will be the deployment of artificial intelligence systems that can directly answer a query from a clinician about a specific patient.

Our distinguished Editorial Board and authors—the heart and mind of OBG Management

The editorial team at OBG Management is proud to work with the distinguished medical leaders who write our articles and serve on our Editorial Board. The guidance we receive from our Board and the expert editorial material generated by our authors is critical to advancing the quality of OBG Management. Our Board members and authors care deeply about improving women’s health and closing gaps between current and optimal practice. Our Board members and authors are truly expert clinicians with vast experience. Our readers can have great confidence in their recommendations.

Improving clinician wellness and resilience and reducing burnout

Clinicians throughout the world are reporting decreased levels of professional fulfillment and increased levels of burnout.^2–4 This epidemic is likely caused by many factors, including the deployment of poorly designed electronic health systems, the administrative guidance for clinicians to work faster with fewer support staff, increasing administrative and secretarial burden on clinicians, and institutional constraints on clinician autonomy. Many of these problems only can be addressed at the level of the health system, but some are in the control of individual clinicians.

In the upcoming years, OBG Management will prioritize deepening the knowledge about the factors that support clinician wellness and share approaches that may help you to improve your wellness and resilience and reduce your experience of burnout. Recent research reports that increasing your focus on showing gratitude to other important people in your life will enhance your wellness. In a study completed in a health care setting, 102 clinicians were randomly assigned to 1 of 3 groups: 1) write about gratitude and work, 2) write about hassles and work, or 3) do not write about work. Those assigned to the 2 writing groups were instructed to write on their topic twice weekly for 4 weeks. At the end of the study the clinicians assigned to the gratitude writing assignment reported less stress and fewer depressive symptoms than the clinicians assigned to the other 2 groups.⁵ The investigators concluded that among clinicians a structured exercise to focus thoughts and feelings on expressions of gratitude is an effective approach to reduce stress and depressive symptoms. I recommend that you complete “the gratitude exercise.”

The future of obstetrics and gynecology is bright

Medical students are electing to pursue a career in obstetrics and gynecology in record numbers. The students entering the field and the residents currently in training are superbly prepared and have demonstrated their commitment to advancing reproductive health by experiences in advocacy, research, and community service. We need to ensure that these super-star young physicians are able to have a 40-year career that is productive and fulfilling.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The mission of OBG Management is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. As we celebrate the beginning of our 30th anniversary year, we recommit to our mission by providing the highest quality of health information through both print and electronic portals.

OBG Management: Print and electronic portals for knowledge acquisition

Experienced clinicians acquire new knowledge and refresh established concepts through discussions with trusted colleagues and by reading journals and books that contain information relevant to their practice. A continuing trend in professional development is the accelerating transition from a reliance on print media (print journals and books) to electronic information delivery. Many clinicians continue to enjoy reading medical journals and magazines. ObGyns are no different; 96% report reading the print edition of medical journals.¹ At OBG Management we are committed to continue to mail you a monthly copy of our journal.

However, in the time-pressured setting of office- and hospital-based patient care, critical information is now frequently accessed through an electronic portal that is web based and focused on immediately answering a high priority question necessary for optimal patient care. OBG Management provides our community with rapid access to electronic versions of the journal and all previously published editorial material. Many web exclusives are found online as well, including audio and video techniques and commentary. The OBG Management website has a powerful search engine, which permits our readers to rapidly and conveniently access all previously published articles. In addition, our community members that have provided us with electronic contact information receive regular electronic communications about recently published literature (Clinical Edge), highly read articles and topical alerts from the journal, and MD-IQ quizzes to help review recent research and guidelines in an interactive medium.

The information base needed to practice medicine is massive and continues to grow rapidly. No single print textbook or journal can cover this vast information base. Libraries of print material are cumbersome to use and ordinarily not accessible at the site of patient care. Electronic portals are the only means of providing immediate access to all medical knowledge. Electronic technology enables the aggregation of vast amounts of information in a database that is rapidly accessible from anywhere, and new search technology is making it easier to quickly locate the information you need.

The next frontier in medical information exchange is the application of artificial intelligence to cull “answers” from the vast aggregation of data. By combining all available medical information and artificial intelligence processes, in the near future, clinicians will be able to instantaneously get an answer to a question they have about how to care for a specific patient. A decade ago, when a question was entered into an Internet search engine, the response was typically a list of potential websites where the answer might be located. In the past few years, with the integration of huge databases and artificial intelligence, some advanced search engines now provide a specific answer to a question, followed by a list of relevant websites. For example, if you enter this question: “What countries have the greatest number of people?” into the Google search tool, in less than 1 second a direct answer is provided: “China has the world’s largest population (1.4 billion), followed by India (1.3 billion). The next most populous nations—the United States, Indonesia, Brazil and Pakistan—combined have less than 1 billion people.” The next step in medical information communication will be the deployment of artificial intelligence systems that can directly answer a query from a clinician about a specific patient.

Our distinguished Editorial Board and authors—the heart and mind of OBG Management

The editorial team at OBG Management is proud to work with the distinguished medical leaders who write our articles and serve on our Editorial Board. The guidance we receive from our Board and the expert editorial material generated by our authors is critical to advancing the quality of OBG Management. Our Board members and authors care deeply about improving women’s health and closing gaps between current and optimal practice. Our Board members and authors are truly expert clinicians with vast experience. Our readers can have great confidence in their recommendations.

Improving clinician wellness and resilience and reducing burnout

Clinicians throughout the world are reporting decreased levels of professional fulfillment and increased levels of burnout.^2–4 This epidemic is likely caused by many factors, including the deployment of poorly designed electronic health systems, the administrative guidance for clinicians to work faster with fewer support staff, increasing administrative and secretarial burden on clinicians, and institutional constraints on clinician autonomy. Many of these problems only can be addressed at the level of the health system, but some are in the control of individual clinicians.

In the upcoming years, OBG Management will prioritize deepening the knowledge about the factors that support clinician wellness and share approaches that may help you to improve your wellness and resilience and reduce your experience of burnout. Recent research reports that increasing your focus on showing gratitude to other important people in your life will enhance your wellness. In a study completed in a health care setting, 102 clinicians were randomly assigned to 1 of 3 groups: 1) write about gratitude and work, 2) write about hassles and work, or 3) do not write about work. Those assigned to the 2 writing groups were instructed to write on their topic twice weekly for 4 weeks. At the end of the study the clinicians assigned to the gratitude writing assignment reported less stress and fewer depressive symptoms than the clinicians assigned to the other 2 groups.⁵ The investigators concluded that among clinicians a structured exercise to focus thoughts and feelings on expressions of gratitude is an effective approach to reduce stress and depressive symptoms. I recommend that you complete “the gratitude exercise.”

The future of obstetrics and gynecology is bright

Medical students are electing to pursue a career in obstetrics and gynecology in record numbers. The students entering the field and the residents currently in training are superbly prepared and have demonstrated their commitment to advancing reproductive health by experiences in advocacy, research, and community service. We need to ensure that these super-star young physicians are able to have a 40-year career that is productive and fulfilling.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The mission of OBG Management is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. As we celebrate the beginning of our 30th anniversary year, we recommit to our mission by providing the highest quality of health information through both print and electronic portals.

OBG Management: Print and electronic portals for knowledge acquisition

Experienced clinicians acquire new knowledge and refresh established concepts through discussions with trusted colleagues and by reading journals and books that contain information relevant to their practice. A continuing trend in professional development is the accelerating transition from a reliance on print media (print journals and books) to electronic information delivery. Many clinicians continue to enjoy reading medical journals and magazines. ObGyns are no different; 96% report reading the print edition of medical journals.¹ At OBG Management we are committed to continue to mail you a monthly copy of our journal.

However, in the time-pressured setting of office- and hospital-based patient care, critical information is now frequently accessed through an electronic portal that is web based and focused on immediately answering a high priority question necessary for optimal patient care. OBG Management provides our community with rapid access to electronic versions of the journal and all previously published editorial material. Many web exclusives are found online as well, including audio and video techniques and commentary. The OBG Management website has a powerful search engine, which permits our readers to rapidly and conveniently access all previously published articles. In addition, our community members that have provided us with electronic contact information receive regular electronic communications about recently published literature (Clinical Edge), highly read articles and topical alerts from the journal, and MD-IQ quizzes to help review recent research and guidelines in an interactive medium.

The information base needed to practice medicine is massive and continues to grow rapidly. No single print textbook or journal can cover this vast information base. Libraries of print material are cumbersome to use and ordinarily not accessible at the site of patient care. Electronic portals are the only means of providing immediate access to all medical knowledge. Electronic technology enables the aggregation of vast amounts of information in a database that is rapidly accessible from anywhere, and new search technology is making it easier to quickly locate the information you need.

The next frontier in medical information exchange is the application of artificial intelligence to cull “answers” from the vast aggregation of data. By combining all available medical information and artificial intelligence processes, in the near future, clinicians will be able to instantaneously get an answer to a question they have about how to care for a specific patient. A decade ago, when a question was entered into an Internet search engine, the response was typically a list of potential websites where the answer might be located. In the past few years, with the integration of huge databases and artificial intelligence, some advanced search engines now provide a specific answer to a question, followed by a list of relevant websites. For example, if you enter this question: “What countries have the greatest number of people?” into the Google search tool, in less than 1 second a direct answer is provided: “China has the world’s largest population (1.4 billion), followed by India (1.3 billion). The next most populous nations—the United States, Indonesia, Brazil and Pakistan—combined have less than 1 billion people.” The next step in medical information communication will be the deployment of artificial intelligence systems that can directly answer a query from a clinician about a specific patient.

Our distinguished Editorial Board and authors—the heart and mind of OBG Management

The editorial team at OBG Management is proud to work with the distinguished medical leaders who write our articles and serve on our Editorial Board. The guidance we receive from our Board and the expert editorial material generated by our authors is critical to advancing the quality of OBG Management. Our Board members and authors care deeply about improving women’s health and closing gaps between current and optimal practice. Our Board members and authors are truly expert clinicians with vast experience. Our readers can have great confidence in their recommendations.

Improving clinician wellness and resilience and reducing burnout

Clinicians throughout the world are reporting decreased levels of professional fulfillment and increased levels of burnout.^2–4 This epidemic is likely caused by many factors, including the deployment of poorly designed electronic health systems, the administrative guidance for clinicians to work faster with fewer support staff, increasing administrative and secretarial burden on clinicians, and institutional constraints on clinician autonomy. Many of these problems only can be addressed at the level of the health system, but some are in the control of individual clinicians.

In the upcoming years, OBG Management will prioritize deepening the knowledge about the factors that support clinician wellness and share approaches that may help you to improve your wellness and resilience and reduce your experience of burnout. Recent research reports that increasing your focus on showing gratitude to other important people in your life will enhance your wellness. In a study completed in a health care setting, 102 clinicians were randomly assigned to 1 of 3 groups: 1) write about gratitude and work, 2) write about hassles and work, or 3) do not write about work. Those assigned to the 2 writing groups were instructed to write on their topic twice weekly for 4 weeks. At the end of the study the clinicians assigned to the gratitude writing assignment reported less stress and fewer depressive symptoms than the clinicians assigned to the other 2 groups.⁵ The investigators concluded that among clinicians a structured exercise to focus thoughts and feelings on expressions of gratitude is an effective approach to reduce stress and depressive symptoms. I recommend that you complete “the gratitude exercise.”

The future of obstetrics and gynecology is bright

Medical students are electing to pursue a career in obstetrics and gynecology in record numbers. The students entering the field and the residents currently in training are superbly prepared and have demonstrated their commitment to advancing reproductive health by experiences in advocacy, research, and community service. We need to ensure that these super-star young physicians are able to have a 40-year career that is productive and fulfilling.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

VICTORIA, B.C. – Several new and improved molecular classifiers show good performance for preoperatively assessing the nature of thyroid nodules, including histologic subsets that continue to pose diagnostic challenges, according to a trio of studies reported at the annual meeting of the American Thyroid Association.

ThyroSeq v3 classifier

In a prospective, blinded, multi-institutional study, investigators validated the ThyroSeq v3 genomic classifier, which uses next-generation sequencing to test for mutations, fusions, gene expression alterations, and copy number variations in 112 genes.

The validation cohort consisted of 234 patients from 10 centers who had thyroid nodules with Bethesda III to V cytology and known surgical outcome, with central pathology review, and successful molecular testing. In total, they had 257 fine needle aspiration samples.

Of the 247 samples from nodules having Bethesda III or IV cytology – those of greatest interest – 28% were cancer or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), reported senior author Yuri Nikiforov, MD, PhD, professor of pathology and director of the division of molecular & genomic pathology at the University of Pittsburgh Medical Center. “Both cancer and NIFTP are surgical diseases, so we felt they belong in one group,” he noted.

Afirma GSC with Hurthle classifiers

In a second study, investigators led by Quan-Yang Duh, MD, professor of surgery, division of general surgery, and chief, section of endocrine surgery, University of California, San Francisco, developed and validated a pair of classifiers to enhance performance of the Afirma platform among Hurthle cell specimens.

“The Hurthle cell lesions tend to give us trouble,” Dr. Duh said. On molecular analysis, those that are malignant seldom harbor mutations that would aid diagnosis, whereas those that are benign are usually classified as suspicious by the original Afirma Gene Expression Classifier (GEC).

“The specific group that is causing trouble are those that are Hurthle cell but not neoplasm, because they are the ones that give you the false positives,” Dr. Duh said. Therefore, it makes sense to stratify lesions on both of these factors, and then subject that specific subset to a more stringent threshold.

Afirma GSC with medullary thyroid cancer classifier

In a third study, investigators developed and validated a classifier for medullary thyroid cancer to be used with the Afirma GSC. They were led by Gregory Randolph, MD, professor of otolaryngology and the Claire and John Bertucci Endowed Chair in Thyroid Surgical Oncology at Harvard Medical School, and division chief of the general and thyroid/parathyroid endocrine surgical divisions at the Massachusetts Eye and Ear Infirmary, Boston.

Better preoperative identification of this cancer is key for several reasons, he maintained.

VICTORIA, B.C. – Several new and improved molecular classifiers show good performance for preoperatively assessing the nature of thyroid nodules, including histologic subsets that continue to pose diagnostic challenges, according to a trio of studies reported at the annual meeting of the American Thyroid Association.

ThyroSeq v3 classifier

In a prospective, blinded, multi-institutional study, investigators validated the ThyroSeq v3 genomic classifier, which uses next-generation sequencing to test for mutations, fusions, gene expression alterations, and copy number variations in 112 genes.

The validation cohort consisted of 234 patients from 10 centers who had thyroid nodules with Bethesda III to V cytology and known surgical outcome, with central pathology review, and successful molecular testing. In total, they had 257 fine needle aspiration samples.

Of the 247 samples from nodules having Bethesda III or IV cytology – those of greatest interest – 28% were cancer or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), reported senior author Yuri Nikiforov, MD, PhD, professor of pathology and director of the division of molecular & genomic pathology at the University of Pittsburgh Medical Center. “Both cancer and NIFTP are surgical diseases, so we felt they belong in one group,” he noted.

Afirma GSC with Hurthle classifiers

In a second study, investigators led by Quan-Yang Duh, MD, professor of surgery, division of general surgery, and chief, section of endocrine surgery, University of California, San Francisco, developed and validated a pair of classifiers to enhance performance of the Afirma platform among Hurthle cell specimens.

“The Hurthle cell lesions tend to give us trouble,” Dr. Duh said. On molecular analysis, those that are malignant seldom harbor mutations that would aid diagnosis, whereas those that are benign are usually classified as suspicious by the original Afirma Gene Expression Classifier (GEC).

“The specific group that is causing trouble are those that are Hurthle cell but not neoplasm, because they are the ones that give you the false positives,” Dr. Duh said. Therefore, it makes sense to stratify lesions on both of these factors, and then subject that specific subset to a more stringent threshold.

Afirma GSC with medullary thyroid cancer classifier

In a third study, investigators developed and validated a classifier for medullary thyroid cancer to be used with the Afirma GSC. They were led by Gregory Randolph, MD, professor of otolaryngology and the Claire and John Bertucci Endowed Chair in Thyroid Surgical Oncology at Harvard Medical School, and division chief of the general and thyroid/parathyroid endocrine surgical divisions at the Massachusetts Eye and Ear Infirmary, Boston.

Better preoperative identification of this cancer is key for several reasons, he maintained.

VICTORIA, B.C. – Several new and improved molecular classifiers show good performance for preoperatively assessing the nature of thyroid nodules, including histologic subsets that continue to pose diagnostic challenges, according to a trio of studies reported at the annual meeting of the American Thyroid Association.

ThyroSeq v3 classifier

In a prospective, blinded, multi-institutional study, investigators validated the ThyroSeq v3 genomic classifier, which uses next-generation sequencing to test for mutations, fusions, gene expression alterations, and copy number variations in 112 genes.

The validation cohort consisted of 234 patients from 10 centers who had thyroid nodules with Bethesda III to V cytology and known surgical outcome, with central pathology review, and successful molecular testing. In total, they had 257 fine needle aspiration samples.

Of the 247 samples from nodules having Bethesda III or IV cytology – those of greatest interest – 28% were cancer or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), reported senior author Yuri Nikiforov, MD, PhD, professor of pathology and director of the division of molecular & genomic pathology at the University of Pittsburgh Medical Center. “Both cancer and NIFTP are surgical diseases, so we felt they belong in one group,” he noted.

Afirma GSC with Hurthle classifiers

In a second study, investigators led by Quan-Yang Duh, MD, professor of surgery, division of general surgery, and chief, section of endocrine surgery, University of California, San Francisco, developed and validated a pair of classifiers to enhance performance of the Afirma platform among Hurthle cell specimens.

“The Hurthle cell lesions tend to give us trouble,” Dr. Duh said. On molecular analysis, those that are malignant seldom harbor mutations that would aid diagnosis, whereas those that are benign are usually classified as suspicious by the original Afirma Gene Expression Classifier (GEC).

“The specific group that is causing trouble are those that are Hurthle cell but not neoplasm, because they are the ones that give you the false positives,” Dr. Duh said. Therefore, it makes sense to stratify lesions on both of these factors, and then subject that specific subset to a more stringent threshold.

Afirma GSC with medullary thyroid cancer classifier

In a third study, investigators developed and validated a classifier for medullary thyroid cancer to be used with the Afirma GSC. They were led by Gregory Randolph, MD, professor of otolaryngology and the Claire and John Bertucci Endowed Chair in Thyroid Surgical Oncology at Harvard Medical School, and division chief of the general and thyroid/parathyroid endocrine surgical divisions at the Massachusetts Eye and Ear Infirmary, Boston.

Better preoperative identification of this cancer is key for several reasons, he maintained.

ATLANTA – Closely monitoring for cytokine release syndrome (CRS) and starting anticytokine therapy early can prevent life-threatening organ toxicities in recipients of chimeric antigen receptor (CAR) T-cell therapy, according to Daniel W. Lee III, MD.

There’s no evidence that early anticytokine therapy impairs antitumor response, he noted. “If you wait to give anticytokine therapy until a patient is intubated, it’s too late,” Dr. Lee said at the annual meeting of the American Society of Hematology. “If you wait until a patient has been hypotensive for days, it’s probably too late. If you intervene earlier, you can avoid intubation.”

ATLANTA – Closely monitoring for cytokine release syndrome (CRS) and starting anticytokine therapy early can prevent life-threatening organ toxicities in recipients of chimeric antigen receptor (CAR) T-cell therapy, according to Daniel W. Lee III, MD.

There’s no evidence that early anticytokine therapy impairs antitumor response, he noted. “If you wait to give anticytokine therapy until a patient is intubated, it’s too late,” Dr. Lee said at the annual meeting of the American Society of Hematology. “If you wait until a patient has been hypotensive for days, it’s probably too late. If you intervene earlier, you can avoid intubation.”

ATLANTA – Closely monitoring for cytokine release syndrome (CRS) and starting anticytokine therapy early can prevent life-threatening organ toxicities in recipients of chimeric antigen receptor (CAR) T-cell therapy, according to Daniel W. Lee III, MD.

There’s no evidence that early anticytokine therapy impairs antitumor response, he noted. “If you wait to give anticytokine therapy until a patient is intubated, it’s too late,” Dr. Lee said at the annual meeting of the American Society of Hematology. “If you wait until a patient has been hypotensive for days, it’s probably too late. If you intervene earlier, you can avoid intubation.”

Imaging Shows Youth Football’s Effects on the Brain

School-age football players with a history of concussion and high impact exposure undergo brain changes after one season of play, according to two studies conducted at the University of Texas Southwestern Medical Center in Dallas and Wake Forest University in Winston-Salem, North Carolina.

Both studies analyzed the default mode network (DMN), a system of brain regions that is active during wakeful rest. Changes in the DMN are observed in patients with mental disorders. Decreased connectivity within the network is also associated with traumatic brain injury.

“The DMN exists in the deep gray matter areas of the brain,” said Elizabeth M. Davenport, PhD, a postdoctoral researcher in the Advanced NeuroScience Imaging Research (ANSIR) lab at UT Southwestern’s O’Donnell Brain Institute. “It includes structures that activate when we are awake and engaging in introspection or processing emotions, which are activities that are important for brain health.”

In the first study, researchers studied youth football players without a history of concussion to identify the effect of repeated subconcussive impacts on the DMN.

“Over a season of football, players are exposed to numerous head impacts. The vast majority of these do not result in concussion,” said Gowtham Krishnan Murugesan, a PhD student in biomedical engineering and member of the ANSIR laboratory. “This work adds to a growing body of literature indicating that subconcussive head impacts can have an effect on the brain. This is a highly understudied area at the youth and high school level.”

For the study, 26 youth football players (ages 9–13) were outfitted with the Head Impact Telemetry System (HITS) for an entire football season. HITS helmets are lined with accelerometers that measure the magnitude, location, and direction of impacts to the head. Impact data from the helmets were used to calculate a risk of concussion exposure for each player.

Players were separated into high and low concussion exposure groups. Players with a history of concussion were excluded. A third group of 13 noncontact sport controls was established. Pre- and post-season resting functional MRI (fMRI) scans were performed on all players and controls, and connectivity within the DMN subcomponents was analyzed. The researchers used machine learning to analyze the fMRI data.

“Machine learning has a lot to add to our research because it gives us a fresh perspective and an ability to analyze the complex relationships within the data,” said Mr. Murugesan. “Our results suggest an increasing functional change in the brain with increasing head impact exposure.”

Five machine learning classification algorithms were used to predict whether players were in the high-exposure, low-exposure or noncontact groups, based on the fMRI results. The algorithm discriminated between high-impact exposure and noncontact controls with 82% accuracy, and between low-impact exposure and noncontact controls with 70% accuracy. The results suggest an increasing functional change with increasing head-impact exposure.

“The brains of these youth and adolescent athletes are undergoing rapid maturation in this age range. This study demonstrates that playing a season of contact sports at the youth level can produce neuroimaging brain changes, particularly for the DMN,” Mr. Murugesan said.

In the second study, 20 high school football players (median age, 16.9) wore helmets outfitted with HITS for a season. Of the 20 players, five had experienced at least one concussion, and 15 had no history of concussion.

Before and following the season, the players underwent an eight-minute magnetoencephalography (MEG) scan, which records and analyzes the magnetic fields produced by brain activity. Researchers then analyzed the MEG power associated with the eight brain regions of the DMN.

Post-season, the five players with a history of concussion had significantly lower connectivity between DMN regions. Players with no history of concussion had, on average, an increase in DMN connectivity.

The results demonstrate that concussions from previous years can influence the changes occurring in the brain during the current season, suggesting that longitudinal effects of concussion affect brain function.

“The brain’s DMN changes differently as a result of previous concussion,” said Dr. Davenport. “Previous concussion seems to prime the brain for additional changes. Concussion history may be affecting the brain’s ability to compensate for subconcussive impacts.”

Both researchers said that larger data sets, longitudinal studies that follow young football players, and research that combines MEG and fMRI are needed to better understand the complex factors involved in concussions.

Neurofeedback May Help Treat Tinnitus

Functional MRI (fMRI) suggests that neurofeedback training has the potential to reduce the severity of tinnitus or eliminate it.

Tinnitus affects approximately one in five people. As patients focus more on the noise, they become more frustrated and anxious, which in turn makes the noise seem worse. The primary auditory cortex has been implicated in tinnitus-related distress.

Researchers examined a potential way to treat tinnitus by having people use neurofeedback training to divert their focus from the sounds in their ears. Neurofeedback is a way of training the brain by allowing an individual to view an external indicator of brain activity and attempt to exert control over it.

“The idea is that in people with tinnitus, there is an overattention drawn to the auditory cortex, making it more active than in a healthy person,” said Matthew S. Sherwood, PhD, a research engineer in the Department of Biomedical, Industrial, and Human Factors Engineering at Wright State University in Fairborn, Ohio. “Our hope is that tinnitus sufferers could use neurofeedback to divert attention away from their tinnitus and possibly make it go away.”

To determine the potential efficacy of this approach, the researchers asked 18 healthy volunteers with normal hearing to undergo five fMRI-neurofeedback training sessions. Study participants were given earplugs through which white noise could be introduced. The earplugs also blocked out the scanner noise.

To obtain fMRI results, the researchers used single-shot echoplanar imaging, an MRI technique that is sensitive to blood oxygen levels, providing an indirect measure of brain activity.

“We started with alternating periods of sound and no sound in order to create a map of the brain and find areas that produced the highest activity during the sound phase,” said Dr. Sherwood. “Then we selected the voxels that were heavily activated when sound was being played.”

The subjects then participated in the fMRI-neurofeedback training phase while inside the MRI scanner. They received white noise through their earplugs and were able to view the activity in their primary auditory cortex as a bar on a screen. Each fMRI-neurofeedback training session contained eight blocks separated into a 30-second “relax” period, followed by a 30-second “lower” period. Participants were instructed to watch the bar during the relax period and attempt to lower it by decreasing primary auditory cortex activity during the lower phase. The researchers gave the participants techniques to help them do this, such as trying to divert attention from sound to other sensations like touch and sight.

“Many focused on breathing because it gave them a feeling of control,” said Dr. Sherwood. “By diverting their attention away from sound, the participants’ auditory cortex activity went down, and the signal we were measuring also went down.”

A control group of nine individuals was provided sham neurofeedback. They performed the same tasks as the other group, but the feedback came not from them, but from a random participant. By performing the exact same procedures with both groups using either real or sham neurofeedback, the researchers were able to distinguish the effect of real neurofeedback on control of the primary auditory cortex.

The study represents the first time that fMRI-neurofeedback training has been applied to demonstrate that there is a significant relationship between control of the primary auditory cortex and attentional processes. This result is important to therapeutic development, said Dr. Sherwood, because the neural mechanisms of tinnitus are unknown, but likely related to attention.

The results represent a promising avenue of research that could lead to improvements in other areas of health, like pain management, according to Dr. Sherwood. “Ultimately, we would like to take what we learned from MRI and develop a neurofeedback program that does not require MRI to use, such as an app or home-based therapy that could apply to tinnitus and other conditions,” he said.

Migraine Is Associated With High Sodium Levels in CSF

Migraineurs have significantly higher sodium concentrations in their CSF than people without migraine, according to the first study to use a technique called sodium MRI to examine patients with migraine.

Diagnosis of migraine is challenging, as the characteristics of migraines and the types of attacks vary widely among patients. Consequently, many patients with migraine are undiagnosed and untreated. Other patients, in contrast, are treated with medications for migraines even though they have a different type of headache, such as tension-type headache.

“It would be helpful to have a diagnostic tool supporting or even diagnosing migraine and differentiating migraine from all other types of headache,” said Melissa Meyer, MD, a radiology resident at the Institute of Clinical Radiology and Nuclear Medicine at University Hospital Mannheim and Heidelberg University in Heidelberg, Germany.

Dr. Meyer and colleagues explored a technique called cerebral sodium MRI as a possible means to help in the diagnosis and understanding of migraine. While MRI most often relies on protons to generate an image, sodium can be visualized as well. Research has shown that sodium plays an important role in brain chemistry.

The researchers recruited 12 women (mean age, 34) who had been clinically evaluated for migraine. The women filled out a questionnaire regarding the length, intensity, and frequency of their migraine attacks and accompanying auras. The researchers also enrolled 12 healthy women of similar age as a control group. Both groups underwent cerebral sodium MRI. Sodium concentrations of patients with migraine and healthy controls were compared and statistically analyzed.

The researchers found no significant differences between the two groups in sodium concentrations in the gray and white matter, brainstem, and cerebellum. Significant differences emerged, however, when the researchers looked at sodium concentrations in the CSF. Overall, sodium concentrations were significantly higher in the CSF of migraineurs than in healthy controls.

“These findings might facilitate the challenging diagnosis of a migraine,” said Dr. Meyer. The researchers hope to learn more about the connection between migraine and sodium in future studies. “As this was an exploratory study, we plan to examine more patients, preferably during or shortly after a migraine attack, for further validation.”

Gadolinium May Not Cause Neurologic Harm

There is no evidence that accumulation of gadolinium in the brain speeds cognitive decline, according to researchers.

“Approximately 400 million doses of gadolinium have been administered since 1988,” said Robert J. McDonald, MD, PhD, a neuroradiologist at the Mayo Clinic in Rochester, Minnesota. “Gadolinium contrast material is used in 40% to 50% of MRI scans performed today.”

Scientists previously believed that gadolinium contrast material could not cross the blood–brain barrier. Recent studies, however, including one by Dr. McDonald and colleagues, found that traces of gadolinium could be retained in the brain for years after MRI.

On September 8, 2017, the FDA recommended adding a warning about gadolinium retention in various organs, including the brain, to labels for gadolinium-based contrast agents used during MRI. The FDA highlighted several specific patient populations at greater risk, including children and pregnant women. Yet little is known about the health effects, if any, of gadolinium that is retained in the brain.

For this study, Dr. McDonald and colleagues set out to identify the neurotoxic potential of intracranial gadolinium deposition following IV administration of gadolinium-based contrast agents during MRI. The researchers used the Mayo Clinic Study of Aging (MCSA), the world’s largest prospective population-based cohort on aging, to study the effects of gadolinium exposure on neurologic and neurocognitive function.

All MCSA participants underwent extensive neurologic evaluation and neuropsychologic testing at baseline and 15-month follow-up intervals. Neurologic and neurocognitive scores were compared using standard methods between MCSA patients with no history of prior gadolinium exposure and those who had undergone prior MRI with gadolinium-based contrast agents. Progression from normal cognitive status to mild cognitive impairment and dementia was assessed using multistate Markov model analysis.

The study included 4,261 cognitively normal men and women between ages 50 and 90 (mean age, 72). Mean length of study participation was 3.7 years. Of the 4,261 participants, 1,092 (25.6%) had received one or more doses of gadolinium-based contrast agents, with at least one participant receiving as many as 28 prior doses. Median time since first gadolinium exposure was 5.6 years.

After adjusting for age, sex, education level, baseline neurocognitive performance, and other factors, gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychologic performance, or diminished motor performance. No dose-related effects were observed among these metrics. Gadolinium exposure was not an independent risk factor in the rate of cognitive decline from normal cognitive status to dementia in this study group.

“There is concern over the safety of gadolinium-based contrast agents, particularly relating to gadolinium retention in the brain and other tissues,” said Dr. McDonald. “This study provides useful data that at the reasonable doses [that] 95% of the population is likely to receive in their lifetime, there is no evidence at this point that gadolinium retention in the brain is associated with adverse clinical outcomes.”

Imaging Shows Youth Football’s Effects on the Brain

School-age football players with a history of concussion and high impact exposure undergo brain changes after one season of play, according to two studies conducted at the University of Texas Southwestern Medical Center in Dallas and Wake Forest University in Winston-Salem, North Carolina.

Both studies analyzed the default mode network (DMN), a system of brain regions that is active during wakeful rest. Changes in the DMN are observed in patients with mental disorders. Decreased connectivity within the network is also associated with traumatic brain injury.

“The DMN exists in the deep gray matter areas of the brain,” said Elizabeth M. Davenport, PhD, a postdoctoral researcher in the Advanced NeuroScience Imaging Research (ANSIR) lab at UT Southwestern’s O’Donnell Brain Institute. “It includes structures that activate when we are awake and engaging in introspection or processing emotions, which are activities that are important for brain health.”

In the first study, researchers studied youth football players without a history of concussion to identify the effect of repeated subconcussive impacts on the DMN.

“Over a season of football, players are exposed to numerous head impacts. The vast majority of these do not result in concussion,” said Gowtham Krishnan Murugesan, a PhD student in biomedical engineering and member of the ANSIR laboratory. “This work adds to a growing body of literature indicating that subconcussive head impacts can have an effect on the brain. This is a highly understudied area at the youth and high school level.”

For the study, 26 youth football players (ages 9–13) were outfitted with the Head Impact Telemetry System (HITS) for an entire football season. HITS helmets are lined with accelerometers that measure the magnitude, location, and direction of impacts to the head. Impact data from the helmets were used to calculate a risk of concussion exposure for each player.

Players were separated into high and low concussion exposure groups. Players with a history of concussion were excluded. A third group of 13 noncontact sport controls was established. Pre- and post-season resting functional MRI (fMRI) scans were performed on all players and controls, and connectivity within the DMN subcomponents was analyzed. The researchers used machine learning to analyze the fMRI data.

“Machine learning has a lot to add to our research because it gives us a fresh perspective and an ability to analyze the complex relationships within the data,” said Mr. Murugesan. “Our results suggest an increasing functional change in the brain with increasing head impact exposure.”

Five machine learning classification algorithms were used to predict whether players were in the high-exposure, low-exposure or noncontact groups, based on the fMRI results. The algorithm discriminated between high-impact exposure and noncontact controls with 82% accuracy, and between low-impact exposure and noncontact controls with 70% accuracy. The results suggest an increasing functional change with increasing head-impact exposure.

“The brains of these youth and adolescent athletes are undergoing rapid maturation in this age range. This study demonstrates that playing a season of contact sports at the youth level can produce neuroimaging brain changes, particularly for the DMN,” Mr. Murugesan said.

In the second study, 20 high school football players (median age, 16.9) wore helmets outfitted with HITS for a season. Of the 20 players, five had experienced at least one concussion, and 15 had no history of concussion.

Before and following the season, the players underwent an eight-minute magnetoencephalography (MEG) scan, which records and analyzes the magnetic fields produced by brain activity. Researchers then analyzed the MEG power associated with the eight brain regions of the DMN.

Post-season, the five players with a history of concussion had significantly lower connectivity between DMN regions. Players with no history of concussion had, on average, an increase in DMN connectivity.

The results demonstrate that concussions from previous years can influence the changes occurring in the brain during the current season, suggesting that longitudinal effects of concussion affect brain function.

“The brain’s DMN changes differently as a result of previous concussion,” said Dr. Davenport. “Previous concussion seems to prime the brain for additional changes. Concussion history may be affecting the brain’s ability to compensate for subconcussive impacts.”

Both researchers said that larger data sets, longitudinal studies that follow young football players, and research that combines MEG and fMRI are needed to better understand the complex factors involved in concussions.

Neurofeedback May Help Treat Tinnitus

Functional MRI (fMRI) suggests that neurofeedback training has the potential to reduce the severity of tinnitus or eliminate it.

Tinnitus affects approximately one in five people. As patients focus more on the noise, they become more frustrated and anxious, which in turn makes the noise seem worse. The primary auditory cortex has been implicated in tinnitus-related distress.

Researchers examined a potential way to treat tinnitus by having people use neurofeedback training to divert their focus from the sounds in their ears. Neurofeedback is a way of training the brain by allowing an individual to view an external indicator of brain activity and attempt to exert control over it.

“The idea is that in people with tinnitus, there is an overattention drawn to the auditory cortex, making it more active than in a healthy person,” said Matthew S. Sherwood, PhD, a research engineer in the Department of Biomedical, Industrial, and Human Factors Engineering at Wright State University in Fairborn, Ohio. “Our hope is that tinnitus sufferers could use neurofeedback to divert attention away from their tinnitus and possibly make it go away.”

To determine the potential efficacy of this approach, the researchers asked 18 healthy volunteers with normal hearing to undergo five fMRI-neurofeedback training sessions. Study participants were given earplugs through which white noise could be introduced. The earplugs also blocked out the scanner noise.

To obtain fMRI results, the researchers used single-shot echoplanar imaging, an MRI technique that is sensitive to blood oxygen levels, providing an indirect measure of brain activity.

“We started with alternating periods of sound and no sound in order to create a map of the brain and find areas that produced the highest activity during the sound phase,” said Dr. Sherwood. “Then we selected the voxels that were heavily activated when sound was being played.”

The subjects then participated in the fMRI-neurofeedback training phase while inside the MRI scanner. They received white noise through their earplugs and were able to view the activity in their primary auditory cortex as a bar on a screen. Each fMRI-neurofeedback training session contained eight blocks separated into a 30-second “relax” period, followed by a 30-second “lower” period. Participants were instructed to watch the bar during the relax period and attempt to lower it by decreasing primary auditory cortex activity during the lower phase. The researchers gave the participants techniques to help them do this, such as trying to divert attention from sound to other sensations like touch and sight.

“Many focused on breathing because it gave them a feeling of control,” said Dr. Sherwood. “By diverting their attention away from sound, the participants’ auditory cortex activity went down, and the signal we were measuring also went down.”

A control group of nine individuals was provided sham neurofeedback. They performed the same tasks as the other group, but the feedback came not from them, but from a random participant. By performing the exact same procedures with both groups using either real or sham neurofeedback, the researchers were able to distinguish the effect of real neurofeedback on control of the primary auditory cortex.

The study represents the first time that fMRI-neurofeedback training has been applied to demonstrate that there is a significant relationship between control of the primary auditory cortex and attentional processes. This result is important to therapeutic development, said Dr. Sherwood, because the neural mechanisms of tinnitus are unknown, but likely related to attention.

The results represent a promising avenue of research that could lead to improvements in other areas of health, like pain management, according to Dr. Sherwood. “Ultimately, we would like to take what we learned from MRI and develop a neurofeedback program that does not require MRI to use, such as an app or home-based therapy that could apply to tinnitus and other conditions,” he said.

Migraine Is Associated With High Sodium Levels in CSF

Migraineurs have significantly higher sodium concentrations in their CSF than people without migraine, according to the first study to use a technique called sodium MRI to examine patients with migraine.

Diagnosis of migraine is challenging, as the characteristics of migraines and the types of attacks vary widely among patients. Consequently, many patients with migraine are undiagnosed and untreated. Other patients, in contrast, are treated with medications for migraines even though they have a different type of headache, such as tension-type headache.

“It would be helpful to have a diagnostic tool supporting or even diagnosing migraine and differentiating migraine from all other types of headache,” said Melissa Meyer, MD, a radiology resident at the Institute of Clinical Radiology and Nuclear Medicine at University Hospital Mannheim and Heidelberg University in Heidelberg, Germany.

Dr. Meyer and colleagues explored a technique called cerebral sodium MRI as a possible means to help in the diagnosis and understanding of migraine. While MRI most often relies on protons to generate an image, sodium can be visualized as well. Research has shown that sodium plays an important role in brain chemistry.

The researchers recruited 12 women (mean age, 34) who had been clinically evaluated for migraine. The women filled out a questionnaire regarding the length, intensity, and frequency of their migraine attacks and accompanying auras. The researchers also enrolled 12 healthy women of similar age as a control group. Both groups underwent cerebral sodium MRI. Sodium concentrations of patients with migraine and healthy controls were compared and statistically analyzed.

The researchers found no significant differences between the two groups in sodium concentrations in the gray and white matter, brainstem, and cerebellum. Significant differences emerged, however, when the researchers looked at sodium concentrations in the CSF. Overall, sodium concentrations were significantly higher in the CSF of migraineurs than in healthy controls.

“These findings might facilitate the challenging diagnosis of a migraine,” said Dr. Meyer. The researchers hope to learn more about the connection between migraine and sodium in future studies. “As this was an exploratory study, we plan to examine more patients, preferably during or shortly after a migraine attack, for further validation.”

Gadolinium May Not Cause Neurologic Harm

There is no evidence that accumulation of gadolinium in the brain speeds cognitive decline, according to researchers.

“Approximately 400 million doses of gadolinium have been administered since 1988,” said Robert J. McDonald, MD, PhD, a neuroradiologist at the Mayo Clinic in Rochester, Minnesota. “Gadolinium contrast material is used in 40% to 50% of MRI scans performed today.”

Scientists previously believed that gadolinium contrast material could not cross the blood–brain barrier. Recent studies, however, including one by Dr. McDonald and colleagues, found that traces of gadolinium could be retained in the brain for years after MRI.

On September 8, 2017, the FDA recommended adding a warning about gadolinium retention in various organs, including the brain, to labels for gadolinium-based contrast agents used during MRI. The FDA highlighted several specific patient populations at greater risk, including children and pregnant women. Yet little is known about the health effects, if any, of gadolinium that is retained in the brain.

For this study, Dr. McDonald and colleagues set out to identify the neurotoxic potential of intracranial gadolinium deposition following IV administration of gadolinium-based contrast agents during MRI. The researchers used the Mayo Clinic Study of Aging (MCSA), the world’s largest prospective population-based cohort on aging, to study the effects of gadolinium exposure on neurologic and neurocognitive function.

All MCSA participants underwent extensive neurologic evaluation and neuropsychologic testing at baseline and 15-month follow-up intervals. Neurologic and neurocognitive scores were compared using standard methods between MCSA patients with no history of prior gadolinium exposure and those who had undergone prior MRI with gadolinium-based contrast agents. Progression from normal cognitive status to mild cognitive impairment and dementia was assessed using multistate Markov model analysis.

The study included 4,261 cognitively normal men and women between ages 50 and 90 (mean age, 72). Mean length of study participation was 3.7 years. Of the 4,261 participants, 1,092 (25.6%) had received one or more doses of gadolinium-based contrast agents, with at least one participant receiving as many as 28 prior doses. Median time since first gadolinium exposure was 5.6 years.

After adjusting for age, sex, education level, baseline neurocognitive performance, and other factors, gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychologic performance, or diminished motor performance. No dose-related effects were observed among these metrics. Gadolinium exposure was not an independent risk factor in the rate of cognitive decline from normal cognitive status to dementia in this study group.

“There is concern over the safety of gadolinium-based contrast agents, particularly relating to gadolinium retention in the brain and other tissues,” said Dr. McDonald. “This study provides useful data that at the reasonable doses [that] 95% of the population is likely to receive in their lifetime, there is no evidence at this point that gadolinium retention in the brain is associated with adverse clinical outcomes.”

Imaging Shows Youth Football’s Effects on the Brain

School-age football players with a history of concussion and high impact exposure undergo brain changes after one season of play, according to two studies conducted at the University of Texas Southwestern Medical Center in Dallas and Wake Forest University in Winston-Salem, North Carolina.

Both studies analyzed the default mode network (DMN), a system of brain regions that is active during wakeful rest. Changes in the DMN are observed in patients with mental disorders. Decreased connectivity within the network is also associated with traumatic brain injury.

“The DMN exists in the deep gray matter areas of the brain,” said Elizabeth M. Davenport, PhD, a postdoctoral researcher in the Advanced NeuroScience Imaging Research (ANSIR) lab at UT Southwestern’s O’Donnell Brain Institute. “It includes structures that activate when we are awake and engaging in introspection or processing emotions, which are activities that are important for brain health.”

In the first study, researchers studied youth football players without a history of concussion to identify the effect of repeated subconcussive impacts on the DMN.

“Over a season of football, players are exposed to numerous head impacts. The vast majority of these do not result in concussion,” said Gowtham Krishnan Murugesan, a PhD student in biomedical engineering and member of the ANSIR laboratory. “This work adds to a growing body of literature indicating that subconcussive head impacts can have an effect on the brain. This is a highly understudied area at the youth and high school level.”

For the study, 26 youth football players (ages 9–13) were outfitted with the Head Impact Telemetry System (HITS) for an entire football season. HITS helmets are lined with accelerometers that measure the magnitude, location, and direction of impacts to the head. Impact data from the helmets were used to calculate a risk of concussion exposure for each player.

Players were separated into high and low concussion exposure groups. Players with a history of concussion were excluded. A third group of 13 noncontact sport controls was established. Pre- and post-season resting functional MRI (fMRI) scans were performed on all players and controls, and connectivity within the DMN subcomponents was analyzed. The researchers used machine learning to analyze the fMRI data.

“Machine learning has a lot to add to our research because it gives us a fresh perspective and an ability to analyze the complex relationships within the data,” said Mr. Murugesan. “Our results suggest an increasing functional change in the brain with increasing head impact exposure.”

Five machine learning classification algorithms were used to predict whether players were in the high-exposure, low-exposure or noncontact groups, based on the fMRI results. The algorithm discriminated between high-impact exposure and noncontact controls with 82% accuracy, and between low-impact exposure and noncontact controls with 70% accuracy. The results suggest an increasing functional change with increasing head-impact exposure.

“The brains of these youth and adolescent athletes are undergoing rapid maturation in this age range. This study demonstrates that playing a season of contact sports at the youth level can produce neuroimaging brain changes, particularly for the DMN,” Mr. Murugesan said.

In the second study, 20 high school football players (median age, 16.9) wore helmets outfitted with HITS for a season. Of the 20 players, five had experienced at least one concussion, and 15 had no history of concussion.

Before and following the season, the players underwent an eight-minute magnetoencephalography (MEG) scan, which records and analyzes the magnetic fields produced by brain activity. Researchers then analyzed the MEG power associated with the eight brain regions of the DMN.

Post-season, the five players with a history of concussion had significantly lower connectivity between DMN regions. Players with no history of concussion had, on average, an increase in DMN connectivity.

The results demonstrate that concussions from previous years can influence the changes occurring in the brain during the current season, suggesting that longitudinal effects of concussion affect brain function.

“The brain’s DMN changes differently as a result of previous concussion,” said Dr. Davenport. “Previous concussion seems to prime the brain for additional changes. Concussion history may be affecting the brain’s ability to compensate for subconcussive impacts.”

Both researchers said that larger data sets, longitudinal studies that follow young football players, and research that combines MEG and fMRI are needed to better understand the complex factors involved in concussions.

Neurofeedback May Help Treat Tinnitus

Functional MRI (fMRI) suggests that neurofeedback training has the potential to reduce the severity of tinnitus or eliminate it.

Tinnitus affects approximately one in five people. As patients focus more on the noise, they become more frustrated and anxious, which in turn makes the noise seem worse. The primary auditory cortex has been implicated in tinnitus-related distress.

Researchers examined a potential way to treat tinnitus by having people use neurofeedback training to divert their focus from the sounds in their ears. Neurofeedback is a way of training the brain by allowing an individual to view an external indicator of brain activity and attempt to exert control over it.

“The idea is that in people with tinnitus, there is an overattention drawn to the auditory cortex, making it more active than in a healthy person,” said Matthew S. Sherwood, PhD, a research engineer in the Department of Biomedical, Industrial, and Human Factors Engineering at Wright State University in Fairborn, Ohio. “Our hope is that tinnitus sufferers could use neurofeedback to divert attention away from their tinnitus and possibly make it go away.”

To determine the potential efficacy of this approach, the researchers asked 18 healthy volunteers with normal hearing to undergo five fMRI-neurofeedback training sessions. Study participants were given earplugs through which white noise could be introduced. The earplugs also blocked out the scanner noise.

To obtain fMRI results, the researchers used single-shot echoplanar imaging, an MRI technique that is sensitive to blood oxygen levels, providing an indirect measure of brain activity.

“We started with alternating periods of sound and no sound in order to create a map of the brain and find areas that produced the highest activity during the sound phase,” said Dr. Sherwood. “Then we selected the voxels that were heavily activated when sound was being played.”

The subjects then participated in the fMRI-neurofeedback training phase while inside the MRI scanner. They received white noise through their earplugs and were able to view the activity in their primary auditory cortex as a bar on a screen. Each fMRI-neurofeedback training session contained eight blocks separated into a 30-second “relax” period, followed by a 30-second “lower” period. Participants were instructed to watch the bar during the relax period and attempt to lower it by decreasing primary auditory cortex activity during the lower phase. The researchers gave the participants techniques to help them do this, such as trying to divert attention from sound to other sensations like touch and sight.

“Many focused on breathing because it gave them a feeling of control,” said Dr. Sherwood. “By diverting their attention away from sound, the participants’ auditory cortex activity went down, and the signal we were measuring also went down.”

A control group of nine individuals was provided sham neurofeedback. They performed the same tasks as the other group, but the feedback came not from them, but from a random participant. By performing the exact same procedures with both groups using either real or sham neurofeedback, the researchers were able to distinguish the effect of real neurofeedback on control of the primary auditory cortex.

The study represents the first time that fMRI-neurofeedback training has been applied to demonstrate that there is a significant relationship between control of the primary auditory cortex and attentional processes. This result is important to therapeutic development, said Dr. Sherwood, because the neural mechanisms of tinnitus are unknown, but likely related to attention.

The results represent a promising avenue of research that could lead to improvements in other areas of health, like pain management, according to Dr. Sherwood. “Ultimately, we would like to take what we learned from MRI and develop a neurofeedback program that does not require MRI to use, such as an app or home-based therapy that could apply to tinnitus and other conditions,” he said.

Migraine Is Associated With High Sodium Levels in CSF

Migraineurs have significantly higher sodium concentrations in their CSF than people without migraine, according to the first study to use a technique called sodium MRI to examine patients with migraine.

Diagnosis of migraine is challenging, as the characteristics of migraines and the types of attacks vary widely among patients. Consequently, many patients with migraine are undiagnosed and untreated. Other patients, in contrast, are treated with medications for migraines even though they have a different type of headache, such as tension-type headache.

“It would be helpful to have a diagnostic tool supporting or even diagnosing migraine and differentiating migraine from all other types of headache,” said Melissa Meyer, MD, a radiology resident at the Institute of Clinical Radiology and Nuclear Medicine at University Hospital Mannheim and Heidelberg University in Heidelberg, Germany.

Dr. Meyer and colleagues explored a technique called cerebral sodium MRI as a possible means to help in the diagnosis and understanding of migraine. While MRI most often relies on protons to generate an image, sodium can be visualized as well. Research has shown that sodium plays an important role in brain chemistry.

The researchers recruited 12 women (mean age, 34) who had been clinically evaluated for migraine. The women filled out a questionnaire regarding the length, intensity, and frequency of their migraine attacks and accompanying auras. The researchers also enrolled 12 healthy women of similar age as a control group. Both groups underwent cerebral sodium MRI. Sodium concentrations of patients with migraine and healthy controls were compared and statistically analyzed.

The researchers found no significant differences between the two groups in sodium concentrations in the gray and white matter, brainstem, and cerebellum. Significant differences emerged, however, when the researchers looked at sodium concentrations in the CSF. Overall, sodium concentrations were significantly higher in the CSF of migraineurs than in healthy controls.

“These findings might facilitate the challenging diagnosis of a migraine,” said Dr. Meyer. The researchers hope to learn more about the connection between migraine and sodium in future studies. “As this was an exploratory study, we plan to examine more patients, preferably during or shortly after a migraine attack, for further validation.”

Gadolinium May Not Cause Neurologic Harm

There is no evidence that accumulation of gadolinium in the brain speeds cognitive decline, according to researchers.

“Approximately 400 million doses of gadolinium have been administered since 1988,” said Robert J. McDonald, MD, PhD, a neuroradiologist at the Mayo Clinic in Rochester, Minnesota. “Gadolinium contrast material is used in 40% to 50% of MRI scans performed today.”

Scientists previously believed that gadolinium contrast material could not cross the blood–brain barrier. Recent studies, however, including one by Dr. McDonald and colleagues, found that traces of gadolinium could be retained in the brain for years after MRI.

On September 8, 2017, the FDA recommended adding a warning about gadolinium retention in various organs, including the brain, to labels for gadolinium-based contrast agents used during MRI. The FDA highlighted several specific patient populations at greater risk, including children and pregnant women. Yet little is known about the health effects, if any, of gadolinium that is retained in the brain.

For this study, Dr. McDonald and colleagues set out to identify the neurotoxic potential of intracranial gadolinium deposition following IV administration of gadolinium-based contrast agents during MRI. The researchers used the Mayo Clinic Study of Aging (MCSA), the world’s largest prospective population-based cohort on aging, to study the effects of gadolinium exposure on neurologic and neurocognitive function.

All MCSA participants underwent extensive neurologic evaluation and neuropsychologic testing at baseline and 15-month follow-up intervals. Neurologic and neurocognitive scores were compared using standard methods between MCSA patients with no history of prior gadolinium exposure and those who had undergone prior MRI with gadolinium-based contrast agents. Progression from normal cognitive status to mild cognitive impairment and dementia was assessed using multistate Markov model analysis.

The study included 4,261 cognitively normal men and women between ages 50 and 90 (mean age, 72). Mean length of study participation was 3.7 years. Of the 4,261 participants, 1,092 (25.6%) had received one or more doses of gadolinium-based contrast agents, with at least one participant receiving as many as 28 prior doses. Median time since first gadolinium exposure was 5.6 years.

After adjusting for age, sex, education level, baseline neurocognitive performance, and other factors, gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychologic performance, or diminished motor performance. No dose-related effects were observed among these metrics. Gadolinium exposure was not an independent risk factor in the rate of cognitive decline from normal cognitive status to dementia in this study group.

“There is concern over the safety of gadolinium-based contrast agents, particularly relating to gadolinium retention in the brain and other tissues,” said Dr. McDonald. “This study provides useful data that at the reasonable doses [that] 95% of the population is likely to receive in their lifetime, there is no evidence at this point that gadolinium retention in the brain is associated with adverse clinical outcomes.”

FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdatedpregnancy with reduced fetal movements and not in labor; 2) full-term/postterm pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetric presentations. In my practice, induction is recommended for all women postterm who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdatedpregnancy with reduced fetal movements and not in labor; 2) full-term/postterm pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetric presentations. In my practice, induction is recommended for all women postterm who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdatedpregnancy with reduced fetal movements and not in labor; 2) full-term/postterm pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetric presentations. In my practice, induction is recommended for all women postterm who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.

In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”

gpointstudio/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.

In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”

gpointstudio/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.

In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”

gpointstudio/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.

Devonyu/thinkstock

[email protected]

The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.

Devonyu/thinkstock

[email protected]

The prevalence of autism spectrum disorder (ASD) in U.S. children and adolescents climbed to 2.41% from 2014 to 2016, Guifeng Xu, MD, and her associates, wrote in a research letter. However, the increased prevalence of ASD over the 3-year period was not statistically significant.

Devonyu/thinkstock

[email protected]

Brachial plexus injury: permanent disability

After concerning test results, a woman went to the hospital for induction of labor. During vaginal delivery, a shoulder dystocia was encountered. The baby was born within 60 seconds using the McRoberts maneuver and suprapubic pressure. The ObGyn charted mild shoulder dystocia.

The child has decreased mobility of his left arm. MRI studies and surgical findings confirmed brachial plexus rupture and avulsion at C5-C7. Despite nerve grafting, the child has a significant disability to his left arm and shoulder.

PARENT'S CLAIM: The ObGyn negligently applied excessive lateral traction, improperly used lateral traction as a maneuver, and instructed the mother to continuously push.

PHYSICIAN'S DEFENSE: Shoulder dystocia was properly diagnosed and resolved using standard maneuvers. Traction and pushing are needed during shoulder dystocia management to determine whether the maneuvers are successful. Brachial plexus injuries can occur because of the normal forces of labor and delivery.

VERDICT: An Illinois defense verdict was returned.

Mother claims PTSD after twin's stillbirth

Expecting twins, a 23-year-old woman at 33.5 weeks' gestation reported pain. The ObGyn noted that her cervix was 4-cm dilated, 1 twin was in breech position, and that labor had begun. He recommended that the patient go to the hospital for cesarean delivery but told her that she could go home, shower, and gather her belongings first. When the mother arrived at the hospital 2.5 hours later, the fetal heart-rate (FHR) monitor indicated that one twin's heart was not active. An emergency cesarean delivery was performed. One twin was safely born, but the other died.

PARENT'S CLAIM: The ObGyn failed to properly address the onset of labor. The twin died because of compression of the umbilical cord. If the mother had gone directly to the hospital, FHR abnormalities would have been apparent and timely intervention could have been taken.

The stillbirth caused the onset of severe emotional distress in the mother leading to posttraumatic stress disorder (PTSD). She had extensive counseling. Her psychologist reported that the patient also suffered from complex grief disorder.

PHYSICIAN'S DEFENSE: The ObGyn's actions did not cause the injury. The twins' hearts were monitored at the last prenatal examination and were normal. It was appropriate for the ObGyn to allow the patient to return home before going to the hospital; the situation was urgent but not emergent. The stillbirth resulted from chorioamnionitis, a microscopic condition that is difficult to detect. A pathologist confirmed the diagnosis after examining the placenta.

The extent of the patient's grief was contested. An expert psychiatrist reported that complex grief disorder is not a recognized medical condition, and that, upon his examination, the patient did not exhibit PTSD symptoms.

VERDICT: A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Brachial plexus injury: permanent disability

After concerning test results, a woman went to the hospital for induction of labor. During vaginal delivery, a shoulder dystocia was encountered. The baby was born within 60 seconds using the McRoberts maneuver and suprapubic pressure. The ObGyn charted mild shoulder dystocia.

The child has decreased mobility of his left arm. MRI studies and surgical findings confirmed brachial plexus rupture and avulsion at C5-C7. Despite nerve grafting, the child has a significant disability to his left arm and shoulder.

PARENT'S CLAIM: The ObGyn negligently applied excessive lateral traction, improperly used lateral traction as a maneuver, and instructed the mother to continuously push.

PHYSICIAN'S DEFENSE: Shoulder dystocia was properly diagnosed and resolved using standard maneuvers. Traction and pushing are needed during shoulder dystocia management to determine whether the maneuvers are successful. Brachial plexus injuries can occur because of the normal forces of labor and delivery.

VERDICT: An Illinois defense verdict was returned.

Mother claims PTSD after twin's stillbirth

Expecting twins, a 23-year-old woman at 33.5 weeks' gestation reported pain. The ObGyn noted that her cervix was 4-cm dilated, 1 twin was in breech position, and that labor had begun. He recommended that the patient go to the hospital for cesarean delivery but told her that she could go home, shower, and gather her belongings first. When the mother arrived at the hospital 2.5 hours later, the fetal heart-rate (FHR) monitor indicated that one twin's heart was not active. An emergency cesarean delivery was performed. One twin was safely born, but the other died.

PARENT'S CLAIM: The ObGyn failed to properly address the onset of labor. The twin died because of compression of the umbilical cord. If the mother had gone directly to the hospital, FHR abnormalities would have been apparent and timely intervention could have been taken.

The stillbirth caused the onset of severe emotional distress in the mother leading to posttraumatic stress disorder (PTSD). She had extensive counseling. Her psychologist reported that the patient also suffered from complex grief disorder.

PHYSICIAN'S DEFENSE: The ObGyn's actions did not cause the injury. The twins' hearts were monitored at the last prenatal examination and were normal. It was appropriate for the ObGyn to allow the patient to return home before going to the hospital; the situation was urgent but not emergent. The stillbirth resulted from chorioamnionitis, a microscopic condition that is difficult to detect. A pathologist confirmed the diagnosis after examining the placenta.

The extent of the patient's grief was contested. An expert psychiatrist reported that complex grief disorder is not a recognized medical condition, and that, upon his examination, the patient did not exhibit PTSD symptoms.

VERDICT: A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Brachial plexus injury: permanent disability

After concerning test results, a woman went to the hospital for induction of labor. During vaginal delivery, a shoulder dystocia was encountered. The baby was born within 60 seconds using the McRoberts maneuver and suprapubic pressure. The ObGyn charted mild shoulder dystocia.

The child has decreased mobility of his left arm. MRI studies and surgical findings confirmed brachial plexus rupture and avulsion at C5-C7. Despite nerve grafting, the child has a significant disability to his left arm and shoulder.

PARENT'S CLAIM: The ObGyn negligently applied excessive lateral traction, improperly used lateral traction as a maneuver, and instructed the mother to continuously push.

PHYSICIAN'S DEFENSE: Shoulder dystocia was properly diagnosed and resolved using standard maneuvers. Traction and pushing are needed during shoulder dystocia management to determine whether the maneuvers are successful. Brachial plexus injuries can occur because of the normal forces of labor and delivery.

VERDICT: An Illinois defense verdict was returned.

Mother claims PTSD after twin's stillbirth

Expecting twins, a 23-year-old woman at 33.5 weeks' gestation reported pain. The ObGyn noted that her cervix was 4-cm dilated, 1 twin was in breech position, and that labor had begun. He recommended that the patient go to the hospital for cesarean delivery but told her that she could go home, shower, and gather her belongings first. When the mother arrived at the hospital 2.5 hours later, the fetal heart-rate (FHR) monitor indicated that one twin's heart was not active. An emergency cesarean delivery was performed. One twin was safely born, but the other died.

PARENT'S CLAIM: The ObGyn failed to properly address the onset of labor. The twin died because of compression of the umbilical cord. If the mother had gone directly to the hospital, FHR abnormalities would have been apparent and timely intervention could have been taken.

The stillbirth caused the onset of severe emotional distress in the mother leading to posttraumatic stress disorder (PTSD). She had extensive counseling. Her psychologist reported that the patient also suffered from complex grief disorder.

PHYSICIAN'S DEFENSE: The ObGyn's actions did not cause the injury. The twins' hearts were monitored at the last prenatal examination and were normal. It was appropriate for the ObGyn to allow the patient to return home before going to the hospital; the situation was urgent but not emergent. The stillbirth resulted from chorioamnionitis, a microscopic condition that is difficult to detect. A pathologist confirmed the diagnosis after examining the placenta.

The extent of the patient's grief was contested. An expert psychiatrist reported that complex grief disorder is not a recognized medical condition, and that, upon his examination, the patient did not exhibit PTSD symptoms.

VERDICT: A New York defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Unnecessary laparotomy: $625,000 award

A woman in her 20s reported cramping and rectal bleeding to her ObGyn. Pelvic and rectal examinations were normal. Her family physician's exam and a gastroenterologist's rectal exam and colonoscopy were all normal. A radiologist (Dr. A) identified a 3-cm by 6-cm mass on transvaginal ultrasonography. A computed tomography (CT) scan read by another radiologist (Dr. B) confirmed the mass. After receiving the radiologists' reports, the ObGyn told the patient that she had a small tumor that needed immediate removal. No mass was found during exploratory laparotomy.

Three years postsurgery, after trying to conceive, the patient underwent exploratory laparoscopy to evaluate her fallopian tubes. A surgeon found significant pelvic adhesions occluding the left fallopian tube. He lysed the adhesions and resected the left fallopian tube.

PATIENT'S CLAIM: The patient sued the ObGyn and both radiologists, alleging that the unnecessary surgeries resulted in reduced fertility.

Postoperatively, the ObGyn told the patient that the surgery, performed for "nothing," was the radiologists' fault, and that she would have no trouble conceiving. He later blamed her fallopian tube damage on a diagnosis of chlamydia that was successfully treated years earlier with no evidence of reinfection.

The ObGyn disregarded Dr. A's recommendation for a CT scan with rectal contrast; instead he ordered oral contrast. The ObGyn also ignored Dr. B's recommendation for magnetic resonance imaging (MRI).

The mass misidentified by the radiologists was described in 2 different places on the anterior wall of the bowel, both outside the purview of a gynecologist. Given the uncertain diagnosis, referral to a general surgeon was mandated; exploratory laparotomy was not indicated. The ObGyn never referred the patient to a general surgeon for evaluation or sent records or films to the surgeon whom he claimed to have consulted before surgery. The general surgeon denied that any such discussion occurred. The surgeon's first contact with the patient occurred when he was called into the operating room because the ObGyn could not find a mass; the patient was under anesthesia and her abdomen was open.

DEFENDANTS' DEFENSE: The ObGyn claimed that he had developed a plan with the general surgeon before surgery: if the mass was a uterine fibroid, he would remove it, but if the mass was mesenteric, the surgeon would operate.

The ObGyn was justified in performing surgery based on the patient's complaints and the radiologists' findings.

The radiologists contended that, since neither of them expressed certainty, both requested further studies, and neither suggested surgery, their treatment was consistent with the standard of care.

VERDICT: A $625,000 Pennsylvania verdict was returned, finding the ObGyn 100% liable.

Both ureters injured during TAH

A 49-year-old woman underwent total abdominal hysterectomy (TAH) for removal of a uterine fibroid performed by her gynecologist and a surgical assistant. The patient had limited urine output immediately after surgery, no urinary output overnight, and abdominal pain. The gynecologist ordered a urology consultation. A CT scan showed bilateral ureteral obstruction; an interventional radiology study confirmed a blockage due to severance of both ureters. A nephrostomy was performed and, 6 weeks later, the ureters were reimplanted.

PATIENT'S CLAIM: The severing of both ureters was a negligent surgical error. While the risk of injuring a single ureter is a recognized complication of TAH, it is unacceptable that both ureters were severed.

DEFENDANTS' DEFENSE: Standard of care was met: bilateral ureteral injury is a known risk of TAH. Before surgery, the patient was fully informed of the risks and signed a consent agreement. There was no intraoperative evidence that the ureters had been damaged. The injuries were detected as soon as medically possible and timely and successfully treated.

VERDICT: An Illinois defense verdict was returned.

Failure to detect breast cancer: $21.9M verdict against radiologist

A woman went to a diagnostic imaging service for ultrasonography (US) after an earlier US was suspicious for a breast mass. She had a history of left breast pain and swelling that had been treated with antibiotics. The radiologist interpreted the second ultrasound as showing no masses; he noted skin thickening and a lymph node abnormality.

Nine months after initial US, the patient had a breast biopsy performed in another state. She was diagnosed with stage 3 breast cancer.

PATIENT'S CLAIM: The radiologist failed to properly interpret the findings of the second ultrasound.

PHYSICIAN'S DEFENSE: The radiologist contended that he was not liable because the technologist failed to place the transducer over the breast lump. The first US films were not provided for comparison.

VERDICT: A $21.9 million Florida verdict was returned.

Vesicovaginal fistula after hysterectomy

A 39-year-old woman with a history of 4 cesarean deliveries and an enlarged fibroid uterus underwent TAH. She subsequently developed urinary incontinence.

PATIENT'S CLAIM: The ObGyn used an inappropriate dissection technique to remove the uterus, causing a bladder injury. He also sutured the vaginal cuff to the bladder, causing the formation of a vesicovaginal fistula. Repair surgeries were unsuccessful and the patient now is permanently incontinent. 

PHYSICIAN'S DEFENSE: The standard of care was met. The patient had a pre-existing bladder weakness due to the size of her uterus and prior surgeries. The bladder injury is a known complication of the surgery. The vaginal cuff adhered to the bladder due to postsurgical scarring or fibrosis. 

VERDICT: A Michigan defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Unnecessary laparotomy: $625,000 award

A woman in her 20s reported cramping and rectal bleeding to her ObGyn. Pelvic and rectal examinations were normal. Her family physician's exam and a gastroenterologist's rectal exam and colonoscopy were all normal. A radiologist (Dr. A) identified a 3-cm by 6-cm mass on transvaginal ultrasonography. A computed tomography (CT) scan read by another radiologist (Dr. B) confirmed the mass. After receiving the radiologists' reports, the ObGyn told the patient that she had a small tumor that needed immediate removal. No mass was found during exploratory laparotomy.

Three years postsurgery, after trying to conceive, the patient underwent exploratory laparoscopy to evaluate her fallopian tubes. A surgeon found significant pelvic adhesions occluding the left fallopian tube. He lysed the adhesions and resected the left fallopian tube.

PATIENT'S CLAIM: The patient sued the ObGyn and both radiologists, alleging that the unnecessary surgeries resulted in reduced fertility.

Postoperatively, the ObGyn told the patient that the surgery, performed for "nothing," was the radiologists' fault, and that she would have no trouble conceiving. He later blamed her fallopian tube damage on a diagnosis of chlamydia that was successfully treated years earlier with no evidence of reinfection.

The ObGyn disregarded Dr. A's recommendation for a CT scan with rectal contrast; instead he ordered oral contrast. The ObGyn also ignored Dr. B's recommendation for magnetic resonance imaging (MRI).

The mass misidentified by the radiologists was described in 2 different places on the anterior wall of the bowel, both outside the purview of a gynecologist. Given the uncertain diagnosis, referral to a general surgeon was mandated; exploratory laparotomy was not indicated. The ObGyn never referred the patient to a general surgeon for evaluation or sent records or films to the surgeon whom he claimed to have consulted before surgery. The general surgeon denied that any such discussion occurred. The surgeon's first contact with the patient occurred when he was called into the operating room because the ObGyn could not find a mass; the patient was under anesthesia and her abdomen was open.

DEFENDANTS' DEFENSE: The ObGyn claimed that he had developed a plan with the general surgeon before surgery: if the mass was a uterine fibroid, he would remove it, but if the mass was mesenteric, the surgeon would operate.

The ObGyn was justified in performing surgery based on the patient's complaints and the radiologists' findings.

The radiologists contended that, since neither of them expressed certainty, both requested further studies, and neither suggested surgery, their treatment was consistent with the standard of care.

VERDICT: A $625,000 Pennsylvania verdict was returned, finding the ObGyn 100% liable.

Both ureters injured during TAH

A 49-year-old woman underwent total abdominal hysterectomy (TAH) for removal of a uterine fibroid performed by her gynecologist and a surgical assistant. The patient had limited urine output immediately after surgery, no urinary output overnight, and abdominal pain. The gynecologist ordered a urology consultation. A CT scan showed bilateral ureteral obstruction; an interventional radiology study confirmed a blockage due to severance of both ureters. A nephrostomy was performed and, 6 weeks later, the ureters were reimplanted.

PATIENT'S CLAIM: The severing of both ureters was a negligent surgical error. While the risk of injuring a single ureter is a recognized complication of TAH, it is unacceptable that both ureters were severed.

DEFENDANTS' DEFENSE: Standard of care was met: bilateral ureteral injury is a known risk of TAH. Before surgery, the patient was fully informed of the risks and signed a consent agreement. There was no intraoperative evidence that the ureters had been damaged. The injuries were detected as soon as medically possible and timely and successfully treated.

VERDICT: An Illinois defense verdict was returned.

Failure to detect breast cancer: $21.9M verdict against radiologist

A woman went to a diagnostic imaging service for ultrasonography (US) after an earlier US was suspicious for a breast mass. She had a history of left breast pain and swelling that had been treated with antibiotics. The radiologist interpreted the second ultrasound as showing no masses; he noted skin thickening and a lymph node abnormality.

Nine months after initial US, the patient had a breast biopsy performed in another state. She was diagnosed with stage 3 breast cancer.

PATIENT'S CLAIM: The radiologist failed to properly interpret the findings of the second ultrasound.

PHYSICIAN'S DEFENSE: The radiologist contended that he was not liable because the technologist failed to place the transducer over the breast lump. The first US films were not provided for comparison.

VERDICT: A $21.9 million Florida verdict was returned.

Vesicovaginal fistula after hysterectomy

A 39-year-old woman with a history of 4 cesarean deliveries and an enlarged fibroid uterus underwent TAH. She subsequently developed urinary incontinence.

PATIENT'S CLAIM: The ObGyn used an inappropriate dissection technique to remove the uterus, causing a bladder injury. He also sutured the vaginal cuff to the bladder, causing the formation of a vesicovaginal fistula. Repair surgeries were unsuccessful and the patient now is permanently incontinent. 

PHYSICIAN'S DEFENSE: The standard of care was met. The patient had a pre-existing bladder weakness due to the size of her uterus and prior surgeries. The bladder injury is a known complication of the surgery. The vaginal cuff adhered to the bladder due to postsurgical scarring or fibrosis. 

VERDICT: A Michigan defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Unnecessary laparotomy: $625,000 award

A woman in her 20s reported cramping and rectal bleeding to her ObGyn. Pelvic and rectal examinations were normal. Her family physician's exam and a gastroenterologist's rectal exam and colonoscopy were all normal. A radiologist (Dr. A) identified a 3-cm by 6-cm mass on transvaginal ultrasonography. A computed tomography (CT) scan read by another radiologist (Dr. B) confirmed the mass. After receiving the radiologists' reports, the ObGyn told the patient that she had a small tumor that needed immediate removal. No mass was found during exploratory laparotomy.

Three years postsurgery, after trying to conceive, the patient underwent exploratory laparoscopy to evaluate her fallopian tubes. A surgeon found significant pelvic adhesions occluding the left fallopian tube. He lysed the adhesions and resected the left fallopian tube.

PATIENT'S CLAIM: The patient sued the ObGyn and both radiologists, alleging that the unnecessary surgeries resulted in reduced fertility.

Postoperatively, the ObGyn told the patient that the surgery, performed for "nothing," was the radiologists' fault, and that she would have no trouble conceiving. He later blamed her fallopian tube damage on a diagnosis of chlamydia that was successfully treated years earlier with no evidence of reinfection.

The ObGyn disregarded Dr. A's recommendation for a CT scan with rectal contrast; instead he ordered oral contrast. The ObGyn also ignored Dr. B's recommendation for magnetic resonance imaging (MRI).

The mass misidentified by the radiologists was described in 2 different places on the anterior wall of the bowel, both outside the purview of a gynecologist. Given the uncertain diagnosis, referral to a general surgeon was mandated; exploratory laparotomy was not indicated. The ObGyn never referred the patient to a general surgeon for evaluation or sent records or films to the surgeon whom he claimed to have consulted before surgery. The general surgeon denied that any such discussion occurred. The surgeon's first contact with the patient occurred when he was called into the operating room because the ObGyn could not find a mass; the patient was under anesthesia and her abdomen was open.

DEFENDANTS' DEFENSE: The ObGyn claimed that he had developed a plan with the general surgeon before surgery: if the mass was a uterine fibroid, he would remove it, but if the mass was mesenteric, the surgeon would operate.

The ObGyn was justified in performing surgery based on the patient's complaints and the radiologists' findings.

The radiologists contended that, since neither of them expressed certainty, both requested further studies, and neither suggested surgery, their treatment was consistent with the standard of care.

VERDICT: A $625,000 Pennsylvania verdict was returned, finding the ObGyn 100% liable.

Both ureters injured during TAH

A 49-year-old woman underwent total abdominal hysterectomy (TAH) for removal of a uterine fibroid performed by her gynecologist and a surgical assistant. The patient had limited urine output immediately after surgery, no urinary output overnight, and abdominal pain. The gynecologist ordered a urology consultation. A CT scan showed bilateral ureteral obstruction; an interventional radiology study confirmed a blockage due to severance of both ureters. A nephrostomy was performed and, 6 weeks later, the ureters were reimplanted.

PATIENT'S CLAIM: The severing of both ureters was a negligent surgical error. While the risk of injuring a single ureter is a recognized complication of TAH, it is unacceptable that both ureters were severed.

DEFENDANTS' DEFENSE: Standard of care was met: bilateral ureteral injury is a known risk of TAH. Before surgery, the patient was fully informed of the risks and signed a consent agreement. There was no intraoperative evidence that the ureters had been damaged. The injuries were detected as soon as medically possible and timely and successfully treated.

VERDICT: An Illinois defense verdict was returned.

Failure to detect breast cancer: $21.9M verdict against radiologist

A woman went to a diagnostic imaging service for ultrasonography (US) after an earlier US was suspicious for a breast mass. She had a history of left breast pain and swelling that had been treated with antibiotics. The radiologist interpreted the second ultrasound as showing no masses; he noted skin thickening and a lymph node abnormality.

Nine months after initial US, the patient had a breast biopsy performed in another state. She was diagnosed with stage 3 breast cancer.

PATIENT'S CLAIM: The radiologist failed to properly interpret the findings of the second ultrasound.

PHYSICIAN'S DEFENSE: The radiologist contended that he was not liable because the technologist failed to place the transducer over the breast lump. The first US films were not provided for comparison.

VERDICT: A $21.9 million Florida verdict was returned.

Vesicovaginal fistula after hysterectomy

A 39-year-old woman with a history of 4 cesarean deliveries and an enlarged fibroid uterus underwent TAH. She subsequently developed urinary incontinence.

PATIENT'S CLAIM: The ObGyn used an inappropriate dissection technique to remove the uterus, causing a bladder injury. He also sutured the vaginal cuff to the bladder, causing the formation of a vesicovaginal fistula. Repair surgeries were unsuccessful and the patient now is permanently incontinent. 

PHYSICIAN'S DEFENSE: The standard of care was met. The patient had a pre-existing bladder weakness due to the size of her uterus and prior surgeries. The bladder injury is a known complication of the surgery. The vaginal cuff adhered to the bladder due to postsurgical scarring or fibrosis. 

VERDICT: A Michigan defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Compared with standard care alone, standard care plus endovascular thrombectomy at six to 24 hours after stroke onset appears to reduce disability and increase functional independence among patients with a mismatch between clinical deficit and infarct. These findings, which were published online ahead of print November 11 in the New England Journal of Medicine, could benefit patients with stroke who arrive at the hospital after the current six-hour treatment window has closed, said the authors.

“When the irreversibly damaged brain area affected by the stroke is small, we see that clot removal can make a significant positive difference, even if performed outside the six-hour window,” said Tudor Jovin, MD, Director of the University of Pittsburgh Medical Center Stroke Institute. “However, this does not diminish the urgency with which patients must be rushed to the emergency room in the event of a stroke. The mantra ‘time is brain’ still holds true.”

The DAWN Trial Examined Late Thrombectomy

Previous research has indicated that thrombectomy provides clinical benefits for patients with acute ischemic stroke when it is performed within six hours of symptom onset. The benefit of treatment appeared to decrease as the time to treatment increased. Nonrandomized studies, however, have shown that reperfusion of occluded proximal anterior cerebral vessels improves outcomes in patients with a mismatch between the volume of brain tissue that may be salvaged and the volume of infarcted tissue, even if performed more than six hours after the patient was last known to be well.

Dr. Jovin and colleagues conducted the DAWN trial, a multicenter, prospective, randomized, open-label study, to evaluate the effects of late thrombectomy. Eligible patients had an occlusion of the intracranial internal carotid artery or proximal middle cerebral artery and had last been known to be well six to 24 hours earlier. Patients either did not meet criteria for treatment with IV alteplase because of late presentation, or had persistent vessel occlusion despite treatment with IV alteplase.

Participants also had a mismatch between the severity of the clinical deficit and the infarct volume, which was assessed using diffusion-weighted MRI or perfusion CT. The investigators sorted mismatches into three groups. Group A included patients age 80 or older with an NIH Stroke Scale (NIHSS) score of 10 or higher and an infarct volume of less than 21 mL. Group B included patients younger than 80 with an NIHSS score of 10 or higher and an infarct volume of less than 31 mL. Group C included patients younger than 80 with an NIHSS score of 20 or higher and had an infarct volume between 31 mL and 51 mL.

The investigators randomized participants to thrombectomy plus standard care or standard care alone. The first primary end point was the mean score for disability on the utility-weighted modified Rankin scale, which ranges from 0 (ie, death) to 10 (ie, no symptoms or disability). The second was the rate of functional independence (ie, a score of 0–2 on the modified Rankin scale) at 90 days. The main safety end point was stroke-related death at 90 days.

Enrollment Was Halted Early

Dr. Jovin and colleagues enrolled 206 patients in the trial. Enrollment was stopped at 31 months, because an interim analysis found that thrombectomy plus standard care was 95% likely to be superior to standard care alone for the first primary end point. In all, 107 patients received thrombectomy plus standard care, and 99 received standard care alone.

Participants’ mean age was 70, and approximately 46% of participants were men. Median NIHSS score was 17, and median infarct volume was 8.25 mL. The treatment arms were generally balanced, except for three factors. History of atrial fibrillation and wake-up stroke were more common in the thrombectomy group, and treatment with IV alteplase was more common in the control group.

The mean utility-weighted modified Rankin scale score at 90 days was 5.5 in the thrombectomy group and 3.4 in the control group. The rate of functional independence at 90 days was 49% in the thrombectomy group and 13% in the control group. The superiority of thrombectomy plus standard treatment to standard treatment alone for both end points remained significant in post hoc sensitivity analyses that adjusted for between-group differences in baseline characteristics.

The rate of stroke-related death at 90 days did not differ significantly between the treatment groups. Nor did the rate of death from any cause at 90 days or the rate of symptomatic intracerebral hemorrhage differ significantly between groups. The rate of neurologic deterioration was lower in the thrombectomy group than in the control group.

Should the Time Window Be Expanded?

By selecting patients who had a region of brain that was poorly perfused, but not yet infarcted, Dr. Jovin and colleagues replaced the conventional six-hour time window for stroke treatment with a “tissue window,” said Werner Hacke, MD, PhD, Chair of the Department of Neurology at the University of Heidelberg in Germany, in an accompanying editorial. The rate of functional independence at 90 days in the DAWN trial (49%) was similar to that in a previous meta-analysis of several trials of mechanical thrombectomy (46%). “These similar findings suggest that the use of a ‘tissue window’ in choosing patients for thrombectomy is as good as the use of a time window,” said Dr. Hacke. “However, it is also worth emphasizing that the 13% rate of functional independence in the control group in the DAWN trial was lower than the 26% rate in the control group in the pooled analysis.” This low rate of functional independence “is probably the best we can expect” for patients who have not had recanalization by 24 hours after stroke onset.

The DAWN trial provides reason to expect that trials investigating late IV thrombolysis that require the presence of ischemic tissue might have positive outcomes. But “the results of the DAWN trial do not support a general liberalization of the time window for thrombectomy or thrombolysis,” Dr. Hacke continued. “Reducing the time from the onset of stroke to treatment remains essential and results in the best outcomes.”

—Erik Greb

Suggested Reading

Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. 2017 Nov 11 [Epub ahead of print].

Hacke W. A new DAWN for imaging-based selection in the treatment of acute stroke. N Engl J Med. 2017 Nov 11 [Epub ahead of print].

Compared with standard care alone, standard care plus endovascular thrombectomy at six to 24 hours after stroke onset appears to reduce disability and increase functional independence among patients with a mismatch between clinical deficit and infarct. These findings, which were published online ahead of print November 11 in the New England Journal of Medicine, could benefit patients with stroke who arrive at the hospital after the current six-hour treatment window has closed, said the authors.

“When the irreversibly damaged brain area affected by the stroke is small, we see that clot removal can make a significant positive difference, even if performed outside the six-hour window,” said Tudor Jovin, MD, Director of the University of Pittsburgh Medical Center Stroke Institute. “However, this does not diminish the urgency with which patients must be rushed to the emergency room in the event of a stroke. The mantra ‘time is brain’ still holds true.”

The DAWN Trial Examined Late Thrombectomy

Previous research has indicated that thrombectomy provides clinical benefits for patients with acute ischemic stroke when it is performed within six hours of symptom onset. The benefit of treatment appeared to decrease as the time to treatment increased. Nonrandomized studies, however, have shown that reperfusion of occluded proximal anterior cerebral vessels improves outcomes in patients with a mismatch between the volume of brain tissue that may be salvaged and the volume of infarcted tissue, even if performed more than six hours after the patient was last known to be well.

Dr. Jovin and colleagues conducted the DAWN trial, a multicenter, prospective, randomized, open-label study, to evaluate the effects of late thrombectomy. Eligible patients had an occlusion of the intracranial internal carotid artery or proximal middle cerebral artery and had last been known to be well six to 24 hours earlier. Patients either did not meet criteria for treatment with IV alteplase because of late presentation, or had persistent vessel occlusion despite treatment with IV alteplase.

Participants also had a mismatch between the severity of the clinical deficit and the infarct volume, which was assessed using diffusion-weighted MRI or perfusion CT. The investigators sorted mismatches into three groups. Group A included patients age 80 or older with an NIH Stroke Scale (NIHSS) score of 10 or higher and an infarct volume of less than 21 mL. Group B included patients younger than 80 with an NIHSS score of 10 or higher and an infarct volume of less than 31 mL. Group C included patients younger than 80 with an NIHSS score of 20 or higher and had an infarct volume between 31 mL and 51 mL.

The investigators randomized participants to thrombectomy plus standard care or standard care alone. The first primary end point was the mean score for disability on the utility-weighted modified Rankin scale, which ranges from 0 (ie, death) to 10 (ie, no symptoms or disability). The second was the rate of functional independence (ie, a score of 0–2 on the modified Rankin scale) at 90 days. The main safety end point was stroke-related death at 90 days.

Enrollment Was Halted Early

Dr. Jovin and colleagues enrolled 206 patients in the trial. Enrollment was stopped at 31 months, because an interim analysis found that thrombectomy plus standard care was 95% likely to be superior to standard care alone for the first primary end point. In all, 107 patients received thrombectomy plus standard care, and 99 received standard care alone.

Participants’ mean age was 70, and approximately 46% of participants were men. Median NIHSS score was 17, and median infarct volume was 8.25 mL. The treatment arms were generally balanced, except for three factors. History of atrial fibrillation and wake-up stroke were more common in the thrombectomy group, and treatment with IV alteplase was more common in the control group.

The mean utility-weighted modified Rankin scale score at 90 days was 5.5 in the thrombectomy group and 3.4 in the control group. The rate of functional independence at 90 days was 49% in the thrombectomy group and 13% in the control group. The superiority of thrombectomy plus standard treatment to standard treatment alone for both end points remained significant in post hoc sensitivity analyses that adjusted for between-group differences in baseline characteristics.

The rate of stroke-related death at 90 days did not differ significantly between the treatment groups. Nor did the rate of death from any cause at 90 days or the rate of symptomatic intracerebral hemorrhage differ significantly between groups. The rate of neurologic deterioration was lower in the thrombectomy group than in the control group.

Should the Time Window Be Expanded?

By selecting patients who had a region of brain that was poorly perfused, but not yet infarcted, Dr. Jovin and colleagues replaced the conventional six-hour time window for stroke treatment with a “tissue window,” said Werner Hacke, MD, PhD, Chair of the Department of Neurology at the University of Heidelberg in Germany, in an accompanying editorial. The rate of functional independence at 90 days in the DAWN trial (49%) was similar to that in a previous meta-analysis of several trials of mechanical thrombectomy (46%). “These similar findings suggest that the use of a ‘tissue window’ in choosing patients for thrombectomy is as good as the use of a time window,” said Dr. Hacke. “However, it is also worth emphasizing that the 13% rate of functional independence in the control group in the DAWN trial was lower than the 26% rate in the control group in the pooled analysis.” This low rate of functional independence “is probably the best we can expect” for patients who have not had recanalization by 24 hours after stroke onset.

The DAWN trial provides reason to expect that trials investigating late IV thrombolysis that require the presence of ischemic tissue might have positive outcomes. But “the results of the DAWN trial do not support a general liberalization of the time window for thrombectomy or thrombolysis,” Dr. Hacke continued. “Reducing the time from the onset of stroke to treatment remains essential and results in the best outcomes.”

—Erik Greb

Suggested Reading

Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. 2017 Nov 11 [Epub ahead of print].

Hacke W. A new DAWN for imaging-based selection in the treatment of acute stroke. N Engl J Med. 2017 Nov 11 [Epub ahead of print].

Compared with standard care alone, standard care plus endovascular thrombectomy at six to 24 hours after stroke onset appears to reduce disability and increase functional independence among patients with a mismatch between clinical deficit and infarct. These findings, which were published online ahead of print November 11 in the New England Journal of Medicine, could benefit patients with stroke who arrive at the hospital after the current six-hour treatment window has closed, said the authors.

“When the irreversibly damaged brain area affected by the stroke is small, we see that clot removal can make a significant positive difference, even if performed outside the six-hour window,” said Tudor Jovin, MD, Director of the University of Pittsburgh Medical Center Stroke Institute. “However, this does not diminish the urgency with which patients must be rushed to the emergency room in the event of a stroke. The mantra ‘time is brain’ still holds true.”

The DAWN Trial Examined Late Thrombectomy

Previous research has indicated that thrombectomy provides clinical benefits for patients with acute ischemic stroke when it is performed within six hours of symptom onset. The benefit of treatment appeared to decrease as the time to treatment increased. Nonrandomized studies, however, have shown that reperfusion of occluded proximal anterior cerebral vessels improves outcomes in patients with a mismatch between the volume of brain tissue that may be salvaged and the volume of infarcted tissue, even if performed more than six hours after the patient was last known to be well.

Dr. Jovin and colleagues conducted the DAWN trial, a multicenter, prospective, randomized, open-label study, to evaluate the effects of late thrombectomy. Eligible patients had an occlusion of the intracranial internal carotid artery or proximal middle cerebral artery and had last been known to be well six to 24 hours earlier. Patients either did not meet criteria for treatment with IV alteplase because of late presentation, or had persistent vessel occlusion despite treatment with IV alteplase.

Participants also had a mismatch between the severity of the clinical deficit and the infarct volume, which was assessed using diffusion-weighted MRI or perfusion CT. The investigators sorted mismatches into three groups. Group A included patients age 80 or older with an NIH Stroke Scale (NIHSS) score of 10 or higher and an infarct volume of less than 21 mL. Group B included patients younger than 80 with an NIHSS score of 10 or higher and an infarct volume of less than 31 mL. Group C included patients younger than 80 with an NIHSS score of 20 or higher and had an infarct volume between 31 mL and 51 mL.

The investigators randomized participants to thrombectomy plus standard care or standard care alone. The first primary end point was the mean score for disability on the utility-weighted modified Rankin scale, which ranges from 0 (ie, death) to 10 (ie, no symptoms or disability). The second was the rate of functional independence (ie, a score of 0–2 on the modified Rankin scale) at 90 days. The main safety end point was stroke-related death at 90 days.

Enrollment Was Halted Early

Dr. Jovin and colleagues enrolled 206 patients in the trial. Enrollment was stopped at 31 months, because an interim analysis found that thrombectomy plus standard care was 95% likely to be superior to standard care alone for the first primary end point. In all, 107 patients received thrombectomy plus standard care, and 99 received standard care alone.

Participants’ mean age was 70, and approximately 46% of participants were men. Median NIHSS score was 17, and median infarct volume was 8.25 mL. The treatment arms were generally balanced, except for three factors. History of atrial fibrillation and wake-up stroke were more common in the thrombectomy group, and treatment with IV alteplase was more common in the control group.

The mean utility-weighted modified Rankin scale score at 90 days was 5.5 in the thrombectomy group and 3.4 in the control group. The rate of functional independence at 90 days was 49% in the thrombectomy group and 13% in the control group. The superiority of thrombectomy plus standard treatment to standard treatment alone for both end points remained significant in post hoc sensitivity analyses that adjusted for between-group differences in baseline characteristics.

The rate of stroke-related death at 90 days did not differ significantly between the treatment groups. Nor did the rate of death from any cause at 90 days or the rate of symptomatic intracerebral hemorrhage differ significantly between groups. The rate of neurologic deterioration was lower in the thrombectomy group than in the control group.

Should the Time Window Be Expanded?

By selecting patients who had a region of brain that was poorly perfused, but not yet infarcted, Dr. Jovin and colleagues replaced the conventional six-hour time window for stroke treatment with a “tissue window,” said Werner Hacke, MD, PhD, Chair of the Department of Neurology at the University of Heidelberg in Germany, in an accompanying editorial. The rate of functional independence at 90 days in the DAWN trial (49%) was similar to that in a previous meta-analysis of several trials of mechanical thrombectomy (46%). “These similar findings suggest that the use of a ‘tissue window’ in choosing patients for thrombectomy is as good as the use of a time window,” said Dr. Hacke. “However, it is also worth emphasizing that the 13% rate of functional independence in the control group in the DAWN trial was lower than the 26% rate in the control group in the pooled analysis.” This low rate of functional independence “is probably the best we can expect” for patients who have not had recanalization by 24 hours after stroke onset.

The DAWN trial provides reason to expect that trials investigating late IV thrombolysis that require the presence of ischemic tissue might have positive outcomes. But “the results of the DAWN trial do not support a general liberalization of the time window for thrombectomy or thrombolysis,” Dr. Hacke continued. “Reducing the time from the onset of stroke to treatment remains essential and results in the best outcomes.”

—Erik Greb

Suggested Reading

Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. 2017 Nov 11 [Epub ahead of print].

Hacke W. A new DAWN for imaging-based selection in the treatment of acute stroke. N Engl J Med. 2017 Nov 11 [Epub ahead of print].