The transition from undergraduate medical education (UME) to graduate medical education in the United States needs comprehensive reform, says a new report from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.

The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.

The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.

The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:

• Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
• Inattention to assuring congruence between applicant goals and program missions
• Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
• Increasing financial costs to students
• Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates

Seeking a common framework for competence

Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.

To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.

While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”

Among the committee’s three dozen recommendations are the following:

• The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
• Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
• The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
• An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”

Less than half of applicants get in-depth reviews

The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.

Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.

Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.

The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
 

Osteopathic students’ dilemma

To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.

Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.

The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.

This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.

For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.

Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.

Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.

A version of this article first appeared on Medscape.com.

The transition from undergraduate medical education (UME) to graduate medical education in the United States needs comprehensive reform, says a new report from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.

The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.

The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.

The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:

• Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
• Inattention to assuring congruence between applicant goals and program missions
• Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
• Increasing financial costs to students
• Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates

Seeking a common framework for competence

Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.

To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.

While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”

Among the committee’s three dozen recommendations are the following:

• The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
• Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
• The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
• An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”

Less than half of applicants get in-depth reviews

The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.

Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.

Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.

The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
 

Osteopathic students’ dilemma

To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.

Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.

The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.

This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.

For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.

Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.

Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.

A version of this article first appeared on Medscape.com.

The transition from undergraduate medical education (UME) to graduate medical education in the United States needs comprehensive reform, says a new report from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.

The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.

The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.

The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:

• Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
• Inattention to assuring congruence between applicant goals and program missions
• Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
• Increasing financial costs to students
• Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates

Seeking a common framework for competence

Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.

To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.

While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”

Among the committee’s three dozen recommendations are the following:

• The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
• Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
• The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
• An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”

Less than half of applicants get in-depth reviews

The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.

Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.

Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.

The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
 

Osteopathic students’ dilemma

To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.

Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.

The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.

This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.

For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.

Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.

Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has expanded the indication for brivaracetam (Briviact, UCB) as both monotherapy or adjunctive therapy for partial-onset seizures in patients as young as 1 month of age.

All three brivaracetam formulations (tablets, oral solution, and IV) may now be used. The approval marks the first time that the IV formulation will be available for children, the company said in a news release.

The medication is already approved in the United States as monotherapy and adjunctive therapy in adults with epilepsy.

In an open-label follow-up pediatric study, an estimated 71.4% of patients aged 1 month to 17 years with partial-onset seizures remained on brivaracetam therapy at 1 year, and 64.3% did so at 2 years, the company reported.

“We often see children with seizures hospitalized, so it’s important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration,” Raman Sankar, MD, PhD, distinguished professor and chief of pediatric neurology, University of California, Los Angeles, said in the release.

“The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” he added.
 

Safety profile

Dr. Sankar noted that with approval now of both the IV and oral formulations for partial-onset seizures in such young children, “we have a new option that helps meet a critical need in pediatric epilepsy.”

The most common adverse reactions with brivaracetam include somnolence and sedation, dizziness, fatigue, nausea, and vomiting. In the pediatric clinical trials, the safety profile for pediatric patients was similar to adults.

In the adult trials, psychiatric adverse reactions, including nonpsychotic and psychotic symptoms, were reported in approximately 13% of adults taking at least 50 mg/day of brivaracetam compared with 8% taking placebo.

Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults.

Patients should be advised to report these symptoms immediately to a health care professional, the company noted.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has expanded the indication for brivaracetam (Briviact, UCB) as both monotherapy or adjunctive therapy for partial-onset seizures in patients as young as 1 month of age.

All three brivaracetam formulations (tablets, oral solution, and IV) may now be used. The approval marks the first time that the IV formulation will be available for children, the company said in a news release.

The medication is already approved in the United States as monotherapy and adjunctive therapy in adults with epilepsy.

In an open-label follow-up pediatric study, an estimated 71.4% of patients aged 1 month to 17 years with partial-onset seizures remained on brivaracetam therapy at 1 year, and 64.3% did so at 2 years, the company reported.

“We often see children with seizures hospitalized, so it’s important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration,” Raman Sankar, MD, PhD, distinguished professor and chief of pediatric neurology, University of California, Los Angeles, said in the release.

“The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” he added.
 

Safety profile

Dr. Sankar noted that with approval now of both the IV and oral formulations for partial-onset seizures in such young children, “we have a new option that helps meet a critical need in pediatric epilepsy.”

The most common adverse reactions with brivaracetam include somnolence and sedation, dizziness, fatigue, nausea, and vomiting. In the pediatric clinical trials, the safety profile for pediatric patients was similar to adults.

In the adult trials, psychiatric adverse reactions, including nonpsychotic and psychotic symptoms, were reported in approximately 13% of adults taking at least 50 mg/day of brivaracetam compared with 8% taking placebo.

Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults.

Patients should be advised to report these symptoms immediately to a health care professional, the company noted.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has expanded the indication for brivaracetam (Briviact, UCB) as both monotherapy or adjunctive therapy for partial-onset seizures in patients as young as 1 month of age.

All three brivaracetam formulations (tablets, oral solution, and IV) may now be used. The approval marks the first time that the IV formulation will be available for children, the company said in a news release.

The medication is already approved in the United States as monotherapy and adjunctive therapy in adults with epilepsy.

In an open-label follow-up pediatric study, an estimated 71.4% of patients aged 1 month to 17 years with partial-onset seizures remained on brivaracetam therapy at 1 year, and 64.3% did so at 2 years, the company reported.

“We often see children with seizures hospitalized, so it’s important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration,” Raman Sankar, MD, PhD, distinguished professor and chief of pediatric neurology, University of California, Los Angeles, said in the release.

“The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” he added.
 

Safety profile

Dr. Sankar noted that with approval now of both the IV and oral formulations for partial-onset seizures in such young children, “we have a new option that helps meet a critical need in pediatric epilepsy.”

The most common adverse reactions with brivaracetam include somnolence and sedation, dizziness, fatigue, nausea, and vomiting. In the pediatric clinical trials, the safety profile for pediatric patients was similar to adults.

In the adult trials, psychiatric adverse reactions, including nonpsychotic and psychotic symptoms, were reported in approximately 13% of adults taking at least 50 mg/day of brivaracetam compared with 8% taking placebo.

Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults.

Patients should be advised to report these symptoms immediately to a health care professional, the company noted.

A version of this article first appeared on Medscape.com.

Consuming alcohol increases the risk for an atrial fibrillation (AF) episode hours later, according to a study published online Aug. 30 in Annals of Internal Medicine. Modifying the drinking behavior of patients with a history of AF events could make a difference.

coldsnowstorm/iStock / Getty Images Plus

Past research has associated long-term alcohol consumption with the development of AF, and abstinence from alcohol has been associated with a lower overall AF burden. However, lead study author Greg Marcus, MD, a cardioelectrophysiolgist at the University of California, San Francisco, noted that many patients say that alcohol is a trigger for discrete AF episodes.

To test whether that was possible, the researchers enrolled 100 patients who had a history of AF events and who consumed at least one drink per month. Participants wore a transdermal alcohol sensor and an ambulatory, single-lead electrocardiogram device for 4 weeks. They were instructed to press a button on the electrocardiogram device each time they consumed a standard alcoholic beverage. In addition, blood samples were tested for phosphatidylethanol (PEth) at the participants’ 2-week and 4-week visits. PEth is a phospholipid formed in the blood after alcohol intake. It remains in the blood for up to 4 weeks after alcohol consumption.

The study findings confirmed what the patients had reported. The odds of an AF episode were 38% greater with every 0.1% increase in peak blood alcohol concentration over the previous 12 hours (odds ratio [OR], 1.38; 95% confidence interval, 1.04-1.83; P = .024). Moreover, an episode of AF was associated with twofold greater odds (OR, 2.02; 95% CI, 1.38-3.17) of having consumed one alcoholic drink in the past 4 hours. It was associated with more than threefold greater odds of having consumed two or more drinks (OR, 3.58; 95% CI, 1.63-7.89).

“The major takeaway is, among atrial fibrillation patients, consuming alcohol substantially heightened their risk for any given atrial fibrillation event in the subsequent few hours,” Dr. Marcus said. “The more alcohol consumed, the higher that risk.”

The acute effect of alcohol on these arrhythmias also means that modifying alcohol consumption could immediately benefit some patients. “These data combined with other evidence suggest that recommending minimizing or completely eliminating alcohol will likely be helpful to them,” Dr. Marcus said.

The study’s reliance on wearables and sensors was impressive, said Mariann R. Piano, PhD, director of the Center for Research Development and Scholarship, Vanderbilt University, Nashville, Tenn. Often, these types of studies are “self-reported and confounded by recall bias,” she said. But this study passively documented arrhythmia events and blood alcohol level without any patient input. The additional measures of alcohol consumption were used to validate the blood alcohol sensor.

The study’s focus on patients with a history of AF highlighted a high-risk patient group, according to Dr. Piano, who coauthored an editorial about the study. However, the findings may not be applicable to the general population.

Dr. Marcus said alcohol’s role in causing these types of arrhythmias is probably a matter of degree. AF patients are more prone to events than is the general population and are therefore more sensitive to alcohol, he said. But excessive alcohol consumption could increase the chance of AF in the general population.

The study is not without its limitations, however. For instance, “it would have been really ideal if we knew what that blood alcohol was” before an episode, Dr. Piano said. The number of drinks is a good start, but two drinks can affect persons differently, depending on their weight and height. Also, baseline PEth values suggest that patients had been drinking before the study, she said. Ideally, patients could have been asked to abstain from alcohol for a period before the study to determine a negative baseline PEth value and minimize the effects of previous drinking on AF episodes.

Moving forward, this research should inform how clinicians care for their AF patients, both experts agree. “We need to talk to patients about how much they drink,” Dr. Piano said. In addition, patients should be advised to closely monitor what they’re drinking.

“This definitely sharpens the focus of the importance of a thorough alcohol history when we see an atrial fibrillation patient and to counsel them to reduce or eliminate alcohol, even among those that don’t have alcohol use disorders,” Dr. Marcus said.

Preliminary results of the study were presented as a late-breaking clinical trials presentation at the American College of Cardiology meeting in May.

Dr. Marcus has received grants from Baylis, Jawbone, and Eight Sleep and has received personal fees from InCarda and Johnson & Johnson. Coauthors have received personal fees from VivaLNK, Huba Pharmaceuticals, Johnson & Johnson, and Merck and grants from Samsung and Amgen Inc. The editorialists have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Consuming alcohol increases the risk for an atrial fibrillation (AF) episode hours later, according to a study published online Aug. 30 in Annals of Internal Medicine. Modifying the drinking behavior of patients with a history of AF events could make a difference.

coldsnowstorm/iStock / Getty Images Plus

Past research has associated long-term alcohol consumption with the development of AF, and abstinence from alcohol has been associated with a lower overall AF burden. However, lead study author Greg Marcus, MD, a cardioelectrophysiolgist at the University of California, San Francisco, noted that many patients say that alcohol is a trigger for discrete AF episodes.

To test whether that was possible, the researchers enrolled 100 patients who had a history of AF events and who consumed at least one drink per month. Participants wore a transdermal alcohol sensor and an ambulatory, single-lead electrocardiogram device for 4 weeks. They were instructed to press a button on the electrocardiogram device each time they consumed a standard alcoholic beverage. In addition, blood samples were tested for phosphatidylethanol (PEth) at the participants’ 2-week and 4-week visits. PEth is a phospholipid formed in the blood after alcohol intake. It remains in the blood for up to 4 weeks after alcohol consumption.

The study findings confirmed what the patients had reported. The odds of an AF episode were 38% greater with every 0.1% increase in peak blood alcohol concentration over the previous 12 hours (odds ratio [OR], 1.38; 95% confidence interval, 1.04-1.83; P = .024). Moreover, an episode of AF was associated with twofold greater odds (OR, 2.02; 95% CI, 1.38-3.17) of having consumed one alcoholic drink in the past 4 hours. It was associated with more than threefold greater odds of having consumed two or more drinks (OR, 3.58; 95% CI, 1.63-7.89).

“The major takeaway is, among atrial fibrillation patients, consuming alcohol substantially heightened their risk for any given atrial fibrillation event in the subsequent few hours,” Dr. Marcus said. “The more alcohol consumed, the higher that risk.”

The acute effect of alcohol on these arrhythmias also means that modifying alcohol consumption could immediately benefit some patients. “These data combined with other evidence suggest that recommending minimizing or completely eliminating alcohol will likely be helpful to them,” Dr. Marcus said.

The study’s reliance on wearables and sensors was impressive, said Mariann R. Piano, PhD, director of the Center for Research Development and Scholarship, Vanderbilt University, Nashville, Tenn. Often, these types of studies are “self-reported and confounded by recall bias,” she said. But this study passively documented arrhythmia events and blood alcohol level without any patient input. The additional measures of alcohol consumption were used to validate the blood alcohol sensor.

The study’s focus on patients with a history of AF highlighted a high-risk patient group, according to Dr. Piano, who coauthored an editorial about the study. However, the findings may not be applicable to the general population.

Dr. Marcus said alcohol’s role in causing these types of arrhythmias is probably a matter of degree. AF patients are more prone to events than is the general population and are therefore more sensitive to alcohol, he said. But excessive alcohol consumption could increase the chance of AF in the general population.

The study is not without its limitations, however. For instance, “it would have been really ideal if we knew what that blood alcohol was” before an episode, Dr. Piano said. The number of drinks is a good start, but two drinks can affect persons differently, depending on their weight and height. Also, baseline PEth values suggest that patients had been drinking before the study, she said. Ideally, patients could have been asked to abstain from alcohol for a period before the study to determine a negative baseline PEth value and minimize the effects of previous drinking on AF episodes.

Moving forward, this research should inform how clinicians care for their AF patients, both experts agree. “We need to talk to patients about how much they drink,” Dr. Piano said. In addition, patients should be advised to closely monitor what they’re drinking.

“This definitely sharpens the focus of the importance of a thorough alcohol history when we see an atrial fibrillation patient and to counsel them to reduce or eliminate alcohol, even among those that don’t have alcohol use disorders,” Dr. Marcus said.

Preliminary results of the study were presented as a late-breaking clinical trials presentation at the American College of Cardiology meeting in May.

Dr. Marcus has received grants from Baylis, Jawbone, and Eight Sleep and has received personal fees from InCarda and Johnson & Johnson. Coauthors have received personal fees from VivaLNK, Huba Pharmaceuticals, Johnson & Johnson, and Merck and grants from Samsung and Amgen Inc. The editorialists have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Consuming alcohol increases the risk for an atrial fibrillation (AF) episode hours later, according to a study published online Aug. 30 in Annals of Internal Medicine. Modifying the drinking behavior of patients with a history of AF events could make a difference.

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Past research has associated long-term alcohol consumption with the development of AF, and abstinence from alcohol has been associated with a lower overall AF burden. However, lead study author Greg Marcus, MD, a cardioelectrophysiolgist at the University of California, San Francisco, noted that many patients say that alcohol is a trigger for discrete AF episodes.

To test whether that was possible, the researchers enrolled 100 patients who had a history of AF events and who consumed at least one drink per month. Participants wore a transdermal alcohol sensor and an ambulatory, single-lead electrocardiogram device for 4 weeks. They were instructed to press a button on the electrocardiogram device each time they consumed a standard alcoholic beverage. In addition, blood samples were tested for phosphatidylethanol (PEth) at the participants’ 2-week and 4-week visits. PEth is a phospholipid formed in the blood after alcohol intake. It remains in the blood for up to 4 weeks after alcohol consumption.

The study findings confirmed what the patients had reported. The odds of an AF episode were 38% greater with every 0.1% increase in peak blood alcohol concentration over the previous 12 hours (odds ratio [OR], 1.38; 95% confidence interval, 1.04-1.83; P = .024). Moreover, an episode of AF was associated with twofold greater odds (OR, 2.02; 95% CI, 1.38-3.17) of having consumed one alcoholic drink in the past 4 hours. It was associated with more than threefold greater odds of having consumed two or more drinks (OR, 3.58; 95% CI, 1.63-7.89).

“The major takeaway is, among atrial fibrillation patients, consuming alcohol substantially heightened their risk for any given atrial fibrillation event in the subsequent few hours,” Dr. Marcus said. “The more alcohol consumed, the higher that risk.”

The acute effect of alcohol on these arrhythmias also means that modifying alcohol consumption could immediately benefit some patients. “These data combined with other evidence suggest that recommending minimizing or completely eliminating alcohol will likely be helpful to them,” Dr. Marcus said.

The study’s reliance on wearables and sensors was impressive, said Mariann R. Piano, PhD, director of the Center for Research Development and Scholarship, Vanderbilt University, Nashville, Tenn. Often, these types of studies are “self-reported and confounded by recall bias,” she said. But this study passively documented arrhythmia events and blood alcohol level without any patient input. The additional measures of alcohol consumption were used to validate the blood alcohol sensor.

The study’s focus on patients with a history of AF highlighted a high-risk patient group, according to Dr. Piano, who coauthored an editorial about the study. However, the findings may not be applicable to the general population.

Dr. Marcus said alcohol’s role in causing these types of arrhythmias is probably a matter of degree. AF patients are more prone to events than is the general population and are therefore more sensitive to alcohol, he said. But excessive alcohol consumption could increase the chance of AF in the general population.

The study is not without its limitations, however. For instance, “it would have been really ideal if we knew what that blood alcohol was” before an episode, Dr. Piano said. The number of drinks is a good start, but two drinks can affect persons differently, depending on their weight and height. Also, baseline PEth values suggest that patients had been drinking before the study, she said. Ideally, patients could have been asked to abstain from alcohol for a period before the study to determine a negative baseline PEth value and minimize the effects of previous drinking on AF episodes.

Moving forward, this research should inform how clinicians care for their AF patients, both experts agree. “We need to talk to patients about how much they drink,” Dr. Piano said. In addition, patients should be advised to closely monitor what they’re drinking.

“This definitely sharpens the focus of the importance of a thorough alcohol history when we see an atrial fibrillation patient and to counsel them to reduce or eliminate alcohol, even among those that don’t have alcohol use disorders,” Dr. Marcus said.

Preliminary results of the study were presented as a late-breaking clinical trials presentation at the American College of Cardiology meeting in May.

Dr. Marcus has received grants from Baylis, Jawbone, and Eight Sleep and has received personal fees from InCarda and Johnson & Johnson. Coauthors have received personal fees from VivaLNK, Huba Pharmaceuticals, Johnson & Johnson, and Merck and grants from Samsung and Amgen Inc. The editorialists have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Herpes zoster infection is another well-known complication of RA and its treatment, including glucocorticoid therapy. An increased incidence has recently been noted in people who use JAK inhibitors, though other bDMARDs including TNF inhibitors are also known to increase risk. Redeker et al. compare the incidence of herpes zoster in people with RA using csDMARDs, bDMARDs, and tsDMARDs using a German prospective RA registry. In nearly 14,000 patients, 559 cases of herpes zoster were documented; after adjusting for age, sex, and glucocorticoid use, an increased risk was noted for treatment with monoclonal anti-TNF therapy, B-cell directed therapy, and JAK inhibitors compared to csDMARDs, whereas soluble TNF receptor fusion protein, T cell costimulation modulators and IL-6 inhibitors were not associated with a higher risk of herpes zoster compared with csDMARDs. Unfortunately, zoster vaccination status was not extracted for all patients. The study confirms what we already know with direct risk comparison between different agents and underscores the importance of vaccination in RA patients, especially those being treated with glucocorticoids and tsDMARDs.

Finally, another important consideration in the use of bDMARDs is the increase in cancer risk due to a potential reduction in immunosurveillance. Initial meta-analyses of clinical trials of anti-TNF agents highlighted an early increase in cancer risk, though later studies including meta-analyses and registry studies with longer follow-up durations have been equivocal. Huss et al. examine a Swedish registry of people with RA and no prior history of cancer and found a small increase in cancer-risk in patients with RA compared to the general population (HR 1.2). However, there was no increase in overall cancer incidence in patients treated with TNF inhibitors, rituximab, abatacept, or JAK inhibitors compared to RA patients naïve to bDMARDs and tsDMARDs. Interestingly, urinary tract cancer risk was slightly increased in several treatment groups, though the effect size was small. Considering the generally long duration of follow-up (with the exception of JAK inhibitors), this study is very reassuring regarding long-term risk of cancer of bDMARD use and useful in counseling people with RA on therapeutic risks.

Herpes zoster infection is another well-known complication of RA and its treatment, including glucocorticoid therapy. An increased incidence has recently been noted in people who use JAK inhibitors, though other bDMARDs including TNF inhibitors are also known to increase risk. Redeker et al. compare the incidence of herpes zoster in people with RA using csDMARDs, bDMARDs, and tsDMARDs using a German prospective RA registry. In nearly 14,000 patients, 559 cases of herpes zoster were documented; after adjusting for age, sex, and glucocorticoid use, an increased risk was noted for treatment with monoclonal anti-TNF therapy, B-cell directed therapy, and JAK inhibitors compared to csDMARDs, whereas soluble TNF receptor fusion protein, T cell costimulation modulators and IL-6 inhibitors were not associated with a higher risk of herpes zoster compared with csDMARDs. Unfortunately, zoster vaccination status was not extracted for all patients. The study confirms what we already know with direct risk comparison between different agents and underscores the importance of vaccination in RA patients, especially those being treated with glucocorticoids and tsDMARDs.

Finally, another important consideration in the use of bDMARDs is the increase in cancer risk due to a potential reduction in immunosurveillance. Initial meta-analyses of clinical trials of anti-TNF agents highlighted an early increase in cancer risk, though later studies including meta-analyses and registry studies with longer follow-up durations have been equivocal. Huss et al. examine a Swedish registry of people with RA and no prior history of cancer and found a small increase in cancer-risk in patients with RA compared to the general population (HR 1.2). However, there was no increase in overall cancer incidence in patients treated with TNF inhibitors, rituximab, abatacept, or JAK inhibitors compared to RA patients naïve to bDMARDs and tsDMARDs. Interestingly, urinary tract cancer risk was slightly increased in several treatment groups, though the effect size was small. Considering the generally long duration of follow-up (with the exception of JAK inhibitors), this study is very reassuring regarding long-term risk of cancer of bDMARD use and useful in counseling people with RA on therapeutic risks.

Herpes zoster infection is another well-known complication of RA and its treatment, including glucocorticoid therapy. An increased incidence has recently been noted in people who use JAK inhibitors, though other bDMARDs including TNF inhibitors are also known to increase risk. Redeker et al. compare the incidence of herpes zoster in people with RA using csDMARDs, bDMARDs, and tsDMARDs using a German prospective RA registry. In nearly 14,000 patients, 559 cases of herpes zoster were documented; after adjusting for age, sex, and glucocorticoid use, an increased risk was noted for treatment with monoclonal anti-TNF therapy, B-cell directed therapy, and JAK inhibitors compared to csDMARDs, whereas soluble TNF receptor fusion protein, T cell costimulation modulators and IL-6 inhibitors were not associated with a higher risk of herpes zoster compared with csDMARDs. Unfortunately, zoster vaccination status was not extracted for all patients. The study confirms what we already know with direct risk comparison between different agents and underscores the importance of vaccination in RA patients, especially those being treated with glucocorticoids and tsDMARDs.

Finally, another important consideration in the use of bDMARDs is the increase in cancer risk due to a potential reduction in immunosurveillance. Initial meta-analyses of clinical trials of anti-TNF agents highlighted an early increase in cancer risk, though later studies including meta-analyses and registry studies with longer follow-up durations have been equivocal. Huss et al. examine a Swedish registry of people with RA and no prior history of cancer and found a small increase in cancer-risk in patients with RA compared to the general population (HR 1.2). However, there was no increase in overall cancer incidence in patients treated with TNF inhibitors, rituximab, abatacept, or JAK inhibitors compared to RA patients naïve to bDMARDs and tsDMARDs. Interestingly, urinary tract cancer risk was slightly increased in several treatment groups, though the effect size was small. Considering the generally long duration of follow-up (with the exception of JAK inhibitors), this study is very reassuring regarding long-term risk of cancer of bDMARD use and useful in counseling people with RA on therapeutic risks.

A Louisiana physician, who refers to himself as a “former assassin,” was indicted by a federal grand jury for his role in distributing more than 1.2 million doses of schedule II controlled substances outside the scope of professional practice and not for a legitimate medical purpose, according to the U.S. Department of Justice. The substances include oxycodone and morphine.

Adrian Dexter Talbot, MD, 55, of Slidell, La., is also charged with maintaining a medical clinic for the purpose of illegally distributing controlled substances, per the indictment.

Because the opioid prescriptions were filled using beneficiaries’ health insurance, Dr. Talbot is also charged with defrauding Medicare, Medicaid, and Blue Cross and Blue Shield of Louisiana of more than $5.1 million.

When contacted by this news organization for comment on the case via Twitter, Dr. Talbot or a representative responded with a link to his self-published book on Amazon. In his author bio, Dr. Talbot refers to himself as “a former assassin,” “retired military commander,” and “leader of the Medellin Cartel’s New York operations at the age of 16.” The Medellin Cartel is a notorious drug distribution empire.

Dr. Talbot is listed as the author of another book on Google Books detailing his time as a “former teenage assassin” and leader of the cartel, told as he struggles with early onset Alzheimer’s.
 

Dr. Talbot could spend decades in prison

According to the National Institute on Drug Abuse, 444 residents of the Bayou State lost their lives because of an opioid-related drug overdose in 2018. During that year, the state’s health care providers wrote more than 79.4 opioid prescriptions for every 100 persons, which puts the state in the top five in the United States in 2018, when the average U.S. rate was 51.4 prescriptions per 100 persons.

Charged with one count each of conspiracy to unlawfully distribute and dispense controlled substances and maintaining drug-involved premises and conspiracy to commit health care fraud, Dr. Talbot is also charged with four counts of unlawfully distributing and dispensing controlled substances. He is scheduled for a federal court appearance on September 10.

In addition to presigning prescriptions for individuals he didn’t meet or examine, federal officials allege Dr. Talbot hired another health care provider to similarly presign prescriptions for people who weren’t examined at a medical practice in Slidell, where Dr. Talbot was employed. The DOJ says Dr. Talbot took a full-time job in Pineville, La., and presigned prescriptions while no longer physically present at the Slidell clinic.

A speaker’s bio for Dr. Talbot indicates he worked as chief of medical services for the Alexandria Veterans Affairs Health Care System in Pineville.

According to the DOJ’s indictment, Dr. Talbot was aware that patients were filling the prescriptions that were provided outside the scope of professional practice and not for a legitimate medical purpose. This is what triggered the DOJ’s fraudulent billing claim. 

Dr. Talbot faces a maximum penalty of 10 years for conspiracy to commit health care fraud and 20 years each for the other counts, if convicted.
 

Dr. Talbot was candidate for local coroner

In February 2015, Dr. Talbot announced his candidacy for coroner for St. Tammany Parish, about an hour’s drive south of New Orleans, reported the Times Picayune. The seat was open because the previous coroner had resigned and ultimately pleaded guilty to a federal corruption charge.

The Times Picayune reported at the time that Dr. Talbot was a U.S. Navy veteran, in addition to serving as medical director and a primary care physician at the Medical Care Center in Slidell. Among the services provided to his patients were evaluations and treatment for substance use and mental health disorders, according to a press release issued by Dr. Talbot’s campaign.

Dr. Talbot’s medical license was issued in 1999 and inactive as of 2017, per the Louisiana State Board of Medical Examiners.
 

Louisiana expects $325M in multistate settlement with opioid companies

Louisiana is a party to a multistate and multijurisdictional lawsuit where the state is expected to receive more than $325 million in a settlement reached with drug distributors Cardinal, McKesson, and AmerisourceBergen, and drug manufacturer Johnson & Johnson, reported the Louisiana Illuminator in July. The total settlement may reach $26 billion dollars.

The Associated Press reported in July that there have been at least $40 billion in completed or proposed settlements, penalties, and fines between governments as a result of the opioid epidemic since 2007.

That total doesn’t include a proposed settlement involving members of the Sackler family, who own Purdue Pharmaceuticals, which manufactured and marketed the opioid painkiller OxyContin. The Sackler family have agreed to pay approximately $4.3 billion and surrender ownership of their bankrupt company, reported NPR. The family’s proposed settlement is part of a deal involving Purdue Pharmaceuticals worth more than $10 billion, reported Reuters.

In 2020, there were more than 81,000 drug overdose deaths, the highest number recorded in a 12-month period, per the U.S. Centers for Disease Control and Prevention. Fentanyl, an illicitly manufactured synthetic opioid, was the lead driver of those deaths.

A version of this article first appeared on Medscape.com.

A Louisiana physician, who refers to himself as a “former assassin,” was indicted by a federal grand jury for his role in distributing more than 1.2 million doses of schedule II controlled substances outside the scope of professional practice and not for a legitimate medical purpose, according to the U.S. Department of Justice. The substances include oxycodone and morphine.

Adrian Dexter Talbot, MD, 55, of Slidell, La., is also charged with maintaining a medical clinic for the purpose of illegally distributing controlled substances, per the indictment.

Because the opioid prescriptions were filled using beneficiaries’ health insurance, Dr. Talbot is also charged with defrauding Medicare, Medicaid, and Blue Cross and Blue Shield of Louisiana of more than $5.1 million.

When contacted by this news organization for comment on the case via Twitter, Dr. Talbot or a representative responded with a link to his self-published book on Amazon. In his author bio, Dr. Talbot refers to himself as “a former assassin,” “retired military commander,” and “leader of the Medellin Cartel’s New York operations at the age of 16.” The Medellin Cartel is a notorious drug distribution empire.

Dr. Talbot is listed as the author of another book on Google Books detailing his time as a “former teenage assassin” and leader of the cartel, told as he struggles with early onset Alzheimer’s.
 

Dr. Talbot could spend decades in prison

According to the National Institute on Drug Abuse, 444 residents of the Bayou State lost their lives because of an opioid-related drug overdose in 2018. During that year, the state’s health care providers wrote more than 79.4 opioid prescriptions for every 100 persons, which puts the state in the top five in the United States in 2018, when the average U.S. rate was 51.4 prescriptions per 100 persons.

Charged with one count each of conspiracy to unlawfully distribute and dispense controlled substances and maintaining drug-involved premises and conspiracy to commit health care fraud, Dr. Talbot is also charged with four counts of unlawfully distributing and dispensing controlled substances. He is scheduled for a federal court appearance on September 10.

In addition to presigning prescriptions for individuals he didn’t meet or examine, federal officials allege Dr. Talbot hired another health care provider to similarly presign prescriptions for people who weren’t examined at a medical practice in Slidell, where Dr. Talbot was employed. The DOJ says Dr. Talbot took a full-time job in Pineville, La., and presigned prescriptions while no longer physically present at the Slidell clinic.

A speaker’s bio for Dr. Talbot indicates he worked as chief of medical services for the Alexandria Veterans Affairs Health Care System in Pineville.

According to the DOJ’s indictment, Dr. Talbot was aware that patients were filling the prescriptions that were provided outside the scope of professional practice and not for a legitimate medical purpose. This is what triggered the DOJ’s fraudulent billing claim. 

Dr. Talbot faces a maximum penalty of 10 years for conspiracy to commit health care fraud and 20 years each for the other counts, if convicted.
 

Dr. Talbot was candidate for local coroner

In February 2015, Dr. Talbot announced his candidacy for coroner for St. Tammany Parish, about an hour’s drive south of New Orleans, reported the Times Picayune. The seat was open because the previous coroner had resigned and ultimately pleaded guilty to a federal corruption charge.

The Times Picayune reported at the time that Dr. Talbot was a U.S. Navy veteran, in addition to serving as medical director and a primary care physician at the Medical Care Center in Slidell. Among the services provided to his patients were evaluations and treatment for substance use and mental health disorders, according to a press release issued by Dr. Talbot’s campaign.

Dr. Talbot’s medical license was issued in 1999 and inactive as of 2017, per the Louisiana State Board of Medical Examiners.
 

Louisiana expects $325M in multistate settlement with opioid companies

Louisiana is a party to a multistate and multijurisdictional lawsuit where the state is expected to receive more than $325 million in a settlement reached with drug distributors Cardinal, McKesson, and AmerisourceBergen, and drug manufacturer Johnson & Johnson, reported the Louisiana Illuminator in July. The total settlement may reach $26 billion dollars.

The Associated Press reported in July that there have been at least $40 billion in completed or proposed settlements, penalties, and fines between governments as a result of the opioid epidemic since 2007.

That total doesn’t include a proposed settlement involving members of the Sackler family, who own Purdue Pharmaceuticals, which manufactured and marketed the opioid painkiller OxyContin. The Sackler family have agreed to pay approximately $4.3 billion and surrender ownership of their bankrupt company, reported NPR. The family’s proposed settlement is part of a deal involving Purdue Pharmaceuticals worth more than $10 billion, reported Reuters.

In 2020, there were more than 81,000 drug overdose deaths, the highest number recorded in a 12-month period, per the U.S. Centers for Disease Control and Prevention. Fentanyl, an illicitly manufactured synthetic opioid, was the lead driver of those deaths.

A version of this article first appeared on Medscape.com.

A Louisiana physician, who refers to himself as a “former assassin,” was indicted by a federal grand jury for his role in distributing more than 1.2 million doses of schedule II controlled substances outside the scope of professional practice and not for a legitimate medical purpose, according to the U.S. Department of Justice. The substances include oxycodone and morphine.

Adrian Dexter Talbot, MD, 55, of Slidell, La., is also charged with maintaining a medical clinic for the purpose of illegally distributing controlled substances, per the indictment.

Because the opioid prescriptions were filled using beneficiaries’ health insurance, Dr. Talbot is also charged with defrauding Medicare, Medicaid, and Blue Cross and Blue Shield of Louisiana of more than $5.1 million.

When contacted by this news organization for comment on the case via Twitter, Dr. Talbot or a representative responded with a link to his self-published book on Amazon. In his author bio, Dr. Talbot refers to himself as “a former assassin,” “retired military commander,” and “leader of the Medellin Cartel’s New York operations at the age of 16.” The Medellin Cartel is a notorious drug distribution empire.

Dr. Talbot is listed as the author of another book on Google Books detailing his time as a “former teenage assassin” and leader of the cartel, told as he struggles with early onset Alzheimer’s.
 

Dr. Talbot could spend decades in prison

According to the National Institute on Drug Abuse, 444 residents of the Bayou State lost their lives because of an opioid-related drug overdose in 2018. During that year, the state’s health care providers wrote more than 79.4 opioid prescriptions for every 100 persons, which puts the state in the top five in the United States in 2018, when the average U.S. rate was 51.4 prescriptions per 100 persons.

Charged with one count each of conspiracy to unlawfully distribute and dispense controlled substances and maintaining drug-involved premises and conspiracy to commit health care fraud, Dr. Talbot is also charged with four counts of unlawfully distributing and dispensing controlled substances. He is scheduled for a federal court appearance on September 10.

In addition to presigning prescriptions for individuals he didn’t meet or examine, federal officials allege Dr. Talbot hired another health care provider to similarly presign prescriptions for people who weren’t examined at a medical practice in Slidell, where Dr. Talbot was employed. The DOJ says Dr. Talbot took a full-time job in Pineville, La., and presigned prescriptions while no longer physically present at the Slidell clinic.

A speaker’s bio for Dr. Talbot indicates he worked as chief of medical services for the Alexandria Veterans Affairs Health Care System in Pineville.

According to the DOJ’s indictment, Dr. Talbot was aware that patients were filling the prescriptions that were provided outside the scope of professional practice and not for a legitimate medical purpose. This is what triggered the DOJ’s fraudulent billing claim. 

Dr. Talbot faces a maximum penalty of 10 years for conspiracy to commit health care fraud and 20 years each for the other counts, if convicted.
 

Dr. Talbot was candidate for local coroner

In February 2015, Dr. Talbot announced his candidacy for coroner for St. Tammany Parish, about an hour’s drive south of New Orleans, reported the Times Picayune. The seat was open because the previous coroner had resigned and ultimately pleaded guilty to a federal corruption charge.

The Times Picayune reported at the time that Dr. Talbot was a U.S. Navy veteran, in addition to serving as medical director and a primary care physician at the Medical Care Center in Slidell. Among the services provided to his patients were evaluations and treatment for substance use and mental health disorders, according to a press release issued by Dr. Talbot’s campaign.

Dr. Talbot’s medical license was issued in 1999 and inactive as of 2017, per the Louisiana State Board of Medical Examiners.
 

Louisiana expects $325M in multistate settlement with opioid companies

Louisiana is a party to a multistate and multijurisdictional lawsuit where the state is expected to receive more than $325 million in a settlement reached with drug distributors Cardinal, McKesson, and AmerisourceBergen, and drug manufacturer Johnson & Johnson, reported the Louisiana Illuminator in July. The total settlement may reach $26 billion dollars.

The Associated Press reported in July that there have been at least $40 billion in completed or proposed settlements, penalties, and fines between governments as a result of the opioid epidemic since 2007.

That total doesn’t include a proposed settlement involving members of the Sackler family, who own Purdue Pharmaceuticals, which manufactured and marketed the opioid painkiller OxyContin. The Sackler family have agreed to pay approximately $4.3 billion and surrender ownership of their bankrupt company, reported NPR. The family’s proposed settlement is part of a deal involving Purdue Pharmaceuticals worth more than $10 billion, reported Reuters.

In 2020, there were more than 81,000 drug overdose deaths, the highest number recorded in a 12-month period, per the U.S. Centers for Disease Control and Prevention. Fentanyl, an illicitly manufactured synthetic opioid, was the lead driver of those deaths.

A version of this article first appeared on Medscape.com.

In the study by Sternberg et al, radiographic progression-free survival (rPFS) and safety were compared between patients aged > 70 and younger than age 70 who were enrolled in the CARD study. In the CARD study, patients with metastatic castrate-resistant prostate cancer (mCRPC) were randomized to cabazitaxel versus abiraterone or enzlutamide after having failed previous treatment. Patients aged > 70 who received cabazitaxel had a higher rPFS than those who received abiraterone or enzalutamide. Grade > 3 adverse effects were identified in 58% of patients receiving cabazitaxel versus 49% in those receiving abiraterone or enzalutamide.

In the study by Smith et al., quality of life (QoL) as measured via time to deterioration of patient report outcomes (PRO) was evaluated in patients enrolled on the ARAMIS trial (darolutamide versus placebo in patients with non-metastatic castrate-resistant prostate cancer (nmCRPC). PRO was assessed via surveys as an exploratory endpoint in this study via FACT-P PCS (prostate cancer subscale) and EORTC QLQ-PR25. Overall, the findings were consistent with either an overall improvement in QoL or improvement in urinary and bowel symptoms over time. In a separate study, Fallah et al conducted a pooled analysis of survival and safety outcomes of 3 second generation androgen receptor blockers (apalutamide, darolutamide, and enzalutamide) in men with nmCRPC. They compared results for men age under 80 versus those 80 and above. Metastasis-free survival and overall survival were higher for the treatment groups compared with placebo groups for both age categories. Side effects were slightly higher in the group aged 80 and above.

In summary, quality of life is an endpoint of critical importance to patients. Inclusion of patient reported outcomes as measured via surveys that provide quantitative assessments aid providers in discussing treatment options with patients. In addition, such QoL instruments aid in assessments based on age. Age bias is common in oncology, and the included studies provide further evidence that age alone should not be a reason to adjust treatment recommendations. Inclusion of geriatric assessments into such studies may further aid in determining risks and benefits of particular prostate cancer treatments in future studies

In the study by Sternberg et al, radiographic progression-free survival (rPFS) and safety were compared between patients aged > 70 and younger than age 70 who were enrolled in the CARD study. In the CARD study, patients with metastatic castrate-resistant prostate cancer (mCRPC) were randomized to cabazitaxel versus abiraterone or enzlutamide after having failed previous treatment. Patients aged > 70 who received cabazitaxel had a higher rPFS than those who received abiraterone or enzalutamide. Grade > 3 adverse effects were identified in 58% of patients receiving cabazitaxel versus 49% in those receiving abiraterone or enzalutamide.

In the study by Smith et al., quality of life (QoL) as measured via time to deterioration of patient report outcomes (PRO) was evaluated in patients enrolled on the ARAMIS trial (darolutamide versus placebo in patients with non-metastatic castrate-resistant prostate cancer (nmCRPC). PRO was assessed via surveys as an exploratory endpoint in this study via FACT-P PCS (prostate cancer subscale) and EORTC QLQ-PR25. Overall, the findings were consistent with either an overall improvement in QoL or improvement in urinary and bowel symptoms over time. In a separate study, Fallah et al conducted a pooled analysis of survival and safety outcomes of 3 second generation androgen receptor blockers (apalutamide, darolutamide, and enzalutamide) in men with nmCRPC. They compared results for men age under 80 versus those 80 and above. Metastasis-free survival and overall survival were higher for the treatment groups compared with placebo groups for both age categories. Side effects were slightly higher in the group aged 80 and above.

In summary, quality of life is an endpoint of critical importance to patients. Inclusion of patient reported outcomes as measured via surveys that provide quantitative assessments aid providers in discussing treatment options with patients. In addition, such QoL instruments aid in assessments based on age. Age bias is common in oncology, and the included studies provide further evidence that age alone should not be a reason to adjust treatment recommendations. Inclusion of geriatric assessments into such studies may further aid in determining risks and benefits of particular prostate cancer treatments in future studies

In the study by Sternberg et al, radiographic progression-free survival (rPFS) and safety were compared between patients aged > 70 and younger than age 70 who were enrolled in the CARD study. In the CARD study, patients with metastatic castrate-resistant prostate cancer (mCRPC) were randomized to cabazitaxel versus abiraterone or enzlutamide after having failed previous treatment. Patients aged > 70 who received cabazitaxel had a higher rPFS than those who received abiraterone or enzalutamide. Grade > 3 adverse effects were identified in 58% of patients receiving cabazitaxel versus 49% in those receiving abiraterone or enzalutamide.

In the study by Smith et al., quality of life (QoL) as measured via time to deterioration of patient report outcomes (PRO) was evaluated in patients enrolled on the ARAMIS trial (darolutamide versus placebo in patients with non-metastatic castrate-resistant prostate cancer (nmCRPC). PRO was assessed via surveys as an exploratory endpoint in this study via FACT-P PCS (prostate cancer subscale) and EORTC QLQ-PR25. Overall, the findings were consistent with either an overall improvement in QoL or improvement in urinary and bowel symptoms over time. In a separate study, Fallah et al conducted a pooled analysis of survival and safety outcomes of 3 second generation androgen receptor blockers (apalutamide, darolutamide, and enzalutamide) in men with nmCRPC. They compared results for men age under 80 versus those 80 and above. Metastasis-free survival and overall survival were higher for the treatment groups compared with placebo groups for both age categories. Side effects were slightly higher in the group aged 80 and above.

In summary, quality of life is an endpoint of critical importance to patients. Inclusion of patient reported outcomes as measured via surveys that provide quantitative assessments aid providers in discussing treatment options with patients. In addition, such QoL instruments aid in assessments based on age. Age bias is common in oncology, and the included studies provide further evidence that age alone should not be a reason to adjust treatment recommendations. Inclusion of geriatric assessments into such studies may further aid in determining risks and benefits of particular prostate cancer treatments in future studies

Carotid artery stenting (CAS) and carotid endarterectomy (CEA) provided comparable outcomes over time in asymptomatic patients receiving good medical therapy in the largest trial to date of what to do with severe carotid artery narrowing that is yet to cause a stroke.

aaM Photography, Ltd./iStock

Among more than 3,600 patients, stenting and surgery performed by experienced physicians involved a 1.0% risk for causing disabling stroke or death within 30 days.

The annual rate of fatal or disabling strokes was about 0.5% with either procedure over an average 5 years’ follow-up – essentially halving the annual stroke risk had neither procedure been performed, according to Alison Halliday, MD, principal investigator of the Asymptomatic Carotid Surgery Trial-2 (ACST-2).

The results were reported Aug. 29 in a Hot Line session at the virtual annual congress of the European Society of Cardiology and published simultaneously online in The Lancet.

Session chair Gilles Montalescot, MD, Sorbonne University, Paris, noted that ACST-2 doubled the number of randomly assigned patients with asymptomatic carotid stenosis studied in previous trials, “so, a huge contribution to the evidence base in this field and apparently good news for both revascularization techniques.”
 

Thirty-day and 5-year outcomes

The trial was conducted in 33 countries between January 2008 and December 2020, enrolling 3,625 patients (70% were male; mean age, 70 years) with carotid stenosis of at least 60% on ultrasonography, in whom stenting or surgery was suitable but both the doctor and patient were “substantially uncertain” which procedure to prefer.

Among the 1,811 patients assigned to stenting, 87% underwent the procedure at a median of 14 days; 6% crossed over to surgery, typically because of a highly calcified lesion or a more tortuous carotid than anticipated; and 6% had no intervention.

Among the 1,814 patients assigned to surgery, 92% had the procedure at a median of 14 days; 3% crossed over to stenting, typically because of patient or doctor preference or reluctance to undergo general anesthesia; and 4% had no intervention.

Patients without complications who had stenting stayed on average 1 day less than did those undergoing surgery.

During an earlier press briefing, Dr. Halliday highlighted the need for procedural competency and said doctors had to submit a record of their CEA or CAS experience and, consistent with current guidelines, had to demonstrate an independently verified stroke or death rate of 6% or less for symptomatic patients and 3% or lower for asymptomatic patients.

The results showed the 30-day risk for death, myocardial infarction (MI), or any stroke was 3.9% with carotid stenting and 3.2% with surgery (P = .26).

But with stenting, there was a slightly higher risk for procedural nondisabling strokes (48 vs. 29; P = .03), including 15 strokes vs. 5 strokes, respectively, that left patients with no residual symptoms. This is “consistent with large, recent nationally representative registry data,” observed Dr. Halliday, of the University of Oxford (England).

For those undergoing surgery, cranial nerve palsies were reported in 5.4% vs. no patients undergoing stenting.

At 5 years, the nonprocedural fatal or disabling stroke rate was 2.5% in each group (rate ratio [RR], 0.98; P = .91), with any nonprocedural stroke occurring in 5.3% of patients with stenting vs. 4.5% with surgery (RR, 1.16; P = .33).

The investigators performed a meta-analysis combining the ACST-2 results with those of eight prior trials (four in asymptomatic and four in symptomatic patients) that yielded a similar nonsignificant result for any nonprocedural stroke (RR, 1.11; P = .21).

Based on the results from ACST-2 plus the major trials, stenting and surgery involve “similar risks and similar benefits,” Dr. Halliday concluded.

Discussant Marco Roffi, MD, University Hospital of Geneva, said, “In centers with documented expertise, carotid artery stenting should be offered as an alternative to carotid endarterectomy in patients with asymptomatic stenosis and suitable anatomy.”

While the trial provides “good news” for patients, he pointed out that a reduction in the sample size from 5,000 to 3,625 limited the statistical power and that enrollment over a long period of time may have introduced confounders, such as changes in equipment technique, and medical therapy.

Also, many centers enrolled few patients, raising the concern over low-volume centers and operators, Dr. Roffi said. “We know that 8% of the centers enrolled 39% of the patients,” and “information on the credentialing and experience of the interventionalists was limited.”

Further, a lack of systematic MI assessment may have favored the surgery group, and more recent developments in stenting with the potential of reducing periprocedural stroke were rarely used, such as proximal emboli protection in only 15% and double-layer stents in 11%.

Friedhelm Beyersdorf, MD, University Hospital of Freiburg, Germany, said that, as a vascular surgeon, he finds it understandable that there might be a higher incidence of nonfatal strokes when treating carotid stenosis with stents, given the vulnerability of these lesions.

“Nevertheless, the main conclusion from the entire study is that carotid artery treatment is extremely safe, it has to be done in order to avoid strokes, and, obviously, there seems to be an advantage for surgery in terms of nondisabling stroke,” he said.

Session chair Dr. Montalescot, however, said that what the study cannot address – and what was the subject of many online audience comments – is whether either intervention should be performed in these patients. 

Unlike earlier trials comparing interventions to medical therapy, Dr. Halliday said ACST-2 enrolled patients for whom the decision had been made that revascularization was needed. In addition, 99%-100% were receiving antithrombotic therapy at baseline, 85%-90% were receiving antihypertensives, and about 85% were taking statins.

Longer-term follow-up should provide a better picture of the nonprocedural stroke risk, with patients asked annually about exactly what medications and doses they are taking, she said.

“We will have an enormous list of exactly what’s gone on and the intensity of that therapy, which is, of course, much more intense than when we carried out our first trial. But these were people in whom a procedure was thought to be necessary,” she noted.

When asked during the press conference which procedure she would choose, Dr. Halliday, a surgeon, observed that patient preference is important but that the nature of the lesion itself often determines the optimal choice.

“If you know the competence of the people doing it is equal, then the less invasive procedure – providing it has good long-term viability, and that’s why we’re following for 10 years – is the more important,” she added.

The study was funded by the UK Medical Research Council and Health Technology Assessment Programme. Dr. Halliday reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Carotid artery stenting (CAS) and carotid endarterectomy (CEA) provided comparable outcomes over time in asymptomatic patients receiving good medical therapy in the largest trial to date of what to do with severe carotid artery narrowing that is yet to cause a stroke.

aaM Photography, Ltd./iStock

Among more than 3,600 patients, stenting and surgery performed by experienced physicians involved a 1.0% risk for causing disabling stroke or death within 30 days.

The annual rate of fatal or disabling strokes was about 0.5% with either procedure over an average 5 years’ follow-up – essentially halving the annual stroke risk had neither procedure been performed, according to Alison Halliday, MD, principal investigator of the Asymptomatic Carotid Surgery Trial-2 (ACST-2).

The results were reported Aug. 29 in a Hot Line session at the virtual annual congress of the European Society of Cardiology and published simultaneously online in The Lancet.

Session chair Gilles Montalescot, MD, Sorbonne University, Paris, noted that ACST-2 doubled the number of randomly assigned patients with asymptomatic carotid stenosis studied in previous trials, “so, a huge contribution to the evidence base in this field and apparently good news for both revascularization techniques.”
 

Thirty-day and 5-year outcomes

The trial was conducted in 33 countries between January 2008 and December 2020, enrolling 3,625 patients (70% were male; mean age, 70 years) with carotid stenosis of at least 60% on ultrasonography, in whom stenting or surgery was suitable but both the doctor and patient were “substantially uncertain” which procedure to prefer.

Among the 1,811 patients assigned to stenting, 87% underwent the procedure at a median of 14 days; 6% crossed over to surgery, typically because of a highly calcified lesion or a more tortuous carotid than anticipated; and 6% had no intervention.

Among the 1,814 patients assigned to surgery, 92% had the procedure at a median of 14 days; 3% crossed over to stenting, typically because of patient or doctor preference or reluctance to undergo general anesthesia; and 4% had no intervention.

Patients without complications who had stenting stayed on average 1 day less than did those undergoing surgery.

During an earlier press briefing, Dr. Halliday highlighted the need for procedural competency and said doctors had to submit a record of their CEA or CAS experience and, consistent with current guidelines, had to demonstrate an independently verified stroke or death rate of 6% or less for symptomatic patients and 3% or lower for asymptomatic patients.

The results showed the 30-day risk for death, myocardial infarction (MI), or any stroke was 3.9% with carotid stenting and 3.2% with surgery (P = .26).

But with stenting, there was a slightly higher risk for procedural nondisabling strokes (48 vs. 29; P = .03), including 15 strokes vs. 5 strokes, respectively, that left patients with no residual symptoms. This is “consistent with large, recent nationally representative registry data,” observed Dr. Halliday, of the University of Oxford (England).

For those undergoing surgery, cranial nerve palsies were reported in 5.4% vs. no patients undergoing stenting.

At 5 years, the nonprocedural fatal or disabling stroke rate was 2.5% in each group (rate ratio [RR], 0.98; P = .91), with any nonprocedural stroke occurring in 5.3% of patients with stenting vs. 4.5% with surgery (RR, 1.16; P = .33).

The investigators performed a meta-analysis combining the ACST-2 results with those of eight prior trials (four in asymptomatic and four in symptomatic patients) that yielded a similar nonsignificant result for any nonprocedural stroke (RR, 1.11; P = .21).

Based on the results from ACST-2 plus the major trials, stenting and surgery involve “similar risks and similar benefits,” Dr. Halliday concluded.

Discussant Marco Roffi, MD, University Hospital of Geneva, said, “In centers with documented expertise, carotid artery stenting should be offered as an alternative to carotid endarterectomy in patients with asymptomatic stenosis and suitable anatomy.”

While the trial provides “good news” for patients, he pointed out that a reduction in the sample size from 5,000 to 3,625 limited the statistical power and that enrollment over a long period of time may have introduced confounders, such as changes in equipment technique, and medical therapy.

Also, many centers enrolled few patients, raising the concern over low-volume centers and operators, Dr. Roffi said. “We know that 8% of the centers enrolled 39% of the patients,” and “information on the credentialing and experience of the interventionalists was limited.”

Further, a lack of systematic MI assessment may have favored the surgery group, and more recent developments in stenting with the potential of reducing periprocedural stroke were rarely used, such as proximal emboli protection in only 15% and double-layer stents in 11%.

Friedhelm Beyersdorf, MD, University Hospital of Freiburg, Germany, said that, as a vascular surgeon, he finds it understandable that there might be a higher incidence of nonfatal strokes when treating carotid stenosis with stents, given the vulnerability of these lesions.

“Nevertheless, the main conclusion from the entire study is that carotid artery treatment is extremely safe, it has to be done in order to avoid strokes, and, obviously, there seems to be an advantage for surgery in terms of nondisabling stroke,” he said.

Session chair Dr. Montalescot, however, said that what the study cannot address – and what was the subject of many online audience comments – is whether either intervention should be performed in these patients. 

Unlike earlier trials comparing interventions to medical therapy, Dr. Halliday said ACST-2 enrolled patients for whom the decision had been made that revascularization was needed. In addition, 99%-100% were receiving antithrombotic therapy at baseline, 85%-90% were receiving antihypertensives, and about 85% were taking statins.

Longer-term follow-up should provide a better picture of the nonprocedural stroke risk, with patients asked annually about exactly what medications and doses they are taking, she said.

“We will have an enormous list of exactly what’s gone on and the intensity of that therapy, which is, of course, much more intense than when we carried out our first trial. But these were people in whom a procedure was thought to be necessary,” she noted.

When asked during the press conference which procedure she would choose, Dr. Halliday, a surgeon, observed that patient preference is important but that the nature of the lesion itself often determines the optimal choice.

“If you know the competence of the people doing it is equal, then the less invasive procedure – providing it has good long-term viability, and that’s why we’re following for 10 years – is the more important,” she added.

The study was funded by the UK Medical Research Council and Health Technology Assessment Programme. Dr. Halliday reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Carotid artery stenting (CAS) and carotid endarterectomy (CEA) provided comparable outcomes over time in asymptomatic patients receiving good medical therapy in the largest trial to date of what to do with severe carotid artery narrowing that is yet to cause a stroke.

aaM Photography, Ltd./iStock

Among more than 3,600 patients, stenting and surgery performed by experienced physicians involved a 1.0% risk for causing disabling stroke or death within 30 days.

The annual rate of fatal or disabling strokes was about 0.5% with either procedure over an average 5 years’ follow-up – essentially halving the annual stroke risk had neither procedure been performed, according to Alison Halliday, MD, principal investigator of the Asymptomatic Carotid Surgery Trial-2 (ACST-2).

The results were reported Aug. 29 in a Hot Line session at the virtual annual congress of the European Society of Cardiology and published simultaneously online in The Lancet.

Session chair Gilles Montalescot, MD, Sorbonne University, Paris, noted that ACST-2 doubled the number of randomly assigned patients with asymptomatic carotid stenosis studied in previous trials, “so, a huge contribution to the evidence base in this field and apparently good news for both revascularization techniques.”
 

Thirty-day and 5-year outcomes

The trial was conducted in 33 countries between January 2008 and December 2020, enrolling 3,625 patients (70% were male; mean age, 70 years) with carotid stenosis of at least 60% on ultrasonography, in whom stenting or surgery was suitable but both the doctor and patient were “substantially uncertain” which procedure to prefer.

Among the 1,811 patients assigned to stenting, 87% underwent the procedure at a median of 14 days; 6% crossed over to surgery, typically because of a highly calcified lesion or a more tortuous carotid than anticipated; and 6% had no intervention.

Among the 1,814 patients assigned to surgery, 92% had the procedure at a median of 14 days; 3% crossed over to stenting, typically because of patient or doctor preference or reluctance to undergo general anesthesia; and 4% had no intervention.

Patients without complications who had stenting stayed on average 1 day less than did those undergoing surgery.

During an earlier press briefing, Dr. Halliday highlighted the need for procedural competency and said doctors had to submit a record of their CEA or CAS experience and, consistent with current guidelines, had to demonstrate an independently verified stroke or death rate of 6% or less for symptomatic patients and 3% or lower for asymptomatic patients.

The results showed the 30-day risk for death, myocardial infarction (MI), or any stroke was 3.9% with carotid stenting and 3.2% with surgery (P = .26).

But with stenting, there was a slightly higher risk for procedural nondisabling strokes (48 vs. 29; P = .03), including 15 strokes vs. 5 strokes, respectively, that left patients with no residual symptoms. This is “consistent with large, recent nationally representative registry data,” observed Dr. Halliday, of the University of Oxford (England).

For those undergoing surgery, cranial nerve palsies were reported in 5.4% vs. no patients undergoing stenting.

At 5 years, the nonprocedural fatal or disabling stroke rate was 2.5% in each group (rate ratio [RR], 0.98; P = .91), with any nonprocedural stroke occurring in 5.3% of patients with stenting vs. 4.5% with surgery (RR, 1.16; P = .33).

The investigators performed a meta-analysis combining the ACST-2 results with those of eight prior trials (four in asymptomatic and four in symptomatic patients) that yielded a similar nonsignificant result for any nonprocedural stroke (RR, 1.11; P = .21).

Based on the results from ACST-2 plus the major trials, stenting and surgery involve “similar risks and similar benefits,” Dr. Halliday concluded.

Discussant Marco Roffi, MD, University Hospital of Geneva, said, “In centers with documented expertise, carotid artery stenting should be offered as an alternative to carotid endarterectomy in patients with asymptomatic stenosis and suitable anatomy.”

While the trial provides “good news” for patients, he pointed out that a reduction in the sample size from 5,000 to 3,625 limited the statistical power and that enrollment over a long period of time may have introduced confounders, such as changes in equipment technique, and medical therapy.

Also, many centers enrolled few patients, raising the concern over low-volume centers and operators, Dr. Roffi said. “We know that 8% of the centers enrolled 39% of the patients,” and “information on the credentialing and experience of the interventionalists was limited.”

Further, a lack of systematic MI assessment may have favored the surgery group, and more recent developments in stenting with the potential of reducing periprocedural stroke were rarely used, such as proximal emboli protection in only 15% and double-layer stents in 11%.

Friedhelm Beyersdorf, MD, University Hospital of Freiburg, Germany, said that, as a vascular surgeon, he finds it understandable that there might be a higher incidence of nonfatal strokes when treating carotid stenosis with stents, given the vulnerability of these lesions.

“Nevertheless, the main conclusion from the entire study is that carotid artery treatment is extremely safe, it has to be done in order to avoid strokes, and, obviously, there seems to be an advantage for surgery in terms of nondisabling stroke,” he said.

Session chair Dr. Montalescot, however, said that what the study cannot address – and what was the subject of many online audience comments – is whether either intervention should be performed in these patients. 

Unlike earlier trials comparing interventions to medical therapy, Dr. Halliday said ACST-2 enrolled patients for whom the decision had been made that revascularization was needed. In addition, 99%-100% were receiving antithrombotic therapy at baseline, 85%-90% were receiving antihypertensives, and about 85% were taking statins.

Longer-term follow-up should provide a better picture of the nonprocedural stroke risk, with patients asked annually about exactly what medications and doses they are taking, she said.

“We will have an enormous list of exactly what’s gone on and the intensity of that therapy, which is, of course, much more intense than when we carried out our first trial. But these were people in whom a procedure was thought to be necessary,” she noted.

When asked during the press conference which procedure she would choose, Dr. Halliday, a surgeon, observed that patient preference is important but that the nature of the lesion itself often determines the optimal choice.

“If you know the competence of the people doing it is equal, then the less invasive procedure – providing it has good long-term viability, and that’s why we’re following for 10 years – is the more important,” she added.

The study was funded by the UK Medical Research Council and Health Technology Assessment Programme. Dr. Halliday reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Diagnosis: Pemphigus Foliaceous

Laboratory workup including a complete blood cell count with differential, comprehensive metabolic panel, antinuclear antibodies, Sjögren syndrome A and B antibodies, hepatitis profile, rapid plasma reagin, HIV screen, aldolase, anti–Jo-1, T-Spot TB test (Quest Diagnostics), and tissue cultures was unremarkable. Two 4-mm punch biopsies were obtained from the left cheek and upper back, both of which demonstrated intragranular acantholysis suggestive of pemphigus foliaceous (Figure 1A). A subsequent punch biopsy from the right lower abdomen sent for direct immunofluorescence demonstrated netlike positivity of IgG and C3 in the upper epidermis (Figure 1B), and serum sent for indirect immunofluorescence demonstrated intercellular IgG antibodies to desmoglein (Dsg) 1 on monkey esophagus and positive Dsg-1 antibodies on enzyme-linked immunosorbent assay, confirming the diagnosis.

The patient was started on a 60-mg prednisone taper as well as dapsone 50 mg daily; the dapsone was titrated up to 100 mg daily. After tapering down to 10 mg daily of prednisone over 2 months and continuing dapsone with minimal improvement, he was given 2 infusions of rituximab 1000 mg 2 weeks apart. The scalp plaque was dramatically improved at 3-month follow-up (Figure 2), with partial improvement of the cheek plaques (Figure 3). Dapsone was increased to 150 mg daily, and he was encouraged to use triamcinolone acetonide ointment 0.1% twice daily, which led to further improvement.

Pemphigus foliaceus is an autoimmune blistering disease that most commonly occurs in middle-aged adults. It generally is less common than pemphigus vulgaris, except in Finland, Tunisia, and Brazil, where there is an endemic condition with an identical clinical and histological presentation known as fogo selvagem.¹

The pathogenesis of pemphigus foliaceous is characterized by IgG autoantibodies against Dsg-1, a transmembrane glycoprotein involved in the cellular adhesion of keratinocytes, which is preferentially expressed in the superficial epidermis.^2-7 Dysfunction of Dsg-1 results in the separation of superficial epidermal cells, resulting in intraepidermal blisters.^2,7 In contrast to pemphigus vulgaris, there typically is a lack of oral mucosal involvement due to compensation by Dsg-3 in the mucosa.⁴ Potential triggers for pemphigus foliaceous include exposure to UV radiation; radiotherapy; pregnancy; physiologic stress; and drugs, most commonly captopril, penicillamine, and thiols.⁸

Pemphigus foliaceous lesions clinically appear as eroded and crusted lesions on an erythematous base, commonly in a seborrheic distribution on the face, scalp, and trunk with sparing of the oral mucosa,^2,6 but lesions can progress to a widespread and more severe exfoliative dermatitis.⁷ Lesions also can appear as psoriasiform plaques and often are initially misdiagnosed as psoriasis, particularly in patients with skin of color.^9,10

Diagnosis of pemphigus foliaceous typically is made using a combination of histology as well as both direct and indirect immunofluorescence. Histologically, pemphigus foliaceus presents with subcorneal acantholysis, which is most prominent in the granular layer and occasionally the presence of neutrophils and eosinophils in the blister cavity.⁷ Direct immunofluorescence demonstrates netlike intercellular IgG and C3 in the upper portion of the epidermis.¹¹ Indirect immunofluorescence can help detect circulating IgG antibodies to Dsg-1, with guinea pig esophagus being the ideal substrate.^11,12

First-line treatment of pemphigus foliaceus consists of systemic glucocorticoid therapy, often administered with azathioprine, methotrexate, or mycophenolate mofetil.^2,6,13 Although first-line treatment is effective in 60% to 80% of patients,² relapsing cases can be treated with cyclophosphamide, intravenous immunoglobulin, immunoadsorption, plasmapheresis, or rituximab.²

Rituximab is a chimeric monoclonal antibody targeting CD20⁺ B cells, leading to decreased antibody production, which has been shown to be effective in treating severe and refractory cases of pemphigus foliaceus.^6,13Rituximab with short-course prednisone has been found to be more effective in achieving complete remission at 24 months than prednisone alone.¹⁴ In patients with contraindications to systemic glucocorticoid therapy, rituximab has been shown as an effective first-line therapy.¹⁵ One-quarter of patients treated with rituximab relapsed within 2 years of treatment⁶ (average time to relapse, 6–26 months).¹⁶ High-dose rituximab regimens, along with a higher number of rituximab treatment cycles, have been shown to prolong time to relapse.⁶ Further, higher baseline levels of Dsg-1 antibody have been correlated to earlier relapse and can be used following rituximab therapy to monitor disease progression.^6,16

The differential diagnosis for pemphigus foliaceous includes disseminated blastomycosis, hypertrophic lupus erythematosus, sebopsoriasis, and secondary syphilis. Disseminated blastomycosis presents with cutaneous manifestations such as nodules, papules, or pustules evolving over weeks to months into ulcers with subsequent scarring.¹⁷ Hypertrophic lupus erythematosus presents with papules and nodules with associated keratotic scaling on the face, palms, and extensor surfaces of the limbs.¹⁸ Sebopsoriasis is characterized by well-defined lesions with an overlying scale distributed on the scalp, face, and chest.¹⁹ Secondary syphilis presents as early hyperpigmented macules transitioning to acral papulosquamous lesions involving the palms and soles.²⁰

The Diagnosis: Pemphigus Foliaceous

Laboratory workup including a complete blood cell count with differential, comprehensive metabolic panel, antinuclear antibodies, Sjögren syndrome A and B antibodies, hepatitis profile, rapid plasma reagin, HIV screen, aldolase, anti–Jo-1, T-Spot TB test (Quest Diagnostics), and tissue cultures was unremarkable. Two 4-mm punch biopsies were obtained from the left cheek and upper back, both of which demonstrated intragranular acantholysis suggestive of pemphigus foliaceous (Figure 1A). A subsequent punch biopsy from the right lower abdomen sent for direct immunofluorescence demonstrated netlike positivity of IgG and C3 in the upper epidermis (Figure 1B), and serum sent for indirect immunofluorescence demonstrated intercellular IgG antibodies to desmoglein (Dsg) 1 on monkey esophagus and positive Dsg-1 antibodies on enzyme-linked immunosorbent assay, confirming the diagnosis.

The patient was started on a 60-mg prednisone taper as well as dapsone 50 mg daily; the dapsone was titrated up to 100 mg daily. After tapering down to 10 mg daily of prednisone over 2 months and continuing dapsone with minimal improvement, he was given 2 infusions of rituximab 1000 mg 2 weeks apart. The scalp plaque was dramatically improved at 3-month follow-up (Figure 2), with partial improvement of the cheek plaques (Figure 3). Dapsone was increased to 150 mg daily, and he was encouraged to use triamcinolone acetonide ointment 0.1% twice daily, which led to further improvement.

Pemphigus foliaceus is an autoimmune blistering disease that most commonly occurs in middle-aged adults. It generally is less common than pemphigus vulgaris, except in Finland, Tunisia, and Brazil, where there is an endemic condition with an identical clinical and histological presentation known as fogo selvagem.¹

The pathogenesis of pemphigus foliaceous is characterized by IgG autoantibodies against Dsg-1, a transmembrane glycoprotein involved in the cellular adhesion of keratinocytes, which is preferentially expressed in the superficial epidermis.^2-7 Dysfunction of Dsg-1 results in the separation of superficial epidermal cells, resulting in intraepidermal blisters.^2,7 In contrast to pemphigus vulgaris, there typically is a lack of oral mucosal involvement due to compensation by Dsg-3 in the mucosa.⁴ Potential triggers for pemphigus foliaceous include exposure to UV radiation; radiotherapy; pregnancy; physiologic stress; and drugs, most commonly captopril, penicillamine, and thiols.⁸

Pemphigus foliaceous lesions clinically appear as eroded and crusted lesions on an erythematous base, commonly in a seborrheic distribution on the face, scalp, and trunk with sparing of the oral mucosa,^2,6 but lesions can progress to a widespread and more severe exfoliative dermatitis.⁷ Lesions also can appear as psoriasiform plaques and often are initially misdiagnosed as psoriasis, particularly in patients with skin of color.^9,10

Diagnosis of pemphigus foliaceous typically is made using a combination of histology as well as both direct and indirect immunofluorescence. Histologically, pemphigus foliaceus presents with subcorneal acantholysis, which is most prominent in the granular layer and occasionally the presence of neutrophils and eosinophils in the blister cavity.⁷ Direct immunofluorescence demonstrates netlike intercellular IgG and C3 in the upper portion of the epidermis.¹¹ Indirect immunofluorescence can help detect circulating IgG antibodies to Dsg-1, with guinea pig esophagus being the ideal substrate.^11,12

First-line treatment of pemphigus foliaceus consists of systemic glucocorticoid therapy, often administered with azathioprine, methotrexate, or mycophenolate mofetil.^2,6,13 Although first-line treatment is effective in 60% to 80% of patients,² relapsing cases can be treated with cyclophosphamide, intravenous immunoglobulin, immunoadsorption, plasmapheresis, or rituximab.²

Rituximab is a chimeric monoclonal antibody targeting CD20⁺ B cells, leading to decreased antibody production, which has been shown to be effective in treating severe and refractory cases of pemphigus foliaceus.^6,13Rituximab with short-course prednisone has been found to be more effective in achieving complete remission at 24 months than prednisone alone.¹⁴ In patients with contraindications to systemic glucocorticoid therapy, rituximab has been shown as an effective first-line therapy.¹⁵ One-quarter of patients treated with rituximab relapsed within 2 years of treatment⁶ (average time to relapse, 6–26 months).¹⁶ High-dose rituximab regimens, along with a higher number of rituximab treatment cycles, have been shown to prolong time to relapse.⁶ Further, higher baseline levels of Dsg-1 antibody have been correlated to earlier relapse and can be used following rituximab therapy to monitor disease progression.^6,16

The differential diagnosis for pemphigus foliaceous includes disseminated blastomycosis, hypertrophic lupus erythematosus, sebopsoriasis, and secondary syphilis. Disseminated blastomycosis presents with cutaneous manifestations such as nodules, papules, or pustules evolving over weeks to months into ulcers with subsequent scarring.¹⁷ Hypertrophic lupus erythematosus presents with papules and nodules with associated keratotic scaling on the face, palms, and extensor surfaces of the limbs.¹⁸ Sebopsoriasis is characterized by well-defined lesions with an overlying scale distributed on the scalp, face, and chest.¹⁹ Secondary syphilis presents as early hyperpigmented macules transitioning to acral papulosquamous lesions involving the palms and soles.²⁰

The Diagnosis: Pemphigus Foliaceous

Laboratory workup including a complete blood cell count with differential, comprehensive metabolic panel, antinuclear antibodies, Sjögren syndrome A and B antibodies, hepatitis profile, rapid plasma reagin, HIV screen, aldolase, anti–Jo-1, T-Spot TB test (Quest Diagnostics), and tissue cultures was unremarkable. Two 4-mm punch biopsies were obtained from the left cheek and upper back, both of which demonstrated intragranular acantholysis suggestive of pemphigus foliaceous (Figure 1A). A subsequent punch biopsy from the right lower abdomen sent for direct immunofluorescence demonstrated netlike positivity of IgG and C3 in the upper epidermis (Figure 1B), and serum sent for indirect immunofluorescence demonstrated intercellular IgG antibodies to desmoglein (Dsg) 1 on monkey esophagus and positive Dsg-1 antibodies on enzyme-linked immunosorbent assay, confirming the diagnosis.

The patient was started on a 60-mg prednisone taper as well as dapsone 50 mg daily; the dapsone was titrated up to 100 mg daily. After tapering down to 10 mg daily of prednisone over 2 months and continuing dapsone with minimal improvement, he was given 2 infusions of rituximab 1000 mg 2 weeks apart. The scalp plaque was dramatically improved at 3-month follow-up (Figure 2), with partial improvement of the cheek plaques (Figure 3). Dapsone was increased to 150 mg daily, and he was encouraged to use triamcinolone acetonide ointment 0.1% twice daily, which led to further improvement.

Pemphigus foliaceus is an autoimmune blistering disease that most commonly occurs in middle-aged adults. It generally is less common than pemphigus vulgaris, except in Finland, Tunisia, and Brazil, where there is an endemic condition with an identical clinical and histological presentation known as fogo selvagem.¹

The pathogenesis of pemphigus foliaceous is characterized by IgG autoantibodies against Dsg-1, a transmembrane glycoprotein involved in the cellular adhesion of keratinocytes, which is preferentially expressed in the superficial epidermis.^2-7 Dysfunction of Dsg-1 results in the separation of superficial epidermal cells, resulting in intraepidermal blisters.^2,7 In contrast to pemphigus vulgaris, there typically is a lack of oral mucosal involvement due to compensation by Dsg-3 in the mucosa.⁴ Potential triggers for pemphigus foliaceous include exposure to UV radiation; radiotherapy; pregnancy; physiologic stress; and drugs, most commonly captopril, penicillamine, and thiols.⁸

Pemphigus foliaceous lesions clinically appear as eroded and crusted lesions on an erythematous base, commonly in a seborrheic distribution on the face, scalp, and trunk with sparing of the oral mucosa,^2,6 but lesions can progress to a widespread and more severe exfoliative dermatitis.⁷ Lesions also can appear as psoriasiform plaques and often are initially misdiagnosed as psoriasis, particularly in patients with skin of color.^9,10

Diagnosis of pemphigus foliaceous typically is made using a combination of histology as well as both direct and indirect immunofluorescence. Histologically, pemphigus foliaceus presents with subcorneal acantholysis, which is most prominent in the granular layer and occasionally the presence of neutrophils and eosinophils in the blister cavity.⁷ Direct immunofluorescence demonstrates netlike intercellular IgG and C3 in the upper portion of the epidermis.¹¹ Indirect immunofluorescence can help detect circulating IgG antibodies to Dsg-1, with guinea pig esophagus being the ideal substrate.^11,12

First-line treatment of pemphigus foliaceus consists of systemic glucocorticoid therapy, often administered with azathioprine, methotrexate, or mycophenolate mofetil.^2,6,13 Although first-line treatment is effective in 60% to 80% of patients,² relapsing cases can be treated with cyclophosphamide, intravenous immunoglobulin, immunoadsorption, plasmapheresis, or rituximab.²

Rituximab is a chimeric monoclonal antibody targeting CD20⁺ B cells, leading to decreased antibody production, which has been shown to be effective in treating severe and refractory cases of pemphigus foliaceus.^6,13Rituximab with short-course prednisone has been found to be more effective in achieving complete remission at 24 months than prednisone alone.¹⁴ In patients with contraindications to systemic glucocorticoid therapy, rituximab has been shown as an effective first-line therapy.¹⁵ One-quarter of patients treated with rituximab relapsed within 2 years of treatment⁶ (average time to relapse, 6–26 months).¹⁶ High-dose rituximab regimens, along with a higher number of rituximab treatment cycles, have been shown to prolong time to relapse.⁶ Further, higher baseline levels of Dsg-1 antibody have been correlated to earlier relapse and can be used following rituximab therapy to monitor disease progression.^6,16

The differential diagnosis for pemphigus foliaceous includes disseminated blastomycosis, hypertrophic lupus erythematosus, sebopsoriasis, and secondary syphilis. Disseminated blastomycosis presents with cutaneous manifestations such as nodules, papules, or pustules evolving over weeks to months into ulcers with subsequent scarring.¹⁷ Hypertrophic lupus erythematosus presents with papules and nodules with associated keratotic scaling on the face, palms, and extensor surfaces of the limbs.¹⁸ Sebopsoriasis is characterized by well-defined lesions with an overlying scale distributed on the scalp, face, and chest.¹⁹ Secondary syphilis presents as early hyperpigmented macules transitioning to acral papulosquamous lesions involving the palms and soles.²⁰

A protocol of immediate angiography provided no mortality benefit over a strategy or delayed or more selective angiography among patients resuscitated from out-of-hospital cardiac arrest and without ST-segment elevation, new randomized results show.

Cathy Yeulet/thinkstock

“Among patients with resuscitated out-of-hospital cardiac arrest of possible cardiac origin, with shockable and nonshockable arrest rhythm and no ST-elevation, a strategy of immediate, unselected coronary angiography was not found to be beneficial over a delayed and selective approach with regard to the 30-day risk of all-cause death,” concluded principal investigator Steffen Desch, MD, University of Leipzig (Germany) Heart Center.

The results support previous results of the Coronary Angiography after Cardiac Arrest (COACT) trial, in patients with shockable rhythms, which also showed no differences in clinical outcomes between immediate and delayed coronary angiography at both 90 days and 1 year, he noted.  

“What the clinicians wanted to know is, is it really necessary to get up at 3 a.m. in the morning to perform a coronary angiography on these patients, and that’s certainly out,” Dr. Desch said in an interview. “So, there’s really no room for this strategy anymore. You can take your time and wait a day or 2.”

These findings, from the TOMAHAWK trial, were presented Aug. 29 at the annual congress of the European Society of Cardiology and simultaneously published online in the New England Journal of Medicine.
 

Larger group without ST-segment elevation

Prognosis after out-of-hospital cardiac arrest is extremely poor, with an overall survival rate of less than 10%, Dr. Desch noted. “Actually, only 20% make it to the hospital; the vast majority of these patients die out in the field, so there’s really a great need in improving treatment.”

Acute coronary syndrome accounts for up to 60% of out-of-hospital arrests in which a cardiac cause has been identified, the authors wrote in their report. ST-segment elevation on postresuscitation electrocardiography “has good positive predictive value” for acute coronary lesions triggering the arrest, but in the far larger subgroup of patients without ST-segment elevation, “the spectrum of underlying causes is considerably broader and includes both cardiac and noncardiac causes.”

In patients with myocardial infarction, early revascularization would prevent negative consequences of myocardial injury, but unselected early coronary angiography would put patients not having an MI at unnecessary risk for procedural complications or delay in the diagnosis of the actual cause of their arrest, they noted. 

In this trial, the researchers randomly assigned 554 patients from 31 sites in Germany and Denmark who were successfully resuscitated after cardiac arrest of possible cardiac origin to immediate transfer for coronary angiography or to initial intensive care assessment with delayed or selective angiography after a minimum delay of at least 1 day.

In the end, the average delay in this arm was 2 days, Dr. Desch noted. If the clinical course indicated that a coronary cause was unlikely, angiography might not be performed at all in this group.  

No patient had ST-segment elevation on postresuscitation electrocardiography. The primary endpoint was death from any cause at 30 days; secondary end points were death from any cause or severe neurologic deficit at 30 days.

Results showed that 95% of patients in the immediate angiography group actually underwent the procedure, compared with 62% of those in the delayed group, a finding that was “logical” given the study design, he said.

At 30 days, 54% of patients in the immediate angiography group and 46% in the delayed group had died, a nonsignificant difference (P = .06). Because the researchers had performed an interim analysis, Dr. Desch explained, the final P value for significance in this trial was not .05, but rather .034, to account for multiple comparisons.

The secondary end point of death from any cause or severe neurologic deficit at 30 days “was actually nominally significant in favor of the delayed group,” he said. “So, this is not corrected for multiple testing, it’s just a hypothesis that’s in the room, but it’s certainly worthy of discussion that the immediate strategy might actually cause harm.”

There was no difference between the groups in peak release of myocardial enzymes, or any other safety end points, including bleeding, stroke, or renal failure, Dr. Desch said.

Further analyses showed no large differences between subgroups, including age, diabetes, first monitored rhythm, confirmed MI as the trigger of the arrest, sex, and the time from cardiac arrest to the return of spontaneous circulation, he noted.
 

Opportunity to minimize harm

Discussant for the results during the presentation was Susanna Price, MBBS, PhD, Royal Brompton Hospital, London.

Dr. Price concluded: “What this means for me, is it gives me information that’s useful regarding the opportunity to minimize harm, which is a lot of what critical care is about, so we don’t necessarily now have to move these patients very acutely when they’ve just come in through the ED [emergency department]. It has implications for resource utilization, but also implications for mobilizing patients around the hospital during COVID-19.”

It’s also important to note that coronary angiography was still carried out in certain patients, “so we still have to have that dialogue with our interventional cardiologists for certain patients who may need to go to the cath lab, and what it should now allow us to do is give appropriate focus to how to manage these patients when they come in to the ED or to our ICUs [intensive care units],” she said.

Dr. Price added, though, that perhaps “the most important slide” in the presentation was that showing 90% of these patients had a witnessed cardiac arrest, “and yet a third of these patients, 168 of them, had no bystander CPR at all.” 

She pointed to the “chain of survival” after cardiac arrest, of which Charles D. Deakin, MD, University Hospital Southampton (England), wrote that “not all links are equal.”

“Early recognition and calling for help, early CPR, early defibrillation where appropriate are very, very important, and we need to be addressing all of these, as well as what happens in the cath lab and after admission,” Dr. Price said.

This research was funded by the German Center for Cardiovascular Research. Dr. Desch and Dr. Price reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

A protocol of immediate angiography provided no mortality benefit over a strategy or delayed or more selective angiography among patients resuscitated from out-of-hospital cardiac arrest and without ST-segment elevation, new randomized results show.

Cathy Yeulet/thinkstock

“Among patients with resuscitated out-of-hospital cardiac arrest of possible cardiac origin, with shockable and nonshockable arrest rhythm and no ST-elevation, a strategy of immediate, unselected coronary angiography was not found to be beneficial over a delayed and selective approach with regard to the 30-day risk of all-cause death,” concluded principal investigator Steffen Desch, MD, University of Leipzig (Germany) Heart Center.

The results support previous results of the Coronary Angiography after Cardiac Arrest (COACT) trial, in patients with shockable rhythms, which also showed no differences in clinical outcomes between immediate and delayed coronary angiography at both 90 days and 1 year, he noted.  

“What the clinicians wanted to know is, is it really necessary to get up at 3 a.m. in the morning to perform a coronary angiography on these patients, and that’s certainly out,” Dr. Desch said in an interview. “So, there’s really no room for this strategy anymore. You can take your time and wait a day or 2.”

These findings, from the TOMAHAWK trial, were presented Aug. 29 at the annual congress of the European Society of Cardiology and simultaneously published online in the New England Journal of Medicine.
 

Larger group without ST-segment elevation

Prognosis after out-of-hospital cardiac arrest is extremely poor, with an overall survival rate of less than 10%, Dr. Desch noted. “Actually, only 20% make it to the hospital; the vast majority of these patients die out in the field, so there’s really a great need in improving treatment.”

Acute coronary syndrome accounts for up to 60% of out-of-hospital arrests in which a cardiac cause has been identified, the authors wrote in their report. ST-segment elevation on postresuscitation electrocardiography “has good positive predictive value” for acute coronary lesions triggering the arrest, but in the far larger subgroup of patients without ST-segment elevation, “the spectrum of underlying causes is considerably broader and includes both cardiac and noncardiac causes.”

In patients with myocardial infarction, early revascularization would prevent negative consequences of myocardial injury, but unselected early coronary angiography would put patients not having an MI at unnecessary risk for procedural complications or delay in the diagnosis of the actual cause of their arrest, they noted. 

In this trial, the researchers randomly assigned 554 patients from 31 sites in Germany and Denmark who were successfully resuscitated after cardiac arrest of possible cardiac origin to immediate transfer for coronary angiography or to initial intensive care assessment with delayed or selective angiography after a minimum delay of at least 1 day.

In the end, the average delay in this arm was 2 days, Dr. Desch noted. If the clinical course indicated that a coronary cause was unlikely, angiography might not be performed at all in this group.  

No patient had ST-segment elevation on postresuscitation electrocardiography. The primary endpoint was death from any cause at 30 days; secondary end points were death from any cause or severe neurologic deficit at 30 days.

Results showed that 95% of patients in the immediate angiography group actually underwent the procedure, compared with 62% of those in the delayed group, a finding that was “logical” given the study design, he said.

At 30 days, 54% of patients in the immediate angiography group and 46% in the delayed group had died, a nonsignificant difference (P = .06). Because the researchers had performed an interim analysis, Dr. Desch explained, the final P value for significance in this trial was not .05, but rather .034, to account for multiple comparisons.

The secondary end point of death from any cause or severe neurologic deficit at 30 days “was actually nominally significant in favor of the delayed group,” he said. “So, this is not corrected for multiple testing, it’s just a hypothesis that’s in the room, but it’s certainly worthy of discussion that the immediate strategy might actually cause harm.”

There was no difference between the groups in peak release of myocardial enzymes, or any other safety end points, including bleeding, stroke, or renal failure, Dr. Desch said.

Further analyses showed no large differences between subgroups, including age, diabetes, first monitored rhythm, confirmed MI as the trigger of the arrest, sex, and the time from cardiac arrest to the return of spontaneous circulation, he noted.
 

Opportunity to minimize harm

Discussant for the results during the presentation was Susanna Price, MBBS, PhD, Royal Brompton Hospital, London.

Dr. Price concluded: “What this means for me, is it gives me information that’s useful regarding the opportunity to minimize harm, which is a lot of what critical care is about, so we don’t necessarily now have to move these patients very acutely when they’ve just come in through the ED [emergency department]. It has implications for resource utilization, but also implications for mobilizing patients around the hospital during COVID-19.”

It’s also important to note that coronary angiography was still carried out in certain patients, “so we still have to have that dialogue with our interventional cardiologists for certain patients who may need to go to the cath lab, and what it should now allow us to do is give appropriate focus to how to manage these patients when they come in to the ED or to our ICUs [intensive care units],” she said.

Dr. Price added, though, that perhaps “the most important slide” in the presentation was that showing 90% of these patients had a witnessed cardiac arrest, “and yet a third of these patients, 168 of them, had no bystander CPR at all.” 

She pointed to the “chain of survival” after cardiac arrest, of which Charles D. Deakin, MD, University Hospital Southampton (England), wrote that “not all links are equal.”

“Early recognition and calling for help, early CPR, early defibrillation where appropriate are very, very important, and we need to be addressing all of these, as well as what happens in the cath lab and after admission,” Dr. Price said.

This research was funded by the German Center for Cardiovascular Research. Dr. Desch and Dr. Price reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

A protocol of immediate angiography provided no mortality benefit over a strategy or delayed or more selective angiography among patients resuscitated from out-of-hospital cardiac arrest and without ST-segment elevation, new randomized results show.

Cathy Yeulet/thinkstock

“Among patients with resuscitated out-of-hospital cardiac arrest of possible cardiac origin, with shockable and nonshockable arrest rhythm and no ST-elevation, a strategy of immediate, unselected coronary angiography was not found to be beneficial over a delayed and selective approach with regard to the 30-day risk of all-cause death,” concluded principal investigator Steffen Desch, MD, University of Leipzig (Germany) Heart Center.

The results support previous results of the Coronary Angiography after Cardiac Arrest (COACT) trial, in patients with shockable rhythms, which also showed no differences in clinical outcomes between immediate and delayed coronary angiography at both 90 days and 1 year, he noted.  

“What the clinicians wanted to know is, is it really necessary to get up at 3 a.m. in the morning to perform a coronary angiography on these patients, and that’s certainly out,” Dr. Desch said in an interview. “So, there’s really no room for this strategy anymore. You can take your time and wait a day or 2.”

These findings, from the TOMAHAWK trial, were presented Aug. 29 at the annual congress of the European Society of Cardiology and simultaneously published online in the New England Journal of Medicine.
 

Larger group without ST-segment elevation

Prognosis after out-of-hospital cardiac arrest is extremely poor, with an overall survival rate of less than 10%, Dr. Desch noted. “Actually, only 20% make it to the hospital; the vast majority of these patients die out in the field, so there’s really a great need in improving treatment.”

Acute coronary syndrome accounts for up to 60% of out-of-hospital arrests in which a cardiac cause has been identified, the authors wrote in their report. ST-segment elevation on postresuscitation electrocardiography “has good positive predictive value” for acute coronary lesions triggering the arrest, but in the far larger subgroup of patients without ST-segment elevation, “the spectrum of underlying causes is considerably broader and includes both cardiac and noncardiac causes.”

In patients with myocardial infarction, early revascularization would prevent negative consequences of myocardial injury, but unselected early coronary angiography would put patients not having an MI at unnecessary risk for procedural complications or delay in the diagnosis of the actual cause of their arrest, they noted. 

In this trial, the researchers randomly assigned 554 patients from 31 sites in Germany and Denmark who were successfully resuscitated after cardiac arrest of possible cardiac origin to immediate transfer for coronary angiography or to initial intensive care assessment with delayed or selective angiography after a minimum delay of at least 1 day.

In the end, the average delay in this arm was 2 days, Dr. Desch noted. If the clinical course indicated that a coronary cause was unlikely, angiography might not be performed at all in this group.  

No patient had ST-segment elevation on postresuscitation electrocardiography. The primary endpoint was death from any cause at 30 days; secondary end points were death from any cause or severe neurologic deficit at 30 days.

Results showed that 95% of patients in the immediate angiography group actually underwent the procedure, compared with 62% of those in the delayed group, a finding that was “logical” given the study design, he said.

At 30 days, 54% of patients in the immediate angiography group and 46% in the delayed group had died, a nonsignificant difference (P = .06). Because the researchers had performed an interim analysis, Dr. Desch explained, the final P value for significance in this trial was not .05, but rather .034, to account for multiple comparisons.

The secondary end point of death from any cause or severe neurologic deficit at 30 days “was actually nominally significant in favor of the delayed group,” he said. “So, this is not corrected for multiple testing, it’s just a hypothesis that’s in the room, but it’s certainly worthy of discussion that the immediate strategy might actually cause harm.”

There was no difference between the groups in peak release of myocardial enzymes, or any other safety end points, including bleeding, stroke, or renal failure, Dr. Desch said.

Further analyses showed no large differences between subgroups, including age, diabetes, first monitored rhythm, confirmed MI as the trigger of the arrest, sex, and the time from cardiac arrest to the return of spontaneous circulation, he noted.
 

Opportunity to minimize harm

Discussant for the results during the presentation was Susanna Price, MBBS, PhD, Royal Brompton Hospital, London.

Dr. Price concluded: “What this means for me, is it gives me information that’s useful regarding the opportunity to minimize harm, which is a lot of what critical care is about, so we don’t necessarily now have to move these patients very acutely when they’ve just come in through the ED [emergency department]. It has implications for resource utilization, but also implications for mobilizing patients around the hospital during COVID-19.”

It’s also important to note that coronary angiography was still carried out in certain patients, “so we still have to have that dialogue with our interventional cardiologists for certain patients who may need to go to the cath lab, and what it should now allow us to do is give appropriate focus to how to manage these patients when they come in to the ED or to our ICUs [intensive care units],” she said.

Dr. Price added, though, that perhaps “the most important slide” in the presentation was that showing 90% of these patients had a witnessed cardiac arrest, “and yet a third of these patients, 168 of them, had no bystander CPR at all.” 

She pointed to the “chain of survival” after cardiac arrest, of which Charles D. Deakin, MD, University Hospital Southampton (England), wrote that “not all links are equal.”

“Early recognition and calling for help, early CPR, early defibrillation where appropriate are very, very important, and we need to be addressing all of these, as well as what happens in the cath lab and after admission,” Dr. Price said.

This research was funded by the German Center for Cardiovascular Research. Dr. Desch and Dr. Price reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.

Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”

In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.

Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.

The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.

Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.

In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.

Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.

“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.

The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.

Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
 

Predicting use and identifying risk factors

“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.

“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.

The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.