Ted Bosworth

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

If either high sensitivity cardiac troponin (hs-cTnT) or coronary artery calcium (CAC) are elevated, the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) climbs substantially, which suggests these biomarkers yield more prognostic information when they are used together, according to a cohort study with a median 15 years of follow-up.

Among those with a double negative result, meaning hs-cTnT was less than the limit of detection (<3 ng/L) and the CAC score was zero, only 2.8% developed ASCVD within 10 years, but the rates climbed to 4.6% if hs-cTnT was detectable and to 9.8% if the CAC score exceeded zero even when the other biomarker was negative.

“The increased risk for ASCVD among those with discordant results indicate that their prognostic information is complementary, favoring their conjoined use for risk prediction,” reported a multicenter team of investigators led by Allan S. Jaffe, MD, professor of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

The study was performed with data from 6,749 participants in the Multi-Ethnic Study of Atherosclerosis (MESA), which is a longitudinal, community-based study funded by the National Heart, Lung, and Blood Institute. Over the course of long-term follow-up in a patient population that was about half female, 39% non-Hispanic white, 28% Black, 22% Hispanic American, and 12% Asian, ASCVD events were evaluated in relation to both biomarkers measured at baseline.

At baseline, both biomarkers were negative in 22%, both positive in 40%, and discordant in 38%.

After a median follow-up of 15 years, when 1,002 ASCVD events had occurred, the crude rate of ASCVD was 2.8 per 1,000 person-years in the double-negative group. When compared with this, the adjusted hazard ratio for ASCVD among those with double positive biomarkers was 3.5 (P < .00001). Increased risk was also highly significant if just hs-cTnT was positive (HR, 1.59; P = .003) or if just CAC was positive (HR, 2.74; P < .00001).

The added value of using both biomarkers to identify individuals at very low risk of ASCVD makes sense, according to the authors of an accompanying editorial. Written by a team led by John W. McEvoy, MB, BCh, National University of Ireland, Galway, the editorial explained why the information is complementary.

“CAC indicates subclinical atherosclerosis, whereas hs-cTnT indicates myocardial ischemia or damage, not just from coronary stenosis but also due to other conditions like hypertensive heart and left ventricular hypertrophy,” the authors stated.

Although they maintained that adding N-terminal pro-brain natriuretic peptide, which could be drawn from the same blood sample as hs-cTnT, might prove to be an even better but still simple strategy to identify low-risk patients, they praised the concept of combining biomarkers.

“If one’s wish is to identify truly low-risk individuals, then it appears that it takes two negative ASCVD biomarkers to make that wish come true,” the authors of the editorial concluded.

Relative to alternative methods of ASCVD risk assessment, measurement of these biomarkers might be useful for sparing patients from interventions, such as lipid lowering with statin therapy, being considered on the basis of conventional risk factors alone.

Dr. Jaffe said in an interview that he considers the two-biomarker assessment to be a useful tool in the low-risk population that he studied, but he does not consider this strategy as a substitute for other methods, such as those outline in the 2019 ACC/AHA guidelines that address the entire spectrum of risk, although work is planned to see if this approach can be extended to this broader group.*

“The data we have presented now is a good start and suggests that these two objective measures can identify those who are at very low risk and avoid adding individuals who may not be at as low risk if only one of the two tests is used,” Dr. Jaffe explained.

“Given there are now techniques to measure coronary calcium from any chest CT study, and that high sensitivity cardiac troponin is a relatively inexpensive test, putting them together should really help risk stratify patients,” he added.

When asked whether this approach will eventually replace conventional methods of ASCVD risk assessment, such as those proposed in the 2019 American College of Cardiology/American Heart Association guidelines for the primary prevention of cardiovascular disease (Circulation. 2019;140:e596-e646), he said maybe.

“The answer is that we will probe that question in our ongoing studies using continuous data in an attempt to evaluate how to use this approach to risk stratify larger numbers of individuals,” Dr. Jaffe replied.

The senior investigator, Dr. Jaffe, has consulting relationships with many pharmaceutical companies. The editorial authors had no relevant disclosures.

SOURCE: Sandoval Y et al. J Am Coll Cardiol. 2020;76:357-370.

*Correction, 7/27/20: An earlier version of this article mischaracterized Dr. Jaffe's statement.

If either high sensitivity cardiac troponin (hs-cTnT) or coronary artery calcium (CAC) are elevated, the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) climbs substantially, which suggests these biomarkers yield more prognostic information when they are used together, according to a cohort study with a median 15 years of follow-up.

Among those with a double negative result, meaning hs-cTnT was less than the limit of detection (<3 ng/L) and the CAC score was zero, only 2.8% developed ASCVD within 10 years, but the rates climbed to 4.6% if hs-cTnT was detectable and to 9.8% if the CAC score exceeded zero even when the other biomarker was negative.

“The increased risk for ASCVD among those with discordant results indicate that their prognostic information is complementary, favoring their conjoined use for risk prediction,” reported a multicenter team of investigators led by Allan S. Jaffe, MD, professor of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

The study was performed with data from 6,749 participants in the Multi-Ethnic Study of Atherosclerosis (MESA), which is a longitudinal, community-based study funded by the National Heart, Lung, and Blood Institute. Over the course of long-term follow-up in a patient population that was about half female, 39% non-Hispanic white, 28% Black, 22% Hispanic American, and 12% Asian, ASCVD events were evaluated in relation to both biomarkers measured at baseline.

At baseline, both biomarkers were negative in 22%, both positive in 40%, and discordant in 38%.

After a median follow-up of 15 years, when 1,002 ASCVD events had occurred, the crude rate of ASCVD was 2.8 per 1,000 person-years in the double-negative group. When compared with this, the adjusted hazard ratio for ASCVD among those with double positive biomarkers was 3.5 (P < .00001). Increased risk was also highly significant if just hs-cTnT was positive (HR, 1.59; P = .003) or if just CAC was positive (HR, 2.74; P < .00001).

The added value of using both biomarkers to identify individuals at very low risk of ASCVD makes sense, according to the authors of an accompanying editorial. Written by a team led by John W. McEvoy, MB, BCh, National University of Ireland, Galway, the editorial explained why the information is complementary.

“CAC indicates subclinical atherosclerosis, whereas hs-cTnT indicates myocardial ischemia or damage, not just from coronary stenosis but also due to other conditions like hypertensive heart and left ventricular hypertrophy,” the authors stated.

Although they maintained that adding N-terminal pro-brain natriuretic peptide, which could be drawn from the same blood sample as hs-cTnT, might prove to be an even better but still simple strategy to identify low-risk patients, they praised the concept of combining biomarkers.

“If one’s wish is to identify truly low-risk individuals, then it appears that it takes two negative ASCVD biomarkers to make that wish come true,” the authors of the editorial concluded.

Relative to alternative methods of ASCVD risk assessment, measurement of these biomarkers might be useful for sparing patients from interventions, such as lipid lowering with statin therapy, being considered on the basis of conventional risk factors alone.

Dr. Jaffe said in an interview that he considers the two-biomarker assessment to be a useful tool in the low-risk population that he studied, but he does not consider this strategy as a substitute for other methods, such as those outline in the 2019 ACC/AHA guidelines that address the entire spectrum of risk, although work is planned to see if this approach can be extended to this broader group.*

“The data we have presented now is a good start and suggests that these two objective measures can identify those who are at very low risk and avoid adding individuals who may not be at as low risk if only one of the two tests is used,” Dr. Jaffe explained.

“Given there are now techniques to measure coronary calcium from any chest CT study, and that high sensitivity cardiac troponin is a relatively inexpensive test, putting them together should really help risk stratify patients,” he added.

When asked whether this approach will eventually replace conventional methods of ASCVD risk assessment, such as those proposed in the 2019 American College of Cardiology/American Heart Association guidelines for the primary prevention of cardiovascular disease (Circulation. 2019;140:e596-e646), he said maybe.

“The answer is that we will probe that question in our ongoing studies using continuous data in an attempt to evaluate how to use this approach to risk stratify larger numbers of individuals,” Dr. Jaffe replied.

The senior investigator, Dr. Jaffe, has consulting relationships with many pharmaceutical companies. The editorial authors had no relevant disclosures.

SOURCE: Sandoval Y et al. J Am Coll Cardiol. 2020;76:357-370.

*Correction, 7/27/20: An earlier version of this article mischaracterized Dr. Jaffe's statement.

If either high sensitivity cardiac troponin (hs-cTnT) or coronary artery calcium (CAC) are elevated, the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) climbs substantially, which suggests these biomarkers yield more prognostic information when they are used together, according to a cohort study with a median 15 years of follow-up.

Among those with a double negative result, meaning hs-cTnT was less than the limit of detection (<3 ng/L) and the CAC score was zero, only 2.8% developed ASCVD within 10 years, but the rates climbed to 4.6% if hs-cTnT was detectable and to 9.8% if the CAC score exceeded zero even when the other biomarker was negative.

“The increased risk for ASCVD among those with discordant results indicate that their prognostic information is complementary, favoring their conjoined use for risk prediction,” reported a multicenter team of investigators led by Allan S. Jaffe, MD, professor of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.

The study was performed with data from 6,749 participants in the Multi-Ethnic Study of Atherosclerosis (MESA), which is a longitudinal, community-based study funded by the National Heart, Lung, and Blood Institute. Over the course of long-term follow-up in a patient population that was about half female, 39% non-Hispanic white, 28% Black, 22% Hispanic American, and 12% Asian, ASCVD events were evaluated in relation to both biomarkers measured at baseline.

At baseline, both biomarkers were negative in 22%, both positive in 40%, and discordant in 38%.

After a median follow-up of 15 years, when 1,002 ASCVD events had occurred, the crude rate of ASCVD was 2.8 per 1,000 person-years in the double-negative group. When compared with this, the adjusted hazard ratio for ASCVD among those with double positive biomarkers was 3.5 (P < .00001). Increased risk was also highly significant if just hs-cTnT was positive (HR, 1.59; P = .003) or if just CAC was positive (HR, 2.74; P < .00001).

The added value of using both biomarkers to identify individuals at very low risk of ASCVD makes sense, according to the authors of an accompanying editorial. Written by a team led by John W. McEvoy, MB, BCh, National University of Ireland, Galway, the editorial explained why the information is complementary.

“CAC indicates subclinical atherosclerosis, whereas hs-cTnT indicates myocardial ischemia or damage, not just from coronary stenosis but also due to other conditions like hypertensive heart and left ventricular hypertrophy,” the authors stated.

Although they maintained that adding N-terminal pro-brain natriuretic peptide, which could be drawn from the same blood sample as hs-cTnT, might prove to be an even better but still simple strategy to identify low-risk patients, they praised the concept of combining biomarkers.

“If one’s wish is to identify truly low-risk individuals, then it appears that it takes two negative ASCVD biomarkers to make that wish come true,” the authors of the editorial concluded.

Relative to alternative methods of ASCVD risk assessment, measurement of these biomarkers might be useful for sparing patients from interventions, such as lipid lowering with statin therapy, being considered on the basis of conventional risk factors alone.

Dr. Jaffe said in an interview that he considers the two-biomarker assessment to be a useful tool in the low-risk population that he studied, but he does not consider this strategy as a substitute for other methods, such as those outline in the 2019 ACC/AHA guidelines that address the entire spectrum of risk, although work is planned to see if this approach can be extended to this broader group.*

“The data we have presented now is a good start and suggests that these two objective measures can identify those who are at very low risk and avoid adding individuals who may not be at as low risk if only one of the two tests is used,” Dr. Jaffe explained.

“Given there are now techniques to measure coronary calcium from any chest CT study, and that high sensitivity cardiac troponin is a relatively inexpensive test, putting them together should really help risk stratify patients,” he added.

When asked whether this approach will eventually replace conventional methods of ASCVD risk assessment, such as those proposed in the 2019 American College of Cardiology/American Heart Association guidelines for the primary prevention of cardiovascular disease (Circulation. 2019;140:e596-e646), he said maybe.

“The answer is that we will probe that question in our ongoing studies using continuous data in an attempt to evaluate how to use this approach to risk stratify larger numbers of individuals,” Dr. Jaffe replied.

The senior investigator, Dr. Jaffe, has consulting relationships with many pharmaceutical companies. The editorial authors had no relevant disclosures.

SOURCE: Sandoval Y et al. J Am Coll Cardiol. 2020;76:357-370.

*Correction, 7/27/20: An earlier version of this article mischaracterized Dr. Jaffe's statement.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

A large proportion of results from heart failure trials registered with clinicaltrials.gov are published a year or more after completion or not at all, which violates the U.S. FDA Amendments Act (FDAAA), according to a detailed analysis of the interventional and observational trials in this database.

Of the 1,429 heart failure trials identified, 75% of which were randomized interventional studies and the remainder of which were observational, fewer than 20% met the FDAAA 1-year reporting requirement, and 44% have yet to be published at all, reported a team of collaborative investigators led by cardiologists from the Inova Heart and Vascular Institute (IHVI), Falls Church, Va.

“I believe the critical issue is that the FDAAA has thus far never been enforced,” reported Christopher M. O’Connor, MD, a cardiologist and president of IHVI. He was the senior author of the study, reported in the Journal of the American College of Cardiology.

To improve systematic reporting of clinical trials, including negative results, clinicaltrials.gov was created in 2000. In 2007, the FDAAA enacted rules to broaden the requirements for reporting and to make timely reporting of results mandatory.

Ten years later, the FDA was finally authorized to issue a penalty of $10,000 for failure to release results in a timely fashion, a provision of the 2007 amendment but not confirmed at that time, the investigators reported. In the majority of cases, timely reporting was defined as within 12 months of completion of the trial.

The new study shows that reporting of completed trials, timely or otherwise, remains low. Of the 1,243 trials completed after 2007, the proportion meeting the 1-year reporting requirement was just 20%. Although a significant improvement over the 13% reporting in this time frame before 2007, more than 80% of findings are not being released in a timely manner more than 10 years after this was made mandatory.

There are a number of reasons to consider this to be a serious issue, according to Mandeep R. Mehra, MD, of Brigham and Women’s Hospital, Boston. One of the authors of an accompanying editorial regarding this analysis, Dr. Mehra called underreporting “a public health matter because it is an impediment to medical discovery and poses plausible threats to patient safety.”

Among studies registered after 2007, publication rates were higher for trials funded by the National Institutes of Health (71%) relative to industry (49%) or the U.S. Veterans Affairs (45%).

Publication rates were also higher among interventional relative to observational trials (59% vs. 46%) and trials that enrolled more than 1,000 patients relative to those enrolling fewer than 150 (77% vs. 51%), although trial size was not a significant predictor of publication on multivariate analysis. Clinical endpoints, such as death or hospitalization, were also associated with a greater likelihood of publication relative to nonclinical endpoints.

Of the 251 trials terminated before completion, findings were published within 1 year in only 6%. Two years after completion, only 20% were published at all.

Results consistent with the primary hypothesis did not predict timely publication, but only 39% of the studies listed a primary hypothesis. Since 2017, this is another violation of the FDAAA, according to Dr. O’Connor.

The problem is not unique to heart failure trials, according to the authors who cited numerous studies showing low rates of timely publication in other therapeutic areas. Heart failure was selected for evaluation in this study mainly to keep the analysis feasible, although the authors contend this is an area with an urgent need for better treatments.

The problem needs to be fixed, according to Dr. Mehra. In his editorial, he called for rules to be “transitioned to regulations and action taken for underreporting.” Dr. O’Connor agreed.

“A combination of carrots and sticks might be needed to achieve sufficient result sharing,” Dr. O’Connor said. He suggested that stakeholders, such as investigators, sponsors, regulators, and journal editors, should collaborate to address the problem.

So far, the FDA has never levied a fine for lack of reporting or for failure to report in a timely manner. Routine imposition of large fines might not be viable, given the complex reasons that delay or inhibit publication of trial findings, but it would be a large source of revenue.

“According to the FDAAA TrialsTracker, a live tool that tracks FDAAA compliance and promotes trial transparency, the U.S. government could already have imposed more than $2.8 billion in fines for trials due after January 2018,” Dr. O’Connor reported.

The first and senior authors are among those who report financial relationships with pharmaceutical companies.

SOURCE: Psotka MA et al. J Am Coll Cardiol. 2020;75:3151-61.

A large proportion of results from heart failure trials registered with clinicaltrials.gov are published a year or more after completion or not at all, which violates the U.S. FDA Amendments Act (FDAAA), according to a detailed analysis of the interventional and observational trials in this database.

Of the 1,429 heart failure trials identified, 75% of which were randomized interventional studies and the remainder of which were observational, fewer than 20% met the FDAAA 1-year reporting requirement, and 44% have yet to be published at all, reported a team of collaborative investigators led by cardiologists from the Inova Heart and Vascular Institute (IHVI), Falls Church, Va.

“I believe the critical issue is that the FDAAA has thus far never been enforced,” reported Christopher M. O’Connor, MD, a cardiologist and president of IHVI. He was the senior author of the study, reported in the Journal of the American College of Cardiology.

To improve systematic reporting of clinical trials, including negative results, clinicaltrials.gov was created in 2000. In 2007, the FDAAA enacted rules to broaden the requirements for reporting and to make timely reporting of results mandatory.

Ten years later, the FDA was finally authorized to issue a penalty of $10,000 for failure to release results in a timely fashion, a provision of the 2007 amendment but not confirmed at that time, the investigators reported. In the majority of cases, timely reporting was defined as within 12 months of completion of the trial.

The new study shows that reporting of completed trials, timely or otherwise, remains low. Of the 1,243 trials completed after 2007, the proportion meeting the 1-year reporting requirement was just 20%. Although a significant improvement over the 13% reporting in this time frame before 2007, more than 80% of findings are not being released in a timely manner more than 10 years after this was made mandatory.

There are a number of reasons to consider this to be a serious issue, according to Mandeep R. Mehra, MD, of Brigham and Women’s Hospital, Boston. One of the authors of an accompanying editorial regarding this analysis, Dr. Mehra called underreporting “a public health matter because it is an impediment to medical discovery and poses plausible threats to patient safety.”

Among studies registered after 2007, publication rates were higher for trials funded by the National Institutes of Health (71%) relative to industry (49%) or the U.S. Veterans Affairs (45%).

Publication rates were also higher among interventional relative to observational trials (59% vs. 46%) and trials that enrolled more than 1,000 patients relative to those enrolling fewer than 150 (77% vs. 51%), although trial size was not a significant predictor of publication on multivariate analysis. Clinical endpoints, such as death or hospitalization, were also associated with a greater likelihood of publication relative to nonclinical endpoints.

Of the 251 trials terminated before completion, findings were published within 1 year in only 6%. Two years after completion, only 20% were published at all.

Results consistent with the primary hypothesis did not predict timely publication, but only 39% of the studies listed a primary hypothesis. Since 2017, this is another violation of the FDAAA, according to Dr. O’Connor.

The problem is not unique to heart failure trials, according to the authors who cited numerous studies showing low rates of timely publication in other therapeutic areas. Heart failure was selected for evaluation in this study mainly to keep the analysis feasible, although the authors contend this is an area with an urgent need for better treatments.

The problem needs to be fixed, according to Dr. Mehra. In his editorial, he called for rules to be “transitioned to regulations and action taken for underreporting.” Dr. O’Connor agreed.

“A combination of carrots and sticks might be needed to achieve sufficient result sharing,” Dr. O’Connor said. He suggested that stakeholders, such as investigators, sponsors, regulators, and journal editors, should collaborate to address the problem.

So far, the FDA has never levied a fine for lack of reporting or for failure to report in a timely manner. Routine imposition of large fines might not be viable, given the complex reasons that delay or inhibit publication of trial findings, but it would be a large source of revenue.

“According to the FDAAA TrialsTracker, a live tool that tracks FDAAA compliance and promotes trial transparency, the U.S. government could already have imposed more than $2.8 billion in fines for trials due after January 2018,” Dr. O’Connor reported.

The first and senior authors are among those who report financial relationships with pharmaceutical companies.

SOURCE: Psotka MA et al. J Am Coll Cardiol. 2020;75:3151-61.

A large proportion of results from heart failure trials registered with clinicaltrials.gov are published a year or more after completion or not at all, which violates the U.S. FDA Amendments Act (FDAAA), according to a detailed analysis of the interventional and observational trials in this database.

Of the 1,429 heart failure trials identified, 75% of which were randomized interventional studies and the remainder of which were observational, fewer than 20% met the FDAAA 1-year reporting requirement, and 44% have yet to be published at all, reported a team of collaborative investigators led by cardiologists from the Inova Heart and Vascular Institute (IHVI), Falls Church, Va.

“I believe the critical issue is that the FDAAA has thus far never been enforced,” reported Christopher M. O’Connor, MD, a cardiologist and president of IHVI. He was the senior author of the study, reported in the Journal of the American College of Cardiology.

To improve systematic reporting of clinical trials, including negative results, clinicaltrials.gov was created in 2000. In 2007, the FDAAA enacted rules to broaden the requirements for reporting and to make timely reporting of results mandatory.

Ten years later, the FDA was finally authorized to issue a penalty of $10,000 for failure to release results in a timely fashion, a provision of the 2007 amendment but not confirmed at that time, the investigators reported. In the majority of cases, timely reporting was defined as within 12 months of completion of the trial.

The new study shows that reporting of completed trials, timely or otherwise, remains low. Of the 1,243 trials completed after 2007, the proportion meeting the 1-year reporting requirement was just 20%. Although a significant improvement over the 13% reporting in this time frame before 2007, more than 80% of findings are not being released in a timely manner more than 10 years after this was made mandatory.

There are a number of reasons to consider this to be a serious issue, according to Mandeep R. Mehra, MD, of Brigham and Women’s Hospital, Boston. One of the authors of an accompanying editorial regarding this analysis, Dr. Mehra called underreporting “a public health matter because it is an impediment to medical discovery and poses plausible threats to patient safety.”

Among studies registered after 2007, publication rates were higher for trials funded by the National Institutes of Health (71%) relative to industry (49%) or the U.S. Veterans Affairs (45%).

Publication rates were also higher among interventional relative to observational trials (59% vs. 46%) and trials that enrolled more than 1,000 patients relative to those enrolling fewer than 150 (77% vs. 51%), although trial size was not a significant predictor of publication on multivariate analysis. Clinical endpoints, such as death or hospitalization, were also associated with a greater likelihood of publication relative to nonclinical endpoints.

Of the 251 trials terminated before completion, findings were published within 1 year in only 6%. Two years after completion, only 20% were published at all.

Results consistent with the primary hypothesis did not predict timely publication, but only 39% of the studies listed a primary hypothesis. Since 2017, this is another violation of the FDAAA, according to Dr. O’Connor.

The problem is not unique to heart failure trials, according to the authors who cited numerous studies showing low rates of timely publication in other therapeutic areas. Heart failure was selected for evaluation in this study mainly to keep the analysis feasible, although the authors contend this is an area with an urgent need for better treatments.

The problem needs to be fixed, according to Dr. Mehra. In his editorial, he called for rules to be “transitioned to regulations and action taken for underreporting.” Dr. O’Connor agreed.

“A combination of carrots and sticks might be needed to achieve sufficient result sharing,” Dr. O’Connor said. He suggested that stakeholders, such as investigators, sponsors, regulators, and journal editors, should collaborate to address the problem.

So far, the FDA has never levied a fine for lack of reporting or for failure to report in a timely manner. Routine imposition of large fines might not be viable, given the complex reasons that delay or inhibit publication of trial findings, but it would be a large source of revenue.

“According to the FDAAA TrialsTracker, a live tool that tracks FDAAA compliance and promotes trial transparency, the U.S. government could already have imposed more than $2.8 billion in fines for trials due after January 2018,” Dr. O’Connor reported.

The first and senior authors are among those who report financial relationships with pharmaceutical companies.

SOURCE: Psotka MA et al. J Am Coll Cardiol. 2020;75:3151-61.

A quality initiative to restrict the use of Foley catheters in middle-aged and geriatric trauma patients with hip fracture reduced the risk of urinary tract infections (UTI) and led to earlier discharge, findings from a study revealed. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We reduced the use of Foley catheters in our target population by more than 50%, which led to a decrease in the rate of hospital-acquired UTI and positively affected other perioperative outcomes,” reported Sanjit R. Konda, MD, an orthopedic surgeon with New York University Langone Health.

The quality initiative was introduced about 2 years ago specifically to reduce the risk of UTI in older patients admitted for femur or hip fractures. Previously at the level 1 trauma center where this quality initiative was introduced, placement of Foley catheters in these types of patients had been routine.

After the policy change, Foley catheters were only offered to these trauma patients 55 years of age or older when more than three episodes or urinary retention had been documented with a bladder scan. Urinary retention was defined as a volume of at least 600 mL.

When outcomes in 184 patients treated in the 15 months after the policy change were compared with 393 treated in the prior 38 months, Foley catheter use was substantially and significantly reduced (43.5% vs. 95.5%; P < .001), Dr. Konda said in an interview.

Although the lower rate of UTI following the policy change fell short of statistical significance (10.33% vs. 14.5%; P = .167), the policy change was associated with a decreased time to surgery (33.27 vs. 38.54 hours; P = .001), shorter length of stay (6.89 vs. 8.34 days; P < .001), and higher rate of home discharge (22.8% vs. 15.6%; P = .038).

When those who avoided a Foley catheter were compared with those who did not after the policy change, there was a significant reduction in UTI (4.81% vs. 17.4%; P = .014). In addition, patients who avoided a Foley catheter had a decreased time to surgery (P = .014), shorter length of stay (P < .001) and an almost 900% greater likelihood of home discharge (odds ratio, 9.9; P < .001).

“This quality initiative does increase the number of bladder scans required, meaning more work for nurses, but the program was developed in collaboration with our nursing staff, who were supportive of the goals,” Dr. Konda reported.

Reducing the incidence of UTI is an important initiative because the Centers for Medicare & Medicaid Services and other third-party payers employ this as a quality metric, according to Dr. Konda. This explains why hospital administrators generally embrace effective strategies to reduce UTI rates.

The improvement in outcomes, including the reduction in UTIs and length of stay, has cost implications, which will be evaluated in a future analysis, according to Dr. Konda.

Although this quality initiative was undertaken in a level 1 trauma center, Dr. Konda believes the same principles can be applied to other settings.

Jennifer A. Meddings, MD, an associate professor of medicine at the University of Michigan, Ann Arbor, agreed. Active in the evaluation of strategies to reduce hospital-acquired complications, Dr. Meddings published a study of procedural appropriateness ratings to guide strategies for improving the likelihood that catheters are employed only when needed (BMJ Qual Saf. 2019;28:56-66).

“In addition to avoiding UTI, reducing unnecessary placement of Foley catheters also eliminates the risk of trauma to the urinary tract,” Dr. Meddings said. This is a complication that is not well appreciated because the trauma is not always documented, according to Dr. Meddings, who believes increased risk of both UTI and urinary tract trauma should discourage use of Foley catheters when there is not a specific indication.

Although there are criteria other than excess bladder volume to determine when to consider a Foley catheter, Dr. Meddings encourages any systematic approach that increases the likelihood that catheters are not placed unnecessarily. She emphasized that a hip fracture by itself “is not a criterion for catheterization.”

Dr. Konda reported a financial relationship with Stryker.
 

A quality initiative to restrict the use of Foley catheters in middle-aged and geriatric trauma patients with hip fracture reduced the risk of urinary tract infections (UTI) and led to earlier discharge, findings from a study revealed. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We reduced the use of Foley catheters in our target population by more than 50%, which led to a decrease in the rate of hospital-acquired UTI and positively affected other perioperative outcomes,” reported Sanjit R. Konda, MD, an orthopedic surgeon with New York University Langone Health.

The quality initiative was introduced about 2 years ago specifically to reduce the risk of UTI in older patients admitted for femur or hip fractures. Previously at the level 1 trauma center where this quality initiative was introduced, placement of Foley catheters in these types of patients had been routine.

After the policy change, Foley catheters were only offered to these trauma patients 55 years of age or older when more than three episodes or urinary retention had been documented with a bladder scan. Urinary retention was defined as a volume of at least 600 mL.

When outcomes in 184 patients treated in the 15 months after the policy change were compared with 393 treated in the prior 38 months, Foley catheter use was substantially and significantly reduced (43.5% vs. 95.5%; P < .001), Dr. Konda said in an interview.

Although the lower rate of UTI following the policy change fell short of statistical significance (10.33% vs. 14.5%; P = .167), the policy change was associated with a decreased time to surgery (33.27 vs. 38.54 hours; P = .001), shorter length of stay (6.89 vs. 8.34 days; P < .001), and higher rate of home discharge (22.8% vs. 15.6%; P = .038).

When those who avoided a Foley catheter were compared with those who did not after the policy change, there was a significant reduction in UTI (4.81% vs. 17.4%; P = .014). In addition, patients who avoided a Foley catheter had a decreased time to surgery (P = .014), shorter length of stay (P < .001) and an almost 900% greater likelihood of home discharge (odds ratio, 9.9; P < .001).

“This quality initiative does increase the number of bladder scans required, meaning more work for nurses, but the program was developed in collaboration with our nursing staff, who were supportive of the goals,” Dr. Konda reported.

Reducing the incidence of UTI is an important initiative because the Centers for Medicare & Medicaid Services and other third-party payers employ this as a quality metric, according to Dr. Konda. This explains why hospital administrators generally embrace effective strategies to reduce UTI rates.

The improvement in outcomes, including the reduction in UTIs and length of stay, has cost implications, which will be evaluated in a future analysis, according to Dr. Konda.

Although this quality initiative was undertaken in a level 1 trauma center, Dr. Konda believes the same principles can be applied to other settings.

Jennifer A. Meddings, MD, an associate professor of medicine at the University of Michigan, Ann Arbor, agreed. Active in the evaluation of strategies to reduce hospital-acquired complications, Dr. Meddings published a study of procedural appropriateness ratings to guide strategies for improving the likelihood that catheters are employed only when needed (BMJ Qual Saf. 2019;28:56-66).

“In addition to avoiding UTI, reducing unnecessary placement of Foley catheters also eliminates the risk of trauma to the urinary tract,” Dr. Meddings said. This is a complication that is not well appreciated because the trauma is not always documented, according to Dr. Meddings, who believes increased risk of both UTI and urinary tract trauma should discourage use of Foley catheters when there is not a specific indication.

Although there are criteria other than excess bladder volume to determine when to consider a Foley catheter, Dr. Meddings encourages any systematic approach that increases the likelihood that catheters are not placed unnecessarily. She emphasized that a hip fracture by itself “is not a criterion for catheterization.”

Dr. Konda reported a financial relationship with Stryker.
 

A quality initiative to restrict the use of Foley catheters in middle-aged and geriatric trauma patients with hip fracture reduced the risk of urinary tract infections (UTI) and led to earlier discharge, findings from a study revealed. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We reduced the use of Foley catheters in our target population by more than 50%, which led to a decrease in the rate of hospital-acquired UTI and positively affected other perioperative outcomes,” reported Sanjit R. Konda, MD, an orthopedic surgeon with New York University Langone Health.

The quality initiative was introduced about 2 years ago specifically to reduce the risk of UTI in older patients admitted for femur or hip fractures. Previously at the level 1 trauma center where this quality initiative was introduced, placement of Foley catheters in these types of patients had been routine.

After the policy change, Foley catheters were only offered to these trauma patients 55 years of age or older when more than three episodes or urinary retention had been documented with a bladder scan. Urinary retention was defined as a volume of at least 600 mL.

When outcomes in 184 patients treated in the 15 months after the policy change were compared with 393 treated in the prior 38 months, Foley catheter use was substantially and significantly reduced (43.5% vs. 95.5%; P < .001), Dr. Konda said in an interview.

Although the lower rate of UTI following the policy change fell short of statistical significance (10.33% vs. 14.5%; P = .167), the policy change was associated with a decreased time to surgery (33.27 vs. 38.54 hours; P = .001), shorter length of stay (6.89 vs. 8.34 days; P < .001), and higher rate of home discharge (22.8% vs. 15.6%; P = .038).

When those who avoided a Foley catheter were compared with those who did not after the policy change, there was a significant reduction in UTI (4.81% vs. 17.4%; P = .014). In addition, patients who avoided a Foley catheter had a decreased time to surgery (P = .014), shorter length of stay (P < .001) and an almost 900% greater likelihood of home discharge (odds ratio, 9.9; P < .001).

“This quality initiative does increase the number of bladder scans required, meaning more work for nurses, but the program was developed in collaboration with our nursing staff, who were supportive of the goals,” Dr. Konda reported.

Reducing the incidence of UTI is an important initiative because the Centers for Medicare & Medicaid Services and other third-party payers employ this as a quality metric, according to Dr. Konda. This explains why hospital administrators generally embrace effective strategies to reduce UTI rates.

The improvement in outcomes, including the reduction in UTIs and length of stay, has cost implications, which will be evaluated in a future analysis, according to Dr. Konda.

Although this quality initiative was undertaken in a level 1 trauma center, Dr. Konda believes the same principles can be applied to other settings.

Jennifer A. Meddings, MD, an associate professor of medicine at the University of Michigan, Ann Arbor, agreed. Active in the evaluation of strategies to reduce hospital-acquired complications, Dr. Meddings published a study of procedural appropriateness ratings to guide strategies for improving the likelihood that catheters are employed only when needed (BMJ Qual Saf. 2019;28:56-66).

“In addition to avoiding UTI, reducing unnecessary placement of Foley catheters also eliminates the risk of trauma to the urinary tract,” Dr. Meddings said. This is a complication that is not well appreciated because the trauma is not always documented, according to Dr. Meddings, who believes increased risk of both UTI and urinary tract trauma should discourage use of Foley catheters when there is not a specific indication.

Although there are criteria other than excess bladder volume to determine when to consider a Foley catheter, Dr. Meddings encourages any systematic approach that increases the likelihood that catheters are not placed unnecessarily. She emphasized that a hip fracture by itself “is not a criterion for catheterization.”

Dr. Konda reported a financial relationship with Stryker.
 

A simple tool to guide choice of antithrombotic therapy following total joint arthroplasty led to a reduction in pulmonary embolism (PE) after being introduced systemwide, according to a prospectively tracked evaluation of a large patient cohort. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We developed a simplified scoring system for evaluating risk of thromboembolism and guiding prophylaxis that led to a significant reduction in events across a large integrated health care system,” reported James Wylie, MD, associate medical director for hip and knee preservation and orthopedic research at Intermountain Healthcare, Salt Lake City, Utah.

The goal of the methodology was to create a uniform and evidence-based approach to risk assessment in order to guide selection of appropriate venous thromboembolism (VTE) prophylaxis. The tool takes into account the need to individualize antithrombotic drugs for risk of both VTE and for bleeding.

“VTE is a major threat following total joint replacement, but not all patients require anticoagulants. Recent evidence supports a shift to aspirin for low-risk patients,” explained Dr. Wylie in an interview.

The risk tool assigns points for such factors as history of VTE, older age, history of coronary artery disease, history of cancer, and increased body mass index. There are two possible ratings to guide strategies. Those with standard risk are candidates for 81 mg of aspirin twice daily. Those with high risk are candidates for 2.5 mg of apixaban, also administered twice daily. Custom dosing of warfarin is an alternative for the latter group. Regardless of strategy, prophylaxis is administered for 30 days following arthroplasty

“The risk score is calculated automatically, because you have to click a box in the electronic medical record for all of those factors as part of admission orders,” Dr. Wylie said.

The protocol was introduced in July 2017 and adoption was tracked prospectively over 18 months. In an evaluable cohort of 20,284 patients, PE rates in the 71% of patients adherent to the protocol were compared with the 29% who were not.

Over the observation period, the rates of PE were 0.34% and 0.62% (P = .004) for those adherent and nonadherent, respectively. The rate of unplanned readmissions and death, which were secondary outcomes, were both numerically lower in the group treated by adherent surgeons, but the differences did not reach statistical significance.

Adoption of the protocol by surgeons did increase over the course of the observation period, and this correlated with a decrease in unplanned readmissions. Bleeding-related readmission was a rare event in this analysis and did not significantly increase over time, according to Dr. Wylie.

The risk assessment tool, developed by a multispecialty team at Intermountain Healthcare, was based on a review of hundreds of published papers and guidelines, according to Nathan Momberger, MD, who is the associate medical director of total joint replacement at Intermountain and was a coauthor on this study. A member of the team that developed the risk assessment tool, Dr. Momberger noted that new risk score was developed at a time when clinicians have been moving quickly away from warfarin to direct oral anticoagulants.

“None of our surgeons were using the same VTE prophylaxis when we started this project,” Dr. Momberger said. This was a motivation for developing a systemwide approach. In the 22 participating hospitals, there were 50 surgeons performing total knee arthroplasty and 40 surgeons were performing total hip surgery at the time the new protocol was introduced.

Further analyses will provide a more detailed analysis of the effect of the protocol on other thrombotic events, including deep vein thrombosis, and on cost. Since these data were analyzed, protocol adoption has increased and now exceeds 80%, according to Dr. Wylie.

Although a standardized approach to VTE prophylaxis following total joint arthroplasty is attractive, the ideal strategy remains controversial, according to Sunny Parikh, MD, an orthopedic surgeon affiliated with Colchester (England) General Hospital.

As a coauthor of a recent study that quantified symptomatic VTE rates at his and a neighboring hospital over a 3-year period (BMC Musculoskelet Disord. 2020;21:95), Dr. Parikh reported that VTE rates did not reach zero even with a prolonged course of the low-molecular-weight heparin enoxaparin.

At 90 days, the symptomatic VTE rate was only 0.3% for total knee arthroplasty but reached 1.2% for total hip arthroplasty.

“At the time of this study we were using enoxaparin for 28 days following total hip replacements and for 14 days following total knee replacements,” Dr. Parikh reported. Since this study, his institution has switched to a regimen recommended by the U.K.’s National Institute for Health and Clinical Excellence (NICE).

Under the NICE guidelines, VTE prophylaxis for total hip arthroplasty is 40 mg enoxaparin once daily for 14 days followed by 75 mg aspirin for another 14 days, according to Dr. Parikh. For total knee arthroplasty, the standard regimen is 75 mg aspirin for 14 days.

For those who might not be best managed with the standard approach, “there is no clear guideline.” Rather, in patients with renal or liver impairment, “we discuss the case with the hematology team to adjust the doses,” Dr. Parikh reported.

The advantage of a standardized approach applied to all or most patients is that is eliminates disparities, but Dr. Parikh agreed that risk-adjusted prophylaxis might be warranted for optimal outcomes.

Dr. Wylie reported a financial relationship with Arthrex.
 

A simple tool to guide choice of antithrombotic therapy following total joint arthroplasty led to a reduction in pulmonary embolism (PE) after being introduced systemwide, according to a prospectively tracked evaluation of a large patient cohort. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We developed a simplified scoring system for evaluating risk of thromboembolism and guiding prophylaxis that led to a significant reduction in events across a large integrated health care system,” reported James Wylie, MD, associate medical director for hip and knee preservation and orthopedic research at Intermountain Healthcare, Salt Lake City, Utah.

The goal of the methodology was to create a uniform and evidence-based approach to risk assessment in order to guide selection of appropriate venous thromboembolism (VTE) prophylaxis. The tool takes into account the need to individualize antithrombotic drugs for risk of both VTE and for bleeding.

“VTE is a major threat following total joint replacement, but not all patients require anticoagulants. Recent evidence supports a shift to aspirin for low-risk patients,” explained Dr. Wylie in an interview.

The risk tool assigns points for such factors as history of VTE, older age, history of coronary artery disease, history of cancer, and increased body mass index. There are two possible ratings to guide strategies. Those with standard risk are candidates for 81 mg of aspirin twice daily. Those with high risk are candidates for 2.5 mg of apixaban, also administered twice daily. Custom dosing of warfarin is an alternative for the latter group. Regardless of strategy, prophylaxis is administered for 30 days following arthroplasty

“The risk score is calculated automatically, because you have to click a box in the electronic medical record for all of those factors as part of admission orders,” Dr. Wylie said.

The protocol was introduced in July 2017 and adoption was tracked prospectively over 18 months. In an evaluable cohort of 20,284 patients, PE rates in the 71% of patients adherent to the protocol were compared with the 29% who were not.

Over the observation period, the rates of PE were 0.34% and 0.62% (P = .004) for those adherent and nonadherent, respectively. The rate of unplanned readmissions and death, which were secondary outcomes, were both numerically lower in the group treated by adherent surgeons, but the differences did not reach statistical significance.

Adoption of the protocol by surgeons did increase over the course of the observation period, and this correlated with a decrease in unplanned readmissions. Bleeding-related readmission was a rare event in this analysis and did not significantly increase over time, according to Dr. Wylie.

The risk assessment tool, developed by a multispecialty team at Intermountain Healthcare, was based on a review of hundreds of published papers and guidelines, according to Nathan Momberger, MD, who is the associate medical director of total joint replacement at Intermountain and was a coauthor on this study. A member of the team that developed the risk assessment tool, Dr. Momberger noted that new risk score was developed at a time when clinicians have been moving quickly away from warfarin to direct oral anticoagulants.

“None of our surgeons were using the same VTE prophylaxis when we started this project,” Dr. Momberger said. This was a motivation for developing a systemwide approach. In the 22 participating hospitals, there were 50 surgeons performing total knee arthroplasty and 40 surgeons were performing total hip surgery at the time the new protocol was introduced.

Further analyses will provide a more detailed analysis of the effect of the protocol on other thrombotic events, including deep vein thrombosis, and on cost. Since these data were analyzed, protocol adoption has increased and now exceeds 80%, according to Dr. Wylie.

Although a standardized approach to VTE prophylaxis following total joint arthroplasty is attractive, the ideal strategy remains controversial, according to Sunny Parikh, MD, an orthopedic surgeon affiliated with Colchester (England) General Hospital.

As a coauthor of a recent study that quantified symptomatic VTE rates at his and a neighboring hospital over a 3-year period (BMC Musculoskelet Disord. 2020;21:95), Dr. Parikh reported that VTE rates did not reach zero even with a prolonged course of the low-molecular-weight heparin enoxaparin.

At 90 days, the symptomatic VTE rate was only 0.3% for total knee arthroplasty but reached 1.2% for total hip arthroplasty.

“At the time of this study we were using enoxaparin for 28 days following total hip replacements and for 14 days following total knee replacements,” Dr. Parikh reported. Since this study, his institution has switched to a regimen recommended by the U.K.’s National Institute for Health and Clinical Excellence (NICE).

Under the NICE guidelines, VTE prophylaxis for total hip arthroplasty is 40 mg enoxaparin once daily for 14 days followed by 75 mg aspirin for another 14 days, according to Dr. Parikh. For total knee arthroplasty, the standard regimen is 75 mg aspirin for 14 days.

For those who might not be best managed with the standard approach, “there is no clear guideline.” Rather, in patients with renal or liver impairment, “we discuss the case with the hematology team to adjust the doses,” Dr. Parikh reported.

The advantage of a standardized approach applied to all or most patients is that is eliminates disparities, but Dr. Parikh agreed that risk-adjusted prophylaxis might be warranted for optimal outcomes.

Dr. Wylie reported a financial relationship with Arthrex.
 

A simple tool to guide choice of antithrombotic therapy following total joint arthroplasty led to a reduction in pulmonary embolism (PE) after being introduced systemwide, according to a prospectively tracked evaluation of a large patient cohort. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“We developed a simplified scoring system for evaluating risk of thromboembolism and guiding prophylaxis that led to a significant reduction in events across a large integrated health care system,” reported James Wylie, MD, associate medical director for hip and knee preservation and orthopedic research at Intermountain Healthcare, Salt Lake City, Utah.

The goal of the methodology was to create a uniform and evidence-based approach to risk assessment in order to guide selection of appropriate venous thromboembolism (VTE) prophylaxis. The tool takes into account the need to individualize antithrombotic drugs for risk of both VTE and for bleeding.

“VTE is a major threat following total joint replacement, but not all patients require anticoagulants. Recent evidence supports a shift to aspirin for low-risk patients,” explained Dr. Wylie in an interview.

The risk tool assigns points for such factors as history of VTE, older age, history of coronary artery disease, history of cancer, and increased body mass index. There are two possible ratings to guide strategies. Those with standard risk are candidates for 81 mg of aspirin twice daily. Those with high risk are candidates for 2.5 mg of apixaban, also administered twice daily. Custom dosing of warfarin is an alternative for the latter group. Regardless of strategy, prophylaxis is administered for 30 days following arthroplasty

“The risk score is calculated automatically, because you have to click a box in the electronic medical record for all of those factors as part of admission orders,” Dr. Wylie said.

The protocol was introduced in July 2017 and adoption was tracked prospectively over 18 months. In an evaluable cohort of 20,284 patients, PE rates in the 71% of patients adherent to the protocol were compared with the 29% who were not.

Over the observation period, the rates of PE were 0.34% and 0.62% (P = .004) for those adherent and nonadherent, respectively. The rate of unplanned readmissions and death, which were secondary outcomes, were both numerically lower in the group treated by adherent surgeons, but the differences did not reach statistical significance.

Adoption of the protocol by surgeons did increase over the course of the observation period, and this correlated with a decrease in unplanned readmissions. Bleeding-related readmission was a rare event in this analysis and did not significantly increase over time, according to Dr. Wylie.

The risk assessment tool, developed by a multispecialty team at Intermountain Healthcare, was based on a review of hundreds of published papers and guidelines, according to Nathan Momberger, MD, who is the associate medical director of total joint replacement at Intermountain and was a coauthor on this study. A member of the team that developed the risk assessment tool, Dr. Momberger noted that new risk score was developed at a time when clinicians have been moving quickly away from warfarin to direct oral anticoagulants.

“None of our surgeons were using the same VTE prophylaxis when we started this project,” Dr. Momberger said. This was a motivation for developing a systemwide approach. In the 22 participating hospitals, there were 50 surgeons performing total knee arthroplasty and 40 surgeons were performing total hip surgery at the time the new protocol was introduced.

Further analyses will provide a more detailed analysis of the effect of the protocol on other thrombotic events, including deep vein thrombosis, and on cost. Since these data were analyzed, protocol adoption has increased and now exceeds 80%, according to Dr. Wylie.

Although a standardized approach to VTE prophylaxis following total joint arthroplasty is attractive, the ideal strategy remains controversial, according to Sunny Parikh, MD, an orthopedic surgeon affiliated with Colchester (England) General Hospital.

As a coauthor of a recent study that quantified symptomatic VTE rates at his and a neighboring hospital over a 3-year period (BMC Musculoskelet Disord. 2020;21:95), Dr. Parikh reported that VTE rates did not reach zero even with a prolonged course of the low-molecular-weight heparin enoxaparin.

At 90 days, the symptomatic VTE rate was only 0.3% for total knee arthroplasty but reached 1.2% for total hip arthroplasty.

“At the time of this study we were using enoxaparin for 28 days following total hip replacements and for 14 days following total knee replacements,” Dr. Parikh reported. Since this study, his institution has switched to a regimen recommended by the U.K.’s National Institute for Health and Clinical Excellence (NICE).

Under the NICE guidelines, VTE prophylaxis for total hip arthroplasty is 40 mg enoxaparin once daily for 14 days followed by 75 mg aspirin for another 14 days, according to Dr. Parikh. For total knee arthroplasty, the standard regimen is 75 mg aspirin for 14 days.

For those who might not be best managed with the standard approach, “there is no clear guideline.” Rather, in patients with renal or liver impairment, “we discuss the case with the hematology team to adjust the doses,” Dr. Parikh reported.

The advantage of a standardized approach applied to all or most patients is that is eliminates disparities, but Dr. Parikh agreed that risk-adjusted prophylaxis might be warranted for optimal outcomes.

Dr. Wylie reported a financial relationship with Arthrex.
 

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

When results in a series of robotic-assisted total knee arthroplasties (TKA) were compared with a series of arthroplasties performed manually by the same surgeon, results were comparable even though the robotic procedures included a learning phase. The results of the study were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“Robotics appears to level the playing field for those who are less experienced, so that robotic total knee arthroplasty might be particularly well suited to low-volume surgeons,” reported Sridhar R. Rachala, MD, assistant professor of orthopaedic surgery, University of Buffalo (N.Y.).

In this retrospective cohort study, radiographic and clinical outcomes were evaluated in 164 total knee arthroplasties performed manually over an 8-month period and compared with 300 procedures performed robotically by the same experienced surgeon over the subsequent 15-month period.

There were no significant differences between patient groups for mean age or body mass index. Dr. Rachala, who performed both sets of procedures, reported inherent differences in technique. Specifically, the mechanical alignment was planned for a traditional neutral mechanical axis, while the robotic procedures were planned in kinematic alignment.

When evaluated at 1 year, the mean KOOS JR (Knee Injury and Osteoarthritis Outcome for Joint Replacement) scores were not significantly different for the robotic and manually performed procedures (76.0 vs. 73.9; P = .54). There were also no differences in the final extension (P = .64) or flexion (P = .59).

However, the difference in mean length of stay (2.0 vs. 2.4 days; P = .0002) favored the robotic approach, and the higher proportion of patients discharged to home after robotic surgery (73% vs. 66%; P = .11) suggested a favorable trend. Planned and postoperative alignment was within two degrees for both groups and not significantly different.

“The robotic series were at a disadvantage because it included cases that I performed when first switching to this approach,” reported Dr. Rachala in an interview.

Although a growing number of total hip arthroplasties are performed robotically, there have not so far been many comparisons of clinical outcomes among surgeons experienced with both approaches, according to Dr. Rachala. Acknowledging that a single-surgeon experience could be considered a limitation of this series, Dr. Rachala also considers it a potential strength. Dr. Rachala was highly experienced with manually instrumented total knee arthroplasty when he switched.

“Positioning and alignment are not just more accurate but easier to perform with robotic assistance,” he said, explaining why this approach is likely to offer a particular advantage to surgeons who perform these types of arthroplasties at low volume. He noted that robotic programming helps prevent errors and adopt alternative more personalized alignments.

Although Dr. Rachala acknowledged that long-term and controlled studies are needed, his experience suggests that robotic-assisted procedures are emerging as a viable alternative with advantages for the surgeon as well as the patient.

The principle that robotic assistance can add consistency to total joint arthroplasty is valid, according to Gwo-Chin Lee, MD, an associate professor of orthopaedic surgery, University of Pennsylvania, Philadelphia. “Robotic-assisted arthroplasty improves the accuracy and consistency of the procedure, which can potentially reduce the likelihood of failure. In knees, it is proven to be valuable in unicompartmental replacements in which results are correlated to a surgeon’s surgical volume. It has an equalizing effect relative to a surgeon with more extensive experience,” Dr. Lee said.

The senior author of a recent systematic review and meta-analysis of robotic-assisted unicompartmental knee arthroplasty (J Knee Surg. 2020 Jan 30; doi: 10.1055/s-0040-1701455), Dr. Lee said, “While the impact of robotics on other metrics including patient satisfaction and early recovery continues to be debated among surgeons who specialize in total knee arthroplasties, the technology can aid surgeons in component position, sizing, and ligament balance, particularly for the lower-volume surgeons and ultimately lead to more predictable outcomes.”

Dr. Rachala reports a financial relationship with Avanos and Stryker.

SOURCE: Rachala S et al. AAOS 2020. Abstract P0091.

Prior to shoulder surgery, application of 3% hydrogen peroxide is a simple and inexpensive strategy to reduce the risk of postoperative cultures of Cutibacterium acnes, according to findings from a prospective randomized trial. The results were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“This approach is simple, cheap, and does not rely on patient compliance,” explained Surena Namdari, MD, associate professor of orthopedic surgery at Thomas Jefferson University, Philadelphia.

C. acnes, formerly known as Propionibacterium acnes, is increasingly seen as an important target for prevention of postoperative shoulder infections because of published reports that it is the most commonly isolated bacterium from such infections, Dr. Namdari said in an interview.

In the prospective, randomized trial, male patients scheduled for shoulder arthroscopy were recruited if they did not have active acne, history of psoriatic or eczematous lesions, or recent antibiotic use. Most of the preoperative preparation of the surgical site was the same in the experimental and control arms. This included hair clipping, application of 2% chlorhexidine, and cleansing with saturated 7.5% povidone-iodine solution surgical scrub brushes.

The difference was that 3% hydrogen peroxide–soaked gauzes were applied to perioperative skin of those randomized to the experimental group but not to controls. All patients received routine preoperative oral antibiotics as well as perioperative applications of a formulation containing 2% chlorhexidine gluconate and 70% isopropyl alcohol.

Following surgery, 11 (18.6%) of the 59 patients in the experimental arm versus 23 (34.8%) of the 66 patients randomized to the control group had positive cultures for C. acnes (P = .047), according to the trial results, which have now been published (J Shoulder Elbow Surg. 2020;29:212-6).

There were no cases of skin reactions in either the experimental or control groups.

Topical skin cleansers that contain peroxide, such as benzoyl peroxide, have been shown to have a C. acnes decolonizing effect if applied repeatedly in the days prior to surgery, but Dr. Namdari suggested the problem with this approach is that it depends on patient compliance. A prophylaxis included in the preoperative routine eliminates this potential problem.

C. acnes is an anaerobic bacterium that is part of the resident flora of the skin around several joints, including the knee and the hip, but it is particularly common in the posterior shoulder. Colonization has been found substantially more common in men than in women, according to Dr. Namdari.

The specific threat posed by C. acnes to risk of postoperative infections “is still being defined,” and this trial was not large enough to associate the reduction in postoperative C. acnes cultures with a reduced risk of an adverse clinical outcome, but Dr. Namdari says that the data do show that the nearly 50% reduction in positive cultures was achieved efficiently and inexpensively with no apparent risk.

Several previous studies have also evaluated strategies for reducing C. acnes skin burden on the basis of expected protection against postoperative infection. In one, which associated a 3-day preoperative course of benzoyl peroxide with a reduction in the skin burden of C. acnes, the authors also concluded that this approach deserves consideration in routine skin preparation for shoulder arthroplasty (J Shoulder Elbow Surg. 2018;27:1539-44).

“We believe that a preoperative skin prep protocol that reduces C. acnes load on the skin would likely lead to reduced postoperative infections,” reported the senior author, Mohit N. Gilotra, MD, assistant professor, University of Maryland, Baltimore. Contacted about the rationale for reducing C. acnes skin burden without objective evidence of an impact on postoperative infection risk, Dr. Gilotra indicated these strategies make sense.

“It seems to be true for staph infections and is a reasonable assumption to make here,” he added. “Future work will help determine how much benzoyl peroxide, hydrogen peroxide, or other skin prep can reduce surgical site infection.”

Dr. Namdari reports financial relationships with multiple device and pharmaceutical companies but none relevant to this study.

SOURCE: Namdari S et al. AAOS 2020. Abstract P0808.

Prior to shoulder surgery, application of 3% hydrogen peroxide is a simple and inexpensive strategy to reduce the risk of postoperative cultures of Cutibacterium acnes, according to findings from a prospective randomized trial. The results were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“This approach is simple, cheap, and does not rely on patient compliance,” explained Surena Namdari, MD, associate professor of orthopedic surgery at Thomas Jefferson University, Philadelphia.

C. acnes, formerly known as Propionibacterium acnes, is increasingly seen as an important target for prevention of postoperative shoulder infections because of published reports that it is the most commonly isolated bacterium from such infections, Dr. Namdari said in an interview.

In the prospective, randomized trial, male patients scheduled for shoulder arthroscopy were recruited if they did not have active acne, history of psoriatic or eczematous lesions, or recent antibiotic use. Most of the preoperative preparation of the surgical site was the same in the experimental and control arms. This included hair clipping, application of 2% chlorhexidine, and cleansing with saturated 7.5% povidone-iodine solution surgical scrub brushes.

The difference was that 3% hydrogen peroxide–soaked gauzes were applied to perioperative skin of those randomized to the experimental group but not to controls. All patients received routine preoperative oral antibiotics as well as perioperative applications of a formulation containing 2% chlorhexidine gluconate and 70% isopropyl alcohol.

Following surgery, 11 (18.6%) of the 59 patients in the experimental arm versus 23 (34.8%) of the 66 patients randomized to the control group had positive cultures for C. acnes (P = .047), according to the trial results, which have now been published (J Shoulder Elbow Surg. 2020;29:212-6).

There were no cases of skin reactions in either the experimental or control groups.

Topical skin cleansers that contain peroxide, such as benzoyl peroxide, have been shown to have a C. acnes decolonizing effect if applied repeatedly in the days prior to surgery, but Dr. Namdari suggested the problem with this approach is that it depends on patient compliance. A prophylaxis included in the preoperative routine eliminates this potential problem.

C. acnes is an anaerobic bacterium that is part of the resident flora of the skin around several joints, including the knee and the hip, but it is particularly common in the posterior shoulder. Colonization has been found substantially more common in men than in women, according to Dr. Namdari.

The specific threat posed by C. acnes to risk of postoperative infections “is still being defined,” and this trial was not large enough to associate the reduction in postoperative C. acnes cultures with a reduced risk of an adverse clinical outcome, but Dr. Namdari says that the data do show that the nearly 50% reduction in positive cultures was achieved efficiently and inexpensively with no apparent risk.

Several previous studies have also evaluated strategies for reducing C. acnes skin burden on the basis of expected protection against postoperative infection. In one, which associated a 3-day preoperative course of benzoyl peroxide with a reduction in the skin burden of C. acnes, the authors also concluded that this approach deserves consideration in routine skin preparation for shoulder arthroplasty (J Shoulder Elbow Surg. 2018;27:1539-44).

“We believe that a preoperative skin prep protocol that reduces C. acnes load on the skin would likely lead to reduced postoperative infections,” reported the senior author, Mohit N. Gilotra, MD, assistant professor, University of Maryland, Baltimore. Contacted about the rationale for reducing C. acnes skin burden without objective evidence of an impact on postoperative infection risk, Dr. Gilotra indicated these strategies make sense.

“It seems to be true for staph infections and is a reasonable assumption to make here,” he added. “Future work will help determine how much benzoyl peroxide, hydrogen peroxide, or other skin prep can reduce surgical site infection.”

Dr. Namdari reports financial relationships with multiple device and pharmaceutical companies but none relevant to this study.

SOURCE: Namdari S et al. AAOS 2020. Abstract P0808.

Prior to shoulder surgery, application of 3% hydrogen peroxide is a simple and inexpensive strategy to reduce the risk of postoperative cultures of Cutibacterium acnes, according to findings from a prospective randomized trial. The results were reported in an abstract scheduled for release at the annual meeting of the American Academy of Orthopaedic Surgeons. The meeting was canceled because of COVID-19.

“This approach is simple, cheap, and does not rely on patient compliance,” explained Surena Namdari, MD, associate professor of orthopedic surgery at Thomas Jefferson University, Philadelphia.

C. acnes, formerly known as Propionibacterium acnes, is increasingly seen as an important target for prevention of postoperative shoulder infections because of published reports that it is the most commonly isolated bacterium from such infections, Dr. Namdari said in an interview.

In the prospective, randomized trial, male patients scheduled for shoulder arthroscopy were recruited if they did not have active acne, history of psoriatic or eczematous lesions, or recent antibiotic use. Most of the preoperative preparation of the surgical site was the same in the experimental and control arms. This included hair clipping, application of 2% chlorhexidine, and cleansing with saturated 7.5% povidone-iodine solution surgical scrub brushes.

The difference was that 3% hydrogen peroxide–soaked gauzes were applied to perioperative skin of those randomized to the experimental group but not to controls. All patients received routine preoperative oral antibiotics as well as perioperative applications of a formulation containing 2% chlorhexidine gluconate and 70% isopropyl alcohol.

Following surgery, 11 (18.6%) of the 59 patients in the experimental arm versus 23 (34.8%) of the 66 patients randomized to the control group had positive cultures for C. acnes (P = .047), according to the trial results, which have now been published (J Shoulder Elbow Surg. 2020;29:212-6).

There were no cases of skin reactions in either the experimental or control groups.

Topical skin cleansers that contain peroxide, such as benzoyl peroxide, have been shown to have a C. acnes decolonizing effect if applied repeatedly in the days prior to surgery, but Dr. Namdari suggested the problem with this approach is that it depends on patient compliance. A prophylaxis included in the preoperative routine eliminates this potential problem.

C. acnes is an anaerobic bacterium that is part of the resident flora of the skin around several joints, including the knee and the hip, but it is particularly common in the posterior shoulder. Colonization has been found substantially more common in men than in women, according to Dr. Namdari.

The specific threat posed by C. acnes to risk of postoperative infections “is still being defined,” and this trial was not large enough to associate the reduction in postoperative C. acnes cultures with a reduced risk of an adverse clinical outcome, but Dr. Namdari says that the data do show that the nearly 50% reduction in positive cultures was achieved efficiently and inexpensively with no apparent risk.

Several previous studies have also evaluated strategies for reducing C. acnes skin burden on the basis of expected protection against postoperative infection. In one, which associated a 3-day preoperative course of benzoyl peroxide with a reduction in the skin burden of C. acnes, the authors also concluded that this approach deserves consideration in routine skin preparation for shoulder arthroplasty (J Shoulder Elbow Surg. 2018;27:1539-44).

“We believe that a preoperative skin prep protocol that reduces C. acnes load on the skin would likely lead to reduced postoperative infections,” reported the senior author, Mohit N. Gilotra, MD, assistant professor, University of Maryland, Baltimore. Contacted about the rationale for reducing C. acnes skin burden without objective evidence of an impact on postoperative infection risk, Dr. Gilotra indicated these strategies make sense.

“It seems to be true for staph infections and is a reasonable assumption to make here,” he added. “Future work will help determine how much benzoyl peroxide, hydrogen peroxide, or other skin prep can reduce surgical site infection.”

Dr. Namdari reports financial relationships with multiple device and pharmaceutical companies but none relevant to this study.

SOURCE: Namdari S et al. AAOS 2020. Abstract P0808.