Guidelines

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

An updated consensus statement on transcatheter left atrial appendage closure (LAAC) has put a newfound focus on patient selection for the procedure, specifically recommending that the procedure is appropriate for patients with nonvalvular atrial fibrillation who have risk for thromboembolism, aren’t well suited for direct oral anticoagulants (DOACs) and have a good chance of living for at least another year.

The statement, published online in the Journal of the Society for Cardiovascular Angiography & Interventions, also makes recommendations for how much experience operators should have, how many procedures they should perform to keep their skills up, and when and how to use imaging and prescribe DOACs, among other suggestions.

The statement represents the first updated guidance for LAAC since 2015. “Since then this field has really expanded and evolved,” writing group chair Jacqueline Saw, MD, said in an interview. “For instance, the indications are more matured and specific, and the procedural technical steps have matured. Imaging has also advanced, there’s more understanding about postprocedural care and there are also new devices that have been approved.”

Dr. Saw, an interventional cardiologist at Vancouver General Hospital and St. Paul’s Hospital, and a professor at the University of British Columbia in Vancouver, called the statement “a piece that puts everything together.”

“This document really summarizes the whole practice for doing transcatheter procedures,” she added, “so it’s all-in-one document in terms of recommendation of who we do the procedure for, how we should do it, how we should image and guide the procedure, and what complications to look out for and how to manage patients post procedure, be it with antithrombotic therapy and/or device surveillance.”

 13 recommendations

In all, the statement carries 13 recommendations for LAAC. The Society for Cardiovascular Angiography & Interventions and the Heart Rhythm Society commissioned the writing group. The American College of Cardiology and Society of Cardiovascular Computed Tomography have endorsed the statement. The following are among the recommendations:

• Transcatheter LAAC is appropriate for patients with nonvalvular atrial fibrillation with high thromboembolic risk but for whom long-term oral anticoagulation may be contraindicated and who have at least 1 year’s life expectancy.
• Operators should have performed at least 50 prior left-sided ablations or structural procedures and at least 25 transseptal punctures (TSPs). Interventional-imaging physicians should have experience in guiding 25 or more TSPs before supporting LAAC procedures independently.
• To maintain skills, operators should do 25 or more TSPs and at least 12 LAACs over each 2-year period.
• On-site cardiovascular surgery backup should be available for new programs and for operators early in their learning curve.
• Baseline imaging with transesophageal echocardiography (TEE) or cardiac computed tomography should be performed before LAAC.
• Intraprocedural imaging guidance with TEE or intracardiac echocardiography.
• Follow labeling of each specific LAAC device for technical aspects of the procedure.
• Familiarity with avoiding, recognizing, and managing LAAC complications.
• Predischarge 2-dimensional TEE to rule out pericardial effusion and device embolization.
• Anticoagulation for device-related thrombus.
• Make all efforts to minimize peridevice leaks during implantation because their clinical impact and management isn’t well understood.
• Antithrombotic therapy with warfarin, DOAC, or dual-antiplatelet therapy after LAAC based on the studied regimen and instructions for each specific device, tailored to the bleeding risks for each patient.
• TEE or cardiac computed tomography at 45-90 days after LAAC for device surveillance to assess for peridevice leak and device-related thrombus.

The statement also includes precautionary recommendations. It advises against using routine closure of LAAC-associated iatrogenic atrial septal defects and states that combined procedures with LAAC, such as structural interventions and pulmonary vein isolation, should be avoided because randomized controlled trial data are pending.

“These recommendations are based upon data from updated publications and randomized trial data as well as large registries, including the National Cardiovascular Data Registry, so I think this is a very practical statement that puts all these pieces together for any budding interventionalist doing this procedure and even experienced operations,” Dr. Saw said.

Authors of an accompanying editorial agreed that the “rigorous standards” set out in the statement will help maintain “a high level of procedural safety in the setting of rapid expansion.”

The editorialists, Faisal M. Merchant, MD, of Emory University, Atlanta, and Mohamad Alkhouli, MD, professor of medicine at Mayo Clinic School of Medicine, Rochester, Minn., point out that the incidence of pericardial effusion has decreased from more than 5% in the pivotal Watchman trials to less than 1.5% in the most recent report from the National Cardiovascular Data Registry, which shows that more than 100,000 procedures have been performed in the United States.

But most important as the field moves forward, they stress, is patient selection. The recommendation of limiting patients to those with a life expectancy of 1 year “is a tacit recognition of the fact that the benefits of LAAC take time to accrue, and many older and frail patients are unlikely to derive meaningful benefit.”

Dr. Merchant and Dr. Alkhouli also note that there remains a conundrum in patient selection that remains from the original LAAC trials, which enrolled patients who were eligible for anticoagulation. “Somewhat paradoxically, after its approval, LAAC is mostly prescribed to patients who are not felt to be good anticoagulation candidates.” This leaves physicians “in the precarious position of extrapolating data to patients who were excluded from the original clinical trials.”

Therefore, the consensus statement “is right to put patient selection front and center in its recommendations, but as the field of LAAC comes of age, better evidence to support patient selection will be the real sign of maturity.”

Dr. Saw said she envisions another update over the next 2 years or so as ongoing clinical trials comparing DOAC and LAAC, namely the CHAMPION-AF and OPTION trials, report results.

Dr. Saw and Dr. Merchant, reported no conflicts of interest. Dr. Alkhouli has financial ties to Boston Scientific, Abbott, and Philips.

An updated consensus statement on transcatheter left atrial appendage closure (LAAC) has put a newfound focus on patient selection for the procedure, specifically recommending that the procedure is appropriate for patients with nonvalvular atrial fibrillation who have risk for thromboembolism, aren’t well suited for direct oral anticoagulants (DOACs) and have a good chance of living for at least another year.

The statement, published online in the Journal of the Society for Cardiovascular Angiography & Interventions, also makes recommendations for how much experience operators should have, how many procedures they should perform to keep their skills up, and when and how to use imaging and prescribe DOACs, among other suggestions.

The statement represents the first updated guidance for LAAC since 2015. “Since then this field has really expanded and evolved,” writing group chair Jacqueline Saw, MD, said in an interview. “For instance, the indications are more matured and specific, and the procedural technical steps have matured. Imaging has also advanced, there’s more understanding about postprocedural care and there are also new devices that have been approved.”

Dr. Saw, an interventional cardiologist at Vancouver General Hospital and St. Paul’s Hospital, and a professor at the University of British Columbia in Vancouver, called the statement “a piece that puts everything together.”

“This document really summarizes the whole practice for doing transcatheter procedures,” she added, “so it’s all-in-one document in terms of recommendation of who we do the procedure for, how we should do it, how we should image and guide the procedure, and what complications to look out for and how to manage patients post procedure, be it with antithrombotic therapy and/or device surveillance.”

 13 recommendations

In all, the statement carries 13 recommendations for LAAC. The Society for Cardiovascular Angiography & Interventions and the Heart Rhythm Society commissioned the writing group. The American College of Cardiology and Society of Cardiovascular Computed Tomography have endorsed the statement. The following are among the recommendations:

• Transcatheter LAAC is appropriate for patients with nonvalvular atrial fibrillation with high thromboembolic risk but for whom long-term oral anticoagulation may be contraindicated and who have at least 1 year’s life expectancy.
• Operators should have performed at least 50 prior left-sided ablations or structural procedures and at least 25 transseptal punctures (TSPs). Interventional-imaging physicians should have experience in guiding 25 or more TSPs before supporting LAAC procedures independently.
• To maintain skills, operators should do 25 or more TSPs and at least 12 LAACs over each 2-year period.
• On-site cardiovascular surgery backup should be available for new programs and for operators early in their learning curve.
• Baseline imaging with transesophageal echocardiography (TEE) or cardiac computed tomography should be performed before LAAC.
• Intraprocedural imaging guidance with TEE or intracardiac echocardiography.
• Follow labeling of each specific LAAC device for technical aspects of the procedure.
• Familiarity with avoiding, recognizing, and managing LAAC complications.
• Predischarge 2-dimensional TEE to rule out pericardial effusion and device embolization.
• Anticoagulation for device-related thrombus.
• Make all efforts to minimize peridevice leaks during implantation because their clinical impact and management isn’t well understood.
• Antithrombotic therapy with warfarin, DOAC, or dual-antiplatelet therapy after LAAC based on the studied regimen and instructions for each specific device, tailored to the bleeding risks for each patient.
• TEE or cardiac computed tomography at 45-90 days after LAAC for device surveillance to assess for peridevice leak and device-related thrombus.

The statement also includes precautionary recommendations. It advises against using routine closure of LAAC-associated iatrogenic atrial septal defects and states that combined procedures with LAAC, such as structural interventions and pulmonary vein isolation, should be avoided because randomized controlled trial data are pending.

“These recommendations are based upon data from updated publications and randomized trial data as well as large registries, including the National Cardiovascular Data Registry, so I think this is a very practical statement that puts all these pieces together for any budding interventionalist doing this procedure and even experienced operations,” Dr. Saw said.

Authors of an accompanying editorial agreed that the “rigorous standards” set out in the statement will help maintain “a high level of procedural safety in the setting of rapid expansion.”

The editorialists, Faisal M. Merchant, MD, of Emory University, Atlanta, and Mohamad Alkhouli, MD, professor of medicine at Mayo Clinic School of Medicine, Rochester, Minn., point out that the incidence of pericardial effusion has decreased from more than 5% in the pivotal Watchman trials to less than 1.5% in the most recent report from the National Cardiovascular Data Registry, which shows that more than 100,000 procedures have been performed in the United States.

But most important as the field moves forward, they stress, is patient selection. The recommendation of limiting patients to those with a life expectancy of 1 year “is a tacit recognition of the fact that the benefits of LAAC take time to accrue, and many older and frail patients are unlikely to derive meaningful benefit.”

Dr. Merchant and Dr. Alkhouli also note that there remains a conundrum in patient selection that remains from the original LAAC trials, which enrolled patients who were eligible for anticoagulation. “Somewhat paradoxically, after its approval, LAAC is mostly prescribed to patients who are not felt to be good anticoagulation candidates.” This leaves physicians “in the precarious position of extrapolating data to patients who were excluded from the original clinical trials.”

Therefore, the consensus statement “is right to put patient selection front and center in its recommendations, but as the field of LAAC comes of age, better evidence to support patient selection will be the real sign of maturity.”

Dr. Saw said she envisions another update over the next 2 years or so as ongoing clinical trials comparing DOAC and LAAC, namely the CHAMPION-AF and OPTION trials, report results.

Dr. Saw and Dr. Merchant, reported no conflicts of interest. Dr. Alkhouli has financial ties to Boston Scientific, Abbott, and Philips.

An updated consensus statement on transcatheter left atrial appendage closure (LAAC) has put a newfound focus on patient selection for the procedure, specifically recommending that the procedure is appropriate for patients with nonvalvular atrial fibrillation who have risk for thromboembolism, aren’t well suited for direct oral anticoagulants (DOACs) and have a good chance of living for at least another year.

The statement, published online in the Journal of the Society for Cardiovascular Angiography & Interventions, also makes recommendations for how much experience operators should have, how many procedures they should perform to keep their skills up, and when and how to use imaging and prescribe DOACs, among other suggestions.

The statement represents the first updated guidance for LAAC since 2015. “Since then this field has really expanded and evolved,” writing group chair Jacqueline Saw, MD, said in an interview. “For instance, the indications are more matured and specific, and the procedural technical steps have matured. Imaging has also advanced, there’s more understanding about postprocedural care and there are also new devices that have been approved.”

Dr. Saw, an interventional cardiologist at Vancouver General Hospital and St. Paul’s Hospital, and a professor at the University of British Columbia in Vancouver, called the statement “a piece that puts everything together.”

“This document really summarizes the whole practice for doing transcatheter procedures,” she added, “so it’s all-in-one document in terms of recommendation of who we do the procedure for, how we should do it, how we should image and guide the procedure, and what complications to look out for and how to manage patients post procedure, be it with antithrombotic therapy and/or device surveillance.”

 13 recommendations

In all, the statement carries 13 recommendations for LAAC. The Society for Cardiovascular Angiography & Interventions and the Heart Rhythm Society commissioned the writing group. The American College of Cardiology and Society of Cardiovascular Computed Tomography have endorsed the statement. The following are among the recommendations:

• Transcatheter LAAC is appropriate for patients with nonvalvular atrial fibrillation with high thromboembolic risk but for whom long-term oral anticoagulation may be contraindicated and who have at least 1 year’s life expectancy.
• Operators should have performed at least 50 prior left-sided ablations or structural procedures and at least 25 transseptal punctures (TSPs). Interventional-imaging physicians should have experience in guiding 25 or more TSPs before supporting LAAC procedures independently.
• To maintain skills, operators should do 25 or more TSPs and at least 12 LAACs over each 2-year period.
• On-site cardiovascular surgery backup should be available for new programs and for operators early in their learning curve.
• Baseline imaging with transesophageal echocardiography (TEE) or cardiac computed tomography should be performed before LAAC.
• Intraprocedural imaging guidance with TEE or intracardiac echocardiography.
• Follow labeling of each specific LAAC device for technical aspects of the procedure.
• Familiarity with avoiding, recognizing, and managing LAAC complications.
• Predischarge 2-dimensional TEE to rule out pericardial effusion and device embolization.
• Anticoagulation for device-related thrombus.
• Make all efforts to minimize peridevice leaks during implantation because their clinical impact and management isn’t well understood.
• Antithrombotic therapy with warfarin, DOAC, or dual-antiplatelet therapy after LAAC based on the studied regimen and instructions for each specific device, tailored to the bleeding risks for each patient.
• TEE or cardiac computed tomography at 45-90 days after LAAC for device surveillance to assess for peridevice leak and device-related thrombus.

The statement also includes precautionary recommendations. It advises against using routine closure of LAAC-associated iatrogenic atrial septal defects and states that combined procedures with LAAC, such as structural interventions and pulmonary vein isolation, should be avoided because randomized controlled trial data are pending.

“These recommendations are based upon data from updated publications and randomized trial data as well as large registries, including the National Cardiovascular Data Registry, so I think this is a very practical statement that puts all these pieces together for any budding interventionalist doing this procedure and even experienced operations,” Dr. Saw said.

Authors of an accompanying editorial agreed that the “rigorous standards” set out in the statement will help maintain “a high level of procedural safety in the setting of rapid expansion.”

The editorialists, Faisal M. Merchant, MD, of Emory University, Atlanta, and Mohamad Alkhouli, MD, professor of medicine at Mayo Clinic School of Medicine, Rochester, Minn., point out that the incidence of pericardial effusion has decreased from more than 5% in the pivotal Watchman trials to less than 1.5% in the most recent report from the National Cardiovascular Data Registry, which shows that more than 100,000 procedures have been performed in the United States.

But most important as the field moves forward, they stress, is patient selection. The recommendation of limiting patients to those with a life expectancy of 1 year “is a tacit recognition of the fact that the benefits of LAAC take time to accrue, and many older and frail patients are unlikely to derive meaningful benefit.”

Dr. Merchant and Dr. Alkhouli also note that there remains a conundrum in patient selection that remains from the original LAAC trials, which enrolled patients who were eligible for anticoagulation. “Somewhat paradoxically, after its approval, LAAC is mostly prescribed to patients who are not felt to be good anticoagulation candidates.” This leaves physicians “in the precarious position of extrapolating data to patients who were excluded from the original clinical trials.”

Therefore, the consensus statement “is right to put patient selection front and center in its recommendations, but as the field of LAAC comes of age, better evidence to support patient selection will be the real sign of maturity.”

Dr. Saw said she envisions another update over the next 2 years or so as ongoing clinical trials comparing DOAC and LAAC, namely the CHAMPION-AF and OPTION trials, report results.

Dr. Saw and Dr. Merchant, reported no conflicts of interest. Dr. Alkhouli has financial ties to Boston Scientific, Abbott, and Philips.

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

A statement released by the American Heart Association and the American College of Cardiology advocates use of supervised exercise training in patients with heart failure with preserved ejection fraction (HFpEF), as well as coverage for these services by third-party payers.

The authors hope to boost the stature of supervised exercise training (SET) in HFpEF among practitioners and show Medicare and insurers that it deserves reimbursement. Currently, they noted, clinicians tend to recognize exercise as therapy more in HF with reduced ejection fraction (HFrEF). And Medicare covers exercise training within broader cardiac rehabilitation programs for patients with HFrEF but not HFpEF.

Yet exercise has been broadly effective in HFpEF clinical trials, as outlined in the document. And there are good mechanistic reasons to believe that patients with the disorder can gain as much or more from SET than those with HFrEF.

“The signals for improvement from exercise training, in symptoms and objective measures of exercise capacity, are considerably larger for HFpEF than for HFrEF,” Dalane W. Kitzman, MD, Wake Forest University, Winston-Salem, N.C., said in an interview.

So, it’s a bit of a paradox that clinicians don’t prescribe it as often in HFpEF, probably because of the lack of reimbursement but also from less “awareness” and understanding of the disease itself, he proposed.

Dr. Kitzman is senior author on the statement sponsored by the AHA and the ACC. It was published in the societies’ flagship journals Circulation and the Journal of the American College of Cardiology. The statement was also endorsed by the Heart Failure Society of America, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the American Association of Heart Failure Nurses.
 

Carefully chosen words

The statement makes its case in HFpEF specifically for SET rather than cardiac rehabilitation, the latter typically a comprehensive program that goes beyond exercise, Dr. Kitzman noted. And SET is closer to the exercise interventions used in the supportive HFpEF trials.

“Also, Medicare in recent years has approved something called ‘supervised exercise training’ for other disorders, such as peripheral artery disease.” So, the document specifies SET “to be fully aligned with the evidence base,” he said, as well as “align it with a type of treatment that Medicare has a precedent for approving for other disorders.”
 

Data and physiologic basis

Core features of the AHA/ACC statement is its review of HFpEF exercise physiology, survey of randomized trials supporting SET in the disease, and characterization of exercise as an especially suitable pleiotropic therapy.

Increasingly, “HFpEF is now accepted as a systemic disorder that affects and impacts all organs,” Dr. Kitzman observed. “With a systemic multiorgan disorder, it would make sense that a broad treatment like exercise might be just the right thing. We think that’s the reason that its benefits are really quite large in magnitude.”

The document notes that exercise seems “potentially well suited for the treatment of both the cardiac and, in particular, the extracardiac abnormalities that contribute to exercise intolerance in HFpEF.”

Its effects in the disorder are “anti-inflammatory, rheological, lipid lowering, antihypertensive, positive inotropic, positive lusitropic, negative chronotropic, vasodilation, diuretic, weight-reducing, hypoglycemic, hypnotic, and antidepressive,” the statement notes. It achieves them via multiple pathways involving the heart, lungs, vasculature and, notably, the skeletal muscles.

“It’s been widely overlooked that at least 50% of low exercise capacity and symptoms in HFpEF are due to skeletal muscle dysfunction,” said Dr. Kitzman, an authority on exercise physiology in heart failure.

“But we’ve spent about 95% of our attention trying to modify and understand the cardiac component.” Skeletal muscles, he said, “are not an innocent bystander. They’re part of the problem. And that’s why we should really spend more time focusing on them.”

Dr. Kitzman disclosed receiving consulting fees from Bayer, Medtronic, Corvia Medical, Boehringer Ingelheim, Keyto, Rivus, NovoNordisk, AstraZeneca, and Pfizer; holding stock in Gilead; and receiving grants to his institution from Bayer, Novo Nordisk, AstraZeneca, Rivus, and Pfizer.

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

A statement released by the American Heart Association and the American College of Cardiology advocates use of supervised exercise training in patients with heart failure with preserved ejection fraction (HFpEF), as well as coverage for these services by third-party payers.

The authors hope to boost the stature of supervised exercise training (SET) in HFpEF among practitioners and show Medicare and insurers that it deserves reimbursement. Currently, they noted, clinicians tend to recognize exercise as therapy more in HF with reduced ejection fraction (HFrEF). And Medicare covers exercise training within broader cardiac rehabilitation programs for patients with HFrEF but not HFpEF.

Yet exercise has been broadly effective in HFpEF clinical trials, as outlined in the document. And there are good mechanistic reasons to believe that patients with the disorder can gain as much or more from SET than those with HFrEF.

“The signals for improvement from exercise training, in symptoms and objective measures of exercise capacity, are considerably larger for HFpEF than for HFrEF,” Dalane W. Kitzman, MD, Wake Forest University, Winston-Salem, N.C., said in an interview.

So, it’s a bit of a paradox that clinicians don’t prescribe it as often in HFpEF, probably because of the lack of reimbursement but also from less “awareness” and understanding of the disease itself, he proposed.

Dr. Kitzman is senior author on the statement sponsored by the AHA and the ACC. It was published in the societies’ flagship journals Circulation and the Journal of the American College of Cardiology. The statement was also endorsed by the Heart Failure Society of America, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the American Association of Heart Failure Nurses.
 

Carefully chosen words

The statement makes its case in HFpEF specifically for SET rather than cardiac rehabilitation, the latter typically a comprehensive program that goes beyond exercise, Dr. Kitzman noted. And SET is closer to the exercise interventions used in the supportive HFpEF trials.

“Also, Medicare in recent years has approved something called ‘supervised exercise training’ for other disorders, such as peripheral artery disease.” So, the document specifies SET “to be fully aligned with the evidence base,” he said, as well as “align it with a type of treatment that Medicare has a precedent for approving for other disorders.”
 

Data and physiologic basis

Core features of the AHA/ACC statement is its review of HFpEF exercise physiology, survey of randomized trials supporting SET in the disease, and characterization of exercise as an especially suitable pleiotropic therapy.

Increasingly, “HFpEF is now accepted as a systemic disorder that affects and impacts all organs,” Dr. Kitzman observed. “With a systemic multiorgan disorder, it would make sense that a broad treatment like exercise might be just the right thing. We think that’s the reason that its benefits are really quite large in magnitude.”

The document notes that exercise seems “potentially well suited for the treatment of both the cardiac and, in particular, the extracardiac abnormalities that contribute to exercise intolerance in HFpEF.”

Its effects in the disorder are “anti-inflammatory, rheological, lipid lowering, antihypertensive, positive inotropic, positive lusitropic, negative chronotropic, vasodilation, diuretic, weight-reducing, hypoglycemic, hypnotic, and antidepressive,” the statement notes. It achieves them via multiple pathways involving the heart, lungs, vasculature and, notably, the skeletal muscles.

“It’s been widely overlooked that at least 50% of low exercise capacity and symptoms in HFpEF are due to skeletal muscle dysfunction,” said Dr. Kitzman, an authority on exercise physiology in heart failure.

“But we’ve spent about 95% of our attention trying to modify and understand the cardiac component.” Skeletal muscles, he said, “are not an innocent bystander. They’re part of the problem. And that’s why we should really spend more time focusing on them.”

Dr. Kitzman disclosed receiving consulting fees from Bayer, Medtronic, Corvia Medical, Boehringer Ingelheim, Keyto, Rivus, NovoNordisk, AstraZeneca, and Pfizer; holding stock in Gilead; and receiving grants to his institution from Bayer, Novo Nordisk, AstraZeneca, Rivus, and Pfizer.

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

A statement released by the American Heart Association and the American College of Cardiology advocates use of supervised exercise training in patients with heart failure with preserved ejection fraction (HFpEF), as well as coverage for these services by third-party payers.

The authors hope to boost the stature of supervised exercise training (SET) in HFpEF among practitioners and show Medicare and insurers that it deserves reimbursement. Currently, they noted, clinicians tend to recognize exercise as therapy more in HF with reduced ejection fraction (HFrEF). And Medicare covers exercise training within broader cardiac rehabilitation programs for patients with HFrEF but not HFpEF.

Yet exercise has been broadly effective in HFpEF clinical trials, as outlined in the document. And there are good mechanistic reasons to believe that patients with the disorder can gain as much or more from SET than those with HFrEF.

“The signals for improvement from exercise training, in symptoms and objective measures of exercise capacity, are considerably larger for HFpEF than for HFrEF,” Dalane W. Kitzman, MD, Wake Forest University, Winston-Salem, N.C., said in an interview.

So, it’s a bit of a paradox that clinicians don’t prescribe it as often in HFpEF, probably because of the lack of reimbursement but also from less “awareness” and understanding of the disease itself, he proposed.

Dr. Kitzman is senior author on the statement sponsored by the AHA and the ACC. It was published in the societies’ flagship journals Circulation and the Journal of the American College of Cardiology. The statement was also endorsed by the Heart Failure Society of America, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the American Association of Heart Failure Nurses.
 

Carefully chosen words

The statement makes its case in HFpEF specifically for SET rather than cardiac rehabilitation, the latter typically a comprehensive program that goes beyond exercise, Dr. Kitzman noted. And SET is closer to the exercise interventions used in the supportive HFpEF trials.

“Also, Medicare in recent years has approved something called ‘supervised exercise training’ for other disorders, such as peripheral artery disease.” So, the document specifies SET “to be fully aligned with the evidence base,” he said, as well as “align it with a type of treatment that Medicare has a precedent for approving for other disorders.”
 

Data and physiologic basis

Core features of the AHA/ACC statement is its review of HFpEF exercise physiology, survey of randomized trials supporting SET in the disease, and characterization of exercise as an especially suitable pleiotropic therapy.

Increasingly, “HFpEF is now accepted as a systemic disorder that affects and impacts all organs,” Dr. Kitzman observed. “With a systemic multiorgan disorder, it would make sense that a broad treatment like exercise might be just the right thing. We think that’s the reason that its benefits are really quite large in magnitude.”

The document notes that exercise seems “potentially well suited for the treatment of both the cardiac and, in particular, the extracardiac abnormalities that contribute to exercise intolerance in HFpEF.”

Its effects in the disorder are “anti-inflammatory, rheological, lipid lowering, antihypertensive, positive inotropic, positive lusitropic, negative chronotropic, vasodilation, diuretic, weight-reducing, hypoglycemic, hypnotic, and antidepressive,” the statement notes. It achieves them via multiple pathways involving the heart, lungs, vasculature and, notably, the skeletal muscles.

“It’s been widely overlooked that at least 50% of low exercise capacity and symptoms in HFpEF are due to skeletal muscle dysfunction,” said Dr. Kitzman, an authority on exercise physiology in heart failure.

“But we’ve spent about 95% of our attention trying to modify and understand the cardiac component.” Skeletal muscles, he said, “are not an innocent bystander. They’re part of the problem. And that’s why we should really spend more time focusing on them.”

Dr. Kitzman disclosed receiving consulting fees from Bayer, Medtronic, Corvia Medical, Boehringer Ingelheim, Keyto, Rivus, NovoNordisk, AstraZeneca, and Pfizer; holding stock in Gilead; and receiving grants to his institution from Bayer, Novo Nordisk, AstraZeneca, Rivus, and Pfizer.

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

Patients with moderate to severe osteoarthritis (OA) or osteonecrosis (ON) eligible for total joint arthroplasty (TJA) who have failed one or more nonoperative therapies should proceed directly to surgery, according to new guidelines from the American College of Rheumatology and the American Association of Hip and Knee Surgeons.

“One of the reasons for creating this guideline was that many patients have been subjected to delays for surgery after completing nonoperative therapy, despite persistent moderate to severe pain, loss of function, and moderate to severe radiographic OA or ON,” said coauthors Susan M. Goodman, MD, a rheumatologist at Hospital for Special Surgery in New York, and Charles Hannon, MD, an orthopedic surgeon at Washington University in St. Louis, in an email interview with this news organization. “This guideline supports surgery being performed in an expeditious fashion after the decision has been made to proceed with surgery by both the physician and patient through a shared decision-making process,” they said.

The guidelines also state that obesity by itself should not be a reason to delay TJA. “We could not find a rationale for a strict cut off for weight/body mass index (BMI). Our literature review revealed that though many adverse events were, in fact, increased in patients with morbid obesity, there is also an increase in adverse events for those who had bariatric surgery prior to their arthroplasty,” they added, noting that patients need to be made aware of the increased risk for adverse events in patients with obesity. Though the guidelines do not pose any BMI cutoffs, they state that weight loss should be “strongly encouraged.” These new recommendations are conditional, and all had a “low” to “very low” certainty of evidence; however, there was high consensus on the recommendations from the expert panel.

The guidelines also recommended:

• Delaying TJA to achieve smoking and nicotine cessation or reduction.
• Delaying TJA to improve glycemic control in patients with diabetes, although the group did not recommend any specific measure or threshold.
• Not delaying TJA in patients with a severe deformity, bone loss, or a neuropathic joint.

The new guidelines formalize what many surgeons have already been doing for the past few years, said Arjun Saxena, MD, MBA, an orthopedic surgeon in Philadelphia who was not involved with the guidelines. “A lot of total joint programs have really focused on patient optimization, including smoking cessation, glycemic control, and weight loss prior to surgery,” he said.

Most importantly, the guidelines put an emphasis on how the decision to proceed with TJA should be a shared decision between a physician and patient, he added. Some insurance companies with prior authorization policies may require a patient to try additional nonoperative therapies before approving surgery, creating barriers to care, he said. “Hopefully [these new recommendations] will help third parties understand that joint replacement is a big decision – most doctors aren’t going to recommend that unless it’s necessary or something that is going to help patients,” he said. “I understand that there is a certain need for preauthorization, but just having strict guidelines isn’t appropriate. You really need to look at the whole picture,” he added.

The full manuscript has been submitted for review and is expected to be jointly published in American College of Rheumatology and the American Association of Hip and Knee Surgeons journals later this year.

Dr. Saxena consults for the orthopedic implant company Corin.

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

Patients with moderate to severe osteoarthritis (OA) or osteonecrosis (ON) eligible for total joint arthroplasty (TJA) who have failed one or more nonoperative therapies should proceed directly to surgery, according to new guidelines from the American College of Rheumatology and the American Association of Hip and Knee Surgeons.

“One of the reasons for creating this guideline was that many patients have been subjected to delays for surgery after completing nonoperative therapy, despite persistent moderate to severe pain, loss of function, and moderate to severe radiographic OA or ON,” said coauthors Susan M. Goodman, MD, a rheumatologist at Hospital for Special Surgery in New York, and Charles Hannon, MD, an orthopedic surgeon at Washington University in St. Louis, in an email interview with this news organization. “This guideline supports surgery being performed in an expeditious fashion after the decision has been made to proceed with surgery by both the physician and patient through a shared decision-making process,” they said.

The guidelines also state that obesity by itself should not be a reason to delay TJA. “We could not find a rationale for a strict cut off for weight/body mass index (BMI). Our literature review revealed that though many adverse events were, in fact, increased in patients with morbid obesity, there is also an increase in adverse events for those who had bariatric surgery prior to their arthroplasty,” they added, noting that patients need to be made aware of the increased risk for adverse events in patients with obesity. Though the guidelines do not pose any BMI cutoffs, they state that weight loss should be “strongly encouraged.” These new recommendations are conditional, and all had a “low” to “very low” certainty of evidence; however, there was high consensus on the recommendations from the expert panel.

The guidelines also recommended:

• Delaying TJA to achieve smoking and nicotine cessation or reduction.
• Delaying TJA to improve glycemic control in patients with diabetes, although the group did not recommend any specific measure or threshold.
• Not delaying TJA in patients with a severe deformity, bone loss, or a neuropathic joint.

The new guidelines formalize what many surgeons have already been doing for the past few years, said Arjun Saxena, MD, MBA, an orthopedic surgeon in Philadelphia who was not involved with the guidelines. “A lot of total joint programs have really focused on patient optimization, including smoking cessation, glycemic control, and weight loss prior to surgery,” he said.

Most importantly, the guidelines put an emphasis on how the decision to proceed with TJA should be a shared decision between a physician and patient, he added. Some insurance companies with prior authorization policies may require a patient to try additional nonoperative therapies before approving surgery, creating barriers to care, he said. “Hopefully [these new recommendations] will help third parties understand that joint replacement is a big decision – most doctors aren’t going to recommend that unless it’s necessary or something that is going to help patients,” he said. “I understand that there is a certain need for preauthorization, but just having strict guidelines isn’t appropriate. You really need to look at the whole picture,” he added.

The full manuscript has been submitted for review and is expected to be jointly published in American College of Rheumatology and the American Association of Hip and Knee Surgeons journals later this year.

Dr. Saxena consults for the orthopedic implant company Corin.

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

Patients with moderate to severe osteoarthritis (OA) or osteonecrosis (ON) eligible for total joint arthroplasty (TJA) who have failed one or more nonoperative therapies should proceed directly to surgery, according to new guidelines from the American College of Rheumatology and the American Association of Hip and Knee Surgeons.

“One of the reasons for creating this guideline was that many patients have been subjected to delays for surgery after completing nonoperative therapy, despite persistent moderate to severe pain, loss of function, and moderate to severe radiographic OA or ON,” said coauthors Susan M. Goodman, MD, a rheumatologist at Hospital for Special Surgery in New York, and Charles Hannon, MD, an orthopedic surgeon at Washington University in St. Louis, in an email interview with this news organization. “This guideline supports surgery being performed in an expeditious fashion after the decision has been made to proceed with surgery by both the physician and patient through a shared decision-making process,” they said.

The guidelines also state that obesity by itself should not be a reason to delay TJA. “We could not find a rationale for a strict cut off for weight/body mass index (BMI). Our literature review revealed that though many adverse events were, in fact, increased in patients with morbid obesity, there is also an increase in adverse events for those who had bariatric surgery prior to their arthroplasty,” they added, noting that patients need to be made aware of the increased risk for adverse events in patients with obesity. Though the guidelines do not pose any BMI cutoffs, they state that weight loss should be “strongly encouraged.” These new recommendations are conditional, and all had a “low” to “very low” certainty of evidence; however, there was high consensus on the recommendations from the expert panel.

The guidelines also recommended:

• Delaying TJA to achieve smoking and nicotine cessation or reduction.
• Delaying TJA to improve glycemic control in patients with diabetes, although the group did not recommend any specific measure or threshold.
• Not delaying TJA in patients with a severe deformity, bone loss, or a neuropathic joint.

The new guidelines formalize what many surgeons have already been doing for the past few years, said Arjun Saxena, MD, MBA, an orthopedic surgeon in Philadelphia who was not involved with the guidelines. “A lot of total joint programs have really focused on patient optimization, including smoking cessation, glycemic control, and weight loss prior to surgery,” he said.

Most importantly, the guidelines put an emphasis on how the decision to proceed with TJA should be a shared decision between a physician and patient, he added. Some insurance companies with prior authorization policies may require a patient to try additional nonoperative therapies before approving surgery, creating barriers to care, he said. “Hopefully [these new recommendations] will help third parties understand that joint replacement is a big decision – most doctors aren’t going to recommend that unless it’s necessary or something that is going to help patients,” he said. “I understand that there is a certain need for preauthorization, but just having strict guidelines isn’t appropriate. You really need to look at the whole picture,” he added.

The full manuscript has been submitted for review and is expected to be jointly published in American College of Rheumatology and the American Association of Hip and Knee Surgeons journals later this year.

Dr. Saxena consults for the orthopedic implant company Corin.

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

The American Gastroenterological Association (AGA) has released a new clinical practice guideline defining the role of biomarkers in monitoring and managing ulcerative colitis (UC).

There is growing data on how to incorporate biomarkers in the care of patients with inflammatory bowel disease, reported lead guideline panelist Siddharth Singh, MD, of University of California San Diego, La Jolla, Calif., and colleagues.

“[I]n routine clinical practice, repeated endoscopic assessment is invasive, expensive, and may be impractical,” the panelists wrote. Their report is in Gastroenterology. “There is an important need for understanding how noninvasive biomarkers may serve as accurate and reliable surrogates for endoscopic assessment of inflammation and whether they can be more readily implemented in a UC care pathway.”

After reviewing relevant randomized controlled trials and observational studies, Dr. Singh and colleagues issued seven conditional recommendations, three of which concern patients in symptomatic remission, and four of which apply to patients with symptomatically active UC.

“The key take-home message is that the routine measurement of noninvasive biomarkers in addition to assessment of patient reported symptoms is critical in evaluating the disease burden of UC,” said Jordan E. Axelrad, MD, MPH, director of clinical and translational research at NYU Langone Health’s Inflammatory Bowel Disease Center, New York. “Many of these recommendations regarding the assessment of disease activity beyond symptoms alone are widely accepted, particularity at tertiary IBD centers; however, this guideline serves to formalize and structure the recommendations, with appropriate test cutoff values, in a simple UC care pathway.”
 

Recommendations for patients in symptomatic remission

For patients in remission, the guideline advises monitoring both symptoms and biomarkers, with biomarkers measured every 6-12 months.

Asymptomatic patients with normal biomarkers can skip routine endoscopy to evaluate disease activity, according to the guideline, but those with abnormal fecal calprotectin, fecal lactoferrin, or serum C-reactive protein (CRP) are candidates for endoscopic assessment instead of empiric treatment adjustment. Patients may still need periodic colonoscopy for dysplasia surveillance.

Recommendations for patients with symptomatically active disease

The recommendations for patients with symptomatically active UC follow a similar pathway. The guideline advises an evaluation strategy combining symptoms and biomarkers instead of symptoms alone.

For example, patients with moderate to severe symptoms suggestive of flare and elevated biomarkers are candidates for treatment adjustment without endoscopy.

Still, patient preferences should be considered, Dr. Singh and colleagues noted.

“Patients who place greater value in confirming inflammation, particularly when making significant treatment decisions (such as starting or switching immunosuppressive therapies), and lesser value on the inconvenience of endoscopy, may choose to pursue endoscopic evaluation before treatment adjustment,” they wrote.

For patients with mild symptoms, endoscopy is generally recommended, according to the guideline, unless the patient recently had moderate to severe symptoms and has improved after treatment adjustment; in that case, biomarkers can be used to fine-tune therapy without the need for endoscopy.

Again, providers should engage in shared-decision making, the guideline advises. Patients with mild symptoms but no biomarker results may reasonably elect to undergo endoscopy prior to testing biomarkers, while patients with mild symptoms and normal biomarkers may reasonably elect to retest biomarkers in 3-6 months.
 

Data remain insufficient to recommend biomarkers over endoscopy

Dr. Singh and colleagues concluded the guideline by highlighting an insufficient level of direct evidence necessary to recommend a biomarker-based treat-to-target strategy over endoscopy-based monitoring strategy, despite indirect evidence suggesting this may be the case.

“[T]here have not been any studies comparing a biomarker-based strategy with an endoscopy-based strategy for assessment and monitoring of endoscopic remission,” they wrote. “This was identified as a knowledge gap by the panel.”

The authors disclosed relationships with Pfizer, AbbVie, Lilly, and others. Dr. Axelrad disclosed relationships with Janssen, AbbVie, Pfizer, and others.

The American Gastroenterological Association (AGA) has released a new clinical practice guideline defining the role of biomarkers in monitoring and managing ulcerative colitis (UC).

There is growing data on how to incorporate biomarkers in the care of patients with inflammatory bowel disease, reported lead guideline panelist Siddharth Singh, MD, of University of California San Diego, La Jolla, Calif., and colleagues.

“[I]n routine clinical practice, repeated endoscopic assessment is invasive, expensive, and may be impractical,” the panelists wrote. Their report is in Gastroenterology. “There is an important need for understanding how noninvasive biomarkers may serve as accurate and reliable surrogates for endoscopic assessment of inflammation and whether they can be more readily implemented in a UC care pathway.”

After reviewing relevant randomized controlled trials and observational studies, Dr. Singh and colleagues issued seven conditional recommendations, three of which concern patients in symptomatic remission, and four of which apply to patients with symptomatically active UC.

“The key take-home message is that the routine measurement of noninvasive biomarkers in addition to assessment of patient reported symptoms is critical in evaluating the disease burden of UC,” said Jordan E. Axelrad, MD, MPH, director of clinical and translational research at NYU Langone Health’s Inflammatory Bowel Disease Center, New York. “Many of these recommendations regarding the assessment of disease activity beyond symptoms alone are widely accepted, particularity at tertiary IBD centers; however, this guideline serves to formalize and structure the recommendations, with appropriate test cutoff values, in a simple UC care pathway.”
 

Recommendations for patients in symptomatic remission

For patients in remission, the guideline advises monitoring both symptoms and biomarkers, with biomarkers measured every 6-12 months.

Asymptomatic patients with normal biomarkers can skip routine endoscopy to evaluate disease activity, according to the guideline, but those with abnormal fecal calprotectin, fecal lactoferrin, or serum C-reactive protein (CRP) are candidates for endoscopic assessment instead of empiric treatment adjustment. Patients may still need periodic colonoscopy for dysplasia surveillance.

Recommendations for patients with symptomatically active disease

The recommendations for patients with symptomatically active UC follow a similar pathway. The guideline advises an evaluation strategy combining symptoms and biomarkers instead of symptoms alone.

For example, patients with moderate to severe symptoms suggestive of flare and elevated biomarkers are candidates for treatment adjustment without endoscopy.

Still, patient preferences should be considered, Dr. Singh and colleagues noted.

“Patients who place greater value in confirming inflammation, particularly when making significant treatment decisions (such as starting or switching immunosuppressive therapies), and lesser value on the inconvenience of endoscopy, may choose to pursue endoscopic evaluation before treatment adjustment,” they wrote.

For patients with mild symptoms, endoscopy is generally recommended, according to the guideline, unless the patient recently had moderate to severe symptoms and has improved after treatment adjustment; in that case, biomarkers can be used to fine-tune therapy without the need for endoscopy.

Again, providers should engage in shared-decision making, the guideline advises. Patients with mild symptoms but no biomarker results may reasonably elect to undergo endoscopy prior to testing biomarkers, while patients with mild symptoms and normal biomarkers may reasonably elect to retest biomarkers in 3-6 months.
 

Data remain insufficient to recommend biomarkers over endoscopy

Dr. Singh and colleagues concluded the guideline by highlighting an insufficient level of direct evidence necessary to recommend a biomarker-based treat-to-target strategy over endoscopy-based monitoring strategy, despite indirect evidence suggesting this may be the case.

“[T]here have not been any studies comparing a biomarker-based strategy with an endoscopy-based strategy for assessment and monitoring of endoscopic remission,” they wrote. “This was identified as a knowledge gap by the panel.”

The authors disclosed relationships with Pfizer, AbbVie, Lilly, and others. Dr. Axelrad disclosed relationships with Janssen, AbbVie, Pfizer, and others.

The American Gastroenterological Association (AGA) has released a new clinical practice guideline defining the role of biomarkers in monitoring and managing ulcerative colitis (UC).

There is growing data on how to incorporate biomarkers in the care of patients with inflammatory bowel disease, reported lead guideline panelist Siddharth Singh, MD, of University of California San Diego, La Jolla, Calif., and colleagues.

“[I]n routine clinical practice, repeated endoscopic assessment is invasive, expensive, and may be impractical,” the panelists wrote. Their report is in Gastroenterology. “There is an important need for understanding how noninvasive biomarkers may serve as accurate and reliable surrogates for endoscopic assessment of inflammation and whether they can be more readily implemented in a UC care pathway.”

After reviewing relevant randomized controlled trials and observational studies, Dr. Singh and colleagues issued seven conditional recommendations, three of which concern patients in symptomatic remission, and four of which apply to patients with symptomatically active UC.

“The key take-home message is that the routine measurement of noninvasive biomarkers in addition to assessment of patient reported symptoms is critical in evaluating the disease burden of UC,” said Jordan E. Axelrad, MD, MPH, director of clinical and translational research at NYU Langone Health’s Inflammatory Bowel Disease Center, New York. “Many of these recommendations regarding the assessment of disease activity beyond symptoms alone are widely accepted, particularity at tertiary IBD centers; however, this guideline serves to formalize and structure the recommendations, with appropriate test cutoff values, in a simple UC care pathway.”
 

Recommendations for patients in symptomatic remission

For patients in remission, the guideline advises monitoring both symptoms and biomarkers, with biomarkers measured every 6-12 months.

Asymptomatic patients with normal biomarkers can skip routine endoscopy to evaluate disease activity, according to the guideline, but those with abnormal fecal calprotectin, fecal lactoferrin, or serum C-reactive protein (CRP) are candidates for endoscopic assessment instead of empiric treatment adjustment. Patients may still need periodic colonoscopy for dysplasia surveillance.

Recommendations for patients with symptomatically active disease

The recommendations for patients with symptomatically active UC follow a similar pathway. The guideline advises an evaluation strategy combining symptoms and biomarkers instead of symptoms alone.

For example, patients with moderate to severe symptoms suggestive of flare and elevated biomarkers are candidates for treatment adjustment without endoscopy.

Still, patient preferences should be considered, Dr. Singh and colleagues noted.

“Patients who place greater value in confirming inflammation, particularly when making significant treatment decisions (such as starting or switching immunosuppressive therapies), and lesser value on the inconvenience of endoscopy, may choose to pursue endoscopic evaluation before treatment adjustment,” they wrote.

For patients with mild symptoms, endoscopy is generally recommended, according to the guideline, unless the patient recently had moderate to severe symptoms and has improved after treatment adjustment; in that case, biomarkers can be used to fine-tune therapy without the need for endoscopy.

Again, providers should engage in shared-decision making, the guideline advises. Patients with mild symptoms but no biomarker results may reasonably elect to undergo endoscopy prior to testing biomarkers, while patients with mild symptoms and normal biomarkers may reasonably elect to retest biomarkers in 3-6 months.
 

Data remain insufficient to recommend biomarkers over endoscopy

Dr. Singh and colleagues concluded the guideline by highlighting an insufficient level of direct evidence necessary to recommend a biomarker-based treat-to-target strategy over endoscopy-based monitoring strategy, despite indirect evidence suggesting this may be the case.

“[T]here have not been any studies comparing a biomarker-based strategy with an endoscopy-based strategy for assessment and monitoring of endoscopic remission,” they wrote. “This was identified as a knowledge gap by the panel.”

The authors disclosed relationships with Pfizer, AbbVie, Lilly, and others. Dr. Axelrad disclosed relationships with Janssen, AbbVie, Pfizer, and others.

The latest guideline for perioperative management of antirheumatic medication in patients undergoing total hip (THA) and total knee arthroplasty (TKA) offers recommendations based on the latest evidence, but many of those recommendations are based on a low level of evidence, according to a speaker at the 2023 Rheumatology Winter Clinical Symposium.

Martin Bergman, MD, clinical professor of medicine at Drexel University, Philadelphia, said the development of the American College of Rheumatology/American Association of Hip and Knee Surgeons guideline was necessary because there was a lack of consensus on when to stop treatments prior to patients with rheumatologic disease undergoing THA and TKA, and when it was appropriate to restart those treatments.

“We all were having the same problem, and I think everybody recognized that just stopping medicines forever didn’t make sense, but maybe continuing medicines also didn’t make sense,” Dr. Bergman said.

While the 2017 ACR/AAHKS perioperative management guideline contained good recommendations, the “explosion” of new medications in rheumatology made it necessary to update the guideline with the latest data on new medications such as immunosuppressants.
 

2022 guideline recommendations

In the 2022 guideline, which covers disease-modifying treatments taken by patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis, the authors reaffirmed their recommendations to continue methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, and apremilast through total joint arthroplasty.

Where the 2022 guideline differs from the 2017 guideline is in which biologics are covered and under what circumstances they should be withheld and restarted around surgery. The 2022 guideline includes recommendations for abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, rituximab, secukinumab, tocilizumab, and ustekinumab. Each biologic has its own recommended stop and restart times based around the dosing interval and respective method of administration. Dr. Bergman said a general rule with biologics under the new guideline is that the timing of surgery should occur approximately 1 week after the first missed dose of the medication. The only biologic that does not follow this pattern is rituximab, where surgery should be planned for 1 month after the last missed dose.

Dr. Bergman noted that how the guidelines handle interval dosing with infliximab may present a problem. The guideline provides recommendations for patients receiving infliximab every 4 weeks, every 6 weeks, and every 8 weeks. However, Dr. Bergman said this can create a scenario where a patient receiving infliximab at a dose of 3 mg/kg every 8 weeks has surgery at 9 weeks, a patient receiving 5 mg/kg every 6 weeks has surgery at 7 weeks, and a patient receiving 10 mg/kg every 4 weeks has surgery at 5 weeks. “There is some intellectual problem with it,” he said.

Another change from the 2017 guideline is how long to wait for surgery after stopping Janus kinase inhibitors. While the 2017 guideline recommended withholding JAK inhibitors 7 days before surgery, the 2022 guideline lowered that waiting period to 3 days, Dr. Bergman explained.

Concerning use of steroids around THA and TKA surgery, “the days of stress steroid dosing are done,” Dr. Bergman said. “You don’t have to stress dose them. You just follow them, and you keep them on their steroid dose.”

The new guideline recommends restarting therapy once the wound is healed and there is no physical evidence of infection at approximately 2 weeks. “There’s no data to support this,” he said, and his concern is that patients who have stopped a tumor necrosis factor inhibitor may flare if they don’t restart their medication.

While the guideline also covered recommendations for systemic lupus erythematosus, they are “very similar” to the recommendations for inflammatory arthritis, Dr. Bergman noted. “If you have somebody who is not very sick, you stop the medications,” he said, “but try to stop anything else about a week before the surgery. If they’re sick, you basically have to keep them on their medications.”
 

Caveats in guideline

The recommendations in the 2022 guideline come with a number of caveats, Dr. Bergman noted. For instance, the authors acknowledged limitations in the guideline regarding providing recommendations for only THA and TKA, the “paucity of evidence” around direct infection risk resulting from medications in the perioperative period for THA and TKA, the nonseparation of biologics when assessing infection risk, and the use of dosing interval as a metric for stopping the drug without considering the drug’s half-life.

A “crucial caveat,” Dr. Bergman said, was that the guideline focused on infection risk based on a statement from a panel of patients prior to the development of the 2017 guideline, which “stated very clearly any risk of infection, while rare, was more significant to them than the possibility of postoperative flares, despite flares being reported in over 60% of patients after surgery.

“For the patients, the paramount question was infection, infection, infection, infection. That’s all they cared about, and that is the basis behind a lot of the decision-making here,” Dr. Bergman said.

Another caveat came from a communication Dr. Bergman received from one of the panel members. The panel member noted there were no conclusions or recommendations provided in the guideline for how to manage perioperative flares, such as restarting a corticosteroid or biologic agent. “There was a lot of discussion about what to do with steroids if patients flare, or what to do with [other] medications if they flare, and they just couldn’t come to a consensus,” Dr. Bergman said. “It’s just not discussed.”

Dr. Bergman said he is “somewhat critical” of the ACR/AAHKS guideline, but noted it is an “ambitious project” given the lack of evidence for the recommendations. “The alternative was stop the medications forever and having people really flare, or at least try to get some semblance of rationality behind what we’re going to do,” he said.
 

Response from attendees

Jack Cush, MD, a rheumatologist based in Dallas and executive editor of RheumNow.com, took issue with the new recommendations surrounding stopping infliximab. When giving a patient infliximab every 8 weeks at 3 mg/kg, “you’re giving [it] at the nadir of the drug,” he said.

Rather than drug half-life, “it’s about inflammation,” he emphasized. “Inflammation is dominant in causing infection. It drives risk more than anything. The worst thing you can do is wash someone out.

“If you’re going beyond 8 weeks on infliximab, you’re getting closer to washing them out,” he pointed out. “I think it’s a really bad idea.”

Allan Gibofsky, MD, JD, professor of medicine at Weill Cornell Medicine and codirector of the Clinic for Inflammatory Arthritis and Biologic Therapy at Hospital for Special Surgery, both in New York, explained that the guideline is not standard of care, which would be subject to malpractice if not implemented properly.

“When you have guidelines, you follow them unless there are clinical situations which would necessitate another approach to the patient,” he said. “Professional institutions and associations will never put forth rules, they will put forth guidelines so you have the opportunity to deviate from them when the appropriate clinical situation dictates.”

Dr. Bergman reported being a speaker and consultant for AbbVie, Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, and Regeneron; he holds stock in Johnson & Johnson and Merck.

The latest guideline for perioperative management of antirheumatic medication in patients undergoing total hip (THA) and total knee arthroplasty (TKA) offers recommendations based on the latest evidence, but many of those recommendations are based on a low level of evidence, according to a speaker at the 2023 Rheumatology Winter Clinical Symposium.

Martin Bergman, MD, clinical professor of medicine at Drexel University, Philadelphia, said the development of the American College of Rheumatology/American Association of Hip and Knee Surgeons guideline was necessary because there was a lack of consensus on when to stop treatments prior to patients with rheumatologic disease undergoing THA and TKA, and when it was appropriate to restart those treatments.

“We all were having the same problem, and I think everybody recognized that just stopping medicines forever didn’t make sense, but maybe continuing medicines also didn’t make sense,” Dr. Bergman said.

While the 2017 ACR/AAHKS perioperative management guideline contained good recommendations, the “explosion” of new medications in rheumatology made it necessary to update the guideline with the latest data on new medications such as immunosuppressants.
 

2022 guideline recommendations

In the 2022 guideline, which covers disease-modifying treatments taken by patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis, the authors reaffirmed their recommendations to continue methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, and apremilast through total joint arthroplasty.

Where the 2022 guideline differs from the 2017 guideline is in which biologics are covered and under what circumstances they should be withheld and restarted around surgery. The 2022 guideline includes recommendations for abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, rituximab, secukinumab, tocilizumab, and ustekinumab. Each biologic has its own recommended stop and restart times based around the dosing interval and respective method of administration. Dr. Bergman said a general rule with biologics under the new guideline is that the timing of surgery should occur approximately 1 week after the first missed dose of the medication. The only biologic that does not follow this pattern is rituximab, where surgery should be planned for 1 month after the last missed dose.

Dr. Bergman noted that how the guidelines handle interval dosing with infliximab may present a problem. The guideline provides recommendations for patients receiving infliximab every 4 weeks, every 6 weeks, and every 8 weeks. However, Dr. Bergman said this can create a scenario where a patient receiving infliximab at a dose of 3 mg/kg every 8 weeks has surgery at 9 weeks, a patient receiving 5 mg/kg every 6 weeks has surgery at 7 weeks, and a patient receiving 10 mg/kg every 4 weeks has surgery at 5 weeks. “There is some intellectual problem with it,” he said.

Another change from the 2017 guideline is how long to wait for surgery after stopping Janus kinase inhibitors. While the 2017 guideline recommended withholding JAK inhibitors 7 days before surgery, the 2022 guideline lowered that waiting period to 3 days, Dr. Bergman explained.

Concerning use of steroids around THA and TKA surgery, “the days of stress steroid dosing are done,” Dr. Bergman said. “You don’t have to stress dose them. You just follow them, and you keep them on their steroid dose.”

The new guideline recommends restarting therapy once the wound is healed and there is no physical evidence of infection at approximately 2 weeks. “There’s no data to support this,” he said, and his concern is that patients who have stopped a tumor necrosis factor inhibitor may flare if they don’t restart their medication.

While the guideline also covered recommendations for systemic lupus erythematosus, they are “very similar” to the recommendations for inflammatory arthritis, Dr. Bergman noted. “If you have somebody who is not very sick, you stop the medications,” he said, “but try to stop anything else about a week before the surgery. If they’re sick, you basically have to keep them on their medications.”
 

Caveats in guideline

The recommendations in the 2022 guideline come with a number of caveats, Dr. Bergman noted. For instance, the authors acknowledged limitations in the guideline regarding providing recommendations for only THA and TKA, the “paucity of evidence” around direct infection risk resulting from medications in the perioperative period for THA and TKA, the nonseparation of biologics when assessing infection risk, and the use of dosing interval as a metric for stopping the drug without considering the drug’s half-life.

A “crucial caveat,” Dr. Bergman said, was that the guideline focused on infection risk based on a statement from a panel of patients prior to the development of the 2017 guideline, which “stated very clearly any risk of infection, while rare, was more significant to them than the possibility of postoperative flares, despite flares being reported in over 60% of patients after surgery.

“For the patients, the paramount question was infection, infection, infection, infection. That’s all they cared about, and that is the basis behind a lot of the decision-making here,” Dr. Bergman said.

Another caveat came from a communication Dr. Bergman received from one of the panel members. The panel member noted there were no conclusions or recommendations provided in the guideline for how to manage perioperative flares, such as restarting a corticosteroid or biologic agent. “There was a lot of discussion about what to do with steroids if patients flare, or what to do with [other] medications if they flare, and they just couldn’t come to a consensus,” Dr. Bergman said. “It’s just not discussed.”

Dr. Bergman said he is “somewhat critical” of the ACR/AAHKS guideline, but noted it is an “ambitious project” given the lack of evidence for the recommendations. “The alternative was stop the medications forever and having people really flare, or at least try to get some semblance of rationality behind what we’re going to do,” he said.
 

Response from attendees

Jack Cush, MD, a rheumatologist based in Dallas and executive editor of RheumNow.com, took issue with the new recommendations surrounding stopping infliximab. When giving a patient infliximab every 8 weeks at 3 mg/kg, “you’re giving [it] at the nadir of the drug,” he said.

Rather than drug half-life, “it’s about inflammation,” he emphasized. “Inflammation is dominant in causing infection. It drives risk more than anything. The worst thing you can do is wash someone out.

“If you’re going beyond 8 weeks on infliximab, you’re getting closer to washing them out,” he pointed out. “I think it’s a really bad idea.”

Allan Gibofsky, MD, JD, professor of medicine at Weill Cornell Medicine and codirector of the Clinic for Inflammatory Arthritis and Biologic Therapy at Hospital for Special Surgery, both in New York, explained that the guideline is not standard of care, which would be subject to malpractice if not implemented properly.

“When you have guidelines, you follow them unless there are clinical situations which would necessitate another approach to the patient,” he said. “Professional institutions and associations will never put forth rules, they will put forth guidelines so you have the opportunity to deviate from them when the appropriate clinical situation dictates.”

Dr. Bergman reported being a speaker and consultant for AbbVie, Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, and Regeneron; he holds stock in Johnson & Johnson and Merck.

The latest guideline for perioperative management of antirheumatic medication in patients undergoing total hip (THA) and total knee arthroplasty (TKA) offers recommendations based on the latest evidence, but many of those recommendations are based on a low level of evidence, according to a speaker at the 2023 Rheumatology Winter Clinical Symposium.

Martin Bergman, MD, clinical professor of medicine at Drexel University, Philadelphia, said the development of the American College of Rheumatology/American Association of Hip and Knee Surgeons guideline was necessary because there was a lack of consensus on when to stop treatments prior to patients with rheumatologic disease undergoing THA and TKA, and when it was appropriate to restart those treatments.

“We all were having the same problem, and I think everybody recognized that just stopping medicines forever didn’t make sense, but maybe continuing medicines also didn’t make sense,” Dr. Bergman said.

While the 2017 ACR/AAHKS perioperative management guideline contained good recommendations, the “explosion” of new medications in rheumatology made it necessary to update the guideline with the latest data on new medications such as immunosuppressants.
 

2022 guideline recommendations

In the 2022 guideline, which covers disease-modifying treatments taken by patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis, the authors reaffirmed their recommendations to continue methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, and apremilast through total joint arthroplasty.

Where the 2022 guideline differs from the 2017 guideline is in which biologics are covered and under what circumstances they should be withheld and restarted around surgery. The 2022 guideline includes recommendations for abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, rituximab, secukinumab, tocilizumab, and ustekinumab. Each biologic has its own recommended stop and restart times based around the dosing interval and respective method of administration. Dr. Bergman said a general rule with biologics under the new guideline is that the timing of surgery should occur approximately 1 week after the first missed dose of the medication. The only biologic that does not follow this pattern is rituximab, where surgery should be planned for 1 month after the last missed dose.

Dr. Bergman noted that how the guidelines handle interval dosing with infliximab may present a problem. The guideline provides recommendations for patients receiving infliximab every 4 weeks, every 6 weeks, and every 8 weeks. However, Dr. Bergman said this can create a scenario where a patient receiving infliximab at a dose of 3 mg/kg every 8 weeks has surgery at 9 weeks, a patient receiving 5 mg/kg every 6 weeks has surgery at 7 weeks, and a patient receiving 10 mg/kg every 4 weeks has surgery at 5 weeks. “There is some intellectual problem with it,” he said.

Another change from the 2017 guideline is how long to wait for surgery after stopping Janus kinase inhibitors. While the 2017 guideline recommended withholding JAK inhibitors 7 days before surgery, the 2022 guideline lowered that waiting period to 3 days, Dr. Bergman explained.

Concerning use of steroids around THA and TKA surgery, “the days of stress steroid dosing are done,” Dr. Bergman said. “You don’t have to stress dose them. You just follow them, and you keep them on their steroid dose.”

The new guideline recommends restarting therapy once the wound is healed and there is no physical evidence of infection at approximately 2 weeks. “There’s no data to support this,” he said, and his concern is that patients who have stopped a tumor necrosis factor inhibitor may flare if they don’t restart their medication.

While the guideline also covered recommendations for systemic lupus erythematosus, they are “very similar” to the recommendations for inflammatory arthritis, Dr. Bergman noted. “If you have somebody who is not very sick, you stop the medications,” he said, “but try to stop anything else about a week before the surgery. If they’re sick, you basically have to keep them on their medications.”
 

Caveats in guideline

The recommendations in the 2022 guideline come with a number of caveats, Dr. Bergman noted. For instance, the authors acknowledged limitations in the guideline regarding providing recommendations for only THA and TKA, the “paucity of evidence” around direct infection risk resulting from medications in the perioperative period for THA and TKA, the nonseparation of biologics when assessing infection risk, and the use of dosing interval as a metric for stopping the drug without considering the drug’s half-life.

A “crucial caveat,” Dr. Bergman said, was that the guideline focused on infection risk based on a statement from a panel of patients prior to the development of the 2017 guideline, which “stated very clearly any risk of infection, while rare, was more significant to them than the possibility of postoperative flares, despite flares being reported in over 60% of patients after surgery.

“For the patients, the paramount question was infection, infection, infection, infection. That’s all they cared about, and that is the basis behind a lot of the decision-making here,” Dr. Bergman said.

Another caveat came from a communication Dr. Bergman received from one of the panel members. The panel member noted there were no conclusions or recommendations provided in the guideline for how to manage perioperative flares, such as restarting a corticosteroid or biologic agent. “There was a lot of discussion about what to do with steroids if patients flare, or what to do with [other] medications if they flare, and they just couldn’t come to a consensus,” Dr. Bergman said. “It’s just not discussed.”

Dr. Bergman said he is “somewhat critical” of the ACR/AAHKS guideline, but noted it is an “ambitious project” given the lack of evidence for the recommendations. “The alternative was stop the medications forever and having people really flare, or at least try to get some semblance of rationality behind what we’re going to do,” he said.
 

Response from attendees

Jack Cush, MD, a rheumatologist based in Dallas and executive editor of RheumNow.com, took issue with the new recommendations surrounding stopping infliximab. When giving a patient infliximab every 8 weeks at 3 mg/kg, “you’re giving [it] at the nadir of the drug,” he said.

Rather than drug half-life, “it’s about inflammation,” he emphasized. “Inflammation is dominant in causing infection. It drives risk more than anything. The worst thing you can do is wash someone out.

“If you’re going beyond 8 weeks on infliximab, you’re getting closer to washing them out,” he pointed out. “I think it’s a really bad idea.”

Allan Gibofsky, MD, JD, professor of medicine at Weill Cornell Medicine and codirector of the Clinic for Inflammatory Arthritis and Biologic Therapy at Hospital for Special Surgery, both in New York, explained that the guideline is not standard of care, which would be subject to malpractice if not implemented properly.

“When you have guidelines, you follow them unless there are clinical situations which would necessitate another approach to the patient,” he said. “Professional institutions and associations will never put forth rules, they will put forth guidelines so you have the opportunity to deviate from them when the appropriate clinical situation dictates.”

Dr. Bergman reported being a speaker and consultant for AbbVie, Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, and Regeneron; he holds stock in Johnson & Johnson and Merck.

The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.

It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.

enot-poloskun/Getty Images

Minimum of 250 procedures

To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:

• A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
• A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
• An option for additional post-fellowship training based on the trainee’s career goals.

The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.

Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.

To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.

Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.

In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.

Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.

Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.

The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.

The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

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

The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.

It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.

enot-poloskun/Getty Images

Minimum of 250 procedures

To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:

• A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
• A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
• An option for additional post-fellowship training based on the trainee’s career goals.

The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.

Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.

To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.

Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.

In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.

Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.

Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.

The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.

The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

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

The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.

It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.

enot-poloskun/Getty Images

Minimum of 250 procedures

To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:

• A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
• A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
• An option for additional post-fellowship training based on the trainee’s career goals.

The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.

Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.

To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.

Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.

In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.

Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.

Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.

The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.

The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

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

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.