High failure rate for magnetic rod system in scoliosis surgery

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February 14, 2020 – A surgical magnetic rod system used to treat scoliosis in children has a high failure rate, necessitating multiple surgeries and causing significant morbidity in these young patients, new research suggests.

The Magnetic Expansion Control (MAGEC) rod system (NuVasive), which was developed to replace traditional rods because of their high failure rate, has itself turned out to have a less than stellar success rate.

Researchers found that the most common complications associated with the MAGEC rod system are failure of the distraction mechanism used to stretch soft tissues to make space for bone growth, as well as rod fracture.

“This rod system fails very often compared to any standard spinal implant,” study investigator Aakash Agarwal, PhD, director of research at Spinal Balance Inc and adjunct professor of bioengineering at the University of Toledo, in Ohio, told Medscape Medical News.

The relatively high frequency of such adverse events is of “great concern,” said Agarwal, who recommended that neurosurgeons use more gradual distractions to minimize stress on spinal rods.

The study was published online October 19 in Spine Surgery and Related Research.
 

A Mainstay of Treatment

Scoliosis refers to the lateral curving of the spine, usually in the thoracic or thoracolumbar region. The degree of scoliosis is typically determined with x-rays.

Early-onset scoliosis (EOS) occurs in children younger than 5 years. It occurs more often in boys than girls. Although only about 1 or 2 in 10,000 children develop the condition, it can be severe, sometimes interfering with normal organ development.

Surgical intervention is required when bracing and casting fail to stop progression of the scoliotic curve. The aim of the surgery is to allow growth of the spine and ribcage and to correct and limit the extent of spinal deformity, said Agarwal.

Only children with adequate potential for spine and ribcage growth are candidates for the surgery. The age of eligible patients can vary but is typically up to about age 10 for girls and age 12 or 13 for boys, said Agarwal.

Although other surgical techniques are sometimes used, the distraction-based mechanism has been the mainstay of surgical intervention in EOS for more than a decade, he noted.

“The concept uses distraction, or stretching of the spine, to create additional soft-tissue space between the vertebrae for the bone to gradually grow into,” he said.

This has traditionally been achieved by putting two rods – proximally and distally – in each side of the spine. The attachment points of the rods must be repeatedly loosened and pushed apart.

Traditional growth rods are subject to risk of fracture and autofusion, which is stiffening of soft tissues in vertebral segments caused by trauma to the spine with excessive distraction.

Trauma Nightmare

The major problem with traditional growth rods is the need for invasive surgery every 6 to 12 months, said Agarwal.

“The trauma of repeated surgery is a nightmare for both the patients and the surgeons, from increased complications with each subsequent surgery to infections and unplanned surgeries,” he said.

This limitation led to the development of the titanium-based MAGEC rods. This noninvasive magnetic distraction system allows the rod to be expanded from outside the body using a remote control.

This approach results in a “drastic reduction” in the number of consecutive surgeries and has the potential to reduce growth rod fracture and autofusion, said Agarwal.

The system also allows for more gradual distractions of the growth rods.

“With the MAGEC system, you can stretch the spine a little bit every week without invasive surgery,” said Agarwal.

His own research showed that smaller and more frequent distractions result in much less stress in the rods. He suggests, for example, a distraction of 1.5-2.0 mm every month, rather than 4.5-6.0 mm every 3 months.

In the United States, the MAGEC system is used for all children undergoing distraction-based corrections. But in developing countries, at least 70% of patients still undergo surgery using traditional growth rods, owing to the very high initial cost associated with MAGEC rods, said Agarwal.

He believes traditional rods should not be used at all. In regions where MAGEC rods are unaffordable or inaccessible, surgeons should use alternative surgical techniques, he said.

“Given the variety of surgeon options, use of traditional growth rods isn’t justified,” he said.

For this new study, Agarwal and his colleagues searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify relevant adverse events. Operated through the U.S. Food and Drug Administration, MAUDE is a voluntary reporting system for adverse events involving medical devices.

Of the 163 reports related to the MAGEC system through June of last year, 129 were for failures of the distraction mechanism, 24 were for rod fracture, and 10 were for other medical complications, such as infection and tissue necrosis.

 

 

Bare Minimum

These reports are “just the bare minimum,” said Agarwal. “For example, tissue necrosis – or metallosis due to wear – is present in almost all cases with MAGEC,” but these cases aren’t reported because of “absence of clinical symptoms.”

Agarwal called these MAGEC-related complications “very worrisome.”

“Every single failure of rod fracture or noninvasive distraction mechanism failure in MAGEC leads to another open surgery. And with each surgery, the risk of other complications, such as infection, goes up very significantly,” he said.

He added that the failure of the distraction of the growth rods reduces the overall efficacy of the device.

“Newer studies even question if there is a real quality-of-life difference with use of MAGEC rods over the myriad of other options,” he said.

He stressed the need for better technical and clinical controls to avoid such adverse events – for example, more frequent use of minimum distraction.

The researchers also retrieved MAUDE data on the top five failures associated with standard instrumentation used in spinal fusion. These included pedicle screw breakage post surgery (336 reports), set screw damage during surgery (257), rod breakage post surgery (175), interbody cage breakage during surgery (118), and pedicle screw breakage during surgery (75).

The rates of adverse events involving the MAGEC rods, which are used in relatively rare surgical procedures, “seem high” in comparison, said Agarwal.

Commenting for Medscape Medical News, Lee Tan, MD, assistant professor of neurologic surgery, University of California, San Francisco, praised the authors for conducting an “interesting” study on the complications and mode of failure related to MAGEC rods in scoliosis correction using a large database.

“They identified distraction mechanism failure and pedicle screw breakage as the most common device-related complication and standard instrumentation-related complication, respectively,” said Tan.

“This is very useful information during patient education and preoperative counseling. It also identifies the areas for improvement and innovation on this important topic. I commend the authors for their excellent work,” he said.

The study received no funding. Agarwal has received royalties from and consults for Spinal Balance and is an editorial board member for Clinical Spine Surgery and Spine.

This article first appeared on Medscape.com.

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February 14, 2020 – A surgical magnetic rod system used to treat scoliosis in children has a high failure rate, necessitating multiple surgeries and causing significant morbidity in these young patients, new research suggests.

The Magnetic Expansion Control (MAGEC) rod system (NuVasive), which was developed to replace traditional rods because of their high failure rate, has itself turned out to have a less than stellar success rate.

Researchers found that the most common complications associated with the MAGEC rod system are failure of the distraction mechanism used to stretch soft tissues to make space for bone growth, as well as rod fracture.

“This rod system fails very often compared to any standard spinal implant,” study investigator Aakash Agarwal, PhD, director of research at Spinal Balance Inc and adjunct professor of bioengineering at the University of Toledo, in Ohio, told Medscape Medical News.

The relatively high frequency of such adverse events is of “great concern,” said Agarwal, who recommended that neurosurgeons use more gradual distractions to minimize stress on spinal rods.

The study was published online October 19 in Spine Surgery and Related Research.
 

A Mainstay of Treatment

Scoliosis refers to the lateral curving of the spine, usually in the thoracic or thoracolumbar region. The degree of scoliosis is typically determined with x-rays.

Early-onset scoliosis (EOS) occurs in children younger than 5 years. It occurs more often in boys than girls. Although only about 1 or 2 in 10,000 children develop the condition, it can be severe, sometimes interfering with normal organ development.

Surgical intervention is required when bracing and casting fail to stop progression of the scoliotic curve. The aim of the surgery is to allow growth of the spine and ribcage and to correct and limit the extent of spinal deformity, said Agarwal.

Only children with adequate potential for spine and ribcage growth are candidates for the surgery. The age of eligible patients can vary but is typically up to about age 10 for girls and age 12 or 13 for boys, said Agarwal.

Although other surgical techniques are sometimes used, the distraction-based mechanism has been the mainstay of surgical intervention in EOS for more than a decade, he noted.

“The concept uses distraction, or stretching of the spine, to create additional soft-tissue space between the vertebrae for the bone to gradually grow into,” he said.

This has traditionally been achieved by putting two rods – proximally and distally – in each side of the spine. The attachment points of the rods must be repeatedly loosened and pushed apart.

Traditional growth rods are subject to risk of fracture and autofusion, which is stiffening of soft tissues in vertebral segments caused by trauma to the spine with excessive distraction.

Trauma Nightmare

The major problem with traditional growth rods is the need for invasive surgery every 6 to 12 months, said Agarwal.

“The trauma of repeated surgery is a nightmare for both the patients and the surgeons, from increased complications with each subsequent surgery to infections and unplanned surgeries,” he said.

This limitation led to the development of the titanium-based MAGEC rods. This noninvasive magnetic distraction system allows the rod to be expanded from outside the body using a remote control.

This approach results in a “drastic reduction” in the number of consecutive surgeries and has the potential to reduce growth rod fracture and autofusion, said Agarwal.

The system also allows for more gradual distractions of the growth rods.

“With the MAGEC system, you can stretch the spine a little bit every week without invasive surgery,” said Agarwal.

His own research showed that smaller and more frequent distractions result in much less stress in the rods. He suggests, for example, a distraction of 1.5-2.0 mm every month, rather than 4.5-6.0 mm every 3 months.

In the United States, the MAGEC system is used for all children undergoing distraction-based corrections. But in developing countries, at least 70% of patients still undergo surgery using traditional growth rods, owing to the very high initial cost associated with MAGEC rods, said Agarwal.

He believes traditional rods should not be used at all. In regions where MAGEC rods are unaffordable or inaccessible, surgeons should use alternative surgical techniques, he said.

“Given the variety of surgeon options, use of traditional growth rods isn’t justified,” he said.

For this new study, Agarwal and his colleagues searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify relevant adverse events. Operated through the U.S. Food and Drug Administration, MAUDE is a voluntary reporting system for adverse events involving medical devices.

Of the 163 reports related to the MAGEC system through June of last year, 129 were for failures of the distraction mechanism, 24 were for rod fracture, and 10 were for other medical complications, such as infection and tissue necrosis.

 

 

Bare Minimum

These reports are “just the bare minimum,” said Agarwal. “For example, tissue necrosis – or metallosis due to wear – is present in almost all cases with MAGEC,” but these cases aren’t reported because of “absence of clinical symptoms.”

Agarwal called these MAGEC-related complications “very worrisome.”

“Every single failure of rod fracture or noninvasive distraction mechanism failure in MAGEC leads to another open surgery. And with each surgery, the risk of other complications, such as infection, goes up very significantly,” he said.

He added that the failure of the distraction of the growth rods reduces the overall efficacy of the device.

“Newer studies even question if there is a real quality-of-life difference with use of MAGEC rods over the myriad of other options,” he said.

He stressed the need for better technical and clinical controls to avoid such adverse events – for example, more frequent use of minimum distraction.

The researchers also retrieved MAUDE data on the top five failures associated with standard instrumentation used in spinal fusion. These included pedicle screw breakage post surgery (336 reports), set screw damage during surgery (257), rod breakage post surgery (175), interbody cage breakage during surgery (118), and pedicle screw breakage during surgery (75).

The rates of adverse events involving the MAGEC rods, which are used in relatively rare surgical procedures, “seem high” in comparison, said Agarwal.

Commenting for Medscape Medical News, Lee Tan, MD, assistant professor of neurologic surgery, University of California, San Francisco, praised the authors for conducting an “interesting” study on the complications and mode of failure related to MAGEC rods in scoliosis correction using a large database.

“They identified distraction mechanism failure and pedicle screw breakage as the most common device-related complication and standard instrumentation-related complication, respectively,” said Tan.

“This is very useful information during patient education and preoperative counseling. It also identifies the areas for improvement and innovation on this important topic. I commend the authors for their excellent work,” he said.

The study received no funding. Agarwal has received royalties from and consults for Spinal Balance and is an editorial board member for Clinical Spine Surgery and Spine.

This article first appeared on Medscape.com.

February 14, 2020 – A surgical magnetic rod system used to treat scoliosis in children has a high failure rate, necessitating multiple surgeries and causing significant morbidity in these young patients, new research suggests.

The Magnetic Expansion Control (MAGEC) rod system (NuVasive), which was developed to replace traditional rods because of their high failure rate, has itself turned out to have a less than stellar success rate.

Researchers found that the most common complications associated with the MAGEC rod system are failure of the distraction mechanism used to stretch soft tissues to make space for bone growth, as well as rod fracture.

“This rod system fails very often compared to any standard spinal implant,” study investigator Aakash Agarwal, PhD, director of research at Spinal Balance Inc and adjunct professor of bioengineering at the University of Toledo, in Ohio, told Medscape Medical News.

The relatively high frequency of such adverse events is of “great concern,” said Agarwal, who recommended that neurosurgeons use more gradual distractions to minimize stress on spinal rods.

The study was published online October 19 in Spine Surgery and Related Research.
 

A Mainstay of Treatment

Scoliosis refers to the lateral curving of the spine, usually in the thoracic or thoracolumbar region. The degree of scoliosis is typically determined with x-rays.

Early-onset scoliosis (EOS) occurs in children younger than 5 years. It occurs more often in boys than girls. Although only about 1 or 2 in 10,000 children develop the condition, it can be severe, sometimes interfering with normal organ development.

Surgical intervention is required when bracing and casting fail to stop progression of the scoliotic curve. The aim of the surgery is to allow growth of the spine and ribcage and to correct and limit the extent of spinal deformity, said Agarwal.

Only children with adequate potential for spine and ribcage growth are candidates for the surgery. The age of eligible patients can vary but is typically up to about age 10 for girls and age 12 or 13 for boys, said Agarwal.

Although other surgical techniques are sometimes used, the distraction-based mechanism has been the mainstay of surgical intervention in EOS for more than a decade, he noted.

“The concept uses distraction, or stretching of the spine, to create additional soft-tissue space between the vertebrae for the bone to gradually grow into,” he said.

This has traditionally been achieved by putting two rods – proximally and distally – in each side of the spine. The attachment points of the rods must be repeatedly loosened and pushed apart.

Traditional growth rods are subject to risk of fracture and autofusion, which is stiffening of soft tissues in vertebral segments caused by trauma to the spine with excessive distraction.

Trauma Nightmare

The major problem with traditional growth rods is the need for invasive surgery every 6 to 12 months, said Agarwal.

“The trauma of repeated surgery is a nightmare for both the patients and the surgeons, from increased complications with each subsequent surgery to infections and unplanned surgeries,” he said.

This limitation led to the development of the titanium-based MAGEC rods. This noninvasive magnetic distraction system allows the rod to be expanded from outside the body using a remote control.

This approach results in a “drastic reduction” in the number of consecutive surgeries and has the potential to reduce growth rod fracture and autofusion, said Agarwal.

The system also allows for more gradual distractions of the growth rods.

“With the MAGEC system, you can stretch the spine a little bit every week without invasive surgery,” said Agarwal.

His own research showed that smaller and more frequent distractions result in much less stress in the rods. He suggests, for example, a distraction of 1.5-2.0 mm every month, rather than 4.5-6.0 mm every 3 months.

In the United States, the MAGEC system is used for all children undergoing distraction-based corrections. But in developing countries, at least 70% of patients still undergo surgery using traditional growth rods, owing to the very high initial cost associated with MAGEC rods, said Agarwal.

He believes traditional rods should not be used at all. In regions where MAGEC rods are unaffordable or inaccessible, surgeons should use alternative surgical techniques, he said.

“Given the variety of surgeon options, use of traditional growth rods isn’t justified,” he said.

For this new study, Agarwal and his colleagues searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify relevant adverse events. Operated through the U.S. Food and Drug Administration, MAUDE is a voluntary reporting system for adverse events involving medical devices.

Of the 163 reports related to the MAGEC system through June of last year, 129 were for failures of the distraction mechanism, 24 were for rod fracture, and 10 were for other medical complications, such as infection and tissue necrosis.

 

 

Bare Minimum

These reports are “just the bare minimum,” said Agarwal. “For example, tissue necrosis – or metallosis due to wear – is present in almost all cases with MAGEC,” but these cases aren’t reported because of “absence of clinical symptoms.”

Agarwal called these MAGEC-related complications “very worrisome.”

“Every single failure of rod fracture or noninvasive distraction mechanism failure in MAGEC leads to another open surgery. And with each surgery, the risk of other complications, such as infection, goes up very significantly,” he said.

He added that the failure of the distraction of the growth rods reduces the overall efficacy of the device.

“Newer studies even question if there is a real quality-of-life difference with use of MAGEC rods over the myriad of other options,” he said.

He stressed the need for better technical and clinical controls to avoid such adverse events – for example, more frequent use of minimum distraction.

The researchers also retrieved MAUDE data on the top five failures associated with standard instrumentation used in spinal fusion. These included pedicle screw breakage post surgery (336 reports), set screw damage during surgery (257), rod breakage post surgery (175), interbody cage breakage during surgery (118), and pedicle screw breakage during surgery (75).

The rates of adverse events involving the MAGEC rods, which are used in relatively rare surgical procedures, “seem high” in comparison, said Agarwal.

Commenting for Medscape Medical News, Lee Tan, MD, assistant professor of neurologic surgery, University of California, San Francisco, praised the authors for conducting an “interesting” study on the complications and mode of failure related to MAGEC rods in scoliosis correction using a large database.

“They identified distraction mechanism failure and pedicle screw breakage as the most common device-related complication and standard instrumentation-related complication, respectively,” said Tan.

“This is very useful information during patient education and preoperative counseling. It also identifies the areas for improvement and innovation on this important topic. I commend the authors for their excellent work,” he said.

The study received no funding. Agarwal has received royalties from and consults for Spinal Balance and is an editorial board member for Clinical Spine Surgery and Spine.

This article first appeared on Medscape.com.

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What medical conferences are being canceled by coronavirus?

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In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

  • Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
  • American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
  • American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
  • American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
  • American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
  • Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
  • American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
  • American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
  • American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

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In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

  • Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
  • American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
  • American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
  • American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
  • American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
  • Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
  • American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
  • American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
  • American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

  • Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
  • American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
  • American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
  • American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
  • American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
  • Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
  • American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
  • American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
  • American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

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rTMS for depression continues to evolve

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– Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.

Dr. Alan Schatzberg

“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”

The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.

Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.



In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.

“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”

In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.

“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”

Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.

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– Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.

Dr. Alan Schatzberg

“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”

The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.

Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.



In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.

“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”

In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.

“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”

Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.

– Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.

Dr. Alan Schatzberg

“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.

Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”

The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.

Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.



In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.

“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”

In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.

“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”

Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.

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Screen all adults for hepatitis C, says USPSTF

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Adults aged 18-79 years should be screened for hepatitis C virus infection, according to an updated grade B recommendation from the U.S. Preventive Services Task Force.

Cases of acute hepatitis C virus (HCV) infection have spiked in the last decade, in part because of increased use of injection drugs and in part because of better surveillance, Douglas K. Owens, MD, of Stanford (Calif.) University, and colleagues wrote in the recommendation statement published in JAMA.

The recommendation applies to all asymptomatic adults aged 18-79 years without known liver disease, and expands on the 2013 recommendation to screen adults born between 1945 and 1965. The grade B designation means that the task force concluded with moderate certainty that HCV screening for adults aged 18-79 years had “substantial net benefit.”

The recommendations are based on an evidence report including 8 randomized, controlled trials, 48 other treatment studies, and 33 cohort studies published through February 2019 for a total of 179,230 individuals.

The screening is a one-time procedure for most adults, according to the task force, but clinicians should periodically screen individuals at increased risk, such as those with a past or current history of injection drug use. In addition, clinicians should consider screening individuals at increased risk who are above or below the recommended age range.

Although the task force identified no direct evidence on the benefit of screening for HCV infection in asymptomatic adults, a notable finding was that the newer direct-acting antiviral (DAA) regimens are sufficiently effective to support the expanded screening recommendation, they said. However, clinicians should inform patients that screening is voluntary and conducted only with the patient’s knowledge. Clinicians should educate patients about hepatitis C and give them an opportunity to ask questions and to make a decision about screening, according to the task force.

In the evidence report, a total of 49 studies including 10,181 individuals showed DAA treatment associated with pooled sustained virologic response rates greater than 95% across all virus genotypes, and a short-term serious adverse event rate of 1.9%. In addition, sustained virologic response following an antiviral therapy was associated with a reduction in risk of all-cause mortality (pooled hazard ratio 0.40) and of hepatocellular carcinoma (pooled HR 0.29) compared with cases of no sustained virologic response.

The evidence report findings were limited by several factors, including the relatively small number of randomized trials involving current DAA treatments, limited data on baseline symptoms, limited data on adolescents, and limited evidence on potential long-term harms of DAA therapy, noted Richard Chou, MD, of Oregon Health & Science University, Portland, and colleagues. However, new pooled evidence “indicates that SVR rates with currently recommended all-oral DAA regimens are substantially higher (more than 95%) than with interferon-based therapies evaluated in the prior review (68%-78%),” they said.

Several editorials were published concurrently with the recommendation.

In an editorial published in JAMA, Camilla S. Graham, MD, of Harvard Medical School, Boston, and Stacey Trooskin, MD, of the University of Pennsylvania, Philadelphia, wrote that the new recommendation reflects changes in hepatitis C virus management.

“With the approvals of sofosbuvir and simeprevir in 2013, patients with hepatitis C, a chronic viral illness associated with the deaths of more U.S. patients than the next 60 reportable infectious diseases combined, including HIV and tuberculosis, could expect a greater than 90% rate of achieving sustained virologic response (SVR, defined as undetectable HCV levels 12 weeks or longer after treatment completion, which is consistent with virologic cure of HCV infection) following 12 weeks of treatment,” they said.

These medications are effective but expensive; however, the combination of the availability of generic medications and the ongoing opioid epidemic in the United States are important contributors to the expanded recommendations, which “are welcome,” and may help meeting WHO 2030 targets for reducing new HCV infections, they said.

Dr. Graham disclosed personal fees from UpToDate. Dr. Trooskin disclosed grants from Gilead Sciences and personal fees from Merck, AbbVie, and Gilead Sciences.

In an editorial published in JAMA Internal Medicine, Jennifer C. Price, MD, and Danielle Brandman, MD, both of the University of California, San Francisco, wrote that “the advancements in HCV diagnosis and treatment have been extraordinary,” but that the new recommendation does not go far enough. “Implementation of HCV screening and linkage to treatment requires large-scale coordinated efforts, innovation, and resources. For example, point-of-care HCV RNA testing would enable scale-up of HCV screening and confirmatory testing among individuals at greatest risk of HCV infection,” they said. “Additionally, barriers remain between diagnosis and treatment, such as access to a health care provider who can treat HCV and authorization to receive affordable DAAs,” they noted. “Although the USPSTF HCV screening recommendation is a step forward for controlling HCV infection in the U.S., it will take a coordinated and funded effort to ensure that the anticipated benefits are realized,” they concluded.

Dr. Price disclosed research funding from Gilead Sciences and Merck. Dr. Brandman disclosed research funding from Gilead Sciences, Pfizer, Conatus, Allergan, and Grifols, as well as personal fees from Alnylam.

In an editorial published in JAMA Network Open, Eli S. Rosenberg, PhD, of the University at Albany (N.Y.) School of Public Health, and Joshua A. Barocas, MD, of Boston University, emphasized the need to change the stigma surrounding HCV infection in the United States.

“Given the changing epidemiology of HCV infection, new public health priorities, advancements in treatment, and unmet diagnostic needs, it is wise to periodically reevaluate screening recommendations to ensure that they are maximally addressing these areas and patients’ individual needs,” they said. “The Affordable Care Act requires private insurers and Medicaid to cover preventive services recommended by the USPSTF with a grade of A or B with no cost sharing (i.e., no deductible or copayment),” they noted. Although the new recommendation for one-time screening will likely identify more cases, improve outcomes, and reduce deaths, the editorialists cautioned that “one-time screening should not be interpreted like catch-up vaccinations, whereby we immunize someone at any age for hepatitis B virus, for example, and they are then immunized for the remainder of their life,” and that reassessments are needed, especially for younger adults.

In addition, they emphasized the need to reduce the stigma surrounding HCV and allow for recommendations based on risk, rather than age. “We have forced the USPSTF to adopt age-based screening recommendations because we, as a society, have created a culture in which we have stigmatized these behaviors and we, as practitioners, have proven to be inadequate at eliciting HCV risk behaviors,” they said. “Our responsibility as a society and practice community is to address structural and individual factors that limit our ability to most precisely address the needs of our patients and truly move toward HCV elimination,” they concluded.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The task force researchers had no financial conflicts to disclose.

SOURCES: Owens DK et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2020.1123; Chou R et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.20788; Graham CS, Trooskin S. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.22313; Price JC and Brandman D. JAMA Intern Med. 2020 Mar 2. doi: 10.1001/jamainternmed.2019.7334; Rosenberg ES, Barocas JA. JAMA Network Open. 2020 Mar 2. doi: 10.1001/jamanetworkopen.2020.0538.

Use AGA patient education to help your patients better understand HCV, including their risk and treatment options, at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.

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Adults aged 18-79 years should be screened for hepatitis C virus infection, according to an updated grade B recommendation from the U.S. Preventive Services Task Force.

Cases of acute hepatitis C virus (HCV) infection have spiked in the last decade, in part because of increased use of injection drugs and in part because of better surveillance, Douglas K. Owens, MD, of Stanford (Calif.) University, and colleagues wrote in the recommendation statement published in JAMA.

The recommendation applies to all asymptomatic adults aged 18-79 years without known liver disease, and expands on the 2013 recommendation to screen adults born between 1945 and 1965. The grade B designation means that the task force concluded with moderate certainty that HCV screening for adults aged 18-79 years had “substantial net benefit.”

The recommendations are based on an evidence report including 8 randomized, controlled trials, 48 other treatment studies, and 33 cohort studies published through February 2019 for a total of 179,230 individuals.

The screening is a one-time procedure for most adults, according to the task force, but clinicians should periodically screen individuals at increased risk, such as those with a past or current history of injection drug use. In addition, clinicians should consider screening individuals at increased risk who are above or below the recommended age range.

Although the task force identified no direct evidence on the benefit of screening for HCV infection in asymptomatic adults, a notable finding was that the newer direct-acting antiviral (DAA) regimens are sufficiently effective to support the expanded screening recommendation, they said. However, clinicians should inform patients that screening is voluntary and conducted only with the patient’s knowledge. Clinicians should educate patients about hepatitis C and give them an opportunity to ask questions and to make a decision about screening, according to the task force.

In the evidence report, a total of 49 studies including 10,181 individuals showed DAA treatment associated with pooled sustained virologic response rates greater than 95% across all virus genotypes, and a short-term serious adverse event rate of 1.9%. In addition, sustained virologic response following an antiviral therapy was associated with a reduction in risk of all-cause mortality (pooled hazard ratio 0.40) and of hepatocellular carcinoma (pooled HR 0.29) compared with cases of no sustained virologic response.

The evidence report findings were limited by several factors, including the relatively small number of randomized trials involving current DAA treatments, limited data on baseline symptoms, limited data on adolescents, and limited evidence on potential long-term harms of DAA therapy, noted Richard Chou, MD, of Oregon Health & Science University, Portland, and colleagues. However, new pooled evidence “indicates that SVR rates with currently recommended all-oral DAA regimens are substantially higher (more than 95%) than with interferon-based therapies evaluated in the prior review (68%-78%),” they said.

Several editorials were published concurrently with the recommendation.

In an editorial published in JAMA, Camilla S. Graham, MD, of Harvard Medical School, Boston, and Stacey Trooskin, MD, of the University of Pennsylvania, Philadelphia, wrote that the new recommendation reflects changes in hepatitis C virus management.

“With the approvals of sofosbuvir and simeprevir in 2013, patients with hepatitis C, a chronic viral illness associated with the deaths of more U.S. patients than the next 60 reportable infectious diseases combined, including HIV and tuberculosis, could expect a greater than 90% rate of achieving sustained virologic response (SVR, defined as undetectable HCV levels 12 weeks or longer after treatment completion, which is consistent with virologic cure of HCV infection) following 12 weeks of treatment,” they said.

These medications are effective but expensive; however, the combination of the availability of generic medications and the ongoing opioid epidemic in the United States are important contributors to the expanded recommendations, which “are welcome,” and may help meeting WHO 2030 targets for reducing new HCV infections, they said.

Dr. Graham disclosed personal fees from UpToDate. Dr. Trooskin disclosed grants from Gilead Sciences and personal fees from Merck, AbbVie, and Gilead Sciences.

In an editorial published in JAMA Internal Medicine, Jennifer C. Price, MD, and Danielle Brandman, MD, both of the University of California, San Francisco, wrote that “the advancements in HCV diagnosis and treatment have been extraordinary,” but that the new recommendation does not go far enough. “Implementation of HCV screening and linkage to treatment requires large-scale coordinated efforts, innovation, and resources. For example, point-of-care HCV RNA testing would enable scale-up of HCV screening and confirmatory testing among individuals at greatest risk of HCV infection,” they said. “Additionally, barriers remain between diagnosis and treatment, such as access to a health care provider who can treat HCV and authorization to receive affordable DAAs,” they noted. “Although the USPSTF HCV screening recommendation is a step forward for controlling HCV infection in the U.S., it will take a coordinated and funded effort to ensure that the anticipated benefits are realized,” they concluded.

Dr. Price disclosed research funding from Gilead Sciences and Merck. Dr. Brandman disclosed research funding from Gilead Sciences, Pfizer, Conatus, Allergan, and Grifols, as well as personal fees from Alnylam.

In an editorial published in JAMA Network Open, Eli S. Rosenberg, PhD, of the University at Albany (N.Y.) School of Public Health, and Joshua A. Barocas, MD, of Boston University, emphasized the need to change the stigma surrounding HCV infection in the United States.

“Given the changing epidemiology of HCV infection, new public health priorities, advancements in treatment, and unmet diagnostic needs, it is wise to periodically reevaluate screening recommendations to ensure that they are maximally addressing these areas and patients’ individual needs,” they said. “The Affordable Care Act requires private insurers and Medicaid to cover preventive services recommended by the USPSTF with a grade of A or B with no cost sharing (i.e., no deductible or copayment),” they noted. Although the new recommendation for one-time screening will likely identify more cases, improve outcomes, and reduce deaths, the editorialists cautioned that “one-time screening should not be interpreted like catch-up vaccinations, whereby we immunize someone at any age for hepatitis B virus, for example, and they are then immunized for the remainder of their life,” and that reassessments are needed, especially for younger adults.

In addition, they emphasized the need to reduce the stigma surrounding HCV and allow for recommendations based on risk, rather than age. “We have forced the USPSTF to adopt age-based screening recommendations because we, as a society, have created a culture in which we have stigmatized these behaviors and we, as practitioners, have proven to be inadequate at eliciting HCV risk behaviors,” they said. “Our responsibility as a society and practice community is to address structural and individual factors that limit our ability to most precisely address the needs of our patients and truly move toward HCV elimination,” they concluded.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The task force researchers had no financial conflicts to disclose.

SOURCES: Owens DK et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2020.1123; Chou R et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.20788; Graham CS, Trooskin S. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.22313; Price JC and Brandman D. JAMA Intern Med. 2020 Mar 2. doi: 10.1001/jamainternmed.2019.7334; Rosenberg ES, Barocas JA. JAMA Network Open. 2020 Mar 2. doi: 10.1001/jamanetworkopen.2020.0538.

Use AGA patient education to help your patients better understand HCV, including their risk and treatment options, at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.

Adults aged 18-79 years should be screened for hepatitis C virus infection, according to an updated grade B recommendation from the U.S. Preventive Services Task Force.

Cases of acute hepatitis C virus (HCV) infection have spiked in the last decade, in part because of increased use of injection drugs and in part because of better surveillance, Douglas K. Owens, MD, of Stanford (Calif.) University, and colleagues wrote in the recommendation statement published in JAMA.

The recommendation applies to all asymptomatic adults aged 18-79 years without known liver disease, and expands on the 2013 recommendation to screen adults born between 1945 and 1965. The grade B designation means that the task force concluded with moderate certainty that HCV screening for adults aged 18-79 years had “substantial net benefit.”

The recommendations are based on an evidence report including 8 randomized, controlled trials, 48 other treatment studies, and 33 cohort studies published through February 2019 for a total of 179,230 individuals.

The screening is a one-time procedure for most adults, according to the task force, but clinicians should periodically screen individuals at increased risk, such as those with a past or current history of injection drug use. In addition, clinicians should consider screening individuals at increased risk who are above or below the recommended age range.

Although the task force identified no direct evidence on the benefit of screening for HCV infection in asymptomatic adults, a notable finding was that the newer direct-acting antiviral (DAA) regimens are sufficiently effective to support the expanded screening recommendation, they said. However, clinicians should inform patients that screening is voluntary and conducted only with the patient’s knowledge. Clinicians should educate patients about hepatitis C and give them an opportunity to ask questions and to make a decision about screening, according to the task force.

In the evidence report, a total of 49 studies including 10,181 individuals showed DAA treatment associated with pooled sustained virologic response rates greater than 95% across all virus genotypes, and a short-term serious adverse event rate of 1.9%. In addition, sustained virologic response following an antiviral therapy was associated with a reduction in risk of all-cause mortality (pooled hazard ratio 0.40) and of hepatocellular carcinoma (pooled HR 0.29) compared with cases of no sustained virologic response.

The evidence report findings were limited by several factors, including the relatively small number of randomized trials involving current DAA treatments, limited data on baseline symptoms, limited data on adolescents, and limited evidence on potential long-term harms of DAA therapy, noted Richard Chou, MD, of Oregon Health & Science University, Portland, and colleagues. However, new pooled evidence “indicates that SVR rates with currently recommended all-oral DAA regimens are substantially higher (more than 95%) than with interferon-based therapies evaluated in the prior review (68%-78%),” they said.

Several editorials were published concurrently with the recommendation.

In an editorial published in JAMA, Camilla S. Graham, MD, of Harvard Medical School, Boston, and Stacey Trooskin, MD, of the University of Pennsylvania, Philadelphia, wrote that the new recommendation reflects changes in hepatitis C virus management.

“With the approvals of sofosbuvir and simeprevir in 2013, patients with hepatitis C, a chronic viral illness associated with the deaths of more U.S. patients than the next 60 reportable infectious diseases combined, including HIV and tuberculosis, could expect a greater than 90% rate of achieving sustained virologic response (SVR, defined as undetectable HCV levels 12 weeks or longer after treatment completion, which is consistent with virologic cure of HCV infection) following 12 weeks of treatment,” they said.

These medications are effective but expensive; however, the combination of the availability of generic medications and the ongoing opioid epidemic in the United States are important contributors to the expanded recommendations, which “are welcome,” and may help meeting WHO 2030 targets for reducing new HCV infections, they said.

Dr. Graham disclosed personal fees from UpToDate. Dr. Trooskin disclosed grants from Gilead Sciences and personal fees from Merck, AbbVie, and Gilead Sciences.

In an editorial published in JAMA Internal Medicine, Jennifer C. Price, MD, and Danielle Brandman, MD, both of the University of California, San Francisco, wrote that “the advancements in HCV diagnosis and treatment have been extraordinary,” but that the new recommendation does not go far enough. “Implementation of HCV screening and linkage to treatment requires large-scale coordinated efforts, innovation, and resources. For example, point-of-care HCV RNA testing would enable scale-up of HCV screening and confirmatory testing among individuals at greatest risk of HCV infection,” they said. “Additionally, barriers remain between diagnosis and treatment, such as access to a health care provider who can treat HCV and authorization to receive affordable DAAs,” they noted. “Although the USPSTF HCV screening recommendation is a step forward for controlling HCV infection in the U.S., it will take a coordinated and funded effort to ensure that the anticipated benefits are realized,” they concluded.

Dr. Price disclosed research funding from Gilead Sciences and Merck. Dr. Brandman disclosed research funding from Gilead Sciences, Pfizer, Conatus, Allergan, and Grifols, as well as personal fees from Alnylam.

In an editorial published in JAMA Network Open, Eli S. Rosenberg, PhD, of the University at Albany (N.Y.) School of Public Health, and Joshua A. Barocas, MD, of Boston University, emphasized the need to change the stigma surrounding HCV infection in the United States.

“Given the changing epidemiology of HCV infection, new public health priorities, advancements in treatment, and unmet diagnostic needs, it is wise to periodically reevaluate screening recommendations to ensure that they are maximally addressing these areas and patients’ individual needs,” they said. “The Affordable Care Act requires private insurers and Medicaid to cover preventive services recommended by the USPSTF with a grade of A or B with no cost sharing (i.e., no deductible or copayment),” they noted. Although the new recommendation for one-time screening will likely identify more cases, improve outcomes, and reduce deaths, the editorialists cautioned that “one-time screening should not be interpreted like catch-up vaccinations, whereby we immunize someone at any age for hepatitis B virus, for example, and they are then immunized for the remainder of their life,” and that reassessments are needed, especially for younger adults.

In addition, they emphasized the need to reduce the stigma surrounding HCV and allow for recommendations based on risk, rather than age. “We have forced the USPSTF to adopt age-based screening recommendations because we, as a society, have created a culture in which we have stigmatized these behaviors and we, as practitioners, have proven to be inadequate at eliciting HCV risk behaviors,” they said. “Our responsibility as a society and practice community is to address structural and individual factors that limit our ability to most precisely address the needs of our patients and truly move toward HCV elimination,” they concluded.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The task force researchers had no financial conflicts to disclose.

SOURCES: Owens DK et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2020.1123; Chou R et al. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.20788; Graham CS, Trooskin S. JAMA. 2020 Mar 2. doi: 10.1001/jama.2019.22313; Price JC and Brandman D. JAMA Intern Med. 2020 Mar 2. doi: 10.1001/jamainternmed.2019.7334; Rosenberg ES, Barocas JA. JAMA Network Open. 2020 Mar 2. doi: 10.1001/jamanetworkopen.2020.0538.

Use AGA patient education to help your patients better understand HCV, including their risk and treatment options, at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.

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Upcoming vaccine may offset surge in polio subtypes

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Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

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Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

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ERAS protocol for cesarean delivery reduces opioid usage

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– An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News
Dr. Kathryn Ruymann

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

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– An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News
Dr. Kathryn Ruymann

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

– An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News
Dr. Kathryn Ruymann

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

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REPORTING FROM THE PREGNANCY MEETING

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ACIP vaccination update

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ACIP vaccination update

Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.1

Individuals who should receive hepatitis A vaccine

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.4 This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.5 Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.2

Vaccines available for preventing hepatitis A virus infection

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.1 First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.1 Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.1Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.1

 

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.6

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.6

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.7 It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.8

Continue to: Two MenB vaccines...

 

 

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.9 For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.9 MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.10

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.12

Vaccines containing diphtheria and tetanus toxoids and acellular pertussis antigens

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.11 It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.11

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.11 The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

 

 

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.13

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.14

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.15

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.16,17

References

1. Nelson N. Hepatitis A vaccine. Presentation to the ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Hepatitis-2-Nelson-508.pdf. Accessed February 24, 2020.

2. Fiore AE, Wasley A, Bell BP; Advisory Committee on Immunization Practices (ACIP). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(No. RR-7):1-23.

3. CDC. Prevention of hepatitis A through active or passive immunization. MMWR Wkly. 2006;55:1-23.

4. Doshani M, Weng M, Moore KL, et al. Recommendations of the Advisory Committee on Immunization Practices for use of hepatitis A vaccine for persons experiencing homelessness. MMWR Morb Mortal Wkly Rep. 2019;68:153-156.

5. Foster M, Ramachandran S, Myatt K, et al. Hepatitis A virus outbreaks associated with drug use and homelessness—California, Kentucky, Michigan, and Utah, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1208-1210.

6. Hills SL, Walter EB, Atmar RL, et al. Japanese encephalitis vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2019;68:1-33.

7. CDC. Meningococcal vaccination: what everyone should know. www.cdc.gov/vaccines/vpd/mening/public/index.html. Accessed February 24, 2020.

8. MacNeil JR, Rubin L, Folaranmi T, et al. Use of seroproup B meningococcal vaccine in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2015; 64:1171-1176.

9. Patton M, Stephens D, Moore K, et al. Updated recommendations for use of MenB-FHbp seropgroup B meningococcal vaccine—Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66:509-513.

10. Mbaeyi S. Serogroup B Meningococcal vaccine booster doses. Presentation to ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Meningococcal-2-Mbaeyi-508.pdf. Accessed February 24, 2020.

11. Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(No. RR-2):1-44.

12. Lee A. Immunogenicity and safety of DTaP5-IPV-HepB-Hib (Vaxelis™), a pediatric hexavalent combination vaccine. Presentation to the Advisory Committee on Immunization Practices; ­February 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Combo-vaccine-2-Lee-508.pdf. Accessed February 24, 2020.

13. Havers F. Tdap and Td: summary of work group considerations and proposed policy options. Presentation to ACIP; October 23, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-10/Pertussis-03-Havers-508.pdf. Accessed February 24, 2020.

14. Campos-Outcalt D. Influenza update. J Fam Pract. 2019;68:­456-458.

15. Campos-Outcalt D. Pneumococcal conjugate vaccine update. J Fam Pract. 2019;68:564-566.

16. Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019; 68:698–702.

17. Campos-Outcalt D. ACIP issues 2 new recs on HPV vaccine [­audio]. J Fam Pract. September 2019. www.mdedge.com/familymedicine/article/205784/vaccines/acip-issues-2-new-recs-hpv-vaccination. Accessed February 24, 2020.

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Author and Disclosure Information

University of Arizona, Phoenix
dougco@email.arizona.edu

Dr. Campos-Outcalt is a member of the US Community Preventive Services Task Force and served on the Advisory Committee on Immunization Practices (ACIP) for 9 years—5 years as a liaison for the American Academy of Family Physicians and 4 years as a voting member.

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dougco@email.arizona.edu

Dr. Campos-Outcalt is a member of the US Community Preventive Services Task Force and served on the Advisory Committee on Immunization Practices (ACIP) for 9 years—5 years as a liaison for the American Academy of Family Physicians and 4 years as a voting member.

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University of Arizona, Phoenix
dougco@email.arizona.edu

Dr. Campos-Outcalt is a member of the US Community Preventive Services Task Force and served on the Advisory Committee on Immunization Practices (ACIP) for 9 years—5 years as a liaison for the American Academy of Family Physicians and 4 years as a voting member.

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Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.1

Individuals who should receive hepatitis A vaccine

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.4 This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.5 Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.2

Vaccines available for preventing hepatitis A virus infection

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.1 First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.1 Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.1Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.1

 

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.6

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.6

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.7 It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.8

Continue to: Two MenB vaccines...

 

 

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.9 For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.9 MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.10

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.12

Vaccines containing diphtheria and tetanus toxoids and acellular pertussis antigens

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.11 It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.11

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.11 The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

 

 

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.13

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.14

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.15

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.16,17

Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.1

Individuals who should receive hepatitis A vaccine

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.4 This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.5 Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.2

Vaccines available for preventing hepatitis A virus infection

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.1 First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.1 Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.1Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.1

 

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.6

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.6

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.7 It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.8

Continue to: Two MenB vaccines...

 

 

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.9 For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.9 MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.10

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.12

Vaccines containing diphtheria and tetanus toxoids and acellular pertussis antigens

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.11 It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.11

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.11 The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

 

 

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.13

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.14

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.15

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.16,17

References

1. Nelson N. Hepatitis A vaccine. Presentation to the ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Hepatitis-2-Nelson-508.pdf. Accessed February 24, 2020.

2. Fiore AE, Wasley A, Bell BP; Advisory Committee on Immunization Practices (ACIP). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(No. RR-7):1-23.

3. CDC. Prevention of hepatitis A through active or passive immunization. MMWR Wkly. 2006;55:1-23.

4. Doshani M, Weng M, Moore KL, et al. Recommendations of the Advisory Committee on Immunization Practices for use of hepatitis A vaccine for persons experiencing homelessness. MMWR Morb Mortal Wkly Rep. 2019;68:153-156.

5. Foster M, Ramachandran S, Myatt K, et al. Hepatitis A virus outbreaks associated with drug use and homelessness—California, Kentucky, Michigan, and Utah, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1208-1210.

6. Hills SL, Walter EB, Atmar RL, et al. Japanese encephalitis vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2019;68:1-33.

7. CDC. Meningococcal vaccination: what everyone should know. www.cdc.gov/vaccines/vpd/mening/public/index.html. Accessed February 24, 2020.

8. MacNeil JR, Rubin L, Folaranmi T, et al. Use of seroproup B meningococcal vaccine in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2015; 64:1171-1176.

9. Patton M, Stephens D, Moore K, et al. Updated recommendations for use of MenB-FHbp seropgroup B meningococcal vaccine—Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66:509-513.

10. Mbaeyi S. Serogroup B Meningococcal vaccine booster doses. Presentation to ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Meningococcal-2-Mbaeyi-508.pdf. Accessed February 24, 2020.

11. Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(No. RR-2):1-44.

12. Lee A. Immunogenicity and safety of DTaP5-IPV-HepB-Hib (Vaxelis™), a pediatric hexavalent combination vaccine. Presentation to the Advisory Committee on Immunization Practices; ­February 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Combo-vaccine-2-Lee-508.pdf. Accessed February 24, 2020.

13. Havers F. Tdap and Td: summary of work group considerations and proposed policy options. Presentation to ACIP; October 23, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-10/Pertussis-03-Havers-508.pdf. Accessed February 24, 2020.

14. Campos-Outcalt D. Influenza update. J Fam Pract. 2019;68:­456-458.

15. Campos-Outcalt D. Pneumococcal conjugate vaccine update. J Fam Pract. 2019;68:564-566.

16. Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019; 68:698–702.

17. Campos-Outcalt D. ACIP issues 2 new recs on HPV vaccine [­audio]. J Fam Pract. September 2019. www.mdedge.com/familymedicine/article/205784/vaccines/acip-issues-2-new-recs-hpv-vaccination. Accessed February 24, 2020.

References

1. Nelson N. Hepatitis A vaccine. Presentation to the ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Hepatitis-2-Nelson-508.pdf. Accessed February 24, 2020.

2. Fiore AE, Wasley A, Bell BP; Advisory Committee on Immunization Practices (ACIP). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(No. RR-7):1-23.

3. CDC. Prevention of hepatitis A through active or passive immunization. MMWR Wkly. 2006;55:1-23.

4. Doshani M, Weng M, Moore KL, et al. Recommendations of the Advisory Committee on Immunization Practices for use of hepatitis A vaccine for persons experiencing homelessness. MMWR Morb Mortal Wkly Rep. 2019;68:153-156.

5. Foster M, Ramachandran S, Myatt K, et al. Hepatitis A virus outbreaks associated with drug use and homelessness—California, Kentucky, Michigan, and Utah, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1208-1210.

6. Hills SL, Walter EB, Atmar RL, et al. Japanese encephalitis vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2019;68:1-33.

7. CDC. Meningococcal vaccination: what everyone should know. www.cdc.gov/vaccines/vpd/mening/public/index.html. Accessed February 24, 2020.

8. MacNeil JR, Rubin L, Folaranmi T, et al. Use of seroproup B meningococcal vaccine in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2015; 64:1171-1176.

9. Patton M, Stephens D, Moore K, et al. Updated recommendations for use of MenB-FHbp seropgroup B meningococcal vaccine—Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66:509-513.

10. Mbaeyi S. Serogroup B Meningococcal vaccine booster doses. Presentation to ACIP; June 27, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Meningococcal-2-Mbaeyi-508.pdf. Accessed February 24, 2020.

11. Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(No. RR-2):1-44.

12. Lee A. Immunogenicity and safety of DTaP5-IPV-HepB-Hib (Vaxelis™), a pediatric hexavalent combination vaccine. Presentation to the Advisory Committee on Immunization Practices; ­February 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Combo-vaccine-2-Lee-508.pdf. Accessed February 24, 2020.

13. Havers F. Tdap and Td: summary of work group considerations and proposed policy options. Presentation to ACIP; October 23, 2019. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-10/Pertussis-03-Havers-508.pdf. Accessed February 24, 2020.

14. Campos-Outcalt D. Influenza update. J Fam Pract. 2019;68:­456-458.

15. Campos-Outcalt D. Pneumococcal conjugate vaccine update. J Fam Pract. 2019;68:564-566.

16. Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019; 68:698–702.

17. Campos-Outcalt D. ACIP issues 2 new recs on HPV vaccine [­audio]. J Fam Pract. September 2019. www.mdedge.com/familymedicine/article/205784/vaccines/acip-issues-2-new-recs-hpv-vaccination. Accessed February 24, 2020.

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Dengue vaccine deemed acceptable by most doctors, fewer parents

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Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

itsmejust/Thinkstock

Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

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Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

itsmejust/Thinkstock

Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

itsmejust/Thinkstock

Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

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Salpingectomy adds little time and no complications to cesarean delivery

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– Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

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– Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

– Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

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Borderline personality disorder common in chronic pain patients

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– A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.

Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.

“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.

“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.

The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Treatment resistance

Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.

Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.

He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.

“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.

To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).

“The point of this research is that you cannot help these patients in the long-run if you only treat their pain. We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
 

Screen for BPD

The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.

“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.

Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.

“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.

Cao and Hansen have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.

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– A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.

Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.

“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.

“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.

The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Treatment resistance

Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.

Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.

He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.

“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.

To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).

“The point of this research is that you cannot help these patients in the long-run if you only treat their pain. We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
 

Screen for BPD

The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.

“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.

Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.

“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.

Cao and Hansen have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.

– A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.

Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.

“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.

“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.

The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Treatment resistance

Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.

Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.

He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.

“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.

To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).

“The point of this research is that you cannot help these patients in the long-run if you only treat their pain. We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
 

Screen for BPD

The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.

“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.

Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.

“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.

Cao and Hansen have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.

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