MDedge Surgery

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

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.

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.

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.

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.

GRAPEVINE, TEX. – 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

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.

jremaly@mdedge.com

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

GRAPEVINE, TEX. – 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

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.

jremaly@mdedge.com

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

GRAPEVINE, TEX. – 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

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.

jremaly@mdedge.com

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

GRAPEVINE, TEXAS – 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.

koakes@mdedge.com

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

GRAPEVINE, TEXAS – 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.

koakes@mdedge.com

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

GRAPEVINE, TEXAS – 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.

koakes@mdedge.com

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

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.

Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.

Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.

Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.

The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.

Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.

Whitehouse.gov

The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.

During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.

For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.

The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.

Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.

mschneider@mdedge.com

The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.

Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.

Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.

Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.

The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.

Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.

Whitehouse.gov

The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.

During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.

For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.

The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.

Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.

mschneider@mdedge.com

The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.

Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.

Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.

Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.

The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.

Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.

Whitehouse.gov

The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.

During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.

For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.

The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.

Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.

mschneider@mdedge.com

NATIONAL HARBOR, MD. – Following a percutaneous intervention with a second-generation drug-eluting stent, a judicious interruption of antiplatelet therapy for noncardiac surgery does not increase risk of net adverse clinical events, according to a large dataset presented at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Drawn from a multicenter registry in South Korea, it is likely that those in whom antiplatelet therapy was stopped during the perioperative period were at a lower relative risk, but the data remain reassuring, according to Jung-Sun Kim, MD, PhD, professor of medicine at Yonsei University, Seoul, South Korea.

In the registry of patients with a second-generation drug-eluting stent (DES) undergoing noncardiac surgery, “antiplatelet therapy was discontinued in almost half of the patients,” Dr. Kim reported. When these patients were compared with those who did not discontinue antiplatelet therapy, the data, called an “exploratory analysis,” suggested “no increased risk” of a composite of major adverse cardiac events (MACE) or major bleeding.

The retrospective analysis involved 3,582 percutaneous intervention (PCI) patients who had received a second-generation DES and subsequently underwent noncardiac surgery. In 1,750 of these patients, antiplatelet therapy was temporarily discontinued. The remaining 1,832 remained on some form of antiplatelet treatment, whether aspirin, a P2Y12 inhibitor, or dual-antiplatelet therapy.

There were no significant differences in crude rates between groups in rates at 30 days of a composite endpoint of MACE, major bleeding as defined by the International Society on Thrombosis and Haemostasis, or net adverse clinical events (NACE), a composite of adverse events that included MACE and major bleeding.

Relative risks for antiplatelet discontinuation remained generally low even after multiple stratifications performed to explore different variables, including the types of antiplatelet therapy being taken at the time of discontinuation, the types of noncardiac surgery performed, and the duration of discontinuation.

Of these variables, the interval of discontinuation appeared to be most relevant. Antiplatelet discontinuation of 3 days or less appeared to be associated with a higher risk of bleeding, although the difference did not reach significance. Discontinuations of 9 days or more were associated with increased risk of MACE, and this difference did reach statistical significance (hazard ratio, 3.38; 95% confidence interval, 1.36-8.38).

“Discontinuation of antiplatelet therapy for a period of 4-8 days appears to be optimal,” Dr. Kim said.

In general, risk of MACE, major bleeding, or NACE could not be linked to type of surgery, with the exception of intra-abdominal surgery. For this procedure, there appeared to be a lower risk of MACE in those who discontinued relative to those who remained on antiplatelet therapy, Dr. Kim reported.

Importantly, because of the fact that the decision to stop antiplatelet treatment was made by treating physicians, the characteristics of those who discontinued or remained on antiplatelet therapy differed meaningfully. Specifically, those in the discontinuation group were younger and were less likely to have additional risks for thrombotic events such as diabetes or chronic kidney disease. In those who discontinued antiplatelets, the average time since PCI was 23 months versus 16 months in the continuation group.

In addition, “more of the patients underwent higher-risk surgeries in the discontinuation group,” Dr. Kim added.

Relative rates of MACE and NACE remained similar even after risk adjustment, but Dr. Kim advised that the data should be “interpreted cautiously” because of the retrospective nature of the analysis.

A panel of experts invited to comment on the presentation agreed. These data were considered reassuring for clinicians considering an interruption of antiplatelet therapy following PCI with a second-generation DES, but there was uncertainty about their value for defining which patients are the best candidates.

The decision to discontinue antiplatelet drugs for noncardiac surgery is an important and common dilemma, but these data might be best characterized as “a testament to Korean cardiologists making good decisions,” said David J. Moliterno, MD, chairman of the department of medicine at University of Kentucky Health Care, Lexington.

Dr. Kim reported no potential financial conflicts of interest.

NATIONAL HARBOR, MD. – Following a percutaneous intervention with a second-generation drug-eluting stent, a judicious interruption of antiplatelet therapy for noncardiac surgery does not increase risk of net adverse clinical events, according to a large dataset presented at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Drawn from a multicenter registry in South Korea, it is likely that those in whom antiplatelet therapy was stopped during the perioperative period were at a lower relative risk, but the data remain reassuring, according to Jung-Sun Kim, MD, PhD, professor of medicine at Yonsei University, Seoul, South Korea.

In the registry of patients with a second-generation drug-eluting stent (DES) undergoing noncardiac surgery, “antiplatelet therapy was discontinued in almost half of the patients,” Dr. Kim reported. When these patients were compared with those who did not discontinue antiplatelet therapy, the data, called an “exploratory analysis,” suggested “no increased risk” of a composite of major adverse cardiac events (MACE) or major bleeding.

The retrospective analysis involved 3,582 percutaneous intervention (PCI) patients who had received a second-generation DES and subsequently underwent noncardiac surgery. In 1,750 of these patients, antiplatelet therapy was temporarily discontinued. The remaining 1,832 remained on some form of antiplatelet treatment, whether aspirin, a P2Y12 inhibitor, or dual-antiplatelet therapy.

There were no significant differences in crude rates between groups in rates at 30 days of a composite endpoint of MACE, major bleeding as defined by the International Society on Thrombosis and Haemostasis, or net adverse clinical events (NACE), a composite of adverse events that included MACE and major bleeding.

Relative risks for antiplatelet discontinuation remained generally low even after multiple stratifications performed to explore different variables, including the types of antiplatelet therapy being taken at the time of discontinuation, the types of noncardiac surgery performed, and the duration of discontinuation.

Of these variables, the interval of discontinuation appeared to be most relevant. Antiplatelet discontinuation of 3 days or less appeared to be associated with a higher risk of bleeding, although the difference did not reach significance. Discontinuations of 9 days or more were associated with increased risk of MACE, and this difference did reach statistical significance (hazard ratio, 3.38; 95% confidence interval, 1.36-8.38).

“Discontinuation of antiplatelet therapy for a period of 4-8 days appears to be optimal,” Dr. Kim said.

In general, risk of MACE, major bleeding, or NACE could not be linked to type of surgery, with the exception of intra-abdominal surgery. For this procedure, there appeared to be a lower risk of MACE in those who discontinued relative to those who remained on antiplatelet therapy, Dr. Kim reported.

Importantly, because of the fact that the decision to stop antiplatelet treatment was made by treating physicians, the characteristics of those who discontinued or remained on antiplatelet therapy differed meaningfully. Specifically, those in the discontinuation group were younger and were less likely to have additional risks for thrombotic events such as diabetes or chronic kidney disease. In those who discontinued antiplatelets, the average time since PCI was 23 months versus 16 months in the continuation group.

In addition, “more of the patients underwent higher-risk surgeries in the discontinuation group,” Dr. Kim added.

Relative rates of MACE and NACE remained similar even after risk adjustment, but Dr. Kim advised that the data should be “interpreted cautiously” because of the retrospective nature of the analysis.

A panel of experts invited to comment on the presentation agreed. These data were considered reassuring for clinicians considering an interruption of antiplatelet therapy following PCI with a second-generation DES, but there was uncertainty about their value for defining which patients are the best candidates.

The decision to discontinue antiplatelet drugs for noncardiac surgery is an important and common dilemma, but these data might be best characterized as “a testament to Korean cardiologists making good decisions,” said David J. Moliterno, MD, chairman of the department of medicine at University of Kentucky Health Care, Lexington.

Dr. Kim reported no potential financial conflicts of interest.

NATIONAL HARBOR, MD. – Following a percutaneous intervention with a second-generation drug-eluting stent, a judicious interruption of antiplatelet therapy for noncardiac surgery does not increase risk of net adverse clinical events, according to a large dataset presented at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

Drawn from a multicenter registry in South Korea, it is likely that those in whom antiplatelet therapy was stopped during the perioperative period were at a lower relative risk, but the data remain reassuring, according to Jung-Sun Kim, MD, PhD, professor of medicine at Yonsei University, Seoul, South Korea.

In the registry of patients with a second-generation drug-eluting stent (DES) undergoing noncardiac surgery, “antiplatelet therapy was discontinued in almost half of the patients,” Dr. Kim reported. When these patients were compared with those who did not discontinue antiplatelet therapy, the data, called an “exploratory analysis,” suggested “no increased risk” of a composite of major adverse cardiac events (MACE) or major bleeding.

The retrospective analysis involved 3,582 percutaneous intervention (PCI) patients who had received a second-generation DES and subsequently underwent noncardiac surgery. In 1,750 of these patients, antiplatelet therapy was temporarily discontinued. The remaining 1,832 remained on some form of antiplatelet treatment, whether aspirin, a P2Y12 inhibitor, or dual-antiplatelet therapy.

There were no significant differences in crude rates between groups in rates at 30 days of a composite endpoint of MACE, major bleeding as defined by the International Society on Thrombosis and Haemostasis, or net adverse clinical events (NACE), a composite of adverse events that included MACE and major bleeding.

Relative risks for antiplatelet discontinuation remained generally low even after multiple stratifications performed to explore different variables, including the types of antiplatelet therapy being taken at the time of discontinuation, the types of noncardiac surgery performed, and the duration of discontinuation.

Of these variables, the interval of discontinuation appeared to be most relevant. Antiplatelet discontinuation of 3 days or less appeared to be associated with a higher risk of bleeding, although the difference did not reach significance. Discontinuations of 9 days or more were associated with increased risk of MACE, and this difference did reach statistical significance (hazard ratio, 3.38; 95% confidence interval, 1.36-8.38).

“Discontinuation of antiplatelet therapy for a period of 4-8 days appears to be optimal,” Dr. Kim said.

In general, risk of MACE, major bleeding, or NACE could not be linked to type of surgery, with the exception of intra-abdominal surgery. For this procedure, there appeared to be a lower risk of MACE in those who discontinued relative to those who remained on antiplatelet therapy, Dr. Kim reported.

Importantly, because of the fact that the decision to stop antiplatelet treatment was made by treating physicians, the characteristics of those who discontinued or remained on antiplatelet therapy differed meaningfully. Specifically, those in the discontinuation group were younger and were less likely to have additional risks for thrombotic events such as diabetes or chronic kidney disease. In those who discontinued antiplatelets, the average time since PCI was 23 months versus 16 months in the continuation group.

In addition, “more of the patients underwent higher-risk surgeries in the discontinuation group,” Dr. Kim added.

Relative rates of MACE and NACE remained similar even after risk adjustment, but Dr. Kim advised that the data should be “interpreted cautiously” because of the retrospective nature of the analysis.

A panel of experts invited to comment on the presentation agreed. These data were considered reassuring for clinicians considering an interruption of antiplatelet therapy following PCI with a second-generation DES, but there was uncertainty about their value for defining which patients are the best candidates.

The decision to discontinue antiplatelet drugs for noncardiac surgery is an important and common dilemma, but these data might be best characterized as “a testament to Korean cardiologists making good decisions,” said David J. Moliterno, MD, chairman of the department of medicine at University of Kentucky Health Care, Lexington.

Dr. Kim reported no potential financial conflicts of interest.

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com

LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.

Mitchel L. Zoler/MDedge News

The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.

These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.

The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.

The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.

Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.

A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.

She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.

Dr. Voeks reported no disclosures.

mzoler@mdedge.com

SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.

LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.

Mitchel L. Zoler/MDedge News

The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.

These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.

The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.

The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.

Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.

A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.

She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.

Dr. Voeks reported no disclosures.

mzoler@mdedge.com

SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.

LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.

Mitchel L. Zoler/MDedge News

The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.

These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.

The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.

The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.

Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.

A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.

She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.

Dr. Voeks reported no disclosures.

mzoler@mdedge.com

SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.