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Congress has heard our rally cry
AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.
We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
Small business relief
- Small Business Administration (SBA) loans:
Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.
Allows 501(c)(3) non-profits to gain access to the program.
Increases the maximum loan amount to $10 million.
Expands allowable uses of loans to include payroll support, such as:
1. Paid sick or medical leave.
2. Employee salaries.
3. Mortgage payments.
Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.
- Public Health and Social Services Emergency Fund:
$100 billion for health care services related to the COVID-19.
Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.
- Coronavirus Economic Stabilization Act:
$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
Medicare provisions
- Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
- Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
- Increased Medicare telehealth flexibilities during the emergency period.
- AGA will continue to advocate for audio-only coverage as this issue is still not resolved.
Other key health care provisions
- Liability protections for health care professionals during the emergency response.
- Coverage of preventive services and vaccines.
- $16 billion to replenish the Strategic National Stockpile.
- $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).
Correspondence to congressional leadership
- March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
- March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
- March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.
AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.
We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
Small business relief
- Small Business Administration (SBA) loans:
Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.
Allows 501(c)(3) non-profits to gain access to the program.
Increases the maximum loan amount to $10 million.
Expands allowable uses of loans to include payroll support, such as:
1. Paid sick or medical leave.
2. Employee salaries.
3. Mortgage payments.
Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.
- Public Health and Social Services Emergency Fund:
$100 billion for health care services related to the COVID-19.
Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.
- Coronavirus Economic Stabilization Act:
$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
Medicare provisions
- Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
- Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
- Increased Medicare telehealth flexibilities during the emergency period.
- AGA will continue to advocate for audio-only coverage as this issue is still not resolved.
Other key health care provisions
- Liability protections for health care professionals during the emergency response.
- Coverage of preventive services and vaccines.
- $16 billion to replenish the Strategic National Stockpile.
- $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).
Correspondence to congressional leadership
- March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
- March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
- March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.
AGA has advocated for provisions to protect our providers and businesses and we’re happy to report that the following provisions are in the third installation of the COVID-19 economic relief legislation.
We’ll continue to push for direct funding for physicians recognizing that many practices and ASCs are struggling.
Small business relief
- Small Business Administration (SBA) loans:
Businesses with 500 employees or less are eligible unless the covered industry’s SBA size standard allows more than 500 employees.
Allows 501(c)(3) non-profits to gain access to the program.
Increases the maximum loan amount to $10 million.
Expands allowable uses of loans to include payroll support, such as:
1. Paid sick or medical leave.
2. Employee salaries.
3. Mortgage payments.
Provides a process for loan forgiveness for certain payroll costs as well as mortgage, rent and utility obligations.
- Public Health and Social Services Emergency Fund:
$100 billion for health care services related to the COVID-19.
Reimbursement to eligible health care providers for health care related expenses or lost revenues that are attributable to the pandemic.
- Coronavirus Economic Stabilization Act:
$454 billion for loans, loan guarantees and other investments for companies with losses tied to the pandemic that threaten continued operation.
Medicare provisions
- Suspension of sequestration – Physicians avoid a 2% cut in their Medicare reimbursement.
- Extension of geographic index floor – Increases Medicare payments for providers in nonurban areas.
- Increased Medicare telehealth flexibilities during the emergency period.
- AGA will continue to advocate for audio-only coverage as this issue is still not resolved.
Other key health care provisions
- Liability protections for health care professionals during the emergency response.
- Coverage of preventive services and vaccines.
- $16 billion to replenish the Strategic National Stockpile.
- $1 billion for the Defense Production Act to ensure production of personal protective equipment (PPE).
Correspondence to congressional leadership
- March 25, 2020 – With the American Medical Association, a letter is sent requesting the inclusion of support for physician practices in any economic stimulus package.
- March 24, 2020 – With the Alliance of Specialty Medicine, a letter is sent asking for relief for independent physicians’ offices.
- March 20, 2020 – A joint society letter is sent asking for increased funding for and access to PPE; softened prior authorization, telehealth reimbursement and Medicare reporting requirements; and financial safeguards for health care professionals and practices.
From the EVP/CEO: How CHEST is helping to flatten the curve
As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.
In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.
An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.
We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.
With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).
The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.
I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.
In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.
Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.
As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.
In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.
An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.
We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.
With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).
The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.
I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.
In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.
Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.
As you know, the COVID-19 pandemic has caused immense strain on global health systems. With our membership at the epicenter, many of you have experienced firsthand the shortages that result from a surging patient population – lack of personal protective equipment (PPE), access to ventilators, and increasing demand for more qualified health-care workers needed on the front lines to treat and care for patients. As the staff leader of your organization, I feel an immense responsibility to support our community through this crisis.
In recent weeks, CHEST petitioned the federal and local governments on several issues, advocating for tax relief for COVID responders, expansion of liability protections, and the development of a provider relief fund. We will continue to collaborate with other societies and push such efforts. However, we also recognize an obligation to make a more tangible, real-time difference in the circumstances of our membership and the lives of the patients you are working to save.
An opportunity arose when we received a call from Dr. Doreen Addrizzo-Harris, Immediate Past President of the CHEST Foundation and Professor of Medicine at NYU Langone Health. In late March, New York City was seeing an uptick in patients with confirmed COVID infection in critical condition that was escalating by the day. The situation was beginning to resemble the trajectory of hotspots in Wuhan, China and Italy, and it was already taking a toll on health-care teams. Dr. Adrizzo-Harris asked whether there was any way to leverage the strength of the CHEST community to provide help. Already, our headquarters team had received unsolicited offers to travel to areas in need from our members. The question was how could we more proactively identify such willing and able clinicians.
We quickly drew upon our existing CHEST Analytics platform to target physicians outside New York City who might be well-positioned to travel. We harnessed our communication channels to get the word out. The response was immediate, with more than 100 people completing applications to join forces with their colleagues in New York. In the first 10 days of recruitment efforts, we added an additional 250 interested volunteers to the system. The positive response from members showed both the willingness of qualified medical staff to assist on the front lines but also highlighted deficiencies in other registration systems overwhelmed with requests in the face of this pandemic. Finding certified pulmonary and critical care physicians who are willing to step in where they are needed is time- and labor-intensive and detracts from health systems’ ability to focus on care. Watching the projections in other regions, we recognized other areas may soon need this same help.
With this in mind, CHEST approached ATS and our long-time partner PA Consulting to help us address the problem on a national scale. We felt we had the resources to leverage our databases and our analytic tools to create a more efficient process that would put physicians in hospitals where they could do the most good more efficiently. We knew that if we could apply our knowledge and deploy our heroic members, we could develop a solution that could save lives and relieve frontline clinicians. By leveraging the existing CHEST Analytics platform, the team created a solution that can be used by provider institutions, government agencies, and willing clinicians to quickly and effectively provide care where it is needed most. The team has engineered the solution to be scalable nationally and expandable to other critical care specialties (eg, anesthesia, emergency, nursing, respiratory therapy).
The Clinician Matching Network formally launched on April 14, 2020. It provides a two-way input that accepts sign up from individual clinicians and gathers needs and requirements from hospital systems, connecting health-care providers with the systems most in need of the specific support they are equipped to provide. We believe this has the potential to enable us to move ahead of the curve of the crisis.
I am very proud of the teams that lead this effort and have gained a greater appreciation of how CHEST, in partnership with other medical societies, can fully utilize data and analytics toward implementing public health solutions. The design and development of the Clinician Matching Network was accomplished in less than a week, leveraging a methodology that will enable the team to continuously improve and iterate through weekly releases, adding functionality quickly as the pandemic evolves.
In the weeks ahead, communications will be distributed to hospitals and hospital systems to help identify their staffing needs, encourage them to input their needs into the Clinician Matching Network, and expand the clinician-to-hospital matching effort. We aim to increase the number of collaborationg associations to grow the pool of clinicians who can be deployed to areas in need.
Please visit www.chestnet.org/clinician-matching to learn more, sign up to serve, tell us about the needs of your institution, or collaborate toward this cause.
Itchy, vesicular rash
Pemphigoid gestationis
It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.
The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.
Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.
Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.
Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.
This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
Pemphigoid gestationis
It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.
The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.
Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.
Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.
Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.
This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
Pemphigoid gestationis
It typically presents with the abrupt onset of very pruritic urticarial plaques and papules, which start around the umbilicus and then spread to involve the trunk and extremities. The papules and plaques evolve to generalized tense blisters, which typically spare the face, palms, soles, and mucous membranes. Half of affected patients may present in an atypical distribution involving the extremities, palms, or soles. Patients may be at an increased risk for the development of Graves disease.
The cause of pemphigoid gestationis is a factor known as “herpes gestationis factor” that induces C3 deposition along the dermal-epidermal junction. As in bullous pemphigoid, patients with pemphigoid gestationis have antibodies to a transmembrane hemidesmosomal protein called BPAG2/BP180/collagen XVII.
Three-quarters of patients worsen at the time of delivery and up to 10% of newborns will have bullous lesions secondary to placental transfer of antibodies. In most cases, lesions will spontaneously resolve over a few weeks following delivery. Recurrence with future pregnancies is common, with severity increasing with each pregnancy. Recurrence with menstruation and with the use of oral contraceptives can also occur. Although there is no increase in maternal mortality, onset in the first or second trimester and presence of blisters is associated with decreased gestational age of baby at delivery and lower-birth-weight infants. There is no increase in fetal mortality.
Histopathology reveals a subepidermal vesicle and perivascular infiltrate consisting of lymphocytes and eosinophils. Diagnosis can be confirmed with direct immunofluorescence showing C3 in a linear band along the basement membrane zone. IgG may be present as well. Complement added indirect immunofluorescence reveals circulating anti–basement zone IgG, which allows differentiation from pruritic urticarial papules and plaques of pregnancy.
Treatment for localized disease includes class I topical steroids and oral antihistamines. More severe cases require systemic corticosteroid treatment. Systemic steroids may cause lower-birth-weight infants.
This case and the photos were submitted by Dr. Hanson of Associated Skin Care Specialists in Eden Prairie, Minn. The case was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
Almost half of med practices furloughing staff, one-fifth have layoffs
Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.
The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.
A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.
Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.
The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.
The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.
“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.
“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”
Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
Elective procedures down
In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.
Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.
“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”
Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.
A version of this article originally appeared on Medscape.com.
Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.
The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.
A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.
Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.
The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.
The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.
“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.
“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”
Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
Elective procedures down
In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.
Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.
“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”
Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.
A version of this article originally appeared on Medscape.com.
Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.
The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.
A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.
Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.
The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.
The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.
“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.
“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”
Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
Elective procedures down
In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.
Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.
“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”
Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.
A version of this article originally appeared on Medscape.com.
FDA approves first targeted drug for bile duct cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.
The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.
It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.
These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.
At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.
Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.
“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”
The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).
As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
Results from open-label clinical trial
The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.
All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.
The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.
Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.
“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.
The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.
It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.
These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.
At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.
Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.
“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”
The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).
As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
Results from open-label clinical trial
The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.
All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.
The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.
Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.
“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a new targeted therapy for use in some patients with cholangiocarcinoma, a rare cancer of the bile ducts.
The product is pemigatinib (Pemazyre, Incyte), an oral kinase inhibitor.
It was approved specifically for use in patients with advanced cholangiocarcinoma who have received prior treatment and who have tumors that have a fusion or other rearrangement of the fibroblast growth factor receptor 2 (FGFR2) gene.
These FGFR2 genetic abnormalities are found in about 9% to 14% of patients with cholangiocarcinoma, notes the FDA.
At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery, the agency also notes. Until now, a combination of chemotherapy drugs has been the standard initial treatment.
Now the subgroup of patients with FGFR2 tumors have the option of a targeted therapy.
“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” commented Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, New York City, in a press release. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”
The accelerated approval was based on the overall response rate (ORR) and duration of response in an open-label clinical trial that involved 107 patients (the FIGHT-202 study).
As a condition of the accelerated approval, the manufacturer will complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival or overall survival, the FDA noted.
Results from open-label clinical trial
The FIGHT-202 study enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma who had received prior treatment and who had tumors with an FGFR2 fusion or rearrangement.
All patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients underwent scanning every 8 weeks to assess ORR.
The ORR was 36% (38 of 107 patients), which included 2.8% of patients with a complete response and 33% with partial response.
Among the 38 patients who had a response, 24 patients (63%) had a response that lasted 6 months or longer, and 7 patients (18%) had a response that lasted 12 months or longer.
“With pemigatinib, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy,” commented Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The most common adverse reactions, which occurred in 20% or more of patients who received pemigatinib, were electrolyte disorders (hyperphosphatemia and hypophosphatemia), alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity was seen rarely, the agency notes.
This article first appeared on Medscape.com.
FDA approves first new breast cancer drug with international group
The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.
Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.
The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.
While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.
“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.
Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.
The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.
“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.
The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.
Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.
Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.
The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.
“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.
The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.
According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.
Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.
The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.
While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.
“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.
Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.
The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.
“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.
The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.
Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.
Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.
The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.
“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.
The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.
According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer. This is the first new drug approved under Project Orbis, an international collaboration.
Tucatinib, which is a small-molecule tyrosine kinase inhibitor, is approved in combination with trastuzumab and capecitabine to treat patients who have received one or more prior treatments for advanced disease.
The FDA collaborated with the regulatory authorities of Australia, Canada, Singapore, and Switzerland on this review. However, only the FDA has approved tucatinib; the application is still under review at the other agencies.
While working with Project Orbis in 2019, the FDA granted an accelerated, conditional approval to a drug combination that included previously approved agents.
“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.
Collaboration among regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, according to the FDA.
The new drug is a “valuable addition” to the roster of treatments for advanced HER2-positive breast cancer, said study investigator Eric Winer, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, in a company press statement.
“With highly significant and clinically important results for overall and progression-free survival, the addition of [tucatinib] to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” he said.
The new approval is based on safety and efficacy results from the phase 2 HER2CLIMB trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
Nearly half (48%) of patients in the study had brain metastases at the start of the trial. The primary outcome measure was progression-free survival (PFS). All patients received trastuzumab and capecitabine and were randomly assigned to either tucatinib or placebo.
Median PFS in the tucatinib patient group was 7.8 months, compared with 5.6 months in the placebo group. The PFS results in the subgroup of patients with brain metastases were nearly the same.
Median overall survival in the tucatinib patient group was 21.9 months versus 17.4 months in the placebo group.
The new drug is a rare success in the treatment of breast cancer brain metastases, said Jawad Fares, MD, of Northwestern University, Chicago, Illinois, who spoke to Medscape Medical News when the phase 3 trial data were first presented at the 2019 San Antonio Breast Cancer Symposium.
“Outcomes in the field have been pretty dismal,” summarized Fares, who was not involved in the study.
The results of the HER2CLIMB study, which was funded by Seattle Genetics, were published in the New England Journal of Medicine last year.
According to the FDA, common side effects with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
Tucatinib can cause serious side effects, including diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should start antidiarrheals as clinically indicated if diarrhea occurs and should interrupt treatment or reduce the dosage. Tucatinib can also cause severe hepatotoxicity; patients should be monitored with liver tests.
This article first appeared on Medscape.com.
Differentiating hypersensitivity reactions to monoclonal antibodies
MAUI, HAWAII – Desensitization is a powerful and effective tool in patients with certain types of hypersensitivity reactions to therapeutic monoclonal antibodies, but it’s best considered a last resort reserved for individuals with no options left other than the offending biologic, Anna Postolova, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Why so selective? Desensitization is considered a high-risk intervention. It’s typically done as an inpatient procedure involving an overnight hospital stay followed by an elaborate 12-step protocol involving administration of small quantities of the culprit biologic in ascending concentrations over a 5- to 6-hour period.
Moreover, for an intravenous agent, such as infliximab (Remicade), desensitization has to be repeated prior to giving every dose of the biologic. So it makes sense to skip desensitization and simply switch to an alternative tumor necrosis factor inhibitor or a different class of biologic unless experience has shown that the culprit monoclonal antibody is the only one that works for that patient. It’s known, for example, that infliximab has no crossreactivity with adalimumab (Humira), explained Dr. Postolova, a dual rheumatologist and allergist/immunologist at Stanford (Calif.) University.
Defining type and severity of the hypersensitivity reaction
Dr. Postolova favors the hypersensitivity reaction classification system developed by Mariana Castells, MD, PhD, and coworkers at Brigham and Women’s Hospital, Boston.
They divide the field into immediate and delayed hypersensitivity reactions. Immediate hypersensitivity reactions arise rapidly, between minutes and a few hours. They can be categorized as infusion reactions, cytokine-release reactions, and IgE-mediated reactions. Phenotypically, infusion reactions and cytokine-release reactions are typically characterized by various combinations of chills, fever, flushing, hypertension, tachycardia, nausea, vomiting, syncope, and shortness of breath.
IgE-mediated reactions can also involve flushing and shortness of breath, and in addition itch, urticaria, and hypotension. These are anaphylactic reactions. Neither hypertension nor fever is part of the anaphylactic picture; those findings point instead to an infusion reaction or cytokine-release reaction.
Most allergists grade reaction severity on a 1-3 scale. Grade 1 reactions are considered mild and involve symptoms limited to the skin, such as flushing, or a single other organ system.
“That being said, if my patient is having a reaction with bronchospasm, I consider that a moderate, grade 2 reaction, and I stop the infusion. There’s only so much you can do for bronchospasm. It’s a very serious reaction,” Dr. Postolova observed.
Grade 2 reactions ordinarily involve two or more organ systems, but without hypotension or cyanosis. Grade 3 reactions are severe anaphylactic reactions with cardiovascular and/or neurologic compromise.
Delayed hypersensitivity reactions are of two types: serum sickness–like reactions and type IV cell-mediated mucocutaneous reactions.
Type IV reactions can range from a mild maculopapular rash to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS (drug reaction with eosinophilia and systemic symptoms). Onset of type IV reactions can occur after 12 hours up to several weeks after exposure.
Serum sickness–like reactions typically begin 5-7 days after the infusion. These reactions are marked by evidence of immune overactivation: fever, arthralgia, arthritis, malaise, purpura, skin rash, and even renal failure.
Management of reactions
A patient with a grade 3 reaction who needs to continue using the culprit monoclonal antibody should be referred to an allergist for skin testing in an effort to identify an IgE-mediated reaction.
The timing of the referral for skin testing is important: The allergist wants to test roughly 4-6 weeks after the hypersensitivity reaction. Test too early and the results will be uninformative because the patient will still be anergic. On the other hand, after 7-8 weeks the patient will have lost the allergy. So there is a sweet spot.
If the patient is skin test positive – with the caveat that skin testing in this setting is not well validated – then the allergist will suggest desensitization, usually as an inpatient.
In contrast, infusion reactions can be handled in the rheumatologist’s infusion center. They are self-limited upon repeat exposure with premedication using antihistamines, NSAIDs, oral or injectable steroids, and perhaps montelukast (Singulair).
If a patient initially thought to have an infusion reaction continues to experience reactions even after the biologic is being delivered more slowly and under the protection of premedication, it’s time to consider the possibility that what’s really going on is a cytokine-release reaction or an IgE-mediated reaction. Diagnostic skin testing is in order.
For a skin test–negative patient with a suspected cytokine-release reaction, the allergist may propose a therapeutic challenge. This is reserved for patients who the allergist believe will not experience an immediate reaction, and unlike desensitization it’s not an intervention intended to induce drug tolerance. The challenge involves giving 10% of a full dose of the biologic, waiting in the allergist’s office for 30-60 minutes, then giving the other 90% of the medication, followed by an hour of in-office observation.
The solution to severe type IV delayed hypersensitivity reactions is strict medication avoidance, not desensitization, according to Dr. Postolova.
Top offending monoclonal antibodies
Infliximab and rituximab (Rituxan) are the most common culprits when it comes to immediate hypersensitivity reactions. About 10% of infliximab-treated patients develop these reactions. Although the reaction can occur with the first dose, the peak incidence is with the seventh infusion. Patients with anti-infliximab IgG antibodies are at 140%-300% increased risk; however, concomitant disease-modifying antirheumatic drug therapy lessens that risk.
Infusion reactions or cytokine-release reactions occur upon the first infusion of rituximab in about 25% of treated rheumatology patients and in a higher proportion of cancer patients. Most of these reactions are mild and don’t recur when the biologic is administered more slowly and with premedication. Severe recurrent reactions upon subsequent exposure are much more likely to be an IgE-mediated hypersensitivity reaction.
“Stop the medication, send the patient to your local allergist for skin testing, and they’ll use a desensitization protocol if rituximab is the best drug for your patient,” Dr. Postolova advised.
She reported having no financial conflicts regarding her presentation.
MAUI, HAWAII – Desensitization is a powerful and effective tool in patients with certain types of hypersensitivity reactions to therapeutic monoclonal antibodies, but it’s best considered a last resort reserved for individuals with no options left other than the offending biologic, Anna Postolova, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Why so selective? Desensitization is considered a high-risk intervention. It’s typically done as an inpatient procedure involving an overnight hospital stay followed by an elaborate 12-step protocol involving administration of small quantities of the culprit biologic in ascending concentrations over a 5- to 6-hour period.
Moreover, for an intravenous agent, such as infliximab (Remicade), desensitization has to be repeated prior to giving every dose of the biologic. So it makes sense to skip desensitization and simply switch to an alternative tumor necrosis factor inhibitor or a different class of biologic unless experience has shown that the culprit monoclonal antibody is the only one that works for that patient. It’s known, for example, that infliximab has no crossreactivity with adalimumab (Humira), explained Dr. Postolova, a dual rheumatologist and allergist/immunologist at Stanford (Calif.) University.
Defining type and severity of the hypersensitivity reaction
Dr. Postolova favors the hypersensitivity reaction classification system developed by Mariana Castells, MD, PhD, and coworkers at Brigham and Women’s Hospital, Boston.
They divide the field into immediate and delayed hypersensitivity reactions. Immediate hypersensitivity reactions arise rapidly, between minutes and a few hours. They can be categorized as infusion reactions, cytokine-release reactions, and IgE-mediated reactions. Phenotypically, infusion reactions and cytokine-release reactions are typically characterized by various combinations of chills, fever, flushing, hypertension, tachycardia, nausea, vomiting, syncope, and shortness of breath.
IgE-mediated reactions can also involve flushing and shortness of breath, and in addition itch, urticaria, and hypotension. These are anaphylactic reactions. Neither hypertension nor fever is part of the anaphylactic picture; those findings point instead to an infusion reaction or cytokine-release reaction.
Most allergists grade reaction severity on a 1-3 scale. Grade 1 reactions are considered mild and involve symptoms limited to the skin, such as flushing, or a single other organ system.
“That being said, if my patient is having a reaction with bronchospasm, I consider that a moderate, grade 2 reaction, and I stop the infusion. There’s only so much you can do for bronchospasm. It’s a very serious reaction,” Dr. Postolova observed.
Grade 2 reactions ordinarily involve two or more organ systems, but without hypotension or cyanosis. Grade 3 reactions are severe anaphylactic reactions with cardiovascular and/or neurologic compromise.
Delayed hypersensitivity reactions are of two types: serum sickness–like reactions and type IV cell-mediated mucocutaneous reactions.
Type IV reactions can range from a mild maculopapular rash to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS (drug reaction with eosinophilia and systemic symptoms). Onset of type IV reactions can occur after 12 hours up to several weeks after exposure.
Serum sickness–like reactions typically begin 5-7 days after the infusion. These reactions are marked by evidence of immune overactivation: fever, arthralgia, arthritis, malaise, purpura, skin rash, and even renal failure.
Management of reactions
A patient with a grade 3 reaction who needs to continue using the culprit monoclonal antibody should be referred to an allergist for skin testing in an effort to identify an IgE-mediated reaction.
The timing of the referral for skin testing is important: The allergist wants to test roughly 4-6 weeks after the hypersensitivity reaction. Test too early and the results will be uninformative because the patient will still be anergic. On the other hand, after 7-8 weeks the patient will have lost the allergy. So there is a sweet spot.
If the patient is skin test positive – with the caveat that skin testing in this setting is not well validated – then the allergist will suggest desensitization, usually as an inpatient.
In contrast, infusion reactions can be handled in the rheumatologist’s infusion center. They are self-limited upon repeat exposure with premedication using antihistamines, NSAIDs, oral or injectable steroids, and perhaps montelukast (Singulair).
If a patient initially thought to have an infusion reaction continues to experience reactions even after the biologic is being delivered more slowly and under the protection of premedication, it’s time to consider the possibility that what’s really going on is a cytokine-release reaction or an IgE-mediated reaction. Diagnostic skin testing is in order.
For a skin test–negative patient with a suspected cytokine-release reaction, the allergist may propose a therapeutic challenge. This is reserved for patients who the allergist believe will not experience an immediate reaction, and unlike desensitization it’s not an intervention intended to induce drug tolerance. The challenge involves giving 10% of a full dose of the biologic, waiting in the allergist’s office for 30-60 minutes, then giving the other 90% of the medication, followed by an hour of in-office observation.
The solution to severe type IV delayed hypersensitivity reactions is strict medication avoidance, not desensitization, according to Dr. Postolova.
Top offending monoclonal antibodies
Infliximab and rituximab (Rituxan) are the most common culprits when it comes to immediate hypersensitivity reactions. About 10% of infliximab-treated patients develop these reactions. Although the reaction can occur with the first dose, the peak incidence is with the seventh infusion. Patients with anti-infliximab IgG antibodies are at 140%-300% increased risk; however, concomitant disease-modifying antirheumatic drug therapy lessens that risk.
Infusion reactions or cytokine-release reactions occur upon the first infusion of rituximab in about 25% of treated rheumatology patients and in a higher proportion of cancer patients. Most of these reactions are mild and don’t recur when the biologic is administered more slowly and with premedication. Severe recurrent reactions upon subsequent exposure are much more likely to be an IgE-mediated hypersensitivity reaction.
“Stop the medication, send the patient to your local allergist for skin testing, and they’ll use a desensitization protocol if rituximab is the best drug for your patient,” Dr. Postolova advised.
She reported having no financial conflicts regarding her presentation.
MAUI, HAWAII – Desensitization is a powerful and effective tool in patients with certain types of hypersensitivity reactions to therapeutic monoclonal antibodies, but it’s best considered a last resort reserved for individuals with no options left other than the offending biologic, Anna Postolova, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Why so selective? Desensitization is considered a high-risk intervention. It’s typically done as an inpatient procedure involving an overnight hospital stay followed by an elaborate 12-step protocol involving administration of small quantities of the culprit biologic in ascending concentrations over a 5- to 6-hour period.
Moreover, for an intravenous agent, such as infliximab (Remicade), desensitization has to be repeated prior to giving every dose of the biologic. So it makes sense to skip desensitization and simply switch to an alternative tumor necrosis factor inhibitor or a different class of biologic unless experience has shown that the culprit monoclonal antibody is the only one that works for that patient. It’s known, for example, that infliximab has no crossreactivity with adalimumab (Humira), explained Dr. Postolova, a dual rheumatologist and allergist/immunologist at Stanford (Calif.) University.
Defining type and severity of the hypersensitivity reaction
Dr. Postolova favors the hypersensitivity reaction classification system developed by Mariana Castells, MD, PhD, and coworkers at Brigham and Women’s Hospital, Boston.
They divide the field into immediate and delayed hypersensitivity reactions. Immediate hypersensitivity reactions arise rapidly, between minutes and a few hours. They can be categorized as infusion reactions, cytokine-release reactions, and IgE-mediated reactions. Phenotypically, infusion reactions and cytokine-release reactions are typically characterized by various combinations of chills, fever, flushing, hypertension, tachycardia, nausea, vomiting, syncope, and shortness of breath.
IgE-mediated reactions can also involve flushing and shortness of breath, and in addition itch, urticaria, and hypotension. These are anaphylactic reactions. Neither hypertension nor fever is part of the anaphylactic picture; those findings point instead to an infusion reaction or cytokine-release reaction.
Most allergists grade reaction severity on a 1-3 scale. Grade 1 reactions are considered mild and involve symptoms limited to the skin, such as flushing, or a single other organ system.
“That being said, if my patient is having a reaction with bronchospasm, I consider that a moderate, grade 2 reaction, and I stop the infusion. There’s only so much you can do for bronchospasm. It’s a very serious reaction,” Dr. Postolova observed.
Grade 2 reactions ordinarily involve two or more organ systems, but without hypotension or cyanosis. Grade 3 reactions are severe anaphylactic reactions with cardiovascular and/or neurologic compromise.
Delayed hypersensitivity reactions are of two types: serum sickness–like reactions and type IV cell-mediated mucocutaneous reactions.
Type IV reactions can range from a mild maculopapular rash to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS (drug reaction with eosinophilia and systemic symptoms). Onset of type IV reactions can occur after 12 hours up to several weeks after exposure.
Serum sickness–like reactions typically begin 5-7 days after the infusion. These reactions are marked by evidence of immune overactivation: fever, arthralgia, arthritis, malaise, purpura, skin rash, and even renal failure.
Management of reactions
A patient with a grade 3 reaction who needs to continue using the culprit monoclonal antibody should be referred to an allergist for skin testing in an effort to identify an IgE-mediated reaction.
The timing of the referral for skin testing is important: The allergist wants to test roughly 4-6 weeks after the hypersensitivity reaction. Test too early and the results will be uninformative because the patient will still be anergic. On the other hand, after 7-8 weeks the patient will have lost the allergy. So there is a sweet spot.
If the patient is skin test positive – with the caveat that skin testing in this setting is not well validated – then the allergist will suggest desensitization, usually as an inpatient.
In contrast, infusion reactions can be handled in the rheumatologist’s infusion center. They are self-limited upon repeat exposure with premedication using antihistamines, NSAIDs, oral or injectable steroids, and perhaps montelukast (Singulair).
If a patient initially thought to have an infusion reaction continues to experience reactions even after the biologic is being delivered more slowly and under the protection of premedication, it’s time to consider the possibility that what’s really going on is a cytokine-release reaction or an IgE-mediated reaction. Diagnostic skin testing is in order.
For a skin test–negative patient with a suspected cytokine-release reaction, the allergist may propose a therapeutic challenge. This is reserved for patients who the allergist believe will not experience an immediate reaction, and unlike desensitization it’s not an intervention intended to induce drug tolerance. The challenge involves giving 10% of a full dose of the biologic, waiting in the allergist’s office for 30-60 minutes, then giving the other 90% of the medication, followed by an hour of in-office observation.
The solution to severe type IV delayed hypersensitivity reactions is strict medication avoidance, not desensitization, according to Dr. Postolova.
Top offending monoclonal antibodies
Infliximab and rituximab (Rituxan) are the most common culprits when it comes to immediate hypersensitivity reactions. About 10% of infliximab-treated patients develop these reactions. Although the reaction can occur with the first dose, the peak incidence is with the seventh infusion. Patients with anti-infliximab IgG antibodies are at 140%-300% increased risk; however, concomitant disease-modifying antirheumatic drug therapy lessens that risk.
Infusion reactions or cytokine-release reactions occur upon the first infusion of rituximab in about 25% of treated rheumatology patients and in a higher proportion of cancer patients. Most of these reactions are mild and don’t recur when the biologic is administered more slowly and with premedication. Severe recurrent reactions upon subsequent exposure are much more likely to be an IgE-mediated hypersensitivity reaction.
“Stop the medication, send the patient to your local allergist for skin testing, and they’ll use a desensitization protocol if rituximab is the best drug for your patient,” Dr. Postolova advised.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM RWCS 2020
Proximal fractures linked to higher mortality
Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.
Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.
“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*
The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.
The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.
Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.
In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.
The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.
Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.
Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.
In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.
SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.
Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.
Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.
Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.
“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*
The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.
The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.
Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.
In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.
The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.
Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.
Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.
In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.
SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.
Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.
Bone fracture in older adults is associated with greater mortality risk, but the location of the break may be a key factor, according to a new study of outcomes in a Danish database.
Over the follow-up period, those with proximal fractures – breaks in the hip, femur, pelvis, rib, clavicle, and humerus – were more likely to be hospitalized and to die, compared with their matched controls, than were those were with distal fractures in regions like the ankle, forearm, hand, or foot, where the mortality was similar to the matched controls.
“Compared with someone with similar comorbidities without a proximal fracture, there seemed to be an increased hospitalization rate for things like diabetes, heart disease, and lung disease, and then for some of those hospitalizations, there seemed to be an increased mortality, compared with people who hadn’t fractured who were hospitalized,” said Jacqueline Center, MBBS, PhD, of the Garvan Institute of Medical Research, Sydney, in an interview. The study abstract was released online by the Endocrine Society. It had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.*
The study included 212,498 women and 95,372 men aged over 50 years who had a fragility fracture between 2001 and 2014. The researchers excluded high-trauma fractures. They matched each fracture patient with four nonfracture patients, based on sex, age, and comorbidity status. There were 30,677 deaths among women over 384,995 person-years of follow-up, and 19,519 deaths in men over 163,482 person-years of follow-up. Women were a mean age of 72 at the time of fracture, while men were a mean age of 75.
The researchers found that proximal fractures were associated with increased risk of mortality, compared with nonfractured controls, with hazard ratios ranging between 1.5 and 4.0. Distal fractures were not associated with any increased mortality risk.
Comorbidities were common in the study population, with 75% of men and 60% of women having at least one. The risk of mortality increased with increasing numbers of comorbidities in each fracture type, but only proximal fractures were associated with an independent increase in mortality risk over and above comorbidity status.
In the 2 years following fracture, compared with matched controls, proximal fractures were associated with a greater risk of major hospital admission for conditions like cardiovascular disease, cancer, stroke, diabetes, pneumonia, and pulmonary disease. There was no significant difference between controls and those with distal fractures in hospital admission rate. The 2-year mortality risk was higher among subjects with proximal fractures, compared with patients in the no-fracture control group, regardless of whether they were admitted to the hospital, but there was no significant difference in those with distal fractures.
The differing clinical trajectories between those with proximal and distal fractures is a key finding, according to Dr. Center. The cause still isn’t clear, but she suspects that, in those patients who do badly, the fractures are either a signal that something is happening with existing comorbidities of the underlying frailty or that it may exacerbate them. Comorbidity independently and additively contributes to mortality, so that someone with a hip fracture and no comorbidities might have a similar mortality risk as someone with an upper-arm fracture and a couple of comorbidities. “I think it tells us that the person has to be treated as a whole. We need to treat the fracture to treat the underlying osteoporosis, but we also need to look closely at the person with the fracture and treat their comorbidities as well, because they seem to be more vulnerable,” Dr. Center said.
Although patients and clinicians are attuned to the concerns over hip fractures, other fractures should also be noted, according to Nelson Watts, MD, who is director of osteoporosis and bone-health services at Mercy Health in Cincinnati and was not involved in the research. “I think the message for clinicians and patients is that all of these [proximal] fractures need to be taken seriously. The good news is that that we have medications that can cut the risk of further fractures by 50%-70%,” he said in an interview.
Dr. Center has been on an advisory board for Amgen. Dr. Watts has been a speaker for Amgen and Radius and has conducted numerous clinical trials of osteoporosis drugs.
In addition to a series of news conferences, the Endocrine Society is also planning to host ENDO Online 2020 during June 8-22, which will feature on-demand and live programming for clinicians and researchers.
SOURCE: Center J et al. ENDO 2020, Abstract OR13-03.
Correction, 4/21/20: An earlier version of this article misstated when the interview with Dr. Center took place.
FROM ENDO 2020
Addressing CVD’s role in U.S. maternal mortality: Multispecialty collaboration is needed
Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.
Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.
The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.
“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”
It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
The data and the depth of the crisis
The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.
In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”
“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.
These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.
The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).
With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.
“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”
Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.
The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.
In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.
The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.
“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.
Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.
“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”
Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.
“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.
The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.
“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.
Ongoing efforts
Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.
In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.
Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.
In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.
Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.
“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”
This referral should occur early – preferably in the antenatal period, she added.
The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.
Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.
“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.
CVD-related risks in the post partum
Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.
That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.
James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.
Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.
“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”
Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.
Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.
The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.
“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”
It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
The data and the depth of the crisis
The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.
In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”
“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.
These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.
The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).
With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.
“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”
Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.
The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.
In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.
The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.
“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.
Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.
“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”
Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.
“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.
The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.
“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.
Ongoing efforts
Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.
In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.
Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.
In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.
Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.
“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”
This referral should occur early – preferably in the antenatal period, she added.
The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.
Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.
“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.
CVD-related risks in the post partum
Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.
That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.
James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.
Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.
“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”
Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.
Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.
The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.
“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”
It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
The data and the depth of the crisis
The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.
In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”
“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.
These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.
The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).
With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.
“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”
Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.
The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.
In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.
The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.
“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.
Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.
“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”
Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.
“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.
The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.
“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.
Ongoing efforts
Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.
In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.
Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.
In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.
Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.
“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”
This referral should occur early – preferably in the antenatal period, she added.
The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.
Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.
“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.
CVD-related risks in the post partum
Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.
That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.
James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.
Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.
“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”
A message from our president to the GI community
Dear colleagues,
The coronavirus pandemic has affected every facet of society, bringing almost unprecedented challenges to our world, and especially to our world of health care.
But our profession has been ignited in the way only a crisis can spark. Many of you are working on the front lines of patient care, at personal risk, lacking sufficient information and adequate resources. This is heroic work.
AGA’s priority during this time of disruption is to get practical guidance into your hands to help you treat patients, and protect yourselves and your coworkers. We’re also advocating on your behalf to get the resources you need and economic relief necessitated by the measures taken to fight the pandemic.
We are continually updating our COVID-19 website, www.gastro.org/covid. Check it for the latest clinical guidance, practice management information, and advocacy initiatives.
Our journals have started a collection of submissions related to COVID-19. Your AGA colleagues on the Clinical Guidelines Committee and Clinical Practice Updates Committee have been hard at work developing guidance for questions that you have asked us on Twitter, @AmerGastroAssn and the AGA Community. So join us there where resources and insights are being shared in real time.
Your commitment to our patients is a testament to your professionalism. Our commitment at AGA is to support you.
We’ll get through this together.
Hashem B. El-Serag, MD, MPH, AGAF
President, AGA Institute
Dear colleagues,
The coronavirus pandemic has affected every facet of society, bringing almost unprecedented challenges to our world, and especially to our world of health care.
But our profession has been ignited in the way only a crisis can spark. Many of you are working on the front lines of patient care, at personal risk, lacking sufficient information and adequate resources. This is heroic work.
AGA’s priority during this time of disruption is to get practical guidance into your hands to help you treat patients, and protect yourselves and your coworkers. We’re also advocating on your behalf to get the resources you need and economic relief necessitated by the measures taken to fight the pandemic.
We are continually updating our COVID-19 website, www.gastro.org/covid. Check it for the latest clinical guidance, practice management information, and advocacy initiatives.
Our journals have started a collection of submissions related to COVID-19. Your AGA colleagues on the Clinical Guidelines Committee and Clinical Practice Updates Committee have been hard at work developing guidance for questions that you have asked us on Twitter, @AmerGastroAssn and the AGA Community. So join us there where resources and insights are being shared in real time.
Your commitment to our patients is a testament to your professionalism. Our commitment at AGA is to support you.
We’ll get through this together.
Hashem B. El-Serag, MD, MPH, AGAF
President, AGA Institute
Dear colleagues,
The coronavirus pandemic has affected every facet of society, bringing almost unprecedented challenges to our world, and especially to our world of health care.
But our profession has been ignited in the way only a crisis can spark. Many of you are working on the front lines of patient care, at personal risk, lacking sufficient information and adequate resources. This is heroic work.
AGA’s priority during this time of disruption is to get practical guidance into your hands to help you treat patients, and protect yourselves and your coworkers. We’re also advocating on your behalf to get the resources you need and economic relief necessitated by the measures taken to fight the pandemic.
We are continually updating our COVID-19 website, www.gastro.org/covid. Check it for the latest clinical guidance, practice management information, and advocacy initiatives.
Our journals have started a collection of submissions related to COVID-19. Your AGA colleagues on the Clinical Guidelines Committee and Clinical Practice Updates Committee have been hard at work developing guidance for questions that you have asked us on Twitter, @AmerGastroAssn and the AGA Community. So join us there where resources and insights are being shared in real time.
Your commitment to our patients is a testament to your professionalism. Our commitment at AGA is to support you.
We’ll get through this together.
Hashem B. El-Serag, MD, MPH, AGAF
President, AGA Institute