Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

As it gears up for the first in-person scientific sessions for 3 years, the American Diabetes Association has issued an addendum to its most recent annual clinical practice recommendations published in December 2021, the 2022 Standards of Medical Care in Diabetes, based on recent trial evidence and consensus.

The update informs clinicians about:

• The effect of the nonsteroidal mineralocorticoid antagonist (Kerendia) on cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease.
• The effect of a sodium-glucose cotransporter 2 (SGLT2) inhibitor on heart failure and renal outcomes in patients with type 2 diabetes.

The National Kidney Foundation and the American Society of Nephrology Task Force recommendation to remove race in the formula for calculating estimated glomerular filtration rate (eGFR).

Checking with Dr Gabbay -- RM 08/16

“This is the fifth year that we are able to update the Standards of Care after it has been published through our Living Standards of Care updates, making it possible to give diabetes care providers the most important information and the latest evidence relevant to their practice,” Robert A. Gabbay, MD, PhD, ADA chief scientific and medical officer, said in a press release from the organization.

The addendum, entitled, “Living Standards of Care,” updates Section 10, “Cardiovascular Disease and Risk Management,” and Section 11, “Chronic Kidney Disease and Risk Management” of the 2022 Standards of Medical Care in Diabetes. 

The amendments were approved by the ADA Professional Practice Committee, which is responsible for developing the Standards of Care. The American College of Cardiology reviewed and endorsed the section on CVD and risk management.

The Living Standards Update was published online in Diabetes Care.
 

CVD and risk management

In the Addendum to Section 10, “Cardiovascular Disease and Risk Management,” the committee writes:

• “For patients with type 2 diabetes and chronic kidney disease treated with maximum tolerated doses of ACE inhibitors or angiotensin receptor blockers, addition of finerenone should be considered to improve cardiovascular outcomes and reduce the risk of chronic kidney disease progression. A”
• “Patients with type 2 diabetes and chronic kidney disease should be considered for treatment with finerenone to reduce cardiovascular outcomes and the risk of chronic kidney disease progression.”
• “In patients with type 2 diabetes and established heart failure with either preserved or reduced ejection fraction, an SGLT2 inhibitor [with proven benefit in this patient population] is recommended to reduce risk of worsening heart failure, hospitalizations for heart failure, and cardiovascular death. ”

In the section “Statin Treatment,” the addendum no longer states that “a prospective trial of a newer fibrate ... is ongoing,” because that trial investigating pemafibrate (Kowa), a novel selective peroxisome proliferator-activated receptor alpha modulator (or fibrate), has been discontinued.
 

Chronic kidney disease and risk management

In the Addendum to Section 11, “Chronic Kidney Disease and Risk Management,” the committee writes: 

• “Traditionally, eGFR is calculated from serum creatinine using a validated formula. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is preferred. ... Historically, a correction factor for muscle mass was included in a modified equation for African Americans; however, due to various issues with inequities, it was decided to the equation such that it applies to all. Hence, a committee was convened, resulting in the recommendation for immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the U.S.” (This is based on an National Kidney Foundation and American Society of Nephrology Task Force recommendation.)
• “Additionally, increased use of cystatin C, especially to confirm estimated GFR in adults who are at risk for or have chronic kidney disease, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone.” 

Evidence from clinical trials

The update is based on findings from the following clinical trials:

• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)
• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)
• FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD
• Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
• Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients with PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)
• Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT).

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

As it gears up for the first in-person scientific sessions for 3 years, the American Diabetes Association has issued an addendum to its most recent annual clinical practice recommendations published in December 2021, the 2022 Standards of Medical Care in Diabetes, based on recent trial evidence and consensus.

The update informs clinicians about:

• The effect of the nonsteroidal mineralocorticoid antagonist (Kerendia) on cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease.
• The effect of a sodium-glucose cotransporter 2 (SGLT2) inhibitor on heart failure and renal outcomes in patients with type 2 diabetes.

The National Kidney Foundation and the American Society of Nephrology Task Force recommendation to remove race in the formula for calculating estimated glomerular filtration rate (eGFR).

Checking with Dr Gabbay -- RM 08/16

“This is the fifth year that we are able to update the Standards of Care after it has been published through our Living Standards of Care updates, making it possible to give diabetes care providers the most important information and the latest evidence relevant to their practice,” Robert A. Gabbay, MD, PhD, ADA chief scientific and medical officer, said in a press release from the organization.

The addendum, entitled, “Living Standards of Care,” updates Section 10, “Cardiovascular Disease and Risk Management,” and Section 11, “Chronic Kidney Disease and Risk Management” of the 2022 Standards of Medical Care in Diabetes. 

The amendments were approved by the ADA Professional Practice Committee, which is responsible for developing the Standards of Care. The American College of Cardiology reviewed and endorsed the section on CVD and risk management.

The Living Standards Update was published online in Diabetes Care.
 

CVD and risk management

In the Addendum to Section 10, “Cardiovascular Disease and Risk Management,” the committee writes:

• “For patients with type 2 diabetes and chronic kidney disease treated with maximum tolerated doses of ACE inhibitors or angiotensin receptor blockers, addition of finerenone should be considered to improve cardiovascular outcomes and reduce the risk of chronic kidney disease progression. A”
• “Patients with type 2 diabetes and chronic kidney disease should be considered for treatment with finerenone to reduce cardiovascular outcomes and the risk of chronic kidney disease progression.”
• “In patients with type 2 diabetes and established heart failure with either preserved or reduced ejection fraction, an SGLT2 inhibitor [with proven benefit in this patient population] is recommended to reduce risk of worsening heart failure, hospitalizations for heart failure, and cardiovascular death. ”

In the section “Statin Treatment,” the addendum no longer states that “a prospective trial of a newer fibrate ... is ongoing,” because that trial investigating pemafibrate (Kowa), a novel selective peroxisome proliferator-activated receptor alpha modulator (or fibrate), has been discontinued.
 

Chronic kidney disease and risk management

In the Addendum to Section 11, “Chronic Kidney Disease and Risk Management,” the committee writes: 

• “Traditionally, eGFR is calculated from serum creatinine using a validated formula. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is preferred. ... Historically, a correction factor for muscle mass was included in a modified equation for African Americans; however, due to various issues with inequities, it was decided to the equation such that it applies to all. Hence, a committee was convened, resulting in the recommendation for immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the U.S.” (This is based on an National Kidney Foundation and American Society of Nephrology Task Force recommendation.)
• “Additionally, increased use of cystatin C, especially to confirm estimated GFR in adults who are at risk for or have chronic kidney disease, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone.” 

Evidence from clinical trials

The update is based on findings from the following clinical trials:

• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)
• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)
• FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD
• Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
• Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients with PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)
• Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT).

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

As it gears up for the first in-person scientific sessions for 3 years, the American Diabetes Association has issued an addendum to its most recent annual clinical practice recommendations published in December 2021, the 2022 Standards of Medical Care in Diabetes, based on recent trial evidence and consensus.

The update informs clinicians about:

• The effect of the nonsteroidal mineralocorticoid antagonist (Kerendia) on cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease.
• The effect of a sodium-glucose cotransporter 2 (SGLT2) inhibitor on heart failure and renal outcomes in patients with type 2 diabetes.

The National Kidney Foundation and the American Society of Nephrology Task Force recommendation to remove race in the formula for calculating estimated glomerular filtration rate (eGFR).

Checking with Dr Gabbay -- RM 08/16

“This is the fifth year that we are able to update the Standards of Care after it has been published through our Living Standards of Care updates, making it possible to give diabetes care providers the most important information and the latest evidence relevant to their practice,” Robert A. Gabbay, MD, PhD, ADA chief scientific and medical officer, said in a press release from the organization.

The addendum, entitled, “Living Standards of Care,” updates Section 10, “Cardiovascular Disease and Risk Management,” and Section 11, “Chronic Kidney Disease and Risk Management” of the 2022 Standards of Medical Care in Diabetes. 

The amendments were approved by the ADA Professional Practice Committee, which is responsible for developing the Standards of Care. The American College of Cardiology reviewed and endorsed the section on CVD and risk management.

The Living Standards Update was published online in Diabetes Care.
 

CVD and risk management

In the Addendum to Section 10, “Cardiovascular Disease and Risk Management,” the committee writes:

• “For patients with type 2 diabetes and chronic kidney disease treated with maximum tolerated doses of ACE inhibitors or angiotensin receptor blockers, addition of finerenone should be considered to improve cardiovascular outcomes and reduce the risk of chronic kidney disease progression. A”
• “Patients with type 2 diabetes and chronic kidney disease should be considered for treatment with finerenone to reduce cardiovascular outcomes and the risk of chronic kidney disease progression.”
• “In patients with type 2 diabetes and established heart failure with either preserved or reduced ejection fraction, an SGLT2 inhibitor [with proven benefit in this patient population] is recommended to reduce risk of worsening heart failure, hospitalizations for heart failure, and cardiovascular death. ”

In the section “Statin Treatment,” the addendum no longer states that “a prospective trial of a newer fibrate ... is ongoing,” because that trial investigating pemafibrate (Kowa), a novel selective peroxisome proliferator-activated receptor alpha modulator (or fibrate), has been discontinued.
 

Chronic kidney disease and risk management

In the Addendum to Section 11, “Chronic Kidney Disease and Risk Management,” the committee writes: 

• “Traditionally, eGFR is calculated from serum creatinine using a validated formula. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is preferred. ... Historically, a correction factor for muscle mass was included in a modified equation for African Americans; however, due to various issues with inequities, it was decided to the equation such that it applies to all. Hence, a committee was convened, resulting in the recommendation for immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the U.S.” (This is based on an National Kidney Foundation and American Society of Nephrology Task Force recommendation.)
• “Additionally, increased use of cystatin C, especially to confirm estimated GFR in adults who are at risk for or have chronic kidney disease, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone.” 

Evidence from clinical trials

The update is based on findings from the following clinical trials:

• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)
• Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)
• FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD
• Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
• Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients with PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)
• Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT).

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

During the first year of the pandemic, profound changes in screen use and sleep timing occurred among U.S. adolescents as a result of spending more time using electronic devices, going to bed later, and getting up later, compared with before the pandemic, new research indicates.

The excessive screen time negatively affected sleep, said lead investigator Orsolya Kiss, PhD, with the Center for Health Sciences at SRI International, Menlo Park, Calif.

And what’s “concerning,” she told this news organization, is that there is no indication of any spontaneous decline in screen use in 2021, when there were fewer restrictions.

Dr. Kiss said she is “very much interested to see what future studies will show.”

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Sleep takes a pandemic hit

“Adolescents and families have turned to online activities and social platforms more than ever before to maintain wellbeing, [to] connect with friends and family, and for online schooling,” Dr. Kiss said in a conference statement.

She and her colleagues examined longitudinal data from 5,027 adolescents aged 11-14 years who are participating in the ongoing Adolescent Brain Cognitive Development (ABCD) study.

As part of the study, participants reported sleep and daily screen time use prior to and at six time points during the first year of the pandemic (May 2020 to March 2021).

During the first year of the pandemic, relative to before the pandemic, recreational screen time was dramatically higher, with adolescents spending about 45 minutes more on social media and 20 minutes more playing video games, Dr. Kiss reported.

The jump in screen time was coupled with changes in sleep patterns.

Adolescents’ wake up times were delayed about 1.5 hours during May and August 2020, relative to prepandemic levels. The delay was partly due to summer break; wake-up times returned to earlier times in the fall of 2020.

During all pandemic assessments, bedtimes were delayed by about 1 hour, even when the new school year started. This was particularly the case in older adolescents and girls.

The findings highlight the need to promote “balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change,” the authors wrote in their conference abstract.
 

Mental illness risk

In an interview, Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, noted that “during adolescence, the tendency to become more of a night owl naturally worsens, and when kids have no sleep schedule imposed on them, these patterns become exacerbated.”

Dr. Benca, who was not involved in the study, also noted that altered sleep patterns are risk factors for psychiatric illness.

“Adolescence, in particular, is so critical for brain development, and it really raises the question of whether sleep disturbances in adolescence or poor sleep patterns are contributing to the increase psychiatric epidemic we’re seeing in adolescents and children these days,” said Dr. Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, N.C.

Also weighing in on the study, journalist and author Lisa Lewis, MS, based in Southern California, said, “It’s not surprising that tech use and social media – which is such an important part of their social worlds – went up during the pandemic.”

Ms. Lewis, a parent of two teenagers, played a key role in California’s new healthy school start times law, the first of its kind in the nation, and is the author of the newly released book, The Sleep-Deprived Teen (Mango Publishing).

“Far too many adolescents aren’t getting anywhere close to the 8-10 hours of nightly sleep they need,” Ms. Lewis said in an interview.

She noted that the the American Academy of Pediatrics recommends no tech use an hour before bed.

“And there are other house rules parents can implement, such as charging all devices in a central location, like the kitchen. Making sleep a priority helps teens, but it helps parents too: No one functions well when they’re sleep-deprived,” Ms. Lewis added.

Support for the study was provided by the National Institutes of Health. The authors have disclosed no relevant financial relationships. Dr. Benca is a consultant for Idorsia Pharmaceuticals. Ms. Lewis has no relevant disclosures.

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

The Food and Drug Administration published a warning from the medical device company Baxter International, citing problems with their device used for at-home respiratory therapy. The release cautions Volara system users that using certain therapies from the device may cause a change in lung pressure and a decrease in oxygen level. This cautionary warning was issued following a single reported case of oxygen loss while using the device.

The Volara system is meant to help patients with persistent pulmonary problems who are transitioning from the hospital to the outpatient setting. It can connect to three pieces commonly used in treating the respiratory conditions – a tracheostomy tube, a mask, and an in-line ventilator. The device offers three therapies – one to expand lungs (OLE), one to shake mucus from the lungs (CHFO), and a nebulizer to deliver medication.

This particular warning is relevant only to patients who use the system with an in-line ventilator or to patients who use OLE and CHFO therapies. The concern is that a rapid change in lung pressure (barotrauma), could damage the tissue by overextending the surface of the organ. Additionally, as noted in the reported case, Volara users may be at risk for a decrease in the level of oxygen while using the device (oxygen desaturation).

If patients have been directed to use Volara by a physician, the FDA recommends they continue to use it as prescribed. But they should look out for signs of respiratory distress. These include changes in alertness, the appearance of a blue tint around the mouth, increased breathing rate, and wheezing. If a patient or caregiver sees these signs, the patient should stop using Volara immediately and should seek help if their symptoms don’t improve.

In response to these precautions, Baxter says it will update the instructions for the use of its device and will add additional warnings. The company says it will dispatch a trainer to patients’ homes to help them understand the newest guidelines.

Both the FDA and Baxter urge patients who have experienced any problems with the device to report it to the hotlines listed at the bottom of their release.

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

The Food and Drug Administration published a warning from the medical device company Baxter International, citing problems with their device used for at-home respiratory therapy. The release cautions Volara system users that using certain therapies from the device may cause a change in lung pressure and a decrease in oxygen level. This cautionary warning was issued following a single reported case of oxygen loss while using the device.

The Volara system is meant to help patients with persistent pulmonary problems who are transitioning from the hospital to the outpatient setting. It can connect to three pieces commonly used in treating the respiratory conditions – a tracheostomy tube, a mask, and an in-line ventilator. The device offers three therapies – one to expand lungs (OLE), one to shake mucus from the lungs (CHFO), and a nebulizer to deliver medication.

This particular warning is relevant only to patients who use the system with an in-line ventilator or to patients who use OLE and CHFO therapies. The concern is that a rapid change in lung pressure (barotrauma), could damage the tissue by overextending the surface of the organ. Additionally, as noted in the reported case, Volara users may be at risk for a decrease in the level of oxygen while using the device (oxygen desaturation).

If patients have been directed to use Volara by a physician, the FDA recommends they continue to use it as prescribed. But they should look out for signs of respiratory distress. These include changes in alertness, the appearance of a blue tint around the mouth, increased breathing rate, and wheezing. If a patient or caregiver sees these signs, the patient should stop using Volara immediately and should seek help if their symptoms don’t improve.

In response to these precautions, Baxter says it will update the instructions for the use of its device and will add additional warnings. The company says it will dispatch a trainer to patients’ homes to help them understand the newest guidelines.

Both the FDA and Baxter urge patients who have experienced any problems with the device to report it to the hotlines listed at the bottom of their release.

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

The Food and Drug Administration published a warning from the medical device company Baxter International, citing problems with their device used for at-home respiratory therapy. The release cautions Volara system users that using certain therapies from the device may cause a change in lung pressure and a decrease in oxygen level. This cautionary warning was issued following a single reported case of oxygen loss while using the device.

The Volara system is meant to help patients with persistent pulmonary problems who are transitioning from the hospital to the outpatient setting. It can connect to three pieces commonly used in treating the respiratory conditions – a tracheostomy tube, a mask, and an in-line ventilator. The device offers three therapies – one to expand lungs (OLE), one to shake mucus from the lungs (CHFO), and a nebulizer to deliver medication.

This particular warning is relevant only to patients who use the system with an in-line ventilator or to patients who use OLE and CHFO therapies. The concern is that a rapid change in lung pressure (barotrauma), could damage the tissue by overextending the surface of the organ. Additionally, as noted in the reported case, Volara users may be at risk for a decrease in the level of oxygen while using the device (oxygen desaturation).

If patients have been directed to use Volara by a physician, the FDA recommends they continue to use it as prescribed. But they should look out for signs of respiratory distress. These include changes in alertness, the appearance of a blue tint around the mouth, increased breathing rate, and wheezing. If a patient or caregiver sees these signs, the patient should stop using Volara immediately and should seek help if their symptoms don’t improve.

In response to these precautions, Baxter says it will update the instructions for the use of its device and will add additional warnings. The company says it will dispatch a trainer to patients’ homes to help them understand the newest guidelines.

Both the FDA and Baxter urge patients who have experienced any problems with the device to report it to the hotlines listed at the bottom of their release.

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

The U.S. Food and Drug Administration has announced a Class I recall for Philips Respironics V60 and V60 Plus ventilators, citing a power failure leading to potential oxygen deprivation. Class I recalls, the most severe, are reserved for devices that may cause serious injury or death, as noted in the FDA’s announcement. As of April 14, one death and four injuries have been associated with this device failure.

These ventilators are commonly used in hospitals or under medical supervision for patients who have difficulty regulating breathing on their own. Normally, if oxygen flow is interrupted, the device sounds alarms, alerting supervisors. The failure comes when a power fluctuation causes the device to randomly shut down, which forces the alarm system to reboot. This internal disruption is the reason for the recall.

When the device shuts down out of the blue, it may or may not sound the requisite alarm that would allow providers to intervene. If the device does not sound the alarm, patients may lose oxygen for an extended period, without a provider even knowing.

Philips was notified of these problems and began the recall process on March 10. Currently, it is estimated that 56,671 devices have been distributed throughout the United States. The FDA and Philips Respironics advise that if providers are already using these ventilators, they may continue to do so in accordance with extra set of instructions.

First, customers should connect the device to an external alarm or nurse call system. Second, they should use an external oxygen monitor and a pulse oximeter to keep track of air flow. Finally, if one is available, there should be a backup ventilator on the premises. That way, if there is an interruption in oxygen flow, someone will be alerted and can quickly intervene.

If there is a problem, the patient should be removed from the Philips ventilator and immediately placed on an alternate device. The FDA instructs customers who have experienced problems to report them to its MedWatch database.

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

The U.S. Food and Drug Administration has announced a Class I recall for Philips Respironics V60 and V60 Plus ventilators, citing a power failure leading to potential oxygen deprivation. Class I recalls, the most severe, are reserved for devices that may cause serious injury or death, as noted in the FDA’s announcement. As of April 14, one death and four injuries have been associated with this device failure.

These ventilators are commonly used in hospitals or under medical supervision for patients who have difficulty regulating breathing on their own. Normally, if oxygen flow is interrupted, the device sounds alarms, alerting supervisors. The failure comes when a power fluctuation causes the device to randomly shut down, which forces the alarm system to reboot. This internal disruption is the reason for the recall.

When the device shuts down out of the blue, it may or may not sound the requisite alarm that would allow providers to intervene. If the device does not sound the alarm, patients may lose oxygen for an extended period, without a provider even knowing.

Philips was notified of these problems and began the recall process on March 10. Currently, it is estimated that 56,671 devices have been distributed throughout the United States. The FDA and Philips Respironics advise that if providers are already using these ventilators, they may continue to do so in accordance with extra set of instructions.

First, customers should connect the device to an external alarm or nurse call system. Second, they should use an external oxygen monitor and a pulse oximeter to keep track of air flow. Finally, if one is available, there should be a backup ventilator on the premises. That way, if there is an interruption in oxygen flow, someone will be alerted and can quickly intervene.

If there is a problem, the patient should be removed from the Philips ventilator and immediately placed on an alternate device. The FDA instructs customers who have experienced problems to report them to its MedWatch database.

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

The U.S. Food and Drug Administration has announced a Class I recall for Philips Respironics V60 and V60 Plus ventilators, citing a power failure leading to potential oxygen deprivation. Class I recalls, the most severe, are reserved for devices that may cause serious injury or death, as noted in the FDA’s announcement. As of April 14, one death and four injuries have been associated with this device failure.

These ventilators are commonly used in hospitals or under medical supervision for patients who have difficulty regulating breathing on their own. Normally, if oxygen flow is interrupted, the device sounds alarms, alerting supervisors. The failure comes when a power fluctuation causes the device to randomly shut down, which forces the alarm system to reboot. This internal disruption is the reason for the recall.

When the device shuts down out of the blue, it may or may not sound the requisite alarm that would allow providers to intervene. If the device does not sound the alarm, patients may lose oxygen for an extended period, without a provider even knowing.

Philips was notified of these problems and began the recall process on March 10. Currently, it is estimated that 56,671 devices have been distributed throughout the United States. The FDA and Philips Respironics advise that if providers are already using these ventilators, they may continue to do so in accordance with extra set of instructions.

First, customers should connect the device to an external alarm or nurse call system. Second, they should use an external oxygen monitor and a pulse oximeter to keep track of air flow. Finally, if one is available, there should be a backup ventilator on the premises. That way, if there is an interruption in oxygen flow, someone will be alerted and can quickly intervene.

If there is a problem, the patient should be removed from the Philips ventilator and immediately placed on an alternate device. The FDA instructs customers who have experienced problems to report them to its MedWatch database.

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

Approximately half of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with glofitamab showed clinical response, based on phase 2 data from 154 adults.

“We know that relapsed diffuse large B-cell lymphoma has a particularly poor prognosis,” especially for patients who have undergone at least two therapies, Dr. Michael Dickinson, MBBS, of the University of Melbourne said in a presentation at the annual meeting of the American Society of Clinical Oncology.

Bispecific T cell–recruiting antibodies are emerging as a novel treatment option for B-cell cancers, said Dr. Dickinson.

Glofitamab is distinct among these therapies for its configuration that is bivalent for CD20 and monovalent for CD3, providing more potency than a 1:1 format, Dr. Dickinson explained in his presentation.

The study population included 154 adults aged 21-90 years with DLBCL who had received at least two prior treatments; all had received prior anti-CD20 Ab, and 149 had received anthracycline. The median age of the patients was 66 years, 65% were male, 75% had Ann Arbor stage III or IV disease, and 90% were refractory to any prior therapy.

The patients received intravenous glutamate-pyruvate transaminase, followed by an initial intravenous dose of glofitamab 7 days later. Glofitamab was given as step-up doses starting with 2.5 mg to a target of 30 mg.

The primary endpoint was complete response (CR) during initial treatment using Independent Review Committee (IRC) criteria, with overall response rate, duration of response, duration of complete response, progression-free survival, and overall survival as key secondary outcomes.

At a median of 12.6 months’ follow-up, the CR and overall response rates were 39.4% and 51.6%, respectively.

“Responses were achieved early; the median time to first complete response was 42 days,” Dr. Dickinson reported. Of the 38 patients with CR at the data cutoff point, 33 remained in complete remission (87%) based on IRC criteria. Complete response rates were consistent across prespecified subgroups, notably 42% of patients with no prior chimeric antigen receptor T-cell therapy and 70% and 34%, of those who were relapsed or refractory, respectively, to their last prior treatments.

The median duration of overall response was 18.4 months, and the median duration of complete response had not yet been estimated, Dr. Dickinson said. The median progression-free survival and overall survival rates were 4.9 months and 11.5 months, respectively, and the estimated 12-month overall survival was 49.8%.

“These are highly clinically significant results for this difficult to treat population,” Dr. Dickinson said in his presentation.

The most common adverse event was cytokine release syndrome (CRS), which occurred in 63% of patients. Of these, 3.9% were grade 3 or 4. Patients received corticosteroids (27.8%) or tocilizumab for management of CRS.

“As we have shown before, this is a first-course phenomenon, becoming far less frequent once step up dosing is complete,” Dr. Dickinson said in the presentation. “The median time to CRS is predictable, occurring around 10 hours after the IV infusion,” he said. Overall, 3.2% of the patients discontinued because of an adverse event.

A total of eight deaths occurred during the study; five of these were related to COVID-19 and the remaining three were in patients with manifest progression of disease.

Infections are to be expected in such a heavily treated population, and 14.9% of patients developed infections of grade 3 or higher, said Dr. Dickinson. Neutropenia of any grade occurred in 37.7%, febrile neutropenia in 2.6%. Neurological events occurred in 38.3% of patients; 3.2% were grade 3 or higher.

The study did not prospectively record immune effector cell–associated neurotoxicity syndrome, Dr. Dickinson said, but an estimate suggests a rate of 2.6%, and none of the events were considered to be related to glofitamab, he noted.

The researchers also looked at a supporting cohort of 35 patients with a median follow up of more than 2 years. In this group, the complete remission rate was 35% and the median duration of remission was 34.2 months. “Our six longest patients have been in remission for longer than 3 years,” Dr. Dickinson said.

The latest glofitamab data “reflect routine practice and an area of need for this disease,” said Dr. Dickinson.

“I think these results will prove to be very meaningful for our patients with large cell lymphoma, and this drug will prove to be an important treatment option,” he said.
 

More follow-up needed, but findings show promise

A number of CD20/CD3-bispecific antibodies are in development for patients with relapsed/refractory B-cell lymphomas, said study discussant Kerry J. Savage, MD, of the University of British Columbia, Vancouver, who served as the discussant for the session.

Glofitamab differs from other treatments in that it is bivalent for CD20 and monovalent for CD3, “which imparts greater potency,” she noted. Glofitamab also has a silent Fc region that is designed to extend half-life and reduce toxicity.

Patients in the current study had at least two prior regimens, and importantly, “CR rates were similar, regardless of prior therapy,” said Dr. Savage. The longer follow-up cohort provides “a hint that the response may be durable.”

Looking ahead, “the important thing will be response durability” with longer follow-up, she added. “We don’t know the curative potential yet, but the results are encouraging so far.”

In the meantime, “the best use of bispecific antibodies is through clinical trials,” Dr. Savage said. “Keep an eye out for bispecific antibody combination trials as well.”

The study was funded by F. Hoffmann–La Roche. Dr. Dickinson disclosed honoraria from or serving as a consultant to companies including Amgen, Bristol Myers-Squibb, Gilead Sciences, Janssen, MSD, Novartis, and Roche. Dr. Savage disclosed relationships, funding, and support from multiple companies including Bristol Myers-Squibb, Janssen Oncology, Kyowa, Merck, Novartis Canada Pharmaceuticals, Seattle Genetics and Roche.

Approximately half of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with glofitamab showed clinical response, based on phase 2 data from 154 adults.

“We know that relapsed diffuse large B-cell lymphoma has a particularly poor prognosis,” especially for patients who have undergone at least two therapies, Dr. Michael Dickinson, MBBS, of the University of Melbourne said in a presentation at the annual meeting of the American Society of Clinical Oncology.

Bispecific T cell–recruiting antibodies are emerging as a novel treatment option for B-cell cancers, said Dr. Dickinson.

Glofitamab is distinct among these therapies for its configuration that is bivalent for CD20 and monovalent for CD3, providing more potency than a 1:1 format, Dr. Dickinson explained in his presentation.

The study population included 154 adults aged 21-90 years with DLBCL who had received at least two prior treatments; all had received prior anti-CD20 Ab, and 149 had received anthracycline. The median age of the patients was 66 years, 65% were male, 75% had Ann Arbor stage III or IV disease, and 90% were refractory to any prior therapy.

The patients received intravenous glutamate-pyruvate transaminase, followed by an initial intravenous dose of glofitamab 7 days later. Glofitamab was given as step-up doses starting with 2.5 mg to a target of 30 mg.

The primary endpoint was complete response (CR) during initial treatment using Independent Review Committee (IRC) criteria, with overall response rate, duration of response, duration of complete response, progression-free survival, and overall survival as key secondary outcomes.

At a median of 12.6 months’ follow-up, the CR and overall response rates were 39.4% and 51.6%, respectively.

“Responses were achieved early; the median time to first complete response was 42 days,” Dr. Dickinson reported. Of the 38 patients with CR at the data cutoff point, 33 remained in complete remission (87%) based on IRC criteria. Complete response rates were consistent across prespecified subgroups, notably 42% of patients with no prior chimeric antigen receptor T-cell therapy and 70% and 34%, of those who were relapsed or refractory, respectively, to their last prior treatments.

The median duration of overall response was 18.4 months, and the median duration of complete response had not yet been estimated, Dr. Dickinson said. The median progression-free survival and overall survival rates were 4.9 months and 11.5 months, respectively, and the estimated 12-month overall survival was 49.8%.

“These are highly clinically significant results for this difficult to treat population,” Dr. Dickinson said in his presentation.

The most common adverse event was cytokine release syndrome (CRS), which occurred in 63% of patients. Of these, 3.9% were grade 3 or 4. Patients received corticosteroids (27.8%) or tocilizumab for management of CRS.

“As we have shown before, this is a first-course phenomenon, becoming far less frequent once step up dosing is complete,” Dr. Dickinson said in the presentation. “The median time to CRS is predictable, occurring around 10 hours after the IV infusion,” he said. Overall, 3.2% of the patients discontinued because of an adverse event.

A total of eight deaths occurred during the study; five of these were related to COVID-19 and the remaining three were in patients with manifest progression of disease.

Infections are to be expected in such a heavily treated population, and 14.9% of patients developed infections of grade 3 or higher, said Dr. Dickinson. Neutropenia of any grade occurred in 37.7%, febrile neutropenia in 2.6%. Neurological events occurred in 38.3% of patients; 3.2% were grade 3 or higher.

The study did not prospectively record immune effector cell–associated neurotoxicity syndrome, Dr. Dickinson said, but an estimate suggests a rate of 2.6%, and none of the events were considered to be related to glofitamab, he noted.

The researchers also looked at a supporting cohort of 35 patients with a median follow up of more than 2 years. In this group, the complete remission rate was 35% and the median duration of remission was 34.2 months. “Our six longest patients have been in remission for longer than 3 years,” Dr. Dickinson said.

The latest glofitamab data “reflect routine practice and an area of need for this disease,” said Dr. Dickinson.

“I think these results will prove to be very meaningful for our patients with large cell lymphoma, and this drug will prove to be an important treatment option,” he said.
 

More follow-up needed, but findings show promise

A number of CD20/CD3-bispecific antibodies are in development for patients with relapsed/refractory B-cell lymphomas, said study discussant Kerry J. Savage, MD, of the University of British Columbia, Vancouver, who served as the discussant for the session.

Glofitamab differs from other treatments in that it is bivalent for CD20 and monovalent for CD3, “which imparts greater potency,” she noted. Glofitamab also has a silent Fc region that is designed to extend half-life and reduce toxicity.

Patients in the current study had at least two prior regimens, and importantly, “CR rates were similar, regardless of prior therapy,” said Dr. Savage. The longer follow-up cohort provides “a hint that the response may be durable.”

Looking ahead, “the important thing will be response durability” with longer follow-up, she added. “We don’t know the curative potential yet, but the results are encouraging so far.”

In the meantime, “the best use of bispecific antibodies is through clinical trials,” Dr. Savage said. “Keep an eye out for bispecific antibody combination trials as well.”

The study was funded by F. Hoffmann–La Roche. Dr. Dickinson disclosed honoraria from or serving as a consultant to companies including Amgen, Bristol Myers-Squibb, Gilead Sciences, Janssen, MSD, Novartis, and Roche. Dr. Savage disclosed relationships, funding, and support from multiple companies including Bristol Myers-Squibb, Janssen Oncology, Kyowa, Merck, Novartis Canada Pharmaceuticals, Seattle Genetics and Roche.

Approximately half of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) treated with glofitamab showed clinical response, based on phase 2 data from 154 adults.

“We know that relapsed diffuse large B-cell lymphoma has a particularly poor prognosis,” especially for patients who have undergone at least two therapies, Dr. Michael Dickinson, MBBS, of the University of Melbourne said in a presentation at the annual meeting of the American Society of Clinical Oncology.

Bispecific T cell–recruiting antibodies are emerging as a novel treatment option for B-cell cancers, said Dr. Dickinson.

Glofitamab is distinct among these therapies for its configuration that is bivalent for CD20 and monovalent for CD3, providing more potency than a 1:1 format, Dr. Dickinson explained in his presentation.

The study population included 154 adults aged 21-90 years with DLBCL who had received at least two prior treatments; all had received prior anti-CD20 Ab, and 149 had received anthracycline. The median age of the patients was 66 years, 65% were male, 75% had Ann Arbor stage III or IV disease, and 90% were refractory to any prior therapy.

The patients received intravenous glutamate-pyruvate transaminase, followed by an initial intravenous dose of glofitamab 7 days later. Glofitamab was given as step-up doses starting with 2.5 mg to a target of 30 mg.

The primary endpoint was complete response (CR) during initial treatment using Independent Review Committee (IRC) criteria, with overall response rate, duration of response, duration of complete response, progression-free survival, and overall survival as key secondary outcomes.

At a median of 12.6 months’ follow-up, the CR and overall response rates were 39.4% and 51.6%, respectively.

“Responses were achieved early; the median time to first complete response was 42 days,” Dr. Dickinson reported. Of the 38 patients with CR at the data cutoff point, 33 remained in complete remission (87%) based on IRC criteria. Complete response rates were consistent across prespecified subgroups, notably 42% of patients with no prior chimeric antigen receptor T-cell therapy and 70% and 34%, of those who were relapsed or refractory, respectively, to their last prior treatments.

The median duration of overall response was 18.4 months, and the median duration of complete response had not yet been estimated, Dr. Dickinson said. The median progression-free survival and overall survival rates were 4.9 months and 11.5 months, respectively, and the estimated 12-month overall survival was 49.8%.

“These are highly clinically significant results for this difficult to treat population,” Dr. Dickinson said in his presentation.

The most common adverse event was cytokine release syndrome (CRS), which occurred in 63% of patients. Of these, 3.9% were grade 3 or 4. Patients received corticosteroids (27.8%) or tocilizumab for management of CRS.

“As we have shown before, this is a first-course phenomenon, becoming far less frequent once step up dosing is complete,” Dr. Dickinson said in the presentation. “The median time to CRS is predictable, occurring around 10 hours after the IV infusion,” he said. Overall, 3.2% of the patients discontinued because of an adverse event.

A total of eight deaths occurred during the study; five of these were related to COVID-19 and the remaining three were in patients with manifest progression of disease.

Infections are to be expected in such a heavily treated population, and 14.9% of patients developed infections of grade 3 or higher, said Dr. Dickinson. Neutropenia of any grade occurred in 37.7%, febrile neutropenia in 2.6%. Neurological events occurred in 38.3% of patients; 3.2% were grade 3 or higher.

The study did not prospectively record immune effector cell–associated neurotoxicity syndrome, Dr. Dickinson said, but an estimate suggests a rate of 2.6%, and none of the events were considered to be related to glofitamab, he noted.

The researchers also looked at a supporting cohort of 35 patients with a median follow up of more than 2 years. In this group, the complete remission rate was 35% and the median duration of remission was 34.2 months. “Our six longest patients have been in remission for longer than 3 years,” Dr. Dickinson said.

The latest glofitamab data “reflect routine practice and an area of need for this disease,” said Dr. Dickinson.

“I think these results will prove to be very meaningful for our patients with large cell lymphoma, and this drug will prove to be an important treatment option,” he said.
 

More follow-up needed, but findings show promise

A number of CD20/CD3-bispecific antibodies are in development for patients with relapsed/refractory B-cell lymphomas, said study discussant Kerry J. Savage, MD, of the University of British Columbia, Vancouver, who served as the discussant for the session.

Glofitamab differs from other treatments in that it is bivalent for CD20 and monovalent for CD3, “which imparts greater potency,” she noted. Glofitamab also has a silent Fc region that is designed to extend half-life and reduce toxicity.

Patients in the current study had at least two prior regimens, and importantly, “CR rates were similar, regardless of prior therapy,” said Dr. Savage. The longer follow-up cohort provides “a hint that the response may be durable.”

Looking ahead, “the important thing will be response durability” with longer follow-up, she added. “We don’t know the curative potential yet, but the results are encouraging so far.”

In the meantime, “the best use of bispecific antibodies is through clinical trials,” Dr. Savage said. “Keep an eye out for bispecific antibody combination trials as well.”

The study was funded by F. Hoffmann–La Roche. Dr. Dickinson disclosed honoraria from or serving as a consultant to companies including Amgen, Bristol Myers-Squibb, Gilead Sciences, Janssen, MSD, Novartis, and Roche. Dr. Savage disclosed relationships, funding, and support from multiple companies including Bristol Myers-Squibb, Janssen Oncology, Kyowa, Merck, Novartis Canada Pharmaceuticals, Seattle Genetics and Roche.

Living the dream, diagnosing the nightmare

Does a bad dream mean you should be consulting your doctor about an impending neurologic disease? Maybe.

New research published in eClinicalMedicine suggests that, for some people, bad dreams and nightmares have been associated with developing Parkinson’s disease later in life. Dr. Abidemi I. Otaiku of the University of Birmingham (England) analyzed data from a cohort study involving 3,818 older men, of whom 2.3% were diagnosed with Parkinson’s during the 12 years of follow-up.

©Wavebreakmedia Ltd/Thinkstock

Dr. Otaiku found those with frequent nightmares – at least once per week – were twice as likely to develop Parkinson’s than were those without, with most of the diagnoses coming in the first 5 years.

Although more research needs to be done, “identifying the significance of bad dreams and nightmares could indicate that individuals who experience changes to their dreams in older age – without any obvious trigger – should seek medical advice,” he said in a Eurekalert statement.

Dr. Otaiku pointed out that studying dreams can tell us a lot about how our brains work and are structured. By using electroencephalography, Dr. Otaiku plans to look into the biological reasons for why we dream the way we do.

So could it be that those killer clowns are actually giving you a heads up on your health?
 

Maybe next time try a paper route

There’s just no winning with teenagers sometimes. You tell them to go outside, they’ll sit in the dark playing video games all night. You tell them to get better grades, they’ll skip school. You tell them to get a hobby, they’ll scam the German government for millions of euros.

The COVID-19 pandemic has been tricky for governments to manage. Massive amounts of infrastructure needed to be set up, and that means corners got cut. Germany was no exception in this regard; the government entrusted the Kassenärztlichen Vereinigung, a doctor’s association, with overseeing COVID testing and payment at private test centers. To make things a bit easier, all they required private test centers to provide to receive reimbursement was an invoice.

AvailableLight/Getty Images

This is where our 17-year-old from Freiburg comes in. In a spark of entrepreneurial genius, he decided to falsify documents and create an entirely fictional COVID test center. The KV approved it, and between March and July of 2021, he sent in thousands of fake invoices. Over that 4-month period, he submitted 500,000 invoices and received 5.7 million euros as compensation. That’s a few thousand tests per day, which was absolutely absurd, but he avoided scrutiny for months.

In the end, it wasn’t even the KV that noticed the fraud, but the bank. A bank employee noticed millions flowing into the account of a teenager and suspected money laundering, alerting the government. Fortunately for our young friend, since he was under 18 when he hatched his scheme, he was tried as a minor, avoiding jail time. His ill-gotten gains were confiscated, he has to pay a relatively minimal fine, and he will be on probation for 1 year. And presumably, he’ll be on the receiving end of the grounding of a lifetime.
 

You look like I need more sleep

Like most people, not getting our beauty sleep can make us look tired and feel less attractive, but a new study from Sweden shows that the sleep deprived also are more likely to find others less attractive. That’s probably not a good finding for singles who often go out trying to meet someone after a long day of work.

PRImageFactory/iStock/Getty Images

For the study, 45 young men and women were required to spend one night with no sleep and then another night with the possibility of 8 hours of sleep. The following mornings, eye-tracking technology was used as they looked at images of happy, angry, fearful, and neutral faces. The subjects then rated the faces for attractiveness, trustworthiness, and healthiness.

“The finding that sleep-deprived subjects in our experiment rated angry faces as less trustworthy and healthy-looking and neutral and fearful faces as less attractive indicates that sleep loss is associated with more negative social impressions of others,” senior author Christian Benedict of Uppsala University said in a statement.

When we are sleep deprived, the researchers added, we might not stop to really look at someone else, which has a negative impact on how we perceive people because we are not focusing on what their facial expressions are really telling us.

We already knew that not sleeping well has many negative effects on us, but now – thank you very much, science – we have something else to think about. Better hope your crush at work gets enough sleep so you’ll be accurately noticed.
 

The expanding-hole illusion of science

Time for a LOTME-style reality check: I think, therefore I am.

So far, so good. Next step: I think, therefore I am. I think.

Works for us. Now for the biggie: I think I am seeing the black hole in the middle of this image expanding.

Laeng, Nabil, and Kitaoka

Does that work for you? Do you perceive the black hole as expanding? If you do, then you fit in with the 86% of subjects in a recent study who perceived the same thing.

Lead author Bruno Laeng of the University of Oslo explained the effect in a statement from Frontiers Science News. “The circular smear or shadow gradient of the central black hole evokes a marked impression of optic flow, as if the observer were heading forward into a hole or tunnel. ... The pupil reacts to how we perceive light – even if this ‘light’ is imaginary like in the illusion – and not just to the amount of light energy that actually enters the eye.”

The illusion is so good at deceiving the brain “that it even prompts a dilation reflex of the pupils to let in more light, just as would happen if we were really moving into a dark area,” the investigators said.

Of the 50 men and women who had their eye movements measured while looking at the illusion, only 14% didn’t perceive the illusion when the hole was black. When the hole was a color, that figure went up to 20%. There also was a strong dilation reflex with black holes, but colored holes caused the subjects’ pupils to constrict, they noted.

Dr. Laeng and his associates can’t explain why some people don’t see the movement, but they did offer this: “Pupils’ dilation or contraction reflex is not a closed-loop mechanism, like a photocell opening a door, impervious to any other information than the actual amount of light stimulating the photoreceptor. Rather, the eye adjusts to perceived and even imagined light, not simply to physical energy.”

And now, back to our reality check: We think we perceive the light of a cheeseburger, therefore it’s time for lunch.

Living the dream, diagnosing the nightmare

Does a bad dream mean you should be consulting your doctor about an impending neurologic disease? Maybe.

New research published in eClinicalMedicine suggests that, for some people, bad dreams and nightmares have been associated with developing Parkinson’s disease later in life. Dr. Abidemi I. Otaiku of the University of Birmingham (England) analyzed data from a cohort study involving 3,818 older men, of whom 2.3% were diagnosed with Parkinson’s during the 12 years of follow-up.

©Wavebreakmedia Ltd/Thinkstock

Dr. Otaiku found those with frequent nightmares – at least once per week – were twice as likely to develop Parkinson’s than were those without, with most of the diagnoses coming in the first 5 years.

Although more research needs to be done, “identifying the significance of bad dreams and nightmares could indicate that individuals who experience changes to their dreams in older age – without any obvious trigger – should seek medical advice,” he said in a Eurekalert statement.

Dr. Otaiku pointed out that studying dreams can tell us a lot about how our brains work and are structured. By using electroencephalography, Dr. Otaiku plans to look into the biological reasons for why we dream the way we do.

So could it be that those killer clowns are actually giving you a heads up on your health?
 

Maybe next time try a paper route

There’s just no winning with teenagers sometimes. You tell them to go outside, they’ll sit in the dark playing video games all night. You tell them to get better grades, they’ll skip school. You tell them to get a hobby, they’ll scam the German government for millions of euros.

The COVID-19 pandemic has been tricky for governments to manage. Massive amounts of infrastructure needed to be set up, and that means corners got cut. Germany was no exception in this regard; the government entrusted the Kassenärztlichen Vereinigung, a doctor’s association, with overseeing COVID testing and payment at private test centers. To make things a bit easier, all they required private test centers to provide to receive reimbursement was an invoice.

AvailableLight/Getty Images

This is where our 17-year-old from Freiburg comes in. In a spark of entrepreneurial genius, he decided to falsify documents and create an entirely fictional COVID test center. The KV approved it, and between March and July of 2021, he sent in thousands of fake invoices. Over that 4-month period, he submitted 500,000 invoices and received 5.7 million euros as compensation. That’s a few thousand tests per day, which was absolutely absurd, but he avoided scrutiny for months.

In the end, it wasn’t even the KV that noticed the fraud, but the bank. A bank employee noticed millions flowing into the account of a teenager and suspected money laundering, alerting the government. Fortunately for our young friend, since he was under 18 when he hatched his scheme, he was tried as a minor, avoiding jail time. His ill-gotten gains were confiscated, he has to pay a relatively minimal fine, and he will be on probation for 1 year. And presumably, he’ll be on the receiving end of the grounding of a lifetime.
 

You look like I need more sleep

Like most people, not getting our beauty sleep can make us look tired and feel less attractive, but a new study from Sweden shows that the sleep deprived also are more likely to find others less attractive. That’s probably not a good finding for singles who often go out trying to meet someone after a long day of work.

PRImageFactory/iStock/Getty Images

For the study, 45 young men and women were required to spend one night with no sleep and then another night with the possibility of 8 hours of sleep. The following mornings, eye-tracking technology was used as they looked at images of happy, angry, fearful, and neutral faces. The subjects then rated the faces for attractiveness, trustworthiness, and healthiness.

“The finding that sleep-deprived subjects in our experiment rated angry faces as less trustworthy and healthy-looking and neutral and fearful faces as less attractive indicates that sleep loss is associated with more negative social impressions of others,” senior author Christian Benedict of Uppsala University said in a statement.

When we are sleep deprived, the researchers added, we might not stop to really look at someone else, which has a negative impact on how we perceive people because we are not focusing on what their facial expressions are really telling us.

We already knew that not sleeping well has many negative effects on us, but now – thank you very much, science – we have something else to think about. Better hope your crush at work gets enough sleep so you’ll be accurately noticed.
 

The expanding-hole illusion of science

Time for a LOTME-style reality check: I think, therefore I am.

So far, so good. Next step: I think, therefore I am. I think.

Works for us. Now for the biggie: I think I am seeing the black hole in the middle of this image expanding.

Laeng, Nabil, and Kitaoka

Does that work for you? Do you perceive the black hole as expanding? If you do, then you fit in with the 86% of subjects in a recent study who perceived the same thing.

Lead author Bruno Laeng of the University of Oslo explained the effect in a statement from Frontiers Science News. “The circular smear or shadow gradient of the central black hole evokes a marked impression of optic flow, as if the observer were heading forward into a hole or tunnel. ... The pupil reacts to how we perceive light – even if this ‘light’ is imaginary like in the illusion – and not just to the amount of light energy that actually enters the eye.”

The illusion is so good at deceiving the brain “that it even prompts a dilation reflex of the pupils to let in more light, just as would happen if we were really moving into a dark area,” the investigators said.

Of the 50 men and women who had their eye movements measured while looking at the illusion, only 14% didn’t perceive the illusion when the hole was black. When the hole was a color, that figure went up to 20%. There also was a strong dilation reflex with black holes, but colored holes caused the subjects’ pupils to constrict, they noted.

Dr. Laeng and his associates can’t explain why some people don’t see the movement, but they did offer this: “Pupils’ dilation or contraction reflex is not a closed-loop mechanism, like a photocell opening a door, impervious to any other information than the actual amount of light stimulating the photoreceptor. Rather, the eye adjusts to perceived and even imagined light, not simply to physical energy.”

And now, back to our reality check: We think we perceive the light of a cheeseburger, therefore it’s time for lunch.

Living the dream, diagnosing the nightmare

Does a bad dream mean you should be consulting your doctor about an impending neurologic disease? Maybe.

New research published in eClinicalMedicine suggests that, for some people, bad dreams and nightmares have been associated with developing Parkinson’s disease later in life. Dr. Abidemi I. Otaiku of the University of Birmingham (England) analyzed data from a cohort study involving 3,818 older men, of whom 2.3% were diagnosed with Parkinson’s during the 12 years of follow-up.

©Wavebreakmedia Ltd/Thinkstock

Dr. Otaiku found those with frequent nightmares – at least once per week – were twice as likely to develop Parkinson’s than were those without, with most of the diagnoses coming in the first 5 years.

Although more research needs to be done, “identifying the significance of bad dreams and nightmares could indicate that individuals who experience changes to their dreams in older age – without any obvious trigger – should seek medical advice,” he said in a Eurekalert statement.

Dr. Otaiku pointed out that studying dreams can tell us a lot about how our brains work and are structured. By using electroencephalography, Dr. Otaiku plans to look into the biological reasons for why we dream the way we do.

So could it be that those killer clowns are actually giving you a heads up on your health?
 

Maybe next time try a paper route

There’s just no winning with teenagers sometimes. You tell them to go outside, they’ll sit in the dark playing video games all night. You tell them to get better grades, they’ll skip school. You tell them to get a hobby, they’ll scam the German government for millions of euros.

The COVID-19 pandemic has been tricky for governments to manage. Massive amounts of infrastructure needed to be set up, and that means corners got cut. Germany was no exception in this regard; the government entrusted the Kassenärztlichen Vereinigung, a doctor’s association, with overseeing COVID testing and payment at private test centers. To make things a bit easier, all they required private test centers to provide to receive reimbursement was an invoice.

AvailableLight/Getty Images

This is where our 17-year-old from Freiburg comes in. In a spark of entrepreneurial genius, he decided to falsify documents and create an entirely fictional COVID test center. The KV approved it, and between March and July of 2021, he sent in thousands of fake invoices. Over that 4-month period, he submitted 500,000 invoices and received 5.7 million euros as compensation. That’s a few thousand tests per day, which was absolutely absurd, but he avoided scrutiny for months.

In the end, it wasn’t even the KV that noticed the fraud, but the bank. A bank employee noticed millions flowing into the account of a teenager and suspected money laundering, alerting the government. Fortunately for our young friend, since he was under 18 when he hatched his scheme, he was tried as a minor, avoiding jail time. His ill-gotten gains were confiscated, he has to pay a relatively minimal fine, and he will be on probation for 1 year. And presumably, he’ll be on the receiving end of the grounding of a lifetime.
 

You look like I need more sleep

Like most people, not getting our beauty sleep can make us look tired and feel less attractive, but a new study from Sweden shows that the sleep deprived also are more likely to find others less attractive. That’s probably not a good finding for singles who often go out trying to meet someone after a long day of work.

PRImageFactory/iStock/Getty Images

For the study, 45 young men and women were required to spend one night with no sleep and then another night with the possibility of 8 hours of sleep. The following mornings, eye-tracking technology was used as they looked at images of happy, angry, fearful, and neutral faces. The subjects then rated the faces for attractiveness, trustworthiness, and healthiness.

“The finding that sleep-deprived subjects in our experiment rated angry faces as less trustworthy and healthy-looking and neutral and fearful faces as less attractive indicates that sleep loss is associated with more negative social impressions of others,” senior author Christian Benedict of Uppsala University said in a statement.

When we are sleep deprived, the researchers added, we might not stop to really look at someone else, which has a negative impact on how we perceive people because we are not focusing on what their facial expressions are really telling us.

We already knew that not sleeping well has many negative effects on us, but now – thank you very much, science – we have something else to think about. Better hope your crush at work gets enough sleep so you’ll be accurately noticed.
 

The expanding-hole illusion of science

Time for a LOTME-style reality check: I think, therefore I am.

So far, so good. Next step: I think, therefore I am. I think.

Works for us. Now for the biggie: I think I am seeing the black hole in the middle of this image expanding.

Laeng, Nabil, and Kitaoka

Does that work for you? Do you perceive the black hole as expanding? If you do, then you fit in with the 86% of subjects in a recent study who perceived the same thing.

Lead author Bruno Laeng of the University of Oslo explained the effect in a statement from Frontiers Science News. “The circular smear or shadow gradient of the central black hole evokes a marked impression of optic flow, as if the observer were heading forward into a hole or tunnel. ... The pupil reacts to how we perceive light – even if this ‘light’ is imaginary like in the illusion – and not just to the amount of light energy that actually enters the eye.”

The illusion is so good at deceiving the brain “that it even prompts a dilation reflex of the pupils to let in more light, just as would happen if we were really moving into a dark area,” the investigators said.

Of the 50 men and women who had their eye movements measured while looking at the illusion, only 14% didn’t perceive the illusion when the hole was black. When the hole was a color, that figure went up to 20%. There also was a strong dilation reflex with black holes, but colored holes caused the subjects’ pupils to constrict, they noted.

Dr. Laeng and his associates can’t explain why some people don’t see the movement, but they did offer this: “Pupils’ dilation or contraction reflex is not a closed-loop mechanism, like a photocell opening a door, impervious to any other information than the actual amount of light stimulating the photoreceptor. Rather, the eye adjusts to perceived and even imagined light, not simply to physical energy.”

And now, back to our reality check: We think we perceive the light of a cheeseburger, therefore it’s time for lunch.