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High-intensity interval training cuts cardiometabolic risks in women with PCOS
High-intensity interval training (HIIT) was better than moderate-intensity continuous training (MICT) for improving several measures of cardiometabolic health in women with polycystic ovary syndrome (PCOS) in a prospective, randomized, single-center study with 27 women.
After 12 weeks on a supervised exercise regimen, the women with PCOS who followed the HIIT program had significantly better improvements in aerobic capacity, insulin sensitivity, and level of sex hormone–binding globulin, Rhiannon K. Patten, MSc, said at the annual meeting of the Endocrine Society.
“HIIT can offer superior improvements in health outcomes, and should be considered as an effective tool to reduce cardiometabolic risk in women with PCOS,” concluded Ms. Patten, a researcher in the Institute for Health and Sport at Victoria University in Melbourne in her presentation (Abstract OR10-1).
“The changes we see [after 12 weeks on the HIIT regimen] seem to occur despite no change in body mass index, so rather than focus on weight loss we encourage participants to focus on the health improvements that seem to be greater with HIIT. We actively encourage the HIIT protocol right now,” she said.
Both regimens use a stationary cycle ergometer. In the HIIT protocol patients twice weekly pedal through 12 1-minute intervals at a heart rate of 90%-100% maximum, interspersed with 1 minute rest intervals. On a third day per week, patients pedal to a heart rate of 90%-95% maximum for 6-8 intervals maintained for 2 minutes and interspersed with rest intervals of 2 minutes. The MICT regimen used as a comparator has participants pedal to 60%-70% of their maximum heart rate continuously for 50 minutes 3 days weekly.
HIIT saves time
“These findings are relevant to clinical practice, because they demonstrate that HIIT is effective in women with PCOS. Reducing the time devoted to exercise to achieve fitness goals is attractive to patients. The reduced time to achieve training benefits with HIIT should improve patient compliance,” commented Andrea Dunaif, MD, professor and chief of the division of endocrinology, diabetes, and bone disease of the Mount Sinai Health System in New York, who was not involved with the study.
The overall weekly exercise time on the MICT regimen, 150 minutes, halves down to 75 minutes a week in the HIIT program. Guideline recommendations released in 2018 by the International PCOS Network recommended these as acceptable alternative exercise strategies. Ms. Patten and her associates sought to determine whether one strategy surpassed the other, the first time this has been examined in women with PCOS, she said.
They randomized 27 sedentary women 18-45 years old with a body mass index (BMI) above 25 kg/m2 and diagnosed with PCOS by the Rotterdam criteria to a 12-week supervised exercise program on either the HIIT or MICT protocol. Their average BMI at entry was 36-37 kg/m2. The study excluded women who smoked, were pregnant, had an illness or injury that would prevent exercise, or were on an oral contraceptive or insulin-sensitizing medication.
At the end of 12 weeks, neither group had a significant change in average weight or BMI, and waist circumference dropped by an average of just over 2 cm in both treatment groups. Lean mass increased by a mean 1 kg in the HIIT group, a significant change, compared with a nonsignificant 0.3 kg average increase in the MICT group.
Increased aerobic capacity ‘partially explains’ improved insulin sensitivity
Aerobic capacity, measured as peak oxygen consumption (VO2peak), increased by an average 5.7 mL/kg per min among the HIIT patients, significantly more than the mean 3.2 mL/kg per min increase among those in the MICT program.
The insulin sensitivity index rose by a significant, relative 35% among the HIIT patients, but barely budged in the MICT group. Fasting glucose fell significantly and the glucose infusion rate increased significantly among the women who performed HIIT, but again showed little change among those doing MICT.
Analysis showed a significant link between the increase in VO2peak and the increase in insulin sensitivity among the women engaged in HIIT, Ms. Patten reported. The improvement in the insulin sensitivity index was “partially explained” by the increase in VO2peak, she said.
Assessment of hormone levels showed a significant increase in sex hormone–binding globulin in the HIIT patients while those in the MICT group showed a small decline in this level. The free androgen index fell by a relative 39% on average in the HIIT group, a significant drop, but decreased by a much smaller and not significant amount among the women who did MICT. The women who performed HIIT also showed a significant drop in their free testosterone level, a change not seen with MICT.
Women who performed the HIIT protocol also had a significant improvement in their menstrual cyclicity, and significant improvements in depression, stress, and anxiety, Ms Patten reported. She next plans to do longer follow-up on study participants, out to 6 and 12 months after the end of the exercise protocol.
“Overall, the findings suggest that HIIT is superior to MICT for improving fitness and insulin sensitivity in the short term. Results from a number of studies in individuals without PCOS suggest that HIIT is superior to MICT for improving fitness short term,” commented Dr. Dunaif. “This study makes an important contribution by directly investigating the impact of training intensity in women with PCOS. Larger studies will be needed before the superiority of HIIT is established for women with PCOS, and study durations of at least several months will be needed to assess the impact on reproductive outcomes such as ovulation,” she said in an interview. She also called for assessing the effects of HIIT in more diverse populations of women with PCOS.
Ms. Patten had no disclosures. Dr. Dunaif has been a consultant to Equator Therapeutics, Fractyl Laboratories, and Globe Life Sciences.
High-intensity interval training (HIIT) was better than moderate-intensity continuous training (MICT) for improving several measures of cardiometabolic health in women with polycystic ovary syndrome (PCOS) in a prospective, randomized, single-center study with 27 women.
After 12 weeks on a supervised exercise regimen, the women with PCOS who followed the HIIT program had significantly better improvements in aerobic capacity, insulin sensitivity, and level of sex hormone–binding globulin, Rhiannon K. Patten, MSc, said at the annual meeting of the Endocrine Society.
“HIIT can offer superior improvements in health outcomes, and should be considered as an effective tool to reduce cardiometabolic risk in women with PCOS,” concluded Ms. Patten, a researcher in the Institute for Health and Sport at Victoria University in Melbourne in her presentation (Abstract OR10-1).
“The changes we see [after 12 weeks on the HIIT regimen] seem to occur despite no change in body mass index, so rather than focus on weight loss we encourage participants to focus on the health improvements that seem to be greater with HIIT. We actively encourage the HIIT protocol right now,” she said.
Both regimens use a stationary cycle ergometer. In the HIIT protocol patients twice weekly pedal through 12 1-minute intervals at a heart rate of 90%-100% maximum, interspersed with 1 minute rest intervals. On a third day per week, patients pedal to a heart rate of 90%-95% maximum for 6-8 intervals maintained for 2 minutes and interspersed with rest intervals of 2 minutes. The MICT regimen used as a comparator has participants pedal to 60%-70% of their maximum heart rate continuously for 50 minutes 3 days weekly.
HIIT saves time
“These findings are relevant to clinical practice, because they demonstrate that HIIT is effective in women with PCOS. Reducing the time devoted to exercise to achieve fitness goals is attractive to patients. The reduced time to achieve training benefits with HIIT should improve patient compliance,” commented Andrea Dunaif, MD, professor and chief of the division of endocrinology, diabetes, and bone disease of the Mount Sinai Health System in New York, who was not involved with the study.
The overall weekly exercise time on the MICT regimen, 150 minutes, halves down to 75 minutes a week in the HIIT program. Guideline recommendations released in 2018 by the International PCOS Network recommended these as acceptable alternative exercise strategies. Ms. Patten and her associates sought to determine whether one strategy surpassed the other, the first time this has been examined in women with PCOS, she said.
They randomized 27 sedentary women 18-45 years old with a body mass index (BMI) above 25 kg/m2 and diagnosed with PCOS by the Rotterdam criteria to a 12-week supervised exercise program on either the HIIT or MICT protocol. Their average BMI at entry was 36-37 kg/m2. The study excluded women who smoked, were pregnant, had an illness or injury that would prevent exercise, or were on an oral contraceptive or insulin-sensitizing medication.
At the end of 12 weeks, neither group had a significant change in average weight or BMI, and waist circumference dropped by an average of just over 2 cm in both treatment groups. Lean mass increased by a mean 1 kg in the HIIT group, a significant change, compared with a nonsignificant 0.3 kg average increase in the MICT group.
Increased aerobic capacity ‘partially explains’ improved insulin sensitivity
Aerobic capacity, measured as peak oxygen consumption (VO2peak), increased by an average 5.7 mL/kg per min among the HIIT patients, significantly more than the mean 3.2 mL/kg per min increase among those in the MICT program.
The insulin sensitivity index rose by a significant, relative 35% among the HIIT patients, but barely budged in the MICT group. Fasting glucose fell significantly and the glucose infusion rate increased significantly among the women who performed HIIT, but again showed little change among those doing MICT.
Analysis showed a significant link between the increase in VO2peak and the increase in insulin sensitivity among the women engaged in HIIT, Ms. Patten reported. The improvement in the insulin sensitivity index was “partially explained” by the increase in VO2peak, she said.
Assessment of hormone levels showed a significant increase in sex hormone–binding globulin in the HIIT patients while those in the MICT group showed a small decline in this level. The free androgen index fell by a relative 39% on average in the HIIT group, a significant drop, but decreased by a much smaller and not significant amount among the women who did MICT. The women who performed HIIT also showed a significant drop in their free testosterone level, a change not seen with MICT.
Women who performed the HIIT protocol also had a significant improvement in their menstrual cyclicity, and significant improvements in depression, stress, and anxiety, Ms Patten reported. She next plans to do longer follow-up on study participants, out to 6 and 12 months after the end of the exercise protocol.
“Overall, the findings suggest that HIIT is superior to MICT for improving fitness and insulin sensitivity in the short term. Results from a number of studies in individuals without PCOS suggest that HIIT is superior to MICT for improving fitness short term,” commented Dr. Dunaif. “This study makes an important contribution by directly investigating the impact of training intensity in women with PCOS. Larger studies will be needed before the superiority of HIIT is established for women with PCOS, and study durations of at least several months will be needed to assess the impact on reproductive outcomes such as ovulation,” she said in an interview. She also called for assessing the effects of HIIT in more diverse populations of women with PCOS.
Ms. Patten had no disclosures. Dr. Dunaif has been a consultant to Equator Therapeutics, Fractyl Laboratories, and Globe Life Sciences.
High-intensity interval training (HIIT) was better than moderate-intensity continuous training (MICT) for improving several measures of cardiometabolic health in women with polycystic ovary syndrome (PCOS) in a prospective, randomized, single-center study with 27 women.
After 12 weeks on a supervised exercise regimen, the women with PCOS who followed the HIIT program had significantly better improvements in aerobic capacity, insulin sensitivity, and level of sex hormone–binding globulin, Rhiannon K. Patten, MSc, said at the annual meeting of the Endocrine Society.
“HIIT can offer superior improvements in health outcomes, and should be considered as an effective tool to reduce cardiometabolic risk in women with PCOS,” concluded Ms. Patten, a researcher in the Institute for Health and Sport at Victoria University in Melbourne in her presentation (Abstract OR10-1).
“The changes we see [after 12 weeks on the HIIT regimen] seem to occur despite no change in body mass index, so rather than focus on weight loss we encourage participants to focus on the health improvements that seem to be greater with HIIT. We actively encourage the HIIT protocol right now,” she said.
Both regimens use a stationary cycle ergometer. In the HIIT protocol patients twice weekly pedal through 12 1-minute intervals at a heart rate of 90%-100% maximum, interspersed with 1 minute rest intervals. On a third day per week, patients pedal to a heart rate of 90%-95% maximum for 6-8 intervals maintained for 2 minutes and interspersed with rest intervals of 2 minutes. The MICT regimen used as a comparator has participants pedal to 60%-70% of their maximum heart rate continuously for 50 minutes 3 days weekly.
HIIT saves time
“These findings are relevant to clinical practice, because they demonstrate that HIIT is effective in women with PCOS. Reducing the time devoted to exercise to achieve fitness goals is attractive to patients. The reduced time to achieve training benefits with HIIT should improve patient compliance,” commented Andrea Dunaif, MD, professor and chief of the division of endocrinology, diabetes, and bone disease of the Mount Sinai Health System in New York, who was not involved with the study.
The overall weekly exercise time on the MICT regimen, 150 minutes, halves down to 75 minutes a week in the HIIT program. Guideline recommendations released in 2018 by the International PCOS Network recommended these as acceptable alternative exercise strategies. Ms. Patten and her associates sought to determine whether one strategy surpassed the other, the first time this has been examined in women with PCOS, she said.
They randomized 27 sedentary women 18-45 years old with a body mass index (BMI) above 25 kg/m2 and diagnosed with PCOS by the Rotterdam criteria to a 12-week supervised exercise program on either the HIIT or MICT protocol. Their average BMI at entry was 36-37 kg/m2. The study excluded women who smoked, were pregnant, had an illness or injury that would prevent exercise, or were on an oral contraceptive or insulin-sensitizing medication.
At the end of 12 weeks, neither group had a significant change in average weight or BMI, and waist circumference dropped by an average of just over 2 cm in both treatment groups. Lean mass increased by a mean 1 kg in the HIIT group, a significant change, compared with a nonsignificant 0.3 kg average increase in the MICT group.
Increased aerobic capacity ‘partially explains’ improved insulin sensitivity
Aerobic capacity, measured as peak oxygen consumption (VO2peak), increased by an average 5.7 mL/kg per min among the HIIT patients, significantly more than the mean 3.2 mL/kg per min increase among those in the MICT program.
The insulin sensitivity index rose by a significant, relative 35% among the HIIT patients, but barely budged in the MICT group. Fasting glucose fell significantly and the glucose infusion rate increased significantly among the women who performed HIIT, but again showed little change among those doing MICT.
Analysis showed a significant link between the increase in VO2peak and the increase in insulin sensitivity among the women engaged in HIIT, Ms. Patten reported. The improvement in the insulin sensitivity index was “partially explained” by the increase in VO2peak, she said.
Assessment of hormone levels showed a significant increase in sex hormone–binding globulin in the HIIT patients while those in the MICT group showed a small decline in this level. The free androgen index fell by a relative 39% on average in the HIIT group, a significant drop, but decreased by a much smaller and not significant amount among the women who did MICT. The women who performed HIIT also showed a significant drop in their free testosterone level, a change not seen with MICT.
Women who performed the HIIT protocol also had a significant improvement in their menstrual cyclicity, and significant improvements in depression, stress, and anxiety, Ms Patten reported. She next plans to do longer follow-up on study participants, out to 6 and 12 months after the end of the exercise protocol.
“Overall, the findings suggest that HIIT is superior to MICT for improving fitness and insulin sensitivity in the short term. Results from a number of studies in individuals without PCOS suggest that HIIT is superior to MICT for improving fitness short term,” commented Dr. Dunaif. “This study makes an important contribution by directly investigating the impact of training intensity in women with PCOS. Larger studies will be needed before the superiority of HIIT is established for women with PCOS, and study durations of at least several months will be needed to assess the impact on reproductive outcomes such as ovulation,” she said in an interview. She also called for assessing the effects of HIIT in more diverse populations of women with PCOS.
Ms. Patten had no disclosures. Dr. Dunaif has been a consultant to Equator Therapeutics, Fractyl Laboratories, and Globe Life Sciences.
FROM ENDO 2021
Women with PCOS at increased risk for COVID-19
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Reassuring’ data on COVID-19 vaccines in pregnancy
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population. 
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population.
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population.
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Most breast cancer screening centers not following guidelines
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Baby born to partially vaccinated mom has COVID-19 antibodies
A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.
The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.
“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.
Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.
Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.
“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.
“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.
In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.
The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.
Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.
“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.
A version of this article first appeared on Medscape.com.
A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.
The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.
“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.
Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.
Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.
“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.
“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.
In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.
The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.
Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.
“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.
A version of this article first appeared on Medscape.com.
A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.
The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.
“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.
Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.
Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.
“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.
“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.
In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.
The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.
Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.
“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.
A version of this article first appeared on Medscape.com.
Is the WHO’s HPV vaccination target within reach?
The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.
Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.
The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”
However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.
HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).
Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.
In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
HPV vaccination by region
The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.
In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.
The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.
In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.
Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).
Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.
Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.
The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
HPV vaccination by sex
By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).
Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.
From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
Obstacles and the path forward
The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.
An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.
While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.
“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”
Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:
- Secure sufficient and affordable HPV vaccines.
- Increase the quality and coverage of vaccination.
- Improve communication and social mobilization.
- Innovate to improve efficiency of vaccine delivery.
“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”
This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.
The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.
Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.
The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”
However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.
HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).
Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.
In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
HPV vaccination by region
The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.
In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.
The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.
In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.
Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).
Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.
Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.
The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
HPV vaccination by sex
By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).
Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.
From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
Obstacles and the path forward
The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.
An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.
While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.
“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”
Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:
- Secure sufficient and affordable HPV vaccines.
- Increase the quality and coverage of vaccination.
- Improve communication and social mobilization.
- Innovate to improve efficiency of vaccine delivery.
“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”
This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.
The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.
Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.
The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”
However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.
HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).
Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.
In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
HPV vaccination by region
The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.
In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.
The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.
In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.
Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).
Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.
Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.
The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
HPV vaccination by sex
By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).
Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.
From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
Obstacles and the path forward
The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.
An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.
While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.
“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”
Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:
- Secure sufficient and affordable HPV vaccines.
- Increase the quality and coverage of vaccination.
- Improve communication and social mobilization.
- Innovate to improve efficiency of vaccine delivery.
“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”
This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.
FROM PREVENTIVE MEDICINE
Meghan Markle interview resurfaces suicidality screening debate
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists. 
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists.
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists.
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
Pregnant patients with severe COVID-19 disease at increased risk of complications
Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
Disease severity linked to risk of perinatal complications
In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.
The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.
Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.
The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.
Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.
Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).
The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.
Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.
Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.
Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
Similar findings in Washington
In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.
Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).
“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.
“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.
Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.
“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”
The findings also confirm the importance of pregnant people taking precautions to avoid infection.
“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”
The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.
Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
Disease severity linked to risk of perinatal complications
In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.
The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.
Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.
The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.
Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.
Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).
The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.
Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.
Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.
Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
Similar findings in Washington
In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.
Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).
“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.
“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.
Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.
“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”
The findings also confirm the importance of pregnant people taking precautions to avoid infection.
“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”
The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.
Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
Disease severity linked to risk of perinatal complications
In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.
The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.
Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.
The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.
Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.
Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).
The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.
Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.
Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.
Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
Similar findings in Washington
In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.
Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).
“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.
“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.
Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.
“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”
The findings also confirm the importance of pregnant people taking precautions to avoid infection.
“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”
The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.
FROM THE PREGNANCY MEETING
Don’t discontinue osteoporosis meds for COVID-19 vaccines, expert guidance says
COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.
They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.
The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.
There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”
There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.
There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.
A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.
No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.
The guidance includes some recommendations for specific osteoporosis medications.
- Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
- Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
- Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
- Teriparatide and abaloparatide should be continued.
- Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
- Raloxifene should be continued in patients receiving COVID-19 vaccination.
Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
Dr. Jan De Beur has no relevant financial disclosures.
COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.
They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.
The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.
There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”
There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.
There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.
A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.
No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.
The guidance includes some recommendations for specific osteoporosis medications.
- Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
- Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
- Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
- Teriparatide and abaloparatide should be continued.
- Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
- Raloxifene should be continued in patients receiving COVID-19 vaccination.
Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
Dr. Jan De Beur has no relevant financial disclosures.
COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.
They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.
The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.
There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”
There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.
There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.
A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.
No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.
The guidance includes some recommendations for specific osteoporosis medications.
- Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
- Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
- Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
- Teriparatide and abaloparatide should be continued.
- Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
- Raloxifene should be continued in patients receiving COVID-19 vaccination.
Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
Dr. Jan De Beur has no relevant financial disclosures.
Obesity: A ‘double hit’ in pregnant women with heart disease
Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.
The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).
The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).
Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).
In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.
Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.
“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.
The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.
Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.
Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).
Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).
The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.
Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).
“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.
Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.
Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”
Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.
Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”
They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.
Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.
“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.
The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.
The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.
The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).
The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).
Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).
In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.
Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.
“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.
The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.
Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.
Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).
Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).
The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.
Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).
“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.
Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.
Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”
Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.
Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”
They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.
Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.
“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.
The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.
The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Being obese and pregnant raises the risk for cardiac complications in women with preexisting heart disease, new research suggests, highlighting the need for earlier interventions in this high-risk population.
The analysis of 790 pregnancies revealed that 23% of women with obesity, defined as body mass index greater than 30 kg/m2, had a cardiac event during pregnancy versus 14% of women with normal body weight (P = .006).
The difference was driven largely by an increase in heart failure (8% vs. 3%; P = .02), although arrhythmias also trended higher in obese women (14% vs. 10%; P = .19).
Nearly half of the women with obesity and a cardiac event presented in the postpartum period (47%).
In multivariate analysis, both obesity and Canadian Cardiac Disease in Pregnancy Study (CARPREG) II risk score were independent predictors of cardiac events (odds ratios for both, 1.7), the investigators, led by Birgit Pfaller, MD, University of Toronto, reported in the Journal of the American College of Cardiology.
Although obesity has been linked to worse pregnancy outcomes and higher cardiovascular risk after delivery in the general population, the authors noted that this is the first study to examine its effect on outcomes in women with heart disease.
“We wanted to look at this high-risk group of women that had preexisting heart disease, but in addition had obesity, to try and find out if there was a kind of double hit for these women – and that, in the end, is what we found. It’s not just simply having heart disease, not simply having obesity, but the combination that’s problematic,” senior author and cardiologist Candice Silversides, MD, University of Toronto, said in an interview.
The findings are concerning given the rising prevalence of obesity worldwide. National data from 2018 show that slightly more than half of women who gave birth in the United States were significantly overweight or obese before becoming pregnant.
Similarly, in the present analysis of 600 women in the CARPREG study who gave birth from 2004 to 2014, nearly 1 in 5 pregnancies (19%) occurred in women with obesity and 25% were in overweight women.
Obese women were significantly more likely than those without obesity to have coronary artery disease (6% vs. 2%), cardiomyopathies (19% vs. 8%) and left ventricular dysfunction (19% vs. 12%) and to be hypertensive or have a hypertensive disorder of pregnancy (13% vs. 3%).
Preeclampsia developed in 32 women during the index pregnancy and 69% of these women were obese or overweight. Cardiac event rates were similar in women with or without preeclampsia but trended higher in women with preeclampsia with versus without obesity (36% vs. 14%; P = .20).
The ill effects of obesity were also reflected in fetal and neonatal events. Overall, 43% of women with obesity and 33% of normal-weight women had at least one fetal event (P = .02), with higher rates of preterm birth (19% vs. 10%; P = .005) and respiratory distress syndrome (8% vs. 3%; P = .02) in women with obesity. Congenital cardiac malformations were present in 6% of women in both groups.
Taken together, the composite of cardiac events, preeclampsia, or fetal events was significantly more common in women with obesity than in normal-weight women (56% vs. 41%; P = .002).
“We’ve spent the last number of years trying to research and understand what the drivers of these adverse outcomes are in this high-risk pregnant cohort, but on a bigger picture the real issue is how do we start intervening in a meaningful way,” Dr. Silversides said.
Like many in the burgeoning field of cardio-obstetrics, the team proposed a multidisciplinary approach that stresses preconception counseling, educating pregnant women with heart disease and obesity about their risks, ensuring that dietary advice, weight-gain recommendations, and comorbidities are addressed as part of routine care, and providing postpartum surveillance.
Preconception screening “has been the recommendation for a long, long time; it’s just that it doesn’t always happen in reality,” she said. “Many pregnancies aren’t planned and not all women are filtered into preconception counseling. So sometimes you’ll do it at the first antenatal visit and try to ensure women are educated but optimally you want to do it well in advance of pregnancy.”
Part of that preconception counseling “should also include giving them appropriate advice for contraception, if what they want to do is avoid pregnancy,” added Dr. Silversides.
Garima Sharma, MD, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, and colleagues wrote in an accompanying editorial that the adverse events observed in this high-risk cohort have “important implications for cardio-obstetricians and should be incorporated in routine prepregnancy and antenatal counseling, monitoring, and risk stratification for women with existing cardiovascular disease.”
They pointed to a paucity of data incorporating maternal prepregnancy obesity and gestational weight gain in risk prediction and called for larger population-based studies on the additive impact of obesity severity on predicting adverse cardiac events in women with existing cardiovascular disease.
Randomized trials are also urgently needed to evaluate the effect of nutritional and behavioral interventions in pregnancy on short- and long-term outcomes in mother and child.
“As the obesity epidemic continues to grow and public health interventions promoting lifestyle changes for obesity management remain a major challenge, maternal obesity may prove to be the ‘Achilles’ heel’ of sustainable national efforts to reduce maternal mortality and improve health equity. This is a call to action,” Dr. Sharma and colleagues concluded.
The investigators noted that the study was conducted at a single center and used self-reported pregnancy weight collected at the first antenatal visit, which may have underestimated obesity rates. Other limitations are that weight changes over the course of pregnancy were not studied and there was a limited number of women with a body mass index of 40 or higher.
The study was supported by a grant from the Allan E. Tiffin Trust, Toronto General and Western Hospital Foundation, and by a donation from Mrs. Josephine Rogers, Toronto General Hospital. Dr. Silversides is supported by the Miles Nadal Chair in Pregnancy and Heart Disease. Dr. Sharma and colleagues disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.