Ob.Gyn. News

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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

Multifetal pregnancy reduction (MPR) was developed in the 1980s in the wake of significant increases in the incidence of triplets and other higher-order multiples emanating from assisted reproductive technologies (ART). It was offered to reduce fetal number and improve outcomes for remaining fetuses by reducing rates of preterm delivery, fetal growth restriction, and other adverse perinatal outcomes, as well as maternal complications such as preeclampsia and postpartum hemorrhage.

In recent years, improvements in ART – mainly changes in ovulation induction practices and limitations in the number of embryos implanted to two at most – have reversed the increase in higher-order multiples. However, with intrauterine insemination, higher-order multiples still occur, and even without any reproductive assistance, the reality is that multiple pregnancies – particularly twins – continue to exist. In 2018, twins comprised about 3% of births in the United States.¹

Twin pregnancies have a significantly higher risk than singleton gestations of preterm birth, maternal complications, and neonatal morbidity and mortality. The pregnancies are complicated more often by preterm premature rupture of membranes, fetal growth restriction, and hypertensive disorders of pregnancy.

Monochorionic diamniotic twin pregnancies face additional, unique risks of twin-to-twin transfusion syndrome, twin reversed arterial perfusion sequence, and twin-anemia polycythemia sequence. These pregnancies account for about 20% of all twin gestations, and decades of experience with ART have shown us that monochorionic diamniotic gestations occur at a higher rate after in-vitro fertilization.

Although advances have improved the outcomes of multiple births, risks remain and elective MPR is still very relevant for twin gestations. Patients routinely receive counseling about the risks of twin gestations, but they often are not made aware of the option of elective fetal reduction.

We have offered elective reduction (of nonanomalous fetuses) to a singleton for almost 30 years and have published several reports documenting that MPR in dichorionic diamniotic pregnancies reduces the risk of preterm delivery and other complications without increasing the risk of pregnancy loss.

Most recently, we also published data comparing the outcomes of patients with monochorionic diamniotic gestations who underwent elective MPR by radiofrequency ablation (RFA) vs. those with ongoing monochorionic diamniotic gestations.² While the numbers were small, the data show significantly lower rates of preterm birth without an increased risk of pregnancy loss.
 

Experience with dichorionic diamniotic twins, genetic testing

Our most recent review³ of outcomes in dichorionic diamniotic gestations covered 855 patients, 29% of whom underwent planned elective MPR at less than 15 weeks, and 71% of whom had ongoing twin gestations. Those with ongoing twin gestations had adjusted odds ratios of preterm delivery at less than 37 weeks and less than 34 weeks of 5.62 and 2.22, respectively (adjustments controlled for maternal characteristics such as maternal age, BMI, use of chorionic villus sampling [CVS], and history of preterm birth).

Ongoing twin pregnancies were also more likely to have preeclampsia (AOR, 3.33), preterm premature rupture of membranes (3.86), and low birthweight (under the 5th and 10th percentiles). There were no significant differences in the rate of unintended pregnancy loss (2.4% vs. 2.3%), and rates for total pregnancy loss at less than 24 weeks and less than 20 weeks were similar.

An important issue in the consideration of MPR is that prenatal diagnosis of chromosomal abnormalities is very safe in twins. Multiple gestations are at greater risk of chromosomal abnormalities, so performing MPR selectively – if a chromosomally abnormal fetus is present – is desirable for many parents.

A recent meta-analysis and systematic review of studies reporting fetal loss following amniocentesis or CVS in twin pregnancies found an exceedingly low risk of loss. Procedure-related fetal loss (the primary outcome) was lower than previously reported, and the rate of fetal loss before 24 weeks gestation or within 4 weeks after the procedure (secondary outcomes), did not differ from the background risk in twin pregnancies not undergoing invasive prenatal testing.⁴

Our data have shown no significant differences in pregnancy loss between patients who underwent CVS prior to MPR and those who did not. Looking specifically at reduction to a singleton gestation, patients who underwent CVS prior to MPR had a fourfold reduction in loss.⁵ Therefore, we counsel patients that CVS provides useful information – especially now with the common use of chromosomal microarray – at almost negligible risk.
 

MPR for monochorionic diamniotic twins

Most of the literature on MPR from twin to singleton gestations reports on intrathoracic potassium chloride injection used in dichorionic diamniotic twins.

MPR in monochorionic diamniotic twins is reserved in the United States for monochorionic pregnancies in which there are severe fetal anomalies, severe growth restriction, or other significant complications. It is performed in such cases around 20 weeks gestation. However, given the significant risks of monochorionic twin pregnancies, we also have been offering MPR electively and earlier in pregnancy. While many modalities of intrafetal cord occlusion exist, RFA at the cord insertion site into the fetal abdomen is our preferred technique.

In our retrospective review of 315 monochorionic diamniotic twin gestations, the 14 patients who had RFA electively had no pregnancy losses and a significantly lower rate of preterm birth at less than 37-weeks gestation, compared with 301 ongoing monochorionic diamniotic twin pregnancies (29% vs. 76%).⁵ Reduction with RFA, performed at a mean gestational age of 15 weeks, also eliminated the risks unique to monochorionic twins, such as twin-to-twin transfusion syndrome and twin-anemia polycythemia sequence. (Of the ongoing twin gestations, 12% required medically indicated RFA, fetoscopic laser ablation, and/or amnioreduction; 4% had unintended loss of one fetus; and 4% had unintended loss of both fetuses before 24 weeks’ gestation. Fewer than 70% of the ongoing twin gestations had none of the significant adverse outcomes unique to monochorionic twins.)

Interestingly, there were still a couple of cases of fetal growth restriction in patients who underwent elective MPR – a rate higher than that seen in singleton gestations – most likely because of the early timing of the procedure.

Our numbers of MPRs in this review were small, but the data offer at least preliminary evidence that planned elective RFA before 17 weeks gestation may be offered to patients who do not want to assume the risks of monochorionic diamniotic twin pregnancies.

Counseling in twin pregnancies

We perform thorough, early assessments of fetal anatomy in our twin pregnancies, and we undertake thorough medical and obstetrical histories to uncover birth complications or medical conditions that would increase risks of preeclampsia, preterm birth, fetal growth restriction, and other complications.

Because monochorionic gestations are at particularly high risk for heart defects, we also routinely perform fetal echocardiography in these pregnancies.

Genetic testing is offered to all twin pregnancies, and as mentioned above, we especially counsel those considering MPR that such testing provides useful information.

Patients are made aware of the option of MPR and receive nondirective counseling. It is the patient’s choice. We recognize that elective termination is a controversial procedure, but we believe that the option of MPR should be available to patients who want to improve outcomes for their pregnancy.

When anomalies are discovered and selective termination is chosen, we usually try to perform MPR as early as possible. After 16 weeks, we’ve found, the rate of pregnancy loss increases slightly.
 

Dr. Stone is the Ellen and Howard C. Katz Chairman’s Chair, and Dr. DeBolt is a clinical fellow in maternal-fetal medicine, in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Martin JA and Osterman MJK. National Center of Health Statistics. NCHS Data Brief, 2019;no 351.

2. Manasa GR et al. Am J Obstet Gynecol MFM 2021;3:100447.

3. Vieira LA et al. Am J. Obstet Gynecol. 2019;221:253.e1-8.  

4. Di Mascio et al. Ultrasound Obstet Gynecol 2020 Nov;56(5):647-55.

5. Ferrara L et al. Am J Obstet Gynecol. 2008 Oct;199(4):408.e1-4.

Multifetal pregnancy reduction (MPR) was developed in the 1980s in the wake of significant increases in the incidence of triplets and other higher-order multiples emanating from assisted reproductive technologies (ART). It was offered to reduce fetal number and improve outcomes for remaining fetuses by reducing rates of preterm delivery, fetal growth restriction, and other adverse perinatal outcomes, as well as maternal complications such as preeclampsia and postpartum hemorrhage.

In recent years, improvements in ART – mainly changes in ovulation induction practices and limitations in the number of embryos implanted to two at most – have reversed the increase in higher-order multiples. However, with intrauterine insemination, higher-order multiples still occur, and even without any reproductive assistance, the reality is that multiple pregnancies – particularly twins – continue to exist. In 2018, twins comprised about 3% of births in the United States.¹

Twin pregnancies have a significantly higher risk than singleton gestations of preterm birth, maternal complications, and neonatal morbidity and mortality. The pregnancies are complicated more often by preterm premature rupture of membranes, fetal growth restriction, and hypertensive disorders of pregnancy.

Monochorionic diamniotic twin pregnancies face additional, unique risks of twin-to-twin transfusion syndrome, twin reversed arterial perfusion sequence, and twin-anemia polycythemia sequence. These pregnancies account for about 20% of all twin gestations, and decades of experience with ART have shown us that monochorionic diamniotic gestations occur at a higher rate after in-vitro fertilization.

Although advances have improved the outcomes of multiple births, risks remain and elective MPR is still very relevant for twin gestations. Patients routinely receive counseling about the risks of twin gestations, but they often are not made aware of the option of elective fetal reduction.

We have offered elective reduction (of nonanomalous fetuses) to a singleton for almost 30 years and have published several reports documenting that MPR in dichorionic diamniotic pregnancies reduces the risk of preterm delivery and other complications without increasing the risk of pregnancy loss.

Most recently, we also published data comparing the outcomes of patients with monochorionic diamniotic gestations who underwent elective MPR by radiofrequency ablation (RFA) vs. those with ongoing monochorionic diamniotic gestations.² While the numbers were small, the data show significantly lower rates of preterm birth without an increased risk of pregnancy loss.
 

Experience with dichorionic diamniotic twins, genetic testing

Our most recent review³ of outcomes in dichorionic diamniotic gestations covered 855 patients, 29% of whom underwent planned elective MPR at less than 15 weeks, and 71% of whom had ongoing twin gestations. Those with ongoing twin gestations had adjusted odds ratios of preterm delivery at less than 37 weeks and less than 34 weeks of 5.62 and 2.22, respectively (adjustments controlled for maternal characteristics such as maternal age, BMI, use of chorionic villus sampling [CVS], and history of preterm birth).

Ongoing twin pregnancies were also more likely to have preeclampsia (AOR, 3.33), preterm premature rupture of membranes (3.86), and low birthweight (under the 5th and 10th percentiles). There were no significant differences in the rate of unintended pregnancy loss (2.4% vs. 2.3%), and rates for total pregnancy loss at less than 24 weeks and less than 20 weeks were similar.

An important issue in the consideration of MPR is that prenatal diagnosis of chromosomal abnormalities is very safe in twins. Multiple gestations are at greater risk of chromosomal abnormalities, so performing MPR selectively – if a chromosomally abnormal fetus is present – is desirable for many parents.

A recent meta-analysis and systematic review of studies reporting fetal loss following amniocentesis or CVS in twin pregnancies found an exceedingly low risk of loss. Procedure-related fetal loss (the primary outcome) was lower than previously reported, and the rate of fetal loss before 24 weeks gestation or within 4 weeks after the procedure (secondary outcomes), did not differ from the background risk in twin pregnancies not undergoing invasive prenatal testing.⁴

Our data have shown no significant differences in pregnancy loss between patients who underwent CVS prior to MPR and those who did not. Looking specifically at reduction to a singleton gestation, patients who underwent CVS prior to MPR had a fourfold reduction in loss.⁵ Therefore, we counsel patients that CVS provides useful information – especially now with the common use of chromosomal microarray – at almost negligible risk.
 

MPR for monochorionic diamniotic twins

Most of the literature on MPR from twin to singleton gestations reports on intrathoracic potassium chloride injection used in dichorionic diamniotic twins.

MPR in monochorionic diamniotic twins is reserved in the United States for monochorionic pregnancies in which there are severe fetal anomalies, severe growth restriction, or other significant complications. It is performed in such cases around 20 weeks gestation. However, given the significant risks of monochorionic twin pregnancies, we also have been offering MPR electively and earlier in pregnancy. While many modalities of intrafetal cord occlusion exist, RFA at the cord insertion site into the fetal abdomen is our preferred technique.

In our retrospective review of 315 monochorionic diamniotic twin gestations, the 14 patients who had RFA electively had no pregnancy losses and a significantly lower rate of preterm birth at less than 37-weeks gestation, compared with 301 ongoing monochorionic diamniotic twin pregnancies (29% vs. 76%).⁵ Reduction with RFA, performed at a mean gestational age of 15 weeks, also eliminated the risks unique to monochorionic twins, such as twin-to-twin transfusion syndrome and twin-anemia polycythemia sequence. (Of the ongoing twin gestations, 12% required medically indicated RFA, fetoscopic laser ablation, and/or amnioreduction; 4% had unintended loss of one fetus; and 4% had unintended loss of both fetuses before 24 weeks’ gestation. Fewer than 70% of the ongoing twin gestations had none of the significant adverse outcomes unique to monochorionic twins.)

Interestingly, there were still a couple of cases of fetal growth restriction in patients who underwent elective MPR – a rate higher than that seen in singleton gestations – most likely because of the early timing of the procedure.

Our numbers of MPRs in this review were small, but the data offer at least preliminary evidence that planned elective RFA before 17 weeks gestation may be offered to patients who do not want to assume the risks of monochorionic diamniotic twin pregnancies.

Counseling in twin pregnancies

We perform thorough, early assessments of fetal anatomy in our twin pregnancies, and we undertake thorough medical and obstetrical histories to uncover birth complications or medical conditions that would increase risks of preeclampsia, preterm birth, fetal growth restriction, and other complications.

Because monochorionic gestations are at particularly high risk for heart defects, we also routinely perform fetal echocardiography in these pregnancies.

Genetic testing is offered to all twin pregnancies, and as mentioned above, we especially counsel those considering MPR that such testing provides useful information.

Patients are made aware of the option of MPR and receive nondirective counseling. It is the patient’s choice. We recognize that elective termination is a controversial procedure, but we believe that the option of MPR should be available to patients who want to improve outcomes for their pregnancy.

When anomalies are discovered and selective termination is chosen, we usually try to perform MPR as early as possible. After 16 weeks, we’ve found, the rate of pregnancy loss increases slightly.
 

Dr. Stone is the Ellen and Howard C. Katz Chairman’s Chair, and Dr. DeBolt is a clinical fellow in maternal-fetal medicine, in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Martin JA and Osterman MJK. National Center of Health Statistics. NCHS Data Brief, 2019;no 351.

2. Manasa GR et al. Am J Obstet Gynecol MFM 2021;3:100447.

3. Vieira LA et al. Am J. Obstet Gynecol. 2019;221:253.e1-8.  

4. Di Mascio et al. Ultrasound Obstet Gynecol 2020 Nov;56(5):647-55.

5. Ferrara L et al. Am J Obstet Gynecol. 2008 Oct;199(4):408.e1-4.

Multifetal pregnancy reduction (MPR) was developed in the 1980s in the wake of significant increases in the incidence of triplets and other higher-order multiples emanating from assisted reproductive technologies (ART). It was offered to reduce fetal number and improve outcomes for remaining fetuses by reducing rates of preterm delivery, fetal growth restriction, and other adverse perinatal outcomes, as well as maternal complications such as preeclampsia and postpartum hemorrhage.

In recent years, improvements in ART – mainly changes in ovulation induction practices and limitations in the number of embryos implanted to two at most – have reversed the increase in higher-order multiples. However, with intrauterine insemination, higher-order multiples still occur, and even without any reproductive assistance, the reality is that multiple pregnancies – particularly twins – continue to exist. In 2018, twins comprised about 3% of births in the United States.¹

Twin pregnancies have a significantly higher risk than singleton gestations of preterm birth, maternal complications, and neonatal morbidity and mortality. The pregnancies are complicated more often by preterm premature rupture of membranes, fetal growth restriction, and hypertensive disorders of pregnancy.

Monochorionic diamniotic twin pregnancies face additional, unique risks of twin-to-twin transfusion syndrome, twin reversed arterial perfusion sequence, and twin-anemia polycythemia sequence. These pregnancies account for about 20% of all twin gestations, and decades of experience with ART have shown us that monochorionic diamniotic gestations occur at a higher rate after in-vitro fertilization.

Although advances have improved the outcomes of multiple births, risks remain and elective MPR is still very relevant for twin gestations. Patients routinely receive counseling about the risks of twin gestations, but they often are not made aware of the option of elective fetal reduction.

We have offered elective reduction (of nonanomalous fetuses) to a singleton for almost 30 years and have published several reports documenting that MPR in dichorionic diamniotic pregnancies reduces the risk of preterm delivery and other complications without increasing the risk of pregnancy loss.

Most recently, we also published data comparing the outcomes of patients with monochorionic diamniotic gestations who underwent elective MPR by radiofrequency ablation (RFA) vs. those with ongoing monochorionic diamniotic gestations.² While the numbers were small, the data show significantly lower rates of preterm birth without an increased risk of pregnancy loss.
 

Experience with dichorionic diamniotic twins, genetic testing

Our most recent review³ of outcomes in dichorionic diamniotic gestations covered 855 patients, 29% of whom underwent planned elective MPR at less than 15 weeks, and 71% of whom had ongoing twin gestations. Those with ongoing twin gestations had adjusted odds ratios of preterm delivery at less than 37 weeks and less than 34 weeks of 5.62 and 2.22, respectively (adjustments controlled for maternal characteristics such as maternal age, BMI, use of chorionic villus sampling [CVS], and history of preterm birth).

Ongoing twin pregnancies were also more likely to have preeclampsia (AOR, 3.33), preterm premature rupture of membranes (3.86), and low birthweight (under the 5th and 10th percentiles). There were no significant differences in the rate of unintended pregnancy loss (2.4% vs. 2.3%), and rates for total pregnancy loss at less than 24 weeks and less than 20 weeks were similar.

An important issue in the consideration of MPR is that prenatal diagnosis of chromosomal abnormalities is very safe in twins. Multiple gestations are at greater risk of chromosomal abnormalities, so performing MPR selectively – if a chromosomally abnormal fetus is present – is desirable for many parents.

A recent meta-analysis and systematic review of studies reporting fetal loss following amniocentesis or CVS in twin pregnancies found an exceedingly low risk of loss. Procedure-related fetal loss (the primary outcome) was lower than previously reported, and the rate of fetal loss before 24 weeks gestation or within 4 weeks after the procedure (secondary outcomes), did not differ from the background risk in twin pregnancies not undergoing invasive prenatal testing.⁴

Our data have shown no significant differences in pregnancy loss between patients who underwent CVS prior to MPR and those who did not. Looking specifically at reduction to a singleton gestation, patients who underwent CVS prior to MPR had a fourfold reduction in loss.⁵ Therefore, we counsel patients that CVS provides useful information – especially now with the common use of chromosomal microarray – at almost negligible risk.
 

MPR for monochorionic diamniotic twins

Most of the literature on MPR from twin to singleton gestations reports on intrathoracic potassium chloride injection used in dichorionic diamniotic twins.

MPR in monochorionic diamniotic twins is reserved in the United States for monochorionic pregnancies in which there are severe fetal anomalies, severe growth restriction, or other significant complications. It is performed in such cases around 20 weeks gestation. However, given the significant risks of monochorionic twin pregnancies, we also have been offering MPR electively and earlier in pregnancy. While many modalities of intrafetal cord occlusion exist, RFA at the cord insertion site into the fetal abdomen is our preferred technique.

In our retrospective review of 315 monochorionic diamniotic twin gestations, the 14 patients who had RFA electively had no pregnancy losses and a significantly lower rate of preterm birth at less than 37-weeks gestation, compared with 301 ongoing monochorionic diamniotic twin pregnancies (29% vs. 76%).⁵ Reduction with RFA, performed at a mean gestational age of 15 weeks, also eliminated the risks unique to monochorionic twins, such as twin-to-twin transfusion syndrome and twin-anemia polycythemia sequence. (Of the ongoing twin gestations, 12% required medically indicated RFA, fetoscopic laser ablation, and/or amnioreduction; 4% had unintended loss of one fetus; and 4% had unintended loss of both fetuses before 24 weeks’ gestation. Fewer than 70% of the ongoing twin gestations had none of the significant adverse outcomes unique to monochorionic twins.)

Interestingly, there were still a couple of cases of fetal growth restriction in patients who underwent elective MPR – a rate higher than that seen in singleton gestations – most likely because of the early timing of the procedure.

Our numbers of MPRs in this review were small, but the data offer at least preliminary evidence that planned elective RFA before 17 weeks gestation may be offered to patients who do not want to assume the risks of monochorionic diamniotic twin pregnancies.

Counseling in twin pregnancies

We perform thorough, early assessments of fetal anatomy in our twin pregnancies, and we undertake thorough medical and obstetrical histories to uncover birth complications or medical conditions that would increase risks of preeclampsia, preterm birth, fetal growth restriction, and other complications.

Because monochorionic gestations are at particularly high risk for heart defects, we also routinely perform fetal echocardiography in these pregnancies.

Genetic testing is offered to all twin pregnancies, and as mentioned above, we especially counsel those considering MPR that such testing provides useful information.

Patients are made aware of the option of MPR and receive nondirective counseling. It is the patient’s choice. We recognize that elective termination is a controversial procedure, but we believe that the option of MPR should be available to patients who want to improve outcomes for their pregnancy.

When anomalies are discovered and selective termination is chosen, we usually try to perform MPR as early as possible. After 16 weeks, we’ve found, the rate of pregnancy loss increases slightly.
 

Dr. Stone is the Ellen and Howard C. Katz Chairman’s Chair, and Dr. DeBolt is a clinical fellow in maternal-fetal medicine, in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Martin JA and Osterman MJK. National Center of Health Statistics. NCHS Data Brief, 2019;no 351.

2. Manasa GR et al. Am J Obstet Gynecol MFM 2021;3:100447.

3. Vieira LA et al. Am J. Obstet Gynecol. 2019;221:253.e1-8.  

4. Di Mascio et al. Ultrasound Obstet Gynecol 2020 Nov;56(5):647-55.

5. Ferrara L et al. Am J Obstet Gynecol. 2008 Oct;199(4):408.e1-4.

For over 2 years, the world has reeled from the COVID-19 pandemic. Life has changed dramatically, priorities have been re-examined, and the collective approach to health care has shifted tremendously. While concerns regarding coronavirus and its variants are warranted, another “pandemic” is ravaging the world and has yet to be fully addressed: pregnancy-related maternal mortality.

The rate of pregnancy-related deaths in the United States is unconscionable. Compared with other developed nations – such as Germany, the United Kingdom, and Canada – we lag far behind. Data published in 2020 showed that the rate of maternal deaths per 100,000 live births in the United States was 17.4, more than double that of France (8.7 deaths per 100,000 live births),¹ the country with the next-highest rate. Americans like being first – first to invent the light bulb, first to perform a successful solid organ xenotransplantation, first to go to the moon – but holding “first place” in maternal mortality is not something we should wish to maintain.

Ob.gyns. have long raised the alarm regarding the exceedingly high rates of pregnancy-related deaths in the United States. While there have been many advances in antenatal care to reduce these severe adverse events – improvements in surveillance and data reporting, maternal-focused telemedicine services, multidisciplinary care team models, and numerous research initiatives by federal and nonprofit organizations² – the recent wave of legislation restricting reproductive choice may also have the unintended consequence of further increasing the rate of pregnancy-related maternal morbidity and mortality.³

While we have an obligation to provide our maternal and fetal patients with the best possible care, under some circumstances, that care may require prioritizing the mother’s health above all else.

To discuss the judicious use of multifetal pregnancy reduction, we have invited Dr. Joanne Stone, The Ellen and Howard C. Katz Chairman’s Chair, and Dr. Chelsea DeBolt, clinical fellow in maternal-fetal medicine, both in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai.

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. Tikkanen R et al. The Commonwealth Fund. Nov 2020. doi: 10.26099/411v-9255

2. Ahn R et al. Ann Intern Med. 2020;173(11 Suppl):S3-10. doi: 10.7326/M19-3258.

3. Pabayo R et al. Int J Environ Res Public Health. 2020;17(11):3773. doi: 10.3390/ijerph17113773.

For over 2 years, the world has reeled from the COVID-19 pandemic. Life has changed dramatically, priorities have been re-examined, and the collective approach to health care has shifted tremendously. While concerns regarding coronavirus and its variants are warranted, another “pandemic” is ravaging the world and has yet to be fully addressed: pregnancy-related maternal mortality.

The rate of pregnancy-related deaths in the United States is unconscionable. Compared with other developed nations – such as Germany, the United Kingdom, and Canada – we lag far behind. Data published in 2020 showed that the rate of maternal deaths per 100,000 live births in the United States was 17.4, more than double that of France (8.7 deaths per 100,000 live births),¹ the country with the next-highest rate. Americans like being first – first to invent the light bulb, first to perform a successful solid organ xenotransplantation, first to go to the moon – but holding “first place” in maternal mortality is not something we should wish to maintain.

Ob.gyns. have long raised the alarm regarding the exceedingly high rates of pregnancy-related deaths in the United States. While there have been many advances in antenatal care to reduce these severe adverse events – improvements in surveillance and data reporting, maternal-focused telemedicine services, multidisciplinary care team models, and numerous research initiatives by federal and nonprofit organizations² – the recent wave of legislation restricting reproductive choice may also have the unintended consequence of further increasing the rate of pregnancy-related maternal morbidity and mortality.³

While we have an obligation to provide our maternal and fetal patients with the best possible care, under some circumstances, that care may require prioritizing the mother’s health above all else.

To discuss the judicious use of multifetal pregnancy reduction, we have invited Dr. Joanne Stone, The Ellen and Howard C. Katz Chairman’s Chair, and Dr. Chelsea DeBolt, clinical fellow in maternal-fetal medicine, both in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai.

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. Tikkanen R et al. The Commonwealth Fund. Nov 2020. doi: 10.26099/411v-9255

2. Ahn R et al. Ann Intern Med. 2020;173(11 Suppl):S3-10. doi: 10.7326/M19-3258.

3. Pabayo R et al. Int J Environ Res Public Health. 2020;17(11):3773. doi: 10.3390/ijerph17113773.

For over 2 years, the world has reeled from the COVID-19 pandemic. Life has changed dramatically, priorities have been re-examined, and the collective approach to health care has shifted tremendously. While concerns regarding coronavirus and its variants are warranted, another “pandemic” is ravaging the world and has yet to be fully addressed: pregnancy-related maternal mortality.

The rate of pregnancy-related deaths in the United States is unconscionable. Compared with other developed nations – such as Germany, the United Kingdom, and Canada – we lag far behind. Data published in 2020 showed that the rate of maternal deaths per 100,000 live births in the United States was 17.4, more than double that of France (8.7 deaths per 100,000 live births),¹ the country with the next-highest rate. Americans like being first – first to invent the light bulb, first to perform a successful solid organ xenotransplantation, first to go to the moon – but holding “first place” in maternal mortality is not something we should wish to maintain.

Ob.gyns. have long raised the alarm regarding the exceedingly high rates of pregnancy-related deaths in the United States. While there have been many advances in antenatal care to reduce these severe adverse events – improvements in surveillance and data reporting, maternal-focused telemedicine services, multidisciplinary care team models, and numerous research initiatives by federal and nonprofit organizations² – the recent wave of legislation restricting reproductive choice may also have the unintended consequence of further increasing the rate of pregnancy-related maternal morbidity and mortality.³

While we have an obligation to provide our maternal and fetal patients with the best possible care, under some circumstances, that care may require prioritizing the mother’s health above all else.

To discuss the judicious use of multifetal pregnancy reduction, we have invited Dr. Joanne Stone, The Ellen and Howard C. Katz Chairman’s Chair, and Dr. Chelsea DeBolt, clinical fellow in maternal-fetal medicine, both in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai.

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. Tikkanen R et al. The Commonwealth Fund. Nov 2020. doi: 10.26099/411v-9255

2. Ahn R et al. Ann Intern Med. 2020;173(11 Suppl):S3-10. doi: 10.7326/M19-3258.

3. Pabayo R et al. Int J Environ Res Public Health. 2020;17(11):3773. doi: 10.3390/ijerph17113773.

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the Centers for Disease Control and Prevention said April 22.

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the United States in 2021. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of 0.7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.

The demographics of COVID mortality changed slightly, the CDC said in a second report.

Blacks accounted for 13.3% of COVID deaths in 2021 and Hispanics 16.5%, down several percentage points from 2020, the CDC said. Asians made up 3.1% of COVID deaths for 2021, a drop from 3.6% in 2020. White people accounted for 65.2% of COVID deaths in 2021, an increase from 59.6% in 2020.

Non-Hispanic American Indian/Alaskan Native and non-Hispanic Black or African American had the highest overall death rates for COVID, the CDC said.

Breaking the data down by age, the number of COVID deaths among people aged 75 years and older dropped to 178,000 in 2021 from around 207,000 in 2020. The numbers went up in other age groups. Among people aged 65-75, about 101,000 died of COVID in 2021, up from around 76,000 in 2020.

“The results of both studies highlight the need for greater effort to implement effective interventions,” the CDC said in a statement. “We must work to ensure equal treatment in all communities in proportion to their need for effective interventions that can prevent excess COVID-19 deaths.”

Since the pandemic began, about 991,000 people in the United States have died from COVID-related causes, the most among all nations in the world.
 

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.

Dr. Welby likely wouldn’t recognize the practice of medicine today, where nearly three quarters (73.9%) of physicians are employed by hospitals, health systems, or corporate entities, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.

“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”

Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.

“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”

More than half of physician practices owned by hospitals, corporate entities

The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.

“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”

According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.

From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.

Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.

The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.

Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.

Value-based care, venture capital firms driving change

Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”

Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.

Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?

“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”

The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.

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

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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