A 63-year-old woman with a history of hypertension presents to the emergency department (ED) with acute-onset shortness of breath and pleuritic chest pain after traveling across the country for a work conference. She has no history of cancer, liver disease, or renal disease. Her blood pressure is 140/80 mm Hg, and her heart rate, 90 beats/min. You diagnose an acute PE in this patient and start anticoagulation. Should you admit her to the hospital to decrease morbidity and mortality?

According to the CDC, venous thromboembolism (VTE) affects about 900,000 people each year, and about 60,000 to 100,000 of these patients die annually.² Pulmonary embolism is the third leading cause of death from cardiovascular disease, following heart attack and stroke.³ Prompt diagnosis and treatment with systemic anticoagulation improves patient outcomes and decreases the risk for long-term complications.

The 2016 American College of Chest Physicians (CHEST) guideline on antithrombotic therapy for VTE recommends home treatment or early discharge over standard discharge (after the first 5 days of treatment) for patients who meet the following clinical criteria: “clinically stable with good cardiopulmonary reserve; no contraindications such as recent bleeding, severe renal or liver disease, or severe thrombocytopenia (ie, < 70,000/mm³); expected to be compliant with treatment; and feels well enough to be treated at home.”³

The guideline states that various clinical decision tools, such as the Pulmonary Embolism Severity Index (PESI), can aid in identifying low-risk patients to be considered for treatment at home. The PESI uses age, gender, vital signs, mental status, and a history of cancer, lung, and cardiac disease to stratify patients by risk.⁴

A systematic review of 1 randomized controlled trial (RCT) and 7 observational studies found that in low-risk patients, outpatient treatment was as safe as inpatient treatment.⁵ This more recent study determines the net clinical benefit of hospitalized versus outpatient management in a wider range of patients with acute PE, regardless of initial risk.¹

STUDY SUMMARY

Hospitalization confers no benefit to stable PE patients

This retrospective, propensity-matched cohort study compared rates of adverse events in 1127 patients with acute PE managed in the hospital versus outpatient setting.¹ Patients were classified as outpatients if they were discharged from the ED or discharged from the hospital within 48 hours of admission. Patients were included if a symptomatic acute PE was diagnosed via CT or high-probability ventilation-perfusion scan and excluded if they were younger than 19, were diagnosed with a PE during hospitalization, had chronic PE, or were hemodynamically unstable, among other factors. The investigators calculated PESI scores for all patients.

Propensity scores matched patients on 28 characteristics and known risk factors for adverse events to ensure the groups were similar. The primary outcome was rate of adverse events, including recurrent VTE, major bleeding, or death at 14 days. The secondary outcome included rates of the above during the 3-month follow-up period.

Continue to: Of the 1127 eligible patients...

Of the 1127 eligible patients, 1081 were included in the matched cohort, with 576 (53%) treated as hospitalized patients and 505 (47%) treated as outpatients. The mean age of the matched cohorts was 63.2 years for the inpatient group and 63.6 years for the outpatient group. Overall, the cohorts were well matched.

The 14-day rate of adverse events was higher in hospitalized patients than in outpatients (13% vs 3.3%; odds ratio [OR], 5.07), with each of the adverse events that made up the primary outcome occurring more frequently in the hospitalized group (see Table). The rate of adverse events at 3 months was also greater for hospitalized patients compared with outpatients (21.7% vs 6.9%; OR, 4.9). The results remained similar for high-risk patients (Class III-V) based on their PESI score.

WHAT’S NEW

Higher rate of adverse events in inpatients

This trial supports the CHEST guideline recommendations to manage hemodynamically stable patients with acute PE as outpatients.³ It adds to the conversation by demonstrating higher rates of adverse events with hospitalization, even in high-risk subgroups (PESI Class III-V).

CAVEATS

Good study, but it wasn’t an RCT

While this is a well-designed cohort study, it is not an RCT. This study defined outpatient management as patients discharged from the ED or hospitalized for < 48 hours. However, only 59 of the 544 patients in the outpatient group were early hospital discharges; the rest were never admitted. Finally, a specialized thrombosis clinic followed up with the patients within 24 hours of discharge, and patients had telephone access to specialized health care professionals; such organization of care contributed to the safe outpatient management of these PE patients.

CHALLENGES TO IMPLEMENTATION

Insurance coverage may present an issue

Medication coverage of direct oral anticoagulants and low-molecular-weight heparin may present a barrier to patients treated in the outpatient setting who have no insurance or are insured by certain carriers.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018;67[12]:777-779).

A 63-year-old woman with a history of hypertension presents to the emergency department (ED) with acute-onset shortness of breath and pleuritic chest pain after traveling across the country for a work conference. She has no history of cancer, liver disease, or renal disease. Her blood pressure is 140/80 mm Hg, and her heart rate, 90 beats/min. You diagnose an acute PE in this patient and start anticoagulation. Should you admit her to the hospital to decrease morbidity and mortality?

According to the CDC, venous thromboembolism (VTE) affects about 900,000 people each year, and about 60,000 to 100,000 of these patients die annually.² Pulmonary embolism is the third leading cause of death from cardiovascular disease, following heart attack and stroke.³ Prompt diagnosis and treatment with systemic anticoagulation improves patient outcomes and decreases the risk for long-term complications.

The 2016 American College of Chest Physicians (CHEST) guideline on antithrombotic therapy for VTE recommends home treatment or early discharge over standard discharge (after the first 5 days of treatment) for patients who meet the following clinical criteria: “clinically stable with good cardiopulmonary reserve; no contraindications such as recent bleeding, severe renal or liver disease, or severe thrombocytopenia (ie, < 70,000/mm³); expected to be compliant with treatment; and feels well enough to be treated at home.”³

The guideline states that various clinical decision tools, such as the Pulmonary Embolism Severity Index (PESI), can aid in identifying low-risk patients to be considered for treatment at home. The PESI uses age, gender, vital signs, mental status, and a history of cancer, lung, and cardiac disease to stratify patients by risk.⁴

A systematic review of 1 randomized controlled trial (RCT) and 7 observational studies found that in low-risk patients, outpatient treatment was as safe as inpatient treatment.⁵ This more recent study determines the net clinical benefit of hospitalized versus outpatient management in a wider range of patients with acute PE, regardless of initial risk.¹

STUDY SUMMARY

Hospitalization confers no benefit to stable PE patients

This retrospective, propensity-matched cohort study compared rates of adverse events in 1127 patients with acute PE managed in the hospital versus outpatient setting.¹ Patients were classified as outpatients if they were discharged from the ED or discharged from the hospital within 48 hours of admission. Patients were included if a symptomatic acute PE was diagnosed via CT or high-probability ventilation-perfusion scan and excluded if they were younger than 19, were diagnosed with a PE during hospitalization, had chronic PE, or were hemodynamically unstable, among other factors. The investigators calculated PESI scores for all patients.

Propensity scores matched patients on 28 characteristics and known risk factors for adverse events to ensure the groups were similar. The primary outcome was rate of adverse events, including recurrent VTE, major bleeding, or death at 14 days. The secondary outcome included rates of the above during the 3-month follow-up period.

Continue to: Of the 1127 eligible patients...

Of the 1127 eligible patients, 1081 were included in the matched cohort, with 576 (53%) treated as hospitalized patients and 505 (47%) treated as outpatients. The mean age of the matched cohorts was 63.2 years for the inpatient group and 63.6 years for the outpatient group. Overall, the cohorts were well matched.

The 14-day rate of adverse events was higher in hospitalized patients than in outpatients (13% vs 3.3%; odds ratio [OR], 5.07), with each of the adverse events that made up the primary outcome occurring more frequently in the hospitalized group (see Table). The rate of adverse events at 3 months was also greater for hospitalized patients compared with outpatients (21.7% vs 6.9%; OR, 4.9). The results remained similar for high-risk patients (Class III-V) based on their PESI score.

WHAT’S NEW

Higher rate of adverse events in inpatients

This trial supports the CHEST guideline recommendations to manage hemodynamically stable patients with acute PE as outpatients.³ It adds to the conversation by demonstrating higher rates of adverse events with hospitalization, even in high-risk subgroups (PESI Class III-V).

CAVEATS

Good study, but it wasn’t an RCT

While this is a well-designed cohort study, it is not an RCT. This study defined outpatient management as patients discharged from the ED or hospitalized for < 48 hours. However, only 59 of the 544 patients in the outpatient group were early hospital discharges; the rest were never admitted. Finally, a specialized thrombosis clinic followed up with the patients within 24 hours of discharge, and patients had telephone access to specialized health care professionals; such organization of care contributed to the safe outpatient management of these PE patients.

CHALLENGES TO IMPLEMENTATION

Insurance coverage may present an issue

Medication coverage of direct oral anticoagulants and low-molecular-weight heparin may present a barrier to patients treated in the outpatient setting who have no insurance or are insured by certain carriers.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018;67[12]:777-779).

A 63-year-old woman with a history of hypertension presents to the emergency department (ED) with acute-onset shortness of breath and pleuritic chest pain after traveling across the country for a work conference. She has no history of cancer, liver disease, or renal disease. Her blood pressure is 140/80 mm Hg, and her heart rate, 90 beats/min. You diagnose an acute PE in this patient and start anticoagulation. Should you admit her to the hospital to decrease morbidity and mortality?

According to the CDC, venous thromboembolism (VTE) affects about 900,000 people each year, and about 60,000 to 100,000 of these patients die annually.² Pulmonary embolism is the third leading cause of death from cardiovascular disease, following heart attack and stroke.³ Prompt diagnosis and treatment with systemic anticoagulation improves patient outcomes and decreases the risk for long-term complications.

The 2016 American College of Chest Physicians (CHEST) guideline on antithrombotic therapy for VTE recommends home treatment or early discharge over standard discharge (after the first 5 days of treatment) for patients who meet the following clinical criteria: “clinically stable with good cardiopulmonary reserve; no contraindications such as recent bleeding, severe renal or liver disease, or severe thrombocytopenia (ie, < 70,000/mm³); expected to be compliant with treatment; and feels well enough to be treated at home.”³

The guideline states that various clinical decision tools, such as the Pulmonary Embolism Severity Index (PESI), can aid in identifying low-risk patients to be considered for treatment at home. The PESI uses age, gender, vital signs, mental status, and a history of cancer, lung, and cardiac disease to stratify patients by risk.⁴

A systematic review of 1 randomized controlled trial (RCT) and 7 observational studies found that in low-risk patients, outpatient treatment was as safe as inpatient treatment.⁵ This more recent study determines the net clinical benefit of hospitalized versus outpatient management in a wider range of patients with acute PE, regardless of initial risk.¹

STUDY SUMMARY

Hospitalization confers no benefit to stable PE patients

This retrospective, propensity-matched cohort study compared rates of adverse events in 1127 patients with acute PE managed in the hospital versus outpatient setting.¹ Patients were classified as outpatients if they were discharged from the ED or discharged from the hospital within 48 hours of admission. Patients were included if a symptomatic acute PE was diagnosed via CT or high-probability ventilation-perfusion scan and excluded if they were younger than 19, were diagnosed with a PE during hospitalization, had chronic PE, or were hemodynamically unstable, among other factors. The investigators calculated PESI scores for all patients.

Propensity scores matched patients on 28 characteristics and known risk factors for adverse events to ensure the groups were similar. The primary outcome was rate of adverse events, including recurrent VTE, major bleeding, or death at 14 days. The secondary outcome included rates of the above during the 3-month follow-up period.

Continue to: Of the 1127 eligible patients...

Of the 1127 eligible patients, 1081 were included in the matched cohort, with 576 (53%) treated as hospitalized patients and 505 (47%) treated as outpatients. The mean age of the matched cohorts was 63.2 years for the inpatient group and 63.6 years for the outpatient group. Overall, the cohorts were well matched.

The 14-day rate of adverse events was higher in hospitalized patients than in outpatients (13% vs 3.3%; odds ratio [OR], 5.07), with each of the adverse events that made up the primary outcome occurring more frequently in the hospitalized group (see Table). The rate of adverse events at 3 months was also greater for hospitalized patients compared with outpatients (21.7% vs 6.9%; OR, 4.9). The results remained similar for high-risk patients (Class III-V) based on their PESI score.

WHAT’S NEW

Higher rate of adverse events in inpatients

This trial supports the CHEST guideline recommendations to manage hemodynamically stable patients with acute PE as outpatients.³ It adds to the conversation by demonstrating higher rates of adverse events with hospitalization, even in high-risk subgroups (PESI Class III-V).

CAVEATS

Good study, but it wasn’t an RCT

While this is a well-designed cohort study, it is not an RCT. This study defined outpatient management as patients discharged from the ED or hospitalized for < 48 hours. However, only 59 of the 544 patients in the outpatient group were early hospital discharges; the rest were never admitted. Finally, a specialized thrombosis clinic followed up with the patients within 24 hours of discharge, and patients had telephone access to specialized health care professionals; such organization of care contributed to the safe outpatient management of these PE patients.

CHALLENGES TO IMPLEMENTATION

Insurance coverage may present an issue

Medication coverage of direct oral anticoagulants and low-molecular-weight heparin may present a barrier to patients treated in the outpatient setting who have no insurance or are insured by certain carriers.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018;67[12]:777-779).

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

BALTIMORE – In 2015, the University of California changed how its hospitals handle gastroschisis, a condition in which infants are born with their intestines and sometimes other organs protruding through a hole beside the umbilicus.

M. Alexander Otto/MDedge News

Neonatologists, maternal-fetal health experts, and pediatric surgeons standardized a literature-based approach that was gentler and less invasive than usual management, emphasizing sutureless closure, sometimes at bedside on the first day of life, and early feeding. Often, it turned out, that’s all that children require.

It’s made a big difference. “We reduced the number of trips to the operating room and exposure to general anesthesia. We reduced the number of babies intubated and days on the ventilator. We reduced opioid days and antibiotic days” without increasing bacteremia, and “there are probably long-term benefits beyond the NICU,” said Kara Calkins, MD, at the Pediatric Academic Societies annual meeting.

I think this is definitely ahead of the curve for NICUs. My hope is that the vast majority of universities adopt a similar approach,” said Dr. Calkins, who is an assistant professor of neonatology at the University of California, Los Angeles.

“When I was a fellow,” she explained, “we took all of these babies and intubated them right away and put them on a drip to paralyze and sedate them. We put their bowels into a silo,” essentially a plastic bag suspended by a string, in the hopes that gravity would pull the bowels back into the abdomen. More often than not, however, “the surgeon would come by every day and slowly push them” back in over a week or so. “The fear was if you did it too quickly, you’d invoke an abdominal compartment syndrome, or respiratory decompensation. You had a baby intubated for a week, sedated and paralyzed.”

Infants were kept on total parenteral nutrition for weeks, sometimes through a Broviac central catheter.

It was overkill, Dr. Calkins said, when only the intestines are out and the abdominal wall defect isn’t too large or too small, which is the case for many infants.

For those children, sutureless closure over 1-3 days is the new goal. The bowel is worked back into the abdomen and the umbilical cord is pulled to the side to approximate the edges of the wound, and tacked down; the defect then heals itself. Antibiotics are discontinued 48 hours after closure. Gastric and rectal decompression helps with reduction.

Also, “we give drops of breast milk in their cheek right away, every couple of hours starting on the first day of life. Once the output from the gastric tube is clear, we start feeds. We still give total parenteral nutrition, but through a [peripherally inserted central catheter] in the arm,” Dr. Calkins said. “Use of breast milk for this population is important” to help establish a healthy microbiome, among other reasons.

Another improvement that had been made, according to Dr. Calkins, is that if only the intestines are out, women carry their baby to term and deliver vaginally. The old practice was to deliver babies preterm by Cesarean section, she explained.

To see how it’s worked out, Dr. Calkins and her colleagues reviewed 70 gastroschisis cases managed under the new guidelines. They were uncomplicated cases, with no intestinal atresia, stricture, or ischemia.

Paralysis was avoided for silo placement in 53 infants (76%) and 32 (46%) avoided intubation. Antibiotics were discontinued in 56 (80%) within 48 hours of abdominal wall closure, and routine narcotics were discontinued in 53 infants (76%). Feeds were initiated in almost all children within 48 hours of non-bilious gastric tube output.

Compared with 168 infants treated before the changes were made, silo placement dropped from 71% to 58% of infants, and total ventilator days from a median of 5 to 2.

There was no difference in length of stay, perhaps because the “intestinal dysmotility intrinsic to gastroschisis remains a rate limiting factor for discharge,” the team concluded.

There was no industry funding, and Dr. Calkins didn’t have any disclosures.

[email protected]

SOURCE: Rottkamp CA et al., PAS 2019. Abstract 51.

BALTIMORE – In 2015, the University of California changed how its hospitals handle gastroschisis, a condition in which infants are born with their intestines and sometimes other organs protruding through a hole beside the umbilicus.

M. Alexander Otto/MDedge News

Neonatologists, maternal-fetal health experts, and pediatric surgeons standardized a literature-based approach that was gentler and less invasive than usual management, emphasizing sutureless closure, sometimes at bedside on the first day of life, and early feeding. Often, it turned out, that’s all that children require.

It’s made a big difference. “We reduced the number of trips to the operating room and exposure to general anesthesia. We reduced the number of babies intubated and days on the ventilator. We reduced opioid days and antibiotic days” without increasing bacteremia, and “there are probably long-term benefits beyond the NICU,” said Kara Calkins, MD, at the Pediatric Academic Societies annual meeting.

I think this is definitely ahead of the curve for NICUs. My hope is that the vast majority of universities adopt a similar approach,” said Dr. Calkins, who is an assistant professor of neonatology at the University of California, Los Angeles.

“When I was a fellow,” she explained, “we took all of these babies and intubated them right away and put them on a drip to paralyze and sedate them. We put their bowels into a silo,” essentially a plastic bag suspended by a string, in the hopes that gravity would pull the bowels back into the abdomen. More often than not, however, “the surgeon would come by every day and slowly push them” back in over a week or so. “The fear was if you did it too quickly, you’d invoke an abdominal compartment syndrome, or respiratory decompensation. You had a baby intubated for a week, sedated and paralyzed.”

Infants were kept on total parenteral nutrition for weeks, sometimes through a Broviac central catheter.

It was overkill, Dr. Calkins said, when only the intestines are out and the abdominal wall defect isn’t too large or too small, which is the case for many infants.

For those children, sutureless closure over 1-3 days is the new goal. The bowel is worked back into the abdomen and the umbilical cord is pulled to the side to approximate the edges of the wound, and tacked down; the defect then heals itself. Antibiotics are discontinued 48 hours after closure. Gastric and rectal decompression helps with reduction.

Also, “we give drops of breast milk in their cheek right away, every couple of hours starting on the first day of life. Once the output from the gastric tube is clear, we start feeds. We still give total parenteral nutrition, but through a [peripherally inserted central catheter] in the arm,” Dr. Calkins said. “Use of breast milk for this population is important” to help establish a healthy microbiome, among other reasons.

Another improvement that had been made, according to Dr. Calkins, is that if only the intestines are out, women carry their baby to term and deliver vaginally. The old practice was to deliver babies preterm by Cesarean section, she explained.

To see how it’s worked out, Dr. Calkins and her colleagues reviewed 70 gastroschisis cases managed under the new guidelines. They were uncomplicated cases, with no intestinal atresia, stricture, or ischemia.

Paralysis was avoided for silo placement in 53 infants (76%) and 32 (46%) avoided intubation. Antibiotics were discontinued in 56 (80%) within 48 hours of abdominal wall closure, and routine narcotics were discontinued in 53 infants (76%). Feeds were initiated in almost all children within 48 hours of non-bilious gastric tube output.

Compared with 168 infants treated before the changes were made, silo placement dropped from 71% to 58% of infants, and total ventilator days from a median of 5 to 2.

There was no difference in length of stay, perhaps because the “intestinal dysmotility intrinsic to gastroschisis remains a rate limiting factor for discharge,” the team concluded.

There was no industry funding, and Dr. Calkins didn’t have any disclosures.

[email protected]

SOURCE: Rottkamp CA et al., PAS 2019. Abstract 51.

BALTIMORE – In 2015, the University of California changed how its hospitals handle gastroschisis, a condition in which infants are born with their intestines and sometimes other organs protruding through a hole beside the umbilicus.

M. Alexander Otto/MDedge News

Neonatologists, maternal-fetal health experts, and pediatric surgeons standardized a literature-based approach that was gentler and less invasive than usual management, emphasizing sutureless closure, sometimes at bedside on the first day of life, and early feeding. Often, it turned out, that’s all that children require.

It’s made a big difference. “We reduced the number of trips to the operating room and exposure to general anesthesia. We reduced the number of babies intubated and days on the ventilator. We reduced opioid days and antibiotic days” without increasing bacteremia, and “there are probably long-term benefits beyond the NICU,” said Kara Calkins, MD, at the Pediatric Academic Societies annual meeting.

I think this is definitely ahead of the curve for NICUs. My hope is that the vast majority of universities adopt a similar approach,” said Dr. Calkins, who is an assistant professor of neonatology at the University of California, Los Angeles.

“When I was a fellow,” she explained, “we took all of these babies and intubated them right away and put them on a drip to paralyze and sedate them. We put their bowels into a silo,” essentially a plastic bag suspended by a string, in the hopes that gravity would pull the bowels back into the abdomen. More often than not, however, “the surgeon would come by every day and slowly push them” back in over a week or so. “The fear was if you did it too quickly, you’d invoke an abdominal compartment syndrome, or respiratory decompensation. You had a baby intubated for a week, sedated and paralyzed.”

Infants were kept on total parenteral nutrition for weeks, sometimes through a Broviac central catheter.

It was overkill, Dr. Calkins said, when only the intestines are out and the abdominal wall defect isn’t too large or too small, which is the case for many infants.

For those children, sutureless closure over 1-3 days is the new goal. The bowel is worked back into the abdomen and the umbilical cord is pulled to the side to approximate the edges of the wound, and tacked down; the defect then heals itself. Antibiotics are discontinued 48 hours after closure. Gastric and rectal decompression helps with reduction.

Also, “we give drops of breast milk in their cheek right away, every couple of hours starting on the first day of life. Once the output from the gastric tube is clear, we start feeds. We still give total parenteral nutrition, but through a [peripherally inserted central catheter] in the arm,” Dr. Calkins said. “Use of breast milk for this population is important” to help establish a healthy microbiome, among other reasons.

Another improvement that had been made, according to Dr. Calkins, is that if only the intestines are out, women carry their baby to term and deliver vaginally. The old practice was to deliver babies preterm by Cesarean section, she explained.

To see how it’s worked out, Dr. Calkins and her colleagues reviewed 70 gastroschisis cases managed under the new guidelines. They were uncomplicated cases, with no intestinal atresia, stricture, or ischemia.

Paralysis was avoided for silo placement in 53 infants (76%) and 32 (46%) avoided intubation. Antibiotics were discontinued in 56 (80%) within 48 hours of abdominal wall closure, and routine narcotics were discontinued in 53 infants (76%). Feeds were initiated in almost all children within 48 hours of non-bilious gastric tube output.

Compared with 168 infants treated before the changes were made, silo placement dropped from 71% to 58% of infants, and total ventilator days from a median of 5 to 2.

There was no difference in length of stay, perhaps because the “intestinal dysmotility intrinsic to gastroschisis remains a rate limiting factor for discharge,” the team concluded.

There was no industry funding, and Dr. Calkins didn’t have any disclosures.

[email protected]

SOURCE: Rottkamp CA et al., PAS 2019. Abstract 51.

PHILADELPHIA – Brain volumes of specific regions of interest can be used to classify traumatic brain injury subjects that fall into predetermined symptom categories,” according to a study presented at the annual meeting of the American Academy of Neurology.

Traumatic brain injury (TBI) damages brain tissue and causes subsequent volume loss, which may result in clinical symptoms. It is a prevalent worldwide health problem caused by a mechanical insult to the head, resulting in transient or permanent alteration to brain tissue and/or function. Standard neuroimaging with computerized cranial tomography (CT) and structural magnetic resonance imaging (MRI) is often unrevealing during the evaluation of patients with TBI, particularly those classified as mild TBI. I

In this study, James Rock, MD, of Penn Presbyterian Medical Center and the University of Pennsylvania, and his colleagues sought to examine the value of quantitative analysis of regional brain volumes in the evaluation of TBI. The investigators reviewed the medical records and MRI imaging from 44 patients with TBI evaluated at a Level I trauma center. They also read clinical notes to assess reported symptoms and physical findings.

Regional volumes from TBI subjects were derived using the software package Freesurfer image analysis suite, which utilizes a T1-weighted structural scan to calculate volumetric information. A machine learning algorithm, random forests, was employed across volume measurements from 25 regions of interest to determine the most important regions for classifying subjects based on clinical outcome and symptomology.

Basal ganglia volume showed the highest variable importance with regards to classifying subjects who exhibited symptoms of cognitive dysfunction (Mean Decrease in Gini = 1.067, Mean Decrease in Accuracy = 5.966e-03) in quantitative analysis. Left lateral ventricle volume was important in classifying subjects with motor and vestibular alterations (Mean Decrease in Gini = 2.037, Mean Decrease in Accuracy = 2.92e-02). Left choroid plexus volume was the most important region for classifying subjects with sensation and somatic dysfunction (Mean Decrease in Gini = 0.271, Mean Decrease in Accuracy = 4.82e-03).

The researchers noted that their study is ongoing, in an abstract. “It will be extended to a larger cohort to determine whether volume changes in specific [regions of interest] can act as useful clinical biomarkers for chronic symptoms,” they said.

Dr. Diaz-Arrastia received personal compensation from Neural Analytics, Inc, BrainBox Solutions, Inc, and Bioscience Pharma Partners. Dr. Diaz-Arrastia holds stock and/or stock options in Neural Analytics, Inc. and has received research support from BrainBox Solutions. The other authors reported not having anything to disclose..

[email protected]

SOURCE: Rock J et al. AAN 2019. Abstract S2.006 .

PHILADELPHIA – Brain volumes of specific regions of interest can be used to classify traumatic brain injury subjects that fall into predetermined symptom categories,” according to a study presented at the annual meeting of the American Academy of Neurology.

Traumatic brain injury (TBI) damages brain tissue and causes subsequent volume loss, which may result in clinical symptoms. It is a prevalent worldwide health problem caused by a mechanical insult to the head, resulting in transient or permanent alteration to brain tissue and/or function. Standard neuroimaging with computerized cranial tomography (CT) and structural magnetic resonance imaging (MRI) is often unrevealing during the evaluation of patients with TBI, particularly those classified as mild TBI. I

In this study, James Rock, MD, of Penn Presbyterian Medical Center and the University of Pennsylvania, and his colleagues sought to examine the value of quantitative analysis of regional brain volumes in the evaluation of TBI. The investigators reviewed the medical records and MRI imaging from 44 patients with TBI evaluated at a Level I trauma center. They also read clinical notes to assess reported symptoms and physical findings.

Regional volumes from TBI subjects were derived using the software package Freesurfer image analysis suite, which utilizes a T1-weighted structural scan to calculate volumetric information. A machine learning algorithm, random forests, was employed across volume measurements from 25 regions of interest to determine the most important regions for classifying subjects based on clinical outcome and symptomology.

Basal ganglia volume showed the highest variable importance with regards to classifying subjects who exhibited symptoms of cognitive dysfunction (Mean Decrease in Gini = 1.067, Mean Decrease in Accuracy = 5.966e-03) in quantitative analysis. Left lateral ventricle volume was important in classifying subjects with motor and vestibular alterations (Mean Decrease in Gini = 2.037, Mean Decrease in Accuracy = 2.92e-02). Left choroid plexus volume was the most important region for classifying subjects with sensation and somatic dysfunction (Mean Decrease in Gini = 0.271, Mean Decrease in Accuracy = 4.82e-03).

The researchers noted that their study is ongoing, in an abstract. “It will be extended to a larger cohort to determine whether volume changes in specific [regions of interest] can act as useful clinical biomarkers for chronic symptoms,” they said.

Dr. Diaz-Arrastia received personal compensation from Neural Analytics, Inc, BrainBox Solutions, Inc, and Bioscience Pharma Partners. Dr. Diaz-Arrastia holds stock and/or stock options in Neural Analytics, Inc. and has received research support from BrainBox Solutions. The other authors reported not having anything to disclose..

[email protected]

SOURCE: Rock J et al. AAN 2019. Abstract S2.006 .

PHILADELPHIA – Brain volumes of specific regions of interest can be used to classify traumatic brain injury subjects that fall into predetermined symptom categories,” according to a study presented at the annual meeting of the American Academy of Neurology.

Traumatic brain injury (TBI) damages brain tissue and causes subsequent volume loss, which may result in clinical symptoms. It is a prevalent worldwide health problem caused by a mechanical insult to the head, resulting in transient or permanent alteration to brain tissue and/or function. Standard neuroimaging with computerized cranial tomography (CT) and structural magnetic resonance imaging (MRI) is often unrevealing during the evaluation of patients with TBI, particularly those classified as mild TBI. I

In this study, James Rock, MD, of Penn Presbyterian Medical Center and the University of Pennsylvania, and his colleagues sought to examine the value of quantitative analysis of regional brain volumes in the evaluation of TBI. The investigators reviewed the medical records and MRI imaging from 44 patients with TBI evaluated at a Level I trauma center. They also read clinical notes to assess reported symptoms and physical findings.

Regional volumes from TBI subjects were derived using the software package Freesurfer image analysis suite, which utilizes a T1-weighted structural scan to calculate volumetric information. A machine learning algorithm, random forests, was employed across volume measurements from 25 regions of interest to determine the most important regions for classifying subjects based on clinical outcome and symptomology.

Basal ganglia volume showed the highest variable importance with regards to classifying subjects who exhibited symptoms of cognitive dysfunction (Mean Decrease in Gini = 1.067, Mean Decrease in Accuracy = 5.966e-03) in quantitative analysis. Left lateral ventricle volume was important in classifying subjects with motor and vestibular alterations (Mean Decrease in Gini = 2.037, Mean Decrease in Accuracy = 2.92e-02). Left choroid plexus volume was the most important region for classifying subjects with sensation and somatic dysfunction (Mean Decrease in Gini = 0.271, Mean Decrease in Accuracy = 4.82e-03).

The researchers noted that their study is ongoing, in an abstract. “It will be extended to a larger cohort to determine whether volume changes in specific [regions of interest] can act as useful clinical biomarkers for chronic symptoms,” they said.

Dr. Diaz-Arrastia received personal compensation from Neural Analytics, Inc, BrainBox Solutions, Inc, and Bioscience Pharma Partners. Dr. Diaz-Arrastia holds stock and/or stock options in Neural Analytics, Inc. and has received research support from BrainBox Solutions. The other authors reported not having anything to disclose..

[email protected]

SOURCE: Rock J et al. AAN 2019. Abstract S2.006 .

Suicides and calls to the National Suicide Prevention Lifeline spiked after the suicide of actor Robin Williams, based on data from calls and website visits before and after his death.

John J. Kruzel/ Wikimedia Commons

Suicides in the United States tend to follow temporal patterns, with spikes in the spring and early summer, but “some events, including celebrity deaths, serve as ‘shocks’ that disrupt seasonal time trends and may prompt imitation,” wrote Rajeev Ramchand, PhD, of the National Institute of Mental Health, Bethesda, Md., and colleagues in a study published online in the journal Psychiatric Services in Advance (2019 Apr 30. doi: 10.1176/appi.ps.201900007).

The National Suicide Prevention Lifeline (NSPL) experienced a 300% increase in call volume the day after Mr. Williams’ death, however, only 57% of these calls were answered, the researchers said.

The researchers compared daily suicide data, NSPL call volume, and visits to two suicide prevention websites before and after Mr. Williams’ death on August 11, 2014.

Before August 11 in 2012, 2013, and 2014, the average number of daily suicides ranged from 113 to 117; after August 11, 2014, this average spiked to 142, an increase not seen in 2012 or 2013, according to data from the National Center for Health Statistics’ Compressed Mortality File. The NSPL received 12,972 calls on August 12, 2014, following Mr. Williams’ death, compared with a daily average of 4,116 to 6,302 calls during the week before his death. In addition, the Suicide Prevention Resource Center (SPRC), a website that provides technical assistance, training, and suicide prevention material; and Suicide Awareness Voices of Education (SAVE), a website with resources for individuals affected by suicide, as well educational information to raise public awareness, saw significant increases in visits on the day after Mr. Williams’ suicide.

The study findings were limited by several factors including the lack of information on whether calls to NSPL were information seekers or individuals in crisis, the researchers noted. However, the results suggest the need for surge capacity to prepare for increased demand in the wake of a celebrity suicide, they said.

The researchers had no financial conflicts to disclose.

SOURCE: Ramchand R et al. Psychiatric Services in Advance. 2019. doi: 10.1176/appi.ps.201900007 .

Suicides and calls to the National Suicide Prevention Lifeline spiked after the suicide of actor Robin Williams, based on data from calls and website visits before and after his death.

John J. Kruzel/ Wikimedia Commons

Suicides in the United States tend to follow temporal patterns, with spikes in the spring and early summer, but “some events, including celebrity deaths, serve as ‘shocks’ that disrupt seasonal time trends and may prompt imitation,” wrote Rajeev Ramchand, PhD, of the National Institute of Mental Health, Bethesda, Md., and colleagues in a study published online in the journal Psychiatric Services in Advance (2019 Apr 30. doi: 10.1176/appi.ps.201900007).

The National Suicide Prevention Lifeline (NSPL) experienced a 300% increase in call volume the day after Mr. Williams’ death, however, only 57% of these calls were answered, the researchers said.

The researchers compared daily suicide data, NSPL call volume, and visits to two suicide prevention websites before and after Mr. Williams’ death on August 11, 2014.

Before August 11 in 2012, 2013, and 2014, the average number of daily suicides ranged from 113 to 117; after August 11, 2014, this average spiked to 142, an increase not seen in 2012 or 2013, according to data from the National Center for Health Statistics’ Compressed Mortality File. The NSPL received 12,972 calls on August 12, 2014, following Mr. Williams’ death, compared with a daily average of 4,116 to 6,302 calls during the week before his death. In addition, the Suicide Prevention Resource Center (SPRC), a website that provides technical assistance, training, and suicide prevention material; and Suicide Awareness Voices of Education (SAVE), a website with resources for individuals affected by suicide, as well educational information to raise public awareness, saw significant increases in visits on the day after Mr. Williams’ suicide.

The study findings were limited by several factors including the lack of information on whether calls to NSPL were information seekers or individuals in crisis, the researchers noted. However, the results suggest the need for surge capacity to prepare for increased demand in the wake of a celebrity suicide, they said.

The researchers had no financial conflicts to disclose.

SOURCE: Ramchand R et al. Psychiatric Services in Advance. 2019. doi: 10.1176/appi.ps.201900007 .

Suicides and calls to the National Suicide Prevention Lifeline spiked after the suicide of actor Robin Williams, based on data from calls and website visits before and after his death.

John J. Kruzel/ Wikimedia Commons

Suicides in the United States tend to follow temporal patterns, with spikes in the spring and early summer, but “some events, including celebrity deaths, serve as ‘shocks’ that disrupt seasonal time trends and may prompt imitation,” wrote Rajeev Ramchand, PhD, of the National Institute of Mental Health, Bethesda, Md., and colleagues in a study published online in the journal Psychiatric Services in Advance (2019 Apr 30. doi: 10.1176/appi.ps.201900007).

The National Suicide Prevention Lifeline (NSPL) experienced a 300% increase in call volume the day after Mr. Williams’ death, however, only 57% of these calls were answered, the researchers said.

The researchers compared daily suicide data, NSPL call volume, and visits to two suicide prevention websites before and after Mr. Williams’ death on August 11, 2014.

Before August 11 in 2012, 2013, and 2014, the average number of daily suicides ranged from 113 to 117; after August 11, 2014, this average spiked to 142, an increase not seen in 2012 or 2013, according to data from the National Center for Health Statistics’ Compressed Mortality File. The NSPL received 12,972 calls on August 12, 2014, following Mr. Williams’ death, compared with a daily average of 4,116 to 6,302 calls during the week before his death. In addition, the Suicide Prevention Resource Center (SPRC), a website that provides technical assistance, training, and suicide prevention material; and Suicide Awareness Voices of Education (SAVE), a website with resources for individuals affected by suicide, as well educational information to raise public awareness, saw significant increases in visits on the day after Mr. Williams’ suicide.

The study findings were limited by several factors including the lack of information on whether calls to NSPL were information seekers or individuals in crisis, the researchers noted. However, the results suggest the need for surge capacity to prepare for increased demand in the wake of a celebrity suicide, they said.

The researchers had no financial conflicts to disclose.

SOURCE: Ramchand R et al. Psychiatric Services in Advance. 2019. doi: 10.1176/appi.ps.201900007 .

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

Hepatologists and gastroenterologists see multiple and substantial barriers to the use of palliative care in patients with end-stage liver disease, results of a recent survey show.

©Lighthaunter/Thinkstock

Cultural factors, unrealistic expectations of the patient, lack of reimbursement, and competing demands for physicians’ time were some of the barriers to palliative care cited most frequently in the survey, said the researchers, in their report on the survey results that appears in Clinical Gastroenterology and Hepatology.

Moreover, most responding physicians said they felt end-of-life advance care planning discussions take place too late in the course of illness, according to Nneka N. Ufere, MD, of the Gastrointestinal Unit, Department of Medicine, Massachusetts General Hospital, Boston, and co-authors of the report.

“Multiple interventions targeted at patients, caregivers, institutions, and clinicians are needed to overcome barriers to improve the delivery of high-quality palliative and end-of-life care for patients with end-stage liver disease,” the researchers said.

Specialty palliative care can improve quality of life for patients with life-limiting conditions such as end-stage liver disease, which is associated with poor quality of life and a median survival of just two years without liver transplant, the authors said.

Advance care planning, in which patients discuss goals and care preferences in light of the expected course of illness, was a “critical component” of palliative care that can improve the quality of end-of-life care, Dr. Ufere and co-authors said.

Unfortunately, palliative care planning services are underutilized in end-stage liver disease, studies show, while rates of timely advance care planning discussions are low.

To find out why, Dr. Ufere and colleagues asked 1,238 physicians to fill out a web-based questionnaire designed to assess their perceptions of barriers to use of palliative care and barriers to timely advance care planning discussions. A total of 396 physicians (32%) completed the survey between February and April 2018.

Sixty percent were transplant hepatologists, and 79% of the survey participants said they worked in a teaching hospital, according to Dr. Ufere and co-authors, who added that no respondents had formal palliative care training.

Almost all respondents (95%) agreed that centers providing care for end-stage liver disease patients should have palliative care services, and most (86%) said they thought such patients would benefit from palliative care earlier in the course of disease.

While most (84%) agreed that a hepatologist was the best provider to discuss advance care planning with the patient, only about one-quarter (27%) said the hepatologist was best suited to provide palliative care, while most (88%) said the palliative care specialist was best for that role.

When asked about patient and caregiver barriers, nearly all respondents (95%) agreed that cultural factors that influenced palliative care perception was an issue, while 93% said patients’ unrealistic expectations was an issue.

Clinician barriers that respondents perceived included competing demands for clinicians’ time, cited by 91%, fear that palliative care might destroy the patient’s hope, cited by 82%, and the misperception that palliative care starts when active treatment ends, cited by 81%.

One potential solution to the competing demands on clinicians’ time would be development of “collaborative care models” between palliative care and hepatology services, according to Dr. Ufere and co-authors.

“Outpatient specialty palliative care visits, ideally temporally coordinated with the hepatology visits, can play a role not only in attending to symptom assessment and ACP, but also in addressing important psychosocial aspects of care, such as patient coping and well-being,” they said in their report on the survey.

Institutional barriers of note included limited reimbursement for time spent providing palliative care, cited by 76% and lack of a palliative care service, cited by nearly half (46%).

Some of the most commonly affirmed barriers to timely advance care planning discussions included insufficient training in end-of-life communication issues, and insufficient training in cultural competency issues related to the discussions.

In terms of timeliness, only 17% said advance care planning discussions happen at the right time, while 81% said they happen too late, investigators found.

Funding for the research came from the National Institutes of Health. The authors had no disclosures or conflicts of interest related to the report.

SOURCE: Ufere NN, et al. Clin Gastroenterol Hepatol. 2019 Mar 15. doi: 10.1016/j.cgh.2019.03.022.

Hepatologists and gastroenterologists see multiple and substantial barriers to the use of palliative care in patients with end-stage liver disease, results of a recent survey show.

©Lighthaunter/Thinkstock

Cultural factors, unrealistic expectations of the patient, lack of reimbursement, and competing demands for physicians’ time were some of the barriers to palliative care cited most frequently in the survey, said the researchers, in their report on the survey results that appears in Clinical Gastroenterology and Hepatology.

Moreover, most responding physicians said they felt end-of-life advance care planning discussions take place too late in the course of illness, according to Nneka N. Ufere, MD, of the Gastrointestinal Unit, Department of Medicine, Massachusetts General Hospital, Boston, and co-authors of the report.

“Multiple interventions targeted at patients, caregivers, institutions, and clinicians are needed to overcome barriers to improve the delivery of high-quality palliative and end-of-life care for patients with end-stage liver disease,” the researchers said.

Specialty palliative care can improve quality of life for patients with life-limiting conditions such as end-stage liver disease, which is associated with poor quality of life and a median survival of just two years without liver transplant, the authors said.

Advance care planning, in which patients discuss goals and care preferences in light of the expected course of illness, was a “critical component” of palliative care that can improve the quality of end-of-life care, Dr. Ufere and co-authors said.

Unfortunately, palliative care planning services are underutilized in end-stage liver disease, studies show, while rates of timely advance care planning discussions are low.

To find out why, Dr. Ufere and colleagues asked 1,238 physicians to fill out a web-based questionnaire designed to assess their perceptions of barriers to use of palliative care and barriers to timely advance care planning discussions. A total of 396 physicians (32%) completed the survey between February and April 2018.

Sixty percent were transplant hepatologists, and 79% of the survey participants said they worked in a teaching hospital, according to Dr. Ufere and co-authors, who added that no respondents had formal palliative care training.

Almost all respondents (95%) agreed that centers providing care for end-stage liver disease patients should have palliative care services, and most (86%) said they thought such patients would benefit from palliative care earlier in the course of disease.

While most (84%) agreed that a hepatologist was the best provider to discuss advance care planning with the patient, only about one-quarter (27%) said the hepatologist was best suited to provide palliative care, while most (88%) said the palliative care specialist was best for that role.

When asked about patient and caregiver barriers, nearly all respondents (95%) agreed that cultural factors that influenced palliative care perception was an issue, while 93% said patients’ unrealistic expectations was an issue.

Clinician barriers that respondents perceived included competing demands for clinicians’ time, cited by 91%, fear that palliative care might destroy the patient’s hope, cited by 82%, and the misperception that palliative care starts when active treatment ends, cited by 81%.

One potential solution to the competing demands on clinicians’ time would be development of “collaborative care models” between palliative care and hepatology services, according to Dr. Ufere and co-authors.

“Outpatient specialty palliative care visits, ideally temporally coordinated with the hepatology visits, can play a role not only in attending to symptom assessment and ACP, but also in addressing important psychosocial aspects of care, such as patient coping and well-being,” they said in their report on the survey.

Institutional barriers of note included limited reimbursement for time spent providing palliative care, cited by 76% and lack of a palliative care service, cited by nearly half (46%).

Some of the most commonly affirmed barriers to timely advance care planning discussions included insufficient training in end-of-life communication issues, and insufficient training in cultural competency issues related to the discussions.

In terms of timeliness, only 17% said advance care planning discussions happen at the right time, while 81% said they happen too late, investigators found.

Funding for the research came from the National Institutes of Health. The authors had no disclosures or conflicts of interest related to the report.

SOURCE: Ufere NN, et al. Clin Gastroenterol Hepatol. 2019 Mar 15. doi: 10.1016/j.cgh.2019.03.022.

Hepatologists and gastroenterologists see multiple and substantial barriers to the use of palliative care in patients with end-stage liver disease, results of a recent survey show.

©Lighthaunter/Thinkstock

Cultural factors, unrealistic expectations of the patient, lack of reimbursement, and competing demands for physicians’ time were some of the barriers to palliative care cited most frequently in the survey, said the researchers, in their report on the survey results that appears in Clinical Gastroenterology and Hepatology.

Moreover, most responding physicians said they felt end-of-life advance care planning discussions take place too late in the course of illness, according to Nneka N. Ufere, MD, of the Gastrointestinal Unit, Department of Medicine, Massachusetts General Hospital, Boston, and co-authors of the report.

“Multiple interventions targeted at patients, caregivers, institutions, and clinicians are needed to overcome barriers to improve the delivery of high-quality palliative and end-of-life care for patients with end-stage liver disease,” the researchers said.

Specialty palliative care can improve quality of life for patients with life-limiting conditions such as end-stage liver disease, which is associated with poor quality of life and a median survival of just two years without liver transplant, the authors said.

Advance care planning, in which patients discuss goals and care preferences in light of the expected course of illness, was a “critical component” of palliative care that can improve the quality of end-of-life care, Dr. Ufere and co-authors said.

Unfortunately, palliative care planning services are underutilized in end-stage liver disease, studies show, while rates of timely advance care planning discussions are low.

To find out why, Dr. Ufere and colleagues asked 1,238 physicians to fill out a web-based questionnaire designed to assess their perceptions of barriers to use of palliative care and barriers to timely advance care planning discussions. A total of 396 physicians (32%) completed the survey between February and April 2018.

Sixty percent were transplant hepatologists, and 79% of the survey participants said they worked in a teaching hospital, according to Dr. Ufere and co-authors, who added that no respondents had formal palliative care training.

Almost all respondents (95%) agreed that centers providing care for end-stage liver disease patients should have palliative care services, and most (86%) said they thought such patients would benefit from palliative care earlier in the course of disease.

While most (84%) agreed that a hepatologist was the best provider to discuss advance care planning with the patient, only about one-quarter (27%) said the hepatologist was best suited to provide palliative care, while most (88%) said the palliative care specialist was best for that role.

When asked about patient and caregiver barriers, nearly all respondents (95%) agreed that cultural factors that influenced palliative care perception was an issue, while 93% said patients’ unrealistic expectations was an issue.

Clinician barriers that respondents perceived included competing demands for clinicians’ time, cited by 91%, fear that palliative care might destroy the patient’s hope, cited by 82%, and the misperception that palliative care starts when active treatment ends, cited by 81%.

One potential solution to the competing demands on clinicians’ time would be development of “collaborative care models” between palliative care and hepatology services, according to Dr. Ufere and co-authors.

“Outpatient specialty palliative care visits, ideally temporally coordinated with the hepatology visits, can play a role not only in attending to symptom assessment and ACP, but also in addressing important psychosocial aspects of care, such as patient coping and well-being,” they said in their report on the survey.

Institutional barriers of note included limited reimbursement for time spent providing palliative care, cited by 76% and lack of a palliative care service, cited by nearly half (46%).

Some of the most commonly affirmed barriers to timely advance care planning discussions included insufficient training in end-of-life communication issues, and insufficient training in cultural competency issues related to the discussions.

In terms of timeliness, only 17% said advance care planning discussions happen at the right time, while 81% said they happen too late, investigators found.

Funding for the research came from the National Institutes of Health. The authors had no disclosures or conflicts of interest related to the report.

SOURCE: Ufere NN, et al. Clin Gastroenterol Hepatol. 2019 Mar 15. doi: 10.1016/j.cgh.2019.03.022.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.