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Noninfected children of HIV-positive mothers have high rates of obesity

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When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

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When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

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In obesity-related asthma, a new hormonal target

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– A hormone that is oversecreted in obesity may provide a pathway from adipose to lung tissue in individuals with both obesity and asthma, according to new research presented at the annual meeting of the Endocrine Society.

“Obesity-related asthma is a really understudied and new phenomenon. It’s a unique complication of obesity,” said Furkan Burak, MD, in a video interview after an obesity-focused press conference.

“In addition to being a standalone disease, obesity mostly comes as a package. And that’s the problem,” said Dr. Burak, pointing to obesity-related asthma’s clustering with diseases such as diabetes and atherosclerosis.

Asthma affects 10% of the world population, and it’s becoming increasingly understood that obesity-related, adult-onset asthma is a separate disease entity from allergic asthma, which usually begins in childhood, said Dr. Burak, an endocrinology fellow at Brigham and Women’s Hospital, Boston.

“There are two types of asthma related to obesity,” he said. Classic allergic asthma can get worse with obesity; however, asthma can sometimes occur de novo in adults, particularly women, with obesity. “What is important is … that they are less responsive to classic treatments,” such as steroids and beta-agonists. “And the problem is not small: Of asthmatics, 40% are obese. It’s a therapeutic problem, and we are not able to treat them well.”

The fatty acid binding protein 4, aP2, a hormone that is released by adipose tissue, travels to distant organs and regulates metabolic responses. Levels of aP2 are known to be increased in obesity, particularly in individuals with asthma, said Dr. Burak.

Citing work done at Brigham and Women’s Hospital and at Boston’s Harvard Medical School, as well as elsewhere, Dr. Burak and his collaborators noted in the abstract accompanying the presentation that “increased serum aP2 levels strongly correlate with poor metabolic, inflammatory, and cardiovascular outcomes in multiple independent human studies.”

Dr. Burak said he and his colleagues are trying to sort out “how a fat-tissue–borne hormone could potentially cause a problem in the lung.”

A big clue came with the discovery that patients with asthma and obesity have elevated levels of aP2 within their airways when bronchoalveolar lavage is performed, suggesting that the hormone may be the pathological mediator linking obesity to asthma – “a direct link between the fat tissue and the lung,” he said.

Serum aP2 levels were available from the Nurse’s Health Study, so Dr. Burak and his colleagues looked at those levels in randomly selected study participants. “We found that aP2 levels were elevated 25.6% – significantly – in asthmatics, compared with nonasthmatics, but only in obese and overweight [participants, and] not in lean” participants, he said.

Dr. Burak and his colleagues compared 525 individuals with body mass indices of less than 25 kg/m2, of whom 15 had asthma, with 385 individuals with body mass indices of more than 25, of whom 15 of whom had asthma.

Collecting bronchoalveolar lavage fluid from individuals with asthma showed a mean increase of 23% in aP2 levels in patients with obesity compared with lean individuals.

These data taken together show both systemic and local elevations of aP2 in human obesity. “That could contribute to the airway hyperreactivity and to the asthma pathogenesis,” which would confirm findings from animal studies, said Dr. Burak.

Further investigation will focus on individuals who are haploinsufficient for aP2. The group already is known to have lower risk for dyslipidemia, diabetes, and cardiovascular disease, but Dr. Burak and his collaborators also will determine whether asthma incidence is also lower.

The eventual goal is to attack aP2 as a therapeutic target. “Can we inhibit and target aP2 therapeutically in the context of obesity to treat obesity-related asthma? We have a big hope for that.”

Dr. Burak and his colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Burak MF et al. ENDO 2019, Session OR01-1.

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– A hormone that is oversecreted in obesity may provide a pathway from adipose to lung tissue in individuals with both obesity and asthma, according to new research presented at the annual meeting of the Endocrine Society.

“Obesity-related asthma is a really understudied and new phenomenon. It’s a unique complication of obesity,” said Furkan Burak, MD, in a video interview after an obesity-focused press conference.

“In addition to being a standalone disease, obesity mostly comes as a package. And that’s the problem,” said Dr. Burak, pointing to obesity-related asthma’s clustering with diseases such as diabetes and atherosclerosis.

Asthma affects 10% of the world population, and it’s becoming increasingly understood that obesity-related, adult-onset asthma is a separate disease entity from allergic asthma, which usually begins in childhood, said Dr. Burak, an endocrinology fellow at Brigham and Women’s Hospital, Boston.

“There are two types of asthma related to obesity,” he said. Classic allergic asthma can get worse with obesity; however, asthma can sometimes occur de novo in adults, particularly women, with obesity. “What is important is … that they are less responsive to classic treatments,” such as steroids and beta-agonists. “And the problem is not small: Of asthmatics, 40% are obese. It’s a therapeutic problem, and we are not able to treat them well.”

The fatty acid binding protein 4, aP2, a hormone that is released by adipose tissue, travels to distant organs and regulates metabolic responses. Levels of aP2 are known to be increased in obesity, particularly in individuals with asthma, said Dr. Burak.

Citing work done at Brigham and Women’s Hospital and at Boston’s Harvard Medical School, as well as elsewhere, Dr. Burak and his collaborators noted in the abstract accompanying the presentation that “increased serum aP2 levels strongly correlate with poor metabolic, inflammatory, and cardiovascular outcomes in multiple independent human studies.”

Dr. Burak said he and his colleagues are trying to sort out “how a fat-tissue–borne hormone could potentially cause a problem in the lung.”

A big clue came with the discovery that patients with asthma and obesity have elevated levels of aP2 within their airways when bronchoalveolar lavage is performed, suggesting that the hormone may be the pathological mediator linking obesity to asthma – “a direct link between the fat tissue and the lung,” he said.

Serum aP2 levels were available from the Nurse’s Health Study, so Dr. Burak and his colleagues looked at those levels in randomly selected study participants. “We found that aP2 levels were elevated 25.6% – significantly – in asthmatics, compared with nonasthmatics, but only in obese and overweight [participants, and] not in lean” participants, he said.

Dr. Burak and his colleagues compared 525 individuals with body mass indices of less than 25 kg/m2, of whom 15 had asthma, with 385 individuals with body mass indices of more than 25, of whom 15 of whom had asthma.

Collecting bronchoalveolar lavage fluid from individuals with asthma showed a mean increase of 23% in aP2 levels in patients with obesity compared with lean individuals.

These data taken together show both systemic and local elevations of aP2 in human obesity. “That could contribute to the airway hyperreactivity and to the asthma pathogenesis,” which would confirm findings from animal studies, said Dr. Burak.

Further investigation will focus on individuals who are haploinsufficient for aP2. The group already is known to have lower risk for dyslipidemia, diabetes, and cardiovascular disease, but Dr. Burak and his collaborators also will determine whether asthma incidence is also lower.

The eventual goal is to attack aP2 as a therapeutic target. “Can we inhibit and target aP2 therapeutically in the context of obesity to treat obesity-related asthma? We have a big hope for that.”

Dr. Burak and his colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Burak MF et al. ENDO 2019, Session OR01-1.

– A hormone that is oversecreted in obesity may provide a pathway from adipose to lung tissue in individuals with both obesity and asthma, according to new research presented at the annual meeting of the Endocrine Society.

“Obesity-related asthma is a really understudied and new phenomenon. It’s a unique complication of obesity,” said Furkan Burak, MD, in a video interview after an obesity-focused press conference.

“In addition to being a standalone disease, obesity mostly comes as a package. And that’s the problem,” said Dr. Burak, pointing to obesity-related asthma’s clustering with diseases such as diabetes and atherosclerosis.

Asthma affects 10% of the world population, and it’s becoming increasingly understood that obesity-related, adult-onset asthma is a separate disease entity from allergic asthma, which usually begins in childhood, said Dr. Burak, an endocrinology fellow at Brigham and Women’s Hospital, Boston.

“There are two types of asthma related to obesity,” he said. Classic allergic asthma can get worse with obesity; however, asthma can sometimes occur de novo in adults, particularly women, with obesity. “What is important is … that they are less responsive to classic treatments,” such as steroids and beta-agonists. “And the problem is not small: Of asthmatics, 40% are obese. It’s a therapeutic problem, and we are not able to treat them well.”

The fatty acid binding protein 4, aP2, a hormone that is released by adipose tissue, travels to distant organs and regulates metabolic responses. Levels of aP2 are known to be increased in obesity, particularly in individuals with asthma, said Dr. Burak.

Citing work done at Brigham and Women’s Hospital and at Boston’s Harvard Medical School, as well as elsewhere, Dr. Burak and his collaborators noted in the abstract accompanying the presentation that “increased serum aP2 levels strongly correlate with poor metabolic, inflammatory, and cardiovascular outcomes in multiple independent human studies.”

Dr. Burak said he and his colleagues are trying to sort out “how a fat-tissue–borne hormone could potentially cause a problem in the lung.”

A big clue came with the discovery that patients with asthma and obesity have elevated levels of aP2 within their airways when bronchoalveolar lavage is performed, suggesting that the hormone may be the pathological mediator linking obesity to asthma – “a direct link between the fat tissue and the lung,” he said.

Serum aP2 levels were available from the Nurse’s Health Study, so Dr. Burak and his colleagues looked at those levels in randomly selected study participants. “We found that aP2 levels were elevated 25.6% – significantly – in asthmatics, compared with nonasthmatics, but only in obese and overweight [participants, and] not in lean” participants, he said.

Dr. Burak and his colleagues compared 525 individuals with body mass indices of less than 25 kg/m2, of whom 15 had asthma, with 385 individuals with body mass indices of more than 25, of whom 15 of whom had asthma.

Collecting bronchoalveolar lavage fluid from individuals with asthma showed a mean increase of 23% in aP2 levels in patients with obesity compared with lean individuals.

These data taken together show both systemic and local elevations of aP2 in human obesity. “That could contribute to the airway hyperreactivity and to the asthma pathogenesis,” which would confirm findings from animal studies, said Dr. Burak.

Further investigation will focus on individuals who are haploinsufficient for aP2. The group already is known to have lower risk for dyslipidemia, diabetes, and cardiovascular disease, but Dr. Burak and his collaborators also will determine whether asthma incidence is also lower.

The eventual goal is to attack aP2 as a therapeutic target. “Can we inhibit and target aP2 therapeutically in the context of obesity to treat obesity-related asthma? We have a big hope for that.”

Dr. Burak and his colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Burak MF et al. ENDO 2019, Session OR01-1.

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Measles: Latest weekly count is the highest of the year

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Measles cases just set a new weekly high for 2019, and the total number for the year is already the second highest in the last decade, according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.

The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.

“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.


In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.

In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.

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Measles cases just set a new weekly high for 2019, and the total number for the year is already the second highest in the last decade, according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.

The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.

“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.


In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.

In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.

Measles cases just set a new weekly high for 2019, and the total number for the year is already the second highest in the last decade, according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.

The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.

“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.


In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.

In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.

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2018-2019 flu season: Going but not gone yet

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The 2018-2019 flu season again showed real signs of ending as influenza activity levels dropped during the week ending March 23, according to the Centers for Disease Control and Prevention.

Despite those declines, however, current levels of influenza-like illness (ILI) activity are still elevated enough that the CDC issued a health advisory on March 28 to inform clinicians about the “increasing proportion of activity due to influenza A(H3N2) viruses, continued circulation of influenza A(H1N1) viruses, and low levels of influenza B viruses.”



The CDC’s weekly flu report, released March 29, does show that the overall burden is improving. The national proportion of outpatient visits for ILI dropped from 4.3% for the week ending March 16 to 3.8% for the latest reporting week, the CDC’s influenza division reported. The figure for March 16 was originally reported to be 4.4% but was revised in the new report.

The length of this years’ flu season, when measured as the number of weeks at or above the baseline level of 2.2%, is now 18 weeks. By this measure, the last five seasons have averaged 16 weeks, the CDC noted.

Influenza was considered widespread in 34 states and Puerto Rico for the week ending March 23, down from 44 states the previous week. The number of states at the highest level of ILI activity on the CDC’s 1-10 scale dropped from 20 to 11, and those in the high range (8-10) dropped from 26 to 20, data from the CDC’s Outpatient ILI Surveillance Network show.

There was one flu-related pediatric death during the week of March 23 but none reported from earlier weeks, which brings the total to 77 for the 2018-2019 season, the CDC said.

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The 2018-2019 flu season again showed real signs of ending as influenza activity levels dropped during the week ending March 23, according to the Centers for Disease Control and Prevention.

Despite those declines, however, current levels of influenza-like illness (ILI) activity are still elevated enough that the CDC issued a health advisory on March 28 to inform clinicians about the “increasing proportion of activity due to influenza A(H3N2) viruses, continued circulation of influenza A(H1N1) viruses, and low levels of influenza B viruses.”



The CDC’s weekly flu report, released March 29, does show that the overall burden is improving. The national proportion of outpatient visits for ILI dropped from 4.3% for the week ending March 16 to 3.8% for the latest reporting week, the CDC’s influenza division reported. The figure for March 16 was originally reported to be 4.4% but was revised in the new report.

The length of this years’ flu season, when measured as the number of weeks at or above the baseline level of 2.2%, is now 18 weeks. By this measure, the last five seasons have averaged 16 weeks, the CDC noted.

Influenza was considered widespread in 34 states and Puerto Rico for the week ending March 23, down from 44 states the previous week. The number of states at the highest level of ILI activity on the CDC’s 1-10 scale dropped from 20 to 11, and those in the high range (8-10) dropped from 26 to 20, data from the CDC’s Outpatient ILI Surveillance Network show.

There was one flu-related pediatric death during the week of March 23 but none reported from earlier weeks, which brings the total to 77 for the 2018-2019 season, the CDC said.

The 2018-2019 flu season again showed real signs of ending as influenza activity levels dropped during the week ending March 23, according to the Centers for Disease Control and Prevention.

Despite those declines, however, current levels of influenza-like illness (ILI) activity are still elevated enough that the CDC issued a health advisory on March 28 to inform clinicians about the “increasing proportion of activity due to influenza A(H3N2) viruses, continued circulation of influenza A(H1N1) viruses, and low levels of influenza B viruses.”



The CDC’s weekly flu report, released March 29, does show that the overall burden is improving. The national proportion of outpatient visits for ILI dropped from 4.3% for the week ending March 16 to 3.8% for the latest reporting week, the CDC’s influenza division reported. The figure for March 16 was originally reported to be 4.4% but was revised in the new report.

The length of this years’ flu season, when measured as the number of weeks at or above the baseline level of 2.2%, is now 18 weeks. By this measure, the last five seasons have averaged 16 weeks, the CDC noted.

Influenza was considered widespread in 34 states and Puerto Rico for the week ending March 23, down from 44 states the previous week. The number of states at the highest level of ILI activity on the CDC’s 1-10 scale dropped from 20 to 11, and those in the high range (8-10) dropped from 26 to 20, data from the CDC’s Outpatient ILI Surveillance Network show.

There was one flu-related pediatric death during the week of March 23 but none reported from earlier weeks, which brings the total to 77 for the 2018-2019 season, the CDC said.

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Occurrence of pulmonary embolisms in hospitalized patients nearly doubled during 2004-2015

Catheter-directed therapy dominates current major PE treatment
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The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

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Dr. Joshua B. Goldberg

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.



Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0

Body

 

At my center, Allegheny General Hospital, we often rely on catheter-directed therapy to treat major pulmonary embolism. We now perform more catheter-directed interventions than surgical embolectomies. Generally, when treating patients with major pulmonary embolism it comes down to a choice between those two options. We rarely use systemic thrombolysis for major pulmonary embolism any more.

Mitchel L. Zoler/MDedge News
Dr. Raymond L. Benza
Hospital staffs now do a lot of screening for pulmonary embolism, so I’m surprised to see these data showing that the in-hospital diagnosis has been increasing. If the data are representative, it suggests that the staffs must do a better job preventing pulmonary embolism by using appropriate prophylaxis for deep vein thrombosis.

Raymond L. Benza, MD , is professor of medicine at Temple University College of Medicine and program director for advanced heart failure at the Allegheny Health Network in Pittsburgh. He has been a consultant to Actelion, Gilead, and United Therapeutics, and he has received research funding from Bayer. He made these comments in an interview.

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At my center, Allegheny General Hospital, we often rely on catheter-directed therapy to treat major pulmonary embolism. We now perform more catheter-directed interventions than surgical embolectomies. Generally, when treating patients with major pulmonary embolism it comes down to a choice between those two options. We rarely use systemic thrombolysis for major pulmonary embolism any more.

Mitchel L. Zoler/MDedge News
Dr. Raymond L. Benza
Hospital staffs now do a lot of screening for pulmonary embolism, so I’m surprised to see these data showing that the in-hospital diagnosis has been increasing. If the data are representative, it suggests that the staffs must do a better job preventing pulmonary embolism by using appropriate prophylaxis for deep vein thrombosis.

Raymond L. Benza, MD , is professor of medicine at Temple University College of Medicine and program director for advanced heart failure at the Allegheny Health Network in Pittsburgh. He has been a consultant to Actelion, Gilead, and United Therapeutics, and he has received research funding from Bayer. He made these comments in an interview.

Body

 

At my center, Allegheny General Hospital, we often rely on catheter-directed therapy to treat major pulmonary embolism. We now perform more catheter-directed interventions than surgical embolectomies. Generally, when treating patients with major pulmonary embolism it comes down to a choice between those two options. We rarely use systemic thrombolysis for major pulmonary embolism any more.

Mitchel L. Zoler/MDedge News
Dr. Raymond L. Benza
Hospital staffs now do a lot of screening for pulmonary embolism, so I’m surprised to see these data showing that the in-hospital diagnosis has been increasing. If the data are representative, it suggests that the staffs must do a better job preventing pulmonary embolism by using appropriate prophylaxis for deep vein thrombosis.

Raymond L. Benza, MD , is professor of medicine at Temple University College of Medicine and program director for advanced heart failure at the Allegheny Health Network in Pittsburgh. He has been a consultant to Actelion, Gilead, and United Therapeutics, and he has received research funding from Bayer. He made these comments in an interview.

Title
Catheter-directed therapy dominates current major PE treatment
Catheter-directed therapy dominates current major PE treatment

 

The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

Mitchel L. Zoler/MDedge News
Dr. Joshua B. Goldberg

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.



Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0

 

The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

Mitchel L. Zoler/MDedge News
Dr. Joshua B. Goldberg

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.



Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0

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Algorithm ruled out PE, averts radiation exposure in pregnant women

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A diagnostic algorithm adapted for use in pregnancy safely ruled out acute pulmonary embolism in nearly 500 women with suspected pulmonary embolism enrolled in a recent prospective study, investigators are reporting.

Using the adapted algorithm, there was only one deep-vein thrombosis (DVT) and no pulmonary embolism (PE) in follow-up among those women, according to the investigators, including senior author Menno V. Huisman, MD, PhD, of the department of thrombosis and hemostasis at Leiden (Netherlands) University Medical Center and his coauthors.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License
Pulmonary embolism

The main advantage of the algorithm is that it averted CT pulmonary angiography in nearly 40% of patients, thus sparing radiation exposure to mother and fetus in many cases, the investigators added.

“Our algorithm provides solid evidence for the safe management of suspected PE in pregnant women, with selective use of CT pulmonary angiography,” Dr. Huisman and colleagues said in their March 21 report in the New England Journal of Medicine.

In a previous clinical trial, known as the YEARS study, a specialized diagnostic algorithm had a low incidence of failure in men and women with clinically suspected PE, as shown by a venous thromboembolism (VTE) rate of just 0.61% at 3 months and by use of CT pulmonary angiography that was 14 percentage points lower than with a conventional algorithmic approach.

For the current study, Dr. Huisman and his coinvestigators took the YEARS algorithm and adapted it for use in pregnant women with suspected PE presenting at 1 of 18 centers in the Netherlands, France, and Ireland.

Their adapted algorithm was based on the three criteria investigators said were most predictive in the YEARS trial, namely, clinical signs of symptoms of DVT, hemoptysis, and PE as the most likely diagnosis. Patients also underwent D-dimer testing, and if they had clinical signs and symptoms of DVT, underwent compression utrasonography of the symptomatic leg.

Pulmonary embolism was considered ruled out in patients who met none of the three YEARS criteria and had a D-dimer under 1,000 ng/mL, or if they met one to three YEARS criteria and had a D-dimer under 500 ng/mL. Otherwise, patients underwent CT pulmonary angiography and started anticoagulant treatment if results of that test indicated PE.

The primary endpoint of the study was the cumulative 3-month incidence of symptomatic VTE among patients with PE ruled out by this algorithm.

Of 498 patients participating in the study, 477 (96%) had a negative result on the adapted YEARS algorithm at baseline, while 20 (4.0%) received a diagnosis of PE, according to results of the study. One patient was lost to follow-up.

Of the 477 patients with negative results, 1 patient (0.21%) had a diagnosis of symptomatic DVT over the 3 months of follow-up, investigators reported, adding that there were no PE diagnoses over the follow-up period.

That patient with the DVT diagnosis met none of the three YEARS criteria and had a D-dimer level of 480 ng/mL, and so did not undergo CT pulmonary angiography, investigators said.

In the worst-case scenario, the VTE incidence would have been 0.42%, assuming the one patient lost to follow-up would have had a VTE diagnosis over the 3-month follow-up period, they added.

“These data meet the proposed criteria for assessing the safety of diagnostic methods in VTE, even in the context of a low baseline prevalence of disease,” Dr. Huisman and his colleagues wrote.

Overall, CT pulmonary angiography was avoided – avoiding potential radiation exposure-related harms– in 39% of the patients, the investigators said, noting that the proportion of women avoiding the diagnostic test decreased from 65% for those evaluated in the third trimester, 46% in the second trimester, and 32% in the third.

“This decreasing specificity can be explained by the physiological rise in the D-dimer level that commonly occurs during pregnancy,” said Dr. Huisman and his coauthors.

The study was supported by unrestricted grants from Leiden University Medical Center and 17 other participating hospitals. Many authors reported financial ties to the pharmaceutical industry.

SOURCE: van der Pol LM et al. N Engl J Med. 2019;380:1139-49

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A diagnostic algorithm adapted for use in pregnancy safely ruled out acute pulmonary embolism in nearly 500 women with suspected pulmonary embolism enrolled in a recent prospective study, investigators are reporting.

Using the adapted algorithm, there was only one deep-vein thrombosis (DVT) and no pulmonary embolism (PE) in follow-up among those women, according to the investigators, including senior author Menno V. Huisman, MD, PhD, of the department of thrombosis and hemostasis at Leiden (Netherlands) University Medical Center and his coauthors.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License
Pulmonary embolism

The main advantage of the algorithm is that it averted CT pulmonary angiography in nearly 40% of patients, thus sparing radiation exposure to mother and fetus in many cases, the investigators added.

“Our algorithm provides solid evidence for the safe management of suspected PE in pregnant women, with selective use of CT pulmonary angiography,” Dr. Huisman and colleagues said in their March 21 report in the New England Journal of Medicine.

In a previous clinical trial, known as the YEARS study, a specialized diagnostic algorithm had a low incidence of failure in men and women with clinically suspected PE, as shown by a venous thromboembolism (VTE) rate of just 0.61% at 3 months and by use of CT pulmonary angiography that was 14 percentage points lower than with a conventional algorithmic approach.

For the current study, Dr. Huisman and his coinvestigators took the YEARS algorithm and adapted it for use in pregnant women with suspected PE presenting at 1 of 18 centers in the Netherlands, France, and Ireland.

Their adapted algorithm was based on the three criteria investigators said were most predictive in the YEARS trial, namely, clinical signs of symptoms of DVT, hemoptysis, and PE as the most likely diagnosis. Patients also underwent D-dimer testing, and if they had clinical signs and symptoms of DVT, underwent compression utrasonography of the symptomatic leg.

Pulmonary embolism was considered ruled out in patients who met none of the three YEARS criteria and had a D-dimer under 1,000 ng/mL, or if they met one to three YEARS criteria and had a D-dimer under 500 ng/mL. Otherwise, patients underwent CT pulmonary angiography and started anticoagulant treatment if results of that test indicated PE.

The primary endpoint of the study was the cumulative 3-month incidence of symptomatic VTE among patients with PE ruled out by this algorithm.

Of 498 patients participating in the study, 477 (96%) had a negative result on the adapted YEARS algorithm at baseline, while 20 (4.0%) received a diagnosis of PE, according to results of the study. One patient was lost to follow-up.

Of the 477 patients with negative results, 1 patient (0.21%) had a diagnosis of symptomatic DVT over the 3 months of follow-up, investigators reported, adding that there were no PE diagnoses over the follow-up period.

That patient with the DVT diagnosis met none of the three YEARS criteria and had a D-dimer level of 480 ng/mL, and so did not undergo CT pulmonary angiography, investigators said.

In the worst-case scenario, the VTE incidence would have been 0.42%, assuming the one patient lost to follow-up would have had a VTE diagnosis over the 3-month follow-up period, they added.

“These data meet the proposed criteria for assessing the safety of diagnostic methods in VTE, even in the context of a low baseline prevalence of disease,” Dr. Huisman and his colleagues wrote.

Overall, CT pulmonary angiography was avoided – avoiding potential radiation exposure-related harms– in 39% of the patients, the investigators said, noting that the proportion of women avoiding the diagnostic test decreased from 65% for those evaluated in the third trimester, 46% in the second trimester, and 32% in the third.

“This decreasing specificity can be explained by the physiological rise in the D-dimer level that commonly occurs during pregnancy,” said Dr. Huisman and his coauthors.

The study was supported by unrestricted grants from Leiden University Medical Center and 17 other participating hospitals. Many authors reported financial ties to the pharmaceutical industry.

SOURCE: van der Pol LM et al. N Engl J Med. 2019;380:1139-49

 

A diagnostic algorithm adapted for use in pregnancy safely ruled out acute pulmonary embolism in nearly 500 women with suspected pulmonary embolism enrolled in a recent prospective study, investigators are reporting.

Using the adapted algorithm, there was only one deep-vein thrombosis (DVT) and no pulmonary embolism (PE) in follow-up among those women, according to the investigators, including senior author Menno V. Huisman, MD, PhD, of the department of thrombosis and hemostasis at Leiden (Netherlands) University Medical Center and his coauthors.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License
Pulmonary embolism

The main advantage of the algorithm is that it averted CT pulmonary angiography in nearly 40% of patients, thus sparing radiation exposure to mother and fetus in many cases, the investigators added.

“Our algorithm provides solid evidence for the safe management of suspected PE in pregnant women, with selective use of CT pulmonary angiography,” Dr. Huisman and colleagues said in their March 21 report in the New England Journal of Medicine.

In a previous clinical trial, known as the YEARS study, a specialized diagnostic algorithm had a low incidence of failure in men and women with clinically suspected PE, as shown by a venous thromboembolism (VTE) rate of just 0.61% at 3 months and by use of CT pulmonary angiography that was 14 percentage points lower than with a conventional algorithmic approach.

For the current study, Dr. Huisman and his coinvestigators took the YEARS algorithm and adapted it for use in pregnant women with suspected PE presenting at 1 of 18 centers in the Netherlands, France, and Ireland.

Their adapted algorithm was based on the three criteria investigators said were most predictive in the YEARS trial, namely, clinical signs of symptoms of DVT, hemoptysis, and PE as the most likely diagnosis. Patients also underwent D-dimer testing, and if they had clinical signs and symptoms of DVT, underwent compression utrasonography of the symptomatic leg.

Pulmonary embolism was considered ruled out in patients who met none of the three YEARS criteria and had a D-dimer under 1,000 ng/mL, or if they met one to three YEARS criteria and had a D-dimer under 500 ng/mL. Otherwise, patients underwent CT pulmonary angiography and started anticoagulant treatment if results of that test indicated PE.

The primary endpoint of the study was the cumulative 3-month incidence of symptomatic VTE among patients with PE ruled out by this algorithm.

Of 498 patients participating in the study, 477 (96%) had a negative result on the adapted YEARS algorithm at baseline, while 20 (4.0%) received a diagnosis of PE, according to results of the study. One patient was lost to follow-up.

Of the 477 patients with negative results, 1 patient (0.21%) had a diagnosis of symptomatic DVT over the 3 months of follow-up, investigators reported, adding that there were no PE diagnoses over the follow-up period.

That patient with the DVT diagnosis met none of the three YEARS criteria and had a D-dimer level of 480 ng/mL, and so did not undergo CT pulmonary angiography, investigators said.

In the worst-case scenario, the VTE incidence would have been 0.42%, assuming the one patient lost to follow-up would have had a VTE diagnosis over the 3-month follow-up period, they added.

“These data meet the proposed criteria for assessing the safety of diagnostic methods in VTE, even in the context of a low baseline prevalence of disease,” Dr. Huisman and his colleagues wrote.

Overall, CT pulmonary angiography was avoided – avoiding potential radiation exposure-related harms– in 39% of the patients, the investigators said, noting that the proportion of women avoiding the diagnostic test decreased from 65% for those evaluated in the third trimester, 46% in the second trimester, and 32% in the third.

“This decreasing specificity can be explained by the physiological rise in the D-dimer level that commonly occurs during pregnancy,” said Dr. Huisman and his coauthors.

The study was supported by unrestricted grants from Leiden University Medical Center and 17 other participating hospitals. Many authors reported financial ties to the pharmaceutical industry.

SOURCE: van der Pol LM et al. N Engl J Med. 2019;380:1139-49

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H3N2 putting a damper on flu season’s departure

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The decline of influenza activity remains slow, largely “driven by a wave of H3N2 virus activity” in recent weeks, according to the Centers for Disease Control and Prevention.

Fewer states reported the highest level of influenza-like illness (ILI) activity on the CDC’s 1-10 scale for the week ending March 16, but the national proportion of outpatient visits for ILI was 4.4% for the second consecutive week, the CDC’s influenza division reported March 22. The outpatient-visit figure for the week ending March 9 was originally reported as 4.5% last week, but it has been revised down to 4.4% this week.

Another measure of activity – the percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories – actually increased slightly during the week ending March 16, the CDC noted.

For the current week, there were 26 states in the high (8-10) range of activity – 20 states were at level 10 and another 6 states were at level 8 – compared with the previous week, when 21 states were at level 10 and 30 states were in the high range, the CDC’s Outpatient ILI Surveillance Network reported.



There were eight ILI-related deaths in children reported during the week ending March 16, seven of which occurred in previous weeks. The total for the 2018-2019 season so far is 76, the CDC said.

New preliminary estimates on influenza’s burden nationally put the total number of deaths at 25,000-41,500 since the beginning of the season on Oct. 1, 2018. There also have been 375,000-454,000 flu-related hospitalizations, 13.2 million to 15.4 million medical visits, and 28.5 to 32.8 million individual illnesses, the CDC said.

Since the CDC “expects flu activity to remain elevated for a number of weeks,” it continues to recommend flu vaccination and the use of influenza antiviral drugs as “an important second line of defense that can be used to treat flu illness. H3N2 viruses are typically associated with more severe illness in older adults, and flu vaccine may protect less well against H3N2 illness in older adults, making prompt treatment with flu antivirals in this age group especially important during the current period of H3N2 predominance.”

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The decline of influenza activity remains slow, largely “driven by a wave of H3N2 virus activity” in recent weeks, according to the Centers for Disease Control and Prevention.

Fewer states reported the highest level of influenza-like illness (ILI) activity on the CDC’s 1-10 scale for the week ending March 16, but the national proportion of outpatient visits for ILI was 4.4% for the second consecutive week, the CDC’s influenza division reported March 22. The outpatient-visit figure for the week ending March 9 was originally reported as 4.5% last week, but it has been revised down to 4.4% this week.

Another measure of activity – the percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories – actually increased slightly during the week ending March 16, the CDC noted.

For the current week, there were 26 states in the high (8-10) range of activity – 20 states were at level 10 and another 6 states were at level 8 – compared with the previous week, when 21 states were at level 10 and 30 states were in the high range, the CDC’s Outpatient ILI Surveillance Network reported.



There were eight ILI-related deaths in children reported during the week ending March 16, seven of which occurred in previous weeks. The total for the 2018-2019 season so far is 76, the CDC said.

New preliminary estimates on influenza’s burden nationally put the total number of deaths at 25,000-41,500 since the beginning of the season on Oct. 1, 2018. There also have been 375,000-454,000 flu-related hospitalizations, 13.2 million to 15.4 million medical visits, and 28.5 to 32.8 million individual illnesses, the CDC said.

Since the CDC “expects flu activity to remain elevated for a number of weeks,” it continues to recommend flu vaccination and the use of influenza antiviral drugs as “an important second line of defense that can be used to treat flu illness. H3N2 viruses are typically associated with more severe illness in older adults, and flu vaccine may protect less well against H3N2 illness in older adults, making prompt treatment with flu antivirals in this age group especially important during the current period of H3N2 predominance.”

 

The decline of influenza activity remains slow, largely “driven by a wave of H3N2 virus activity” in recent weeks, according to the Centers for Disease Control and Prevention.

Fewer states reported the highest level of influenza-like illness (ILI) activity on the CDC’s 1-10 scale for the week ending March 16, but the national proportion of outpatient visits for ILI was 4.4% for the second consecutive week, the CDC’s influenza division reported March 22. The outpatient-visit figure for the week ending March 9 was originally reported as 4.5% last week, but it has been revised down to 4.4% this week.

Another measure of activity – the percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories – actually increased slightly during the week ending March 16, the CDC noted.

For the current week, there were 26 states in the high (8-10) range of activity – 20 states were at level 10 and another 6 states were at level 8 – compared with the previous week, when 21 states were at level 10 and 30 states were in the high range, the CDC’s Outpatient ILI Surveillance Network reported.



There were eight ILI-related deaths in children reported during the week ending March 16, seven of which occurred in previous weeks. The total for the 2018-2019 season so far is 76, the CDC said.

New preliminary estimates on influenza’s burden nationally put the total number of deaths at 25,000-41,500 since the beginning of the season on Oct. 1, 2018. There also have been 375,000-454,000 flu-related hospitalizations, 13.2 million to 15.4 million medical visits, and 28.5 to 32.8 million individual illnesses, the CDC said.

Since the CDC “expects flu activity to remain elevated for a number of weeks,” it continues to recommend flu vaccination and the use of influenza antiviral drugs as “an important second line of defense that can be used to treat flu illness. H3N2 viruses are typically associated with more severe illness in older adults, and flu vaccine may protect less well against H3N2 illness in older adults, making prompt treatment with flu antivirals in this age group especially important during the current period of H3N2 predominance.”

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FDA approves solriamfetol for daytime sleepiness treatment

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The Food and Drug Administration has approved solriamfetol (Sunosi) for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.

Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.

Find the full press release on the Jazz Pharmaceuticals website.

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The Food and Drug Administration has approved solriamfetol (Sunosi) for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.

Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.

Find the full press release on the Jazz Pharmaceuticals website.

 

The Food and Drug Administration has approved solriamfetol (Sunosi) for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. It is the first dopamine and norepinephrine reuptake inhibitor approved to treat those conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Approval was based on results from TONES (Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness), a phase 3 study that combined four randomized, placebo-controlled trials assessing solriamfetol at various doses, compared with a placebo. After 12 weeks, 68%-74% of patients taking solriamfetol at 75 mg and 78%-90% of those taking solriamfetol at 150 mg reported improvement as assessed by the Patient Global Impression of Change scale.

Solriamfetol is approved at 75 mg and 150 mg for patients with narcolepsy and at 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea. The most common adverse events associated with solriamfetol are headache, nausea, decreased appetite, and anxiety.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home, or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the press release.

Find the full press release on the Jazz Pharmaceuticals website.

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Survey: Americans support regulation of vaping products

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Almost 70% of adults believe that the Food and Drug Administration should raise the legal age to purchase e-cigarettes and tobacco, according to a new survey by NORC at the University of Chicago, a nonpartisan research institution.

“Americans are particularly concerned about teens becoming newly addicted to e-cigarettes, and they support a range of actions the federal government could take to make vaping products less available, less addictive, and less appealing,” Caroline Pearson, senior vice president at NORC, said in a written statement.



The AmeriSpeak Spotlight on Health Poll, conducted Feb. 14-18, 2019 (margin of error, plus or minus 4.12%), showed that 69% of adults strongly or somewhat support raising the age limit to purchase e-cigarettes and tobacco and 55% support restricting sales of flavored e-cigarettes, NORC reported. Almost 40% of the 1,004 respondents expressed support for a complete ban on e-cigarettes.



Despite FDA efforts under Commissioner Scott Gottlieb, MD, to raise awareness of teen vaping, only 21% of those surveyed correctly responded that e-cigarettes generally contain more nicotine that regular cigarettes. Dr. Gottlieb announced his resignation recently, “but he indicated that the Trump Administration will continue efforts to increase regulation of e-cigarettes,” NORC said.

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Almost 70% of adults believe that the Food and Drug Administration should raise the legal age to purchase e-cigarettes and tobacco, according to a new survey by NORC at the University of Chicago, a nonpartisan research institution.

“Americans are particularly concerned about teens becoming newly addicted to e-cigarettes, and they support a range of actions the federal government could take to make vaping products less available, less addictive, and less appealing,” Caroline Pearson, senior vice president at NORC, said in a written statement.



The AmeriSpeak Spotlight on Health Poll, conducted Feb. 14-18, 2019 (margin of error, plus or minus 4.12%), showed that 69% of adults strongly or somewhat support raising the age limit to purchase e-cigarettes and tobacco and 55% support restricting sales of flavored e-cigarettes, NORC reported. Almost 40% of the 1,004 respondents expressed support for a complete ban on e-cigarettes.



Despite FDA efforts under Commissioner Scott Gottlieb, MD, to raise awareness of teen vaping, only 21% of those surveyed correctly responded that e-cigarettes generally contain more nicotine that regular cigarettes. Dr. Gottlieb announced his resignation recently, “but he indicated that the Trump Administration will continue efforts to increase regulation of e-cigarettes,” NORC said.

 

Almost 70% of adults believe that the Food and Drug Administration should raise the legal age to purchase e-cigarettes and tobacco, according to a new survey by NORC at the University of Chicago, a nonpartisan research institution.

“Americans are particularly concerned about teens becoming newly addicted to e-cigarettes, and they support a range of actions the federal government could take to make vaping products less available, less addictive, and less appealing,” Caroline Pearson, senior vice president at NORC, said in a written statement.



The AmeriSpeak Spotlight on Health Poll, conducted Feb. 14-18, 2019 (margin of error, plus or minus 4.12%), showed that 69% of adults strongly or somewhat support raising the age limit to purchase e-cigarettes and tobacco and 55% support restricting sales of flavored e-cigarettes, NORC reported. Almost 40% of the 1,004 respondents expressed support for a complete ban on e-cigarettes.



Despite FDA efforts under Commissioner Scott Gottlieb, MD, to raise awareness of teen vaping, only 21% of those surveyed correctly responded that e-cigarettes generally contain more nicotine that regular cigarettes. Dr. Gottlieb announced his resignation recently, “but he indicated that the Trump Administration will continue efforts to increase regulation of e-cigarettes,” NORC said.

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Flu activity levels down, but outpatient visits highest since 1998-99

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Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

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Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

 

Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

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