Zika virus vaccine trial launches

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A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

 

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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Girl reunites with mother amid uncertainty

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Mon, 06/03/2019 - 08:28

 

Prominent in the news has been the plight of thousands of immigrant families who are separated from one another at the Mexico-United States border. Now, as reunification is occurring for some, what is the aftermath of the forced separations?

A recent report by the PBS News Hour focused on 3-year-old “Sofi” (last name withheld). She and her grandmother and guardian, Angelina, were among those separated when they made their way legally from Mexico to a U.S. immigration checkpoint in Texas, seeking to escape reprisals from a Mexican drug cartel. For 47 days, infant Sofi was on her own without her family, first in a migrant shelter in El Paso, Texas, and then in a facility in Pennsylvania. For Ana, whose mother was in California already, the time apart from Sofi was one of mind-numbing worry over the fate of her daughter and mother.

Now, life is better. Through an interpreter, Ana said: “I feel good, very good to see her with my mom, and to know that she will now be with us, and she won’t be apart from me.”

The separation was hard on Sofi.

“She cried all the time, told me she didn’t want to be there,” said Ana of Sofi’s ordeal. “One time, she didn’t sound OK. She couldn’t speak clearly, and they were giving her a bad look. They would scold her. And she wanted to tell me something, but couldn’t, because they would scold her. So that had me very worried.”

The early days of reunification have gone fairly well. But unease remains. Sofi mentioned medicine she was given and of being punished for crying or refusing to eat. Whether those incidents are real or embellished, and whether emotional scars remain, is the stuff of the unknown.

“We haven’t asked her many questions because she says that it was a bad place. We want to eventually ask her little by little how she was treated. I think that, with time, we need to let her know that they separated her from us for some time,” Angelina said. “We want to take her to see a therapist, for her to be examined to see how she is, how her health is, because she looks good now – but who knows how she will react later on.” Sofi is home. But hundreds of other children reportedly remain separated from their families.

Click here to watch the News Hour report.

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Prominent in the news has been the plight of thousands of immigrant families who are separated from one another at the Mexico-United States border. Now, as reunification is occurring for some, what is the aftermath of the forced separations?

A recent report by the PBS News Hour focused on 3-year-old “Sofi” (last name withheld). She and her grandmother and guardian, Angelina, were among those separated when they made their way legally from Mexico to a U.S. immigration checkpoint in Texas, seeking to escape reprisals from a Mexican drug cartel. For 47 days, infant Sofi was on her own without her family, first in a migrant shelter in El Paso, Texas, and then in a facility in Pennsylvania. For Ana, whose mother was in California already, the time apart from Sofi was one of mind-numbing worry over the fate of her daughter and mother.

Now, life is better. Through an interpreter, Ana said: “I feel good, very good to see her with my mom, and to know that she will now be with us, and she won’t be apart from me.”

The separation was hard on Sofi.

“She cried all the time, told me she didn’t want to be there,” said Ana of Sofi’s ordeal. “One time, she didn’t sound OK. She couldn’t speak clearly, and they were giving her a bad look. They would scold her. And she wanted to tell me something, but couldn’t, because they would scold her. So that had me very worried.”

The early days of reunification have gone fairly well. But unease remains. Sofi mentioned medicine she was given and of being punished for crying or refusing to eat. Whether those incidents are real or embellished, and whether emotional scars remain, is the stuff of the unknown.

“We haven’t asked her many questions because she says that it was a bad place. We want to eventually ask her little by little how she was treated. I think that, with time, we need to let her know that they separated her from us for some time,” Angelina said. “We want to take her to see a therapist, for her to be examined to see how she is, how her health is, because she looks good now – but who knows how she will react later on.” Sofi is home. But hundreds of other children reportedly remain separated from their families.

Click here to watch the News Hour report.

 

Prominent in the news has been the plight of thousands of immigrant families who are separated from one another at the Mexico-United States border. Now, as reunification is occurring for some, what is the aftermath of the forced separations?

A recent report by the PBS News Hour focused on 3-year-old “Sofi” (last name withheld). She and her grandmother and guardian, Angelina, were among those separated when they made their way legally from Mexico to a U.S. immigration checkpoint in Texas, seeking to escape reprisals from a Mexican drug cartel. For 47 days, infant Sofi was on her own without her family, first in a migrant shelter in El Paso, Texas, and then in a facility in Pennsylvania. For Ana, whose mother was in California already, the time apart from Sofi was one of mind-numbing worry over the fate of her daughter and mother.

Now, life is better. Through an interpreter, Ana said: “I feel good, very good to see her with my mom, and to know that she will now be with us, and she won’t be apart from me.”

The separation was hard on Sofi.

“She cried all the time, told me she didn’t want to be there,” said Ana of Sofi’s ordeal. “One time, she didn’t sound OK. She couldn’t speak clearly, and they were giving her a bad look. They would scold her. And she wanted to tell me something, but couldn’t, because they would scold her. So that had me very worried.”

The early days of reunification have gone fairly well. But unease remains. Sofi mentioned medicine she was given and of being punished for crying or refusing to eat. Whether those incidents are real or embellished, and whether emotional scars remain, is the stuff of the unknown.

“We haven’t asked her many questions because she says that it was a bad place. We want to eventually ask her little by little how she was treated. I think that, with time, we need to let her know that they separated her from us for some time,” Angelina said. “We want to take her to see a therapist, for her to be examined to see how she is, how her health is, because she looks good now – but who knows how she will react later on.” Sofi is home. But hundreds of other children reportedly remain separated from their families.

Click here to watch the News Hour report.

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The moves may not be smooth, but dance dad, dance

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Mon, 06/03/2019 - 08:29

 

Many men (yours truly included) are not the smoothest creatures on the dance floor. But what is embarrassing dorky in public works like magic at home, with the clunky moves drawing howls of laughter from family.

But there’s the rub ... behavior that is fun in private can become something to be avoided in public. The drumbeat of generations past about men who are strong and capable can surface, curbing those tapping feet and sending dads to the edge of the dance floor.

That’s why the latest Internet rage is welcome. Videos of dads putting on their best moves are providing an example of how love can overcome less-than-stellar footwork. Check out https://www.youtube.com/watch?v=SGSSHSJPhv4 for an example.

According to Sarah L. Kaufman, dance critic at the Washington Post, “therein lies the coolness of the real-life dancing dad. He’s the opposite of embarrassing! He’s uplifting by way of a profound, unspoken understanding of the situation and of his child.”

Motivated by love and unafraid to show the world their moves, the dorky dancing dad can become heroic dancing dad, especially to a son or daughter who is on shaky ground and in need of support. The behavior of these dads also runs counter to the toxic masculinity that seems to pervade much of American culture.

“Within his body, stereotypes are vanquished. The distant dad is overshadowed by the physically present dad. The clueless dad yields to the one who knows exactly what his kid needs,” Ms. Kaufman wrote.

So go, dancing dad, go!

To read Ms. Kaufman’s article, click here.

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Many men (yours truly included) are not the smoothest creatures on the dance floor. But what is embarrassing dorky in public works like magic at home, with the clunky moves drawing howls of laughter from family.

But there’s the rub ... behavior that is fun in private can become something to be avoided in public. The drumbeat of generations past about men who are strong and capable can surface, curbing those tapping feet and sending dads to the edge of the dance floor.

That’s why the latest Internet rage is welcome. Videos of dads putting on their best moves are providing an example of how love can overcome less-than-stellar footwork. Check out https://www.youtube.com/watch?v=SGSSHSJPhv4 for an example.

According to Sarah L. Kaufman, dance critic at the Washington Post, “therein lies the coolness of the real-life dancing dad. He’s the opposite of embarrassing! He’s uplifting by way of a profound, unspoken understanding of the situation and of his child.”

Motivated by love and unafraid to show the world their moves, the dorky dancing dad can become heroic dancing dad, especially to a son or daughter who is on shaky ground and in need of support. The behavior of these dads also runs counter to the toxic masculinity that seems to pervade much of American culture.

“Within his body, stereotypes are vanquished. The distant dad is overshadowed by the physically present dad. The clueless dad yields to the one who knows exactly what his kid needs,” Ms. Kaufman wrote.

So go, dancing dad, go!

To read Ms. Kaufman’s article, click here.

 

Many men (yours truly included) are not the smoothest creatures on the dance floor. But what is embarrassing dorky in public works like magic at home, with the clunky moves drawing howls of laughter from family.

But there’s the rub ... behavior that is fun in private can become something to be avoided in public. The drumbeat of generations past about men who are strong and capable can surface, curbing those tapping feet and sending dads to the edge of the dance floor.

That’s why the latest Internet rage is welcome. Videos of dads putting on their best moves are providing an example of how love can overcome less-than-stellar footwork. Check out https://www.youtube.com/watch?v=SGSSHSJPhv4 for an example.

According to Sarah L. Kaufman, dance critic at the Washington Post, “therein lies the coolness of the real-life dancing dad. He’s the opposite of embarrassing! He’s uplifting by way of a profound, unspoken understanding of the situation and of his child.”

Motivated by love and unafraid to show the world their moves, the dorky dancing dad can become heroic dancing dad, especially to a son or daughter who is on shaky ground and in need of support. The behavior of these dads also runs counter to the toxic masculinity that seems to pervade much of American culture.

“Within his body, stereotypes are vanquished. The distant dad is overshadowed by the physically present dad. The clueless dad yields to the one who knows exactly what his kid needs,” Ms. Kaufman wrote.

So go, dancing dad, go!

To read Ms. Kaufman’s article, click here.

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Psoriasis registry study provides more data on infliximab’s infection risk

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Tue, 02/07/2023 - 16:54

Among psoriasis patients, treatment with infliximab was associated with an increased risk of serious infections that led to hospitalization, the use of intravenous antimicrobial therapy, or death, according to a prospective cohort study of cases in the United Kingdom and the Republic of Ireland.

The new data suggest a risk associated with infliximab treatment that previous clinical trials and observational studies were insufficiently powered to detect, according to the investigators, led by Zenas Yiu, of the University of Manchester (England). They found no associations between infection risk and treatment with etanercept, adalimumab, or ustekinumab, and they noted that there are no such data yet on more recently approved biologic therapies for psoriasis, such as secukinumab or ixekizumab.

The British Association of Dermatologists (BAD) recommends infliximab, a tumor necrosis factor (TNF)–blocker, only for severe cases of psoriasis (Psoriasis Area and Severity Index greater than or equal to 20 and a Dermatology Life Quality Index greater than 18), or when other biologics fail or cannot be used.

To address the insufficient power of earlier studies, the researchers used data from the BAD Biologic Interventions Register (BADBIR), a large, prospective psoriasis registry in the United Kingdom and Ireland established in 2007. The analysis included 3,421 subjects in the nonbiologic systemic therapy cohort, and 422 subjects in the all-lines infliximab cohort. The median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.*

Treatment with infliximab was associated with a statistically significant increased risk of serious infection (defined as an infection associated with prolonged hospitalization or use of IV antimicrobial therapy; or an infection that resulted in death), with an adjusted hazard ratio of 1.95 (95% confidence interval, 1.01-3.75), compared with nonbiologic systemic treatments. The risk was higher in the first 6 months (adjusted HR, 3.49; 95% CI, 1.14-10.70), and from 6 months to 1 year (aHR, 2.99; 95% CI, 1.10-8.14,) but did not reach statistical significance at 1 year to 2 years (aHR, 2.03; 95% CI, 0.61-6.79).

There was also an increased risk of serious infection with infliximab compared with methotrexate (aHR, 2.96; 95% CI, 1.58-5.57).

“Given our findings of a higher risk of serious infection associated with infliximab, we provide real-world evidence to reinforce the position of infliximab in the psoriasis treatment hierarchy,” the authors wrote, adding that “patients with severe psoriasis who fulfill the criteria for the prescription of infliximab should be counseled” about the risk of serious infection.

Dr. Yiu disclosed having received nonfinancial support form Novartis, two authors had no disclosures, and the remainder had various disclosures related to pharmaceutical companies. BADBIR is funded by BAD, which receives funding from Pfizer, Janssen Cilag, AbbVie, Novartis, Samsung Bioepis and Eli Lilly for providing pharmacovigilance services.

SOURCE: Yiu ZZN et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17036.

*This article was updated to correctly indicate that the median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.

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Among psoriasis patients, treatment with infliximab was associated with an increased risk of serious infections that led to hospitalization, the use of intravenous antimicrobial therapy, or death, according to a prospective cohort study of cases in the United Kingdom and the Republic of Ireland.

The new data suggest a risk associated with infliximab treatment that previous clinical trials and observational studies were insufficiently powered to detect, according to the investigators, led by Zenas Yiu, of the University of Manchester (England). They found no associations between infection risk and treatment with etanercept, adalimumab, or ustekinumab, and they noted that there are no such data yet on more recently approved biologic therapies for psoriasis, such as secukinumab or ixekizumab.

The British Association of Dermatologists (BAD) recommends infliximab, a tumor necrosis factor (TNF)–blocker, only for severe cases of psoriasis (Psoriasis Area and Severity Index greater than or equal to 20 and a Dermatology Life Quality Index greater than 18), or when other biologics fail or cannot be used.

To address the insufficient power of earlier studies, the researchers used data from the BAD Biologic Interventions Register (BADBIR), a large, prospective psoriasis registry in the United Kingdom and Ireland established in 2007. The analysis included 3,421 subjects in the nonbiologic systemic therapy cohort, and 422 subjects in the all-lines infliximab cohort. The median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.*

Treatment with infliximab was associated with a statistically significant increased risk of serious infection (defined as an infection associated with prolonged hospitalization or use of IV antimicrobial therapy; or an infection that resulted in death), with an adjusted hazard ratio of 1.95 (95% confidence interval, 1.01-3.75), compared with nonbiologic systemic treatments. The risk was higher in the first 6 months (adjusted HR, 3.49; 95% CI, 1.14-10.70), and from 6 months to 1 year (aHR, 2.99; 95% CI, 1.10-8.14,) but did not reach statistical significance at 1 year to 2 years (aHR, 2.03; 95% CI, 0.61-6.79).

There was also an increased risk of serious infection with infliximab compared with methotrexate (aHR, 2.96; 95% CI, 1.58-5.57).

“Given our findings of a higher risk of serious infection associated with infliximab, we provide real-world evidence to reinforce the position of infliximab in the psoriasis treatment hierarchy,” the authors wrote, adding that “patients with severe psoriasis who fulfill the criteria for the prescription of infliximab should be counseled” about the risk of serious infection.

Dr. Yiu disclosed having received nonfinancial support form Novartis, two authors had no disclosures, and the remainder had various disclosures related to pharmaceutical companies. BADBIR is funded by BAD, which receives funding from Pfizer, Janssen Cilag, AbbVie, Novartis, Samsung Bioepis and Eli Lilly for providing pharmacovigilance services.

SOURCE: Yiu ZZN et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17036.

*This article was updated to correctly indicate that the median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.

Among psoriasis patients, treatment with infliximab was associated with an increased risk of serious infections that led to hospitalization, the use of intravenous antimicrobial therapy, or death, according to a prospective cohort study of cases in the United Kingdom and the Republic of Ireland.

The new data suggest a risk associated with infliximab treatment that previous clinical trials and observational studies were insufficiently powered to detect, according to the investigators, led by Zenas Yiu, of the University of Manchester (England). They found no associations between infection risk and treatment with etanercept, adalimumab, or ustekinumab, and they noted that there are no such data yet on more recently approved biologic therapies for psoriasis, such as secukinumab or ixekizumab.

The British Association of Dermatologists (BAD) recommends infliximab, a tumor necrosis factor (TNF)–blocker, only for severe cases of psoriasis (Psoriasis Area and Severity Index greater than or equal to 20 and a Dermatology Life Quality Index greater than 18), or when other biologics fail or cannot be used.

To address the insufficient power of earlier studies, the researchers used data from the BAD Biologic Interventions Register (BADBIR), a large, prospective psoriasis registry in the United Kingdom and Ireland established in 2007. The analysis included 3,421 subjects in the nonbiologic systemic therapy cohort, and 422 subjects in the all-lines infliximab cohort. The median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.*

Treatment with infliximab was associated with a statistically significant increased risk of serious infection (defined as an infection associated with prolonged hospitalization or use of IV antimicrobial therapy; or an infection that resulted in death), with an adjusted hazard ratio of 1.95 (95% confidence interval, 1.01-3.75), compared with nonbiologic systemic treatments. The risk was higher in the first 6 months (adjusted HR, 3.49; 95% CI, 1.14-10.70), and from 6 months to 1 year (aHR, 2.99; 95% CI, 1.10-8.14,) but did not reach statistical significance at 1 year to 2 years (aHR, 2.03; 95% CI, 0.61-6.79).

There was also an increased risk of serious infection with infliximab compared with methotrexate (aHR, 2.96; 95% CI, 1.58-5.57).

“Given our findings of a higher risk of serious infection associated with infliximab, we provide real-world evidence to reinforce the position of infliximab in the psoriasis treatment hierarchy,” the authors wrote, adding that “patients with severe psoriasis who fulfill the criteria for the prescription of infliximab should be counseled” about the risk of serious infection.

Dr. Yiu disclosed having received nonfinancial support form Novartis, two authors had no disclosures, and the remainder had various disclosures related to pharmaceutical companies. BADBIR is funded by BAD, which receives funding from Pfizer, Janssen Cilag, AbbVie, Novartis, Samsung Bioepis and Eli Lilly for providing pharmacovigilance services.

SOURCE: Yiu ZZN et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17036.

*This article was updated to correctly indicate that the median follow-up period was 1.49 person-years (interquartile range, 2.50 person-years) for the all-lines (not just first-line) infliximab group, and 1.51 person-years (1.84 person-years) for the nonbiologics group.

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FROM BRITISH JOURNAL OF DERMATOLOGY

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Key clinical point: The study reinforces British guidelines that infliximab should be restricted to most severe cases.

Major finding: Infliximab was associated with a hazard ratio of 1.95 for severe infections, compared with non-biologic systemic therapies.

Study details: Prospective cohort analysis of a psoriasis treatment database of 3,843 individuals.

Disclosures: Dr. Yiu disclosed having received non-financial support form Novartis, two authors had no disclosures, and the remainder had various disclosures related to pharmaceutical companies. BADBIR is funded by BAD, which receives funding from Pfizer, Janssen Cilag, AbbVie, Novartis, Samsung Bioepis and Eli Lilly for providing pharmacovigilance services.

Source: Yiu ZZN et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17036.

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Study supports effects of smoking, drinking on SLE risk in black women

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Fri, 01/18/2019 - 17:53

 

Black women who smoke cigarettes are at increased risk of systemic lupus erythematosus (SLE), while those who drink alcohol in moderation have a decreased risk, data from the prospective Black Women’s Health Study suggests.

The current findings among black women, who are the demographic group at the highest risk of SLE in the U.S. population, are consistent with the previously reported positive association of cigarette smoking with risk of SLE and inverse association of alcohol consumption with SLE,” lead researchers Yvette Cozier, DSc, and Medha Barbhaiya, MD, and their colleagues wrote in a study published in Arthritis Care & Research.

“The role of environmental factors in the pathogenesis of SLE is of great interest, as genetic factors do not explain a major portion of the incidence. Cigarette smoking has been associated with SLE risk in several, but not all, past studies,” wrote Dr. Cozier of the Slone Epidemiology Center at Boston University and Dr. Barbhaiya of the Hospital for Special Surgery, New York, and their coauthors.

Their analysis of data from the Black Women’s Health Study, a prospective study following 59,000 black women in the United States since 1995, identified 127 new cases of SLE between 1995 and 2015 that were confirmed by medical records.

At baseline, 8,851 women (16%) were current smokers, and 10,447 (18%) were past smokers. A total of 14,001 (25%) were current drinkers, and 10,255 (18%) were past drinkers.

The researchers reported that, compared with never smokers, women who had ever smoked had a 45% higher risk for SLE than did never smokers (hazard ratio, 1.45; 95% confidence interval, 0.97-2.18), but the finding was not statistically significant.


The risk of SLE was greater among current smokers (52% higher risk) than among past smokers (41% higher risk), and greater for 20 or more pack-years of smoking (60% higher risk) than for less than 20 pack-years of smoking (37% higher risk), although the authors noted that none of these differences were statistically significant.

Current and past alcohol consumption were associated with nonsignificant reductions in risk for SLE, 29% and 21%, respectively. However, “moderate” current alcohol consumption, measured as four or more drinks per week, was associated with a 57% reduction in risk for SLE (HR, 0.43; 95% CI, 0.19-0.96).

The researchers said that the associations between cigarette smoking and alcohol intake with SLE risk were biologically plausible and may lead to insights into SLE pathogenesis. For example, exposure to toxic components from cigarette smoke was associated with increased oxidative stress and stimulation of autoantibody production, and such exposure can directly damage endogenous proteins and DNA. Alcohol suppresses the synthesis of proinflammatory cytokines and may inhibit DNA synthesis.

The small number of lupus cases in the Black Women’s Health Study cohort limited the statistical power of the analysis. Smoking and alcohol use were also relatively uncommon among women in the Black Women’s Health Study cohort, the investigators said.

“Future studies are needed to confirm these findings and establish the biologic mechanisms by which cigarette smoking and alcohol consumption influence the risk of SLE in this population and others,“ they wrote.

The study was supported by individual investigators’ grant awards from the National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Rheumatology Research Foundation, and the Lupus Foundation of America. The authors declared no relevant conflicts of interest.

SOURCE: Cozier Y et al. Arthritis Care Res. 2018 Aug 9. doi: 10.1002/acr.23703.

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Black women who smoke cigarettes are at increased risk of systemic lupus erythematosus (SLE), while those who drink alcohol in moderation have a decreased risk, data from the prospective Black Women’s Health Study suggests.

The current findings among black women, who are the demographic group at the highest risk of SLE in the U.S. population, are consistent with the previously reported positive association of cigarette smoking with risk of SLE and inverse association of alcohol consumption with SLE,” lead researchers Yvette Cozier, DSc, and Medha Barbhaiya, MD, and their colleagues wrote in a study published in Arthritis Care & Research.

“The role of environmental factors in the pathogenesis of SLE is of great interest, as genetic factors do not explain a major portion of the incidence. Cigarette smoking has been associated with SLE risk in several, but not all, past studies,” wrote Dr. Cozier of the Slone Epidemiology Center at Boston University and Dr. Barbhaiya of the Hospital for Special Surgery, New York, and their coauthors.

Their analysis of data from the Black Women’s Health Study, a prospective study following 59,000 black women in the United States since 1995, identified 127 new cases of SLE between 1995 and 2015 that were confirmed by medical records.

At baseline, 8,851 women (16%) were current smokers, and 10,447 (18%) were past smokers. A total of 14,001 (25%) were current drinkers, and 10,255 (18%) were past drinkers.

The researchers reported that, compared with never smokers, women who had ever smoked had a 45% higher risk for SLE than did never smokers (hazard ratio, 1.45; 95% confidence interval, 0.97-2.18), but the finding was not statistically significant.


The risk of SLE was greater among current smokers (52% higher risk) than among past smokers (41% higher risk), and greater for 20 or more pack-years of smoking (60% higher risk) than for less than 20 pack-years of smoking (37% higher risk), although the authors noted that none of these differences were statistically significant.

Current and past alcohol consumption were associated with nonsignificant reductions in risk for SLE, 29% and 21%, respectively. However, “moderate” current alcohol consumption, measured as four or more drinks per week, was associated with a 57% reduction in risk for SLE (HR, 0.43; 95% CI, 0.19-0.96).

The researchers said that the associations between cigarette smoking and alcohol intake with SLE risk were biologically plausible and may lead to insights into SLE pathogenesis. For example, exposure to toxic components from cigarette smoke was associated with increased oxidative stress and stimulation of autoantibody production, and such exposure can directly damage endogenous proteins and DNA. Alcohol suppresses the synthesis of proinflammatory cytokines and may inhibit DNA synthesis.

The small number of lupus cases in the Black Women’s Health Study cohort limited the statistical power of the analysis. Smoking and alcohol use were also relatively uncommon among women in the Black Women’s Health Study cohort, the investigators said.

“Future studies are needed to confirm these findings and establish the biologic mechanisms by which cigarette smoking and alcohol consumption influence the risk of SLE in this population and others,“ they wrote.

The study was supported by individual investigators’ grant awards from the National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Rheumatology Research Foundation, and the Lupus Foundation of America. The authors declared no relevant conflicts of interest.

SOURCE: Cozier Y et al. Arthritis Care Res. 2018 Aug 9. doi: 10.1002/acr.23703.

 

Black women who smoke cigarettes are at increased risk of systemic lupus erythematosus (SLE), while those who drink alcohol in moderation have a decreased risk, data from the prospective Black Women’s Health Study suggests.

The current findings among black women, who are the demographic group at the highest risk of SLE in the U.S. population, are consistent with the previously reported positive association of cigarette smoking with risk of SLE and inverse association of alcohol consumption with SLE,” lead researchers Yvette Cozier, DSc, and Medha Barbhaiya, MD, and their colleagues wrote in a study published in Arthritis Care & Research.

“The role of environmental factors in the pathogenesis of SLE is of great interest, as genetic factors do not explain a major portion of the incidence. Cigarette smoking has been associated with SLE risk in several, but not all, past studies,” wrote Dr. Cozier of the Slone Epidemiology Center at Boston University and Dr. Barbhaiya of the Hospital for Special Surgery, New York, and their coauthors.

Their analysis of data from the Black Women’s Health Study, a prospective study following 59,000 black women in the United States since 1995, identified 127 new cases of SLE between 1995 and 2015 that were confirmed by medical records.

At baseline, 8,851 women (16%) were current smokers, and 10,447 (18%) were past smokers. A total of 14,001 (25%) were current drinkers, and 10,255 (18%) were past drinkers.

The researchers reported that, compared with never smokers, women who had ever smoked had a 45% higher risk for SLE than did never smokers (hazard ratio, 1.45; 95% confidence interval, 0.97-2.18), but the finding was not statistically significant.


The risk of SLE was greater among current smokers (52% higher risk) than among past smokers (41% higher risk), and greater for 20 or more pack-years of smoking (60% higher risk) than for less than 20 pack-years of smoking (37% higher risk), although the authors noted that none of these differences were statistically significant.

Current and past alcohol consumption were associated with nonsignificant reductions in risk for SLE, 29% and 21%, respectively. However, “moderate” current alcohol consumption, measured as four or more drinks per week, was associated with a 57% reduction in risk for SLE (HR, 0.43; 95% CI, 0.19-0.96).

The researchers said that the associations between cigarette smoking and alcohol intake with SLE risk were biologically plausible and may lead to insights into SLE pathogenesis. For example, exposure to toxic components from cigarette smoke was associated with increased oxidative stress and stimulation of autoantibody production, and such exposure can directly damage endogenous proteins and DNA. Alcohol suppresses the synthesis of proinflammatory cytokines and may inhibit DNA synthesis.

The small number of lupus cases in the Black Women’s Health Study cohort limited the statistical power of the analysis. Smoking and alcohol use were also relatively uncommon among women in the Black Women’s Health Study cohort, the investigators said.

“Future studies are needed to confirm these findings and establish the biologic mechanisms by which cigarette smoking and alcohol consumption influence the risk of SLE in this population and others,“ they wrote.

The study was supported by individual investigators’ grant awards from the National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Rheumatology Research Foundation, and the Lupus Foundation of America. The authors declared no relevant conflicts of interest.

SOURCE: Cozier Y et al. Arthritis Care Res. 2018 Aug 9. doi: 10.1002/acr.23703.

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Key clinical point: Like Asian and white women, black women are at an increased risk of SLE if they smoke and at a decreased risk with moderate alcohol consumption.

Major finding: There was an estimated 45% increase in risk of SLE for ever smoking relative to never smoking, but the finding was of borderline statistical significance. Moderate current alcohol consumption, measured as four or more drinks per week, was associated with a 57% reduction in SLE risk.

Study details: Analysis of data from 59,000 women enrolled in the prospective Black Women’s Health Study between 1995 and 2015.

Disclosures: The study was supported by individual investigators’ grant awards from the National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Rheumatology Research Foundation, and the Lupus Foundation of America. The authors declared no relevant conflicts of interest.

Source: Cozier Y et al. Arthritis Care Res. 2018 Aug 9. doi: 10.1002/acr.23703.

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Adult congenital heart disease guideline gets 10-year update, new classification system

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An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.

Dr. Curt J Daniels


Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.

The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.

“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.

Better road map

The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.

“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”

The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.

Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.

“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.

More than just anatomy

Dr. Robert Jaquiss

In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.

A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.

Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.

“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”

For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.

 

 

Research directions

Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.

For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.

“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.

The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.

Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.

SOURCE: Stout KK et al. J Am Coll Cardiol. 2018 Aug 16. Copublished in Circulation.

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An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.

Dr. Curt J Daniels


Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.

The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.

“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.

Better road map

The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.

“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”

The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.

Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.

“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.

More than just anatomy

Dr. Robert Jaquiss

In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.

A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.

Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.

“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”

For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.

 

 

Research directions

Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.

For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.

“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.

The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.

Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.

SOURCE: Stout KK et al. J Am Coll Cardiol. 2018 Aug 16. Copublished in Circulation.

 

An update to the first-ever guideline on adult congenital heart disease, released today, provides new recommendations and a more nuanced classification system based on data and expertise accrued in the field over the past decade.

Dr. Curt J Daniels


Recommendations for more than two dozen specific lesion types are included in the 2018 American Heart Association/American College of Cardiology Guideline for the Management of Adults With Congenital Heart Disease.

The 172-page document, published online in the Journal of the American College of Cardiology and Circulation, also includes recommendations on general principles ranging from evaluation of suspected disease to palliative care and end-of-life issues.

“The original guidelines, I think everyone would agree, were just a lot more best practice and expert consensus, whereas now we have at least some data to support our recommendations,” said guideline-writing committee vice chair Curt J. Daniels, MD.

Better road map

The document is intended to provide a “better road map” for all providers who will see such patients in their practice, said Dr. Daniels, director of the adult congenital heart disease and pulmonary hypertension program at Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus.

“There are not enough adult congenital heart disease cardiologists and programs in the country to care for the almost 1.5 million adults with congenital heart disease in the United States, so we know these patients are cared for by general cardiologists,” Dr. Daniels said in an interview. “Having some guidelines about when to refer to those patients was a huge part of the purpose of these updated guidelines.”

The revamped classification system underlying the new guidelines seeks to better characterize disease severity based on the complexity of its anatomy and physiology, according to Dr. Daniels.

Previous documents, including the original 2008 AHA/ACC guideline (Circulation. 2008 Nov 7;118:e714-833), focused mainly on anatomic classifications to rank severity, he said.

“Traditionally, we’ve based the severity of congenital heart disease based on the complexity of anatomy they were born with, but that goes only so far,” Dr. Daniels said in an interview.

More than just anatomy

Dr. Robert Jaquiss

In the new system, anatomy is classified as simple (I, e.g., isolated small atrial septal defect), moderately complex (II, e.g., coarctation of the aorta), or greatly complex (III, e.g., cyanotic congenital heart defect), while physiologic stages range from A to D, increasing along with the severity of physiologic variables such as New York Heart Association functional class; exercise capacity; aortic enlargement; arrhythmias; renal, hepatic, or pulmonary function; and venal or arterial stenosis.

A normotensive patient with repaired coarctation of the aorta would be classified as IIA if she had normal end-organ function and exercise capacity, whereas a similar patient with an ascending aortic diameter of 4.0 cm would be classified as IIB, and with the addition of moderate aortic stenosis, would be classified as IIIC, according to an example provided in the guidelines.

Congenital heart disease specialist Robert “Jake” Jaquiss, MD, said in an interview that consideration of physiology alongside anatomy is one of the most important features of the new guidelines.

“This is a way of thinking about patients that involves not just their anatomy, but also considering a variety of domains in which there may be physiologic dysfunction that can modify the underlying anatomy,” said Dr. Jaquiss, chief of pediatric and congenital heart surgery at Children’s Medical Center/University of Texas Southwestern Medical Center, Dallas. “I think that is a more clinically relevant way to think about patients and patient evaluation management, and I commend the authors for that focus.”

For example, one patient who has undergone a Fontan procedure may be fully functional, whereas another with nearly identical anatomy may be burdened by arrhythmias, fluid retention, and impaired exercise function. “If we don’t grasp the physiologic difference, we treat the two patients the same way, which is obviously inappropriate,” Dr. Jaquiss said.

 

 

Research directions

Much more research needs to be done, according to guideline authors, who list 60 unresolved research questions that represent evidence gaps and future directions for study.

For example, outstanding questions related to tetralogy of Fallot focus on the optimal timing for pulmonary valve replacement, the role of pulmonary valve replacement and ventricular tachycardia ablation in decreasing sudden cardiac death risk, and whether implantable cardioverter-defibrillators reduce mortality.

“These are the kinds of evolutionary sort of understandings and alterations in the intervention, both at the original operation and for assessment of care, and what we think about it and how we think about it in 2018 is quite different than how we thought in 2008, and I dare say it’ll be even more different in 2028,” Dr. Jaquiss said.

The AHA/ACC guideline was developed in association with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.

Dr. Daniels reported a relevant relationship with Actelion. Guideline coauthors reported relevant relationships in that same category with Actelion, Boehringer Ingelheim, Cormatrix, Edward Lifesciences, Gilead, Medtronic, Novartis, Sorin (LivaNova), St. Jude Medical, and United Therapeutics. No other disclosures were reported.

SOURCE: Stout KK et al. J Am Coll Cardiol. 2018 Aug 16. Copublished in Circulation.

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Back-to-school stress affects children – and parents

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Even as summer continues on, the long, hot, sunny days and backyard barbecues can be tinged with the realization that the new school year looms ahead. For those in traditional school systems, September is the return to the classroom. This has long been a source of angst for many children who may face a new school or a return to the challenging, even overwhelming, business of learning.

“The end of summer and the beginning of a new school year can be a stressful time for parents and children,” says psychologist Lynn Bufka, PhD, assistant execute director for practice, research, and policy for the American Psychological Association. “While trying to manage work and the household, parents can sometimes overlook their children’s feelings of nervousness or anxiety as school begins. Working with your children to build resilience and manage their emotions can be beneficial for the psychological health of the whole family.”

According to the association, parents can help ease their child’s worries by offering support and encouragement and by listening to their child’s concerns, which can help foster their resilience. A dry run about a week before the big day can help reset the summer sleep schedule. Getting school supplies together and ready for action is another bit of preparation that helps get the mind ready for the reality of school. Visiting a new school, if permitted, can remove some sense of the unknown and lay the path for that first day through the front door. Empathy can be a powerful aid; understanding that a child might be apprehensive can prevent the potentially misguided advice to just tough it out.

But children aren’t the only ones with back-to-school anxiety. Increasingly, this time of year is generating stress for parents. When budgets are stretched tight, the additional school expenses can be a strain. The horrors of school shooting incidents can be on parents’ minds, especially when their child is enrolled in a new and unfamiliar school. An era of heightened competitiveness for postsecondary education and scholarship money comes with the baggage of worry that a son or daughter is lagging and already might be behind the eight ball in the game of life.

Parental stress can be tough to deal with. Budget planning, participating in safe-school activities, fostering relationships with teachers and staff, having a heightened awareness of signs of school-related stress in their children, and maintaining faith in their children’s ability to learn and succeed can go a long way toward easing the parental burden.

Click here to read the APA’s back-to-school tips.

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Even as summer continues on, the long, hot, sunny days and backyard barbecues can be tinged with the realization that the new school year looms ahead. For those in traditional school systems, September is the return to the classroom. This has long been a source of angst for many children who may face a new school or a return to the challenging, even overwhelming, business of learning.

“The end of summer and the beginning of a new school year can be a stressful time for parents and children,” says psychologist Lynn Bufka, PhD, assistant execute director for practice, research, and policy for the American Psychological Association. “While trying to manage work and the household, parents can sometimes overlook their children’s feelings of nervousness or anxiety as school begins. Working with your children to build resilience and manage their emotions can be beneficial for the psychological health of the whole family.”

According to the association, parents can help ease their child’s worries by offering support and encouragement and by listening to their child’s concerns, which can help foster their resilience. A dry run about a week before the big day can help reset the summer sleep schedule. Getting school supplies together and ready for action is another bit of preparation that helps get the mind ready for the reality of school. Visiting a new school, if permitted, can remove some sense of the unknown and lay the path for that first day through the front door. Empathy can be a powerful aid; understanding that a child might be apprehensive can prevent the potentially misguided advice to just tough it out.

But children aren’t the only ones with back-to-school anxiety. Increasingly, this time of year is generating stress for parents. When budgets are stretched tight, the additional school expenses can be a strain. The horrors of school shooting incidents can be on parents’ minds, especially when their child is enrolled in a new and unfamiliar school. An era of heightened competitiveness for postsecondary education and scholarship money comes with the baggage of worry that a son or daughter is lagging and already might be behind the eight ball in the game of life.

Parental stress can be tough to deal with. Budget planning, participating in safe-school activities, fostering relationships with teachers and staff, having a heightened awareness of signs of school-related stress in their children, and maintaining faith in their children’s ability to learn and succeed can go a long way toward easing the parental burden.

Click here to read the APA’s back-to-school tips.

 

Even as summer continues on, the long, hot, sunny days and backyard barbecues can be tinged with the realization that the new school year looms ahead. For those in traditional school systems, September is the return to the classroom. This has long been a source of angst for many children who may face a new school or a return to the challenging, even overwhelming, business of learning.

“The end of summer and the beginning of a new school year can be a stressful time for parents and children,” says psychologist Lynn Bufka, PhD, assistant execute director for practice, research, and policy for the American Psychological Association. “While trying to manage work and the household, parents can sometimes overlook their children’s feelings of nervousness or anxiety as school begins. Working with your children to build resilience and manage their emotions can be beneficial for the psychological health of the whole family.”

According to the association, parents can help ease their child’s worries by offering support and encouragement and by listening to their child’s concerns, which can help foster their resilience. A dry run about a week before the big day can help reset the summer sleep schedule. Getting school supplies together and ready for action is another bit of preparation that helps get the mind ready for the reality of school. Visiting a new school, if permitted, can remove some sense of the unknown and lay the path for that first day through the front door. Empathy can be a powerful aid; understanding that a child might be apprehensive can prevent the potentially misguided advice to just tough it out.

But children aren’t the only ones with back-to-school anxiety. Increasingly, this time of year is generating stress for parents. When budgets are stretched tight, the additional school expenses can be a strain. The horrors of school shooting incidents can be on parents’ minds, especially when their child is enrolled in a new and unfamiliar school. An era of heightened competitiveness for postsecondary education and scholarship money comes with the baggage of worry that a son or daughter is lagging and already might be behind the eight ball in the game of life.

Parental stress can be tough to deal with. Budget planning, participating in safe-school activities, fostering relationships with teachers and staff, having a heightened awareness of signs of school-related stress in their children, and maintaining faith in their children’s ability to learn and succeed can go a long way toward easing the parental burden.

Click here to read the APA’s back-to-school tips.

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Doctor shaming about weight hurts women’s health

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Physicians take the “first do no harm” aphorism seriously. Still, as humans, their biases and opinions can – and do – cause harm. An example, according to an opinion piece written in the Globe and Mail, is the way physicians sometimes treat women who are overweight.

The article cites an Alabama woman named Kayla Rahm, whose complaints of weight gain, abdominal swelling, and shortness of breath fell on the deaf ears of four doctors who, instead of getting to the bottom of her problem, pointed to her weight as the culprit. Ultimately, she had a 50-pound ovarian cyst removed (thankfully, benign.)

“She was seeking help from multiple physicians, and we had missed it – as a medical community, we had missed it,” said Gregory Jones, DO, the obstetrician-gynecologist who performed the eventual surgery, in an interview with the Washington Post.

The weight-related rebuff is all too common for women. The consequences can be tragic. Consider Ellen Maud Bennett, a Canadian woman whose complaints of ill health stretching back years had been met with suggestions to lose weight. All the while, cancer was developing, and when the truth was finally recognized, it was too late.

Her obituary offered this poignant message: “A final message Ellen wanted to share was about the fat shaming she endured from the medical profession. Over the past few years of feeling unwell, she sought out medical intervention and no one offered any support or suggestions beyond weight loss. Ellen’s dying wish was that women of size make her death matter by advocating strongly for their health and not accepting that fat is the only relevant health issue.”

Overweight women are reportedly less likely to be referred for cervical and breast-cancer screenings. Fat shaming can dissuade women from seeking medical help. Instead, they can buy into the view that their health problems are self-imposed.

A recent study conducted in Canada involving more than 54,000 clinically obese people, some with metabolic risk factors and others were who just obese, found that those with no metabolic risk factors were no more likely to die than people of lower weight. “This means that hundreds of thousands of people in North America alone with metabolically healthy obesity will be told to lose weight when it’s questionable how much benefit they’ll actually receive ,” head researcher Jennifer L. Kuk, PhD, said in an interview with Science Daily.

Click here to read about Dr. Kuk’s study.
 

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Physicians take the “first do no harm” aphorism seriously. Still, as humans, their biases and opinions can – and do – cause harm. An example, according to an opinion piece written in the Globe and Mail, is the way physicians sometimes treat women who are overweight.

The article cites an Alabama woman named Kayla Rahm, whose complaints of weight gain, abdominal swelling, and shortness of breath fell on the deaf ears of four doctors who, instead of getting to the bottom of her problem, pointed to her weight as the culprit. Ultimately, she had a 50-pound ovarian cyst removed (thankfully, benign.)

“She was seeking help from multiple physicians, and we had missed it – as a medical community, we had missed it,” said Gregory Jones, DO, the obstetrician-gynecologist who performed the eventual surgery, in an interview with the Washington Post.

The weight-related rebuff is all too common for women. The consequences can be tragic. Consider Ellen Maud Bennett, a Canadian woman whose complaints of ill health stretching back years had been met with suggestions to lose weight. All the while, cancer was developing, and when the truth was finally recognized, it was too late.

Her obituary offered this poignant message: “A final message Ellen wanted to share was about the fat shaming she endured from the medical profession. Over the past few years of feeling unwell, she sought out medical intervention and no one offered any support or suggestions beyond weight loss. Ellen’s dying wish was that women of size make her death matter by advocating strongly for their health and not accepting that fat is the only relevant health issue.”

Overweight women are reportedly less likely to be referred for cervical and breast-cancer screenings. Fat shaming can dissuade women from seeking medical help. Instead, they can buy into the view that their health problems are self-imposed.

A recent study conducted in Canada involving more than 54,000 clinically obese people, some with metabolic risk factors and others were who just obese, found that those with no metabolic risk factors were no more likely to die than people of lower weight. “This means that hundreds of thousands of people in North America alone with metabolically healthy obesity will be told to lose weight when it’s questionable how much benefit they’ll actually receive ,” head researcher Jennifer L. Kuk, PhD, said in an interview with Science Daily.

Click here to read about Dr. Kuk’s study.
 

 

Physicians take the “first do no harm” aphorism seriously. Still, as humans, their biases and opinions can – and do – cause harm. An example, according to an opinion piece written in the Globe and Mail, is the way physicians sometimes treat women who are overweight.

The article cites an Alabama woman named Kayla Rahm, whose complaints of weight gain, abdominal swelling, and shortness of breath fell on the deaf ears of four doctors who, instead of getting to the bottom of her problem, pointed to her weight as the culprit. Ultimately, she had a 50-pound ovarian cyst removed (thankfully, benign.)

“She was seeking help from multiple physicians, and we had missed it – as a medical community, we had missed it,” said Gregory Jones, DO, the obstetrician-gynecologist who performed the eventual surgery, in an interview with the Washington Post.

The weight-related rebuff is all too common for women. The consequences can be tragic. Consider Ellen Maud Bennett, a Canadian woman whose complaints of ill health stretching back years had been met with suggestions to lose weight. All the while, cancer was developing, and when the truth was finally recognized, it was too late.

Her obituary offered this poignant message: “A final message Ellen wanted to share was about the fat shaming she endured from the medical profession. Over the past few years of feeling unwell, she sought out medical intervention and no one offered any support or suggestions beyond weight loss. Ellen’s dying wish was that women of size make her death matter by advocating strongly for their health and not accepting that fat is the only relevant health issue.”

Overweight women are reportedly less likely to be referred for cervical and breast-cancer screenings. Fat shaming can dissuade women from seeking medical help. Instead, they can buy into the view that their health problems are self-imposed.

A recent study conducted in Canada involving more than 54,000 clinically obese people, some with metabolic risk factors and others were who just obese, found that those with no metabolic risk factors were no more likely to die than people of lower weight. “This means that hundreds of thousands of people in North America alone with metabolically healthy obesity will be told to lose weight when it’s questionable how much benefit they’ll actually receive ,” head researcher Jennifer L. Kuk, PhD, said in an interview with Science Daily.

Click here to read about Dr. Kuk’s study.
 

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What should you tell your patients about the risks of ART?

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Fri, 01/18/2019 - 17:53

 

CORONADOPreexisting subfertility appears to account for many, but not all, of the adverse outcomes associated with assisted reproductive technology (ART).

©ktsimage/iStockphoto.com
IVF

In addition, multiples conceived using ART – including twins – continue to be the biggest preventable risk factor for adverse pregnancy and fetal outcomes.

Those are key points that Joseph C. Gambone, DO, MPH, made during a wide-ranging talk about the adverse pregnancy and fetal outcomes related to ART at a meeting on in vitro fertilization (IVF) and embryo transfer sponsored by the University of California, San Diego.

In 2016, Barbara Luke, ScD, MPH, and her colleagues published results from the ongoing Massachusetts Outcomes Study of Reproductive Technologies (J Reprod Med. 2016 Mar-Apr;61[3-4]:114-27). They found that pregnancy plurality is the predominant risk factor for infants and mothers. Of 8,948 birth outcomes resulting from ART, risks for pregnancy-induced hypertension, cesarean delivery, gestational diabetes, preterm birth, birth defects, and small for gestational age were significantly increased among twins.

“Lowering the plurality rate, including twins, should substantially reduce morbidity with ART,” said Dr. Gambone, professor emeritus at the David Geffen School of Medicine at the University of California, Los Angeles, who was not affiliated with the study. Thawed embryos were associated with a higher risk for pregnancy-induced hypertension and large for gestational age offspring, but a lower risk for low birth weight and small for gestational age.

According to data from the Society for Assisted Reproductive Technology, elective singleton embryo transfer increased from 35% of all cycles in 2015 to 42% in 2016, while singleton births increased from 80.5% to 84% during the same time period. In addition, the proportion of twins born in 2015 was 19% and declined to 16% in 2016, while the percentage of triplets or greater born was the same in both years (0.4%).

Meanwhile, in an analysis of more than 1.1 million cycles between 2000 and 2011 drawn from Centers for Disease Control and Prevention surveillance data, researchers found that the most commonly reported patient complication was ovarian hyperstimulation syndrome (a peak of 154 per 10,000 autologous cycles) and hospitalization (a peak of 35 per 10,000 autologous cycles; JAMA. 2015 Jan 6;313[1]:88-90). Other complications remained below 10 per 10,000 cycles and included infection, hemorrhage with transfusion, adverse event from medication, adverse event to anesthesia, and patient death. In all, 58 deaths were reported: 18 because of stimulation and 40 during pregnancy. “Some deaths were due to potentially preventable complications because of unrecognized comorbidities or conditions,” said Dr. Gambone, who was not affiliated with the study. “Women with Turner syndrome who receive donor embryos could be an example.”


Today, the most feared maternal and pregnancy outcome from ART is breast and ovarian cancer from treatment, he said, while the most feared outcome in offspring is birth defects from treatment. On the breast cancer front, an analysis of nearly 2 million women provided some reassurance (Fertil Steril. 2017 Jul;108:137-44). It found no increased risk of breast cancer in women who have birth after ART, compared with women who gave birth after spontaneous conception (adjusted hazard ratio, 0.84). It also found no increased risk in women who received ovarian stimulation or other hormonal treatment for infertility (HRs, 0.86 and 0.79, respectively). A smaller study with a median follow-up of 21 years found no difference in the rate of invasive and in situ breast cancer between women who received IVF treatment and those who did not (JAMA. 2016 Jul 19;316[3]:300-12). However, a recent analysis from Great Britain found a slight increase for in situ breast cancer that was associated with women who had a higher number of treatment cycles (BMJ. 2018;362:k2644).

On the ovarian cancer front, a case-control analysis of 1,900 women conducted by researchers at Mayo Clinic found that infertile women who used fertility drugs were not at increased risk of developing ovarian tumors, compared with infertile women who did not use fertility drugs (adjusted odds ratio, 0.64; Fertil Steril. 2013;99[7]:2031-6). There also was no increased risk because of underlying infertility or any increase in borderline tumors. More recently, an abstract presented at the annual meeting of the European Society of Human Reproduction and Embryology, based on a large cohort study from Denmark, found a slightly higher overall risk of ovarian cancer among the ART women (0.11%), compared with non-ART controls (0.06%). However, the analysis also showed comparably higher rates of ovarian cancer in women who were nulliparous (a risk factor for ovarian cancer) and in the ART women who had a female cause of infertility. In an analysis from Great Britain, increased ovarian tumor risk was limited to women with endometriosis, low parity, or both (BMJ. 2018;362:k2644). Dr. Gambone noted that an article published online Oct. 23, 2017 in Nature Communication implicates the fallopian tube, rather than the ovaries, as a probable source of papillary serous cancers.

Women who are subfertile should be counseled about the increased risk of birth defects, irrespective of whether they undergo IVF or not, said Dr. Gambone, who also runs a private infertility practice in Durango, Colo. Studies consistently show an increased risk associated with subfertility. A large, retrospective cohort analysis of live and stillbirths from 2004 to 2010 in Massachusetts found that congenital anomalies were reported in 2% of ART births, 1.7% of subfertile births, and 1.4% of fertile births (Birth Defects Res. 2017 Aug 15;109[14]:1144-53). The adjusted prevalence ratios for birth defects were 1.5 for ART births and 1.3 for subfertile births, compared with fertile mother births. The researchers observed elevated rates of several birth defects with ART, including tetralogy of Fallot and hypospadias. Subfertility and multiple births affect these associations, with multiple births explaining 36% of the relative effect of ART on nonchromosomal birth defects.

“The absolute risk of birth defects is small with ART,” Dr. Gambone said. “A significant portion [but not all] is related to multiple births and underlying subfertility.” A more recent analysis found that subfertile women were 21% more likely to have babies born with birth defects, compared with fertile women (Pediatrics. 2018 Jul; e20174069).

In a study of the overall risk and etiology of major birth defects, researchers from Utah determined that they affect 1 in 33 babies in the United States at an annual direct cost of $2.6 billion per year (BMJ. 2017;357:j2249). Although major birth defects are the leading cause of infant mortality (20%), a known cause of the defect was established in only 20.2% of cases. “Of that percentage, the majority are chromosome or genetic causes,” Dr. Gambone said. “Interestingly, ART and/or subfertility were not listed in this analysis as causes of birth defects. However, the authors speculated that as genetic technology improves, both genetic and epigenetic causes will be identified.”

Dr. Gambone reported no relevant financial disclosures.

[email protected]

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CORONADOPreexisting subfertility appears to account for many, but not all, of the adverse outcomes associated with assisted reproductive technology (ART).

©ktsimage/iStockphoto.com
IVF

In addition, multiples conceived using ART – including twins – continue to be the biggest preventable risk factor for adverse pregnancy and fetal outcomes.

Those are key points that Joseph C. Gambone, DO, MPH, made during a wide-ranging talk about the adverse pregnancy and fetal outcomes related to ART at a meeting on in vitro fertilization (IVF) and embryo transfer sponsored by the University of California, San Diego.

In 2016, Barbara Luke, ScD, MPH, and her colleagues published results from the ongoing Massachusetts Outcomes Study of Reproductive Technologies (J Reprod Med. 2016 Mar-Apr;61[3-4]:114-27). They found that pregnancy plurality is the predominant risk factor for infants and mothers. Of 8,948 birth outcomes resulting from ART, risks for pregnancy-induced hypertension, cesarean delivery, gestational diabetes, preterm birth, birth defects, and small for gestational age were significantly increased among twins.

“Lowering the plurality rate, including twins, should substantially reduce morbidity with ART,” said Dr. Gambone, professor emeritus at the David Geffen School of Medicine at the University of California, Los Angeles, who was not affiliated with the study. Thawed embryos were associated with a higher risk for pregnancy-induced hypertension and large for gestational age offspring, but a lower risk for low birth weight and small for gestational age.

According to data from the Society for Assisted Reproductive Technology, elective singleton embryo transfer increased from 35% of all cycles in 2015 to 42% in 2016, while singleton births increased from 80.5% to 84% during the same time period. In addition, the proportion of twins born in 2015 was 19% and declined to 16% in 2016, while the percentage of triplets or greater born was the same in both years (0.4%).

Meanwhile, in an analysis of more than 1.1 million cycles between 2000 and 2011 drawn from Centers for Disease Control and Prevention surveillance data, researchers found that the most commonly reported patient complication was ovarian hyperstimulation syndrome (a peak of 154 per 10,000 autologous cycles) and hospitalization (a peak of 35 per 10,000 autologous cycles; JAMA. 2015 Jan 6;313[1]:88-90). Other complications remained below 10 per 10,000 cycles and included infection, hemorrhage with transfusion, adverse event from medication, adverse event to anesthesia, and patient death. In all, 58 deaths were reported: 18 because of stimulation and 40 during pregnancy. “Some deaths were due to potentially preventable complications because of unrecognized comorbidities or conditions,” said Dr. Gambone, who was not affiliated with the study. “Women with Turner syndrome who receive donor embryos could be an example.”


Today, the most feared maternal and pregnancy outcome from ART is breast and ovarian cancer from treatment, he said, while the most feared outcome in offspring is birth defects from treatment. On the breast cancer front, an analysis of nearly 2 million women provided some reassurance (Fertil Steril. 2017 Jul;108:137-44). It found no increased risk of breast cancer in women who have birth after ART, compared with women who gave birth after spontaneous conception (adjusted hazard ratio, 0.84). It also found no increased risk in women who received ovarian stimulation or other hormonal treatment for infertility (HRs, 0.86 and 0.79, respectively). A smaller study with a median follow-up of 21 years found no difference in the rate of invasive and in situ breast cancer between women who received IVF treatment and those who did not (JAMA. 2016 Jul 19;316[3]:300-12). However, a recent analysis from Great Britain found a slight increase for in situ breast cancer that was associated with women who had a higher number of treatment cycles (BMJ. 2018;362:k2644).

On the ovarian cancer front, a case-control analysis of 1,900 women conducted by researchers at Mayo Clinic found that infertile women who used fertility drugs were not at increased risk of developing ovarian tumors, compared with infertile women who did not use fertility drugs (adjusted odds ratio, 0.64; Fertil Steril. 2013;99[7]:2031-6). There also was no increased risk because of underlying infertility or any increase in borderline tumors. More recently, an abstract presented at the annual meeting of the European Society of Human Reproduction and Embryology, based on a large cohort study from Denmark, found a slightly higher overall risk of ovarian cancer among the ART women (0.11%), compared with non-ART controls (0.06%). However, the analysis also showed comparably higher rates of ovarian cancer in women who were nulliparous (a risk factor for ovarian cancer) and in the ART women who had a female cause of infertility. In an analysis from Great Britain, increased ovarian tumor risk was limited to women with endometriosis, low parity, or both (BMJ. 2018;362:k2644). Dr. Gambone noted that an article published online Oct. 23, 2017 in Nature Communication implicates the fallopian tube, rather than the ovaries, as a probable source of papillary serous cancers.

Women who are subfertile should be counseled about the increased risk of birth defects, irrespective of whether they undergo IVF or not, said Dr. Gambone, who also runs a private infertility practice in Durango, Colo. Studies consistently show an increased risk associated with subfertility. A large, retrospective cohort analysis of live and stillbirths from 2004 to 2010 in Massachusetts found that congenital anomalies were reported in 2% of ART births, 1.7% of subfertile births, and 1.4% of fertile births (Birth Defects Res. 2017 Aug 15;109[14]:1144-53). The adjusted prevalence ratios for birth defects were 1.5 for ART births and 1.3 for subfertile births, compared with fertile mother births. The researchers observed elevated rates of several birth defects with ART, including tetralogy of Fallot and hypospadias. Subfertility and multiple births affect these associations, with multiple births explaining 36% of the relative effect of ART on nonchromosomal birth defects.

“The absolute risk of birth defects is small with ART,” Dr. Gambone said. “A significant portion [but not all] is related to multiple births and underlying subfertility.” A more recent analysis found that subfertile women were 21% more likely to have babies born with birth defects, compared with fertile women (Pediatrics. 2018 Jul; e20174069).

In a study of the overall risk and etiology of major birth defects, researchers from Utah determined that they affect 1 in 33 babies in the United States at an annual direct cost of $2.6 billion per year (BMJ. 2017;357:j2249). Although major birth defects are the leading cause of infant mortality (20%), a known cause of the defect was established in only 20.2% of cases. “Of that percentage, the majority are chromosome or genetic causes,” Dr. Gambone said. “Interestingly, ART and/or subfertility were not listed in this analysis as causes of birth defects. However, the authors speculated that as genetic technology improves, both genetic and epigenetic causes will be identified.”

Dr. Gambone reported no relevant financial disclosures.

[email protected]

 

CORONADOPreexisting subfertility appears to account for many, but not all, of the adverse outcomes associated with assisted reproductive technology (ART).

©ktsimage/iStockphoto.com
IVF

In addition, multiples conceived using ART – including twins – continue to be the biggest preventable risk factor for adverse pregnancy and fetal outcomes.

Those are key points that Joseph C. Gambone, DO, MPH, made during a wide-ranging talk about the adverse pregnancy and fetal outcomes related to ART at a meeting on in vitro fertilization (IVF) and embryo transfer sponsored by the University of California, San Diego.

In 2016, Barbara Luke, ScD, MPH, and her colleagues published results from the ongoing Massachusetts Outcomes Study of Reproductive Technologies (J Reprod Med. 2016 Mar-Apr;61[3-4]:114-27). They found that pregnancy plurality is the predominant risk factor for infants and mothers. Of 8,948 birth outcomes resulting from ART, risks for pregnancy-induced hypertension, cesarean delivery, gestational diabetes, preterm birth, birth defects, and small for gestational age were significantly increased among twins.

“Lowering the plurality rate, including twins, should substantially reduce morbidity with ART,” said Dr. Gambone, professor emeritus at the David Geffen School of Medicine at the University of California, Los Angeles, who was not affiliated with the study. Thawed embryos were associated with a higher risk for pregnancy-induced hypertension and large for gestational age offspring, but a lower risk for low birth weight and small for gestational age.

According to data from the Society for Assisted Reproductive Technology, elective singleton embryo transfer increased from 35% of all cycles in 2015 to 42% in 2016, while singleton births increased from 80.5% to 84% during the same time period. In addition, the proportion of twins born in 2015 was 19% and declined to 16% in 2016, while the percentage of triplets or greater born was the same in both years (0.4%).

Meanwhile, in an analysis of more than 1.1 million cycles between 2000 and 2011 drawn from Centers for Disease Control and Prevention surveillance data, researchers found that the most commonly reported patient complication was ovarian hyperstimulation syndrome (a peak of 154 per 10,000 autologous cycles) and hospitalization (a peak of 35 per 10,000 autologous cycles; JAMA. 2015 Jan 6;313[1]:88-90). Other complications remained below 10 per 10,000 cycles and included infection, hemorrhage with transfusion, adverse event from medication, adverse event to anesthesia, and patient death. In all, 58 deaths were reported: 18 because of stimulation and 40 during pregnancy. “Some deaths were due to potentially preventable complications because of unrecognized comorbidities or conditions,” said Dr. Gambone, who was not affiliated with the study. “Women with Turner syndrome who receive donor embryos could be an example.”


Today, the most feared maternal and pregnancy outcome from ART is breast and ovarian cancer from treatment, he said, while the most feared outcome in offspring is birth defects from treatment. On the breast cancer front, an analysis of nearly 2 million women provided some reassurance (Fertil Steril. 2017 Jul;108:137-44). It found no increased risk of breast cancer in women who have birth after ART, compared with women who gave birth after spontaneous conception (adjusted hazard ratio, 0.84). It also found no increased risk in women who received ovarian stimulation or other hormonal treatment for infertility (HRs, 0.86 and 0.79, respectively). A smaller study with a median follow-up of 21 years found no difference in the rate of invasive and in situ breast cancer between women who received IVF treatment and those who did not (JAMA. 2016 Jul 19;316[3]:300-12). However, a recent analysis from Great Britain found a slight increase for in situ breast cancer that was associated with women who had a higher number of treatment cycles (BMJ. 2018;362:k2644).

On the ovarian cancer front, a case-control analysis of 1,900 women conducted by researchers at Mayo Clinic found that infertile women who used fertility drugs were not at increased risk of developing ovarian tumors, compared with infertile women who did not use fertility drugs (adjusted odds ratio, 0.64; Fertil Steril. 2013;99[7]:2031-6). There also was no increased risk because of underlying infertility or any increase in borderline tumors. More recently, an abstract presented at the annual meeting of the European Society of Human Reproduction and Embryology, based on a large cohort study from Denmark, found a slightly higher overall risk of ovarian cancer among the ART women (0.11%), compared with non-ART controls (0.06%). However, the analysis also showed comparably higher rates of ovarian cancer in women who were nulliparous (a risk factor for ovarian cancer) and in the ART women who had a female cause of infertility. In an analysis from Great Britain, increased ovarian tumor risk was limited to women with endometriosis, low parity, or both (BMJ. 2018;362:k2644). Dr. Gambone noted that an article published online Oct. 23, 2017 in Nature Communication implicates the fallopian tube, rather than the ovaries, as a probable source of papillary serous cancers.

Women who are subfertile should be counseled about the increased risk of birth defects, irrespective of whether they undergo IVF or not, said Dr. Gambone, who also runs a private infertility practice in Durango, Colo. Studies consistently show an increased risk associated with subfertility. A large, retrospective cohort analysis of live and stillbirths from 2004 to 2010 in Massachusetts found that congenital anomalies were reported in 2% of ART births, 1.7% of subfertile births, and 1.4% of fertile births (Birth Defects Res. 2017 Aug 15;109[14]:1144-53). The adjusted prevalence ratios for birth defects were 1.5 for ART births and 1.3 for subfertile births, compared with fertile mother births. The researchers observed elevated rates of several birth defects with ART, including tetralogy of Fallot and hypospadias. Subfertility and multiple births affect these associations, with multiple births explaining 36% of the relative effect of ART on nonchromosomal birth defects.

“The absolute risk of birth defects is small with ART,” Dr. Gambone said. “A significant portion [but not all] is related to multiple births and underlying subfertility.” A more recent analysis found that subfertile women were 21% more likely to have babies born with birth defects, compared with fertile women (Pediatrics. 2018 Jul; e20174069).

In a study of the overall risk and etiology of major birth defects, researchers from Utah determined that they affect 1 in 33 babies in the United States at an annual direct cost of $2.6 billion per year (BMJ. 2017;357:j2249). Although major birth defects are the leading cause of infant mortality (20%), a known cause of the defect was established in only 20.2% of cases. “Of that percentage, the majority are chromosome or genetic causes,” Dr. Gambone said. “Interestingly, ART and/or subfertility were not listed in this analysis as causes of birth defects. However, the authors speculated that as genetic technology improves, both genetic and epigenetic causes will be identified.”

Dr. Gambone reported no relevant financial disclosures.

[email protected]

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Vascular training for general surgery residents continues downward trend

Do general surgery residents need that much experience?
Article Type
Changed
Thu, 08/08/2019 - 13:26

Operative experience in open arterial vascular surgery procedures for general surgery residents has significantly declined, according to the results of a study of the Accreditation Council for Graduate Medical Education (ACGME) national case log reports, which lists the mean numbers of operations performed.

“Because fundamental vascular surgery skills are necessary for operative general surgery, vascular surgery should remain an essential content area. However, programs cannot solely depend on operative experience to teach fundamental vascular surgery skills,” John R. Potts III, MD, FACS, and R. James Valentine, MD, FACS, stated in their report published online in Annals of Surgery.

The number of individuals completing ACGME-accredited general surgery and vascular surgery training each year of the study was obtained from public reports of the ACGME as well as the available summary national data regarding the reported operative experience of residents completing general surgery programs.

The researchers found that over 15 years (academic year 2001-2002 through AY 2016-2017), the total vascular operations performed by general surgery residents significantly declined as did the total open arterial vascular procedures, including those in seven of nine categories (P less than .0001).

The issue of adequate exposure to vascular procedures for general surgery residents is complex. “The number of individuals completing general surgery residency annually has increased by approximately 20% since AY 2001-2. During the same period, the number of open arterial operations reported by general surgery residents decreased by approximately 38%. Thus, the declining experience is clearly not simply a matter of distributing the same number of operations to a larger number of individuals,” the investigators reported.

The ACGME-designated “essential content areas” have increased in recent years for general surgery trainees to now encompass alimentary tract, abdomen, breast, head and neck, endocrine system, the surgical management of trauma, soft tissues, pediatric surgery, surgical critical care, surgical oncology, and vascular surgery. The essential content areas compete to varying degrees for the trainee’s time, potentially cutting into not just vascular cases but other areas as well. It is also the case that general surgery trainees are often in an institutional setting where they are competing with vascular surgery residents for the same pool of vascular surgery patients.

During those last 5 years, significant declines occurred in five categories: aneurysm, cerebrovascular disease, arteriovenous dialysis access, peripheral vascular disease, and extra-anatomic bypass, according to the authors.

“Knowledge of arterial anatomy, approaches, control, and repair are crucial to the practice of operative general surgery. In the face of declining experience for their resident as surgeon in open arterial operations, general surgery programs must augment resident education in the principles of vascular surgery through other means,” the authors concluded.

Portions of this study were presented at the2018 meeting of the American Surgical Association.

Dr. Potts and Dr. Valentine reported that they had no conflicts of interest.
 

SOURCE: Potts JR et al. Ann Surg. 2018 Jul 24. doi: 10.1097/SLA.0000000000002951.

Body

In the role of discussant at the American Surgical Association meeting where this research was presented, K. Craig Kent, MD, a vascular surgeon and former president of the Society for Vascular Surgery, stated: “We don’t have enough open arterial cases to teach our general surgery residents. There is a problem on the other side, too, which is we don’t have enough open arterial cases to teach our vascular surgeons to be confident, open, vascular surgeons. What’s my solution? ... we need to share. We should take the opportunity whenever there’s a great arterial case to have everybody, vascular and general surgery trainees, participate,” he stated.

Dr. K. Craig Kent
“To that end, when I was on the vascular board, we created a series of exposure codes, where a general surgeon would get credit if they scrubbed and exposed the carotid artery, the femoral artery, and then the vascular surgery trainees would go on and do the bypass,” he added.

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Body

In the role of discussant at the American Surgical Association meeting where this research was presented, K. Craig Kent, MD, a vascular surgeon and former president of the Society for Vascular Surgery, stated: “We don’t have enough open arterial cases to teach our general surgery residents. There is a problem on the other side, too, which is we don’t have enough open arterial cases to teach our vascular surgeons to be confident, open, vascular surgeons. What’s my solution? ... we need to share. We should take the opportunity whenever there’s a great arterial case to have everybody, vascular and general surgery trainees, participate,” he stated.

Dr. K. Craig Kent
“To that end, when I was on the vascular board, we created a series of exposure codes, where a general surgeon would get credit if they scrubbed and exposed the carotid artery, the femoral artery, and then the vascular surgery trainees would go on and do the bypass,” he added.

Body

In the role of discussant at the American Surgical Association meeting where this research was presented, K. Craig Kent, MD, a vascular surgeon and former president of the Society for Vascular Surgery, stated: “We don’t have enough open arterial cases to teach our general surgery residents. There is a problem on the other side, too, which is we don’t have enough open arterial cases to teach our vascular surgeons to be confident, open, vascular surgeons. What’s my solution? ... we need to share. We should take the opportunity whenever there’s a great arterial case to have everybody, vascular and general surgery trainees, participate,” he stated.

Dr. K. Craig Kent
“To that end, when I was on the vascular board, we created a series of exposure codes, where a general surgeon would get credit if they scrubbed and exposed the carotid artery, the femoral artery, and then the vascular surgery trainees would go on and do the bypass,” he added.

Title
Do general surgery residents need that much experience?
Do general surgery residents need that much experience?

Operative experience in open arterial vascular surgery procedures for general surgery residents has significantly declined, according to the results of a study of the Accreditation Council for Graduate Medical Education (ACGME) national case log reports, which lists the mean numbers of operations performed.

“Because fundamental vascular surgery skills are necessary for operative general surgery, vascular surgery should remain an essential content area. However, programs cannot solely depend on operative experience to teach fundamental vascular surgery skills,” John R. Potts III, MD, FACS, and R. James Valentine, MD, FACS, stated in their report published online in Annals of Surgery.

The number of individuals completing ACGME-accredited general surgery and vascular surgery training each year of the study was obtained from public reports of the ACGME as well as the available summary national data regarding the reported operative experience of residents completing general surgery programs.

The researchers found that over 15 years (academic year 2001-2002 through AY 2016-2017), the total vascular operations performed by general surgery residents significantly declined as did the total open arterial vascular procedures, including those in seven of nine categories (P less than .0001).

The issue of adequate exposure to vascular procedures for general surgery residents is complex. “The number of individuals completing general surgery residency annually has increased by approximately 20% since AY 2001-2. During the same period, the number of open arterial operations reported by general surgery residents decreased by approximately 38%. Thus, the declining experience is clearly not simply a matter of distributing the same number of operations to a larger number of individuals,” the investigators reported.

The ACGME-designated “essential content areas” have increased in recent years for general surgery trainees to now encompass alimentary tract, abdomen, breast, head and neck, endocrine system, the surgical management of trauma, soft tissues, pediatric surgery, surgical critical care, surgical oncology, and vascular surgery. The essential content areas compete to varying degrees for the trainee’s time, potentially cutting into not just vascular cases but other areas as well. It is also the case that general surgery trainees are often in an institutional setting where they are competing with vascular surgery residents for the same pool of vascular surgery patients.

During those last 5 years, significant declines occurred in five categories: aneurysm, cerebrovascular disease, arteriovenous dialysis access, peripheral vascular disease, and extra-anatomic bypass, according to the authors.

“Knowledge of arterial anatomy, approaches, control, and repair are crucial to the practice of operative general surgery. In the face of declining experience for their resident as surgeon in open arterial operations, general surgery programs must augment resident education in the principles of vascular surgery through other means,” the authors concluded.

Portions of this study were presented at the2018 meeting of the American Surgical Association.

Dr. Potts and Dr. Valentine reported that they had no conflicts of interest.
 

SOURCE: Potts JR et al. Ann Surg. 2018 Jul 24. doi: 10.1097/SLA.0000000000002951.

Operative experience in open arterial vascular surgery procedures for general surgery residents has significantly declined, according to the results of a study of the Accreditation Council for Graduate Medical Education (ACGME) national case log reports, which lists the mean numbers of operations performed.

“Because fundamental vascular surgery skills are necessary for operative general surgery, vascular surgery should remain an essential content area. However, programs cannot solely depend on operative experience to teach fundamental vascular surgery skills,” John R. Potts III, MD, FACS, and R. James Valentine, MD, FACS, stated in their report published online in Annals of Surgery.

The number of individuals completing ACGME-accredited general surgery and vascular surgery training each year of the study was obtained from public reports of the ACGME as well as the available summary national data regarding the reported operative experience of residents completing general surgery programs.

The researchers found that over 15 years (academic year 2001-2002 through AY 2016-2017), the total vascular operations performed by general surgery residents significantly declined as did the total open arterial vascular procedures, including those in seven of nine categories (P less than .0001).

The issue of adequate exposure to vascular procedures for general surgery residents is complex. “The number of individuals completing general surgery residency annually has increased by approximately 20% since AY 2001-2. During the same period, the number of open arterial operations reported by general surgery residents decreased by approximately 38%. Thus, the declining experience is clearly not simply a matter of distributing the same number of operations to a larger number of individuals,” the investigators reported.

The ACGME-designated “essential content areas” have increased in recent years for general surgery trainees to now encompass alimentary tract, abdomen, breast, head and neck, endocrine system, the surgical management of trauma, soft tissues, pediatric surgery, surgical critical care, surgical oncology, and vascular surgery. The essential content areas compete to varying degrees for the trainee’s time, potentially cutting into not just vascular cases but other areas as well. It is also the case that general surgery trainees are often in an institutional setting where they are competing with vascular surgery residents for the same pool of vascular surgery patients.

During those last 5 years, significant declines occurred in five categories: aneurysm, cerebrovascular disease, arteriovenous dialysis access, peripheral vascular disease, and extra-anatomic bypass, according to the authors.

“Knowledge of arterial anatomy, approaches, control, and repair are crucial to the practice of operative general surgery. In the face of declining experience for their resident as surgeon in open arterial operations, general surgery programs must augment resident education in the principles of vascular surgery through other means,” the authors concluded.

Portions of this study were presented at the2018 meeting of the American Surgical Association.

Dr. Potts and Dr. Valentine reported that they had no conflicts of interest.
 

SOURCE: Potts JR et al. Ann Surg. 2018 Jul 24. doi: 10.1097/SLA.0000000000002951.

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Key clinical point: General surgery residents may need more open vascular experience.

Major finding: The number of open arterial operations reported by general surgery residents has decreased by approximately 38% since academic year 2001-2002.

Study details: An analysis of 15 years of ACGME resident national case load reports.

Disclosures: Dr. Potts and Dr. Valentine reported that they had no conflicts of interest.

Source: Potts JR III et al. Ann Surg. 2018 Jul 24. doi: 10.1097/SLA.0000000000002951.

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