Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

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

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

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

The retrospective study was published in JAMA Network Open.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The retrospective study was published in JAMA Network Open.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The retrospective study was published in JAMA Network Open.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To the Editor:

A 53-year-old Hispanic woman presented to our dermatology clinic for evaluation of an expanding plaque on the right cheek of 2 months’ duration. The patient stated the plaque began as a pimple, which she picked with subsequent spread laterally across the cheek. The area was intermittently tender, but she denied tingling, burning, or pruritus of the site. She had been treated with doxycycline and amoxicillin–clavulanic acid prior to presentation without improvement. She had a history of levamisole-induced vasculitis approximately 6 months prior. A review of systems was notable for diffuse joint pain. The patient denied tobacco, alcohol, or illicit drug use in the preceding 3 months and denied any changes in her medications or in health within the last year.

Physical examination revealed a well-appearing, alert, and afebrile patient with a pink, well-demarcated plaque on the right cheek (Figure 1). The borders of the plaque were indurated, and the lateral aspect of the plaque was eroded secondary to digital manipulation by the patient. She had no cervical lymphadenopathy. There were no other abnormal cutaneous findings.

There is a broad differential diagnosis for a pink expanding plaque on the face, which requires histopathologic correlation for correct diagnosis. Three broad categories in the differential are infectious (eg, bacterial, fungal), medication related (eg, fixed drug eruption), and granulomatous (eg, granuloma faciale [GF], sarcoidosis, tumid lupus, leprosy, granulomatous rosacea). A biopsy of the lesion revealed a mixed inflammatory cell dermal infiltrate with perivascular accentuation and intense vasculitis that was consistent with GF (Figure 2). Gomori methenamine-silver, periodic acid–Schiff, Fite-Faraco, acid-fast bacilli, and Gram staining were negative for organisms. Tissue cultures were negative for bacterial, mycobacterial, and fungal etiology. The patient was started on high-potency topical steroids with a 50% improvement in the appearance of the skin lesion at 1-month follow-up.

Granuloma faciale is a rare chronic inflammatory dermatosis with a predilection for the face that is difficult to diagnose and treat. The diagnosis is based on clinical and histologic findings, and it typically presents as single or multiple, well-demarcated, red-brown nodules, papules, or plaques that range from several millimeters to centimeters in diameter.^1,2 Extrafacial lesions may be seen.³ Granuloma faciale usually is asymptomatic but occasionally has associated pruritus and rarely ulceration. The prevalence and pathophysiology of GF is not well defined; however, GF more commonly is reported in middle-aged White males.¹

Histologic examination of GF reveals a mixed inflammatory cellular infiltrate in the upper dermis. A grenz zone, which is a narrow area of the papillary dermis uninvolved by the underlying pathology, may be seen.¹ Contrary to the name, granulomas are not found histologically. Rather, vascular changes or damage frequently are present and may indicate a small vessel vasculitis pathologic mechanism. Granuloma faciale also has been associated with follicular ostia accentuation and telangiectases.⁴

Many cases of GF have been misdiagnosed as sarcoidosis, lymphoma, lupus, and basal cell carcinoma.¹ In addition, GF shares many clinical and histologic features with erythema elevatum diutinum (EED). However, the defining features that suggest EED over GF is that EED has a predilection for the skin overlying the joints. Histopathologically, EED displays granulomas and fibrosis with few eosinophils.^5,6

The variable response of GF to treatments and lack of efficacy data have contributed to the complexity and uncertainty of managing GF. The current first-line therapies are topical tacrolimus,⁷ cryotherapy,⁸ or corticosteroid therapy.⁹

To the Editor:

A 53-year-old Hispanic woman presented to our dermatology clinic for evaluation of an expanding plaque on the right cheek of 2 months’ duration. The patient stated the plaque began as a pimple, which she picked with subsequent spread laterally across the cheek. The area was intermittently tender, but she denied tingling, burning, or pruritus of the site. She had been treated with doxycycline and amoxicillin–clavulanic acid prior to presentation without improvement. She had a history of levamisole-induced vasculitis approximately 6 months prior. A review of systems was notable for diffuse joint pain. The patient denied tobacco, alcohol, or illicit drug use in the preceding 3 months and denied any changes in her medications or in health within the last year.

Physical examination revealed a well-appearing, alert, and afebrile patient with a pink, well-demarcated plaque on the right cheek (Figure 1). The borders of the plaque were indurated, and the lateral aspect of the plaque was eroded secondary to digital manipulation by the patient. She had no cervical lymphadenopathy. There were no other abnormal cutaneous findings.

There is a broad differential diagnosis for a pink expanding plaque on the face, which requires histopathologic correlation for correct diagnosis. Three broad categories in the differential are infectious (eg, bacterial, fungal), medication related (eg, fixed drug eruption), and granulomatous (eg, granuloma faciale [GF], sarcoidosis, tumid lupus, leprosy, granulomatous rosacea). A biopsy of the lesion revealed a mixed inflammatory cell dermal infiltrate with perivascular accentuation and intense vasculitis that was consistent with GF (Figure 2). Gomori methenamine-silver, periodic acid–Schiff, Fite-Faraco, acid-fast bacilli, and Gram staining were negative for organisms. Tissue cultures were negative for bacterial, mycobacterial, and fungal etiology. The patient was started on high-potency topical steroids with a 50% improvement in the appearance of the skin lesion at 1-month follow-up.

Granuloma faciale is a rare chronic inflammatory dermatosis with a predilection for the face that is difficult to diagnose and treat. The diagnosis is based on clinical and histologic findings, and it typically presents as single or multiple, well-demarcated, red-brown nodules, papules, or plaques that range from several millimeters to centimeters in diameter.^1,2 Extrafacial lesions may be seen.³ Granuloma faciale usually is asymptomatic but occasionally has associated pruritus and rarely ulceration. The prevalence and pathophysiology of GF is not well defined; however, GF more commonly is reported in middle-aged White males.¹

Histologic examination of GF reveals a mixed inflammatory cellular infiltrate in the upper dermis. A grenz zone, which is a narrow area of the papillary dermis uninvolved by the underlying pathology, may be seen.¹ Contrary to the name, granulomas are not found histologically. Rather, vascular changes or damage frequently are present and may indicate a small vessel vasculitis pathologic mechanism. Granuloma faciale also has been associated with follicular ostia accentuation and telangiectases.⁴

Many cases of GF have been misdiagnosed as sarcoidosis, lymphoma, lupus, and basal cell carcinoma.¹ In addition, GF shares many clinical and histologic features with erythema elevatum diutinum (EED). However, the defining features that suggest EED over GF is that EED has a predilection for the skin overlying the joints. Histopathologically, EED displays granulomas and fibrosis with few eosinophils.^5,6

The variable response of GF to treatments and lack of efficacy data have contributed to the complexity and uncertainty of managing GF. The current first-line therapies are topical tacrolimus,⁷ cryotherapy,⁸ or corticosteroid therapy.⁹

To the Editor:

A 53-year-old Hispanic woman presented to our dermatology clinic for evaluation of an expanding plaque on the right cheek of 2 months’ duration. The patient stated the plaque began as a pimple, which she picked with subsequent spread laterally across the cheek. The area was intermittently tender, but she denied tingling, burning, or pruritus of the site. She had been treated with doxycycline and amoxicillin–clavulanic acid prior to presentation without improvement. She had a history of levamisole-induced vasculitis approximately 6 months prior. A review of systems was notable for diffuse joint pain. The patient denied tobacco, alcohol, or illicit drug use in the preceding 3 months and denied any changes in her medications or in health within the last year.

Physical examination revealed a well-appearing, alert, and afebrile patient with a pink, well-demarcated plaque on the right cheek (Figure 1). The borders of the plaque were indurated, and the lateral aspect of the plaque was eroded secondary to digital manipulation by the patient. She had no cervical lymphadenopathy. There were no other abnormal cutaneous findings.

There is a broad differential diagnosis for a pink expanding plaque on the face, which requires histopathologic correlation for correct diagnosis. Three broad categories in the differential are infectious (eg, bacterial, fungal), medication related (eg, fixed drug eruption), and granulomatous (eg, granuloma faciale [GF], sarcoidosis, tumid lupus, leprosy, granulomatous rosacea). A biopsy of the lesion revealed a mixed inflammatory cell dermal infiltrate with perivascular accentuation and intense vasculitis that was consistent with GF (Figure 2). Gomori methenamine-silver, periodic acid–Schiff, Fite-Faraco, acid-fast bacilli, and Gram staining were negative for organisms. Tissue cultures were negative for bacterial, mycobacterial, and fungal etiology. The patient was started on high-potency topical steroids with a 50% improvement in the appearance of the skin lesion at 1-month follow-up.

Granuloma faciale is a rare chronic inflammatory dermatosis with a predilection for the face that is difficult to diagnose and treat. The diagnosis is based on clinical and histologic findings, and it typically presents as single or multiple, well-demarcated, red-brown nodules, papules, or plaques that range from several millimeters to centimeters in diameter.^1,2 Extrafacial lesions may be seen.³ Granuloma faciale usually is asymptomatic but occasionally has associated pruritus and rarely ulceration. The prevalence and pathophysiology of GF is not well defined; however, GF more commonly is reported in middle-aged White males.¹

Histologic examination of GF reveals a mixed inflammatory cellular infiltrate in the upper dermis. A grenz zone, which is a narrow area of the papillary dermis uninvolved by the underlying pathology, may be seen.¹ Contrary to the name, granulomas are not found histologically. Rather, vascular changes or damage frequently are present and may indicate a small vessel vasculitis pathologic mechanism. Granuloma faciale also has been associated with follicular ostia accentuation and telangiectases.⁴

Many cases of GF have been misdiagnosed as sarcoidosis, lymphoma, lupus, and basal cell carcinoma.¹ In addition, GF shares many clinical and histologic features with erythema elevatum diutinum (EED). However, the defining features that suggest EED over GF is that EED has a predilection for the skin overlying the joints. Histopathologically, EED displays granulomas and fibrosis with few eosinophils.^5,6

The variable response of GF to treatments and lack of efficacy data have contributed to the complexity and uncertainty of managing GF. The current first-line therapies are topical tacrolimus,⁷ cryotherapy,⁸ or corticosteroid therapy.⁹

Mohs micrographic surgery (MMS) frequently is used in surgical removal of cancerous cutaneous lesions on cosmetically sensitive areas and anatomically challenging sites, including the ears. The vascular supply of the ear is complex and includes several watershed regions that are susceptible to injury during surgical resection or operative closure.

Case Reports

Patient 1—An 82-year-old woman with a 100-pack-year smoking history and no known history of diabetes mellitus or coronary artery disease presented with a superficial and micronodular basal cell carcinoma (BCC) of the left postauricular skin of approximately 18 months’ duration. Mohs micrographic surgery was performed for lesion removal. The BCC was noted to be deeply penetrating and by the second stage was to the depth of the deep subcutaneous tissue (Figure 1A [inset]). Frozen section histopathology revealed a micronodular and superficial BCC. A 2.1×2.0-cm postoperative defect including the posterior surface of the ear, postauricular sulcus, and postauricular scalp remained. To minimize the area left to heal via secondary intention, partial layered closure was performed by placing four 4-0 polyglactin sutures from the scalp side of the defect on the postauricular skin to the postauricular sulcus (Figure 1A).

The patient presented to the clinic on postoperative day (POD) 4, noting pain and redness since the evening of the surgery on the anterior surface of the ear, specifically the cavum concha. Physical examination revealed that the incision site appeared to be healing as expected, but the cavum concha demonstrated erosions and ecchymosis (Figure 1B). A fluid culture was collected, and the patient was started on doxycycline 100 mg twice daily for 10 days. The patient returned to the clinic at POD 10 with skin sloughing and a small border of dark purple discoloration, consistent with early necrosis.

At the 1-month postsurgery follow-up visit, the wound had persistent anterior sloughing and discoloration with adherent debris suggestive of vascular compromise. At the 5-month wound check, the left conchal bowl had a 1-cm through-and-through defect of the concha cavum (Figure 1B [inset]). The favored etiology was occlusion of the posterior auricular artery during the patient’s MMS and reconstruction. Once healed, options including reconstruction, prosthesis, and no treatment were discussed with the patient. The patient decided to pursue partial closure of the defect.

Patient 2—A 71-year-old man with coronary artery disease and no known smoking or diabetes mellitus history presented with a 0.7×0.6-cm cutaneous squamous cell carcinoma of the left helix (Figure 2A [inset]). Mohs micrographic surgery was completed, resulting in a 1.1×1.0-cm defect that extended to the perichondrium. Given the location and size, a linear closure was performed with a deep layer of 5-0 polyglactin sutures and a cutaneous layer of 6-0 polypropylene sutures. The final closure length was 2.1 cm (Figure 2A).

On POD 14, the patient presented for suture removal and reported the onset of brown discoloration of the ear on POD 3. Physical examination revealed the left ear appeared dusky around the mid helix with extension onto the antihelix (Figure 2B). Because one of the main concerns was necrosis, a thin layer of nitropaste ointment 2% was prescribed to be applied twice daily to the affected area, in addition to liberal application of petroleum jelly. On POD 21, the left mid helix demonstrated a well-defined area of necrosis on the helical rim extending to the antihelix, and conservative treatment was continued. Four weeks later, the left ear had a prominent eschar, which was debrided. On follow-up 6 weeks later, the area was well healed with an obvious notched defect of the helix and scaphoid fossa (Figure 2B [inset]). The favored etiology was occlusion of the middle helical arcade during the patient’s MMS and reconstruction. Reconstructive options were discussed with the patient; however, he declined any further reconstructive intervention.

Comment

Auricular Vasculature—In our patients, the auricular vascular supply was compromised during routine MMS followed by reconstruction, resulting in tissue necrosis. Given the relative frequency of these procedures and the risk for tissue necrosis, a review of the auricular vasculature with special attention to the conchal bowl and helical rim was warranted (Figure 3).

The auricle is supplied by 2 main arterial sources arising from the external carotid artery: the superficial temporal artery (STA) supplying the anterior auricle and the posterior auricular artery (PAA) supplying the posterior auricle and the concha.¹ Anastomoses between these 2 blood supplies occur through perforating arteries and vascular arcades.

As the STA courses cranially, it moves from a deep position—deep to the parotidomasseteric fascia—to the superficial temporal fascia approximately 1 cm anterior and superior to the tragus. In approximately 80% of patients, 3 perpendicular branches stem from the STA—the upper, middle, and lower anterior branches—which supply the ascending helix, tragus, and lower margin of the earlobe, respectively.² The upper anterior branch of the STA joins other branches to form 2 dominant arcades: the first with the nonperforating branches of the PAA forming the upper third of the helical arcade, and the second with the lower anterior branch of the STA forming the middle portion of the helical arcade.^3,4 In 75% of patients, the middle helical arcade was identified as a single connecting artery, whereas in the remaining 25% of patients, a robust capillary network was formed.² In patient 2, the middle helical arcade was likely disrupted during closure, resulting in the helical necrosis seen postoperatively.

The second main blood supply of the auricle is the PAA, which enters in a more superficial position after traversing superiorly from the meatal cartilage, between the mastoid process and the posterior surface of the concha. From this point, the PAA runs in the deep subcutaneous tissue in the groove formed by the conchal cartilage and the mastoid process. Near the midpoint of the postauricular groove, it passes inferior to the postauricular muscle. The PAA has multiple radial branches that anastomose with helical branches; it also sends perforating branches (there were 2–4 branches in a recent study²) through the cartilage to the anterior surface of the concha. The 2 primary perforating arteries most commonly are located at the level of the antihelix and the antitragus.⁵ These arteries transverse through a vascular foramen located approximately 11 mm from the tragus in the horizontal plane and supply blood to the conchal bowl.⁶ In patient 1, the PAA itself, or the perforating arteries that course anteriorly through the vascular foramen, was likely disrupted, resulting in the conchal defect.

Special Considerations Before Surgery—As evidenced by these cases, special attention is needed during operative planning to account for the external ear vascular arcades. Damage to the helical arcades (patient 2) or the perforating arteries within the conchal bowl (patient 1) can lead to unintended consequences such as postoperative tissue necrosis. Tissue manipulation in these areas should be approached cautiously and with the least invasive treatment and closure options available. In doing so, blood flow and tissue integrity can be maintained, resulting in improved postoperative outcomes. Further research is warranted to identify the best intervention in cases involving these watershed regions.

Mohs micrographic surgery (MMS) frequently is used in surgical removal of cancerous cutaneous lesions on cosmetically sensitive areas and anatomically challenging sites, including the ears. The vascular supply of the ear is complex and includes several watershed regions that are susceptible to injury during surgical resection or operative closure.

Case Reports

Patient 1—An 82-year-old woman with a 100-pack-year smoking history and no known history of diabetes mellitus or coronary artery disease presented with a superficial and micronodular basal cell carcinoma (BCC) of the left postauricular skin of approximately 18 months’ duration. Mohs micrographic surgery was performed for lesion removal. The BCC was noted to be deeply penetrating and by the second stage was to the depth of the deep subcutaneous tissue (Figure 1A [inset]). Frozen section histopathology revealed a micronodular and superficial BCC. A 2.1×2.0-cm postoperative defect including the posterior surface of the ear, postauricular sulcus, and postauricular scalp remained. To minimize the area left to heal via secondary intention, partial layered closure was performed by placing four 4-0 polyglactin sutures from the scalp side of the defect on the postauricular skin to the postauricular sulcus (Figure 1A).

The patient presented to the clinic on postoperative day (POD) 4, noting pain and redness since the evening of the surgery on the anterior surface of the ear, specifically the cavum concha. Physical examination revealed that the incision site appeared to be healing as expected, but the cavum concha demonstrated erosions and ecchymosis (Figure 1B). A fluid culture was collected, and the patient was started on doxycycline 100 mg twice daily for 10 days. The patient returned to the clinic at POD 10 with skin sloughing and a small border of dark purple discoloration, consistent with early necrosis.

At the 1-month postsurgery follow-up visit, the wound had persistent anterior sloughing and discoloration with adherent debris suggestive of vascular compromise. At the 5-month wound check, the left conchal bowl had a 1-cm through-and-through defect of the concha cavum (Figure 1B [inset]). The favored etiology was occlusion of the posterior auricular artery during the patient’s MMS and reconstruction. Once healed, options including reconstruction, prosthesis, and no treatment were discussed with the patient. The patient decided to pursue partial closure of the defect.

Patient 2—A 71-year-old man with coronary artery disease and no known smoking or diabetes mellitus history presented with a 0.7×0.6-cm cutaneous squamous cell carcinoma of the left helix (Figure 2A [inset]). Mohs micrographic surgery was completed, resulting in a 1.1×1.0-cm defect that extended to the perichondrium. Given the location and size, a linear closure was performed with a deep layer of 5-0 polyglactin sutures and a cutaneous layer of 6-0 polypropylene sutures. The final closure length was 2.1 cm (Figure 2A).

On POD 14, the patient presented for suture removal and reported the onset of brown discoloration of the ear on POD 3. Physical examination revealed the left ear appeared dusky around the mid helix with extension onto the antihelix (Figure 2B). Because one of the main concerns was necrosis, a thin layer of nitropaste ointment 2% was prescribed to be applied twice daily to the affected area, in addition to liberal application of petroleum jelly. On POD 21, the left mid helix demonstrated a well-defined area of necrosis on the helical rim extending to the antihelix, and conservative treatment was continued. Four weeks later, the left ear had a prominent eschar, which was debrided. On follow-up 6 weeks later, the area was well healed with an obvious notched defect of the helix and scaphoid fossa (Figure 2B [inset]). The favored etiology was occlusion of the middle helical arcade during the patient’s MMS and reconstruction. Reconstructive options were discussed with the patient; however, he declined any further reconstructive intervention.

Comment

Auricular Vasculature—In our patients, the auricular vascular supply was compromised during routine MMS followed by reconstruction, resulting in tissue necrosis. Given the relative frequency of these procedures and the risk for tissue necrosis, a review of the auricular vasculature with special attention to the conchal bowl and helical rim was warranted (Figure 3).

The auricle is supplied by 2 main arterial sources arising from the external carotid artery: the superficial temporal artery (STA) supplying the anterior auricle and the posterior auricular artery (PAA) supplying the posterior auricle and the concha.¹ Anastomoses between these 2 blood supplies occur through perforating arteries and vascular arcades.

As the STA courses cranially, it moves from a deep position—deep to the parotidomasseteric fascia—to the superficial temporal fascia approximately 1 cm anterior and superior to the tragus. In approximately 80% of patients, 3 perpendicular branches stem from the STA—the upper, middle, and lower anterior branches—which supply the ascending helix, tragus, and lower margin of the earlobe, respectively.² The upper anterior branch of the STA joins other branches to form 2 dominant arcades: the first with the nonperforating branches of the PAA forming the upper third of the helical arcade, and the second with the lower anterior branch of the STA forming the middle portion of the helical arcade.^3,4 In 75% of patients, the middle helical arcade was identified as a single connecting artery, whereas in the remaining 25% of patients, a robust capillary network was formed.² In patient 2, the middle helical arcade was likely disrupted during closure, resulting in the helical necrosis seen postoperatively.

The second main blood supply of the auricle is the PAA, which enters in a more superficial position after traversing superiorly from the meatal cartilage, between the mastoid process and the posterior surface of the concha. From this point, the PAA runs in the deep subcutaneous tissue in the groove formed by the conchal cartilage and the mastoid process. Near the midpoint of the postauricular groove, it passes inferior to the postauricular muscle. The PAA has multiple radial branches that anastomose with helical branches; it also sends perforating branches (there were 2–4 branches in a recent study²) through the cartilage to the anterior surface of the concha. The 2 primary perforating arteries most commonly are located at the level of the antihelix and the antitragus.⁵ These arteries transverse through a vascular foramen located approximately 11 mm from the tragus in the horizontal plane and supply blood to the conchal bowl.⁶ In patient 1, the PAA itself, or the perforating arteries that course anteriorly through the vascular foramen, was likely disrupted, resulting in the conchal defect.

Special Considerations Before Surgery—As evidenced by these cases, special attention is needed during operative planning to account for the external ear vascular arcades. Damage to the helical arcades (patient 2) or the perforating arteries within the conchal bowl (patient 1) can lead to unintended consequences such as postoperative tissue necrosis. Tissue manipulation in these areas should be approached cautiously and with the least invasive treatment and closure options available. In doing so, blood flow and tissue integrity can be maintained, resulting in improved postoperative outcomes. Further research is warranted to identify the best intervention in cases involving these watershed regions.

Mohs micrographic surgery (MMS) frequently is used in surgical removal of cancerous cutaneous lesions on cosmetically sensitive areas and anatomically challenging sites, including the ears. The vascular supply of the ear is complex and includes several watershed regions that are susceptible to injury during surgical resection or operative closure.

Case Reports

Patient 1—An 82-year-old woman with a 100-pack-year smoking history and no known history of diabetes mellitus or coronary artery disease presented with a superficial and micronodular basal cell carcinoma (BCC) of the left postauricular skin of approximately 18 months’ duration. Mohs micrographic surgery was performed for lesion removal. The BCC was noted to be deeply penetrating and by the second stage was to the depth of the deep subcutaneous tissue (Figure 1A [inset]). Frozen section histopathology revealed a micronodular and superficial BCC. A 2.1×2.0-cm postoperative defect including the posterior surface of the ear, postauricular sulcus, and postauricular scalp remained. To minimize the area left to heal via secondary intention, partial layered closure was performed by placing four 4-0 polyglactin sutures from the scalp side of the defect on the postauricular skin to the postauricular sulcus (Figure 1A).

The patient presented to the clinic on postoperative day (POD) 4, noting pain and redness since the evening of the surgery on the anterior surface of the ear, specifically the cavum concha. Physical examination revealed that the incision site appeared to be healing as expected, but the cavum concha demonstrated erosions and ecchymosis (Figure 1B). A fluid culture was collected, and the patient was started on doxycycline 100 mg twice daily for 10 days. The patient returned to the clinic at POD 10 with skin sloughing and a small border of dark purple discoloration, consistent with early necrosis.

At the 1-month postsurgery follow-up visit, the wound had persistent anterior sloughing and discoloration with adherent debris suggestive of vascular compromise. At the 5-month wound check, the left conchal bowl had a 1-cm through-and-through defect of the concha cavum (Figure 1B [inset]). The favored etiology was occlusion of the posterior auricular artery during the patient’s MMS and reconstruction. Once healed, options including reconstruction, prosthesis, and no treatment were discussed with the patient. The patient decided to pursue partial closure of the defect.

Patient 2—A 71-year-old man with coronary artery disease and no known smoking or diabetes mellitus history presented with a 0.7×0.6-cm cutaneous squamous cell carcinoma of the left helix (Figure 2A [inset]). Mohs micrographic surgery was completed, resulting in a 1.1×1.0-cm defect that extended to the perichondrium. Given the location and size, a linear closure was performed with a deep layer of 5-0 polyglactin sutures and a cutaneous layer of 6-0 polypropylene sutures. The final closure length was 2.1 cm (Figure 2A).

On POD 14, the patient presented for suture removal and reported the onset of brown discoloration of the ear on POD 3. Physical examination revealed the left ear appeared dusky around the mid helix with extension onto the antihelix (Figure 2B). Because one of the main concerns was necrosis, a thin layer of nitropaste ointment 2% was prescribed to be applied twice daily to the affected area, in addition to liberal application of petroleum jelly. On POD 21, the left mid helix demonstrated a well-defined area of necrosis on the helical rim extending to the antihelix, and conservative treatment was continued. Four weeks later, the left ear had a prominent eschar, which was debrided. On follow-up 6 weeks later, the area was well healed with an obvious notched defect of the helix and scaphoid fossa (Figure 2B [inset]). The favored etiology was occlusion of the middle helical arcade during the patient’s MMS and reconstruction. Reconstructive options were discussed with the patient; however, he declined any further reconstructive intervention.

Comment

Auricular Vasculature—In our patients, the auricular vascular supply was compromised during routine MMS followed by reconstruction, resulting in tissue necrosis. Given the relative frequency of these procedures and the risk for tissue necrosis, a review of the auricular vasculature with special attention to the conchal bowl and helical rim was warranted (Figure 3).

The auricle is supplied by 2 main arterial sources arising from the external carotid artery: the superficial temporal artery (STA) supplying the anterior auricle and the posterior auricular artery (PAA) supplying the posterior auricle and the concha.¹ Anastomoses between these 2 blood supplies occur through perforating arteries and vascular arcades.

As the STA courses cranially, it moves from a deep position—deep to the parotidomasseteric fascia—to the superficial temporal fascia approximately 1 cm anterior and superior to the tragus. In approximately 80% of patients, 3 perpendicular branches stem from the STA—the upper, middle, and lower anterior branches—which supply the ascending helix, tragus, and lower margin of the earlobe, respectively.² The upper anterior branch of the STA joins other branches to form 2 dominant arcades: the first with the nonperforating branches of the PAA forming the upper third of the helical arcade, and the second with the lower anterior branch of the STA forming the middle portion of the helical arcade.^3,4 In 75% of patients, the middle helical arcade was identified as a single connecting artery, whereas in the remaining 25% of patients, a robust capillary network was formed.² In patient 2, the middle helical arcade was likely disrupted during closure, resulting in the helical necrosis seen postoperatively.

The second main blood supply of the auricle is the PAA, which enters in a more superficial position after traversing superiorly from the meatal cartilage, between the mastoid process and the posterior surface of the concha. From this point, the PAA runs in the deep subcutaneous tissue in the groove formed by the conchal cartilage and the mastoid process. Near the midpoint of the postauricular groove, it passes inferior to the postauricular muscle. The PAA has multiple radial branches that anastomose with helical branches; it also sends perforating branches (there were 2–4 branches in a recent study²) through the cartilage to the anterior surface of the concha. The 2 primary perforating arteries most commonly are located at the level of the antihelix and the antitragus.⁵ These arteries transverse through a vascular foramen located approximately 11 mm from the tragus in the horizontal plane and supply blood to the conchal bowl.⁶ In patient 1, the PAA itself, or the perforating arteries that course anteriorly through the vascular foramen, was likely disrupted, resulting in the conchal defect.

Special Considerations Before Surgery—As evidenced by these cases, special attention is needed during operative planning to account for the external ear vascular arcades. Damage to the helical arcades (patient 2) or the perforating arteries within the conchal bowl (patient 1) can lead to unintended consequences such as postoperative tissue necrosis. Tissue manipulation in these areas should be approached cautiously and with the least invasive treatment and closure options available. In doing so, blood flow and tissue integrity can be maintained, resulting in improved postoperative outcomes. Further research is warranted to identify the best intervention in cases involving these watershed regions.

Key clinical point: In patients with early-stage gastric cancer and visceral obesity, robotic gastrectomy (RG) is associated with lower incidence of postoperative complications and improved survival vs. laparoscopic gastrectomy (LG).

Major finding: In patients with high visceral fat area (VFA), RG vs. LG was associated with lower incidences of all complications (2.7% vs. 8.2%; P = .019) and intra-abdominal infectious complications (2.0% vs. 6.6%; P = .048). LG was an independent risk factor for overall (odds ratio [OR] 3.281; P = .012) and intra-abdominal infectious (OR 3.462; P = .021) complications in patients with high VFA. The overall survival in patients with high VFA was significantly higher with RG vs. LG (P = .045).

Study details: This article reports a retrospective study of 1306 patients with clinical stage I-II gastric cancer who underwent minimally invasive gastrectomy between 2012 and 2020.

Disclosures: No funding source was identified for this study. The authors received personal fees outside this work.

Source: Hikage M et al. Advantages of a robotic approach compared with laparoscopy gastrectomy for patients with high visceral fat area. Surg Endosc. 2022 (Mar 16). Doi: 10.1007/s00464-022-09178-x

Key clinical point: In patients with early-stage gastric cancer and visceral obesity, robotic gastrectomy (RG) is associated with lower incidence of postoperative complications and improved survival vs. laparoscopic gastrectomy (LG).

Major finding: In patients with high visceral fat area (VFA), RG vs. LG was associated with lower incidences of all complications (2.7% vs. 8.2%; P = .019) and intra-abdominal infectious complications (2.0% vs. 6.6%; P = .048). LG was an independent risk factor for overall (odds ratio [OR] 3.281; P = .012) and intra-abdominal infectious (OR 3.462; P = .021) complications in patients with high VFA. The overall survival in patients with high VFA was significantly higher with RG vs. LG (P = .045).

Study details: This article reports a retrospective study of 1306 patients with clinical stage I-II gastric cancer who underwent minimally invasive gastrectomy between 2012 and 2020.

Disclosures: No funding source was identified for this study. The authors received personal fees outside this work.

Source: Hikage M et al. Advantages of a robotic approach compared with laparoscopy gastrectomy for patients with high visceral fat area. Surg Endosc. 2022 (Mar 16). Doi: 10.1007/s00464-022-09178-x

Key clinical point: In patients with early-stage gastric cancer and visceral obesity, robotic gastrectomy (RG) is associated with lower incidence of postoperative complications and improved survival vs. laparoscopic gastrectomy (LG).

Major finding: In patients with high visceral fat area (VFA), RG vs. LG was associated with lower incidences of all complications (2.7% vs. 8.2%; P = .019) and intra-abdominal infectious complications (2.0% vs. 6.6%; P = .048). LG was an independent risk factor for overall (odds ratio [OR] 3.281; P = .012) and intra-abdominal infectious (OR 3.462; P = .021) complications in patients with high VFA. The overall survival in patients with high VFA was significantly higher with RG vs. LG (P = .045).

Study details: This article reports a retrospective study of 1306 patients with clinical stage I-II gastric cancer who underwent minimally invasive gastrectomy between 2012 and 2020.

Disclosures: No funding source was identified for this study. The authors received personal fees outside this work.

Source: Hikage M et al. Advantages of a robotic approach compared with laparoscopy gastrectomy for patients with high visceral fat area. Surg Endosc. 2022 (Mar 16). Doi: 10.1007/s00464-022-09178-x

Key clinical point: Adjuvant chemotherapy (ACT) after neoadjuvant chemotherapy (NACT) and surgery significantly improved survival in patients with locally advanced gastric cancer (LAGC) with a lymph node ratio (LNR) of ≥9%.

Major finding: At 3 years, the overall survival (OS) was significantly higher in patients who received ACT (60.1% vs. 49.3%; P = .02) vs. those who did not. ACT was associated with significantly improved OS at 3 years in patients with higher (≥9%) LNR (46.6% vs. 21.7%; P < .001). ACT improved OS at 3 years in patients with an LNR of ≥9% in an external validation cohort (53.0% vs. 26.3%; P = .04).

Study details: This article reports on a multicenter retrospective cohort study including 353 patients with LAGC undergoing curative-intent gastrectomy after NACT and an external validation cohort of 109 patients.

Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.

Source: Lin J-X et al. Association of adjuvant chemotherapy with overall survival among patients with locally advanced gastric cancer after neoadjuvant chemotherapy. JAMA Netw Open. 2022;5(4):e225557 (Apr 1). Doi: 10.1001/jamanetworkopen.2022.5557

Key clinical point: Adjuvant chemotherapy (ACT) after neoadjuvant chemotherapy (NACT) and surgery significantly improved survival in patients with locally advanced gastric cancer (LAGC) with a lymph node ratio (LNR) of ≥9%.

Major finding: At 3 years, the overall survival (OS) was significantly higher in patients who received ACT (60.1% vs. 49.3%; P = .02) vs. those who did not. ACT was associated with significantly improved OS at 3 years in patients with higher (≥9%) LNR (46.6% vs. 21.7%; P < .001). ACT improved OS at 3 years in patients with an LNR of ≥9% in an external validation cohort (53.0% vs. 26.3%; P = .04).

Study details: This article reports on a multicenter retrospective cohort study including 353 patients with LAGC undergoing curative-intent gastrectomy after NACT and an external validation cohort of 109 patients.

Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.

Source: Lin J-X et al. Association of adjuvant chemotherapy with overall survival among patients with locally advanced gastric cancer after neoadjuvant chemotherapy. JAMA Netw Open. 2022;5(4):e225557 (Apr 1). Doi: 10.1001/jamanetworkopen.2022.5557

Key clinical point: Adjuvant chemotherapy (ACT) after neoadjuvant chemotherapy (NACT) and surgery significantly improved survival in patients with locally advanced gastric cancer (LAGC) with a lymph node ratio (LNR) of ≥9%.

Major finding: At 3 years, the overall survival (OS) was significantly higher in patients who received ACT (60.1% vs. 49.3%; P = .02) vs. those who did not. ACT was associated with significantly improved OS at 3 years in patients with higher (≥9%) LNR (46.6% vs. 21.7%; P < .001). ACT improved OS at 3 years in patients with an LNR of ≥9% in an external validation cohort (53.0% vs. 26.3%; P = .04).

Study details: This article reports on a multicenter retrospective cohort study including 353 patients with LAGC undergoing curative-intent gastrectomy after NACT and an external validation cohort of 109 patients.

Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.

Source: Lin J-X et al. Association of adjuvant chemotherapy with overall survival among patients with locally advanced gastric cancer after neoadjuvant chemotherapy. JAMA Netw Open. 2022;5(4):e225557 (Apr 1). Doi: 10.1001/jamanetworkopen.2022.5557