Clinical Guidelines Hub

Tuberculosis (TB) remains a significant public health problem worldwide with an estimated 10.4 million new cases and 1.7 million deaths having occurred in 2016.¹ In that same year, there were 9287 new cases in the United States—the lowest number of TB cases on record.²

TB appears in one of 2 forms: active disease, which causes symptoms, morbidity, and mortality and is a source of transmission to others; and latent TB infection (LTBI), which is asymptomatic and noninfectious but can progress to active disease. The estimated prevalence of LTBI worldwide is 23%,³ although in the United States it is only about 5%.⁴ The proportion of those with LTBI who will develop active disease is estimated at 5% to 10% and is highly variable depending on risks.⁴

In the United States, about two-thirds of active TB cases occur among those who are foreign born, whose rate of active disease is 14.6/100,000.² Five countries account for more than half of foreign-born cases: Mexico, the Philippines, India, Vietnam, and China.²

Who should be tested?

A major public health strategy for controlling TB in the United States is targeted screening for LTBI and treatment to prevent progression to active disease. The US Preventive Services Task Force (USPSTF) recommends screening for LTBI in adults age 18 and older who are at high risk of TB infection.⁴ This is consistent with recommendations from the Centers for Disease Control and Prevention (CDC), although the CDC also recommends testing infants and children at high risk of infection, as well as all those at high risk for progression to active disease (TABLE 1^4-6).⁵

Two types of testing are available for TB screening: the TB skin test (TST) and the interferon-gamma release assay (IGRA). There are 2 IGRA test options: T-SPOT. TB (Oxford Immunotec) and QuantiFERON-TB Gold (Qiagen). The TST and IGRA each has advantages and disadvantages. The TST must be placed intradermally and read correctly, and the patient must return for the interpretation 48 to 72 hours after placement. Test interpretation depends on the patient’s risk category, with either a 5-mm, 10-mm, or 15-mm induration being classified as a positive result (TABLE 2⁷).

IGRA is a blood test that needs to be processed within a limited time frame and is more expensive than the TST. The USPSTF lists the sensitivity and specificity of each option as follows: TST, using a 10-mm cutoff, 79%, 97%; T-SPOT, 90%, 95%; QuantiFERON-TB Gold In-Tube, 80%, 97%.⁴

Which test to use?

Recently the CDC, the American Thoracic Society, and the Infectious Diseases Society of America jointly published revised recommendations on TB testing:⁸

• For children younger than 5 years, TST is the preferred option, although IGRA is acceptable in children older than 3 years of age.
• For individuals at high risk of infection but not at high risk of disease progression, IGRA is recommended if they have received a bacille Calmette-Guerin vaccine or are unlikely to return for TST interpretation.
• For others at high risk of infection but not at high risk of disease progression, IGRA is preferred but TST is acceptable.
• For those who have both a high risk of infection and a high risk of disease progression, evidence is insufficient to recommend one test over another; either type is acceptable.
• For those with neither high risk of infection nor high risk of disease progression, testing is not recommended. However, it may be required by law or for credentialing of some kind (eg, for some health professionals or those who work in schools or nursing homes). If this is the case, IGRA is suggested as the preferred test. If the test result is positive, performing a second test is advised (either TST or an alternative type of IGRA). Consider the individual to be infected only if the second test result is also positive.

If the risk is high for TB infection, but not for disease progression, test with an interferon-gamma release assay, particularly if the patient has been vaccinated or is unlikely to return for skin test interpretation.

If a TB screening result is positive, confirm or rule out active TB by asking about symptoms (cough, fever, weight loss) and performing a chest x-ray. If the radiograph shows signs of active TB, collect 3 sputum samples by induction for analysis by smear microscopy, culture, and, possibly, nucleic acid amplification and rifampin susceptibility testing. Consider consulting your local public health department for advice on, or assistance with, sample collection. Report LTBI to the local health department and seek advice on the appropriate tests and treatments.

Expanded treatment selections

With LTBI there are now 4 treatment options for patients and physicians to consider:⁹ isoniazid given daily or twice weekly for either 6 or 9 months; isoniazid and rifapentine given once weekly for 3 months; or rifampin given daily for 4 months. Factors influencing treatment selection include a patient’s age, concomitant conditions, and the likelihood of bacterial resistance. Free treatment for LTBI may be available; again, check with your local health department.

Tuberculosis (TB) remains a significant public health problem worldwide with an estimated 10.4 million new cases and 1.7 million deaths having occurred in 2016.¹ In that same year, there were 9287 new cases in the United States—the lowest number of TB cases on record.²

TB appears in one of 2 forms: active disease, which causes symptoms, morbidity, and mortality and is a source of transmission to others; and latent TB infection (LTBI), which is asymptomatic and noninfectious but can progress to active disease. The estimated prevalence of LTBI worldwide is 23%,³ although in the United States it is only about 5%.⁴ The proportion of those with LTBI who will develop active disease is estimated at 5% to 10% and is highly variable depending on risks.⁴

In the United States, about two-thirds of active TB cases occur among those who are foreign born, whose rate of active disease is 14.6/100,000.² Five countries account for more than half of foreign-born cases: Mexico, the Philippines, India, Vietnam, and China.²

Who should be tested?

A major public health strategy for controlling TB in the United States is targeted screening for LTBI and treatment to prevent progression to active disease. The US Preventive Services Task Force (USPSTF) recommends screening for LTBI in adults age 18 and older who are at high risk of TB infection.⁴ This is consistent with recommendations from the Centers for Disease Control and Prevention (CDC), although the CDC also recommends testing infants and children at high risk of infection, as well as all those at high risk for progression to active disease (TABLE 1^4-6).⁵

Two types of testing are available for TB screening: the TB skin test (TST) and the interferon-gamma release assay (IGRA). There are 2 IGRA test options: T-SPOT. TB (Oxford Immunotec) and QuantiFERON-TB Gold (Qiagen). The TST and IGRA each has advantages and disadvantages. The TST must be placed intradermally and read correctly, and the patient must return for the interpretation 48 to 72 hours after placement. Test interpretation depends on the patient’s risk category, with either a 5-mm, 10-mm, or 15-mm induration being classified as a positive result (TABLE 2⁷).

IGRA is a blood test that needs to be processed within a limited time frame and is more expensive than the TST. The USPSTF lists the sensitivity and specificity of each option as follows: TST, using a 10-mm cutoff, 79%, 97%; T-SPOT, 90%, 95%; QuantiFERON-TB Gold In-Tube, 80%, 97%.⁴

Which test to use?

Recently the CDC, the American Thoracic Society, and the Infectious Diseases Society of America jointly published revised recommendations on TB testing:⁸

• For children younger than 5 years, TST is the preferred option, although IGRA is acceptable in children older than 3 years of age.
• For individuals at high risk of infection but not at high risk of disease progression, IGRA is recommended if they have received a bacille Calmette-Guerin vaccine or are unlikely to return for TST interpretation.
• For others at high risk of infection but not at high risk of disease progression, IGRA is preferred but TST is acceptable.
• For those who have both a high risk of infection and a high risk of disease progression, evidence is insufficient to recommend one test over another; either type is acceptable.
• For those with neither high risk of infection nor high risk of disease progression, testing is not recommended. However, it may be required by law or for credentialing of some kind (eg, for some health professionals or those who work in schools or nursing homes). If this is the case, IGRA is suggested as the preferred test. If the test result is positive, performing a second test is advised (either TST or an alternative type of IGRA). Consider the individual to be infected only if the second test result is also positive.

If the risk is high for TB infection, but not for disease progression, test with an interferon-gamma release assay, particularly if the patient has been vaccinated or is unlikely to return for skin test interpretation.

If a TB screening result is positive, confirm or rule out active TB by asking about symptoms (cough, fever, weight loss) and performing a chest x-ray. If the radiograph shows signs of active TB, collect 3 sputum samples by induction for analysis by smear microscopy, culture, and, possibly, nucleic acid amplification and rifampin susceptibility testing. Consider consulting your local public health department for advice on, or assistance with, sample collection. Report LTBI to the local health department and seek advice on the appropriate tests and treatments.

Expanded treatment selections

With LTBI there are now 4 treatment options for patients and physicians to consider:⁹ isoniazid given daily or twice weekly for either 6 or 9 months; isoniazid and rifapentine given once weekly for 3 months; or rifampin given daily for 4 months. Factors influencing treatment selection include a patient’s age, concomitant conditions, and the likelihood of bacterial resistance. Free treatment for LTBI may be available; again, check with your local health department.

Tuberculosis (TB) remains a significant public health problem worldwide with an estimated 10.4 million new cases and 1.7 million deaths having occurred in 2016.¹ In that same year, there were 9287 new cases in the United States—the lowest number of TB cases on record.²

TB appears in one of 2 forms: active disease, which causes symptoms, morbidity, and mortality and is a source of transmission to others; and latent TB infection (LTBI), which is asymptomatic and noninfectious but can progress to active disease. The estimated prevalence of LTBI worldwide is 23%,³ although in the United States it is only about 5%.⁴ The proportion of those with LTBI who will develop active disease is estimated at 5% to 10% and is highly variable depending on risks.⁴

In the United States, about two-thirds of active TB cases occur among those who are foreign born, whose rate of active disease is 14.6/100,000.² Five countries account for more than half of foreign-born cases: Mexico, the Philippines, India, Vietnam, and China.²

Who should be tested?

A major public health strategy for controlling TB in the United States is targeted screening for LTBI and treatment to prevent progression to active disease. The US Preventive Services Task Force (USPSTF) recommends screening for LTBI in adults age 18 and older who are at high risk of TB infection.⁴ This is consistent with recommendations from the Centers for Disease Control and Prevention (CDC), although the CDC also recommends testing infants and children at high risk of infection, as well as all those at high risk for progression to active disease (TABLE 1^4-6).⁵

Two types of testing are available for TB screening: the TB skin test (TST) and the interferon-gamma release assay (IGRA). There are 2 IGRA test options: T-SPOT. TB (Oxford Immunotec) and QuantiFERON-TB Gold (Qiagen). The TST and IGRA each has advantages and disadvantages. The TST must be placed intradermally and read correctly, and the patient must return for the interpretation 48 to 72 hours after placement. Test interpretation depends on the patient’s risk category, with either a 5-mm, 10-mm, or 15-mm induration being classified as a positive result (TABLE 2⁷).

IGRA is a blood test that needs to be processed within a limited time frame and is more expensive than the TST. The USPSTF lists the sensitivity and specificity of each option as follows: TST, using a 10-mm cutoff, 79%, 97%; T-SPOT, 90%, 95%; QuantiFERON-TB Gold In-Tube, 80%, 97%.⁴

Which test to use?

Recently the CDC, the American Thoracic Society, and the Infectious Diseases Society of America jointly published revised recommendations on TB testing:⁸

• For children younger than 5 years, TST is the preferred option, although IGRA is acceptable in children older than 3 years of age.
• For individuals at high risk of infection but not at high risk of disease progression, IGRA is recommended if they have received a bacille Calmette-Guerin vaccine or are unlikely to return for TST interpretation.
• For others at high risk of infection but not at high risk of disease progression, IGRA is preferred but TST is acceptable.
• For those who have both a high risk of infection and a high risk of disease progression, evidence is insufficient to recommend one test over another; either type is acceptable.
• For those with neither high risk of infection nor high risk of disease progression, testing is not recommended. However, it may be required by law or for credentialing of some kind (eg, for some health professionals or those who work in schools or nursing homes). If this is the case, IGRA is suggested as the preferred test. If the test result is positive, performing a second test is advised (either TST or an alternative type of IGRA). Consider the individual to be infected only if the second test result is also positive.

If the risk is high for TB infection, but not for disease progression, test with an interferon-gamma release assay, particularly if the patient has been vaccinated or is unlikely to return for skin test interpretation.

If a TB screening result is positive, confirm or rule out active TB by asking about symptoms (cough, fever, weight loss) and performing a chest x-ray. If the radiograph shows signs of active TB, collect 3 sputum samples by induction for analysis by smear microscopy, culture, and, possibly, nucleic acid amplification and rifampin susceptibility testing. Consider consulting your local public health department for advice on, or assistance with, sample collection. Report LTBI to the local health department and seek advice on the appropriate tests and treatments.

Expanded treatment selections

With LTBI there are now 4 treatment options for patients and physicians to consider:⁹ isoniazid given daily or twice weekly for either 6 or 9 months; isoniazid and rifapentine given once weekly for 3 months; or rifampin given daily for 4 months. Factors influencing treatment selection include a patient’s age, concomitant conditions, and the likelihood of bacterial resistance. Free treatment for LTBI may be available; again, check with your local health department.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

Women and their obstetricians should consider vaginal birth after cesarean delivery (VBAC) if their maternal care center can handle emergency deliveries, according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.

Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).

Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.

To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.

“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”

Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.

To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.

The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.

Women and their obstetricians should consider vaginal birth after cesarean delivery (VBAC) if their maternal care center can handle emergency deliveries, according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.

Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).

Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.

To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.

“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”

Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.

To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.

The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.

Women and their obstetricians should consider vaginal birth after cesarean delivery (VBAC) if their maternal care center can handle emergency deliveries, according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.

Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).

Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.

To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.

“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”

Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.

To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.

The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.

Recent studies have helped clarify the natural history risks of intracranial hemorrhage (ICH) and seizure in patients with unruptured brain arteriovenous malformations (AVMs). In addition, researchers have completed the first randomized trial of interventional therapy versus conservative management for unruptured brain AVMs. Nevertheless, data to guide treatment decisions remain limited, and “considerable uncertainties … face physicians managing patients with ruptured and unruptured brain AVMs,” according to a scientific statement for healthcare professionals from the American Heart Association (AHA) and American Stroke Association (ASA). Optimal management of unruptured brain AVMs is a subject of debate, and discussion of treatment options should include careful consideration of natural history risks, the relative risks of intervention strategies, and patients’ life expectancy, the authors said.

The scientific statement on the management of brain AVMs was published in the August issue of Stroke. It updates the American Heart Association’s 2001 statement on this topic. The report reviews epidemiology, diagnosis, natural history, treatment, and management of ruptured and unruptured brain AVMs, as well as areas requiring more evidence. The American Academy of Neurology affirmed the value of the statement as an educational tool for neurologists. The Society of NeuroInterventional Surgery endorsed it, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Cerebrovascular Section affirmed its educational benefit.

An Uncommon Lesion

Brain AVMs are uncommon, may present with spontaneous ICH, seizures, or headache, and typically present in young adults. Neurologists may identify incidental asymptomatic AVMs when patients undergo brain imaging for other reasons. The primary goal of treatment is prevention of hemorrhagic stroke.

Colin P. Derdeyn, MD, Professor of Neurology and Radiology at the University of Iowa in Iowa City and chair of the group that wrote the scientific statement, and colleagues searched all English-language articles on brain AVMs in humans that had been published following the 2001 statement. “Advances … include the accumulation of new data related to epidemiology, biology, imaging, outcomes with treatment, and introduction of new embolic agents,” the authors said. “Most notable of these data are the results of the first randomized trial of intervention for unruptured brain AVMs, the ARUBA trial (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).”

ARUBA enrolled 226 adult patients with unruptured brain AVMs between 2007 and 2013. Patients were randomized to receive medical management alone or medical management with interventional therapy (eg, resection, embolization, or stereotactic radiosurgery alone or in combination).

A preplanned interim analysis found that after a mean follow-up of 33 months, the risk of stroke or death was more than three times higher in the intervention group (30.7%) than in the medical management group (10.1%). The analysis included data from 224 participants at 39 sites worldwide. On the recommendation of the ARUBA Data and Safety Monitoring Board, the National Institute of Neurological Disorders and Stroke stopped enrollment and stated that “under the experimental conditions in this trial, the interim analysis … shows that medical management is superior to intervention in patients with unruptured brain AVMs.”

Although ARUBA and an observational study by Al-Shahi Salman et al support a conservative approach to management, the studies had relatively short follow-up, considering the long duration of hemorrhage risk for patients with untreated brain AVMs. Furthermore, complication rates in the treatment arms in ARUBA were much higher than expected, the authors said. “The primary end points of ARUBA [ie, stroke or death] in the intervention group for Spetzler-Martin (SM) grade I (14.3%), II (43.3%), and III (57.1%) AVMs are higher than would have been expected in contemporary series, particularly for surgery or radiosurgery performed alone,” the authors said.

Additional studies are needed to better define long-term risks of stroke and seizure and to identify specific predictors of hemorrhagic stroke. “Long-term follow-up of participants in the ARUBA trial will be valuable for determining whether the superiority of conservative management over intervention observed in that study persists in the long term,” they said. “Further randomized controlled trials are justified to investigate the reproducibility of the findings of ARUBA and to investigate whether the balance of risk between conservative management and intervention is different in specific groups (eg, patients with SM grade I brain AVM).”

Recommendations for Management

Neurologists can inform patients about natural history risks, which are reliably quantified over approximately 10 years for ICH and approximately five years for epileptic seizure, the authors said. The annual risk of a first-ever ICH from an unruptured brain AVM is approximately 1%. The five-year risk of developing a first seizure is approximately 8%, and the five-year risk of developing epilepsy after a first seizure is approximately 58%.

Discussion of treatment options should consider natural history risks “weighed carefully against the relative risks of different intervention strategies and life expectancy,” the authors said. The SM grading scale is useful for predicting the risk of surgical resection.

For the management of patients with ruptured brain AVMs, the authors recommend that the evaluation of underlying brain AVMs and management of an initial hemorrhage follow the AHA and ASA’s 2015 spontaneous ICH management guidelines. The annual risk of recurrent ICH from a ruptured brain AVM is approximately 5%, and increasing age, deep venous drainage, arterial aneurysms, and female sex may increase the risk.

—Jake Remaly

Suggested Reading

Al-Shahi Salman R, White PM, Counsell CE, et al. Outcome after conservative management or intervention for unruptured brain arteriovenous malformations. JAMA. 2014;311(16):1661-1669.

Derdeyn CP, Zipfel GJ, Albuquerque FC, et al. Management of brain arteriovenous malformations: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2017;48(8):e200-e224.

Hemphill JC 3rd, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(7):2032-2060.

Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014;383(9917):614-621.

Recent studies have helped clarify the natural history risks of intracranial hemorrhage (ICH) and seizure in patients with unruptured brain arteriovenous malformations (AVMs). In addition, researchers have completed the first randomized trial of interventional therapy versus conservative management for unruptured brain AVMs. Nevertheless, data to guide treatment decisions remain limited, and “considerable uncertainties … face physicians managing patients with ruptured and unruptured brain AVMs,” according to a scientific statement for healthcare professionals from the American Heart Association (AHA) and American Stroke Association (ASA). Optimal management of unruptured brain AVMs is a subject of debate, and discussion of treatment options should include careful consideration of natural history risks, the relative risks of intervention strategies, and patients’ life expectancy, the authors said.

The scientific statement on the management of brain AVMs was published in the August issue of Stroke. It updates the American Heart Association’s 2001 statement on this topic. The report reviews epidemiology, diagnosis, natural history, treatment, and management of ruptured and unruptured brain AVMs, as well as areas requiring more evidence. The American Academy of Neurology affirmed the value of the statement as an educational tool for neurologists. The Society of NeuroInterventional Surgery endorsed it, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Cerebrovascular Section affirmed its educational benefit.

An Uncommon Lesion

Brain AVMs are uncommon, may present with spontaneous ICH, seizures, or headache, and typically present in young adults. Neurologists may identify incidental asymptomatic AVMs when patients undergo brain imaging for other reasons. The primary goal of treatment is prevention of hemorrhagic stroke.

Colin P. Derdeyn, MD, Professor of Neurology and Radiology at the University of Iowa in Iowa City and chair of the group that wrote the scientific statement, and colleagues searched all English-language articles on brain AVMs in humans that had been published following the 2001 statement. “Advances … include the accumulation of new data related to epidemiology, biology, imaging, outcomes with treatment, and introduction of new embolic agents,” the authors said. “Most notable of these data are the results of the first randomized trial of intervention for unruptured brain AVMs, the ARUBA trial (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).”

ARUBA enrolled 226 adult patients with unruptured brain AVMs between 2007 and 2013. Patients were randomized to receive medical management alone or medical management with interventional therapy (eg, resection, embolization, or stereotactic radiosurgery alone or in combination).

A preplanned interim analysis found that after a mean follow-up of 33 months, the risk of stroke or death was more than three times higher in the intervention group (30.7%) than in the medical management group (10.1%). The analysis included data from 224 participants at 39 sites worldwide. On the recommendation of the ARUBA Data and Safety Monitoring Board, the National Institute of Neurological Disorders and Stroke stopped enrollment and stated that “under the experimental conditions in this trial, the interim analysis … shows that medical management is superior to intervention in patients with unruptured brain AVMs.”

Although ARUBA and an observational study by Al-Shahi Salman et al support a conservative approach to management, the studies had relatively short follow-up, considering the long duration of hemorrhage risk for patients with untreated brain AVMs. Furthermore, complication rates in the treatment arms in ARUBA were much higher than expected, the authors said. “The primary end points of ARUBA [ie, stroke or death] in the intervention group for Spetzler-Martin (SM) grade I (14.3%), II (43.3%), and III (57.1%) AVMs are higher than would have been expected in contemporary series, particularly for surgery or radiosurgery performed alone,” the authors said.

Additional studies are needed to better define long-term risks of stroke and seizure and to identify specific predictors of hemorrhagic stroke. “Long-term follow-up of participants in the ARUBA trial will be valuable for determining whether the superiority of conservative management over intervention observed in that study persists in the long term,” they said. “Further randomized controlled trials are justified to investigate the reproducibility of the findings of ARUBA and to investigate whether the balance of risk between conservative management and intervention is different in specific groups (eg, patients with SM grade I brain AVM).”

Recommendations for Management

Neurologists can inform patients about natural history risks, which are reliably quantified over approximately 10 years for ICH and approximately five years for epileptic seizure, the authors said. The annual risk of a first-ever ICH from an unruptured brain AVM is approximately 1%. The five-year risk of developing a first seizure is approximately 8%, and the five-year risk of developing epilepsy after a first seizure is approximately 58%.

Discussion of treatment options should consider natural history risks “weighed carefully against the relative risks of different intervention strategies and life expectancy,” the authors said. The SM grading scale is useful for predicting the risk of surgical resection.

For the management of patients with ruptured brain AVMs, the authors recommend that the evaluation of underlying brain AVMs and management of an initial hemorrhage follow the AHA and ASA’s 2015 spontaneous ICH management guidelines. The annual risk of recurrent ICH from a ruptured brain AVM is approximately 5%, and increasing age, deep venous drainage, arterial aneurysms, and female sex may increase the risk.

—Jake Remaly

Suggested Reading

Al-Shahi Salman R, White PM, Counsell CE, et al. Outcome after conservative management or intervention for unruptured brain arteriovenous malformations. JAMA. 2014;311(16):1661-1669.

Derdeyn CP, Zipfel GJ, Albuquerque FC, et al. Management of brain arteriovenous malformations: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2017;48(8):e200-e224.

Hemphill JC 3rd, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(7):2032-2060.

Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014;383(9917):614-621.

Recent studies have helped clarify the natural history risks of intracranial hemorrhage (ICH) and seizure in patients with unruptured brain arteriovenous malformations (AVMs). In addition, researchers have completed the first randomized trial of interventional therapy versus conservative management for unruptured brain AVMs. Nevertheless, data to guide treatment decisions remain limited, and “considerable uncertainties … face physicians managing patients with ruptured and unruptured brain AVMs,” according to a scientific statement for healthcare professionals from the American Heart Association (AHA) and American Stroke Association (ASA). Optimal management of unruptured brain AVMs is a subject of debate, and discussion of treatment options should include careful consideration of natural history risks, the relative risks of intervention strategies, and patients’ life expectancy, the authors said.

The scientific statement on the management of brain AVMs was published in the August issue of Stroke. It updates the American Heart Association’s 2001 statement on this topic. The report reviews epidemiology, diagnosis, natural history, treatment, and management of ruptured and unruptured brain AVMs, as well as areas requiring more evidence. The American Academy of Neurology affirmed the value of the statement as an educational tool for neurologists. The Society of NeuroInterventional Surgery endorsed it, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Cerebrovascular Section affirmed its educational benefit.

An Uncommon Lesion

Brain AVMs are uncommon, may present with spontaneous ICH, seizures, or headache, and typically present in young adults. Neurologists may identify incidental asymptomatic AVMs when patients undergo brain imaging for other reasons. The primary goal of treatment is prevention of hemorrhagic stroke.

Colin P. Derdeyn, MD, Professor of Neurology and Radiology at the University of Iowa in Iowa City and chair of the group that wrote the scientific statement, and colleagues searched all English-language articles on brain AVMs in humans that had been published following the 2001 statement. “Advances … include the accumulation of new data related to epidemiology, biology, imaging, outcomes with treatment, and introduction of new embolic agents,” the authors said. “Most notable of these data are the results of the first randomized trial of intervention for unruptured brain AVMs, the ARUBA trial (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).”

ARUBA enrolled 226 adult patients with unruptured brain AVMs between 2007 and 2013. Patients were randomized to receive medical management alone or medical management with interventional therapy (eg, resection, embolization, or stereotactic radiosurgery alone or in combination).

A preplanned interim analysis found that after a mean follow-up of 33 months, the risk of stroke or death was more than three times higher in the intervention group (30.7%) than in the medical management group (10.1%). The analysis included data from 224 participants at 39 sites worldwide. On the recommendation of the ARUBA Data and Safety Monitoring Board, the National Institute of Neurological Disorders and Stroke stopped enrollment and stated that “under the experimental conditions in this trial, the interim analysis … shows that medical management is superior to intervention in patients with unruptured brain AVMs.”

Although ARUBA and an observational study by Al-Shahi Salman et al support a conservative approach to management, the studies had relatively short follow-up, considering the long duration of hemorrhage risk for patients with untreated brain AVMs. Furthermore, complication rates in the treatment arms in ARUBA were much higher than expected, the authors said. “The primary end points of ARUBA [ie, stroke or death] in the intervention group for Spetzler-Martin (SM) grade I (14.3%), II (43.3%), and III (57.1%) AVMs are higher than would have been expected in contemporary series, particularly for surgery or radiosurgery performed alone,” the authors said.

Additional studies are needed to better define long-term risks of stroke and seizure and to identify specific predictors of hemorrhagic stroke. “Long-term follow-up of participants in the ARUBA trial will be valuable for determining whether the superiority of conservative management over intervention observed in that study persists in the long term,” they said. “Further randomized controlled trials are justified to investigate the reproducibility of the findings of ARUBA and to investigate whether the balance of risk between conservative management and intervention is different in specific groups (eg, patients with SM grade I brain AVM).”

Recommendations for Management

Neurologists can inform patients about natural history risks, which are reliably quantified over approximately 10 years for ICH and approximately five years for epileptic seizure, the authors said. The annual risk of a first-ever ICH from an unruptured brain AVM is approximately 1%. The five-year risk of developing a first seizure is approximately 8%, and the five-year risk of developing epilepsy after a first seizure is approximately 58%.

Discussion of treatment options should consider natural history risks “weighed carefully against the relative risks of different intervention strategies and life expectancy,” the authors said. The SM grading scale is useful for predicting the risk of surgical resection.

For the management of patients with ruptured brain AVMs, the authors recommend that the evaluation of underlying brain AVMs and management of an initial hemorrhage follow the AHA and ASA’s 2015 spontaneous ICH management guidelines. The annual risk of recurrent ICH from a ruptured brain AVM is approximately 5%, and increasing age, deep venous drainage, arterial aneurysms, and female sex may increase the risk.

—Jake Remaly

Suggested Reading

Al-Shahi Salman R, White PM, Counsell CE, et al. Outcome after conservative management or intervention for unruptured brain arteriovenous malformations. JAMA. 2014;311(16):1661-1669.

Derdeyn CP, Zipfel GJ, Albuquerque FC, et al. Management of brain arteriovenous malformations: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2017;48(8):e200-e224.

Hemphill JC 3rd, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(7):2032-2060.

Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014;383(9917):614-621.

The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock

The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock

The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock

New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.

“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”

New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.

“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”

New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.

“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”

Infants with possible prenatal Zika exposure who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurological evaluation with brain imaging within 1 month of birth, according to new interim guidance set forth by the Centers for Disease Control and Prevention.

The new clinical management guidelines, published in the Oct. 20 issue of the Morbidity and Mortality Weekly Report, supersede the most recent CDC guidance, issued in August 2016. The agency deemed the update necessary after a recent convocation sponsored by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. The meeting drew dozens of practicing clinicians and federal agency representatives, who reviewed the ever-evolving body of knowledge on how to best manage the care of these infants. Since Zika emerged as a public health threat, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, a developing microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

CDC/Cynthia Goldsmith

Infants with clinical findings consistent with Zika syndrome and mothers with possible prenatal Zika exposure

These infants should be tested for Zika virus with serum and urine tests. If those are negative and there is no other apparent cause of the symptoms, they should have a cerebrospinal fluid sample tested for Zika RNA and IgM Zika antibodies.

By 1 month, these infants need a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

Infants without clinical findings, whose mothers have lab-confirmed Zika exposure

Initially, these infants should have the same early head ultrasound, hearing, and eye exams as those who display clinical findings. All of these infants also should be tested for Zika virus in the same way as those with clinical findings.

If tests return a positive result, they should have all the investigations and follow-ups recommended for babies with clinical findings. If lab testing is negative, and clinical findings are normal, Zika infection is highly unlikely and they can receive routine care, although clinicians and parents should be on the lookout for any new symptoms that might suggest postnatal Zika syndrome.

Infants without clinical findings, whose mothers had possible, but unconfirmed, Zika exposure

This is a varied and large group, which includes women who were never tested during pregnancy, as well as those who could have had a false negative test. “Because the latter issue is not easily discerned, all mothers with possible exposure to Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” Dr. Adebanjo said.

CDC does not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether any further evaluations would be helpful. But, Dr. Adebanjo said, “If findings consistent with congenital Zika syndrome are identified at any time, referrals to appropriate specialties should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika.”

CDC also reiterated its special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these remain unchanged from 2016, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis will improve and guidance will be updated.”

No one has yet identified the optimal timing for a Zika diagnostic ultrasound. CDC recommends serial ultrasounds be done every 3-4 weeks for women with lab-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggests that viral shedding into the amniotic fluid might be transient. If the procedure is done for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process is key when making screening decisions that should be individually weighed, Dr. Adebanjo said. “For example, serial ultrasounds might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients. Therefore, these decisions should be individualized.”

Neither Dr. Adebanjo nor any of the coauthors had any financial disclosures.

msullivan@frontlinemedcom.com

Infants with possible prenatal Zika exposure who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurological evaluation with brain imaging within 1 month of birth, according to new interim guidance set forth by the Centers for Disease Control and Prevention.

The new clinical management guidelines, published in the Oct. 20 issue of the Morbidity and Mortality Weekly Report, supersede the most recent CDC guidance, issued in August 2016. The agency deemed the update necessary after a recent convocation sponsored by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. The meeting drew dozens of practicing clinicians and federal agency representatives, who reviewed the ever-evolving body of knowledge on how to best manage the care of these infants. Since Zika emerged as a public health threat, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, a developing microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

CDC/Cynthia Goldsmith

Infants with clinical findings consistent with Zika syndrome and mothers with possible prenatal Zika exposure

These infants should be tested for Zika virus with serum and urine tests. If those are negative and there is no other apparent cause of the symptoms, they should have a cerebrospinal fluid sample tested for Zika RNA and IgM Zika antibodies.

By 1 month, these infants need a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

Infants without clinical findings, whose mothers have lab-confirmed Zika exposure

Initially, these infants should have the same early head ultrasound, hearing, and eye exams as those who display clinical findings. All of these infants also should be tested for Zika virus in the same way as those with clinical findings.

If tests return a positive result, they should have all the investigations and follow-ups recommended for babies with clinical findings. If lab testing is negative, and clinical findings are normal, Zika infection is highly unlikely and they can receive routine care, although clinicians and parents should be on the lookout for any new symptoms that might suggest postnatal Zika syndrome.

Infants without clinical findings, whose mothers had possible, but unconfirmed, Zika exposure

This is a varied and large group, which includes women who were never tested during pregnancy, as well as those who could have had a false negative test. “Because the latter issue is not easily discerned, all mothers with possible exposure to Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” Dr. Adebanjo said.

CDC does not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether any further evaluations would be helpful. But, Dr. Adebanjo said, “If findings consistent with congenital Zika syndrome are identified at any time, referrals to appropriate specialties should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika.”

CDC also reiterated its special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these remain unchanged from 2016, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis will improve and guidance will be updated.”

No one has yet identified the optimal timing for a Zika diagnostic ultrasound. CDC recommends serial ultrasounds be done every 3-4 weeks for women with lab-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggests that viral shedding into the amniotic fluid might be transient. If the procedure is done for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process is key when making screening decisions that should be individually weighed, Dr. Adebanjo said. “For example, serial ultrasounds might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients. Therefore, these decisions should be individualized.”

Neither Dr. Adebanjo nor any of the coauthors had any financial disclosures.

msullivan@frontlinemedcom.com

Infants with possible prenatal Zika exposure who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurological evaluation with brain imaging within 1 month of birth, according to new interim guidance set forth by the Centers for Disease Control and Prevention.

The new clinical management guidelines, published in the Oct. 20 issue of the Morbidity and Mortality Weekly Report, supersede the most recent CDC guidance, issued in August 2016. The agency deemed the update necessary after a recent convocation sponsored by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. The meeting drew dozens of practicing clinicians and federal agency representatives, who reviewed the ever-evolving body of knowledge on how to best manage the care of these infants. Since Zika emerged as a public health threat, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, a developing microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

CDC/Cynthia Goldsmith

Infants with clinical findings consistent with Zika syndrome and mothers with possible prenatal Zika exposure

These infants should be tested for Zika virus with serum and urine tests. If those are negative and there is no other apparent cause of the symptoms, they should have a cerebrospinal fluid sample tested for Zika RNA and IgM Zika antibodies.

By 1 month, these infants need a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

Infants without clinical findings, whose mothers have lab-confirmed Zika exposure

Initially, these infants should have the same early head ultrasound, hearing, and eye exams as those who display clinical findings. All of these infants also should be tested for Zika virus in the same way as those with clinical findings.

If tests return a positive result, they should have all the investigations and follow-ups recommended for babies with clinical findings. If lab testing is negative, and clinical findings are normal, Zika infection is highly unlikely and they can receive routine care, although clinicians and parents should be on the lookout for any new symptoms that might suggest postnatal Zika syndrome.

Infants without clinical findings, whose mothers had possible, but unconfirmed, Zika exposure

This is a varied and large group, which includes women who were never tested during pregnancy, as well as those who could have had a false negative test. “Because the latter issue is not easily discerned, all mothers with possible exposure to Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” Dr. Adebanjo said.

CDC does not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether any further evaluations would be helpful. But, Dr. Adebanjo said, “If findings consistent with congenital Zika syndrome are identified at any time, referrals to appropriate specialties should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika.”

CDC also reiterated its special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these remain unchanged from 2016, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis will improve and guidance will be updated.”

No one has yet identified the optimal timing for a Zika diagnostic ultrasound. CDC recommends serial ultrasounds be done every 3-4 weeks for women with lab-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggests that viral shedding into the amniotic fluid might be transient. If the procedure is done for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process is key when making screening decisions that should be individually weighed, Dr. Adebanjo said. “For example, serial ultrasounds might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients. Therefore, these decisions should be individualized.”

Neither Dr. Adebanjo nor any of the coauthors had any financial disclosures.

msullivan@frontlinemedcom.com

The British Society for Rheumatology has issued a new U.K. guideline for the management of systemic lupus erythematosus (SLE), focusing on nearly all aspects of the disease.

From diagnosing, assessing, and managing common manifestations of nonrenal lupus, such as skin rashes and arthritis, through dealing with less common but potentially more serious problems such as kidney disease, the guideline aims to help everyone involved in the management of patients with SLE to give the best, evidenced-based care.

U.K.-specific guidance

The British Society for Rheumatology’s (BSR) guideline is the first to specifically cover lupus management in the United Kingdom, and it builds on existing European League Against Rheumatism (EULAR) guidance published almost a decade ago (Ann Rheum Dis. 2008;67:195-205), and more recent EULAR/European Renal Association–European Dialysis and Transplant Association (Ann Rheum Dis. 2012;71:1771­-82) and American College of Rheumatology (Arthritis Care Res. 2012;64:797-808) recommendations on managing lupus nephritis (LN).

The BSR’s full guideline provides a summary of the EULAR/ERA-EDTA’s LN guidelines, and the degree to which their new guidelines concur.

As with all BSR guidelines, the recommendations have been developed by a multidisciplinary team. This included academic and consultant rheumatologists and nephrologists, rheumatology trainees, a primary care physician, a clinical nurse specialist, a patient representative, and a lay member. This should make the guideline relevant to anyone who may come across someone with SLE, including primary care physicians, dermatologists, and emergency medicine practitioners.

“These recommendations are based on the literature review covering the diagnosis, assessment, monitoring, and treatment of mild, moderate, and severe lupus, including neuropsychiatric disease,” the guideline authors stated. They noted that the reason they looked only at nonrenal disease was because the EULAR/ERA-EDTA recommendations for LN have been published close to the time that work was started on the guideline. Each of the recommendations the multidisciplinary team devised was carefully graded and the degree to which members of the team agreed with each recommendation was calculated.
 

Diagnosis recommendations

One of the key recommendations regarding the diagnosis of SLE is that a combination of clinical features and at least one relevant immunologic irregularity needs to be present. Blood tests, including serologic marker tests, should be performed if there is clinical suspicion of lupus.

Another recommendation on diagnosis is that if antinuclear antibodies are absent, then it is unlikely that the patient has lupus. This is because around 95% of SLE patients will test positive for antinuclear antibodies. Antiphospholipid antibodies should be tested in all patients with lupus at baseline, according to the guideline.
 

Monitoring recommendations

“Patients with SLE should be monitored on a regular basis for disease manifestations, drug toxicities, and comorbidities,” Dr. Gordon and her associates advised in one of the recommendations on monitoring patients. In another, they wrote that those with active disease need reviewing at least every 1-3 months, which should include evaluation of patients’ blood pressure, urine, renal function, anti-dsDNA antibodies, complement, a full blood count, and liver function tests.

It is also important to monitor patients for the presence of antiphospholipid antibodies, which are associated with thrombotic events, and it is always important to be on the lookout for comorbidities such as atherosclerotic disease and manage modifiable risk factors such as hypertension. The guideline does not go into detail about managing all of the potential complications of lupus, however, as these are covered by other national guidelines.
 

Treatment recommendations

Guidance on treatment is separated into how to treat patients with mild, moderate, and severe SLE. The guideline does not cover topical or systemic treatment for isolated cutaneous lupus, nor does it look at how to manage pediatric patients, the authors noted. General guidance is given on how to treat patients, and specific dosing regimens are beyond the scope of the guidelines.

The recommendations encourage the use of a variety of treatments to try to ensure less reliance on the use of steroids to control symptoms. The guideline authors noted that only hydroxychloroquine, corticosteroids, and belimumab are currently licensed treatments for lupus in the United Kingdom.

For mild disease, the disease-modifying antirheumatic drugs hydroxychloroquine and methotrexate are suggested, as are nonsteroidal anti-inflammatory drugs. If prednisolone is used, then it should be in low doses (7.5 mg or less per day). Patients should be encouraged to use sunscreen and sun avoidance to protect them against ultraviolet-induced skin lesions.

For moderate disease, higher steroid doses may be needed and immunosuppressives might be warranted, and in refractory cases, monoclonal antibody treatment may be necessary.

For severe disease, thorough investigation is essential to exclude other possible causes of any renal or neuropsychiatric manifestations. Immunosuppressive treatment is recommended, with biologic therapies considered on a case-by-case basis. Intravenous immunoglobulin and plasmapheresis may also be an option in certain patients.
 

Key standards of care

As general standards of care, Dr. Gordon and her coauthors wrote that “lupus patients should be referred to a physician with experience in managing lupus who can confirm the diagnosis, assess the level of disease activity, and provide advice on treatment and monitoring of the disease, its complications, and side effects of therapy.”

Furthermore, a multidisciplinary team approach is needed, and if a treatment is not helping get patients into a state of low disease activity within an expected time frame, “it is important to consider adherence to treatment and adjusting the therapy to reduce the accumulation of chronic damage.” It is also recommended that patients receive personalized advice, written information, and education about the disease and its drug treatment.

No specific funding was received from any organizations in the public, commercial, or not-for-profit sectors to carry out the work described in the guideline.

Dr. Gordon has undertaken consultancies and received honoraria from Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, MedImmune, Merck Serono, Parexel, Roche, and UCB. She has been a member of the speakers bureau for GlaxoSmithKline, UCB, and Eli Lilly. She also has received research grant support from Aspreva/Vifor Pharma in the past and currently receives it from UCB.

The British Society for Rheumatology has issued a new U.K. guideline for the management of systemic lupus erythematosus (SLE), focusing on nearly all aspects of the disease.

From diagnosing, assessing, and managing common manifestations of nonrenal lupus, such as skin rashes and arthritis, through dealing with less common but potentially more serious problems such as kidney disease, the guideline aims to help everyone involved in the management of patients with SLE to give the best, evidenced-based care.

U.K.-specific guidance

The British Society for Rheumatology’s (BSR) guideline is the first to specifically cover lupus management in the United Kingdom, and it builds on existing European League Against Rheumatism (EULAR) guidance published almost a decade ago (Ann Rheum Dis. 2008;67:195-205), and more recent EULAR/European Renal Association–European Dialysis and Transplant Association (Ann Rheum Dis. 2012;71:1771­-82) and American College of Rheumatology (Arthritis Care Res. 2012;64:797-808) recommendations on managing lupus nephritis (LN).

The BSR’s full guideline provides a summary of the EULAR/ERA-EDTA’s LN guidelines, and the degree to which their new guidelines concur.

As with all BSR guidelines, the recommendations have been developed by a multidisciplinary team. This included academic and consultant rheumatologists and nephrologists, rheumatology trainees, a primary care physician, a clinical nurse specialist, a patient representative, and a lay member. This should make the guideline relevant to anyone who may come across someone with SLE, including primary care physicians, dermatologists, and emergency medicine practitioners.

“These recommendations are based on the literature review covering the diagnosis, assessment, monitoring, and treatment of mild, moderate, and severe lupus, including neuropsychiatric disease,” the guideline authors stated. They noted that the reason they looked only at nonrenal disease was because the EULAR/ERA-EDTA recommendations for LN have been published close to the time that work was started on the guideline. Each of the recommendations the multidisciplinary team devised was carefully graded and the degree to which members of the team agreed with each recommendation was calculated.
 

Diagnosis recommendations

One of the key recommendations regarding the diagnosis of SLE is that a combination of clinical features and at least one relevant immunologic irregularity needs to be present. Blood tests, including serologic marker tests, should be performed if there is clinical suspicion of lupus.

Another recommendation on diagnosis is that if antinuclear antibodies are absent, then it is unlikely that the patient has lupus. This is because around 95% of SLE patients will test positive for antinuclear antibodies. Antiphospholipid antibodies should be tested in all patients with lupus at baseline, according to the guideline.
 

Monitoring recommendations

“Patients with SLE should be monitored on a regular basis for disease manifestations, drug toxicities, and comorbidities,” Dr. Gordon and her associates advised in one of the recommendations on monitoring patients. In another, they wrote that those with active disease need reviewing at least every 1-3 months, which should include evaluation of patients’ blood pressure, urine, renal function, anti-dsDNA antibodies, complement, a full blood count, and liver function tests.

It is also important to monitor patients for the presence of antiphospholipid antibodies, which are associated with thrombotic events, and it is always important to be on the lookout for comorbidities such as atherosclerotic disease and manage modifiable risk factors such as hypertension. The guideline does not go into detail about managing all of the potential complications of lupus, however, as these are covered by other national guidelines.
 

Treatment recommendations

Guidance on treatment is separated into how to treat patients with mild, moderate, and severe SLE. The guideline does not cover topical or systemic treatment for isolated cutaneous lupus, nor does it look at how to manage pediatric patients, the authors noted. General guidance is given on how to treat patients, and specific dosing regimens are beyond the scope of the guidelines.

The recommendations encourage the use of a variety of treatments to try to ensure less reliance on the use of steroids to control symptoms. The guideline authors noted that only hydroxychloroquine, corticosteroids, and belimumab are currently licensed treatments for lupus in the United Kingdom.

For mild disease, the disease-modifying antirheumatic drugs hydroxychloroquine and methotrexate are suggested, as are nonsteroidal anti-inflammatory drugs. If prednisolone is used, then it should be in low doses (7.5 mg or less per day). Patients should be encouraged to use sunscreen and sun avoidance to protect them against ultraviolet-induced skin lesions.

For moderate disease, higher steroid doses may be needed and immunosuppressives might be warranted, and in refractory cases, monoclonal antibody treatment may be necessary.

For severe disease, thorough investigation is essential to exclude other possible causes of any renal or neuropsychiatric manifestations. Immunosuppressive treatment is recommended, with biologic therapies considered on a case-by-case basis. Intravenous immunoglobulin and plasmapheresis may also be an option in certain patients.
 

Key standards of care

As general standards of care, Dr. Gordon and her coauthors wrote that “lupus patients should be referred to a physician with experience in managing lupus who can confirm the diagnosis, assess the level of disease activity, and provide advice on treatment and monitoring of the disease, its complications, and side effects of therapy.”

Furthermore, a multidisciplinary team approach is needed, and if a treatment is not helping get patients into a state of low disease activity within an expected time frame, “it is important to consider adherence to treatment and adjusting the therapy to reduce the accumulation of chronic damage.” It is also recommended that patients receive personalized advice, written information, and education about the disease and its drug treatment.

No specific funding was received from any organizations in the public, commercial, or not-for-profit sectors to carry out the work described in the guideline.

Dr. Gordon has undertaken consultancies and received honoraria from Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, MedImmune, Merck Serono, Parexel, Roche, and UCB. She has been a member of the speakers bureau for GlaxoSmithKline, UCB, and Eli Lilly. She also has received research grant support from Aspreva/Vifor Pharma in the past and currently receives it from UCB.

The British Society for Rheumatology has issued a new U.K. guideline for the management of systemic lupus erythematosus (SLE), focusing on nearly all aspects of the disease.

From diagnosing, assessing, and managing common manifestations of nonrenal lupus, such as skin rashes and arthritis, through dealing with less common but potentially more serious problems such as kidney disease, the guideline aims to help everyone involved in the management of patients with SLE to give the best, evidenced-based care.

U.K.-specific guidance

The British Society for Rheumatology’s (BSR) guideline is the first to specifically cover lupus management in the United Kingdom, and it builds on existing European League Against Rheumatism (EULAR) guidance published almost a decade ago (Ann Rheum Dis. 2008;67:195-205), and more recent EULAR/European Renal Association–European Dialysis and Transplant Association (Ann Rheum Dis. 2012;71:1771­-82) and American College of Rheumatology (Arthritis Care Res. 2012;64:797-808) recommendations on managing lupus nephritis (LN).

The BSR’s full guideline provides a summary of the EULAR/ERA-EDTA’s LN guidelines, and the degree to which their new guidelines concur.

As with all BSR guidelines, the recommendations have been developed by a multidisciplinary team. This included academic and consultant rheumatologists and nephrologists, rheumatology trainees, a primary care physician, a clinical nurse specialist, a patient representative, and a lay member. This should make the guideline relevant to anyone who may come across someone with SLE, including primary care physicians, dermatologists, and emergency medicine practitioners.

“These recommendations are based on the literature review covering the diagnosis, assessment, monitoring, and treatment of mild, moderate, and severe lupus, including neuropsychiatric disease,” the guideline authors stated. They noted that the reason they looked only at nonrenal disease was because the EULAR/ERA-EDTA recommendations for LN have been published close to the time that work was started on the guideline. Each of the recommendations the multidisciplinary team devised was carefully graded and the degree to which members of the team agreed with each recommendation was calculated.
 

Diagnosis recommendations

One of the key recommendations regarding the diagnosis of SLE is that a combination of clinical features and at least one relevant immunologic irregularity needs to be present. Blood tests, including serologic marker tests, should be performed if there is clinical suspicion of lupus.

Another recommendation on diagnosis is that if antinuclear antibodies are absent, then it is unlikely that the patient has lupus. This is because around 95% of SLE patients will test positive for antinuclear antibodies. Antiphospholipid antibodies should be tested in all patients with lupus at baseline, according to the guideline.
 

Monitoring recommendations

“Patients with SLE should be monitored on a regular basis for disease manifestations, drug toxicities, and comorbidities,” Dr. Gordon and her associates advised in one of the recommendations on monitoring patients. In another, they wrote that those with active disease need reviewing at least every 1-3 months, which should include evaluation of patients’ blood pressure, urine, renal function, anti-dsDNA antibodies, complement, a full blood count, and liver function tests.

It is also important to monitor patients for the presence of antiphospholipid antibodies, which are associated with thrombotic events, and it is always important to be on the lookout for comorbidities such as atherosclerotic disease and manage modifiable risk factors such as hypertension. The guideline does not go into detail about managing all of the potential complications of lupus, however, as these are covered by other national guidelines.
 

Treatment recommendations

Guidance on treatment is separated into how to treat patients with mild, moderate, and severe SLE. The guideline does not cover topical or systemic treatment for isolated cutaneous lupus, nor does it look at how to manage pediatric patients, the authors noted. General guidance is given on how to treat patients, and specific dosing regimens are beyond the scope of the guidelines.

The recommendations encourage the use of a variety of treatments to try to ensure less reliance on the use of steroids to control symptoms. The guideline authors noted that only hydroxychloroquine, corticosteroids, and belimumab are currently licensed treatments for lupus in the United Kingdom.

For mild disease, the disease-modifying antirheumatic drugs hydroxychloroquine and methotrexate are suggested, as are nonsteroidal anti-inflammatory drugs. If prednisolone is used, then it should be in low doses (7.5 mg or less per day). Patients should be encouraged to use sunscreen and sun avoidance to protect them against ultraviolet-induced skin lesions.

For moderate disease, higher steroid doses may be needed and immunosuppressives might be warranted, and in refractory cases, monoclonal antibody treatment may be necessary.

For severe disease, thorough investigation is essential to exclude other possible causes of any renal or neuropsychiatric manifestations. Immunosuppressive treatment is recommended, with biologic therapies considered on a case-by-case basis. Intravenous immunoglobulin and plasmapheresis may also be an option in certain patients.
 

Key standards of care

As general standards of care, Dr. Gordon and her coauthors wrote that “lupus patients should be referred to a physician with experience in managing lupus who can confirm the diagnosis, assess the level of disease activity, and provide advice on treatment and monitoring of the disease, its complications, and side effects of therapy.”

Furthermore, a multidisciplinary team approach is needed, and if a treatment is not helping get patients into a state of low disease activity within an expected time frame, “it is important to consider adherence to treatment and adjusting the therapy to reduce the accumulation of chronic damage.” It is also recommended that patients receive personalized advice, written information, and education about the disease and its drug treatment.

No specific funding was received from any organizations in the public, commercial, or not-for-profit sectors to carry out the work described in the guideline.

Dr. Gordon has undertaken consultancies and received honoraria from Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, MedImmune, Merck Serono, Parexel, Roche, and UCB. She has been a member of the speakers bureau for GlaxoSmithKline, UCB, and Eli Lilly. She also has received research grant support from Aspreva/Vifor Pharma in the past and currently receives it from UCB.