Damian McNamara

MIAMI BEACH — Maternal serum α-fetoprotein is no longer an effective or cost-effective second-trimester screen for neural tube defects in an era when women routinely undergo first-trimester Down syndrome screening and subsequent ultrasound, Dr. Todd J. Rosen said at the annual meeting of the Society for Maternal-Fetal Medicine.

Before ultrasound was commonplace—back in the 1970s and 1980s—women got an α-fetoprotein (AFP) test for spina bifida and anencephaly. “Now more and more women are screening for Down syndrome in the first trimester, and it is routine for women to do an ultrasound screen as well,” said Dr. Rosen of the division of maternal-fetal medicine, Columbia University, New York. Dr. Rosen and his associates assessed clinical and cost effectiveness of AFP testing for U.S. women who had a first-trimester Down syndrome risk assessment and second-trimester ultrasound examination. They used a decision analysis model that assumed ultrasound provides 100% detection of anencephaly and 92% detection of spina bifida (the lowest percentage reported in the literature). To put AFP testing in the most favorable light, the model assumed a 92% detection rate for spina bifida (the highest in the literature) with a 3% false-positive rate.

The model predicted an estimated 4,000 neural tube defects among the approximate 4 million births in the United States in 2003. Screening of all these women with ultrasound would detect 2,208 of the 2,400 cases of spina bifida. AFP testing would yield 120,000 positive results and detect 176 of the 192 cases of spina bifida missed by ultrasound.

“The AFP test induces anxiety—for every 10,000 women who screen positive, only 3 will have a baby with spina bifida,” Dr. Rosen said. AFP screening in women who undergo first- and second-trimester ultrasound examinations has a poor predictive value and causes more pregnancy losses from amniocentesis than cases of spina bifida it detects, he added.

In addition, “by continuing to do AFP, we are spending all this money,” Dr. Rosen said. For example, universal screening in the study cohort would cost $184 million. Because about 40% of women terminate a pregnancy because of spina bifida (in this model, 70 of 176 women), the cost becomes $2.6 million for each case prevented. With the assumption that 50% of women with an elevated AFP result have amniocentesis, and the procedure's loss rate is 1 fetus per 250, 245 women would lose their pregnancies, he estimated.

“As doctors we are really caught. We want to do what is right for patients, but we have a high risk of malpractice [suits],” he said. “Because we are so wary of missing anything, we err on the side of overtesting and this can do more harm than good.”

MIAMI BEACH — Maternal serum α-fetoprotein is no longer an effective or cost-effective second-trimester screen for neural tube defects in an era when women routinely undergo first-trimester Down syndrome screening and subsequent ultrasound, Dr. Todd J. Rosen said at the annual meeting of the Society for Maternal-Fetal Medicine.

Before ultrasound was commonplace—back in the 1970s and 1980s—women got an α-fetoprotein (AFP) test for spina bifida and anencephaly. “Now more and more women are screening for Down syndrome in the first trimester, and it is routine for women to do an ultrasound screen as well,” said Dr. Rosen of the division of maternal-fetal medicine, Columbia University, New York. Dr. Rosen and his associates assessed clinical and cost effectiveness of AFP testing for U.S. women who had a first-trimester Down syndrome risk assessment and second-trimester ultrasound examination. They used a decision analysis model that assumed ultrasound provides 100% detection of anencephaly and 92% detection of spina bifida (the lowest percentage reported in the literature). To put AFP testing in the most favorable light, the model assumed a 92% detection rate for spina bifida (the highest in the literature) with a 3% false-positive rate.

The model predicted an estimated 4,000 neural tube defects among the approximate 4 million births in the United States in 2003. Screening of all these women with ultrasound would detect 2,208 of the 2,400 cases of spina bifida. AFP testing would yield 120,000 positive results and detect 176 of the 192 cases of spina bifida missed by ultrasound.

“The AFP test induces anxiety—for every 10,000 women who screen positive, only 3 will have a baby with spina bifida,” Dr. Rosen said. AFP screening in women who undergo first- and second-trimester ultrasound examinations has a poor predictive value and causes more pregnancy losses from amniocentesis than cases of spina bifida it detects, he added.

In addition, “by continuing to do AFP, we are spending all this money,” Dr. Rosen said. For example, universal screening in the study cohort would cost $184 million. Because about 40% of women terminate a pregnancy because of spina bifida (in this model, 70 of 176 women), the cost becomes $2.6 million for each case prevented. With the assumption that 50% of women with an elevated AFP result have amniocentesis, and the procedure's loss rate is 1 fetus per 250, 245 women would lose their pregnancies, he estimated.

“As doctors we are really caught. We want to do what is right for patients, but we have a high risk of malpractice [suits],” he said. “Because we are so wary of missing anything, we err on the side of overtesting and this can do more harm than good.”

MIAMI BEACH — Maternal serum α-fetoprotein is no longer an effective or cost-effective second-trimester screen for neural tube defects in an era when women routinely undergo first-trimester Down syndrome screening and subsequent ultrasound, Dr. Todd J. Rosen said at the annual meeting of the Society for Maternal-Fetal Medicine.

Before ultrasound was commonplace—back in the 1970s and 1980s—women got an α-fetoprotein (AFP) test for spina bifida and anencephaly. “Now more and more women are screening for Down syndrome in the first trimester, and it is routine for women to do an ultrasound screen as well,” said Dr. Rosen of the division of maternal-fetal medicine, Columbia University, New York. Dr. Rosen and his associates assessed clinical and cost effectiveness of AFP testing for U.S. women who had a first-trimester Down syndrome risk assessment and second-trimester ultrasound examination. They used a decision analysis model that assumed ultrasound provides 100% detection of anencephaly and 92% detection of spina bifida (the lowest percentage reported in the literature). To put AFP testing in the most favorable light, the model assumed a 92% detection rate for spina bifida (the highest in the literature) with a 3% false-positive rate.

The model predicted an estimated 4,000 neural tube defects among the approximate 4 million births in the United States in 2003. Screening of all these women with ultrasound would detect 2,208 of the 2,400 cases of spina bifida. AFP testing would yield 120,000 positive results and detect 176 of the 192 cases of spina bifida missed by ultrasound.

“The AFP test induces anxiety—for every 10,000 women who screen positive, only 3 will have a baby with spina bifida,” Dr. Rosen said. AFP screening in women who undergo first- and second-trimester ultrasound examinations has a poor predictive value and causes more pregnancy losses from amniocentesis than cases of spina bifida it detects, he added.

In addition, “by continuing to do AFP, we are spending all this money,” Dr. Rosen said. For example, universal screening in the study cohort would cost $184 million. Because about 40% of women terminate a pregnancy because of spina bifida (in this model, 70 of 176 women), the cost becomes $2.6 million for each case prevented. With the assumption that 50% of women with an elevated AFP result have amniocentesis, and the procedure's loss rate is 1 fetus per 250, 245 women would lose their pregnancies, he estimated.

“As doctors we are really caught. We want to do what is right for patients, but we have a high risk of malpractice [suits],” he said. “Because we are so wary of missing anything, we err on the side of overtesting and this can do more harm than good.”

NAPLES, FLA. — Monitor patients who are starting effective highly active antiretroviral treatment for signs of immune reconstitution syndrome, Dr. Andrew Blauvelt advised at a symposium sponsored by the Dermatology Foundation.

Watch for infections caused by mycobacteria, cytomegalo-virus, herpes zoster, and staphylococcus. Eosinophilic folliculitis may also be seen in these patients. Sarcoidosis, acne, erythema nodosum, tattoo intolerance, and atopic dermatitis are among inflammatory consequences, Dr. Blauvelt said.

Immune reconstitution syndrome typically appears within the first 8 weeks of starting highly active antiretroviral treatment (HAART), particularly in patients with a low CD4 count. “The theory is that you have mycobacteria in you and your immune system is too weak to fight. But with HAART therapy, the body is finally able to mount an attack,” said Dr. Blauvelt, professor of dermatology at Oregon Health and Science University, Portland. He is also affiliated with the university's department of molecular microbiology and immunology.

In general, it is not necessary to alter the HAART regimen in a patient who develops the syndrome, Dr. Blauvelt said.

Instead, treat the syndrome with disease-specific strategies for infections and topical or systemic corticosteroids for inflammatory diseases.

NAPLES, FLA. — Monitor patients who are starting effective highly active antiretroviral treatment for signs of immune reconstitution syndrome, Dr. Andrew Blauvelt advised at a symposium sponsored by the Dermatology Foundation.

Watch for infections caused by mycobacteria, cytomegalo-virus, herpes zoster, and staphylococcus. Eosinophilic folliculitis may also be seen in these patients. Sarcoidosis, acne, erythema nodosum, tattoo intolerance, and atopic dermatitis are among inflammatory consequences, Dr. Blauvelt said.

Immune reconstitution syndrome typically appears within the first 8 weeks of starting highly active antiretroviral treatment (HAART), particularly in patients with a low CD4 count. “The theory is that you have mycobacteria in you and your immune system is too weak to fight. But with HAART therapy, the body is finally able to mount an attack,” said Dr. Blauvelt, professor of dermatology at Oregon Health and Science University, Portland. He is also affiliated with the university's department of molecular microbiology and immunology.

In general, it is not necessary to alter the HAART regimen in a patient who develops the syndrome, Dr. Blauvelt said.

Instead, treat the syndrome with disease-specific strategies for infections and topical or systemic corticosteroids for inflammatory diseases.

NAPLES, FLA. — Monitor patients who are starting effective highly active antiretroviral treatment for signs of immune reconstitution syndrome, Dr. Andrew Blauvelt advised at a symposium sponsored by the Dermatology Foundation.

Watch for infections caused by mycobacteria, cytomegalo-virus, herpes zoster, and staphylococcus. Eosinophilic folliculitis may also be seen in these patients. Sarcoidosis, acne, erythema nodosum, tattoo intolerance, and atopic dermatitis are among inflammatory consequences, Dr. Blauvelt said.

Immune reconstitution syndrome typically appears within the first 8 weeks of starting highly active antiretroviral treatment (HAART), particularly in patients with a low CD4 count. “The theory is that you have mycobacteria in you and your immune system is too weak to fight. But with HAART therapy, the body is finally able to mount an attack,” said Dr. Blauvelt, professor of dermatology at Oregon Health and Science University, Portland. He is also affiliated with the university's department of molecular microbiology and immunology.

In general, it is not necessary to alter the HAART regimen in a patient who develops the syndrome, Dr. Blauvelt said.

Instead, treat the syndrome with disease-specific strategies for infections and topical or systemic corticosteroids for inflammatory diseases.

MIAMI BEACH — Contrary to prior reports, very-low-birth-weight multiples have significantly greater morbidity and mortality than weight-matched singleton fetuses, according to a study presented at the annual meeting of the Society for Maternal-Fetal Medicine.

Researchers assessed outcomes for 1,779 infants born between July 1993 and July 2004 who weighed less than 1,500 g at birth.

They compared risk of death and severe intraventricular hemorrhage (IVH) among 475 infants from multiple gestations and 1,304 singletons.

When the researchers examined the data for multiple fetuses, “we saw increased neonatal death and/or severe IVH,” Dr. Edward Hayes, of Thomas Jefferson University Hospital in Philadelphia, said during a poster presentation. The risk of death for a VLBW infant born as part of a multiple pregnancy was higher than that of a VLBW singleton (odds ratio 1.3).

The risk increased as birth weights decreased, Dr. Hayes said. The multiples group included 206 infants born weighing less than 1,000 g and 86 weighing less than 750 g.

Mortality risk among multiples below 1,000 g carried an odds ratio of 1.5, and below 750 g the odds ratio was 1.9, compared with weight-matched singletons. “The risk was twice as high when you're a multiple [below 750 g],” Dr. Hayes said. The singletons group included 578 born weighing less than 1,000 g and 262 weighing less than 750 g.

The mean gestational age at birth was 28 weeks in both groups; the mean birth weight was 1,039 g in the multiple group and 1,035 g among singletons. There were no significant differences between the groups in mean gestational age or mean birth weight.

However, significant differences existed between mothers in the two groups. For example, the percentage who were white differed (68% of mothers of multiples vs. 43% of mothers of singletons); as did mean maternal age (29 years vs. 26 years); birth at the facility (95% vs. 86%); use of prenatal steroids (74% vs. 58%); preeclampsia (14% vs. 24%), and preterm labor (74% vs. 62%). The investigators used a multivariate analysis to control for these differences and then compared groups for neonatal morbidity and mortality.

The risk of severe, grade 3–4 intraventricular hemorrhage was higher among VLBW infants born as part of a multiple pregnancy (odds ratio 1.2) versus similar singletons. The risk of this outcome was similar for neonates in the multiple groups below 1,000 g or 750 g (odds ratio 1.1 for both).

The etiology of the higher risk among multiple gestation VLBW infants remains unknown, Dr. Hayes said. Researchers have theorized that multiples are more stressed than singletons because they share the same space in utero. “But I don't agree,” he said. He instead proposed that prenatal steroids play a role. “More data are coming out showing it's just the number of fetuses—you're giving the same dose of medicine to more. It's 12 mg of betamethasone whether you have one or more fetuses.”

The practice of giving the same dosage of prenatal steroids despite the number of fetuses is not likely to change soon, Dr. Hayes said. “There is no evidence in the literature for giving multiples a higher dose of steroids.”

MIAMI BEACH — Contrary to prior reports, very-low-birth-weight multiples have significantly greater morbidity and mortality than weight-matched singleton fetuses, according to a study presented at the annual meeting of the Society for Maternal-Fetal Medicine.

Researchers assessed outcomes for 1,779 infants born between July 1993 and July 2004 who weighed less than 1,500 g at birth.

They compared risk of death and severe intraventricular hemorrhage (IVH) among 475 infants from multiple gestations and 1,304 singletons.

When the researchers examined the data for multiple fetuses, “we saw increased neonatal death and/or severe IVH,” Dr. Edward Hayes, of Thomas Jefferson University Hospital in Philadelphia, said during a poster presentation. The risk of death for a VLBW infant born as part of a multiple pregnancy was higher than that of a VLBW singleton (odds ratio 1.3).

The risk increased as birth weights decreased, Dr. Hayes said. The multiples group included 206 infants born weighing less than 1,000 g and 86 weighing less than 750 g.

Mortality risk among multiples below 1,000 g carried an odds ratio of 1.5, and below 750 g the odds ratio was 1.9, compared with weight-matched singletons. “The risk was twice as high when you're a multiple [below 750 g],” Dr. Hayes said. The singletons group included 578 born weighing less than 1,000 g and 262 weighing less than 750 g.

The mean gestational age at birth was 28 weeks in both groups; the mean birth weight was 1,039 g in the multiple group and 1,035 g among singletons. There were no significant differences between the groups in mean gestational age or mean birth weight.

However, significant differences existed between mothers in the two groups. For example, the percentage who were white differed (68% of mothers of multiples vs. 43% of mothers of singletons); as did mean maternal age (29 years vs. 26 years); birth at the facility (95% vs. 86%); use of prenatal steroids (74% vs. 58%); preeclampsia (14% vs. 24%), and preterm labor (74% vs. 62%). The investigators used a multivariate analysis to control for these differences and then compared groups for neonatal morbidity and mortality.

The risk of severe, grade 3–4 intraventricular hemorrhage was higher among VLBW infants born as part of a multiple pregnancy (odds ratio 1.2) versus similar singletons. The risk of this outcome was similar for neonates in the multiple groups below 1,000 g or 750 g (odds ratio 1.1 for both).

The etiology of the higher risk among multiple gestation VLBW infants remains unknown, Dr. Hayes said. Researchers have theorized that multiples are more stressed than singletons because they share the same space in utero. “But I don't agree,” he said. He instead proposed that prenatal steroids play a role. “More data are coming out showing it's just the number of fetuses—you're giving the same dose of medicine to more. It's 12 mg of betamethasone whether you have one or more fetuses.”

The practice of giving the same dosage of prenatal steroids despite the number of fetuses is not likely to change soon, Dr. Hayes said. “There is no evidence in the literature for giving multiples a higher dose of steroids.”

MIAMI BEACH — Contrary to prior reports, very-low-birth-weight multiples have significantly greater morbidity and mortality than weight-matched singleton fetuses, according to a study presented at the annual meeting of the Society for Maternal-Fetal Medicine.

Researchers assessed outcomes for 1,779 infants born between July 1993 and July 2004 who weighed less than 1,500 g at birth.

They compared risk of death and severe intraventricular hemorrhage (IVH) among 475 infants from multiple gestations and 1,304 singletons.

When the researchers examined the data for multiple fetuses, “we saw increased neonatal death and/or severe IVH,” Dr. Edward Hayes, of Thomas Jefferson University Hospital in Philadelphia, said during a poster presentation. The risk of death for a VLBW infant born as part of a multiple pregnancy was higher than that of a VLBW singleton (odds ratio 1.3).

The risk increased as birth weights decreased, Dr. Hayes said. The multiples group included 206 infants born weighing less than 1,000 g and 86 weighing less than 750 g.

Mortality risk among multiples below 1,000 g carried an odds ratio of 1.5, and below 750 g the odds ratio was 1.9, compared with weight-matched singletons. “The risk was twice as high when you're a multiple [below 750 g],” Dr. Hayes said. The singletons group included 578 born weighing less than 1,000 g and 262 weighing less than 750 g.

The mean gestational age at birth was 28 weeks in both groups; the mean birth weight was 1,039 g in the multiple group and 1,035 g among singletons. There were no significant differences between the groups in mean gestational age or mean birth weight.

However, significant differences existed between mothers in the two groups. For example, the percentage who were white differed (68% of mothers of multiples vs. 43% of mothers of singletons); as did mean maternal age (29 years vs. 26 years); birth at the facility (95% vs. 86%); use of prenatal steroids (74% vs. 58%); preeclampsia (14% vs. 24%), and preterm labor (74% vs. 62%). The investigators used a multivariate analysis to control for these differences and then compared groups for neonatal morbidity and mortality.

The risk of severe, grade 3–4 intraventricular hemorrhage was higher among VLBW infants born as part of a multiple pregnancy (odds ratio 1.2) versus similar singletons. The risk of this outcome was similar for neonates in the multiple groups below 1,000 g or 750 g (odds ratio 1.1 for both).

The etiology of the higher risk among multiple gestation VLBW infants remains unknown, Dr. Hayes said. Researchers have theorized that multiples are more stressed than singletons because they share the same space in utero. “But I don't agree,” he said. He instead proposed that prenatal steroids play a role. “More data are coming out showing it's just the number of fetuses—you're giving the same dose of medicine to more. It's 12 mg of betamethasone whether you have one or more fetuses.”

The practice of giving the same dosage of prenatal steroids despite the number of fetuses is not likely to change soon, Dr. Hayes said. “There is no evidence in the literature for giving multiples a higher dose of steroids.”

MIAMI — Fetal pulse oximetry failed to significantly decrease the cesarean delivery rate or to improve neonatal outcomes in a randomized, multicenter study of more than 5,000 women, Dr. Steven L. Bloom said at the annual meeting of the Society for Maternal-Fetal Medicine.

“Unfortunately, the results of this study … suggest that fetal oximetry has not realized its promise of reducing cesarean births,” said Dr. Bloom, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

Dr. Bloom and his associates randomized 2,629 nulliparous women at term in early labor to an “open oximetry” group; physicians delivering the babies of the women in this group could view fetal oxygen saturation values. For comparison, investigators randomized another 2,712 women to a “masked oximetry” group. The oximetry was an adjunct to continuous electronic fetal monitoring.

A total of 692 women in the open group and 747 women in the masked group delivered via cesarean section (26.3% vs. 27.5%). A nonreassuring fetal heart rate was the reason for cesarean section for 187 women in the open group and 214 women in the masked group (7.1% vs. 7.9%). Dystocia was the reason for 490 women in the open group and 521 women in the masked group (18.6% vs. 19.2%).

“The overall cesarean rate, as well as the rates of cesarean deliveries for specific indications, was not different,” said Dr. Bloom, interim chair of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.

A study published in 2000 had shown that the rate of cesarean delivery for nonreassuring fetal heart rate was reduced significantly from 10% to 5% with the addition of fetal pulse oximetry. That study also showed a doubling of the rate of cesarean section due to dystocia, so there was no significant reduction in the overall cesarean rate—26% with fetal heart rate monitoring alone vs. 29% with fetal heart rate monitoring plus oximetry (Am. J. Obstet. Gynecol. 2000;183:1049–58).

Based on these earlier findings, the American College of Obstetricians and Gynecologists in 2001 issued a Committee Opinion stating that it did not endorse adoption of fetal pulse oximetry into clinical practice, citing concerns that the device could “escalate the cost of medical care without necessarily improving clinical outcome.” ACOG also recommended further study of the device.

The U.S. Food and Drug Administration required additional research when it granted conditional approval for the fetal pulse oximeter device in 2000.

Results of the first large, randomized trial since 2000 are not encouraging.

Dr. Bloom and his associates designed the study to assess whether knowledge of fetal oxygen saturation values in the perinatal period would significantly change the overall cesarean rate. Any changes in cesarean rate for a nonreassuring fetal heart rate or dystocia, as well as any impact on maternal and infant safety, were secondary objectives.

Infant outcomes did not differ significantly: 0.7% of each group was intubated in the delivery room and 0.3% of each group had confirmed sepsis. In addition, 0.2% of the open group and 0.1% of the masked group had 5-minute Apgar scores of 3 or less; 0.6% of the open group and 0.5% of the masked group had an umbilical artery pH less than 7; and 4.8% of the open group and 5.4% of the masked group were admitted to the neonatal intensive care unit.

There was no significant difference in maternal morbidity between groups. In each group, 10.7% experienced chorioamnionitis; 4.3% of the open group and 4.4% of the masked group had postpartum endometritis; and 0.2% of the open group and 0.1% of the masked group had a wound complication.

MIAMI — Fetal pulse oximetry failed to significantly decrease the cesarean delivery rate or to improve neonatal outcomes in a randomized, multicenter study of more than 5,000 women, Dr. Steven L. Bloom said at the annual meeting of the Society for Maternal-Fetal Medicine.

“Unfortunately, the results of this study … suggest that fetal oximetry has not realized its promise of reducing cesarean births,” said Dr. Bloom, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

Dr. Bloom and his associates randomized 2,629 nulliparous women at term in early labor to an “open oximetry” group; physicians delivering the babies of the women in this group could view fetal oxygen saturation values. For comparison, investigators randomized another 2,712 women to a “masked oximetry” group. The oximetry was an adjunct to continuous electronic fetal monitoring.

A total of 692 women in the open group and 747 women in the masked group delivered via cesarean section (26.3% vs. 27.5%). A nonreassuring fetal heart rate was the reason for cesarean section for 187 women in the open group and 214 women in the masked group (7.1% vs. 7.9%). Dystocia was the reason for 490 women in the open group and 521 women in the masked group (18.6% vs. 19.2%).

“The overall cesarean rate, as well as the rates of cesarean deliveries for specific indications, was not different,” said Dr. Bloom, interim chair of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.

A study published in 2000 had shown that the rate of cesarean delivery for nonreassuring fetal heart rate was reduced significantly from 10% to 5% with the addition of fetal pulse oximetry. That study also showed a doubling of the rate of cesarean section due to dystocia, so there was no significant reduction in the overall cesarean rate—26% with fetal heart rate monitoring alone vs. 29% with fetal heart rate monitoring plus oximetry (Am. J. Obstet. Gynecol. 2000;183:1049–58).

Based on these earlier findings, the American College of Obstetricians and Gynecologists in 2001 issued a Committee Opinion stating that it did not endorse adoption of fetal pulse oximetry into clinical practice, citing concerns that the device could “escalate the cost of medical care without necessarily improving clinical outcome.” ACOG also recommended further study of the device.

The U.S. Food and Drug Administration required additional research when it granted conditional approval for the fetal pulse oximeter device in 2000.

Results of the first large, randomized trial since 2000 are not encouraging.

Dr. Bloom and his associates designed the study to assess whether knowledge of fetal oxygen saturation values in the perinatal period would significantly change the overall cesarean rate. Any changes in cesarean rate for a nonreassuring fetal heart rate or dystocia, as well as any impact on maternal and infant safety, were secondary objectives.

Infant outcomes did not differ significantly: 0.7% of each group was intubated in the delivery room and 0.3% of each group had confirmed sepsis. In addition, 0.2% of the open group and 0.1% of the masked group had 5-minute Apgar scores of 3 or less; 0.6% of the open group and 0.5% of the masked group had an umbilical artery pH less than 7; and 4.8% of the open group and 5.4% of the masked group were admitted to the neonatal intensive care unit.

There was no significant difference in maternal morbidity between groups. In each group, 10.7% experienced chorioamnionitis; 4.3% of the open group and 4.4% of the masked group had postpartum endometritis; and 0.2% of the open group and 0.1% of the masked group had a wound complication.

MIAMI — Fetal pulse oximetry failed to significantly decrease the cesarean delivery rate or to improve neonatal outcomes in a randomized, multicenter study of more than 5,000 women, Dr. Steven L. Bloom said at the annual meeting of the Society for Maternal-Fetal Medicine.

“Unfortunately, the results of this study … suggest that fetal oximetry has not realized its promise of reducing cesarean births,” said Dr. Bloom, who presented the findings on behalf of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network in Bethesda, Md.

Dr. Bloom and his associates randomized 2,629 nulliparous women at term in early labor to an “open oximetry” group; physicians delivering the babies of the women in this group could view fetal oxygen saturation values. For comparison, investigators randomized another 2,712 women to a “masked oximetry” group. The oximetry was an adjunct to continuous electronic fetal monitoring.

A total of 692 women in the open group and 747 women in the masked group delivered via cesarean section (26.3% vs. 27.5%). A nonreassuring fetal heart rate was the reason for cesarean section for 187 women in the open group and 214 women in the masked group (7.1% vs. 7.9%). Dystocia was the reason for 490 women in the open group and 521 women in the masked group (18.6% vs. 19.2%).

“The overall cesarean rate, as well as the rates of cesarean deliveries for specific indications, was not different,” said Dr. Bloom, interim chair of the department of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.

A study published in 2000 had shown that the rate of cesarean delivery for nonreassuring fetal heart rate was reduced significantly from 10% to 5% with the addition of fetal pulse oximetry. That study also showed a doubling of the rate of cesarean section due to dystocia, so there was no significant reduction in the overall cesarean rate—26% with fetal heart rate monitoring alone vs. 29% with fetal heart rate monitoring plus oximetry (Am. J. Obstet. Gynecol. 2000;183:1049–58).

Based on these earlier findings, the American College of Obstetricians and Gynecologists in 2001 issued a Committee Opinion stating that it did not endorse adoption of fetal pulse oximetry into clinical practice, citing concerns that the device could “escalate the cost of medical care without necessarily improving clinical outcome.” ACOG also recommended further study of the device.

The U.S. Food and Drug Administration required additional research when it granted conditional approval for the fetal pulse oximeter device in 2000.

Results of the first large, randomized trial since 2000 are not encouraging.

Dr. Bloom and his associates designed the study to assess whether knowledge of fetal oxygen saturation values in the perinatal period would significantly change the overall cesarean rate. Any changes in cesarean rate for a nonreassuring fetal heart rate or dystocia, as well as any impact on maternal and infant safety, were secondary objectives.

Infant outcomes did not differ significantly: 0.7% of each group was intubated in the delivery room and 0.3% of each group had confirmed sepsis. In addition, 0.2% of the open group and 0.1% of the masked group had 5-minute Apgar scores of 3 or less; 0.6% of the open group and 0.5% of the masked group had an umbilical artery pH less than 7; and 4.8% of the open group and 5.4% of the masked group were admitted to the neonatal intensive care unit.

There was no significant difference in maternal morbidity between groups. In each group, 10.7% experienced chorioamnionitis; 4.3% of the open group and 4.4% of the masked group had postpartum endometritis; and 0.2% of the open group and 0.1% of the masked group had a wound complication.

SCOTTSDALE, ARIZ. – When it comes to triptan use in treatment of acute migraine, consider the maxim: Go big or stay home.

A high dose of a given triptan may be associated with an elevated risk for side effects; however, it also is more likely to be effective. Patients who do not respond to a lower dose given in the hope of avoiding adverse events are not going to come back to give the drug a second chance at a higher dose, Dr. Lawrence C. Newman said at a symposium sponsored by the American Headache Society.

“Studies generally show that the higher dose ranges are more effective for the triptans. We want to get treatment right the first time,” Dr. Newman said. Underdosing, he added, might cause a lack of efficacy and drive a patient to discontinue therapy or refuse another migraine-specific medication in the future.

A patient who experiences an adverse event, which is more likely at a high dose, will never take a triptan again, a meeting attendee observed. “I respect your opinion, but you are blurring the line between a preventive and acute medication,” Dr. Newman replied. “We find from acute studies that the higher doses are more effective. If I've had a patient try a medication at low dose for three attacks, and tell them I want to try the same medication for the next three attacks, they say no.”

Dr. Newman is director of the Headache Institute, St. Luke's-Roosevelt Hospital Center, New York City, and a consultant, adviser, and/or a member of the speakers' bureau for triptan manufacturers GlaxoSmithKline, Endo Pharmaceuticals, Pfizer Inc., Merck & Co., and Ortho-McNeil Inc.

Each triptan is available in different dosages, making it easy to reduce the dose if a patient experiences an adverse effect, Dr. Newman said. “Studies generally show … the side-effect profile does not differ significantly between the higher and lower doses.

There are currently seven triptans on the market, available in a number of formulations. All are available in tablet form, and some are available also as nasal sprays (sumatriptan, zolmitriptan), dissolvable wafers taken orally (rizatriptan, zolmitriptan), or injections (sumatriptan).

If headaches recur, treat attacks earlier, increase the dose, switch triptans, particularly to naratriptan or frovatriptan, add an NSAID, or switch to dihydroergotamine mesylate, Dr. Newman suggested.

“Do not give up on the triptan class because one does not work. There is evidence that some patients respond to one but not to another,” Dr. Newman said. “And treat at least two migraine attacks before switching medications.”

Because of the heterogeneity of migraines from one attack to another and between patients, patients need strategies to treat milder and more severe attacks, Dr. Newman suggested. “Give them a rescue medication so they don't have to call you at 3 in the morning.”

An optimal treatment plan goes beyond medication, Dr. Newman said. “Discussion needs to focus on lifestyle and behavioral modifications that include identifying and avoiding potential headache triggers, and [the importance of establishing] proper sleep hygiene and regular meal and exercise times.”

Early intervention is best. Patients need to manage their pain when it is mild. Patients may be treated 30 minutes into an attack when their pain is already moderate. Those who treat pain when it is mild use fewer medications, thus lowering the likelihood of rebound headache.

Dr. Newman recommended the Migraine Disability Assessment (MIDAS) questionnaire to gauge the degree of disability from the headache (Neurology 2001;56:S20–8). Patients with a higher-grade disability are much more likely to benefit from a specific treatment such as a triptan, compared with a general analgesic or NSAID.

The seven-item MIDAS questionnaire assesses days lost at school or work due to a headache, its impact on activities of daily living, headache frequency, and ratings of headache severity on a scale of 0–10. Other disability scales, such as the Headache Impact Test (HIT-6; Quality Metric Inc.), are also useful, Dr. Newman pointed out.

The MIDAS score, together with clinical judgment, ties in with a stratified care approach to migraine management. Low-end therapies include NSAIDS, analgesics, and triptans for so-called low-need patients who have infrequent but severe migraines. Consider combination analgesics, NSAIDs, antiemetics, triptans, and prophylactic therapy for moderate-need patients. Consider triptans, ergots, alkaloids, opioids, prophylaxis, and consultation for high-need patients. Other researchers validated the efficacy of such a stratified approach to management of migraine patients (JAMA 2000;284:2599–606).

SCOTTSDALE, ARIZ. – When it comes to triptan use in treatment of acute migraine, consider the maxim: Go big or stay home.

A high dose of a given triptan may be associated with an elevated risk for side effects; however, it also is more likely to be effective. Patients who do not respond to a lower dose given in the hope of avoiding adverse events are not going to come back to give the drug a second chance at a higher dose, Dr. Lawrence C. Newman said at a symposium sponsored by the American Headache Society.

“Studies generally show that the higher dose ranges are more effective for the triptans. We want to get treatment right the first time,” Dr. Newman said. Underdosing, he added, might cause a lack of efficacy and drive a patient to discontinue therapy or refuse another migraine-specific medication in the future.

A patient who experiences an adverse event, which is more likely at a high dose, will never take a triptan again, a meeting attendee observed. “I respect your opinion, but you are blurring the line between a preventive and acute medication,” Dr. Newman replied. “We find from acute studies that the higher doses are more effective. If I've had a patient try a medication at low dose for three attacks, and tell them I want to try the same medication for the next three attacks, they say no.”

Dr. Newman is director of the Headache Institute, St. Luke's-Roosevelt Hospital Center, New York City, and a consultant, adviser, and/or a member of the speakers' bureau for triptan manufacturers GlaxoSmithKline, Endo Pharmaceuticals, Pfizer Inc., Merck & Co., and Ortho-McNeil Inc.

Each triptan is available in different dosages, making it easy to reduce the dose if a patient experiences an adverse effect, Dr. Newman said. “Studies generally show … the side-effect profile does not differ significantly between the higher and lower doses.

There are currently seven triptans on the market, available in a number of formulations. All are available in tablet form, and some are available also as nasal sprays (sumatriptan, zolmitriptan), dissolvable wafers taken orally (rizatriptan, zolmitriptan), or injections (sumatriptan).

If headaches recur, treat attacks earlier, increase the dose, switch triptans, particularly to naratriptan or frovatriptan, add an NSAID, or switch to dihydroergotamine mesylate, Dr. Newman suggested.

“Do not give up on the triptan class because one does not work. There is evidence that some patients respond to one but not to another,” Dr. Newman said. “And treat at least two migraine attacks before switching medications.”

Because of the heterogeneity of migraines from one attack to another and between patients, patients need strategies to treat milder and more severe attacks, Dr. Newman suggested. “Give them a rescue medication so they don't have to call you at 3 in the morning.”

An optimal treatment plan goes beyond medication, Dr. Newman said. “Discussion needs to focus on lifestyle and behavioral modifications that include identifying and avoiding potential headache triggers, and [the importance of establishing] proper sleep hygiene and regular meal and exercise times.”

Early intervention is best. Patients need to manage their pain when it is mild. Patients may be treated 30 minutes into an attack when their pain is already moderate. Those who treat pain when it is mild use fewer medications, thus lowering the likelihood of rebound headache.

Dr. Newman recommended the Migraine Disability Assessment (MIDAS) questionnaire to gauge the degree of disability from the headache (Neurology 2001;56:S20–8). Patients with a higher-grade disability are much more likely to benefit from a specific treatment such as a triptan, compared with a general analgesic or NSAID.

The seven-item MIDAS questionnaire assesses days lost at school or work due to a headache, its impact on activities of daily living, headache frequency, and ratings of headache severity on a scale of 0–10. Other disability scales, such as the Headache Impact Test (HIT-6; Quality Metric Inc.), are also useful, Dr. Newman pointed out.

The MIDAS score, together with clinical judgment, ties in with a stratified care approach to migraine management. Low-end therapies include NSAIDS, analgesics, and triptans for so-called low-need patients who have infrequent but severe migraines. Consider combination analgesics, NSAIDs, antiemetics, triptans, and prophylactic therapy for moderate-need patients. Consider triptans, ergots, alkaloids, opioids, prophylaxis, and consultation for high-need patients. Other researchers validated the efficacy of such a stratified approach to management of migraine patients (JAMA 2000;284:2599–606).

SCOTTSDALE, ARIZ. – When it comes to triptan use in treatment of acute migraine, consider the maxim: Go big or stay home.

A high dose of a given triptan may be associated with an elevated risk for side effects; however, it also is more likely to be effective. Patients who do not respond to a lower dose given in the hope of avoiding adverse events are not going to come back to give the drug a second chance at a higher dose, Dr. Lawrence C. Newman said at a symposium sponsored by the American Headache Society.

“Studies generally show that the higher dose ranges are more effective for the triptans. We want to get treatment right the first time,” Dr. Newman said. Underdosing, he added, might cause a lack of efficacy and drive a patient to discontinue therapy or refuse another migraine-specific medication in the future.

A patient who experiences an adverse event, which is more likely at a high dose, will never take a triptan again, a meeting attendee observed. “I respect your opinion, but you are blurring the line between a preventive and acute medication,” Dr. Newman replied. “We find from acute studies that the higher doses are more effective. If I've had a patient try a medication at low dose for three attacks, and tell them I want to try the same medication for the next three attacks, they say no.”

Dr. Newman is director of the Headache Institute, St. Luke's-Roosevelt Hospital Center, New York City, and a consultant, adviser, and/or a member of the speakers' bureau for triptan manufacturers GlaxoSmithKline, Endo Pharmaceuticals, Pfizer Inc., Merck & Co., and Ortho-McNeil Inc.

Each triptan is available in different dosages, making it easy to reduce the dose if a patient experiences an adverse effect, Dr. Newman said. “Studies generally show … the side-effect profile does not differ significantly between the higher and lower doses.

There are currently seven triptans on the market, available in a number of formulations. All are available in tablet form, and some are available also as nasal sprays (sumatriptan, zolmitriptan), dissolvable wafers taken orally (rizatriptan, zolmitriptan), or injections (sumatriptan).

If headaches recur, treat attacks earlier, increase the dose, switch triptans, particularly to naratriptan or frovatriptan, add an NSAID, or switch to dihydroergotamine mesylate, Dr. Newman suggested.

“Do not give up on the triptan class because one does not work. There is evidence that some patients respond to one but not to another,” Dr. Newman said. “And treat at least two migraine attacks before switching medications.”

Because of the heterogeneity of migraines from one attack to another and between patients, patients need strategies to treat milder and more severe attacks, Dr. Newman suggested. “Give them a rescue medication so they don't have to call you at 3 in the morning.”

An optimal treatment plan goes beyond medication, Dr. Newman said. “Discussion needs to focus on lifestyle and behavioral modifications that include identifying and avoiding potential headache triggers, and [the importance of establishing] proper sleep hygiene and regular meal and exercise times.”

Early intervention is best. Patients need to manage their pain when it is mild. Patients may be treated 30 minutes into an attack when their pain is already moderate. Those who treat pain when it is mild use fewer medications, thus lowering the likelihood of rebound headache.

Dr. Newman recommended the Migraine Disability Assessment (MIDAS) questionnaire to gauge the degree of disability from the headache (Neurology 2001;56:S20–8). Patients with a higher-grade disability are much more likely to benefit from a specific treatment such as a triptan, compared with a general analgesic or NSAID.

The seven-item MIDAS questionnaire assesses days lost at school or work due to a headache, its impact on activities of daily living, headache frequency, and ratings of headache severity on a scale of 0–10. Other disability scales, such as the Headache Impact Test (HIT-6; Quality Metric Inc.), are also useful, Dr. Newman pointed out.

The MIDAS score, together with clinical judgment, ties in with a stratified care approach to migraine management. Low-end therapies include NSAIDS, analgesics, and triptans for so-called low-need patients who have infrequent but severe migraines. Consider combination analgesics, NSAIDs, antiemetics, triptans, and prophylactic therapy for moderate-need patients. Consider triptans, ergots, alkaloids, opioids, prophylaxis, and consultation for high-need patients. Other researchers validated the efficacy of such a stratified approach to management of migraine patients (JAMA 2000;284:2599–606).

SCOTTSDALE, ARIZ. – Consider a range of explanations when a chronic daily headache patient does not improve with standard therapy, Dr. Joel R. Saper suggested at a symposium sponsored by the American Headache Society.

Some top reasons include medication-overuse headache (formerly known as rebound headache), a wrong diagnosis, and psychobiologic or behavioral barriers to treatment, when a person with chronic daily headache fails to improve. Improperly selected or improperly dosed medication are other possible culprits, said Dr. Saper, founder and director of the Michigan Head Pain & Neurological Institute at the University of Michigan, Ann Arbor.

“My best two pieces of advice are to consider that individual as the first patient you've ever seen with chronic daily headache,” Dr. Saper said, “and it's not daily chronic headache until you've ruled out everything else.” The differential diagnosis includes the other primary headache disorders and organic causes of intractable headache such as sphenoid sinusitis, an Arnold-Chiari malformation, and pseudotumor cerebri.

“The more you treat patients with chronic daily headache, the more you learn you did not get it right the first time,” Dr. Saper said.

Patients who take almost any headache medications 2 or 3 days a week for months are at higher risk for medication-overuse headache (Curr. Pain Headache Rep. 2005;9:430–5). This progressive disorder is characterized by predictable and escalating headache frequency and medication use in patients with pre-existing headache.

“If you start a drug and are not there to deal with its consequences, you put all of us at risk,” Dr. Saper said. “You better be willing to monitor them” and change therapy when warranted.

Headache is a symptom of more than 300 illnesses, making diagnosis of a primary disorder difficult. Causes of headache include cerebral venous occlusion, Lyme disease, infiltrative disease, exposure to toxins, AIDS, and opportunistic meningitis.

Psychiatric, behavioral, and drug misuse barriers are more pervasive than perhaps appreciated, Dr. Saper said. Remember the basics, such as a thorough physical examination, comprehensive history, and getting collateral information from relatives, he suggested.

“Are we dealing in some cases with challenging headaches or a challenging individual with headaches? It is important to ask when someone is not getting better,” Dr. Saper said.

Drug abuse and medication noncompliance are also possible when a patient is not improving, he said.

Interventional procedures are sometimes necessary to treat intractable headaches. A neural blockade such as an epidural or C2-C3 might help, or consider neural stimulation, Dr. Saper said.

Sometimes, hospitalization is required to reach a correct diagnosis. “An outpatient visit is a snapshot, a moment that you spend with that patient,” Dr. Saper said. “When trained staff is with a patient 24 hours a day, you begin to learn something about that case you would not learn in an outpatient setting.” For example, how does a patient interact with their family? Does the patient sneak down to the hospital cafeteria and eat something they are not supposed to?

SCOTTSDALE, ARIZ. – Consider a range of explanations when a chronic daily headache patient does not improve with standard therapy, Dr. Joel R. Saper suggested at a symposium sponsored by the American Headache Society.

Some top reasons include medication-overuse headache (formerly known as rebound headache), a wrong diagnosis, and psychobiologic or behavioral barriers to treatment, when a person with chronic daily headache fails to improve. Improperly selected or improperly dosed medication are other possible culprits, said Dr. Saper, founder and director of the Michigan Head Pain & Neurological Institute at the University of Michigan, Ann Arbor.

“My best two pieces of advice are to consider that individual as the first patient you've ever seen with chronic daily headache,” Dr. Saper said, “and it's not daily chronic headache until you've ruled out everything else.” The differential diagnosis includes the other primary headache disorders and organic causes of intractable headache such as sphenoid sinusitis, an Arnold-Chiari malformation, and pseudotumor cerebri.

“The more you treat patients with chronic daily headache, the more you learn you did not get it right the first time,” Dr. Saper said.

Patients who take almost any headache medications 2 or 3 days a week for months are at higher risk for medication-overuse headache (Curr. Pain Headache Rep. 2005;9:430–5). This progressive disorder is characterized by predictable and escalating headache frequency and medication use in patients with pre-existing headache.

“If you start a drug and are not there to deal with its consequences, you put all of us at risk,” Dr. Saper said. “You better be willing to monitor them” and change therapy when warranted.

Headache is a symptom of more than 300 illnesses, making diagnosis of a primary disorder difficult. Causes of headache include cerebral venous occlusion, Lyme disease, infiltrative disease, exposure to toxins, AIDS, and opportunistic meningitis.

Psychiatric, behavioral, and drug misuse barriers are more pervasive than perhaps appreciated, Dr. Saper said. Remember the basics, such as a thorough physical examination, comprehensive history, and getting collateral information from relatives, he suggested.

“Are we dealing in some cases with challenging headaches or a challenging individual with headaches? It is important to ask when someone is not getting better,” Dr. Saper said.

Drug abuse and medication noncompliance are also possible when a patient is not improving, he said.

Interventional procedures are sometimes necessary to treat intractable headaches. A neural blockade such as an epidural or C2-C3 might help, or consider neural stimulation, Dr. Saper said.

Sometimes, hospitalization is required to reach a correct diagnosis. “An outpatient visit is a snapshot, a moment that you spend with that patient,” Dr. Saper said. “When trained staff is with a patient 24 hours a day, you begin to learn something about that case you would not learn in an outpatient setting.” For example, how does a patient interact with their family? Does the patient sneak down to the hospital cafeteria and eat something they are not supposed to?

SCOTTSDALE, ARIZ. – Consider a range of explanations when a chronic daily headache patient does not improve with standard therapy, Dr. Joel R. Saper suggested at a symposium sponsored by the American Headache Society.

Some top reasons include medication-overuse headache (formerly known as rebound headache), a wrong diagnosis, and psychobiologic or behavioral barriers to treatment, when a person with chronic daily headache fails to improve. Improperly selected or improperly dosed medication are other possible culprits, said Dr. Saper, founder and director of the Michigan Head Pain & Neurological Institute at the University of Michigan, Ann Arbor.

“My best two pieces of advice are to consider that individual as the first patient you've ever seen with chronic daily headache,” Dr. Saper said, “and it's not daily chronic headache until you've ruled out everything else.” The differential diagnosis includes the other primary headache disorders and organic causes of intractable headache such as sphenoid sinusitis, an Arnold-Chiari malformation, and pseudotumor cerebri.

“The more you treat patients with chronic daily headache, the more you learn you did not get it right the first time,” Dr. Saper said.

Patients who take almost any headache medications 2 or 3 days a week for months are at higher risk for medication-overuse headache (Curr. Pain Headache Rep. 2005;9:430–5). This progressive disorder is characterized by predictable and escalating headache frequency and medication use in patients with pre-existing headache.

“If you start a drug and are not there to deal with its consequences, you put all of us at risk,” Dr. Saper said. “You better be willing to monitor them” and change therapy when warranted.

Headache is a symptom of more than 300 illnesses, making diagnosis of a primary disorder difficult. Causes of headache include cerebral venous occlusion, Lyme disease, infiltrative disease, exposure to toxins, AIDS, and opportunistic meningitis.

Psychiatric, behavioral, and drug misuse barriers are more pervasive than perhaps appreciated, Dr. Saper said. Remember the basics, such as a thorough physical examination, comprehensive history, and getting collateral information from relatives, he suggested.

“Are we dealing in some cases with challenging headaches or a challenging individual with headaches? It is important to ask when someone is not getting better,” Dr. Saper said.

Drug abuse and medication noncompliance are also possible when a patient is not improving, he said.

Interventional procedures are sometimes necessary to treat intractable headaches. A neural blockade such as an epidural or C2-C3 might help, or consider neural stimulation, Dr. Saper said.

Sometimes, hospitalization is required to reach a correct diagnosis. “An outpatient visit is a snapshot, a moment that you spend with that patient,” Dr. Saper said. “When trained staff is with a patient 24 hours a day, you begin to learn something about that case you would not learn in an outpatient setting.” For example, how does a patient interact with their family? Does the patient sneak down to the hospital cafeteria and eat something they are not supposed to?

NAPLES, FLA. — Although physicians see fewer direct cutaneous manifestations of HIV infection in this era of highly active antiretroviral treatment, the drugs themselves can cause important dermatologic reactions, according to a presentation at a symposium sponsored by the Dermatology Foundation.

Most drugs in highly active antiretroviral treatment (HAART) can cause morbilliform eruptions. Hyperpigmentation, hypersensitivity, and retinoidlike effects are among agent-specific adverse effects. Most adverse sequelae are reversible and resolve when the responsible agent is stopped, said Dr. Andrew Blauvelt, professor of dermatology at Oregon Health & Science University, Portland.

The hyperpigmentation caused by zidovudine (AZT) correlates with pigmentation and therefore occurs more often in patients of color. The drug deposits additional melanin in the epidermis and dermis, although nail and mucocutaneous pigmentation is also possible. The dose-dependent darkening is potentially reversible.

Abacavir hypersensitivity presents as morbilliform eruptions in about 10% of patients, 2%–3% of whom also experience a severe systemic reaction. Symptoms include fever, abdominal pain, nausea, diarrhea, dyspnea, cough, myalgias, arthralgias, and hypotension. “Stop the drug as soon as possible and never rechallenge the patient” with abacavir, Dr. Blauvelt said. The rash alone is not generally a reason to stop the drug. The eruptions typically appear within 6 weeks of starting abacavir and resolve when the drug is stopped.

Nevirapine can cause Stevens-Johnson syndrome. “Stevens-Johnson can occur with any of these drugs, but it is most commonly reported with nevirapine,” he said. Early identification is possible. Some patients complain of mucosal problems, particularly eye, mouth, and/or genital area symptoms before they develop full-blown Stevens-Johnson syndrome. “For me there is a role for systemic steroids in Stevens-Johnson, but only if it is an early case. This is still a controversial area.”

Morbilliform eruptions appear in 19% of patients treated with nevirapine, including 8% who develop Stevens-Johnson syndrome, “a pretty high number,” Dr. Blauvelt said.

Dr. Blauvelt suggested starting the drug at lower doses and increasing it gradually to prevent drug reactions. If a nevirapine-treated patient has a reaction, never rechallenge them with the same drug, he added.

Indinavir, ritonavir, stavudine, and zidovudine can cause lipodystrophy. “It's controversial which agents are the most likely culprits for causing lipodystrophy,” he said. In his opinion, indinavir is No. 1.

“You have probably seen this if you have any people with HIV in your practice,” Dr. Blauvelt said. Although lipodystrophy can cause breast enlargement, buffalo hump, and abdominal protuberance, dermatologists are most likely to see patients with facial atrophy. Lipodystrophy generally occurs within 6–12 months of initiation of therapy, and like other drug reactions, is potentially reversible, he said.

Indinavir can cause retinoidlike effects that include recurrent paronychia, pyogenic granulomas, and alopecia. The etiology is unknown, Dr. Blauvelt said, but the effects might be caused by similarities in binding proteins between HIV protease and retinoic acid.

For more information about HAART, visit www.aidsinfo.nih.gov

Stevens-Johnson syndrome, which can be caused by nevirapine or other HAART agents, may start with mucosal symptoms involving the mouth, eyes, or genital area. Courtesy Dr. Andrew Blauvelt

NAPLES, FLA. — Although physicians see fewer direct cutaneous manifestations of HIV infection in this era of highly active antiretroviral treatment, the drugs themselves can cause important dermatologic reactions, according to a presentation at a symposium sponsored by the Dermatology Foundation.

Most drugs in highly active antiretroviral treatment (HAART) can cause morbilliform eruptions. Hyperpigmentation, hypersensitivity, and retinoidlike effects are among agent-specific adverse effects. Most adverse sequelae are reversible and resolve when the responsible agent is stopped, said Dr. Andrew Blauvelt, professor of dermatology at Oregon Health & Science University, Portland.

The hyperpigmentation caused by zidovudine (AZT) correlates with pigmentation and therefore occurs more often in patients of color. The drug deposits additional melanin in the epidermis and dermis, although nail and mucocutaneous pigmentation is also possible. The dose-dependent darkening is potentially reversible.

Abacavir hypersensitivity presents as morbilliform eruptions in about 10% of patients, 2%–3% of whom also experience a severe systemic reaction. Symptoms include fever, abdominal pain, nausea, diarrhea, dyspnea, cough, myalgias, arthralgias, and hypotension. “Stop the drug as soon as possible and never rechallenge the patient” with abacavir, Dr. Blauvelt said. The rash alone is not generally a reason to stop the drug. The eruptions typically appear within 6 weeks of starting abacavir and resolve when the drug is stopped.

Nevirapine can cause Stevens-Johnson syndrome. “Stevens-Johnson can occur with any of these drugs, but it is most commonly reported with nevirapine,” he said. Early identification is possible. Some patients complain of mucosal problems, particularly eye, mouth, and/or genital area symptoms before they develop full-blown Stevens-Johnson syndrome. “For me there is a role for systemic steroids in Stevens-Johnson, but only if it is an early case. This is still a controversial area.”

Morbilliform eruptions appear in 19% of patients treated with nevirapine, including 8% who develop Stevens-Johnson syndrome, “a pretty high number,” Dr. Blauvelt said.

Dr. Blauvelt suggested starting the drug at lower doses and increasing it gradually to prevent drug reactions. If a nevirapine-treated patient has a reaction, never rechallenge them with the same drug, he added.

Indinavir, ritonavir, stavudine, and zidovudine can cause lipodystrophy. “It's controversial which agents are the most likely culprits for causing lipodystrophy,” he said. In his opinion, indinavir is No. 1.

“You have probably seen this if you have any people with HIV in your practice,” Dr. Blauvelt said. Although lipodystrophy can cause breast enlargement, buffalo hump, and abdominal protuberance, dermatologists are most likely to see patients with facial atrophy. Lipodystrophy generally occurs within 6–12 months of initiation of therapy, and like other drug reactions, is potentially reversible, he said.

Indinavir can cause retinoidlike effects that include recurrent paronychia, pyogenic granulomas, and alopecia. The etiology is unknown, Dr. Blauvelt said, but the effects might be caused by similarities in binding proteins between HIV protease and retinoic acid.

For more information about HAART, visit www.aidsinfo.nih.gov

Stevens-Johnson syndrome, which can be caused by nevirapine or other HAART agents, may start with mucosal symptoms involving the mouth, eyes, or genital area. Courtesy Dr. Andrew Blauvelt

NAPLES, FLA. — Although physicians see fewer direct cutaneous manifestations of HIV infection in this era of highly active antiretroviral treatment, the drugs themselves can cause important dermatologic reactions, according to a presentation at a symposium sponsored by the Dermatology Foundation.

Most drugs in highly active antiretroviral treatment (HAART) can cause morbilliform eruptions. Hyperpigmentation, hypersensitivity, and retinoidlike effects are among agent-specific adverse effects. Most adverse sequelae are reversible and resolve when the responsible agent is stopped, said Dr. Andrew Blauvelt, professor of dermatology at Oregon Health & Science University, Portland.

The hyperpigmentation caused by zidovudine (AZT) correlates with pigmentation and therefore occurs more often in patients of color. The drug deposits additional melanin in the epidermis and dermis, although nail and mucocutaneous pigmentation is also possible. The dose-dependent darkening is potentially reversible.

Abacavir hypersensitivity presents as morbilliform eruptions in about 10% of patients, 2%–3% of whom also experience a severe systemic reaction. Symptoms include fever, abdominal pain, nausea, diarrhea, dyspnea, cough, myalgias, arthralgias, and hypotension. “Stop the drug as soon as possible and never rechallenge the patient” with abacavir, Dr. Blauvelt said. The rash alone is not generally a reason to stop the drug. The eruptions typically appear within 6 weeks of starting abacavir and resolve when the drug is stopped.

Nevirapine can cause Stevens-Johnson syndrome. “Stevens-Johnson can occur with any of these drugs, but it is most commonly reported with nevirapine,” he said. Early identification is possible. Some patients complain of mucosal problems, particularly eye, mouth, and/or genital area symptoms before they develop full-blown Stevens-Johnson syndrome. “For me there is a role for systemic steroids in Stevens-Johnson, but only if it is an early case. This is still a controversial area.”

Morbilliform eruptions appear in 19% of patients treated with nevirapine, including 8% who develop Stevens-Johnson syndrome, “a pretty high number,” Dr. Blauvelt said.

Dr. Blauvelt suggested starting the drug at lower doses and increasing it gradually to prevent drug reactions. If a nevirapine-treated patient has a reaction, never rechallenge them with the same drug, he added.

Indinavir, ritonavir, stavudine, and zidovudine can cause lipodystrophy. “It's controversial which agents are the most likely culprits for causing lipodystrophy,” he said. In his opinion, indinavir is No. 1.

“You have probably seen this if you have any people with HIV in your practice,” Dr. Blauvelt said. Although lipodystrophy can cause breast enlargement, buffalo hump, and abdominal protuberance, dermatologists are most likely to see patients with facial atrophy. Lipodystrophy generally occurs within 6–12 months of initiation of therapy, and like other drug reactions, is potentially reversible, he said.

Indinavir can cause retinoidlike effects that include recurrent paronychia, pyogenic granulomas, and alopecia. The etiology is unknown, Dr. Blauvelt said, but the effects might be caused by similarities in binding proteins between HIV protease and retinoic acid.

For more information about HAART, visit www.aidsinfo.nih.gov

Stevens-Johnson syndrome, which can be caused by nevirapine or other HAART agents, may start with mucosal symptoms involving the mouth, eyes, or genital area. Courtesy Dr. Andrew Blauvelt

BOCA RATON, FLA. — Automated home monitoring improved short-term outcomes for patients with heart failure, compared with standard disease management alone, in a multicenter, randomized study, Dr. Andrew R. Weintraub reported at the annual meeting of the Heart Failure Society of America.

Previously, researchers showed the benefit of disease management for heart failure patients, but the studies were nonrandomized, single-center, or assessed nonspecialized teams. Then the prospective, randomized Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) study demonstrated a significant reduction in hospitalizations from heart failure and cardiovascular disease, as well as a shorter length of stay with disease management (Circulation 2004;110:1450–5), said Dr. Weintraub, director of the Coronary Care Unit at the Tufts-New England Medical Center, Boston.

To determine whether the addition of automated home monitoring would further reduce hospitalization and resource use for patients enrolled in the disease management program, Dr. Weintraub and his associates randomized 93 patients to a control group of disease management and another 95 to an intervention group with home monitoring.

The control patients received the same disease management as in the SPAN-CHF study, which included an initial nurse home visit, weekly or biweekly telephone monitoring, and the availability of a nurse manager 24 hours a day via pager. Intervention patients received the same services, but also weighed themselves on an interactive scale, measured their blood pressure, and took their pulse daily using an automated home monitor (Philips Medical Systems, Bothell, Wash.). Intervention patients answered health status and compliance questions daily via text messaging (Health Hero Network, Mountain View, Calif.)

The investigators enrolled patients within 2 weeks of discharge after their first episode of heart failure. All had a measurement of left ventricular function within 6 months (mean 30%). The patients were aged 18–90 years. There was a high incidence of ACE inhibitor, angiotensin receptor blocker, and β-blocker use. Patient demographics were similar. Both groups had a wide range in baseline ejection fractions, said Dr. Weintraub.

“We detected a trend in reduction with intervention of heart failure hospitalized days, cardiac hospitalized days, and all-cause hospitalized days,” said Dr. Weintraub, who received research support from GlaxoSmithKline Inc., Agilent Technologies/Philips Medical Systems, and the Health Hero Network.

The mean number of hospitalizations for heart failure lasting more than 90 days in the intervention group was 0.5, compared with 1.8 for the control group (relative risk 0.28). Hospitalizations for all cardiac causes were 0.8 in the intervention group, compared with 2.2 in the control group (RR 0.37). There were no significant differences between groups in all-cause hospitalizations.

There were no differences in hospitalization rates according to gender, age, left ventricular ejection fraction, New York Heart Association classification, or hypertension. However, “our patients with diabetes at baseline were significantly more likely to be hospitalized for heart failure,” Dr. Weintraub added (odds ratio 4.3).

“We documented the 90-day benefit of adding an automated home monitoring system to a previously validated telephonic disease management program,” Dr. Weintraub said. “The addition … produced further improvement in the short-term, heart failure-related clinical outcomes in patients recently hospitalized for heart failure.”

In response to an attendee's comment that there was more nurse-patient interaction in the automated-home-monitoring group, Dr. Weintraub said he tracked interactions in each group, and “the nurse managers indicated the time spent with automated-home-monitoring patients above the normal standard care was an additional 15%–20%.”

“So you think most of the benefit was from self-management of disease?” the attendee asked. Dr. Weintraub replied, “Yes, but the nurses facilitated that benefit.”

BOCA RATON, FLA. — Automated home monitoring improved short-term outcomes for patients with heart failure, compared with standard disease management alone, in a multicenter, randomized study, Dr. Andrew R. Weintraub reported at the annual meeting of the Heart Failure Society of America.

Previously, researchers showed the benefit of disease management for heart failure patients, but the studies were nonrandomized, single-center, or assessed nonspecialized teams. Then the prospective, randomized Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) study demonstrated a significant reduction in hospitalizations from heart failure and cardiovascular disease, as well as a shorter length of stay with disease management (Circulation 2004;110:1450–5), said Dr. Weintraub, director of the Coronary Care Unit at the Tufts-New England Medical Center, Boston.

To determine whether the addition of automated home monitoring would further reduce hospitalization and resource use for patients enrolled in the disease management program, Dr. Weintraub and his associates randomized 93 patients to a control group of disease management and another 95 to an intervention group with home monitoring.

The control patients received the same disease management as in the SPAN-CHF study, which included an initial nurse home visit, weekly or biweekly telephone monitoring, and the availability of a nurse manager 24 hours a day via pager. Intervention patients received the same services, but also weighed themselves on an interactive scale, measured their blood pressure, and took their pulse daily using an automated home monitor (Philips Medical Systems, Bothell, Wash.). Intervention patients answered health status and compliance questions daily via text messaging (Health Hero Network, Mountain View, Calif.)

The investigators enrolled patients within 2 weeks of discharge after their first episode of heart failure. All had a measurement of left ventricular function within 6 months (mean 30%). The patients were aged 18–90 years. There was a high incidence of ACE inhibitor, angiotensin receptor blocker, and β-blocker use. Patient demographics were similar. Both groups had a wide range in baseline ejection fractions, said Dr. Weintraub.

“We detected a trend in reduction with intervention of heart failure hospitalized days, cardiac hospitalized days, and all-cause hospitalized days,” said Dr. Weintraub, who received research support from GlaxoSmithKline Inc., Agilent Technologies/Philips Medical Systems, and the Health Hero Network.

The mean number of hospitalizations for heart failure lasting more than 90 days in the intervention group was 0.5, compared with 1.8 for the control group (relative risk 0.28). Hospitalizations for all cardiac causes were 0.8 in the intervention group, compared with 2.2 in the control group (RR 0.37). There were no significant differences between groups in all-cause hospitalizations.

There were no differences in hospitalization rates according to gender, age, left ventricular ejection fraction, New York Heart Association classification, or hypertension. However, “our patients with diabetes at baseline were significantly more likely to be hospitalized for heart failure,” Dr. Weintraub added (odds ratio 4.3).

“We documented the 90-day benefit of adding an automated home monitoring system to a previously validated telephonic disease management program,” Dr. Weintraub said. “The addition … produced further improvement in the short-term, heart failure-related clinical outcomes in patients recently hospitalized for heart failure.”

In response to an attendee's comment that there was more nurse-patient interaction in the automated-home-monitoring group, Dr. Weintraub said he tracked interactions in each group, and “the nurse managers indicated the time spent with automated-home-monitoring patients above the normal standard care was an additional 15%–20%.”

“So you think most of the benefit was from self-management of disease?” the attendee asked. Dr. Weintraub replied, “Yes, but the nurses facilitated that benefit.”

BOCA RATON, FLA. — Automated home monitoring improved short-term outcomes for patients with heart failure, compared with standard disease management alone, in a multicenter, randomized study, Dr. Andrew R. Weintraub reported at the annual meeting of the Heart Failure Society of America.

Previously, researchers showed the benefit of disease management for heart failure patients, but the studies were nonrandomized, single-center, or assessed nonspecialized teams. Then the prospective, randomized Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) study demonstrated a significant reduction in hospitalizations from heart failure and cardiovascular disease, as well as a shorter length of stay with disease management (Circulation 2004;110:1450–5), said Dr. Weintraub, director of the Coronary Care Unit at the Tufts-New England Medical Center, Boston.

To determine whether the addition of automated home monitoring would further reduce hospitalization and resource use for patients enrolled in the disease management program, Dr. Weintraub and his associates randomized 93 patients to a control group of disease management and another 95 to an intervention group with home monitoring.

The control patients received the same disease management as in the SPAN-CHF study, which included an initial nurse home visit, weekly or biweekly telephone monitoring, and the availability of a nurse manager 24 hours a day via pager. Intervention patients received the same services, but also weighed themselves on an interactive scale, measured their blood pressure, and took their pulse daily using an automated home monitor (Philips Medical Systems, Bothell, Wash.). Intervention patients answered health status and compliance questions daily via text messaging (Health Hero Network, Mountain View, Calif.)

The investigators enrolled patients within 2 weeks of discharge after their first episode of heart failure. All had a measurement of left ventricular function within 6 months (mean 30%). The patients were aged 18–90 years. There was a high incidence of ACE inhibitor, angiotensin receptor blocker, and β-blocker use. Patient demographics were similar. Both groups had a wide range in baseline ejection fractions, said Dr. Weintraub.

“We detected a trend in reduction with intervention of heart failure hospitalized days, cardiac hospitalized days, and all-cause hospitalized days,” said Dr. Weintraub, who received research support from GlaxoSmithKline Inc., Agilent Technologies/Philips Medical Systems, and the Health Hero Network.

The mean number of hospitalizations for heart failure lasting more than 90 days in the intervention group was 0.5, compared with 1.8 for the control group (relative risk 0.28). Hospitalizations for all cardiac causes were 0.8 in the intervention group, compared with 2.2 in the control group (RR 0.37). There were no significant differences between groups in all-cause hospitalizations.

There were no differences in hospitalization rates according to gender, age, left ventricular ejection fraction, New York Heart Association classification, or hypertension. However, “our patients with diabetes at baseline were significantly more likely to be hospitalized for heart failure,” Dr. Weintraub added (odds ratio 4.3).

“We documented the 90-day benefit of adding an automated home monitoring system to a previously validated telephonic disease management program,” Dr. Weintraub said. “The addition … produced further improvement in the short-term, heart failure-related clinical outcomes in patients recently hospitalized for heart failure.”

In response to an attendee's comment that there was more nurse-patient interaction in the automated-home-monitoring group, Dr. Weintraub said he tracked interactions in each group, and “the nurse managers indicated the time spent with automated-home-monitoring patients above the normal standard care was an additional 15%–20%.”

“So you think most of the benefit was from self-management of disease?” the attendee asked. Dr. Weintraub replied, “Yes, but the nurses facilitated that benefit.”

NAPLES, FLA. — Proper technique is paramount to optimize outcome and avoid complications with either calcium hydroxyapatite or poly-L-lactic acid fillers, according to a presentation at a Dermatology Foundation-sponsored symposium.

Infiltration of local anesthesia, needle size, injection technique, multiple treatment sessions, and tips to avoid complications are among clinical pearls for optimal use of calcium hydroxyapatite (Radiesse, BioForm Medical) and poly-L-lactic acid (Sculptra, Sanofi-Aventis).

"Radiesse is for structure and support and Sculptra is for diffuse volume," said Dr. Ken K. Lee, director of dermatologic surgery at Oregon Health and Science University in Portland. The two fillers are not mutually exclusive, he added. "I use these two together all the time."

Focal treatment is the goal with these fillers, Dr. Lee said. "There is a paradigm shift from filling to contouring. Contouring really was only available before with fat transfer." The gauge of needles typically used to inject calcium hydroxyapatite (27G) or poly-L-lactic acid (25G or 26G) can hurt, Dr. Lee said. He recommended local infiltration with lidocaine with epinephrine prior to injection to reduce pain and bruising. Dr. Lee does not have a disclosure regarding either filler product.

The goal with calcium hydroxyapatite is not to fill in fine lines, but to give more structure, Dr. Lee explained. The synthetic particles form scaffolding for tissue in-growth. "It is off label for cosmetic use—I do tell patients that."

Radiesse is packaged in 1.3-cc and 0.3-cc syringes. Inject into "deep dermis and a little bit into subcutaneous fat," Dr. Lee said. He recommended a threading and fanning technique, injecting only a small amount at each pass, such as 0.05 cc. Stop injection before exiting the skin and knead or mold any firm nodules after injection, he suggested.

"I don't just thread the material along the nasolabial line, I also crisscross to enhance the volume effect," Dr. Lee said. "This stuff is really thick and hard to get out of the needle, which is good. You don't want a lot of material in any one area."

Dr. Lee informs patients in advance that if they have prominent nasolabial lines or marionette lines they will likely need three syringes over two treatment sessions. "Then it doesn't look like you've failed them."

Volume from a single injection typically lasts about 9 months, Dr. Lee said. The double session strategy extends duration of effect to 1 year or longer. "Somehow getting it to last up to a year is much more appealing to patients. The downside is that complications last a long time, too."

Avoid filling thin eyelids and lips with calcium hydroxyapatite, Dr. Lee advised. Deposits can be seen in these areas. Dr. Lee said, "I really recommend collagen or hyaluronic acid for lips."

Poly-L-lactic acid, similar to calcium hydroxyapatite, is injected into the deep dermis or subcutaneous layer. Do not inject this filler superficially, Dr. Lee cautioned. "I aim for the subcutaneous layer. It is more difficult to consistently place in deep dermis and there are more complications." Inject a small amount on withdrawal.

Poly-L-lactic acid is a synthetic, biodegradable, biocompatible polymer that stimulates a patient's own collagen. Dr. Lee reconstitutes the filler with sterile water and 2% lidocaine. It is stable up to 72 hours after reconstitution. The vial is stored at room temperature but should be warmed prior to use, Dr. Lee suggested. "I have the patient hold the vial prior to injection. It helps to avoid clogging of the needle."

Massaging right after injections is very important, Dr. Lee said. "I tell patients to massage five times a day for 5 minutes for 5 days for distribution of the Sculptra."

Up to six treatment sessions may be necessary for full effect. Schedule treatment sessions about 4–6 weeks apart, Dr. Lee suggested. Volume enhancement with poly-L-lactic acid can last 2 years or more.

Hematoma is the most commonly reported complication in studies, Dr. Lee said. Subcutaneous papules are another potential problem. "You really have to be careful," he said. "Sculptra in cosmetic patients has really shown me how much volume affects the drooping of the skin."

NAPLES, FLA. — Proper technique is paramount to optimize outcome and avoid complications with either calcium hydroxyapatite or poly-L-lactic acid fillers, according to a presentation at a Dermatology Foundation-sponsored symposium.

Infiltration of local anesthesia, needle size, injection technique, multiple treatment sessions, and tips to avoid complications are among clinical pearls for optimal use of calcium hydroxyapatite (Radiesse, BioForm Medical) and poly-L-lactic acid (Sculptra, Sanofi-Aventis).

"Radiesse is for structure and support and Sculptra is for diffuse volume," said Dr. Ken K. Lee, director of dermatologic surgery at Oregon Health and Science University in Portland. The two fillers are not mutually exclusive, he added. "I use these two together all the time."

Focal treatment is the goal with these fillers, Dr. Lee said. "There is a paradigm shift from filling to contouring. Contouring really was only available before with fat transfer." The gauge of needles typically used to inject calcium hydroxyapatite (27G) or poly-L-lactic acid (25G or 26G) can hurt, Dr. Lee said. He recommended local infiltration with lidocaine with epinephrine prior to injection to reduce pain and bruising. Dr. Lee does not have a disclosure regarding either filler product.

The goal with calcium hydroxyapatite is not to fill in fine lines, but to give more structure, Dr. Lee explained. The synthetic particles form scaffolding for tissue in-growth. "It is off label for cosmetic use—I do tell patients that."

Radiesse is packaged in 1.3-cc and 0.3-cc syringes. Inject into "deep dermis and a little bit into subcutaneous fat," Dr. Lee said. He recommended a threading and fanning technique, injecting only a small amount at each pass, such as 0.05 cc. Stop injection before exiting the skin and knead or mold any firm nodules after injection, he suggested.

"I don't just thread the material along the nasolabial line, I also crisscross to enhance the volume effect," Dr. Lee said. "This stuff is really thick and hard to get out of the needle, which is good. You don't want a lot of material in any one area."

Dr. Lee informs patients in advance that if they have prominent nasolabial lines or marionette lines they will likely need three syringes over two treatment sessions. "Then it doesn't look like you've failed them."

Volume from a single injection typically lasts about 9 months, Dr. Lee said. The double session strategy extends duration of effect to 1 year or longer. "Somehow getting it to last up to a year is much more appealing to patients. The downside is that complications last a long time, too."

Avoid filling thin eyelids and lips with calcium hydroxyapatite, Dr. Lee advised. Deposits can be seen in these areas. Dr. Lee said, "I really recommend collagen or hyaluronic acid for lips."

Poly-L-lactic acid, similar to calcium hydroxyapatite, is injected into the deep dermis or subcutaneous layer. Do not inject this filler superficially, Dr. Lee cautioned. "I aim for the subcutaneous layer. It is more difficult to consistently place in deep dermis and there are more complications." Inject a small amount on withdrawal.

Poly-L-lactic acid is a synthetic, biodegradable, biocompatible polymer that stimulates a patient's own collagen. Dr. Lee reconstitutes the filler with sterile water and 2% lidocaine. It is stable up to 72 hours after reconstitution. The vial is stored at room temperature but should be warmed prior to use, Dr. Lee suggested. "I have the patient hold the vial prior to injection. It helps to avoid clogging of the needle."

Massaging right after injections is very important, Dr. Lee said. "I tell patients to massage five times a day for 5 minutes for 5 days for distribution of the Sculptra."

Up to six treatment sessions may be necessary for full effect. Schedule treatment sessions about 4–6 weeks apart, Dr. Lee suggested. Volume enhancement with poly-L-lactic acid can last 2 years or more.

Hematoma is the most commonly reported complication in studies, Dr. Lee said. Subcutaneous papules are another potential problem. "You really have to be careful," he said. "Sculptra in cosmetic patients has really shown me how much volume affects the drooping of the skin."

NAPLES, FLA. — Proper technique is paramount to optimize outcome and avoid complications with either calcium hydroxyapatite or poly-L-lactic acid fillers, according to a presentation at a Dermatology Foundation-sponsored symposium.

Infiltration of local anesthesia, needle size, injection technique, multiple treatment sessions, and tips to avoid complications are among clinical pearls for optimal use of calcium hydroxyapatite (Radiesse, BioForm Medical) and poly-L-lactic acid (Sculptra, Sanofi-Aventis).

"Radiesse is for structure and support and Sculptra is for diffuse volume," said Dr. Ken K. Lee, director of dermatologic surgery at Oregon Health and Science University in Portland. The two fillers are not mutually exclusive, he added. "I use these two together all the time."

Focal treatment is the goal with these fillers, Dr. Lee said. "There is a paradigm shift from filling to contouring. Contouring really was only available before with fat transfer." The gauge of needles typically used to inject calcium hydroxyapatite (27G) or poly-L-lactic acid (25G or 26G) can hurt, Dr. Lee said. He recommended local infiltration with lidocaine with epinephrine prior to injection to reduce pain and bruising. Dr. Lee does not have a disclosure regarding either filler product.

The goal with calcium hydroxyapatite is not to fill in fine lines, but to give more structure, Dr. Lee explained. The synthetic particles form scaffolding for tissue in-growth. "It is off label for cosmetic use—I do tell patients that."

Radiesse is packaged in 1.3-cc and 0.3-cc syringes. Inject into "deep dermis and a little bit into subcutaneous fat," Dr. Lee said. He recommended a threading and fanning technique, injecting only a small amount at each pass, such as 0.05 cc. Stop injection before exiting the skin and knead or mold any firm nodules after injection, he suggested.

"I don't just thread the material along the nasolabial line, I also crisscross to enhance the volume effect," Dr. Lee said. "This stuff is really thick and hard to get out of the needle, which is good. You don't want a lot of material in any one area."

Dr. Lee informs patients in advance that if they have prominent nasolabial lines or marionette lines they will likely need three syringes over two treatment sessions. "Then it doesn't look like you've failed them."

Volume from a single injection typically lasts about 9 months, Dr. Lee said. The double session strategy extends duration of effect to 1 year or longer. "Somehow getting it to last up to a year is much more appealing to patients. The downside is that complications last a long time, too."

Avoid filling thin eyelids and lips with calcium hydroxyapatite, Dr. Lee advised. Deposits can be seen in these areas. Dr. Lee said, "I really recommend collagen or hyaluronic acid for lips."

Poly-L-lactic acid, similar to calcium hydroxyapatite, is injected into the deep dermis or subcutaneous layer. Do not inject this filler superficially, Dr. Lee cautioned. "I aim for the subcutaneous layer. It is more difficult to consistently place in deep dermis and there are more complications." Inject a small amount on withdrawal.

Poly-L-lactic acid is a synthetic, biodegradable, biocompatible polymer that stimulates a patient's own collagen. Dr. Lee reconstitutes the filler with sterile water and 2% lidocaine. It is stable up to 72 hours after reconstitution. The vial is stored at room temperature but should be warmed prior to use, Dr. Lee suggested. "I have the patient hold the vial prior to injection. It helps to avoid clogging of the needle."

Massaging right after injections is very important, Dr. Lee said. "I tell patients to massage five times a day for 5 minutes for 5 days for distribution of the Sculptra."

Up to six treatment sessions may be necessary for full effect. Schedule treatment sessions about 4–6 weeks apart, Dr. Lee suggested. Volume enhancement with poly-L-lactic acid can last 2 years or more.

Hematoma is the most commonly reported complication in studies, Dr. Lee said. Subcutaneous papules are another potential problem. "You really have to be careful," he said. "Sculptra in cosmetic patients has really shown me how much volume affects the drooping of the skin."

SCOTTSDALE, ARIZ. — Existing data suggest that a subset of migraine patients may benefit from closure of their patent foramen ovale, Dr. David W. Dodick said during a symposium sponsored by the American Headache Society.

However, any clinical decision of the merits of surgical closure of a patent foramen ovale for patients with migraine should await the results of a number of ongoing safety and efficacy trials, he stressed.

Closures are being done with regularity as a treatment for migraines in the United States and Europe despite the lack of safety and efficacy data. “This [procedure] is gathering momentum, to say the least. We have a responsibility to know the data and give patients proper and appropriate advice,” said Dr. Dodick, professor of neurology at Mayo Clinic Arizona. “This is something patients will come into your office wanting to talk about, if they haven't already.”

Physicians are in a tough spot between patient demand and a dearth of data to support patent foramen ovale (PFO) closure for migraine relief, he acknowledged.

Some research indicates an association between a PFO and migraines with aura, particularly in patients with a large left-to-right shunt. In one study, patients with migraine with aura were three times more likely to have a PFO than those who experienced migraines without aura (Neurology 1999;53:2213–4).

The main take-home message for now remains that PFO appears to be more prevalent in patients whose migraines involve aura, Dr. Dodick said.

A left-to-right shunt is also more common among migraine-with-aura patients. In addition, both large atrial shunts and large PFOs are dominantly inherited and might therefore share a genetic origin (Heart 2004;90:1315–20).

One of the large, prospective trials underway is the Migraine Intervention with STARFlex Technology (MIST) study. Patients with migraine with aura will be assessed by a cardiologist and then randomized to closure or no closure.

Although results are not finalized, enrollment data show 60% of 370 participants having a right-to-left shunt (versus 27% of the general population) and 38% having a large PFO (versus 7% of the general population).

Updates and an animation that shows a possible role of PFO in migraine can be viewed on www.migraine-mist.org

PFO closure might effectively treat migraine in a subgroup of patients, Dr. Dodick proposed. A number of studies suggest that closure eliminates migraines in about one-third of migraineurs, reduces frequency in another third, and does not alter attacks in another third of patients.

“Are there factors that will reliably predict which patients will benefit? If these studies are positive, how will we know that a patient in front of us in the future will benefit significantly from this invasive procedure?” he asked.

Many headache specialists are taking a conservative stance. “While many patients have disabling migraines, many people think migraines are not life threatening. They are life altering but not life threatening,” Dr. Dodick. “And the surgery is invasive.” There is an overall peri-interventional adverse-event rate of about 6% (Catheter Cardiovasc. Interv. 2004;62:512–6).

Some physicians do not believe PFO closure will make a difference. They oppose the prospective, controlled trials underway in the United States and Canada. However, Dr. Dodick said, “like it or not, the studies are being done—which I think is good.”

SCOTTSDALE, ARIZ. — Existing data suggest that a subset of migraine patients may benefit from closure of their patent foramen ovale, Dr. David W. Dodick said during a symposium sponsored by the American Headache Society.

However, any clinical decision of the merits of surgical closure of a patent foramen ovale for patients with migraine should await the results of a number of ongoing safety and efficacy trials, he stressed.

Closures are being done with regularity as a treatment for migraines in the United States and Europe despite the lack of safety and efficacy data. “This [procedure] is gathering momentum, to say the least. We have a responsibility to know the data and give patients proper and appropriate advice,” said Dr. Dodick, professor of neurology at Mayo Clinic Arizona. “This is something patients will come into your office wanting to talk about, if they haven't already.”

Physicians are in a tough spot between patient demand and a dearth of data to support patent foramen ovale (PFO) closure for migraine relief, he acknowledged.

Some research indicates an association between a PFO and migraines with aura, particularly in patients with a large left-to-right shunt. In one study, patients with migraine with aura were three times more likely to have a PFO than those who experienced migraines without aura (Neurology 1999;53:2213–4).

The main take-home message for now remains that PFO appears to be more prevalent in patients whose migraines involve aura, Dr. Dodick said.

A left-to-right shunt is also more common among migraine-with-aura patients. In addition, both large atrial shunts and large PFOs are dominantly inherited and might therefore share a genetic origin (Heart 2004;90:1315–20).

One of the large, prospective trials underway is the Migraine Intervention with STARFlex Technology (MIST) study. Patients with migraine with aura will be assessed by a cardiologist and then randomized to closure or no closure.

Although results are not finalized, enrollment data show 60% of 370 participants having a right-to-left shunt (versus 27% of the general population) and 38% having a large PFO (versus 7% of the general population).

Updates and an animation that shows a possible role of PFO in migraine can be viewed on www.migraine-mist.org

PFO closure might effectively treat migraine in a subgroup of patients, Dr. Dodick proposed. A number of studies suggest that closure eliminates migraines in about one-third of migraineurs, reduces frequency in another third, and does not alter attacks in another third of patients.

“Are there factors that will reliably predict which patients will benefit? If these studies are positive, how will we know that a patient in front of us in the future will benefit significantly from this invasive procedure?” he asked.

Many headache specialists are taking a conservative stance. “While many patients have disabling migraines, many people think migraines are not life threatening. They are life altering but not life threatening,” Dr. Dodick. “And the surgery is invasive.” There is an overall peri-interventional adverse-event rate of about 6% (Catheter Cardiovasc. Interv. 2004;62:512–6).

Some physicians do not believe PFO closure will make a difference. They oppose the prospective, controlled trials underway in the United States and Canada. However, Dr. Dodick said, “like it or not, the studies are being done—which I think is good.”

SCOTTSDALE, ARIZ. — Existing data suggest that a subset of migraine patients may benefit from closure of their patent foramen ovale, Dr. David W. Dodick said during a symposium sponsored by the American Headache Society.

However, any clinical decision of the merits of surgical closure of a patent foramen ovale for patients with migraine should await the results of a number of ongoing safety and efficacy trials, he stressed.

Closures are being done with regularity as a treatment for migraines in the United States and Europe despite the lack of safety and efficacy data. “This [procedure] is gathering momentum, to say the least. We have a responsibility to know the data and give patients proper and appropriate advice,” said Dr. Dodick, professor of neurology at Mayo Clinic Arizona. “This is something patients will come into your office wanting to talk about, if they haven't already.”

Physicians are in a tough spot between patient demand and a dearth of data to support patent foramen ovale (PFO) closure for migraine relief, he acknowledged.

Some research indicates an association between a PFO and migraines with aura, particularly in patients with a large left-to-right shunt. In one study, patients with migraine with aura were three times more likely to have a PFO than those who experienced migraines without aura (Neurology 1999;53:2213–4).

The main take-home message for now remains that PFO appears to be more prevalent in patients whose migraines involve aura, Dr. Dodick said.

A left-to-right shunt is also more common among migraine-with-aura patients. In addition, both large atrial shunts and large PFOs are dominantly inherited and might therefore share a genetic origin (Heart 2004;90:1315–20).

One of the large, prospective trials underway is the Migraine Intervention with STARFlex Technology (MIST) study. Patients with migraine with aura will be assessed by a cardiologist and then randomized to closure or no closure.

Although results are not finalized, enrollment data show 60% of 370 participants having a right-to-left shunt (versus 27% of the general population) and 38% having a large PFO (versus 7% of the general population).

Updates and an animation that shows a possible role of PFO in migraine can be viewed on www.migraine-mist.org

PFO closure might effectively treat migraine in a subgroup of patients, Dr. Dodick proposed. A number of studies suggest that closure eliminates migraines in about one-third of migraineurs, reduces frequency in another third, and does not alter attacks in another third of patients.

“Are there factors that will reliably predict which patients will benefit? If these studies are positive, how will we know that a patient in front of us in the future will benefit significantly from this invasive procedure?” he asked.

Many headache specialists are taking a conservative stance. “While many patients have disabling migraines, many people think migraines are not life threatening. They are life altering but not life threatening,” Dr. Dodick. “And the surgery is invasive.” There is an overall peri-interventional adverse-event rate of about 6% (Catheter Cardiovasc. Interv. 2004;62:512–6).

Some physicians do not believe PFO closure will make a difference. They oppose the prospective, controlled trials underway in the United States and Canada. However, Dr. Dodick said, “like it or not, the studies are being done—which I think is good.”