Patrice Wendling

Major Finding: At 32-36 weeks' gestation, a 6.7-g increase in fetal birth weight was associated with a 1-mg/dL decrease in HDL cholesterol.

Data Source: A prospective study of 143 women whose cholesterol and triglyceride levels and whose fetuses' birth weights were measured five times during pregnancy.

Disclosures: The study was funded by the Doris Duke Charitable Foundation Clinical Research Fellowship and the National Institutes of Health. The authors disclosed no conflicts of interest.

CHICAGO — Decreased maternal HDL cholesterol during pregnancy is significantly associated with increased fetal birth weight, according to initial data from the ongoing prospective, longitudinal GROW study.

This association was particularly apparent in overweight and obese women, Dr. Uma Perni and Dr. Vinod K. Misra, both of the University of Michigan, Ann Arbor, wrote in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

“We believe that having an unhealthy lipid profile may be part of what causes large infants, who then are later at risk for chronic diseases in their lifetime,” Dr. Perni said in an interview.

Prenatal events are thought to establish lifelong physiological patterns that may manifest as diseases in later life. In 1995, the British Medical Journal named this idea the “Barker Hypothesis” based on work by British physician and epidemiologist David Barker who demonstrated that people who had a low birth weight are at greater risk of developing coronary heart disease.

The Gestational Regulators of Weight (GROW) study is the first to document the relationship between variations in birth weight and maternal serum lipids measured at multiple time points during pregnancy, according to the authors.

The researchers measured serum levels of triglycerides, HDL cholesterol (HDL-C), LDL cholesterol (LDL-C), and total cholesterol in 143 women at five time points during pregnancy: 6-10 weeks' gestation, 10-14 weeks, 16-20 weeks, 22-26 weeks, and 32-36 weeks. Linear regression analyses were conducted, with fetal birth weight adjusted for gestational age determined by a first-trimester dating scan.

In all, 85 women had a low/normal weight (body mass index 18-26 kg/m

A significant inverse relationship was observed between adjusted birth weight and HDL-C at all five time points, reported Dr. Perni, an ob.gyn. at the University of Michigan, and Dr. Misra of the department of pediatrics and communicable diseases at C.S. Mott Children's Hospital, Ann Arbor. For example, at 32-36 weeks' gestation, a 6.7-g increase in birth weight was associated with a 1-mg/dL decrease in HDL-C. The increase in birth weight associated with a 1-mg/dL decrease in HDL-C was 5.7 g at 6-10 weeks' gestation, 5.4 g at 10-14 weeks, 5.0 g at 16-20 weeks, and 6.2 g at 22-26 weeks. Birth weight was also significantly associated with triglycerides at 10-14 weeks' gestation, 22-26 weeks, and 32-36 weeks. No significant association was observed between birth weight and total cholesterol or LDL-C at any time point.

After analyses were stratified by maternal prepregnancy BMI, the association between HDL-C and birth weight was significant for low- and normal-weight women only at 32-36 weeks' gestation. At that time point, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 5.4 g. The association, however, remained significant for overweight and obese women at all time points, the authors reported. At 32-36 weeks' gestation, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 9.6 g.

“The findings suggest that the metabolic pathways influencing infant health may have very different effects in obese women,” Dr. Misra said in an interview.

Physicians face a clinical dilemma when dealing with hyperlipidemia in pregnant women who are overweight and obese, as statin use is contraindicated in pregnancy.

“One thing that we could look into is preconceptionally optimizing lipid profiles,” Dr. Perni said. “During pregnancy, we need to investigate further the safety of various lipid-lowering medications.”

'Having an unhealthy lipid profile may be part of what causes large infants.'

Source DR. PERNI

Major Finding: At 32-36 weeks' gestation, a 6.7-g increase in fetal birth weight was associated with a 1-mg/dL decrease in HDL cholesterol.

Data Source: A prospective study of 143 women whose cholesterol and triglyceride levels and whose fetuses' birth weights were measured five times during pregnancy.

Disclosures: The study was funded by the Doris Duke Charitable Foundation Clinical Research Fellowship and the National Institutes of Health. The authors disclosed no conflicts of interest.

CHICAGO — Decreased maternal HDL cholesterol during pregnancy is significantly associated with increased fetal birth weight, according to initial data from the ongoing prospective, longitudinal GROW study.

This association was particularly apparent in overweight and obese women, Dr. Uma Perni and Dr. Vinod K. Misra, both of the University of Michigan, Ann Arbor, wrote in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

“We believe that having an unhealthy lipid profile may be part of what causes large infants, who then are later at risk for chronic diseases in their lifetime,” Dr. Perni said in an interview.

Prenatal events are thought to establish lifelong physiological patterns that may manifest as diseases in later life. In 1995, the British Medical Journal named this idea the “Barker Hypothesis” based on work by British physician and epidemiologist David Barker who demonstrated that people who had a low birth weight are at greater risk of developing coronary heart disease.

The Gestational Regulators of Weight (GROW) study is the first to document the relationship between variations in birth weight and maternal serum lipids measured at multiple time points during pregnancy, according to the authors.

The researchers measured serum levels of triglycerides, HDL cholesterol (HDL-C), LDL cholesterol (LDL-C), and total cholesterol in 143 women at five time points during pregnancy: 6-10 weeks' gestation, 10-14 weeks, 16-20 weeks, 22-26 weeks, and 32-36 weeks. Linear regression analyses were conducted, with fetal birth weight adjusted for gestational age determined by a first-trimester dating scan.

In all, 85 women had a low/normal weight (body mass index 18-26 kg/m

A significant inverse relationship was observed between adjusted birth weight and HDL-C at all five time points, reported Dr. Perni, an ob.gyn. at the University of Michigan, and Dr. Misra of the department of pediatrics and communicable diseases at C.S. Mott Children's Hospital, Ann Arbor. For example, at 32-36 weeks' gestation, a 6.7-g increase in birth weight was associated with a 1-mg/dL decrease in HDL-C. The increase in birth weight associated with a 1-mg/dL decrease in HDL-C was 5.7 g at 6-10 weeks' gestation, 5.4 g at 10-14 weeks, 5.0 g at 16-20 weeks, and 6.2 g at 22-26 weeks. Birth weight was also significantly associated with triglycerides at 10-14 weeks' gestation, 22-26 weeks, and 32-36 weeks. No significant association was observed between birth weight and total cholesterol or LDL-C at any time point.

After analyses were stratified by maternal prepregnancy BMI, the association between HDL-C and birth weight was significant for low- and normal-weight women only at 32-36 weeks' gestation. At that time point, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 5.4 g. The association, however, remained significant for overweight and obese women at all time points, the authors reported. At 32-36 weeks' gestation, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 9.6 g.

“The findings suggest that the metabolic pathways influencing infant health may have very different effects in obese women,” Dr. Misra said in an interview.

Physicians face a clinical dilemma when dealing with hyperlipidemia in pregnant women who are overweight and obese, as statin use is contraindicated in pregnancy.

“One thing that we could look into is preconceptionally optimizing lipid profiles,” Dr. Perni said. “During pregnancy, we need to investigate further the safety of various lipid-lowering medications.”

'Having an unhealthy lipid profile may be part of what causes large infants.'

Source DR. PERNI

Major Finding: At 32-36 weeks' gestation, a 6.7-g increase in fetal birth weight was associated with a 1-mg/dL decrease in HDL cholesterol.

Data Source: A prospective study of 143 women whose cholesterol and triglyceride levels and whose fetuses' birth weights were measured five times during pregnancy.

Disclosures: The study was funded by the Doris Duke Charitable Foundation Clinical Research Fellowship and the National Institutes of Health. The authors disclosed no conflicts of interest.

CHICAGO — Decreased maternal HDL cholesterol during pregnancy is significantly associated with increased fetal birth weight, according to initial data from the ongoing prospective, longitudinal GROW study.

This association was particularly apparent in overweight and obese women, Dr. Uma Perni and Dr. Vinod K. Misra, both of the University of Michigan, Ann Arbor, wrote in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

“We believe that having an unhealthy lipid profile may be part of what causes large infants, who then are later at risk for chronic diseases in their lifetime,” Dr. Perni said in an interview.

Prenatal events are thought to establish lifelong physiological patterns that may manifest as diseases in later life. In 1995, the British Medical Journal named this idea the “Barker Hypothesis” based on work by British physician and epidemiologist David Barker who demonstrated that people who had a low birth weight are at greater risk of developing coronary heart disease.

The Gestational Regulators of Weight (GROW) study is the first to document the relationship between variations in birth weight and maternal serum lipids measured at multiple time points during pregnancy, according to the authors.

The researchers measured serum levels of triglycerides, HDL cholesterol (HDL-C), LDL cholesterol (LDL-C), and total cholesterol in 143 women at five time points during pregnancy: 6-10 weeks' gestation, 10-14 weeks, 16-20 weeks, 22-26 weeks, and 32-36 weeks. Linear regression analyses were conducted, with fetal birth weight adjusted for gestational age determined by a first-trimester dating scan.

In all, 85 women had a low/normal weight (body mass index 18-26 kg/m

A significant inverse relationship was observed between adjusted birth weight and HDL-C at all five time points, reported Dr. Perni, an ob.gyn. at the University of Michigan, and Dr. Misra of the department of pediatrics and communicable diseases at C.S. Mott Children's Hospital, Ann Arbor. For example, at 32-36 weeks' gestation, a 6.7-g increase in birth weight was associated with a 1-mg/dL decrease in HDL-C. The increase in birth weight associated with a 1-mg/dL decrease in HDL-C was 5.7 g at 6-10 weeks' gestation, 5.4 g at 10-14 weeks, 5.0 g at 16-20 weeks, and 6.2 g at 22-26 weeks. Birth weight was also significantly associated with triglycerides at 10-14 weeks' gestation, 22-26 weeks, and 32-36 weeks. No significant association was observed between birth weight and total cholesterol or LDL-C at any time point.

After analyses were stratified by maternal prepregnancy BMI, the association between HDL-C and birth weight was significant for low- and normal-weight women only at 32-36 weeks' gestation. At that time point, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 5.4 g. The association, however, remained significant for overweight and obese women at all time points, the authors reported. At 32-36 weeks' gestation, a 1-mg/dL decrease in HDL-C was associated with an increased birth weight of 9.6 g.

“The findings suggest that the metabolic pathways influencing infant health may have very different effects in obese women,” Dr. Misra said in an interview.

Physicians face a clinical dilemma when dealing with hyperlipidemia in pregnant women who are overweight and obese, as statin use is contraindicated in pregnancy.

“One thing that we could look into is preconceptionally optimizing lipid profiles,” Dr. Perni said. “During pregnancy, we need to investigate further the safety of various lipid-lowering medications.”

'Having an unhealthy lipid profile may be part of what causes large infants.'

Source DR. PERNI

Major Finding: Among nonpregnant women, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given intramuscular progesterone.

Data Source: A prospective trial involving 365 patients.

Disclosures: The study was supported in part by EMD Serono Inc., which distributes Crinone. Dr. Yanushpolsky disclosed receiving compensation from Columbia Laboratories for time and travel expenses to present the data. Her coauthors disclosed being members of the scientific advisory boards for MediCult, Humagen, MidAtlantic Diagnostics, WIN Fertility, and EMD Serono.

ATLANTA — Intramuscular progesterone delayed the onset of luteal phase bleeding, compared with Crinone 8% progesterone vaginal gel in nonpregnant women undergoing in vitro fertilization and embryo transfer in a prospective trial involving 365 patients.

“This isn't necessarily a good thing because it gives them false hope,” lead researcher Dr. Elena Yanushpolsky said in an interview. “Patients think they're pregnant for a longer time when they're not, and the injections are painful.”

Several meta-analyses as well as a recent large prospective, randomized trial have compared the efficacy of Crinone and intramuscular progesterone (IMP) for luteal phase support during in vitro fertilization (IVF) and reported similar pregnancy rates and IVF cycle outcomes.

However, a few studies observed an increased incidence of luteal phase bleeding in patients supplemented with Crinone.

In the current study, patient-reported luteal phase bleeding occurred with equal frequency among pregnant patients in the Crinone and IMP arms (22% vs. 19%). This was true for ongoing pregnancies (13% vs. 18%), as well as for failed pregnancies (40.5% vs. 21%).

Among nonpregnant women, however, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given IMP.

This effect was ameliorated by the administration of estrogen, according to Dr. Yanushpolsky and her colleagues at the Brigham and Women's Hospital in Boston.

“It's an issue of hormone metabolism, but not efficacy,” she said.

Overall, pregnancy rates were similar at 67% among the 190 Crinone patients vs. 64% among the 175 IMP patients, the investigators reported in a poster at the annual meeting of the American Society for Reproductive Medicine.

There were no differences in age or day 3 follicle-stimulating hormone (FSH) levels between patients who experienced bleeding and those who did not, but those who had luteal phase bleeding had significantly lower pregnancy and delivery rates, and a significantly higher likelihood of failed pregnancy.

The investigators theorized that IMP may delay bleeding because of some metabolite, while the addition of estrogen may play a role in delaying the breakdown of the endometrial lining in nonpregnant women given Crinone.

Dr. Yanushpolsky noted that anecdotally, clinicians were also reporting a low incidence of luteal phase bleeding with estrogen supplementation in women receiving either IMP or Crinone.

This prompted a post hoc analysis in 90 patients who received luteal estrogen supplementation in addition to their study medication, demonstrating that estrogen supplementation reduces luteal phase bleeding, but does not improve IVF outcomes.

Overall, patients supplemented with estrogen experienced significantly fewer episodes of luteal phase bleeding than those who did not receive estrogen (14% vs. 35%, P = .0002).

This was true within the Crinone (17% vs. 38%) and IMP treatment arms (12% vs. 30%), and among nonpregnant (23% vs. 55%) and pregnant (10% vs. 24%) patients.

Pregnancy rates, however, were similar at 64% among those who received estrogen support vs. 65% among those who did not.

Likewise, there was no difference in pregnancy rates when patients received estrogen supplementation or did not in either the Crinone arm (65% vs. 67%) or IMP arm (63% vs. 62%).

Women in the study received either IMP 50 mg/day starting 24 hours after egg retrieval or Crinone 8% gel starting 48 hours after retrieval. Their mean age was 34 years.

Major Finding: Among nonpregnant women, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given intramuscular progesterone.

Data Source: A prospective trial involving 365 patients.

Disclosures: The study was supported in part by EMD Serono Inc., which distributes Crinone. Dr. Yanushpolsky disclosed receiving compensation from Columbia Laboratories for time and travel expenses to present the data. Her coauthors disclosed being members of the scientific advisory boards for MediCult, Humagen, MidAtlantic Diagnostics, WIN Fertility, and EMD Serono.

ATLANTA — Intramuscular progesterone delayed the onset of luteal phase bleeding, compared with Crinone 8% progesterone vaginal gel in nonpregnant women undergoing in vitro fertilization and embryo transfer in a prospective trial involving 365 patients.

“This isn't necessarily a good thing because it gives them false hope,” lead researcher Dr. Elena Yanushpolsky said in an interview. “Patients think they're pregnant for a longer time when they're not, and the injections are painful.”

Several meta-analyses as well as a recent large prospective, randomized trial have compared the efficacy of Crinone and intramuscular progesterone (IMP) for luteal phase support during in vitro fertilization (IVF) and reported similar pregnancy rates and IVF cycle outcomes.

However, a few studies observed an increased incidence of luteal phase bleeding in patients supplemented with Crinone.

In the current study, patient-reported luteal phase bleeding occurred with equal frequency among pregnant patients in the Crinone and IMP arms (22% vs. 19%). This was true for ongoing pregnancies (13% vs. 18%), as well as for failed pregnancies (40.5% vs. 21%).

Among nonpregnant women, however, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given IMP.

This effect was ameliorated by the administration of estrogen, according to Dr. Yanushpolsky and her colleagues at the Brigham and Women's Hospital in Boston.

“It's an issue of hormone metabolism, but not efficacy,” she said.

Overall, pregnancy rates were similar at 67% among the 190 Crinone patients vs. 64% among the 175 IMP patients, the investigators reported in a poster at the annual meeting of the American Society for Reproductive Medicine.

There were no differences in age or day 3 follicle-stimulating hormone (FSH) levels between patients who experienced bleeding and those who did not, but those who had luteal phase bleeding had significantly lower pregnancy and delivery rates, and a significantly higher likelihood of failed pregnancy.

The investigators theorized that IMP may delay bleeding because of some metabolite, while the addition of estrogen may play a role in delaying the breakdown of the endometrial lining in nonpregnant women given Crinone.

Dr. Yanushpolsky noted that anecdotally, clinicians were also reporting a low incidence of luteal phase bleeding with estrogen supplementation in women receiving either IMP or Crinone.

This prompted a post hoc analysis in 90 patients who received luteal estrogen supplementation in addition to their study medication, demonstrating that estrogen supplementation reduces luteal phase bleeding, but does not improve IVF outcomes.

Overall, patients supplemented with estrogen experienced significantly fewer episodes of luteal phase bleeding than those who did not receive estrogen (14% vs. 35%, P = .0002).

This was true within the Crinone (17% vs. 38%) and IMP treatment arms (12% vs. 30%), and among nonpregnant (23% vs. 55%) and pregnant (10% vs. 24%) patients.

Pregnancy rates, however, were similar at 64% among those who received estrogen support vs. 65% among those who did not.

Likewise, there was no difference in pregnancy rates when patients received estrogen supplementation or did not in either the Crinone arm (65% vs. 67%) or IMP arm (63% vs. 62%).

Women in the study received either IMP 50 mg/day starting 24 hours after egg retrieval or Crinone 8% gel starting 48 hours after retrieval. Their mean age was 34 years.

Major Finding: Among nonpregnant women, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given intramuscular progesterone.

Data Source: A prospective trial involving 365 patients.

Disclosures: The study was supported in part by EMD Serono Inc., which distributes Crinone. Dr. Yanushpolsky disclosed receiving compensation from Columbia Laboratories for time and travel expenses to present the data. Her coauthors disclosed being members of the scientific advisory boards for MediCult, Humagen, MidAtlantic Diagnostics, WIN Fertility, and EMD Serono.

ATLANTA — Intramuscular progesterone delayed the onset of luteal phase bleeding, compared with Crinone 8% progesterone vaginal gel in nonpregnant women undergoing in vitro fertilization and embryo transfer in a prospective trial involving 365 patients.

“This isn't necessarily a good thing because it gives them false hope,” lead researcher Dr. Elena Yanushpolsky said in an interview. “Patients think they're pregnant for a longer time when they're not, and the injections are painful.”

Several meta-analyses as well as a recent large prospective, randomized trial have compared the efficacy of Crinone and intramuscular progesterone (IMP) for luteal phase support during in vitro fertilization (IVF) and reported similar pregnancy rates and IVF cycle outcomes.

However, a few studies observed an increased incidence of luteal phase bleeding in patients supplemented with Crinone.

In the current study, patient-reported luteal phase bleeding occurred with equal frequency among pregnant patients in the Crinone and IMP arms (22% vs. 19%). This was true for ongoing pregnancies (13% vs. 18%), as well as for failed pregnancies (40.5% vs. 21%).

Among nonpregnant women, however, the incidence of luteal phase bleeding was significantly higher at 56.5% in women treated with Crinone vs. 38% in those given IMP.

This effect was ameliorated by the administration of estrogen, according to Dr. Yanushpolsky and her colleagues at the Brigham and Women's Hospital in Boston.

“It's an issue of hormone metabolism, but not efficacy,” she said.

Overall, pregnancy rates were similar at 67% among the 190 Crinone patients vs. 64% among the 175 IMP patients, the investigators reported in a poster at the annual meeting of the American Society for Reproductive Medicine.

There were no differences in age or day 3 follicle-stimulating hormone (FSH) levels between patients who experienced bleeding and those who did not, but those who had luteal phase bleeding had significantly lower pregnancy and delivery rates, and a significantly higher likelihood of failed pregnancy.

The investigators theorized that IMP may delay bleeding because of some metabolite, while the addition of estrogen may play a role in delaying the breakdown of the endometrial lining in nonpregnant women given Crinone.

Dr. Yanushpolsky noted that anecdotally, clinicians were also reporting a low incidence of luteal phase bleeding with estrogen supplementation in women receiving either IMP or Crinone.

This prompted a post hoc analysis in 90 patients who received luteal estrogen supplementation in addition to their study medication, demonstrating that estrogen supplementation reduces luteal phase bleeding, but does not improve IVF outcomes.

Overall, patients supplemented with estrogen experienced significantly fewer episodes of luteal phase bleeding than those who did not receive estrogen (14% vs. 35%, P = .0002).

This was true within the Crinone (17% vs. 38%) and IMP treatment arms (12% vs. 30%), and among nonpregnant (23% vs. 55%) and pregnant (10% vs. 24%) patients.

Pregnancy rates, however, were similar at 64% among those who received estrogen support vs. 65% among those who did not.

Likewise, there was no difference in pregnancy rates when patients received estrogen supplementation or did not in either the Crinone arm (65% vs. 67%) or IMP arm (63% vs. 62%).

Women in the study received either IMP 50 mg/day starting 24 hours after egg retrieval or Crinone 8% gel starting 48 hours after retrieval. Their mean age was 34 years.

HOLLYWOOD, FLA. — Recommendations in favor of sentinel lymph node biopsy and against PET/CT scanning are key changes in the latest update to the breast cancer guidelines from the National Comprehensive Cancer Network.

Sentinel lymph node biopsy (SLNB) was an option in the staging of clinically negative axilla breast cancer in previous guidelines, but now becomes the standard recommendation, Dr. Robert W. Carlson reported at the National Comprehensive Cancer Network (NCCN) annual conference on clinical practice guidelines and quality cancer care.

The move is the most important change in the updated guidelines because it impacts 95% of women with newly diagnosed breast cancer, he said in an interview. A recent study reported that by 2005, 65% of women who presented with stage I/II breast cancer had their axilla evaluated by sentinel lymph node biopsy (J. Natl. Cancer Inst. 2008;100:462-74).

SLNB allows identification of the sentinel lymph node in more than 95% of cases in the hands of an experienced clinician, has a false-negative rate of less than 5% in recent series, and results in an axillary recurrence rate of less than 1% if the sentinel lymph node is negative, said Dr. Carlson, professor of medicine at Stanford (Calif.) University and chair of the NCCN breast cancer panel. The procedure also results in edema rates of about 7%, compared with 10%-20% among women undergoing formal axillary dissection.

Dr. Carlson acknowledged that SLNB surgeons are not available in all parts of the United States, SLNB may not be generalized to other countries because of resource limitations, and the recommendation could conceivably promote the adoption of SLNB by providers who are not skilled in the procedure.

The guidelines specify, however, that patients who are sentinel node candidates without access to an experienced sentinel node team should be referred to an experienced team.

For candidates with access to an experienced team who are node positive at the time of diagnosis, the recommendation is for an axillary lymph node dissection. An alternative is to perform a fine-needle aspiration or core biopsy of the suspicious lymph node and, if it is found to be negative, to proceed to sentinel lymph node mapping and evaluation, he said.

For patients who have access to an experienced team and have node-negative axilla, the recommendation is for sentinel node mapping; only if the sentinel node is positive or could not be identified would the woman then go on to formal axillary dissection, he said.

SLN biopsy is reasonable to perform in women with pure ductal carcinoma in situ who are undergoing mastectomy or other surgeries that can compromise the ability to perform a SLN procedure should invasive cancer be found, according to a footnote in the new guidelines.

PET and PET/CT Scanning

The panel spoke out on the use of PET and PET/CT scanning—an area in which it had been silent in previous guidelines. The decision was prompted by the overuse of PET and PET/CT scans, despite their having relatively low sensitivity and specificity in the evaluation of breast cancer, Dr. Carlson said. Sensitivity was only 20%-60% in early disease in two studies; in a review of nine studies in recurrent/metastatic disease, sensitivity was 81%-93% and specificity 75%-100%.

“It's a situation where a positive result is at least as likely to mislead you as it is to assist you in determining optimal treatment sequences,” he said.

As for what's fueling the overuse, Dr. Carlson suggested in an interview that it may be that the technology is new and the scans are simple to order and very expensive, so there are financial rewards for those who perform the test frequently.

“We live in a society where if something has a high price tag, we assume it has value. And so I think that a lot of patients misunderstand that the newest technology is not necessarily the best technology, even if it is extraordinarily expensive,” he said.

The panel added a footnote stating that “PET or PET/CT is not indicated in the staging of clinical stage I/II or operable stage III breast cancer.”

Based on level IIb evidence, PET/CT is considered an “optional study” in stage III inoperable cancer and may be most helpful where standard staging studies are equivocal or suspicious.

Another new footnote states that PET or PET/CT scanning “should generally be discouraged for the evaluation of metastatic disease, except in those clinical situations where other staging studies are equivocal or suspicious. Even in these situations, biopsy of equivocal or suspicious sites is more likely to provide useful information.”

Genetics

Genetic counseling was upgraded from a footnote to a recommended component of the general work-up, if the patient is at high risk for hereditary breast cancer. The major reason for the emphasis is to make sure physicians perform genetic testing, Dr. Carlson said.

“Doing genetic testing is not really part of breast cancer treatment, but it is so central to what we should be doing that it's important to do and consider early,” he said. “There are also some subtleties, in terms of how you treat the breast locally, that are affected by whether the BRCA1 and BRCA2 mutations are present … and might shift the balance towards mastectomy, as opposed to breast conservation.”

The panel also recommended that the general work-up should include determination of tumor estrogen/progesterone (ER/PR) status and HER2 status. The recommendation is based on two studies utilizing a 21-gene assay (Oncotype DX) in women with hormone receptive–positive, node-negative cancer who receive tamoxifen alone or with chemotherapy.

In the NSABP (National Surgical Adjuvant Breast and Bowel Project) B-14 trial, women with a low recurrence score based on their genetic test had superior survival at 10 years, compared with those with intermediate or high recurrence scores. In the NSABP B-20 trial, only those women with high recurrence scores benefited from tamoxifen plus chemotherapy.

“The recurrence score might be able to stratify women who will benefit from the application of cytotoxic chemotherapy,” Dr. Carlson said.

He went on to note, however, that major use of the assay is limited to ER-positive, HER2-negative, node-negative disease because the assay has been validated only in this setting and in women who were treated with tamoxifen and first-generation chemotherapy, and because most HER2-positive disease has a high recurrence score. There were insufficient data to make a recommendation on the 70-gene Mammoprint assay, he said.

Paclitaxel

Doxorubicin/cyclophosphamide followed by paclitaxel every 3 weeks was removed from the list of recommended adjuvant regimens based on data showing that the thrice-weekly regimen was inferior to paclitaxel every 2 weeks or weekly.

HER2-Targeted Therapy

The panel declined to add either trastuzumab or lapatinib in combination with endocrine therapy to its algorithm as preferred agents for the treatment of ER-positive, HER2-positive, metastatic disease. They cited a lack of evidence demonstrating an overall survival benefit with the agents, and concerns that early use of HER2-targeted therapies in combination with endocrine therapy may negatively impact survival benefit from trastuzumab therapy downstream.

The subject was revisited after the Food and Drug Administration recently added an indication to the lapatinib (Tykerb) package insert for lapatinib in combination with letrozole (Femara) for patients with advanced, ER-positive, HER2-positive cancer in whom hormone therapy is indicated. Overall NCCN panel recommendations regarding HER2 targeted therapy and endocrine therapy will be announced at a later date, Dr. Carlson said.

Disclosures: Dr. Carlson disclosed receiving research support from and being a consultant for AstraZeneca Pharmaceuticals LP, receiving grant support from BiPAR Pharmaceuticals and Genentech Inc., and being a consultant for Pfizer Inc.

HOLLYWOOD, FLA. — Recommendations in favor of sentinel lymph node biopsy and against PET/CT scanning are key changes in the latest update to the breast cancer guidelines from the National Comprehensive Cancer Network.

Sentinel lymph node biopsy (SLNB) was an option in the staging of clinically negative axilla breast cancer in previous guidelines, but now becomes the standard recommendation, Dr. Robert W. Carlson reported at the National Comprehensive Cancer Network (NCCN) annual conference on clinical practice guidelines and quality cancer care.

The move is the most important change in the updated guidelines because it impacts 95% of women with newly diagnosed breast cancer, he said in an interview. A recent study reported that by 2005, 65% of women who presented with stage I/II breast cancer had their axilla evaluated by sentinel lymph node biopsy (J. Natl. Cancer Inst. 2008;100:462-74).

SLNB allows identification of the sentinel lymph node in more than 95% of cases in the hands of an experienced clinician, has a false-negative rate of less than 5% in recent series, and results in an axillary recurrence rate of less than 1% if the sentinel lymph node is negative, said Dr. Carlson, professor of medicine at Stanford (Calif.) University and chair of the NCCN breast cancer panel. The procedure also results in edema rates of about 7%, compared with 10%-20% among women undergoing formal axillary dissection.

Dr. Carlson acknowledged that SLNB surgeons are not available in all parts of the United States, SLNB may not be generalized to other countries because of resource limitations, and the recommendation could conceivably promote the adoption of SLNB by providers who are not skilled in the procedure.

The guidelines specify, however, that patients who are sentinel node candidates without access to an experienced sentinel node team should be referred to an experienced team.

For candidates with access to an experienced team who are node positive at the time of diagnosis, the recommendation is for an axillary lymph node dissection. An alternative is to perform a fine-needle aspiration or core biopsy of the suspicious lymph node and, if it is found to be negative, to proceed to sentinel lymph node mapping and evaluation, he said.

For patients who have access to an experienced team and have node-negative axilla, the recommendation is for sentinel node mapping; only if the sentinel node is positive or could not be identified would the woman then go on to formal axillary dissection, he said.

SLN biopsy is reasonable to perform in women with pure ductal carcinoma in situ who are undergoing mastectomy or other surgeries that can compromise the ability to perform a SLN procedure should invasive cancer be found, according to a footnote in the new guidelines.

PET and PET/CT Scanning

The panel spoke out on the use of PET and PET/CT scanning—an area in which it had been silent in previous guidelines. The decision was prompted by the overuse of PET and PET/CT scans, despite their having relatively low sensitivity and specificity in the evaluation of breast cancer, Dr. Carlson said. Sensitivity was only 20%-60% in early disease in two studies; in a review of nine studies in recurrent/metastatic disease, sensitivity was 81%-93% and specificity 75%-100%.

“It's a situation where a positive result is at least as likely to mislead you as it is to assist you in determining optimal treatment sequences,” he said.

As for what's fueling the overuse, Dr. Carlson suggested in an interview that it may be that the technology is new and the scans are simple to order and very expensive, so there are financial rewards for those who perform the test frequently.

“We live in a society where if something has a high price tag, we assume it has value. And so I think that a lot of patients misunderstand that the newest technology is not necessarily the best technology, even if it is extraordinarily expensive,” he said.

The panel added a footnote stating that “PET or PET/CT is not indicated in the staging of clinical stage I/II or operable stage III breast cancer.”

Based on level IIb evidence, PET/CT is considered an “optional study” in stage III inoperable cancer and may be most helpful where standard staging studies are equivocal or suspicious.

Another new footnote states that PET or PET/CT scanning “should generally be discouraged for the evaluation of metastatic disease, except in those clinical situations where other staging studies are equivocal or suspicious. Even in these situations, biopsy of equivocal or suspicious sites is more likely to provide useful information.”

Genetics

Genetic counseling was upgraded from a footnote to a recommended component of the general work-up, if the patient is at high risk for hereditary breast cancer. The major reason for the emphasis is to make sure physicians perform genetic testing, Dr. Carlson said.

“Doing genetic testing is not really part of breast cancer treatment, but it is so central to what we should be doing that it's important to do and consider early,” he said. “There are also some subtleties, in terms of how you treat the breast locally, that are affected by whether the BRCA1 and BRCA2 mutations are present … and might shift the balance towards mastectomy, as opposed to breast conservation.”

The panel also recommended that the general work-up should include determination of tumor estrogen/progesterone (ER/PR) status and HER2 status. The recommendation is based on two studies utilizing a 21-gene assay (Oncotype DX) in women with hormone receptive–positive, node-negative cancer who receive tamoxifen alone or with chemotherapy.

In the NSABP (National Surgical Adjuvant Breast and Bowel Project) B-14 trial, women with a low recurrence score based on their genetic test had superior survival at 10 years, compared with those with intermediate or high recurrence scores. In the NSABP B-20 trial, only those women with high recurrence scores benefited from tamoxifen plus chemotherapy.

“The recurrence score might be able to stratify women who will benefit from the application of cytotoxic chemotherapy,” Dr. Carlson said.

He went on to note, however, that major use of the assay is limited to ER-positive, HER2-negative, node-negative disease because the assay has been validated only in this setting and in women who were treated with tamoxifen and first-generation chemotherapy, and because most HER2-positive disease has a high recurrence score. There were insufficient data to make a recommendation on the 70-gene Mammoprint assay, he said.

Paclitaxel

Doxorubicin/cyclophosphamide followed by paclitaxel every 3 weeks was removed from the list of recommended adjuvant regimens based on data showing that the thrice-weekly regimen was inferior to paclitaxel every 2 weeks or weekly.

HER2-Targeted Therapy

The panel declined to add either trastuzumab or lapatinib in combination with endocrine therapy to its algorithm as preferred agents for the treatment of ER-positive, HER2-positive, metastatic disease. They cited a lack of evidence demonstrating an overall survival benefit with the agents, and concerns that early use of HER2-targeted therapies in combination with endocrine therapy may negatively impact survival benefit from trastuzumab therapy downstream.

The subject was revisited after the Food and Drug Administration recently added an indication to the lapatinib (Tykerb) package insert for lapatinib in combination with letrozole (Femara) for patients with advanced, ER-positive, HER2-positive cancer in whom hormone therapy is indicated. Overall NCCN panel recommendations regarding HER2 targeted therapy and endocrine therapy will be announced at a later date, Dr. Carlson said.

Disclosures: Dr. Carlson disclosed receiving research support from and being a consultant for AstraZeneca Pharmaceuticals LP, receiving grant support from BiPAR Pharmaceuticals and Genentech Inc., and being a consultant for Pfizer Inc.

HOLLYWOOD, FLA. — Recommendations in favor of sentinel lymph node biopsy and against PET/CT scanning are key changes in the latest update to the breast cancer guidelines from the National Comprehensive Cancer Network.

Sentinel lymph node biopsy (SLNB) was an option in the staging of clinically negative axilla breast cancer in previous guidelines, but now becomes the standard recommendation, Dr. Robert W. Carlson reported at the National Comprehensive Cancer Network (NCCN) annual conference on clinical practice guidelines and quality cancer care.

The move is the most important change in the updated guidelines because it impacts 95% of women with newly diagnosed breast cancer, he said in an interview. A recent study reported that by 2005, 65% of women who presented with stage I/II breast cancer had their axilla evaluated by sentinel lymph node biopsy (J. Natl. Cancer Inst. 2008;100:462-74).

SLNB allows identification of the sentinel lymph node in more than 95% of cases in the hands of an experienced clinician, has a false-negative rate of less than 5% in recent series, and results in an axillary recurrence rate of less than 1% if the sentinel lymph node is negative, said Dr. Carlson, professor of medicine at Stanford (Calif.) University and chair of the NCCN breast cancer panel. The procedure also results in edema rates of about 7%, compared with 10%-20% among women undergoing formal axillary dissection.

Dr. Carlson acknowledged that SLNB surgeons are not available in all parts of the United States, SLNB may not be generalized to other countries because of resource limitations, and the recommendation could conceivably promote the adoption of SLNB by providers who are not skilled in the procedure.

The guidelines specify, however, that patients who are sentinel node candidates without access to an experienced sentinel node team should be referred to an experienced team.

For candidates with access to an experienced team who are node positive at the time of diagnosis, the recommendation is for an axillary lymph node dissection. An alternative is to perform a fine-needle aspiration or core biopsy of the suspicious lymph node and, if it is found to be negative, to proceed to sentinel lymph node mapping and evaluation, he said.

For patients who have access to an experienced team and have node-negative axilla, the recommendation is for sentinel node mapping; only if the sentinel node is positive or could not be identified would the woman then go on to formal axillary dissection, he said.

SLN biopsy is reasonable to perform in women with pure ductal carcinoma in situ who are undergoing mastectomy or other surgeries that can compromise the ability to perform a SLN procedure should invasive cancer be found, according to a footnote in the new guidelines.

PET and PET/CT Scanning

The panel spoke out on the use of PET and PET/CT scanning—an area in which it had been silent in previous guidelines. The decision was prompted by the overuse of PET and PET/CT scans, despite their having relatively low sensitivity and specificity in the evaluation of breast cancer, Dr. Carlson said. Sensitivity was only 20%-60% in early disease in two studies; in a review of nine studies in recurrent/metastatic disease, sensitivity was 81%-93% and specificity 75%-100%.

“It's a situation where a positive result is at least as likely to mislead you as it is to assist you in determining optimal treatment sequences,” he said.

As for what's fueling the overuse, Dr. Carlson suggested in an interview that it may be that the technology is new and the scans are simple to order and very expensive, so there are financial rewards for those who perform the test frequently.

“We live in a society where if something has a high price tag, we assume it has value. And so I think that a lot of patients misunderstand that the newest technology is not necessarily the best technology, even if it is extraordinarily expensive,” he said.

The panel added a footnote stating that “PET or PET/CT is not indicated in the staging of clinical stage I/II or operable stage III breast cancer.”

Based on level IIb evidence, PET/CT is considered an “optional study” in stage III inoperable cancer and may be most helpful where standard staging studies are equivocal or suspicious.

Another new footnote states that PET or PET/CT scanning “should generally be discouraged for the evaluation of metastatic disease, except in those clinical situations where other staging studies are equivocal or suspicious. Even in these situations, biopsy of equivocal or suspicious sites is more likely to provide useful information.”

Genetics

Genetic counseling was upgraded from a footnote to a recommended component of the general work-up, if the patient is at high risk for hereditary breast cancer. The major reason for the emphasis is to make sure physicians perform genetic testing, Dr. Carlson said.

“Doing genetic testing is not really part of breast cancer treatment, but it is so central to what we should be doing that it's important to do and consider early,” he said. “There are also some subtleties, in terms of how you treat the breast locally, that are affected by whether the BRCA1 and BRCA2 mutations are present … and might shift the balance towards mastectomy, as opposed to breast conservation.”

The panel also recommended that the general work-up should include determination of tumor estrogen/progesterone (ER/PR) status and HER2 status. The recommendation is based on two studies utilizing a 21-gene assay (Oncotype DX) in women with hormone receptive–positive, node-negative cancer who receive tamoxifen alone or with chemotherapy.

In the NSABP (National Surgical Adjuvant Breast and Bowel Project) B-14 trial, women with a low recurrence score based on their genetic test had superior survival at 10 years, compared with those with intermediate or high recurrence scores. In the NSABP B-20 trial, only those women with high recurrence scores benefited from tamoxifen plus chemotherapy.

“The recurrence score might be able to stratify women who will benefit from the application of cytotoxic chemotherapy,” Dr. Carlson said.

He went on to note, however, that major use of the assay is limited to ER-positive, HER2-negative, node-negative disease because the assay has been validated only in this setting and in women who were treated with tamoxifen and first-generation chemotherapy, and because most HER2-positive disease has a high recurrence score. There were insufficient data to make a recommendation on the 70-gene Mammoprint assay, he said.

Paclitaxel

Doxorubicin/cyclophosphamide followed by paclitaxel every 3 weeks was removed from the list of recommended adjuvant regimens based on data showing that the thrice-weekly regimen was inferior to paclitaxel every 2 weeks or weekly.

HER2-Targeted Therapy

The panel declined to add either trastuzumab or lapatinib in combination with endocrine therapy to its algorithm as preferred agents for the treatment of ER-positive, HER2-positive, metastatic disease. They cited a lack of evidence demonstrating an overall survival benefit with the agents, and concerns that early use of HER2-targeted therapies in combination with endocrine therapy may negatively impact survival benefit from trastuzumab therapy downstream.

The subject was revisited after the Food and Drug Administration recently added an indication to the lapatinib (Tykerb) package insert for lapatinib in combination with letrozole (Femara) for patients with advanced, ER-positive, HER2-positive cancer in whom hormone therapy is indicated. Overall NCCN panel recommendations regarding HER2 targeted therapy and endocrine therapy will be announced at a later date, Dr. Carlson said.

Disclosures: Dr. Carlson disclosed receiving research support from and being a consultant for AstraZeneca Pharmaceuticals LP, receiving grant support from BiPAR Pharmaceuticals and Genentech Inc., and being a consultant for Pfizer Inc.

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 64,489 women who underwent routine level II second-trimester ultrasound at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%-20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 years vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6% vs. 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth. No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

Another attendee asked whether the investigators observed a pattern as to when the fetal deaths occurred. The incidence of stillbirth occurred relatively equally across gestational ages, with 26.7% occurring at 24-27 weeks' gestation, 16.7% at 28-31 weeks, 24.1% at 32-36 weeks, and 32.5% at 37-42 weeks, Dr. Stout said.

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 64,489 women who underwent routine level II second-trimester ultrasound at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%-20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 years vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6% vs. 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth. No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

Another attendee asked whether the investigators observed a pattern as to when the fetal deaths occurred. The incidence of stillbirth occurred relatively equally across gestational ages, with 26.7% occurring at 24-27 weeks' gestation, 16.7% at 28-31 weeks, 24.1% at 32-36 weeks, and 32.5% at 37-42 weeks, Dr. Stout said.

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 64,489 women who underwent routine level II second-trimester ultrasound at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%-20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 years vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6% vs. 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth. No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

Another attendee asked whether the investigators observed a pattern as to when the fetal deaths occurred. The incidence of stillbirth occurred relatively equally across gestational ages, with 26.7% occurring at 24-27 weeks' gestation, 16.7% at 28-31 weeks, 24.1% at 32-36 weeks, and 32.5% at 37-42 weeks, Dr. Stout said.

Major Finding: For white women, 91% of stillbirths occurred antepartum and only 9% were intrapartum, in contrast to black women, for whom 67% were antepartum and 33% were intrapartum.

Data Source: Population-based, case-control study of 512 stillbirths by the Stillbirth Collaborative Research Network.

Disclosures: The study was funded by the National Institute of Child Health and Human Development. Dr. Silver disclosed no conflicts of interest.

CHICAGO — Black women are more likely than white women to have stillbirths that are intrapartum and due to obstetric complications and infections, according to an analysis of 512 stillbirths by the Stillbirth Collaborative Research Network.

“The proportion of stillbirths due to various causes differs by race/ethnicity and may contribute to racial disparity in stillbirth,” Dr. Robert M. Silver said at the annual meeting of the Society for Maternal-Fetal Medicine.

Roughly 26,000 stillbirths occur each year in the United States, according to the National Center for Health Statistics (2005 data).

Non-Hispanic blacks have the highest stillbirth rate at 11.1/1,000 live births, compared with the national stillbirth rate of 6.2/1,000 live births in 2005, he noted.

The current analysis was based on all stillbirths and a representative sample of live births occurring from March 2006 to August 2008 in five geographically diverse regions in 59 hospitals.

Of the 958 eligible stillbirths, 512 had complete postmortem examinations. Roughly 36% of women were white; 22.5%, black; 34.5%, Hispanic; and 7%, other.

For white women, 91% of stillbirths occurred antepartum, and only 9% were intrapartum.

This is in contrast to black women, for whom 67% of stillbirths were antepartum and 33% were intrapartum, Dr. Silver reported on behalf of the Stillbirth Collaborative Research Network of the National Institute of Child Health and Human Development.

The investigators were able to identify a probable cause of death in 61% of stillbirths and a possible or probable cause in 81%. Forty percent of cases had more than one possible or probable cause.

The most common cause of stillbirth, occurring in 35% of cases, was placental abnormality due most often to thrombosis, infarction, or placental insufficiency.

Another 29% of cases were associated with an obstetric complication. Of these, half or 15% of the entire cohort were due to a sequence involving cervical insufficiency, preterm labor, and chorioamnionitis, said Dr. Silver, chief of maternal-fetal medicine at the University of Utah in Salt Lake City.

Other stillbirth causes included fetal abnormalities (15%), infection (13%), maternal medical conditions (10.5%), cord abnormalities (10%), and hypertension (9%).

Infection and obstetric complications were more common in intrapartum cases, while placental insufficiency was more frequent in antepartum stillbirth, he said.

Infection occurred in 10% of antepartum vs. 25% of intrapartum stillbirths; obstetric complications, in 15% of antepartum and 100% of intrapartum stillbirths; and placental causes in 39% vs. 19.5%.

Overall, more than one-third of women had stillbirths between 20 and 24 weeks' gestation.

Of note, 78% of intrapartum stillbirths occurred at weeks 20-24, almost exclusively in cases where there was no obstetric intervention for fetal indications due to a previable or periviable gestation.

“Future research should focus on placental and obstetric causes of [stillbirth] and racial disparity in stillbirth,” said Dr. Silver, who described the analysis as the “first scratch of a very large data set.”

Major Finding: For white women, 91% of stillbirths occurred antepartum and only 9% were intrapartum, in contrast to black women, for whom 67% were antepartum and 33% were intrapartum.

Data Source: Population-based, case-control study of 512 stillbirths by the Stillbirth Collaborative Research Network.

Disclosures: The study was funded by the National Institute of Child Health and Human Development. Dr. Silver disclosed no conflicts of interest.

CHICAGO — Black women are more likely than white women to have stillbirths that are intrapartum and due to obstetric complications and infections, according to an analysis of 512 stillbirths by the Stillbirth Collaborative Research Network.

“The proportion of stillbirths due to various causes differs by race/ethnicity and may contribute to racial disparity in stillbirth,” Dr. Robert M. Silver said at the annual meeting of the Society for Maternal-Fetal Medicine.

Roughly 26,000 stillbirths occur each year in the United States, according to the National Center for Health Statistics (2005 data).

Non-Hispanic blacks have the highest stillbirth rate at 11.1/1,000 live births, compared with the national stillbirth rate of 6.2/1,000 live births in 2005, he noted.

The current analysis was based on all stillbirths and a representative sample of live births occurring from March 2006 to August 2008 in five geographically diverse regions in 59 hospitals.

Of the 958 eligible stillbirths, 512 had complete postmortem examinations. Roughly 36% of women were white; 22.5%, black; 34.5%, Hispanic; and 7%, other.

For white women, 91% of stillbirths occurred antepartum, and only 9% were intrapartum.

This is in contrast to black women, for whom 67% of stillbirths were antepartum and 33% were intrapartum, Dr. Silver reported on behalf of the Stillbirth Collaborative Research Network of the National Institute of Child Health and Human Development.

The investigators were able to identify a probable cause of death in 61% of stillbirths and a possible or probable cause in 81%. Forty percent of cases had more than one possible or probable cause.

The most common cause of stillbirth, occurring in 35% of cases, was placental abnormality due most often to thrombosis, infarction, or placental insufficiency.

Another 29% of cases were associated with an obstetric complication. Of these, half or 15% of the entire cohort were due to a sequence involving cervical insufficiency, preterm labor, and chorioamnionitis, said Dr. Silver, chief of maternal-fetal medicine at the University of Utah in Salt Lake City.

Other stillbirth causes included fetal abnormalities (15%), infection (13%), maternal medical conditions (10.5%), cord abnormalities (10%), and hypertension (9%).

Infection and obstetric complications were more common in intrapartum cases, while placental insufficiency was more frequent in antepartum stillbirth, he said.

Infection occurred in 10% of antepartum vs. 25% of intrapartum stillbirths; obstetric complications, in 15% of antepartum and 100% of intrapartum stillbirths; and placental causes in 39% vs. 19.5%.

Overall, more than one-third of women had stillbirths between 20 and 24 weeks' gestation.

Of note, 78% of intrapartum stillbirths occurred at weeks 20-24, almost exclusively in cases where there was no obstetric intervention for fetal indications due to a previable or periviable gestation.

“Future research should focus on placental and obstetric causes of [stillbirth] and racial disparity in stillbirth,” said Dr. Silver, who described the analysis as the “first scratch of a very large data set.”

Major Finding: For white women, 91% of stillbirths occurred antepartum and only 9% were intrapartum, in contrast to black women, for whom 67% were antepartum and 33% were intrapartum.

Data Source: Population-based, case-control study of 512 stillbirths by the Stillbirth Collaborative Research Network.

Disclosures: The study was funded by the National Institute of Child Health and Human Development. Dr. Silver disclosed no conflicts of interest.

CHICAGO — Black women are more likely than white women to have stillbirths that are intrapartum and due to obstetric complications and infections, according to an analysis of 512 stillbirths by the Stillbirth Collaborative Research Network.

“The proportion of stillbirths due to various causes differs by race/ethnicity and may contribute to racial disparity in stillbirth,” Dr. Robert M. Silver said at the annual meeting of the Society for Maternal-Fetal Medicine.

Roughly 26,000 stillbirths occur each year in the United States, according to the National Center for Health Statistics (2005 data).

Non-Hispanic blacks have the highest stillbirth rate at 11.1/1,000 live births, compared with the national stillbirth rate of 6.2/1,000 live births in 2005, he noted.

The current analysis was based on all stillbirths and a representative sample of live births occurring from March 2006 to August 2008 in five geographically diverse regions in 59 hospitals.

Of the 958 eligible stillbirths, 512 had complete postmortem examinations. Roughly 36% of women were white; 22.5%, black; 34.5%, Hispanic; and 7%, other.

For white women, 91% of stillbirths occurred antepartum, and only 9% were intrapartum.

This is in contrast to black women, for whom 67% of stillbirths were antepartum and 33% were intrapartum, Dr. Silver reported on behalf of the Stillbirth Collaborative Research Network of the National Institute of Child Health and Human Development.

The investigators were able to identify a probable cause of death in 61% of stillbirths and a possible or probable cause in 81%. Forty percent of cases had more than one possible or probable cause.

The most common cause of stillbirth, occurring in 35% of cases, was placental abnormality due most often to thrombosis, infarction, or placental insufficiency.

Another 29% of cases were associated with an obstetric complication. Of these, half or 15% of the entire cohort were due to a sequence involving cervical insufficiency, preterm labor, and chorioamnionitis, said Dr. Silver, chief of maternal-fetal medicine at the University of Utah in Salt Lake City.

Other stillbirth causes included fetal abnormalities (15%), infection (13%), maternal medical conditions (10.5%), cord abnormalities (10%), and hypertension (9%).

Infection and obstetric complications were more common in intrapartum cases, while placental insufficiency was more frequent in antepartum stillbirth, he said.

Infection occurred in 10% of antepartum vs. 25% of intrapartum stillbirths; obstetric complications, in 15% of antepartum and 100% of intrapartum stillbirths; and placental causes in 39% vs. 19.5%.

Overall, more than one-third of women had stillbirths between 20 and 24 weeks' gestation.

Of note, 78% of intrapartum stillbirths occurred at weeks 20-24, almost exclusively in cases where there was no obstetric intervention for fetal indications due to a previable or periviable gestation.

“Future research should focus on placental and obstetric causes of [stillbirth] and racial disparity in stillbirth,” said Dr. Silver, who described the analysis as the “first scratch of a very large data set.”

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

Major Finding: Death or neurologic impairment at 18-24 months was just under 14% among the offspring of women at high risk for preterm birth, irrespective of whether they were given a single course or multiple courses of antenatal corticosteroids.

Data Source: The MACS trial of 1,858 women at high risk for preterm birth.

Disclosures: MACS was funded by the Canadian Institutes of Health Research. The authors disclosed no conflicts of interest.

CHICAGO — The risk of death or neurologic impairment was similar at 2 years after exposure to either single or multiple courses of antenatal corticosteroids, according to a follow-up analysis of data from the multicenter MACS trial.

“Continued follow-up of these children is important and necessary to determine if there are subtle effects of steroid exposure that only become evident in later years,” Dr. Elizabeth Asztalos said at the annual meeting of the Society of Maternal-Fetal Medicine.

The findings are encouraging as the same group previously reported that multiple courses of antenatal corticosteroids (ACS) given at 14-day intervals do not improve preterm birth outcomes and are associated with a significant decrease in weight, length, and head circumference at birth (Lancet 2008;372:2143-51). “Therefore, this treatment schedule is not recommended,” the authors wrote.

MACS, the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, included women who were at high risk of preterm birth at 25-32 weeks' gestation. All of the women received an initial course of ACS. There were 1,858 women who were undelivered and remained at high risk at 14-21 days after the initial course of ACS. These women were randomized to either ACS or placebo given every 14 days until week 33 or delivery, whichever came first.

The secondary composite outcome of death or neurologic impairment was evaluated at 18-24 months. Neurologic impairment was defined as cerebral palsy or abnormal cognitive development defined by a Mental Development Index (MDI) score of less than 70 on the Bayley Scales of Infant Development–Second Edition.

Evaluations were conducted in 1,069 infants exposed to multiple courses of ACS and 1,035 infants exposed to placebo at a median of 22 months old.

The occurrence rate of the composite outcome was nearly identical—13.8% (148) of the ACS group and in 13.7% (142) of the placebo group, said Dr. Asztalos of the department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre in Toronto. Also, the components of the composite outcome were nearly identical—mortality (49 vs. 47), cerebral palsy (24 vs. 25), and cognitive impairment (86 vs. 84).

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.

Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.

Disclosures: None was reported.

CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.

Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.

A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.

In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.

The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.

Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.

No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.

The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.

Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.

A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.

The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.

Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.

Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.

In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.

He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.

FT. LAUDERDALE, FLA. — What do atypical antipsychotics, an analeptic, and targeted magnets have in common? They all might play a role in the treatment of anorexia nervosa.

“When you have a disorder that is so treatment resistant, it's like metastatic breast cancer; you have to think outside the box for new interventions,” Dr. Allan S. Kaplan said at a workshop on eating disorders at the annual meeting of the American College of Psychiatrists.

Current statistics indicate that 20% of patients diagnosed with anorexia are resistant to any intervention. The needs of these patients have been largely neglected even though their numbers continue to grow as a result of the mortality decreasing from 22% in older studies to about 8%–10% today, said Dr. Kaplan, professor of psychiatry at the University of Toronto.

In his experience, many of these patients are now in their 40s and 50s and have been ill for 20-30 years. Most have significant medical complications: renal failure, cardiac arrhythmias, and osteoporosis with resulting hip fractures that have left them wheelchair-bound.

“They are unbelievably disabled,” he said. “They are more disabled on quality-of-life scales than a comparative group of schizophrenics in the hospital.”

One novel approach that might be useful is use of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective in some patients with depression, schizophrenia, and obsessive-compulsive disorder. Current magnets stimulate superficial cortical areas of the brain, but Dr. Kaplan suggests that a better target might be the insula—a cerebral cortex structure that plays a role in interoceptive awareness and motor control. His group recently completed an unpublished meta-analysis of neuroimaging studies in anorexia that provides evidence for overactivity in the insula.

The team members have subsequently contracted with an Israeli biotechnology firm to construct a patented magnet for rTMS that will specifically target the insula.

The approach is not without controversy, Dr. Kaplan acknowledged. Although the seizure rate with rTMS is very low in patients with depression, patients with anorexia are at an increased risk for seizures at a rate of about 10% in general.

Atypical antipsychotics have come under increased scrutiny for anorexia, but with limited success in the few small studies and case reports to date. A recent meta-analysis of 43 publications concluded that there is not enough evidence in anorexia to confirm that these medications increase weight (Eur. Eat. Disord. Rev. 2010;18:10-21).

Olanzapine is the atypical antipsychotic that has been the most reported drug in the literature for treating anorexia and has been the subject of three small randomized controlled trials. Researchers in Ottawa showed that 10 weeks of olanzapine plus intensive day treatment resulted in faster weight gain and a greater decrease in obsessive symptoms than placebo in 34 patients with anorexia, but overall the same amount of weight gain (Am. J. Psychiatry 2008;165:1281-8).

Dr. Kaplan and Dr. Evelyn Attia of Columbia University reported in a separate unpublished trial in 2005 that patients gained a mean of almost 2 kgrafter 8 weeks of up to 10 mg olanzapine. Patients credited this not to an increase in hunger, but to being less anxious and consumed by thoughts of weight and shape. Importantly, there was no change in lipids, glucose, or insulin sensitivity, suggesting something might be different about the way the anorexic brain handles these drugs, he said.

Positive results on both weight gain and cognition have been seen with ziprasidone and quetiapine, but their use has been limited by concerns about QT interval prolongation, which is already an issue in anorexia. Because of this concern, olanzapine was selected instead of ziprasidone as the study drug for a large multicenter anorexia trial that is planned, he said.

Finally, workshop attendee Dr. Charles Price reported an acute response in a single patient with anorexia given modafinil and followed for 6 months. In a counterintuitive finding, the drug did not have the weight loss aspects observed with other stimulants.

“Basically, it cured her anorexia; now it is an 'N' of one,” said Dr. Price, who is in private practice in Reno, Nev.

Dr. Kaplan reported having no conflicts of interest. Dr. Attia reported having received research support from Pfizer and Eli Lilly.

FT. LAUDERDALE, FLA. — What do atypical antipsychotics, an analeptic, and targeted magnets have in common? They all might play a role in the treatment of anorexia nervosa.

“When you have a disorder that is so treatment resistant, it's like metastatic breast cancer; you have to think outside the box for new interventions,” Dr. Allan S. Kaplan said at a workshop on eating disorders at the annual meeting of the American College of Psychiatrists.

Current statistics indicate that 20% of patients diagnosed with anorexia are resistant to any intervention. The needs of these patients have been largely neglected even though their numbers continue to grow as a result of the mortality decreasing from 22% in older studies to about 8%–10% today, said Dr. Kaplan, professor of psychiatry at the University of Toronto.

In his experience, many of these patients are now in their 40s and 50s and have been ill for 20-30 years. Most have significant medical complications: renal failure, cardiac arrhythmias, and osteoporosis with resulting hip fractures that have left them wheelchair-bound.

“They are unbelievably disabled,” he said. “They are more disabled on quality-of-life scales than a comparative group of schizophrenics in the hospital.”

One novel approach that might be useful is use of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective in some patients with depression, schizophrenia, and obsessive-compulsive disorder. Current magnets stimulate superficial cortical areas of the brain, but Dr. Kaplan suggests that a better target might be the insula—a cerebral cortex structure that plays a role in interoceptive awareness and motor control. His group recently completed an unpublished meta-analysis of neuroimaging studies in anorexia that provides evidence for overactivity in the insula.

The team members have subsequently contracted with an Israeli biotechnology firm to construct a patented magnet for rTMS that will specifically target the insula.

The approach is not without controversy, Dr. Kaplan acknowledged. Although the seizure rate with rTMS is very low in patients with depression, patients with anorexia are at an increased risk for seizures at a rate of about 10% in general.

Atypical antipsychotics have come under increased scrutiny for anorexia, but with limited success in the few small studies and case reports to date. A recent meta-analysis of 43 publications concluded that there is not enough evidence in anorexia to confirm that these medications increase weight (Eur. Eat. Disord. Rev. 2010;18:10-21).

Olanzapine is the atypical antipsychotic that has been the most reported drug in the literature for treating anorexia and has been the subject of three small randomized controlled trials. Researchers in Ottawa showed that 10 weeks of olanzapine plus intensive day treatment resulted in faster weight gain and a greater decrease in obsessive symptoms than placebo in 34 patients with anorexia, but overall the same amount of weight gain (Am. J. Psychiatry 2008;165:1281-8).

Dr. Kaplan and Dr. Evelyn Attia of Columbia University reported in a separate unpublished trial in 2005 that patients gained a mean of almost 2 kgrafter 8 weeks of up to 10 mg olanzapine. Patients credited this not to an increase in hunger, but to being less anxious and consumed by thoughts of weight and shape. Importantly, there was no change in lipids, glucose, or insulin sensitivity, suggesting something might be different about the way the anorexic brain handles these drugs, he said.

Positive results on both weight gain and cognition have been seen with ziprasidone and quetiapine, but their use has been limited by concerns about QT interval prolongation, which is already an issue in anorexia. Because of this concern, olanzapine was selected instead of ziprasidone as the study drug for a large multicenter anorexia trial that is planned, he said.

Finally, workshop attendee Dr. Charles Price reported an acute response in a single patient with anorexia given modafinil and followed for 6 months. In a counterintuitive finding, the drug did not have the weight loss aspects observed with other stimulants.

“Basically, it cured her anorexia; now it is an 'N' of one,” said Dr. Price, who is in private practice in Reno, Nev.

Dr. Kaplan reported having no conflicts of interest. Dr. Attia reported having received research support from Pfizer and Eli Lilly.

FT. LAUDERDALE, FLA. — What do atypical antipsychotics, an analeptic, and targeted magnets have in common? They all might play a role in the treatment of anorexia nervosa.

“When you have a disorder that is so treatment resistant, it's like metastatic breast cancer; you have to think outside the box for new interventions,” Dr. Allan S. Kaplan said at a workshop on eating disorders at the annual meeting of the American College of Psychiatrists.

Current statistics indicate that 20% of patients diagnosed with anorexia are resistant to any intervention. The needs of these patients have been largely neglected even though their numbers continue to grow as a result of the mortality decreasing from 22% in older studies to about 8%–10% today, said Dr. Kaplan, professor of psychiatry at the University of Toronto.

In his experience, many of these patients are now in their 40s and 50s and have been ill for 20-30 years. Most have significant medical complications: renal failure, cardiac arrhythmias, and osteoporosis with resulting hip fractures that have left them wheelchair-bound.

“They are unbelievably disabled,” he said. “They are more disabled on quality-of-life scales than a comparative group of schizophrenics in the hospital.”

One novel approach that might be useful is use of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective in some patients with depression, schizophrenia, and obsessive-compulsive disorder. Current magnets stimulate superficial cortical areas of the brain, but Dr. Kaplan suggests that a better target might be the insula—a cerebral cortex structure that plays a role in interoceptive awareness and motor control. His group recently completed an unpublished meta-analysis of neuroimaging studies in anorexia that provides evidence for overactivity in the insula.

The team members have subsequently contracted with an Israeli biotechnology firm to construct a patented magnet for rTMS that will specifically target the insula.

The approach is not without controversy, Dr. Kaplan acknowledged. Although the seizure rate with rTMS is very low in patients with depression, patients with anorexia are at an increased risk for seizures at a rate of about 10% in general.

Atypical antipsychotics have come under increased scrutiny for anorexia, but with limited success in the few small studies and case reports to date. A recent meta-analysis of 43 publications concluded that there is not enough evidence in anorexia to confirm that these medications increase weight (Eur. Eat. Disord. Rev. 2010;18:10-21).

Olanzapine is the atypical antipsychotic that has been the most reported drug in the literature for treating anorexia and has been the subject of three small randomized controlled trials. Researchers in Ottawa showed that 10 weeks of olanzapine plus intensive day treatment resulted in faster weight gain and a greater decrease in obsessive symptoms than placebo in 34 patients with anorexia, but overall the same amount of weight gain (Am. J. Psychiatry 2008;165:1281-8).

Dr. Kaplan and Dr. Evelyn Attia of Columbia University reported in a separate unpublished trial in 2005 that patients gained a mean of almost 2 kgrafter 8 weeks of up to 10 mg olanzapine. Patients credited this not to an increase in hunger, but to being less anxious and consumed by thoughts of weight and shape. Importantly, there was no change in lipids, glucose, or insulin sensitivity, suggesting something might be different about the way the anorexic brain handles these drugs, he said.

Positive results on both weight gain and cognition have been seen with ziprasidone and quetiapine, but their use has been limited by concerns about QT interval prolongation, which is already an issue in anorexia. Because of this concern, olanzapine was selected instead of ziprasidone as the study drug for a large multicenter anorexia trial that is planned, he said.

Finally, workshop attendee Dr. Charles Price reported an acute response in a single patient with anorexia given modafinil and followed for 6 months. In a counterintuitive finding, the drug did not have the weight loss aspects observed with other stimulants.

“Basically, it cured her anorexia; now it is an 'N' of one,” said Dr. Price, who is in private practice in Reno, Nev.

Dr. Kaplan reported having no conflicts of interest. Dr. Attia reported having received research support from Pfizer and Eli Lilly.

CHANDLER, ARIZ. — Computed tomography alone is safe for cervical spine clearance in obtunded blunt trauma patients with gross extremity movement, according to the authors of a prospective, uncontrolled study of 197 patients.

No patient had a missed cervical spinal cord injury or neurologic sequelae as a result of a missed cervical spine injury, Dr. William H. Leukhardt said at the annual meeting of the Eastern Association for the Surgery of Trauma.

MRI is widely used to exclude ligamentous and spinal cord injuries that CT may fail to detect, but the optimal method for clearing the cervical spine in obtunded blunt trauma patients is not established. MRI is accurate but is associated with increased costs, and it exposes unstable patients to risks during transport and acquisition, said Dr. Leukhardt, a general surgery resident with MetroHealth Medical Center in Cleveland. Indeed, the death of a patient during MRI prompted the level I trauma center to change its protocol to eliminate routine MRIs in obtunded patients with blunt trauma.

The use of CT alone in the study also was associated with earlier removal of cervical collars, fewer complications, and shorter hospital stay when compared with a previous study by the same group in a similar cohort that underwent MRI in addition to CT to clear the cervical spine (J. Trauma 2007;63:544-9).

The study launched a fiery debate at the meeting over whether the use of CT alone could put patients at risk of a catastrophic injury because of missed fractures or undiagnosed ligamentous spine injuries. Autopsies performed in 22 of the 53 overall deaths revealed no cervical spine fractures, though one patient did have an isolated C5-C6 ligament injury.

Invited discussant Dr. Marie Crandall, an assistant professor of surgery and preventive medicine at Northwestern University in Chicago, called the study “wildly underpowered to inform your decision to take off C-collars.” She said that at least 600 patients would be needed to find no harm with the CT-only protocol.

Dr. Crandall said there are other, lower-cost alternatives for detecting ligamentous injury, such as fluorographic flexion-extension studies or simply keeping patients in C-collars for 6 weeks. “The first-year costs of the care of the spinal cord injury patient range from $200,000 to $400,000 for a quadriplegic,” she said. “You'd have to do a heck of a lot of MRIs in 1 year to equal those costs.”

Dr. Leukhardt responded that the study included only patients with gross movement in all four extremities and excluded those with limited movement or neurologic deficits. A case involving para- or quadriplegia or neurologic deficits from a missed injury would be tragic, he said. “However, we have sufficient evidence from what we've found so far and reason to believe this is doing the most good for the most number of patients.”

Dr. John Como, the study's principal investigator, said in an interview that it is not necessary to perform MRIs on all patients and that the one ligamentous injury identified in the study was deemed to be a stable injury that did not require immobilization.

Dr. Leukhardt also said that the complications of MRI cannot be understated; there have been reports of increased intracranial pressure, and patients have coded during MRI when they were a long way from a critical care unit. “I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated,” he said.

Dr. Samir Fakhry, an audience member, said that all cervical spine studies, including the current one, have failed to determine just how many missed injuries are acceptable to the medical community and society.

He agreed with Dr. Crandall about the danger of causing a potentially irreversible spinal injury in patients cleared by CT alone. “We have a technology that we are betting a patient's life on, and it's not infallible,” said Dr. Fakhry, professor and chief of general surgery at the Medical Center of South Carolina in Charleston.

In the study, CT scans were obtained using a 16- or 64-slice scanner; all were negative for an acute injury according to the attending radiologist. Cervical spine injury was defined by a fracture line extending on two consecutive cuts, marked prevertebral soft-tissue swelling or hematoma, malalignment not explained by degenerative changes, abnormal facets or posterior malalignment on sagittal reconstruction, and occipital condyle injury involving the craniocervical junction.

The patients had their cervical spines cleared and cervical collars removed at a mean of 3.3 days (range 0-15), significantly earlier than the 7.5 days reported in the previous study, Dr. Leukhardt said.

There was a 90% reduction in the occurrence of cervical spine decubitus ulcers, from 5.2% in the previous cohort to 0.5%. Hospital length of stay also decreased, from a mean of 23.4 days under the old protocol to 13.8 days. The difference in hospital stay is not attributable entirely to the change in spinal clearance protocol, but could also reflect differences in the populations not accounted for by age, gender, or injury severity.

The mean age of the patients was 48 years in the current cohort vs. 44 years in the previous cohort; males composed 73% vs. 78% of the respective cohorts; and the mean Injury Severity Scores were 23.2 vs. 24.4.

Dr. Leukhardt acknowledged that the study was limited by the lack of uniformity of longitudinal follow-up, lack of physician follow-up in some patients, and loss of some patients to follow-up.

Disclosures: Dr. Leukhardt and his colleagues disclosed no study sponsorship or relevant conflicts of interest.

'I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated.'

Source DR. LEUKHARDT

CHANDLER, ARIZ. — Computed tomography alone is safe for cervical spine clearance in obtunded blunt trauma patients with gross extremity movement, according to the authors of a prospective, uncontrolled study of 197 patients.

No patient had a missed cervical spinal cord injury or neurologic sequelae as a result of a missed cervical spine injury, Dr. William H. Leukhardt said at the annual meeting of the Eastern Association for the Surgery of Trauma.

MRI is widely used to exclude ligamentous and spinal cord injuries that CT may fail to detect, but the optimal method for clearing the cervical spine in obtunded blunt trauma patients is not established. MRI is accurate but is associated with increased costs, and it exposes unstable patients to risks during transport and acquisition, said Dr. Leukhardt, a general surgery resident with MetroHealth Medical Center in Cleveland. Indeed, the death of a patient during MRI prompted the level I trauma center to change its protocol to eliminate routine MRIs in obtunded patients with blunt trauma.

The use of CT alone in the study also was associated with earlier removal of cervical collars, fewer complications, and shorter hospital stay when compared with a previous study by the same group in a similar cohort that underwent MRI in addition to CT to clear the cervical spine (J. Trauma 2007;63:544-9).

The study launched a fiery debate at the meeting over whether the use of CT alone could put patients at risk of a catastrophic injury because of missed fractures or undiagnosed ligamentous spine injuries. Autopsies performed in 22 of the 53 overall deaths revealed no cervical spine fractures, though one patient did have an isolated C5-C6 ligament injury.

Invited discussant Dr. Marie Crandall, an assistant professor of surgery and preventive medicine at Northwestern University in Chicago, called the study “wildly underpowered to inform your decision to take off C-collars.” She said that at least 600 patients would be needed to find no harm with the CT-only protocol.

Dr. Crandall said there are other, lower-cost alternatives for detecting ligamentous injury, such as fluorographic flexion-extension studies or simply keeping patients in C-collars for 6 weeks. “The first-year costs of the care of the spinal cord injury patient range from $200,000 to $400,000 for a quadriplegic,” she said. “You'd have to do a heck of a lot of MRIs in 1 year to equal those costs.”

Dr. Leukhardt responded that the study included only patients with gross movement in all four extremities and excluded those with limited movement or neurologic deficits. A case involving para- or quadriplegia or neurologic deficits from a missed injury would be tragic, he said. “However, we have sufficient evidence from what we've found so far and reason to believe this is doing the most good for the most number of patients.”

Dr. John Como, the study's principal investigator, said in an interview that it is not necessary to perform MRIs on all patients and that the one ligamentous injury identified in the study was deemed to be a stable injury that did not require immobilization.

Dr. Leukhardt also said that the complications of MRI cannot be understated; there have been reports of increased intracranial pressure, and patients have coded during MRI when they were a long way from a critical care unit. “I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated,” he said.

Dr. Samir Fakhry, an audience member, said that all cervical spine studies, including the current one, have failed to determine just how many missed injuries are acceptable to the medical community and society.

He agreed with Dr. Crandall about the danger of causing a potentially irreversible spinal injury in patients cleared by CT alone. “We have a technology that we are betting a patient's life on, and it's not infallible,” said Dr. Fakhry, professor and chief of general surgery at the Medical Center of South Carolina in Charleston.

In the study, CT scans were obtained using a 16- or 64-slice scanner; all were negative for an acute injury according to the attending radiologist. Cervical spine injury was defined by a fracture line extending on two consecutive cuts, marked prevertebral soft-tissue swelling or hematoma, malalignment not explained by degenerative changes, abnormal facets or posterior malalignment on sagittal reconstruction, and occipital condyle injury involving the craniocervical junction.

The patients had their cervical spines cleared and cervical collars removed at a mean of 3.3 days (range 0-15), significantly earlier than the 7.5 days reported in the previous study, Dr. Leukhardt said.

There was a 90% reduction in the occurrence of cervical spine decubitus ulcers, from 5.2% in the previous cohort to 0.5%. Hospital length of stay also decreased, from a mean of 23.4 days under the old protocol to 13.8 days. The difference in hospital stay is not attributable entirely to the change in spinal clearance protocol, but could also reflect differences in the populations not accounted for by age, gender, or injury severity.

The mean age of the patients was 48 years in the current cohort vs. 44 years in the previous cohort; males composed 73% vs. 78% of the respective cohorts; and the mean Injury Severity Scores were 23.2 vs. 24.4.

Dr. Leukhardt acknowledged that the study was limited by the lack of uniformity of longitudinal follow-up, lack of physician follow-up in some patients, and loss of some patients to follow-up.

Disclosures: Dr. Leukhardt and his colleagues disclosed no study sponsorship or relevant conflicts of interest.

'I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated.'

Source DR. LEUKHARDT

CHANDLER, ARIZ. — Computed tomography alone is safe for cervical spine clearance in obtunded blunt trauma patients with gross extremity movement, according to the authors of a prospective, uncontrolled study of 197 patients.

No patient had a missed cervical spinal cord injury or neurologic sequelae as a result of a missed cervical spine injury, Dr. William H. Leukhardt said at the annual meeting of the Eastern Association for the Surgery of Trauma.

MRI is widely used to exclude ligamentous and spinal cord injuries that CT may fail to detect, but the optimal method for clearing the cervical spine in obtunded blunt trauma patients is not established. MRI is accurate but is associated with increased costs, and it exposes unstable patients to risks during transport and acquisition, said Dr. Leukhardt, a general surgery resident with MetroHealth Medical Center in Cleveland. Indeed, the death of a patient during MRI prompted the level I trauma center to change its protocol to eliminate routine MRIs in obtunded patients with blunt trauma.

The use of CT alone in the study also was associated with earlier removal of cervical collars, fewer complications, and shorter hospital stay when compared with a previous study by the same group in a similar cohort that underwent MRI in addition to CT to clear the cervical spine (J. Trauma 2007;63:544-9).

The study launched a fiery debate at the meeting over whether the use of CT alone could put patients at risk of a catastrophic injury because of missed fractures or undiagnosed ligamentous spine injuries. Autopsies performed in 22 of the 53 overall deaths revealed no cervical spine fractures, though one patient did have an isolated C5-C6 ligament injury.

Invited discussant Dr. Marie Crandall, an assistant professor of surgery and preventive medicine at Northwestern University in Chicago, called the study “wildly underpowered to inform your decision to take off C-collars.” She said that at least 600 patients would be needed to find no harm with the CT-only protocol.

Dr. Crandall said there are other, lower-cost alternatives for detecting ligamentous injury, such as fluorographic flexion-extension studies or simply keeping patients in C-collars for 6 weeks. “The first-year costs of the care of the spinal cord injury patient range from $200,000 to $400,000 for a quadriplegic,” she said. “You'd have to do a heck of a lot of MRIs in 1 year to equal those costs.”

Dr. Leukhardt responded that the study included only patients with gross movement in all four extremities and excluded those with limited movement or neurologic deficits. A case involving para- or quadriplegia or neurologic deficits from a missed injury would be tragic, he said. “However, we have sufficient evidence from what we've found so far and reason to believe this is doing the most good for the most number of patients.”

Dr. John Como, the study's principal investigator, said in an interview that it is not necessary to perform MRIs on all patients and that the one ligamentous injury identified in the study was deemed to be a stable injury that did not require immobilization.

Dr. Leukhardt also said that the complications of MRI cannot be understated; there have been reports of increased intracranial pressure, and patients have coded during MRI when they were a long way from a critical care unit. “I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated,” he said.

Dr. Samir Fakhry, an audience member, said that all cervical spine studies, including the current one, have failed to determine just how many missed injuries are acceptable to the medical community and society.

He agreed with Dr. Crandall about the danger of causing a potentially irreversible spinal injury in patients cleared by CT alone. “We have a technology that we are betting a patient's life on, and it's not infallible,” said Dr. Fakhry, professor and chief of general surgery at the Medical Center of South Carolina in Charleston.

In the study, CT scans were obtained using a 16- or 64-slice scanner; all were negative for an acute injury according to the attending radiologist. Cervical spine injury was defined by a fracture line extending on two consecutive cuts, marked prevertebral soft-tissue swelling or hematoma, malalignment not explained by degenerative changes, abnormal facets or posterior malalignment on sagittal reconstruction, and occipital condyle injury involving the craniocervical junction.

The patients had their cervical spines cleared and cervical collars removed at a mean of 3.3 days (range 0-15), significantly earlier than the 7.5 days reported in the previous study, Dr. Leukhardt said.

There was a 90% reduction in the occurrence of cervical spine decubitus ulcers, from 5.2% in the previous cohort to 0.5%. Hospital length of stay also decreased, from a mean of 23.4 days under the old protocol to 13.8 days. The difference in hospital stay is not attributable entirely to the change in spinal clearance protocol, but could also reflect differences in the populations not accounted for by age, gender, or injury severity.

The mean age of the patients was 48 years in the current cohort vs. 44 years in the previous cohort; males composed 73% vs. 78% of the respective cohorts; and the mean Injury Severity Scores were 23.2 vs. 24.4.

Dr. Leukhardt acknowledged that the study was limited by the lack of uniformity of longitudinal follow-up, lack of physician follow-up in some patients, and loss of some patients to follow-up.

Disclosures: Dr. Leukhardt and his colleagues disclosed no study sponsorship or relevant conflicts of interest.

'I believe CT is a safe practice, and in this population, it is reasonable to use MRI only in patients where it is indicated.'

Source DR. LEUKHARDT

CHANDLER, ARIZ. — Rebound elevation of serum lactate is a significant predictor of morbidity and mortality in critically ill trauma patients, based on a prospective study of 698 patients.

“Rebound hyperlactatemia better predicts mortality than [do] admission lactate values alone,” Dr. Megan Brenner said at the annual meeting of the Eastern Association for the Surgery of Trauma.

A stepwise regression analysis of patients showed that rebound hyperlactatemia increases mortality 2.5-fold, said Dr. Brenner of the University of Maryland, Baltimore. Mortality was 15.8% in patients with rebound hyperlactatemia vs. 8.2% in those who achieved lactate normalization without a second abnormal lactate elevation.

Of the 698 patients, 538 had high admission serum lactate (greater than 1.6 mmol/L) with subsequent lactate normalization (0.5-1.6 mmol/L), 43 had a normal admission lactate, and 117 had an elevated admission lactate that never normalized. Of those 538 patients, 305 achieved lactate normalization and did not have another abnormal elevation, and 233 had a second abnormal elevation (mean 2.2 mmol/L) at a mean of 31 hours after initial normalization and 94 hours after admission. The mean age of the cohort was 43 years, 78% were male, and 84% had suffered a blunt trauma.

Patients with rebound hyperlactatemia also had significantly greater number of ICU days (odds ratio 11.8) and ventilator days (OR 9.8) and significantly greater hospital length of stay (OR 11.4).

Rebound hyperlactatemia was a better predictor of mortality (OR 2.5) than were admission lactate values (OR 1.07) in the analysis, which adjusted for age, sex, Injury Severity Score (ISS), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation (APACHE). The mean ISS was 29 for the cohort, mean SOFA was 3.7, and mean APACHE was 12.

An analysis of all 698 patients showed that admission lactate levels correlate with mortality only (OR 1.07) and do not affect ICU days, ventilator days, and length of stay. Dr. Brenner recommends checking serum lactate values daily for a minimum of the first 4 hospital days. If lactate levels are used as an end point of resuscitation, continued monitoring of the patient is warranted. Frequent lactate monitoring may be needed to identify at-risk subgroups of patients.

Invited discussant Dr. Carina Biggs, a surgeon at Kings County Hospital Center, N.Y., asked why lactate rather than base deficit was evaluated, as the latter has been shown to be a marker of mortality.

Dr. Brenner said that lactate levels rather than base deficit were evaluated because prior research has shown that they are more useful than base deficit for predicting outcome in trauma patients.

Disclosures: Dr. Brenner and Dr. Biggs disclosed no relevant conflicts of interest.

My Take

Also Consider Vital Signs, Mechanism

Either lactate or base deficit is a good marker to initially screen injured patients for severity of injury. But two things must be factored into the equation. First, these values are only an indicator and should be used with physical examination and vital signs. Second, the value of the base deficit as an outcome predictor depends on the mechanism of injury, being most useful for patients sustaining penetrating trauma (Am. Surg. 2002;68:689-94).

Other studies have correlated the severity of the base deficit with outcomes, so the abnormal value alone is not as meaningful as the magnitude of abnormality (J. Trauma 1988;10:1464-7). It may be helpful to keep this in mind, as this study seems to have a lot of patients with elevated lactate levels, and those levels remained high in many of those patients.

GRACE S. ROZYCKI, M.D., is chief of the division of trauma/surgical critical care, department of surgery, Emory University, Atlanta.

Vitals

CHANDLER, ARIZ. — Rebound elevation of serum lactate is a significant predictor of morbidity and mortality in critically ill trauma patients, based on a prospective study of 698 patients.

“Rebound hyperlactatemia better predicts mortality than [do] admission lactate values alone,” Dr. Megan Brenner said at the annual meeting of the Eastern Association for the Surgery of Trauma.

A stepwise regression analysis of patients showed that rebound hyperlactatemia increases mortality 2.5-fold, said Dr. Brenner of the University of Maryland, Baltimore. Mortality was 15.8% in patients with rebound hyperlactatemia vs. 8.2% in those who achieved lactate normalization without a second abnormal lactate elevation.

Of the 698 patients, 538 had high admission serum lactate (greater than 1.6 mmol/L) with subsequent lactate normalization (0.5-1.6 mmol/L), 43 had a normal admission lactate, and 117 had an elevated admission lactate that never normalized. Of those 538 patients, 305 achieved lactate normalization and did not have another abnormal elevation, and 233 had a second abnormal elevation (mean 2.2 mmol/L) at a mean of 31 hours after initial normalization and 94 hours after admission. The mean age of the cohort was 43 years, 78% were male, and 84% had suffered a blunt trauma.

Patients with rebound hyperlactatemia also had significantly greater number of ICU days (odds ratio 11.8) and ventilator days (OR 9.8) and significantly greater hospital length of stay (OR 11.4).

Rebound hyperlactatemia was a better predictor of mortality (OR 2.5) than were admission lactate values (OR 1.07) in the analysis, which adjusted for age, sex, Injury Severity Score (ISS), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation (APACHE). The mean ISS was 29 for the cohort, mean SOFA was 3.7, and mean APACHE was 12.

An analysis of all 698 patients showed that admission lactate levels correlate with mortality only (OR 1.07) and do not affect ICU days, ventilator days, and length of stay. Dr. Brenner recommends checking serum lactate values daily for a minimum of the first 4 hospital days. If lactate levels are used as an end point of resuscitation, continued monitoring of the patient is warranted. Frequent lactate monitoring may be needed to identify at-risk subgroups of patients.

Invited discussant Dr. Carina Biggs, a surgeon at Kings County Hospital Center, N.Y., asked why lactate rather than base deficit was evaluated, as the latter has been shown to be a marker of mortality.

Dr. Brenner said that lactate levels rather than base deficit were evaluated because prior research has shown that they are more useful than base deficit for predicting outcome in trauma patients.

Disclosures: Dr. Brenner and Dr. Biggs disclosed no relevant conflicts of interest.

My Take

Also Consider Vital Signs, Mechanism

Either lactate or base deficit is a good marker to initially screen injured patients for severity of injury. But two things must be factored into the equation. First, these values are only an indicator and should be used with physical examination and vital signs. Second, the value of the base deficit as an outcome predictor depends on the mechanism of injury, being most useful for patients sustaining penetrating trauma (Am. Surg. 2002;68:689-94).

Other studies have correlated the severity of the base deficit with outcomes, so the abnormal value alone is not as meaningful as the magnitude of abnormality (J. Trauma 1988;10:1464-7). It may be helpful to keep this in mind, as this study seems to have a lot of patients with elevated lactate levels, and those levels remained high in many of those patients.

GRACE S. ROZYCKI, M.D., is chief of the division of trauma/surgical critical care, department of surgery, Emory University, Atlanta.

Vitals

CHANDLER, ARIZ. — Rebound elevation of serum lactate is a significant predictor of morbidity and mortality in critically ill trauma patients, based on a prospective study of 698 patients.

“Rebound hyperlactatemia better predicts mortality than [do] admission lactate values alone,” Dr. Megan Brenner said at the annual meeting of the Eastern Association for the Surgery of Trauma.

A stepwise regression analysis of patients showed that rebound hyperlactatemia increases mortality 2.5-fold, said Dr. Brenner of the University of Maryland, Baltimore. Mortality was 15.8% in patients with rebound hyperlactatemia vs. 8.2% in those who achieved lactate normalization without a second abnormal lactate elevation.

Of the 698 patients, 538 had high admission serum lactate (greater than 1.6 mmol/L) with subsequent lactate normalization (0.5-1.6 mmol/L), 43 had a normal admission lactate, and 117 had an elevated admission lactate that never normalized. Of those 538 patients, 305 achieved lactate normalization and did not have another abnormal elevation, and 233 had a second abnormal elevation (mean 2.2 mmol/L) at a mean of 31 hours after initial normalization and 94 hours after admission. The mean age of the cohort was 43 years, 78% were male, and 84% had suffered a blunt trauma.

Patients with rebound hyperlactatemia also had significantly greater number of ICU days (odds ratio 11.8) and ventilator days (OR 9.8) and significantly greater hospital length of stay (OR 11.4).

Rebound hyperlactatemia was a better predictor of mortality (OR 2.5) than were admission lactate values (OR 1.07) in the analysis, which adjusted for age, sex, Injury Severity Score (ISS), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation (APACHE). The mean ISS was 29 for the cohort, mean SOFA was 3.7, and mean APACHE was 12.

An analysis of all 698 patients showed that admission lactate levels correlate with mortality only (OR 1.07) and do not affect ICU days, ventilator days, and length of stay. Dr. Brenner recommends checking serum lactate values daily for a minimum of the first 4 hospital days. If lactate levels are used as an end point of resuscitation, continued monitoring of the patient is warranted. Frequent lactate monitoring may be needed to identify at-risk subgroups of patients.

Invited discussant Dr. Carina Biggs, a surgeon at Kings County Hospital Center, N.Y., asked why lactate rather than base deficit was evaluated, as the latter has been shown to be a marker of mortality.

Dr. Brenner said that lactate levels rather than base deficit were evaluated because prior research has shown that they are more useful than base deficit for predicting outcome in trauma patients.

Disclosures: Dr. Brenner and Dr. Biggs disclosed no relevant conflicts of interest.

My Take

Also Consider Vital Signs, Mechanism

Either lactate or base deficit is a good marker to initially screen injured patients for severity of injury. But two things must be factored into the equation. First, these values are only an indicator and should be used with physical examination and vital signs. Second, the value of the base deficit as an outcome predictor depends on the mechanism of injury, being most useful for patients sustaining penetrating trauma (Am. Surg. 2002;68:689-94).

Other studies have correlated the severity of the base deficit with outcomes, so the abnormal value alone is not as meaningful as the magnitude of abnormality (J. Trauma 1988;10:1464-7). It may be helpful to keep this in mind, as this study seems to have a lot of patients with elevated lactate levels, and those levels remained high in many of those patients.

GRACE S. ROZYCKI, M.D., is chief of the division of trauma/surgical critical care, department of surgery, Emory University, Atlanta.

Vitals