Patrice Wendling

Major Finding: Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

Data Source: The mean change in menstrual blood loss volume was quantified using the alkaline hematin method.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where duel indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. While dienogest is a new progestin in the United States, it is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. An identically designed trial conducted in Europe and Australia produced similar results.

Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know. The data [don't] support that,” he said.

A recently published comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436–4).

Estradiol-containing oral contraceptives have demonstrated effective contraception, but have been problematic in terms of cycle control, notably with bleeding irregularities leading to premature discontinuation. E2V/DNG is administered using a dynamic estrogen step-down and progestin step-up dosing regimen designed to overcome unacceptable cycle control.

In the current study, a total of 190 women from the United States and Canada with heavy and/or prolonged menstrual bleeding without recognizable pelvic pathology were randomized in a 2:1 ratio to E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28 or placebo on days 1–28. Their mean age was 37 years.

A total of 54 withdrew from the study, 44 discontinued treatment, 5 never took the study medication, and 6 were lost to follow-up. In all, 84 women in the E2V/DNG arm and 51 in the placebo arm were available for analysis.

Dr. Jensen noted that a composite of up to eight individual criteria were used for achieving a complete response. Based on a subjective assessment, 81% of the women given E2V/DNG reported improvement vs. 38% of those given placebo.

Major Finding: Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

Data Source: The mean change in menstrual blood loss volume was quantified using the alkaline hematin method.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where duel indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. While dienogest is a new progestin in the United States, it is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. An identically designed trial conducted in Europe and Australia produced similar results.

Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know. The data [don't] support that,” he said.

A recently published comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436–4).

Estradiol-containing oral contraceptives have demonstrated effective contraception, but have been problematic in terms of cycle control, notably with bleeding irregularities leading to premature discontinuation. E2V/DNG is administered using a dynamic estrogen step-down and progestin step-up dosing regimen designed to overcome unacceptable cycle control.

In the current study, a total of 190 women from the United States and Canada with heavy and/or prolonged menstrual bleeding without recognizable pelvic pathology were randomized in a 2:1 ratio to E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28 or placebo on days 1–28. Their mean age was 37 years.

A total of 54 withdrew from the study, 44 discontinued treatment, 5 never took the study medication, and 6 were lost to follow-up. In all, 84 women in the E2V/DNG arm and 51 in the placebo arm were available for analysis.

Dr. Jensen noted that a composite of up to eight individual criteria were used for achieving a complete response. Based on a subjective assessment, 81% of the women given E2V/DNG reported improvement vs. 38% of those given placebo.

Major Finding: Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

Data Source: The mean change in menstrual blood loss volume was quantified using the alkaline hematin method.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo.

The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where duel indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. While dienogest is a new progestin in the United States, it is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. An identically designed trial conducted in Europe and Australia produced similar results.

Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know. The data [don't] support that,” he said.

A recently published comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436–4).

Estradiol-containing oral contraceptives have demonstrated effective contraception, but have been problematic in terms of cycle control, notably with bleeding irregularities leading to premature discontinuation. E2V/DNG is administered using a dynamic estrogen step-down and progestin step-up dosing regimen designed to overcome unacceptable cycle control.

In the current study, a total of 190 women from the United States and Canada with heavy and/or prolonged menstrual bleeding without recognizable pelvic pathology were randomized in a 2:1 ratio to E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28 or placebo on days 1–28. Their mean age was 37 years.

A total of 54 withdrew from the study, 44 discontinued treatment, 5 never took the study medication, and 6 were lost to follow-up. In all, 84 women in the E2V/DNG arm and 51 in the placebo arm were available for analysis.

Dr. Jensen noted that a composite of up to eight individual criteria were used for achieving a complete response. Based on a subjective assessment, 81% of the women given E2V/DNG reported improvement vs. 38% of those given placebo.

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” Dr. Siegel said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and his associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3, maximum 32.2), compared with benign lesions (minimum 0.01, maximum 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios also may be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher when more invasive cells were present, even within squamous cell or basal cell cancers.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies,” he added

In the current study, investigators used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'There is no other way.'”

The incidence and economic impact of skin cancer is rising. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel has received research grants from several companies that make imaging products. Dr. Dasgeb had no disclosures.

'We believe it has tremendous promise to reduce unnecessary biopsies.'

Source DR. SIEGEL

An elastogram (left) and ultrasound image (right) showing squamous cell carcinoma of the skin. Adding elastography may improve diagnostic accuracy.

Source Courtesy Radiological Society of North America

'The feedback from Mohs' surgeons was amazing.'

Source DR. DASGEB

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” Dr. Siegel said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and his associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3, maximum 32.2), compared with benign lesions (minimum 0.01, maximum 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios also may be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher when more invasive cells were present, even within squamous cell or basal cell cancers.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies,” he added

In the current study, investigators used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'There is no other way.'”

The incidence and economic impact of skin cancer is rising. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel has received research grants from several companies that make imaging products. Dr. Dasgeb had no disclosures.

'We believe it has tremendous promise to reduce unnecessary biopsies.'

Source DR. SIEGEL

An elastogram (left) and ultrasound image (right) showing squamous cell carcinoma of the skin. Adding elastography may improve diagnostic accuracy.

Source Courtesy Radiological Society of North America

'The feedback from Mohs' surgeons was amazing.'

Source DR. DASGEB

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported at the annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” Dr. Siegel said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and his associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3, maximum 32.2), compared with benign lesions (minimum 0.01, maximum 3). None of the malignant lesions violated a strain-ratio cutoff of 3-5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios also may be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher when more invasive cells were present, even within squamous cell or basal cell cancers.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies,” he added

In the current study, investigators used a clinically available 14- to 16-mHz ultrasound unit.

The findings were enthusiastically received when presented by Dr. Dasgeb at the Michigan Dermatological Society in November.

“The feedback from Mohs' surgeons was amazing,” she said in an interview. “A couple of clinical dermatologists said, 'There is no other way.'”

The incidence and economic impact of skin cancer is rising. It is estimated that one in five Americans will develop skin cancer at some point in their lives.

Disclosures: Dr. Siegel has received research grants from several companies that make imaging products. Dr. Dasgeb had no disclosures.

'We believe it has tremendous promise to reduce unnecessary biopsies.'

Source DR. SIEGEL

An elastogram (left) and ultrasound image (right) showing squamous cell carcinoma of the skin. Adding elastography may improve diagnostic accuracy.

Source Courtesy Radiological Society of North America

'The feedback from Mohs' surgeons was amazing.'

Source DR. DASGEB

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12-20 years, revealed that lumbar spine abnormalities are most common in children with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 52% or 97 patients.

Disk disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When body mass index was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disk disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at The Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of American children, aged 6-11 years, and 18% of American adolescents, aged 12-19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor and colleague Dr. Michael Lipton told reporters.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

“They are decades ahead of their time,” Dr. Lipton added.

The investigators excluded patients with trauma and scoliosis, as well as genetic, metabolic and developmental conditions with a predisposition toward spinal abnormalities.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School in Boston, said that the findings are worrisome and emphasized the need to stem the rising tide of pediatric obesity in this country.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children.

Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents who had a BMI greater than the 85th percentile and two who had a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain.

A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults.

Dr. Burns noted that in one study back pain accounted for only 0.4% of pediatric ED visits (Clin. Pediatr. 1999;38:401-6).

Dr. Burns and his associates disclosed no relevant conflicts of interest.

VITALS

This study provides added evidence regarding the damage that childhood obesity can cause.

Source DR. BURNS

This MRI shows a large disc extrusion of the lumbar spine causing narrowing of the spinal canal and compression of the spinal nerve roots.

Source Courtesy Radiological Society of North America

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12-20 years, revealed that lumbar spine abnormalities are most common in children with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 52% or 97 patients.

Disk disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When body mass index was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disk disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at The Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of American children, aged 6-11 years, and 18% of American adolescents, aged 12-19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor and colleague Dr. Michael Lipton told reporters.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

“They are decades ahead of their time,” Dr. Lipton added.

The investigators excluded patients with trauma and scoliosis, as well as genetic, metabolic and developmental conditions with a predisposition toward spinal abnormalities.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School in Boston, said that the findings are worrisome and emphasized the need to stem the rising tide of pediatric obesity in this country.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children.

Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents who had a BMI greater than the 85th percentile and two who had a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain.

A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults.

Dr. Burns noted that in one study back pain accounted for only 0.4% of pediatric ED visits (Clin. Pediatr. 1999;38:401-6).

Dr. Burns and his associates disclosed no relevant conflicts of interest.

VITALS

This study provides added evidence regarding the damage that childhood obesity can cause.

Source DR. BURNS

This MRI shows a large disc extrusion of the lumbar spine causing narrowing of the spinal canal and compression of the spinal nerve roots.

Source Courtesy Radiological Society of North America

CHICAGO — Adolescents who are overweight or obese are at risk for spinal disease not typically seen until adulthood.

A review of low back MRIs on 228 adolescents, aged 12-20 years, revealed that lumbar spine abnormalities are most common in children with a high body mass index (BMI) and back pain, Dr. Judah G. Burns reported at the annual meeting of the Radiological Society of North America.

Among the 188 patients with back pain who met the inclusion criteria, MRI abnormalities were observed in 52% or 97 patients.

Disk disease was identified in 91 of the 97 patients, including multilevel disease in 40%.

When body mass index was calculated for 108 of the children with available weight data, lumbar spine abnormalities were observed in 28 of 44 (64%) children with a BMI greater than the 85th percentile for age, compared with 28 of 64 (44%) children at or below a healthy weight.

The finding that overweight children are more likely to have disk disease might be intuitive, given what is known in the adult population, but this is the first study to document this association and provides additional evidence regarding the damage that childhood obesity can cause, said Dr. Burns, a fellow in diagnostic neuroradiology at The Children's Hospital at Montefiore in New York City.

“We have another link in the chain of the end-organ damage that can result from obesity, and from a public health perspective I think that's significant,” he said at a press briefing at the meeting.

The Centers for Disease Control and Prevention reports that 17% of American children, aged 6-11 years, and 18% of American adolescents, aged 12-19, are overweight.

The abnormalities observed in the study are typically associated with degenerative disease of the spine, which occurs with aging and is not usually seen until people are in their 30s, 40s, or 50s, coauthor and colleague Dr. Michael Lipton told reporters.

“We basically have evidence of something that is accelerating the aging process dramatically in these children,” he said.

“They are decades ahead of their time,” Dr. Lipton added.

The investigators excluded patients with trauma and scoliosis, as well as genetic, metabolic and developmental conditions with a predisposition toward spinal abnormalities.

Press briefing moderator Dr. Deborah Levine, a professor at Harvard Medical School in Boston, said that the findings are worrisome and emphasized the need to stem the rising tide of pediatric obesity in this country.

She did, however, question whether the study might have over-represented children with severe back pain, since MRI is not typically performed for this indication in children.

Dr. Burns responded that the reasons prompting patients to go to the emergency department and receive an MRI were not entirely clear, but that severity of pain might have been the case for many.

The study included 40 adolescents without back pain, and 8 (20%) of these patients had an abnormal MRI. Among these, abnormal MRIs were observed in six adolescents who had a BMI greater than the 85th percentile and two who had a BMI less than the 85th percentile, although the difference was not statistically significant, Dr. Burns said.

He said the findings do not support the routine use of MRI in children with back pain.

A prospective study is needed in obese children, not necessarily with back pain, to determine the longitudinal effects of obesity and whether lumbar disease is as common in adolescents as it is in adults.

Dr. Burns noted that in one study back pain accounted for only 0.4% of pediatric ED visits (Clin. Pediatr. 1999;38:401-6).

Dr. Burns and his associates disclosed no relevant conflicts of interest.

VITALS

This study provides added evidence regarding the damage that childhood obesity can cause.

Source DR. BURNS

This MRI shows a large disc extrusion of the lumbar spine causing narrowing of the spinal canal and compression of the spinal nerve roots.

Source Courtesy Radiological Society of North America

Disclosures: Dr. Stephenson disclosed receiving faculty honorarium from EMD Serono Inc. The study was supported by the Canadian Blood Services/Bayer Partnership Fund, the National Institutes of Health, and Talecris BioTherapeutics.

ATLANTA — Intravenous immunoglobulin was not beneficial in the treatment of idiopathic secondary recurrent miscarriage in the largest prospective randomized IVIG trial in this setting.

The live birth rate was 70% for women who received intravenous immunoglobulin and 63% for those given saline in the phase III multicenter trial of 77 women with a history of pregnancy of at least 20 weeks followed by at least three unexplained miscarriages of less than 20 weeks, all with the current partner. The difference was not statistically significant.

Once a pregnancy reached 6 weeks' gestation, the live birth rate was 94% in both groups, said Dr. Mary D. Stephenson, director of the recurrent pregnancy loss program at the University of Chicago.

Mean birth weights were significantly higher in the IVIG group at 3,711 g vs. 3,140 g in the control group (P value less than .010). When preterm infants and twins were excluded, however, birth weights were not statistically different (3,711 g vs. 3,358 g).

The study was designed to enroll 178 women, but was stopped early based on these interim results, said Dr. Stephenson, who called the key finding surprising.

She suggested that the favorable live birth rates in both groups may have been due to close monitoring with ultrasound in the first trimester and supportive care throughout the pregnancy, which have been shown to be advantageous in women with recurrent miscarriage.

“I also think it could be because we're not yet there in being able to select the most appropriate patients that could benefit from such immunotherapy,” she said. “Only 18% of prior miscarriages had been sent for chromosome testing, so that raises the question as to whether there were too many miscarriages that may have had random chromosome errors.”

A recent meta-analysis of eight randomized trials involving 442 women found a significant increase in live births following IVIG use in women with a secondary recurrent miscarriage (odds ratio, 2.71), while women with a primary miscarriage did not have the same benefit (OR, 0.66). The authors recommended further randomized trials, however, as the studies had small sample sizes and lacked homogeneity (BJOG 2007;114:134-42). When data from the current study were combined with data from the four prior secondary miscarriage trials in the meta-analysis, the odds ratio for a live birth was 2.16, favoring IVIG, Dr. Stephenson said.

The current study enrolled 82 women and after 5 withdrawals, randomized 38 women to IVIG (Gamunex or Gamimune) 500 mg/kg and 39 women to an equivalent volume of normal saline infused prior to ovulation for a maximum of six cycles and continued every 4 weeks until 18-20 weeks of pregnancy.

There were 23 pregnancies in the IVIG group and 24 in the control group. There was no difference in mean maternal age (36 vs. 35 years), mean body mass index (26 vs. 25 kg/m

Disclosures: Dr. Stephenson disclosed receiving faculty honorarium from EMD Serono Inc. The study was supported by the Canadian Blood Services/Bayer Partnership Fund, the National Institutes of Health, and Talecris BioTherapeutics.

ATLANTA — Intravenous immunoglobulin was not beneficial in the treatment of idiopathic secondary recurrent miscarriage in the largest prospective randomized IVIG trial in this setting.

The live birth rate was 70% for women who received intravenous immunoglobulin and 63% for those given saline in the phase III multicenter trial of 77 women with a history of pregnancy of at least 20 weeks followed by at least three unexplained miscarriages of less than 20 weeks, all with the current partner. The difference was not statistically significant.

Once a pregnancy reached 6 weeks' gestation, the live birth rate was 94% in both groups, said Dr. Mary D. Stephenson, director of the recurrent pregnancy loss program at the University of Chicago.

Mean birth weights were significantly higher in the IVIG group at 3,711 g vs. 3,140 g in the control group (P value less than .010). When preterm infants and twins were excluded, however, birth weights were not statistically different (3,711 g vs. 3,358 g).

The study was designed to enroll 178 women, but was stopped early based on these interim results, said Dr. Stephenson, who called the key finding surprising.

She suggested that the favorable live birth rates in both groups may have been due to close monitoring with ultrasound in the first trimester and supportive care throughout the pregnancy, which have been shown to be advantageous in women with recurrent miscarriage.

“I also think it could be because we're not yet there in being able to select the most appropriate patients that could benefit from such immunotherapy,” she said. “Only 18% of prior miscarriages had been sent for chromosome testing, so that raises the question as to whether there were too many miscarriages that may have had random chromosome errors.”

A recent meta-analysis of eight randomized trials involving 442 women found a significant increase in live births following IVIG use in women with a secondary recurrent miscarriage (odds ratio, 2.71), while women with a primary miscarriage did not have the same benefit (OR, 0.66). The authors recommended further randomized trials, however, as the studies had small sample sizes and lacked homogeneity (BJOG 2007;114:134-42). When data from the current study were combined with data from the four prior secondary miscarriage trials in the meta-analysis, the odds ratio for a live birth was 2.16, favoring IVIG, Dr. Stephenson said.

The current study enrolled 82 women and after 5 withdrawals, randomized 38 women to IVIG (Gamunex or Gamimune) 500 mg/kg and 39 women to an equivalent volume of normal saline infused prior to ovulation for a maximum of six cycles and continued every 4 weeks until 18-20 weeks of pregnancy.

There were 23 pregnancies in the IVIG group and 24 in the control group. There was no difference in mean maternal age (36 vs. 35 years), mean body mass index (26 vs. 25 kg/m

Disclosures: Dr. Stephenson disclosed receiving faculty honorarium from EMD Serono Inc. The study was supported by the Canadian Blood Services/Bayer Partnership Fund, the National Institutes of Health, and Talecris BioTherapeutics.

ATLANTA — Intravenous immunoglobulin was not beneficial in the treatment of idiopathic secondary recurrent miscarriage in the largest prospective randomized IVIG trial in this setting.

The live birth rate was 70% for women who received intravenous immunoglobulin and 63% for those given saline in the phase III multicenter trial of 77 women with a history of pregnancy of at least 20 weeks followed by at least three unexplained miscarriages of less than 20 weeks, all with the current partner. The difference was not statistically significant.

Once a pregnancy reached 6 weeks' gestation, the live birth rate was 94% in both groups, said Dr. Mary D. Stephenson, director of the recurrent pregnancy loss program at the University of Chicago.

Mean birth weights were significantly higher in the IVIG group at 3,711 g vs. 3,140 g in the control group (P value less than .010). When preterm infants and twins were excluded, however, birth weights were not statistically different (3,711 g vs. 3,358 g).

The study was designed to enroll 178 women, but was stopped early based on these interim results, said Dr. Stephenson, who called the key finding surprising.

She suggested that the favorable live birth rates in both groups may have been due to close monitoring with ultrasound in the first trimester and supportive care throughout the pregnancy, which have been shown to be advantageous in women with recurrent miscarriage.

“I also think it could be because we're not yet there in being able to select the most appropriate patients that could benefit from such immunotherapy,” she said. “Only 18% of prior miscarriages had been sent for chromosome testing, so that raises the question as to whether there were too many miscarriages that may have had random chromosome errors.”

A recent meta-analysis of eight randomized trials involving 442 women found a significant increase in live births following IVIG use in women with a secondary recurrent miscarriage (odds ratio, 2.71), while women with a primary miscarriage did not have the same benefit (OR, 0.66). The authors recommended further randomized trials, however, as the studies had small sample sizes and lacked homogeneity (BJOG 2007;114:134-42). When data from the current study were combined with data from the four prior secondary miscarriage trials in the meta-analysis, the odds ratio for a live birth was 2.16, favoring IVIG, Dr. Stephenson said.

The current study enrolled 82 women and after 5 withdrawals, randomized 38 women to IVIG (Gamunex or Gamimune) 500 mg/kg and 39 women to an equivalent volume of normal saline infused prior to ovulation for a maximum of six cycles and continued every 4 weeks until 18-20 weeks of pregnancy.

There were 23 pregnancies in the IVIG group and 24 in the control group. There was no difference in mean maternal age (36 vs. 35 years), mean body mass index (26 vs. 25 kg/m

Disclosures: Dr. Gabrielli disclosed no conflicts of interest.

HAMBURG, GERMANY — Magnetic resonance imaging has a limited role when added to ultrasound in the prenatal diagnosis of fetal anomalies, results of a prospective cohort study suggested.

“Prenatal ultrasound is accurate in over 90% of cases, and MRI adds significant information in [only] a minority of cases,” lead author Dr. Sandro Gabrielli said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

In 273 consecutive patients, MRI was performed to evaluate its accuracy compared with ultrasound in cases that were included because they were complex, because they were difficult to diagnose with ultrasound, or because ultrasound quality was poor.

Both ultrasound and MRI findings were in agreement with postnatal diagnoses in 90% of cases. Ultrasound was better than MRI in an additional 1% of cases and MRI was better in an additional 6%. Both modalities missed anomalies in 3%.

MRI was performed by expert pediatric neuroradiologists and radiologists, who were blinded to the ultrasound findings. The mean gestational age at diagnosis was 28 weeks for ultrasound and 30 weeks for MRI, at a range of 24-32 and 26-34 weeks, respectively.

“It is impossible to identify specific indications for MRI, apart from cases in which ultrasound gives suboptimal results,” said Dr. Gabrielli of the department of obstetrics and gynecology at St. Orsola University Hospital in Bologna, Italy.

Relevant additional information was provided by MRI in 2 of 126 central nervous system anomalies, 4 of 42 thoracic defects, and 2 of 35 abdominal malformations. Ultrasound provided extra information in one CNS anomaly, one thoracic defect, and one abdominal malformation. The seven cases in which both modalities failed to reveal anomalies were three cases of the rare cerebro-oculo-facio-skeletal syndrome, three CNS anomalies, and one abdominal malformation.

During a discussion of the study, audience members noted that both techniques are highly operator dependent. The ultrasound and MRI examiners in the study were all experts, responded Dr. Gabrielli, who added that results did improve over the course of the series, which ran from 2001 to 2009.

Dr. Ilan Timor-Tritsch, who also presented during the session and is director of obstetrical and gynecological ultrasound at New York University Medical Center, called for the development of teams of obstetricians interested in all aspects of fetal ultrasound and MRI to improve diagnostic accuracy. “MRI, at least in the United States, is in many, many places the replacement for a poor ultrasound.”

Disclosures: Dr. Gabrielli disclosed no conflicts of interest.

HAMBURG, GERMANY — Magnetic resonance imaging has a limited role when added to ultrasound in the prenatal diagnosis of fetal anomalies, results of a prospective cohort study suggested.

“Prenatal ultrasound is accurate in over 90% of cases, and MRI adds significant information in [only] a minority of cases,” lead author Dr. Sandro Gabrielli said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

In 273 consecutive patients, MRI was performed to evaluate its accuracy compared with ultrasound in cases that were included because they were complex, because they were difficult to diagnose with ultrasound, or because ultrasound quality was poor.

Both ultrasound and MRI findings were in agreement with postnatal diagnoses in 90% of cases. Ultrasound was better than MRI in an additional 1% of cases and MRI was better in an additional 6%. Both modalities missed anomalies in 3%.

MRI was performed by expert pediatric neuroradiologists and radiologists, who were blinded to the ultrasound findings. The mean gestational age at diagnosis was 28 weeks for ultrasound and 30 weeks for MRI, at a range of 24-32 and 26-34 weeks, respectively.

“It is impossible to identify specific indications for MRI, apart from cases in which ultrasound gives suboptimal results,” said Dr. Gabrielli of the department of obstetrics and gynecology at St. Orsola University Hospital in Bologna, Italy.

Relevant additional information was provided by MRI in 2 of 126 central nervous system anomalies, 4 of 42 thoracic defects, and 2 of 35 abdominal malformations. Ultrasound provided extra information in one CNS anomaly, one thoracic defect, and one abdominal malformation. The seven cases in which both modalities failed to reveal anomalies were three cases of the rare cerebro-oculo-facio-skeletal syndrome, three CNS anomalies, and one abdominal malformation.

During a discussion of the study, audience members noted that both techniques are highly operator dependent. The ultrasound and MRI examiners in the study were all experts, responded Dr. Gabrielli, who added that results did improve over the course of the series, which ran from 2001 to 2009.

Dr. Ilan Timor-Tritsch, who also presented during the session and is director of obstetrical and gynecological ultrasound at New York University Medical Center, called for the development of teams of obstetricians interested in all aspects of fetal ultrasound and MRI to improve diagnostic accuracy. “MRI, at least in the United States, is in many, many places the replacement for a poor ultrasound.”

Disclosures: Dr. Gabrielli disclosed no conflicts of interest.

HAMBURG, GERMANY — Magnetic resonance imaging has a limited role when added to ultrasound in the prenatal diagnosis of fetal anomalies, results of a prospective cohort study suggested.

“Prenatal ultrasound is accurate in over 90% of cases, and MRI adds significant information in [only] a minority of cases,” lead author Dr. Sandro Gabrielli said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

In 273 consecutive patients, MRI was performed to evaluate its accuracy compared with ultrasound in cases that were included because they were complex, because they were difficult to diagnose with ultrasound, or because ultrasound quality was poor.

Both ultrasound and MRI findings were in agreement with postnatal diagnoses in 90% of cases. Ultrasound was better than MRI in an additional 1% of cases and MRI was better in an additional 6%. Both modalities missed anomalies in 3%.

MRI was performed by expert pediatric neuroradiologists and radiologists, who were blinded to the ultrasound findings. The mean gestational age at diagnosis was 28 weeks for ultrasound and 30 weeks for MRI, at a range of 24-32 and 26-34 weeks, respectively.

“It is impossible to identify specific indications for MRI, apart from cases in which ultrasound gives suboptimal results,” said Dr. Gabrielli of the department of obstetrics and gynecology at St. Orsola University Hospital in Bologna, Italy.

Relevant additional information was provided by MRI in 2 of 126 central nervous system anomalies, 4 of 42 thoracic defects, and 2 of 35 abdominal malformations. Ultrasound provided extra information in one CNS anomaly, one thoracic defect, and one abdominal malformation. The seven cases in which both modalities failed to reveal anomalies were three cases of the rare cerebro-oculo-facio-skeletal syndrome, three CNS anomalies, and one abdominal malformation.

During a discussion of the study, audience members noted that both techniques are highly operator dependent. The ultrasound and MRI examiners in the study were all experts, responded Dr. Gabrielli, who added that results did improve over the course of the series, which ran from 2001 to 2009.

Dr. Ilan Timor-Tritsch, who also presented during the session and is director of obstetrical and gynecological ultrasound at New York University Medical Center, called for the development of teams of obstetricians interested in all aspects of fetal ultrasound and MRI to improve diagnostic accuracy. “MRI, at least in the United States, is in many, many places the replacement for a poor ultrasound.”

Disclosures: Dr. Zegers-Hochschild disclosed no conflicts of interest. Dr. Adamson reported receiving funding from EMD Serono Inc., Institute Biochimique SA, and LabCorp.

ATLANTA — Access to infertility treatment influences utilization rates but also changes outcomes, including high-order multiple births, research suggests.

Investigators used data collected from 2000 to 2004 from 54 countries through the International Committee Monitoring Assisted Reproductive Technologies (ICMART) to determine how economic factors influence the risk and benefit decisions made by providers and patients.

They found that assisted reproductive technology (ART) is used most frequently in societies that recognize infertility treatment as a reproductive right and consequently provide free access to treatment. When ART is funded out of pocket, it reaches only a small proportion of infertile couples, Dr. Fernando Zegers-Hochschild, ICMART vice chair, said at the annual meeting of the American Society for Reproductive Medicine (ASRM).

An estimated 64% of presumably infertile women requiring ART, aged 20-44 years, have access to ART treatment in Israel, where reimbursement is among the most generous in the world. This compares with 40% in Denmark and 32% in Australia, where cycles are free or reimbursed, and just 7% in the United States, where reimbursement is nil or limited.

In 2004, there were 1,083-2,000 ART cycles for every million inhabitants in Israel, Denmark, and Australia, while in the United States, there were only 357 cycles per million people. The number of ART cycles fell to just 50-150 cycles per million people in developing Latin American countries without reimbursement.

When ART is funded out of pocket, more embryos are transferred in order to achieve pregnancy with fewer attempts, generating an excess of twins and high-order multiple births, Dr. Zegers-Hochschild said. The financial motivation is not surprising, given the roughly $15,000 price tag per ART cycle. Financial pressure from patients and publication of performance data also are driving competition for high success rates and the transfer of more embryos.

In 2004, 67% of transfers in Sweden were single-embryo transfers, and the remaining 33% were two-embryo transfers. In contrast, 8% of transfers in the United States that year involved one embryo; 40%, two embryos; 32%, three embryos; and 20%, four or more embryos.

During the same year, the twin and high-order multiple birth rates in Sweden were 5.6% and 0.1% vs. 30.4% and 1.1% in the United States, the latter down from 4.3% in 2000. Part of the reduction in the U.S. triplet rate has been achieved through the use of embryo reduction, which is not reported by the Centers for Disease Control and Prevention, said Dr. Zegers-Hochschild of the unit of reproductive medicine, Clinicas las Condes, Santiago, Chile.

This relationship between access and infertility treatment outcomes is also present within countries. In a separate presentation at the same meeting, Yale University investigators in New Haven, Conn., led by Dr. J. Ryan Martin, reported that the number of embryos transferred per cycle, cancellation rate, twin rate, and multiple live birth rate were all significantly higher in states that did not mandate insurance coverage for in vitro fertilization (IVF). Only six states mandate coverage of two or more IVF cycles: Connecticut, Illinois, Massachusetts, Maryland, New Jersey, and Rhode Island.

Single-embryo transfer (SET) policies are being considered in several states to reduce multiple births, notably in California where residents are wrestling with the cost of premature octuplets born to “octomom” Nadya Suleman after she had six embryos transferred during infertility treatment. SET mandates have been put in place in countries like Belgium, with the potential cost savings from neonatal care of premature ART babies used to help fund infertility treatment, Dr. Zegers-Hochschild said in an interview.

Although ASRM immediate past president and fellow ICMART officer Dr. David Adamson agreed that the U.S. twin and triplet rates need to be reduced, he urged caution regarding SET mandates.

“This is very complicated medicine,” he said in an interview. “The delivery rate per retrieval in the United States is almost 50% better than in other countries. So, how much do you bring down the success rate to limit poor outcomes or complications?”

Evoking across-the-board regulations would interfere with the physician's ability to treat patients individually and does not address what happens if treatment fails. For example, ART treatment is reimbursed in Sweden, but if the treatment fails, a woman has to go back to the end of the line and possibly wait a year for another cycle, said Dr. Adamson, an ob.gyn. who specializes in reproductive endocrinology and infertility in Palo Alto, Calif. This can have devastating consequences, particularly for older women, and has prompted increasing use of private infertility clinics and personal financing.

“It must be a balance of risks and benefits,” Dr. Adamson said. “It is a decision of complexity that should be left to the physician and patient. And, professional guidelines must be followed.”

In October 2009, ASRM and the Society for Assisted Reproductive Technology issued new embryo transfer guidelines that “consideration should be given to transferring only a single embryo” for patients under age 35 who have a favorable prognosis, and recommended transferring only one more embryo than called for in four age-based prognostic categories. The number of embryos recommended for transfer increases with age (“Embryo Transfer Guidelines Tightened,” November, 2009, p. 1).

The societies also encourage individual fertility programs to generate and use their own data regarding patient characteristics and the number of embryos to be transferred. The ICMART database contains data from 54 countries, including 26 in which 100% of clinics reported their outcomes. In 2004 there were 724,247 ART cycles, up 53% from 475,054 in 2000, resulting in 132,809 deliveries and 165,278 babies.

Although the socioeconomic aspects of ART utilization are intricate and unique to each country, both Dr. Adamson and Dr. Zegers-Hochschild agreed that society needs to first recognize infertility as a public health issue if reimbursement and outcomes are to improve. The World Health Organization has recognized infertility as a public health issue and as a disease in its recently revised glossary of ART terminology developed with ICMART (Fertil. Steril. 2009;92:1520-4). (See related article, p. 11.) The CDC recognizes infertility as a public health issue, but not yet as a disease, Dr. Adamson said.

Study Shows Patient Support for Single-Egg IVF Transfer

The majority of patients were supportive of a mandatory single-blastocyst transfer policy in a survey of 262 infertile women.

The idea of mandating single-blastocyst transfer during infertility treatment is being debated in several states following the widely publicized case of Nadya Suleman and her octuplets, but also raises concerns that such policies don't provide the flexibility needed to treat individual patients.

The anonymous 50-question survey was conducted between September 2008 and May 2009 at the University of Iowa after 2003 implementation of a mandatory single-blastocyst transfer policy at the university for women aged 38 years and younger with no history of failed in vitro fertilization who also had at least seven fertilized oocytes and one good-quality blastocyst on the day of transfer.

Overall, 94% of patients were supportive on some level of the mandatory policy, Sarina Martini reported at the meeting. The level of support on a 4-point scale ranged from 25% being “extremely” supportive; 42%, “supportive”; 27%, “somewhat” supportive; and 6%, “not at all” supportive.

Support for the mandatory policy was not significantly different in women who qualified for the policy versus those who did not. Of the 262 women surveyed, 99 (38%) could transfer only one embryo.

Personal or societal concern about multiple-gestation pregnancy was the only significant predictor of support in an analysis that also included age, level of education, parity and gravidity, embryos in storage, children at home, previous in vitro fertilization/embryo transfers, failed transfers, duration of infertility, and insurance coverage.

The mean age of the women was 33 years, 86% had a college education or higher, 97% were married, 40% were nulliparous, and 42% had less than 20% insurance coverage for in vitro fertilization. Only 25% had been infertile for more than 5 years.

Overall, 87% of women felt that they had the right amount of input regarding the number of embryos to be transferred versus 13% who felt it was not enough, said Ms. Martini, a medical student at the University of Iowa in Iowa City. When asked specifically how much input they had in deciding the number of embryos transferred, 35% of women said they had no input; 14%, “a little” input; 20%, “moderate” input; and 31%, “a lot” of input.

The mean number of embryos transferred was 1.6, and the median was 2. In all, 71% were fresh transfers, and 29% were cryopreserved.

The mandatory transfer policy is for fresh transfers only, and is coupled with a standardized educational summary on the comparative risks of multiple versus singleton pregnancies to maternal and child health, Ms. Martini said. The policy has not affected ongoing pregnancy rates, which have been maintained at 55%-60%, while multiple pregnancies have been significantly reduced from 40% in 2003 to 10% in 2007.

Audience members seemed eager for details on the educational materials, with one physician remarking that his clinic in Tampa has had little success with a voluntary policy offering women a subsequent frozen embryo transfer free of charge if they agree to initial single-embryo transfer. Others questioned if the survey responses could have been influenced by a partner, to which Ms. Martini responded that all but one or two patients completed the survey with the assistance of a nurse and had partners in the waiting room. The investigators plan to follow the patients to see if attitudes change over time.

Disclosures: The authors reported no conflicts of interest.

Disclosures: Dr. Zegers-Hochschild disclosed no conflicts of interest. Dr. Adamson reported receiving funding from EMD Serono Inc., Institute Biochimique SA, and LabCorp.

ATLANTA — Access to infertility treatment influences utilization rates but also changes outcomes, including high-order multiple births, research suggests.

Investigators used data collected from 2000 to 2004 from 54 countries through the International Committee Monitoring Assisted Reproductive Technologies (ICMART) to determine how economic factors influence the risk and benefit decisions made by providers and patients.

They found that assisted reproductive technology (ART) is used most frequently in societies that recognize infertility treatment as a reproductive right and consequently provide free access to treatment. When ART is funded out of pocket, it reaches only a small proportion of infertile couples, Dr. Fernando Zegers-Hochschild, ICMART vice chair, said at the annual meeting of the American Society for Reproductive Medicine (ASRM).

An estimated 64% of presumably infertile women requiring ART, aged 20-44 years, have access to ART treatment in Israel, where reimbursement is among the most generous in the world. This compares with 40% in Denmark and 32% in Australia, where cycles are free or reimbursed, and just 7% in the United States, where reimbursement is nil or limited.

In 2004, there were 1,083-2,000 ART cycles for every million inhabitants in Israel, Denmark, and Australia, while in the United States, there were only 357 cycles per million people. The number of ART cycles fell to just 50-150 cycles per million people in developing Latin American countries without reimbursement.

When ART is funded out of pocket, more embryos are transferred in order to achieve pregnancy with fewer attempts, generating an excess of twins and high-order multiple births, Dr. Zegers-Hochschild said. The financial motivation is not surprising, given the roughly $15,000 price tag per ART cycle. Financial pressure from patients and publication of performance data also are driving competition for high success rates and the transfer of more embryos.

In 2004, 67% of transfers in Sweden were single-embryo transfers, and the remaining 33% were two-embryo transfers. In contrast, 8% of transfers in the United States that year involved one embryo; 40%, two embryos; 32%, three embryos; and 20%, four or more embryos.

During the same year, the twin and high-order multiple birth rates in Sweden were 5.6% and 0.1% vs. 30.4% and 1.1% in the United States, the latter down from 4.3% in 2000. Part of the reduction in the U.S. triplet rate has been achieved through the use of embryo reduction, which is not reported by the Centers for Disease Control and Prevention, said Dr. Zegers-Hochschild of the unit of reproductive medicine, Clinicas las Condes, Santiago, Chile.

This relationship between access and infertility treatment outcomes is also present within countries. In a separate presentation at the same meeting, Yale University investigators in New Haven, Conn., led by Dr. J. Ryan Martin, reported that the number of embryos transferred per cycle, cancellation rate, twin rate, and multiple live birth rate were all significantly higher in states that did not mandate insurance coverage for in vitro fertilization (IVF). Only six states mandate coverage of two or more IVF cycles: Connecticut, Illinois, Massachusetts, Maryland, New Jersey, and Rhode Island.

Single-embryo transfer (SET) policies are being considered in several states to reduce multiple births, notably in California where residents are wrestling with the cost of premature octuplets born to “octomom” Nadya Suleman after she had six embryos transferred during infertility treatment. SET mandates have been put in place in countries like Belgium, with the potential cost savings from neonatal care of premature ART babies used to help fund infertility treatment, Dr. Zegers-Hochschild said in an interview.

Although ASRM immediate past president and fellow ICMART officer Dr. David Adamson agreed that the U.S. twin and triplet rates need to be reduced, he urged caution regarding SET mandates.

“This is very complicated medicine,” he said in an interview. “The delivery rate per retrieval in the United States is almost 50% better than in other countries. So, how much do you bring down the success rate to limit poor outcomes or complications?”

Evoking across-the-board regulations would interfere with the physician's ability to treat patients individually and does not address what happens if treatment fails. For example, ART treatment is reimbursed in Sweden, but if the treatment fails, a woman has to go back to the end of the line and possibly wait a year for another cycle, said Dr. Adamson, an ob.gyn. who specializes in reproductive endocrinology and infertility in Palo Alto, Calif. This can have devastating consequences, particularly for older women, and has prompted increasing use of private infertility clinics and personal financing.

“It must be a balance of risks and benefits,” Dr. Adamson said. “It is a decision of complexity that should be left to the physician and patient. And, professional guidelines must be followed.”

In October 2009, ASRM and the Society for Assisted Reproductive Technology issued new embryo transfer guidelines that “consideration should be given to transferring only a single embryo” for patients under age 35 who have a favorable prognosis, and recommended transferring only one more embryo than called for in four age-based prognostic categories. The number of embryos recommended for transfer increases with age (“Embryo Transfer Guidelines Tightened,” November, 2009, p. 1).

The societies also encourage individual fertility programs to generate and use their own data regarding patient characteristics and the number of embryos to be transferred. The ICMART database contains data from 54 countries, including 26 in which 100% of clinics reported their outcomes. In 2004 there were 724,247 ART cycles, up 53% from 475,054 in 2000, resulting in 132,809 deliveries and 165,278 babies.

Although the socioeconomic aspects of ART utilization are intricate and unique to each country, both Dr. Adamson and Dr. Zegers-Hochschild agreed that society needs to first recognize infertility as a public health issue if reimbursement and outcomes are to improve. The World Health Organization has recognized infertility as a public health issue and as a disease in its recently revised glossary of ART terminology developed with ICMART (Fertil. Steril. 2009;92:1520-4). (See related article, p. 11.) The CDC recognizes infertility as a public health issue, but not yet as a disease, Dr. Adamson said.

Study Shows Patient Support for Single-Egg IVF Transfer

The majority of patients were supportive of a mandatory single-blastocyst transfer policy in a survey of 262 infertile women.

The idea of mandating single-blastocyst transfer during infertility treatment is being debated in several states following the widely publicized case of Nadya Suleman and her octuplets, but also raises concerns that such policies don't provide the flexibility needed to treat individual patients.

The anonymous 50-question survey was conducted between September 2008 and May 2009 at the University of Iowa after 2003 implementation of a mandatory single-blastocyst transfer policy at the university for women aged 38 years and younger with no history of failed in vitro fertilization who also had at least seven fertilized oocytes and one good-quality blastocyst on the day of transfer.

Overall, 94% of patients were supportive on some level of the mandatory policy, Sarina Martini reported at the meeting. The level of support on a 4-point scale ranged from 25% being “extremely” supportive; 42%, “supportive”; 27%, “somewhat” supportive; and 6%, “not at all” supportive.

Support for the mandatory policy was not significantly different in women who qualified for the policy versus those who did not. Of the 262 women surveyed, 99 (38%) could transfer only one embryo.

Personal or societal concern about multiple-gestation pregnancy was the only significant predictor of support in an analysis that also included age, level of education, parity and gravidity, embryos in storage, children at home, previous in vitro fertilization/embryo transfers, failed transfers, duration of infertility, and insurance coverage.

The mean age of the women was 33 years, 86% had a college education or higher, 97% were married, 40% were nulliparous, and 42% had less than 20% insurance coverage for in vitro fertilization. Only 25% had been infertile for more than 5 years.

Overall, 87% of women felt that they had the right amount of input regarding the number of embryos to be transferred versus 13% who felt it was not enough, said Ms. Martini, a medical student at the University of Iowa in Iowa City. When asked specifically how much input they had in deciding the number of embryos transferred, 35% of women said they had no input; 14%, “a little” input; 20%, “moderate” input; and 31%, “a lot” of input.

The mean number of embryos transferred was 1.6, and the median was 2. In all, 71% were fresh transfers, and 29% were cryopreserved.

The mandatory transfer policy is for fresh transfers only, and is coupled with a standardized educational summary on the comparative risks of multiple versus singleton pregnancies to maternal and child health, Ms. Martini said. The policy has not affected ongoing pregnancy rates, which have been maintained at 55%-60%, while multiple pregnancies have been significantly reduced from 40% in 2003 to 10% in 2007.

Audience members seemed eager for details on the educational materials, with one physician remarking that his clinic in Tampa has had little success with a voluntary policy offering women a subsequent frozen embryo transfer free of charge if they agree to initial single-embryo transfer. Others questioned if the survey responses could have been influenced by a partner, to which Ms. Martini responded that all but one or two patients completed the survey with the assistance of a nurse and had partners in the waiting room. The investigators plan to follow the patients to see if attitudes change over time.

Disclosures: The authors reported no conflicts of interest.

Disclosures: Dr. Zegers-Hochschild disclosed no conflicts of interest. Dr. Adamson reported receiving funding from EMD Serono Inc., Institute Biochimique SA, and LabCorp.

ATLANTA — Access to infertility treatment influences utilization rates but also changes outcomes, including high-order multiple births, research suggests.

Investigators used data collected from 2000 to 2004 from 54 countries through the International Committee Monitoring Assisted Reproductive Technologies (ICMART) to determine how economic factors influence the risk and benefit decisions made by providers and patients.

They found that assisted reproductive technology (ART) is used most frequently in societies that recognize infertility treatment as a reproductive right and consequently provide free access to treatment. When ART is funded out of pocket, it reaches only a small proportion of infertile couples, Dr. Fernando Zegers-Hochschild, ICMART vice chair, said at the annual meeting of the American Society for Reproductive Medicine (ASRM).

An estimated 64% of presumably infertile women requiring ART, aged 20-44 years, have access to ART treatment in Israel, where reimbursement is among the most generous in the world. This compares with 40% in Denmark and 32% in Australia, where cycles are free or reimbursed, and just 7% in the United States, where reimbursement is nil or limited.

In 2004, there were 1,083-2,000 ART cycles for every million inhabitants in Israel, Denmark, and Australia, while in the United States, there were only 357 cycles per million people. The number of ART cycles fell to just 50-150 cycles per million people in developing Latin American countries without reimbursement.

When ART is funded out of pocket, more embryos are transferred in order to achieve pregnancy with fewer attempts, generating an excess of twins and high-order multiple births, Dr. Zegers-Hochschild said. The financial motivation is not surprising, given the roughly $15,000 price tag per ART cycle. Financial pressure from patients and publication of performance data also are driving competition for high success rates and the transfer of more embryos.

In 2004, 67% of transfers in Sweden were single-embryo transfers, and the remaining 33% were two-embryo transfers. In contrast, 8% of transfers in the United States that year involved one embryo; 40%, two embryos; 32%, three embryos; and 20%, four or more embryos.

During the same year, the twin and high-order multiple birth rates in Sweden were 5.6% and 0.1% vs. 30.4% and 1.1% in the United States, the latter down from 4.3% in 2000. Part of the reduction in the U.S. triplet rate has been achieved through the use of embryo reduction, which is not reported by the Centers for Disease Control and Prevention, said Dr. Zegers-Hochschild of the unit of reproductive medicine, Clinicas las Condes, Santiago, Chile.

This relationship between access and infertility treatment outcomes is also present within countries. In a separate presentation at the same meeting, Yale University investigators in New Haven, Conn., led by Dr. J. Ryan Martin, reported that the number of embryos transferred per cycle, cancellation rate, twin rate, and multiple live birth rate were all significantly higher in states that did not mandate insurance coverage for in vitro fertilization (IVF). Only six states mandate coverage of two or more IVF cycles: Connecticut, Illinois, Massachusetts, Maryland, New Jersey, and Rhode Island.

Single-embryo transfer (SET) policies are being considered in several states to reduce multiple births, notably in California where residents are wrestling with the cost of premature octuplets born to “octomom” Nadya Suleman after she had six embryos transferred during infertility treatment. SET mandates have been put in place in countries like Belgium, with the potential cost savings from neonatal care of premature ART babies used to help fund infertility treatment, Dr. Zegers-Hochschild said in an interview.

Although ASRM immediate past president and fellow ICMART officer Dr. David Adamson agreed that the U.S. twin and triplet rates need to be reduced, he urged caution regarding SET mandates.

“This is very complicated medicine,” he said in an interview. “The delivery rate per retrieval in the United States is almost 50% better than in other countries. So, how much do you bring down the success rate to limit poor outcomes or complications?”

Evoking across-the-board regulations would interfere with the physician's ability to treat patients individually and does not address what happens if treatment fails. For example, ART treatment is reimbursed in Sweden, but if the treatment fails, a woman has to go back to the end of the line and possibly wait a year for another cycle, said Dr. Adamson, an ob.gyn. who specializes in reproductive endocrinology and infertility in Palo Alto, Calif. This can have devastating consequences, particularly for older women, and has prompted increasing use of private infertility clinics and personal financing.

“It must be a balance of risks and benefits,” Dr. Adamson said. “It is a decision of complexity that should be left to the physician and patient. And, professional guidelines must be followed.”

In October 2009, ASRM and the Society for Assisted Reproductive Technology issued new embryo transfer guidelines that “consideration should be given to transferring only a single embryo” for patients under age 35 who have a favorable prognosis, and recommended transferring only one more embryo than called for in four age-based prognostic categories. The number of embryos recommended for transfer increases with age (“Embryo Transfer Guidelines Tightened,” November, 2009, p. 1).

The societies also encourage individual fertility programs to generate and use their own data regarding patient characteristics and the number of embryos to be transferred. The ICMART database contains data from 54 countries, including 26 in which 100% of clinics reported their outcomes. In 2004 there were 724,247 ART cycles, up 53% from 475,054 in 2000, resulting in 132,809 deliveries and 165,278 babies.

Although the socioeconomic aspects of ART utilization are intricate and unique to each country, both Dr. Adamson and Dr. Zegers-Hochschild agreed that society needs to first recognize infertility as a public health issue if reimbursement and outcomes are to improve. The World Health Organization has recognized infertility as a public health issue and as a disease in its recently revised glossary of ART terminology developed with ICMART (Fertil. Steril. 2009;92:1520-4). (See related article, p. 11.) The CDC recognizes infertility as a public health issue, but not yet as a disease, Dr. Adamson said.

Study Shows Patient Support for Single-Egg IVF Transfer

The majority of patients were supportive of a mandatory single-blastocyst transfer policy in a survey of 262 infertile women.

The idea of mandating single-blastocyst transfer during infertility treatment is being debated in several states following the widely publicized case of Nadya Suleman and her octuplets, but also raises concerns that such policies don't provide the flexibility needed to treat individual patients.

The anonymous 50-question survey was conducted between September 2008 and May 2009 at the University of Iowa after 2003 implementation of a mandatory single-blastocyst transfer policy at the university for women aged 38 years and younger with no history of failed in vitro fertilization who also had at least seven fertilized oocytes and one good-quality blastocyst on the day of transfer.

Overall, 94% of patients were supportive on some level of the mandatory policy, Sarina Martini reported at the meeting. The level of support on a 4-point scale ranged from 25% being “extremely” supportive; 42%, “supportive”; 27%, “somewhat” supportive; and 6%, “not at all” supportive.

Support for the mandatory policy was not significantly different in women who qualified for the policy versus those who did not. Of the 262 women surveyed, 99 (38%) could transfer only one embryo.

Personal or societal concern about multiple-gestation pregnancy was the only significant predictor of support in an analysis that also included age, level of education, parity and gravidity, embryos in storage, children at home, previous in vitro fertilization/embryo transfers, failed transfers, duration of infertility, and insurance coverage.

The mean age of the women was 33 years, 86% had a college education or higher, 97% were married, 40% were nulliparous, and 42% had less than 20% insurance coverage for in vitro fertilization. Only 25% had been infertile for more than 5 years.

Overall, 87% of women felt that they had the right amount of input regarding the number of embryos to be transferred versus 13% who felt it was not enough, said Ms. Martini, a medical student at the University of Iowa in Iowa City. When asked specifically how much input they had in deciding the number of embryos transferred, 35% of women said they had no input; 14%, “a little” input; 20%, “moderate” input; and 31%, “a lot” of input.

The mean number of embryos transferred was 1.6, and the median was 2. In all, 71% were fresh transfers, and 29% were cryopreserved.

The mandatory transfer policy is for fresh transfers only, and is coupled with a standardized educational summary on the comparative risks of multiple versus singleton pregnancies to maternal and child health, Ms. Martini said. The policy has not affected ongoing pregnancy rates, which have been maintained at 55%-60%, while multiple pregnancies have been significantly reduced from 40% in 2003 to 10% in 2007.

Audience members seemed eager for details on the educational materials, with one physician remarking that his clinic in Tampa has had little success with a voluntary policy offering women a subsequent frozen embryo transfer free of charge if they agree to initial single-embryo transfer. Others questioned if the survey responses could have been influenced by a partner, to which Ms. Martini responded that all but one or two patients completed the survey with the assistance of a nurse and had partners in the waiting room. The investigators plan to follow the patients to see if attitudes change over time.

Disclosures: The authors reported no conflicts of interest.

Disclosures: Dr. Van den Bosch said he had no financial conflicts of interest. Dr. Emanuel reported being a stockholder and receiving royalties from Giskit BV.

HAMBURG, GERMANY — Diagnostic accuracy tends to be higher when the uterine cavity is distended with gel rather than saline during sonohysterography in women with abnormal bleeding, research results showed.

Use of gel instillation sonohysterography (GIS) also may resolve cervical leakage during saline infusion sonohysterography (SIS), thereby making the procedure easier on both the patient and the clinician.

“We had a large need for towels and even sometimes boots,” Dr. Mark Emanuel said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

He presented data from the first randomized trial to compare the two techniques, demonstrating a diagnostic accuracy of 89% for GIS and 73% for SIS in 103 women with abnormal uterine bleeding and an abnormal or inconclusive transvaginal ultrasound. The between-group difference failed to reach significance, but statistical calculations showed it would have if an additional 50 patients were added to the cohort. The sensitivity for GIS was 97% vs. 85% for SIS, and the specificity was 82% vs. 77%.

Gel instillation cuts investigation time and can be performed by one clinician, whereas SIS requires two persons to help refill the uterine cavity with saline, said Dr. Emanuel, a gynecologist at Spaarne Hospital, Hoofddorp, the Netherlands.

Cavity distention was up to 3 minutes in most cases after approximately 4 mL of gel were placed in the cervix. That compares with about 10-15 minutes with saline, which had to be reinfused through a catheter in the uterine cavity after about 20 seconds.

“It saves an enormous amount of time,” Dr. Emanuel said in an interview. “To instill a few milliliters of gel is much easier and can be done by almost anyone who can perform transvaginal scanning.”

Scores on visual analog scales measuring GIS and SIS inconvenience with 0 being very inconvenient were not significantly different, however, among clinicians (7.9 vs. 6.4) or patients (7.6 vs. 7.8).

Dr. Emanuel said gel instillation is a safe alternative to SIS and provides clinicians with a more stable image. “If you want to do 3-D scanning it's mandatory that you use gel,” he said. “For 3-D scanning, you don't want any moving fragments because they create artifacts. Saline infusion with 3-D is very difficult.”

During the same session, Dr. Thierry Van den Bosch, who has worked extensively with gel instillation, said it produces lower failure rates and at least similar diagnostic accuracy. In an observational study of two consecutive cohorts of 402 women, the technical failure rate for GIS was 1.9%, compared with 5% for SIS. Failure due to inadequate uterine cavity distention was 0.3% vs. 1.5%.

The sensitivity for GIS was 85% vs. 77.8% for SIS, and the specificity was 78.1% vs. 80.7%. Negative predictive values were “comparable” at 88.6% for GIS and 79.1% for SIS, said Dr. Van den Bosch of the University Hospitals, Catholic University of Leuven (Belgium).

He also presented data from a study in which six gynecologists were asked to predict intracavity uterine pathology in 111 consecutive women from the hospital's bleeding clinic based on 3-D volumes, including unenhanced ultrasound as well as GIS with and without power Doppler. The only clinical information they had was patients' age (mean 50.4 years) and menopausal status (63% were premenopausal).

Although the examiners were able to accurately differentiate normal from abnormal endometrium in the majority of cases, interobserver variability for these “off-line” assessments was substantial. The best agreement between three examiners was a Schouten kappa of 0.69, with an overall kappa of 0.51.

“Certainly interobserver variability should be improved, and I think it illustrates how difficult it is to give your opinion [when you are] not seeing the patient or doing the ultrasound yourself,” said Dr. Van den Bosch. “Perhaps if we had more strict [diagnostic sonographic] criteria we would have done better.”

The first experience with GIS was reported in 2007 (Fertil. Steril. 2007;87:152-5), but concerns were raised at the time about the safety of the gels (Fertil. Steril. 2007;88:536-7).

Dr. Van den Bosch said a study he presented at last year's congress showed that the addition of lidocaine to the gel did not alter patients' pain and should not be used because of the potential for anaphylactic reactions.

It's been suggested that gels containing chlorhexidine may reduce the risk of infection, but concerns have been raised about embryotoxicity in younger women.

An audience member questioned whether pregnancy has been an issue after gel exposure. Several patients have gotten pregnant without difficulty, said Dr. Van den Bosch.

Dr. Emanuels said that one gel has been reformulated without lidocaine and includes substances used in medicine for years, and that testing in mouse models shows no evidence of embryotoxicity.

Cost and ultrasound image quality are similar with the three commercially available gels, but manipulation of the gel should be avoided as it creates air bubbles that can disturb the ultrasound image, the investigators noted.

Disclosures: Dr. Van den Bosch said he had no financial conflicts of interest. Dr. Emanuel reported being a stockholder and receiving royalties from Giskit BV.

HAMBURG, GERMANY — Diagnostic accuracy tends to be higher when the uterine cavity is distended with gel rather than saline during sonohysterography in women with abnormal bleeding, research results showed.

Use of gel instillation sonohysterography (GIS) also may resolve cervical leakage during saline infusion sonohysterography (SIS), thereby making the procedure easier on both the patient and the clinician.

“We had a large need for towels and even sometimes boots,” Dr. Mark Emanuel said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

He presented data from the first randomized trial to compare the two techniques, demonstrating a diagnostic accuracy of 89% for GIS and 73% for SIS in 103 women with abnormal uterine bleeding and an abnormal or inconclusive transvaginal ultrasound. The between-group difference failed to reach significance, but statistical calculations showed it would have if an additional 50 patients were added to the cohort. The sensitivity for GIS was 97% vs. 85% for SIS, and the specificity was 82% vs. 77%.

Gel instillation cuts investigation time and can be performed by one clinician, whereas SIS requires two persons to help refill the uterine cavity with saline, said Dr. Emanuel, a gynecologist at Spaarne Hospital, Hoofddorp, the Netherlands.

Cavity distention was up to 3 minutes in most cases after approximately 4 mL of gel were placed in the cervix. That compares with about 10-15 minutes with saline, which had to be reinfused through a catheter in the uterine cavity after about 20 seconds.

“It saves an enormous amount of time,” Dr. Emanuel said in an interview. “To instill a few milliliters of gel is much easier and can be done by almost anyone who can perform transvaginal scanning.”

Scores on visual analog scales measuring GIS and SIS inconvenience with 0 being very inconvenient were not significantly different, however, among clinicians (7.9 vs. 6.4) or patients (7.6 vs. 7.8).

Dr. Emanuel said gel instillation is a safe alternative to SIS and provides clinicians with a more stable image. “If you want to do 3-D scanning it's mandatory that you use gel,” he said. “For 3-D scanning, you don't want any moving fragments because they create artifacts. Saline infusion with 3-D is very difficult.”

During the same session, Dr. Thierry Van den Bosch, who has worked extensively with gel instillation, said it produces lower failure rates and at least similar diagnostic accuracy. In an observational study of two consecutive cohorts of 402 women, the technical failure rate for GIS was 1.9%, compared with 5% for SIS. Failure due to inadequate uterine cavity distention was 0.3% vs. 1.5%.

The sensitivity for GIS was 85% vs. 77.8% for SIS, and the specificity was 78.1% vs. 80.7%. Negative predictive values were “comparable” at 88.6% for GIS and 79.1% for SIS, said Dr. Van den Bosch of the University Hospitals, Catholic University of Leuven (Belgium).

He also presented data from a study in which six gynecologists were asked to predict intracavity uterine pathology in 111 consecutive women from the hospital's bleeding clinic based on 3-D volumes, including unenhanced ultrasound as well as GIS with and without power Doppler. The only clinical information they had was patients' age (mean 50.4 years) and menopausal status (63% were premenopausal).

Although the examiners were able to accurately differentiate normal from abnormal endometrium in the majority of cases, interobserver variability for these “off-line” assessments was substantial. The best agreement between three examiners was a Schouten kappa of 0.69, with an overall kappa of 0.51.

“Certainly interobserver variability should be improved, and I think it illustrates how difficult it is to give your opinion [when you are] not seeing the patient or doing the ultrasound yourself,” said Dr. Van den Bosch. “Perhaps if we had more strict [diagnostic sonographic] criteria we would have done better.”

The first experience with GIS was reported in 2007 (Fertil. Steril. 2007;87:152-5), but concerns were raised at the time about the safety of the gels (Fertil. Steril. 2007;88:536-7).

Dr. Van den Bosch said a study he presented at last year's congress showed that the addition of lidocaine to the gel did not alter patients' pain and should not be used because of the potential for anaphylactic reactions.

It's been suggested that gels containing chlorhexidine may reduce the risk of infection, but concerns have been raised about embryotoxicity in younger women.

An audience member questioned whether pregnancy has been an issue after gel exposure. Several patients have gotten pregnant without difficulty, said Dr. Van den Bosch.

Dr. Emanuels said that one gel has been reformulated without lidocaine and includes substances used in medicine for years, and that testing in mouse models shows no evidence of embryotoxicity.

Cost and ultrasound image quality are similar with the three commercially available gels, but manipulation of the gel should be avoided as it creates air bubbles that can disturb the ultrasound image, the investigators noted.

Disclosures: Dr. Van den Bosch said he had no financial conflicts of interest. Dr. Emanuel reported being a stockholder and receiving royalties from Giskit BV.

HAMBURG, GERMANY — Diagnostic accuracy tends to be higher when the uterine cavity is distended with gel rather than saline during sonohysterography in women with abnormal bleeding, research results showed.

Use of gel instillation sonohysterography (GIS) also may resolve cervical leakage during saline infusion sonohysterography (SIS), thereby making the procedure easier on both the patient and the clinician.

“We had a large need for towels and even sometimes boots,” Dr. Mark Emanuel said at the 19th World Congress on Ultrasound in Obstetrics and Gynecology.

He presented data from the first randomized trial to compare the two techniques, demonstrating a diagnostic accuracy of 89% for GIS and 73% for SIS in 103 women with abnormal uterine bleeding and an abnormal or inconclusive transvaginal ultrasound. The between-group difference failed to reach significance, but statistical calculations showed it would have if an additional 50 patients were added to the cohort. The sensitivity for GIS was 97% vs. 85% for SIS, and the specificity was 82% vs. 77%.

Gel instillation cuts investigation time and can be performed by one clinician, whereas SIS requires two persons to help refill the uterine cavity with saline, said Dr. Emanuel, a gynecologist at Spaarne Hospital, Hoofddorp, the Netherlands.

Cavity distention was up to 3 minutes in most cases after approximately 4 mL of gel were placed in the cervix. That compares with about 10-15 minutes with saline, which had to be reinfused through a catheter in the uterine cavity after about 20 seconds.

“It saves an enormous amount of time,” Dr. Emanuel said in an interview. “To instill a few milliliters of gel is much easier and can be done by almost anyone who can perform transvaginal scanning.”

Scores on visual analog scales measuring GIS and SIS inconvenience with 0 being very inconvenient were not significantly different, however, among clinicians (7.9 vs. 6.4) or patients (7.6 vs. 7.8).

Dr. Emanuel said gel instillation is a safe alternative to SIS and provides clinicians with a more stable image. “If you want to do 3-D scanning it's mandatory that you use gel,” he said. “For 3-D scanning, you don't want any moving fragments because they create artifacts. Saline infusion with 3-D is very difficult.”

During the same session, Dr. Thierry Van den Bosch, who has worked extensively with gel instillation, said it produces lower failure rates and at least similar diagnostic accuracy. In an observational study of two consecutive cohorts of 402 women, the technical failure rate for GIS was 1.9%, compared with 5% for SIS. Failure due to inadequate uterine cavity distention was 0.3% vs. 1.5%.

The sensitivity for GIS was 85% vs. 77.8% for SIS, and the specificity was 78.1% vs. 80.7%. Negative predictive values were “comparable” at 88.6% for GIS and 79.1% for SIS, said Dr. Van den Bosch of the University Hospitals, Catholic University of Leuven (Belgium).

He also presented data from a study in which six gynecologists were asked to predict intracavity uterine pathology in 111 consecutive women from the hospital's bleeding clinic based on 3-D volumes, including unenhanced ultrasound as well as GIS with and without power Doppler. The only clinical information they had was patients' age (mean 50.4 years) and menopausal status (63% were premenopausal).

Although the examiners were able to accurately differentiate normal from abnormal endometrium in the majority of cases, interobserver variability for these “off-line” assessments was substantial. The best agreement between three examiners was a Schouten kappa of 0.69, with an overall kappa of 0.51.

“Certainly interobserver variability should be improved, and I think it illustrates how difficult it is to give your opinion [when you are] not seeing the patient or doing the ultrasound yourself,” said Dr. Van den Bosch. “Perhaps if we had more strict [diagnostic sonographic] criteria we would have done better.”

The first experience with GIS was reported in 2007 (Fertil. Steril. 2007;87:152-5), but concerns were raised at the time about the safety of the gels (Fertil. Steril. 2007;88:536-7).

Dr. Van den Bosch said a study he presented at last year's congress showed that the addition of lidocaine to the gel did not alter patients' pain and should not be used because of the potential for anaphylactic reactions.

It's been suggested that gels containing chlorhexidine may reduce the risk of infection, but concerns have been raised about embryotoxicity in younger women.

An audience member questioned whether pregnancy has been an issue after gel exposure. Several patients have gotten pregnant without difficulty, said Dr. Van den Bosch.

Dr. Emanuels said that one gel has been reformulated without lidocaine and includes substances used in medicine for years, and that testing in mouse models shows no evidence of embryotoxicity.

Cost and ultrasound image quality are similar with the three commercially available gels, but manipulation of the gel should be avoided as it creates air bubbles that can disturb the ultrasound image, the investigators noted.

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported Decthe annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared to benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3–5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14–16-mHz ultrasound unit.

Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

Elastography estimates the elastic properties of tissue. Malignancies, such as this sqamous cell carcinoma (shown left on elastrogram and right on unenhanced ultrasound) can be differentiated because they are stiffer than benign growths.

Source Courtesy Radiological Society of North America

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported Decthe annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared to benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3–5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14–16-mHz ultrasound unit.

Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

Elastography estimates the elastic properties of tissue. Malignancies, such as this sqamous cell carcinoma (shown left on elastrogram and right on unenhanced ultrasound) can be differentiated because they are stiffer than benign growths.

Source Courtesy Radiological Society of North America

CHICAGO — An ultrasound technique that measures tissue elasticity could dramatically alter the way in which skin cancer is diagnosed.

In a prospective study of 56 patients with proliferative malignant neoplasms or benign skin lesions, the use of ultrasound elastography analysis prior to biopsy correctly differentiated benign from malignant lesions in 100% of cases, Dr. Eliot Siegel reported Decthe annual meeting of the Radiological Society of North America.

“We believe that ultrasound has tremendous potential that is completely untapped now to characterize and delineate the extent of skin lesions currently evaluated visually,” he said. “We believe it has tremendous promise to reduce unnecessary biopsies.”

Elastography noninvasively estimates the axial tissue strain, or elastic properties of tissue. Cystic lesions demonstrate high levels of elasticity, while malignant lesions are relatively “hard” with a very low level of elasticity.

Ultrasound with elastography, more so than optical or light images, is unique in its ability to provide the proper depth at which to analyze lesions—around 5 mm below the surface, said Dr. Siegel, vice chair of radiology and a professor at the University of Maryland in Baltimore. This may be useful in the early detection of melanoma before the classic signs such as asymmetry or changes in border are present on the skin's surface. In addition, elastography could have a role during surgery.

“This also could guide the surgeon as the surgeon is doing an excision or biopsy to not just look at the tip of the iceberg that they can see at the skin surface, but actually to be able to look deeper, so they can see exactly which areas they can cut out safely and still remove the entire tumor without unnecessarily removing more than that,” he said.

Elastography software is available on most new ultrasound machines, and has been used with promising results for breast, thyroid, and liver cancer. It has not been used to explore skin lesions, except for one prior study from 2007.

That study used absolute strain values, whereas Dr. Siegel and associates also calculated strain ratios. Malignant lesions had higher strain ratios (minimum 5.3; maximum 32.2), compared to benign lesions (min. 0.01; max. 3). None of the malignant lesions violated a strain-ratio cutoff of 3–5, Dr. Siegel said. He presented a few examples, including a squamous cell carcinoma with a ratio of 13.27 and a benign keloid with a ratio of 1.25.

Although preliminary, the data suggest that strain ratios may also be useful in distinguishing between malignant lesions. Squamous cell carcinomas had a higher ratio overall, said coauthor Dr. Bahar Dasgeb, a radiologist and second-year dermatology resident at Wayne State University in Detroit. Moreover, the strain ratio was higher, even within squamous cell or basal cell cancers, when more invasive cells were present.

If strain ratios are combined with higher ultrasound frequencies, it's possible that the anatomic information gleaned from elastography “could rival the information that a pathologist would see after the lesion was excised,” Dr. Siegel said.

“That's really the direction that we'd like to head into for research and development, as we look at much higher ultrasound frequencies.”

The current study used a clinically available 14–16-mHz ultrasound unit.

Dr. Siegel disclosed receiving research grants from several imaging companies. Dr. Dasgeb had no disclosures.

Elastography estimates the elastic properties of tissue. Malignancies, such as this sqamous cell carcinoma (shown left on elastrogram and right on unenhanced ultrasound) can be differentiated because they are stiffer than benign growths.

Source Courtesy Radiological Society of North America

NEW ORLEANS — Nearly two-thirds of 9,675 medical patients at risk for venous thromboembolism received no inpatient pharmacologic prophylaxis and more than 98% received no outpatient prophylaxis, a retrospective analysis showed.

The analysis is unique in that it assessed both inpatient and outpatient pharmacologic venous thromboembolism (VTE) prophylaxis in medical patients at risk of VTE, Dr. Alpesh N. Amin and his associates reported in a poster at the annual meeting of the American Society of Hematology.

“Further efforts to improve VTE prevention in medical patients are required, with particular emphasis needed on the transition to outpatient prophylaxis,” the authors concluded. Most hospitalized medical patients have at least one VTE risk factor, with the risk persisting for several weeks after discharge. In addition to hospitalization for a medical illness, VTE risk factors in the study included age at least 60 years (40.5% of patients), malignancy (28%), and obesity (19%).

Overall, 6,185 patients (64%) did not receive any pharmacologic VTE prophylaxis while hospitalized, reported Dr. Amin, executive director of the hospitalist program and professor and chair of medicine at the University of California at Irvine, and his associates. Lack of thromboprophylaxis was most apparent in patients with cancer, occurring in about 70% of 2,544 patients.

Among the 3,490 patients who received pharmacologic VTE prophylaxis, 2,045 received enoxaparin and 1,044 received unfractionated heparin. Enoxaparin was the most commonly prescribed prophylactic agent in patients with heart failure, severe lung disease, or infectious disease; heparin was the most commonly prescribed agent in patients with cancer.

“Even when pharmacological VTE prophylaxis was provided for the duration of hospitalization, the median length of hospital stay was just 3 days in this study, which falls short of the 6–14 days of VTE prophylaxis provided in clinical trials in medical at-risk patients,” Dr. Amin and his associates wrote.

A total of 2,854 patients (29.5%) first received prophylaxis on the last day or next-to-last day of their hospital stay.

In the 30 days following hospital discharge, 98.2% of the medical patients analyzed received no further pharmacologic VTE prophylaxis. Among the 174 medical discharges who did receive outpatient pharmacologic prophylaxis, most received warfarin alone, followed by enoxaparin plus warfarin. Patients with heart failure had the highest level of outpatient prophylaxis within 30 days after discharge (4.8%), and infectious disease patients had the lowest level (1.1%).

For the study, inpatient data from the Premier's Perspective database were cross-matched at the individual patient level with Ingenix LabRx outpatient data from the i3 database (January 2005–December 2007). Patients at least 40 years old and at risk of VTE according to the 2004 American College of Chest Physicians guidelines were included if they had cancer (without surgery), heart failure, severe lung disease, or infectious disease. The data, which came from hospitals in diverse geographic areas, “may not be representative of the U.S. population as a whole,” the researchers noted.

The study excluded patients with contraindications to pharmacologic VTE prophylaxis and those without health plan eligibility in the 3 months before and the 6 months after hospitalization.

The authors disclosed receiving editorial support from Sanofi-Aventis U.S. in the preparation of the poster, but noted that they were fully responsible for all content and editorial decisions. Coauthor Jay Lin, Ph.D., is an employee of Sanofi-Aventis, and coauthor Amy Ryan is an employee of Premier Inc.

My Take

VTE Prophylaxis Still Inconsistent

Over the last 2 decades, the medical community has repeatedly demonstrated the lack of uniform VTE prophylaxis for medical patients at risk. This analysis is contemporary and suggests that the push for VTE prevention by the National Quality Forum, the Agency for Healthcare Research and Quality, and the Leapfrog Group has not been that successful in changing practice. It will be interesting to see if the new Joint Commission core measures on VTE prevention lead to improvements.

This study also highlights the inadequate duration of VTE prophylaxis. Research shows that 6–14 days of prophylaxis is effective, yet patients today aren't hospitalized long enough to receive treatment of this duration. Achieving better outpatient prophylaxis is a major challenge, and some of the new anticoagulants soon to be available may help in this regard.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

NEW ORLEANS — Nearly two-thirds of 9,675 medical patients at risk for venous thromboembolism received no inpatient pharmacologic prophylaxis and more than 98% received no outpatient prophylaxis, a retrospective analysis showed.

The analysis is unique in that it assessed both inpatient and outpatient pharmacologic venous thromboembolism (VTE) prophylaxis in medical patients at risk of VTE, Dr. Alpesh N. Amin and his associates reported in a poster at the annual meeting of the American Society of Hematology.

“Further efforts to improve VTE prevention in medical patients are required, with particular emphasis needed on the transition to outpatient prophylaxis,” the authors concluded. Most hospitalized medical patients have at least one VTE risk factor, with the risk persisting for several weeks after discharge. In addition to hospitalization for a medical illness, VTE risk factors in the study included age at least 60 years (40.5% of patients), malignancy (28%), and obesity (19%).

Overall, 6,185 patients (64%) did not receive any pharmacologic VTE prophylaxis while hospitalized, reported Dr. Amin, executive director of the hospitalist program and professor and chair of medicine at the University of California at Irvine, and his associates. Lack of thromboprophylaxis was most apparent in patients with cancer, occurring in about 70% of 2,544 patients.

Among the 3,490 patients who received pharmacologic VTE prophylaxis, 2,045 received enoxaparin and 1,044 received unfractionated heparin. Enoxaparin was the most commonly prescribed prophylactic agent in patients with heart failure, severe lung disease, or infectious disease; heparin was the most commonly prescribed agent in patients with cancer.

“Even when pharmacological VTE prophylaxis was provided for the duration of hospitalization, the median length of hospital stay was just 3 days in this study, which falls short of the 6–14 days of VTE prophylaxis provided in clinical trials in medical at-risk patients,” Dr. Amin and his associates wrote.

A total of 2,854 patients (29.5%) first received prophylaxis on the last day or next-to-last day of their hospital stay.

In the 30 days following hospital discharge, 98.2% of the medical patients analyzed received no further pharmacologic VTE prophylaxis. Among the 174 medical discharges who did receive outpatient pharmacologic prophylaxis, most received warfarin alone, followed by enoxaparin plus warfarin. Patients with heart failure had the highest level of outpatient prophylaxis within 30 days after discharge (4.8%), and infectious disease patients had the lowest level (1.1%).

For the study, inpatient data from the Premier's Perspective database were cross-matched at the individual patient level with Ingenix LabRx outpatient data from the i3 database (January 2005–December 2007). Patients at least 40 years old and at risk of VTE according to the 2004 American College of Chest Physicians guidelines were included if they had cancer (without surgery), heart failure, severe lung disease, or infectious disease. The data, which came from hospitals in diverse geographic areas, “may not be representative of the U.S. population as a whole,” the researchers noted.

The study excluded patients with contraindications to pharmacologic VTE prophylaxis and those without health plan eligibility in the 3 months before and the 6 months after hospitalization.

The authors disclosed receiving editorial support from Sanofi-Aventis U.S. in the preparation of the poster, but noted that they were fully responsible for all content and editorial decisions. Coauthor Jay Lin, Ph.D., is an employee of Sanofi-Aventis, and coauthor Amy Ryan is an employee of Premier Inc.

My Take

VTE Prophylaxis Still Inconsistent

Over the last 2 decades, the medical community has repeatedly demonstrated the lack of uniform VTE prophylaxis for medical patients at risk. This analysis is contemporary and suggests that the push for VTE prevention by the National Quality Forum, the Agency for Healthcare Research and Quality, and the Leapfrog Group has not been that successful in changing practice. It will be interesting to see if the new Joint Commission core measures on VTE prevention lead to improvements.

This study also highlights the inadequate duration of VTE prophylaxis. Research shows that 6–14 days of prophylaxis is effective, yet patients today aren't hospitalized long enough to receive treatment of this duration. Achieving better outpatient prophylaxis is a major challenge, and some of the new anticoagulants soon to be available may help in this regard.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

NEW ORLEANS — Nearly two-thirds of 9,675 medical patients at risk for venous thromboembolism received no inpatient pharmacologic prophylaxis and more than 98% received no outpatient prophylaxis, a retrospective analysis showed.

The analysis is unique in that it assessed both inpatient and outpatient pharmacologic venous thromboembolism (VTE) prophylaxis in medical patients at risk of VTE, Dr. Alpesh N. Amin and his associates reported in a poster at the annual meeting of the American Society of Hematology.

“Further efforts to improve VTE prevention in medical patients are required, with particular emphasis needed on the transition to outpatient prophylaxis,” the authors concluded. Most hospitalized medical patients have at least one VTE risk factor, with the risk persisting for several weeks after discharge. In addition to hospitalization for a medical illness, VTE risk factors in the study included age at least 60 years (40.5% of patients), malignancy (28%), and obesity (19%).

Overall, 6,185 patients (64%) did not receive any pharmacologic VTE prophylaxis while hospitalized, reported Dr. Amin, executive director of the hospitalist program and professor and chair of medicine at the University of California at Irvine, and his associates. Lack of thromboprophylaxis was most apparent in patients with cancer, occurring in about 70% of 2,544 patients.

Among the 3,490 patients who received pharmacologic VTE prophylaxis, 2,045 received enoxaparin and 1,044 received unfractionated heparin. Enoxaparin was the most commonly prescribed prophylactic agent in patients with heart failure, severe lung disease, or infectious disease; heparin was the most commonly prescribed agent in patients with cancer.

“Even when pharmacological VTE prophylaxis was provided for the duration of hospitalization, the median length of hospital stay was just 3 days in this study, which falls short of the 6–14 days of VTE prophylaxis provided in clinical trials in medical at-risk patients,” Dr. Amin and his associates wrote.

A total of 2,854 patients (29.5%) first received prophylaxis on the last day or next-to-last day of their hospital stay.

In the 30 days following hospital discharge, 98.2% of the medical patients analyzed received no further pharmacologic VTE prophylaxis. Among the 174 medical discharges who did receive outpatient pharmacologic prophylaxis, most received warfarin alone, followed by enoxaparin plus warfarin. Patients with heart failure had the highest level of outpatient prophylaxis within 30 days after discharge (4.8%), and infectious disease patients had the lowest level (1.1%).

For the study, inpatient data from the Premier's Perspective database were cross-matched at the individual patient level with Ingenix LabRx outpatient data from the i3 database (January 2005–December 2007). Patients at least 40 years old and at risk of VTE according to the 2004 American College of Chest Physicians guidelines were included if they had cancer (without surgery), heart failure, severe lung disease, or infectious disease. The data, which came from hospitals in diverse geographic areas, “may not be representative of the U.S. population as a whole,” the researchers noted.

The study excluded patients with contraindications to pharmacologic VTE prophylaxis and those without health plan eligibility in the 3 months before and the 6 months after hospitalization.

The authors disclosed receiving editorial support from Sanofi-Aventis U.S. in the preparation of the poster, but noted that they were fully responsible for all content and editorial decisions. Coauthor Jay Lin, Ph.D., is an employee of Sanofi-Aventis, and coauthor Amy Ryan is an employee of Premier Inc.

My Take

VTE Prophylaxis Still Inconsistent

Over the last 2 decades, the medical community has repeatedly demonstrated the lack of uniform VTE prophylaxis for medical patients at risk. This analysis is contemporary and suggests that the push for VTE prevention by the National Quality Forum, the Agency for Healthcare Research and Quality, and the Leapfrog Group has not been that successful in changing practice. It will be interesting to see if the new Joint Commission core measures on VTE prevention lead to improvements.

This study also highlights the inadequate duration of VTE prophylaxis. Research shows that 6–14 days of prophylaxis is effective, yet patients today aren't hospitalized long enough to receive treatment of this duration. Achieving better outpatient prophylaxis is a major challenge, and some of the new anticoagulants soon to be available may help in this regard.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history in humans and requires frequent dose adjustments.

Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of venous thromboembolism (VTE) in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, demonstrating noninferiority to warfarin for prevention of recurrent or fatal VTE. After 6 months of treatment, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman said during a plenary session at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and in 1.9% of warfarin patients (hazard ratio 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (P = .0002, HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was reported in no patients on dabigatran and three patients on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University in Hamilton, Ont. and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be withdrawn from European markets and to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150 mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing during the meeting, Dr. Schulman responded that the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Price was a key issue raised during both the press briefing and the discussion following the formal study presentation. Dr. Schulman told the audience that it was unclear what the price would be for the treatment of VTE, which has a different dosage than for VTE prevention in orthopedic patients. During the press briefing, he suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin; for example, 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; then they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

Results of the trial were published simultaneously in the New England Journal of Medicine (2009;361:2342–52[doi:10.1056/NEJMoa0906598]).

The study was sponsored by Boehringer Ingelheim. Dr. Shulman disclosed receiving honoraria from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, GlaxoSmithKline and Sanofi-Aventis, lecture fees from LeoPharma and Sanofi-Aventis, and an unrestricted grant from Bayer.

My Take

New Anticoagulants Hold Promise

Safer oral anticoagulants are needed, and this study highlights an emerging option for replacing warfarin.

However, this study design didn't address the important potential for new oral anticoagulants to meet both the acute and chronic anticoagulation indications for VTE. This study treated VTE acutely with traditional inpatient parenteral anticoagulants.

For hospitalists, the value in these new anticoagulants will be the potential to write a prescription for oral therapy straight from the emergency department, essentially turning uncomplicated acute VTE into an outpatient condition.

Hospitalists will be on the front lines in managing possible complications of new anticoagulants. Renally impaired patients were excluded from this study, yet patients on these medications might develop acute kidney injury and require hospitalization unexpectedly. How will we reverse this agent if needed? This will be uncharted territory for hospitalists.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

DR. MICHOTA

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history in humans and requires frequent dose adjustments.

Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of venous thromboembolism (VTE) in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, demonstrating noninferiority to warfarin for prevention of recurrent or fatal VTE. After 6 months of treatment, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman said during a plenary session at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and in 1.9% of warfarin patients (hazard ratio 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (P = .0002, HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was reported in no patients on dabigatran and three patients on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University in Hamilton, Ont. and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be withdrawn from European markets and to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150 mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing during the meeting, Dr. Schulman responded that the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Price was a key issue raised during both the press briefing and the discussion following the formal study presentation. Dr. Schulman told the audience that it was unclear what the price would be for the treatment of VTE, which has a different dosage than for VTE prevention in orthopedic patients. During the press briefing, he suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin; for example, 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; then they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

Results of the trial were published simultaneously in the New England Journal of Medicine (2009;361:2342–52[doi:10.1056/NEJMoa0906598]).

The study was sponsored by Boehringer Ingelheim. Dr. Shulman disclosed receiving honoraria from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, GlaxoSmithKline and Sanofi-Aventis, lecture fees from LeoPharma and Sanofi-Aventis, and an unrestricted grant from Bayer.

My Take

New Anticoagulants Hold Promise

Safer oral anticoagulants are needed, and this study highlights an emerging option for replacing warfarin.

However, this study design didn't address the important potential for new oral anticoagulants to meet both the acute and chronic anticoagulation indications for VTE. This study treated VTE acutely with traditional inpatient parenteral anticoagulants.

For hospitalists, the value in these new anticoagulants will be the potential to write a prescription for oral therapy straight from the emergency department, essentially turning uncomplicated acute VTE into an outpatient condition.

Hospitalists will be on the front lines in managing possible complications of new anticoagulants. Renally impaired patients were excluded from this study, yet patients on these medications might develop acute kidney injury and require hospitalization unexpectedly. How will we reverse this agent if needed? This will be uncharted territory for hospitalists.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

DR. MICHOTA

NEW ORLEANS — Dabigatran etexilate had comparable efficacy and significantly lower or comparable bleeding rates to warfarin in patients with acute venous thromboembolism, according to data from the RE-COVER trial.

The direct thrombin inhibitor is among several emerging oral anticoagulants that might replace warfarin, which has accumulated a notorious safety record over its 60-year history in humans and requires frequent dose adjustments.

Dabigatran, which is approved as Pradaxa in 40 countries for the primary prevention of venous thromboembolism (VTE) in patients who have undergone total knee or hip replacement, is not approved for use in the United States.

Dabigatran met this phase III study's primary end point, demonstrating noninferiority to warfarin for prevention of recurrent or fatal VTE. After 6 months of treatment, 2.4% of 1,274 patients randomized to dabigatran and 2.1% of patients assigned to warfarin experienced recurrent VTE or related death (hazard ratio 1.10), Dr. Sam Schulman said during a plenary session at the annual meeting of the American Society of Hematology.

Major bleeding events occurred in 1.6% of dabigatran patients and in 1.9% of warfarin patients (hazard ratio 0.82). Dabigatran reduced the risk of any bleeding event at 6 months by 29% (P = .0002, HR 0.71). Fatal bleeding occurred in one patient in each arm; intracranial bleeding was reported in no patients on dabigatran and three patients on warfarin.

“Dabigatran etexilate provides a convenient, oral fixed-dose treatment for acute VTE that offers an alternative to warfarin in the treatment of VTE,” said Dr. Schulman, professor of medicine at McMaster University in Hamilton, Ont. and director of the clinical thromboembolism program at Hamilton General Hospital.

Liver function abnormalities, which caused the only previously available oral direct thrombin inhibitor, ximelagatran, to be withdrawn from European markets and to be denied FDA approval, were infrequent in both groups. A combination of elevated alanine aminotransferase level three times the upper limit of normal and bilirubin two times the upper limit of normal occurred in two dabigatran patients and four warfarin patients.

The number of MIs was similar with dabigatran and warfarin (four vs. two), he said. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial in patients with atrial fibrillation, dabigatran at the same 150 mg twice-daily dose was associated with lower rates of stroke, compared with warfarin, and a slight but significant increase of MI (N. Engl. J. Med. 2009;361:1139–51).

When this point was raised by reporters at a press briefing during the meeting, Dr. Schulman responded that the number of MIs with dabigatran was too small to support conclusions. He speculated that it may be an issue of dose dependence, based on data from the phase II RE-DEEM study of dabigatran in patients with acute coronary syndrome.

“As always, it is a question of finding the right dose,” he said. “Whether in general oral thrombin inhibitors increase the risk of MI, I don't think we can say that. I know there was a rumor of this with ximelagatran in orthopedic studies” based on “very vague data.”

Price was a key issue raised during both the press briefing and the discussion following the formal study presentation. Dr. Schulman told the audience that it was unclear what the price would be for the treatment of VTE, which has a different dosage than for VTE prevention in orthopedic patients. During the press briefing, he suggested that the price to treat VTE would be about double that for the orthopedic indication, which is about $7 per day for dabigatran versus $8 a day plus lab monitoring costs for low-molecular-weight heparin.

Press briefing moderator Dr. Bradford Schwartz, regional dean of the college of medicine at the University of Illinois at Urbana-Champaign, said oral dabigatran will “simplify the management of a feared disorder.”

Dr. Mary Cushman of the University of Vermont in Burlington, who introduced the formal study presentation, said anticoagulation is underutilized in the United States because of the difficulties in managing warfarin; for example, 50% of elderly patients eligible for treatment are not treated and remain at risk for stroke. Dabigatran meets some of the requirements for an “optimal new anticoagulant,” she added, in that it is an oral agent that does not require lab monitoring and has few drug and food interactions.

Patients in the double-blind multinational trial had symptomatic VTE for a maximum of 14 days and were given initial parenteral anticoagulation therapy and warfarin or placebo until they reached an international normalized ratio (INR) of 2.0 or more on 2 consecutive days; then they were randomized to dabigatran 150 mg b.i.d. or warfarin dose-adjusted to an INR of 2.0 and 3.0. Patients with a creatinine clearance rate less than 30 mL per minute, who were excluded from the study, should not be treated with dabigatran, Dr. Schulman advised.

Results of the trial were published simultaneously in the New England Journal of Medicine (2009;361:2342–52[doi:10.1056/NEJMoa0906598]).

The study was sponsored by Boehringer Ingelheim. Dr. Shulman disclosed receiving honoraria from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, GlaxoSmithKline and Sanofi-Aventis, lecture fees from LeoPharma and Sanofi-Aventis, and an unrestricted grant from Bayer.

My Take

New Anticoagulants Hold Promise

Safer oral anticoagulants are needed, and this study highlights an emerging option for replacing warfarin.

However, this study design didn't address the important potential for new oral anticoagulants to meet both the acute and chronic anticoagulation indications for VTE. This study treated VTE acutely with traditional inpatient parenteral anticoagulants.

For hospitalists, the value in these new anticoagulants will be the potential to write a prescription for oral therapy straight from the emergency department, essentially turning uncomplicated acute VTE into an outpatient condition.

Hospitalists will be on the front lines in managing possible complications of new anticoagulants. Renally impaired patients were excluded from this study, yet patients on these medications might develop acute kidney injury and require hospitalization unexpectedly. How will we reverse this agent if needed? This will be uncharted territory for hospitalists.

FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.

DR. MICHOTA