Michele G. Sullivan

Major Finding: A handheld transcranial magnetic stimulator eliminated migraine pain after 2 hours in 97% of patients with migraine and aura, compared with 65% of sham-treated patients; it was more effective in patients using migraine prevention drugs.

Data Source: A sham-controlled randomized trial of 201 patients.

Disclosures: Neuralieve Inc., maker of the device, funded the study. The lead author is a paid consultant and stockholder in the company. All of the other authors also have financial ties to the company.

Active stimulation of the cortex with a single-pulse, transcranial magnetic handheld device gave patients with migraine and aura increased freedom from migraine pain.

The device was especially effective in patients who took migraine prevention drugs, according to Dr. Richard Lipton of the Albert Einstein College of Medicine, New York, and his associates, who reported that at 2 hours after treatment, 97% of those in the active group were pain free, compared with 65% of those in the sham group.

“For patients who commonly have aura as a signal of an impending migraine, treatment with [the device] may abort progression of the attack and abate disabling pain and other symptoms,” wrote the authors (Lancet Neurol. 2010;[doi:10.1016/S1474-4422(10)70054-5]).

The portable machine delivers a brief magnetic pulse into the cortex of the brain, causing a counterclockwise flow of current. The intervention is thought to inhibit cortical spreading depression and thus prevent migraine from developing.

In a double-blind, sham-controlled trial, 201 patients with migraine and aura were randomized to either the actual device (102) or sham (99). They were instructed to apply the device below the occipital bone and deliver two pulses of energy as soon as possible after the onset of aura, and always within 1 hour. The patients were allowed to take migraine prevention drugs, but not analgesics, triptans, ergots, or other drugs that could confound pain assessment. They could take rescue drugs 2 hours after a treatment.

M ost of the patients were women (130); their mean age was 39 years. They had a mean of four migraine attacks a month. Of the total, 37 did not treat a migraine; the 164 who did were included in a modified intent-to-treat analysis.

Significantly more of the actively-treated than sham-treated patients were pain free 2 hours after treatment (39% vs. 22%, respectively). The difference in being pain free remained significant at 24 hours (29% active group vs. 16% sham group), and at 48 hours (27% vs. 13%).

Other migraine symptoms at 2 hours– nausea, photophobia, and phonophobia–were significantly less common in the active group, but only in patients whose pain level was moderate or severe at baseline. Among those with no or mild pain at baseline, there were no differences in those symptoms at 2 hours after treatment.

The investigators said use of migraine prevention drugs was significantly associated with a better 2-hour pain outcome. For those in the active group, the absolute risk reduction of pain at 2 hours was 32% for those who took the drugs and 8% for those who did not take them.

The device was well tolerated. One serious adverse event, a case of optic neuritis, occurred during the trial. It happened before a treatment, however, and so was deemed unrelated to the device.

One of the device's biggest benefits is that it is not invasive. “Treatment can be delivered to a circumscribed region of the brain, [in] contrast with drugs that are delivered systemically,” they wrote.

In an accompanying editorial, Dr. Hans-Christoph Diener said the findings were encouraging (Lancet Neurol. 2010; [doi:10.1016/S1474-4422(10)70063-6]). “The use of TMS could be a major step forward in [treating] migraine with aura, particularly in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated.”

However, Dr. Diener, of the University of Duisburg-Essen, Germany, noted that caveats remain. TMS can theoretically trigger seizures, and should not be used in patients with concomitant epilepsy until the device has been investigated in such a population.

In addition, he noted that triptans are very effective and inexpensive medications. “Therefore, the manufacturer of the TMS device must show cost-effectiveness compared with standard drug treatment with triptans,” he said.

Major Finding: A handheld transcranial magnetic stimulator eliminated migraine pain after 2 hours in 97% of patients with migraine and aura, compared with 65% of sham-treated patients; it was more effective in patients using migraine prevention drugs.

Data Source: A sham-controlled randomized trial of 201 patients.

Disclosures: Neuralieve Inc., maker of the device, funded the study. The lead author is a paid consultant and stockholder in the company. All of the other authors also have financial ties to the company.

Active stimulation of the cortex with a single-pulse, transcranial magnetic handheld device gave patients with migraine and aura increased freedom from migraine pain.

The device was especially effective in patients who took migraine prevention drugs, according to Dr. Richard Lipton of the Albert Einstein College of Medicine, New York, and his associates, who reported that at 2 hours after treatment, 97% of those in the active group were pain free, compared with 65% of those in the sham group.

“For patients who commonly have aura as a signal of an impending migraine, treatment with [the device] may abort progression of the attack and abate disabling pain and other symptoms,” wrote the authors (Lancet Neurol. 2010;[doi:10.1016/S1474-4422(10)70054-5]).

The portable machine delivers a brief magnetic pulse into the cortex of the brain, causing a counterclockwise flow of current. The intervention is thought to inhibit cortical spreading depression and thus prevent migraine from developing.

In a double-blind, sham-controlled trial, 201 patients with migraine and aura were randomized to either the actual device (102) or sham (99). They were instructed to apply the device below the occipital bone and deliver two pulses of energy as soon as possible after the onset of aura, and always within 1 hour. The patients were allowed to take migraine prevention drugs, but not analgesics, triptans, ergots, or other drugs that could confound pain assessment. They could take rescue drugs 2 hours after a treatment.

M ost of the patients were women (130); their mean age was 39 years. They had a mean of four migraine attacks a month. Of the total, 37 did not treat a migraine; the 164 who did were included in a modified intent-to-treat analysis.

Significantly more of the actively-treated than sham-treated patients were pain free 2 hours after treatment (39% vs. 22%, respectively). The difference in being pain free remained significant at 24 hours (29% active group vs. 16% sham group), and at 48 hours (27% vs. 13%).

Other migraine symptoms at 2 hours– nausea, photophobia, and phonophobia–were significantly less common in the active group, but only in patients whose pain level was moderate or severe at baseline. Among those with no or mild pain at baseline, there were no differences in those symptoms at 2 hours after treatment.

The investigators said use of migraine prevention drugs was significantly associated with a better 2-hour pain outcome. For those in the active group, the absolute risk reduction of pain at 2 hours was 32% for those who took the drugs and 8% for those who did not take them.

The device was well tolerated. One serious adverse event, a case of optic neuritis, occurred during the trial. It happened before a treatment, however, and so was deemed unrelated to the device.

One of the device's biggest benefits is that it is not invasive. “Treatment can be delivered to a circumscribed region of the brain, [in] contrast with drugs that are delivered systemically,” they wrote.

In an accompanying editorial, Dr. Hans-Christoph Diener said the findings were encouraging (Lancet Neurol. 2010; [doi:10.1016/S1474-4422(10)70063-6]). “The use of TMS could be a major step forward in [treating] migraine with aura, particularly in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated.”

However, Dr. Diener, of the University of Duisburg-Essen, Germany, noted that caveats remain. TMS can theoretically trigger seizures, and should not be used in patients with concomitant epilepsy until the device has been investigated in such a population.

In addition, he noted that triptans are very effective and inexpensive medications. “Therefore, the manufacturer of the TMS device must show cost-effectiveness compared with standard drug treatment with triptans,” he said.

Major Finding: A handheld transcranial magnetic stimulator eliminated migraine pain after 2 hours in 97% of patients with migraine and aura, compared with 65% of sham-treated patients; it was more effective in patients using migraine prevention drugs.

Data Source: A sham-controlled randomized trial of 201 patients.

Disclosures: Neuralieve Inc., maker of the device, funded the study. The lead author is a paid consultant and stockholder in the company. All of the other authors also have financial ties to the company.

Active stimulation of the cortex with a single-pulse, transcranial magnetic handheld device gave patients with migraine and aura increased freedom from migraine pain.

The device was especially effective in patients who took migraine prevention drugs, according to Dr. Richard Lipton of the Albert Einstein College of Medicine, New York, and his associates, who reported that at 2 hours after treatment, 97% of those in the active group were pain free, compared with 65% of those in the sham group.

“For patients who commonly have aura as a signal of an impending migraine, treatment with [the device] may abort progression of the attack and abate disabling pain and other symptoms,” wrote the authors (Lancet Neurol. 2010;[doi:10.1016/S1474-4422(10)70054-5]).

The portable machine delivers a brief magnetic pulse into the cortex of the brain, causing a counterclockwise flow of current. The intervention is thought to inhibit cortical spreading depression and thus prevent migraine from developing.

In a double-blind, sham-controlled trial, 201 patients with migraine and aura were randomized to either the actual device (102) or sham (99). They were instructed to apply the device below the occipital bone and deliver two pulses of energy as soon as possible after the onset of aura, and always within 1 hour. The patients were allowed to take migraine prevention drugs, but not analgesics, triptans, ergots, or other drugs that could confound pain assessment. They could take rescue drugs 2 hours after a treatment.

M ost of the patients were women (130); their mean age was 39 years. They had a mean of four migraine attacks a month. Of the total, 37 did not treat a migraine; the 164 who did were included in a modified intent-to-treat analysis.

Significantly more of the actively-treated than sham-treated patients were pain free 2 hours after treatment (39% vs. 22%, respectively). The difference in being pain free remained significant at 24 hours (29% active group vs. 16% sham group), and at 48 hours (27% vs. 13%).

Other migraine symptoms at 2 hours– nausea, photophobia, and phonophobia–were significantly less common in the active group, but only in patients whose pain level was moderate or severe at baseline. Among those with no or mild pain at baseline, there were no differences in those symptoms at 2 hours after treatment.

The investigators said use of migraine prevention drugs was significantly associated with a better 2-hour pain outcome. For those in the active group, the absolute risk reduction of pain at 2 hours was 32% for those who took the drugs and 8% for those who did not take them.

The device was well tolerated. One serious adverse event, a case of optic neuritis, occurred during the trial. It happened before a treatment, however, and so was deemed unrelated to the device.

One of the device's biggest benefits is that it is not invasive. “Treatment can be delivered to a circumscribed region of the brain, [in] contrast with drugs that are delivered systemically,” they wrote.

In an accompanying editorial, Dr. Hans-Christoph Diener said the findings were encouraging (Lancet Neurol. 2010; [doi:10.1016/S1474-4422(10)70063-6]). “The use of TMS could be a major step forward in [treating] migraine with aura, particularly in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated.”

However, Dr. Diener, of the University of Duisburg-Essen, Germany, noted that caveats remain. TMS can theoretically trigger seizures, and should not be used in patients with concomitant epilepsy until the device has been investigated in such a population.

In addition, he noted that triptans are very effective and inexpensive medications. “Therefore, the manufacturer of the TMS device must show cost-effectiveness compared with standard drug treatment with triptans,” he said.

Major Finding: At 2 years after suffering a TBI, significantly more APOE e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

Data Source: A long-term follow-up study of 648 patients with traumatic brain injury.

Disclosures: Dr. Ponsford reported that she had no financial disclosures.

WASHINGTON – Apolipoprotein E e4 genetic status appears to affect long-term recovery from traumatic brain injury significantly, particularly in those who carry two copies of the e4 allele.

At 2 years post injury, apolipoprotein E (APOE) e4 carriers were significantly more likely than noncarriers to have moderate or severe disabilities, and significantly less likely to have a good functional recovery, Jennie Ponsford, Ph.D., said at the World Congress on Brain Injury.

“We know that the APOE e4 allele has an impact on a number of processes involved in recovery, including increased inflammation, diminished cholesterol synthesis, and reduced neurite outgrowth,” she said in an interview. “These effects seem to go on for a long period of time, so it makes sense that their biggest impact would be seen when recovery is almost complete.”

The observation of poorer recovery in e4 carriers suggests the possibility of targeted rehabilitation, suggested Dr. Ponsford, a neuropsychologist at Monash University, Melbourne, Australia. “If you know at the beginning of treatment, that this 25% of your population is going to have a poorer prognosis, you might be able to put more or a different kind of rehabilitation into effect early on.”

Dr. Ponsford presented a long-term follow-up study of 648 patients who were admitted to a regional rehabilitation center between 2000 and 2007. Most of the subjects were male (67%); their mean age was 35 years. The study examined the relationship between APOE e4 status and the initial Glasgow Coma Scale (GCS) score, days of posttraumatic amnesia (PTA), and the Glasgow Outcome Scale–Extended (GOS-E). The GOS-E rates long-term recovery on an 8-point scale, in which good recovery is a score of 7 or 8. All of the subjects gave a saliva sample for APOE genotyping.

Genotyping showed that 166 (26%) patients carried the e4 allele. Of these, 6 were homozygous (e4/e4) and 160 were heterozygous (152 with e3/e4 and 8 with e2/e4). Of the remaining 482, 404 were e3/e3; 75 were e2/e3; and three were e2/e2.

Overall, the mean GCS score was 8, and did not vary significantly between the groups. APOE e4 had no significant effect on the mean length of PTA (31 days).

Recovery was assessed at 1, 2, and 3 or 5 years post injury; the mean time between injury and assessment was 1.9 years. After controlling for age and sex, Dr. Ponsford found that APOE e4 carriers had significantly poorer outcomes than noncarriers. Significantly more e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

“There also appeared to be somewhat of a dose-response effect, with homozygous e4 carriers having a tendency to have much worse outcomes,” she said. The median GOS-E score for this group was 4.8, which was significantly lower than the median score of 6 in the e4 noncarriers and lower (but not significantly so) than those who were heterozygous for the allele.

However, she noted that the very low number of homozygous e4 patients made it impossible to draw any strong conclusions.

In addition to increasing inflammation and interfering with cell repair, the APOE e4 gene is involved in the binding and deposition of amyloid beta (Abeta), the protein thought to be involved in the development of Alzheimer's disease. Dr. Ponsford said there are no data to indicate that a traumatic brain injury predisposes a person to develop Alzheimer's. However, the gene's interaction with Abeta may impair recovery from a brain injury.

Document

70198_fx1.sml

There appeared to be a dose-response effect, with homozygous e4 carriers having much worse outcomes.

Source DR. PONSFORD

Major Finding: At 2 years after suffering a TBI, significantly more APOE e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

Data Source: A long-term follow-up study of 648 patients with traumatic brain injury.

Disclosures: Dr. Ponsford reported that she had no financial disclosures.

WASHINGTON – Apolipoprotein E e4 genetic status appears to affect long-term recovery from traumatic brain injury significantly, particularly in those who carry two copies of the e4 allele.

At 2 years post injury, apolipoprotein E (APOE) e4 carriers were significantly more likely than noncarriers to have moderate or severe disabilities, and significantly less likely to have a good functional recovery, Jennie Ponsford, Ph.D., said at the World Congress on Brain Injury.

“We know that the APOE e4 allele has an impact on a number of processes involved in recovery, including increased inflammation, diminished cholesterol synthesis, and reduced neurite outgrowth,” she said in an interview. “These effects seem to go on for a long period of time, so it makes sense that their biggest impact would be seen when recovery is almost complete.”

The observation of poorer recovery in e4 carriers suggests the possibility of targeted rehabilitation, suggested Dr. Ponsford, a neuropsychologist at Monash University, Melbourne, Australia. “If you know at the beginning of treatment, that this 25% of your population is going to have a poorer prognosis, you might be able to put more or a different kind of rehabilitation into effect early on.”

Dr. Ponsford presented a long-term follow-up study of 648 patients who were admitted to a regional rehabilitation center between 2000 and 2007. Most of the subjects were male (67%); their mean age was 35 years. The study examined the relationship between APOE e4 status and the initial Glasgow Coma Scale (GCS) score, days of posttraumatic amnesia (PTA), and the Glasgow Outcome Scale–Extended (GOS-E). The GOS-E rates long-term recovery on an 8-point scale, in which good recovery is a score of 7 or 8. All of the subjects gave a saliva sample for APOE genotyping.

Genotyping showed that 166 (26%) patients carried the e4 allele. Of these, 6 were homozygous (e4/e4) and 160 were heterozygous (152 with e3/e4 and 8 with e2/e4). Of the remaining 482, 404 were e3/e3; 75 were e2/e3; and three were e2/e2.

Overall, the mean GCS score was 8, and did not vary significantly between the groups. APOE e4 had no significant effect on the mean length of PTA (31 days).

Recovery was assessed at 1, 2, and 3 or 5 years post injury; the mean time between injury and assessment was 1.9 years. After controlling for age and sex, Dr. Ponsford found that APOE e4 carriers had significantly poorer outcomes than noncarriers. Significantly more e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

“There also appeared to be somewhat of a dose-response effect, with homozygous e4 carriers having a tendency to have much worse outcomes,” she said. The median GOS-E score for this group was 4.8, which was significantly lower than the median score of 6 in the e4 noncarriers and lower (but not significantly so) than those who were heterozygous for the allele.

However, she noted that the very low number of homozygous e4 patients made it impossible to draw any strong conclusions.

In addition to increasing inflammation and interfering with cell repair, the APOE e4 gene is involved in the binding and deposition of amyloid beta (Abeta), the protein thought to be involved in the development of Alzheimer's disease. Dr. Ponsford said there are no data to indicate that a traumatic brain injury predisposes a person to develop Alzheimer's. However, the gene's interaction with Abeta may impair recovery from a brain injury.

Document

70198_fx1.sml

There appeared to be a dose-response effect, with homozygous e4 carriers having much worse outcomes.

Source DR. PONSFORD

Major Finding: At 2 years after suffering a TBI, significantly more APOE e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

Data Source: A long-term follow-up study of 648 patients with traumatic brain injury.

Disclosures: Dr. Ponsford reported that she had no financial disclosures.

WASHINGTON – Apolipoprotein E e4 genetic status appears to affect long-term recovery from traumatic brain injury significantly, particularly in those who carry two copies of the e4 allele.

At 2 years post injury, apolipoprotein E (APOE) e4 carriers were significantly more likely than noncarriers to have moderate or severe disabilities, and significantly less likely to have a good functional recovery, Jennie Ponsford, Ph.D., said at the World Congress on Brain Injury.

“We know that the APOE e4 allele has an impact on a number of processes involved in recovery, including increased inflammation, diminished cholesterol synthesis, and reduced neurite outgrowth,” she said in an interview. “These effects seem to go on for a long period of time, so it makes sense that their biggest impact would be seen when recovery is almost complete.”

The observation of poorer recovery in e4 carriers suggests the possibility of targeted rehabilitation, suggested Dr. Ponsford, a neuropsychologist at Monash University, Melbourne, Australia. “If you know at the beginning of treatment, that this 25% of your population is going to have a poorer prognosis, you might be able to put more or a different kind of rehabilitation into effect early on.”

Dr. Ponsford presented a long-term follow-up study of 648 patients who were admitted to a regional rehabilitation center between 2000 and 2007. Most of the subjects were male (67%); their mean age was 35 years. The study examined the relationship between APOE e4 status and the initial Glasgow Coma Scale (GCS) score, days of posttraumatic amnesia (PTA), and the Glasgow Outcome Scale–Extended (GOS-E). The GOS-E rates long-term recovery on an 8-point scale, in which good recovery is a score of 7 or 8. All of the subjects gave a saliva sample for APOE genotyping.

Genotyping showed that 166 (26%) patients carried the e4 allele. Of these, 6 were homozygous (e4/e4) and 160 were heterozygous (152 with e3/e4 and 8 with e2/e4). Of the remaining 482, 404 were e3/e3; 75 were e2/e3; and three were e2/e2.

Overall, the mean GCS score was 8, and did not vary significantly between the groups. APOE e4 had no significant effect on the mean length of PTA (31 days).

Recovery was assessed at 1, 2, and 3 or 5 years post injury; the mean time between injury and assessment was 1.9 years. After controlling for age and sex, Dr. Ponsford found that APOE e4 carriers had significantly poorer outcomes than noncarriers. Significantly more e4 carriers had severe disability than did noncarriers (27% vs. 15%), and significantly fewer e4 carriers had good recovery (30% vs. 39%).

“There also appeared to be somewhat of a dose-response effect, with homozygous e4 carriers having a tendency to have much worse outcomes,” she said. The median GOS-E score for this group was 4.8, which was significantly lower than the median score of 6 in the e4 noncarriers and lower (but not significantly so) than those who were heterozygous for the allele.

However, she noted that the very low number of homozygous e4 patients made it impossible to draw any strong conclusions.

In addition to increasing inflammation and interfering with cell repair, the APOE e4 gene is involved in the binding and deposition of amyloid beta (Abeta), the protein thought to be involved in the development of Alzheimer's disease. Dr. Ponsford said there are no data to indicate that a traumatic brain injury predisposes a person to develop Alzheimer's. However, the gene's interaction with Abeta may impair recovery from a brain injury.

Document

70198_fx1.sml

There appeared to be a dose-response effect, with homozygous e4 carriers having much worse outcomes.

Source DR. PONSFORD

Major Finding: Available information on the burden of VTE has been based on two epidemiologic studies and on limited data from hospital discharge surveys or analysis of provider claims databases.

Data Source: A workshop and a review of the literature by a national work group convened by the Centers for Disease Control and Prevention and the American Society of Hematology.

Disclosures: Dr. Raskob disclosed that he has received consulting fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Johnson & Johnson, Daiichi Sankyo, Sanofi-Aventis, and Takeda.

There is no shortage of clinical guidelines that describe the risk factors for deep vein thrombosis and pulmonary embolism, and that recommend how to effectively treat and prevent them. What is lacking, a national work group has concluded, is any way to track whether those guidelines are being implemented.

Also missing is information about how such guidelines might affect the incidence of venous thromboembolism (VTE). These questions can be answered only through collection of data by a national surveillance program, according to Gary E. Raskob, Ph.D., and his colleagues.

The work group, which was convened by the Centers for Disease Control and Prevention and the American Society of Hematology, consisted of physicians, epidemiologists, and health care policy experts. Following a 1-day workshop, the group summarized the literature on the clinical impact of deep vein thrombosis (DVT) and pulmonary embolism (PE) in several areas of medicine, wrote Dr. Raskob, of the University of Oklahoma Health Sciences Center, Oklahoma City, and his coauthors (Am. J. Prev. Med. 2010;38:S502-9).

The available information on the clinical and economic burden of VTE “has been based on two population-based epidemiologic studies and on limited data from hospital discharge surveys or analysis of healthcare provider claims databases,” the work group wrote.

Each year, about 900,000 cases of VTE occur in the United States. The risk of VTE increases with age, and is somewhat higher for men than for women (114 vs. 105/100,000).

There are few data on whether the incidence of DVT varies by ethnic group, and the available studies vary widely in methodology and conclusions. A California patient discharge review that spanned 1991-1994 found an annual incidence among whites of 230/1 million population, compared with 293/1 million for blacks, 139/1 million for Hispanics, and 60/1 million for Asian/Pacific Islanders.

Most VTEs are associated with a recent hospitalization; therefore, the work group said, hospitalization is an opportune time to institute prevention measures and to educate patients on the risks of blood clots.

Among its recommendations, the work group suggested that the CDC:

▸ Establish a demographic picture of DVT and PE in the United States.

▸ Determine whether there are incidence differences among minorities, compared with white populations.

▸ Further define risk factors among various patient groups (pregnant patients, surgical patients, children, residents of long-term care facilities, and patients with a family history of VTE).

▸ Evaluate whether evidence-based preventive measures are being appropriately applied.

▸ Detect changes in the incidence of DVT and PE and relate these changes to any increase in the use of preventive measures.

The group also recommended that the CDC initiate a two-pronged national public awareness campaign, focusing on increasing overall understanding of the disorder and its risk factors, and encouraging patients who are about to undergo surgery or hospitalization to discuss the subject with their physicians.

My Take

VTE Deserves More Attention

It's time for physicians and the public to take an in-depth look at this issue. Although at least four clinical treatment and prevention guidelines are available, they are not always employed in practice.

All of us know that every patient in the hospital should be receiving VTE prophylaxis, for example. Unfortunately, not every patient is getting it.

Several factors probably contribute to the problem. In some cases, we simply forget about VTE prevention. When a physician is dealing with acute problems in a very sick patient, VTE prevention might not be the first thing on that doctor's mind. Also, there are physicians who simply are not aware of the prevention guidelines, and so they don't implement them.

Finally, physicians who see discharged patients in the community—where 75% of VTEs occur—might not appreciate the importance of continuing prophylaxis after discharge. Physicians who don't provide care for patients in the hospital can go for years without seeing a clot, so they may underestimate the magnitude of the problem.

FRANKLIN A. MICHOTA, M.D., is the director of academic affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reported no relevant conflicts of interest.

Major Finding: Available information on the burden of VTE has been based on two epidemiologic studies and on limited data from hospital discharge surveys or analysis of provider claims databases.

Data Source: A workshop and a review of the literature by a national work group convened by the Centers for Disease Control and Prevention and the American Society of Hematology.

Disclosures: Dr. Raskob disclosed that he has received consulting fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Johnson & Johnson, Daiichi Sankyo, Sanofi-Aventis, and Takeda.

There is no shortage of clinical guidelines that describe the risk factors for deep vein thrombosis and pulmonary embolism, and that recommend how to effectively treat and prevent them. What is lacking, a national work group has concluded, is any way to track whether those guidelines are being implemented.

Also missing is information about how such guidelines might affect the incidence of venous thromboembolism (VTE). These questions can be answered only through collection of data by a national surveillance program, according to Gary E. Raskob, Ph.D., and his colleagues.

The work group, which was convened by the Centers for Disease Control and Prevention and the American Society of Hematology, consisted of physicians, epidemiologists, and health care policy experts. Following a 1-day workshop, the group summarized the literature on the clinical impact of deep vein thrombosis (DVT) and pulmonary embolism (PE) in several areas of medicine, wrote Dr. Raskob, of the University of Oklahoma Health Sciences Center, Oklahoma City, and his coauthors (Am. J. Prev. Med. 2010;38:S502-9).

The available information on the clinical and economic burden of VTE “has been based on two population-based epidemiologic studies and on limited data from hospital discharge surveys or analysis of healthcare provider claims databases,” the work group wrote.

Each year, about 900,000 cases of VTE occur in the United States. The risk of VTE increases with age, and is somewhat higher for men than for women (114 vs. 105/100,000).

There are few data on whether the incidence of DVT varies by ethnic group, and the available studies vary widely in methodology and conclusions. A California patient discharge review that spanned 1991-1994 found an annual incidence among whites of 230/1 million population, compared with 293/1 million for blacks, 139/1 million for Hispanics, and 60/1 million for Asian/Pacific Islanders.

Most VTEs are associated with a recent hospitalization; therefore, the work group said, hospitalization is an opportune time to institute prevention measures and to educate patients on the risks of blood clots.

Among its recommendations, the work group suggested that the CDC:

▸ Establish a demographic picture of DVT and PE in the United States.

▸ Determine whether there are incidence differences among minorities, compared with white populations.

▸ Further define risk factors among various patient groups (pregnant patients, surgical patients, children, residents of long-term care facilities, and patients with a family history of VTE).

▸ Evaluate whether evidence-based preventive measures are being appropriately applied.

▸ Detect changes in the incidence of DVT and PE and relate these changes to any increase in the use of preventive measures.

The group also recommended that the CDC initiate a two-pronged national public awareness campaign, focusing on increasing overall understanding of the disorder and its risk factors, and encouraging patients who are about to undergo surgery or hospitalization to discuss the subject with their physicians.

My Take

VTE Deserves More Attention

It's time for physicians and the public to take an in-depth look at this issue. Although at least four clinical treatment and prevention guidelines are available, they are not always employed in practice.

All of us know that every patient in the hospital should be receiving VTE prophylaxis, for example. Unfortunately, not every patient is getting it.

Several factors probably contribute to the problem. In some cases, we simply forget about VTE prevention. When a physician is dealing with acute problems in a very sick patient, VTE prevention might not be the first thing on that doctor's mind. Also, there are physicians who simply are not aware of the prevention guidelines, and so they don't implement them.

Finally, physicians who see discharged patients in the community—where 75% of VTEs occur—might not appreciate the importance of continuing prophylaxis after discharge. Physicians who don't provide care for patients in the hospital can go for years without seeing a clot, so they may underestimate the magnitude of the problem.

FRANKLIN A. MICHOTA, M.D., is the director of academic affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reported no relevant conflicts of interest.

Major Finding: Available information on the burden of VTE has been based on two epidemiologic studies and on limited data from hospital discharge surveys or analysis of provider claims databases.

Data Source: A workshop and a review of the literature by a national work group convened by the Centers for Disease Control and Prevention and the American Society of Hematology.

Disclosures: Dr. Raskob disclosed that he has received consulting fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Johnson & Johnson, Daiichi Sankyo, Sanofi-Aventis, and Takeda.

There is no shortage of clinical guidelines that describe the risk factors for deep vein thrombosis and pulmonary embolism, and that recommend how to effectively treat and prevent them. What is lacking, a national work group has concluded, is any way to track whether those guidelines are being implemented.

Also missing is information about how such guidelines might affect the incidence of venous thromboembolism (VTE). These questions can be answered only through collection of data by a national surveillance program, according to Gary E. Raskob, Ph.D., and his colleagues.

The work group, which was convened by the Centers for Disease Control and Prevention and the American Society of Hematology, consisted of physicians, epidemiologists, and health care policy experts. Following a 1-day workshop, the group summarized the literature on the clinical impact of deep vein thrombosis (DVT) and pulmonary embolism (PE) in several areas of medicine, wrote Dr. Raskob, of the University of Oklahoma Health Sciences Center, Oklahoma City, and his coauthors (Am. J. Prev. Med. 2010;38:S502-9).

The available information on the clinical and economic burden of VTE “has been based on two population-based epidemiologic studies and on limited data from hospital discharge surveys or analysis of healthcare provider claims databases,” the work group wrote.

Each year, about 900,000 cases of VTE occur in the United States. The risk of VTE increases with age, and is somewhat higher for men than for women (114 vs. 105/100,000).

There are few data on whether the incidence of DVT varies by ethnic group, and the available studies vary widely in methodology and conclusions. A California patient discharge review that spanned 1991-1994 found an annual incidence among whites of 230/1 million population, compared with 293/1 million for blacks, 139/1 million for Hispanics, and 60/1 million for Asian/Pacific Islanders.

Most VTEs are associated with a recent hospitalization; therefore, the work group said, hospitalization is an opportune time to institute prevention measures and to educate patients on the risks of blood clots.

Among its recommendations, the work group suggested that the CDC:

▸ Establish a demographic picture of DVT and PE in the United States.

▸ Determine whether there are incidence differences among minorities, compared with white populations.

▸ Further define risk factors among various patient groups (pregnant patients, surgical patients, children, residents of long-term care facilities, and patients with a family history of VTE).

▸ Evaluate whether evidence-based preventive measures are being appropriately applied.

▸ Detect changes in the incidence of DVT and PE and relate these changes to any increase in the use of preventive measures.

The group also recommended that the CDC initiate a two-pronged national public awareness campaign, focusing on increasing overall understanding of the disorder and its risk factors, and encouraging patients who are about to undergo surgery or hospitalization to discuss the subject with their physicians.

My Take

VTE Deserves More Attention

It's time for physicians and the public to take an in-depth look at this issue. Although at least four clinical treatment and prevention guidelines are available, they are not always employed in practice.

All of us know that every patient in the hospital should be receiving VTE prophylaxis, for example. Unfortunately, not every patient is getting it.

Several factors probably contribute to the problem. In some cases, we simply forget about VTE prevention. When a physician is dealing with acute problems in a very sick patient, VTE prevention might not be the first thing on that doctor's mind. Also, there are physicians who simply are not aware of the prevention guidelines, and so they don't implement them.

Finally, physicians who see discharged patients in the community—where 75% of VTEs occur—might not appreciate the importance of continuing prophylaxis after discharge. Physicians who don't provide care for patients in the hospital can go for years without seeing a clot, so they may underestimate the magnitude of the problem.

FRANKLIN A. MICHOTA, M.D., is the director of academic affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reported no relevant conflicts of interest.

A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.

The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).

The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.

Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.

The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.

Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).

The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.

Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.

A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.

The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).

The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.

Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.

The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.

Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).

The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.

Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.

A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.

The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).

The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.

Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.

The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.

Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).

The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.

Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.

ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.

Patients treated with the laser at a 120-mcm spot size healed an average of 1.2 days faster than those treated with a 300-mcm spot size, but they expressed similar levels of satisfaction with both sizes, Dr. Julie Woodward (photographed on the left) said at the annual meeting of the American Academy of Cosmetic Surgery.

Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.

"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."

All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).

Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.

Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.

Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.

Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.

Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.

Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.

There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.

 "This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.

The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.

ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.

Patients treated with the laser at a 120-mcm spot size healed an average of 1.2 days faster than those treated with a 300-mcm spot size, but they expressed similar levels of satisfaction with both sizes, Dr. Julie Woodward (photographed on the left) said at the annual meeting of the American Academy of Cosmetic Surgery.

Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.

"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."

All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).

Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.

Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.

Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.

Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.

Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.

Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.

There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.

 "This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.

The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.

ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.

Patients treated with the laser at a 120-mcm spot size healed an average of 1.2 days faster than those treated with a 300-mcm spot size, but they expressed similar levels of satisfaction with both sizes, Dr. Julie Woodward (photographed on the left) said at the annual meeting of the American Academy of Cosmetic Surgery.

Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.

"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."

All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).

Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.

Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.

Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.

Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.

Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.

Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.

There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.

 "This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.

The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.

HOT SPRINGS, VA. — Delaying gallbladder surgery in elderly patients with acute cholecystitis might save money in the short run, but it racks up a bigger bill later in health outcomes and cash outlay, judging by a Medicare claims database study.

Early surgery significantly reduced cholecystitis recurrence and emergency gallstone-related readmissions, saving Medicare $7,000 for each avoided readmission, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association.

Dr. Riall of the University of Texas Medical Branch at Galveston, and her colleagues tracked Medicare claims data for almost 30,000 elderly patients (mean age 78 years) who were admitted for acute cholecystitis from 1996 to 2005. They examined cost and health outcomes for 24 months after the admission.

Most patients (89%) were white. More than half of the admissions (64%) were emergent; 36% were urgent. About one-quarter were admitted by a surgeon.

The majority of the patients (75%) underwent cholecystectomy during their initial hospitalization, and 71% of the procedures were laparoscopic. The median length of stay was 5 days, and the median Medicare payment was $7,362. There was a 2% in-hospital mortality rate.

For the 25% of patients who did not undergo surgery during their initial hospitalization, the median hospital length of stay was 4 days and the median Medicare payment was $4,251. However, Dr. Riall said, surgical patients had significantly fewer rehospitalizations over the 24-month follow-up period than did nonsurgical patients. Among the 21,907 who had the surgery and were discharged alive, 1.6% were rehospitalized for gallstone-related problems and 2.5% (556 patients) for surgical complications. The overall Kaplan-Meier readmission rate in this group was 4.4% with all readmissions occurring in the first 60 days postoperatively; the median Medicare payment for each readmission was $5,000.

These measures were all significantly different among patients who initially did not undergo cholecystectomy. Among the 7,250 who were discharged alive, 1,980 were later rehospitalized for gallbladder problems and 1,604 died in the 2 years following initial hospitalization. The Kaplan-Meier 2-year readmission rate was 38%, after adjustment for patient deaths, as these patients were no longer at risk of readmission. Of the patients readmitted for gallstone-related problems, 1,372 (19% of the discharged group) underwent a cholecystectomy and 608 (8%) did not. The overall median Medicare payment for readmission was $7,000. Another 694 of the discharged patients (9.6%) also had a later cholecystectomy on an outpatient basis and did not require emergency readmission.

Mortality rates over the next 24 months also were significantly different between the groups: 15% for those who had surgery during initial hospitalization, vs. 29% for those who did not.

Although the survival difference was significant, Dr. Riall warned against making too many assumptions about mortality. “It's almost certain that most patients who did not undergo cholecystectomy were sicker and had a higher 2-year mortality without cholecystitis,” said Dr. Riall, who did not report having any conflicts of interest.

HOT SPRINGS, VA. — Delaying gallbladder surgery in elderly patients with acute cholecystitis might save money in the short run, but it racks up a bigger bill later in health outcomes and cash outlay, judging by a Medicare claims database study.

Early surgery significantly reduced cholecystitis recurrence and emergency gallstone-related readmissions, saving Medicare $7,000 for each avoided readmission, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association.

Dr. Riall of the University of Texas Medical Branch at Galveston, and her colleagues tracked Medicare claims data for almost 30,000 elderly patients (mean age 78 years) who were admitted for acute cholecystitis from 1996 to 2005. They examined cost and health outcomes for 24 months after the admission.

Most patients (89%) were white. More than half of the admissions (64%) were emergent; 36% were urgent. About one-quarter were admitted by a surgeon.

The majority of the patients (75%) underwent cholecystectomy during their initial hospitalization, and 71% of the procedures were laparoscopic. The median length of stay was 5 days, and the median Medicare payment was $7,362. There was a 2% in-hospital mortality rate.

For the 25% of patients who did not undergo surgery during their initial hospitalization, the median hospital length of stay was 4 days and the median Medicare payment was $4,251. However, Dr. Riall said, surgical patients had significantly fewer rehospitalizations over the 24-month follow-up period than did nonsurgical patients. Among the 21,907 who had the surgery and were discharged alive, 1.6% were rehospitalized for gallstone-related problems and 2.5% (556 patients) for surgical complications. The overall Kaplan-Meier readmission rate in this group was 4.4% with all readmissions occurring in the first 60 days postoperatively; the median Medicare payment for each readmission was $5,000.

These measures were all significantly different among patients who initially did not undergo cholecystectomy. Among the 7,250 who were discharged alive, 1,980 were later rehospitalized for gallbladder problems and 1,604 died in the 2 years following initial hospitalization. The Kaplan-Meier 2-year readmission rate was 38%, after adjustment for patient deaths, as these patients were no longer at risk of readmission. Of the patients readmitted for gallstone-related problems, 1,372 (19% of the discharged group) underwent a cholecystectomy and 608 (8%) did not. The overall median Medicare payment for readmission was $7,000. Another 694 of the discharged patients (9.6%) also had a later cholecystectomy on an outpatient basis and did not require emergency readmission.

Mortality rates over the next 24 months also were significantly different between the groups: 15% for those who had surgery during initial hospitalization, vs. 29% for those who did not.

Although the survival difference was significant, Dr. Riall warned against making too many assumptions about mortality. “It's almost certain that most patients who did not undergo cholecystectomy were sicker and had a higher 2-year mortality without cholecystitis,” said Dr. Riall, who did not report having any conflicts of interest.

HOT SPRINGS, VA. — Delaying gallbladder surgery in elderly patients with acute cholecystitis might save money in the short run, but it racks up a bigger bill later in health outcomes and cash outlay, judging by a Medicare claims database study.

Early surgery significantly reduced cholecystitis recurrence and emergency gallstone-related readmissions, saving Medicare $7,000 for each avoided readmission, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association.

Dr. Riall of the University of Texas Medical Branch at Galveston, and her colleagues tracked Medicare claims data for almost 30,000 elderly patients (mean age 78 years) who were admitted for acute cholecystitis from 1996 to 2005. They examined cost and health outcomes for 24 months after the admission.

Most patients (89%) were white. More than half of the admissions (64%) were emergent; 36% were urgent. About one-quarter were admitted by a surgeon.

The majority of the patients (75%) underwent cholecystectomy during their initial hospitalization, and 71% of the procedures were laparoscopic. The median length of stay was 5 days, and the median Medicare payment was $7,362. There was a 2% in-hospital mortality rate.

For the 25% of patients who did not undergo surgery during their initial hospitalization, the median hospital length of stay was 4 days and the median Medicare payment was $4,251. However, Dr. Riall said, surgical patients had significantly fewer rehospitalizations over the 24-month follow-up period than did nonsurgical patients. Among the 21,907 who had the surgery and were discharged alive, 1.6% were rehospitalized for gallstone-related problems and 2.5% (556 patients) for surgical complications. The overall Kaplan-Meier readmission rate in this group was 4.4% with all readmissions occurring in the first 60 days postoperatively; the median Medicare payment for each readmission was $5,000.

These measures were all significantly different among patients who initially did not undergo cholecystectomy. Among the 7,250 who were discharged alive, 1,980 were later rehospitalized for gallbladder problems and 1,604 died in the 2 years following initial hospitalization. The Kaplan-Meier 2-year readmission rate was 38%, after adjustment for patient deaths, as these patients were no longer at risk of readmission. Of the patients readmitted for gallstone-related problems, 1,372 (19% of the discharged group) underwent a cholecystectomy and 608 (8%) did not. The overall median Medicare payment for readmission was $7,000. Another 694 of the discharged patients (9.6%) also had a later cholecystectomy on an outpatient basis and did not require emergency readmission.

Mortality rates over the next 24 months also were significantly different between the groups: 15% for those who had surgery during initial hospitalization, vs. 29% for those who did not.

Although the survival difference was significant, Dr. Riall warned against making too many assumptions about mortality. “It's almost certain that most patients who did not undergo cholecystectomy were sicker and had a higher 2-year mortality without cholecystitis,” said Dr. Riall, who did not report having any conflicts of interest.

BANGKOK, THAILAND — Expressive and receptive language abilities are lower in 3-year-olds who were exposed to sodium valproate in utero than in children exposed to other individual antiepileptic drugs during gestation, according to a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is statistically significant and clinically important, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. The primary outcome is cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at the time of assessment. Test scores were adjusted for factors known to affect child intellect, including maternal IQ, maternal age, gestational age, antiepileptic drug (AED) dose, and prenatal exposure to folate.

“Maternal IQ, AED dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery, Liverpool, England, and professor of clinical neuropsychology at the University of Liverpool. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

The study confirms earlier NEAD findings, which strongly suggest that women of childbearing age who need AED therapy should avoid valproate if possible. “For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” Dr. Baker said. “In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy occurs.”

BANGKOK, THAILAND — Expressive and receptive language abilities are lower in 3-year-olds who were exposed to sodium valproate in utero than in children exposed to other individual antiepileptic drugs during gestation, according to a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is statistically significant and clinically important, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. The primary outcome is cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at the time of assessment. Test scores were adjusted for factors known to affect child intellect, including maternal IQ, maternal age, gestational age, antiepileptic drug (AED) dose, and prenatal exposure to folate.

“Maternal IQ, AED dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery, Liverpool, England, and professor of clinical neuropsychology at the University of Liverpool. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

The study confirms earlier NEAD findings, which strongly suggest that women of childbearing age who need AED therapy should avoid valproate if possible. “For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” Dr. Baker said. “In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy occurs.”

BANGKOK, THAILAND — Expressive and receptive language abilities are lower in 3-year-olds who were exposed to sodium valproate in utero than in children exposed to other individual antiepileptic drugs during gestation, according to a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is statistically significant and clinically important, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. The primary outcome is cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at the time of assessment. Test scores were adjusted for factors known to affect child intellect, including maternal IQ, maternal age, gestational age, antiepileptic drug (AED) dose, and prenatal exposure to folate.

“Maternal IQ, AED dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery, Liverpool, England, and professor of clinical neuropsychology at the University of Liverpool. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

The study confirms earlier NEAD findings, which strongly suggest that women of childbearing age who need AED therapy should avoid valproate if possible. “For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” Dr. Baker said. “In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy occurs.”

BANGKOK, THAILAND — Long-term antiepileptic drug therapy is associated with poorer bone health in premenopausal women.

Dr. Rungsan Chaisewikul of Siriraj Hospital, Bangkok, included 50 women with epilepsy and 51 matched controls in his study, presented during the meeting's poster session. All of the women were premenopausal, with a mean age of 33 years. Patients had been on antiepileptic drugs (AEDs) for at least 3 years. Most of the women (62%) were taking more than one drug, and most (84%) were taking an enzyme-inducing AED. All participants had bone mineral density (BMD) measured at the lumbar spine, left femur, and left radius.

Compared with the controls, the patients had significantly lower T scores at the femoral neck (0.30 vs. −0.08). BMD at the lumbar spine was lower, but not significantly lower, in patients than in controls, as was BMD at the radius.

Based on measurements at the femoral neck and lumbar spine, significantly more patients than controls were rated as having osteopenia and osteoporosis. More patients than controls also were rated as osteopenic or osteoporotic when considering the radius measurement, although that difference was not statistically significant.

BANGKOK, THAILAND — Long-term antiepileptic drug therapy is associated with poorer bone health in premenopausal women.

Dr. Rungsan Chaisewikul of Siriraj Hospital, Bangkok, included 50 women with epilepsy and 51 matched controls in his study, presented during the meeting's poster session. All of the women were premenopausal, with a mean age of 33 years. Patients had been on antiepileptic drugs (AEDs) for at least 3 years. Most of the women (62%) were taking more than one drug, and most (84%) were taking an enzyme-inducing AED. All participants had bone mineral density (BMD) measured at the lumbar spine, left femur, and left radius.

Compared with the controls, the patients had significantly lower T scores at the femoral neck (0.30 vs. −0.08). BMD at the lumbar spine was lower, but not significantly lower, in patients than in controls, as was BMD at the radius.

Based on measurements at the femoral neck and lumbar spine, significantly more patients than controls were rated as having osteopenia and osteoporosis. More patients than controls also were rated as osteopenic or osteoporotic when considering the radius measurement, although that difference was not statistically significant.

BANGKOK, THAILAND — Long-term antiepileptic drug therapy is associated with poorer bone health in premenopausal women.

Dr. Rungsan Chaisewikul of Siriraj Hospital, Bangkok, included 50 women with epilepsy and 51 matched controls in his study, presented during the meeting's poster session. All of the women were premenopausal, with a mean age of 33 years. Patients had been on antiepileptic drugs (AEDs) for at least 3 years. Most of the women (62%) were taking more than one drug, and most (84%) were taking an enzyme-inducing AED. All participants had bone mineral density (BMD) measured at the lumbar spine, left femur, and left radius.

Compared with the controls, the patients had significantly lower T scores at the femoral neck (0.30 vs. −0.08). BMD at the lumbar spine was lower, but not significantly lower, in patients than in controls, as was BMD at the radius.

Based on measurements at the femoral neck and lumbar spine, significantly more patients than controls were rated as having osteopenia and osteoporosis. More patients than controls also were rated as osteopenic or osteoporotic when considering the radius measurement, although that difference was not statistically significant.

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

Major Finding: Doppler ultrasound imaging in high-risk pregnancies was associated with a 29% reduction in perinatal mortality, and a 10% reduction in cesareans that was confined to emergency procedures.

Data Source: A Cochrane review of 18 studies comprising more than 10,000 patients.

Disclosures: The study was funded by the University of Liverpool and the National Institute for Health Research. None of the authors reported any conflict of interest.

The use of Doppler ultrasound imaging in high-risk pregnancies is associated with a significant 29% reduction in perinatal deaths, significantly fewer labor inductions, and a 10% decrease in the rate of cesarean sections, a Cochrane database review has concluded.

The mortality benefit is probably directly tied to the reduction in cesareans associated with Doppler imaging. “The evidence from this review suggests that better timing of cesarean sections may be the 'cause' of reduced perinatal mortality,” wrote Dr. Zarko Alfirevic of the University of Liverpool (England) and colleagues.

“The overall decrease in cesarean sections appears to be confined to emergency procedures, which leads us to believe that clinicians with no access to Doppler studies are more often faced with a seriously compromised baby in labor,” they said.

This review is the first Cochrane update on the topic since 1996. Unfortunately, many of the 18 studies included in the database review had serious methodological flaws, making it difficult to base any strong clinical recommendations on them. “The quality of the current evidence was not [high]; therefore the results should be interpreted with some caution,” they said (Cochrane Database Syst. Rev. 2010;CD007529 [doi:10.1002/14651858.CD007529.pub2]).

The studies, comprising more than 10,000 women, were conducted from 1987 to 2003, many of them before the 2001 Consolidated Standards of Reporting Trials (CONSORT) agreement.

At that time, “most studies simply did not report information on random sequence generation and allocation blinding that is nowadays considered essential for quality assessment,” the authors wrote. They felt that only three studies had both adequate sequence generation and concealment allocation, and that blinding was adequate in only two. Nine were considered to be free of selection bias.

In considering all 18 studies, the investigators found Doppler imaging was associated with a significant 29% reduction in perinatal mortality, with a number needed to treat of 203.

When the authors examined the association in the subgroups of singleton and multiple pregnancies, they saw lower, but still significant, positive associations with Doppler imaging.

Doppler was also associated with a significant 10% reduction in the rate of cesarean sections. When cesareans were broken down into elective and emergency, the benefit appeared to be confined to emergency procedures, with a 19% risk reduction.

Doppler also significantly influenced the rate of labor induction, with an 11% decrease compared with no Doppler. There was no benefit in vaginal vs. operative births, intubation, or ventilation.

Four trials compared Doppler imaging to electronic fetal monitoring. Two of the four studies were of good quality, but the analysis in these four studies was not well powered, the authors said.

Overall, the two methods were not significantly different in terms of perinatal mortality, stillbirths, or potentially preventable deaths.

The rate of cesarean sections was slightly, but not significantly, lower with Doppler.

The authors concluded that Doppler should be added to fetal monitoring protocols in high-risk pregnancies, but refrained from making other recommendations.

Major Finding: In women at low risk of needing general anesthesia during childbirth, there was no significant association with eating and drinking during labor and the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes.

Data Source: A Cochrane database review of five randomized controlled trials comprising 3,130 women.

Disclosures: The review was sponsored by the University of the Witwatersrand and the University of Liverpool, as well as the National Institute for Health Research, and by a World Health Organization grant. One of the authors was the primary investigator on a study included in the review.

Women at low risk of complications during childbirth should be allowed to take food and water as they desire during active labor, a Cochrane database review has concluded.

“The review identified no benefits or harms of restricting foods and fluids during labor in women at low risk of needing anesthesia,” wrote lead author Mandisa Singata, R.N., and her associates. “Given these findings, women should be free to eat and drink in labor or not, as they wish” (Cochrane Database Syst. Rev. 2010;CD003930 [doi:10.1002/14651858.CD003930.pub2]).

The review of five studies comprising 3,130 women suggests that the prohibition on oral intake during labor may be based on outdated concerns, wrote Ms. Singata of the University of Witwatersrand, East London, South Africa, and her associates.

“Restricting oral food and fluid intake … is a strongly held obstetric and anesthetic tradition,” related to research performed in the 1940s on regurgitation under general anesthetic and resulting inhalation pneumonia. “Most [eating prohibitions] are based on historical, but important, concerns related to these risks. … The incidence is very rare with modern anesthetic techniques and the use of regional rather than general anesthesia.”

Ms. Singata and her colleagues identified five randomized controlled trials that examined this issue. The studies were conducted from 1999 to 2009.

All included women at low risk of requiring general anesthesia during childbirth. One study looked at restricting intake to ice chips and sips of water vs. full access to food and drink. Two compared water only to encouraging the consumption of some food and fluid, and two compared water only to carbohydrate drinks during labor.

The analysis was dominated by the largest and most recent study, which contained 2,443 women. The other four studies together comprised 687 women. The largest study was conducted in a “highly medicalized environment,” in which 30% of women had a cesarean section, over 50% had oxytocin, just under 70% received intravenous fluids and epidural anesthesia, and 27% underwent operative vaginal birth.

“In addition, 20% of the women in the water-only arm ate during labor and 295 in the food and fluid arm chose not to eat in labor. This clearly reflects the wide variation in women's wishes for food and fluids during labor,” the authors wrote.

When considering any restriction of food and fluid versus allowing them, the authors found no significant associations with the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes. Neither were there significant relationships with duration of labor, maternal nausea or vomiting, narcotic pain relief, or infant admission to intensive care.

None of the outcomes were significantly related in any of the other analyses: complete restriction of food and fluid vs. freedom to eat and drink, water only vs. freedom to eat and drink, or complete food and fluid restriction vs. carbohydrate-based fluid only.

Major Finding: In women at low risk of needing general anesthesia during childbirth, there was no significant association with eating and drinking during labor and the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes.

Data Source: A Cochrane database review of five randomized controlled trials comprising 3,130 women.

Disclosures: The review was sponsored by the University of the Witwatersrand and the University of Liverpool, as well as the National Institute for Health Research, and by a World Health Organization grant. One of the authors was the primary investigator on a study included in the review.

Women at low risk of complications during childbirth should be allowed to take food and water as they desire during active labor, a Cochrane database review has concluded.

“The review identified no benefits or harms of restricting foods and fluids during labor in women at low risk of needing anesthesia,” wrote lead author Mandisa Singata, R.N., and her associates. “Given these findings, women should be free to eat and drink in labor or not, as they wish” (Cochrane Database Syst. Rev. 2010;CD003930 [doi:10.1002/14651858.CD003930.pub2]).

The review of five studies comprising 3,130 women suggests that the prohibition on oral intake during labor may be based on outdated concerns, wrote Ms. Singata of the University of Witwatersrand, East London, South Africa, and her associates.

“Restricting oral food and fluid intake … is a strongly held obstetric and anesthetic tradition,” related to research performed in the 1940s on regurgitation under general anesthetic and resulting inhalation pneumonia. “Most [eating prohibitions] are based on historical, but important, concerns related to these risks. … The incidence is very rare with modern anesthetic techniques and the use of regional rather than general anesthesia.”

Ms. Singata and her colleagues identified five randomized controlled trials that examined this issue. The studies were conducted from 1999 to 2009.

All included women at low risk of requiring general anesthesia during childbirth. One study looked at restricting intake to ice chips and sips of water vs. full access to food and drink. Two compared water only to encouraging the consumption of some food and fluid, and two compared water only to carbohydrate drinks during labor.

The analysis was dominated by the largest and most recent study, which contained 2,443 women. The other four studies together comprised 687 women. The largest study was conducted in a “highly medicalized environment,” in which 30% of women had a cesarean section, over 50% had oxytocin, just under 70% received intravenous fluids and epidural anesthesia, and 27% underwent operative vaginal birth.

“In addition, 20% of the women in the water-only arm ate during labor and 295 in the food and fluid arm chose not to eat in labor. This clearly reflects the wide variation in women's wishes for food and fluids during labor,” the authors wrote.

When considering any restriction of food and fluid versus allowing them, the authors found no significant associations with the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes. Neither were there significant relationships with duration of labor, maternal nausea or vomiting, narcotic pain relief, or infant admission to intensive care.

None of the outcomes were significantly related in any of the other analyses: complete restriction of food and fluid vs. freedom to eat and drink, water only vs. freedom to eat and drink, or complete food and fluid restriction vs. carbohydrate-based fluid only.

Major Finding: In women at low risk of needing general anesthesia during childbirth, there was no significant association with eating and drinking during labor and the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes.

Data Source: A Cochrane database review of five randomized controlled trials comprising 3,130 women.

Disclosures: The review was sponsored by the University of the Witwatersrand and the University of Liverpool, as well as the National Institute for Health Research, and by a World Health Organization grant. One of the authors was the primary investigator on a study included in the review.

Women at low risk of complications during childbirth should be allowed to take food and water as they desire during active labor, a Cochrane database review has concluded.

“The review identified no benefits or harms of restricting foods and fluids during labor in women at low risk of needing anesthesia,” wrote lead author Mandisa Singata, R.N., and her associates. “Given these findings, women should be free to eat and drink in labor or not, as they wish” (Cochrane Database Syst. Rev. 2010;CD003930 [doi:10.1002/14651858.CD003930.pub2]).

The review of five studies comprising 3,130 women suggests that the prohibition on oral intake during labor may be based on outdated concerns, wrote Ms. Singata of the University of Witwatersrand, East London, South Africa, and her associates.

“Restricting oral food and fluid intake … is a strongly held obstetric and anesthetic tradition,” related to research performed in the 1940s on regurgitation under general anesthetic and resulting inhalation pneumonia. “Most [eating prohibitions] are based on historical, but important, concerns related to these risks. … The incidence is very rare with modern anesthetic techniques and the use of regional rather than general anesthesia.”

Ms. Singata and her colleagues identified five randomized controlled trials that examined this issue. The studies were conducted from 1999 to 2009.

All included women at low risk of requiring general anesthesia during childbirth. One study looked at restricting intake to ice chips and sips of water vs. full access to food and drink. Two compared water only to encouraging the consumption of some food and fluid, and two compared water only to carbohydrate drinks during labor.

The analysis was dominated by the largest and most recent study, which contained 2,443 women. The other four studies together comprised 687 women. The largest study was conducted in a “highly medicalized environment,” in which 30% of women had a cesarean section, over 50% had oxytocin, just under 70% received intravenous fluids and epidural anesthesia, and 27% underwent operative vaginal birth.

“In addition, 20% of the women in the water-only arm ate during labor and 295 in the food and fluid arm chose not to eat in labor. This clearly reflects the wide variation in women's wishes for food and fluids during labor,” the authors wrote.

When considering any restriction of food and fluid versus allowing them, the authors found no significant associations with the rate of cesarean section, operative vaginal birth, or Apgar scores of less than 7 at 5 minutes. Neither were there significant relationships with duration of labor, maternal nausea or vomiting, narcotic pain relief, or infant admission to intensive care.

None of the outcomes were significantly related in any of the other analyses: complete restriction of food and fluid vs. freedom to eat and drink, water only vs. freedom to eat and drink, or complete food and fluid restriction vs. carbohydrate-based fluid only.