Sherry Boschert

SAN FRANCISCO — Combining alefacept with acitretin and narrow-band UVB in patients with plaque-type psoriasis is well tolerated and can induce early responses, three case reports indicate.

The triple therapy potentially can speed withdrawal of methotrexate or UVB therapy, Dr. Angela Moore reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The study was funded by Biogen Idec Inc., which makes alefacept.

Alefacept, a biologic T cell inhibitor, usually has an onset of action of 14–16 weeks when it is used as a single agent. Monotherapy with low-dose acitretin has an onset of action of about 3 months. The combination of low-dose acitretin with narrow-band UVB has previously been shown to speed responses, wrote Dr. Moore, a dermatologist in Arlington, Tex.

She and her associates evaluated the triple therapy in three patients with moderate to severe plaque-type psoriasis that was refractory to numerous treatments.

One patient, with a 20% body surface area (BSA) involvement, initially was treated with acitretin and narrow-band UVB. When he didn't show any improvement during 6 weeks of therapy, alefacept was added. After 7 weeks of the triple therapy, BSA involvement had declined to 3%.

A second patient, who had more than 80% BSA involvement, began to respond after 9 weeks of triple therapy. By week 11, BSA involvement was down to just 3%.

The third patient had 70% BSA involvement at the start of triple therapy. He showed significant improvement after 6 weeks, and his BSA involvement was only 4% at week 11.

While taking alefacept, CD4+ T cell counts decreased in all three patients. However, none of them developed clinical signs of infection or other side effects, Dr. Moore wrote.

SAN FRANCISCO — Combining alefacept with acitretin and narrow-band UVB in patients with plaque-type psoriasis is well tolerated and can induce early responses, three case reports indicate.

The triple therapy potentially can speed withdrawal of methotrexate or UVB therapy, Dr. Angela Moore reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The study was funded by Biogen Idec Inc., which makes alefacept.

Alefacept, a biologic T cell inhibitor, usually has an onset of action of 14–16 weeks when it is used as a single agent. Monotherapy with low-dose acitretin has an onset of action of about 3 months. The combination of low-dose acitretin with narrow-band UVB has previously been shown to speed responses, wrote Dr. Moore, a dermatologist in Arlington, Tex.

She and her associates evaluated the triple therapy in three patients with moderate to severe plaque-type psoriasis that was refractory to numerous treatments.

One patient, with a 20% body surface area (BSA) involvement, initially was treated with acitretin and narrow-band UVB. When he didn't show any improvement during 6 weeks of therapy, alefacept was added. After 7 weeks of the triple therapy, BSA involvement had declined to 3%.

A second patient, who had more than 80% BSA involvement, began to respond after 9 weeks of triple therapy. By week 11, BSA involvement was down to just 3%.

The third patient had 70% BSA involvement at the start of triple therapy. He showed significant improvement after 6 weeks, and his BSA involvement was only 4% at week 11.

While taking alefacept, CD4+ T cell counts decreased in all three patients. However, none of them developed clinical signs of infection or other side effects, Dr. Moore wrote.

SAN FRANCISCO — Combining alefacept with acitretin and narrow-band UVB in patients with plaque-type psoriasis is well tolerated and can induce early responses, three case reports indicate.

The triple therapy potentially can speed withdrawal of methotrexate or UVB therapy, Dr. Angela Moore reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The study was funded by Biogen Idec Inc., which makes alefacept.

Alefacept, a biologic T cell inhibitor, usually has an onset of action of 14–16 weeks when it is used as a single agent. Monotherapy with low-dose acitretin has an onset of action of about 3 months. The combination of low-dose acitretin with narrow-band UVB has previously been shown to speed responses, wrote Dr. Moore, a dermatologist in Arlington, Tex.

She and her associates evaluated the triple therapy in three patients with moderate to severe plaque-type psoriasis that was refractory to numerous treatments.

One patient, with a 20% body surface area (BSA) involvement, initially was treated with acitretin and narrow-band UVB. When he didn't show any improvement during 6 weeks of therapy, alefacept was added. After 7 weeks of the triple therapy, BSA involvement had declined to 3%.

A second patient, who had more than 80% BSA involvement, began to respond after 9 weeks of triple therapy. By week 11, BSA involvement was down to just 3%.

The third patient had 70% BSA involvement at the start of triple therapy. He showed significant improvement after 6 weeks, and his BSA involvement was only 4% at week 11.

While taking alefacept, CD4+ T cell counts decreased in all three patients. However, none of them developed clinical signs of infection or other side effects, Dr. Moore wrote.

SAN FRANCISCO — Adalimumab is effective in treating both mild to moderate and moderate to severe skin disease in patients who have psoriatic arthritis, Dr. Dafna D. Gladman reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

Adalimumab, a tumor necrosis factor blocker, was approved by the Food and Drug Administration in 2005 for the treatment of rheumatoid arthritis and psoriatic arthritis.

To assess whether the severity of skin disease affected the response of psoriasis to the drug, Dr. Gladman and her associates performed a post hoc analysis of a 24-week, placebo-controlled phase III trial involving patients with moderately active to severely active psoriatic arthritis.

Previous therapy with nonsteroidal anti-inflammatory drugs had produced inadequate responses in all patients.

Among those patients in the adalimumab-treated group, 53 patients had mild to moderate skin disease, with a Psoriasis Area and Severity Index (PASI) score of less than 10 at baseline. Sixteen patients had moderate to severe skin disease, with a PASI score of 10 or greater.

PASI responses occurred quickly and were maintained.

After 24 weeks of drug treatment, the two subgroups had similar response rates. Comparing the mild-moderate and moderate-severe groups, a PASI 50 score (a 50% reduction from baseline) was achieved by 39 patients (74%) and 13 patients (81%), respectively; a PASI 90 score was achieved by 23 patients (43%) and 6 patients (38%) in the respective groups, reported Dr. Gladman of the University of Toronto.

Dr. Gladman is a primary investigator for Abbott Laboratories Inc., which manufactures adalimumab under the Humira brand.

Both patient subgroups, she noted, achieved “meaningful improvements” in quality of life, compared with baseline, as measured by the Dermatology Life Quality Index.

SAN FRANCISCO — Adalimumab is effective in treating both mild to moderate and moderate to severe skin disease in patients who have psoriatic arthritis, Dr. Dafna D. Gladman reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

Adalimumab, a tumor necrosis factor blocker, was approved by the Food and Drug Administration in 2005 for the treatment of rheumatoid arthritis and psoriatic arthritis.

To assess whether the severity of skin disease affected the response of psoriasis to the drug, Dr. Gladman and her associates performed a post hoc analysis of a 24-week, placebo-controlled phase III trial involving patients with moderately active to severely active psoriatic arthritis.

Previous therapy with nonsteroidal anti-inflammatory drugs had produced inadequate responses in all patients.

Among those patients in the adalimumab-treated group, 53 patients had mild to moderate skin disease, with a Psoriasis Area and Severity Index (PASI) score of less than 10 at baseline. Sixteen patients had moderate to severe skin disease, with a PASI score of 10 or greater.

PASI responses occurred quickly and were maintained.

After 24 weeks of drug treatment, the two subgroups had similar response rates. Comparing the mild-moderate and moderate-severe groups, a PASI 50 score (a 50% reduction from baseline) was achieved by 39 patients (74%) and 13 patients (81%), respectively; a PASI 90 score was achieved by 23 patients (43%) and 6 patients (38%) in the respective groups, reported Dr. Gladman of the University of Toronto.

Dr. Gladman is a primary investigator for Abbott Laboratories Inc., which manufactures adalimumab under the Humira brand.

Both patient subgroups, she noted, achieved “meaningful improvements” in quality of life, compared with baseline, as measured by the Dermatology Life Quality Index.

SAN FRANCISCO — Adalimumab is effective in treating both mild to moderate and moderate to severe skin disease in patients who have psoriatic arthritis, Dr. Dafna D. Gladman reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

Adalimumab, a tumor necrosis factor blocker, was approved by the Food and Drug Administration in 2005 for the treatment of rheumatoid arthritis and psoriatic arthritis.

To assess whether the severity of skin disease affected the response of psoriasis to the drug, Dr. Gladman and her associates performed a post hoc analysis of a 24-week, placebo-controlled phase III trial involving patients with moderately active to severely active psoriatic arthritis.

Previous therapy with nonsteroidal anti-inflammatory drugs had produced inadequate responses in all patients.

Among those patients in the adalimumab-treated group, 53 patients had mild to moderate skin disease, with a Psoriasis Area and Severity Index (PASI) score of less than 10 at baseline. Sixteen patients had moderate to severe skin disease, with a PASI score of 10 or greater.

PASI responses occurred quickly and were maintained.

After 24 weeks of drug treatment, the two subgroups had similar response rates. Comparing the mild-moderate and moderate-severe groups, a PASI 50 score (a 50% reduction from baseline) was achieved by 39 patients (74%) and 13 patients (81%), respectively; a PASI 90 score was achieved by 23 patients (43%) and 6 patients (38%) in the respective groups, reported Dr. Gladman of the University of Toronto.

Dr. Gladman is a primary investigator for Abbott Laboratories Inc., which manufactures adalimumab under the Humira brand.

Both patient subgroups, she noted, achieved “meaningful improvements” in quality of life, compared with baseline, as measured by the Dermatology Life Quality Index.

SAN FRANCISCO — Allergy to the materials in an implanted cardioverter defibrillator can cause a contact dermatitis over the implantation site that may be mistaken for infection, Dr. Margaret Lee-Bellantoni said.

Although allergic reactions to implantable cardioverter defibrillators (ICDs) are rare, the rapidly increasing number of patients being given ICDs probably will mean more cases of defibrillator dermatitis. “We do expect to see more,” she said at the annual meeting of the American Contact Dermatitis Society.

During 1996–2001, the number of patients with ICDs increased by 24% annually, noted Dr. Lee-Bellantoni of Tufts-New England Medical Center, Boston.

She described the case of a 57-year-old man with a history of coronary artery disease and myocardial infarction who received an ICD to manage ventricular tachycardia. His first ICD, implanted in 1991, was replaced in 1994 and again in 1997 and 2004. One week after the 2004 ICD was placed in the extraperitoneal space of the man's abdomen, he developed a wound dehiscence near the center of the incision site. He had no fever, chills, or leukocytosis, but developed erythema over the ICD area. The dehiscence healed but the erythema persisted, so he was treated with oral antibiotics for presumed infection. The erythema expanded over the ICD implantation, still with no pain, pruritus, or fever. The patient was hospitalized twice with a diagnosis of infection of the left lower abdomen and was given IV antibiotics, including vancomycin.

During the second hospitalization, the patient came to the attention of dermatologists, who took a tissue biopsy. The results were nondiagnostic but consistent with possible hypersensitivity. Culture was negative for bacteria and fungi.

“Although the cardiologists knew there was something weird going on, they were still essentially worried about infection. But the dermatologists were worried about hypersensitivity reaction,” Dr. Lee-Bellantoni said.

The dermatologists obtained an ICD materials test kit from the ICD manufacturer containing materials from the 11 components that come into contact with patient tissue. They patch-tested the patient to the plastics, silicones, epoxies, and other materials in the kit, as well as to a standard group of preservatives, fragrances, and other potential allergens.

The results showed evidence of contact hypersensitivity to polyurethane 75D and peroxide-cured silicone rubber, which were present in the patient's ICD. This information helped cardiologists choose a different ICD for him. After replacement of the offending ICD with the new one in a different location, the erythema gradually resolved.

The cost of the patient's two hospitalizations and antibiotic treatment totalled $9,544. The patch test, which cost $1,286, was “really cost effective,” Dr. Lee-Bellantoni said. Plus, “you really can't overestimate the emotional cost to the patient in terms of stress over the possibility of resistant infection, nosocomial infection, and work time lost.”

Suspect contact allergy in the absence of proven infection in a patient with erythema at the ICD site, she suggested.

Amine catalysts used in polyurethanes and epoxy systems as hardeners and curing agents are very strong sensitizers. Polyurethanes and epoxies may be used for surface coatings of various manufactured items.

The patient had a history of exposure to these and other potential sensitizers in his work as a motorcycle shop manager and in previous woodworking environments. Regardless, multiple ICD placements could, by themselves, be enough to sensitize someone to these agents, she said.

There are 30 cases in the literature of hypersensitivity to ICDs or to pacemakers. If a reaction is suspected, a negative patch test does not necessarily rule out sensitization because it is difficult to get a response to the tiny piece of material used in the tests, she cautioned.

A 57-year-old man developed erythema at the site of his ICD-associated incision.

The erythema is shown to have resolved by 7 months, after replacing and moving the ICD. Photos Courtesy Dr. Pamela Scheinman

SAN FRANCISCO — Allergy to the materials in an implanted cardioverter defibrillator can cause a contact dermatitis over the implantation site that may be mistaken for infection, Dr. Margaret Lee-Bellantoni said.

Although allergic reactions to implantable cardioverter defibrillators (ICDs) are rare, the rapidly increasing number of patients being given ICDs probably will mean more cases of defibrillator dermatitis. “We do expect to see more,” she said at the annual meeting of the American Contact Dermatitis Society.

During 1996–2001, the number of patients with ICDs increased by 24% annually, noted Dr. Lee-Bellantoni of Tufts-New England Medical Center, Boston.

She described the case of a 57-year-old man with a history of coronary artery disease and myocardial infarction who received an ICD to manage ventricular tachycardia. His first ICD, implanted in 1991, was replaced in 1994 and again in 1997 and 2004. One week after the 2004 ICD was placed in the extraperitoneal space of the man's abdomen, he developed a wound dehiscence near the center of the incision site. He had no fever, chills, or leukocytosis, but developed erythema over the ICD area. The dehiscence healed but the erythema persisted, so he was treated with oral antibiotics for presumed infection. The erythema expanded over the ICD implantation, still with no pain, pruritus, or fever. The patient was hospitalized twice with a diagnosis of infection of the left lower abdomen and was given IV antibiotics, including vancomycin.

During the second hospitalization, the patient came to the attention of dermatologists, who took a tissue biopsy. The results were nondiagnostic but consistent with possible hypersensitivity. Culture was negative for bacteria and fungi.

“Although the cardiologists knew there was something weird going on, they were still essentially worried about infection. But the dermatologists were worried about hypersensitivity reaction,” Dr. Lee-Bellantoni said.

The dermatologists obtained an ICD materials test kit from the ICD manufacturer containing materials from the 11 components that come into contact with patient tissue. They patch-tested the patient to the plastics, silicones, epoxies, and other materials in the kit, as well as to a standard group of preservatives, fragrances, and other potential allergens.

The results showed evidence of contact hypersensitivity to polyurethane 75D and peroxide-cured silicone rubber, which were present in the patient's ICD. This information helped cardiologists choose a different ICD for him. After replacement of the offending ICD with the new one in a different location, the erythema gradually resolved.

The cost of the patient's two hospitalizations and antibiotic treatment totalled $9,544. The patch test, which cost $1,286, was “really cost effective,” Dr. Lee-Bellantoni said. Plus, “you really can't overestimate the emotional cost to the patient in terms of stress over the possibility of resistant infection, nosocomial infection, and work time lost.”

Suspect contact allergy in the absence of proven infection in a patient with erythema at the ICD site, she suggested.

Amine catalysts used in polyurethanes and epoxy systems as hardeners and curing agents are very strong sensitizers. Polyurethanes and epoxies may be used for surface coatings of various manufactured items.

The patient had a history of exposure to these and other potential sensitizers in his work as a motorcycle shop manager and in previous woodworking environments. Regardless, multiple ICD placements could, by themselves, be enough to sensitize someone to these agents, she said.

There are 30 cases in the literature of hypersensitivity to ICDs or to pacemakers. If a reaction is suspected, a negative patch test does not necessarily rule out sensitization because it is difficult to get a response to the tiny piece of material used in the tests, she cautioned.

A 57-year-old man developed erythema at the site of his ICD-associated incision.

The erythema is shown to have resolved by 7 months, after replacing and moving the ICD. Photos Courtesy Dr. Pamela Scheinman

SAN FRANCISCO — Allergy to the materials in an implanted cardioverter defibrillator can cause a contact dermatitis over the implantation site that may be mistaken for infection, Dr. Margaret Lee-Bellantoni said.

Although allergic reactions to implantable cardioverter defibrillators (ICDs) are rare, the rapidly increasing number of patients being given ICDs probably will mean more cases of defibrillator dermatitis. “We do expect to see more,” she said at the annual meeting of the American Contact Dermatitis Society.

During 1996–2001, the number of patients with ICDs increased by 24% annually, noted Dr. Lee-Bellantoni of Tufts-New England Medical Center, Boston.

She described the case of a 57-year-old man with a history of coronary artery disease and myocardial infarction who received an ICD to manage ventricular tachycardia. His first ICD, implanted in 1991, was replaced in 1994 and again in 1997 and 2004. One week after the 2004 ICD was placed in the extraperitoneal space of the man's abdomen, he developed a wound dehiscence near the center of the incision site. He had no fever, chills, or leukocytosis, but developed erythema over the ICD area. The dehiscence healed but the erythema persisted, so he was treated with oral antibiotics for presumed infection. The erythema expanded over the ICD implantation, still with no pain, pruritus, or fever. The patient was hospitalized twice with a diagnosis of infection of the left lower abdomen and was given IV antibiotics, including vancomycin.

During the second hospitalization, the patient came to the attention of dermatologists, who took a tissue biopsy. The results were nondiagnostic but consistent with possible hypersensitivity. Culture was negative for bacteria and fungi.

“Although the cardiologists knew there was something weird going on, they were still essentially worried about infection. But the dermatologists were worried about hypersensitivity reaction,” Dr. Lee-Bellantoni said.

The dermatologists obtained an ICD materials test kit from the ICD manufacturer containing materials from the 11 components that come into contact with patient tissue. They patch-tested the patient to the plastics, silicones, epoxies, and other materials in the kit, as well as to a standard group of preservatives, fragrances, and other potential allergens.

The results showed evidence of contact hypersensitivity to polyurethane 75D and peroxide-cured silicone rubber, which were present in the patient's ICD. This information helped cardiologists choose a different ICD for him. After replacement of the offending ICD with the new one in a different location, the erythema gradually resolved.

The cost of the patient's two hospitalizations and antibiotic treatment totalled $9,544. The patch test, which cost $1,286, was “really cost effective,” Dr. Lee-Bellantoni said. Plus, “you really can't overestimate the emotional cost to the patient in terms of stress over the possibility of resistant infection, nosocomial infection, and work time lost.”

Suspect contact allergy in the absence of proven infection in a patient with erythema at the ICD site, she suggested.

Amine catalysts used in polyurethanes and epoxy systems as hardeners and curing agents are very strong sensitizers. Polyurethanes and epoxies may be used for surface coatings of various manufactured items.

The patient had a history of exposure to these and other potential sensitizers in his work as a motorcycle shop manager and in previous woodworking environments. Regardless, multiple ICD placements could, by themselves, be enough to sensitize someone to these agents, she said.

There are 30 cases in the literature of hypersensitivity to ICDs or to pacemakers. If a reaction is suspected, a negative patch test does not necessarily rule out sensitization because it is difficult to get a response to the tiny piece of material used in the tests, she cautioned.

A 57-year-old man developed erythema at the site of his ICD-associated incision.

The erythema is shown to have resolved by 7 months, after replacing and moving the ICD. Photos Courtesy Dr. Pamela Scheinman

SAN DIEGO – All three main treatments for problem sleepiness can perk patients up, but they differ in cost and side effects, Dr. Milton Erman said at a psychopharmacology congress sponsored by the Neuroscience Education Institute.

Caffeine is the cheapest, most accessible, and most widely used stimulant. The two other treatment options are prescription medications, which are more expensive: modafinil or CNS stimulants (most commonly amphetamines or methylphenidate).

Caffeine tolerance develops rapidly, however, and there's a moderate risk for dependence. Stopping a daily caffeine habit too quickly can trigger a “caffeine headache.” Side effects from regular caffeine use include nervousness, irritability, insomnia, and GI problems, said Dr. Erman of the University of California, San Diego.

“Many of my insomniac patients tell me proudly that they aren't using caffeine” to indicate that caffeine can't be blamed for their insomnia, he said. Ironically, a bit of caffeine in the morning may be just what they need. “The problem with many of these insomniac patients is that they can't get going, get functioning in the morning,” he said. Limited caffeine use in the morning may help them function better.

Use of CNS stimulants also leads to tolerance, and there is a high potential for dependence. Side effects include nervousness, headaches, insomnia, anorexia, GI problems, and mood changes. General CNS stimulants such as amphetamines have a high risk of abuse and hyperactivity because of their broad mechanism of action.

One experimental study of sleep deprivation that compared amphetamines with modafinil treatment to maintain wakefulness suggested that the two drugs are equally potent. In real life, however, “I think amphetamines are more potent,” he said. Patients with narcolepsy who have used amphetamines in the past often aren't satisfied with the effects of modafinil.

Modafinil works more specifically on wakefulness circuits and has fewer side effects than other stimulants. Tolerance is not an issue–it maintains most of its efficacy over time–and use of the drug does not lead to dependence. Side effects include headache, nausea, dry mouth, insomnia, and hyperactivity.

The risk of headache relates to the dosing of modafinil. In early research on the drug, headache appeared primarily in patients who titrated up to a dose of 400 mg/day by the third day. In subsequent research that gave patients 7–9 days to titrate up to 400 mg/day, headache was much less of a problem, Dr. Erman said.

“Modafinil works quite well, particularly if we're not talking about the most severely hypersomnolent patients,” such as narcoleptics who have become accustomed to taking stimulants, he said.

Dr. Erman is a speaker and consultant for, and has received research funding from, the company that makes modafinil, Cephalon Inc. Modafinil is approved to treat sleepiness from shift work, narcolepsy, and sleep apnea.

The most common cause of problem sleepiness is sleep apnea, which occurs in perhaps 10% of the population, he said. Restless leg syndrome can interrupt sleep and lead to daytime sleepiness. Narcolepsy is fairly uncommon. Insomnia can cause excessive sleepiness, but more often, insomniac patients are hypervigilant. “If anything, they are more alert” than they want to be, he said.

Secondary causes of sleepiness include chronic pain and any medical condition that causes pain or discomfort, which may interrupt sleep. Medications used to alleviate pain also can lead to daytime sleepiness because they affect breathing during sleep and increase the risk for sleep apnea.

Check to see if patients who complain of sleepiness are taking drugs that cause sedation or that disrupt sleep, Dr. Erman added, and consider alternative therapies.

Lifestyle issues, such as graveyard shift work, also contribute to excessive sleepiness,. The pace of U.S. culture commonly leads to chronic sleep deprivation that affects daytime function. “As a society, we really haven't dealt with this,” he said.

SAN DIEGO – All three main treatments for problem sleepiness can perk patients up, but they differ in cost and side effects, Dr. Milton Erman said at a psychopharmacology congress sponsored by the Neuroscience Education Institute.

Caffeine is the cheapest, most accessible, and most widely used stimulant. The two other treatment options are prescription medications, which are more expensive: modafinil or CNS stimulants (most commonly amphetamines or methylphenidate).

Caffeine tolerance develops rapidly, however, and there's a moderate risk for dependence. Stopping a daily caffeine habit too quickly can trigger a “caffeine headache.” Side effects from regular caffeine use include nervousness, irritability, insomnia, and GI problems, said Dr. Erman of the University of California, San Diego.

“Many of my insomniac patients tell me proudly that they aren't using caffeine” to indicate that caffeine can't be blamed for their insomnia, he said. Ironically, a bit of caffeine in the morning may be just what they need. “The problem with many of these insomniac patients is that they can't get going, get functioning in the morning,” he said. Limited caffeine use in the morning may help them function better.

Use of CNS stimulants also leads to tolerance, and there is a high potential for dependence. Side effects include nervousness, headaches, insomnia, anorexia, GI problems, and mood changes. General CNS stimulants such as amphetamines have a high risk of abuse and hyperactivity because of their broad mechanism of action.

One experimental study of sleep deprivation that compared amphetamines with modafinil treatment to maintain wakefulness suggested that the two drugs are equally potent. In real life, however, “I think amphetamines are more potent,” he said. Patients with narcolepsy who have used amphetamines in the past often aren't satisfied with the effects of modafinil.

Modafinil works more specifically on wakefulness circuits and has fewer side effects than other stimulants. Tolerance is not an issue–it maintains most of its efficacy over time–and use of the drug does not lead to dependence. Side effects include headache, nausea, dry mouth, insomnia, and hyperactivity.

The risk of headache relates to the dosing of modafinil. In early research on the drug, headache appeared primarily in patients who titrated up to a dose of 400 mg/day by the third day. In subsequent research that gave patients 7–9 days to titrate up to 400 mg/day, headache was much less of a problem, Dr. Erman said.

“Modafinil works quite well, particularly if we're not talking about the most severely hypersomnolent patients,” such as narcoleptics who have become accustomed to taking stimulants, he said.

Dr. Erman is a speaker and consultant for, and has received research funding from, the company that makes modafinil, Cephalon Inc. Modafinil is approved to treat sleepiness from shift work, narcolepsy, and sleep apnea.

The most common cause of problem sleepiness is sleep apnea, which occurs in perhaps 10% of the population, he said. Restless leg syndrome can interrupt sleep and lead to daytime sleepiness. Narcolepsy is fairly uncommon. Insomnia can cause excessive sleepiness, but more often, insomniac patients are hypervigilant. “If anything, they are more alert” than they want to be, he said.

Secondary causes of sleepiness include chronic pain and any medical condition that causes pain or discomfort, which may interrupt sleep. Medications used to alleviate pain also can lead to daytime sleepiness because they affect breathing during sleep and increase the risk for sleep apnea.

Check to see if patients who complain of sleepiness are taking drugs that cause sedation or that disrupt sleep, Dr. Erman added, and consider alternative therapies.

Lifestyle issues, such as graveyard shift work, also contribute to excessive sleepiness,. The pace of U.S. culture commonly leads to chronic sleep deprivation that affects daytime function. “As a society, we really haven't dealt with this,” he said.

SAN DIEGO – All three main treatments for problem sleepiness can perk patients up, but they differ in cost and side effects, Dr. Milton Erman said at a psychopharmacology congress sponsored by the Neuroscience Education Institute.

Caffeine is the cheapest, most accessible, and most widely used stimulant. The two other treatment options are prescription medications, which are more expensive: modafinil or CNS stimulants (most commonly amphetamines or methylphenidate).

Caffeine tolerance develops rapidly, however, and there's a moderate risk for dependence. Stopping a daily caffeine habit too quickly can trigger a “caffeine headache.” Side effects from regular caffeine use include nervousness, irritability, insomnia, and GI problems, said Dr. Erman of the University of California, San Diego.

“Many of my insomniac patients tell me proudly that they aren't using caffeine” to indicate that caffeine can't be blamed for their insomnia, he said. Ironically, a bit of caffeine in the morning may be just what they need. “The problem with many of these insomniac patients is that they can't get going, get functioning in the morning,” he said. Limited caffeine use in the morning may help them function better.

Use of CNS stimulants also leads to tolerance, and there is a high potential for dependence. Side effects include nervousness, headaches, insomnia, anorexia, GI problems, and mood changes. General CNS stimulants such as amphetamines have a high risk of abuse and hyperactivity because of their broad mechanism of action.

One experimental study of sleep deprivation that compared amphetamines with modafinil treatment to maintain wakefulness suggested that the two drugs are equally potent. In real life, however, “I think amphetamines are more potent,” he said. Patients with narcolepsy who have used amphetamines in the past often aren't satisfied with the effects of modafinil.

Modafinil works more specifically on wakefulness circuits and has fewer side effects than other stimulants. Tolerance is not an issue–it maintains most of its efficacy over time–and use of the drug does not lead to dependence. Side effects include headache, nausea, dry mouth, insomnia, and hyperactivity.

The risk of headache relates to the dosing of modafinil. In early research on the drug, headache appeared primarily in patients who titrated up to a dose of 400 mg/day by the third day. In subsequent research that gave patients 7–9 days to titrate up to 400 mg/day, headache was much less of a problem, Dr. Erman said.

“Modafinil works quite well, particularly if we're not talking about the most severely hypersomnolent patients,” such as narcoleptics who have become accustomed to taking stimulants, he said.

Dr. Erman is a speaker and consultant for, and has received research funding from, the company that makes modafinil, Cephalon Inc. Modafinil is approved to treat sleepiness from shift work, narcolepsy, and sleep apnea.

The most common cause of problem sleepiness is sleep apnea, which occurs in perhaps 10% of the population, he said. Restless leg syndrome can interrupt sleep and lead to daytime sleepiness. Narcolepsy is fairly uncommon. Insomnia can cause excessive sleepiness, but more often, insomniac patients are hypervigilant. “If anything, they are more alert” than they want to be, he said.

Secondary causes of sleepiness include chronic pain and any medical condition that causes pain or discomfort, which may interrupt sleep. Medications used to alleviate pain also can lead to daytime sleepiness because they affect breathing during sleep and increase the risk for sleep apnea.

Check to see if patients who complain of sleepiness are taking drugs that cause sedation or that disrupt sleep, Dr. Erman added, and consider alternative therapies.

Lifestyle issues, such as graveyard shift work, also contribute to excessive sleepiness,. The pace of U.S. culture commonly leads to chronic sleep deprivation that affects daytime function. “As a society, we really haven't dealt with this,” he said.

SAN FRANCISCO — Patients with hepatitis C and cirrhosis who had a sustained response to interferon monotherapy were less likely to develop hepatocellular carcinoma or die of liver-related causes than were patients without a sustained response in a large Italian study, Dr. Savino Bruno reported.

Newer regimens using pegylated interferon plus ribavirin have been shown in separate studies to increase the likelihood of a sustained virologic response, so all patients with hepatitis C virus (HCV) who are candidates for treatment should be given the newer combination therapy—even patients with established cirrhosis, Dr. Bruno said at the annual meeting of the American Association for the Study of Liver Diseases.

Several previous clinical trials of the efficacy of interferon-based therapies in clearing HCV, conducted mostly in Japan, hinted at a slight protective effect from sustained virologic response. This is the first study in a large Western population-based cohort designed to study the protection conferred by sustained virologic response. Such response is defined as undetectable serum HCV-RNA levels 24 weeks after stopping interferon.

In the current study, investigators reviewed data on 1,214 consecutive patients with HCV and Child's class A cirrhosis who were treated with interferon at 23 Italian medical centers from 1992 through 1997. Patients had a mean age of 60 years, 62% were male, and 55% were infected with HCV genotype 1.

The available records showed a sustained virologic response in 16%, and 6% of these developed hepatocellular carcinoma over a mean follow-up period of nearly 8 years.

Among the 84% of patients without a sustained virologic response, 17% developed hepatocellular carcinoma, said Dr. Bruno, head of the liver unit at Fatebenefratelli and Oftalmico Hospital, Milan, and his associates. Dr. Bruno has no relationships with the company that makes interferon.

Only 2% of patients in the sustained virologic response group died of liver-related causes, compared with 12% of patients who did not have a sustained virologic response.

Factors that increased the risk for hepatocellular carcinoma were older age (58 years and up), being male, and not having a sustained virologic response, according to a multivariate analysis.

Lack of a sustained response to treatment doubled the risk of developing cancer and quadrupled the risk for liver-related death. Older age quadrupled the risk for cancer.

Because a sustained response to treatment didn't completely eliminate the risk of hepatocellular carcinoma, especially in older patients, cancer surveillance in these patients must continue, Dr. Bruno said.

The study excluded patients who were coinfected with hepatitis B or HIV.

SAN FRANCISCO — Patients with hepatitis C and cirrhosis who had a sustained response to interferon monotherapy were less likely to develop hepatocellular carcinoma or die of liver-related causes than were patients without a sustained response in a large Italian study, Dr. Savino Bruno reported.

Newer regimens using pegylated interferon plus ribavirin have been shown in separate studies to increase the likelihood of a sustained virologic response, so all patients with hepatitis C virus (HCV) who are candidates for treatment should be given the newer combination therapy—even patients with established cirrhosis, Dr. Bruno said at the annual meeting of the American Association for the Study of Liver Diseases.

Several previous clinical trials of the efficacy of interferon-based therapies in clearing HCV, conducted mostly in Japan, hinted at a slight protective effect from sustained virologic response. This is the first study in a large Western population-based cohort designed to study the protection conferred by sustained virologic response. Such response is defined as undetectable serum HCV-RNA levels 24 weeks after stopping interferon.

In the current study, investigators reviewed data on 1,214 consecutive patients with HCV and Child's class A cirrhosis who were treated with interferon at 23 Italian medical centers from 1992 through 1997. Patients had a mean age of 60 years, 62% were male, and 55% were infected with HCV genotype 1.

The available records showed a sustained virologic response in 16%, and 6% of these developed hepatocellular carcinoma over a mean follow-up period of nearly 8 years.

Among the 84% of patients without a sustained virologic response, 17% developed hepatocellular carcinoma, said Dr. Bruno, head of the liver unit at Fatebenefratelli and Oftalmico Hospital, Milan, and his associates. Dr. Bruno has no relationships with the company that makes interferon.

Only 2% of patients in the sustained virologic response group died of liver-related causes, compared with 12% of patients who did not have a sustained virologic response.

Factors that increased the risk for hepatocellular carcinoma were older age (58 years and up), being male, and not having a sustained virologic response, according to a multivariate analysis.

Lack of a sustained response to treatment doubled the risk of developing cancer and quadrupled the risk for liver-related death. Older age quadrupled the risk for cancer.

Because a sustained response to treatment didn't completely eliminate the risk of hepatocellular carcinoma, especially in older patients, cancer surveillance in these patients must continue, Dr. Bruno said.

The study excluded patients who were coinfected with hepatitis B or HIV.

SAN FRANCISCO — Patients with hepatitis C and cirrhosis who had a sustained response to interferon monotherapy were less likely to develop hepatocellular carcinoma or die of liver-related causes than were patients without a sustained response in a large Italian study, Dr. Savino Bruno reported.

Newer regimens using pegylated interferon plus ribavirin have been shown in separate studies to increase the likelihood of a sustained virologic response, so all patients with hepatitis C virus (HCV) who are candidates for treatment should be given the newer combination therapy—even patients with established cirrhosis, Dr. Bruno said at the annual meeting of the American Association for the Study of Liver Diseases.

Several previous clinical trials of the efficacy of interferon-based therapies in clearing HCV, conducted mostly in Japan, hinted at a slight protective effect from sustained virologic response. This is the first study in a large Western population-based cohort designed to study the protection conferred by sustained virologic response. Such response is defined as undetectable serum HCV-RNA levels 24 weeks after stopping interferon.

In the current study, investigators reviewed data on 1,214 consecutive patients with HCV and Child's class A cirrhosis who were treated with interferon at 23 Italian medical centers from 1992 through 1997. Patients had a mean age of 60 years, 62% were male, and 55% were infected with HCV genotype 1.

The available records showed a sustained virologic response in 16%, and 6% of these developed hepatocellular carcinoma over a mean follow-up period of nearly 8 years.

Among the 84% of patients without a sustained virologic response, 17% developed hepatocellular carcinoma, said Dr. Bruno, head of the liver unit at Fatebenefratelli and Oftalmico Hospital, Milan, and his associates. Dr. Bruno has no relationships with the company that makes interferon.

Only 2% of patients in the sustained virologic response group died of liver-related causes, compared with 12% of patients who did not have a sustained virologic response.

Factors that increased the risk for hepatocellular carcinoma were older age (58 years and up), being male, and not having a sustained virologic response, according to a multivariate analysis.

Lack of a sustained response to treatment doubled the risk of developing cancer and quadrupled the risk for liver-related death. Older age quadrupled the risk for cancer.

Because a sustained response to treatment didn't completely eliminate the risk of hepatocellular carcinoma, especially in older patients, cancer surveillance in these patients must continue, Dr. Bruno said.

The study excluded patients who were coinfected with hepatitis B or HIV.

KAILUA KONA, HAWAII — The proliferation of CT scans by internists and other physicians has brought an increasing number of incidental findings of postmenopausal ovarian cysts, Dr. William J. Hoskins said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Before the widespread use of CT scans and ultrasonography, “we thought that postmenopausal women didn't get ovarian cysts, and if they did, they were bad” cysts. “Now we know that finding a simple ovarian cyst in a postmenopausal patient is a relatively common thing,” he said.

Clinicians also have learned that it's okay to follow simple ovarian cysts less than 6 cm in diameter in postmenopausal women because if the cyst stays stable or decreases in size, the chances of its being a malignancy are extraordinarily small, said Dr. Hoskins, professor of obstetrics and gynecology at Mercer University, Savannah, Ga. No one really knows how long to follow a small cyst, but most experts suggest 1 year, he added.

Check it after 6 weeks, and again at 3 months, 6 months, and 1 year. If it grows or changes from a simple to a complex cyst, conventional wisdom—based on relatively good data—suggests that the patient needs surgery, Dr. Hoskins said.

The “vast majority” of simple postmenopausal cysts on the ovaries will be 2–3 cm in size and will not need any treatment, he said at the meeting, which was sponsored by Boston University.

One study that examined asymptomatic, postmenopausal women every 3 months for 1 year found that 17% had an ovarian cyst on the initial examination and 24% had a cyst sometime during the study, Dr. Dolores H. Pretorius said during a question-and-answer session after Dr. Hoskins' talk.

“Clearly, the ovary is still dynamic and still changes” in postmenopausal women, and small, simple ovarian cysts should not be removed but followed every 3 months for changes.

“If it's getting bigger or if we've had a lot of diastolic flow on Doppler on that cyst, then we worry about it,” said Dr. Pretorius, professor of radiology and director of imaging at the University of California, San Diego.

In premenopausal women, an unsuspected ovarian mass larger than 8 cm calls for cystectomy.

If the mass is found during surgery for other indications, get the consent of the patient's spouse or a relative before cystectomy, Dr. Hoskins said.

An incidental ovarian mass smaller than 8 cm in a premenopausal woman may be managed with observation unless it is suspicious for cancer, he said.

In 2004, an estimated 25,580 women developed ovarian cancer and 16,090 women died of the disease.

KAILUA KONA, HAWAII — The proliferation of CT scans by internists and other physicians has brought an increasing number of incidental findings of postmenopausal ovarian cysts, Dr. William J. Hoskins said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Before the widespread use of CT scans and ultrasonography, “we thought that postmenopausal women didn't get ovarian cysts, and if they did, they were bad” cysts. “Now we know that finding a simple ovarian cyst in a postmenopausal patient is a relatively common thing,” he said.

Clinicians also have learned that it's okay to follow simple ovarian cysts less than 6 cm in diameter in postmenopausal women because if the cyst stays stable or decreases in size, the chances of its being a malignancy are extraordinarily small, said Dr. Hoskins, professor of obstetrics and gynecology at Mercer University, Savannah, Ga. No one really knows how long to follow a small cyst, but most experts suggest 1 year, he added.

Check it after 6 weeks, and again at 3 months, 6 months, and 1 year. If it grows or changes from a simple to a complex cyst, conventional wisdom—based on relatively good data—suggests that the patient needs surgery, Dr. Hoskins said.

The “vast majority” of simple postmenopausal cysts on the ovaries will be 2–3 cm in size and will not need any treatment, he said at the meeting, which was sponsored by Boston University.

One study that examined asymptomatic, postmenopausal women every 3 months for 1 year found that 17% had an ovarian cyst on the initial examination and 24% had a cyst sometime during the study, Dr. Dolores H. Pretorius said during a question-and-answer session after Dr. Hoskins' talk.

“Clearly, the ovary is still dynamic and still changes” in postmenopausal women, and small, simple ovarian cysts should not be removed but followed every 3 months for changes.

“If it's getting bigger or if we've had a lot of diastolic flow on Doppler on that cyst, then we worry about it,” said Dr. Pretorius, professor of radiology and director of imaging at the University of California, San Diego.

In premenopausal women, an unsuspected ovarian mass larger than 8 cm calls for cystectomy.

If the mass is found during surgery for other indications, get the consent of the patient's spouse or a relative before cystectomy, Dr. Hoskins said.

An incidental ovarian mass smaller than 8 cm in a premenopausal woman may be managed with observation unless it is suspicious for cancer, he said.

In 2004, an estimated 25,580 women developed ovarian cancer and 16,090 women died of the disease.

KAILUA KONA, HAWAII — The proliferation of CT scans by internists and other physicians has brought an increasing number of incidental findings of postmenopausal ovarian cysts, Dr. William J. Hoskins said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Before the widespread use of CT scans and ultrasonography, “we thought that postmenopausal women didn't get ovarian cysts, and if they did, they were bad” cysts. “Now we know that finding a simple ovarian cyst in a postmenopausal patient is a relatively common thing,” he said.

Clinicians also have learned that it's okay to follow simple ovarian cysts less than 6 cm in diameter in postmenopausal women because if the cyst stays stable or decreases in size, the chances of its being a malignancy are extraordinarily small, said Dr. Hoskins, professor of obstetrics and gynecology at Mercer University, Savannah, Ga. No one really knows how long to follow a small cyst, but most experts suggest 1 year, he added.

Check it after 6 weeks, and again at 3 months, 6 months, and 1 year. If it grows or changes from a simple to a complex cyst, conventional wisdom—based on relatively good data—suggests that the patient needs surgery, Dr. Hoskins said.

The “vast majority” of simple postmenopausal cysts on the ovaries will be 2–3 cm in size and will not need any treatment, he said at the meeting, which was sponsored by Boston University.

One study that examined asymptomatic, postmenopausal women every 3 months for 1 year found that 17% had an ovarian cyst on the initial examination and 24% had a cyst sometime during the study, Dr. Dolores H. Pretorius said during a question-and-answer session after Dr. Hoskins' talk.

“Clearly, the ovary is still dynamic and still changes” in postmenopausal women, and small, simple ovarian cysts should not be removed but followed every 3 months for changes.

“If it's getting bigger or if we've had a lot of diastolic flow on Doppler on that cyst, then we worry about it,” said Dr. Pretorius, professor of radiology and director of imaging at the University of California, San Diego.

In premenopausal women, an unsuspected ovarian mass larger than 8 cm calls for cystectomy.

If the mass is found during surgery for other indications, get the consent of the patient's spouse or a relative before cystectomy, Dr. Hoskins said.

An incidental ovarian mass smaller than 8 cm in a premenopausal woman may be managed with observation unless it is suspicious for cancer, he said.

In 2004, an estimated 25,580 women developed ovarian cancer and 16,090 women died of the disease.

KAILUA KONA, HAWAII — In the last 5 years, the annual number of bariatric procedures has increased 10-fold, from 30,000 to 300,000 worldwide, Dr. Louis F. Martin said at a meeting on medical negligence and risk management.

With that increase has come debate about whether new mechanisms are needed to credential bariatric surgeons and how best to minimize risks for patients and physicians alike. “There's just a frontier atmosphere right now,” said Dr. Martin, professor of surgery at Louisiana State University, New Orleans.

Kimberly D. Baker, a Seattle-baseddefense lawyer who also holds a BS degree in nursing, agreed.

Contributing to this problem is thepublic's fascination with “makeover” television shows, which have stoked interest in bariatric surgery not just among persons who weigh 400–500 pounds but also among much smaller people, she said in a commentary session at the meeting, sponsored by Boston University.

In response to the demand, some surgeons are taking advantage of hospital privileges that allow them to do general abdominal surgery by claiming that hospital liability insurance covers them to perform much more complex bariatric procedures without having to prove their competence, she said.

“Hospitals are really not being put on notice about the extent or scope” of practice by some surgeons doing these procedures, Ms. Baker said.

She predicts future lawsuits against bariatric surgery programs that overrepresent their attributes. “If your surgical center or hospital is going to tout itself as the biggest and the best for bariatric surgery patients, you better have the right credentialed individuals, a quality improvement program in place, and the data to back it up,” she advised.

Dr. Martin noted that the guidelines of several surgical organizations state that bariatric surgery programs should have a multidisciplinary team approach, specialized equipment, and a high level of expertise. The multidisciplinary approach should encompass support from dietary, psychological, medical, and exercise or physical therapy professionals to effect behavior modification in the patient.

“The operation is a blend of surgery and behavior modification and does require a different model,” Dr. Martin said. In 2005, fewer than half of academic general surgical residency training programs had a multidisciplinary bariatric surgical program, he noted.

Bariatric surgeons hope to establish a data collection system through insurance companies to follow outcomes, he added. This could help provide continuous quality improvement in the field.

Knowledgeable bariatric surgeons take extensive preoperative steps to decrease the risks of the surgery to patients, Dr. Martin said. For example, his program only accepts morbidly obese patients who can walk for at least 10 minutes on a treadmill, because if they are unable to do so, their cardiovascular system might not withstand surgery.

Patients are required to lose at least 10% of their initial weight before surgery, show acceptable pulmonary function on a spirometer, agree not to smoke, and undergo regular testing for nicotine if they have a history of smoking. Sleep studies, pulmonary exercises to improve blood gas levels, and other steps to improve pulmonary function pay off, he said.

“If you don't do that, and they have the trauma of surgery, they get very short of breath,” Dr. Martin explained.

He gives large doses of Lovenox and takes other measures to prevent deep vein thromboses and pulmonary emboli.

All patients undergo an extensive psychological evaluation and must participate in behavior modification groups. They are asked to prove they can change their behavior before surgery by increasing the distance they can walk in 10 minutes or by walking a mile.

KAILUA KONA, HAWAII — In the last 5 years, the annual number of bariatric procedures has increased 10-fold, from 30,000 to 300,000 worldwide, Dr. Louis F. Martin said at a meeting on medical negligence and risk management.

With that increase has come debate about whether new mechanisms are needed to credential bariatric surgeons and how best to minimize risks for patients and physicians alike. “There's just a frontier atmosphere right now,” said Dr. Martin, professor of surgery at Louisiana State University, New Orleans.

Kimberly D. Baker, a Seattle-baseddefense lawyer who also holds a BS degree in nursing, agreed.

Contributing to this problem is thepublic's fascination with “makeover” television shows, which have stoked interest in bariatric surgery not just among persons who weigh 400–500 pounds but also among much smaller people, she said in a commentary session at the meeting, sponsored by Boston University.

In response to the demand, some surgeons are taking advantage of hospital privileges that allow them to do general abdominal surgery by claiming that hospital liability insurance covers them to perform much more complex bariatric procedures without having to prove their competence, she said.

“Hospitals are really not being put on notice about the extent or scope” of practice by some surgeons doing these procedures, Ms. Baker said.

She predicts future lawsuits against bariatric surgery programs that overrepresent their attributes. “If your surgical center or hospital is going to tout itself as the biggest and the best for bariatric surgery patients, you better have the right credentialed individuals, a quality improvement program in place, and the data to back it up,” she advised.

Dr. Martin noted that the guidelines of several surgical organizations state that bariatric surgery programs should have a multidisciplinary team approach, specialized equipment, and a high level of expertise. The multidisciplinary approach should encompass support from dietary, psychological, medical, and exercise or physical therapy professionals to effect behavior modification in the patient.

“The operation is a blend of surgery and behavior modification and does require a different model,” Dr. Martin said. In 2005, fewer than half of academic general surgical residency training programs had a multidisciplinary bariatric surgical program, he noted.

Bariatric surgeons hope to establish a data collection system through insurance companies to follow outcomes, he added. This could help provide continuous quality improvement in the field.

Knowledgeable bariatric surgeons take extensive preoperative steps to decrease the risks of the surgery to patients, Dr. Martin said. For example, his program only accepts morbidly obese patients who can walk for at least 10 minutes on a treadmill, because if they are unable to do so, their cardiovascular system might not withstand surgery.

Patients are required to lose at least 10% of their initial weight before surgery, show acceptable pulmonary function on a spirometer, agree not to smoke, and undergo regular testing for nicotine if they have a history of smoking. Sleep studies, pulmonary exercises to improve blood gas levels, and other steps to improve pulmonary function pay off, he said.

“If you don't do that, and they have the trauma of surgery, they get very short of breath,” Dr. Martin explained.

He gives large doses of Lovenox and takes other measures to prevent deep vein thromboses and pulmonary emboli.

All patients undergo an extensive psychological evaluation and must participate in behavior modification groups. They are asked to prove they can change their behavior before surgery by increasing the distance they can walk in 10 minutes or by walking a mile.

KAILUA KONA, HAWAII — In the last 5 years, the annual number of bariatric procedures has increased 10-fold, from 30,000 to 300,000 worldwide, Dr. Louis F. Martin said at a meeting on medical negligence and risk management.

With that increase has come debate about whether new mechanisms are needed to credential bariatric surgeons and how best to minimize risks for patients and physicians alike. “There's just a frontier atmosphere right now,” said Dr. Martin, professor of surgery at Louisiana State University, New Orleans.

Kimberly D. Baker, a Seattle-baseddefense lawyer who also holds a BS degree in nursing, agreed.

Contributing to this problem is thepublic's fascination with “makeover” television shows, which have stoked interest in bariatric surgery not just among persons who weigh 400–500 pounds but also among much smaller people, she said in a commentary session at the meeting, sponsored by Boston University.

In response to the demand, some surgeons are taking advantage of hospital privileges that allow them to do general abdominal surgery by claiming that hospital liability insurance covers them to perform much more complex bariatric procedures without having to prove their competence, she said.

“Hospitals are really not being put on notice about the extent or scope” of practice by some surgeons doing these procedures, Ms. Baker said.

She predicts future lawsuits against bariatric surgery programs that overrepresent their attributes. “If your surgical center or hospital is going to tout itself as the biggest and the best for bariatric surgery patients, you better have the right credentialed individuals, a quality improvement program in place, and the data to back it up,” she advised.

Dr. Martin noted that the guidelines of several surgical organizations state that bariatric surgery programs should have a multidisciplinary team approach, specialized equipment, and a high level of expertise. The multidisciplinary approach should encompass support from dietary, psychological, medical, and exercise or physical therapy professionals to effect behavior modification in the patient.

“The operation is a blend of surgery and behavior modification and does require a different model,” Dr. Martin said. In 2005, fewer than half of academic general surgical residency training programs had a multidisciplinary bariatric surgical program, he noted.

Bariatric surgeons hope to establish a data collection system through insurance companies to follow outcomes, he added. This could help provide continuous quality improvement in the field.

Knowledgeable bariatric surgeons take extensive preoperative steps to decrease the risks of the surgery to patients, Dr. Martin said. For example, his program only accepts morbidly obese patients who can walk for at least 10 minutes on a treadmill, because if they are unable to do so, their cardiovascular system might not withstand surgery.

Patients are required to lose at least 10% of their initial weight before surgery, show acceptable pulmonary function on a spirometer, agree not to smoke, and undergo regular testing for nicotine if they have a history of smoking. Sleep studies, pulmonary exercises to improve blood gas levels, and other steps to improve pulmonary function pay off, he said.

“If you don't do that, and they have the trauma of surgery, they get very short of breath,” Dr. Martin explained.

He gives large doses of Lovenox and takes other measures to prevent deep vein thromboses and pulmonary emboli.

All patients undergo an extensive psychological evaluation and must participate in behavior modification groups. They are asked to prove they can change their behavior before surgery by increasing the distance they can walk in 10 minutes or by walking a mile.

SALT LAKE CITY — For children with cystic fibrosis and pancreatic insufficiency, vitamin A supplements are sometimes too much of a good thing, Dr. Rose C. Graham-Maar said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Guidelines in 2002 recommended vitamin A supplementation for the 90% of cystic fibrosis patients who have pancreatic insufficiency, which puts them at risk for vitamin A malabsorption.

A study of 73 preadolescents aged 8–12 years with cystic fibrosis found that they took high doses of supplementary vitamin A, especially preformed retinol, which is more likely than provitamin A to cause liver or bone toxicity. The patients had higher serum retinol concentrations, compared with 663 children of similar age included in the National Health and Nutrition Examination Survey, said Dr. Graham-Maar, of the Children's Hospital of Philadelphia, and her associates.

Daily vitamin A intake exceeded recommendations for people with cystic fibrosis and pancreatic insufficiency in 36 patients (49%), and were above the upper limit of daily recommended intake for the general population in 64 patients (88%). “The doses in these kids are higher than we think they need,” although there's no clinical proof yet of harm, Dr. Graham-Maar said in an interview.

There are no good clinical measures, short of a liver biopsy, to assess vitamin A toxicity, she noted. Even if serum levels are normal, excess vitamin A in the body can cause liver disease or osteoporosis, which “we see in kids with cystic fibrosis on a fairly regular basis.”

Excess vitamin A ingestion can cause hepatic fibrosis, cirrhosis, liver failure, osteoporosis, anorexia, and weight loss—all problems seen in cystic fibrosis, confounding whether the disease or other factors contribute to these problems.

SALT LAKE CITY — For children with cystic fibrosis and pancreatic insufficiency, vitamin A supplements are sometimes too much of a good thing, Dr. Rose C. Graham-Maar said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Guidelines in 2002 recommended vitamin A supplementation for the 90% of cystic fibrosis patients who have pancreatic insufficiency, which puts them at risk for vitamin A malabsorption.

A study of 73 preadolescents aged 8–12 years with cystic fibrosis found that they took high doses of supplementary vitamin A, especially preformed retinol, which is more likely than provitamin A to cause liver or bone toxicity. The patients had higher serum retinol concentrations, compared with 663 children of similar age included in the National Health and Nutrition Examination Survey, said Dr. Graham-Maar, of the Children's Hospital of Philadelphia, and her associates.

Daily vitamin A intake exceeded recommendations for people with cystic fibrosis and pancreatic insufficiency in 36 patients (49%), and were above the upper limit of daily recommended intake for the general population in 64 patients (88%). “The doses in these kids are higher than we think they need,” although there's no clinical proof yet of harm, Dr. Graham-Maar said in an interview.

There are no good clinical measures, short of a liver biopsy, to assess vitamin A toxicity, she noted. Even if serum levels are normal, excess vitamin A in the body can cause liver disease or osteoporosis, which “we see in kids with cystic fibrosis on a fairly regular basis.”

Excess vitamin A ingestion can cause hepatic fibrosis, cirrhosis, liver failure, osteoporosis, anorexia, and weight loss—all problems seen in cystic fibrosis, confounding whether the disease or other factors contribute to these problems.

SALT LAKE CITY — For children with cystic fibrosis and pancreatic insufficiency, vitamin A supplements are sometimes too much of a good thing, Dr. Rose C. Graham-Maar said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Guidelines in 2002 recommended vitamin A supplementation for the 90% of cystic fibrosis patients who have pancreatic insufficiency, which puts them at risk for vitamin A malabsorption.

A study of 73 preadolescents aged 8–12 years with cystic fibrosis found that they took high doses of supplementary vitamin A, especially preformed retinol, which is more likely than provitamin A to cause liver or bone toxicity. The patients had higher serum retinol concentrations, compared with 663 children of similar age included in the National Health and Nutrition Examination Survey, said Dr. Graham-Maar, of the Children's Hospital of Philadelphia, and her associates.

Daily vitamin A intake exceeded recommendations for people with cystic fibrosis and pancreatic insufficiency in 36 patients (49%), and were above the upper limit of daily recommended intake for the general population in 64 patients (88%). “The doses in these kids are higher than we think they need,” although there's no clinical proof yet of harm, Dr. Graham-Maar said in an interview.

There are no good clinical measures, short of a liver biopsy, to assess vitamin A toxicity, she noted. Even if serum levels are normal, excess vitamin A in the body can cause liver disease or osteoporosis, which “we see in kids with cystic fibrosis on a fairly regular basis.”

Excess vitamin A ingestion can cause hepatic fibrosis, cirrhosis, liver failure, osteoporosis, anorexia, and weight loss—all problems seen in cystic fibrosis, confounding whether the disease or other factors contribute to these problems.

SAN DIEGO — Pregnancies in 51% of 155 women surveyed after laparoscopic tubal reconstructive surgery suggest a success rate comparable with that seen after laparotomy to repair tubes, Dr. Liselotte Mettler said at an international congress of the Society of Laparoendoscopic Surgeons.

The responses came from 195 women who were sent questionnaires in June 2003, after undergoing laparoscopic tubal surgery during the period between 2000 and 2002. The surgeries were performed by two ob.gyn. specialists and five residents at one institution to treat ectopic pregnancy, unilateral or bilateral tubal occlusions, or tubes needing alteration, she said.

Six of eight patients who underwent tubal end-to-end anastomoses became pregnant after the tubal reversals, for a 75% success rate, “which I think is pretty good,” said Dr. Mettler of the University of Schleswig-Holstein, Kiel, Germany.

The surgeries also included 64 salpingotomies, 74 salpingectomies, 25 salpingostomies, and 24 fimbrioplasties.

SAN DIEGO — Pregnancies in 51% of 155 women surveyed after laparoscopic tubal reconstructive surgery suggest a success rate comparable with that seen after laparotomy to repair tubes, Dr. Liselotte Mettler said at an international congress of the Society of Laparoendoscopic Surgeons.

The responses came from 195 women who were sent questionnaires in June 2003, after undergoing laparoscopic tubal surgery during the period between 2000 and 2002. The surgeries were performed by two ob.gyn. specialists and five residents at one institution to treat ectopic pregnancy, unilateral or bilateral tubal occlusions, or tubes needing alteration, she said.

Six of eight patients who underwent tubal end-to-end anastomoses became pregnant after the tubal reversals, for a 75% success rate, “which I think is pretty good,” said Dr. Mettler of the University of Schleswig-Holstein, Kiel, Germany.

The surgeries also included 64 salpingotomies, 74 salpingectomies, 25 salpingostomies, and 24 fimbrioplasties.

SAN DIEGO — Pregnancies in 51% of 155 women surveyed after laparoscopic tubal reconstructive surgery suggest a success rate comparable with that seen after laparotomy to repair tubes, Dr. Liselotte Mettler said at an international congress of the Society of Laparoendoscopic Surgeons.

The responses came from 195 women who were sent questionnaires in June 2003, after undergoing laparoscopic tubal surgery during the period between 2000 and 2002. The surgeries were performed by two ob.gyn. specialists and five residents at one institution to treat ectopic pregnancy, unilateral or bilateral tubal occlusions, or tubes needing alteration, she said.

Six of eight patients who underwent tubal end-to-end anastomoses became pregnant after the tubal reversals, for a 75% success rate, “which I think is pretty good,” said Dr. Mettler of the University of Schleswig-Holstein, Kiel, Germany.

The surgeries also included 64 salpingotomies, 74 salpingectomies, 25 salpingostomies, and 24 fimbrioplasties.

KAILUA KONA, HAWAII — Insignificant trauma to the mother may not be insignificant to the fetus, Dr. William G. Barsan said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Severe maternal injury is likely to lead to fetal loss in 40%–50% of cases, but severe maternal injuries are relatively rare. Minor injuries to the mother result from 88% of trauma in pregnancy; 60%–70% of fetal losses resulting from maternal trauma follow relatively minor maternal injuries, said Dr. Barsan, professor and chair of emergency medicine at the University of Michigan, Ann Arbor.

Placental abruption is the cause of fetal death in 50%–70% of losses after maternal trauma. “This is the one that may occur with relatively minor trauma” and can be hard to detect, he said.

In one study of nine fetal deaths after 25-mph motor vehicle crashes in which the mothers were not wearing seat belts, six of the women sustained only “insignificant” injures, such as bruising or abrasions, Dr. Barsan noted.

A separate study of 22 fetal deaths resulting from motor vehicle crashes found that six mothers sustained no injuries at all, and nine had bruised abdomens. Other maternal injuries included three ruptured uteri, two chest injuries, one extremity fracture, and one head injury with shock.

Perform electronic fetal monitoring for 4 hours on any pregnant woman with a viable fetus who sustains a significant impact to the torso from falling, crashing, or other causes, Dr. Barsan advised. In one study, all patients with placental abruption after trauma developed uterine contractions every 2–5 minutes at some point during a 4-hour monitoring period.

Many women will have uterine contractions after trauma, and most will not have placental abruption. At Dr. Barsan's institution, women with frequent uterine contractions after trauma receive an additional 24 hours of electronic fetal monitoring.

“This seems to be a protocol that works pretty well” to identify patients at risk of placental abruption, he said at the conference sponsored by Boston University.

Even if the patient says that she fell yesterday, or last night, do 4 hours of monitoring, he added. Traumas unrelated to the torso—such as hammering a finger—do not call for monitoring.

If there are no adverse outcomes within the first few days after trauma, pregnancy outcomes can be expected to be similar to cases without trauma, he said.

Besides placental abruption, maternal hypovolemic shock kills less than 5% of fetuses after maternal trauma; direct fetal injury causes less than 10% of deaths, and about 10% of fetuses die because the mother died after trauma.

No cause is recognized in more than 10% of fetal deaths after maternal trauma, he said.

The cause of placental abruption in motor vehicle accidents was demonstrated in crash testing using “pregnant” dummy-within-a-dummy models and computer modeling.

A frontal impact first throws the uterus forward against the abdominal wall, increasing anterior intrauterine pressure up to 550 mm/Hg. Then the torso gets thrown forward and the body flexes forward, crushing the uterus between the torso and the knees and causing a second increase in intrauterine pressure, which may become as great as 600 mm/Hg.

All this creates a high degree of negative pressure in the back of the uterus that can pull the placenta off the uterine wall, Dr. Barsan explained.

'[Placental abruption] is the one that may occur with relatively minor trauma' and can be hard to detect. DR. BARSAN

Fetal Loss From Maternal Trauma

U.S. deliveries per year 4 million

Pregnancies complicated by trauma 6%–7%

Fetal loss in pregnancies with trauma 1%–2%

Number of fetuses lost from trauma 2,600–5,200

Source: Dr. Barsan

KAILUA KONA, HAWAII — Insignificant trauma to the mother may not be insignificant to the fetus, Dr. William G. Barsan said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Severe maternal injury is likely to lead to fetal loss in 40%–50% of cases, but severe maternal injuries are relatively rare. Minor injuries to the mother result from 88% of trauma in pregnancy; 60%–70% of fetal losses resulting from maternal trauma follow relatively minor maternal injuries, said Dr. Barsan, professor and chair of emergency medicine at the University of Michigan, Ann Arbor.

Placental abruption is the cause of fetal death in 50%–70% of losses after maternal trauma. “This is the one that may occur with relatively minor trauma” and can be hard to detect, he said.

In one study of nine fetal deaths after 25-mph motor vehicle crashes in which the mothers were not wearing seat belts, six of the women sustained only “insignificant” injures, such as bruising or abrasions, Dr. Barsan noted.

A separate study of 22 fetal deaths resulting from motor vehicle crashes found that six mothers sustained no injuries at all, and nine had bruised abdomens. Other maternal injuries included three ruptured uteri, two chest injuries, one extremity fracture, and one head injury with shock.

Perform electronic fetal monitoring for 4 hours on any pregnant woman with a viable fetus who sustains a significant impact to the torso from falling, crashing, or other causes, Dr. Barsan advised. In one study, all patients with placental abruption after trauma developed uterine contractions every 2–5 minutes at some point during a 4-hour monitoring period.

Many women will have uterine contractions after trauma, and most will not have placental abruption. At Dr. Barsan's institution, women with frequent uterine contractions after trauma receive an additional 24 hours of electronic fetal monitoring.

“This seems to be a protocol that works pretty well” to identify patients at risk of placental abruption, he said at the conference sponsored by Boston University.

Even if the patient says that she fell yesterday, or last night, do 4 hours of monitoring, he added. Traumas unrelated to the torso—such as hammering a finger—do not call for monitoring.

If there are no adverse outcomes within the first few days after trauma, pregnancy outcomes can be expected to be similar to cases without trauma, he said.

Besides placental abruption, maternal hypovolemic shock kills less than 5% of fetuses after maternal trauma; direct fetal injury causes less than 10% of deaths, and about 10% of fetuses die because the mother died after trauma.

No cause is recognized in more than 10% of fetal deaths after maternal trauma, he said.

The cause of placental abruption in motor vehicle accidents was demonstrated in crash testing using “pregnant” dummy-within-a-dummy models and computer modeling.

A frontal impact first throws the uterus forward against the abdominal wall, increasing anterior intrauterine pressure up to 550 mm/Hg. Then the torso gets thrown forward and the body flexes forward, crushing the uterus between the torso and the knees and causing a second increase in intrauterine pressure, which may become as great as 600 mm/Hg.

All this creates a high degree of negative pressure in the back of the uterus that can pull the placenta off the uterine wall, Dr. Barsan explained.

'[Placental abruption] is the one that may occur with relatively minor trauma' and can be hard to detect. DR. BARSAN

Fetal Loss From Maternal Trauma

U.S. deliveries per year 4 million

Pregnancies complicated by trauma 6%–7%

Fetal loss in pregnancies with trauma 1%–2%

Number of fetuses lost from trauma 2,600–5,200

Source: Dr. Barsan

KAILUA KONA, HAWAII — Insignificant trauma to the mother may not be insignificant to the fetus, Dr. William G. Barsan said at a conference on obstetrics, gynecology, perinatal medicine, neonatology, and the law.

Severe maternal injury is likely to lead to fetal loss in 40%–50% of cases, but severe maternal injuries are relatively rare. Minor injuries to the mother result from 88% of trauma in pregnancy; 60%–70% of fetal losses resulting from maternal trauma follow relatively minor maternal injuries, said Dr. Barsan, professor and chair of emergency medicine at the University of Michigan, Ann Arbor.

Placental abruption is the cause of fetal death in 50%–70% of losses after maternal trauma. “This is the one that may occur with relatively minor trauma” and can be hard to detect, he said.

In one study of nine fetal deaths after 25-mph motor vehicle crashes in which the mothers were not wearing seat belts, six of the women sustained only “insignificant” injures, such as bruising or abrasions, Dr. Barsan noted.

A separate study of 22 fetal deaths resulting from motor vehicle crashes found that six mothers sustained no injuries at all, and nine had bruised abdomens. Other maternal injuries included three ruptured uteri, two chest injuries, one extremity fracture, and one head injury with shock.

Perform electronic fetal monitoring for 4 hours on any pregnant woman with a viable fetus who sustains a significant impact to the torso from falling, crashing, or other causes, Dr. Barsan advised. In one study, all patients with placental abruption after trauma developed uterine contractions every 2–5 minutes at some point during a 4-hour monitoring period.

Many women will have uterine contractions after trauma, and most will not have placental abruption. At Dr. Barsan's institution, women with frequent uterine contractions after trauma receive an additional 24 hours of electronic fetal monitoring.

“This seems to be a protocol that works pretty well” to identify patients at risk of placental abruption, he said at the conference sponsored by Boston University.

Even if the patient says that she fell yesterday, or last night, do 4 hours of monitoring, he added. Traumas unrelated to the torso—such as hammering a finger—do not call for monitoring.

If there are no adverse outcomes within the first few days after trauma, pregnancy outcomes can be expected to be similar to cases without trauma, he said.

Besides placental abruption, maternal hypovolemic shock kills less than 5% of fetuses after maternal trauma; direct fetal injury causes less than 10% of deaths, and about 10% of fetuses die because the mother died after trauma.

No cause is recognized in more than 10% of fetal deaths after maternal trauma, he said.

The cause of placental abruption in motor vehicle accidents was demonstrated in crash testing using “pregnant” dummy-within-a-dummy models and computer modeling.

A frontal impact first throws the uterus forward against the abdominal wall, increasing anterior intrauterine pressure up to 550 mm/Hg. Then the torso gets thrown forward and the body flexes forward, crushing the uterus between the torso and the knees and causing a second increase in intrauterine pressure, which may become as great as 600 mm/Hg.

All this creates a high degree of negative pressure in the back of the uterus that can pull the placenta off the uterine wall, Dr. Barsan explained.

'[Placental abruption] is the one that may occur with relatively minor trauma' and can be hard to detect. DR. BARSAN

Fetal Loss From Maternal Trauma

U.S. deliveries per year 4 million

Pregnancies complicated by trauma 6%–7%

Fetal loss in pregnancies with trauma 1%–2%

Number of fetuses lost from trauma 2,600–5,200

Source: Dr. Barsan