Bruce K. Dixon

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

Patients who have diabetes can take more active roles in their care and improve glycemic control by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of researchers who are examing the benefits of personal digital assistant (PDA) use with outpatients, with the goal of leveling the self-care playing field across socioeconomic groups.

However, their recently published pilot study showed although it is feasible to incorporate PDA use in diabetes self-care, it also poses challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Tex.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375-84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill. The system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

Nineteen participants dropped out of the study; 6 more did not return and/or could not be reached after several attempts.

The 18 participants who completed the PDA intervention had a mean drop of 18% in hemoglobin A1c (HbA_1c), from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. Further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript that has been accepted for online publication this May in Telemedicine and e-Health.

“The more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that other researchers have documented comparable reductions in blood glucose associated with PDAs or similar technology.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh. “[Most] of the patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit.”

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities in the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A & M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, the researchers found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led them to relax the rules on data entry. To make data entry easier, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs also curbs the widespread adoption of self-management technology, he said. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education” so patients depend on clinics, “and eventually they end up in the emergency room.”

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Researchers hope PDA use can extend to patients across all socioeconomic levels. Courtesy Dr. Samuel N. Forjuoh

Patients who have diabetes can take more active roles in their care and improve glycemic control by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of researchers who are examing the benefits of personal digital assistant (PDA) use with outpatients, with the goal of leveling the self-care playing field across socioeconomic groups.

However, their recently published pilot study showed although it is feasible to incorporate PDA use in diabetes self-care, it also poses challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Tex.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375-84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill. The system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

Nineteen participants dropped out of the study; 6 more did not return and/or could not be reached after several attempts.

The 18 participants who completed the PDA intervention had a mean drop of 18% in hemoglobin A1c (HbA_1c), from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. Further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript that has been accepted for online publication this May in Telemedicine and e-Health.

“The more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that other researchers have documented comparable reductions in blood glucose associated with PDAs or similar technology.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh. “[Most] of the patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit.”

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities in the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A & M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, the researchers found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led them to relax the rules on data entry. To make data entry easier, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs also curbs the widespread adoption of self-management technology, he said. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education” so patients depend on clinics, “and eventually they end up in the emergency room.”

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Researchers hope PDA use can extend to patients across all socioeconomic levels. Courtesy Dr. Samuel N. Forjuoh

Patients who have diabetes can take more active roles in their care and improve glycemic control by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of researchers who are examing the benefits of personal digital assistant (PDA) use with outpatients, with the goal of leveling the self-care playing field across socioeconomic groups.

However, their recently published pilot study showed although it is feasible to incorporate PDA use in diabetes self-care, it also poses challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Tex.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375-84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill. The system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

Nineteen participants dropped out of the study; 6 more did not return and/or could not be reached after several attempts.

The 18 participants who completed the PDA intervention had a mean drop of 18% in hemoglobin A1c (HbA_1c), from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. Further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript that has been accepted for online publication this May in Telemedicine and e-Health.

“The more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that other researchers have documented comparable reductions in blood glucose associated with PDAs or similar technology.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh. “[Most] of the patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit.”

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities in the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A & M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, the researchers found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led them to relax the rules on data entry. To make data entry easier, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs also curbs the widespread adoption of self-management technology, he said. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education” so patients depend on clinics, “and eventually they end up in the emergency room.”

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Researchers hope PDA use can extend to patients across all socioeconomic levels. Courtesy Dr. Samuel N. Forjuoh

CHICAGO — Body weight and injection technique should guide the choice of needle length when immunizing adolescents during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle—using both pinching and flattening of the injection site—in relation to the recipient's body weight,” Dr. Michael Koster said.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

For both the pinching technique and the muscle-flattening technique on adolescents weighing 88–155 pounds, a 1-inch needle is appropriate. For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

The investigation included 141 participants aged 11–15 years. Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds, said Dr. Koster, now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigators recorded the adolescents' height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms. These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology. As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds. “Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said, adding that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex. For example, both sizes of needles are recommended for those who weigh less than 132 pounds. The 1-inch needle is recommended for females who weigh 132–198 pounds and males who weigh 132–260 pounds. The AAP recommends an even longer (11/2-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 11/2-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14–24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 11/2-inch needle groups, subjects (females over 198 pounds and males over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule. HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 11/2-inch needle group were statistically significantly higher than in those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said, adding that there is heightened need for these data because several vaccines recently have been licensed and recommended for all adolescents in the United States.

'Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds.' DR. KOSTER

CHICAGO — Body weight and injection technique should guide the choice of needle length when immunizing adolescents during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle—using both pinching and flattening of the injection site—in relation to the recipient's body weight,” Dr. Michael Koster said.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

For both the pinching technique and the muscle-flattening technique on adolescents weighing 88–155 pounds, a 1-inch needle is appropriate. For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

The investigation included 141 participants aged 11–15 years. Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds, said Dr. Koster, now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigators recorded the adolescents' height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms. These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology. As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds. “Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said, adding that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex. For example, both sizes of needles are recommended for those who weigh less than 132 pounds. The 1-inch needle is recommended for females who weigh 132–198 pounds and males who weigh 132–260 pounds. The AAP recommends an even longer (11/2-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 11/2-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14–24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 11/2-inch needle groups, subjects (females over 198 pounds and males over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule. HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 11/2-inch needle group were statistically significantly higher than in those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said, adding that there is heightened need for these data because several vaccines recently have been licensed and recommended for all adolescents in the United States.

'Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds.' DR. KOSTER

CHICAGO — Body weight and injection technique should guide the choice of needle length when immunizing adolescents during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle—using both pinching and flattening of the injection site—in relation to the recipient's body weight,” Dr. Michael Koster said.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

For both the pinching technique and the muscle-flattening technique on adolescents weighing 88–155 pounds, a 1-inch needle is appropriate. For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

The investigation included 141 participants aged 11–15 years. Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds, said Dr. Koster, now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigators recorded the adolescents' height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms. These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology. As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds. “Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said, adding that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex. For example, both sizes of needles are recommended for those who weigh less than 132 pounds. The 1-inch needle is recommended for females who weigh 132–198 pounds and males who weigh 132–260 pounds. The AAP recommends an even longer (11/2-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 11/2-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14–24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 11/2-inch needle groups, subjects (females over 198 pounds and males over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule. HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 11/2-inch needle group were statistically significantly higher than in those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said, adding that there is heightened need for these data because several vaccines recently have been licensed and recommended for all adolescents in the United States.

'Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds.' DR. KOSTER

CHICAGO — The impaired social interaction and communication characteristic of autistic children is the result of abnormally functioning mirror neurons in the brain, judging from the findings of a novel imaging study.

A controlled study of 25 children revealed those with autism have increased gray matter in several areas of the parietal lobes, Manzar Ashtari, Ph.D., said at the annual meeting of the Radiological Society of North America.

“What we found was that the larger the brain matter, the more restrictive the child's interest and the more stereotypical his or her behavior, indicating the increased gray matter in autistic children is abnormal,” said Dr. Ashtari, senior neuroscientist at Children's Hospital of Philadelphia. “This suggests that the inability of autistic children to relate to people and life situations in an ordinary way may result from an abnormally functioning mirror neuron system,” she said.

Mirror neurons are brain cells that are active both when an individual is performing an action and experiencing an emotion or sensation, and when that individual witnesses the same actions, emotions, and sensations in others, Dr. Ashtari explained. “Mirror neurons were first discovered in the macaque monkey, and there is a similar system in the human brain,” she said, adding that the mirror neuron system is part of the motor system and plays an essential role in controlling our own actions. The “broken mirror” theory of autism, which was first proposed about a decade ago, argues that dysfunction of the mirror neuron system is a root cause of social disability in autism.

The study led by Dr. Ashtari was conducted at the Fay J. Lindner Center for Autism, North Shore-Long Island Jewish Health System, Bethpage, N.Y., and involved 13 boys diagnosed with high-functioning autism or Asper-ger syndrome who had IQs greater than 70, and 12 healthy controls. The subjects, average age 11 years, underwent diffusion tensor imaging (DTI), a technique that tracks the movement of water molecules in the brain.

Although DTI traditionally is used to study the brain's white matter and fiber content, Dr. Ashtari's team applied it to the assessment of gray matter by employing apparent diffusion coefficient based morphometry, which highlights brain regions with changes in gray matter volume.

In addition to the gray matter abnormalities linked to the mirror neuron system, the investigators reported that the amount of gray matter in the left parietal area correlated with higher IQs in the control group but not in the autistic children. While this finding was interesting, said Dr. Ashtari, the difference did not reach statistical significance. “However, this does suggest that the gray matter in children with autism is dysfunctional.”

Dr. Antonia Hamilton doubts the “broken mirror” theory. “I am skeptical of the mirror neuron-autism link, and the Ashtari study does nothing to change my mind,” she said in an interview. In her own study, Dr. Hamilton reported that children with autism do not suffer general imitation impairment or a global mirror neuron system deficit (Neuropsychologia 2007;45:1859–68).

“Mirror neurons are active any time you perform an action with your own hand. When you pick up a cup of coffee, or see another person picking up a cup of coffee, the same neurons are involved,” said Dr. Hamilton, a lecturer at the School of Psychology, University of Nottingham (England). “My experiment found that autistic children do fine when it comes to these practical, goal-oriented actions; however, they do not do well with social actions that involve imitation, such as smiling or waving at another person,” she explained.

Dr. Hamilton studied 25 children with an independent clinical diagnosis of autism or autism spectrum disorder (ASD). The group had a mean age of 8 years and a mean verbal mental age of just over 4 years and were compared with 29 controls. Children were tested in their ability to copy the experimenter's hand movement to a target location on a table top, using mirror imitation. The investigators found no evidence for differences in performance between the ASD group and the matched controls. Both showed the typical pattern of hand errors on contralateral trials. “We can conclude that typical and autistic children have the same tendency to imitate the goal of another person's action,” the scientists said, noting the concurrency of their results with previous studies.

In a second experiment, 23 children with ASD and 31 controls completed a grasp imitation and motor planning task. “Motor planning is known to rely on the frontoparietal circuit which makes up the mirror neuron system, so the [autistic mirror neuron dysfunction, or] AMND predicts poor performance in autism spectrum disorder, which was not found,” they wrote.

In another experiment, the children with autism showed no impairment in gesture recognition, and in fact performed better than did the matched controls. The authors concluded that their data are not compatible with the hypothesis of an action representation deficit or mirror neuron deficit in children with autism spectrum disorder.

“The broken-mirror-in-autism idea is a very appealing hypothesis which has received a lot of press in the last few years, despite the fact that there [is a scarcity of] hard data to support it,” Dr. Hamilton said in an interview.

“Also, none of the studies of imitation in autism—which claim to support the mirror neuron idea—have really shown that the problem is in the mirror neurons themselves, rather than some other social process which controls the mirror neurons,” she added.

Yellow areas highlight clusters of increased gray matter in the right and left parietal cortex as seen on DTI. Radiological Society of North America

CHICAGO — The impaired social interaction and communication characteristic of autistic children is the result of abnormally functioning mirror neurons in the brain, judging from the findings of a novel imaging study.

A controlled study of 25 children revealed those with autism have increased gray matter in several areas of the parietal lobes, Manzar Ashtari, Ph.D., said at the annual meeting of the Radiological Society of North America.

“What we found was that the larger the brain matter, the more restrictive the child's interest and the more stereotypical his or her behavior, indicating the increased gray matter in autistic children is abnormal,” said Dr. Ashtari, senior neuroscientist at Children's Hospital of Philadelphia. “This suggests that the inability of autistic children to relate to people and life situations in an ordinary way may result from an abnormally functioning mirror neuron system,” she said.

Mirror neurons are brain cells that are active both when an individual is performing an action and experiencing an emotion or sensation, and when that individual witnesses the same actions, emotions, and sensations in others, Dr. Ashtari explained. “Mirror neurons were first discovered in the macaque monkey, and there is a similar system in the human brain,” she said, adding that the mirror neuron system is part of the motor system and plays an essential role in controlling our own actions. The “broken mirror” theory of autism, which was first proposed about a decade ago, argues that dysfunction of the mirror neuron system is a root cause of social disability in autism.

The study led by Dr. Ashtari was conducted at the Fay J. Lindner Center for Autism, North Shore-Long Island Jewish Health System, Bethpage, N.Y., and involved 13 boys diagnosed with high-functioning autism or Asper-ger syndrome who had IQs greater than 70, and 12 healthy controls. The subjects, average age 11 years, underwent diffusion tensor imaging (DTI), a technique that tracks the movement of water molecules in the brain.

Although DTI traditionally is used to study the brain's white matter and fiber content, Dr. Ashtari's team applied it to the assessment of gray matter by employing apparent diffusion coefficient based morphometry, which highlights brain regions with changes in gray matter volume.

In addition to the gray matter abnormalities linked to the mirror neuron system, the investigators reported that the amount of gray matter in the left parietal area correlated with higher IQs in the control group but not in the autistic children. While this finding was interesting, said Dr. Ashtari, the difference did not reach statistical significance. “However, this does suggest that the gray matter in children with autism is dysfunctional.”

Dr. Antonia Hamilton doubts the “broken mirror” theory. “I am skeptical of the mirror neuron-autism link, and the Ashtari study does nothing to change my mind,” she said in an interview. In her own study, Dr. Hamilton reported that children with autism do not suffer general imitation impairment or a global mirror neuron system deficit (Neuropsychologia 2007;45:1859–68).

“Mirror neurons are active any time you perform an action with your own hand. When you pick up a cup of coffee, or see another person picking up a cup of coffee, the same neurons are involved,” said Dr. Hamilton, a lecturer at the School of Psychology, University of Nottingham (England). “My experiment found that autistic children do fine when it comes to these practical, goal-oriented actions; however, they do not do well with social actions that involve imitation, such as smiling or waving at another person,” she explained.

Dr. Hamilton studied 25 children with an independent clinical diagnosis of autism or autism spectrum disorder (ASD). The group had a mean age of 8 years and a mean verbal mental age of just over 4 years and were compared with 29 controls. Children were tested in their ability to copy the experimenter's hand movement to a target location on a table top, using mirror imitation. The investigators found no evidence for differences in performance between the ASD group and the matched controls. Both showed the typical pattern of hand errors on contralateral trials. “We can conclude that typical and autistic children have the same tendency to imitate the goal of another person's action,” the scientists said, noting the concurrency of their results with previous studies.

In a second experiment, 23 children with ASD and 31 controls completed a grasp imitation and motor planning task. “Motor planning is known to rely on the frontoparietal circuit which makes up the mirror neuron system, so the [autistic mirror neuron dysfunction, or] AMND predicts poor performance in autism spectrum disorder, which was not found,” they wrote.

In another experiment, the children with autism showed no impairment in gesture recognition, and in fact performed better than did the matched controls. The authors concluded that their data are not compatible with the hypothesis of an action representation deficit or mirror neuron deficit in children with autism spectrum disorder.

“The broken-mirror-in-autism idea is a very appealing hypothesis which has received a lot of press in the last few years, despite the fact that there [is a scarcity of] hard data to support it,” Dr. Hamilton said in an interview.

“Also, none of the studies of imitation in autism—which claim to support the mirror neuron idea—have really shown that the problem is in the mirror neurons themselves, rather than some other social process which controls the mirror neurons,” she added.

Yellow areas highlight clusters of increased gray matter in the right and left parietal cortex as seen on DTI. Radiological Society of North America

CHICAGO — The impaired social interaction and communication characteristic of autistic children is the result of abnormally functioning mirror neurons in the brain, judging from the findings of a novel imaging study.

A controlled study of 25 children revealed those with autism have increased gray matter in several areas of the parietal lobes, Manzar Ashtari, Ph.D., said at the annual meeting of the Radiological Society of North America.

“What we found was that the larger the brain matter, the more restrictive the child's interest and the more stereotypical his or her behavior, indicating the increased gray matter in autistic children is abnormal,” said Dr. Ashtari, senior neuroscientist at Children's Hospital of Philadelphia. “This suggests that the inability of autistic children to relate to people and life situations in an ordinary way may result from an abnormally functioning mirror neuron system,” she said.

Mirror neurons are brain cells that are active both when an individual is performing an action and experiencing an emotion or sensation, and when that individual witnesses the same actions, emotions, and sensations in others, Dr. Ashtari explained. “Mirror neurons were first discovered in the macaque monkey, and there is a similar system in the human brain,” she said, adding that the mirror neuron system is part of the motor system and plays an essential role in controlling our own actions. The “broken mirror” theory of autism, which was first proposed about a decade ago, argues that dysfunction of the mirror neuron system is a root cause of social disability in autism.

The study led by Dr. Ashtari was conducted at the Fay J. Lindner Center for Autism, North Shore-Long Island Jewish Health System, Bethpage, N.Y., and involved 13 boys diagnosed with high-functioning autism or Asper-ger syndrome who had IQs greater than 70, and 12 healthy controls. The subjects, average age 11 years, underwent diffusion tensor imaging (DTI), a technique that tracks the movement of water molecules in the brain.

Although DTI traditionally is used to study the brain's white matter and fiber content, Dr. Ashtari's team applied it to the assessment of gray matter by employing apparent diffusion coefficient based morphometry, which highlights brain regions with changes in gray matter volume.

In addition to the gray matter abnormalities linked to the mirror neuron system, the investigators reported that the amount of gray matter in the left parietal area correlated with higher IQs in the control group but not in the autistic children. While this finding was interesting, said Dr. Ashtari, the difference did not reach statistical significance. “However, this does suggest that the gray matter in children with autism is dysfunctional.”

Dr. Antonia Hamilton doubts the “broken mirror” theory. “I am skeptical of the mirror neuron-autism link, and the Ashtari study does nothing to change my mind,” she said in an interview. In her own study, Dr. Hamilton reported that children with autism do not suffer general imitation impairment or a global mirror neuron system deficit (Neuropsychologia 2007;45:1859–68).

“Mirror neurons are active any time you perform an action with your own hand. When you pick up a cup of coffee, or see another person picking up a cup of coffee, the same neurons are involved,” said Dr. Hamilton, a lecturer at the School of Psychology, University of Nottingham (England). “My experiment found that autistic children do fine when it comes to these practical, goal-oriented actions; however, they do not do well with social actions that involve imitation, such as smiling or waving at another person,” she explained.

Dr. Hamilton studied 25 children with an independent clinical diagnosis of autism or autism spectrum disorder (ASD). The group had a mean age of 8 years and a mean verbal mental age of just over 4 years and were compared with 29 controls. Children were tested in their ability to copy the experimenter's hand movement to a target location on a table top, using mirror imitation. The investigators found no evidence for differences in performance between the ASD group and the matched controls. Both showed the typical pattern of hand errors on contralateral trials. “We can conclude that typical and autistic children have the same tendency to imitate the goal of another person's action,” the scientists said, noting the concurrency of their results with previous studies.

In a second experiment, 23 children with ASD and 31 controls completed a grasp imitation and motor planning task. “Motor planning is known to rely on the frontoparietal circuit which makes up the mirror neuron system, so the [autistic mirror neuron dysfunction, or] AMND predicts poor performance in autism spectrum disorder, which was not found,” they wrote.

In another experiment, the children with autism showed no impairment in gesture recognition, and in fact performed better than did the matched controls. The authors concluded that their data are not compatible with the hypothesis of an action representation deficit or mirror neuron deficit in children with autism spectrum disorder.

“The broken-mirror-in-autism idea is a very appealing hypothesis which has received a lot of press in the last few years, despite the fact that there [is a scarcity of] hard data to support it,” Dr. Hamilton said in an interview.

“Also, none of the studies of imitation in autism—which claim to support the mirror neuron idea—have really shown that the problem is in the mirror neurons themselves, rather than some other social process which controls the mirror neurons,” she added.

Yellow areas highlight clusters of increased gray matter in the right and left parietal cortex as seen on DTI. Radiological Society of North America

Black box restrictions imposed by the Food and Drug Administration on the use of ultrasound contrast agents have caused consternation among cardiologists and radiologists who fear that the agency's decision will have a chilling effect upon the use and further development of these “microbubble” agents.

Efforts at getting the FDA to reconsider the label change, which was issued in October (CARDIOLOGY NEWS, November 2008, p. 20), may have borne fruit in December, when a delegation of four cardiologists met with Dr. Rafel D. Rieves, acting director of the FDA's Division of Medical Imaging and Hematology Products, and his staff in Silver Spring, Md. The cardiologists were Dr. Steven B. Feinstein of the Rush Medical College, Chicago; Dr. Jonathan H. Goldman of the University of California, San Francisco; Dr. Paul A. Grayburn of the Baylor University Medical Center, Dallas; and Dr. Michael L. Main of the Mid-America Heart Institute, Kansas City, Missouri.

The emissaries represented an international group of 160 cardiologists, radiologists, and other medical imaging professionals who had earlier signed a letter to Dr. Rieves asking that the FDA division convene a panel of cardiologists to assess fully the adverse events that have been attributed to the contrast agents and determine the most appropriate corrective actions.

The letter, dated Nov. 10, 2007, said the black box warning ignores the proven efficacy and established safety of perflutren gas microspheres for use as echocardiographic contrast agents, as well as the potential risks of alternative procedures and the likely confounding effect of pseudocomplications that may be pertinent to some of the deaths associated with use of the ultrasound contrast agents.

“Our presentation to the division of medical imaging focused on the critical role that ultrasound contrast agents play in the diagnosis and management of patients with acute coronary syndromes, decompensated heart failure, and respiratory failure,” Dr. Main said in an interview.

“These are patient groups [that] must now undergo more invasive alternative testing when their baseline echocardiographic imaging is inadequate. We were encouraged that the FDA seemed receptive to the basic premise, which was that the risk-benefit ratio of ultrasound contrast is so favorable that the new contraindications will result in more harm than good,” said Dr. Main, medical director of the echocardiography laboratory at the Mid America Heart Institute of St. Luke's Health System.

Dr. Main has received research support from and has a consultant relationship with, POINT Biomedical Corp., Acusphere Inc., and Bristol-Myers Squibb Medical Imaging Inc. Dr. Goldman is a POINT Biomedical shareholder and has a consultant relationship with Bristol-Myers Squibb Medical Imaging. Dr. Grayburn has received grant support from Acusphere, POINT Biomedical, Medtronic Inc., and Guidant Corp.

Two ultrasound contrast agents, Definity (Bristol-Meyers Squibb) and Optison (GE Healthcare), are approved for use to improve suboptimal echocardiograms. Both consist of injectable, perflutren-filled lipid microspheres. Optison is back on the market following a 2-year hiatus attributed to a manufacturing recall.

In issuing the warning, the FDA said it had received reports of serious cardiopulmonary reactions following contrast injection, including 10 deaths following the administration of Definity and 1 death following an Optison injection. Of those 11 deaths, 4 were caused by cardiac arrest and occurred during or within 30 minutes of infusion; the remaining 7 deaths occurred within 12 hours of administration.

In addition, about 190 nonfatal serious reactions were reported in the United States following administration of Definity and Optison.

The boxed warning states that “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes” after administration of Definity or Optison. Referring to contraindications described on the label, the warning requires that all patients be assessed for the presence of any condition that precludes administration of the contrast agent. In addition, patients are to be monitored during, and for 30 minutes following, contrast administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia. Resuscitation equipment and trained personnel should be readily available.

Additional pressure on the FDA has come from the 12,000-member American Society of Echocardiography (ASE). In late November, ASE President Thomas Ryan wrote a letter to Dr. Andrew C. von Eschenbach, the FDA Commissioner, requesting an opportunity to engage in a dialogue with the agency regarding its decision to issue the black box warning.

“The risk of an adverse event resulting from the administration of a contrast agent must be weighed against the value of a correct diagnosis,” said Dr. Ryan, who noted that he has no conflicts of interest related to the topic. “Because contrast agents improve accuracy and reduce the need for additional downstream testing, we believe their continued use in appropriate cases is justified and consistent with the mission of both the FDA and the ASE,” wrote Dr. Ryan, who is the John G. & Jeanne Bonnet McCoy Chair in Cardiovascular Medicine and the director of the Ohio State University Heart Center in Columbus.

A spokesman for the FDA said, “the letter has been received, and the agency is working on a response.” The agency had no further comment on the issue.

“The near-term result of this black box warning, in my opinion, will be a dramatic drop in the use of ultrasound contrast agents, and as a result, the quality of echocardiograms will go down until this scare wears off,” Dr. Peter S. Rahko said in an interview.

“The reaction of the FDA and the rules they imposed seem to be excessive,” said Dr. Rahko of the departments of medicine and public health and director of the adult echocardiography laboratory at the University of Wisconsin, Madison.

But Dr. Rahko does agree with the FDA's expressed concerns that an unknown proportion of patients may suffer allergic reactions to the microsphere contrast agents, which has occurred on a few occasions at Wisconsin.

When the black box warning was issued, the use of contrast-enhanced ultrasound ceased at the University of Wisconsin and other centers. The Wisconsin team developed a two-stage screening protocol for stable and critically ill patients (see box), said Dr. Rahko, who was one of the original investigators in the Definity trials but has no financial conflicts related to the topic.

Visualization of a left ventricular thrombus is clearer in an echocardiogram with contrast (right) than in a noncontrast image. IMAGES COURTESY DR. PETER S. RAHKO/UNIVERSITY OF WISCONSIN HOSPITAL

Adjusting to the Black Box Alert

After the FDA issued its warning on ultrasound contrast agents, Dr. Rahko and his colleagues at the University of Wisconsin halted their practice of automatically ordering contrast following a bad-quality echocardiogram.

Previously, “If the patient was appropriate, then the contrast could be administered in the intensive care unit with the assistance of nursing personnel and others taking care of the patient,” Dr. Rahko said.

The hospital now operates with a more costly and time-consuming two-tiered protocol that is tailored to stable and unstable patients undergoing echocardiography.

For an unstable hospitalized patient, the baseline sonogram is read by a cardiologist; if it's of poor quality and a redo with Definity seems appropriate, the cardiologist recommends that the study should be repeated with contrast. “The patient care team now becomes the responsible party ordering the contrast.”

The protocol for stable patients scheduled for echo in the inpatient or outpatient setting shifts responsibility for the final decision to the patient and includes screening for conditions that might contraindicate the use of the microspheres. “Our nurses—in the echo lab or at other sites—screen the patients using oxymetry to make sure that oxygen saturation levels are appropriate and that patients don't have significant hypoxia or lung disease,” Dr. Rahko explained.

Patients who are stable and cleared for a contrast injection are given an information sheet that explains the procedure, why it's being done, and the risks it poses. The patient then decides whether or not to proceed. And “we keep the patient under direct observation for 30 minutes, in case of an allergic reaction,” he said.

Black box restrictions imposed by the Food and Drug Administration on the use of ultrasound contrast agents have caused consternation among cardiologists and radiologists who fear that the agency's decision will have a chilling effect upon the use and further development of these “microbubble” agents.

Efforts at getting the FDA to reconsider the label change, which was issued in October (CARDIOLOGY NEWS, November 2008, p. 20), may have borne fruit in December, when a delegation of four cardiologists met with Dr. Rafel D. Rieves, acting director of the FDA's Division of Medical Imaging and Hematology Products, and his staff in Silver Spring, Md. The cardiologists were Dr. Steven B. Feinstein of the Rush Medical College, Chicago; Dr. Jonathan H. Goldman of the University of California, San Francisco; Dr. Paul A. Grayburn of the Baylor University Medical Center, Dallas; and Dr. Michael L. Main of the Mid-America Heart Institute, Kansas City, Missouri.

The emissaries represented an international group of 160 cardiologists, radiologists, and other medical imaging professionals who had earlier signed a letter to Dr. Rieves asking that the FDA division convene a panel of cardiologists to assess fully the adverse events that have been attributed to the contrast agents and determine the most appropriate corrective actions.

The letter, dated Nov. 10, 2007, said the black box warning ignores the proven efficacy and established safety of perflutren gas microspheres for use as echocardiographic contrast agents, as well as the potential risks of alternative procedures and the likely confounding effect of pseudocomplications that may be pertinent to some of the deaths associated with use of the ultrasound contrast agents.

“Our presentation to the division of medical imaging focused on the critical role that ultrasound contrast agents play in the diagnosis and management of patients with acute coronary syndromes, decompensated heart failure, and respiratory failure,” Dr. Main said in an interview.

“These are patient groups [that] must now undergo more invasive alternative testing when their baseline echocardiographic imaging is inadequate. We were encouraged that the FDA seemed receptive to the basic premise, which was that the risk-benefit ratio of ultrasound contrast is so favorable that the new contraindications will result in more harm than good,” said Dr. Main, medical director of the echocardiography laboratory at the Mid America Heart Institute of St. Luke's Health System.

Dr. Main has received research support from and has a consultant relationship with, POINT Biomedical Corp., Acusphere Inc., and Bristol-Myers Squibb Medical Imaging Inc. Dr. Goldman is a POINT Biomedical shareholder and has a consultant relationship with Bristol-Myers Squibb Medical Imaging. Dr. Grayburn has received grant support from Acusphere, POINT Biomedical, Medtronic Inc., and Guidant Corp.

Two ultrasound contrast agents, Definity (Bristol-Meyers Squibb) and Optison (GE Healthcare), are approved for use to improve suboptimal echocardiograms. Both consist of injectable, perflutren-filled lipid microspheres. Optison is back on the market following a 2-year hiatus attributed to a manufacturing recall.

In issuing the warning, the FDA said it had received reports of serious cardiopulmonary reactions following contrast injection, including 10 deaths following the administration of Definity and 1 death following an Optison injection. Of those 11 deaths, 4 were caused by cardiac arrest and occurred during or within 30 minutes of infusion; the remaining 7 deaths occurred within 12 hours of administration.

In addition, about 190 nonfatal serious reactions were reported in the United States following administration of Definity and Optison.

The boxed warning states that “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes” after administration of Definity or Optison. Referring to contraindications described on the label, the warning requires that all patients be assessed for the presence of any condition that precludes administration of the contrast agent. In addition, patients are to be monitored during, and for 30 minutes following, contrast administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia. Resuscitation equipment and trained personnel should be readily available.

Additional pressure on the FDA has come from the 12,000-member American Society of Echocardiography (ASE). In late November, ASE President Thomas Ryan wrote a letter to Dr. Andrew C. von Eschenbach, the FDA Commissioner, requesting an opportunity to engage in a dialogue with the agency regarding its decision to issue the black box warning.

“The risk of an adverse event resulting from the administration of a contrast agent must be weighed against the value of a correct diagnosis,” said Dr. Ryan, who noted that he has no conflicts of interest related to the topic. “Because contrast agents improve accuracy and reduce the need for additional downstream testing, we believe their continued use in appropriate cases is justified and consistent with the mission of both the FDA and the ASE,” wrote Dr. Ryan, who is the John G. & Jeanne Bonnet McCoy Chair in Cardiovascular Medicine and the director of the Ohio State University Heart Center in Columbus.

A spokesman for the FDA said, “the letter has been received, and the agency is working on a response.” The agency had no further comment on the issue.

“The near-term result of this black box warning, in my opinion, will be a dramatic drop in the use of ultrasound contrast agents, and as a result, the quality of echocardiograms will go down until this scare wears off,” Dr. Peter S. Rahko said in an interview.

“The reaction of the FDA and the rules they imposed seem to be excessive,” said Dr. Rahko of the departments of medicine and public health and director of the adult echocardiography laboratory at the University of Wisconsin, Madison.

But Dr. Rahko does agree with the FDA's expressed concerns that an unknown proportion of patients may suffer allergic reactions to the microsphere contrast agents, which has occurred on a few occasions at Wisconsin.

When the black box warning was issued, the use of contrast-enhanced ultrasound ceased at the University of Wisconsin and other centers. The Wisconsin team developed a two-stage screening protocol for stable and critically ill patients (see box), said Dr. Rahko, who was one of the original investigators in the Definity trials but has no financial conflicts related to the topic.

Visualization of a left ventricular thrombus is clearer in an echocardiogram with contrast (right) than in a noncontrast image. IMAGES COURTESY DR. PETER S. RAHKO/UNIVERSITY OF WISCONSIN HOSPITAL

Adjusting to the Black Box Alert

After the FDA issued its warning on ultrasound contrast agents, Dr. Rahko and his colleagues at the University of Wisconsin halted their practice of automatically ordering contrast following a bad-quality echocardiogram.

Previously, “If the patient was appropriate, then the contrast could be administered in the intensive care unit with the assistance of nursing personnel and others taking care of the patient,” Dr. Rahko said.

The hospital now operates with a more costly and time-consuming two-tiered protocol that is tailored to stable and unstable patients undergoing echocardiography.

For an unstable hospitalized patient, the baseline sonogram is read by a cardiologist; if it's of poor quality and a redo with Definity seems appropriate, the cardiologist recommends that the study should be repeated with contrast. “The patient care team now becomes the responsible party ordering the contrast.”

The protocol for stable patients scheduled for echo in the inpatient or outpatient setting shifts responsibility for the final decision to the patient and includes screening for conditions that might contraindicate the use of the microspheres. “Our nurses—in the echo lab or at other sites—screen the patients using oxymetry to make sure that oxygen saturation levels are appropriate and that patients don't have significant hypoxia or lung disease,” Dr. Rahko explained.

Patients who are stable and cleared for a contrast injection are given an information sheet that explains the procedure, why it's being done, and the risks it poses. The patient then decides whether or not to proceed. And “we keep the patient under direct observation for 30 minutes, in case of an allergic reaction,” he said.

Black box restrictions imposed by the Food and Drug Administration on the use of ultrasound contrast agents have caused consternation among cardiologists and radiologists who fear that the agency's decision will have a chilling effect upon the use and further development of these “microbubble” agents.

Efforts at getting the FDA to reconsider the label change, which was issued in October (CARDIOLOGY NEWS, November 2008, p. 20), may have borne fruit in December, when a delegation of four cardiologists met with Dr. Rafel D. Rieves, acting director of the FDA's Division of Medical Imaging and Hematology Products, and his staff in Silver Spring, Md. The cardiologists were Dr. Steven B. Feinstein of the Rush Medical College, Chicago; Dr. Jonathan H. Goldman of the University of California, San Francisco; Dr. Paul A. Grayburn of the Baylor University Medical Center, Dallas; and Dr. Michael L. Main of the Mid-America Heart Institute, Kansas City, Missouri.

The emissaries represented an international group of 160 cardiologists, radiologists, and other medical imaging professionals who had earlier signed a letter to Dr. Rieves asking that the FDA division convene a panel of cardiologists to assess fully the adverse events that have been attributed to the contrast agents and determine the most appropriate corrective actions.

The letter, dated Nov. 10, 2007, said the black box warning ignores the proven efficacy and established safety of perflutren gas microspheres for use as echocardiographic contrast agents, as well as the potential risks of alternative procedures and the likely confounding effect of pseudocomplications that may be pertinent to some of the deaths associated with use of the ultrasound contrast agents.

“Our presentation to the division of medical imaging focused on the critical role that ultrasound contrast agents play in the diagnosis and management of patients with acute coronary syndromes, decompensated heart failure, and respiratory failure,” Dr. Main said in an interview.

“These are patient groups [that] must now undergo more invasive alternative testing when their baseline echocardiographic imaging is inadequate. We were encouraged that the FDA seemed receptive to the basic premise, which was that the risk-benefit ratio of ultrasound contrast is so favorable that the new contraindications will result in more harm than good,” said Dr. Main, medical director of the echocardiography laboratory at the Mid America Heart Institute of St. Luke's Health System.

Dr. Main has received research support from and has a consultant relationship with, POINT Biomedical Corp., Acusphere Inc., and Bristol-Myers Squibb Medical Imaging Inc. Dr. Goldman is a POINT Biomedical shareholder and has a consultant relationship with Bristol-Myers Squibb Medical Imaging. Dr. Grayburn has received grant support from Acusphere, POINT Biomedical, Medtronic Inc., and Guidant Corp.

Two ultrasound contrast agents, Definity (Bristol-Meyers Squibb) and Optison (GE Healthcare), are approved for use to improve suboptimal echocardiograms. Both consist of injectable, perflutren-filled lipid microspheres. Optison is back on the market following a 2-year hiatus attributed to a manufacturing recall.

In issuing the warning, the FDA said it had received reports of serious cardiopulmonary reactions following contrast injection, including 10 deaths following the administration of Definity and 1 death following an Optison injection. Of those 11 deaths, 4 were caused by cardiac arrest and occurred during or within 30 minutes of infusion; the remaining 7 deaths occurred within 12 hours of administration.

In addition, about 190 nonfatal serious reactions were reported in the United States following administration of Definity and Optison.

The boxed warning states that “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes” after administration of Definity or Optison. Referring to contraindications described on the label, the warning requires that all patients be assessed for the presence of any condition that precludes administration of the contrast agent. In addition, patients are to be monitored during, and for 30 minutes following, contrast administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia. Resuscitation equipment and trained personnel should be readily available.

Additional pressure on the FDA has come from the 12,000-member American Society of Echocardiography (ASE). In late November, ASE President Thomas Ryan wrote a letter to Dr. Andrew C. von Eschenbach, the FDA Commissioner, requesting an opportunity to engage in a dialogue with the agency regarding its decision to issue the black box warning.

“The risk of an adverse event resulting from the administration of a contrast agent must be weighed against the value of a correct diagnosis,” said Dr. Ryan, who noted that he has no conflicts of interest related to the topic. “Because contrast agents improve accuracy and reduce the need for additional downstream testing, we believe their continued use in appropriate cases is justified and consistent with the mission of both the FDA and the ASE,” wrote Dr. Ryan, who is the John G. & Jeanne Bonnet McCoy Chair in Cardiovascular Medicine and the director of the Ohio State University Heart Center in Columbus.

A spokesman for the FDA said, “the letter has been received, and the agency is working on a response.” The agency had no further comment on the issue.

“The near-term result of this black box warning, in my opinion, will be a dramatic drop in the use of ultrasound contrast agents, and as a result, the quality of echocardiograms will go down until this scare wears off,” Dr. Peter S. Rahko said in an interview.

“The reaction of the FDA and the rules they imposed seem to be excessive,” said Dr. Rahko of the departments of medicine and public health and director of the adult echocardiography laboratory at the University of Wisconsin, Madison.

But Dr. Rahko does agree with the FDA's expressed concerns that an unknown proportion of patients may suffer allergic reactions to the microsphere contrast agents, which has occurred on a few occasions at Wisconsin.

When the black box warning was issued, the use of contrast-enhanced ultrasound ceased at the University of Wisconsin and other centers. The Wisconsin team developed a two-stage screening protocol for stable and critically ill patients (see box), said Dr. Rahko, who was one of the original investigators in the Definity trials but has no financial conflicts related to the topic.

Visualization of a left ventricular thrombus is clearer in an echocardiogram with contrast (right) than in a noncontrast image. IMAGES COURTESY DR. PETER S. RAHKO/UNIVERSITY OF WISCONSIN HOSPITAL

Adjusting to the Black Box Alert

After the FDA issued its warning on ultrasound contrast agents, Dr. Rahko and his colleagues at the University of Wisconsin halted their practice of automatically ordering contrast following a bad-quality echocardiogram.

Previously, “If the patient was appropriate, then the contrast could be administered in the intensive care unit with the assistance of nursing personnel and others taking care of the patient,” Dr. Rahko said.

The hospital now operates with a more costly and time-consuming two-tiered protocol that is tailored to stable and unstable patients undergoing echocardiography.

For an unstable hospitalized patient, the baseline sonogram is read by a cardiologist; if it's of poor quality and a redo with Definity seems appropriate, the cardiologist recommends that the study should be repeated with contrast. “The patient care team now becomes the responsible party ordering the contrast.”

The protocol for stable patients scheduled for echo in the inpatient or outpatient setting shifts responsibility for the final decision to the patient and includes screening for conditions that might contraindicate the use of the microspheres. “Our nurses—in the echo lab or at other sites—screen the patients using oxymetry to make sure that oxygen saturation levels are appropriate and that patients don't have significant hypoxia or lung disease,” Dr. Rahko explained.

Patients who are stable and cleared for a contrast injection are given an information sheet that explains the procedure, why it's being done, and the risks it poses. The patient then decides whether or not to proceed. And “we keep the patient under direct observation for 30 minutes, in case of an allergic reaction,” he said.

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.

CHICAGO – For adolescents, body weight and injection technique should guide the choice of needle length during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle–using both pinching and flattening of the injection site–in relation to the recipient's body weight,” said Dr. Michael Koster.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

With use of the pinching technique on adolescents weighing 88-155 pounds, a 1-inch needle is appropriate.

For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

With use of the muscle-flattening technique, the longer needle likewise is recommended when body weight is 88-155 pounds, and the 5/8-inch needle is appropriate for adolescents weighing less than 88 pounds, said Dr. Koster, who is now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigation included 141 participants. They were aged 11-15 years, with 87% of them aged 12-13 years.

Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds.

The investigators recorded the adolescents 'height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms.

These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology.

As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds.

“Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said.

He added that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex.

For example, both sizes of needles are recommended for girls and boys who weigh less than 132 pounds. The 1-inch needle is recommended for girls who weigh 132-198 pounds and boys who weigh 132-260 pounds.

The AAP recommends an even longer (1½-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 1½-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14-24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 1½-inch needle groups, subjects (girls over 198 pounds and boys over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule.

HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 1½-inch needle group were statistically higher to a significant degree than those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said.

He added that there is heightened need for these data because several vaccines–including Tdap (tetanus, diphtheria, and pertussis), meningococcal conjugate vaccine, and human papillomavirus vaccine–recently have been licensed and recommended for all adolescents in the United States.

Independent of technique, a 5/8-inch needle is appropriate to use on subjects less than 88 pounds. DR. KOSTER

CHICAGO – For adolescents, body weight and injection technique should guide the choice of needle length during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle–using both pinching and flattening of the injection site–in relation to the recipient's body weight,” said Dr. Michael Koster.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

With use of the pinching technique on adolescents weighing 88-155 pounds, a 1-inch needle is appropriate.

For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

With use of the muscle-flattening technique, the longer needle likewise is recommended when body weight is 88-155 pounds, and the 5/8-inch needle is appropriate for adolescents weighing less than 88 pounds, said Dr. Koster, who is now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigation included 141 participants. They were aged 11-15 years, with 87% of them aged 12-13 years.

Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds.

The investigators recorded the adolescents 'height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms.

These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology.

As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds.

“Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said.

He added that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex.

For example, both sizes of needles are recommended for girls and boys who weigh less than 132 pounds. The 1-inch needle is recommended for girls who weigh 132-198 pounds and boys who weigh 132-260 pounds.

The AAP recommends an even longer (1½-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 1½-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14-24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 1½-inch needle groups, subjects (girls over 198 pounds and boys over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule.

HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 1½-inch needle group were statistically higher to a significant degree than those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said.

He added that there is heightened need for these data because several vaccines–including Tdap (tetanus, diphtheria, and pertussis), meningococcal conjugate vaccine, and human papillomavirus vaccine–recently have been licensed and recommended for all adolescents in the United States.

Independent of technique, a 5/8-inch needle is appropriate to use on subjects less than 88 pounds. DR. KOSTER

CHICAGO – For adolescents, body weight and injection technique should guide the choice of needle length during immunizations, according to a poster study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“We looked at the performance of a 5/8-inch vs. a 1-inch needle–using both pinching and flattening of the injection site–in relation to the recipient's body weight,” said Dr. Michael Koster.

Using a needle that is too short may result in reduced immunogenicity and more adverse reactions to vaccines that are intended for intramuscular injection, whereas using a needle that is too long may strike bone and injure underlying neurovascular structures, Dr. Koster said in an interview.

With use of the pinching technique on adolescents weighing 88-155 pounds, a 1-inch needle is appropriate.

For those weighing less than 88 pounds, the shorter needle is best, said Dr. Koster, who conducted the study at Schneider Children's Hospital at North Shore in Manhasset, N.Y.

With use of the muscle-flattening technique, the longer needle likewise is recommended when body weight is 88-155 pounds, and the 5/8-inch needle is appropriate for adolescents weighing less than 88 pounds, said Dr. Koster, who is now a pediatric infectious disease fellow at Hasbro Children's Hospital in Providence, R.I.

The investigation included 141 participants. They were aged 11-15 years, with 87% of them aged 12-13 years.

Of the total, 28% of the participants weighed less than 88 pounds, while about 20% weighed more than 132 pounds.

The investigators recorded the adolescents 'height, weight, and arm circumference, and conducted upper-arm ultrasonography during both muscle pinching and skin flattening of the participants' nondominant arms.

These ultrasound measurements were duplicated by a second investigator and averaged for analysis.

“When injecting someone [while using] the pinching technique, you increase muscle and subcutaneous tissue layers, in which case you'll want a little longer needle. When flattening, typically using the forefinger and thumb, you can go up to [a weight of] about 50 kilos [110 pounds] and be safe in terms of getting the vaccine into the muscle without striking bone,” Dr. Koster said at the meeting, which was sponsored by the American Society for Microbiology.

As a general rule, with the pinching technique, a 1-inch needle is appropriate most of the time, and the shorter needle is appropriate only for patients who weigh less than 88 pounds.

With the flattening technique, the shorter length is appropriate only three-quarters of the time and only on patients weighing less than 110 pounds.

“Independent of technique, it would be appropriate to use a 5/8-inch needle on subjects less than 88 pounds,” he said.

Although females had a larger subcutaneous layer than did males of the same body weight, the difference did not result in the use of a different needle length, Dr. Koster said.

He added that body weight was a better predictor of required needle size than was arm circumference.

The American Academy of Pediatrics Red Book makes needle length recommendations for adolescents only in terms of body weight and sex.

For example, both sizes of needles are recommended for girls and boys who weigh less than 132 pounds. The 1-inch needle is recommended for girls who weigh 132-198 pounds and boys who weigh 132-260 pounds.

The AAP recommends an even longer (1½-inch) needle for females over 198 pounds and males over 260 pounds. Only 2 of the 141 subjects were that heavy, and the data on these two still are being analyzed.

Data from previous studies have suggested that obese adolescents who are immunized with 1-inch needles develop lower hepatitis B virus (HBV) vaccine titer levels, compared with those vaccinated with 1½-inch needles, and this seemed to have been borne out by findings in a limited study of 24 obese subjects aged 14-24 years (J. Adol. Health 2006;38:101).

In that study, after randomization to 1-inch and 1½-inch needle groups, subjects (girls over 198 pounds and boys over 265 pounds) were given an HBV vaccination using a 0-, 1-, and 4-month schedule.

HBV surface antibody was obtained 2 months after the third vaccination, and data showed that the final titer levels in the 1½-inch needle group were statistically higher to a significant degree than those in the 1-inch needle group.

“I hope that adjustments are made in the 2009 Red Book to reflect our finding that optimal needle length is influenced by intramuscular injection technique,” Dr. Koster said.

He added that there is heightened need for these data because several vaccines–including Tdap (tetanus, diphtheria, and pertussis), meningococcal conjugate vaccine, and human papillomavirus vaccine–recently have been licensed and recommended for all adolescents in the United States.

Independent of technique, a 5/8-inch needle is appropriate to use on subjects less than 88 pounds. DR. KOSTER

CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the Department of Internal Medicine and Infectious Diseases at the University Medical Center Utrecht in the Netherlands. “The timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film. So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of the patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of the patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiograph.

The cohort was then split into two equal groups: one with radiographic deterioration, and one without radiographic deterioration. The researchers compared the groups for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up.

“We saw no difference in any of those three parameters; so, we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said. “Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value.”

CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the Department of Internal Medicine and Infectious Diseases at the University Medical Center Utrecht in the Netherlands. “The timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film. So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of the patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of the patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiograph.

The cohort was then split into two equal groups: one with radiographic deterioration, and one without radiographic deterioration. The researchers compared the groups for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up.

“We saw no difference in any of those three parameters; so, we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said. “Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value.”

CHICAGO — Routine follow-up chest radiography may not be appropriate for patients with severe community-acquired pneumonia who clinically respond to initial antibiotic therapy, according to a multicenter study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

“In addition, chest radiographs obtained prior to hospital discharge, as advised by the American Thoracic Society in their 1993 guideline, seem to be unnecessary,” according to the authors, whose study was published shortly after the conference (Clin. Infect. Dis. 2007;45:983–91).

The use of follow-up chest x-rays of patients hospitalized for severe community-acquired pneumonia (CAP) has become common clinical practice, and the absence of guidelines leaves physicians reliant on recommendations derived from grade D evidence, said lead author and presenter Dr. Anke H.W. Bruns, a research fellow in the Department of Internal Medicine and Infectious Diseases at the University Medical Center Utrecht in the Netherlands. “The timing of those follow-up chest x-rays is difficult, in part because we know little about time-to-resolution of findings related to infection on a film. So, follow-up radiographs probably are ordered unnecessarily.”

To address this question, the researchers studied 288 patients enrolled between July 2000 and June 2003 from a prospective randomized trial on the cost-effectiveness of an early switch from parenteral to oral therapy for severe CAP.

The mean age of the patients was 70 years, and two-thirds were men. The mean pneumonia severity index at admission was 113, half the patients had comorbidities, and virtually all patients had been placed on a β-lactam (82%) or β-lactam-macrolide combination (14%).

Of the 140 cases with proven microbiological etiology, 44% had Streptococcus pneumoniae. Another 20% had atypical pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila. The remaining 36% were infected with unidentified pathogens, Dr. Bruns explained.

Patients were observed for a maximum of 28 days, and those who were still hospitalized on day 7 underwent follow-up chest radiography. After hospital discharge, all patients were asked to return to the outpatient clinic for clinical evaluation, blood chemistry analysis, and a chest radiograph at day 28. Scores for clinical improvement on day 7 and for clinical cure on day 28 were calculated for each patient. The cumulative dropout rate for radiographs was 21% at day 7 and 32% at day 28.

Radiologists reviewed the radiographs for the presence of pulmonary infiltrates, pleural fluid, atelectasis, pulmonary edema, and other findings. During follow-up, clearance of pulmonary infiltrates and resolution of chest radiograph abnormalities were established.

At 1 week, 33% of the patients had clearance of pulmonary infiltrates, and only 25% demonstrated resolution of chest radiograph abnormalities. At 1 month, 62% of the patients had clearance of infiltrates, and 53% had resolution of radiograph abnormalities. Resolution occurred more slowly in patients with proven S. pneumoniae pneumonia, the investigators reported.

Resolution of radiograph abnormalities lagged behind clinical improvement: At 1 week, clinical improvement was observed in more than half of patients, while resolution of chest radiograph abnormalities was seen in only one-quarter of patients. At 1 month, 78% of patients had clinical cures, and 53% showed resolution on radiograph.

The cohort was then split into two equal groups: one with radiographic deterioration, and one without radiographic deterioration. The researchers compared the groups for outcomes that included clinical cure at 1 month, mortality, and intervention during follow-up.

“We saw no difference in any of those three parameters; so, we can state that chest radiograph deterioration during follow-up was not associated with poor outcome,” Dr. Bruns said at the conference sponsored by the American Society for Microbiology.

Clinical parameters that independently predicted delayed resolution of chest radiograph findings at 1 week included dullness to percussion, multilobar disease, high respiratory rate, and high C-reactive protein (CRP) level. CRP level greater than 200 mg/L at admission also predicted delayed resolution of chest radiograph abnormalities at day 28.

The authors noted that the number of interventions in patients with deterioration of chest radiograph findings was comparable to the number of interventions in other patients, suggesting that physicians' decisions were not made solely on the basis of chest radiograph findings.

“Performing a chest x-ray to exclude a noninfectious cause of pneumonia within 4 weeks of initial diagnosis is not indicated, because at this point half of patients have radiographic findings that are a result of normal clinical course and do not necessarily indicate pathology,” Dr. Bruns said. “Chest radiograph deterioration during follow-up was not associated with poor outcome, so in our opinion, routine in-hospital follow-up radiographs in severe CAP have no additional value.”

CHICAGO – A brief computerized intervention conducted while violent youths are in the emergency department is feasible, well received, and effective at changing their attitudes toward aggression and alcohol, according to Dr. Rebecca Cunningham.

Data from the first 2 years of a 5-year study of adolescents aged 14-18 years entering an urban level I emergency department in Flint, Mich., were presented at the annual meeting of the Society for Academic Emergency Medicine.

“Violent injury is a leading cause of morbidity for urban teens and often is associated with alcohol misuse. Their visits to emergency departments may represent a teachable moment to address the problem of aggression and binge drinking,” said Dr. Cunningham of the department of emergency medicine at the University of Michigan, Ann Arbor.

Between September and November 2006, all youths aged 14-18 years entering the emergency department were asked to complete a computerized survey of risk behaviors. Teens who had attempted suicide, were victims of sexual assault, or had unstable vitals were excluded.

Teens with a history of violence in the preceding year or alcohol use were randomly assigned to one of three arms: a 30-minute interactive brief intervention delivered via a computer; a brief intervention by a research therapist; or a control group that received an informational brochure dealing with drinking and violence.

The brief intervention contained a review of goals, tailored feedback on risk behaviors, role playing for practicing risk reduction, and referrals, Dr. Cunningham explained.

Because of the low literacy rate among these patients, those using computers wore earphones through which everything was read to them. They simply listened and tapped out the responses, she said.

The program, which is tailored to individuals based on their screening results, also draws out the youths' own goals. “That helps the kids to think about what they would like their lives to be, to think about the consequences of their behavior, then to realize how these two might be discrepant,” Dr. Cunningham said.

Of the 648 youths screened during the recruitment phase of the study, 22% met risk criteria both for past alcohol use and aggressive behavior often involving the carrying of weapons, Dr. Cunningham said.

Of the total cohort, 48% were male and half were African American. So far, all but 5% have completed the intervention prior to discharge.

“All parts of the brief intervention can be stopped and started at any time without interfering with clinical care,” she said, adding that few teens needed assistance with the computer survey (6%) or intervention (2%).

After the intervention, patients showed significant changes in attitudes toward alcohol use and violence, including the carrying of weapons. In addition, the intervention was well received, with almost a third of the participants saying they “'liked it a lot,' “Dr. Cunningham said.

More work is needed to evaluate the effectiveness of the brief intervention on reducing violent behavior among urban teens in the ED, she concluded.

Patients also showed significant changes in attitudes toward alcohol use after the intervention. DR. CUNNINGHAM

CHICAGO – A brief computerized intervention conducted while violent youths are in the emergency department is feasible, well received, and effective at changing their attitudes toward aggression and alcohol, according to Dr. Rebecca Cunningham.

Data from the first 2 years of a 5-year study of adolescents aged 14-18 years entering an urban level I emergency department in Flint, Mich., were presented at the annual meeting of the Society for Academic Emergency Medicine.

“Violent injury is a leading cause of morbidity for urban teens and often is associated with alcohol misuse. Their visits to emergency departments may represent a teachable moment to address the problem of aggression and binge drinking,” said Dr. Cunningham of the department of emergency medicine at the University of Michigan, Ann Arbor.

Between September and November 2006, all youths aged 14-18 years entering the emergency department were asked to complete a computerized survey of risk behaviors. Teens who had attempted suicide, were victims of sexual assault, or had unstable vitals were excluded.

Teens with a history of violence in the preceding year or alcohol use were randomly assigned to one of three arms: a 30-minute interactive brief intervention delivered via a computer; a brief intervention by a research therapist; or a control group that received an informational brochure dealing with drinking and violence.

The brief intervention contained a review of goals, tailored feedback on risk behaviors, role playing for practicing risk reduction, and referrals, Dr. Cunningham explained.

Because of the low literacy rate among these patients, those using computers wore earphones through which everything was read to them. They simply listened and tapped out the responses, she said.

The program, which is tailored to individuals based on their screening results, also draws out the youths' own goals. “That helps the kids to think about what they would like their lives to be, to think about the consequences of their behavior, then to realize how these two might be discrepant,” Dr. Cunningham said.

Of the 648 youths screened during the recruitment phase of the study, 22% met risk criteria both for past alcohol use and aggressive behavior often involving the carrying of weapons, Dr. Cunningham said.

Of the total cohort, 48% were male and half were African American. So far, all but 5% have completed the intervention prior to discharge.

“All parts of the brief intervention can be stopped and started at any time without interfering with clinical care,” she said, adding that few teens needed assistance with the computer survey (6%) or intervention (2%).

After the intervention, patients showed significant changes in attitudes toward alcohol use and violence, including the carrying of weapons. In addition, the intervention was well received, with almost a third of the participants saying they “'liked it a lot,' “Dr. Cunningham said.

More work is needed to evaluate the effectiveness of the brief intervention on reducing violent behavior among urban teens in the ED, she concluded.

Patients also showed significant changes in attitudes toward alcohol use after the intervention. DR. CUNNINGHAM

CHICAGO – A brief computerized intervention conducted while violent youths are in the emergency department is feasible, well received, and effective at changing their attitudes toward aggression and alcohol, according to Dr. Rebecca Cunningham.

Data from the first 2 years of a 5-year study of adolescents aged 14-18 years entering an urban level I emergency department in Flint, Mich., were presented at the annual meeting of the Society for Academic Emergency Medicine.

“Violent injury is a leading cause of morbidity for urban teens and often is associated with alcohol misuse. Their visits to emergency departments may represent a teachable moment to address the problem of aggression and binge drinking,” said Dr. Cunningham of the department of emergency medicine at the University of Michigan, Ann Arbor.

Between September and November 2006, all youths aged 14-18 years entering the emergency department were asked to complete a computerized survey of risk behaviors. Teens who had attempted suicide, were victims of sexual assault, or had unstable vitals were excluded.

Teens with a history of violence in the preceding year or alcohol use were randomly assigned to one of three arms: a 30-minute interactive brief intervention delivered via a computer; a brief intervention by a research therapist; or a control group that received an informational brochure dealing with drinking and violence.

The brief intervention contained a review of goals, tailored feedback on risk behaviors, role playing for practicing risk reduction, and referrals, Dr. Cunningham explained.

Because of the low literacy rate among these patients, those using computers wore earphones through which everything was read to them. They simply listened and tapped out the responses, she said.

The program, which is tailored to individuals based on their screening results, also draws out the youths' own goals. “That helps the kids to think about what they would like their lives to be, to think about the consequences of their behavior, then to realize how these two might be discrepant,” Dr. Cunningham said.

Of the 648 youths screened during the recruitment phase of the study, 22% met risk criteria both for past alcohol use and aggressive behavior often involving the carrying of weapons, Dr. Cunningham said.

Of the total cohort, 48% were male and half were African American. So far, all but 5% have completed the intervention prior to discharge.

“All parts of the brief intervention can be stopped and started at any time without interfering with clinical care,” she said, adding that few teens needed assistance with the computer survey (6%) or intervention (2%).

After the intervention, patients showed significant changes in attitudes toward alcohol use and violence, including the carrying of weapons. In addition, the intervention was well received, with almost a third of the participants saying they “'liked it a lot,' “Dr. Cunningham said.

More work is needed to evaluate the effectiveness of the brief intervention on reducing violent behavior among urban teens in the ED, she concluded.

Patients also showed significant changes in attitudes toward alcohol use after the intervention. DR. CUNNINGHAM

CHICAGO — Atrophic dermatofibrosarcoma protuberans is an underrecognized variant that must be treated with wide local excision, Dr. Shari Clarke said at the annual meeting of the American Society for Dermatologic Surgery.

Although both wide local excision and Mohs micrographic surgery are considered treatments of choice, the latter quickly is becoming the favored method because of its lower rate of recurrence, she said.

In presenting three cases of the atrophic variant of dermatofibrosarcoma protuberans (DFSP), she explained that these lesions are slow-growing, locally aggressive fibrohistiocytic tumors that rarely metastasize but have a marked tendency toward local recurrence.

"Clinically, DFSP presents as indurated violaceous plaques which later develop nodules, and they're most commonly located on the trunk," explained Dr. Clarke of the department of dermatology at the Milton S. Hershey Medical Center, Pennsylvania State University, Hershey.

Histologically, DFSPs are characterized by monomorphous spindle cells in a storiform pattern that infiltrate between adipocytes. Later, the tumor can involve the upper dermis, deeper subcutaneous fat, or striated muscle, which correlates with the development of nodules and, as "we've demonstrated in our cases, the CD34 staining is very useful in distinguishing DFSPs from other fibrohistiocytic tumors," Dr. Clarke explained.

A total of five distinct early clinical variants of DFSP have been described in the literature, including confluent nodules forming sclerotic plaques, keloidlike sclerotic plaques, tumor, angiomalike, and atrophic DFSP. As exemplified in three cases described by Dr. Clarke, atrophic DFSP may or may not develop nodules in the later stages. In the first two cases, wide excision was used because the procedures were performed by a plastic surgeon.

The third case, involving the crural fold, was performed by a Mohs surgeon.

The first patient, a 43-year-old woman with a 13-year history of asymptomatic nodules that began as an atrophic plaque on the back of her neck, was clinically diagnosed as having multiple neurofibromas. She presented for a second opinion as the nodules continued to enlarge.

A punch biopsy showed monomorphous spindle cells in a fibrous stroma infiltrating the septa between the adipose. CD34 stains were positive and she was given a diagnosis of DFSP, but since her original clinical exam showed atrophic plaque, the diagnosis was changed to atrophic DFSP, Dr. Clarke explained.

A wide excision with 2-cm margins was performed, producing a gross examination specimen measuring 20 by 15 cm. Intraoperative frozen sections with CD34 showed clear 2-cm margins and the wound was reconstructed with a transverse rectus abdominal muscle cutaneous flap utilizing the inferior epigastric artery and vein for blood supply.

The second patient was a 14-year-old girl who presented with a 7-year history of an enlarging, asymptomatic plaque on her right thigh. She was clinically diagnosed as having a keloid and treated without improvement. Surveillance was stopped for a number of years because the patient thought it was "just a scar," Dr. Clarke said, but the nodules continued to enlarge.

On examination, there was an atrophic plaque with scattered nodules that was found on biopsy to be a DFSP.

As with the first patient, the diagnosis was changed to atrophic DFSP.

"She had an excision with 2-cm margins, and the excised specimen was about 30 by 15 cm. Resection was performed down to the quadriceps complex with the 2-cm margins and intraoperative frozen sections showed clear margins," Dr. Clarke said. Reconstruction consisted of a split thickness skin graft from the uninvolved leg.

The third patient was a 40-year-old woman with a 4-by-2.5 cm violaceous atrophic plaque of the right crural fold, said Dr. Clarke, explaining that the patient initially was biopsied and misdiagnosed as having a dermatofibroma.

A repeat biopsy and tumor appearance confirmed atrophic DFSP, which was cleared in two stages using Mohs surgery. The final defect measured 11 by 6 cm. The reconstruction used an advancement flap. Histology showed spindle cells, and a CD34 stain was grossly positive. There has been no evidence of recurrence in the intervening 8 years, said Dr. Clarke, who had no relevant conflicts to disclose.

"Atrophic DFSP, otherwise known as DFSP nonprotuberans or morpheaform DFSP, has been reported infrequently in the dermatologic literature, and like typical DFSP, the atrophic variant has an insidious and aggressive local growth pattern, a similar age of onset, and predominant truncal location," she said, noting that there appears to be a slight female predominance.

Although the atrophic variety is clinically distinct, the treatment and histology are the same as they are for typical DFSP. Adjuvant treatment with imatinib looks promising for very difficult cases.

"Exciting advances in the molecular genetics behind DFSPs have recently been elucidated and have important implications for treatment," she explained, adding that 90% of DFSPs overexpress platelet-derived growth factor β.

"This is important because imatinib mesylate [Gleevec] currently approved for treating chronic myeloid leukemia, acts as a selective tyrosine kinase inhibitor of the platelet-derived growth factor receptor β and has been used successfully in isolated case reports for the presurgical treatment of locally advanced DFSPs and inoperable recurrent or metastatic disease," she said.

Dr. Clarke suggested using 400 mg of imatinib mesylate, the dose used for gastrointestinal stromal tumors, either daily or twice daily. "The side effects are typically mild, although severe edema and liver toxicity have been reported in the elderly," she said.

A patient with DFSPis shown before undergoing wide local excision (left) and 3-months post excision (right). Photos courtesy Rogerio Neves, M.D., Ph.D.

CHICAGO — Atrophic dermatofibrosarcoma protuberans is an underrecognized variant that must be treated with wide local excision, Dr. Shari Clarke said at the annual meeting of the American Society for Dermatologic Surgery.

Although both wide local excision and Mohs micrographic surgery are considered treatments of choice, the latter quickly is becoming the favored method because of its lower rate of recurrence, she said.

In presenting three cases of the atrophic variant of dermatofibrosarcoma protuberans (DFSP), she explained that these lesions are slow-growing, locally aggressive fibrohistiocytic tumors that rarely metastasize but have a marked tendency toward local recurrence.

"Clinically, DFSP presents as indurated violaceous plaques which later develop nodules, and they're most commonly located on the trunk," explained Dr. Clarke of the department of dermatology at the Milton S. Hershey Medical Center, Pennsylvania State University, Hershey.

Histologically, DFSPs are characterized by monomorphous spindle cells in a storiform pattern that infiltrate between adipocytes. Later, the tumor can involve the upper dermis, deeper subcutaneous fat, or striated muscle, which correlates with the development of nodules and, as "we've demonstrated in our cases, the CD34 staining is very useful in distinguishing DFSPs from other fibrohistiocytic tumors," Dr. Clarke explained.

A total of five distinct early clinical variants of DFSP have been described in the literature, including confluent nodules forming sclerotic plaques, keloidlike sclerotic plaques, tumor, angiomalike, and atrophic DFSP. As exemplified in three cases described by Dr. Clarke, atrophic DFSP may or may not develop nodules in the later stages. In the first two cases, wide excision was used because the procedures were performed by a plastic surgeon.

The third case, involving the crural fold, was performed by a Mohs surgeon.

The first patient, a 43-year-old woman with a 13-year history of asymptomatic nodules that began as an atrophic plaque on the back of her neck, was clinically diagnosed as having multiple neurofibromas. She presented for a second opinion as the nodules continued to enlarge.

A punch biopsy showed monomorphous spindle cells in a fibrous stroma infiltrating the septa between the adipose. CD34 stains were positive and she was given a diagnosis of DFSP, but since her original clinical exam showed atrophic plaque, the diagnosis was changed to atrophic DFSP, Dr. Clarke explained.

A wide excision with 2-cm margins was performed, producing a gross examination specimen measuring 20 by 15 cm. Intraoperative frozen sections with CD34 showed clear 2-cm margins and the wound was reconstructed with a transverse rectus abdominal muscle cutaneous flap utilizing the inferior epigastric artery and vein for blood supply.

The second patient was a 14-year-old girl who presented with a 7-year history of an enlarging, asymptomatic plaque on her right thigh. She was clinically diagnosed as having a keloid and treated without improvement. Surveillance was stopped for a number of years because the patient thought it was "just a scar," Dr. Clarke said, but the nodules continued to enlarge.

On examination, there was an atrophic plaque with scattered nodules that was found on biopsy to be a DFSP.

As with the first patient, the diagnosis was changed to atrophic DFSP.

"She had an excision with 2-cm margins, and the excised specimen was about 30 by 15 cm. Resection was performed down to the quadriceps complex with the 2-cm margins and intraoperative frozen sections showed clear margins," Dr. Clarke said. Reconstruction consisted of a split thickness skin graft from the uninvolved leg.

The third patient was a 40-year-old woman with a 4-by-2.5 cm violaceous atrophic plaque of the right crural fold, said Dr. Clarke, explaining that the patient initially was biopsied and misdiagnosed as having a dermatofibroma.

A repeat biopsy and tumor appearance confirmed atrophic DFSP, which was cleared in two stages using Mohs surgery. The final defect measured 11 by 6 cm. The reconstruction used an advancement flap. Histology showed spindle cells, and a CD34 stain was grossly positive. There has been no evidence of recurrence in the intervening 8 years, said Dr. Clarke, who had no relevant conflicts to disclose.

"Atrophic DFSP, otherwise known as DFSP nonprotuberans or morpheaform DFSP, has been reported infrequently in the dermatologic literature, and like typical DFSP, the atrophic variant has an insidious and aggressive local growth pattern, a similar age of onset, and predominant truncal location," she said, noting that there appears to be a slight female predominance.

Although the atrophic variety is clinically distinct, the treatment and histology are the same as they are for typical DFSP. Adjuvant treatment with imatinib looks promising for very difficult cases.

"Exciting advances in the molecular genetics behind DFSPs have recently been elucidated and have important implications for treatment," she explained, adding that 90% of DFSPs overexpress platelet-derived growth factor β.

"This is important because imatinib mesylate [Gleevec] currently approved for treating chronic myeloid leukemia, acts as a selective tyrosine kinase inhibitor of the platelet-derived growth factor receptor β and has been used successfully in isolated case reports for the presurgical treatment of locally advanced DFSPs and inoperable recurrent or metastatic disease," she said.

Dr. Clarke suggested using 400 mg of imatinib mesylate, the dose used for gastrointestinal stromal tumors, either daily or twice daily. "The side effects are typically mild, although severe edema and liver toxicity have been reported in the elderly," she said.

A patient with DFSPis shown before undergoing wide local excision (left) and 3-months post excision (right). Photos courtesy Rogerio Neves, M.D., Ph.D.

CHICAGO — Atrophic dermatofibrosarcoma protuberans is an underrecognized variant that must be treated with wide local excision, Dr. Shari Clarke said at the annual meeting of the American Society for Dermatologic Surgery.

Although both wide local excision and Mohs micrographic surgery are considered treatments of choice, the latter quickly is becoming the favored method because of its lower rate of recurrence, she said.

In presenting three cases of the atrophic variant of dermatofibrosarcoma protuberans (DFSP), she explained that these lesions are slow-growing, locally aggressive fibrohistiocytic tumors that rarely metastasize but have a marked tendency toward local recurrence.

"Clinically, DFSP presents as indurated violaceous plaques which later develop nodules, and they're most commonly located on the trunk," explained Dr. Clarke of the department of dermatology at the Milton S. Hershey Medical Center, Pennsylvania State University, Hershey.

Histologically, DFSPs are characterized by monomorphous spindle cells in a storiform pattern that infiltrate between adipocytes. Later, the tumor can involve the upper dermis, deeper subcutaneous fat, or striated muscle, which correlates with the development of nodules and, as "we've demonstrated in our cases, the CD34 staining is very useful in distinguishing DFSPs from other fibrohistiocytic tumors," Dr. Clarke explained.

A total of five distinct early clinical variants of DFSP have been described in the literature, including confluent nodules forming sclerotic plaques, keloidlike sclerotic plaques, tumor, angiomalike, and atrophic DFSP. As exemplified in three cases described by Dr. Clarke, atrophic DFSP may or may not develop nodules in the later stages. In the first two cases, wide excision was used because the procedures were performed by a plastic surgeon.

The third case, involving the crural fold, was performed by a Mohs surgeon.

The first patient, a 43-year-old woman with a 13-year history of asymptomatic nodules that began as an atrophic plaque on the back of her neck, was clinically diagnosed as having multiple neurofibromas. She presented for a second opinion as the nodules continued to enlarge.

A punch biopsy showed monomorphous spindle cells in a fibrous stroma infiltrating the septa between the adipose. CD34 stains were positive and she was given a diagnosis of DFSP, but since her original clinical exam showed atrophic plaque, the diagnosis was changed to atrophic DFSP, Dr. Clarke explained.

A wide excision with 2-cm margins was performed, producing a gross examination specimen measuring 20 by 15 cm. Intraoperative frozen sections with CD34 showed clear 2-cm margins and the wound was reconstructed with a transverse rectus abdominal muscle cutaneous flap utilizing the inferior epigastric artery and vein for blood supply.

The second patient was a 14-year-old girl who presented with a 7-year history of an enlarging, asymptomatic plaque on her right thigh. She was clinically diagnosed as having a keloid and treated without improvement. Surveillance was stopped for a number of years because the patient thought it was "just a scar," Dr. Clarke said, but the nodules continued to enlarge.

On examination, there was an atrophic plaque with scattered nodules that was found on biopsy to be a DFSP.

As with the first patient, the diagnosis was changed to atrophic DFSP.

"She had an excision with 2-cm margins, and the excised specimen was about 30 by 15 cm. Resection was performed down to the quadriceps complex with the 2-cm margins and intraoperative frozen sections showed clear margins," Dr. Clarke said. Reconstruction consisted of a split thickness skin graft from the uninvolved leg.

The third patient was a 40-year-old woman with a 4-by-2.5 cm violaceous atrophic plaque of the right crural fold, said Dr. Clarke, explaining that the patient initially was biopsied and misdiagnosed as having a dermatofibroma.

A repeat biopsy and tumor appearance confirmed atrophic DFSP, which was cleared in two stages using Mohs surgery. The final defect measured 11 by 6 cm. The reconstruction used an advancement flap. Histology showed spindle cells, and a CD34 stain was grossly positive. There has been no evidence of recurrence in the intervening 8 years, said Dr. Clarke, who had no relevant conflicts to disclose.

"Atrophic DFSP, otherwise known as DFSP nonprotuberans or morpheaform DFSP, has been reported infrequently in the dermatologic literature, and like typical DFSP, the atrophic variant has an insidious and aggressive local growth pattern, a similar age of onset, and predominant truncal location," she said, noting that there appears to be a slight female predominance.

Although the atrophic variety is clinically distinct, the treatment and histology are the same as they are for typical DFSP. Adjuvant treatment with imatinib looks promising for very difficult cases.

"Exciting advances in the molecular genetics behind DFSPs have recently been elucidated and have important implications for treatment," she explained, adding that 90% of DFSPs overexpress platelet-derived growth factor β.

"This is important because imatinib mesylate [Gleevec] currently approved for treating chronic myeloid leukemia, acts as a selective tyrosine kinase inhibitor of the platelet-derived growth factor receptor β and has been used successfully in isolated case reports for the presurgical treatment of locally advanced DFSPs and inoperable recurrent or metastatic disease," she said.

Dr. Clarke suggested using 400 mg of imatinib mesylate, the dose used for gastrointestinal stromal tumors, either daily or twice daily. "The side effects are typically mild, although severe edema and liver toxicity have been reported in the elderly," she said.

A patient with DFSPis shown before undergoing wide local excision (left) and 3-months post excision (right). Photos courtesy Rogerio Neves, M.D., Ph.D.