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Vacuum-Assisted Wound Therapy Uses Expanded
CHICAGO The indications for negative-pressure wound therapy are expanding to include infected wounds and complicated wounds with exposed bone, tendon, or even orthopedic hardware, Dr. Anton Sidawy said.
"While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies," he said at a symposium on vascular surgery sponsored by Northwestern University.
"It is not," Dr. Sidawy cautioned, "going to substitute for a good blood supply to the wound area and appropriate local wound therapy."
Negative-pressure wound therapy, also known as vacuum-assisted closure (VAC) therapy, was developed roughly two decades ago, and involves the application of subatmospheric pressure to a wound through a pump attached to a foam sponge with an adhesive dressing. VAC is thought to accelerate wound contraction, increase local blood flow, and promote wound drainage and edema resolution.
Its widespread success in the diabetic population with microcirculatory pathology also suggests that the microdeformations of the wound surface caused by the negative pressure act on a cellular level to stimulate cell proliferation, angiogenesis, and granulation tissue formation, said Dr. Sidawy, chief of surgical services, Washington VA Medical Center, and professor of surgery at Georgetown and George Washington University Medical Centers, Washington.
Infected wounds typically do not do as well with VAC therapy, but progress has been made with recent studies demonstrating decreased bacterial burden after VAC therapy. Management of infected wounds has been aided by the use of VAC devices that allow for the instillation of fluids so contaminated wounds can be continuously irrigated with antibiotic fluids and by silver-impregnated dressings (GranuFoam Silver Dressing, KCI Inc., San Antonio, Texas) that have antimicrobial effects (Ann. Plast. Surg. 2007;59:5862).
Physicians in the Iraqi theater have turned to VAC to manage contaminated soft-tissue injuries caused by the blast effect of high-energy missiles. Dr. Sidawy cited a retrospective pilot study of 88 high-energy, contaminated soft-tissue injuries in 77 patients in which all wounds treated with VAC were closed definitively before discharge, with no wound complications (J. Trauma 2006;61:120711).
Large, complex circumferential soft tissue defects or burns can be managed with VAC to facilitate the coverage of exposed vessels and stimulate the growth of granulation tissue, Dr. Charles Fox of the Walter Reed Army Medical Center in Washington said in an interview. At times, maintaining a seal on a VAC can be challenging, particularly with external fixation or wounds of the hands and feet.
"An impervious stockinette sealed at either end with a Coban [compression wrap] may be substituted for the large OpSites [dressings] that do not adhere to a very wet cavitary wound," Dr. Fox said. "This strategy has been used for some complicated wounds in the Iraqi theater."
By reducing tissue edema, and thereby reducing the circumference of the extremity and the surface area of the wound, VAC therapy has also revolutionized how physicians treat wounds with exposed bone, tendon, or orthopedic hardware. Such complicated wounds, particularly on the lower third of the leg, traditionally required microvascular free-tissue transfer for coverage of the defect. Now, both small and large defects can be treated with VAC, although larger surface wounds still need free-tissue transfer, Dr. Sidawy said.
In a landmark study, VAC therapy was used to obtain successful coverage without complication in 71 of 75 open wounds of the lower extremity with exposed bone, tendon, or hardware. Of these wounds, 52 were below the knee and orthopedic hardware was exposed in 12 (Plast. Reconstr. Surg. 2001;108:118491).
'While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies.' DR. SIDAWY
CHICAGO The indications for negative-pressure wound therapy are expanding to include infected wounds and complicated wounds with exposed bone, tendon, or even orthopedic hardware, Dr. Anton Sidawy said.
"While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies," he said at a symposium on vascular surgery sponsored by Northwestern University.
"It is not," Dr. Sidawy cautioned, "going to substitute for a good blood supply to the wound area and appropriate local wound therapy."
Negative-pressure wound therapy, also known as vacuum-assisted closure (VAC) therapy, was developed roughly two decades ago, and involves the application of subatmospheric pressure to a wound through a pump attached to a foam sponge with an adhesive dressing. VAC is thought to accelerate wound contraction, increase local blood flow, and promote wound drainage and edema resolution.
Its widespread success in the diabetic population with microcirculatory pathology also suggests that the microdeformations of the wound surface caused by the negative pressure act on a cellular level to stimulate cell proliferation, angiogenesis, and granulation tissue formation, said Dr. Sidawy, chief of surgical services, Washington VA Medical Center, and professor of surgery at Georgetown and George Washington University Medical Centers, Washington.
Infected wounds typically do not do as well with VAC therapy, but progress has been made with recent studies demonstrating decreased bacterial burden after VAC therapy. Management of infected wounds has been aided by the use of VAC devices that allow for the instillation of fluids so contaminated wounds can be continuously irrigated with antibiotic fluids and by silver-impregnated dressings (GranuFoam Silver Dressing, KCI Inc., San Antonio, Texas) that have antimicrobial effects (Ann. Plast. Surg. 2007;59:5862).
Physicians in the Iraqi theater have turned to VAC to manage contaminated soft-tissue injuries caused by the blast effect of high-energy missiles. Dr. Sidawy cited a retrospective pilot study of 88 high-energy, contaminated soft-tissue injuries in 77 patients in which all wounds treated with VAC were closed definitively before discharge, with no wound complications (J. Trauma 2006;61:120711).
Large, complex circumferential soft tissue defects or burns can be managed with VAC to facilitate the coverage of exposed vessels and stimulate the growth of granulation tissue, Dr. Charles Fox of the Walter Reed Army Medical Center in Washington said in an interview. At times, maintaining a seal on a VAC can be challenging, particularly with external fixation or wounds of the hands and feet.
"An impervious stockinette sealed at either end with a Coban [compression wrap] may be substituted for the large OpSites [dressings] that do not adhere to a very wet cavitary wound," Dr. Fox said. "This strategy has been used for some complicated wounds in the Iraqi theater."
By reducing tissue edema, and thereby reducing the circumference of the extremity and the surface area of the wound, VAC therapy has also revolutionized how physicians treat wounds with exposed bone, tendon, or orthopedic hardware. Such complicated wounds, particularly on the lower third of the leg, traditionally required microvascular free-tissue transfer for coverage of the defect. Now, both small and large defects can be treated with VAC, although larger surface wounds still need free-tissue transfer, Dr. Sidawy said.
In a landmark study, VAC therapy was used to obtain successful coverage without complication in 71 of 75 open wounds of the lower extremity with exposed bone, tendon, or hardware. Of these wounds, 52 were below the knee and orthopedic hardware was exposed in 12 (Plast. Reconstr. Surg. 2001;108:118491).
'While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies.' DR. SIDAWY
CHICAGO The indications for negative-pressure wound therapy are expanding to include infected wounds and complicated wounds with exposed bone, tendon, or even orthopedic hardware, Dr. Anton Sidawy said.
"While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies," he said at a symposium on vascular surgery sponsored by Northwestern University.
"It is not," Dr. Sidawy cautioned, "going to substitute for a good blood supply to the wound area and appropriate local wound therapy."
Negative-pressure wound therapy, also known as vacuum-assisted closure (VAC) therapy, was developed roughly two decades ago, and involves the application of subatmospheric pressure to a wound through a pump attached to a foam sponge with an adhesive dressing. VAC is thought to accelerate wound contraction, increase local blood flow, and promote wound drainage and edema resolution.
Its widespread success in the diabetic population with microcirculatory pathology also suggests that the microdeformations of the wound surface caused by the negative pressure act on a cellular level to stimulate cell proliferation, angiogenesis, and granulation tissue formation, said Dr. Sidawy, chief of surgical services, Washington VA Medical Center, and professor of surgery at Georgetown and George Washington University Medical Centers, Washington.
Infected wounds typically do not do as well with VAC therapy, but progress has been made with recent studies demonstrating decreased bacterial burden after VAC therapy. Management of infected wounds has been aided by the use of VAC devices that allow for the instillation of fluids so contaminated wounds can be continuously irrigated with antibiotic fluids and by silver-impregnated dressings (GranuFoam Silver Dressing, KCI Inc., San Antonio, Texas) that have antimicrobial effects (Ann. Plast. Surg. 2007;59:5862).
Physicians in the Iraqi theater have turned to VAC to manage contaminated soft-tissue injuries caused by the blast effect of high-energy missiles. Dr. Sidawy cited a retrospective pilot study of 88 high-energy, contaminated soft-tissue injuries in 77 patients in which all wounds treated with VAC were closed definitively before discharge, with no wound complications (J. Trauma 2006;61:120711).
Large, complex circumferential soft tissue defects or burns can be managed with VAC to facilitate the coverage of exposed vessels and stimulate the growth of granulation tissue, Dr. Charles Fox of the Walter Reed Army Medical Center in Washington said in an interview. At times, maintaining a seal on a VAC can be challenging, particularly with external fixation or wounds of the hands and feet.
"An impervious stockinette sealed at either end with a Coban [compression wrap] may be substituted for the large OpSites [dressings] that do not adhere to a very wet cavitary wound," Dr. Fox said. "This strategy has been used for some complicated wounds in the Iraqi theater."
By reducing tissue edema, and thereby reducing the circumference of the extremity and the surface area of the wound, VAC therapy has also revolutionized how physicians treat wounds with exposed bone, tendon, or orthopedic hardware. Such complicated wounds, particularly on the lower third of the leg, traditionally required microvascular free-tissue transfer for coverage of the defect. Now, both small and large defects can be treated with VAC, although larger surface wounds still need free-tissue transfer, Dr. Sidawy said.
In a landmark study, VAC therapy was used to obtain successful coverage without complication in 71 of 75 open wounds of the lower extremity with exposed bone, tendon, or hardware. Of these wounds, 52 were below the knee and orthopedic hardware was exposed in 12 (Plast. Reconstr. Surg. 2001;108:118491).
'While it's not a cure-all, this device can be applied to a variety of wounds caused by many etiologies.' DR. SIDAWY
One-Course Antenatal Steroids Reaffirmed
DALLAS — Multiple courses of antenatal corticosteroids did not offer additional benefits to infants born to mothers at high risk of preterm delivery, and were associated with significantly smaller birth weight, birth length, and head circumference in a phase IV study of 1,858 women.
In 2000, the National Institutes of Health reaffirmed that a single course of antenatal corticosteroids should be considered for pregnant women between 24 and 34 weeks of gestation who are at risk for preterm delivery within 7 days, but concluded that the data available at that time were inadequate to argue for or against repeat or rescue courses of antenatal corticosteroids (ACS) for fetal maturation.
Treatment consists of two doses of 12 mg betamethasone given intramuscularly 24 hours apart or four doses of 6 mg betamethasone given intramuscularly 12 hours apart.
In their latest October 2007 Guidelines for Perinatal Care, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics advise that “repeated corticosteroid courses should not be used routinely because clinical trials show decreased brain size, decreased birth weight, and adrenal insufficiency in neonates exposed to repeated doses.”
In the current study, the primary composite outcome of mortality, severe respiratory distress syndrome, grade 3–4 intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, or necrotizing enterocolitis was similar between infants born to women who received multiple courses of corticosteroids (12.9%) and those born to women receiving placebo (12.5%) after an initial course of corticosteroids. The odds ratio was 1.04.
The rate of still births also was not significantly different between groups (43 vs. 40, OR 1.08), principal investigator Dr. Kellie Murphy reported on behalf of the Women in the Multiple Courses of Antenatal Corticosteroids or Preterm Birth Study (MACS) group at the annual meeting of the Society for Maternal-Fetal Medicine.
The interventional study was conducted at 80 centers and included women at 26–30 weeks of gestation who remained at high risk for early delivery 14 or more days after being given a single course of ACS. At randomization, 937 received two doses of 12 mg betamethasone intramuscularly 24 hours apart every 14 days until 33 6/7 weeks or delivery and 921 received placebo. The mean age in both groups was 29 years.
The 1,164 babies born to women in the repeat-corticosteroid group weighed less (2,216 g vs. 2,330 g), were shorter (44.5 cm vs. 45.4 cm), and had a smaller head circumference (31.1 cm vs. 31.7 cm), compared with the 1,140 babies born to mothers in the placebo group. All the differences were statistically significant.
“What was surprising to us is that even though the majority of patients, 70%, received only one or two [additional] doses, which one wouldn't think was a large amount, there was still a significant decrease in all those parameters,” said Dr. Murphy, a perinatologist at Mount Sinai Hospital, Toronto.
In all, 385 women received one additional course, 305 received two additional courses, and 247 received three to five courses.
An unplanned ad hoc analysis of infants born less than 7 days after study drug exposure and those born less at than 32 weeks' gestational age showed no significant difference in the primary composite outcome between groups.
Dr. Murphy acknowledged during the question-and-answer session that the MACS findings are quite different from those of the recent Australian ACTORDS study in which repeat doses of antenatal steroids reduced neonatal morbidity without changes in body size or survival free of neurosensory disability at 2 years (N. Engl. J. Med. 2007;357:1179–89).
That study used a single intramuscular injection of betamethasone 11.4 mg repeated weekly, not times two; the definition of respiratory distress syndrome was slightly different; and z-scores were used to determine outcomes—all of which may account for the different findings, she said.
The MACS group concluded that multiple courses of ACS should not be given every 14 days to women at increased risk of preterm birth after receiving an initial course. When asked by an audience member about the efficacy of a single course of ACS, Dr. Murphy replied, “I still believe that it is efficacious and beneficial.”
The study was funded by the Canadian Institutes of Health Research. Dr. Murphy disclosed no relevant financial conflicts of interest.
DALLAS — Multiple courses of antenatal corticosteroids did not offer additional benefits to infants born to mothers at high risk of preterm delivery, and were associated with significantly smaller birth weight, birth length, and head circumference in a phase IV study of 1,858 women.
In 2000, the National Institutes of Health reaffirmed that a single course of antenatal corticosteroids should be considered for pregnant women between 24 and 34 weeks of gestation who are at risk for preterm delivery within 7 days, but concluded that the data available at that time were inadequate to argue for or against repeat or rescue courses of antenatal corticosteroids (ACS) for fetal maturation.
Treatment consists of two doses of 12 mg betamethasone given intramuscularly 24 hours apart or four doses of 6 mg betamethasone given intramuscularly 12 hours apart.
In their latest October 2007 Guidelines for Perinatal Care, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics advise that “repeated corticosteroid courses should not be used routinely because clinical trials show decreased brain size, decreased birth weight, and adrenal insufficiency in neonates exposed to repeated doses.”
In the current study, the primary composite outcome of mortality, severe respiratory distress syndrome, grade 3–4 intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, or necrotizing enterocolitis was similar between infants born to women who received multiple courses of corticosteroids (12.9%) and those born to women receiving placebo (12.5%) after an initial course of corticosteroids. The odds ratio was 1.04.
The rate of still births also was not significantly different between groups (43 vs. 40, OR 1.08), principal investigator Dr. Kellie Murphy reported on behalf of the Women in the Multiple Courses of Antenatal Corticosteroids or Preterm Birth Study (MACS) group at the annual meeting of the Society for Maternal-Fetal Medicine.
The interventional study was conducted at 80 centers and included women at 26–30 weeks of gestation who remained at high risk for early delivery 14 or more days after being given a single course of ACS. At randomization, 937 received two doses of 12 mg betamethasone intramuscularly 24 hours apart every 14 days until 33 6/7 weeks or delivery and 921 received placebo. The mean age in both groups was 29 years.
The 1,164 babies born to women in the repeat-corticosteroid group weighed less (2,216 g vs. 2,330 g), were shorter (44.5 cm vs. 45.4 cm), and had a smaller head circumference (31.1 cm vs. 31.7 cm), compared with the 1,140 babies born to mothers in the placebo group. All the differences were statistically significant.
“What was surprising to us is that even though the majority of patients, 70%, received only one or two [additional] doses, which one wouldn't think was a large amount, there was still a significant decrease in all those parameters,” said Dr. Murphy, a perinatologist at Mount Sinai Hospital, Toronto.
In all, 385 women received one additional course, 305 received two additional courses, and 247 received three to five courses.
An unplanned ad hoc analysis of infants born less than 7 days after study drug exposure and those born less at than 32 weeks' gestational age showed no significant difference in the primary composite outcome between groups.
Dr. Murphy acknowledged during the question-and-answer session that the MACS findings are quite different from those of the recent Australian ACTORDS study in which repeat doses of antenatal steroids reduced neonatal morbidity without changes in body size or survival free of neurosensory disability at 2 years (N. Engl. J. Med. 2007;357:1179–89).
That study used a single intramuscular injection of betamethasone 11.4 mg repeated weekly, not times two; the definition of respiratory distress syndrome was slightly different; and z-scores were used to determine outcomes—all of which may account for the different findings, she said.
The MACS group concluded that multiple courses of ACS should not be given every 14 days to women at increased risk of preterm birth after receiving an initial course. When asked by an audience member about the efficacy of a single course of ACS, Dr. Murphy replied, “I still believe that it is efficacious and beneficial.”
The study was funded by the Canadian Institutes of Health Research. Dr. Murphy disclosed no relevant financial conflicts of interest.
DALLAS — Multiple courses of antenatal corticosteroids did not offer additional benefits to infants born to mothers at high risk of preterm delivery, and were associated with significantly smaller birth weight, birth length, and head circumference in a phase IV study of 1,858 women.
In 2000, the National Institutes of Health reaffirmed that a single course of antenatal corticosteroids should be considered for pregnant women between 24 and 34 weeks of gestation who are at risk for preterm delivery within 7 days, but concluded that the data available at that time were inadequate to argue for or against repeat or rescue courses of antenatal corticosteroids (ACS) for fetal maturation.
Treatment consists of two doses of 12 mg betamethasone given intramuscularly 24 hours apart or four doses of 6 mg betamethasone given intramuscularly 12 hours apart.
In their latest October 2007 Guidelines for Perinatal Care, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics advise that “repeated corticosteroid courses should not be used routinely because clinical trials show decreased brain size, decreased birth weight, and adrenal insufficiency in neonates exposed to repeated doses.”
In the current study, the primary composite outcome of mortality, severe respiratory distress syndrome, grade 3–4 intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, or necrotizing enterocolitis was similar between infants born to women who received multiple courses of corticosteroids (12.9%) and those born to women receiving placebo (12.5%) after an initial course of corticosteroids. The odds ratio was 1.04.
The rate of still births also was not significantly different between groups (43 vs. 40, OR 1.08), principal investigator Dr. Kellie Murphy reported on behalf of the Women in the Multiple Courses of Antenatal Corticosteroids or Preterm Birth Study (MACS) group at the annual meeting of the Society for Maternal-Fetal Medicine.
The interventional study was conducted at 80 centers and included women at 26–30 weeks of gestation who remained at high risk for early delivery 14 or more days after being given a single course of ACS. At randomization, 937 received two doses of 12 mg betamethasone intramuscularly 24 hours apart every 14 days until 33 6/7 weeks or delivery and 921 received placebo. The mean age in both groups was 29 years.
The 1,164 babies born to women in the repeat-corticosteroid group weighed less (2,216 g vs. 2,330 g), were shorter (44.5 cm vs. 45.4 cm), and had a smaller head circumference (31.1 cm vs. 31.7 cm), compared with the 1,140 babies born to mothers in the placebo group. All the differences were statistically significant.
“What was surprising to us is that even though the majority of patients, 70%, received only one or two [additional] doses, which one wouldn't think was a large amount, there was still a significant decrease in all those parameters,” said Dr. Murphy, a perinatologist at Mount Sinai Hospital, Toronto.
In all, 385 women received one additional course, 305 received two additional courses, and 247 received three to five courses.
An unplanned ad hoc analysis of infants born less than 7 days after study drug exposure and those born less at than 32 weeks' gestational age showed no significant difference in the primary composite outcome between groups.
Dr. Murphy acknowledged during the question-and-answer session that the MACS findings are quite different from those of the recent Australian ACTORDS study in which repeat doses of antenatal steroids reduced neonatal morbidity without changes in body size or survival free of neurosensory disability at 2 years (N. Engl. J. Med. 2007;357:1179–89).
That study used a single intramuscular injection of betamethasone 11.4 mg repeated weekly, not times two; the definition of respiratory distress syndrome was slightly different; and z-scores were used to determine outcomes—all of which may account for the different findings, she said.
The MACS group concluded that multiple courses of ACS should not be given every 14 days to women at increased risk of preterm birth after receiving an initial course. When asked by an audience member about the efficacy of a single course of ACS, Dr. Murphy replied, “I still believe that it is efficacious and beneficial.”
The study was funded by the Canadian Institutes of Health Research. Dr. Murphy disclosed no relevant financial conflicts of interest.
Buccal Matches Vaginal Misoprostol in Efficacy
DALLAS — Buccal misoprostol was as effective as vaginal for cervical ripening, but was associated with a significantly higher incidence of tachysystole in a prospective randomized trial of 738 women.
Although tachysystole was increased, maternal and neonatal complications were comparable between groups, Dr. Zoi Russell said at the annual meeting of the Society for Maternal-Fetal Medicine.
The efficacy of misoprostol (Cytotec) for cervical ripening or labor induction has been confirmed in more than 100 randomized trials, but physicians are seeking the optimal route and dose of administration for the synthetic prostaglandin E1 analogue.
Vaginal routes have the advantage of more sustained activity and greater bioavailability, while oral and sublingual routes have more rapid onset and a lower rate of gastrointestinal side effects, said Dr. Russell of the University of South Florida, Tampa.
In the current study, women at a gestational age of more than 26 weeks with a medical indication for labor induction and an unripe cervix were randomized to initial doses of 100 mcg buccal misoprostol administered between the cheek and gum or 25 mcg misoprostol administered intravaginally, and increased to 200 mcg and 50 mcg after two doses. Doses were given every 3–6 hours in both groups, until a Bishop score of at least 7, labor, intervention, or a total of six misoprostol doses.
In both groups, the median age was 25 years, the initial Bishop score was 2, and the Bishop score at induction was 8.
In all, 364 women were randomized to the vaginal group and 374 to the buccal group. However, 44 in each group were excluded for protocol violations, leaving 320 vaginal patients and 330 buccal patients available for analysis.
The buccal group appeared to deliver faster than the vaginal group when all routes of delivery were included (19.8 vs. 22.5 hours), but the difference did not persist when cesarean deliveries were excluded, Dr. Russell said.
The study's primary outcome of median interval from first dose to vaginal delivery was not significantly different between the buccal (19 hours) and vaginal (21 hours) groups.
There were no significant differences between groups in cesarean rates (111 vs. 103) or cesarean deliveries performed for reasons of nonreassuring fetal surveillance (61 vs. 54).
Buccal misoprostol was significantly associated with higher rates of intervention for nonreassuring fetal surveillance (36 vs. 20) and tachysystole (46 vs. 26), defined as three to six contractions of 1–2 minutes for two consecutive 10-minute periods. However, buccal administration was also significantly associated with less need for oxytocin augmentation (237 vs. 259), said Dr. Russell, who reported receiving no financial support for the study and disclosed no relevant conflicts of interest.
An earlier Cochrane meta-analysis of three small trials with a total of 502 women reported that the buccal route was associated with a trend to fewer cesarean sections than the vaginal route, but concluded that sublingual or buccal misoprostol should not enter clinical use until its safety and optimal dosage have been established by larger trials (Cochrane Database Syst. Rev. 2004;CD004221 [doi: 10.1002/14651858.CD004221.pub2]).
When asked if the current data are enough to support clinical use of buccal misoprostol, Dr. Russell said in an interview that the study was designed as an efficacy study, and as such, showed that “buccal can be at least as effective as vaginal misoprostol in ripening the cervix and induction of labor in the third trimester.
“Although the maternal and neonatal outcomes were similar between the two groups, our study would be underpowered to detect any significant differences in rare but serious adverse outcomes,” she said. “That is a question that can only be answered by a much larger study—a safety study.”
DALLAS — Buccal misoprostol was as effective as vaginal for cervical ripening, but was associated with a significantly higher incidence of tachysystole in a prospective randomized trial of 738 women.
Although tachysystole was increased, maternal and neonatal complications were comparable between groups, Dr. Zoi Russell said at the annual meeting of the Society for Maternal-Fetal Medicine.
The efficacy of misoprostol (Cytotec) for cervical ripening or labor induction has been confirmed in more than 100 randomized trials, but physicians are seeking the optimal route and dose of administration for the synthetic prostaglandin E1 analogue.
Vaginal routes have the advantage of more sustained activity and greater bioavailability, while oral and sublingual routes have more rapid onset and a lower rate of gastrointestinal side effects, said Dr. Russell of the University of South Florida, Tampa.
In the current study, women at a gestational age of more than 26 weeks with a medical indication for labor induction and an unripe cervix were randomized to initial doses of 100 mcg buccal misoprostol administered between the cheek and gum or 25 mcg misoprostol administered intravaginally, and increased to 200 mcg and 50 mcg after two doses. Doses were given every 3–6 hours in both groups, until a Bishop score of at least 7, labor, intervention, or a total of six misoprostol doses.
In both groups, the median age was 25 years, the initial Bishop score was 2, and the Bishop score at induction was 8.
In all, 364 women were randomized to the vaginal group and 374 to the buccal group. However, 44 in each group were excluded for protocol violations, leaving 320 vaginal patients and 330 buccal patients available for analysis.
The buccal group appeared to deliver faster than the vaginal group when all routes of delivery were included (19.8 vs. 22.5 hours), but the difference did not persist when cesarean deliveries were excluded, Dr. Russell said.
The study's primary outcome of median interval from first dose to vaginal delivery was not significantly different between the buccal (19 hours) and vaginal (21 hours) groups.
There were no significant differences between groups in cesarean rates (111 vs. 103) or cesarean deliveries performed for reasons of nonreassuring fetal surveillance (61 vs. 54).
Buccal misoprostol was significantly associated with higher rates of intervention for nonreassuring fetal surveillance (36 vs. 20) and tachysystole (46 vs. 26), defined as three to six contractions of 1–2 minutes for two consecutive 10-minute periods. However, buccal administration was also significantly associated with less need for oxytocin augmentation (237 vs. 259), said Dr. Russell, who reported receiving no financial support for the study and disclosed no relevant conflicts of interest.
An earlier Cochrane meta-analysis of three small trials with a total of 502 women reported that the buccal route was associated with a trend to fewer cesarean sections than the vaginal route, but concluded that sublingual or buccal misoprostol should not enter clinical use until its safety and optimal dosage have been established by larger trials (Cochrane Database Syst. Rev. 2004;CD004221 [doi: 10.1002/14651858.CD004221.pub2]).
When asked if the current data are enough to support clinical use of buccal misoprostol, Dr. Russell said in an interview that the study was designed as an efficacy study, and as such, showed that “buccal can be at least as effective as vaginal misoprostol in ripening the cervix and induction of labor in the third trimester.
“Although the maternal and neonatal outcomes were similar between the two groups, our study would be underpowered to detect any significant differences in rare but serious adverse outcomes,” she said. “That is a question that can only be answered by a much larger study—a safety study.”
DALLAS — Buccal misoprostol was as effective as vaginal for cervical ripening, but was associated with a significantly higher incidence of tachysystole in a prospective randomized trial of 738 women.
Although tachysystole was increased, maternal and neonatal complications were comparable between groups, Dr. Zoi Russell said at the annual meeting of the Society for Maternal-Fetal Medicine.
The efficacy of misoprostol (Cytotec) for cervical ripening or labor induction has been confirmed in more than 100 randomized trials, but physicians are seeking the optimal route and dose of administration for the synthetic prostaglandin E1 analogue.
Vaginal routes have the advantage of more sustained activity and greater bioavailability, while oral and sublingual routes have more rapid onset and a lower rate of gastrointestinal side effects, said Dr. Russell of the University of South Florida, Tampa.
In the current study, women at a gestational age of more than 26 weeks with a medical indication for labor induction and an unripe cervix were randomized to initial doses of 100 mcg buccal misoprostol administered between the cheek and gum or 25 mcg misoprostol administered intravaginally, and increased to 200 mcg and 50 mcg after two doses. Doses were given every 3–6 hours in both groups, until a Bishop score of at least 7, labor, intervention, or a total of six misoprostol doses.
In both groups, the median age was 25 years, the initial Bishop score was 2, and the Bishop score at induction was 8.
In all, 364 women were randomized to the vaginal group and 374 to the buccal group. However, 44 in each group were excluded for protocol violations, leaving 320 vaginal patients and 330 buccal patients available for analysis.
The buccal group appeared to deliver faster than the vaginal group when all routes of delivery were included (19.8 vs. 22.5 hours), but the difference did not persist when cesarean deliveries were excluded, Dr. Russell said.
The study's primary outcome of median interval from first dose to vaginal delivery was not significantly different between the buccal (19 hours) and vaginal (21 hours) groups.
There were no significant differences between groups in cesarean rates (111 vs. 103) or cesarean deliveries performed for reasons of nonreassuring fetal surveillance (61 vs. 54).
Buccal misoprostol was significantly associated with higher rates of intervention for nonreassuring fetal surveillance (36 vs. 20) and tachysystole (46 vs. 26), defined as three to six contractions of 1–2 minutes for two consecutive 10-minute periods. However, buccal administration was also significantly associated with less need for oxytocin augmentation (237 vs. 259), said Dr. Russell, who reported receiving no financial support for the study and disclosed no relevant conflicts of interest.
An earlier Cochrane meta-analysis of three small trials with a total of 502 women reported that the buccal route was associated with a trend to fewer cesarean sections than the vaginal route, but concluded that sublingual or buccal misoprostol should not enter clinical use until its safety and optimal dosage have been established by larger trials (Cochrane Database Syst. Rev. 2004;CD004221 [doi: 10.1002/14651858.CD004221.pub2]).
When asked if the current data are enough to support clinical use of buccal misoprostol, Dr. Russell said in an interview that the study was designed as an efficacy study, and as such, showed that “buccal can be at least as effective as vaginal misoprostol in ripening the cervix and induction of labor in the third trimester.
“Although the maternal and neonatal outcomes were similar between the two groups, our study would be underpowered to detect any significant differences in rare but serious adverse outcomes,” she said. “That is a question that can only be answered by a much larger study—a safety study.”
CV Risk Rises With Early-Preeclampsia History
DALLAS — Early cardiovascular risk-factor screening is warranted in women with a history of early-onset preeclampsia, according to results of a study in 617 women.
Significantly more women with a history of early-onset preeclampsia exhibited at least one major cardiovascular risk factor, as defined by the American Heart Association, when screened 6 months after delivery, and compared with healthy controls (89% vs. 71%).
The percentages of women exhibiting at least two and at least three cardiovascular risk factors were also significantly higher in the preeclampsia group, Dr. Bas Van Rijn said at the annual meeting of the Society for Maternal-Fetal Medicine.
Among women in the preeclampsia group 51% had two or more cardiovascular risk factors vs. 26% in the control group, and 19% had three or more risk factors vs. 6% in the control group.
“We advise using global risk estimations, such as the Framingham chart, to identify women that require lifestyle intervention programs aimed at primary prevention of cardiovascular disease,” said Dr. Van Rijn of the division of perinatology and gynecology, University Medical Center Utrecht (the Netherlands).
The study included 243 women (mean age 30.5 years) admitted from 1995 to 2005 for early-onset preeclampsia and delivery before 34 weeks and a population-based control group of 374 healthy, nonpregnant women (mean 28.3 years). Women with chronic hypertension (greater than 140/90 mm Hg) were excluded. Outcomes were adjusted for age.
When compared with matched controls, women in the preeclampsia group had significantly higher rates of obesity (body mass index 26.1 vs. 24.3 kg/m
HDL-cholesterol levels were significantly lower among cases versus controls (55 vs. 61 mg/dL).
No significant differences were found for rates of diabetes mellitus and smoking.
In all, 15.2% of women with a history of preeclampsia met the criteria for metabolic syndrome, as formulated by the AHA and World Health Organization versus only 4.3% of controls (odds ratio 3.6).
The estimated 10-year risk of first cardiovascular disease events, as calculated by the Framingham CHD risk prediction scores, remained less than 10% for all of the women. This places the women in the AHA low-risk range, which is a 1%–3% absolute risk of developing a major cardiovascular event in the coming years, he said.
However, this is a bit deceptive, mainly because of the young age of the women, Dr. Van Rijn added.
For example, if one adds 10 years to the Framingham risk score (mean age 40 years), the risk category for the preeclampsia group would be 5%–10%, which is comparable to a woman who has experienced a myocardial infarction.
“Women with a history of early-onset preeclampsia exhibit many risk factors, but their relatively young age is masking their absolute cardiovascular risk,” said Dr. Van Rijn, who disclosed no financial conflicts of interest.
The study was sponsored by the Netherlands Organization for Scientific Research.
DALLAS — Early cardiovascular risk-factor screening is warranted in women with a history of early-onset preeclampsia, according to results of a study in 617 women.
Significantly more women with a history of early-onset preeclampsia exhibited at least one major cardiovascular risk factor, as defined by the American Heart Association, when screened 6 months after delivery, and compared with healthy controls (89% vs. 71%).
The percentages of women exhibiting at least two and at least three cardiovascular risk factors were also significantly higher in the preeclampsia group, Dr. Bas Van Rijn said at the annual meeting of the Society for Maternal-Fetal Medicine.
Among women in the preeclampsia group 51% had two or more cardiovascular risk factors vs. 26% in the control group, and 19% had three or more risk factors vs. 6% in the control group.
“We advise using global risk estimations, such as the Framingham chart, to identify women that require lifestyle intervention programs aimed at primary prevention of cardiovascular disease,” said Dr. Van Rijn of the division of perinatology and gynecology, University Medical Center Utrecht (the Netherlands).
The study included 243 women (mean age 30.5 years) admitted from 1995 to 2005 for early-onset preeclampsia and delivery before 34 weeks and a population-based control group of 374 healthy, nonpregnant women (mean 28.3 years). Women with chronic hypertension (greater than 140/90 mm Hg) were excluded. Outcomes were adjusted for age.
When compared with matched controls, women in the preeclampsia group had significantly higher rates of obesity (body mass index 26.1 vs. 24.3 kg/m
HDL-cholesterol levels were significantly lower among cases versus controls (55 vs. 61 mg/dL).
No significant differences were found for rates of diabetes mellitus and smoking.
In all, 15.2% of women with a history of preeclampsia met the criteria for metabolic syndrome, as formulated by the AHA and World Health Organization versus only 4.3% of controls (odds ratio 3.6).
The estimated 10-year risk of first cardiovascular disease events, as calculated by the Framingham CHD risk prediction scores, remained less than 10% for all of the women. This places the women in the AHA low-risk range, which is a 1%–3% absolute risk of developing a major cardiovascular event in the coming years, he said.
However, this is a bit deceptive, mainly because of the young age of the women, Dr. Van Rijn added.
For example, if one adds 10 years to the Framingham risk score (mean age 40 years), the risk category for the preeclampsia group would be 5%–10%, which is comparable to a woman who has experienced a myocardial infarction.
“Women with a history of early-onset preeclampsia exhibit many risk factors, but their relatively young age is masking their absolute cardiovascular risk,” said Dr. Van Rijn, who disclosed no financial conflicts of interest.
The study was sponsored by the Netherlands Organization for Scientific Research.
DALLAS — Early cardiovascular risk-factor screening is warranted in women with a history of early-onset preeclampsia, according to results of a study in 617 women.
Significantly more women with a history of early-onset preeclampsia exhibited at least one major cardiovascular risk factor, as defined by the American Heart Association, when screened 6 months after delivery, and compared with healthy controls (89% vs. 71%).
The percentages of women exhibiting at least two and at least three cardiovascular risk factors were also significantly higher in the preeclampsia group, Dr. Bas Van Rijn said at the annual meeting of the Society for Maternal-Fetal Medicine.
Among women in the preeclampsia group 51% had two or more cardiovascular risk factors vs. 26% in the control group, and 19% had three or more risk factors vs. 6% in the control group.
“We advise using global risk estimations, such as the Framingham chart, to identify women that require lifestyle intervention programs aimed at primary prevention of cardiovascular disease,” said Dr. Van Rijn of the division of perinatology and gynecology, University Medical Center Utrecht (the Netherlands).
The study included 243 women (mean age 30.5 years) admitted from 1995 to 2005 for early-onset preeclampsia and delivery before 34 weeks and a population-based control group of 374 healthy, nonpregnant women (mean 28.3 years). Women with chronic hypertension (greater than 140/90 mm Hg) were excluded. Outcomes were adjusted for age.
When compared with matched controls, women in the preeclampsia group had significantly higher rates of obesity (body mass index 26.1 vs. 24.3 kg/m
HDL-cholesterol levels were significantly lower among cases versus controls (55 vs. 61 mg/dL).
No significant differences were found for rates of diabetes mellitus and smoking.
In all, 15.2% of women with a history of preeclampsia met the criteria for metabolic syndrome, as formulated by the AHA and World Health Organization versus only 4.3% of controls (odds ratio 3.6).
The estimated 10-year risk of first cardiovascular disease events, as calculated by the Framingham CHD risk prediction scores, remained less than 10% for all of the women. This places the women in the AHA low-risk range, which is a 1%–3% absolute risk of developing a major cardiovascular event in the coming years, he said.
However, this is a bit deceptive, mainly because of the young age of the women, Dr. Van Rijn added.
For example, if one adds 10 years to the Framingham risk score (mean age 40 years), the risk category for the preeclampsia group would be 5%–10%, which is comparable to a woman who has experienced a myocardial infarction.
“Women with a history of early-onset preeclampsia exhibit many risk factors, but their relatively young age is masking their absolute cardiovascular risk,” said Dr. Van Rijn, who disclosed no financial conflicts of interest.
The study was sponsored by the Netherlands Organization for Scientific Research.
Chronic Idiopathic Cough May Warrant Iron Deficiency Testing
CHICAGO — A small but provocative Italian study suggests that women complaining of chronic idiopathic cough should be evaluated for iron deficiency.
Researchers at the University of Turin (Italy) observed that cough and signs and symptoms of pharyngolaryngitis were improved or resolved after iron supplementation in 16 healthy nonsmoking women who had idiopathic cough and iron deficiency (average serum ferritin 9.4 ng/mL) and mild anemia (hemoglobin 11.6 g/dL).
The women, aged 18–56 years, had no history of atopy, asthma, or other bronchopulmonary diseases, and no evidence of gastroesophageal reflux. All had normal results on lung function tests, lead investigator Dr. Caterina B. Bucca reported at the annual meeting of the American College of Chest Physicians.
The women presented with marked oral redness and soreness, atrophy of oral mucosa and tongue papillae, and angular cheilosis. Nine patients had dysphonia. Exhaled nitric oxide was normal (average 14.9 parts per billion) in all patients.
Histamine challenge showed bronchial hyperresponsiveness in 4 women, extrathoracic airway hyperresponsiveness in 14 women, and cough hyperresponsiveness in 15 women. A significant association was observed between PC5 coughs (the histamine concentration that provokes five coughs) and PC25 MIF50 (provocative concentration causing a greater than 25% fall in maximal midinspiratory flow at 50% of vital capacity), reported Dr. Bucca of the department of biomedical sciences and human oncology at the University of Turin. After iron supplementation, signs and symptoms of pharyngolaryngitis were resolved in 10 women and improved in 6 women. Significant increases were observed in PC20 FEV1 (provocative concentration causing a 20% drop in forced expiratory volume in 1 second): 18.8 mg/mL to 24.1 mg/mL; significant increases were also seen in PC25 MIF50 (6.2 mg/mL to 22.2 mg/mL) and in PC5 coughs (3.8 mg/mL to 17.8 mg/mL).
Dr. Bucca suggested that the tentative explanation of how iron deficiency causes cough is based on the knowledge that iron deficiency impairs immunologic defenses and induces the release of inflammatory cytokines.
“This leads to damage of the airway mucosa, which becomes more permeable to noxious stimuli so that the nervous receptors responsible for the onset of cough are more easily reached by irritants,” Dr. Bucca said in an interview. “Infections of the pharynx and larynx are also favored so that cough is often associated with painful and inflamed throat and with dysphonia.”
Iron deficiency is present in 20% of women in industrialized countries, and in the United States nearly one-third of women have virtually no iron stores. Cough is also more frequent in women than in men.
Dr. Bucca is currently evaluating the nutritional status of all patients who present to her clinic for chronic cough, either idiopathic or associated with diseases of the upper airway, and is planning an epidemiologic study to assess the prevalence of cough and iron deficiency in women of childbearing age.
CHICAGO — A small but provocative Italian study suggests that women complaining of chronic idiopathic cough should be evaluated for iron deficiency.
Researchers at the University of Turin (Italy) observed that cough and signs and symptoms of pharyngolaryngitis were improved or resolved after iron supplementation in 16 healthy nonsmoking women who had idiopathic cough and iron deficiency (average serum ferritin 9.4 ng/mL) and mild anemia (hemoglobin 11.6 g/dL).
The women, aged 18–56 years, had no history of atopy, asthma, or other bronchopulmonary diseases, and no evidence of gastroesophageal reflux. All had normal results on lung function tests, lead investigator Dr. Caterina B. Bucca reported at the annual meeting of the American College of Chest Physicians.
The women presented with marked oral redness and soreness, atrophy of oral mucosa and tongue papillae, and angular cheilosis. Nine patients had dysphonia. Exhaled nitric oxide was normal (average 14.9 parts per billion) in all patients.
Histamine challenge showed bronchial hyperresponsiveness in 4 women, extrathoracic airway hyperresponsiveness in 14 women, and cough hyperresponsiveness in 15 women. A significant association was observed between PC5 coughs (the histamine concentration that provokes five coughs) and PC25 MIF50 (provocative concentration causing a greater than 25% fall in maximal midinspiratory flow at 50% of vital capacity), reported Dr. Bucca of the department of biomedical sciences and human oncology at the University of Turin. After iron supplementation, signs and symptoms of pharyngolaryngitis were resolved in 10 women and improved in 6 women. Significant increases were observed in PC20 FEV1 (provocative concentration causing a 20% drop in forced expiratory volume in 1 second): 18.8 mg/mL to 24.1 mg/mL; significant increases were also seen in PC25 MIF50 (6.2 mg/mL to 22.2 mg/mL) and in PC5 coughs (3.8 mg/mL to 17.8 mg/mL).
Dr. Bucca suggested that the tentative explanation of how iron deficiency causes cough is based on the knowledge that iron deficiency impairs immunologic defenses and induces the release of inflammatory cytokines.
“This leads to damage of the airway mucosa, which becomes more permeable to noxious stimuli so that the nervous receptors responsible for the onset of cough are more easily reached by irritants,” Dr. Bucca said in an interview. “Infections of the pharynx and larynx are also favored so that cough is often associated with painful and inflamed throat and with dysphonia.”
Iron deficiency is present in 20% of women in industrialized countries, and in the United States nearly one-third of women have virtually no iron stores. Cough is also more frequent in women than in men.
Dr. Bucca is currently evaluating the nutritional status of all patients who present to her clinic for chronic cough, either idiopathic or associated with diseases of the upper airway, and is planning an epidemiologic study to assess the prevalence of cough and iron deficiency in women of childbearing age.
CHICAGO — A small but provocative Italian study suggests that women complaining of chronic idiopathic cough should be evaluated for iron deficiency.
Researchers at the University of Turin (Italy) observed that cough and signs and symptoms of pharyngolaryngitis were improved or resolved after iron supplementation in 16 healthy nonsmoking women who had idiopathic cough and iron deficiency (average serum ferritin 9.4 ng/mL) and mild anemia (hemoglobin 11.6 g/dL).
The women, aged 18–56 years, had no history of atopy, asthma, or other bronchopulmonary diseases, and no evidence of gastroesophageal reflux. All had normal results on lung function tests, lead investigator Dr. Caterina B. Bucca reported at the annual meeting of the American College of Chest Physicians.
The women presented with marked oral redness and soreness, atrophy of oral mucosa and tongue papillae, and angular cheilosis. Nine patients had dysphonia. Exhaled nitric oxide was normal (average 14.9 parts per billion) in all patients.
Histamine challenge showed bronchial hyperresponsiveness in 4 women, extrathoracic airway hyperresponsiveness in 14 women, and cough hyperresponsiveness in 15 women. A significant association was observed between PC5 coughs (the histamine concentration that provokes five coughs) and PC25 MIF50 (provocative concentration causing a greater than 25% fall in maximal midinspiratory flow at 50% of vital capacity), reported Dr. Bucca of the department of biomedical sciences and human oncology at the University of Turin. After iron supplementation, signs and symptoms of pharyngolaryngitis were resolved in 10 women and improved in 6 women. Significant increases were observed in PC20 FEV1 (provocative concentration causing a 20% drop in forced expiratory volume in 1 second): 18.8 mg/mL to 24.1 mg/mL; significant increases were also seen in PC25 MIF50 (6.2 mg/mL to 22.2 mg/mL) and in PC5 coughs (3.8 mg/mL to 17.8 mg/mL).
Dr. Bucca suggested that the tentative explanation of how iron deficiency causes cough is based on the knowledge that iron deficiency impairs immunologic defenses and induces the release of inflammatory cytokines.
“This leads to damage of the airway mucosa, which becomes more permeable to noxious stimuli so that the nervous receptors responsible for the onset of cough are more easily reached by irritants,” Dr. Bucca said in an interview. “Infections of the pharynx and larynx are also favored so that cough is often associated with painful and inflamed throat and with dysphonia.”
Iron deficiency is present in 20% of women in industrialized countries, and in the United States nearly one-third of women have virtually no iron stores. Cough is also more frequent in women than in men.
Dr. Bucca is currently evaluating the nutritional status of all patients who present to her clinic for chronic cough, either idiopathic or associated with diseases of the upper airway, and is planning an epidemiologic study to assess the prevalence of cough and iron deficiency in women of childbearing age.
Breast Tomosynthesis May Reduce Recall Rates
CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.
Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.
The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America. The total radiation dose of 1.5 mGy is about half that of a single mammographic exposure.
The technique is neither clinically available nor approved by the Food and Drug Administration, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the FDA for approval of the combined modality of tomosynthesis and digital mammography.
The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of whom 141 were recalled for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 lesions were benign, and 48 were malignant.
Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases scored the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For the cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1–5 showing the likelihood of disease in that patient and assign a probability of malignancy score rating from 1 to 100.
The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologists' performance, as shown by receiver-operator curve analyses, said Dr. Rafferty of the radiology department at Harvard University Medical School in Boston. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries. A receiver-operator analysis showed that for all the readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.
Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.
The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.
In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy. Dr. Rafferty has received research support from Hologic, the study sponsor.
Architectural distortion is clearer in tomosynthesis slices (right) than on digital mammography (left).
A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).
Spiculated cancer with microcalcification is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). HOLOGIC, INC.
CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.
Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.
The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America. The total radiation dose of 1.5 mGy is about half that of a single mammographic exposure.
The technique is neither clinically available nor approved by the Food and Drug Administration, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the FDA for approval of the combined modality of tomosynthesis and digital mammography.
The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of whom 141 were recalled for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 lesions were benign, and 48 were malignant.
Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases scored the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For the cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1–5 showing the likelihood of disease in that patient and assign a probability of malignancy score rating from 1 to 100.
The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologists' performance, as shown by receiver-operator curve analyses, said Dr. Rafferty of the radiology department at Harvard University Medical School in Boston. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries. A receiver-operator analysis showed that for all the readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.
Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.
The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.
In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy. Dr. Rafferty has received research support from Hologic, the study sponsor.
Architectural distortion is clearer in tomosynthesis slices (right) than on digital mammography (left).
A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).
Spiculated cancer with microcalcification is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). HOLOGIC, INC.
CHICAGO — The addition of digital breast tomosynthesis to digital mammography at screening could improve diagnostic accuracy and reduce recall rates by about 40%, according to results of a multicenter study.
Tomosynthesis creates a single three-dimensional image of the breast by combining data from 11 projection two-dimensional radiographs acquired during a single sweep of the x-ray tube around the patient.
The technique improves breast visualization by reducing the overlap of normal breast structures, Dr. Elizabeth Rafferty reported during a late-breaking session at the annual meeting of the Radiological Society of North America. The total radiation dose of 1.5 mGy is about half that of a single mammographic exposure.
The technique is neither clinically available nor approved by the Food and Drug Administration, but based on findings from a data set of 316 women, Hologic Inc. (Bedford, Mass.) has petitioned the FDA for approval of the combined modality of tomosynthesis and digital mammography.
The data set was derived from a study in which 1,083 women, age 18 years or more, underwent two-view, full-field digital mammogram (FFDM) and digital tomosynthesis exams at five U.S. centers. The 316 women in the study included 100 women who presented for diagnostic examinations and 216 women who presented for screening exams, of whom 141 were recalled for additional imaging and 75 had normal exams. In all, 96 women underwent biopsy; 48 lesions were benign, and 48 were malignant.
Twelve board-certified radiologists trained on 200 tomosynthesis imaging cases scored the digital mammography images as Breast Imaging Reporting and Data System (BIRADS) 0, 1, and 2. For the cases scored as a BIRADS 0, the radiologists were asked to give a forced BIRADS score of 1–5 showing the likelihood of disease in that patient and assign a probability of malignancy score rating from 1 to 100.
The combination of FFDM and tomosynthesis resulted in highly significant improvements in the radiologists' performance, as shown by receiver-operator curve analyses, said Dr. Rafferty of the radiology department at Harvard University Medical School in Boston. The performance benefits were seen primarily in the analysis of masses, architectural distortion, and focal asymmetries. A receiver-operator analysis showed that for all the readers, the combined modality of tomosynthesis and FFDM was superior to FFDM alone when using the forced BIRADS score and the probability of malignancy scale.
Using multicase and multireader analyses, the diagnostic accuracy (area under the curve) improved significantly for the forced BIRADS score from 0.83 with FFDM alone to 0.90 with FFDM plus tomosynthesis, with 0.5 representing a worthless diagnostic test and 1 a perfect test. The area under the curve for the probability of malignancy scale also significantly improved from 0.82 to 0.89 with the combined modality.
The investigators hypothesized that tomosynthesis would provide little gain in the assessment of clustered breast calcifications because calcifications are well seen on traditional mammography and aren't typically obscured by surrounding tissue. The data bore out this hypothesis, with only a slight, nonsignificant improvement from 0.80 to 0.84 observed in the area under the curve.
In noncalcified cases, the difference in the area under the curve for FFDM versus the combined modality was highly significant (0.82 vs. 0.92), representing good versus excellent dignostic accuracy. Dr. Rafferty has received research support from Hologic, the study sponsor.
Architectural distortion is clearer in tomosynthesis slices (right) than on digital mammography (left).
A spiculated cancer is better seen in the tomosynthesis slice (right) than on digital mammography (left).
Spiculated cancer with microcalcification is more apparent in the tomosynthesis slice (right) than on digital mammography image (left). HOLOGIC, INC.
Neonatal Outcomes Vary With Diabetes Type
DALLAS — Women with type 2 diabetes had a similar incidence of adverse obstetric outcomes as those with type 1 diabetes but fewer adverse neonatal outcomes in a retrospective cohort analysis of 384 pregnancies.
As expected, patients with both type 1 and type 2 diabetes had worse obstetric and neonatal outcomes, compared with nondiabetic controls, Dr. Kristin M. Knight and colleagues at the University of Rochester (N.Y.) reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
Using a preexisting database of pregestational diabetes patients, the researchers analyzed maternal and fetal outcomes of singleton pregnancies between July 2000 and August 2006 in 64 women with type 1 diabetes, 64 women with type 2 diabetes, and 256 matched controls with normal glucose screening during pregnancy.
Patients with type 2 diabetes were significantly older (mean 30.1 years) than patients with type 1 diabetes (26.8 years) or controls (27.4 years), and had a significantly higher prepregnancy body mass index (37 vs. 27 vs. 24 kg m
Both groups with diabetes had higher incidences of cesarean delivery, preeclampsia, preterm delivery, polyhydramnios, large-for-gestational-age infants, and neonatal ICU admission than did the 256 nondiabetic controls. However, the incidences were not different for women with type 2 vs. type 1 diabetes, the researchers noted.
Women with type 1 diabetes had a higher incidence of composite poor neonatal outcome (perinatal death, respiratory distress syndrome, sepsis, meconium aspiration, hypoglycemia, seizures, necrotizing enterocolitis, or intubation) than did women with type 2 diabetes and controls.
Those with type 1 diabetes had significantly more fetal congenital anomalies than did controls (6.3% vs. 1.2%). While such anomalies were elevated in women with type 2 diabetes, they were not significantly different (3.2%).
This finding differs from some of the other literature that's available, Dr. Knight said in an interview. This might be because the study population included only women seeking prenatal care, which is not the norm in clinical practice, and thus might have underrepresented poorer outcomes in patients with type 2 diabetes.
Overall, few data are available regarding pregnancy outcomes in type 2 diabetes, even though this type of diabetes is becoming increasingly common in reproductive-age women, she said. “Type 2 diabetic patients should receive the same degree of preconceptional counseling, diligent glucose control, and antenatal surveillance as type 1 diabetic patients, in order to minimize the occurrence of poor perinatal outcome,” the authors wrote.
In a second poster at the meeting, diabetic macrovascular and microvascular disease during pregnancy was associated with reduced intrauterine fetal growth among 358 women with type 1 diabetes enrolled in a “Diabetes in Pregnancy” program at the University of Cincinnati.
The women were enrolled before 14 weeks' gestation, prospectively followed through the postpartum period, and treated with intensive insulin therapy.
They were classified at entry based on vascular status, with no vasculopathy present in 192, hypertension or background retinopathy in 79, proliferative retinopathy in only 18, nephropathy in only 42, and proliferative retinopathy and nephropathy in 26. Their mean ages were 24, 27, 27, 26, and 29 years, respectively; and they had been diagnosed with diabetes mellitus for 10, 15, 18, 14, and 18 years, respectively.
After controlling for gestation at delivery and maternal age and race, the odds ratio for delivery of a low-birth-weight infant (less than 2,500 g), compared with women without vasculopathy, was highest in women with proliferative retinopathy and nephropathy, Dr. Sina Haeri of the department of obstetrics and gynecology, Washington Hospital Center, and associates reported. Likewise, after controlling for maternal age and race, the odds ratio for delivery of a small-for-gestational-age infant, compared with women with no vasculopathy, was highest in those with proliferative retinopathy and nephropathy.
DALLAS — Women with type 2 diabetes had a similar incidence of adverse obstetric outcomes as those with type 1 diabetes but fewer adverse neonatal outcomes in a retrospective cohort analysis of 384 pregnancies.
As expected, patients with both type 1 and type 2 diabetes had worse obstetric and neonatal outcomes, compared with nondiabetic controls, Dr. Kristin M. Knight and colleagues at the University of Rochester (N.Y.) reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
Using a preexisting database of pregestational diabetes patients, the researchers analyzed maternal and fetal outcomes of singleton pregnancies between July 2000 and August 2006 in 64 women with type 1 diabetes, 64 women with type 2 diabetes, and 256 matched controls with normal glucose screening during pregnancy.
Patients with type 2 diabetes were significantly older (mean 30.1 years) than patients with type 1 diabetes (26.8 years) or controls (27.4 years), and had a significantly higher prepregnancy body mass index (37 vs. 27 vs. 24 kg m
Both groups with diabetes had higher incidences of cesarean delivery, preeclampsia, preterm delivery, polyhydramnios, large-for-gestational-age infants, and neonatal ICU admission than did the 256 nondiabetic controls. However, the incidences were not different for women with type 2 vs. type 1 diabetes, the researchers noted.
Women with type 1 diabetes had a higher incidence of composite poor neonatal outcome (perinatal death, respiratory distress syndrome, sepsis, meconium aspiration, hypoglycemia, seizures, necrotizing enterocolitis, or intubation) than did women with type 2 diabetes and controls.
Those with type 1 diabetes had significantly more fetal congenital anomalies than did controls (6.3% vs. 1.2%). While such anomalies were elevated in women with type 2 diabetes, they were not significantly different (3.2%).
This finding differs from some of the other literature that's available, Dr. Knight said in an interview. This might be because the study population included only women seeking prenatal care, which is not the norm in clinical practice, and thus might have underrepresented poorer outcomes in patients with type 2 diabetes.
Overall, few data are available regarding pregnancy outcomes in type 2 diabetes, even though this type of diabetes is becoming increasingly common in reproductive-age women, she said. “Type 2 diabetic patients should receive the same degree of preconceptional counseling, diligent glucose control, and antenatal surveillance as type 1 diabetic patients, in order to minimize the occurrence of poor perinatal outcome,” the authors wrote.
In a second poster at the meeting, diabetic macrovascular and microvascular disease during pregnancy was associated with reduced intrauterine fetal growth among 358 women with type 1 diabetes enrolled in a “Diabetes in Pregnancy” program at the University of Cincinnati.
The women were enrolled before 14 weeks' gestation, prospectively followed through the postpartum period, and treated with intensive insulin therapy.
They were classified at entry based on vascular status, with no vasculopathy present in 192, hypertension or background retinopathy in 79, proliferative retinopathy in only 18, nephropathy in only 42, and proliferative retinopathy and nephropathy in 26. Their mean ages were 24, 27, 27, 26, and 29 years, respectively; and they had been diagnosed with diabetes mellitus for 10, 15, 18, 14, and 18 years, respectively.
After controlling for gestation at delivery and maternal age and race, the odds ratio for delivery of a low-birth-weight infant (less than 2,500 g), compared with women without vasculopathy, was highest in women with proliferative retinopathy and nephropathy, Dr. Sina Haeri of the department of obstetrics and gynecology, Washington Hospital Center, and associates reported. Likewise, after controlling for maternal age and race, the odds ratio for delivery of a small-for-gestational-age infant, compared with women with no vasculopathy, was highest in those with proliferative retinopathy and nephropathy.
DALLAS — Women with type 2 diabetes had a similar incidence of adverse obstetric outcomes as those with type 1 diabetes but fewer adverse neonatal outcomes in a retrospective cohort analysis of 384 pregnancies.
As expected, patients with both type 1 and type 2 diabetes had worse obstetric and neonatal outcomes, compared with nondiabetic controls, Dr. Kristin M. Knight and colleagues at the University of Rochester (N.Y.) reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
Using a preexisting database of pregestational diabetes patients, the researchers analyzed maternal and fetal outcomes of singleton pregnancies between July 2000 and August 2006 in 64 women with type 1 diabetes, 64 women with type 2 diabetes, and 256 matched controls with normal glucose screening during pregnancy.
Patients with type 2 diabetes were significantly older (mean 30.1 years) than patients with type 1 diabetes (26.8 years) or controls (27.4 years), and had a significantly higher prepregnancy body mass index (37 vs. 27 vs. 24 kg m
Both groups with diabetes had higher incidences of cesarean delivery, preeclampsia, preterm delivery, polyhydramnios, large-for-gestational-age infants, and neonatal ICU admission than did the 256 nondiabetic controls. However, the incidences were not different for women with type 2 vs. type 1 diabetes, the researchers noted.
Women with type 1 diabetes had a higher incidence of composite poor neonatal outcome (perinatal death, respiratory distress syndrome, sepsis, meconium aspiration, hypoglycemia, seizures, necrotizing enterocolitis, or intubation) than did women with type 2 diabetes and controls.
Those with type 1 diabetes had significantly more fetal congenital anomalies than did controls (6.3% vs. 1.2%). While such anomalies were elevated in women with type 2 diabetes, they were not significantly different (3.2%).
This finding differs from some of the other literature that's available, Dr. Knight said in an interview. This might be because the study population included only women seeking prenatal care, which is not the norm in clinical practice, and thus might have underrepresented poorer outcomes in patients with type 2 diabetes.
Overall, few data are available regarding pregnancy outcomes in type 2 diabetes, even though this type of diabetes is becoming increasingly common in reproductive-age women, she said. “Type 2 diabetic patients should receive the same degree of preconceptional counseling, diligent glucose control, and antenatal surveillance as type 1 diabetic patients, in order to minimize the occurrence of poor perinatal outcome,” the authors wrote.
In a second poster at the meeting, diabetic macrovascular and microvascular disease during pregnancy was associated with reduced intrauterine fetal growth among 358 women with type 1 diabetes enrolled in a “Diabetes in Pregnancy” program at the University of Cincinnati.
The women were enrolled before 14 weeks' gestation, prospectively followed through the postpartum period, and treated with intensive insulin therapy.
They were classified at entry based on vascular status, with no vasculopathy present in 192, hypertension or background retinopathy in 79, proliferative retinopathy in only 18, nephropathy in only 42, and proliferative retinopathy and nephropathy in 26. Their mean ages were 24, 27, 27, 26, and 29 years, respectively; and they had been diagnosed with diabetes mellitus for 10, 15, 18, 14, and 18 years, respectively.
After controlling for gestation at delivery and maternal age and race, the odds ratio for delivery of a low-birth-weight infant (less than 2,500 g), compared with women without vasculopathy, was highest in women with proliferative retinopathy and nephropathy, Dr. Sina Haeri of the department of obstetrics and gynecology, Washington Hospital Center, and associates reported. Likewise, after controlling for maternal age and race, the odds ratio for delivery of a small-for-gestational-age infant, compared with women with no vasculopathy, was highest in those with proliferative retinopathy and nephropathy.
Postpartum Depression Tied to Prior Obesity
DALLAS — Obese women may be at increased risk for postpartum depression, new research suggests.
In a prospective analysis of 1,282 women who gave birth to singleton infants at term, nearly 30% of women with a prepregnancy body mass index of 30 or more screened positive for postpartum depression 8 weeks after delivery.
The study is the first to use a validated screening tool to evaluate the risk of postpartum depression (PPD) by maternal BMI strata, according to the researchers, who used a score of 12 or more on the Edinburgh Postnatal Depression Screen to define a positive PPD screen.
Women at the extremes of BMI and those with greater weight gains in pregnancy were also at increased risk for PPD, Dr. Yvette LaCoursiere and colleagues at the University of Utah, Salt Lake City, reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
A positive PPD screen was reported in 19% of underweight women (BMI below 18.5), 13% of normal-weight (BMI 18.5–24.9), 16% of overweight women (BMI 25–29.9), 18% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29% with class III obesity (BMI greater than or equal to 40). The number of women in each BMI stratum was: 115, 724, 256, 116, 43, and 31, respectively, with incomplete data available on 3 others.
BMI remained a risk factor for PPD even after the researchers controlled for maternal age (mean 27 years), race (86% white, 9% Hispanic), parity (two children), education (mean 14 years), and stressors including financial, traumatic, partner associated, and emotional.
“We're not screening women aggressively for postpartum depression, in general,” Dr. LaCoursiere said in an interview. “When I look at how this changed my practice, if I have women who are obese before delivery I have them come back at a 2-week visit and make sure they get a screening test because they have a very high chance of developing depression.”
Weight gain during pregnancy also influenced a woman's chance of becoming depressed. A positive PPD screen was observed for 10% of normal-weight women who gained 24 pounds or less, 11% of those who gained 25–34 pounds, and 16% of those who gained more than 35 pounds. The rates were similar among overweight women (12%, 14%, and 20%, respectively), but did not increase in a stepwise fashion among the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.
Contrary to what one would expect, normal-weight women are more likely than are obese women to exceed the recommended pregnancy weight gain of 25–35 pounds, with obese women typically gaining only about 16–24 pounds during pregnancy, Dr. LaCoursiere said.
The modified Body Shape Questionnaire (BSQ) was also used, and revealed that poor body image was associated with obesity and weight gain during pregnancy. Scores on the BSQ increased significantly with increasing BMI strata (32, 39, 44, 48, 51, and 49; P less than .05).
Surprisingly, only 54% of physicians discussed mood during the postpartum visit and 26% addressed weight, Dr. LaCoursiere said. Fewer than 30 women reported that their evaluation of mood was conducted with a written tool. During pregnancy, 77% of providers addressed weight and 53% discussed mood.
“It might be that we need to make this part of the nursing system so that a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand,” she said. “Another thing that's tough for OBs is what to do with that result when you find it. Most should feel fairly comfortable treating at least mild depression and knowing what resources are available and whom to refer to.”
In all, 50 women (4%) reported using alcohol during pregnancy, 224 (17%) had a history of depression, 109 (9%) had a history of PPD, 23 (2%) had a history of other psychiatric diagnoses, and 175 (14%) had a family history of other psychiatric diagnoses.
At first glance, the percentage of women with a history of depression or PPD seems high. The data may be inflated because they are self-reported and thus do not necessarily reflect those who accessed care and were treated, Dr. LaCoursiere said.
DALLAS — Obese women may be at increased risk for postpartum depression, new research suggests.
In a prospective analysis of 1,282 women who gave birth to singleton infants at term, nearly 30% of women with a prepregnancy body mass index of 30 or more screened positive for postpartum depression 8 weeks after delivery.
The study is the first to use a validated screening tool to evaluate the risk of postpartum depression (PPD) by maternal BMI strata, according to the researchers, who used a score of 12 or more on the Edinburgh Postnatal Depression Screen to define a positive PPD screen.
Women at the extremes of BMI and those with greater weight gains in pregnancy were also at increased risk for PPD, Dr. Yvette LaCoursiere and colleagues at the University of Utah, Salt Lake City, reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
A positive PPD screen was reported in 19% of underweight women (BMI below 18.5), 13% of normal-weight (BMI 18.5–24.9), 16% of overweight women (BMI 25–29.9), 18% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29% with class III obesity (BMI greater than or equal to 40). The number of women in each BMI stratum was: 115, 724, 256, 116, 43, and 31, respectively, with incomplete data available on 3 others.
BMI remained a risk factor for PPD even after the researchers controlled for maternal age (mean 27 years), race (86% white, 9% Hispanic), parity (two children), education (mean 14 years), and stressors including financial, traumatic, partner associated, and emotional.
“We're not screening women aggressively for postpartum depression, in general,” Dr. LaCoursiere said in an interview. “When I look at how this changed my practice, if I have women who are obese before delivery I have them come back at a 2-week visit and make sure they get a screening test because they have a very high chance of developing depression.”
Weight gain during pregnancy also influenced a woman's chance of becoming depressed. A positive PPD screen was observed for 10% of normal-weight women who gained 24 pounds or less, 11% of those who gained 25–34 pounds, and 16% of those who gained more than 35 pounds. The rates were similar among overweight women (12%, 14%, and 20%, respectively), but did not increase in a stepwise fashion among the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.
Contrary to what one would expect, normal-weight women are more likely than are obese women to exceed the recommended pregnancy weight gain of 25–35 pounds, with obese women typically gaining only about 16–24 pounds during pregnancy, Dr. LaCoursiere said.
The modified Body Shape Questionnaire (BSQ) was also used, and revealed that poor body image was associated with obesity and weight gain during pregnancy. Scores on the BSQ increased significantly with increasing BMI strata (32, 39, 44, 48, 51, and 49; P less than .05).
Surprisingly, only 54% of physicians discussed mood during the postpartum visit and 26% addressed weight, Dr. LaCoursiere said. Fewer than 30 women reported that their evaluation of mood was conducted with a written tool. During pregnancy, 77% of providers addressed weight and 53% discussed mood.
“It might be that we need to make this part of the nursing system so that a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand,” she said. “Another thing that's tough for OBs is what to do with that result when you find it. Most should feel fairly comfortable treating at least mild depression and knowing what resources are available and whom to refer to.”
In all, 50 women (4%) reported using alcohol during pregnancy, 224 (17%) had a history of depression, 109 (9%) had a history of PPD, 23 (2%) had a history of other psychiatric diagnoses, and 175 (14%) had a family history of other psychiatric diagnoses.
At first glance, the percentage of women with a history of depression or PPD seems high. The data may be inflated because they are self-reported and thus do not necessarily reflect those who accessed care and were treated, Dr. LaCoursiere said.
DALLAS — Obese women may be at increased risk for postpartum depression, new research suggests.
In a prospective analysis of 1,282 women who gave birth to singleton infants at term, nearly 30% of women with a prepregnancy body mass index of 30 or more screened positive for postpartum depression 8 weeks after delivery.
The study is the first to use a validated screening tool to evaluate the risk of postpartum depression (PPD) by maternal BMI strata, according to the researchers, who used a score of 12 or more on the Edinburgh Postnatal Depression Screen to define a positive PPD screen.
Women at the extremes of BMI and those with greater weight gains in pregnancy were also at increased risk for PPD, Dr. Yvette LaCoursiere and colleagues at the University of Utah, Salt Lake City, reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
A positive PPD screen was reported in 19% of underweight women (BMI below 18.5), 13% of normal-weight (BMI 18.5–24.9), 16% of overweight women (BMI 25–29.9), 18% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29% with class III obesity (BMI greater than or equal to 40). The number of women in each BMI stratum was: 115, 724, 256, 116, 43, and 31, respectively, with incomplete data available on 3 others.
BMI remained a risk factor for PPD even after the researchers controlled for maternal age (mean 27 years), race (86% white, 9% Hispanic), parity (two children), education (mean 14 years), and stressors including financial, traumatic, partner associated, and emotional.
“We're not screening women aggressively for postpartum depression, in general,” Dr. LaCoursiere said in an interview. “When I look at how this changed my practice, if I have women who are obese before delivery I have them come back at a 2-week visit and make sure they get a screening test because they have a very high chance of developing depression.”
Weight gain during pregnancy also influenced a woman's chance of becoming depressed. A positive PPD screen was observed for 10% of normal-weight women who gained 24 pounds or less, 11% of those who gained 25–34 pounds, and 16% of those who gained more than 35 pounds. The rates were similar among overweight women (12%, 14%, and 20%, respectively), but did not increase in a stepwise fashion among the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.
Contrary to what one would expect, normal-weight women are more likely than are obese women to exceed the recommended pregnancy weight gain of 25–35 pounds, with obese women typically gaining only about 16–24 pounds during pregnancy, Dr. LaCoursiere said.
The modified Body Shape Questionnaire (BSQ) was also used, and revealed that poor body image was associated with obesity and weight gain during pregnancy. Scores on the BSQ increased significantly with increasing BMI strata (32, 39, 44, 48, 51, and 49; P less than .05).
Surprisingly, only 54% of physicians discussed mood during the postpartum visit and 26% addressed weight, Dr. LaCoursiere said. Fewer than 30 women reported that their evaluation of mood was conducted with a written tool. During pregnancy, 77% of providers addressed weight and 53% discussed mood.
“It might be that we need to make this part of the nursing system so that a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand,” she said. “Another thing that's tough for OBs is what to do with that result when you find it. Most should feel fairly comfortable treating at least mild depression and knowing what resources are available and whom to refer to.”
In all, 50 women (4%) reported using alcohol during pregnancy, 224 (17%) had a history of depression, 109 (9%) had a history of PPD, 23 (2%) had a history of other psychiatric diagnoses, and 175 (14%) had a family history of other psychiatric diagnoses.
At first glance, the percentage of women with a history of depression or PPD seems high. The data may be inflated because they are self-reported and thus do not necessarily reflect those who accessed care and were treated, Dr. LaCoursiere said.
Reasons for Quitting Smoking Depend on the Patient's Age
CHICAGO — Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.
Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.
Older smokers were significantly more likely than were younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).
Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported smoking more than two packs per day (15% vs. 11%).
Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.
“With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it,” she said.
The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.
Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.
At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.
CHICAGO — Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.
Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.
Older smokers were significantly more likely than were younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).
Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported smoking more than two packs per day (15% vs. 11%).
Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.
“With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it,” she said.
The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.
Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.
At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.
CHICAGO — Older smokers are motivated to quit smoking by very different factors than are younger smokers, and tailoring cessation services to recognize these unique differences can improve quit rates, Virginia Reichert, N.P., said at the annual meeting of the American College of Chest Physicians.
Ms. Reichert and colleagues at the Center for Tobacco Control, North Shore-Long Island Jewish Health System, Great Neck, N.Y., reported the findings of a comparison study of 2,052 smokers; 143 were aged older than 65 years and 1,909 were aged 65 years or younger.
Older smokers were significantly more likely than were younger ones to report quitting smoking because of physician pressure (32% vs. 19%) and a recent change in health status (27% vs. 19%). Younger smokers attributed their reasons for quitting to general health concerns (81% vs. 68%), the cost of cigarettes (37% vs. 22%), and cigarette odor (33% vs. 18%).
Older smokers were significantly more likely than were younger smokers to report a recent hospitalization (23% vs. 13%), a diagnosis of comorbid cardiac disease (78% vs. 38%), cancer (20% vs. 6%), and chronic obstructive pulmonary disease and/or asthma (37% vs. 23%). Significantly more older smokers also reported smoking more than two packs per day (15% vs. 11%).
Older smokers were significantly more likely to report not wanting to give up their first cigarette in the morning as an obstacle to quitting (69% vs. 54%). In contrast, younger smokers were significantly more likely to cite weight gain (29% vs. 15%), handling social situations (24% vs. 7%), and stress relief without cigarettes (59% vs. 45%) as obstacles to quitting.
“With the younger smokers … you can develop strategies to manage stress and weight before they quit, so it's not an issue that will keep them from doing it,” she said.
The two groups did share many similar beliefs, including the surprising finding that the majority of both younger (62%) and older (68%) smokers erroneously believe that nicotine causes cancer. “There's something right there that health care providers can impact, because they're not going to use the patches if they believe nicotine causes cancer,” she said.
Roughly three-fourths of patients in both groups reported feeling guilty about smoking; while 72% of younger and 60% of older smokers worried that smoking would give them cancer. Nearly one-third of patients reported being depressed for much of the previous year, and a similar percentage reported receiving help or medication for their depression.
At 30 days, 57% of younger and 58% of older smokers were smoke free, as verified by a carbon monoxide monitor. Among those who quit, 34% of younger smokers and 52% of older smokers remained smoke free at 1 year, Ms. Reichert said.
Index Guides Discharge After Pulmonary Embolism
CHICAGO — The Pulmonary Embolism Severity Index provides clinicians with a useful tool for selecting patients with acute pulmonary embolism for outpatient therapy, Col. Lisa K. Moores, MC USA, said.
Recent evidence suggests that many patients presenting in the emergency department with nonmassive pulmonary embolism (PE) can be safely treated as outpatients using low-molecular-weight heparins or discharged early. Based on this growing body of evidence, the British Thoracic Society now recommends outpatient treatment for clinically stable patients with PE.
The Pulmonary Embolism Severity Index (PESI) and Geneva score are two standardized prognostic models that have been recently developed to identify patients at low risk for PE. The PESI uses 11 clinical findings routinely available at presentation that were previously shown to be associated with mortality in patients with PE or other acute diseases, said Dr. Moores, assistant dean for clinical sciences at the Uniformed Services University of the Health Sciences, Bethesda, Md.
These variables include demographics (age and male sex), comorbid conditions (cancer, chronic heart failure, and chronic lung disease), and six signs, including a heart rate of 110 bpm or more, systolic blood pressure less than 100 mm Hg, respiratory rate of 30 bpm or more, temperature less than 36° C, altered mental state, and oxygen saturation less than 90%.
A score is calculated by using age, then adding points based on the various factors present. Patients are then stratified by their score into five severity classes of increasing risk of death and other adverse outcomes.
A validation study demonstrated that patients in PESI class I (no more than 65 points) and class II (66–85 points) had a 30-day mortality of 1.6% or less and 3.5% or less, respectively (Am. J. Respir. Crit. Care Med. 2005;172:1041–6). Nonfatal cardiogenic shock or cardiorespiratory arrest occurred in 1% or less in class I and 1.3% or less in class II, and no patient in these two classes had nonfatal bleeding or recurrent venous thromboembolism, Dr. Moores said at the annual meeting of the American College of Chest Physicians (ACCP).
The Geneva score has been validated in two studies and uses six factors to stratify patients as low risk (up to 2 points) or high risk (3 points or more). Those factors are cancer, heart failure, previous deep vein thrombosis, systolic BP less than 100 mm Hg, arterial oxygen pressure less than 60 mm Hg, and deep vein thrombosis on ultrasound. Of 180 low-risk patients, only 4 (2%) had an adverse outcome, compared with 23 of 88 (26%) high-risk patients (Thromb. Haemost. 2000;84:548–52).
Dr. Moores acknowledged that the PESI model is “harder to get your hands around” than the Geneva model, but said some of the most intriguing data of 2007 suggests that the PESI is “more accurate and clinically useful.” An independent, head-to-head comparison in which the models were retrospectively applied to a cohort of 599 patients with objectively confirmed PE, indicated a 30-day mortality in Geneva low-risk patients of 5.6%, compared with a mortality in PESI low-risk (class I and class II) patients of 0.9% (Chest 2007;132:24–30). The PESI classified significantly fewer patients as low risk than did the Geneva model (36% vs. 84%), but the area under the receiver operating characteristic curve was higher for the PESI (0.76 vs. 0.61).
“More patients can be classified via Geneva as low risk, but the difference in mortality rates between the two systems suggests doing it more safely with the PESI,” she said.
Dr. Moores suggests that patients with a higher PESI class (class III-IV) should be observed in the ICU or a telemetry unit for the first 24 hours. In addition, clinicians should consider evaluating biomarkers in these patients such as troponin, brain natriuretic peptide, and N-terminal pro-brain natriuretic peptide levels, which when elevated have been correlated with PE death.
An audience member asked if the PESI or Geneva models can be used to select patients for thrombolysis, but Dr. Moores said the predictive values drop off in higher risk patients. “Where the crossover point is to say a patient needs thrombolysis is not yet available,” she said.
CHICAGO — The Pulmonary Embolism Severity Index provides clinicians with a useful tool for selecting patients with acute pulmonary embolism for outpatient therapy, Col. Lisa K. Moores, MC USA, said.
Recent evidence suggests that many patients presenting in the emergency department with nonmassive pulmonary embolism (PE) can be safely treated as outpatients using low-molecular-weight heparins or discharged early. Based on this growing body of evidence, the British Thoracic Society now recommends outpatient treatment for clinically stable patients with PE.
The Pulmonary Embolism Severity Index (PESI) and Geneva score are two standardized prognostic models that have been recently developed to identify patients at low risk for PE. The PESI uses 11 clinical findings routinely available at presentation that were previously shown to be associated with mortality in patients with PE or other acute diseases, said Dr. Moores, assistant dean for clinical sciences at the Uniformed Services University of the Health Sciences, Bethesda, Md.
These variables include demographics (age and male sex), comorbid conditions (cancer, chronic heart failure, and chronic lung disease), and six signs, including a heart rate of 110 bpm or more, systolic blood pressure less than 100 mm Hg, respiratory rate of 30 bpm or more, temperature less than 36° C, altered mental state, and oxygen saturation less than 90%.
A score is calculated by using age, then adding points based on the various factors present. Patients are then stratified by their score into five severity classes of increasing risk of death and other adverse outcomes.
A validation study demonstrated that patients in PESI class I (no more than 65 points) and class II (66–85 points) had a 30-day mortality of 1.6% or less and 3.5% or less, respectively (Am. J. Respir. Crit. Care Med. 2005;172:1041–6). Nonfatal cardiogenic shock or cardiorespiratory arrest occurred in 1% or less in class I and 1.3% or less in class II, and no patient in these two classes had nonfatal bleeding or recurrent venous thromboembolism, Dr. Moores said at the annual meeting of the American College of Chest Physicians (ACCP).
The Geneva score has been validated in two studies and uses six factors to stratify patients as low risk (up to 2 points) or high risk (3 points or more). Those factors are cancer, heart failure, previous deep vein thrombosis, systolic BP less than 100 mm Hg, arterial oxygen pressure less than 60 mm Hg, and deep vein thrombosis on ultrasound. Of 180 low-risk patients, only 4 (2%) had an adverse outcome, compared with 23 of 88 (26%) high-risk patients (Thromb. Haemost. 2000;84:548–52).
Dr. Moores acknowledged that the PESI model is “harder to get your hands around” than the Geneva model, but said some of the most intriguing data of 2007 suggests that the PESI is “more accurate and clinically useful.” An independent, head-to-head comparison in which the models were retrospectively applied to a cohort of 599 patients with objectively confirmed PE, indicated a 30-day mortality in Geneva low-risk patients of 5.6%, compared with a mortality in PESI low-risk (class I and class II) patients of 0.9% (Chest 2007;132:24–30). The PESI classified significantly fewer patients as low risk than did the Geneva model (36% vs. 84%), but the area under the receiver operating characteristic curve was higher for the PESI (0.76 vs. 0.61).
“More patients can be classified via Geneva as low risk, but the difference in mortality rates between the two systems suggests doing it more safely with the PESI,” she said.
Dr. Moores suggests that patients with a higher PESI class (class III-IV) should be observed in the ICU or a telemetry unit for the first 24 hours. In addition, clinicians should consider evaluating biomarkers in these patients such as troponin, brain natriuretic peptide, and N-terminal pro-brain natriuretic peptide levels, which when elevated have been correlated with PE death.
An audience member asked if the PESI or Geneva models can be used to select patients for thrombolysis, but Dr. Moores said the predictive values drop off in higher risk patients. “Where the crossover point is to say a patient needs thrombolysis is not yet available,” she said.
CHICAGO — The Pulmonary Embolism Severity Index provides clinicians with a useful tool for selecting patients with acute pulmonary embolism for outpatient therapy, Col. Lisa K. Moores, MC USA, said.
Recent evidence suggests that many patients presenting in the emergency department with nonmassive pulmonary embolism (PE) can be safely treated as outpatients using low-molecular-weight heparins or discharged early. Based on this growing body of evidence, the British Thoracic Society now recommends outpatient treatment for clinically stable patients with PE.
The Pulmonary Embolism Severity Index (PESI) and Geneva score are two standardized prognostic models that have been recently developed to identify patients at low risk for PE. The PESI uses 11 clinical findings routinely available at presentation that were previously shown to be associated with mortality in patients with PE or other acute diseases, said Dr. Moores, assistant dean for clinical sciences at the Uniformed Services University of the Health Sciences, Bethesda, Md.
These variables include demographics (age and male sex), comorbid conditions (cancer, chronic heart failure, and chronic lung disease), and six signs, including a heart rate of 110 bpm or more, systolic blood pressure less than 100 mm Hg, respiratory rate of 30 bpm or more, temperature less than 36° C, altered mental state, and oxygen saturation less than 90%.
A score is calculated by using age, then adding points based on the various factors present. Patients are then stratified by their score into five severity classes of increasing risk of death and other adverse outcomes.
A validation study demonstrated that patients in PESI class I (no more than 65 points) and class II (66–85 points) had a 30-day mortality of 1.6% or less and 3.5% or less, respectively (Am. J. Respir. Crit. Care Med. 2005;172:1041–6). Nonfatal cardiogenic shock or cardiorespiratory arrest occurred in 1% or less in class I and 1.3% or less in class II, and no patient in these two classes had nonfatal bleeding or recurrent venous thromboembolism, Dr. Moores said at the annual meeting of the American College of Chest Physicians (ACCP).
The Geneva score has been validated in two studies and uses six factors to stratify patients as low risk (up to 2 points) or high risk (3 points or more). Those factors are cancer, heart failure, previous deep vein thrombosis, systolic BP less than 100 mm Hg, arterial oxygen pressure less than 60 mm Hg, and deep vein thrombosis on ultrasound. Of 180 low-risk patients, only 4 (2%) had an adverse outcome, compared with 23 of 88 (26%) high-risk patients (Thromb. Haemost. 2000;84:548–52).
Dr. Moores acknowledged that the PESI model is “harder to get your hands around” than the Geneva model, but said some of the most intriguing data of 2007 suggests that the PESI is “more accurate and clinically useful.” An independent, head-to-head comparison in which the models were retrospectively applied to a cohort of 599 patients with objectively confirmed PE, indicated a 30-day mortality in Geneva low-risk patients of 5.6%, compared with a mortality in PESI low-risk (class I and class II) patients of 0.9% (Chest 2007;132:24–30). The PESI classified significantly fewer patients as low risk than did the Geneva model (36% vs. 84%), but the area under the receiver operating characteristic curve was higher for the PESI (0.76 vs. 0.61).
“More patients can be classified via Geneva as low risk, but the difference in mortality rates between the two systems suggests doing it more safely with the PESI,” she said.
Dr. Moores suggests that patients with a higher PESI class (class III-IV) should be observed in the ICU or a telemetry unit for the first 24 hours. In addition, clinicians should consider evaluating biomarkers in these patients such as troponin, brain natriuretic peptide, and N-terminal pro-brain natriuretic peptide levels, which when elevated have been correlated with PE death.
An audience member asked if the PESI or Geneva models can be used to select patients for thrombolysis, but Dr. Moores said the predictive values drop off in higher risk patients. “Where the crossover point is to say a patient needs thrombolysis is not yet available,” she said.