Sharon Worcester

Available data, though limited, suggest topical quinolone antibiotics are better than systemic antibiotics for treating chronic suppurative otitis media, according to a new Cochrane review of systemic antibiotic and topical treatments for the condition.

For the review, Dr. Carolyn A. Macfadyen of the Liverpool School of Tropical Medicine (England), and her colleagues searched the literature and identified nine relevant randomized controlled trials, including four that enrolled children under age 16 years. The trials involved a total of 833 randomized participants and 842 analyzed participants or ears.

Findings from the studies, which had short follow-up and were regarded by the authors as poorly reported, suggest that quinolone antibiotic drops such as ciprofloxacin had better ear-drying effects than either systemic quinolone antibiotics (relative risk 3.18) or systemic nonquinolone antibiotics (relative risk 3.21) at 1–2 weeks after the start of treatment. This finding was based on pooled data from two trials involving 116 patients with chronic suppurative otitis media (CSOM).

Systemic antibiotics plus topical quinolones were superior to systemic quinolones alone (relative risk 2.75), according to pooled data from two trials involving 90 CSOM patients.

Limited evidence from one trial with 31 patients suggested there was no significant benefit for topical nonquinolones or antiseptics, compared with systemic antibiotics at 2–4 weeks, and limited evidence based on three trials with 204 participants suggested there was no benefit to adding systemic treatment to topical treatment at 1–2 weeks, the investigators reported (The Cochrane Database of Syst. Rev. 2006;DOI:10.1002/14651858.CD005608).

Good evidence regarding long-term outcomes—such as ear-drying, complication prevention, healing of eardrum perforations, and hearing improvement—was lacking, as were data defining the role of topical nonquinolones and antiseptics, data on treating complicated CSOM, and data on safety. These matters should be addressed in future studies, the authors recommended. The lack of safety data and information on the risk of ototoxicity with alternative treatments, which is of particular concern, warrants regular medical follow-up, clinical vigilance, and monitoring for adverse treatment effects and disease complications in patients being treated for CSOM, they said.

Available data, though limited, suggest topical quinolone antibiotics are better than systemic antibiotics for treating chronic suppurative otitis media, according to a new Cochrane review of systemic antibiotic and topical treatments for the condition.

For the review, Dr. Carolyn A. Macfadyen of the Liverpool School of Tropical Medicine (England), and her colleagues searched the literature and identified nine relevant randomized controlled trials, including four that enrolled children under age 16 years. The trials involved a total of 833 randomized participants and 842 analyzed participants or ears.

Findings from the studies, which had short follow-up and were regarded by the authors as poorly reported, suggest that quinolone antibiotic drops such as ciprofloxacin had better ear-drying effects than either systemic quinolone antibiotics (relative risk 3.18) or systemic nonquinolone antibiotics (relative risk 3.21) at 1–2 weeks after the start of treatment. This finding was based on pooled data from two trials involving 116 patients with chronic suppurative otitis media (CSOM).

Systemic antibiotics plus topical quinolones were superior to systemic quinolones alone (relative risk 2.75), according to pooled data from two trials involving 90 CSOM patients.

Limited evidence from one trial with 31 patients suggested there was no significant benefit for topical nonquinolones or antiseptics, compared with systemic antibiotics at 2–4 weeks, and limited evidence based on three trials with 204 participants suggested there was no benefit to adding systemic treatment to topical treatment at 1–2 weeks, the investigators reported (The Cochrane Database of Syst. Rev. 2006;DOI:10.1002/14651858.CD005608).

Good evidence regarding long-term outcomes—such as ear-drying, complication prevention, healing of eardrum perforations, and hearing improvement—was lacking, as were data defining the role of topical nonquinolones and antiseptics, data on treating complicated CSOM, and data on safety. These matters should be addressed in future studies, the authors recommended. The lack of safety data and information on the risk of ototoxicity with alternative treatments, which is of particular concern, warrants regular medical follow-up, clinical vigilance, and monitoring for adverse treatment effects and disease complications in patients being treated for CSOM, they said.

Available data, though limited, suggest topical quinolone antibiotics are better than systemic antibiotics for treating chronic suppurative otitis media, according to a new Cochrane review of systemic antibiotic and topical treatments for the condition.

For the review, Dr. Carolyn A. Macfadyen of the Liverpool School of Tropical Medicine (England), and her colleagues searched the literature and identified nine relevant randomized controlled trials, including four that enrolled children under age 16 years. The trials involved a total of 833 randomized participants and 842 analyzed participants or ears.

Findings from the studies, which had short follow-up and were regarded by the authors as poorly reported, suggest that quinolone antibiotic drops such as ciprofloxacin had better ear-drying effects than either systemic quinolone antibiotics (relative risk 3.18) or systemic nonquinolone antibiotics (relative risk 3.21) at 1–2 weeks after the start of treatment. This finding was based on pooled data from two trials involving 116 patients with chronic suppurative otitis media (CSOM).

Systemic antibiotics plus topical quinolones were superior to systemic quinolones alone (relative risk 2.75), according to pooled data from two trials involving 90 CSOM patients.

Limited evidence from one trial with 31 patients suggested there was no significant benefit for topical nonquinolones or antiseptics, compared with systemic antibiotics at 2–4 weeks, and limited evidence based on three trials with 204 participants suggested there was no benefit to adding systemic treatment to topical treatment at 1–2 weeks, the investigators reported (The Cochrane Database of Syst. Rev. 2006;DOI:10.1002/14651858.CD005608).

Good evidence regarding long-term outcomes—such as ear-drying, complication prevention, healing of eardrum perforations, and hearing improvement—was lacking, as were data defining the role of topical nonquinolones and antiseptics, data on treating complicated CSOM, and data on safety. These matters should be addressed in future studies, the authors recommended. The lack of safety data and information on the risk of ototoxicity with alternative treatments, which is of particular concern, warrants regular medical follow-up, clinical vigilance, and monitoring for adverse treatment effects and disease complications in patients being treated for CSOM, they said.

ATLANTA — Women with urinary incontinence are willing to pay a substantial amount of money for symptom improvement, a new study shows.

The finding underscores the extent of the negative impact that incontinence has on quality of life, Dr. Leslee Subak said at the annual meeting of the American Urogynecologic Society.

A total of 300 women with varying degrees of urinary incontinence were surveyed to determine both the amount that women typically spend in the course of coping with their incontinence and the amounts they think they would be willing to spend to achieve 25%, 50%, 75%, or 100% symptom improvement.

Overall, the women were willing to pay more than $800 per year for symptom resolution—an amount comparable to what those with other chronic medical conditions, such as migraine headaches and acid reflux, have said they would be willing to pay for symptom resolution, said Dr. Subak, an obstetrician/gynecologist at the University of California, San Francisco.

The median the women were willing to pay monthly was $20 for 25% improvement, $30 for 50% improvement, $40 for 75% improvement, and $50 for resolution.

African American women were willing to pay fivefold more than white women for symptom improvement, Hispanic women were willing to pay twofold more than white women, and those in the upper household income quartile were willing to pay twofold more than those in other income categories.

Costs associated with routine care for incontinence—such as for pads and laundry, also were higher for African American women, compared with white women.

Estimated weekly costs were a mean of $9.50 per week and median of $3.65 per week overall, Dr. Subak said, noting that African American women paid 80% more than white women, those with moderate and severe incontinence paid twofold more than those with mild incontinence, and those with urge incontinence paid 50% more than those with stress incontinence.

About 90% of the women studied had at least some cost associated with incontinence, she added.

The women, who were an average age of 56 years, were asked to quantify the weekly costs associated with their incontinence, and the figures obtained were multiplied by national resource costs to determine cost estimates.

ATLANTA — Women with urinary incontinence are willing to pay a substantial amount of money for symptom improvement, a new study shows.

The finding underscores the extent of the negative impact that incontinence has on quality of life, Dr. Leslee Subak said at the annual meeting of the American Urogynecologic Society.

A total of 300 women with varying degrees of urinary incontinence were surveyed to determine both the amount that women typically spend in the course of coping with their incontinence and the amounts they think they would be willing to spend to achieve 25%, 50%, 75%, or 100% symptom improvement.

Overall, the women were willing to pay more than $800 per year for symptom resolution—an amount comparable to what those with other chronic medical conditions, such as migraine headaches and acid reflux, have said they would be willing to pay for symptom resolution, said Dr. Subak, an obstetrician/gynecologist at the University of California, San Francisco.

The median the women were willing to pay monthly was $20 for 25% improvement, $30 for 50% improvement, $40 for 75% improvement, and $50 for resolution.

African American women were willing to pay fivefold more than white women for symptom improvement, Hispanic women were willing to pay twofold more than white women, and those in the upper household income quartile were willing to pay twofold more than those in other income categories.

Costs associated with routine care for incontinence—such as for pads and laundry, also were higher for African American women, compared with white women.

Estimated weekly costs were a mean of $9.50 per week and median of $3.65 per week overall, Dr. Subak said, noting that African American women paid 80% more than white women, those with moderate and severe incontinence paid twofold more than those with mild incontinence, and those with urge incontinence paid 50% more than those with stress incontinence.

About 90% of the women studied had at least some cost associated with incontinence, she added.

The women, who were an average age of 56 years, were asked to quantify the weekly costs associated with their incontinence, and the figures obtained were multiplied by national resource costs to determine cost estimates.

ATLANTA — Women with urinary incontinence are willing to pay a substantial amount of money for symptom improvement, a new study shows.

The finding underscores the extent of the negative impact that incontinence has on quality of life, Dr. Leslee Subak said at the annual meeting of the American Urogynecologic Society.

A total of 300 women with varying degrees of urinary incontinence were surveyed to determine both the amount that women typically spend in the course of coping with their incontinence and the amounts they think they would be willing to spend to achieve 25%, 50%, 75%, or 100% symptom improvement.

Overall, the women were willing to pay more than $800 per year for symptom resolution—an amount comparable to what those with other chronic medical conditions, such as migraine headaches and acid reflux, have said they would be willing to pay for symptom resolution, said Dr. Subak, an obstetrician/gynecologist at the University of California, San Francisco.

The median the women were willing to pay monthly was $20 for 25% improvement, $30 for 50% improvement, $40 for 75% improvement, and $50 for resolution.

African American women were willing to pay fivefold more than white women for symptom improvement, Hispanic women were willing to pay twofold more than white women, and those in the upper household income quartile were willing to pay twofold more than those in other income categories.

Costs associated with routine care for incontinence—such as for pads and laundry, also were higher for African American women, compared with white women.

Estimated weekly costs were a mean of $9.50 per week and median of $3.65 per week overall, Dr. Subak said, noting that African American women paid 80% more than white women, those with moderate and severe incontinence paid twofold more than those with mild incontinence, and those with urge incontinence paid 50% more than those with stress incontinence.

About 90% of the women studied had at least some cost associated with incontinence, she added.

The women, who were an average age of 56 years, were asked to quantify the weekly costs associated with their incontinence, and the figures obtained were multiplied by national resource costs to determine cost estimates.

ATLANTA — The promising results seen in initial studies of SURx transvaginal radio frequency for the treatment of stress urinary incontinence were not replicated in a recent series of patients.

“We were unable to replicate previously reported response with the SURx procedure despite adequate technique, and although we found it to be safe, we have decided not to continue to offer this as a treatment option for our patients,” Dr. Gunhilde Buchsbaum said at the annual meeting of the American Urogynecologic Society.

Initial studies of the SURx system, which was approved for use in the United States in 1997, showed cure rates and patient satisfaction rates in the 80% range. In the current study comprising 15 patients treated at the University of Rochester (N.Y.) Medical Center from January 2003 to April 2004, the success rate was low, patient satisfaction was low, and the rate of additional treatment was high, said Dr. Buchsbaum of the departments of obstetrics and gynecology, and urology at the university.

Before treatment, all patients had a mean Valsalva leak-point pressure (VLPP) of 150 cm H₂O, and seven had concomitant urge. The mean number of leaks per day was about six. The patients were treated with a total radio frequency application time of 188 seconds for both sides. There were no complications.

After surgery, 6 of the 15 patients had a negative cough stress test, and 9 reported ongoing stress urinary incontinence symptoms and had a positive cough stress test. The average number of leaks per day in those with ongoing symptoms was reduced from six to four.

Five patients said they were extremely satisfied with the procedure, one was satisfied, and nine were not satisfied. Seven patients sought additional treatment within a year; four had tension-free vaginal tape placement, one had Burch colposuspension, and two were fitted with a continence ring.

The treatment was discontinued at the medical center because the 40% cure rate was deemed unacceptable, Dr. Buchsbaum said. “Every procedure has a learning curve; however …it is important for any procedure marketed for widespread use to have minimal operator dependency,” she said.

ATLANTA — The promising results seen in initial studies of SURx transvaginal radio frequency for the treatment of stress urinary incontinence were not replicated in a recent series of patients.

“We were unable to replicate previously reported response with the SURx procedure despite adequate technique, and although we found it to be safe, we have decided not to continue to offer this as a treatment option for our patients,” Dr. Gunhilde Buchsbaum said at the annual meeting of the American Urogynecologic Society.

Initial studies of the SURx system, which was approved for use in the United States in 1997, showed cure rates and patient satisfaction rates in the 80% range. In the current study comprising 15 patients treated at the University of Rochester (N.Y.) Medical Center from January 2003 to April 2004, the success rate was low, patient satisfaction was low, and the rate of additional treatment was high, said Dr. Buchsbaum of the departments of obstetrics and gynecology, and urology at the university.

Before treatment, all patients had a mean Valsalva leak-point pressure (VLPP) of 150 cm H₂O, and seven had concomitant urge. The mean number of leaks per day was about six. The patients were treated with a total radio frequency application time of 188 seconds for both sides. There were no complications.

After surgery, 6 of the 15 patients had a negative cough stress test, and 9 reported ongoing stress urinary incontinence symptoms and had a positive cough stress test. The average number of leaks per day in those with ongoing symptoms was reduced from six to four.

Five patients said they were extremely satisfied with the procedure, one was satisfied, and nine were not satisfied. Seven patients sought additional treatment within a year; four had tension-free vaginal tape placement, one had Burch colposuspension, and two were fitted with a continence ring.

The treatment was discontinued at the medical center because the 40% cure rate was deemed unacceptable, Dr. Buchsbaum said. “Every procedure has a learning curve; however …it is important for any procedure marketed for widespread use to have minimal operator dependency,” she said.

ATLANTA — The promising results seen in initial studies of SURx transvaginal radio frequency for the treatment of stress urinary incontinence were not replicated in a recent series of patients.

“We were unable to replicate previously reported response with the SURx procedure despite adequate technique, and although we found it to be safe, we have decided not to continue to offer this as a treatment option for our patients,” Dr. Gunhilde Buchsbaum said at the annual meeting of the American Urogynecologic Society.

Initial studies of the SURx system, which was approved for use in the United States in 1997, showed cure rates and patient satisfaction rates in the 80% range. In the current study comprising 15 patients treated at the University of Rochester (N.Y.) Medical Center from January 2003 to April 2004, the success rate was low, patient satisfaction was low, and the rate of additional treatment was high, said Dr. Buchsbaum of the departments of obstetrics and gynecology, and urology at the university.

Before treatment, all patients had a mean Valsalva leak-point pressure (VLPP) of 150 cm H₂O, and seven had concomitant urge. The mean number of leaks per day was about six. The patients were treated with a total radio frequency application time of 188 seconds for both sides. There were no complications.

After surgery, 6 of the 15 patients had a negative cough stress test, and 9 reported ongoing stress urinary incontinence symptoms and had a positive cough stress test. The average number of leaks per day in those with ongoing symptoms was reduced from six to four.

Five patients said they were extremely satisfied with the procedure, one was satisfied, and nine were not satisfied. Seven patients sought additional treatment within a year; four had tension-free vaginal tape placement, one had Burch colposuspension, and two were fitted with a continence ring.

The treatment was discontinued at the medical center because the 40% cure rate was deemed unacceptable, Dr. Buchsbaum said. “Every procedure has a learning curve; however …it is important for any procedure marketed for widespread use to have minimal operator dependency,” she said.

MIAMI BEACH — Contingent screening is an attractive option for prenatal detection of trisomy 21, Dr. Fergal Malone said at the annual meeting of the Society for Maternal-Fetal Medicine.

This screening method was analyzed using data from the First and Second Trimester Evaluation of Risk (FASTER) trial, a National Institute of Child Health and Human Development-funded study of pregnant women who underwent screening in both trimesters.

The outcomes of contingent screening were compared with the outcomes of two other commonly described screening methods: stepwise sequential screening and integrated screening in more than 32,000 women in the FASTER trial population.

The results of the analysis showed that contingent screening had a detection rate of 93%, with a false-positive rate of 4% in a relative comparison of the three methods for detection of trisomy 21 in the FASTER population. The first-trimester detection rate was 65%, with 2% of patients requiring chorionic villus sampling (CVS), and the second-trimester detection rate was 28%, with another 3% of patients requiring amniocentesis.

Only 22% of patients required additional screening in the second trimester, said Dr. Malone of the Royal College of Surgeons in Dublin.

Stepwise sequential screening had a 95% detection rate with a 5% false-positive rate and a 65% early detection rate. But 98% of patients were required to return for second-trimester screening to achieve these target rates.

Integrated screening had a comparable 92% detection rate, with a false-positive rate of 5%. This method provided no early detection, and required that 100% of patients return for second-trimester screening.

The contingent screening approach assigns patients to one of three trisomy 21 risk groups based on the first-trimester ultrasound measurement of nuchal translucence and the first-trimester serum measurement of pregnancy-associated plasma protein-A (PAPP-A) and free β-hCG.

Patients in the highest risk group (greater than 1:30 risk in this study) undergo CVS, those in the lowest risk group (less than 1:1,500 risk) receive no further testing, and those in the borderline risk group (between 1:30 and 1:1,500 risk) undergo quad screening (serum alpha fetoprotein, hCG, unconjugated estriol, and inhibin A) in the second trimester and receive a final risk assessment based on all the measures, with a risk cutoff for further testing of 1:270, Dr. Malone explained.

Stepwise sequential screening divides patients into two risk groups that are based on nuchal translucency, PAPP-A, and free β-hCG measures in the first trimester, with those with a risk of greater than 1:30 receiving immediate CVS, and all others returning for second-trimester quad screening.

Integrated screening consists of nuchal translucency and PAPP-A screening in the first trimester, with no risk assessment given at that time, and quad screening in the second trimester.

A risk assessment that is based upon all the measures is given following the second-trimester screening, with a cutoff of 1:270 for additional screening. This method raises ethical concerns about withholding results during the first trimester and possibly causing a delay in a patient's potential decision to terminate due to aneuploidy.

“While contingent screening appears very attractive, there are some practical issues that need to be considered before endorsing this approach for widespread implementation,” Dr. Malone stressed.

For example, the outcomes reported require that patients precisely follow the risk cutoffs used in this study.

The question is whether a woman with a risk of 1:31 versus the cutoff of 1:30 would forego chorionic villus sampling and wait for second-trimester screening results.

If the patients do not accept and follow these risk cutoff values precisely, the actual observed performance of contingent screening will be less efficient, he explained.

Other practical concerns regarding contingent screening include the effects of borderline-risk patients who fail to return for later screening and the fact that most patients screened by this method would have no neural-tube-defect risk assessment performed; steps would need to be taken to establish alternate methods for such screening, such as sonographic central nervous system anatomy evaluation, or single-marker alpha-fetoprotein testing, he said.

Contingent screening appears to effectively balance the benefits of first-trimester screening while focusing the added value of second-trimester screening measures on just a small segment of the population of pregnant women, Dr. Malone said.

“But before widespread use of this screening can be endorsed, prospective implementation studies will be required to confirm its efficacy in actual clinical practice,” he concluded.

MIAMI BEACH — Contingent screening is an attractive option for prenatal detection of trisomy 21, Dr. Fergal Malone said at the annual meeting of the Society for Maternal-Fetal Medicine.

This screening method was analyzed using data from the First and Second Trimester Evaluation of Risk (FASTER) trial, a National Institute of Child Health and Human Development-funded study of pregnant women who underwent screening in both trimesters.

The outcomes of contingent screening were compared with the outcomes of two other commonly described screening methods: stepwise sequential screening and integrated screening in more than 32,000 women in the FASTER trial population.

The results of the analysis showed that contingent screening had a detection rate of 93%, with a false-positive rate of 4% in a relative comparison of the three methods for detection of trisomy 21 in the FASTER population. The first-trimester detection rate was 65%, with 2% of patients requiring chorionic villus sampling (CVS), and the second-trimester detection rate was 28%, with another 3% of patients requiring amniocentesis.

Only 22% of patients required additional screening in the second trimester, said Dr. Malone of the Royal College of Surgeons in Dublin.

Stepwise sequential screening had a 95% detection rate with a 5% false-positive rate and a 65% early detection rate. But 98% of patients were required to return for second-trimester screening to achieve these target rates.

Integrated screening had a comparable 92% detection rate, with a false-positive rate of 5%. This method provided no early detection, and required that 100% of patients return for second-trimester screening.

The contingent screening approach assigns patients to one of three trisomy 21 risk groups based on the first-trimester ultrasound measurement of nuchal translucence and the first-trimester serum measurement of pregnancy-associated plasma protein-A (PAPP-A) and free β-hCG.

Patients in the highest risk group (greater than 1:30 risk in this study) undergo CVS, those in the lowest risk group (less than 1:1,500 risk) receive no further testing, and those in the borderline risk group (between 1:30 and 1:1,500 risk) undergo quad screening (serum alpha fetoprotein, hCG, unconjugated estriol, and inhibin A) in the second trimester and receive a final risk assessment based on all the measures, with a risk cutoff for further testing of 1:270, Dr. Malone explained.

Stepwise sequential screening divides patients into two risk groups that are based on nuchal translucency, PAPP-A, and free β-hCG measures in the first trimester, with those with a risk of greater than 1:30 receiving immediate CVS, and all others returning for second-trimester quad screening.

Integrated screening consists of nuchal translucency and PAPP-A screening in the first trimester, with no risk assessment given at that time, and quad screening in the second trimester.

A risk assessment that is based upon all the measures is given following the second-trimester screening, with a cutoff of 1:270 for additional screening. This method raises ethical concerns about withholding results during the first trimester and possibly causing a delay in a patient's potential decision to terminate due to aneuploidy.

“While contingent screening appears very attractive, there are some practical issues that need to be considered before endorsing this approach for widespread implementation,” Dr. Malone stressed.

For example, the outcomes reported require that patients precisely follow the risk cutoffs used in this study.

The question is whether a woman with a risk of 1:31 versus the cutoff of 1:30 would forego chorionic villus sampling and wait for second-trimester screening results.

If the patients do not accept and follow these risk cutoff values precisely, the actual observed performance of contingent screening will be less efficient, he explained.

Other practical concerns regarding contingent screening include the effects of borderline-risk patients who fail to return for later screening and the fact that most patients screened by this method would have no neural-tube-defect risk assessment performed; steps would need to be taken to establish alternate methods for such screening, such as sonographic central nervous system anatomy evaluation, or single-marker alpha-fetoprotein testing, he said.

Contingent screening appears to effectively balance the benefits of first-trimester screening while focusing the added value of second-trimester screening measures on just a small segment of the population of pregnant women, Dr. Malone said.

“But before widespread use of this screening can be endorsed, prospective implementation studies will be required to confirm its efficacy in actual clinical practice,” he concluded.

MIAMI BEACH — Contingent screening is an attractive option for prenatal detection of trisomy 21, Dr. Fergal Malone said at the annual meeting of the Society for Maternal-Fetal Medicine.

This screening method was analyzed using data from the First and Second Trimester Evaluation of Risk (FASTER) trial, a National Institute of Child Health and Human Development-funded study of pregnant women who underwent screening in both trimesters.

The outcomes of contingent screening were compared with the outcomes of two other commonly described screening methods: stepwise sequential screening and integrated screening in more than 32,000 women in the FASTER trial population.

The results of the analysis showed that contingent screening had a detection rate of 93%, with a false-positive rate of 4% in a relative comparison of the three methods for detection of trisomy 21 in the FASTER population. The first-trimester detection rate was 65%, with 2% of patients requiring chorionic villus sampling (CVS), and the second-trimester detection rate was 28%, with another 3% of patients requiring amniocentesis.

Only 22% of patients required additional screening in the second trimester, said Dr. Malone of the Royal College of Surgeons in Dublin.

Stepwise sequential screening had a 95% detection rate with a 5% false-positive rate and a 65% early detection rate. But 98% of patients were required to return for second-trimester screening to achieve these target rates.

Integrated screening had a comparable 92% detection rate, with a false-positive rate of 5%. This method provided no early detection, and required that 100% of patients return for second-trimester screening.

The contingent screening approach assigns patients to one of three trisomy 21 risk groups based on the first-trimester ultrasound measurement of nuchal translucence and the first-trimester serum measurement of pregnancy-associated plasma protein-A (PAPP-A) and free β-hCG.

Patients in the highest risk group (greater than 1:30 risk in this study) undergo CVS, those in the lowest risk group (less than 1:1,500 risk) receive no further testing, and those in the borderline risk group (between 1:30 and 1:1,500 risk) undergo quad screening (serum alpha fetoprotein, hCG, unconjugated estriol, and inhibin A) in the second trimester and receive a final risk assessment based on all the measures, with a risk cutoff for further testing of 1:270, Dr. Malone explained.

Stepwise sequential screening divides patients into two risk groups that are based on nuchal translucency, PAPP-A, and free β-hCG measures in the first trimester, with those with a risk of greater than 1:30 receiving immediate CVS, and all others returning for second-trimester quad screening.

Integrated screening consists of nuchal translucency and PAPP-A screening in the first trimester, with no risk assessment given at that time, and quad screening in the second trimester.

A risk assessment that is based upon all the measures is given following the second-trimester screening, with a cutoff of 1:270 for additional screening. This method raises ethical concerns about withholding results during the first trimester and possibly causing a delay in a patient's potential decision to terminate due to aneuploidy.

“While contingent screening appears very attractive, there are some practical issues that need to be considered before endorsing this approach for widespread implementation,” Dr. Malone stressed.

For example, the outcomes reported require that patients precisely follow the risk cutoffs used in this study.

The question is whether a woman with a risk of 1:31 versus the cutoff of 1:30 would forego chorionic villus sampling and wait for second-trimester screening results.

If the patients do not accept and follow these risk cutoff values precisely, the actual observed performance of contingent screening will be less efficient, he explained.

Other practical concerns regarding contingent screening include the effects of borderline-risk patients who fail to return for later screening and the fact that most patients screened by this method would have no neural-tube-defect risk assessment performed; steps would need to be taken to establish alternate methods for such screening, such as sonographic central nervous system anatomy evaluation, or single-marker alpha-fetoprotein testing, he said.

Contingent screening appears to effectively balance the benefits of first-trimester screening while focusing the added value of second-trimester screening measures on just a small segment of the population of pregnant women, Dr. Malone said.

“But before widespread use of this screening can be endorsed, prospective implementation studies will be required to confirm its efficacy in actual clinical practice,” he concluded.

MIAMI BEACH — Continuous subcutaneous insulin lispro infusion seems to be superior to multiple daily insulin lispro injections for the treatment of pregnant women with type 1 diabetes, Dr. Giorgio Mello said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled study of 71 pregnant women with type 1 diabetes and 142 matched, nondiabetic, pregnant controls, continuous subcutaneous insulin infusions (CSII) were found to mimic more closely than multiple daily injections (given as a premeal bolus) the normal postprandial glucose excursion pattern, said Dr. Mello of the University of Florence, Italy.

Patients in both groups had similar average daily glucose levels. However, at 16−, 26−, and 36-week evaluations, those in the CSII group had 24-hour glycemic profiles similar to the normal group; those in the multiple daily injections group had a significantly longer time period in the three-meal postprandial areas.

Fetuses in the CSII group, but not in the multiple daily injection group, had growth patterns similar to those of controls, as measured by ultrasound scans performed every 2 weeks between 25 and 38 weeks' gestation, Dr. Mello noted.

MIAMI BEACH — Continuous subcutaneous insulin lispro infusion seems to be superior to multiple daily insulin lispro injections for the treatment of pregnant women with type 1 diabetes, Dr. Giorgio Mello said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled study of 71 pregnant women with type 1 diabetes and 142 matched, nondiabetic, pregnant controls, continuous subcutaneous insulin infusions (CSII) were found to mimic more closely than multiple daily injections (given as a premeal bolus) the normal postprandial glucose excursion pattern, said Dr. Mello of the University of Florence, Italy.

Patients in both groups had similar average daily glucose levels. However, at 16−, 26−, and 36-week evaluations, those in the CSII group had 24-hour glycemic profiles similar to the normal group; those in the multiple daily injections group had a significantly longer time period in the three-meal postprandial areas.

Fetuses in the CSII group, but not in the multiple daily injection group, had growth patterns similar to those of controls, as measured by ultrasound scans performed every 2 weeks between 25 and 38 weeks' gestation, Dr. Mello noted.

MIAMI BEACH — Continuous subcutaneous insulin lispro infusion seems to be superior to multiple daily insulin lispro injections for the treatment of pregnant women with type 1 diabetes, Dr. Giorgio Mello said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled study of 71 pregnant women with type 1 diabetes and 142 matched, nondiabetic, pregnant controls, continuous subcutaneous insulin infusions (CSII) were found to mimic more closely than multiple daily injections (given as a premeal bolus) the normal postprandial glucose excursion pattern, said Dr. Mello of the University of Florence, Italy.

Patients in both groups had similar average daily glucose levels. However, at 16−, 26−, and 36-week evaluations, those in the CSII group had 24-hour glycemic profiles similar to the normal group; those in the multiple daily injections group had a significantly longer time period in the three-meal postprandial areas.

Fetuses in the CSII group, but not in the multiple daily injection group, had growth patterns similar to those of controls, as measured by ultrasound scans performed every 2 weeks between 25 and 38 weeks' gestation, Dr. Mello noted.

ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common, and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco.

Transfusion also resulted in a significantly longer hospital stay. The mean stay was 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II who had a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of any morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource utilization.

Red blood cell transfusions, which had no detectable benefit in this study, are overused, and are associated with increased morbidity and increased health care expenses, Dr. Levin concluded.

ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common, and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco.

Transfusion also resulted in a significantly longer hospital stay. The mean stay was 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II who had a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of any morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource utilization.

Red blood cell transfusions, which had no detectable benefit in this study, are overused, and are associated with increased morbidity and increased health care expenses, Dr. Levin concluded.

ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common, and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco.

Transfusion also resulted in a significantly longer hospital stay. The mean stay was 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II who had a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of any morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource utilization.

Red blood cell transfusions, which had no detectable benefit in this study, are overused, and are associated with increased morbidity and increased health care expenses, Dr. Levin concluded.

ATLANTA — Lateral orbital fullness noted during upper blepharoplasty is usually caused by orbital fat that can be resected, but the finding can be a result of lacrimal gland prolapse, Dr. Hanspaul Makkar said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Resection of prolapsed lacrimal gland tissue will cause decreased tear production and could compromise aesthetic outcome, so it is important to be aware of this potential finding, said Dr. Makkar of the University of California, San Francisco.

A preoperative examination is imperative. Lacrimal gland prolapse—which results from dehiscence of ligaments that connect the gland to the orbital rim fossa, and which can occur as a result of trauma or the normal aging process—should be suspected if the tissue feels firmer and is more circumscribed than surrounding tissue. Palpation will reveal a nontender, sharply bordered, and easily reducible mass, he explained. However, a nonreducible or tender mass merits work-up for a lacrimal gland tumor or inflammatory process.

Keep in mind that in patients with marked herniation of fat, lacrimal gland prolapse might not be detectable except during surgical exploration.

Correction of lacrimal gland prolapse can be achieved easily by resuspending the lacrimal gland to the orbital rim during the upper blepharoplasty procedure. This step is necessary for a good cosmetic outcome.

Dr. Makkar described two of his own patients whose unexpected lacrimal gland prolapse was detected perioperatively. The patients were treated with the resuspension procedure, and outcomes at 6 months were excellent with no signs of recurrent lacrimal gland ptosis, he said.

ATLANTA — Lateral orbital fullness noted during upper blepharoplasty is usually caused by orbital fat that can be resected, but the finding can be a result of lacrimal gland prolapse, Dr. Hanspaul Makkar said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Resection of prolapsed lacrimal gland tissue will cause decreased tear production and could compromise aesthetic outcome, so it is important to be aware of this potential finding, said Dr. Makkar of the University of California, San Francisco.

A preoperative examination is imperative. Lacrimal gland prolapse—which results from dehiscence of ligaments that connect the gland to the orbital rim fossa, and which can occur as a result of trauma or the normal aging process—should be suspected if the tissue feels firmer and is more circumscribed than surrounding tissue. Palpation will reveal a nontender, sharply bordered, and easily reducible mass, he explained. However, a nonreducible or tender mass merits work-up for a lacrimal gland tumor or inflammatory process.

Keep in mind that in patients with marked herniation of fat, lacrimal gland prolapse might not be detectable except during surgical exploration.

Correction of lacrimal gland prolapse can be achieved easily by resuspending the lacrimal gland to the orbital rim during the upper blepharoplasty procedure. This step is necessary for a good cosmetic outcome.

Dr. Makkar described two of his own patients whose unexpected lacrimal gland prolapse was detected perioperatively. The patients were treated with the resuspension procedure, and outcomes at 6 months were excellent with no signs of recurrent lacrimal gland ptosis, he said.

ATLANTA — Lateral orbital fullness noted during upper blepharoplasty is usually caused by orbital fat that can be resected, but the finding can be a result of lacrimal gland prolapse, Dr. Hanspaul Makkar said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Resection of prolapsed lacrimal gland tissue will cause decreased tear production and could compromise aesthetic outcome, so it is important to be aware of this potential finding, said Dr. Makkar of the University of California, San Francisco.

A preoperative examination is imperative. Lacrimal gland prolapse—which results from dehiscence of ligaments that connect the gland to the orbital rim fossa, and which can occur as a result of trauma or the normal aging process—should be suspected if the tissue feels firmer and is more circumscribed than surrounding tissue. Palpation will reveal a nontender, sharply bordered, and easily reducible mass, he explained. However, a nonreducible or tender mass merits work-up for a lacrimal gland tumor or inflammatory process.

Keep in mind that in patients with marked herniation of fat, lacrimal gland prolapse might not be detectable except during surgical exploration.

Correction of lacrimal gland prolapse can be achieved easily by resuspending the lacrimal gland to the orbital rim during the upper blepharoplasty procedure. This step is necessary for a good cosmetic outcome.

Dr. Makkar described two of his own patients whose unexpected lacrimal gland prolapse was detected perioperatively. The patients were treated with the resuspension procedure, and outcomes at 6 months were excellent with no signs of recurrent lacrimal gland ptosis, he said.

ATLANTA — Patients with acne vulgaris may benefit from treatment with a device that combines pulsed light and radiofrequency energy, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%.

Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 vs. 0.07, respectively). Heat shock protein 70 and procollagen-1 appeared unaffected by treatment.

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current has a direct effect on Propionibacterium acnes by photochemical activation of porphyrins, and by selective hyperthermia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

The technology is effective and safe for the typically young patients who present with acne vulgaris, but it is not a cure, he said. The effects are temporary and provide about a 3- to 4-month disease-free interval when the device is used as the sole acne treatment modality.

The mechanisms of action of this technology need to be further defined, and the optimal treatment settings and number need to be determined. Additional study of the use of this technology along with other treatment modalities is also warranted, Dr. Sadick concluded.

Dr. Sadick is a research consultant for Syneron Inc.

A patient is shown before undergoing treatment with the Aurora AC device.

Partial clearance is evident above after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

ATLANTA — Patients with acne vulgaris may benefit from treatment with a device that combines pulsed light and radiofrequency energy, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%.

Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 vs. 0.07, respectively). Heat shock protein 70 and procollagen-1 appeared unaffected by treatment.

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current has a direct effect on Propionibacterium acnes by photochemical activation of porphyrins, and by selective hyperthermia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

The technology is effective and safe for the typically young patients who present with acne vulgaris, but it is not a cure, he said. The effects are temporary and provide about a 3- to 4-month disease-free interval when the device is used as the sole acne treatment modality.

The mechanisms of action of this technology need to be further defined, and the optimal treatment settings and number need to be determined. Additional study of the use of this technology along with other treatment modalities is also warranted, Dr. Sadick concluded.

Dr. Sadick is a research consultant for Syneron Inc.

A patient is shown before undergoing treatment with the Aurora AC device.

Partial clearance is evident above after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

ATLANTA — Patients with acne vulgaris may benefit from treatment with a device that combines pulsed light and radiofrequency energy, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%.

Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 vs. 0.07, respectively). Heat shock protein 70 and procollagen-1 appeared unaffected by treatment.

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current has a direct effect on Propionibacterium acnes by photochemical activation of porphyrins, and by selective hyperthermia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

The technology is effective and safe for the typically young patients who present with acne vulgaris, but it is not a cure, he said. The effects are temporary and provide about a 3- to 4-month disease-free interval when the device is used as the sole acne treatment modality.

The mechanisms of action of this technology need to be further defined, and the optimal treatment settings and number need to be determined. Additional study of the use of this technology along with other treatment modalities is also warranted, Dr. Sadick concluded.

Dr. Sadick is a research consultant for Syneron Inc.

A patient is shown before undergoing treatment with the Aurora AC device.

Partial clearance is evident above after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

Periodic Breathing Common in CHF

Periodic breathing during sleep and during exercise appear to be very common in patients with stable heart failure, affecting about half of them, reported Dr. Ugo Corrà of the Salvatore Maugeri Foundation, Veruno, Italy, and associates.

Periodic breathing is an abnormal oscillatory ventilation pattern consisting of cyclic hyperpnea and hypopnea, which can occur in heart failure (HF) patients during sleep or on exertion. Often, the coexistence of the two types of periodic breathing in one patient is hidden from the physician because one type is detected only on exercise testing and the other only in sleep studies.

Dr. Corrà and associates assessed the prognostic value of sleep periodic breathing and exertional periodic breathing in a prospective study of 133 patients with stable, moderate to severe HF as a result of ischemic or idiopathic dilated cardiomyopathy (Circulation 2006;113:44–50).

A total of 67 patients (50%) had some form of periodic breathing: 39 patients (29%) had severe sleep periodic breathing alone, 6 (4%) had exertional periodic breathing alone, and 22 (16%) had both.

During a mean of 3 years of follow-up, 30 patients (23%) died of cardiac causes. Mortality was 9% in patients with no periodic breathing disorders, 17% in those with exertional periodic breathing alone, 31% in those with sleep periodic breathing alone, and 54% in those with both breathing disorders.

Thus, the combination of both sleep and exertional periodic breathing is “a peculiarly ominous condition,” the investigators said.

CRP Doesn't Predict Plaque Burden

C-reactive protein levels appear to be a poor predictor of atherosclerotic plaque burden, reported Dr. Amit Khera of the University of Texas Southwestern Medical Center, Dallas, and associates.

The researchers measured CRP levels in an ethnically diverse, population-based probability sample of subjects aged 30–64 years who were enrolled in a large clinical trial on heart disease. They then assessed correlations between CRP and coronary artery calcification as measured by electron-beam CT in 2,726 of the subjects.

In addition, because not all atherosclerotic plaque is calcified, the investigators examined possible correlations between CRP levels and a novel measure of “soft” plaque—MRI assessment of detectable levels of aortic plaque—in 2,393 subjects.

CRP levels were only modestly associated with atherosclerotic burden, and the correlation was stronger in men than it was in women.

However, this correlation disappeared after the researchers adjusted data for subject age, body mass index, and standard cardiovascular risk factors such as smoking and diabetes (Circulation 2006;113:38–43).

The study results suggest that the link between high CRP levels and incident cardiovascular events “may reflect the composition, morphology, and stability of plaque rather than overall atherosclerotic burden,” they added.

Sizing Up Impact of VTE

More than 900,000 people in the United States experience venous thromboembolism events each year, and a third of these events are fatal, Dr. John A. Heit of the Mayo Clinic, Rochester, Minn., and his colleagues reported in a poster at the annual meeting of the American Society of Hematology.

Using community, hospital, and U.S. census data, the investigators developed an incidence-based model, which estimated that the total annual number of nonfatal venous thromboembolism (VTE) events in the United States is 613,423, including 376,365 cases of deep vein thrombosis (DVT) and 237,058 cases of pulmonary embolism (PE). The estimated annual number of fatal VTE events is 296,370, including 2,258 cases of DVT and 294,112 cases of PE.

Only 7% of VTE-related deaths occur in patients who are diagnosed and treated. More than a third (34%) are a result of sudden, fatal PE, and 59% follow undiagnosed VTE. Two-thirds of VTE events occur in hospitals where safe and effective prophylaxis is available, Dr. Heit noted.

Effective VTE prophylaxis and expert consensus guidelines on the use of prophylaxis are widely available; universal prophylaxis could significantly reduce VTE incidence and related deaths in this country, and its impact deserves further study, the investigators concluded.

Periodic Breathing Common in CHF

Periodic breathing during sleep and during exercise appear to be very common in patients with stable heart failure, affecting about half of them, reported Dr. Ugo Corrà of the Salvatore Maugeri Foundation, Veruno, Italy, and associates.

Periodic breathing is an abnormal oscillatory ventilation pattern consisting of cyclic hyperpnea and hypopnea, which can occur in heart failure (HF) patients during sleep or on exertion. Often, the coexistence of the two types of periodic breathing in one patient is hidden from the physician because one type is detected only on exercise testing and the other only in sleep studies.

Dr. Corrà and associates assessed the prognostic value of sleep periodic breathing and exertional periodic breathing in a prospective study of 133 patients with stable, moderate to severe HF as a result of ischemic or idiopathic dilated cardiomyopathy (Circulation 2006;113:44–50).

A total of 67 patients (50%) had some form of periodic breathing: 39 patients (29%) had severe sleep periodic breathing alone, 6 (4%) had exertional periodic breathing alone, and 22 (16%) had both.

During a mean of 3 years of follow-up, 30 patients (23%) died of cardiac causes. Mortality was 9% in patients with no periodic breathing disorders, 17% in those with exertional periodic breathing alone, 31% in those with sleep periodic breathing alone, and 54% in those with both breathing disorders.

Thus, the combination of both sleep and exertional periodic breathing is “a peculiarly ominous condition,” the investigators said.

CRP Doesn't Predict Plaque Burden

C-reactive protein levels appear to be a poor predictor of atherosclerotic plaque burden, reported Dr. Amit Khera of the University of Texas Southwestern Medical Center, Dallas, and associates.

The researchers measured CRP levels in an ethnically diverse, population-based probability sample of subjects aged 30–64 years who were enrolled in a large clinical trial on heart disease. They then assessed correlations between CRP and coronary artery calcification as measured by electron-beam CT in 2,726 of the subjects.

In addition, because not all atherosclerotic plaque is calcified, the investigators examined possible correlations between CRP levels and a novel measure of “soft” plaque—MRI assessment of detectable levels of aortic plaque—in 2,393 subjects.

CRP levels were only modestly associated with atherosclerotic burden, and the correlation was stronger in men than it was in women.

However, this correlation disappeared after the researchers adjusted data for subject age, body mass index, and standard cardiovascular risk factors such as smoking and diabetes (Circulation 2006;113:38–43).

The study results suggest that the link between high CRP levels and incident cardiovascular events “may reflect the composition, morphology, and stability of plaque rather than overall atherosclerotic burden,” they added.

Sizing Up Impact of VTE

More than 900,000 people in the United States experience venous thromboembolism events each year, and a third of these events are fatal, Dr. John A. Heit of the Mayo Clinic, Rochester, Minn., and his colleagues reported in a poster at the annual meeting of the American Society of Hematology.

Using community, hospital, and U.S. census data, the investigators developed an incidence-based model, which estimated that the total annual number of nonfatal venous thromboembolism (VTE) events in the United States is 613,423, including 376,365 cases of deep vein thrombosis (DVT) and 237,058 cases of pulmonary embolism (PE). The estimated annual number of fatal VTE events is 296,370, including 2,258 cases of DVT and 294,112 cases of PE.

Only 7% of VTE-related deaths occur in patients who are diagnosed and treated. More than a third (34%) are a result of sudden, fatal PE, and 59% follow undiagnosed VTE. Two-thirds of VTE events occur in hospitals where safe and effective prophylaxis is available, Dr. Heit noted.

Effective VTE prophylaxis and expert consensus guidelines on the use of prophylaxis are widely available; universal prophylaxis could significantly reduce VTE incidence and related deaths in this country, and its impact deserves further study, the investigators concluded.

Periodic Breathing Common in CHF

Periodic breathing during sleep and during exercise appear to be very common in patients with stable heart failure, affecting about half of them, reported Dr. Ugo Corrà of the Salvatore Maugeri Foundation, Veruno, Italy, and associates.

Periodic breathing is an abnormal oscillatory ventilation pattern consisting of cyclic hyperpnea and hypopnea, which can occur in heart failure (HF) patients during sleep or on exertion. Often, the coexistence of the two types of periodic breathing in one patient is hidden from the physician because one type is detected only on exercise testing and the other only in sleep studies.

Dr. Corrà and associates assessed the prognostic value of sleep periodic breathing and exertional periodic breathing in a prospective study of 133 patients with stable, moderate to severe HF as a result of ischemic or idiopathic dilated cardiomyopathy (Circulation 2006;113:44–50).

A total of 67 patients (50%) had some form of periodic breathing: 39 patients (29%) had severe sleep periodic breathing alone, 6 (4%) had exertional periodic breathing alone, and 22 (16%) had both.

During a mean of 3 years of follow-up, 30 patients (23%) died of cardiac causes. Mortality was 9% in patients with no periodic breathing disorders, 17% in those with exertional periodic breathing alone, 31% in those with sleep periodic breathing alone, and 54% in those with both breathing disorders.

Thus, the combination of both sleep and exertional periodic breathing is “a peculiarly ominous condition,” the investigators said.

CRP Doesn't Predict Plaque Burden

C-reactive protein levels appear to be a poor predictor of atherosclerotic plaque burden, reported Dr. Amit Khera of the University of Texas Southwestern Medical Center, Dallas, and associates.

The researchers measured CRP levels in an ethnically diverse, population-based probability sample of subjects aged 30–64 years who were enrolled in a large clinical trial on heart disease. They then assessed correlations between CRP and coronary artery calcification as measured by electron-beam CT in 2,726 of the subjects.

In addition, because not all atherosclerotic plaque is calcified, the investigators examined possible correlations between CRP levels and a novel measure of “soft” plaque—MRI assessment of detectable levels of aortic plaque—in 2,393 subjects.

CRP levels were only modestly associated with atherosclerotic burden, and the correlation was stronger in men than it was in women.

However, this correlation disappeared after the researchers adjusted data for subject age, body mass index, and standard cardiovascular risk factors such as smoking and diabetes (Circulation 2006;113:38–43).

The study results suggest that the link between high CRP levels and incident cardiovascular events “may reflect the composition, morphology, and stability of plaque rather than overall atherosclerotic burden,” they added.

Sizing Up Impact of VTE

More than 900,000 people in the United States experience venous thromboembolism events each year, and a third of these events are fatal, Dr. John A. Heit of the Mayo Clinic, Rochester, Minn., and his colleagues reported in a poster at the annual meeting of the American Society of Hematology.

Using community, hospital, and U.S. census data, the investigators developed an incidence-based model, which estimated that the total annual number of nonfatal venous thromboembolism (VTE) events in the United States is 613,423, including 376,365 cases of deep vein thrombosis (DVT) and 237,058 cases of pulmonary embolism (PE). The estimated annual number of fatal VTE events is 296,370, including 2,258 cases of DVT and 294,112 cases of PE.

Only 7% of VTE-related deaths occur in patients who are diagnosed and treated. More than a third (34%) are a result of sudden, fatal PE, and 59% follow undiagnosed VTE. Two-thirds of VTE events occur in hospitals where safe and effective prophylaxis is available, Dr. Heit noted.

Effective VTE prophylaxis and expert consensus guidelines on the use of prophylaxis are widely available; universal prophylaxis could significantly reduce VTE incidence and related deaths in this country, and its impact deserves further study, the investigators concluded.

A temporary shortfall in the supply of carvedilol may cause some patients to have difficulty filling their prescriptions, the drug's maker, GlaxoSmithKline, announced in a “Dear Healthcare Professional” letter.

The company is working diligently to resolve the situation, the letter states.

Coreg (carvedilol) is indicated for mild and moderate heart failure and for essential hypertension, as well as for severe heart failure and post-myocardial infarction left ventricular dysfunction. It is the only β-blocking drug approved by the U.S. Food and Drug Administration for treatment of the latter two indications.

Because of the life-threatening nature of these two indications, GlaxoSmithKline (GSK) is working to provide emergency overnight shipments to local pharmacies of such patients who cannot get prescriptions filled.

To conserve available drug for those with the greatest need, the company asked that new patients with mild or moderate heart failure or essential hypertension not be started on Coreg and that a switch to Toprol-XL (metoprolol) be considered for those with mild to moderate heart failure who are already being treated with carvedilol; metoprolol is the only other β-blocker approved for use in this population.

Patients who are switched or who stop carvedilol treatment should be monitored carefully, the letter states.

Newly introduced documentation procedures are the cause of the delays in the release of the drug, according to GSK. The procedures were implemented as part of a consent decree with the FDA that was signed last year by GSK after the company was cited for manufacturing deficiencies associated with Paxil CR (paroxetine) and Avandamet (rosiglitazone and metformin), which are produced at the same Cidra, Puerto Rico, manufacturing facility that makes Coreg.

The consent decree requires third-party review documentation prior to any product release from the facility, and this process has delayed release of the drug and caused the “spot shortages,” according to a company spokesperson, who predicted the problem will be resolved in a matter of weeks rather than months.

The delays are also affecting Paxil CR and Avandamet supplies, but a “Dear Healthcare Professional” letter was not issued in regard to these drugs, because unlike severe heart failure patients and patients with post-myocardial infarction left ventricular dysfunction, patients on these drugs have alternative treatment options and are not generally considered to have life-threatening illness, she explained.

For information regarding the Coreg supply or to work with GSK to get emergency shipments of Coreg to local pharmacies for patients in need of the drug, call 888-825-5249.

A temporary shortfall in the supply of carvedilol may cause some patients to have difficulty filling their prescriptions, the drug's maker, GlaxoSmithKline, announced in a “Dear Healthcare Professional” letter.

The company is working diligently to resolve the situation, the letter states.

Coreg (carvedilol) is indicated for mild and moderate heart failure and for essential hypertension, as well as for severe heart failure and post-myocardial infarction left ventricular dysfunction. It is the only β-blocking drug approved by the U.S. Food and Drug Administration for treatment of the latter two indications.

Because of the life-threatening nature of these two indications, GlaxoSmithKline (GSK) is working to provide emergency overnight shipments to local pharmacies of such patients who cannot get prescriptions filled.

To conserve available drug for those with the greatest need, the company asked that new patients with mild or moderate heart failure or essential hypertension not be started on Coreg and that a switch to Toprol-XL (metoprolol) be considered for those with mild to moderate heart failure who are already being treated with carvedilol; metoprolol is the only other β-blocker approved for use in this population.

Patients who are switched or who stop carvedilol treatment should be monitored carefully, the letter states.

Newly introduced documentation procedures are the cause of the delays in the release of the drug, according to GSK. The procedures were implemented as part of a consent decree with the FDA that was signed last year by GSK after the company was cited for manufacturing deficiencies associated with Paxil CR (paroxetine) and Avandamet (rosiglitazone and metformin), which are produced at the same Cidra, Puerto Rico, manufacturing facility that makes Coreg.

The consent decree requires third-party review documentation prior to any product release from the facility, and this process has delayed release of the drug and caused the “spot shortages,” according to a company spokesperson, who predicted the problem will be resolved in a matter of weeks rather than months.

The delays are also affecting Paxil CR and Avandamet supplies, but a “Dear Healthcare Professional” letter was not issued in regard to these drugs, because unlike severe heart failure patients and patients with post-myocardial infarction left ventricular dysfunction, patients on these drugs have alternative treatment options and are not generally considered to have life-threatening illness, she explained.

For information regarding the Coreg supply or to work with GSK to get emergency shipments of Coreg to local pharmacies for patients in need of the drug, call 888-825-5249.

A temporary shortfall in the supply of carvedilol may cause some patients to have difficulty filling their prescriptions, the drug's maker, GlaxoSmithKline, announced in a “Dear Healthcare Professional” letter.

The company is working diligently to resolve the situation, the letter states.

Coreg (carvedilol) is indicated for mild and moderate heart failure and for essential hypertension, as well as for severe heart failure and post-myocardial infarction left ventricular dysfunction. It is the only β-blocking drug approved by the U.S. Food and Drug Administration for treatment of the latter two indications.

Because of the life-threatening nature of these two indications, GlaxoSmithKline (GSK) is working to provide emergency overnight shipments to local pharmacies of such patients who cannot get prescriptions filled.

To conserve available drug for those with the greatest need, the company asked that new patients with mild or moderate heart failure or essential hypertension not be started on Coreg and that a switch to Toprol-XL (metoprolol) be considered for those with mild to moderate heart failure who are already being treated with carvedilol; metoprolol is the only other β-blocker approved for use in this population.

Patients who are switched or who stop carvedilol treatment should be monitored carefully, the letter states.

Newly introduced documentation procedures are the cause of the delays in the release of the drug, according to GSK. The procedures were implemented as part of a consent decree with the FDA that was signed last year by GSK after the company was cited for manufacturing deficiencies associated with Paxil CR (paroxetine) and Avandamet (rosiglitazone and metformin), which are produced at the same Cidra, Puerto Rico, manufacturing facility that makes Coreg.

The consent decree requires third-party review documentation prior to any product release from the facility, and this process has delayed release of the drug and caused the “spot shortages,” according to a company spokesperson, who predicted the problem will be resolved in a matter of weeks rather than months.

The delays are also affecting Paxil CR and Avandamet supplies, but a “Dear Healthcare Professional” letter was not issued in regard to these drugs, because unlike severe heart failure patients and patients with post-myocardial infarction left ventricular dysfunction, patients on these drugs have alternative treatment options and are not generally considered to have life-threatening illness, she explained.

For information regarding the Coreg supply or to work with GSK to get emergency shipments of Coreg to local pharmacies for patients in need of the drug, call 888-825-5249.