Patrice Wendling

CHICAGO — Adherence to national cancer treatment guidelines was associated with decreased local and regional recurrence, improved disease-free and overall survival, and decreased treatment-associated morbidity in a study of 327 consecutive clinically node-negative melanoma patients.

A review of cancer registry data at Rush North Shore Medical Center in Skokie, Ill., revealed that 72% of patients were treated in compliance with National Comprehensive Cancer Network (NCCN) recommendations for margins of excision, Dr. Jennifer Erickson Foster and colleagues reported at a symposium sponsored by the Society of Surgical Oncology.

Appropriate lymph node staging and treatment was received by 271 patients or 83%. Interestingly, when treatment was performed by a surgical oncologist, margin compliance was 95% and lymph node compliance 92%, said Dr. Foster, the lead investigator. A recommended completion lymph node dissection was performed for a positive sentinel lymph node in 78% of patients.

Patients treated in a noncompliant fashion with regard to margins had a threefold increase in postoperative complications in comparison with those treated in a compliant fashion. Similarly, patients treated in a lymph node-noncompliant fashion were 2.4 times more likely to have a postoperative complication. Both findings were statistically significant, said Dr. Erickson Foster, who reported no conflicts of interest for the investigators.

Noncompliance with NCCN guidelines for margins of excision was associated with increased locoregional (26% vs. 6%) and distant recurrence (8% vs. 6%), as compared with compliant cases. Locoregional disease alone as the first site of relapse was seen in 33% of lymph node-noncompliant cases vs. 6% of lymph node-compliant cases.

Five-year disease-free survival was higher among margin-compliant cases, compared with margin-noncompliant cases (86% vs. 68%), as was 5-year overall survival (93% vs. 83%). Similar increases in disease-free (85% vs. 54%) and overall (95% vs. 66%) survival were observed with compliance to lymph node staging and treatment recommendations.

The mean follow-up was 51 months (minimum 18 months) and mean age 66 years; 53% of the patients were women, and 32% of melanomas were located on the trunk, a finding consistent with cutaneous melanoma. Postoperative complications were reported in 55 patients (17%), with major complications in 4%, including one myocardial infarction, one pneumothorax, two cases of lymphedema, and two cases of facial nerve injury.

"These findings are provocative and suggest that compliance with NCCN guidelines improves outcomes in clinically node-negative melanoma patients," senior author Dr. Tina J. Hieken, of Rush Medical College, in Chicago, said in an interview. "We recommend that clinicians treating melanoma patients become familiar with these guidelines and utilize them to assist clinical decision making."

During the question-and-answer session, Dr. Foster noted that 20 different physicians representing nine specialties performed melanoma treatment in the study. Compliance did improve among specialties as time went on, but only surgical oncologists had greater than 90% compliance for margins of excision and lymph node staging and treatment.

Audience member Dr. Daniel G. Coit, who cochaired the NCCN guideline committee for melanoma, stressed that noncompliance with recommendations should not be equated with poor medical care. "Guidelines don't define best medical care; the doctors and patients define best medical care," he said.

Both Dr. Foster and Dr. Hieken agreed that physicians regularly depart from guidelines for a variety of reasons, such as aesthetic considerations, patient preferences, patient comorbidities, and tumor features.

"Guidelines are a point of departure," said Dr. Coit of Memorial Sloan-Kettering Cancer Center in New York. "They are not how we must do it, and we need to be very careful about how we define that, because there are other people who don't know that and will be looking at these kinds of presentations very carefully, and they're going to come to the wrong conclusion."

CHICAGO — Adherence to national cancer treatment guidelines was associated with decreased local and regional recurrence, improved disease-free and overall survival, and decreased treatment-associated morbidity in a study of 327 consecutive clinically node-negative melanoma patients.

A review of cancer registry data at Rush North Shore Medical Center in Skokie, Ill., revealed that 72% of patients were treated in compliance with National Comprehensive Cancer Network (NCCN) recommendations for margins of excision, Dr. Jennifer Erickson Foster and colleagues reported at a symposium sponsored by the Society of Surgical Oncology.

Appropriate lymph node staging and treatment was received by 271 patients or 83%. Interestingly, when treatment was performed by a surgical oncologist, margin compliance was 95% and lymph node compliance 92%, said Dr. Foster, the lead investigator. A recommended completion lymph node dissection was performed for a positive sentinel lymph node in 78% of patients.

Patients treated in a noncompliant fashion with regard to margins had a threefold increase in postoperative complications in comparison with those treated in a compliant fashion. Similarly, patients treated in a lymph node-noncompliant fashion were 2.4 times more likely to have a postoperative complication. Both findings were statistically significant, said Dr. Erickson Foster, who reported no conflicts of interest for the investigators.

Noncompliance with NCCN guidelines for margins of excision was associated with increased locoregional (26% vs. 6%) and distant recurrence (8% vs. 6%), as compared with compliant cases. Locoregional disease alone as the first site of relapse was seen in 33% of lymph node-noncompliant cases vs. 6% of lymph node-compliant cases.

Five-year disease-free survival was higher among margin-compliant cases, compared with margin-noncompliant cases (86% vs. 68%), as was 5-year overall survival (93% vs. 83%). Similar increases in disease-free (85% vs. 54%) and overall (95% vs. 66%) survival were observed with compliance to lymph node staging and treatment recommendations.

The mean follow-up was 51 months (minimum 18 months) and mean age 66 years; 53% of the patients were women, and 32% of melanomas were located on the trunk, a finding consistent with cutaneous melanoma. Postoperative complications were reported in 55 patients (17%), with major complications in 4%, including one myocardial infarction, one pneumothorax, two cases of lymphedema, and two cases of facial nerve injury.

"These findings are provocative and suggest that compliance with NCCN guidelines improves outcomes in clinically node-negative melanoma patients," senior author Dr. Tina J. Hieken, of Rush Medical College, in Chicago, said in an interview. "We recommend that clinicians treating melanoma patients become familiar with these guidelines and utilize them to assist clinical decision making."

During the question-and-answer session, Dr. Foster noted that 20 different physicians representing nine specialties performed melanoma treatment in the study. Compliance did improve among specialties as time went on, but only surgical oncologists had greater than 90% compliance for margins of excision and lymph node staging and treatment.

Audience member Dr. Daniel G. Coit, who cochaired the NCCN guideline committee for melanoma, stressed that noncompliance with recommendations should not be equated with poor medical care. "Guidelines don't define best medical care; the doctors and patients define best medical care," he said.

Both Dr. Foster and Dr. Hieken agreed that physicians regularly depart from guidelines for a variety of reasons, such as aesthetic considerations, patient preferences, patient comorbidities, and tumor features.

"Guidelines are a point of departure," said Dr. Coit of Memorial Sloan-Kettering Cancer Center in New York. "They are not how we must do it, and we need to be very careful about how we define that, because there are other people who don't know that and will be looking at these kinds of presentations very carefully, and they're going to come to the wrong conclusion."

CHICAGO — Adherence to national cancer treatment guidelines was associated with decreased local and regional recurrence, improved disease-free and overall survival, and decreased treatment-associated morbidity in a study of 327 consecutive clinically node-negative melanoma patients.

A review of cancer registry data at Rush North Shore Medical Center in Skokie, Ill., revealed that 72% of patients were treated in compliance with National Comprehensive Cancer Network (NCCN) recommendations for margins of excision, Dr. Jennifer Erickson Foster and colleagues reported at a symposium sponsored by the Society of Surgical Oncology.

Appropriate lymph node staging and treatment was received by 271 patients or 83%. Interestingly, when treatment was performed by a surgical oncologist, margin compliance was 95% and lymph node compliance 92%, said Dr. Foster, the lead investigator. A recommended completion lymph node dissection was performed for a positive sentinel lymph node in 78% of patients.

Patients treated in a noncompliant fashion with regard to margins had a threefold increase in postoperative complications in comparison with those treated in a compliant fashion. Similarly, patients treated in a lymph node-noncompliant fashion were 2.4 times more likely to have a postoperative complication. Both findings were statistically significant, said Dr. Erickson Foster, who reported no conflicts of interest for the investigators.

Noncompliance with NCCN guidelines for margins of excision was associated with increased locoregional (26% vs. 6%) and distant recurrence (8% vs. 6%), as compared with compliant cases. Locoregional disease alone as the first site of relapse was seen in 33% of lymph node-noncompliant cases vs. 6% of lymph node-compliant cases.

Five-year disease-free survival was higher among margin-compliant cases, compared with margin-noncompliant cases (86% vs. 68%), as was 5-year overall survival (93% vs. 83%). Similar increases in disease-free (85% vs. 54%) and overall (95% vs. 66%) survival were observed with compliance to lymph node staging and treatment recommendations.

The mean follow-up was 51 months (minimum 18 months) and mean age 66 years; 53% of the patients were women, and 32% of melanomas were located on the trunk, a finding consistent with cutaneous melanoma. Postoperative complications were reported in 55 patients (17%), with major complications in 4%, including one myocardial infarction, one pneumothorax, two cases of lymphedema, and two cases of facial nerve injury.

"These findings are provocative and suggest that compliance with NCCN guidelines improves outcomes in clinically node-negative melanoma patients," senior author Dr. Tina J. Hieken, of Rush Medical College, in Chicago, said in an interview. "We recommend that clinicians treating melanoma patients become familiar with these guidelines and utilize them to assist clinical decision making."

During the question-and-answer session, Dr. Foster noted that 20 different physicians representing nine specialties performed melanoma treatment in the study. Compliance did improve among specialties as time went on, but only surgical oncologists had greater than 90% compliance for margins of excision and lymph node staging and treatment.

Audience member Dr. Daniel G. Coit, who cochaired the NCCN guideline committee for melanoma, stressed that noncompliance with recommendations should not be equated with poor medical care. "Guidelines don't define best medical care; the doctors and patients define best medical care," he said.

Both Dr. Foster and Dr. Hieken agreed that physicians regularly depart from guidelines for a variety of reasons, such as aesthetic considerations, patient preferences, patient comorbidities, and tumor features.

"Guidelines are a point of departure," said Dr. Coit of Memorial Sloan-Kettering Cancer Center in New York. "They are not how we must do it, and we need to be very careful about how we define that, because there are other people who don't know that and will be looking at these kinds of presentations very carefully, and they're going to come to the wrong conclusion."

CHICAGO — Isolated limb infusion, a minimally invasive technique to deliver regional chemotherapy, was useful but not optimal in two melanoma studies presented at a symposium sponsored by the Society of Surgical Oncology.

In the largest isolated limb infusion (ILI) series conducted to date, involving 185 patients with advanced metastatic melanoma confined to the limb, the overall survival rate was 84% at a median follow-up of 20 months, said lead investigator Dr. Hidde Kroon, a fellow at the Sydney Melanoma Unit in Australia, where the study was performed and the technique was developed.

He reported the highest rates to date for complete response (38%) and for partial response (46%) to chemotherapy. Stable disease was seen in 10% of patients and progressive disease in 6%.

In the largest study outside Australia, however, U.S. and Taiwanese investigators concluded that isolated limb infusion was an effective way to regionally administer the cytotoxic agent melphalan, but that its efficacy fell short of isolated limb perfusion (ILP).

Sydney Melanoma Unit Experience

Dr. Kroon said that the duration of response was significantly longer in patients achieving a complete response (median 22 months) than was observed overall (median 13 months) in the Australian study.

"Response rates and duration of response after isolated limb infusion are at the lower end of those reported after conventional isolated limb perfusion," Dr. Kroon acknowledged.

"However, ILI was performed in patients with [higher stages] of disease and more comorbidities, which might explain the lower response rates, since stage of disease is a significant risk factor for responses," he said.

Most patients in the study (134, or 72%) had M.D. Anderson stage IIIA or IIIAB disease, with 3% having stage I, 8% stage II, and 16% stage IV disease.

Isolated limb infusion is essentially a low-flow ILP performed without oxygenation via percutaneous catheters. It is a minimally invasive alternative to the more labor-intensive ILP, requires no routine blood transfusion, and can be easily repeated if necessary, Dr. Kroon explained. Results have been promising, but it has not been established whether it is equally effective as isolated limb perfusion.

Patients in the Australian series were treated from 1992 to 2006 with a single isolated limb infusion of melphalan and actinomycin D for 20–30 minutes under mild hyperthermic conditions. Their mean age was 74 years (range, 29–93 years), and the majority (62%) were female. Disease was present in the lower limb in 172 patients, and in the upper limb in 13.

The response rate significantly decreased with increasing stage of disease, Dr. Kroon said.

Response rates were 83% in stage I patients, 53% in stage II, 43% in stage IIIA, 33% in stage IIIAB, and 23% in stage IV.

Median overall survival was 38 months, but increased significantly to 53 months in patients achieving a complete response, he reported.

In a multivariate analysis, independent prognostic factors for complete response were lower disease stage (hazard ratio, 1.69) and greater increase in CO₂ level during the procedure (HR, 1.65).

The procedure was well tolerated, with only five patients developing grade 4 toxicity, and there were no amputations, said Dr. Kroon, who reported no conflicts of interest.

"We conclude that isolated limb infusion is a safe and effective alternative to conventional isolated limb perfusion to treat advanced metastatic melanoma in a limb," he said.

U.S./Taiwanese Experience

Lead investigator Dr. Georgia Beasley of the Duke University Medical Center in Durham, N.C., and associates compared outcomes after 59 ILP treatments in 54 patients against outcomes after 61 ILI treatments in 58 patients, all with in-transit malignant melanoma of the extremity.

Among 50 evaluable ILI patients, complete response was reported in 15 (30%), partial response in 7 (14%), stable disease in 5 (10%), and progressive disease in 23 (46%). The median duration of complete response was 12 months.

Isolated limb perfusion was associated with significantly better response at 3 months (complete response, 57%; partial response, 31%; and no response, 12%); however, significantly more ILP patients had grade 3 or greater toxicity, Dr. Beasley said.

There were nine compartment syndromes and two amputations among ILP patients, versus four compartment syndromes and no amputations among ILI patients.

"In our experience, limb infusion using melphalan did not appear to be as effective as limb perfusion, although the toxicity appears less," Dr. Beasley said.

The investigators noted that correcting the melphalan dose for ideal body weight appeared to minimize toxicity without altering response rates; 66% of ILI patients had their dose corrected, versus only 22% of ILP patients.

CHICAGO — Isolated limb infusion, a minimally invasive technique to deliver regional chemotherapy, was useful but not optimal in two melanoma studies presented at a symposium sponsored by the Society of Surgical Oncology.

In the largest isolated limb infusion (ILI) series conducted to date, involving 185 patients with advanced metastatic melanoma confined to the limb, the overall survival rate was 84% at a median follow-up of 20 months, said lead investigator Dr. Hidde Kroon, a fellow at the Sydney Melanoma Unit in Australia, where the study was performed and the technique was developed.

He reported the highest rates to date for complete response (38%) and for partial response (46%) to chemotherapy. Stable disease was seen in 10% of patients and progressive disease in 6%.

In the largest study outside Australia, however, U.S. and Taiwanese investigators concluded that isolated limb infusion was an effective way to regionally administer the cytotoxic agent melphalan, but that its efficacy fell short of isolated limb perfusion (ILP).

Sydney Melanoma Unit Experience

Dr. Kroon said that the duration of response was significantly longer in patients achieving a complete response (median 22 months) than was observed overall (median 13 months) in the Australian study.

"Response rates and duration of response after isolated limb infusion are at the lower end of those reported after conventional isolated limb perfusion," Dr. Kroon acknowledged.

"However, ILI was performed in patients with [higher stages] of disease and more comorbidities, which might explain the lower response rates, since stage of disease is a significant risk factor for responses," he said.

Most patients in the study (134, or 72%) had M.D. Anderson stage IIIA or IIIAB disease, with 3% having stage I, 8% stage II, and 16% stage IV disease.

Isolated limb infusion is essentially a low-flow ILP performed without oxygenation via percutaneous catheters. It is a minimally invasive alternative to the more labor-intensive ILP, requires no routine blood transfusion, and can be easily repeated if necessary, Dr. Kroon explained. Results have been promising, but it has not been established whether it is equally effective as isolated limb perfusion.

Patients in the Australian series were treated from 1992 to 2006 with a single isolated limb infusion of melphalan and actinomycin D for 20–30 minutes under mild hyperthermic conditions. Their mean age was 74 years (range, 29–93 years), and the majority (62%) were female. Disease was present in the lower limb in 172 patients, and in the upper limb in 13.

The response rate significantly decreased with increasing stage of disease, Dr. Kroon said.

Response rates were 83% in stage I patients, 53% in stage II, 43% in stage IIIA, 33% in stage IIIAB, and 23% in stage IV.

Median overall survival was 38 months, but increased significantly to 53 months in patients achieving a complete response, he reported.

In a multivariate analysis, independent prognostic factors for complete response were lower disease stage (hazard ratio, 1.69) and greater increase in CO₂ level during the procedure (HR, 1.65).

The procedure was well tolerated, with only five patients developing grade 4 toxicity, and there were no amputations, said Dr. Kroon, who reported no conflicts of interest.

"We conclude that isolated limb infusion is a safe and effective alternative to conventional isolated limb perfusion to treat advanced metastatic melanoma in a limb," he said.

U.S./Taiwanese Experience

Lead investigator Dr. Georgia Beasley of the Duke University Medical Center in Durham, N.C., and associates compared outcomes after 59 ILP treatments in 54 patients against outcomes after 61 ILI treatments in 58 patients, all with in-transit malignant melanoma of the extremity.

Among 50 evaluable ILI patients, complete response was reported in 15 (30%), partial response in 7 (14%), stable disease in 5 (10%), and progressive disease in 23 (46%). The median duration of complete response was 12 months.

Isolated limb perfusion was associated with significantly better response at 3 months (complete response, 57%; partial response, 31%; and no response, 12%); however, significantly more ILP patients had grade 3 or greater toxicity, Dr. Beasley said.

There were nine compartment syndromes and two amputations among ILP patients, versus four compartment syndromes and no amputations among ILI patients.

"In our experience, limb infusion using melphalan did not appear to be as effective as limb perfusion, although the toxicity appears less," Dr. Beasley said.

The investigators noted that correcting the melphalan dose for ideal body weight appeared to minimize toxicity without altering response rates; 66% of ILI patients had their dose corrected, versus only 22% of ILP patients.

CHICAGO — Isolated limb infusion, a minimally invasive technique to deliver regional chemotherapy, was useful but not optimal in two melanoma studies presented at a symposium sponsored by the Society of Surgical Oncology.

In the largest isolated limb infusion (ILI) series conducted to date, involving 185 patients with advanced metastatic melanoma confined to the limb, the overall survival rate was 84% at a median follow-up of 20 months, said lead investigator Dr. Hidde Kroon, a fellow at the Sydney Melanoma Unit in Australia, where the study was performed and the technique was developed.

He reported the highest rates to date for complete response (38%) and for partial response (46%) to chemotherapy. Stable disease was seen in 10% of patients and progressive disease in 6%.

In the largest study outside Australia, however, U.S. and Taiwanese investigators concluded that isolated limb infusion was an effective way to regionally administer the cytotoxic agent melphalan, but that its efficacy fell short of isolated limb perfusion (ILP).

Sydney Melanoma Unit Experience

Dr. Kroon said that the duration of response was significantly longer in patients achieving a complete response (median 22 months) than was observed overall (median 13 months) in the Australian study.

"Response rates and duration of response after isolated limb infusion are at the lower end of those reported after conventional isolated limb perfusion," Dr. Kroon acknowledged.

"However, ILI was performed in patients with [higher stages] of disease and more comorbidities, which might explain the lower response rates, since stage of disease is a significant risk factor for responses," he said.

Most patients in the study (134, or 72%) had M.D. Anderson stage IIIA or IIIAB disease, with 3% having stage I, 8% stage II, and 16% stage IV disease.

Isolated limb infusion is essentially a low-flow ILP performed without oxygenation via percutaneous catheters. It is a minimally invasive alternative to the more labor-intensive ILP, requires no routine blood transfusion, and can be easily repeated if necessary, Dr. Kroon explained. Results have been promising, but it has not been established whether it is equally effective as isolated limb perfusion.

Patients in the Australian series were treated from 1992 to 2006 with a single isolated limb infusion of melphalan and actinomycin D for 20–30 minutes under mild hyperthermic conditions. Their mean age was 74 years (range, 29–93 years), and the majority (62%) were female. Disease was present in the lower limb in 172 patients, and in the upper limb in 13.

The response rate significantly decreased with increasing stage of disease, Dr. Kroon said.

Response rates were 83% in stage I patients, 53% in stage II, 43% in stage IIIA, 33% in stage IIIAB, and 23% in stage IV.

Median overall survival was 38 months, but increased significantly to 53 months in patients achieving a complete response, he reported.

In a multivariate analysis, independent prognostic factors for complete response were lower disease stage (hazard ratio, 1.69) and greater increase in CO₂ level during the procedure (HR, 1.65).

The procedure was well tolerated, with only five patients developing grade 4 toxicity, and there were no amputations, said Dr. Kroon, who reported no conflicts of interest.

"We conclude that isolated limb infusion is a safe and effective alternative to conventional isolated limb perfusion to treat advanced metastatic melanoma in a limb," he said.

U.S./Taiwanese Experience

Lead investigator Dr. Georgia Beasley of the Duke University Medical Center in Durham, N.C., and associates compared outcomes after 59 ILP treatments in 54 patients against outcomes after 61 ILI treatments in 58 patients, all with in-transit malignant melanoma of the extremity.

Among 50 evaluable ILI patients, complete response was reported in 15 (30%), partial response in 7 (14%), stable disease in 5 (10%), and progressive disease in 23 (46%). The median duration of complete response was 12 months.

Isolated limb perfusion was associated with significantly better response at 3 months (complete response, 57%; partial response, 31%; and no response, 12%); however, significantly more ILP patients had grade 3 or greater toxicity, Dr. Beasley said.

There were nine compartment syndromes and two amputations among ILP patients, versus four compartment syndromes and no amputations among ILI patients.

"In our experience, limb infusion using melphalan did not appear to be as effective as limb perfusion, although the toxicity appears less," Dr. Beasley said.

The investigators noted that correcting the melphalan dose for ideal body weight appeared to minimize toxicity without altering response rates; 66% of ILI patients had their dose corrected, versus only 22% of ILP patients.

DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

DALLAS — Contrary to some previous findings, race played a role in the rates of recurrent spontaneous preterm birth in a retrospective study of 847 women receiving 17α-hydroxyprogesterone caproate.

Black women had a significant doubling in the rate of recurrent spontaneous preterm birth (SPTB) at less than 32 weeks' gestation, compared with white women (10% vs. 5%), Dr. Edwin Guzman reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine. The odds ratio (OR) was 2.1.

While the overall rate of SPTB at less than 37 weeks did not differ by maternal race (34% vs. 33%), rates of preterm birth at less than 34 weeks (15% vs. 9%, OR 1.8), less than 30 weeks (8% vs. 3%, OR 2.8), and less than 28 weeks (7% vs. 2%, OR 4.9) were also significantly higher in black women compared with white women.

Black race was the only maternal characteristic that was significantly different between the 86 women who delivered before 34 weeks and the 761 women who delivered at 34 weeks or more (27% vs. 17%, OR 1.8). Other variables analyzed included Medicaid status, 17α-hydroxyprogesterone caproate (17P) start between 21 and 26.9 weeks, more than one prior preterm delivery, less than 12 years of education, marital status, and current smoker.

At admission, the 151 black women were more likely than were the 696 white women to be younger (29 vs. 30 years), to be Medicaid beneficiaries (48% vs. 16.5%), to be unmarried (60% vs. 16%), to lack a high school education (14% vs. 7.5%), and to have had more than one prior preterm birth (43% vs. 24%). Clinical data were collected prospectively from high-risk women enrolled in an outpatient program from May 2004 through September 2006 who received weekly 250-mg injections of 17P.

Analyses of pregnancy outcomes by insurance type and maternal race showed that among 187 Medicaid recipients, black women had significantly higher rates of SPTB at less than 37 weeks (42% vs. 26%, OR 2.0), though the rates of SPTB at less than 34, 32, 30, and 28 weeks were similar for white and black women.

Among the 660 women with commercial insurance, while the overall rate of SPTB at less than 37 weeks was similar for white and black women, black women had significantly higher rates of recurrent SPTB at less than 34, 32, 30, and 28 weeks, reported Dr. Guzman of Saint Peter's University Hospital, New Brunswick, N.J.

There has been renewed interest in the use of 17P following publication of a randomized clinical trial of 17P versus placebo conducted by the Maternal-Fetal Medicine Units (MFMU) Network of the National Institute of Child Health and Human Development (N. Engl. J. Med. 2003;348:2379–85). In contrast with previous studies of women with prior preterm delivery, a subgroup analysis of the MFMU data revealed no differences in the rate of recurrent preterm birth between black and white women receiving 17P.

Final data on U.S. births in 2004 showed that approximately 11.5% of white newborns and 18% of black newborns were born prematurely (Natl. Vital Stat. Rep. 2006;55:1–101). Black women having a prior preterm infant also have been shown to be at a higher risk for recurrent preterm birth than white women with a similar history (Am. J. Obstet. Gynecol. 2007;196:131.e1–6).

The purpose of the current study was to determine if response to 17P treatment differed by maternal race when 17P administration occurred in a real-world clinical setting, reported Dr. Guzman, who disclosed no financial conflicts of interest and received no funding for the study.

In an interview, Dr. Guzman speculated that the difference in findings between the MFMU network study and his study may be related to differences in populations in terms of socioeconomic status and care received, and noted that further study is needed as progesterone is now the standard of care in women who have had a previous preterm birth.

DALLAS — Contrary to some previous findings, race played a role in the rates of recurrent spontaneous preterm birth in a retrospective study of 847 women receiving 17α-hydroxyprogesterone caproate.

Black women had a significant doubling in the rate of recurrent spontaneous preterm birth (SPTB) at less than 32 weeks' gestation, compared with white women (10% vs. 5%), Dr. Edwin Guzman reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine. The odds ratio (OR) was 2.1.

While the overall rate of SPTB at less than 37 weeks did not differ by maternal race (34% vs. 33%), rates of preterm birth at less than 34 weeks (15% vs. 9%, OR 1.8), less than 30 weeks (8% vs. 3%, OR 2.8), and less than 28 weeks (7% vs. 2%, OR 4.9) were also significantly higher in black women compared with white women.

Black race was the only maternal characteristic that was significantly different between the 86 women who delivered before 34 weeks and the 761 women who delivered at 34 weeks or more (27% vs. 17%, OR 1.8). Other variables analyzed included Medicaid status, 17α-hydroxyprogesterone caproate (17P) start between 21 and 26.9 weeks, more than one prior preterm delivery, less than 12 years of education, marital status, and current smoker.

At admission, the 151 black women were more likely than were the 696 white women to be younger (29 vs. 30 years), to be Medicaid beneficiaries (48% vs. 16.5%), to be unmarried (60% vs. 16%), to lack a high school education (14% vs. 7.5%), and to have had more than one prior preterm birth (43% vs. 24%). Clinical data were collected prospectively from high-risk women enrolled in an outpatient program from May 2004 through September 2006 who received weekly 250-mg injections of 17P.

Analyses of pregnancy outcomes by insurance type and maternal race showed that among 187 Medicaid recipients, black women had significantly higher rates of SPTB at less than 37 weeks (42% vs. 26%, OR 2.0), though the rates of SPTB at less than 34, 32, 30, and 28 weeks were similar for white and black women.

Among the 660 women with commercial insurance, while the overall rate of SPTB at less than 37 weeks was similar for white and black women, black women had significantly higher rates of recurrent SPTB at less than 34, 32, 30, and 28 weeks, reported Dr. Guzman of Saint Peter's University Hospital, New Brunswick, N.J.

There has been renewed interest in the use of 17P following publication of a randomized clinical trial of 17P versus placebo conducted by the Maternal-Fetal Medicine Units (MFMU) Network of the National Institute of Child Health and Human Development (N. Engl. J. Med. 2003;348:2379–85). In contrast with previous studies of women with prior preterm delivery, a subgroup analysis of the MFMU data revealed no differences in the rate of recurrent preterm birth between black and white women receiving 17P.

Final data on U.S. births in 2004 showed that approximately 11.5% of white newborns and 18% of black newborns were born prematurely (Natl. Vital Stat. Rep. 2006;55:1–101). Black women having a prior preterm infant also have been shown to be at a higher risk for recurrent preterm birth than white women with a similar history (Am. J. Obstet. Gynecol. 2007;196:131.e1–6).

The purpose of the current study was to determine if response to 17P treatment differed by maternal race when 17P administration occurred in a real-world clinical setting, reported Dr. Guzman, who disclosed no financial conflicts of interest and received no funding for the study.

In an interview, Dr. Guzman speculated that the difference in findings between the MFMU network study and his study may be related to differences in populations in terms of socioeconomic status and care received, and noted that further study is needed as progesterone is now the standard of care in women who have had a previous preterm birth.

DALLAS — Contrary to some previous findings, race played a role in the rates of recurrent spontaneous preterm birth in a retrospective study of 847 women receiving 17α-hydroxyprogesterone caproate.

Black women had a significant doubling in the rate of recurrent spontaneous preterm birth (SPTB) at less than 32 weeks' gestation, compared with white women (10% vs. 5%), Dr. Edwin Guzman reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine. The odds ratio (OR) was 2.1.

While the overall rate of SPTB at less than 37 weeks did not differ by maternal race (34% vs. 33%), rates of preterm birth at less than 34 weeks (15% vs. 9%, OR 1.8), less than 30 weeks (8% vs. 3%, OR 2.8), and less than 28 weeks (7% vs. 2%, OR 4.9) were also significantly higher in black women compared with white women.

Black race was the only maternal characteristic that was significantly different between the 86 women who delivered before 34 weeks and the 761 women who delivered at 34 weeks or more (27% vs. 17%, OR 1.8). Other variables analyzed included Medicaid status, 17α-hydroxyprogesterone caproate (17P) start between 21 and 26.9 weeks, more than one prior preterm delivery, less than 12 years of education, marital status, and current smoker.

At admission, the 151 black women were more likely than were the 696 white women to be younger (29 vs. 30 years), to be Medicaid beneficiaries (48% vs. 16.5%), to be unmarried (60% vs. 16%), to lack a high school education (14% vs. 7.5%), and to have had more than one prior preterm birth (43% vs. 24%). Clinical data were collected prospectively from high-risk women enrolled in an outpatient program from May 2004 through September 2006 who received weekly 250-mg injections of 17P.

Analyses of pregnancy outcomes by insurance type and maternal race showed that among 187 Medicaid recipients, black women had significantly higher rates of SPTB at less than 37 weeks (42% vs. 26%, OR 2.0), though the rates of SPTB at less than 34, 32, 30, and 28 weeks were similar for white and black women.

Among the 660 women with commercial insurance, while the overall rate of SPTB at less than 37 weeks was similar for white and black women, black women had significantly higher rates of recurrent SPTB at less than 34, 32, 30, and 28 weeks, reported Dr. Guzman of Saint Peter's University Hospital, New Brunswick, N.J.

There has been renewed interest in the use of 17P following publication of a randomized clinical trial of 17P versus placebo conducted by the Maternal-Fetal Medicine Units (MFMU) Network of the National Institute of Child Health and Human Development (N. Engl. J. Med. 2003;348:2379–85). In contrast with previous studies of women with prior preterm delivery, a subgroup analysis of the MFMU data revealed no differences in the rate of recurrent preterm birth between black and white women receiving 17P.

Final data on U.S. births in 2004 showed that approximately 11.5% of white newborns and 18% of black newborns were born prematurely (Natl. Vital Stat. Rep. 2006;55:1–101). Black women having a prior preterm infant also have been shown to be at a higher risk for recurrent preterm birth than white women with a similar history (Am. J. Obstet. Gynecol. 2007;196:131.e1–6).

The purpose of the current study was to determine if response to 17P treatment differed by maternal race when 17P administration occurred in a real-world clinical setting, reported Dr. Guzman, who disclosed no financial conflicts of interest and received no funding for the study.

In an interview, Dr. Guzman speculated that the difference in findings between the MFMU network study and his study may be related to differences in populations in terms of socioeconomic status and care received, and noted that further study is needed as progesterone is now the standard of care in women who have had a previous preterm birth.

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

Mean hemoglobin A_1c values did not differ significantly between women with type 1 and type 2 diabetes (7.1% vs. 6.9%). The majority of women with type 2 diabetes (91%) were on insulin during pregnancy.

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, he noted.

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 (see graph below).

“The implication is that in women with type 1 diabetes, you need to keep a close eye on the babies because growth restriction is, of course, associated with neonatal death, poor outcome, and respiratory distress,” Dr. Haeri said in an interview. The poorer neonatal outcomes were observed even though the population was tightly controlled, with a self-monitored fasting and preprandial blood glucose goal of less than 100 mg/dL and a 90-minute postprandial goal of less than 140 mg/dL.

Type 2 diabetic patients should receive the same counseling and treatments as type 1 patients. DR. KNIGHT

ELSEVIER GLOBAL MEDICAL NEWS

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

Mean hemoglobin A_1c values did not differ significantly between women with type 1 and type 2 diabetes (7.1% vs. 6.9%). The majority of women with type 2 diabetes (91%) were on insulin during pregnancy.

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, he noted.

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 (see graph below).

“The implication is that in women with type 1 diabetes, you need to keep a close eye on the babies because growth restriction is, of course, associated with neonatal death, poor outcome, and respiratory distress,” Dr. Haeri said in an interview. The poorer neonatal outcomes were observed even though the population was tightly controlled, with a self-monitored fasting and preprandial blood glucose goal of less than 100 mg/dL and a 90-minute postprandial goal of less than 140 mg/dL.

Type 2 diabetic patients should receive the same counseling and treatments as type 1 patients. DR. KNIGHT

ELSEVIER GLOBAL MEDICAL NEWS

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

Mean hemoglobin A_1c values did not differ significantly between women with type 1 and type 2 diabetes (7.1% vs. 6.9%). The majority of women with type 2 diabetes (91%) were on insulin during pregnancy.

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, he noted.

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 (see graph below).

“The implication is that in women with type 1 diabetes, you need to keep a close eye on the babies because growth restriction is, of course, associated with neonatal death, poor outcome, and respiratory distress,” Dr. Haeri said in an interview. The poorer neonatal outcomes were observed even though the population was tightly controlled, with a self-monitored fasting and preprandial blood glucose goal of less than 100 mg/dL and a 90-minute postprandial goal of less than 140 mg/dL.

Type 2 diabetic patients should receive the same counseling and treatments as type 1 patients. DR. KNIGHT

ELSEVIER GLOBAL MEDICAL NEWS

DALLAS — Several years after a pregnancy complicated by eclampsia, significantly more women demonstrate subcortical cerebral white matter lesions on MRI, compared with women with a normotensive pregnancy.

In a study of 103 women, white matter lesions were observed in 16 of 39 (41%) formerly eclamptic women, in 10 of 35 (29%) formerly preeclamptic women, and 5 of 29 (17%) women who had a normotensive pregnancy, lead investigator Annet Aukes and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The average time from index pregnancy was not significantly different between the formerly eclamptic and normotensive groups (7 years vs. 5 years), who were the focus of the analysis. Their mean age was 38 years.

The findings are remarkable because the predominant opinion holds that eclampsia is a one-time event from which women can expect a full clinical recovery.

“We conclude that the paradigm that eclampsia is reversible should be revised,” said Ms. Aukes, an MD/PhD student at the University of Groningen (the Netherlands).

The researchers also observed that the number of eclamptic seizures appeared to be related to the presence and severity of the brain matter lesions. In all, 19 eclamptic women had one grand mal seizure, 10 had two, and 10 had three or more. Women who reported three or more eclamptic seizures were three times more likely to have white matter lesions than were women with no seizures, she said.

The total volume of the lesions was significantly greater among formerly eclamptic women than controls (0.04 mL vs. 0.004 mL).

The neurologic disturbances in eclampsia and preeclampsia are thought to represent a form of posterior reversible encephalopathy syndrome (PRES), which is recognized as a complication in various non-pregnancy-related disorders, including several of iatrogenic or neurotoxic origin, connective tissue disease, and acute glomerulonephritis. It can be reversed by lowering blood pressure and/or discontinuing the offending drug.

In PRES, it is thought that an acute elevation of systemic blood pressure exceeds the upper limit of cerebral autoregulation. This causes forced dilation of cerebral arteries, disruption of the blood-brain barrier, and formation of vasogenic cerebral edema, Ms. Aukes explained.

More recently, it has been hypothesized that when vasogenic edema becomes severe enough, it can result in reduced tissue perfusion and cytotoxic edema because of irreversible ischemic changes that lead to white matter lesions.

The theory is supported by studies, she said, including one in which persistent brain white matter lesions, consistent with the appearance of cerebral tissue loss, were demonstrated in nearly one-fourth of 27 eclamptic women when imaged 6 weeks after delivery (Am. J. Obstet. Gyn. 2004;190:714–20).

A study by Ms. Aukes and associates presented at last year's Society for Maternal-Fetal Medicine meeting demonstrated that formerly eclamptic women reported significantly more disruptions in cognitive function 7.6 years after the index pregnancy than did healthy parous controls (Am. J. Obstet. Gynecol. 2007;197; 365.e1–6).

An audience member asked if baseline imaging data were available on the women who seized to determine if the lesions were predisposing to eclampsia or if they were a result of eclampsia. Ms. Aukes responded that very few women had imaging at the time of their seizures, and thus they had not linked the data. “We're not sure if these lesions were preexisting or occurred during or after the seizures,” she said.

The investigators did not report any conflicts of interest and did not receive funding for the study.

A fluid-attenuated inversion-recovery MRI of a formerly eclamptic patient reveals white matter lesions (arrows). Neuro-Imaging Center of the School of Behavioural and Cognitive Neurosciences in Groningen

DALLAS — Several years after a pregnancy complicated by eclampsia, significantly more women demonstrate subcortical cerebral white matter lesions on MRI, compared with women with a normotensive pregnancy.

In a study of 103 women, white matter lesions were observed in 16 of 39 (41%) formerly eclamptic women, in 10 of 35 (29%) formerly preeclamptic women, and 5 of 29 (17%) women who had a normotensive pregnancy, lead investigator Annet Aukes and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The average time from index pregnancy was not significantly different between the formerly eclamptic and normotensive groups (7 years vs. 5 years), who were the focus of the analysis. Their mean age was 38 years.

The findings are remarkable because the predominant opinion holds that eclampsia is a one-time event from which women can expect a full clinical recovery.

“We conclude that the paradigm that eclampsia is reversible should be revised,” said Ms. Aukes, an MD/PhD student at the University of Groningen (the Netherlands).

The researchers also observed that the number of eclamptic seizures appeared to be related to the presence and severity of the brain matter lesions. In all, 19 eclamptic women had one grand mal seizure, 10 had two, and 10 had three or more. Women who reported three or more eclamptic seizures were three times more likely to have white matter lesions than were women with no seizures, she said.

The total volume of the lesions was significantly greater among formerly eclamptic women than controls (0.04 mL vs. 0.004 mL).

The neurologic disturbances in eclampsia and preeclampsia are thought to represent a form of posterior reversible encephalopathy syndrome (PRES), which is recognized as a complication in various non-pregnancy-related disorders, including several of iatrogenic or neurotoxic origin, connective tissue disease, and acute glomerulonephritis. It can be reversed by lowering blood pressure and/or discontinuing the offending drug.

In PRES, it is thought that an acute elevation of systemic blood pressure exceeds the upper limit of cerebral autoregulation. This causes forced dilation of cerebral arteries, disruption of the blood-brain barrier, and formation of vasogenic cerebral edema, Ms. Aukes explained.

More recently, it has been hypothesized that when vasogenic edema becomes severe enough, it can result in reduced tissue perfusion and cytotoxic edema because of irreversible ischemic changes that lead to white matter lesions.

The theory is supported by studies, she said, including one in which persistent brain white matter lesions, consistent with the appearance of cerebral tissue loss, were demonstrated in nearly one-fourth of 27 eclamptic women when imaged 6 weeks after delivery (Am. J. Obstet. Gyn. 2004;190:714–20).

A study by Ms. Aukes and associates presented at last year's Society for Maternal-Fetal Medicine meeting demonstrated that formerly eclamptic women reported significantly more disruptions in cognitive function 7.6 years after the index pregnancy than did healthy parous controls (Am. J. Obstet. Gynecol. 2007;197; 365.e1–6).

An audience member asked if baseline imaging data were available on the women who seized to determine if the lesions were predisposing to eclampsia or if they were a result of eclampsia. Ms. Aukes responded that very few women had imaging at the time of their seizures, and thus they had not linked the data. “We're not sure if these lesions were preexisting or occurred during or after the seizures,” she said.

The investigators did not report any conflicts of interest and did not receive funding for the study.

A fluid-attenuated inversion-recovery MRI of a formerly eclamptic patient reveals white matter lesions (arrows). Neuro-Imaging Center of the School of Behavioural and Cognitive Neurosciences in Groningen

DALLAS — Several years after a pregnancy complicated by eclampsia, significantly more women demonstrate subcortical cerebral white matter lesions on MRI, compared with women with a normotensive pregnancy.

In a study of 103 women, white matter lesions were observed in 16 of 39 (41%) formerly eclamptic women, in 10 of 35 (29%) formerly preeclamptic women, and 5 of 29 (17%) women who had a normotensive pregnancy, lead investigator Annet Aukes and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The average time from index pregnancy was not significantly different between the formerly eclamptic and normotensive groups (7 years vs. 5 years), who were the focus of the analysis. Their mean age was 38 years.

The findings are remarkable because the predominant opinion holds that eclampsia is a one-time event from which women can expect a full clinical recovery.

“We conclude that the paradigm that eclampsia is reversible should be revised,” said Ms. Aukes, an MD/PhD student at the University of Groningen (the Netherlands).

The researchers also observed that the number of eclamptic seizures appeared to be related to the presence and severity of the brain matter lesions. In all, 19 eclamptic women had one grand mal seizure, 10 had two, and 10 had three or more. Women who reported three or more eclamptic seizures were three times more likely to have white matter lesions than were women with no seizures, she said.

The total volume of the lesions was significantly greater among formerly eclamptic women than controls (0.04 mL vs. 0.004 mL).

The neurologic disturbances in eclampsia and preeclampsia are thought to represent a form of posterior reversible encephalopathy syndrome (PRES), which is recognized as a complication in various non-pregnancy-related disorders, including several of iatrogenic or neurotoxic origin, connective tissue disease, and acute glomerulonephritis. It can be reversed by lowering blood pressure and/or discontinuing the offending drug.

In PRES, it is thought that an acute elevation of systemic blood pressure exceeds the upper limit of cerebral autoregulation. This causes forced dilation of cerebral arteries, disruption of the blood-brain barrier, and formation of vasogenic cerebral edema, Ms. Aukes explained.

More recently, it has been hypothesized that when vasogenic edema becomes severe enough, it can result in reduced tissue perfusion and cytotoxic edema because of irreversible ischemic changes that lead to white matter lesions.

The theory is supported by studies, she said, including one in which persistent brain white matter lesions, consistent with the appearance of cerebral tissue loss, were demonstrated in nearly one-fourth of 27 eclamptic women when imaged 6 weeks after delivery (Am. J. Obstet. Gyn. 2004;190:714–20).

A study by Ms. Aukes and associates presented at last year's Society for Maternal-Fetal Medicine meeting demonstrated that formerly eclamptic women reported significantly more disruptions in cognitive function 7.6 years after the index pregnancy than did healthy parous controls (Am. J. Obstet. Gynecol. 2007;197; 365.e1–6).

An audience member asked if baseline imaging data were available on the women who seized to determine if the lesions were predisposing to eclampsia or if they were a result of eclampsia. Ms. Aukes responded that very few women had imaging at the time of their seizures, and thus they had not linked the data. “We're not sure if these lesions were preexisting or occurred during or after the seizures,” she said.

The investigators did not report any conflicts of interest and did not receive funding for the study.

A fluid-attenuated inversion-recovery MRI of a formerly eclamptic patient reveals white matter lesions (arrows). Neuro-Imaging Center of the School of Behavioural and Cognitive Neurosciences in Groningen

Echocardiographically measured left atrial size was significantly related to ischemic stroke and all-cause mortality in a follow-up analysis of 1,886 blacks in the Atherosclerosis Risk in Communities study.

At a median of 9 years follow-up, there were 103 strokes (6.47/1,000 person-years) and 206 deaths (13.3/1,000 person-years) in participants in the Jackson, Miss., cohort of the study. Their mean age was 59 years; 65% were women.

Left atrial size was significantly related to hypertension, diabetes, and body mass index, Dr. Harsha S. Nagarajarao reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

In an effort to adjust left atrial (LA) size to body size, LA size was indexed to height and was then divided into quintiles, with 377 patients in the top quintile of LA size (2.57–3.55 cm/m) and 1,509 patients in the bottom four quintiles (1.29–2.56 cm/m). Significantly more patients in the top quintile of LA size were hypertensive (74.3% vs. 57%), diabetic (29% vs. 21.3%), and had a higher mean BMI, compared with those with lower LA size (34.6 vs. 29.4 kg/m

In a multivariate analysis, LA size on echocardiogram was significantly associated with ischemic stroke (hazard ratio 1.58) and all-cause mortality (HR 1.47), even after adjustment for age, sex, cigarette smoking, diabetes, hypertension, BMI, ratio of total cholesterol to HDL cholesterol, and triglyceride levels.

Left atrial size remained significantly related to all-cause mortality (HR 1.40) after further adjustment for left ventricular hypertrophy, Dr. Nagarajarao of the University of Mississippi Medical Center, in Jackson, and colleagues reported.

Non-Hispanic whites also have an increased incidence of stroke with increased LA size, but LA size is more important in blacks because of that population's increased stroke risk, Dr. Nagarajarao said in an interview. Blacks have a twofold higher incidence of stroke when compared with non-Hispanic whites, he added.

“Echocardiography may be a potentially useful noninvasive tool in identifying additional risk factors for stroke, and identifying participants with larger LA size may allow us to take preventive measures in identifying risk factors and treating them,” he said.

Last year, investigators at the University of Mississippi Medical Center also reported that echocardiographically derived left ventricular mass index (LVMI) was an independent predictor of incident ischemic stroke among 1,792 blacks in the Jackson cohort, after adjustment for similar cardiovascular risk factors (Stroke 2007;38:2686–91). In addition, the relation between LVMI and stroke remained significant after adding LA size and mitral annular calcification to the multivariable analysis.

Clinicians at the center determine LA size routinely on echocardiography in all patients at risk of stroke, Dr. Nagarajarao said. When asked which measurement is preferred, he said both LVMI and LA size have the potential to be independent predictors of risk factors, adding that it is important to recognize that each is independent of the other.

Previous studies have shown that the BP medication hydrochlorothiazide has reduced LA size when used along with controlling hypertension, although further study is needed to determine whether this has any effect on reducing stroke incidence, he said.

Echocardiographically measured left atrial size was significantly related to ischemic stroke and all-cause mortality in a follow-up analysis of 1,886 blacks in the Atherosclerosis Risk in Communities study.

At a median of 9 years follow-up, there were 103 strokes (6.47/1,000 person-years) and 206 deaths (13.3/1,000 person-years) in participants in the Jackson, Miss., cohort of the study. Their mean age was 59 years; 65% were women.

Left atrial size was significantly related to hypertension, diabetes, and body mass index, Dr. Harsha S. Nagarajarao reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

In an effort to adjust left atrial (LA) size to body size, LA size was indexed to height and was then divided into quintiles, with 377 patients in the top quintile of LA size (2.57–3.55 cm/m) and 1,509 patients in the bottom four quintiles (1.29–2.56 cm/m). Significantly more patients in the top quintile of LA size were hypertensive (74.3% vs. 57%), diabetic (29% vs. 21.3%), and had a higher mean BMI, compared with those with lower LA size (34.6 vs. 29.4 kg/m

In a multivariate analysis, LA size on echocardiogram was significantly associated with ischemic stroke (hazard ratio 1.58) and all-cause mortality (HR 1.47), even after adjustment for age, sex, cigarette smoking, diabetes, hypertension, BMI, ratio of total cholesterol to HDL cholesterol, and triglyceride levels.

Left atrial size remained significantly related to all-cause mortality (HR 1.40) after further adjustment for left ventricular hypertrophy, Dr. Nagarajarao of the University of Mississippi Medical Center, in Jackson, and colleagues reported.

Non-Hispanic whites also have an increased incidence of stroke with increased LA size, but LA size is more important in blacks because of that population's increased stroke risk, Dr. Nagarajarao said in an interview. Blacks have a twofold higher incidence of stroke when compared with non-Hispanic whites, he added.

“Echocardiography may be a potentially useful noninvasive tool in identifying additional risk factors for stroke, and identifying participants with larger LA size may allow us to take preventive measures in identifying risk factors and treating them,” he said.

Last year, investigators at the University of Mississippi Medical Center also reported that echocardiographically derived left ventricular mass index (LVMI) was an independent predictor of incident ischemic stroke among 1,792 blacks in the Jackson cohort, after adjustment for similar cardiovascular risk factors (Stroke 2007;38:2686–91). In addition, the relation between LVMI and stroke remained significant after adding LA size and mitral annular calcification to the multivariable analysis.

Clinicians at the center determine LA size routinely on echocardiography in all patients at risk of stroke, Dr. Nagarajarao said. When asked which measurement is preferred, he said both LVMI and LA size have the potential to be independent predictors of risk factors, adding that it is important to recognize that each is independent of the other.

Previous studies have shown that the BP medication hydrochlorothiazide has reduced LA size when used along with controlling hypertension, although further study is needed to determine whether this has any effect on reducing stroke incidence, he said.

Echocardiographically measured left atrial size was significantly related to ischemic stroke and all-cause mortality in a follow-up analysis of 1,886 blacks in the Atherosclerosis Risk in Communities study.

At a median of 9 years follow-up, there were 103 strokes (6.47/1,000 person-years) and 206 deaths (13.3/1,000 person-years) in participants in the Jackson, Miss., cohort of the study. Their mean age was 59 years; 65% were women.

Left atrial size was significantly related to hypertension, diabetes, and body mass index, Dr. Harsha S. Nagarajarao reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

In an effort to adjust left atrial (LA) size to body size, LA size was indexed to height and was then divided into quintiles, with 377 patients in the top quintile of LA size (2.57–3.55 cm/m) and 1,509 patients in the bottom four quintiles (1.29–2.56 cm/m). Significantly more patients in the top quintile of LA size were hypertensive (74.3% vs. 57%), diabetic (29% vs. 21.3%), and had a higher mean BMI, compared with those with lower LA size (34.6 vs. 29.4 kg/m

In a multivariate analysis, LA size on echocardiogram was significantly associated with ischemic stroke (hazard ratio 1.58) and all-cause mortality (HR 1.47), even after adjustment for age, sex, cigarette smoking, diabetes, hypertension, BMI, ratio of total cholesterol to HDL cholesterol, and triglyceride levels.

Left atrial size remained significantly related to all-cause mortality (HR 1.40) after further adjustment for left ventricular hypertrophy, Dr. Nagarajarao of the University of Mississippi Medical Center, in Jackson, and colleagues reported.

Non-Hispanic whites also have an increased incidence of stroke with increased LA size, but LA size is more important in blacks because of that population's increased stroke risk, Dr. Nagarajarao said in an interview. Blacks have a twofold higher incidence of stroke when compared with non-Hispanic whites, he added.

“Echocardiography may be a potentially useful noninvasive tool in identifying additional risk factors for stroke, and identifying participants with larger LA size may allow us to take preventive measures in identifying risk factors and treating them,” he said.

Last year, investigators at the University of Mississippi Medical Center also reported that echocardiographically derived left ventricular mass index (LVMI) was an independent predictor of incident ischemic stroke among 1,792 blacks in the Jackson cohort, after adjustment for similar cardiovascular risk factors (Stroke 2007;38:2686–91). In addition, the relation between LVMI and stroke remained significant after adding LA size and mitral annular calcification to the multivariable analysis.

Clinicians at the center determine LA size routinely on echocardiography in all patients at risk of stroke, Dr. Nagarajarao said. When asked which measurement is preferred, he said both LVMI and LA size have the potential to be independent predictors of risk factors, adding that it is important to recognize that each is independent of the other.

Previous studies have shown that the BP medication hydrochlorothiazide has reduced LA size when used along with controlling hypertension, although further study is needed to determine whether this has any effect on reducing stroke incidence, he 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 (BMI) of 30 kg/m

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 18.7% of underweight women (BMI below 18.5), 12.7% of normal-weight (BMI 18.5–24.9), 15.9% of overweight women (BMI 25–29.9), 17.6% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29.4% 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.

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 9.6% 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 in overweight women (12%, 13.6%, and 20%, respectively), but did not increase in a stepwise fashion in the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.

Contrary to expectations, 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).

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. “We [should] make this part of the nursing system so a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand. Another thing that's tough for OBs is what to do with that result when you find it. Most should feel 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 (17.4%) had a history of depression, 109 (8.5%) 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. The percentage of women with a history of depression or PPD seems high, but 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 (BMI) of 30 kg/m

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 18.7% of underweight women (BMI below 18.5), 12.7% of normal-weight (BMI 18.5–24.9), 15.9% of overweight women (BMI 25–29.9), 17.6% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29.4% 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.

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 9.6% 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 in overweight women (12%, 13.6%, and 20%, respectively), but did not increase in a stepwise fashion in the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.

Contrary to expectations, 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).

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. “We [should] make this part of the nursing system so a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand. Another thing that's tough for OBs is what to do with that result when you find it. Most should feel 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 (17.4%) had a history of depression, 109 (8.5%) 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. The percentage of women with a history of depression or PPD seems high, but 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 (BMI) of 30 kg/m

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 18.7% of underweight women (BMI below 18.5), 12.7% of normal-weight (BMI 18.5–24.9), 15.9% of overweight women (BMI 25–29.9), 17.6% with class I obesity (BMI 30–34.9), 28% with class II obesity (BMI 35–39.9), and 29.4% 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.

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 9.6% 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 in overweight women (12%, 13.6%, and 20%, respectively), but did not increase in a stepwise fashion in the mildly obese (23%, 9%, and 21%, respectively). There were too few women with class II and III obesity to analyze.

Contrary to expectations, 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).

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. “We [should] make this part of the nursing system so a woman has to answer a survey when she first comes through the door, so the doctor has the information in hand. Another thing that's tough for OBs is what to do with that result when you find it. Most should feel 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 (17.4%) had a history of depression, 109 (8.5%) 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. The percentage of women with a history of depression or PPD seems high, but 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.

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, vs. 14, or 22%, respectively).

Baseline characteristics, including age (65 years vs. 64 years), male gender (30 vs. 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

Most of the patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview. “We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation.”

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained.

One definition is the inability of aspirin to protect patients from ischemic vascular events, though the term has also been used to describe aspirin's inability to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still receiving low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories, Beaumont, Tex., markets the test and supplied the materials for the study.

“This platform was chosen based on the quantitative nature of the test system and also on the fact that it has been closely correlated with LTA, the gold standard of platelet aggregation tests,” said Dr. Polena, who received no funding for the study and reported no conflicts of interest. “Correlation between both systems typically demonstrates an r value of more than 0.8.”

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, vs. 14, or 22%, respectively).

Baseline characteristics, including age (65 years vs. 64 years), male gender (30 vs. 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

Most of the patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview. “We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation.”

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained.

One definition is the inability of aspirin to protect patients from ischemic vascular events, though the term has also been used to describe aspirin's inability to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still receiving low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories, Beaumont, Tex., markets the test and supplied the materials for the study.

“This platform was chosen based on the quantitative nature of the test system and also on the fact that it has been closely correlated with LTA, the gold standard of platelet aggregation tests,” said Dr. Polena, who received no funding for the study and reported no conflicts of interest. “Correlation between both systems typically demonstrates an r value of more than 0.8.”

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, vs. 14, or 22%, respectively).

Baseline characteristics, including age (65 years vs. 64 years), male gender (30 vs. 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

Most of the patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview. “We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation.”

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained.

One definition is the inability of aspirin to protect patients from ischemic vascular events, though the term has also been used to describe aspirin's inability to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still receiving low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories, Beaumont, Tex., markets the test and supplied the materials for the study.

“This platform was chosen based on the quantitative nature of the test system and also on the fact that it has been closely correlated with LTA, the gold standard of platelet aggregation tests,” said Dr. Polena, who received no funding for the study and reported no conflicts of interest. “Correlation between both systems typically demonstrates an r value of more than 0.8.”