Patrice Wendling

CHICAGO — Antegrade cerebral perfusion offers a survival advantage for high-risk newborns undergoing single-ventricle palliation, Dr. Robert Hannan said at the annual meeting of the Society of Thoracic Surgeons.

He reported on a retrospective analysis of 126 consecutive Rachs-1 category 6 patients who underwent stage 1 palliation of hypoplastic or nonhypoplastic left heart syndrome or a Damus-Kaye-Stansel procedure with either deep hypothermic circulatory arrest or antegrade cerebral perfusion at the Congenital Heart Institute at Miami Children's Hospital from 1995 to 2004.

In early 2001, hospital staff decided to limit the use of deep hypothermic circulatory arrest (DHCA) because of reports on the efficacy and safety of antegrade cerebral perfusion (ACP) and because of what Dr. Hannan called, “persuasive evidence that prolonged periods of deep hypothermic arrest lead to higher short- and long-term morbidity.”

A total of 67 patients were repaired with prolonged DHCA, and 59 with ACP and a short period of DHCA. Dr. Hannan and colleagues further stratified the groups into high-risk (weight less than 2.5 kg or other cardiac diagnosis) and usual-risk groups.

Patients were typically perfused through a shunt at the subclavian-innominate junction during arch reconstruction. Pulmonary artery transection was performed with the body perfused and the heart beating, he said. Circulatory arrest was used for changing the position of the cannulas and the atrial septectomy.

The 30-day survival was significantly higher in the ACP group than the DHCA group (90% vs. 70%). The high-risk ACP patients had a trend toward increased survival, compared with their DHCA counterparts (80% [12/15] vs. 62% [8/13]). But the difference was not significant.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% [45/59] vs. 54% [36/67]). But disappointingly, the high-risk groups continued to show a high interim mortality (48% [7/15] vs. 39% [5/13]), he said.

In the DHCA era, there were 32 deaths among 67 patients (48%), compared with 17 deaths in 59 patients in the ACP era (29%).

Cox regression analysis determined that an increase of just 1 kg in the weight of patients below 2.5 kg would lower the risk of death by 47%.

Dr. Hannan acknowledged that multiple changes were made during the study period in the hospital's perfusion strategy, ICU management, and anesthesia practices that confounded the effect of ACP. Perfusion changes included the adoption of a mixed alpha-stat/pH-stat strategy to manage acid base status, increased hematocrit while on bypass, and hyperoxygenation.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% vs 54%). DR. HANNAN

CHICAGO — Antegrade cerebral perfusion offers a survival advantage for high-risk newborns undergoing single-ventricle palliation, Dr. Robert Hannan said at the annual meeting of the Society of Thoracic Surgeons.

He reported on a retrospective analysis of 126 consecutive Rachs-1 category 6 patients who underwent stage 1 palliation of hypoplastic or nonhypoplastic left heart syndrome or a Damus-Kaye-Stansel procedure with either deep hypothermic circulatory arrest or antegrade cerebral perfusion at the Congenital Heart Institute at Miami Children's Hospital from 1995 to 2004.

In early 2001, hospital staff decided to limit the use of deep hypothermic circulatory arrest (DHCA) because of reports on the efficacy and safety of antegrade cerebral perfusion (ACP) and because of what Dr. Hannan called, “persuasive evidence that prolonged periods of deep hypothermic arrest lead to higher short- and long-term morbidity.”

A total of 67 patients were repaired with prolonged DHCA, and 59 with ACP and a short period of DHCA. Dr. Hannan and colleagues further stratified the groups into high-risk (weight less than 2.5 kg or other cardiac diagnosis) and usual-risk groups.

Patients were typically perfused through a shunt at the subclavian-innominate junction during arch reconstruction. Pulmonary artery transection was performed with the body perfused and the heart beating, he said. Circulatory arrest was used for changing the position of the cannulas and the atrial septectomy.

The 30-day survival was significantly higher in the ACP group than the DHCA group (90% vs. 70%). The high-risk ACP patients had a trend toward increased survival, compared with their DHCA counterparts (80% [12/15] vs. 62% [8/13]). But the difference was not significant.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% [45/59] vs. 54% [36/67]). But disappointingly, the high-risk groups continued to show a high interim mortality (48% [7/15] vs. 39% [5/13]), he said.

In the DHCA era, there were 32 deaths among 67 patients (48%), compared with 17 deaths in 59 patients in the ACP era (29%).

Cox regression analysis determined that an increase of just 1 kg in the weight of patients below 2.5 kg would lower the risk of death by 47%.

Dr. Hannan acknowledged that multiple changes were made during the study period in the hospital's perfusion strategy, ICU management, and anesthesia practices that confounded the effect of ACP. Perfusion changes included the adoption of a mixed alpha-stat/pH-stat strategy to manage acid base status, increased hematocrit while on bypass, and hyperoxygenation.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% vs 54%). DR. HANNAN

CHICAGO — Antegrade cerebral perfusion offers a survival advantage for high-risk newborns undergoing single-ventricle palliation, Dr. Robert Hannan said at the annual meeting of the Society of Thoracic Surgeons.

He reported on a retrospective analysis of 126 consecutive Rachs-1 category 6 patients who underwent stage 1 palliation of hypoplastic or nonhypoplastic left heart syndrome or a Damus-Kaye-Stansel procedure with either deep hypothermic circulatory arrest or antegrade cerebral perfusion at the Congenital Heart Institute at Miami Children's Hospital from 1995 to 2004.

In early 2001, hospital staff decided to limit the use of deep hypothermic circulatory arrest (DHCA) because of reports on the efficacy and safety of antegrade cerebral perfusion (ACP) and because of what Dr. Hannan called, “persuasive evidence that prolonged periods of deep hypothermic arrest lead to higher short- and long-term morbidity.”

A total of 67 patients were repaired with prolonged DHCA, and 59 with ACP and a short period of DHCA. Dr. Hannan and colleagues further stratified the groups into high-risk (weight less than 2.5 kg or other cardiac diagnosis) and usual-risk groups.

Patients were typically perfused through a shunt at the subclavian-innominate junction during arch reconstruction. Pulmonary artery transection was performed with the body perfused and the heart beating, he said. Circulatory arrest was used for changing the position of the cannulas and the atrial septectomy.

The 30-day survival was significantly higher in the ACP group than the DHCA group (90% vs. 70%). The high-risk ACP patients had a trend toward increased survival, compared with their DHCA counterparts (80% [12/15] vs. 62% [8/13]). But the difference was not significant.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% [45/59] vs. 54% [36/67]). But disappointingly, the high-risk groups continued to show a high interim mortality (48% [7/15] vs. 39% [5/13]), he said.

In the DHCA era, there were 32 deaths among 67 patients (48%), compared with 17 deaths in 59 patients in the ACP era (29%).

Cox regression analysis determined that an increase of just 1 kg in the weight of patients below 2.5 kg would lower the risk of death by 47%.

Dr. Hannan acknowledged that multiple changes were made during the study period in the hospital's perfusion strategy, ICU management, and anesthesia practices that confounded the effect of ACP. Perfusion changes included the adoption of a mixed alpha-stat/pH-stat strategy to manage acid base status, increased hematocrit while on bypass, and hyperoxygenation.

At 1 year, the ACP group continued to have a significant survival advantage over the DHCA group (76% vs 54%). DR. HANNAN

MIAMI — Omalizumab maintained control of severe allergic asthma and reduced the need for inhaled corticosteroids during 3 years of treatment in an analysis of data from a 52-week open-label extension study.

The findings extend the results of previous studies by showing that asthma control and a favorable safety and tolerability profile were maintained during long-term treatment with the anti-IgE monoclonal antibody, Dr. Jacques Hébert and associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The study was supported by Genentech Inc. and Novartis Pharmaceuticals Corp., which comarket omalizumab (Xolair). The drug gained federal approval in June 2003 for the treatment of moderate to severe asthma in patients age 12 years and older.

In the core 32-week study of 341 patients, omalizumab significantly reduced the use of inhaled corticosteroids and rescue medications while improving symptom scores and quality of life, compared with placebo. A first extension to this trial showed that these favorable efficacy and safety findings were sustained for a further 96 weeks of treatment.

In a second extension of the trial, researchers enrolled 178 patients, of whom 149 (84%) completed the study. Patients underwent a washout period of 12 weeks or more before receiving omalizumab subcutaneously at a dose of 0.016 mg/kg or more per IU/mL of IgE every 2 weeks or 4 weeks for up to 52 weeks. Mean forced expiratory volume in 1 second (FEV1) showed no decline between the start of the first extension (baseline) and week 52 of the second extension (2.24 L vs. 2.26 L). Good or excellent asthma control, based on the physician's overall assessment, was sustained from baseline to week 52 in 121 of the 149 (81%) patients.

During the same period, inhaled corticosteroid doses decreased about 20% among 96 patients who received the same inhaled corticosteroid throughout the first and second extensions and were not taking oral corticosteroids, reported Dr. Hébert, director of the Centre de Recherche Appliquée en Allergie, Quebec City. He has no financial interest in either of the study's sponsors.

Of the 178 patients who enrolled in the second extension, 134 (75%) had at least one adverse event, generally of mild or moderate severity.

MIAMI — Omalizumab maintained control of severe allergic asthma and reduced the need for inhaled corticosteroids during 3 years of treatment in an analysis of data from a 52-week open-label extension study.

The findings extend the results of previous studies by showing that asthma control and a favorable safety and tolerability profile were maintained during long-term treatment with the anti-IgE monoclonal antibody, Dr. Jacques Hébert and associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The study was supported by Genentech Inc. and Novartis Pharmaceuticals Corp., which comarket omalizumab (Xolair). The drug gained federal approval in June 2003 for the treatment of moderate to severe asthma in patients age 12 years and older.

In the core 32-week study of 341 patients, omalizumab significantly reduced the use of inhaled corticosteroids and rescue medications while improving symptom scores and quality of life, compared with placebo. A first extension to this trial showed that these favorable efficacy and safety findings were sustained for a further 96 weeks of treatment.

In a second extension of the trial, researchers enrolled 178 patients, of whom 149 (84%) completed the study. Patients underwent a washout period of 12 weeks or more before receiving omalizumab subcutaneously at a dose of 0.016 mg/kg or more per IU/mL of IgE every 2 weeks or 4 weeks for up to 52 weeks. Mean forced expiratory volume in 1 second (FEV1) showed no decline between the start of the first extension (baseline) and week 52 of the second extension (2.24 L vs. 2.26 L). Good or excellent asthma control, based on the physician's overall assessment, was sustained from baseline to week 52 in 121 of the 149 (81%) patients.

During the same period, inhaled corticosteroid doses decreased about 20% among 96 patients who received the same inhaled corticosteroid throughout the first and second extensions and were not taking oral corticosteroids, reported Dr. Hébert, director of the Centre de Recherche Appliquée en Allergie, Quebec City. He has no financial interest in either of the study's sponsors.

Of the 178 patients who enrolled in the second extension, 134 (75%) had at least one adverse event, generally of mild or moderate severity.

MIAMI — Omalizumab maintained control of severe allergic asthma and reduced the need for inhaled corticosteroids during 3 years of treatment in an analysis of data from a 52-week open-label extension study.

The findings extend the results of previous studies by showing that asthma control and a favorable safety and tolerability profile were maintained during long-term treatment with the anti-IgE monoclonal antibody, Dr. Jacques Hébert and associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The study was supported by Genentech Inc. and Novartis Pharmaceuticals Corp., which comarket omalizumab (Xolair). The drug gained federal approval in June 2003 for the treatment of moderate to severe asthma in patients age 12 years and older.

In the core 32-week study of 341 patients, omalizumab significantly reduced the use of inhaled corticosteroids and rescue medications while improving symptom scores and quality of life, compared with placebo. A first extension to this trial showed that these favorable efficacy and safety findings were sustained for a further 96 weeks of treatment.

In a second extension of the trial, researchers enrolled 178 patients, of whom 149 (84%) completed the study. Patients underwent a washout period of 12 weeks or more before receiving omalizumab subcutaneously at a dose of 0.016 mg/kg or more per IU/mL of IgE every 2 weeks or 4 weeks for up to 52 weeks. Mean forced expiratory volume in 1 second (FEV1) showed no decline between the start of the first extension (baseline) and week 52 of the second extension (2.24 L vs. 2.26 L). Good or excellent asthma control, based on the physician's overall assessment, was sustained from baseline to week 52 in 121 of the 149 (81%) patients.

During the same period, inhaled corticosteroid doses decreased about 20% among 96 patients who received the same inhaled corticosteroid throughout the first and second extensions and were not taking oral corticosteroids, reported Dr. Hébert, director of the Centre de Recherche Appliquée en Allergie, Quebec City. He has no financial interest in either of the study's sponsors.

Of the 178 patients who enrolled in the second extension, 134 (75%) had at least one adverse event, generally of mild or moderate severity.

CHICAGO — Laparoscopic excision of endometriotic lesions of the uterosacral ligament improves not only deep dyspareunia but also the quality of patients' sex life, Dr. Simone Ferrero said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Pain during intercourse affects 60%–79% of women with endometriosis who undergo surgery.

Among women who have deep dyspareunia, those with deep infiltrating endometriosis of the uterosacral ligament have the most severe impairment of their sexual function.

The presence of bilateral lesions on the uterosacral ligament does not influence the severity of symptoms, said Dr. Ferrero of San Martino Hospital and the University of Genoa, Italy.

He presented a prospective study in which 64 women with deep dyspareunia were surveyed before surgical excision of endometriotic lesions and 1 year after surgery using a questionnaire based on the sexual satisfaction subscale of the Derogatis Sexual Functioning Inventory, additional questions regarding the characteristics of dyspareunia, the Global Sexual Satisfaction Index, and a 100-mm visual analog scale to measure the intensity of dyspareunia.

All of the women received 6 months of postoperative treatment with the gonadotropin-releasing hormone analogue, triptorelin.

The main indications for surgery were pain symptoms (29), ovarian cysts (20), and infertility (15).

At 1-year follow-up, 29 of the women had no deep dyspareunia, 25 had decreased intensity (more than a 20-mm change on the visual analog scale), and 10 experienced no change.

One year after surgery patients had had significantly more intercourse per week in the previous 3 months (1.3 vs. 2.3), more satisfying orgasms (2.3 vs. 4.4), were more relaxed and fulfilled after sex (3.2 vs. 4.5), and were less frequently interrupted by pain during intercourse (3.7 vs. 2).

Global Sexual Satisfaction Index scores also significantly improved (P less than or equal to.001).

The surgery didn't significantly change whether the women were “usually satisfied” with their particular partner (5 vs. 5.2).

Women in the study had been with their partners for an average of 11 years; 42 were married, 10 were cohabiting, 6 were engaged, and 6 were single. The average age of the women was 34 years.

CHICAGO — Laparoscopic excision of endometriotic lesions of the uterosacral ligament improves not only deep dyspareunia but also the quality of patients' sex life, Dr. Simone Ferrero said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Pain during intercourse affects 60%–79% of women with endometriosis who undergo surgery.

Among women who have deep dyspareunia, those with deep infiltrating endometriosis of the uterosacral ligament have the most severe impairment of their sexual function.

The presence of bilateral lesions on the uterosacral ligament does not influence the severity of symptoms, said Dr. Ferrero of San Martino Hospital and the University of Genoa, Italy.

He presented a prospective study in which 64 women with deep dyspareunia were surveyed before surgical excision of endometriotic lesions and 1 year after surgery using a questionnaire based on the sexual satisfaction subscale of the Derogatis Sexual Functioning Inventory, additional questions regarding the characteristics of dyspareunia, the Global Sexual Satisfaction Index, and a 100-mm visual analog scale to measure the intensity of dyspareunia.

All of the women received 6 months of postoperative treatment with the gonadotropin-releasing hormone analogue, triptorelin.

The main indications for surgery were pain symptoms (29), ovarian cysts (20), and infertility (15).

At 1-year follow-up, 29 of the women had no deep dyspareunia, 25 had decreased intensity (more than a 20-mm change on the visual analog scale), and 10 experienced no change.

One year after surgery patients had had significantly more intercourse per week in the previous 3 months (1.3 vs. 2.3), more satisfying orgasms (2.3 vs. 4.4), were more relaxed and fulfilled after sex (3.2 vs. 4.5), and were less frequently interrupted by pain during intercourse (3.7 vs. 2).

Global Sexual Satisfaction Index scores also significantly improved (P less than or equal to.001).

The surgery didn't significantly change whether the women were “usually satisfied” with their particular partner (5 vs. 5.2).

Women in the study had been with their partners for an average of 11 years; 42 were married, 10 were cohabiting, 6 were engaged, and 6 were single. The average age of the women was 34 years.

CHICAGO — Laparoscopic excision of endometriotic lesions of the uterosacral ligament improves not only deep dyspareunia but also the quality of patients' sex life, Dr. Simone Ferrero said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Pain during intercourse affects 60%–79% of women with endometriosis who undergo surgery.

Among women who have deep dyspareunia, those with deep infiltrating endometriosis of the uterosacral ligament have the most severe impairment of their sexual function.

The presence of bilateral lesions on the uterosacral ligament does not influence the severity of symptoms, said Dr. Ferrero of San Martino Hospital and the University of Genoa, Italy.

He presented a prospective study in which 64 women with deep dyspareunia were surveyed before surgical excision of endometriotic lesions and 1 year after surgery using a questionnaire based on the sexual satisfaction subscale of the Derogatis Sexual Functioning Inventory, additional questions regarding the characteristics of dyspareunia, the Global Sexual Satisfaction Index, and a 100-mm visual analog scale to measure the intensity of dyspareunia.

All of the women received 6 months of postoperative treatment with the gonadotropin-releasing hormone analogue, triptorelin.

The main indications for surgery were pain symptoms (29), ovarian cysts (20), and infertility (15).

At 1-year follow-up, 29 of the women had no deep dyspareunia, 25 had decreased intensity (more than a 20-mm change on the visual analog scale), and 10 experienced no change.

One year after surgery patients had had significantly more intercourse per week in the previous 3 months (1.3 vs. 2.3), more satisfying orgasms (2.3 vs. 4.4), were more relaxed and fulfilled after sex (3.2 vs. 4.5), and were less frequently interrupted by pain during intercourse (3.7 vs. 2).

Global Sexual Satisfaction Index scores also significantly improved (P less than or equal to.001).

The surgery didn't significantly change whether the women were “usually satisfied” with their particular partner (5 vs. 5.2).

Women in the study had been with their partners for an average of 11 years; 42 were married, 10 were cohabiting, 6 were engaged, and 6 were single. The average age of the women was 34 years.

QUEBEC CITY — Canadian researchers think they've found a way to improve diabetes management by using a Web-based, real-time tracking system linked to patients' electronic medical records.

The Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness study's COMPETE II diabetes tracker is available to both patients and physicians and electronically displays 13 standardized variables, including blood glucose, hemoglobin A_1c levels, blood pressure, blood lipid levels, urinary albumin-creatinine ratios, and the most recent foot and eye exams, Lisa Dolovich, Pharm.D., explained at the annual meeting of the North American Primary Care Research Group.

Dr. Dolovich presented data from the COMPETE II study, in which 511 patients with type 2 diabetes under the care of 48 primary care physicians were randomized to the tracker or to usual care.

The study's primary outcome was the change from baseline to 6 months in the quality of monitoring 8 of the 13 variables, compared with targets for each patient. A composite score was assigned each patient, with a maximum of 11 points. At a mean follow-up of 8.5 months, the mean composite score significantly improved in the intervention group, compared with the control group (change of 2.35 vs. 0.80).

Compared with the control group, diastolic blood pressure was reduced by 2.62 mm Hg, systolic blood pressure by 4.09 mm Hg, and hemoglobin A_1c by 0.2% in the intervention group.

Despite being repeatedly nudged by telephone reminders, 192 (76%) of 253 intervention patients said they were as satisfied or more satisfied with their care as a result of the intervention, and 63% opted to continue receiving automated reminders.

QUEBEC CITY — Canadian researchers think they've found a way to improve diabetes management by using a Web-based, real-time tracking system linked to patients' electronic medical records.

The Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness study's COMPETE II diabetes tracker is available to both patients and physicians and electronically displays 13 standardized variables, including blood glucose, hemoglobin A_1c levels, blood pressure, blood lipid levels, urinary albumin-creatinine ratios, and the most recent foot and eye exams, Lisa Dolovich, Pharm.D., explained at the annual meeting of the North American Primary Care Research Group.

Dr. Dolovich presented data from the COMPETE II study, in which 511 patients with type 2 diabetes under the care of 48 primary care physicians were randomized to the tracker or to usual care.

The study's primary outcome was the change from baseline to 6 months in the quality of monitoring 8 of the 13 variables, compared with targets for each patient. A composite score was assigned each patient, with a maximum of 11 points. At a mean follow-up of 8.5 months, the mean composite score significantly improved in the intervention group, compared with the control group (change of 2.35 vs. 0.80).

Compared with the control group, diastolic blood pressure was reduced by 2.62 mm Hg, systolic blood pressure by 4.09 mm Hg, and hemoglobin A_1c by 0.2% in the intervention group.

Despite being repeatedly nudged by telephone reminders, 192 (76%) of 253 intervention patients said they were as satisfied or more satisfied with their care as a result of the intervention, and 63% opted to continue receiving automated reminders.

QUEBEC CITY — Canadian researchers think they've found a way to improve diabetes management by using a Web-based, real-time tracking system linked to patients' electronic medical records.

The Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness study's COMPETE II diabetes tracker is available to both patients and physicians and electronically displays 13 standardized variables, including blood glucose, hemoglobin A_1c levels, blood pressure, blood lipid levels, urinary albumin-creatinine ratios, and the most recent foot and eye exams, Lisa Dolovich, Pharm.D., explained at the annual meeting of the North American Primary Care Research Group.

Dr. Dolovich presented data from the COMPETE II study, in which 511 patients with type 2 diabetes under the care of 48 primary care physicians were randomized to the tracker or to usual care.

The study's primary outcome was the change from baseline to 6 months in the quality of monitoring 8 of the 13 variables, compared with targets for each patient. A composite score was assigned each patient, with a maximum of 11 points. At a mean follow-up of 8.5 months, the mean composite score significantly improved in the intervention group, compared with the control group (change of 2.35 vs. 0.80).

Compared with the control group, diastolic blood pressure was reduced by 2.62 mm Hg, systolic blood pressure by 4.09 mm Hg, and hemoglobin A_1c by 0.2% in the intervention group.

Despite being repeatedly nudged by telephone reminders, 192 (76%) of 253 intervention patients said they were as satisfied or more satisfied with their care as a result of the intervention, and 63% opted to continue receiving automated reminders.

The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Dr. Alan Johns reported at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002.

The Adiana system “is the next step in the evolution of hysteroscopic devices,” Dr. Johns said in an interview. It may be better than Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said.

“More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity.”

This may be important in women who subsequently choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before the placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns, who practices in Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of September 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women study (EASE) had enrolled 770 women at 16 sites. Almost half (47%) were aged 28–33 years.

A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48% and local plus intravenous analgesia in 17%.

Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) of women, and there were 2 pregnancies. One pregnancy occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube.

There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.

The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Dr. Alan Johns reported at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002.

The Adiana system “is the next step in the evolution of hysteroscopic devices,” Dr. Johns said in an interview. It may be better than Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said.

“More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity.”

This may be important in women who subsequently choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before the placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns, who practices in Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of September 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women study (EASE) had enrolled 770 women at 16 sites. Almost half (47%) were aged 28–33 years.

A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48% and local plus intravenous analgesia in 17%.

Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) of women, and there were 2 pregnancies. One pregnancy occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube.

There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.

The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Dr. Alan Johns reported at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002.

The Adiana system “is the next step in the evolution of hysteroscopic devices,” Dr. Johns said in an interview. It may be better than Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said.

“More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity.”

This may be important in women who subsequently choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before the placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns, who practices in Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of September 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women study (EASE) had enrolled 770 women at 16 sites. Almost half (47%) were aged 28–33 years.

A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48% and local plus intravenous analgesia in 17%.

Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) of women, and there were 2 pregnancies. One pregnancy occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube.

There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.

QUEBEC CITY – Paternal depression is relatively common and can negatively affect child behavior, Shreya Davé reported at the annual meeting of the North American Primary Care Research Group.

A clear link has been established between maternal depression and impaired social development of children. But little is know about paternal depression and its effects.

Ms. Davé presented a cross-sectional study in which questionnaires were sent to 2,352 biological fathers with children aged 4–6 years who were identified from 13 general practices in greater London and Hertfordshire, England.

Questionnaires included a diagnostic depression measure (Patient Health Questionnaire) and standardized inventories on child behavior (Strengths and Difficulties Questionnaire), parenting, couple relationship, alcohol use, and demographics.

Mothers were sent a similar but smaller packet. Their responses were used to assess child behavior and were thought to be a more objective way to assess the relationship of paternal depression and child behavior, said Ms. Davé, a research fellow in the department of primary care and population sciences at University College London.

The prevalence of paternal depression was 8% in the study, with 29 of the 365 fathers who responded scoring positively for depressive symptoms.

Of the 365 responders, 12 (3%) fathers had major depressive symptoms and 17 (5%) had mild or moderate depressive symptoms.

Fathers with major depression were almost 20 times more likely to have a child with signs of peer problems (odds ratio 19.17) and 13 times more likely to have a child with a low score on an assessment of prosocial behavior (OR 13.22), after controlling for maternal depression, couple relationship quality, paternal age, and number of children.

Limitations of the study were its cross-sectional design, low response rate, and wide confidence intervals resulting from the small number of participants, she said. But the findings clearly point to the need for further studies.

If it is addressed proactively, Ms. Davé said, paternal depression is a treatable condition.

QUEBEC CITY – Paternal depression is relatively common and can negatively affect child behavior, Shreya Davé reported at the annual meeting of the North American Primary Care Research Group.

A clear link has been established between maternal depression and impaired social development of children. But little is know about paternal depression and its effects.

Ms. Davé presented a cross-sectional study in which questionnaires were sent to 2,352 biological fathers with children aged 4–6 years who were identified from 13 general practices in greater London and Hertfordshire, England.

Questionnaires included a diagnostic depression measure (Patient Health Questionnaire) and standardized inventories on child behavior (Strengths and Difficulties Questionnaire), parenting, couple relationship, alcohol use, and demographics.

Mothers were sent a similar but smaller packet. Their responses were used to assess child behavior and were thought to be a more objective way to assess the relationship of paternal depression and child behavior, said Ms. Davé, a research fellow in the department of primary care and population sciences at University College London.

The prevalence of paternal depression was 8% in the study, with 29 of the 365 fathers who responded scoring positively for depressive symptoms.

Of the 365 responders, 12 (3%) fathers had major depressive symptoms and 17 (5%) had mild or moderate depressive symptoms.

Fathers with major depression were almost 20 times more likely to have a child with signs of peer problems (odds ratio 19.17) and 13 times more likely to have a child with a low score on an assessment of prosocial behavior (OR 13.22), after controlling for maternal depression, couple relationship quality, paternal age, and number of children.

Limitations of the study were its cross-sectional design, low response rate, and wide confidence intervals resulting from the small number of participants, she said. But the findings clearly point to the need for further studies.

If it is addressed proactively, Ms. Davé said, paternal depression is a treatable condition.

QUEBEC CITY – Paternal depression is relatively common and can negatively affect child behavior, Shreya Davé reported at the annual meeting of the North American Primary Care Research Group.

A clear link has been established between maternal depression and impaired social development of children. But little is know about paternal depression and its effects.

Ms. Davé presented a cross-sectional study in which questionnaires were sent to 2,352 biological fathers with children aged 4–6 years who were identified from 13 general practices in greater London and Hertfordshire, England.

Questionnaires included a diagnostic depression measure (Patient Health Questionnaire) and standardized inventories on child behavior (Strengths and Difficulties Questionnaire), parenting, couple relationship, alcohol use, and demographics.

Mothers were sent a similar but smaller packet. Their responses were used to assess child behavior and were thought to be a more objective way to assess the relationship of paternal depression and child behavior, said Ms. Davé, a research fellow in the department of primary care and population sciences at University College London.

The prevalence of paternal depression was 8% in the study, with 29 of the 365 fathers who responded scoring positively for depressive symptoms.

Of the 365 responders, 12 (3%) fathers had major depressive symptoms and 17 (5%) had mild or moderate depressive symptoms.

Fathers with major depression were almost 20 times more likely to have a child with signs of peer problems (odds ratio 19.17) and 13 times more likely to have a child with a low score on an assessment of prosocial behavior (OR 13.22), after controlling for maternal depression, couple relationship quality, paternal age, and number of children.

Limitations of the study were its cross-sectional design, low response rate, and wide confidence intervals resulting from the small number of participants, she said. But the findings clearly point to the need for further studies.

If it is addressed proactively, Ms. Davé said, paternal depression is a treatable condition.

CHICAGO — Multislice CT with enteroclysis is an effective method to detect colorectal involvement in patients with endometriosis, Dr. Ennio Biscaldi reported at the annual meeting of the Radiological Society of North America.

Women affected by pelvic endometriosis usually undergo surgery to detect bowel involvement. If intestinal loops are involved, a second surgery is then required to resect the involved loop.

The main advantage of CT enteroclysis over the standard of video laparoscopy is that it provides a good view of the intestinal wall and the depth of involvement of the bowel wall, allowing surgeons to determine before the intervention if an intestinal resection is needed.

“With our technique, surgeons have an instrument for preoperative planning,” Dr. Biscaldi said in an interview. “We detect the bowel involvement and evaluate the depth of loop infiltration to plan preoperatively if a nodulectomy or an intestinal resection is needed. The patient is informed in advance, and the abdominal surgeon, if needed, is called to operate with the gynecologist.”

The disadvantages of the imaging technique are that it may underestimate submucosal involvement, may not always recognize very small nodules, and uses ionizing radiation in women of reproductive age, said Dr. Biscaldi, a radiologist with San Martino Hospital, Genoa, Italy.

Dr. Biscaldi and his colleagues reported preliminary results from a study in which 30 women, aged 27–40 years, with known ovarian endometriosis and symptoms of pelvic pain, dyspareunia, and tenesmus suggesting colorectal endometriosis were evaluated with a 16-slice CT scan. The colon was distended with a water enema before the contrast medium (iopamidol at 1.5 cc/kg of body weight) was injected. Within 20 days of the exam, regardless of the scan findings, all women underwent laparoscopy.

In 28 patients, multislice CT enteroclysis detected the site of endometriosis and colorectal wall involvement. Deeper nodules had infiltrated the serosa in 9 patients, the muscularis in 16, and the submucosa in 3.

Endometriosis of the last ileal loop also was identified in one patient.

In seven patients (23%), small, 4- to 5-mm serosal nodules were detected near the colon. They had not infiltrated the intestinal loops and were easily removed, he said. Nine patients underwent nodulectomy, and 19 underwent intestinal resection.

Two patients had no bowel endometriosis.

There have been no false positives with the imaging technique, said Dr. Biscaldi, adding that larger studies are needed to validate the findings.

CHICAGO — Multislice CT with enteroclysis is an effective method to detect colorectal involvement in patients with endometriosis, Dr. Ennio Biscaldi reported at the annual meeting of the Radiological Society of North America.

Women affected by pelvic endometriosis usually undergo surgery to detect bowel involvement. If intestinal loops are involved, a second surgery is then required to resect the involved loop.

The main advantage of CT enteroclysis over the standard of video laparoscopy is that it provides a good view of the intestinal wall and the depth of involvement of the bowel wall, allowing surgeons to determine before the intervention if an intestinal resection is needed.

“With our technique, surgeons have an instrument for preoperative planning,” Dr. Biscaldi said in an interview. “We detect the bowel involvement and evaluate the depth of loop infiltration to plan preoperatively if a nodulectomy or an intestinal resection is needed. The patient is informed in advance, and the abdominal surgeon, if needed, is called to operate with the gynecologist.”

The disadvantages of the imaging technique are that it may underestimate submucosal involvement, may not always recognize very small nodules, and uses ionizing radiation in women of reproductive age, said Dr. Biscaldi, a radiologist with San Martino Hospital, Genoa, Italy.

Dr. Biscaldi and his colleagues reported preliminary results from a study in which 30 women, aged 27–40 years, with known ovarian endometriosis and symptoms of pelvic pain, dyspareunia, and tenesmus suggesting colorectal endometriosis were evaluated with a 16-slice CT scan. The colon was distended with a water enema before the contrast medium (iopamidol at 1.5 cc/kg of body weight) was injected. Within 20 days of the exam, regardless of the scan findings, all women underwent laparoscopy.

In 28 patients, multislice CT enteroclysis detected the site of endometriosis and colorectal wall involvement. Deeper nodules had infiltrated the serosa in 9 patients, the muscularis in 16, and the submucosa in 3.

Endometriosis of the last ileal loop also was identified in one patient.

In seven patients (23%), small, 4- to 5-mm serosal nodules were detected near the colon. They had not infiltrated the intestinal loops and were easily removed, he said. Nine patients underwent nodulectomy, and 19 underwent intestinal resection.

Two patients had no bowel endometriosis.

There have been no false positives with the imaging technique, said Dr. Biscaldi, adding that larger studies are needed to validate the findings.

CHICAGO — Multislice CT with enteroclysis is an effective method to detect colorectal involvement in patients with endometriosis, Dr. Ennio Biscaldi reported at the annual meeting of the Radiological Society of North America.

Women affected by pelvic endometriosis usually undergo surgery to detect bowel involvement. If intestinal loops are involved, a second surgery is then required to resect the involved loop.

The main advantage of CT enteroclysis over the standard of video laparoscopy is that it provides a good view of the intestinal wall and the depth of involvement of the bowel wall, allowing surgeons to determine before the intervention if an intestinal resection is needed.

“With our technique, surgeons have an instrument for preoperative planning,” Dr. Biscaldi said in an interview. “We detect the bowel involvement and evaluate the depth of loop infiltration to plan preoperatively if a nodulectomy or an intestinal resection is needed. The patient is informed in advance, and the abdominal surgeon, if needed, is called to operate with the gynecologist.”

The disadvantages of the imaging technique are that it may underestimate submucosal involvement, may not always recognize very small nodules, and uses ionizing radiation in women of reproductive age, said Dr. Biscaldi, a radiologist with San Martino Hospital, Genoa, Italy.

Dr. Biscaldi and his colleagues reported preliminary results from a study in which 30 women, aged 27–40 years, with known ovarian endometriosis and symptoms of pelvic pain, dyspareunia, and tenesmus suggesting colorectal endometriosis were evaluated with a 16-slice CT scan. The colon was distended with a water enema before the contrast medium (iopamidol at 1.5 cc/kg of body weight) was injected. Within 20 days of the exam, regardless of the scan findings, all women underwent laparoscopy.

In 28 patients, multislice CT enteroclysis detected the site of endometriosis and colorectal wall involvement. Deeper nodules had infiltrated the serosa in 9 patients, the muscularis in 16, and the submucosa in 3.

Endometriosis of the last ileal loop also was identified in one patient.

In seven patients (23%), small, 4- to 5-mm serosal nodules were detected near the colon. They had not infiltrated the intestinal loops and were easily removed, he said. Nine patients underwent nodulectomy, and 19 underwent intestinal resection.

Two patients had no bowel endometriosis.

There have been no false positives with the imaging technique, said Dr. Biscaldi, adding that larger studies are needed to validate the findings.

CHICAGO — Higher intraperitoneal insufflation pressures at trocar entry appear to safely establish appropriate pneumoperitoneum in otherwise healthy obese women undergoing laparoscopic surgery, Dr. Basim Abu-Rafea said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Dr. Abu-Rafea and his colleagues at the University of Western Ontario, London, Canada, concluded that setting the intraperitoneal insufflation pressure (IPIP) at 25–30 mm Hg prior to primary trocar insertion eliminates the need to monitor CO₂ insufflated volume, ensures adequate pneumoperitoneum, and does not appear to be associated with increased hemodynamic risk.

The incidence of adverse events during laparoscopic surgery has been observed to be higher with obesity and increased parity. Research has suggested that IPIPs of 20–30 mm Hg are adequate to lift the abdominal wall. But there are concerns about causing respiratory or cardiovascular suppression or collapse secondary to the high pressures, especially in obese patients.

Dr. Abu-Rafea and his associates conducted a prospective observational cohort study of 100 healthy women who consecutively underwent laparoscopic surgery, primarily for chronic pelvic pain (66) or infertility (23).

The women ranged in age from 19 to 58 years and in weight from 43 kg to 118 kg with body mass indexes of 17–39 kg/m

All were categorized as having American Society of Anesthesiologists (ASA) physical status I or II.

All were given muscle relaxants and general anesthesia, and were in the supine position for the procedures. Pneumoperitoneum was established using a Veress needle.

Heart rate, CO₂ volume, blood pressure, and pulmonary compliance were serially recorded at various IPIPs.

After the primary trocar was introduced and access without injury was confirmed laparoscopically, the IPIP was immediately reduced to the standard operating pressure of 15 mm Hg before the patient was put into a Trendelenburg's position.

At 10 mm Hg, 15 mm Hg, 20 mm Hg, 25 mm Hg, and 30 mm Hg, the means of insufflated CO₂ volumes were calculated at 1.7 L, 3.1 L, 4.0 L, 4.4 L, and 4.7 L, respectively.

In a multivariate analysis, the insufflated CO₂ volume correlated positively with the patients' weight (R = 0.378, P < .0001) and positively with parity (R = −0.508, P < .0001).

Setting the IPIP at 25–30 mm Hg prior to primary trocar insertion would ensure adequate pneumoperitoneum, eliminating the need to monitor CO₂ insufflated volume and avoiding concerns related to body habitus and parity status, he said.

In a previous analysis of the data, the higher entry pressures caused minor hemodynamic alterations but did not adversely affect cardiopulmonary function (J. Minim. Invasive Gynecol. 2005;12:475–79).

When taken together, the findings could change current practice, which is to insufflate to a pressure of 15 mm Hg or to a volume of 3–4 L of CO₂ prior to primary trocar insertion.

“We have clearly demonstrated that the healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced, and then the pressure is immediately reduced to the standard operating pressure of 15 mm Hg,” Dr. Abu-Rafea said in an interview.

In addition, he anticipates that the use of high entry pressures will reduce entry-related injuries resulting from inadequate pneumoperitoneal insufflation. More than half of laparoscopic surgery complications are entry-related and possibly attributable to inadequate pneumoperitoneum prior to trocar insertion, he said.

'The healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced.' DR. ABU-RAFEA

CHICAGO — Higher intraperitoneal insufflation pressures at trocar entry appear to safely establish appropriate pneumoperitoneum in otherwise healthy obese women undergoing laparoscopic surgery, Dr. Basim Abu-Rafea said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Dr. Abu-Rafea and his colleagues at the University of Western Ontario, London, Canada, concluded that setting the intraperitoneal insufflation pressure (IPIP) at 25–30 mm Hg prior to primary trocar insertion eliminates the need to monitor CO₂ insufflated volume, ensures adequate pneumoperitoneum, and does not appear to be associated with increased hemodynamic risk.

The incidence of adverse events during laparoscopic surgery has been observed to be higher with obesity and increased parity. Research has suggested that IPIPs of 20–30 mm Hg are adequate to lift the abdominal wall. But there are concerns about causing respiratory or cardiovascular suppression or collapse secondary to the high pressures, especially in obese patients.

Dr. Abu-Rafea and his associates conducted a prospective observational cohort study of 100 healthy women who consecutively underwent laparoscopic surgery, primarily for chronic pelvic pain (66) or infertility (23).

The women ranged in age from 19 to 58 years and in weight from 43 kg to 118 kg with body mass indexes of 17–39 kg/m

All were categorized as having American Society of Anesthesiologists (ASA) physical status I or II.

All were given muscle relaxants and general anesthesia, and were in the supine position for the procedures. Pneumoperitoneum was established using a Veress needle.

Heart rate, CO₂ volume, blood pressure, and pulmonary compliance were serially recorded at various IPIPs.

After the primary trocar was introduced and access without injury was confirmed laparoscopically, the IPIP was immediately reduced to the standard operating pressure of 15 mm Hg before the patient was put into a Trendelenburg's position.

At 10 mm Hg, 15 mm Hg, 20 mm Hg, 25 mm Hg, and 30 mm Hg, the means of insufflated CO₂ volumes were calculated at 1.7 L, 3.1 L, 4.0 L, 4.4 L, and 4.7 L, respectively.

In a multivariate analysis, the insufflated CO₂ volume correlated positively with the patients' weight (R = 0.378, P < .0001) and positively with parity (R = −0.508, P < .0001).

Setting the IPIP at 25–30 mm Hg prior to primary trocar insertion would ensure adequate pneumoperitoneum, eliminating the need to monitor CO₂ insufflated volume and avoiding concerns related to body habitus and parity status, he said.

In a previous analysis of the data, the higher entry pressures caused minor hemodynamic alterations but did not adversely affect cardiopulmonary function (J. Minim. Invasive Gynecol. 2005;12:475–79).

When taken together, the findings could change current practice, which is to insufflate to a pressure of 15 mm Hg or to a volume of 3–4 L of CO₂ prior to primary trocar insertion.

“We have clearly demonstrated that the healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced, and then the pressure is immediately reduced to the standard operating pressure of 15 mm Hg,” Dr. Abu-Rafea said in an interview.

In addition, he anticipates that the use of high entry pressures will reduce entry-related injuries resulting from inadequate pneumoperitoneal insufflation. More than half of laparoscopic surgery complications are entry-related and possibly attributable to inadequate pneumoperitoneum prior to trocar insertion, he said.

'The healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced.' DR. ABU-RAFEA

CHICAGO — Higher intraperitoneal insufflation pressures at trocar entry appear to safely establish appropriate pneumoperitoneum in otherwise healthy obese women undergoing laparoscopic surgery, Dr. Basim Abu-Rafea said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Dr. Abu-Rafea and his colleagues at the University of Western Ontario, London, Canada, concluded that setting the intraperitoneal insufflation pressure (IPIP) at 25–30 mm Hg prior to primary trocar insertion eliminates the need to monitor CO₂ insufflated volume, ensures adequate pneumoperitoneum, and does not appear to be associated with increased hemodynamic risk.

The incidence of adverse events during laparoscopic surgery has been observed to be higher with obesity and increased parity. Research has suggested that IPIPs of 20–30 mm Hg are adequate to lift the abdominal wall. But there are concerns about causing respiratory or cardiovascular suppression or collapse secondary to the high pressures, especially in obese patients.

Dr. Abu-Rafea and his associates conducted a prospective observational cohort study of 100 healthy women who consecutively underwent laparoscopic surgery, primarily for chronic pelvic pain (66) or infertility (23).

The women ranged in age from 19 to 58 years and in weight from 43 kg to 118 kg with body mass indexes of 17–39 kg/m

All were categorized as having American Society of Anesthesiologists (ASA) physical status I or II.

All were given muscle relaxants and general anesthesia, and were in the supine position for the procedures. Pneumoperitoneum was established using a Veress needle.

Heart rate, CO₂ volume, blood pressure, and pulmonary compliance were serially recorded at various IPIPs.

After the primary trocar was introduced and access without injury was confirmed laparoscopically, the IPIP was immediately reduced to the standard operating pressure of 15 mm Hg before the patient was put into a Trendelenburg's position.

At 10 mm Hg, 15 mm Hg, 20 mm Hg, 25 mm Hg, and 30 mm Hg, the means of insufflated CO₂ volumes were calculated at 1.7 L, 3.1 L, 4.0 L, 4.4 L, and 4.7 L, respectively.

In a multivariate analysis, the insufflated CO₂ volume correlated positively with the patients' weight (R = 0.378, P < .0001) and positively with parity (R = −0.508, P < .0001).

Setting the IPIP at 25–30 mm Hg prior to primary trocar insertion would ensure adequate pneumoperitoneum, eliminating the need to monitor CO₂ insufflated volume and avoiding concerns related to body habitus and parity status, he said.

In a previous analysis of the data, the higher entry pressures caused minor hemodynamic alterations but did not adversely affect cardiopulmonary function (J. Minim. Invasive Gynecol. 2005;12:475–79).

When taken together, the findings could change current practice, which is to insufflate to a pressure of 15 mm Hg or to a volume of 3–4 L of CO₂ prior to primary trocar insertion.

“We have clearly demonstrated that the healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced, and then the pressure is immediately reduced to the standard operating pressure of 15 mm Hg,” Dr. Abu-Rafea said in an interview.

In addition, he anticipates that the use of high entry pressures will reduce entry-related injuries resulting from inadequate pneumoperitoneal insufflation. More than half of laparoscopic surgery complications are entry-related and possibly attributable to inadequate pneumoperitoneum prior to trocar insertion, he said.

'The healthy ASA I-II patient, even if obese, can tolerate high entry pressures until the primary trocar is introduced.' DR. ABU-RAFEA

CHICAGO — Solid thyroid nodules smaller than 1 cm in diameter tend to carry a greater risk of papillary carcinoma than do larger nodules, Dr. Nagesh Ragavendra reported at the annual meeting of the Radiological Society of North America.

The results of this study using fine-needle nonaspiration need to be confirmed in larger investigations as the study was too small to prove statistical significance. But the trend was marked, Dr. Ragavendra said.

The risk was 16% for thyroid nodules 1 cm or less in diameter compared with 8% for nodules 1.1 cm or more.

Surprisingly, the study also found that capsular invasion is relatively common in solid thyroid nodules, said Dr. Ragavendra, professor of radiology and chief of the ultrasound section at the University of California at Los Angeles. Five of the larger-sized nodules had capsular invasion; two had nodal metastases.

Biopsies were performed under ultrasound guidance on 598 focal thyroid nodules in 466 consecutive patients using the fine-needle nonaspiration technique with on-site cytologic examination.

With this technique, cells are extracted with a 25-gauge needle that is repeatedly and rapidly advanced into and withdrawn from the nodule. The needle is not connected to external suction, as is the case with traditional fine-needle aspiration.

Neither technique has proved superior in the cytopathologic studies of thyroid nodules. But it is suggested that fine-needle nonaspiration provides specimens with larger numbers of cells and better preserved cytomorphology, Dr. Ragavendra said.

The sample tends to be less blood tinged with nonaspiration than with aspiration fine-needle biopsy, Dr. Ragavendra added. Further, nonaspiration allows continuous monitoring of the position of the needle tip, thus ensuring proper sampling of the area of interest.

Of the 511 nodules that were 1.1 cm in diameter or larger, histology revealed that 448 (88%) were benign, 39 (8%) were papillary carcinoma, and 24 (5%) were other tumors.

Of the 87 nodules 1 cm or less, 67 (77%) were benign, 14 (16%) were papillary carcinoma, and 6 (7%) were other tumors.

The findings of the investigation do not settle the long-standing debate as to which thyroid nodules should be biopsied. But those with some cystic components tend to be benign, Dr. Ragavendra said. At UCLA, all solid nodules, whether hypoechoic or isoechoic, are candidates for fine-needle biopsy.

CHICAGO — Solid thyroid nodules smaller than 1 cm in diameter tend to carry a greater risk of papillary carcinoma than do larger nodules, Dr. Nagesh Ragavendra reported at the annual meeting of the Radiological Society of North America.

The results of this study using fine-needle nonaspiration need to be confirmed in larger investigations as the study was too small to prove statistical significance. But the trend was marked, Dr. Ragavendra said.

The risk was 16% for thyroid nodules 1 cm or less in diameter compared with 8% for nodules 1.1 cm or more.

Surprisingly, the study also found that capsular invasion is relatively common in solid thyroid nodules, said Dr. Ragavendra, professor of radiology and chief of the ultrasound section at the University of California at Los Angeles. Five of the larger-sized nodules had capsular invasion; two had nodal metastases.

Biopsies were performed under ultrasound guidance on 598 focal thyroid nodules in 466 consecutive patients using the fine-needle nonaspiration technique with on-site cytologic examination.

With this technique, cells are extracted with a 25-gauge needle that is repeatedly and rapidly advanced into and withdrawn from the nodule. The needle is not connected to external suction, as is the case with traditional fine-needle aspiration.

Neither technique has proved superior in the cytopathologic studies of thyroid nodules. But it is suggested that fine-needle nonaspiration provides specimens with larger numbers of cells and better preserved cytomorphology, Dr. Ragavendra said.

The sample tends to be less blood tinged with nonaspiration than with aspiration fine-needle biopsy, Dr. Ragavendra added. Further, nonaspiration allows continuous monitoring of the position of the needle tip, thus ensuring proper sampling of the area of interest.

Of the 511 nodules that were 1.1 cm in diameter or larger, histology revealed that 448 (88%) were benign, 39 (8%) were papillary carcinoma, and 24 (5%) were other tumors.

Of the 87 nodules 1 cm or less, 67 (77%) were benign, 14 (16%) were papillary carcinoma, and 6 (7%) were other tumors.

The findings of the investigation do not settle the long-standing debate as to which thyroid nodules should be biopsied. But those with some cystic components tend to be benign, Dr. Ragavendra said. At UCLA, all solid nodules, whether hypoechoic or isoechoic, are candidates for fine-needle biopsy.

CHICAGO — Solid thyroid nodules smaller than 1 cm in diameter tend to carry a greater risk of papillary carcinoma than do larger nodules, Dr. Nagesh Ragavendra reported at the annual meeting of the Radiological Society of North America.

The results of this study using fine-needle nonaspiration need to be confirmed in larger investigations as the study was too small to prove statistical significance. But the trend was marked, Dr. Ragavendra said.

The risk was 16% for thyroid nodules 1 cm or less in diameter compared with 8% for nodules 1.1 cm or more.

Surprisingly, the study also found that capsular invasion is relatively common in solid thyroid nodules, said Dr. Ragavendra, professor of radiology and chief of the ultrasound section at the University of California at Los Angeles. Five of the larger-sized nodules had capsular invasion; two had nodal metastases.

Biopsies were performed under ultrasound guidance on 598 focal thyroid nodules in 466 consecutive patients using the fine-needle nonaspiration technique with on-site cytologic examination.

With this technique, cells are extracted with a 25-gauge needle that is repeatedly and rapidly advanced into and withdrawn from the nodule. The needle is not connected to external suction, as is the case with traditional fine-needle aspiration.

Neither technique has proved superior in the cytopathologic studies of thyroid nodules. But it is suggested that fine-needle nonaspiration provides specimens with larger numbers of cells and better preserved cytomorphology, Dr. Ragavendra said.

The sample tends to be less blood tinged with nonaspiration than with aspiration fine-needle biopsy, Dr. Ragavendra added. Further, nonaspiration allows continuous monitoring of the position of the needle tip, thus ensuring proper sampling of the area of interest.

Of the 511 nodules that were 1.1 cm in diameter or larger, histology revealed that 448 (88%) were benign, 39 (8%) were papillary carcinoma, and 24 (5%) were other tumors.

Of the 87 nodules 1 cm or less, 67 (77%) were benign, 14 (16%) were papillary carcinoma, and 6 (7%) were other tumors.

The findings of the investigation do not settle the long-standing debate as to which thyroid nodules should be biopsied. But those with some cystic components tend to be benign, Dr. Ragavendra said. At UCLA, all solid nodules, whether hypoechoic or isoechoic, are candidates for fine-needle biopsy.

Smokers with systemic lupus erythematosus are more likely to be seropositive for double-stranded DNA autoantibodies, compared with those patients who never smoked or quit, according to the findings of a recent study.

Epidemiologic data suggests that smoking is associated with autoimmune disease as well as with autoantibody formation.

The cohort analysis included 410 white patients who were participants in the University of California, San Francisco, Lupus Genetics Project. Patients were included if they provided a complete self-report of their smoking history and had adequate medical records of autoantibody status.

Among these patients, 140 were current smokers, 89 former smokers, and 181 never smokers. Current smokers had a significantly higher risk of double-stranded DNA (dsDNA) seropositivity, compared with never smokers (OR 4.0). Current smokers also were more likely than former smokers to be dsDNA seropositive (OR 3.0), in multivariate analyses, (Ann. Rheum. Dis. 2005 Sept. 8; [Epub doi:10.1136/ard.2005.039438]). The association between current smoking and dsDNA seropositivity remained significant after adjustment for gender, age at lupus diagnosis, amount smoked, age when smoking began, and the duration of smoking cessation for former smokers.

“The association of current smoking with dsDNA seropositivity provides evidence supporting a potential pathogenetic mechanism for the formation of such antibodies,” reported Dr. Michelle M. Freemer of San Francisco General Hospital. In some lupus patients, DNA adducts may serve as the antigen for the formation of dsDNA autoantibodies, or antibodies to DNA adducts could act as anti-idiotypes for the formation of dsDNA autoantibodies.

Smokers with systemic lupus erythematosus are more likely to be seropositive for double-stranded DNA autoantibodies, compared with those patients who never smoked or quit, according to the findings of a recent study.

Epidemiologic data suggests that smoking is associated with autoimmune disease as well as with autoantibody formation.

The cohort analysis included 410 white patients who were participants in the University of California, San Francisco, Lupus Genetics Project. Patients were included if they provided a complete self-report of their smoking history and had adequate medical records of autoantibody status.

Among these patients, 140 were current smokers, 89 former smokers, and 181 never smokers. Current smokers had a significantly higher risk of double-stranded DNA (dsDNA) seropositivity, compared with never smokers (OR 4.0). Current smokers also were more likely than former smokers to be dsDNA seropositive (OR 3.0), in multivariate analyses, (Ann. Rheum. Dis. 2005 Sept. 8; [Epub doi:10.1136/ard.2005.039438]). The association between current smoking and dsDNA seropositivity remained significant after adjustment for gender, age at lupus diagnosis, amount smoked, age when smoking began, and the duration of smoking cessation for former smokers.

“The association of current smoking with dsDNA seropositivity provides evidence supporting a potential pathogenetic mechanism for the formation of such antibodies,” reported Dr. Michelle M. Freemer of San Francisco General Hospital. In some lupus patients, DNA adducts may serve as the antigen for the formation of dsDNA autoantibodies, or antibodies to DNA adducts could act as anti-idiotypes for the formation of dsDNA autoantibodies.

Smokers with systemic lupus erythematosus are more likely to be seropositive for double-stranded DNA autoantibodies, compared with those patients who never smoked or quit, according to the findings of a recent study.

Epidemiologic data suggests that smoking is associated with autoimmune disease as well as with autoantibody formation.

The cohort analysis included 410 white patients who were participants in the University of California, San Francisco, Lupus Genetics Project. Patients were included if they provided a complete self-report of their smoking history and had adequate medical records of autoantibody status.

Among these patients, 140 were current smokers, 89 former smokers, and 181 never smokers. Current smokers had a significantly higher risk of double-stranded DNA (dsDNA) seropositivity, compared with never smokers (OR 4.0). Current smokers also were more likely than former smokers to be dsDNA seropositive (OR 3.0), in multivariate analyses, (Ann. Rheum. Dis. 2005 Sept. 8; [Epub doi:10.1136/ard.2005.039438]). The association between current smoking and dsDNA seropositivity remained significant after adjustment for gender, age at lupus diagnosis, amount smoked, age when smoking began, and the duration of smoking cessation for former smokers.

“The association of current smoking with dsDNA seropositivity provides evidence supporting a potential pathogenetic mechanism for the formation of such antibodies,” reported Dr. Michelle M. Freemer of San Francisco General Hospital. In some lupus patients, DNA adducts may serve as the antigen for the formation of dsDNA autoantibodies, or antibodies to DNA adducts could act as anti-idiotypes for the formation of dsDNA autoantibodies.