Damian McNamara

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, and her colleagues studied 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. The mean operating time was 155 minutes. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of causes unrelated to thymoma, Dr. Melfi said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008:1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that the mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements to robotic-assisted thymectomy are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi said she had no relevant financial disclosures.

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, and her colleagues studied 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. The mean operating time was 155 minutes. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of causes unrelated to thymoma, Dr. Melfi said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008:1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that the mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements to robotic-assisted thymectomy are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi said she had no relevant financial disclosures.

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, and her colleagues studied 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. The mean operating time was 155 minutes. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of causes unrelated to thymoma, Dr. Melfi said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008:1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that the mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements to robotic-assisted thymectomy are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi said she had no relevant financial disclosures.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

MIAMI BEACH – Acute menorrhagia or abnormally heavy and prolonged menstrual bleeding can be a serious condition for any adolescent girl, but it becomes even more so if she has an underlying bleeding disorder, according to an expert.

Hormonal therapy, antifibrinolytic therapy, balloon tamponade, and correction of any specific hemostatic defect are the primary management strategies for acute menorrhagia, Dr. Andra H. James said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "It is not clear which therapy should come first and in what order."

This lack of clarity stems in part from a paucity of evidence-based medicine in the literature, said Dr. James, professor of ob.gyn. and assistant professor of medicine at Duke University Medical Center in Durham, N.C.

She recognized the need for more guidance on acute menorrhagia and was the primary author of consensus guidelines on evaluation and management of acute menorrhagia (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;158:124-34). Dr. James and some international experts systemically reviewed what was in the literature – primarily case reports and expert opinion – to devise recommendations for acute menorrhagia for girls and women with and without underlying bleeding disorders.

Important elements of patient history, physical exam, medication review, and laboratory testing are outlined in the guidelines, as well as advice on when an ultrasound examination is warranted.

Adolescents with acute menorrhagia differ from adults in some important ways. Anticoagulation therapy is rarely a cause of abnormal bleeding in a young woman, but "anovulatory bleeding is often a precipitating factor in adolescence," she said.

In addition, acute signs of an underlying bleeding disorder can first appear during the teenage years, Dr. James said.

Thrombocytopenia, von Willebrand disease, platelet function disorders, and clotting factor deficiencies are among the most relevant bleeding disorders in this setting. "These bleeding disorders are important to gynecologists [because] the leading symptom in the women and girls with a bleeding disorder is heavy menstrual bleeding," she said.

There also are girls and women who present with rare factor deficiency disorders, and the relatively fewer treatment options for these patients are outlined in the guidelines.

"Acute menorrhagia is not a benign condition for an adolescent, whether or not they have a bleeding disorder. They are often seen in an acute setting," Dr. James said. "Heavy menstrual bleeding is pretty morbid for adolescents."

She recommended an eight-question screening tool to identify bleeding disorders in patients with menorrhagia (Am. J. Obstet. Gynecol. 2011;204:209.e1-7). Dr. Claire Philipp of Robert Wood Johnson Medical School, New Brunswick, N.J., and her colleagues developed this screen to help gynecologists and primary care physicians determine which patients to refer for hemostatic work-up. The screening questions fall into four categories: menorrhagia severity, family history of a diagnosed bleeding disorder, personal history of excessive bleeding after specific challenges, and history of treatment for anemia.

"I feel pretty good if they have one of those four, I am going to go ahead and test them," Dr. James said.

The screen is more than 90% sensitive for identification of von Willebrand disease, for example, "and you can avoid testing everyone who says they have heavy menstrual bleeding," said Dr. James, who is also founder of the Duke University Medical Center Women’s Hemostasis and Thrombosis Clinic.

"Dr. Erik von Willebrand, who described von Willebrand disease, lost his first patient to her fourth menstrual period," Dr. James said. "But [now] acute menorrhagia in adolescence can be evaluated and can be managed."

The guideline authors also proposed a consensus definition of acute menorrhagia: life-threatening bleeding of uterine origin with sufficient volume, in the absence of pregnancy or malignancy that occurs during childbearing years (teen to perimenopause). The condition occurs in patients with or without a previously diagnosed bleeding disorder. Patients present to the emergency department and require immediate evaluation and intervention.

The guidelines highlight considerations for hormonal treatment, antifibrinolytic therapy, balloon tamponade, and correction of hemostatic deficiencies. Even though treatment relies to a great deal on clinician judgment, "many of us feel comfortable starting with hormone therapy," she said.

Regarding balloon tamponade therapy, "there are no randomized trials, but there are multiple case reports of its effectiveness in the very acute situation in the emergency department," Dr. James said. "We all have conversations about how long we leave the balloon in." Jokingly, she added: "None of us want to take it out before the woman goes to college."

With a nod to a lack of rigorous studies in the literature, Dr. James proposed that groups such as NASPAG establish registries to collect data on acute menorrhagia evaluation and management. She also recommended www.fwgbd.org, the site for the Foundation for Women & Girls with Blood Disorders, for additional information on bleeding disorders. Dr. James is a board member of the foundation.

Dr. James said that she receives research funding from CSL Behring and Grifols. She is also a member of the von Willebrand disease medical advisory board sponsored by CSL Behring, Octapharma, and Baxter.

MIAMI BEACH – Acute menorrhagia or abnormally heavy and prolonged menstrual bleeding can be a serious condition for any adolescent girl, but it becomes even more so if she has an underlying bleeding disorder, according to an expert.

Hormonal therapy, antifibrinolytic therapy, balloon tamponade, and correction of any specific hemostatic defect are the primary management strategies for acute menorrhagia, Dr. Andra H. James said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "It is not clear which therapy should come first and in what order."

This lack of clarity stems in part from a paucity of evidence-based medicine in the literature, said Dr. James, professor of ob.gyn. and assistant professor of medicine at Duke University Medical Center in Durham, N.C.

She recognized the need for more guidance on acute menorrhagia and was the primary author of consensus guidelines on evaluation and management of acute menorrhagia (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;158:124-34). Dr. James and some international experts systemically reviewed what was in the literature – primarily case reports and expert opinion – to devise recommendations for acute menorrhagia for girls and women with and without underlying bleeding disorders.

Important elements of patient history, physical exam, medication review, and laboratory testing are outlined in the guidelines, as well as advice on when an ultrasound examination is warranted.

Adolescents with acute menorrhagia differ from adults in some important ways. Anticoagulation therapy is rarely a cause of abnormal bleeding in a young woman, but "anovulatory bleeding is often a precipitating factor in adolescence," she said.

In addition, acute signs of an underlying bleeding disorder can first appear during the teenage years, Dr. James said.

Thrombocytopenia, von Willebrand disease, platelet function disorders, and clotting factor deficiencies are among the most relevant bleeding disorders in this setting. "These bleeding disorders are important to gynecologists [because] the leading symptom in the women and girls with a bleeding disorder is heavy menstrual bleeding," she said.

There also are girls and women who present with rare factor deficiency disorders, and the relatively fewer treatment options for these patients are outlined in the guidelines.

"Acute menorrhagia is not a benign condition for an adolescent, whether or not they have a bleeding disorder. They are often seen in an acute setting," Dr. James said. "Heavy menstrual bleeding is pretty morbid for adolescents."

She recommended an eight-question screening tool to identify bleeding disorders in patients with menorrhagia (Am. J. Obstet. Gynecol. 2011;204:209.e1-7). Dr. Claire Philipp of Robert Wood Johnson Medical School, New Brunswick, N.J., and her colleagues developed this screen to help gynecologists and primary care physicians determine which patients to refer for hemostatic work-up. The screening questions fall into four categories: menorrhagia severity, family history of a diagnosed bleeding disorder, personal history of excessive bleeding after specific challenges, and history of treatment for anemia.

"I feel pretty good if they have one of those four, I am going to go ahead and test them," Dr. James said.

The screen is more than 90% sensitive for identification of von Willebrand disease, for example, "and you can avoid testing everyone who says they have heavy menstrual bleeding," said Dr. James, who is also founder of the Duke University Medical Center Women’s Hemostasis and Thrombosis Clinic.

"Dr. Erik von Willebrand, who described von Willebrand disease, lost his first patient to her fourth menstrual period," Dr. James said. "But [now] acute menorrhagia in adolescence can be evaluated and can be managed."

The guideline authors also proposed a consensus definition of acute menorrhagia: life-threatening bleeding of uterine origin with sufficient volume, in the absence of pregnancy or malignancy that occurs during childbearing years (teen to perimenopause). The condition occurs in patients with or without a previously diagnosed bleeding disorder. Patients present to the emergency department and require immediate evaluation and intervention.

The guidelines highlight considerations for hormonal treatment, antifibrinolytic therapy, balloon tamponade, and correction of hemostatic deficiencies. Even though treatment relies to a great deal on clinician judgment, "many of us feel comfortable starting with hormone therapy," she said.

Regarding balloon tamponade therapy, "there are no randomized trials, but there are multiple case reports of its effectiveness in the very acute situation in the emergency department," Dr. James said. "We all have conversations about how long we leave the balloon in." Jokingly, she added: "None of us want to take it out before the woman goes to college."

With a nod to a lack of rigorous studies in the literature, Dr. James proposed that groups such as NASPAG establish registries to collect data on acute menorrhagia evaluation and management. She also recommended www.fwgbd.org, the site for the Foundation for Women & Girls with Blood Disorders, for additional information on bleeding disorders. Dr. James is a board member of the foundation.

Dr. James said that she receives research funding from CSL Behring and Grifols. She is also a member of the von Willebrand disease medical advisory board sponsored by CSL Behring, Octapharma, and Baxter.

MIAMI BEACH – Acute menorrhagia or abnormally heavy and prolonged menstrual bleeding can be a serious condition for any adolescent girl, but it becomes even more so if she has an underlying bleeding disorder, according to an expert.

Hormonal therapy, antifibrinolytic therapy, balloon tamponade, and correction of any specific hemostatic defect are the primary management strategies for acute menorrhagia, Dr. Andra H. James said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "It is not clear which therapy should come first and in what order."

This lack of clarity stems in part from a paucity of evidence-based medicine in the literature, said Dr. James, professor of ob.gyn. and assistant professor of medicine at Duke University Medical Center in Durham, N.C.

She recognized the need for more guidance on acute menorrhagia and was the primary author of consensus guidelines on evaluation and management of acute menorrhagia (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;158:124-34). Dr. James and some international experts systemically reviewed what was in the literature – primarily case reports and expert opinion – to devise recommendations for acute menorrhagia for girls and women with and without underlying bleeding disorders.

Important elements of patient history, physical exam, medication review, and laboratory testing are outlined in the guidelines, as well as advice on when an ultrasound examination is warranted.

Adolescents with acute menorrhagia differ from adults in some important ways. Anticoagulation therapy is rarely a cause of abnormal bleeding in a young woman, but "anovulatory bleeding is often a precipitating factor in adolescence," she said.

In addition, acute signs of an underlying bleeding disorder can first appear during the teenage years, Dr. James said.

Thrombocytopenia, von Willebrand disease, platelet function disorders, and clotting factor deficiencies are among the most relevant bleeding disorders in this setting. "These bleeding disorders are important to gynecologists [because] the leading symptom in the women and girls with a bleeding disorder is heavy menstrual bleeding," she said.

There also are girls and women who present with rare factor deficiency disorders, and the relatively fewer treatment options for these patients are outlined in the guidelines.

"Acute menorrhagia is not a benign condition for an adolescent, whether or not they have a bleeding disorder. They are often seen in an acute setting," Dr. James said. "Heavy menstrual bleeding is pretty morbid for adolescents."

She recommended an eight-question screening tool to identify bleeding disorders in patients with menorrhagia (Am. J. Obstet. Gynecol. 2011;204:209.e1-7). Dr. Claire Philipp of Robert Wood Johnson Medical School, New Brunswick, N.J., and her colleagues developed this screen to help gynecologists and primary care physicians determine which patients to refer for hemostatic work-up. The screening questions fall into four categories: menorrhagia severity, family history of a diagnosed bleeding disorder, personal history of excessive bleeding after specific challenges, and history of treatment for anemia.

"I feel pretty good if they have one of those four, I am going to go ahead and test them," Dr. James said.

The screen is more than 90% sensitive for identification of von Willebrand disease, for example, "and you can avoid testing everyone who says they have heavy menstrual bleeding," said Dr. James, who is also founder of the Duke University Medical Center Women’s Hemostasis and Thrombosis Clinic.

"Dr. Erik von Willebrand, who described von Willebrand disease, lost his first patient to her fourth menstrual period," Dr. James said. "But [now] acute menorrhagia in adolescence can be evaluated and can be managed."

The guideline authors also proposed a consensus definition of acute menorrhagia: life-threatening bleeding of uterine origin with sufficient volume, in the absence of pregnancy or malignancy that occurs during childbearing years (teen to perimenopause). The condition occurs in patients with or without a previously diagnosed bleeding disorder. Patients present to the emergency department and require immediate evaluation and intervention.

The guidelines highlight considerations for hormonal treatment, antifibrinolytic therapy, balloon tamponade, and correction of hemostatic deficiencies. Even though treatment relies to a great deal on clinician judgment, "many of us feel comfortable starting with hormone therapy," she said.

Regarding balloon tamponade therapy, "there are no randomized trials, but there are multiple case reports of its effectiveness in the very acute situation in the emergency department," Dr. James said. "We all have conversations about how long we leave the balloon in." Jokingly, she added: "None of us want to take it out before the woman goes to college."

With a nod to a lack of rigorous studies in the literature, Dr. James proposed that groups such as NASPAG establish registries to collect data on acute menorrhagia evaluation and management. She also recommended www.fwgbd.org, the site for the Foundation for Women & Girls with Blood Disorders, for additional information on bleeding disorders. Dr. James is a board member of the foundation.

Dr. James said that she receives research funding from CSL Behring and Grifols. She is also a member of the von Willebrand disease medical advisory board sponsored by CSL Behring, Octapharma, and Baxter.

MIAMI BEACH – "Primary ovarian insufficiency: it’s not menopause!"

So began a primer on the important ways in which affected girls and adolescents can be diagnosed and managed, and importantly, counseled about their future with primary ovarian insufficiency.

"The sequelae of primary ovarian insufficiency are almost shocking," Dr. Beth W. Rackow said. Ovarian function is potentially lost decades before menopause. Diagnosis and long-term monitoring are important because primary ovarian insufficiency (POI) can cause adverse effects on skeletal metabolism, lipid profiles, insulin sensitivity, and endothelial dysfunction, which in turn can potentiate atherosclerosis and cardiovascular disease.

The timing of POI presentation varies – some girls will present before puberty, some with stalled puberty, and others after puberty, Dr. Rackow said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Unlike in menopause, ovarian dysfunction may not be permanent, which is why the term "ovarian insufficiency" is preferred to "ovarian failure," she added.

"It’s very likely you will see women with POI in your practice," Dr. Rackow said. Incidence increases with age, affecting about 1 in 10,000 girls and adolescents by age 20 years; 1 in 1,000 women by age 30; and 1 in 250 by age 35. Overall, about 1% of women will develop POI, she added.

Consider initially sharing a POI diagnosis face to face with parents before you talk to the child "so there is not global shock in the room," Dr. Rackow said. "They can support the child because they already know the diagnosis. They may also have insight into how their child will react." Explain why POI occurs, its impact on future fertility, and management options.

Although there is a genetic component to POI, the etiology for 90% of cases can be unclear, making this a challenging diagnosis. "We often don’t have a reason why a girl is presenting with this condition," said Dr. Rackow, a reproductive endocrinologist who is board certified in pediatric and adolescent gynecology within the department of clinical obstetrics & gynecology at New York Presbyterian Hospital/Columbia University Medical Center.

Follicle depletion and follicle dysfunction are the two main mechanisms. Depletion can stem from a lower baseline number of primordial follicles – "they start with less" – and/or from an increased rate of atresia. Follicle dysfunction, on the other hand, can result from impaired folliculogenesis or inappropriate luteinization that leads, over time, to a decreased complement or complete absence of oocytes.

Future fertility will be a leading concern. The spontaneous pregnancy rate for women with POI is 5%-10%. Some may consider in vitro fertilization or fertility assistance, but a poor to no response to gonadotropins "makes going through fertility treatment very challenging," Dr. Rackow said. There are many options for these patients to have a family, she added, including use of donor oocytes, donated embryos, and adoption. She sometimes tells patients: "You will be a mom someday. It just may be through a different way than you thought."

Psychological support can help patients and families after a diagnosis of POI. Dr. Rackow recommended two websites with more information: IPOFA & Rachel’s Well.

Menstrual anomalies could be your first clue. "Girls who have some abnormal menses for 3 months or more probably deserve further work-up," Dr. Rackow said. Also ask about pubertal history; any prior ovarian surgery, chemotherapy, or radiation; and their medical history because 20% of affected women have autoimmune disease. In addition, about 25% of girls with POI will have a thyroid disorder, but the 3% with adrenal disorders are particularly important to identify quickly. Consider checking the patient for adrenocortical antibodies, which in a girl with POI can point to significantly elevated risk for adrenal insufficiency. "They can get very sick with autoimmune adrenal failure."

In addition to an autoimmune work-up, "clearly we are going to get a karyotype on these patients," Dr. Rackow said. An estimated 6%-14% of women with POI carry a FMR-1 mutation, for example. X chromosome abnormalities, including trisomy X, are also possible.

Useful laboratory assays include measures of human chorionic gonadotropin and follicle stimulating hormone plus estradiol levels. "We tend to see low estradiol ... a sign of no estrogen production from the ovaries," Dr. Rackow said. "Normally, estrogen suppresses FSH more than luteinizing hormone, but in POI you tend to see elevated FSH."

Pelvic ultrasound to check for any antral follicles or any endometrium build-up also can be helpful. Bone densitometry also is helpful as a baseline measure after the POI diagnosis. "The bones can take a significant hit from POI in terms of bone density," Dr. Rackow said.

Following diagnosis of POI, consider annual, routine surveillance for endocrine disorders. Test for complete blood count, complete metabolic panel, calcium, phosphorus, fasting glucose, insulin, thyroid stimulating hormone, and thyroid peroxidase antibodies.

Estrogen replacement is part of management of these patients. "They require higher doses than [do] menopausal women. Also, if you give estrogen, [they] will need progestins for endometrial protection," Dr. Rackow said. Hormone replacement therapy can improve endothelial function within 6 months, potentially improve their long-term cardiovascular health, and mitigate bone loss.

"The lowest dose oral contraceptives have the higher end dose of estrogen you would give for POI. These girls do not need more," Dr. Rackow said. For more information, including hormone replacement therapy dosing guidance, see the September 2011 American College of Obstetrics and Gynecology Committee Opinion No. 502 on primary ovarian insufficiency in the adolescent (Obstet. Gynecol. 2011;118:741-5).

Dr. Rackow said she had no relevant financial disclosures.

MIAMI BEACH – "Primary ovarian insufficiency: it’s not menopause!"

So began a primer on the important ways in which affected girls and adolescents can be diagnosed and managed, and importantly, counseled about their future with primary ovarian insufficiency.

"The sequelae of primary ovarian insufficiency are almost shocking," Dr. Beth W. Rackow said. Ovarian function is potentially lost decades before menopause. Diagnosis and long-term monitoring are important because primary ovarian insufficiency (POI) can cause adverse effects on skeletal metabolism, lipid profiles, insulin sensitivity, and endothelial dysfunction, which in turn can potentiate atherosclerosis and cardiovascular disease.

The timing of POI presentation varies – some girls will present before puberty, some with stalled puberty, and others after puberty, Dr. Rackow said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Unlike in menopause, ovarian dysfunction may not be permanent, which is why the term "ovarian insufficiency" is preferred to "ovarian failure," she added.

"It’s very likely you will see women with POI in your practice," Dr. Rackow said. Incidence increases with age, affecting about 1 in 10,000 girls and adolescents by age 20 years; 1 in 1,000 women by age 30; and 1 in 250 by age 35. Overall, about 1% of women will develop POI, she added.

Consider initially sharing a POI diagnosis face to face with parents before you talk to the child "so there is not global shock in the room," Dr. Rackow said. "They can support the child because they already know the diagnosis. They may also have insight into how their child will react." Explain why POI occurs, its impact on future fertility, and management options.

Although there is a genetic component to POI, the etiology for 90% of cases can be unclear, making this a challenging diagnosis. "We often don’t have a reason why a girl is presenting with this condition," said Dr. Rackow, a reproductive endocrinologist who is board certified in pediatric and adolescent gynecology within the department of clinical obstetrics & gynecology at New York Presbyterian Hospital/Columbia University Medical Center.

Follicle depletion and follicle dysfunction are the two main mechanisms. Depletion can stem from a lower baseline number of primordial follicles – "they start with less" – and/or from an increased rate of atresia. Follicle dysfunction, on the other hand, can result from impaired folliculogenesis or inappropriate luteinization that leads, over time, to a decreased complement or complete absence of oocytes.

Future fertility will be a leading concern. The spontaneous pregnancy rate for women with POI is 5%-10%. Some may consider in vitro fertilization or fertility assistance, but a poor to no response to gonadotropins "makes going through fertility treatment very challenging," Dr. Rackow said. There are many options for these patients to have a family, she added, including use of donor oocytes, donated embryos, and adoption. She sometimes tells patients: "You will be a mom someday. It just may be through a different way than you thought."

Psychological support can help patients and families after a diagnosis of POI. Dr. Rackow recommended two websites with more information: IPOFA & Rachel’s Well.

Menstrual anomalies could be your first clue. "Girls who have some abnormal menses for 3 months or more probably deserve further work-up," Dr. Rackow said. Also ask about pubertal history; any prior ovarian surgery, chemotherapy, or radiation; and their medical history because 20% of affected women have autoimmune disease. In addition, about 25% of girls with POI will have a thyroid disorder, but the 3% with adrenal disorders are particularly important to identify quickly. Consider checking the patient for adrenocortical antibodies, which in a girl with POI can point to significantly elevated risk for adrenal insufficiency. "They can get very sick with autoimmune adrenal failure."

In addition to an autoimmune work-up, "clearly we are going to get a karyotype on these patients," Dr. Rackow said. An estimated 6%-14% of women with POI carry a FMR-1 mutation, for example. X chromosome abnormalities, including trisomy X, are also possible.

Useful laboratory assays include measures of human chorionic gonadotropin and follicle stimulating hormone plus estradiol levels. "We tend to see low estradiol ... a sign of no estrogen production from the ovaries," Dr. Rackow said. "Normally, estrogen suppresses FSH more than luteinizing hormone, but in POI you tend to see elevated FSH."

Pelvic ultrasound to check for any antral follicles or any endometrium build-up also can be helpful. Bone densitometry also is helpful as a baseline measure after the POI diagnosis. "The bones can take a significant hit from POI in terms of bone density," Dr. Rackow said.

Following diagnosis of POI, consider annual, routine surveillance for endocrine disorders. Test for complete blood count, complete metabolic panel, calcium, phosphorus, fasting glucose, insulin, thyroid stimulating hormone, and thyroid peroxidase antibodies.

Estrogen replacement is part of management of these patients. "They require higher doses than [do] menopausal women. Also, if you give estrogen, [they] will need progestins for endometrial protection," Dr. Rackow said. Hormone replacement therapy can improve endothelial function within 6 months, potentially improve their long-term cardiovascular health, and mitigate bone loss.

"The lowest dose oral contraceptives have the higher end dose of estrogen you would give for POI. These girls do not need more," Dr. Rackow said. For more information, including hormone replacement therapy dosing guidance, see the September 2011 American College of Obstetrics and Gynecology Committee Opinion No. 502 on primary ovarian insufficiency in the adolescent (Obstet. Gynecol. 2011;118:741-5).

Dr. Rackow said she had no relevant financial disclosures.

MIAMI BEACH – "Primary ovarian insufficiency: it’s not menopause!"

So began a primer on the important ways in which affected girls and adolescents can be diagnosed and managed, and importantly, counseled about their future with primary ovarian insufficiency.

"The sequelae of primary ovarian insufficiency are almost shocking," Dr. Beth W. Rackow said. Ovarian function is potentially lost decades before menopause. Diagnosis and long-term monitoring are important because primary ovarian insufficiency (POI) can cause adverse effects on skeletal metabolism, lipid profiles, insulin sensitivity, and endothelial dysfunction, which in turn can potentiate atherosclerosis and cardiovascular disease.

The timing of POI presentation varies – some girls will present before puberty, some with stalled puberty, and others after puberty, Dr. Rackow said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Unlike in menopause, ovarian dysfunction may not be permanent, which is why the term "ovarian insufficiency" is preferred to "ovarian failure," she added.

"It’s very likely you will see women with POI in your practice," Dr. Rackow said. Incidence increases with age, affecting about 1 in 10,000 girls and adolescents by age 20 years; 1 in 1,000 women by age 30; and 1 in 250 by age 35. Overall, about 1% of women will develop POI, she added.

Consider initially sharing a POI diagnosis face to face with parents before you talk to the child "so there is not global shock in the room," Dr. Rackow said. "They can support the child because they already know the diagnosis. They may also have insight into how their child will react." Explain why POI occurs, its impact on future fertility, and management options.

Although there is a genetic component to POI, the etiology for 90% of cases can be unclear, making this a challenging diagnosis. "We often don’t have a reason why a girl is presenting with this condition," said Dr. Rackow, a reproductive endocrinologist who is board certified in pediatric and adolescent gynecology within the department of clinical obstetrics & gynecology at New York Presbyterian Hospital/Columbia University Medical Center.

Follicle depletion and follicle dysfunction are the two main mechanisms. Depletion can stem from a lower baseline number of primordial follicles – "they start with less" – and/or from an increased rate of atresia. Follicle dysfunction, on the other hand, can result from impaired folliculogenesis or inappropriate luteinization that leads, over time, to a decreased complement or complete absence of oocytes.

Future fertility will be a leading concern. The spontaneous pregnancy rate for women with POI is 5%-10%. Some may consider in vitro fertilization or fertility assistance, but a poor to no response to gonadotropins "makes going through fertility treatment very challenging," Dr. Rackow said. There are many options for these patients to have a family, she added, including use of donor oocytes, donated embryos, and adoption. She sometimes tells patients: "You will be a mom someday. It just may be through a different way than you thought."

Psychological support can help patients and families after a diagnosis of POI. Dr. Rackow recommended two websites with more information: IPOFA & Rachel’s Well.

Menstrual anomalies could be your first clue. "Girls who have some abnormal menses for 3 months or more probably deserve further work-up," Dr. Rackow said. Also ask about pubertal history; any prior ovarian surgery, chemotherapy, or radiation; and their medical history because 20% of affected women have autoimmune disease. In addition, about 25% of girls with POI will have a thyroid disorder, but the 3% with adrenal disorders are particularly important to identify quickly. Consider checking the patient for adrenocortical antibodies, which in a girl with POI can point to significantly elevated risk for adrenal insufficiency. "They can get very sick with autoimmune adrenal failure."

In addition to an autoimmune work-up, "clearly we are going to get a karyotype on these patients," Dr. Rackow said. An estimated 6%-14% of women with POI carry a FMR-1 mutation, for example. X chromosome abnormalities, including trisomy X, are also possible.

Useful laboratory assays include measures of human chorionic gonadotropin and follicle stimulating hormone plus estradiol levels. "We tend to see low estradiol ... a sign of no estrogen production from the ovaries," Dr. Rackow said. "Normally, estrogen suppresses FSH more than luteinizing hormone, but in POI you tend to see elevated FSH."

Pelvic ultrasound to check for any antral follicles or any endometrium build-up also can be helpful. Bone densitometry also is helpful as a baseline measure after the POI diagnosis. "The bones can take a significant hit from POI in terms of bone density," Dr. Rackow said.

Following diagnosis of POI, consider annual, routine surveillance for endocrine disorders. Test for complete blood count, complete metabolic panel, calcium, phosphorus, fasting glucose, insulin, thyroid stimulating hormone, and thyroid peroxidase antibodies.

Estrogen replacement is part of management of these patients. "They require higher doses than [do] menopausal women. Also, if you give estrogen, [they] will need progestins for endometrial protection," Dr. Rackow said. Hormone replacement therapy can improve endothelial function within 6 months, potentially improve their long-term cardiovascular health, and mitigate bone loss.

"The lowest dose oral contraceptives have the higher end dose of estrogen you would give for POI. These girls do not need more," Dr. Rackow said. For more information, including hormone replacement therapy dosing guidance, see the September 2011 American College of Obstetrics and Gynecology Committee Opinion No. 502 on primary ovarian insufficiency in the adolescent (Obstet. Gynecol. 2011;118:741-5).

Dr. Rackow said she had no relevant financial disclosures.

MIAMI BEACH – High-dose topical steroids provide significant symptomatic relief for young girls with lichen sclerosus, a retrospective study has shown.

Less clear and more controversial, however, is whether this painful and itchy dermatologic condition spontaneously resolves after prepubertal girls reach menarche, Dr. Kathryn Squires** said. "We hypothesize that ... lichen sclerosus is a relapsing and remitting disease."

One important implication is a need for long-term follow-up, particularly because lichen sclerosus carries an increased risk of vulvar squamous cell carcinoma in adult women, Dr. Squires said.

With only a handful of published studies that assess the natural progression of lichen sclerosus in pediatric patients, Dr. Squires and her colleagues decided to find out more. They identified 97 premenarchal girls with lichen sclerosus treated at a gynecology or dermatology clinic at the Washington University in St. Louis* between 1995 and 2010. The mean patient age was 7 years at the time of diagnosis.

A total of 36 patients (or their parent) participated in a 10- to 15-minute, scripted telephone interview with at a mean follow-up of 5.3 years and were studied further. The main outcome was resolution of symptoms of pain and/or pruritus.

Thirty patients (83%) reported a period of remission after initial treatment. A total of 26 patients (72%) were in remission at the time of the telephone interview. Seven (78%) of the nine patients who continued to report symptoms at follow-up were still premenarchal.

"Most young women will experience symptomatic relief with high-dose topical steroid treatment, which in our study was clobetasol ointment," Dr. Squires said. Specifically, this therapeutic approach yielded significant improvement of symptoms within an average of 14 weeks in 33 girls.

Part of the treatment challenge stems from a lack of standardized protocol with regard to dose, frequency and duration of treatment, or need to taper, Dr. Squires said. In the current study, the duration of treatment varied, "but it appears that 3-4 months will be adequate for most patients," she added.

A total of 16 patients reported a relapse that required maintenance therapy. The average length of remission was 3.6 years (range, 1-10 years).

Because of these findings, the prognosis and long-term course of lichen sclerosus diagnosed prior to menarche remains unclear, Dr. Squires said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

"Lichen sclerosus is a common dermatologic condition. It is often found on the vulva, most commonly in postmenopausal women, [but] prepubertal girls account for about 5%-15% of cases," said Dr. Squires of the department of obstetrics and gynecology at Washington University in St. Louis. The condition is likely underrecognized and underreported in this pediatric population, she added.

Lichen sclerosus often presents as characteristic white, sharply demarcated plaques on the vulva and perianal skin. Some girls will have smooth and waxy skin; others present with crinkling or cellophane paper–type skin. Lichenification also can occur, in which case the skin becomes thick and leathery. The labia minora can adhere to adjacent structures in some cases. The precise etiology is unknown.

An unanswered question is whether lichen sclerosus in postmenopausal women is somehow distinct or on a continuum that includes the prepubertal presentations, Dr. Squires said.

A limitation of the telephone follow-up design of the study was the inability to verify physical findings.

Future research could compare the effectiveness and safety of treatment with calcineurin inhibitors versus topical steroids. In addition, it would be helpful to identify any factors that predict relapse versus achievement of complete remission.

Information for patients and families on pediatric vulvar lichen sclerosus is available online from the North American Society for Pediatric and Adolescent Gynecology.

Dr. Squires reported that she had no relevant financial disclosures.

* Correction: The university name was intially misstated as the University of Washington. 5/24/2012

**Correction: The investigator's name was initially misstated as Dr. Lauren C. Squires. 5/30/2012

MIAMI BEACH – High-dose topical steroids provide significant symptomatic relief for young girls with lichen sclerosus, a retrospective study has shown.

Less clear and more controversial, however, is whether this painful and itchy dermatologic condition spontaneously resolves after prepubertal girls reach menarche, Dr. Kathryn Squires** said. "We hypothesize that ... lichen sclerosus is a relapsing and remitting disease."

One important implication is a need for long-term follow-up, particularly because lichen sclerosus carries an increased risk of vulvar squamous cell carcinoma in adult women, Dr. Squires said.

With only a handful of published studies that assess the natural progression of lichen sclerosus in pediatric patients, Dr. Squires and her colleagues decided to find out more. They identified 97 premenarchal girls with lichen sclerosus treated at a gynecology or dermatology clinic at the Washington University in St. Louis* between 1995 and 2010. The mean patient age was 7 years at the time of diagnosis.

A total of 36 patients (or their parent) participated in a 10- to 15-minute, scripted telephone interview with at a mean follow-up of 5.3 years and were studied further. The main outcome was resolution of symptoms of pain and/or pruritus.

Thirty patients (83%) reported a period of remission after initial treatment. A total of 26 patients (72%) were in remission at the time of the telephone interview. Seven (78%) of the nine patients who continued to report symptoms at follow-up were still premenarchal.

"Most young women will experience symptomatic relief with high-dose topical steroid treatment, which in our study was clobetasol ointment," Dr. Squires said. Specifically, this therapeutic approach yielded significant improvement of symptoms within an average of 14 weeks in 33 girls.

Part of the treatment challenge stems from a lack of standardized protocol with regard to dose, frequency and duration of treatment, or need to taper, Dr. Squires said. In the current study, the duration of treatment varied, "but it appears that 3-4 months will be adequate for most patients," she added.

A total of 16 patients reported a relapse that required maintenance therapy. The average length of remission was 3.6 years (range, 1-10 years).

Because of these findings, the prognosis and long-term course of lichen sclerosus diagnosed prior to menarche remains unclear, Dr. Squires said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

"Lichen sclerosus is a common dermatologic condition. It is often found on the vulva, most commonly in postmenopausal women, [but] prepubertal girls account for about 5%-15% of cases," said Dr. Squires of the department of obstetrics and gynecology at Washington University in St. Louis. The condition is likely underrecognized and underreported in this pediatric population, she added.

Lichen sclerosus often presents as characteristic white, sharply demarcated plaques on the vulva and perianal skin. Some girls will have smooth and waxy skin; others present with crinkling or cellophane paper–type skin. Lichenification also can occur, in which case the skin becomes thick and leathery. The labia minora can adhere to adjacent structures in some cases. The precise etiology is unknown.

An unanswered question is whether lichen sclerosus in postmenopausal women is somehow distinct or on a continuum that includes the prepubertal presentations, Dr. Squires said.

A limitation of the telephone follow-up design of the study was the inability to verify physical findings.

Future research could compare the effectiveness and safety of treatment with calcineurin inhibitors versus topical steroids. In addition, it would be helpful to identify any factors that predict relapse versus achievement of complete remission.

Information for patients and families on pediatric vulvar lichen sclerosus is available online from the North American Society for Pediatric and Adolescent Gynecology.

Dr. Squires reported that she had no relevant financial disclosures.

* Correction: The university name was intially misstated as the University of Washington. 5/24/2012

**Correction: The investigator's name was initially misstated as Dr. Lauren C. Squires. 5/30/2012

MIAMI BEACH – High-dose topical steroids provide significant symptomatic relief for young girls with lichen sclerosus, a retrospective study has shown.

Less clear and more controversial, however, is whether this painful and itchy dermatologic condition spontaneously resolves after prepubertal girls reach menarche, Dr. Kathryn Squires** said. "We hypothesize that ... lichen sclerosus is a relapsing and remitting disease."

One important implication is a need for long-term follow-up, particularly because lichen sclerosus carries an increased risk of vulvar squamous cell carcinoma in adult women, Dr. Squires said.

With only a handful of published studies that assess the natural progression of lichen sclerosus in pediatric patients, Dr. Squires and her colleagues decided to find out more. They identified 97 premenarchal girls with lichen sclerosus treated at a gynecology or dermatology clinic at the Washington University in St. Louis* between 1995 and 2010. The mean patient age was 7 years at the time of diagnosis.

A total of 36 patients (or their parent) participated in a 10- to 15-minute, scripted telephone interview with at a mean follow-up of 5.3 years and were studied further. The main outcome was resolution of symptoms of pain and/or pruritus.

Thirty patients (83%) reported a period of remission after initial treatment. A total of 26 patients (72%) were in remission at the time of the telephone interview. Seven (78%) of the nine patients who continued to report symptoms at follow-up were still premenarchal.

"Most young women will experience symptomatic relief with high-dose topical steroid treatment, which in our study was clobetasol ointment," Dr. Squires said. Specifically, this therapeutic approach yielded significant improvement of symptoms within an average of 14 weeks in 33 girls.

Part of the treatment challenge stems from a lack of standardized protocol with regard to dose, frequency and duration of treatment, or need to taper, Dr. Squires said. In the current study, the duration of treatment varied, "but it appears that 3-4 months will be adequate for most patients," she added.

A total of 16 patients reported a relapse that required maintenance therapy. The average length of remission was 3.6 years (range, 1-10 years).

Because of these findings, the prognosis and long-term course of lichen sclerosus diagnosed prior to menarche remains unclear, Dr. Squires said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

"Lichen sclerosus is a common dermatologic condition. It is often found on the vulva, most commonly in postmenopausal women, [but] prepubertal girls account for about 5%-15% of cases," said Dr. Squires of the department of obstetrics and gynecology at Washington University in St. Louis. The condition is likely underrecognized and underreported in this pediatric population, she added.

Lichen sclerosus often presents as characteristic white, sharply demarcated plaques on the vulva and perianal skin. Some girls will have smooth and waxy skin; others present with crinkling or cellophane paper–type skin. Lichenification also can occur, in which case the skin becomes thick and leathery. The labia minora can adhere to adjacent structures in some cases. The precise etiology is unknown.

An unanswered question is whether lichen sclerosus in postmenopausal women is somehow distinct or on a continuum that includes the prepubertal presentations, Dr. Squires said.

A limitation of the telephone follow-up design of the study was the inability to verify physical findings.

Future research could compare the effectiveness and safety of treatment with calcineurin inhibitors versus topical steroids. In addition, it would be helpful to identify any factors that predict relapse versus achievement of complete remission.

Information for patients and families on pediatric vulvar lichen sclerosus is available online from the North American Society for Pediatric and Adolescent Gynecology.

Dr. Squires reported that she had no relevant financial disclosures.

* Correction: The university name was intially misstated as the University of Washington. 5/24/2012

**Correction: The investigator's name was initially misstated as Dr. Lauren C. Squires. 5/30/2012

"Do not use prostate-specific antigen (PSA)–based screening for prostate cancer."

With these words, the U.S. Preventive Services Task Force (USPSTF) finalized its stance against using this blood test to screen men universally in the United States for prostate cancer.

This firm position is unlikely to end the controversy that ensued after the task force released its draft recommendations in October 2011 ("U.S. Task Force: No PSA Testing for Healthy Men.") Editorials opposing and supporting universal prostate specific antigen (PSA) screening accompany publication early online of the final recommendations in the May 22 issue of Annals of Internal Medicine.

The 16-member task force gave population-based PSA screening a grade D recommendation, after a public comment period yielded no new, overwhelming evidence countering the draft recommendations against universal testing. This means the members believe there is moderate or high certainty that the harms of the intervention are equal to or outweigh the benefits.

"Science shows us the benefit is small and the harms significant," Dr. Virginia A. Moyer, the task force chair, said in an interview.

Fever, blood in the urine, transient urinary difficulties, and moderate-to-severe pain associated with biopsy are potential harms associated with screening cited in the recommendations. Risk for perioperative death, cardiovascular events, urinary incontinence, erectile dysfunction, and bowel dysfunction are some of the harms associated with treatment of prostate cancer.

The recommendation applies to "men in the general U.S. population, regardless of age." The new position replaces the 2008 recommendations, which cited insufficient evidence to support improved health outcomes associated with prostate cancer screening for men younger than 75 years and more conclusive evidence pointing to more harm than benefit for men aged 75 years or older.

The new literature-based recommendations leave room for physicians and patients particularly concerned about risk of prostate cancer to consider individual PSA testing. The USPSTF learned during the public comment period that it needed to emphasize that the recommendations do not preclude such discussions, said Dr. Moyer, professor of pediatrics at Baylor College of Medicine, Houston.

"One of the main things we clarified was ... that this is not a recommendation not to talk to patients about it or not to address the patient’s concerns," she said.

Opponents Step Forward

Coming out against the new recommendations is an ad hoc group of nine oncologists, primary care physicians, and preventive medicine specialists. In an accompanying editorial they argue against curtailment of PSA screening, criticize a lack of specialty physician involvement on the task force, and question the quality of evidence in two large trials heavily weighted in the task force’s decision making: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (N. Engl. J. Med. 2009;360:1310-9) and the European Randomized Study for Prostate Cancer (ERSCP) (N. Engl. J. Med. 2012;366:981-90).

"The most important flaws of the PLCO are the greater than 50% ‘contamination’ rate by nonprotocol PSA measurements in the control group, prescreening of 40% of study participants before enrollment in the trial, and the fact that two thirds of patients with abnormal screening tests did not have prompt biopsy," the ad hoc group wrote.

"The study has a known flaw – that a fair number in the control group got screened – which would tend to make the intervention and control groups look more alike," Dr. Moyer acknowledged.

The task force, however, offset this potential bias with inclusion of the European study, she said. The different methodologies used in the two studies provided balance.

The task force does not include urologists or cancer specialists, the ad hoc group also pointed out.

Dr. Moyer said that these specialty physicians were involved in the evidence report initially developed for review by the task force. The members of the task force have "precisely the expertise needed" to advise these doctors on management of asymptomatic men in the primary care setting, she added.

"We are experts in primary care and prevention, and we advise primary care physicians," Dr. Moyer said.

Dr. Otis Brawley Backs Task Force

Backing the task force’s recommendations is Dr. Otis Brawley, chief medical officer of the American Cancer Society. "What many people, doctors as well as lay people, have not truly appreciated is that there are significant harms associated with prostate cancer screening," he said in an interview. "Those harms are seen consistently in every clinical trial that has been done to assess screening."

Dr. Brawley supports individual PSA screening as long as it follows a thorough and balanced informed consent process. "I and the American Cancer Society hold out that there are some people at high risk and some people who are so concerned about prostate cancer that, if they understand the considerable harms and understand that the possibility of benefit is a possibility and not proven, and they want to be screened ... they should be allowed to get screened."

"Part of the reason the task force came down so hard is because this [informed consent] has not been happening," said Dr. Brawley, professor of hematology and oncology at the Emory Clinic in Atlanta.

Another reason, he said, is that "we have all these mass screening events going on. Not only is there no informed decision-making done and not only is there no information regarding harms, but men are being told screening can only benefit them."

Dr. Brawley outlined these and other considerations in a second editorial that accompanies the recommendations.

Going forward, Dr. Brawley recommends that physicians provide patients with a brief, written handout on prostate cancer that summarizes the task force recommendations, including potential benefits and harms of PSA screening. Patients could review the information prior to seeing their physician and then opt in or opt out of this screening, he said.

The American Cancer Society provides a patient handout on "Testing for Prostate Cancer" online. The USPSTF also is posting guidance for physicians on counseling patients in light of its new recommendations.

Dr. Moyer acknowledged that the issues surrounding PSA screening are emotionally charged. "Change is stunningly hard," she said. Our understanding of cancer dates back to the 1950s or earlier. Our thinking has been that you get one cancer cell in your body and then it’s a march to imminent death. We now recognize that cancer is not a monolithic thing."

Regarding prostate cancer, she added, "For the vast majority of men, it will not affect them in their lifetime."

"Unfortunately, at the moment, the PSA is the only test we have," Dr. Moyer said. "The test itself is not very good. The PSA test is too sensitive – it picks up almost anything that happens to the prostate." She added. "The dream is that a better test is developed."

Dr. Moyer and Dr. Brawley had no relevant financial disclosures.

"Do not use prostate-specific antigen (PSA)–based screening for prostate cancer."

With these words, the U.S. Preventive Services Task Force (USPSTF) finalized its stance against using this blood test to screen men universally in the United States for prostate cancer.

This firm position is unlikely to end the controversy that ensued after the task force released its draft recommendations in October 2011 ("U.S. Task Force: No PSA Testing for Healthy Men.") Editorials opposing and supporting universal prostate specific antigen (PSA) screening accompany publication early online of the final recommendations in the May 22 issue of Annals of Internal Medicine.

The 16-member task force gave population-based PSA screening a grade D recommendation, after a public comment period yielded no new, overwhelming evidence countering the draft recommendations against universal testing. This means the members believe there is moderate or high certainty that the harms of the intervention are equal to or outweigh the benefits.

"Science shows us the benefit is small and the harms significant," Dr. Virginia A. Moyer, the task force chair, said in an interview.

Fever, blood in the urine, transient urinary difficulties, and moderate-to-severe pain associated with biopsy are potential harms associated with screening cited in the recommendations. Risk for perioperative death, cardiovascular events, urinary incontinence, erectile dysfunction, and bowel dysfunction are some of the harms associated with treatment of prostate cancer.

The recommendation applies to "men in the general U.S. population, regardless of age." The new position replaces the 2008 recommendations, which cited insufficient evidence to support improved health outcomes associated with prostate cancer screening for men younger than 75 years and more conclusive evidence pointing to more harm than benefit for men aged 75 years or older.

The new literature-based recommendations leave room for physicians and patients particularly concerned about risk of prostate cancer to consider individual PSA testing. The USPSTF learned during the public comment period that it needed to emphasize that the recommendations do not preclude such discussions, said Dr. Moyer, professor of pediatrics at Baylor College of Medicine, Houston.

"One of the main things we clarified was ... that this is not a recommendation not to talk to patients about it or not to address the patient’s concerns," she said.

Opponents Step Forward

Coming out against the new recommendations is an ad hoc group of nine oncologists, primary care physicians, and preventive medicine specialists. In an accompanying editorial they argue against curtailment of PSA screening, criticize a lack of specialty physician involvement on the task force, and question the quality of evidence in two large trials heavily weighted in the task force’s decision making: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (N. Engl. J. Med. 2009;360:1310-9) and the European Randomized Study for Prostate Cancer (ERSCP) (N. Engl. J. Med. 2012;366:981-90).

"The most important flaws of the PLCO are the greater than 50% ‘contamination’ rate by nonprotocol PSA measurements in the control group, prescreening of 40% of study participants before enrollment in the trial, and the fact that two thirds of patients with abnormal screening tests did not have prompt biopsy," the ad hoc group wrote.

"The study has a known flaw – that a fair number in the control group got screened – which would tend to make the intervention and control groups look more alike," Dr. Moyer acknowledged.

The task force, however, offset this potential bias with inclusion of the European study, she said. The different methodologies used in the two studies provided balance.

The task force does not include urologists or cancer specialists, the ad hoc group also pointed out.

Dr. Moyer said that these specialty physicians were involved in the evidence report initially developed for review by the task force. The members of the task force have "precisely the expertise needed" to advise these doctors on management of asymptomatic men in the primary care setting, she added.

"We are experts in primary care and prevention, and we advise primary care physicians," Dr. Moyer said.

Dr. Otis Brawley Backs Task Force

Backing the task force’s recommendations is Dr. Otis Brawley, chief medical officer of the American Cancer Society. "What many people, doctors as well as lay people, have not truly appreciated is that there are significant harms associated with prostate cancer screening," he said in an interview. "Those harms are seen consistently in every clinical trial that has been done to assess screening."

Dr. Brawley supports individual PSA screening as long as it follows a thorough and balanced informed consent process. "I and the American Cancer Society hold out that there are some people at high risk and some people who are so concerned about prostate cancer that, if they understand the considerable harms and understand that the possibility of benefit is a possibility and not proven, and they want to be screened ... they should be allowed to get screened."

"Part of the reason the task force came down so hard is because this [informed consent] has not been happening," said Dr. Brawley, professor of hematology and oncology at the Emory Clinic in Atlanta.

Another reason, he said, is that "we have all these mass screening events going on. Not only is there no informed decision-making done and not only is there no information regarding harms, but men are being told screening can only benefit them."

Dr. Brawley outlined these and other considerations in a second editorial that accompanies the recommendations.

Going forward, Dr. Brawley recommends that physicians provide patients with a brief, written handout on prostate cancer that summarizes the task force recommendations, including potential benefits and harms of PSA screening. Patients could review the information prior to seeing their physician and then opt in or opt out of this screening, he said.

The American Cancer Society provides a patient handout on "Testing for Prostate Cancer" online. The USPSTF also is posting guidance for physicians on counseling patients in light of its new recommendations.

Dr. Moyer acknowledged that the issues surrounding PSA screening are emotionally charged. "Change is stunningly hard," she said. Our understanding of cancer dates back to the 1950s or earlier. Our thinking has been that you get one cancer cell in your body and then it’s a march to imminent death. We now recognize that cancer is not a monolithic thing."

Regarding prostate cancer, she added, "For the vast majority of men, it will not affect them in their lifetime."

"Unfortunately, at the moment, the PSA is the only test we have," Dr. Moyer said. "The test itself is not very good. The PSA test is too sensitive – it picks up almost anything that happens to the prostate." She added. "The dream is that a better test is developed."

Dr. Moyer and Dr. Brawley had no relevant financial disclosures.

"Do not use prostate-specific antigen (PSA)–based screening for prostate cancer."

With these words, the U.S. Preventive Services Task Force (USPSTF) finalized its stance against using this blood test to screen men universally in the United States for prostate cancer.

This firm position is unlikely to end the controversy that ensued after the task force released its draft recommendations in October 2011 ("U.S. Task Force: No PSA Testing for Healthy Men.") Editorials opposing and supporting universal prostate specific antigen (PSA) screening accompany publication early online of the final recommendations in the May 22 issue of Annals of Internal Medicine.

The 16-member task force gave population-based PSA screening a grade D recommendation, after a public comment period yielded no new, overwhelming evidence countering the draft recommendations against universal testing. This means the members believe there is moderate or high certainty that the harms of the intervention are equal to or outweigh the benefits.

"Science shows us the benefit is small and the harms significant," Dr. Virginia A. Moyer, the task force chair, said in an interview.

Fever, blood in the urine, transient urinary difficulties, and moderate-to-severe pain associated with biopsy are potential harms associated with screening cited in the recommendations. Risk for perioperative death, cardiovascular events, urinary incontinence, erectile dysfunction, and bowel dysfunction are some of the harms associated with treatment of prostate cancer.

The recommendation applies to "men in the general U.S. population, regardless of age." The new position replaces the 2008 recommendations, which cited insufficient evidence to support improved health outcomes associated with prostate cancer screening for men younger than 75 years and more conclusive evidence pointing to more harm than benefit for men aged 75 years or older.

The new literature-based recommendations leave room for physicians and patients particularly concerned about risk of prostate cancer to consider individual PSA testing. The USPSTF learned during the public comment period that it needed to emphasize that the recommendations do not preclude such discussions, said Dr. Moyer, professor of pediatrics at Baylor College of Medicine, Houston.

"One of the main things we clarified was ... that this is not a recommendation not to talk to patients about it or not to address the patient’s concerns," she said.

Opponents Step Forward

Coming out against the new recommendations is an ad hoc group of nine oncologists, primary care physicians, and preventive medicine specialists. In an accompanying editorial they argue against curtailment of PSA screening, criticize a lack of specialty physician involvement on the task force, and question the quality of evidence in two large trials heavily weighted in the task force’s decision making: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (N. Engl. J. Med. 2009;360:1310-9) and the European Randomized Study for Prostate Cancer (ERSCP) (N. Engl. J. Med. 2012;366:981-90).

"The most important flaws of the PLCO are the greater than 50% ‘contamination’ rate by nonprotocol PSA measurements in the control group, prescreening of 40% of study participants before enrollment in the trial, and the fact that two thirds of patients with abnormal screening tests did not have prompt biopsy," the ad hoc group wrote.

"The study has a known flaw – that a fair number in the control group got screened – which would tend to make the intervention and control groups look more alike," Dr. Moyer acknowledged.

The task force, however, offset this potential bias with inclusion of the European study, she said. The different methodologies used in the two studies provided balance.

The task force does not include urologists or cancer specialists, the ad hoc group also pointed out.

Dr. Moyer said that these specialty physicians were involved in the evidence report initially developed for review by the task force. The members of the task force have "precisely the expertise needed" to advise these doctors on management of asymptomatic men in the primary care setting, she added.

"We are experts in primary care and prevention, and we advise primary care physicians," Dr. Moyer said.

Dr. Otis Brawley Backs Task Force

Backing the task force’s recommendations is Dr. Otis Brawley, chief medical officer of the American Cancer Society. "What many people, doctors as well as lay people, have not truly appreciated is that there are significant harms associated with prostate cancer screening," he said in an interview. "Those harms are seen consistently in every clinical trial that has been done to assess screening."

Dr. Brawley supports individual PSA screening as long as it follows a thorough and balanced informed consent process. "I and the American Cancer Society hold out that there are some people at high risk and some people who are so concerned about prostate cancer that, if they understand the considerable harms and understand that the possibility of benefit is a possibility and not proven, and they want to be screened ... they should be allowed to get screened."

"Part of the reason the task force came down so hard is because this [informed consent] has not been happening," said Dr. Brawley, professor of hematology and oncology at the Emory Clinic in Atlanta.

Another reason, he said, is that "we have all these mass screening events going on. Not only is there no informed decision-making done and not only is there no information regarding harms, but men are being told screening can only benefit them."

Dr. Brawley outlined these and other considerations in a second editorial that accompanies the recommendations.

Going forward, Dr. Brawley recommends that physicians provide patients with a brief, written handout on prostate cancer that summarizes the task force recommendations, including potential benefits and harms of PSA screening. Patients could review the information prior to seeing their physician and then opt in or opt out of this screening, he said.

The American Cancer Society provides a patient handout on "Testing for Prostate Cancer" online. The USPSTF also is posting guidance for physicians on counseling patients in light of its new recommendations.

Dr. Moyer acknowledged that the issues surrounding PSA screening are emotionally charged. "Change is stunningly hard," she said. Our understanding of cancer dates back to the 1950s or earlier. Our thinking has been that you get one cancer cell in your body and then it’s a march to imminent death. We now recognize that cancer is not a monolithic thing."

Regarding prostate cancer, she added, "For the vast majority of men, it will not affect them in their lifetime."

"Unfortunately, at the moment, the PSA is the only test we have," Dr. Moyer said. "The test itself is not very good. The PSA test is too sensitive – it picks up almost anything that happens to the prostate." She added. "The dream is that a better test is developed."

Dr. Moyer and Dr. Brawley had no relevant financial disclosures.

SAN FRANCISCO – Data from the Interagency Registry for Mechanically Assisted Circulatory Support has identified significant risk factors for death following implantation of left ventricular assist devices as destination therapy. The findings will allow better targeting of patients who can expect 1- and 2-year survival rates on left ventricular assist devices (LVADs) that approach those seen with heart transplantation, according to Dr. James K. Kirklin.

"If we focus on the subset of stable patients without renal or severe right ventricular failure and without previous cardiac surgery, the 2-year survival with a continuous flow device is 80%," said Dr. Kirklin, professor of medicine and director of the division of cardiothoracic surgery at the University of Alabama at Birmingham.

LVAD destination therapy is not appropriate for patients with rapid hemodynamic deterioration, cardiogenic shock, or right ventricular failure, Dr. Kirklin said at the annual meeting of the American Association for Thoracic Surgery. But there is a significant subset of patients who do benefit, including many patients who have advanced heart failure and are not candidates for transplantation.

"Of particular importance is the INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support] level, which describes subsets of NYHA Class IV patients," Dr. Kirklin said. For example, level 1 describes patients in cardiogenic shock at the time of LVAD implant and was "the most important risk factor for early mortality." Of 112 patients with level 1 designation, 32 died during the study.

Also, right ventricular failure severe enough to require right ventricular assist device support in the same operation was the strongest predictor of mortality in the constant phase (hazard ratio, 3.2).

LVADs are increasingly being used as destination therapy, with LVADs accounting for nearly one-third of all mechanical circulatory support activity in the U.S.

Dr. Kirklin and his colleagues studied 5,407 patients who received a durable ventricular assist device or total artificial heart between June 2006 and December 2011 in the National Heart, Lung, and Blood Institute’s INTERMACS. The 1,287 patients who were not transplant-eligible and received a LVAD for destination therapy comprised the study group.

Significant risk factors for death included older age, larger body mass index, diabetes, a history of coronary artery bypass graft surgery, cardiogenic shock, low sodium, increased bilirubin, and use of a pulsatile flow LVAD, the results of a multivariate analysis indicated.

This is a "timely and important presentation," said invited study discussant Dr. Soon J. Park. "[The researchers] report that a significant percentage of destination therapy patients are achieving a survival rate that is comparable to those who undergo heart transplantation. Such a finding is especially astonishing in that these patients, by definition, were those deemed inappropriate [for] donor hearts. For a significant fraction of patients who were destined to die because heart transplant was not an option for them ... a vast majority will now be able to enjoy life on VAD support." Dr. Park is a cardiovascular surgeon at the Mayo Clinic Transplant Center in Rochester, Minn.

Representative survival after cardiac transplantation from the International Society for Heart and Lung Transplant Registry is approximately 80% at 2 years in a population with generally less comorbidities than the current destination therapy study group, Dr. Kirklin said. Of note, the INTERMACS destination therapy patients were older, a mean of 67 years, compared with 55 years in the transplant reference group. This survival rate of 80% was figured into the multivariate mortality risk factor analysis.

"Heart transplant had been the only option to prolong lives in patients with end-stage heart failure. With recent developments in VAD therapy, heart transplant seems to be the only viable option no longer," Dr. Park said. "VAD therapy can be rendered immediately and abundantly and it is going to change the natural history of end-stage heart failure dramatically, whether [the patient is] transplant eligible or not."

During a discussion that followed presentation of the study results, Dr. John Conte, director of mechanical circulatory support and a professor of surgery at Johns Hopkins Medicine, asked Dr. Kirklin if he is now ready to refer a subset of patients to mechanical support instead of heart transplantation.

"Yes," Dr. Kirklin replied. "I must say the actual identification of patients from the transplant list who could be triaged to mechanical support will depend on their comorbidity. "Remember that the low-risk, 40-year-old patient undergoing cardiac transplantation without other important comorbidities is not the patient one would want to triage to mechanical support. It will only be those patients on the transplant list with multiple, adverse comorbidities that we will initially select for triage."

Dr. Park asked Dr. Kirklin if it would ever make sense to consider VAD as primary therapy and reserve heart transplant as a secondary therapy.

"Of course the goal in the future will be to have an array of therapies which maximize long-term survival for patients, so whether that means initial VAD therapy followed by transplant or initial transplant followed by total artificial heart of course depends upon the rigorous analyses we will need to do in the future," Dr. Kirklin replied.

Although permanent treatment is the intention of destination therapy, the clinical situation may evolve over time and some patients may be considered for cardiac transplantation or device explant, Dr. Kirklin said. "These outcomes can be tracked. In the current era, less than 5% of DT [destination therapy] patients underwent transplant or explant within 2 years."

Dr. Kirklin is the principal investigator of the INTERMACS NHLBI contract.

SAN FRANCISCO – Data from the Interagency Registry for Mechanically Assisted Circulatory Support has identified significant risk factors for death following implantation of left ventricular assist devices as destination therapy. The findings will allow better targeting of patients who can expect 1- and 2-year survival rates on left ventricular assist devices (LVADs) that approach those seen with heart transplantation, according to Dr. James K. Kirklin.

"If we focus on the subset of stable patients without renal or severe right ventricular failure and without previous cardiac surgery, the 2-year survival with a continuous flow device is 80%," said Dr. Kirklin, professor of medicine and director of the division of cardiothoracic surgery at the University of Alabama at Birmingham.

LVAD destination therapy is not appropriate for patients with rapid hemodynamic deterioration, cardiogenic shock, or right ventricular failure, Dr. Kirklin said at the annual meeting of the American Association for Thoracic Surgery. But there is a significant subset of patients who do benefit, including many patients who have advanced heart failure and are not candidates for transplantation.

"Of particular importance is the INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support] level, which describes subsets of NYHA Class IV patients," Dr. Kirklin said. For example, level 1 describes patients in cardiogenic shock at the time of LVAD implant and was "the most important risk factor for early mortality." Of 112 patients with level 1 designation, 32 died during the study.

Also, right ventricular failure severe enough to require right ventricular assist device support in the same operation was the strongest predictor of mortality in the constant phase (hazard ratio, 3.2).

LVADs are increasingly being used as destination therapy, with LVADs accounting for nearly one-third of all mechanical circulatory support activity in the U.S.

Dr. Kirklin and his colleagues studied 5,407 patients who received a durable ventricular assist device or total artificial heart between June 2006 and December 2011 in the National Heart, Lung, and Blood Institute’s INTERMACS. The 1,287 patients who were not transplant-eligible and received a LVAD for destination therapy comprised the study group.

Significant risk factors for death included older age, larger body mass index, diabetes, a history of coronary artery bypass graft surgery, cardiogenic shock, low sodium, increased bilirubin, and use of a pulsatile flow LVAD, the results of a multivariate analysis indicated.

This is a "timely and important presentation," said invited study discussant Dr. Soon J. Park. "[The researchers] report that a significant percentage of destination therapy patients are achieving a survival rate that is comparable to those who undergo heart transplantation. Such a finding is especially astonishing in that these patients, by definition, were those deemed inappropriate [for] donor hearts. For a significant fraction of patients who were destined to die because heart transplant was not an option for them ... a vast majority will now be able to enjoy life on VAD support." Dr. Park is a cardiovascular surgeon at the Mayo Clinic Transplant Center in Rochester, Minn.

Representative survival after cardiac transplantation from the International Society for Heart and Lung Transplant Registry is approximately 80% at 2 years in a population with generally less comorbidities than the current destination therapy study group, Dr. Kirklin said. Of note, the INTERMACS destination therapy patients were older, a mean of 67 years, compared with 55 years in the transplant reference group. This survival rate of 80% was figured into the multivariate mortality risk factor analysis.

"Heart transplant had been the only option to prolong lives in patients with end-stage heart failure. With recent developments in VAD therapy, heart transplant seems to be the only viable option no longer," Dr. Park said. "VAD therapy can be rendered immediately and abundantly and it is going to change the natural history of end-stage heart failure dramatically, whether [the patient is] transplant eligible or not."

During a discussion that followed presentation of the study results, Dr. John Conte, director of mechanical circulatory support and a professor of surgery at Johns Hopkins Medicine, asked Dr. Kirklin if he is now ready to refer a subset of patients to mechanical support instead of heart transplantation.

"Yes," Dr. Kirklin replied. "I must say the actual identification of patients from the transplant list who could be triaged to mechanical support will depend on their comorbidity. "Remember that the low-risk, 40-year-old patient undergoing cardiac transplantation without other important comorbidities is not the patient one would want to triage to mechanical support. It will only be those patients on the transplant list with multiple, adverse comorbidities that we will initially select for triage."

Dr. Park asked Dr. Kirklin if it would ever make sense to consider VAD as primary therapy and reserve heart transplant as a secondary therapy.

"Of course the goal in the future will be to have an array of therapies which maximize long-term survival for patients, so whether that means initial VAD therapy followed by transplant or initial transplant followed by total artificial heart of course depends upon the rigorous analyses we will need to do in the future," Dr. Kirklin replied.

Although permanent treatment is the intention of destination therapy, the clinical situation may evolve over time and some patients may be considered for cardiac transplantation or device explant, Dr. Kirklin said. "These outcomes can be tracked. In the current era, less than 5% of DT [destination therapy] patients underwent transplant or explant within 2 years."

Dr. Kirklin is the principal investigator of the INTERMACS NHLBI contract.

SAN FRANCISCO – Data from the Interagency Registry for Mechanically Assisted Circulatory Support has identified significant risk factors for death following implantation of left ventricular assist devices as destination therapy. The findings will allow better targeting of patients who can expect 1- and 2-year survival rates on left ventricular assist devices (LVADs) that approach those seen with heart transplantation, according to Dr. James K. Kirklin.

"If we focus on the subset of stable patients without renal or severe right ventricular failure and without previous cardiac surgery, the 2-year survival with a continuous flow device is 80%," said Dr. Kirklin, professor of medicine and director of the division of cardiothoracic surgery at the University of Alabama at Birmingham.

LVAD destination therapy is not appropriate for patients with rapid hemodynamic deterioration, cardiogenic shock, or right ventricular failure, Dr. Kirklin said at the annual meeting of the American Association for Thoracic Surgery. But there is a significant subset of patients who do benefit, including many patients who have advanced heart failure and are not candidates for transplantation.

"Of particular importance is the INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support] level, which describes subsets of NYHA Class IV patients," Dr. Kirklin said. For example, level 1 describes patients in cardiogenic shock at the time of LVAD implant and was "the most important risk factor for early mortality." Of 112 patients with level 1 designation, 32 died during the study.

Also, right ventricular failure severe enough to require right ventricular assist device support in the same operation was the strongest predictor of mortality in the constant phase (hazard ratio, 3.2).

LVADs are increasingly being used as destination therapy, with LVADs accounting for nearly one-third of all mechanical circulatory support activity in the U.S.

Dr. Kirklin and his colleagues studied 5,407 patients who received a durable ventricular assist device or total artificial heart between June 2006 and December 2011 in the National Heart, Lung, and Blood Institute’s INTERMACS. The 1,287 patients who were not transplant-eligible and received a LVAD for destination therapy comprised the study group.

Significant risk factors for death included older age, larger body mass index, diabetes, a history of coronary artery bypass graft surgery, cardiogenic shock, low sodium, increased bilirubin, and use of a pulsatile flow LVAD, the results of a multivariate analysis indicated.

This is a "timely and important presentation," said invited study discussant Dr. Soon J. Park. "[The researchers] report that a significant percentage of destination therapy patients are achieving a survival rate that is comparable to those who undergo heart transplantation. Such a finding is especially astonishing in that these patients, by definition, were those deemed inappropriate [for] donor hearts. For a significant fraction of patients who were destined to die because heart transplant was not an option for them ... a vast majority will now be able to enjoy life on VAD support." Dr. Park is a cardiovascular surgeon at the Mayo Clinic Transplant Center in Rochester, Minn.

Representative survival after cardiac transplantation from the International Society for Heart and Lung Transplant Registry is approximately 80% at 2 years in a population with generally less comorbidities than the current destination therapy study group, Dr. Kirklin said. Of note, the INTERMACS destination therapy patients were older, a mean of 67 years, compared with 55 years in the transplant reference group. This survival rate of 80% was figured into the multivariate mortality risk factor analysis.

"Heart transplant had been the only option to prolong lives in patients with end-stage heart failure. With recent developments in VAD therapy, heart transplant seems to be the only viable option no longer," Dr. Park said. "VAD therapy can be rendered immediately and abundantly and it is going to change the natural history of end-stage heart failure dramatically, whether [the patient is] transplant eligible or not."

During a discussion that followed presentation of the study results, Dr. John Conte, director of mechanical circulatory support and a professor of surgery at Johns Hopkins Medicine, asked Dr. Kirklin if he is now ready to refer a subset of patients to mechanical support instead of heart transplantation.

"Yes," Dr. Kirklin replied. "I must say the actual identification of patients from the transplant list who could be triaged to mechanical support will depend on their comorbidity. "Remember that the low-risk, 40-year-old patient undergoing cardiac transplantation without other important comorbidities is not the patient one would want to triage to mechanical support. It will only be those patients on the transplant list with multiple, adverse comorbidities that we will initially select for triage."

Dr. Park asked Dr. Kirklin if it would ever make sense to consider VAD as primary therapy and reserve heart transplant as a secondary therapy.

"Of course the goal in the future will be to have an array of therapies which maximize long-term survival for patients, so whether that means initial VAD therapy followed by transplant or initial transplant followed by total artificial heart of course depends upon the rigorous analyses we will need to do in the future," Dr. Kirklin replied.

Although permanent treatment is the intention of destination therapy, the clinical situation may evolve over time and some patients may be considered for cardiac transplantation or device explant, Dr. Kirklin said. "These outcomes can be tracked. In the current era, less than 5% of DT [destination therapy] patients underwent transplant or explant within 2 years."

Dr. Kirklin is the principal investigator of the INTERMACS NHLBI contract.

MIAMI BEACH – A study of more than 150,000 pregnancies indicates adolescents and their newborns run an increased risk for complications.

Dr. Kathy Wilson and her colleagues at Washington Hospital Center and Georgetown University Hospital, in Washington, compared peripartum outcomes among 1,312 teens aged 15 years and younger; 19,403 teens aged 16 to 19 years; and 130,453 adults aged 20-34 years. Each had a singleton pregnancy of at least 24 weeks’ gestation between 2002 and 2008.

Adolescent mothers had higher rates of complications, including anemia, preterm premature rupture of membranes (PPROM), chorioamnionitis, and eclampsia, compared with adults.

Anemia affected 9.4% of the teens under age 16 years and 10.2% of the older teenagers. These rates were significantly higher than was the 8.2% rate in adults.

PPROM was noted in the records of 2.1% of younger teens, 2.5% of older teens, and 1.9% of adults. Chorioamnionitis occurred in 8.8% of young adolescents, 8.0% of older adolescents, and 4.8% of adults. Rates of both complications were significantly different between adolescents and adults.

Other researchers have researched risks in adolescent pregnancy, but most of these studies have been small, Dr. Wilson said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Clinical and demographic data for the 151,476 women in this study come from the Consortium on Safe Labor, which includes electronic medical records from 19 hospitals in the United States. The consortium is sponsored by the National Institute of Child Health and Human Development.

The researchers found a nonsignificant trend for higher prevalence of eclampsia in the adolescent mothers as well – 0.25% of the younger teenagers and 0.12% of the older teenagers vs. 0.008% among adult mothers.

Neonates born to adolescent mothers were more likely to be delivered preterm, to be low birth weight or very low birth weight, to have lower APGAR scores, and to have higher rates of admission to a neonatal intensive care unit.

Preterm births occurred in 21.1% of the teens under age 16 years, 18.3% of teens aged 16-19 years, and 16% of adults.

Low birth weight infants were born to 13.1% of the younger teen mothers, 12% of the older teen mothers, and 7.8% of adult mothers. Very low birth weight infants were born to 2.7% of the young teens, 2.5% of the older teens, and 1.7% of the adults. All differences between infants born to adolescents and adults were statistically significant.

Other findings include a higher percentage of 5-minute APGAR scores below 7 for neonates of younger teen mothers, 2.8%, compared with 2.3% for older teens and 2% for adult mothers. Neonatal ICU admission rates were 14.8% for the newborns of young teens, 14% for those born to older teens, and 11.8% for those born to adults.

Cesarean section rate was one factor that was significantly lower among the younger adolescent mothers. Their c-section rate was 15.9%, compared with 21.1% for the older teenagers and 24.8% for the adults.

Young adolescents were more likely to have public health insurance, 70.3%, compared with 66.6% of older adolescents and 39.1% of adult mothers.

Dr. Wilson had no relevant financial disclosures.

MIAMI BEACH – A study of more than 150,000 pregnancies indicates adolescents and their newborns run an increased risk for complications.

Dr. Kathy Wilson and her colleagues at Washington Hospital Center and Georgetown University Hospital, in Washington, compared peripartum outcomes among 1,312 teens aged 15 years and younger; 19,403 teens aged 16 to 19 years; and 130,453 adults aged 20-34 years. Each had a singleton pregnancy of at least 24 weeks’ gestation between 2002 and 2008.

Adolescent mothers had higher rates of complications, including anemia, preterm premature rupture of membranes (PPROM), chorioamnionitis, and eclampsia, compared with adults.

Anemia affected 9.4% of the teens under age 16 years and 10.2% of the older teenagers. These rates were significantly higher than was the 8.2% rate in adults.

PPROM was noted in the records of 2.1% of younger teens, 2.5% of older teens, and 1.9% of adults. Chorioamnionitis occurred in 8.8% of young adolescents, 8.0% of older adolescents, and 4.8% of adults. Rates of both complications were significantly different between adolescents and adults.

Other researchers have researched risks in adolescent pregnancy, but most of these studies have been small, Dr. Wilson said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Clinical and demographic data for the 151,476 women in this study come from the Consortium on Safe Labor, which includes electronic medical records from 19 hospitals in the United States. The consortium is sponsored by the National Institute of Child Health and Human Development.

The researchers found a nonsignificant trend for higher prevalence of eclampsia in the adolescent mothers as well – 0.25% of the younger teenagers and 0.12% of the older teenagers vs. 0.008% among adult mothers.

Neonates born to adolescent mothers were more likely to be delivered preterm, to be low birth weight or very low birth weight, to have lower APGAR scores, and to have higher rates of admission to a neonatal intensive care unit.

Preterm births occurred in 21.1% of the teens under age 16 years, 18.3% of teens aged 16-19 years, and 16% of adults.

Low birth weight infants were born to 13.1% of the younger teen mothers, 12% of the older teen mothers, and 7.8% of adult mothers. Very low birth weight infants were born to 2.7% of the young teens, 2.5% of the older teens, and 1.7% of the adults. All differences between infants born to adolescents and adults were statistically significant.

Other findings include a higher percentage of 5-minute APGAR scores below 7 for neonates of younger teen mothers, 2.8%, compared with 2.3% for older teens and 2% for adult mothers. Neonatal ICU admission rates were 14.8% for the newborns of young teens, 14% for those born to older teens, and 11.8% for those born to adults.

Cesarean section rate was one factor that was significantly lower among the younger adolescent mothers. Their c-section rate was 15.9%, compared with 21.1% for the older teenagers and 24.8% for the adults.

Young adolescents were more likely to have public health insurance, 70.3%, compared with 66.6% of older adolescents and 39.1% of adult mothers.

Dr. Wilson had no relevant financial disclosures.

MIAMI BEACH – A study of more than 150,000 pregnancies indicates adolescents and their newborns run an increased risk for complications.

Dr. Kathy Wilson and her colleagues at Washington Hospital Center and Georgetown University Hospital, in Washington, compared peripartum outcomes among 1,312 teens aged 15 years and younger; 19,403 teens aged 16 to 19 years; and 130,453 adults aged 20-34 years. Each had a singleton pregnancy of at least 24 weeks’ gestation between 2002 and 2008.

Adolescent mothers had higher rates of complications, including anemia, preterm premature rupture of membranes (PPROM), chorioamnionitis, and eclampsia, compared with adults.

Anemia affected 9.4% of the teens under age 16 years and 10.2% of the older teenagers. These rates were significantly higher than was the 8.2% rate in adults.

PPROM was noted in the records of 2.1% of younger teens, 2.5% of older teens, and 1.9% of adults. Chorioamnionitis occurred in 8.8% of young adolescents, 8.0% of older adolescents, and 4.8% of adults. Rates of both complications were significantly different between adolescents and adults.

Other researchers have researched risks in adolescent pregnancy, but most of these studies have been small, Dr. Wilson said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Clinical and demographic data for the 151,476 women in this study come from the Consortium on Safe Labor, which includes electronic medical records from 19 hospitals in the United States. The consortium is sponsored by the National Institute of Child Health and Human Development.

The researchers found a nonsignificant trend for higher prevalence of eclampsia in the adolescent mothers as well – 0.25% of the younger teenagers and 0.12% of the older teenagers vs. 0.008% among adult mothers.

Neonates born to adolescent mothers were more likely to be delivered preterm, to be low birth weight or very low birth weight, to have lower APGAR scores, and to have higher rates of admission to a neonatal intensive care unit.

Preterm births occurred in 21.1% of the teens under age 16 years, 18.3% of teens aged 16-19 years, and 16% of adults.

Low birth weight infants were born to 13.1% of the younger teen mothers, 12% of the older teen mothers, and 7.8% of adult mothers. Very low birth weight infants were born to 2.7% of the young teens, 2.5% of the older teens, and 1.7% of the adults. All differences between infants born to adolescents and adults were statistically significant.

Other findings include a higher percentage of 5-minute APGAR scores below 7 for neonates of younger teen mothers, 2.8%, compared with 2.3% for older teens and 2% for adult mothers. Neonatal ICU admission rates were 14.8% for the newborns of young teens, 14% for those born to older teens, and 11.8% for those born to adults.

Cesarean section rate was one factor that was significantly lower among the younger adolescent mothers. Their c-section rate was 15.9%, compared with 21.1% for the older teenagers and 24.8% for the adults.

Young adolescents were more likely to have public health insurance, 70.3%, compared with 66.6% of older adolescents and 39.1% of adult mothers.

Dr. Wilson had no relevant financial disclosures.

MIAMI BEACH – Certain clinical factors – and a scoring system that incorporates them – could help physicians in the differential diagnosis of adnexal torsion when girls present with acute abdominal pain, according to a small retrospective study.

Researchers compared 45 pediatric patients who had adnexal torsion confirmed at the time of surgery vs. another 49 without this problem to determine factors associated with higher risk. Abdominal tenderness, type of pain, pain radiation, ovary size (as well presence of a mass, and its size and palpability) were found to be potential predictors. Ultimately, however, the following three combined factors emerged as significantly associated with adnexal torsion:

• Presence of intermittent pain.

• Absence of radiating pain.

• An adnexal mass larger than 4 cm.

"There was a high level of distinction as to who had ovarian torsion and who did not," Dr. Cynthia Abraham said. "If they have these three factors, they should go straight to the OR."

In statistical terms, an area under the curve of 0.8601 on a receiver operating curve for these three factors "suggests an excellent discrimination between adnexal torsion and other causes of abdominal pain."

"This study thus demonstrates that key clinical and imaging parameters can be combined into a model that can aid in the early diagnosis of adnexal torsion," Dr. Abraham said at a poster during the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Girls included in the study were aged 2-18 years.

Even though the condition occurs in only 3% of patients with abdominal pain, adnexal torsion can be life threatening, and the differential diagnosis from other etiologies (for example, appendicitis or gastritis) is important. "The diagnosis is extremely critical and may lead to ovarian salvage," she added. If the diagnosis is missed or delayed, tissue necrosis and a diminished future fertility could ensue.

A weighted scoring system based on these factors would be helpful because "very often gynecologists are called to evaluate many patients who do not have ovarian torsion," said Dr. Abraham, a fourth year resident at the Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park

"Other studies have looked at physical examination and history," Dr. Abraham said. "We looked at a score for ovarian torsion." The scoring system is still in development. "We have not used it yet [in practice]. That is the next step."

Dr. Abraham said she had no relevant financial disclosures.

MIAMI BEACH – Certain clinical factors – and a scoring system that incorporates them – could help physicians in the differential diagnosis of adnexal torsion when girls present with acute abdominal pain, according to a small retrospective study.

Researchers compared 45 pediatric patients who had adnexal torsion confirmed at the time of surgery vs. another 49 without this problem to determine factors associated with higher risk. Abdominal tenderness, type of pain, pain radiation, ovary size (as well presence of a mass, and its size and palpability) were found to be potential predictors. Ultimately, however, the following three combined factors emerged as significantly associated with adnexal torsion:

• Presence of intermittent pain.

• Absence of radiating pain.

• An adnexal mass larger than 4 cm.

"There was a high level of distinction as to who had ovarian torsion and who did not," Dr. Cynthia Abraham said. "If they have these three factors, they should go straight to the OR."

In statistical terms, an area under the curve of 0.8601 on a receiver operating curve for these three factors "suggests an excellent discrimination between adnexal torsion and other causes of abdominal pain."

"This study thus demonstrates that key clinical and imaging parameters can be combined into a model that can aid in the early diagnosis of adnexal torsion," Dr. Abraham said at a poster during the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Girls included in the study were aged 2-18 years.

Even though the condition occurs in only 3% of patients with abdominal pain, adnexal torsion can be life threatening, and the differential diagnosis from other etiologies (for example, appendicitis or gastritis) is important. "The diagnosis is extremely critical and may lead to ovarian salvage," she added. If the diagnosis is missed or delayed, tissue necrosis and a diminished future fertility could ensue.

A weighted scoring system based on these factors would be helpful because "very often gynecologists are called to evaluate many patients who do not have ovarian torsion," said Dr. Abraham, a fourth year resident at the Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park

"Other studies have looked at physical examination and history," Dr. Abraham said. "We looked at a score for ovarian torsion." The scoring system is still in development. "We have not used it yet [in practice]. That is the next step."

Dr. Abraham said she had no relevant financial disclosures.

MIAMI BEACH – Certain clinical factors – and a scoring system that incorporates them – could help physicians in the differential diagnosis of adnexal torsion when girls present with acute abdominal pain, according to a small retrospective study.

Researchers compared 45 pediatric patients who had adnexal torsion confirmed at the time of surgery vs. another 49 without this problem to determine factors associated with higher risk. Abdominal tenderness, type of pain, pain radiation, ovary size (as well presence of a mass, and its size and palpability) were found to be potential predictors. Ultimately, however, the following three combined factors emerged as significantly associated with adnexal torsion:

• Presence of intermittent pain.

• Absence of radiating pain.

• An adnexal mass larger than 4 cm.

"There was a high level of distinction as to who had ovarian torsion and who did not," Dr. Cynthia Abraham said. "If they have these three factors, they should go straight to the OR."

In statistical terms, an area under the curve of 0.8601 on a receiver operating curve for these three factors "suggests an excellent discrimination between adnexal torsion and other causes of abdominal pain."

"This study thus demonstrates that key clinical and imaging parameters can be combined into a model that can aid in the early diagnosis of adnexal torsion," Dr. Abraham said at a poster during the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. Girls included in the study were aged 2-18 years.

Even though the condition occurs in only 3% of patients with abdominal pain, adnexal torsion can be life threatening, and the differential diagnosis from other etiologies (for example, appendicitis or gastritis) is important. "The diagnosis is extremely critical and may lead to ovarian salvage," she added. If the diagnosis is missed or delayed, tissue necrosis and a diminished future fertility could ensue.

A weighted scoring system based on these factors would be helpful because "very often gynecologists are called to evaluate many patients who do not have ovarian torsion," said Dr. Abraham, a fourth year resident at the Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park

"Other studies have looked at physical examination and history," Dr. Abraham said. "We looked at a score for ovarian torsion." The scoring system is still in development. "We have not used it yet [in practice]. That is the next step."

Dr. Abraham said she had no relevant financial disclosures.