During the past 40 years neonatologists have discovered new treatments to improve pulmonary and cardiovascular care of preterm newborns, resulting in a dramatic reduction in newborn mortality and childhood morbidity. Important advances include glucocorticoid administration to mothers at risk for preterm birth, surfactant and nitric oxide administration to the newborn, kangaroo (or skin-to-skin) care, continuous positive airway pressure, and high-frequency ventilation.1 In 1960, only 5% of 1,000-g newborns survived. In 2000, 95% of 1,000-g newborns survive.¹

The successes in pulmonary and cardiovascular care have revealed a new frontier in neonatal care: the prevention of long-term neurologic disability by the early treatment of newborn encephalpathy with therapeutic hypothermia. This novel undertaking is an important one; approximately 1 in 300 newborns are diagnosed with encephalopathy.²

Until recently there were no proven treatments for newborns with encephalopathy. However, therapeutic hypothermia now has been proven to be an effective intervention for the treatment of moderate and severe encephalopathy,^3,4 and its use is expanding to include mild cases.

This increased use can lead to more complex situations arising for obstetricians, for when a neonatologist decides to initiate therapeutic hypothermia of a newborn the parents may wonder if the obstetrician’s management of labor and delivery was suboptimal, contributing to their baby’s brain injury.

Therapeutic hypothermia: The basics
First, we need to define therapeutic hypothermia. Both head hypothermia and whole-body hypothermia are effective techniques for the treatment of newborn encephalopathy.^3,4 Most centers use whole-body (FIGURE) rather than head, hypothermia because it facilitates access to the head for placement of electroencephalogram (EEG) sensors.

The key principles of therapeutic hypothermia include^5,6:

1. Initiate hypothermia within 6 hours of birth.
2. Cool the newborn to a core temperature of 33.5° to 34.5°C (92.3° to 94.1°F). Some centers focus on achieving consistent core temperatures of 33.5°C (92.3°F).
3. Monitor core temperature every 5 to 15 minutes.
4. Cool the newborn for 72 hours.
5. Obtain head ultrasonography to detect intracranial hemorrhage.
6. Initiate continuous or intermittent EEG monitoring.
7. Treat seizures with phenobarbital, lorazepam, or phenytoin.
8. Obtain blood cultures, a complete blood count, blood gas concentrations, alactate coagulation profile, and liver function tests.
9. Sedate the newborn, if necessary.
10. Minimize oral feedings during the initial phase of hypothermia.
11. Obtain sequential magnetic resonance imaging (MRI) studies to assess brain structure and function.
12. For all newborns with suspected encephalopathy, the placenta should be sent to pathology for histologic study.⁷

The data on therapy effectivenessTwo recent meta-analyses independently reported that therapeutic hypothermia reduced the risk of newborn death and major neurodevelopmental disability.^3,4 The Cochrane meta-analysis reported that the therapy reduced the risk of neuromotor delay, developmental delay, cerebral palsy, and abnormal MRI results (TABLE).⁴ The study authors also reported that therapeutic hypothermia reduced the risk of blindness and deafness, although these effects did not reach statistical significance.⁴ Therapeutic hypothermia did increase the risk of newborn sinus bradycardia and thrombocytopenia.^3,4 Compared with usual care, the therapy increased the average survival rate with a normal neurologic outcome at 18 months from 23% to 40%.³ It should be noted that even with therapeutic hypothermia treatment, many newborns with moderate to severe encephalopathy have long-term neurologic disabilities.

Given the success of therapeutic hypothermia for moderate to severe newborn encephalopathy, many neonatologists are expanding the indications for treatment. In some centers current indications for initiation of hypothermia include the following:

• gestational age ≥34 weeks
• suspicion of encephalopathy or a seizure event
• any obstetric sentinel event (including a bradycardia, umbilical cord prolapse, uterine rupture, placental abruption, Apgar score ≤5 at 10 minutes, pH ≤7.1 or base deficit of ≥10 mEq/L or Category III tracing, or fetal tachycardia with recurrent decelerations or fetal heart rate with minimal variability and recurrent decelerations).

Suspicion for encephalopathy might be triggered by any of a large number of newborn behaviors: lethargy, decreased activity, hypotonia, weak suck or incomplete Moro reflexes, constricted pupils, bradycardia, periodic breathing or apnea, hyperalertness, or irritability.⁸

Coordinate neonatology and obstetric communication with the familyGiven the expanding indications for therapeutic hypothermia, an increasing number of newborns will receive this treatment. This scenario makes enhanced communication vital. Consider this situation:

CASE Baby rushed for therapeutic hypothermia upon birthA baby is born limp and blue without a cry. Her hypotonia raises a concern for encephalopathy, and she is whisked off to the neonatal intensive care unit for 72 hours of therapeutic hypothermia. Stunned, the parents begin to wonder, “Will our baby be O.K.?” and “What went wrong?”

When neonatologists recommend therapeutic hypothermia for the newborn with presumptive encephalopathy, they may explain the situation to the parents with words such as brain injury, encephalopathy, hypoxia, and ischemia. Intrapartum events such as a Category II or III fetal heart rate tracing, operative vaginal delivery, or maternal sepsis or abruption might be mentioned as contributing factors. A consulting neurologist may mention injury of the cerebral cortex, subcortical white matter, or lateral thalami. The neonatologists and neurologists might not mention that less than 50% of cases of newborn encephalopathy are thought to be due to the management of labor.²

The obstetrician, as stunned by the events as the parents, may be at a loss about how to communicate effectively with their patient about the newborn’s encephalopathy. Obstetricians can help assure the parents of their continued involvement in the care and reinforce that the hospital’s neonatologists are superb clinicians who will do their best for the baby.

Challenges exist to effective communication. It is often difficult to optimally coordinate and align the communications of the neonatologists, neurologist, nurses, and obstetrician with the family. Communication with the family can be uncoordinated because interactions occur between the family and multiple specialists with unique perspectives and vocabularies. These conversations occur in sequence, separated in time and place. The communication between family and neonatologists typically occurs in the neonatal intensive care unit. Interactions between obstetrician and mother typically occur in the postpartum unit. The neonatologists and obstetricians are assigned to the hospital in rotating coverage shifts, increasing the number of hand-offs and physicians involved in the hospital care of the mother and newborn dyad.

A joint family meeting with the neonatologists, obstetrician, and family early in the course of newborn care might be an optimal approach to coordinating communication with the parents. Conflicting obligations certainly may make a joint meeting difficult to arrange, however.

Reducing the risk of permanent injury to the central and peripheral nervous system of the newborn is the goal of all obstetricians and neonatologists. Many authorities believe that therapeutic hypothermia can reduce the risk of death and major neurodevelopmental disorders in newborns with encephalopathy. Initial data are promising. If long-term follow-up studies prove that this therapy reduces neurologic disability, the treatment represents a major advance in maternal-child care. As we learn more about this novel, and potentially effective therapy, it should be on the minds of those involved with newborn care to involve the ObGyn in coordinated communication with the family and other medical staff.

During the past 40 years neonatologists have discovered new treatments to improve pulmonary and cardiovascular care of preterm newborns, resulting in a dramatic reduction in newborn mortality and childhood morbidity. Important advances include glucocorticoid administration to mothers at risk for preterm birth, surfactant and nitric oxide administration to the newborn, kangaroo (or skin-to-skin) care, continuous positive airway pressure, and high-frequency ventilation.1 In 1960, only 5% of 1,000-g newborns survived. In 2000, 95% of 1,000-g newborns survive.¹

The successes in pulmonary and cardiovascular care have revealed a new frontier in neonatal care: the prevention of long-term neurologic disability by the early treatment of newborn encephalpathy with therapeutic hypothermia. This novel undertaking is an important one; approximately 1 in 300 newborns are diagnosed with encephalopathy.²

Until recently there were no proven treatments for newborns with encephalopathy. However, therapeutic hypothermia now has been proven to be an effective intervention for the treatment of moderate and severe encephalopathy,^3,4 and its use is expanding to include mild cases.

This increased use can lead to more complex situations arising for obstetricians, for when a neonatologist decides to initiate therapeutic hypothermia of a newborn the parents may wonder if the obstetrician’s management of labor and delivery was suboptimal, contributing to their baby’s brain injury.

Therapeutic hypothermia: The basics
First, we need to define therapeutic hypothermia. Both head hypothermia and whole-body hypothermia are effective techniques for the treatment of newborn encephalopathy.^3,4 Most centers use whole-body (FIGURE) rather than head, hypothermia because it facilitates access to the head for placement of electroencephalogram (EEG) sensors.

The key principles of therapeutic hypothermia include^5,6:

1. Initiate hypothermia within 6 hours of birth.
2. Cool the newborn to a core temperature of 33.5° to 34.5°C (92.3° to 94.1°F). Some centers focus on achieving consistent core temperatures of 33.5°C (92.3°F).
3. Monitor core temperature every 5 to 15 minutes.
4. Cool the newborn for 72 hours.
5. Obtain head ultrasonography to detect intracranial hemorrhage.
6. Initiate continuous or intermittent EEG monitoring.
7. Treat seizures with phenobarbital, lorazepam, or phenytoin.
8. Obtain blood cultures, a complete blood count, blood gas concentrations, alactate coagulation profile, and liver function tests.
9. Sedate the newborn, if necessary.
10. Minimize oral feedings during the initial phase of hypothermia.
11. Obtain sequential magnetic resonance imaging (MRI) studies to assess brain structure and function.
12. For all newborns with suspected encephalopathy, the placenta should be sent to pathology for histologic study.⁷

The data on therapy effectivenessTwo recent meta-analyses independently reported that therapeutic hypothermia reduced the risk of newborn death and major neurodevelopmental disability.^3,4 The Cochrane meta-analysis reported that the therapy reduced the risk of neuromotor delay, developmental delay, cerebral palsy, and abnormal MRI results (TABLE).⁴ The study authors also reported that therapeutic hypothermia reduced the risk of blindness and deafness, although these effects did not reach statistical significance.⁴ Therapeutic hypothermia did increase the risk of newborn sinus bradycardia and thrombocytopenia.^3,4 Compared with usual care, the therapy increased the average survival rate with a normal neurologic outcome at 18 months from 23% to 40%.³ It should be noted that even with therapeutic hypothermia treatment, many newborns with moderate to severe encephalopathy have long-term neurologic disabilities.

Given the success of therapeutic hypothermia for moderate to severe newborn encephalopathy, many neonatologists are expanding the indications for treatment. In some centers current indications for initiation of hypothermia include the following:

• gestational age ≥34 weeks
• suspicion of encephalopathy or a seizure event
• any obstetric sentinel event (including a bradycardia, umbilical cord prolapse, uterine rupture, placental abruption, Apgar score ≤5 at 10 minutes, pH ≤7.1 or base deficit of ≥10 mEq/L or Category III tracing, or fetal tachycardia with recurrent decelerations or fetal heart rate with minimal variability and recurrent decelerations).

Suspicion for encephalopathy might be triggered by any of a large number of newborn behaviors: lethargy, decreased activity, hypotonia, weak suck or incomplete Moro reflexes, constricted pupils, bradycardia, periodic breathing or apnea, hyperalertness, or irritability.⁸

Coordinate neonatology and obstetric communication with the familyGiven the expanding indications for therapeutic hypothermia, an increasing number of newborns will receive this treatment. This scenario makes enhanced communication vital. Consider this situation:

CASE Baby rushed for therapeutic hypothermia upon birthA baby is born limp and blue without a cry. Her hypotonia raises a concern for encephalopathy, and she is whisked off to the neonatal intensive care unit for 72 hours of therapeutic hypothermia. Stunned, the parents begin to wonder, “Will our baby be O.K.?” and “What went wrong?”

When neonatologists recommend therapeutic hypothermia for the newborn with presumptive encephalopathy, they may explain the situation to the parents with words such as brain injury, encephalopathy, hypoxia, and ischemia. Intrapartum events such as a Category II or III fetal heart rate tracing, operative vaginal delivery, or maternal sepsis or abruption might be mentioned as contributing factors. A consulting neurologist may mention injury of the cerebral cortex, subcortical white matter, or lateral thalami. The neonatologists and neurologists might not mention that less than 50% of cases of newborn encephalopathy are thought to be due to the management of labor.²

The obstetrician, as stunned by the events as the parents, may be at a loss about how to communicate effectively with their patient about the newborn’s encephalopathy. Obstetricians can help assure the parents of their continued involvement in the care and reinforce that the hospital’s neonatologists are superb clinicians who will do their best for the baby.

Challenges exist to effective communication. It is often difficult to optimally coordinate and align the communications of the neonatologists, neurologist, nurses, and obstetrician with the family. Communication with the family can be uncoordinated because interactions occur between the family and multiple specialists with unique perspectives and vocabularies. These conversations occur in sequence, separated in time and place. The communication between family and neonatologists typically occurs in the neonatal intensive care unit. Interactions between obstetrician and mother typically occur in the postpartum unit. The neonatologists and obstetricians are assigned to the hospital in rotating coverage shifts, increasing the number of hand-offs and physicians involved in the hospital care of the mother and newborn dyad.

A joint family meeting with the neonatologists, obstetrician, and family early in the course of newborn care might be an optimal approach to coordinating communication with the parents. Conflicting obligations certainly may make a joint meeting difficult to arrange, however.

Reducing the risk of permanent injury to the central and peripheral nervous system of the newborn is the goal of all obstetricians and neonatologists. Many authorities believe that therapeutic hypothermia can reduce the risk of death and major neurodevelopmental disorders in newborns with encephalopathy. Initial data are promising. If long-term follow-up studies prove that this therapy reduces neurologic disability, the treatment represents a major advance in maternal-child care. As we learn more about this novel, and potentially effective therapy, it should be on the minds of those involved with newborn care to involve the ObGyn in coordinated communication with the family and other medical staff.

During the past 40 years neonatologists have discovered new treatments to improve pulmonary and cardiovascular care of preterm newborns, resulting in a dramatic reduction in newborn mortality and childhood morbidity. Important advances include glucocorticoid administration to mothers at risk for preterm birth, surfactant and nitric oxide administration to the newborn, kangaroo (or skin-to-skin) care, continuous positive airway pressure, and high-frequency ventilation.1 In 1960, only 5% of 1,000-g newborns survived. In 2000, 95% of 1,000-g newborns survive.¹

The successes in pulmonary and cardiovascular care have revealed a new frontier in neonatal care: the prevention of long-term neurologic disability by the early treatment of newborn encephalpathy with therapeutic hypothermia. This novel undertaking is an important one; approximately 1 in 300 newborns are diagnosed with encephalopathy.²

Until recently there were no proven treatments for newborns with encephalopathy. However, therapeutic hypothermia now has been proven to be an effective intervention for the treatment of moderate and severe encephalopathy,^3,4 and its use is expanding to include mild cases.

This increased use can lead to more complex situations arising for obstetricians, for when a neonatologist decides to initiate therapeutic hypothermia of a newborn the parents may wonder if the obstetrician’s management of labor and delivery was suboptimal, contributing to their baby’s brain injury.

Therapeutic hypothermia: The basics
First, we need to define therapeutic hypothermia. Both head hypothermia and whole-body hypothermia are effective techniques for the treatment of newborn encephalopathy.^3,4 Most centers use whole-body (FIGURE) rather than head, hypothermia because it facilitates access to the head for placement of electroencephalogram (EEG) sensors.

The key principles of therapeutic hypothermia include^5,6:

1. Initiate hypothermia within 6 hours of birth.
2. Cool the newborn to a core temperature of 33.5° to 34.5°C (92.3° to 94.1°F). Some centers focus on achieving consistent core temperatures of 33.5°C (92.3°F).
3. Monitor core temperature every 5 to 15 minutes.
4. Cool the newborn for 72 hours.
5. Obtain head ultrasonography to detect intracranial hemorrhage.
6. Initiate continuous or intermittent EEG monitoring.
7. Treat seizures with phenobarbital, lorazepam, or phenytoin.
8. Obtain blood cultures, a complete blood count, blood gas concentrations, alactate coagulation profile, and liver function tests.
9. Sedate the newborn, if necessary.
10. Minimize oral feedings during the initial phase of hypothermia.
11. Obtain sequential magnetic resonance imaging (MRI) studies to assess brain structure and function.
12. For all newborns with suspected encephalopathy, the placenta should be sent to pathology for histologic study.⁷

The data on therapy effectivenessTwo recent meta-analyses independently reported that therapeutic hypothermia reduced the risk of newborn death and major neurodevelopmental disability.^3,4 The Cochrane meta-analysis reported that the therapy reduced the risk of neuromotor delay, developmental delay, cerebral palsy, and abnormal MRI results (TABLE).⁴ The study authors also reported that therapeutic hypothermia reduced the risk of blindness and deafness, although these effects did not reach statistical significance.⁴ Therapeutic hypothermia did increase the risk of newborn sinus bradycardia and thrombocytopenia.^3,4 Compared with usual care, the therapy increased the average survival rate with a normal neurologic outcome at 18 months from 23% to 40%.³ It should be noted that even with therapeutic hypothermia treatment, many newborns with moderate to severe encephalopathy have long-term neurologic disabilities.

Given the success of therapeutic hypothermia for moderate to severe newborn encephalopathy, many neonatologists are expanding the indications for treatment. In some centers current indications for initiation of hypothermia include the following:

• gestational age ≥34 weeks
• suspicion of encephalopathy or a seizure event
• any obstetric sentinel event (including a bradycardia, umbilical cord prolapse, uterine rupture, placental abruption, Apgar score ≤5 at 10 minutes, pH ≤7.1 or base deficit of ≥10 mEq/L or Category III tracing, or fetal tachycardia with recurrent decelerations or fetal heart rate with minimal variability and recurrent decelerations).

Suspicion for encephalopathy might be triggered by any of a large number of newborn behaviors: lethargy, decreased activity, hypotonia, weak suck or incomplete Moro reflexes, constricted pupils, bradycardia, periodic breathing or apnea, hyperalertness, or irritability.⁸

Coordinate neonatology and obstetric communication with the familyGiven the expanding indications for therapeutic hypothermia, an increasing number of newborns will receive this treatment. This scenario makes enhanced communication vital. Consider this situation:

CASE Baby rushed for therapeutic hypothermia upon birthA baby is born limp and blue without a cry. Her hypotonia raises a concern for encephalopathy, and she is whisked off to the neonatal intensive care unit for 72 hours of therapeutic hypothermia. Stunned, the parents begin to wonder, “Will our baby be O.K.?” and “What went wrong?”

When neonatologists recommend therapeutic hypothermia for the newborn with presumptive encephalopathy, they may explain the situation to the parents with words such as brain injury, encephalopathy, hypoxia, and ischemia. Intrapartum events such as a Category II or III fetal heart rate tracing, operative vaginal delivery, or maternal sepsis or abruption might be mentioned as contributing factors. A consulting neurologist may mention injury of the cerebral cortex, subcortical white matter, or lateral thalami. The neonatologists and neurologists might not mention that less than 50% of cases of newborn encephalopathy are thought to be due to the management of labor.²

The obstetrician, as stunned by the events as the parents, may be at a loss about how to communicate effectively with their patient about the newborn’s encephalopathy. Obstetricians can help assure the parents of their continued involvement in the care and reinforce that the hospital’s neonatologists are superb clinicians who will do their best for the baby.

Challenges exist to effective communication. It is often difficult to optimally coordinate and align the communications of the neonatologists, neurologist, nurses, and obstetrician with the family. Communication with the family can be uncoordinated because interactions occur between the family and multiple specialists with unique perspectives and vocabularies. These conversations occur in sequence, separated in time and place. The communication between family and neonatologists typically occurs in the neonatal intensive care unit. Interactions between obstetrician and mother typically occur in the postpartum unit. The neonatologists and obstetricians are assigned to the hospital in rotating coverage shifts, increasing the number of hand-offs and physicians involved in the hospital care of the mother and newborn dyad.

A joint family meeting with the neonatologists, obstetrician, and family early in the course of newborn care might be an optimal approach to coordinating communication with the parents. Conflicting obligations certainly may make a joint meeting difficult to arrange, however.

Reducing the risk of permanent injury to the central and peripheral nervous system of the newborn is the goal of all obstetricians and neonatologists. Many authorities believe that therapeutic hypothermia can reduce the risk of death and major neurodevelopmental disorders in newborns with encephalopathy. Initial data are promising. If long-term follow-up studies prove that this therapy reduces neurologic disability, the treatment represents a major advance in maternal-child care. As we learn more about this novel, and potentially effective therapy, it should be on the minds of those involved with newborn care to involve the ObGyn in coordinated communication with the family and other medical staff.

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

“What Insect repellents are safe during pregnancy?”

ANUSHKA CHELLIAH, MD, AND PATRICK DUFF, MD (JUNE 2016)

Alternatives to DEET

Picaridin is not mentioned in this brief report from Drs. Chelliah and Duff. I suggest reviewing the July 2015 Consumer Reports article on repellents; picaridin is a likely safer alternative to DEET, with the highest efficacy of all those tested, at least in Sawyer Fisherman’s Formula Picaridin Insect Repellent and Natrapel 8 Hour Insect Repellent. Products that have little or no efficacy also were not mentioned, including Avon Skin So Soft, Coleman Naturals Insect Repellent Snap Band, and SuperBand Wristband. In addition, the concentration of products is very important, as is the precise formulation within brands. For example, Off! Deep Woods VIII (with DEET 25%) is very effective versus Off! FamilyCare II Clean Feel (with picaridin 5%), which has very little benefit.

David H. Janowitz, MD
Houston, Texas

Drs. Chelliah and Duff respond

In our short discussion of mosquito repellents, we based our recommendations on publications from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health. Those publications presented DEET (N,N-diethyl-m-toluamide) at the top of the list for preferred repellents. A recent publication from the Organization of Teratology Information Specialists (MotherToBaby, September 2013) indicated that, in a concentration of 20% to 30%, DEET was safe in pregnancy and was effective in protecting against 90% of all mosquito bites and tick attachments. Increasing the concentration of DEET above 30% does not enhance the product’s effectiveness or prolong its duration of action.

However, Dr. Janowitz is correct in stating that other agents are also highly effective and safe in pregnancy. These agents include picaridin (20%) and oil of lemon/eucalyptus (30%). We thank Dr. Janowitz for directing us to the most recent testing program conducted by Consumer Reports.¹ That testing program demonstrated that Sawyer Fisherman’s Formula Picaridin and Natrapel 8 Hour, which each contain 20% picaridin, and Off! Deep Woods VIII, which contains 25% DEET, kept Aedes mosquitoes from biting for approximately 8 hours. The Sawyer product was also effective in preventing bites from the Culex mosquitoes, which carry West Nile virus, and deer ticks, which can transmit Lyme disease. Repel Lemon Eucalyptus (30%) stopped Aedes mosquito bites for 7 hours.

In the Consumer Reports testing program, IR3535 products, which we recommended in our article, did not perform well, nor did repellents that contained only 7% DEET or less than 20% picaridin. Moreover, products made from natural plant oils—such as citronella, lemongrass oil, cedar oil, geraniol, rosemary oil, and cinnamon oil—were not particularly effective. Some did not last for more than 1 hour; some failed immediately.

When applying any of these products, individuals should observe the following guidelines:

• apply insect repellents only to exposed skin or clothing
• do not apply repellents on cuts, wounds, or abraded skin or immediately after shaving
• avoid the eyes and mouth when applying repellent to the face
• after exposure is over, wash the skin with soap and water
• clothing that has been treated with one of these agents or with permethrin should be washed separately before it is worn again.

Reference

“Tissue extraction: Can the pendulum change direction?”

ARNOLD P. ADVINCULA, MD (JUNE 2016)

We have met the enemy and he is us

While I share the optimism Dr. Advincula expressed in his recent guest editorial regarding a change in the direction of the pendulum that swung away from use of the power morcellator, I feel compelled to express the opinion that this entire fiasco has been nothing other than an outrageous regulatory overreach.

Shortly after the US Food and Drug Administration (FDA) issued its proclamation in April 2014, the Society of Gynecologic Oncology repudiated the bogus statistics that were being used to describe the incidence of leiomyosarcoma and, further, stated that it would not matter how someone’s uterus containing this rare tumor was removed because the outcome would be poor. Similarly, the American Journal of Obstetrics and Gynecology published an article enumerating the expected significant increase in complications and the resulting misery that could be expected for patients whose management was diverted from minimally invasive to open hysterectomy.¹ The AAGL also expressed opinions that this was an unnecessary, and counterproductive, policy—all to no avail.

My optimism, however, is tempered by a number of questions: 1) Why did it take more than a year for 36 nationally recognized gynecologic surgeons to write a letter to the FDA denouncing the warning, yet again, and reiterating the errors in analysis used to establish the policy? 2) Why are gynecologic surgeons only now being asked to serve in the FDA’s Network of Experts? Should not that have been the case before the warning was issued? 3) If the perioperative outcomes are similar using a containment bag compared with open morcellation, what is the benefit of using the containment system? I, for one, think that prolonging a procedure another half hour is significant.

The FDA’s egregious policy clearly has had a net negative impact on the welfare of our patients. The gynecologic surgeon community should have pushed back more forcefully and effectively. I hope the next time something like this happens (and it will) we can be better advocates for our patients. 

Mark S. Finkelston, DO
Shawnee Mission, Kansas

Reference

Dr. Advincula responds

I thank Dr. Finkelston for his thoughts regarding my editorial. There is no doubt that the issues surrounding tissue extraction have been heated. Although I do not have definitive answers that explain all of the various reactions, whether immediate or delayed, to the cascade of events surrounding morcellation, I do believe that much of it was a response to N-of-1 policy-making, as very nicely discussed in a New England Journal of Medicine article by Lisa Rosenbaum.¹ We must continue to foster constructive dialogues with our regulatory bodies and cultivate the spirit of innovation that has brought so many advances to the field of surgery. Ultimately, going forward, it will be important for clinicians and other health care providers to speak up and not remain silent for fear of being vilified.

Reference

Vaginal hysterectomy solves the tissue morcellation dilemma

Dr. Advincula starts his guest editorial with the statement, “With practical, evidence-based, sound clinical judgement, I believe that it can.”

In fact, what “practical, evidence-based, sound clinical judgement” supports is a return to vaginal hysterectomy with transvaginal extracorporeal morcellation techniques. As Dr. Carl Zimmerman said in a recent debate at the Society of Gynecologic Surgeons (SGS annual meeting), “There is no recorded case of a vaginal hysterectomy with morcellation upgrading a patient with leiomyosarcoma.” In addition, the majority of cases in which Dr. Advincula and others are performing robot-assisted laparoscopic hysterectomy or total laparoscopic hysterectomy have this clinical and demographic profile: average age, 42; average parity, G2; average body mass index, 30; most common diagnosis, abnormal uterine bleeding, fibroids; most common pathology, fibroids; average uterine weight, 165 g. The majority of these can be performed much more safely, quickly, and cost effectively by transvaginal hysterectomy/morcellation. Please see an excellent commentary by Dr. Andrew Walter, immediate past president of SGS, on “Why we should strive for a vaginal hysterectomy rate of 40%.”¹

But the main reason Dr. Advincula should not be given a voice on this issue is because he has significant financial conflict of interest with the medical device industry. Should he even be on the OBG <scaps>Management</scaps> board of editors? I do not believe the rest of your editors have anywhere near his level of conflict of interest. Should he not be asked to recuse himself in this debate or abandon his financial connections with the medical device industry? Is this not the whole purpose of the Sunshine Act? Please, should you not be supporting what is in the best interest of our patients and payers?

R. Bruce Councell, MD
Asheville, North Carolina

Reference

Dr. Barbieri responds

At OBG Management, we wholeheartedly agree with Dr. Councell that vaginal hysterectomy is an excellent approach to removing the uterus in most women with noncancer indications for surgery. Our recently featured articles focused on vaginal hysterectomy include: “Transforming vaginal hysterectomy: 7 solutions to the most daunting challenges,” “Is energy-based vessel sealing safer than suturing for vaginal hysterectomy?,” Is same-day discharge feasible and safe for women undergoing vaginal hysterectomy?,” and “Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?” We plan to publish more content on advances in both vaginal and laparoscopic surgery.

We are proud to have Dr. Advincula, an internationally recognized leader in gynecologic surgery, serve on the OBG Management Editorial Board. His expertise and perspective is of great value to our readers. It is true that many leading surgeons, including Dr. Advincula, serve as consultants with manufacturers of surgical devices. Working together, clinical experts and device manufacturers help to advance medical care. In his editorial, Dr. Advincula did disclose these relationships. As a check on the quality and balance in our editorial material, I personally review all content and I have no financial relationships with any pharmaceutical or device manufacturer.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“What Insect repellents are safe during pregnancy?”

ANUSHKA CHELLIAH, MD, AND PATRICK DUFF, MD (JUNE 2016)

Alternatives to DEET

Picaridin is not mentioned in this brief report from Drs. Chelliah and Duff. I suggest reviewing the July 2015 Consumer Reports article on repellents; picaridin is a likely safer alternative to DEET, with the highest efficacy of all those tested, at least in Sawyer Fisherman’s Formula Picaridin Insect Repellent and Natrapel 8 Hour Insect Repellent. Products that have little or no efficacy also were not mentioned, including Avon Skin So Soft, Coleman Naturals Insect Repellent Snap Band, and SuperBand Wristband. In addition, the concentration of products is very important, as is the precise formulation within brands. For example, Off! Deep Woods VIII (with DEET 25%) is very effective versus Off! FamilyCare II Clean Feel (with picaridin 5%), which has very little benefit.

David H. Janowitz, MD
Houston, Texas

Drs. Chelliah and Duff respond

In our short discussion of mosquito repellents, we based our recommendations on publications from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health. Those publications presented DEET (N,N-diethyl-m-toluamide) at the top of the list for preferred repellents. A recent publication from the Organization of Teratology Information Specialists (MotherToBaby, September 2013) indicated that, in a concentration of 20% to 30%, DEET was safe in pregnancy and was effective in protecting against 90% of all mosquito bites and tick attachments. Increasing the concentration of DEET above 30% does not enhance the product’s effectiveness or prolong its duration of action.

However, Dr. Janowitz is correct in stating that other agents are also highly effective and safe in pregnancy. These agents include picaridin (20%) and oil of lemon/eucalyptus (30%). We thank Dr. Janowitz for directing us to the most recent testing program conducted by Consumer Reports.¹ That testing program demonstrated that Sawyer Fisherman’s Formula Picaridin and Natrapel 8 Hour, which each contain 20% picaridin, and Off! Deep Woods VIII, which contains 25% DEET, kept Aedes mosquitoes from biting for approximately 8 hours. The Sawyer product was also effective in preventing bites from the Culex mosquitoes, which carry West Nile virus, and deer ticks, which can transmit Lyme disease. Repel Lemon Eucalyptus (30%) stopped Aedes mosquito bites for 7 hours.

In the Consumer Reports testing program, IR3535 products, which we recommended in our article, did not perform well, nor did repellents that contained only 7% DEET or less than 20% picaridin. Moreover, products made from natural plant oils—such as citronella, lemongrass oil, cedar oil, geraniol, rosemary oil, and cinnamon oil—were not particularly effective. Some did not last for more than 1 hour; some failed immediately.

When applying any of these products, individuals should observe the following guidelines:

• apply insect repellents only to exposed skin or clothing
• do not apply repellents on cuts, wounds, or abraded skin or immediately after shaving
• avoid the eyes and mouth when applying repellent to the face
• after exposure is over, wash the skin with soap and water
• clothing that has been treated with one of these agents or with permethrin should be washed separately before it is worn again.

Reference

“Tissue extraction: Can the pendulum change direction?”

ARNOLD P. ADVINCULA, MD (JUNE 2016)

We have met the enemy and he is us

While I share the optimism Dr. Advincula expressed in his recent guest editorial regarding a change in the direction of the pendulum that swung away from use of the power morcellator, I feel compelled to express the opinion that this entire fiasco has been nothing other than an outrageous regulatory overreach.

Shortly after the US Food and Drug Administration (FDA) issued its proclamation in April 2014, the Society of Gynecologic Oncology repudiated the bogus statistics that were being used to describe the incidence of leiomyosarcoma and, further, stated that it would not matter how someone’s uterus containing this rare tumor was removed because the outcome would be poor. Similarly, the American Journal of Obstetrics and Gynecology published an article enumerating the expected significant increase in complications and the resulting misery that could be expected for patients whose management was diverted from minimally invasive to open hysterectomy.¹ The AAGL also expressed opinions that this was an unnecessary, and counterproductive, policy—all to no avail.

My optimism, however, is tempered by a number of questions: 1) Why did it take more than a year for 36 nationally recognized gynecologic surgeons to write a letter to the FDA denouncing the warning, yet again, and reiterating the errors in analysis used to establish the policy? 2) Why are gynecologic surgeons only now being asked to serve in the FDA’s Network of Experts? Should not that have been the case before the warning was issued? 3) If the perioperative outcomes are similar using a containment bag compared with open morcellation, what is the benefit of using the containment system? I, for one, think that prolonging a procedure another half hour is significant.

The FDA’s egregious policy clearly has had a net negative impact on the welfare of our patients. The gynecologic surgeon community should have pushed back more forcefully and effectively. I hope the next time something like this happens (and it will) we can be better advocates for our patients. 

Mark S. Finkelston, DO
Shawnee Mission, Kansas

Reference

Dr. Advincula responds

I thank Dr. Finkelston for his thoughts regarding my editorial. There is no doubt that the issues surrounding tissue extraction have been heated. Although I do not have definitive answers that explain all of the various reactions, whether immediate or delayed, to the cascade of events surrounding morcellation, I do believe that much of it was a response to N-of-1 policy-making, as very nicely discussed in a New England Journal of Medicine article by Lisa Rosenbaum.¹ We must continue to foster constructive dialogues with our regulatory bodies and cultivate the spirit of innovation that has brought so many advances to the field of surgery. Ultimately, going forward, it will be important for clinicians and other health care providers to speak up and not remain silent for fear of being vilified.

Reference

Vaginal hysterectomy solves the tissue morcellation dilemma

Dr. Advincula starts his guest editorial with the statement, “With practical, evidence-based, sound clinical judgement, I believe that it can.”

In fact, what “practical, evidence-based, sound clinical judgement” supports is a return to vaginal hysterectomy with transvaginal extracorporeal morcellation techniques. As Dr. Carl Zimmerman said in a recent debate at the Society of Gynecologic Surgeons (SGS annual meeting), “There is no recorded case of a vaginal hysterectomy with morcellation upgrading a patient with leiomyosarcoma.” In addition, the majority of cases in which Dr. Advincula and others are performing robot-assisted laparoscopic hysterectomy or total laparoscopic hysterectomy have this clinical and demographic profile: average age, 42; average parity, G2; average body mass index, 30; most common diagnosis, abnormal uterine bleeding, fibroids; most common pathology, fibroids; average uterine weight, 165 g. The majority of these can be performed much more safely, quickly, and cost effectively by transvaginal hysterectomy/morcellation. Please see an excellent commentary by Dr. Andrew Walter, immediate past president of SGS, on “Why we should strive for a vaginal hysterectomy rate of 40%.”¹

But the main reason Dr. Advincula should not be given a voice on this issue is because he has significant financial conflict of interest with the medical device industry. Should he even be on the OBG <scaps>Management</scaps> board of editors? I do not believe the rest of your editors have anywhere near his level of conflict of interest. Should he not be asked to recuse himself in this debate or abandon his financial connections with the medical device industry? Is this not the whole purpose of the Sunshine Act? Please, should you not be supporting what is in the best interest of our patients and payers?

R. Bruce Councell, MD
Asheville, North Carolina

Reference

Dr. Barbieri responds

At OBG Management, we wholeheartedly agree with Dr. Councell that vaginal hysterectomy is an excellent approach to removing the uterus in most women with noncancer indications for surgery. Our recently featured articles focused on vaginal hysterectomy include: “Transforming vaginal hysterectomy: 7 solutions to the most daunting challenges,” “Is energy-based vessel sealing safer than suturing for vaginal hysterectomy?,” Is same-day discharge feasible and safe for women undergoing vaginal hysterectomy?,” and “Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?” We plan to publish more content on advances in both vaginal and laparoscopic surgery.

We are proud to have Dr. Advincula, an internationally recognized leader in gynecologic surgery, serve on the OBG Management Editorial Board. His expertise and perspective is of great value to our readers. It is true that many leading surgeons, including Dr. Advincula, serve as consultants with manufacturers of surgical devices. Working together, clinical experts and device manufacturers help to advance medical care. In his editorial, Dr. Advincula did disclose these relationships. As a check on the quality and balance in our editorial material, I personally review all content and I have no financial relationships with any pharmaceutical or device manufacturer.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“What Insect repellents are safe during pregnancy?”

ANUSHKA CHELLIAH, MD, AND PATRICK DUFF, MD (JUNE 2016)

Alternatives to DEET

Picaridin is not mentioned in this brief report from Drs. Chelliah and Duff. I suggest reviewing the July 2015 Consumer Reports article on repellents; picaridin is a likely safer alternative to DEET, with the highest efficacy of all those tested, at least in Sawyer Fisherman’s Formula Picaridin Insect Repellent and Natrapel 8 Hour Insect Repellent. Products that have little or no efficacy also were not mentioned, including Avon Skin So Soft, Coleman Naturals Insect Repellent Snap Band, and SuperBand Wristband. In addition, the concentration of products is very important, as is the precise formulation within brands. For example, Off! Deep Woods VIII (with DEET 25%) is very effective versus Off! FamilyCare II Clean Feel (with picaridin 5%), which has very little benefit.

David H. Janowitz, MD
Houston, Texas

Drs. Chelliah and Duff respond

In our short discussion of mosquito repellents, we based our recommendations on publications from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health. Those publications presented DEET (N,N-diethyl-m-toluamide) at the top of the list for preferred repellents. A recent publication from the Organization of Teratology Information Specialists (MotherToBaby, September 2013) indicated that, in a concentration of 20% to 30%, DEET was safe in pregnancy and was effective in protecting against 90% of all mosquito bites and tick attachments. Increasing the concentration of DEET above 30% does not enhance the product’s effectiveness or prolong its duration of action.

However, Dr. Janowitz is correct in stating that other agents are also highly effective and safe in pregnancy. These agents include picaridin (20%) and oil of lemon/eucalyptus (30%). We thank Dr. Janowitz for directing us to the most recent testing program conducted by Consumer Reports.¹ That testing program demonstrated that Sawyer Fisherman’s Formula Picaridin and Natrapel 8 Hour, which each contain 20% picaridin, and Off! Deep Woods VIII, which contains 25% DEET, kept Aedes mosquitoes from biting for approximately 8 hours. The Sawyer product was also effective in preventing bites from the Culex mosquitoes, which carry West Nile virus, and deer ticks, which can transmit Lyme disease. Repel Lemon Eucalyptus (30%) stopped Aedes mosquito bites for 7 hours.

In the Consumer Reports testing program, IR3535 products, which we recommended in our article, did not perform well, nor did repellents that contained only 7% DEET or less than 20% picaridin. Moreover, products made from natural plant oils—such as citronella, lemongrass oil, cedar oil, geraniol, rosemary oil, and cinnamon oil—were not particularly effective. Some did not last for more than 1 hour; some failed immediately.

When applying any of these products, individuals should observe the following guidelines:

• apply insect repellents only to exposed skin or clothing
• do not apply repellents on cuts, wounds, or abraded skin or immediately after shaving
• avoid the eyes and mouth when applying repellent to the face
• after exposure is over, wash the skin with soap and water
• clothing that has been treated with one of these agents or with permethrin should be washed separately before it is worn again.

Reference

“Tissue extraction: Can the pendulum change direction?”

ARNOLD P. ADVINCULA, MD (JUNE 2016)

We have met the enemy and he is us

While I share the optimism Dr. Advincula expressed in his recent guest editorial regarding a change in the direction of the pendulum that swung away from use of the power morcellator, I feel compelled to express the opinion that this entire fiasco has been nothing other than an outrageous regulatory overreach.

Shortly after the US Food and Drug Administration (FDA) issued its proclamation in April 2014, the Society of Gynecologic Oncology repudiated the bogus statistics that were being used to describe the incidence of leiomyosarcoma and, further, stated that it would not matter how someone’s uterus containing this rare tumor was removed because the outcome would be poor. Similarly, the American Journal of Obstetrics and Gynecology published an article enumerating the expected significant increase in complications and the resulting misery that could be expected for patients whose management was diverted from minimally invasive to open hysterectomy.¹ The AAGL also expressed opinions that this was an unnecessary, and counterproductive, policy—all to no avail.

My optimism, however, is tempered by a number of questions: 1) Why did it take more than a year for 36 nationally recognized gynecologic surgeons to write a letter to the FDA denouncing the warning, yet again, and reiterating the errors in analysis used to establish the policy? 2) Why are gynecologic surgeons only now being asked to serve in the FDA’s Network of Experts? Should not that have been the case before the warning was issued? 3) If the perioperative outcomes are similar using a containment bag compared with open morcellation, what is the benefit of using the containment system? I, for one, think that prolonging a procedure another half hour is significant.

The FDA’s egregious policy clearly has had a net negative impact on the welfare of our patients. The gynecologic surgeon community should have pushed back more forcefully and effectively. I hope the next time something like this happens (and it will) we can be better advocates for our patients. 

Mark S. Finkelston, DO
Shawnee Mission, Kansas

Reference

Dr. Advincula responds

I thank Dr. Finkelston for his thoughts regarding my editorial. There is no doubt that the issues surrounding tissue extraction have been heated. Although I do not have definitive answers that explain all of the various reactions, whether immediate or delayed, to the cascade of events surrounding morcellation, I do believe that much of it was a response to N-of-1 policy-making, as very nicely discussed in a New England Journal of Medicine article by Lisa Rosenbaum.¹ We must continue to foster constructive dialogues with our regulatory bodies and cultivate the spirit of innovation that has brought so many advances to the field of surgery. Ultimately, going forward, it will be important for clinicians and other health care providers to speak up and not remain silent for fear of being vilified.

Reference

Vaginal hysterectomy solves the tissue morcellation dilemma

Dr. Advincula starts his guest editorial with the statement, “With practical, evidence-based, sound clinical judgement, I believe that it can.”

In fact, what “practical, evidence-based, sound clinical judgement” supports is a return to vaginal hysterectomy with transvaginal extracorporeal morcellation techniques. As Dr. Carl Zimmerman said in a recent debate at the Society of Gynecologic Surgeons (SGS annual meeting), “There is no recorded case of a vaginal hysterectomy with morcellation upgrading a patient with leiomyosarcoma.” In addition, the majority of cases in which Dr. Advincula and others are performing robot-assisted laparoscopic hysterectomy or total laparoscopic hysterectomy have this clinical and demographic profile: average age, 42; average parity, G2; average body mass index, 30; most common diagnosis, abnormal uterine bleeding, fibroids; most common pathology, fibroids; average uterine weight, 165 g. The majority of these can be performed much more safely, quickly, and cost effectively by transvaginal hysterectomy/morcellation. Please see an excellent commentary by Dr. Andrew Walter, immediate past president of SGS, on “Why we should strive for a vaginal hysterectomy rate of 40%.”¹

But the main reason Dr. Advincula should not be given a voice on this issue is because he has significant financial conflict of interest with the medical device industry. Should he even be on the OBG <scaps>Management</scaps> board of editors? I do not believe the rest of your editors have anywhere near his level of conflict of interest. Should he not be asked to recuse himself in this debate or abandon his financial connections with the medical device industry? Is this not the whole purpose of the Sunshine Act? Please, should you not be supporting what is in the best interest of our patients and payers?

R. Bruce Councell, MD
Asheville, North Carolina

Reference

Dr. Barbieri responds

At OBG Management, we wholeheartedly agree with Dr. Councell that vaginal hysterectomy is an excellent approach to removing the uterus in most women with noncancer indications for surgery. Our recently featured articles focused on vaginal hysterectomy include: “Transforming vaginal hysterectomy: 7 solutions to the most daunting challenges,” “Is energy-based vessel sealing safer than suturing for vaginal hysterectomy?,” Is same-day discharge feasible and safe for women undergoing vaginal hysterectomy?,” and “Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?” We plan to publish more content on advances in both vaginal and laparoscopic surgery.

We are proud to have Dr. Advincula, an internationally recognized leader in gynecologic surgery, serve on the OBG Management Editorial Board. His expertise and perspective is of great value to our readers. It is true that many leading surgeons, including Dr. Advincula, serve as consultants with manufacturers of surgical devices. Working together, clinical experts and device manufacturers help to advance medical care. In his editorial, Dr. Advincula did disclose these relationships. As a check on the quality and balance in our editorial material, I personally review all content and I have no financial relationships with any pharmaceutical or device manufacturer.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DISPOSABLE HANDHELD RESECTOR

Distal Access offers nationwide availability of the RESECTR™ 9 French / 3.0 mm High- Performance Disposable Tissue Resector, a disposable, nonpowered, handheld, and hand-driven system designed to combine the benefits of basic manual devices and complex electro-mechanical systems.

The RESECTR platform is “ready-to-use,” says Distal Access, giving clinicians an important tool to see-and-treat lesions in the hospital, clinic, or office. Starting at the cutting tip, aspiration pulls tissue samples into the cutting window where oscillating blades are controlled by the clinician’s index finger and hand. Clinicians can increase or decrease oscillation and cutting based on what they see and feel during the procedure.

According to Distal Access, for small tissue samples, resection time with the RESECTR can be similar to that with electromechanical devices, with a significantly lower cost. The RESECTR is compatible with available fluid management systems and endoscopic devices.

FOR MORE INFORMATION, VISIT: www.resectr.com

PREDICTIVE TOOL FOR PRETERM BIRTH RISK

Sera Prognostics announced that its PreTRM^® Test is the first and only clinically validated blood test to predict preterm birth risk in asymptomatic, singleton pregnancies.

Premature birth, defined as birth before 37 weeks, is the leading cause of death and illness in newborns and is associated with an increased risk of major long-term complications. Previously, the 2 best traditional predictors of premature birth were prior preterm birth history and short cervical length, but these identify only a small percentage of women who deliver early, asserts Sera Prognostics. Implemented during gestational weeks 19 and 20, the PreTRM test uses proteomic technology to measure and analyze 2 proteins in the blood that are highly predictive of preterm birth: IBP4, insulin-like growth factor binding protein 4, and SHBG, sex-hormone binding globulin.

According to Sera Prognostics, data from the 5,501-patient Proteomic Assessment of Preterm Risk (PAPR) study, recently published in American Journal of Obstetrics & Gynecology, confirm that the test can help identify a high percentage of women who are at increased risk early in pregnancy before symptoms occur.

FOR MORE INFORMATION, VISIT: www.pretrm.com

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DISPOSABLE HANDHELD RESECTOR

Distal Access offers nationwide availability of the RESECTR™ 9 French / 3.0 mm High- Performance Disposable Tissue Resector, a disposable, nonpowered, handheld, and hand-driven system designed to combine the benefits of basic manual devices and complex electro-mechanical systems.

The RESECTR platform is “ready-to-use,” says Distal Access, giving clinicians an important tool to see-and-treat lesions in the hospital, clinic, or office. Starting at the cutting tip, aspiration pulls tissue samples into the cutting window where oscillating blades are controlled by the clinician’s index finger and hand. Clinicians can increase or decrease oscillation and cutting based on what they see and feel during the procedure.

According to Distal Access, for small tissue samples, resection time with the RESECTR can be similar to that with electromechanical devices, with a significantly lower cost. The RESECTR is compatible with available fluid management systems and endoscopic devices.

FOR MORE INFORMATION, VISIT: www.resectr.com

PREDICTIVE TOOL FOR PRETERM BIRTH RISK

Sera Prognostics announced that its PreTRM^® Test is the first and only clinically validated blood test to predict preterm birth risk in asymptomatic, singleton pregnancies.

Premature birth, defined as birth before 37 weeks, is the leading cause of death and illness in newborns and is associated with an increased risk of major long-term complications. Previously, the 2 best traditional predictors of premature birth were prior preterm birth history and short cervical length, but these identify only a small percentage of women who deliver early, asserts Sera Prognostics. Implemented during gestational weeks 19 and 20, the PreTRM test uses proteomic technology to measure and analyze 2 proteins in the blood that are highly predictive of preterm birth: IBP4, insulin-like growth factor binding protein 4, and SHBG, sex-hormone binding globulin.

According to Sera Prognostics, data from the 5,501-patient Proteomic Assessment of Preterm Risk (PAPR) study, recently published in American Journal of Obstetrics & Gynecology, confirm that the test can help identify a high percentage of women who are at increased risk early in pregnancy before symptoms occur.

FOR MORE INFORMATION, VISIT: www.pretrm.com

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DISPOSABLE HANDHELD RESECTOR

Distal Access offers nationwide availability of the RESECTR™ 9 French / 3.0 mm High- Performance Disposable Tissue Resector, a disposable, nonpowered, handheld, and hand-driven system designed to combine the benefits of basic manual devices and complex electro-mechanical systems.

The RESECTR platform is “ready-to-use,” says Distal Access, giving clinicians an important tool to see-and-treat lesions in the hospital, clinic, or office. Starting at the cutting tip, aspiration pulls tissue samples into the cutting window where oscillating blades are controlled by the clinician’s index finger and hand. Clinicians can increase or decrease oscillation and cutting based on what they see and feel during the procedure.

According to Distal Access, for small tissue samples, resection time with the RESECTR can be similar to that with electromechanical devices, with a significantly lower cost. The RESECTR is compatible with available fluid management systems and endoscopic devices.

FOR MORE INFORMATION, VISIT: www.resectr.com

PREDICTIVE TOOL FOR PRETERM BIRTH RISK

Sera Prognostics announced that its PreTRM^® Test is the first and only clinically validated blood test to predict preterm birth risk in asymptomatic, singleton pregnancies.

Premature birth, defined as birth before 37 weeks, is the leading cause of death and illness in newborns and is associated with an increased risk of major long-term complications. Previously, the 2 best traditional predictors of premature birth were prior preterm birth history and short cervical length, but these identify only a small percentage of women who deliver early, asserts Sera Prognostics. Implemented during gestational weeks 19 and 20, the PreTRM test uses proteomic technology to measure and analyze 2 proteins in the blood that are highly predictive of preterm birth: IBP4, insulin-like growth factor binding protein 4, and SHBG, sex-hormone binding globulin.

According to Sera Prognostics, data from the 5,501-patient Proteomic Assessment of Preterm Risk (PAPR) study, recently published in American Journal of Obstetrics & Gynecology, confirm that the test can help identify a high percentage of women who are at increased risk early in pregnancy before symptoms occur.

FOR MORE INFORMATION, VISIT: www.pretrm.com

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

MINNEAPOLIS – The use of telecardiology can vastly improve outcomes, reduce hospitalizations, and lower health care costs, explained Michael Shen, MD, a cardiologist and chief medical officer at Duxlink Health in Sunrise, Fla.

Dr. Shen recently spoke at the American Telemedicine Association annual meeting about the impact of telecardiology on the practice of cardiology.

“This is at the very beginning of the technology, and it will be very good for cardiologists to be early adopters – to be the early users – so they can engage the technology as leaders, rather than followers,” explained Dr. Shen.

In a video interview at the meeting, he discussed how telecardiology has advanced over the years and how the technology can improve chronic care management. Dr. Shen also shared details about a telecardiology program implemented in his practice, and he discussed how the program has affected patient care and hospital readmissions.

Dr. Shen had no disclosures.

[email protected]

On Twitter @legal_med

MINNEAPOLIS – The use of telecardiology can vastly improve outcomes, reduce hospitalizations, and lower health care costs, explained Michael Shen, MD, a cardiologist and chief medical officer at Duxlink Health in Sunrise, Fla.

Dr. Shen recently spoke at the American Telemedicine Association annual meeting about the impact of telecardiology on the practice of cardiology.

“This is at the very beginning of the technology, and it will be very good for cardiologists to be early adopters – to be the early users – so they can engage the technology as leaders, rather than followers,” explained Dr. Shen.

In a video interview at the meeting, he discussed how telecardiology has advanced over the years and how the technology can improve chronic care management. Dr. Shen also shared details about a telecardiology program implemented in his practice, and he discussed how the program has affected patient care and hospital readmissions.

Dr. Shen had no disclosures.

[email protected]

On Twitter @legal_med

MINNEAPOLIS – The use of telecardiology can vastly improve outcomes, reduce hospitalizations, and lower health care costs, explained Michael Shen, MD, a cardiologist and chief medical officer at Duxlink Health in Sunrise, Fla.

Dr. Shen recently spoke at the American Telemedicine Association annual meeting about the impact of telecardiology on the practice of cardiology.

“This is at the very beginning of the technology, and it will be very good for cardiologists to be early adopters – to be the early users – so they can engage the technology as leaders, rather than followers,” explained Dr. Shen.

In a video interview at the meeting, he discussed how telecardiology has advanced over the years and how the technology can improve chronic care management. Dr. Shen also shared details about a telecardiology program implemented in his practice, and he discussed how the program has affected patient care and hospital readmissions.

Dr. Shen had no disclosures.

[email protected]

On Twitter @legal_med

SAN DIEGO – Implementation of a simple colon bundle decreased the rate of colonic and enteric resections faster, compared with improvements seen for other procedures, according to a study that involved 23 hospitals in Tennessee.

At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Brian J. Daley, MD, discussed findings from an analysis conducted by members of the Tennessee Surgical Quality Collaborative (TSQC), which he described as “a collection of surgeons who put aside their hospital and regional affiliations to work together to help each other and to help our fellow Tennesseans.” Established in 2008 with member hospitals, the TSQC has grown to 23 member hospitals, including 18 community hospitals and 5 academic medical centers. It provides data on nearly 600 surgeons across the state. “While this only represents about half of the surgical procedures in the state, there is sufficient statistical power to make comments about our surgical performance,” said Dr. Daley of the department of surgery at  the University of Tennessee Medical Center, Knoxville.

©Dmitrii Kotin/Thinkstock.com

To quantify TSQC’s impact on surgical outcomes, surgeons at the member hospitals evaluated the TSQC colon bundle, which was developed in 2012 and implemented in 2013. It bundles four processes of care: maintaining intraoperative oxygen delivery, maintaining a temperature of 36° C, making sure the patient’s blood glucose is normal, and choosing the appropriate antibiotics. “We kept it simple: easy, not expensive, and hopefully helpful,” Dr. Daley said.

With other procedures as a baseline, they used statistical analyses to determine if implementation of the bundle led to an incremental acceleration of reduced complications, compared with other improvements observed in other procedures. “To understand our outcomes, we needed to prove three points: that the trend improved [a negative trend in the resection rate], that this negative trend was more negative than trends for other comparator procedures, and that the trend for intercept was not equal to the comparator in any way,” Dr. Daley explained.

Following adoption of the bundle, he and his associates observed that the rate of decrease in postoperative recurrences was greater in colectomy, compared with that for all other surgical procedures (P less than .001 for both the trend and the intercept statistical models). Adoption of the bundle also positively impacted decreases in postoperative recurrences among enterectomy cases (P less than .001 for both the trend and the intercept statistical models).

“We were able to demonstrate that our TSQC bundle paid dividends in improving colectomy outcomes,” Dr. Daley concluded. “We have seen these efforts spill over into enterectomy. From this we can also infer that participation in the collaborative improves outcomes and is imperative to maintain the acceleration in surgical improvement.”

Dr. Daley reported that he and his coauthors had no relevant financial disclosures.

[email protected]

SAN DIEGO – Implementation of a simple colon bundle decreased the rate of colonic and enteric resections faster, compared with improvements seen for other procedures, according to a study that involved 23 hospitals in Tennessee.

At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Brian J. Daley, MD, discussed findings from an analysis conducted by members of the Tennessee Surgical Quality Collaborative (TSQC), which he described as “a collection of surgeons who put aside their hospital and regional affiliations to work together to help each other and to help our fellow Tennesseans.” Established in 2008 with member hospitals, the TSQC has grown to 23 member hospitals, including 18 community hospitals and 5 academic medical centers. It provides data on nearly 600 surgeons across the state. “While this only represents about half of the surgical procedures in the state, there is sufficient statistical power to make comments about our surgical performance,” said Dr. Daley of the department of surgery at  the University of Tennessee Medical Center, Knoxville.

©Dmitrii Kotin/Thinkstock.com

To quantify TSQC’s impact on surgical outcomes, surgeons at the member hospitals evaluated the TSQC colon bundle, which was developed in 2012 and implemented in 2013. It bundles four processes of care: maintaining intraoperative oxygen delivery, maintaining a temperature of 36° C, making sure the patient’s blood glucose is normal, and choosing the appropriate antibiotics. “We kept it simple: easy, not expensive, and hopefully helpful,” Dr. Daley said.

With other procedures as a baseline, they used statistical analyses to determine if implementation of the bundle led to an incremental acceleration of reduced complications, compared with other improvements observed in other procedures. “To understand our outcomes, we needed to prove three points: that the trend improved [a negative trend in the resection rate], that this negative trend was more negative than trends for other comparator procedures, and that the trend for intercept was not equal to the comparator in any way,” Dr. Daley explained.

Following adoption of the bundle, he and his associates observed that the rate of decrease in postoperative recurrences was greater in colectomy, compared with that for all other surgical procedures (P less than .001 for both the trend and the intercept statistical models). Adoption of the bundle also positively impacted decreases in postoperative recurrences among enterectomy cases (P less than .001 for both the trend and the intercept statistical models).

“We were able to demonstrate that our TSQC bundle paid dividends in improving colectomy outcomes,” Dr. Daley concluded. “We have seen these efforts spill over into enterectomy. From this we can also infer that participation in the collaborative improves outcomes and is imperative to maintain the acceleration in surgical improvement.”

Dr. Daley reported that he and his coauthors had no relevant financial disclosures.

[email protected]

SAN DIEGO – Implementation of a simple colon bundle decreased the rate of colonic and enteric resections faster, compared with improvements seen for other procedures, according to a study that involved 23 hospitals in Tennessee.

At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Brian J. Daley, MD, discussed findings from an analysis conducted by members of the Tennessee Surgical Quality Collaborative (TSQC), which he described as “a collection of surgeons who put aside their hospital and regional affiliations to work together to help each other and to help our fellow Tennesseans.” Established in 2008 with member hospitals, the TSQC has grown to 23 member hospitals, including 18 community hospitals and 5 academic medical centers. It provides data on nearly 600 surgeons across the state. “While this only represents about half of the surgical procedures in the state, there is sufficient statistical power to make comments about our surgical performance,” said Dr. Daley of the department of surgery at  the University of Tennessee Medical Center, Knoxville.

©Dmitrii Kotin/Thinkstock.com

To quantify TSQC’s impact on surgical outcomes, surgeons at the member hospitals evaluated the TSQC colon bundle, which was developed in 2012 and implemented in 2013. It bundles four processes of care: maintaining intraoperative oxygen delivery, maintaining a temperature of 36° C, making sure the patient’s blood glucose is normal, and choosing the appropriate antibiotics. “We kept it simple: easy, not expensive, and hopefully helpful,” Dr. Daley said.

With other procedures as a baseline, they used statistical analyses to determine if implementation of the bundle led to an incremental acceleration of reduced complications, compared with other improvements observed in other procedures. “To understand our outcomes, we needed to prove three points: that the trend improved [a negative trend in the resection rate], that this negative trend was more negative than trends for other comparator procedures, and that the trend for intercept was not equal to the comparator in any way,” Dr. Daley explained.

Following adoption of the bundle, he and his associates observed that the rate of decrease in postoperative recurrences was greater in colectomy, compared with that for all other surgical procedures (P less than .001 for both the trend and the intercept statistical models). Adoption of the bundle also positively impacted decreases in postoperative recurrences among enterectomy cases (P less than .001 for both the trend and the intercept statistical models).

“We were able to demonstrate that our TSQC bundle paid dividends in improving colectomy outcomes,” Dr. Daley concluded. “We have seen these efforts spill over into enterectomy. From this we can also infer that participation in the collaborative improves outcomes and is imperative to maintain the acceleration in surgical improvement.”

Dr. Daley reported that he and his coauthors had no relevant financial disclosures.

[email protected]

Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.

“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).

©Felipe Caparrós Cruz/Thinkstock

Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.

Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.

Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.

Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.

“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.

Read the study results here.

[email protected]

On Twitter @jessnicolecraig

Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.

“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).

©Felipe Caparrós Cruz/Thinkstock

Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.

Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.

Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.

Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.

“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.

Read the study results here.

[email protected]

On Twitter @jessnicolecraig

Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.

“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).

©Felipe Caparrós Cruz/Thinkstock

Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.

Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.

Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.

Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.

“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.

Read the study results here.

[email protected]

On Twitter @jessnicolecraig

HELSINKI – The risk of preterm birth and low birth weight is higher following oocyte donation for in vitro fertilization, compared with autologous IVF, according to a review of more than 100,000 singleton live births.

The findings could help in counseling women and when managing pregnancies resulting from oocyte donation IVF, Mohan S. Kamath, MBBS, reported at the annual meeting of the European Society of Human Reproduction and Embryology.

©ktsimage/iStockphoto.com

In a review of 100,092 singleton live births among women who underwent either fresh donor oocyte or autologous IVF, the rates of several outcomes were increased among the donor recipients. For example, preterm birth, defined as live birth before 37 weeks’ gestation, occurred in 14.8% vs. 9.4% of patients in the groups, respectively (odds ratio, 1.68), early preterm birth (live birth before 32 weeks’ gestation) occurred in 2.1% and 1.8% of patients (OR, 1.77), low birth weight (less than 2,500 g), occurred in 13.8% vs. 9.5% of patients (OR, 1.53), and very low birth weight (less than 1,500 g) occurred in 2.65% vs. 1.9% of patients (OR, 1.42).

The differences between the groups were statistically significant, said Dr. Kamath of Christian Medical College and Hospital, Vellore, India.

After adjusting for potential confounders, including female age, treatment duration, previous live birth, number of embryos transferred, single vs. multiple pregnancies resulting in singleton birth, and day of embryo transfer (before 5 days vs. 5 days or later), the increase in the risk of adverse perinatal outcomes of preterm birth, early preterm birth, and low birth weight remained significant (adjusted OR, 1.56, 1.41, and 1.43, respectively), he said.

The findings are important because the burden of poor ovarian response following IVF has been increasing, likely as a result of delayed childbearing and thus advanced age among those seeking IVF, Dr. Kamath said. However, little information is available regarding maternal or infant outcomes following oocyte donation, and the data that do exist have been conflicting, he said.

The increased risk of pregnancy complications following assisted reproductive technology, compared with spontaneously conceived pregnancies, has been largely attributed to the underlying infertility itself or to embryo-specific epigenetic modifications because of the in vitro fertilization techniques. The current study was conducted to determine whether use of donor oocytes affects obstetric and perinatal outcomes when compared with pregnancies that follow autologous IVF.

Anonymous data were obtained from the Human Fertilisation & Embryology Authority of the United Kingdom, which has collected data on all assisted reproductive treatment in the United Kingdom since 1991. For the current analysis, data from 1991 to 2011, including all singleton live births following fresh oocyte donor and autologous IVF cycles, were evaluated.

Although the dataset did not include information on potential confounders, such as smoking, body mass index, and medical history during pregnancy, the findings provide important insight into potential outcomes, Dr. Kamath said.

Dr. Kamath reported having no financial disclosures.

[email protected]

HELSINKI – The risk of preterm birth and low birth weight is higher following oocyte donation for in vitro fertilization, compared with autologous IVF, according to a review of more than 100,000 singleton live births.

The findings could help in counseling women and when managing pregnancies resulting from oocyte donation IVF, Mohan S. Kamath, MBBS, reported at the annual meeting of the European Society of Human Reproduction and Embryology.

©ktsimage/iStockphoto.com

In a review of 100,092 singleton live births among women who underwent either fresh donor oocyte or autologous IVF, the rates of several outcomes were increased among the donor recipients. For example, preterm birth, defined as live birth before 37 weeks’ gestation, occurred in 14.8% vs. 9.4% of patients in the groups, respectively (odds ratio, 1.68), early preterm birth (live birth before 32 weeks’ gestation) occurred in 2.1% and 1.8% of patients (OR, 1.77), low birth weight (less than 2,500 g), occurred in 13.8% vs. 9.5% of patients (OR, 1.53), and very low birth weight (less than 1,500 g) occurred in 2.65% vs. 1.9% of patients (OR, 1.42).

The differences between the groups were statistically significant, said Dr. Kamath of Christian Medical College and Hospital, Vellore, India.

After adjusting for potential confounders, including female age, treatment duration, previous live birth, number of embryos transferred, single vs. multiple pregnancies resulting in singleton birth, and day of embryo transfer (before 5 days vs. 5 days or later), the increase in the risk of adverse perinatal outcomes of preterm birth, early preterm birth, and low birth weight remained significant (adjusted OR, 1.56, 1.41, and 1.43, respectively), he said.

The findings are important because the burden of poor ovarian response following IVF has been increasing, likely as a result of delayed childbearing and thus advanced age among those seeking IVF, Dr. Kamath said. However, little information is available regarding maternal or infant outcomes following oocyte donation, and the data that do exist have been conflicting, he said.

The increased risk of pregnancy complications following assisted reproductive technology, compared with spontaneously conceived pregnancies, has been largely attributed to the underlying infertility itself or to embryo-specific epigenetic modifications because of the in vitro fertilization techniques. The current study was conducted to determine whether use of donor oocytes affects obstetric and perinatal outcomes when compared with pregnancies that follow autologous IVF.

Anonymous data were obtained from the Human Fertilisation & Embryology Authority of the United Kingdom, which has collected data on all assisted reproductive treatment in the United Kingdom since 1991. For the current analysis, data from 1991 to 2011, including all singleton live births following fresh oocyte donor and autologous IVF cycles, were evaluated.

Although the dataset did not include information on potential confounders, such as smoking, body mass index, and medical history during pregnancy, the findings provide important insight into potential outcomes, Dr. Kamath said.

Dr. Kamath reported having no financial disclosures.

[email protected]

HELSINKI – The risk of preterm birth and low birth weight is higher following oocyte donation for in vitro fertilization, compared with autologous IVF, according to a review of more than 100,000 singleton live births.

The findings could help in counseling women and when managing pregnancies resulting from oocyte donation IVF, Mohan S. Kamath, MBBS, reported at the annual meeting of the European Society of Human Reproduction and Embryology.

©ktsimage/iStockphoto.com

In a review of 100,092 singleton live births among women who underwent either fresh donor oocyte or autologous IVF, the rates of several outcomes were increased among the donor recipients. For example, preterm birth, defined as live birth before 37 weeks’ gestation, occurred in 14.8% vs. 9.4% of patients in the groups, respectively (odds ratio, 1.68), early preterm birth (live birth before 32 weeks’ gestation) occurred in 2.1% and 1.8% of patients (OR, 1.77), low birth weight (less than 2,500 g), occurred in 13.8% vs. 9.5% of patients (OR, 1.53), and very low birth weight (less than 1,500 g) occurred in 2.65% vs. 1.9% of patients (OR, 1.42).

The differences between the groups were statistically significant, said Dr. Kamath of Christian Medical College and Hospital, Vellore, India.

After adjusting for potential confounders, including female age, treatment duration, previous live birth, number of embryos transferred, single vs. multiple pregnancies resulting in singleton birth, and day of embryo transfer (before 5 days vs. 5 days or later), the increase in the risk of adverse perinatal outcomes of preterm birth, early preterm birth, and low birth weight remained significant (adjusted OR, 1.56, 1.41, and 1.43, respectively), he said.

The findings are important because the burden of poor ovarian response following IVF has been increasing, likely as a result of delayed childbearing and thus advanced age among those seeking IVF, Dr. Kamath said. However, little information is available regarding maternal or infant outcomes following oocyte donation, and the data that do exist have been conflicting, he said.

The increased risk of pregnancy complications following assisted reproductive technology, compared with spontaneously conceived pregnancies, has been largely attributed to the underlying infertility itself or to embryo-specific epigenetic modifications because of the in vitro fertilization techniques. The current study was conducted to determine whether use of donor oocytes affects obstetric and perinatal outcomes when compared with pregnancies that follow autologous IVF.

Anonymous data were obtained from the Human Fertilisation & Embryology Authority of the United Kingdom, which has collected data on all assisted reproductive treatment in the United Kingdom since 1991. For the current analysis, data from 1991 to 2011, including all singleton live births following fresh oocyte donor and autologous IVF cycles, were evaluated.

Although the dataset did not include information on potential confounders, such as smoking, body mass index, and medical history during pregnancy, the findings provide important insight into potential outcomes, Dr. Kamath said.

Dr. Kamath reported having no financial disclosures.

[email protected]

Results from the double-blind, randomized, placebo-controlled phase II ACCLAIM study indicate that abatacept has no effect on reducing the number of new gadolinium-enhancing lesions on MRI in patients with relapsing-remitting multiple sclerosis, according to Samia J. Khoury, MD, of Brigham and Women’s Hospital, Boston, and her colleagues from the Immune Tolerance Network.

In the ACCLAIM (A Cooperative Clinical Study of Abatacept in Multiple Sclerosis) study, 42 patients who received abatacept (Orencia) developed a mean of 0.43 new gadolinium-enhancing lesions by week 24, compared with 1.66 for 20 placebo-treated patients (P = .87). None of the secondary MRI endpoints (lesion volume change and percent brain volume change) and clinical endpoints (changes in Multiple Sclerosis Functional Composite score, Expanded Disability Status Scale [EDSS], and annualized relapse rate) at 24 weeks differed significantly between the groups. The rate of patients who met criteria for no evidence of disease activity or its components (no EDSS progression, no clinical exacerbations, and no new gadolinium-enhancing MRI lesion) from week 8 and before week 28 did not differ between the groups.

©solitude72/iStockphoto

During a 28-week extension phase in which the groups switched treatments, patients who switched from abatacept to placebo had a greater number of gadolinium-enhancing lesions than did those who switched from placebo to abatacept (1.25 vs. 0.60, respectively), but the difference was not statistically significant.

Abatacept, which is approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis, is a CTLA4 immunoglobulin fusion protein that inhibits the activation of T lymphocytes by targeting the adaptive arm of the immune system by blocking the CD28-B7 costimulatory pathway. It was thought to have potential to reduce immune-mediated disease activity in relapsing-remitting multiple sclerosis because T lymphocytes have been implicated in its pathogenesis.

The investigators closed enrollment for the trial early because of slow accrual. The 65 total patients who enrolled in the trial were about half of the number designated in the trial design (n = 123) in order to demonstrate a treatment effect of 50% reduction of new gadolinium-enhancing MRI lesions.

The number of participants “was too small to demonstrate efficacy at the 50% level,” the investigators wrote, and “low numbers of new gadolinium-enhancing MRI lesions in the study population reduced the chances of demonstrating a treatment effect for abatacept.”

A prior phase II trial of abatacept that was stopped early due to safety events yielded inconclusive results because of an imbalance in the baseline disease activity of participants.

Read the full report online in Multiple Sclerosis Journal (Mult Scler J. 2016 Aug 1. doi: 10.1177/1352458516662727).

[email protected]

Results from the double-blind, randomized, placebo-controlled phase II ACCLAIM study indicate that abatacept has no effect on reducing the number of new gadolinium-enhancing lesions on MRI in patients with relapsing-remitting multiple sclerosis, according to Samia J. Khoury, MD, of Brigham and Women’s Hospital, Boston, and her colleagues from the Immune Tolerance Network.

In the ACCLAIM (A Cooperative Clinical Study of Abatacept in Multiple Sclerosis) study, 42 patients who received abatacept (Orencia) developed a mean of 0.43 new gadolinium-enhancing lesions by week 24, compared with 1.66 for 20 placebo-treated patients (P = .87). None of the secondary MRI endpoints (lesion volume change and percent brain volume change) and clinical endpoints (changes in Multiple Sclerosis Functional Composite score, Expanded Disability Status Scale [EDSS], and annualized relapse rate) at 24 weeks differed significantly between the groups. The rate of patients who met criteria for no evidence of disease activity or its components (no EDSS progression, no clinical exacerbations, and no new gadolinium-enhancing MRI lesion) from week 8 and before week 28 did not differ between the groups.

©solitude72/iStockphoto

During a 28-week extension phase in which the groups switched treatments, patients who switched from abatacept to placebo had a greater number of gadolinium-enhancing lesions than did those who switched from placebo to abatacept (1.25 vs. 0.60, respectively), but the difference was not statistically significant.

Abatacept, which is approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis, is a CTLA4 immunoglobulin fusion protein that inhibits the activation of T lymphocytes by targeting the adaptive arm of the immune system by blocking the CD28-B7 costimulatory pathway. It was thought to have potential to reduce immune-mediated disease activity in relapsing-remitting multiple sclerosis because T lymphocytes have been implicated in its pathogenesis.

The investigators closed enrollment for the trial early because of slow accrual. The 65 total patients who enrolled in the trial were about half of the number designated in the trial design (n = 123) in order to demonstrate a treatment effect of 50% reduction of new gadolinium-enhancing MRI lesions.

The number of participants “was too small to demonstrate efficacy at the 50% level,” the investigators wrote, and “low numbers of new gadolinium-enhancing MRI lesions in the study population reduced the chances of demonstrating a treatment effect for abatacept.”

A prior phase II trial of abatacept that was stopped early due to safety events yielded inconclusive results because of an imbalance in the baseline disease activity of participants.

Read the full report online in Multiple Sclerosis Journal (Mult Scler J. 2016 Aug 1. doi: 10.1177/1352458516662727).

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Results from the double-blind, randomized, placebo-controlled phase II ACCLAIM study indicate that abatacept has no effect on reducing the number of new gadolinium-enhancing lesions on MRI in patients with relapsing-remitting multiple sclerosis, according to Samia J. Khoury, MD, of Brigham and Women’s Hospital, Boston, and her colleagues from the Immune Tolerance Network.

In the ACCLAIM (A Cooperative Clinical Study of Abatacept in Multiple Sclerosis) study, 42 patients who received abatacept (Orencia) developed a mean of 0.43 new gadolinium-enhancing lesions by week 24, compared with 1.66 for 20 placebo-treated patients (P = .87). None of the secondary MRI endpoints (lesion volume change and percent brain volume change) and clinical endpoints (changes in Multiple Sclerosis Functional Composite score, Expanded Disability Status Scale [EDSS], and annualized relapse rate) at 24 weeks differed significantly between the groups. The rate of patients who met criteria for no evidence of disease activity or its components (no EDSS progression, no clinical exacerbations, and no new gadolinium-enhancing MRI lesion) from week 8 and before week 28 did not differ between the groups.

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During a 28-week extension phase in which the groups switched treatments, patients who switched from abatacept to placebo had a greater number of gadolinium-enhancing lesions than did those who switched from placebo to abatacept (1.25 vs. 0.60, respectively), but the difference was not statistically significant.

Abatacept, which is approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis, is a CTLA4 immunoglobulin fusion protein that inhibits the activation of T lymphocytes by targeting the adaptive arm of the immune system by blocking the CD28-B7 costimulatory pathway. It was thought to have potential to reduce immune-mediated disease activity in relapsing-remitting multiple sclerosis because T lymphocytes have been implicated in its pathogenesis.

The investigators closed enrollment for the trial early because of slow accrual. The 65 total patients who enrolled in the trial were about half of the number designated in the trial design (n = 123) in order to demonstrate a treatment effect of 50% reduction of new gadolinium-enhancing MRI lesions.

The number of participants “was too small to demonstrate efficacy at the 50% level,” the investigators wrote, and “low numbers of new gadolinium-enhancing MRI lesions in the study population reduced the chances of demonstrating a treatment effect for abatacept.”

A prior phase II trial of abatacept that was stopped early due to safety events yielded inconclusive results because of an imbalance in the baseline disease activity of participants.

Read the full report online in Multiple Sclerosis Journal (Mult Scler J. 2016 Aug 1. doi: 10.1177/1352458516662727).

[email protected]